23 May, 2009
New Fax Campaign to Stop The MOTHERS Act
http://tinyurl.com/newfaxstopMA
Please go to http://www.box.net/shared/810kj0b8g7 and print a PDF that you can fax to the Senate: http://tinyurl.com/HELPSenate
Here is the text of the fax if you want to format your own letter:
WHY THE MOTHERS ACT SHOULD NOT BE PASSED
On the surface, The MOTHERS Act (S. 324) reflects its sponsors’ compassion for mothers suffering from postpartum depression and psychosis. But when one looks closely at the important sections of the legislation, it is clear that this costly and sweeping mental health legislation not only fails the mothers of America, it’s intended to inflate the balance sheets of Big Pharma.
- The bill omits language clearly stating there will be an evaluation of the large amount of data available on the known risks of antidepressant and antipsychotic medications currently being prescribed to pregnant women and nursing mothers (including birth defects, heart defects, spontaneous abortions, and infant deaths). See May 9, 2009 Vogue article, “Pregnant Pause: With a flurry of recent reports challenging the safety of antidepressant drugs for unborn babies, doctors and concerned mothers-to-be are rethinking the guidelines” by Alexis Jetter athttp://www.box.net/shared/deulxo16fp
- The bill defines ‘postpartum condition’ as only ‘postpartum depression (PPD) or postpartum psychosis.’ The danger is that per these DSM-extracted terms to label women with mental disorders, this is onlypsychological, not physiological conditions which will be checked for, ruling out discovery of any real physical causes, such as hormonal imbalances or vitamin and mineral deficiencies, and neglecting the treatments thereof. This relates to the issue of “screening tools” in development cited in the bill. Are these merely psychological questionnaires, and who is developing them? Are they pharmaceutically funded?
- The bill cites various “entities” that will be eligible for grants and for participating in research and/or development of screening methods and/or treatments and delivery. Who or what are these “entities?” Are they pharmaceutically funded? Do they have conflicts of interest? There are ongoing investigations of various “non-profit” organizations who heavily promote or conduct screening. For example, Screening for Mental Health, Inc., and its sub-organization Signs of Suicide, who heavily promote and conduct mental health screening, received $4,985,925 from pharmaceutical companies prior to 2008. The National Alliance for the Mentally Ill (NAMI) receives 56% of its funding from pharmaceutical companies. Ten leading psychiatric researchers (many from prominent universities) have been exposed in the last year for failing to disclose millions of dollars in pharmaceutical payments – yet this bill contains no provisions for full disclosure of conflicts of interest for any “entity” receiving federal taxpayer funded grants.
- Given that the Senate Finance Committee recently exposed the financial conflicts of interest of the top ten psychiatric researchers in the U.S., it is no small issue that The MOTHERS Act provides no research guidelines for public disclosure.
- Under The MOTHERS Act’s current language, research will be conducted without peer review – no checks and balances, no one to validate the integrity of the research which then will be used to determine a woman’s mental health status.
- Simultaneously, without allowing any checks and balances whatsoever on the research, it promotes a national “public education” campaign to include Public Service Announcements and television and radio advertisements, essentially giving Pharma an opportunity for free, federally-funded advertising.
SUMMARY: Without a fully completed, published, and publicly disclosed investigation of the dangers of current methods of treatment (drugs), efficacy of non-drug treatments, and discovery and disclosure of the causes for these conditions, clearly defined and available for review by the medical/scientific community and consumers, there should be no endorsement of a national educational or advertising campaign. There must be no new or massive utilization or promotion of any “screening tools” without first disclosing the researchers, entities, and methods used to develop these “screening tools.”
Therefore, as a concerned citizen and voter, I urge you to vote “NO” on The MOTHERS Act (S. 324).
Sincerely, Address:
Stress Testing The MOTHERS Act
by Kelly Patricia O’Meara
May 7, 2009
It seems these days that everything is a test. Yes, the powers that be have decided that taxpayer benevolence now is contingent upon passing a stress test. But much to the dismay of those being tested, the results may reveal, for example, that the nation’s financial wizards and auto giants are actually bankrupt midgets and unworthy of America’s support.
Given that officialdom has embraced the stress test as a barometer of future viability and success and a determinant for public financing, it seems reasonable to request that other important issues that very personally impact the health and welfare of the American people be subjected to similar stress tests. There is none more deserving of stress testing than the proposed MOTHERS Act.
On the surface, the MOTHERS Act reflects its sponsors overwhelming compassion and empathy for women suffering from alleged mental health disorders resulting from childbirth – often referred to as Postpartum Depression. But when one conducts a brief stress test on important sections of the legislation, taxpayers may find that this costly and sweeping mental health legislation actually fails women of America, but goes a long way in inflating the balance sheets of one of the most lucrative industries in the nation – big Pharma.
For instance, the MOTHERS Act legislation that currently is pending in the U.S. Senate states that the Secretary of Health and Human Services may “make grants to eligible entities…” to deliver essential services to individuals with a postpartum condition. What the legislation doesn’t delineate is who and what entities may receive these grants. Are these “entities” funded by pharmaceutical companies? Lawmakers have not specified what constitutes an “entity” so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing.
Furthermore, no research guidelines have been provided for public disclosure. This is no small issue, given that the Senate Finance Committee recently exposed the conflicts of interest of the top ten psychiatric researchers in the U.S. who had received millions of dollars in pharmaceutical funding. Where is the guarantee that the “entities” are not pharmaceutical front-men?
The legislation also allows for the “expansion and intensification of activities” into the research of Postpartum conditions and “evaluation of new treatments.” This is a humdinger. Despite ever-increasing published data and clinical studies challenging the safety of antidepressants and other antipsychotic drugs, there is no guidance provided by lawmakers to mandate that the public be made aware of the avalanche of scientific data that not only questions the efficacy of the drugs available to mothers suffering from these conditions, but also warning of the dangers associated with currently available “treatments.”
The section of the legislation dealing with expanding the research into the causes of Postpartum conditions is wholly void of any guidelines that insure the validity of the research conducted, and provides nothing in the way of public disclosure or peer-review of research before it is launched in education campaigns. In the real world, research is conducted and submitted for peer review. In this instance, it appears that Congress has learned nothing from the ongoing banking debacle and naively believes that the researchers will be on their best behavior – self-policing themselves. This is a dangerous omission in the legislation, especially since the Senate Finance Committee has exposed the serious conflicts of interest that exist between researchers and pharmaceutical companies.
Making matters worse, much of the legislation revolves around funding national education campaigns about Postpartum Depression, including Public Service Announcements and television and radio advertisements. Based on the current language of the legislation, research will be conducted without peer review – no checks and balances; no one to validate the integrity of the research which then will be used to determine a woman’s mental health status. Given that this research will be used to develop questions or tests for screening new mothers for possible mental disorders, one might find it important to know that the research has integrity and has been validated by the scientific community, free of pharmaceutical largesse. Congress apparently didn’t think integrity of the research is important and there are no provisions to protect women from pharmaceutical driven research.
Taxpayers may also expect that such important legislation would make provisions for some kind of oversight; some government entity that could provide feedback on the success or failure of this mental health campaign. One avenue that may help lawmakers’ determine if these new programs are working is the Food and Drug Administration’s MedWatch Adverse Event Reports. MedWatch collects information about people who have experienced adverse reactions to drugs overseen by the FDA. With the increased drugging that most certainly will occur with the increase in diagnosing, it seems logical that lawmakers would insert provisions in the legislation to annually review Adverse Event Reports collected by MedWatch, especially those relating to drugs prescribed in the treatment of Postpartum Depression. Unfortunately, because the nation’s lawmakers have provided no provisions for oversight, countless numbers of women may be harmed by the “treatments” but will be none the wiser because no protections were provided in the legislation.
There also is the very basic question of why the government is endorsing this sweeping mental health legislation and sanctioning a national advertising campaign about Postpartum Depression when there is no definitive data about the cause of the condition or that it is an objective confirmable abnormality – the scientific standard for disease. Given that there are so many unknowns in this legislation, it seems irresponsible to go forward without reasonable protections in place.
Congress must insure that all research and screening tests proposed and endorsed by this legislation be disclosed for peer-review and consumer input before implementing any screening tests and approving any research to be used in the national education campaign, including Public Service Announcements and radio and television advertising.
Given the documented risks related to the current modes of treatments, including antidepressant and antipsychotics, which are commonly prescribed for Postpartum Depression and documented to cause birth defects and host of other issues in pregnant and nursing mothers, Congress must include mandatory reviews of published research and clinical data on the drugs prescribed for the treatment of Postpartum Depression.
Finally, Congress must protect the integrity of the research by providing strict guidelines to insure that there are no conflicts of interest between the researcher and the pharmaceutical industry.
Without these safeguards, the MOTHERS Act cannot today, or ever, pass a stress test of viability and mothers and their children certainly will be on the losing end of this mental health campaign. Sometimes it’s in the best interest of the people for Congress NOT to act, and until our lawmakers are confident that all legislative precautions have been taken to insure optimum results, this is one of those times.
About the author:
Kelly Patricia O’Meara is an award-winning investigative journalist who authored more than two dozen articles examining the psychiatric pharmaceutical industry during her tenure at the Washington Times’ Insight Magazine. Her articles resulted in record sales of the issues in which they appeared and among the national and international press that have featured her articles are Fox News, the O’Reilly Factor, CBS News, BBC, ABC’s 20/20 and Hannity and Colmes. She is also the author of Psyched Out: How Psychiatry Sells Sickness and Pushes Pills that Kill. Prior to working as an investigative journalist, O’Meara spent sixteen years on Capitol Hill and was the lead investigator in several Congressional investigations. She holds a B.S. in Political Science from the University of Maryland.
22 Apr, 2009
URGENT - TAKE ACTION TO STOP THE MOTHERS ACT - FOUR THINGS YOU CAN DO RIGHT NOW
You can sign up for more frequent news updates by subscribing to our Yahoo Group at: http://health.groups.yahoo.com/group/chaada/
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ANNOUNCEMENT:
Dear Friends and Allies,
As you may know by now, the federal MOTHERS Act (H.R. 20) passed the
House of Representatives recently by a vote of 391-8. It is now in the
Senate and the timetable they are pushing for is to pass it and get it
signed into law by May 10th, Mother's Day.
TAKE ACTION NOW TO STOP THE MOTHERS ACT! Four things you can do right now:
1) Download, post, distribute, link, post on blogs - this video: http://tinyurl.com/IndiVid
2) Link to this article from your website or post links from this article on online websites, blogs etc.: http://tinyurl.com/StopTheMA
3) Write or fax your member of Congress:
#####
1) Calls for the development of improved
"screening and diagnostic techniques" with no specification if
these are to be strictly psychological (in other words, questionnaires based
upon a DSM checklist). So there is no credible evidence that women
will be checked for physical conditions such as thyroid conditions, hormonal
imbalances or other real physical conditions.
2) Calls for government-funded national public service announcements
(PSAs) through television, radio, and other means for "raising
awareness about screening," and for "educating new mothers
and their families about postpartum conditions to promote earlier diagnosis
and treatment." So considering postpartum depression is usually
considered a "mental" condition, this means that the government will now be
funding free psycho/pharma ads for the mental health industry.
Coincidentally - there are currently 50 clinical drug trials ongoing for
the "treatment" of postpartum depression. In other words - this could
turn into a big money maker for Pharma - with government-sanctioned PSAs and
drugs promoted to specifically "treat" postpartum depression (that are
already in the pipeline).
3) Calls for a major "education" campaign in health centers for new
mothers and, to promote "earlier diagnosis and treatment... before
new mothers leave the health facility."
What does all of this mean? It means more women put on
drugs. It means more infants subjected to drugs.
Regardless of the hype from the psycho/pharma industry and many groups with
vested interests in pushing this agenda - more screening and more drugs
being promoted to treat "postpartum" depression means more mothers on drugs
- both during and after pregnancy.
Already, doctors, pharmacists, health care providers and consumers have
filed reports with the FDA on the serious damage and deaths to infants
caused by pregnant women taking these drugs.
The graph below shows the reported adverse
reactions in pregnant mothers taking SSRI antidepressants between 2004 and
2007.
Graph on web at: Reports of Miscarriage, Birth Defects, Heart Disease, Pre-Term Births http://tinyurl.com/ActualGraph
Look at the figures. Now times them by one hundred. Because,
by the FDA's own admission, only 1-10% of the actual side effects are ever
reported to the FDA.
Graph on web at: Estimated Infant Injuries and Deaths Based on 5% Median Range Reported http://tinyurl.com/EstimatedGraph
If you ever wanted a time to step up to the plate and make a real
difference, you have it. Because the time is now.
Sincerely,
Amy Philo
CHAADA Co-Founder
"When you get into a tight
place and everything goes against you, till it seems as though you
could not hold on a minute longer, never give up then, for that is just
the place and time that the tide will turn." - Harriet Beecher Stowe
27 Jun, 2008
Mathy Downing and Senator Grassley: Drug companies spend more on bribing doctors than they do on direct to consumer ads
06 Jun, 2008
Levine: Paxil Babies & The MOTHERS Act - PPD, Antidepressants
http://www.alternet.org/story/87298/
Paxil Babies: The Dangers of Antidepressants
By Bruce E. Levine, AlterNet. Posted June 6, 2008.
Mothers suffering from depression are increasingly pushed into taking pills, at great potential risk to themselves and their infants.
Today in the United States, 11 percent of women take antidepressants, the use of antidepressants by pregnant women has dramatically increased, and postpartum depression -- rare in those cultures in which women receive high levels of social support following childbirth -- has become so staggeringly common among U.S. women that Congress is legislating increased medical treatment.
Increasing Use of Antidepressants by Pregnant Mothers
Receiving little attention in 2007 was the study "Increasing Use of Antidepressants in Pregnancy," published by the American Journal of Obstetrics and Gynecology. Medical records of 105,335 pregnant women enrolled in Tennessee Medicaid from 1999-2003 revealed that antidepressant use during pregnancy increased from 5.7 percent in 1999 to 13.4 percent in 2003.
Among Tennessee Medicaid-treated women in 2003, 10 percent took antidepressants during the first trimester, 6.4 percent used antidepressants during the second trimester, and 5.9 percent used them during the third. White women were four times more likely than nonwhite women to have used antidepressants during pregnancy, and older women and those with greater schooling were also more likely to have used antidepressants while pregnant.
In another study of pregnant women treated at seven health maintenance organizations (HMOs), American Journal of Obstetrics and Gynecology reported in February 2008 that "antidepressant use in pregnancy nearly quadrupled from 1996 to 2005" and that nearly 8 percent of pregnant women used antidepressants in 2005.
Effect of Antidepressant on Newborns
To the delight of antidepressant manufacturers, the U.S. Centers for Disease Control (CDC) recently told Americans that we need not worry about the effects of Prozac, Paxil, and Zoloft and other antidepressants on newborns. In June 2007, the CDC issued a press release stating "New Study Finds Few Risks of Birth Defects from Antidepressant Use During Pregnancy." CDC epidemiologist Jennita Reefhuis concluded, "Overall, our results are generally reassuring with respect to the use of antidepressants during pregnancy."
This CDC press release was trumpeted by many U.S. newspapers with headlines such as "Antidepressants Not Big Risk for Defects" (Associated Press) and "Reassurance on Antidepressants in Pregnancy" (The Wall Street Journal). However, the actual research findings are the opposite of reassuring.
We have all heard about "crack babies" (newborns addicted to crack cocaine because their mothers were using it during pregnancy). What about "Paxil babies"? In 2006 the Archives of Pediatric & Adolescent Medicine reported that 30 percent of infants who had prenatal exposure to antidepressants experience some withdrawal symptoms, with 13 percent of them experiencing severe ones, most notably tremors, respiratory distress, gastrointestinal problems, sleep disturbances, and high-pitched crying. Other withdrawal symptoms include rapid heart beat, irritability, feeding difficulties, and profuse sweating.
There are several other serious problems that newborns are more likely to suffer when exposed in utero to antidepressants. A 2006 U.S. Food and Drug Administration (FDA) alert stated, "A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy." In persistent pulmonary hypertension of the newborn, the newborn's arteries to the lungs are constricted, this limiting the amount of blood flow to the lungs and therefore the amount of oxygen into the bloodstream. The FDA alert also noted, "Neonatal PPHN is associated with significant morbidity and mortality."
It turns out that the CDC based its approval of antidepressant use during pregnancy on studies in which women were taking antidepressants the month before they became pregnant or in the first three months of pregnancy. But is it even in fact safe for newborns if mothers use antidepressants only in the first trimester?
Antidepressant use in first trimester, according to The New England Journal of Medicine in 2007, is associated with more than double the risk of anencephaly (birth without forebrain), omphalocele (the child's abdomen does not close properly allowing intestines and other organs to protrude outside the body), and craniosynostosis (premature closure of the connections between the bones of the skull before brain growth is complete).
The Rationale for Antidepressants for Pregnant Mothers
What then is the rationale of those medical authorities who encourage antidepressant use among depressed pregnant mothers? Their claim is that while antidepressants might present some risks, the stress of not receiving medication for depression is more risky for the newborn and mother. However, the research simply does not back up this claim.
Two major studies comparing the health of newborns from depressed mothers who took antidepressants versus newborns of depressed mothers who did not take antidepressants show that newborns are better off with mothers not taking antidepressants. In 2007 theAmerican Journal of Psychiatry reported that the preterm birth rate of antidepressant exposed newborns was 14.3 percent as compared to 0 percent for newborns of depressed mothers who did not use antidepressants; and the rate of admission to the special-care nursery is more than double for antidepressant exposed infants compared to infants of depressed mothers who did not use antidepressants. These findings echo those reported in a 2006 Archives of General Psychiatrystudy using health data from a large sample of infants in British Columbia, Canada during a 39-month period.
Moreover, there is no evidence that antidepressant use by depressed pregnant mothers lowers their likelihood of suicide, and there is a great deal of evidence that antidepressant use can make some people manic, agitated, and violent. And while millions of people swear by their antidepressants, there is increasing evidence that antidepressants do not work much better than placebos. In 2002 Prevention & Treatmentreported an analysis of forty-seven studies that had been sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone. Many of these studies had not been published but all had been submitted to the FDA, so researchers used the Freedom of Information Act to gain access to the data. They discovered that in the majority of the trials, the antidepressant failed to outperform a sugar pill placebo.
Postpartum Depression and the Mothers Act
For politicians, a much safer issue than pushing antidepressants for pregnant mothers is promoting the expansion of medical treatment for postpartum depression. In 2007 the U.S. House of Representatives overwhelmingly passed the "Melanie Blocker-Stokes Postpartum Depression Research and Care Act" and sent it to the U.S. Senate, which renamed it the Mothers Act. The stated goal of The Mothers Act, currently in committee, is to "ensure that new mothers and their families are educated about postpartum depression, screened for symptoms, provided with essential services, and to increase research at the National Institutes of Health on postpartum depression."
But will the Mothers Act merely ensure that federal dollars are used to identify more pregnant and postpartum women as depressed and then convince them that antidepressants are safe and effective? After all, while psychiatry authorities and antidepressant manufacturers admit that antidepressants used by nursing mothers do in fact enter breast milk, they maintain that antidepressant concentration in breast milk is too low to be terribly concerned about (though they do acknowledge that there are no long-term studies to confirm this).
In the "Findings" section of the Mothers Act we are told that postpartum depression is a "devastating mood disorder" and that "postpartum depression is a treatable disorder if promptly diagnosed by a trained provider." But inconvenient truths about postpartum depression are omitted. Not many in Congress would vote for legislation that stated the following: The U.S. could eliminate much of postpartum depression by transforming American values, culture, and economics.
The Mother Act states that "postpartum depression occurs in 10 to 20 percent of new mothers." It should state that postpartum depression occurs in 10 to 20 percent of American mothers. A 2004 BMJ (formerly known as the British Medical Journal) cross-cultural review reported that postpartum depression is rare in Fiji and in traditional African and Chinese populations. The BMJ authors concluded that "structured social supports after childbirth are described in groups of women with low rates of postpartum depression." Structured social supports for women after childbirth are decidedly missing from American culture.
The Mothers Act findings also neglects the 1996 British Journal of Psychiatry finding that postpartum depression is associated with unemployment of the mother (no job to return to), unemployment of the head of the household, unplanned pregnancies, and not breast-feeding.
And the Mothers Act omits relevant truths about Melanie Blocker-Stokes, the woman for whom the initial House bill was named for. Blocker-Stokes was a pharmaceutical sales manager who began suffering severe symptoms of depression after the birth of her child, and she did in fact receive extensive psychiatric treatment. She was hospitalized three times in seven weeks, given four combinations of anti-psychotic, anti-anxiety, and antidepressant medications, and underwent electroconvulsive therapy (electroshock). But despite her psychiatric treatment -- or because of it -- Melanie Blocker-Stokes jumped to her death from the twelfth floor of a Chicago hotel.
Postpartum depression could be dramatically reduced in the United States with a political will to transform American society from one that is dominated by money, productivity, and consumption to one that has vital communities which put energy into caring about the well being of new mothers -- as do cultures where postpartum depression is rare.
The rate of U.S. depression has increased more than tenfold in the last fifty years. During that same time, Americans have received increasing medical treatment for depression, especially antidepressants, which currently gross more than $13 billion annually in the U.S. Nowadays, drug companies, psychiatry officialdom, and U.S. governmental authorities recommend antidepressants even for pregnant women, and an increasing number of American newborns discover that their first worldly challenge is withdrawing from Zoloft.
When exactly will be the appropriate time to challenge mental health professional pretensions and rebel from cultural craziness?
06 Jun, 2008
Update on Petition Signatures
http://www.thepetitionsite.com/1/stop-the-dangerous-and-invasive-mothers-act
8320 signatures so far! Please share our petition!
Byron Richards (Along with many others including Dr. Gary Null, The Health Ranger Mike Adams, Dr. Rebecca Carley, Dr. Stanley Monteith, John Hammell, Genita Petralli, Dr. Fred Baughman, Dr. John Breeding, Jim Gottstein & The Law Project for Psychiatric Rights, CHAADA Member Mathy Milling Downing, Kim Witczak (www.woodymatters.com), NARPA, Julie Edgington, and too many others to list including the more than 8,000 protesters on our petition) has been working furiously to get the word out about this threat to human rights, life, and our future. The MOTHERS Act must be stopped!
But how do we help women who are going through so much with their bodies, hormones, and so many life changes? Here are a few articles by Byron Richards including explanations of why to refuse psychiatric drugs during pregnancy and breastfeeding, and how to help your body stay healthy throughout the changes of motherhood. Also see his action alert which has had well over 5,000 letters sent.
06 Jun, 2008
What REALLY Happened to Melanie Blocker Stokes, namesake of The MOTHERS Act
http://www.youtube.com/watch?v=Qble_vQEC7M
06 Jun, 2008
The MOTHERS Act: Thalidomide Revisited? PR Newswire
http://www.uniteforlife.org/thalidomide.html
http://www.cnbc.com/id/24796918/
The MOTHERS Act: Thalidomide Revisited?
by Fred A. Baughman, Jr., MD** & Amy Philo*
SAN DIEGO, May 23 /PRNewswire/ -- The Richmond (VA) Times-Dispatch reported that on Mother's Day, May 10, 1998, Sharon Alley stabbed her eight month old daughter, Brooke in the heart, killing her. Months before, Alley was prescribed Paxil, became psychotic, and threw then five-week-old Brooke to the floor, fracturing her skull.
Postpartum Support International (PSI) founder Jane Honikman told The Times-Dispatch that Americans don't understand post-partum depression (PPD) and that this "mental illness" is the reason mothers like Sharon Alley kill their children.
In 2007 the House of Representatives passed H.R. 20, "The Melanie Blocker Stokes MOTHERS Act," which mandates mental health screening for all new mothers and referral to a mental health provider for "essential services" for any mother "at risk" of PPD. The bill mandates use of the Edinburgh Postnatal Depression Scale (EPDS), shown to triple the number of women "diagnosed." Swedish researchers recently urged: "Public health authorities should not advocate screening of unproved value." (Krantz, et al, 2008)
S. 1375 / H.R. 20 "The MOTHERS Act" is named for Melanie Stokes, who committed suicide when 3 1/2 months postpartum, following "treatment" with electroshock therapy and myriad drugs, including antidepressants, anti-anxiety drugs, and antipsychotics. Melanie jumped from a 12-story hotel window in Chicago after her fourth psychiatric hospitalization. PSI claims Melanie's treatments for PPD were too little, too late.
The fundamental fact of the matter is that not a single psychiatric "diagnosis" or "disorder" is an actual disease. A disease must have a demonstrable physical abnormality, such as cancer cells on a "Pap" smear or biopsy, or high blood sugar in diabetes, or uric acid in gout. The only actual abnormality -- disease in any mother "treated" with drugs for "PPD" is the intoxication-poisoning due to ingestion of the psychiatric drug itself. This is not to say that emotional turmoil and pain do not exist -- surely they do, but they are not diseases per se, as psychiatry contends to sell drugs as the first line of treatment. In Sharon Alley's case that drug was Paxil. Without actual diseases to treat, no psychiatric drug can be called essential and justifiable for a pregnant woman where exposure of the unborn child is a certainty. Moreover, no drug can be guaranteed risk-free for either the unborn or nursing child.
On May 15, 2000, The Boston Globe reported: "Dr. Jonathan O. Cole, a Harvard psychiatrist who was one of the first to suggest that Prozac and similar antidepressants could precipitate suicide, is now criticizing drug companies and the US Food and Drug Administration, saying they are failing to take the problem seriously."
In 2005 the UK's Medicines and Healthcare Products Regulatory Authority (MHRA), banned antidepressants for those 18 and under due to their worsening the suicide risk.
On May 2, 2007, the FDA expanded the black box suicide warning on antidepressants to apply to young adults ages 18 to 24.
Despite proof that there is no benefit for any Prozac-like, SSRI, antidepressant, over placebo and that these drugs cause suicide, homicide, premature births, stillbirths, and pulmonary hypertension in newborns, they are represented to be safe and are pressed upon normal pregnant women and their unborn and nursing infants by psychiatry, the pharmaceutical industry and government, with profit the only motive. One third of pregnant women in the US already take psychiatric drugs at some point during their pregnancies and most are never warned of the known risks for themselves, their unborn and nursing babies, depriving them of their right to informed consent.
In 1960, Frances O. Kelsey of the FDA blocked an application by the Richardson-Merrell Corporation of Cincinnati to market thalidomide. Her concerns were soon borne out. Reports began appearing from Europe of the growing numbers of babies born with flipper-like limbs, with digits sprouting directly from hips and shoulders -- a condition called phocomelia. In November, 1961, Widukind Lenz, a German pediatrician, blamed thalidomide. He determined that half the mothers with deformed children had taken thalidomide in the first trimester of pregnancy. Before it was over, more than 10,000 such children in 46 countries had been born. But in the U.S., thanks to Kelsey and the FDA, thalidomide never made it to market and just 17 American children were born with thalidomide-induced phocomelia.
However, the FDA no longer protects us -- the public. They have become an arm of the pharmaceutical industry and do their bidding exclusively. They facilitate the victimization that is the psychiatric "diagnosis" and drugging of 20% of US school children and 50-75% of those in foster care. Should The MOTHERS Act be passed by the Senate, it will guarantee that more mothers-to-be, their unborn, still-developing, babies, and more nursing mothers and their nursing infants, will join the ranks of the psychiatrically drugged.
About the authors:
**Fred A. Baughman Jr., MD, Neurologist, Child Neurologist, was Director of the March of Dimes, Birth Defects Clinic of Western Michigan, 1967-1975. He has discovered and described real diseases, including chromosomal abnormalities due to thalidomide (Benda, C. E., Baughman, F. A., Jr.: Chromosomes and Thalidomide Med. Welt. 1963;34:161-66) He is author of the book: THE ADHD FRAUD -- How Psychiatry Makes "Patients" of Normal Children http://www.Trafford.com
*Amy Philo was prescribed Zoloft in 2004 to treat anxiety, following her newborn son's life-threatening choking incident. Zoloft caused her to become homicidal and suicidal, which persisted until she discontinued the drug five months later against medical advice. Amy is now a volunteer health activist and mother of two boys.
###
06 Jun, 2008
Setting "The Record" Straight on "The MOTHERS Act"
http://www.uniteforlife.org/therecordpharmacartel.pdf
FOR IMMEDIATE RELEASE
Setting “The Record” Straight on “The MOTHERS Act”
by Amy Philo
May 21, 2008
“You've thrown the worst fear
That can ever be hurled
Fear to bring children
Into the world
For threatening my baby
Unborn and unnamed
You ain't worth the blood
That runs in your veins
How much do I know
To talk out of turn
You might say that I'm young
You might say I'm unlearned
But there's one thing I know
Though I'm younger than you
Even Jesus would never
Forgive what you do”
– lyrics from “Masters of War” by Bob Dylan
Elise Young, reporter for The Record, a New Jersey paper, recently published an article on a federal bill
called The MOTHERS Act, which was so far south of balanced journalism that it would more
appropriately be categorized as an ad for the psycho/pharmaceutical industry. It certainly was not an
unbiased look at the very strong and widespread opposition to the bill based on valid criticisms. No,
this reporter was more interested in a puff piece for the Psycho/Pharma cartel complete with the
standard (and very tired old line) that the only possible opposition to a bill which would increase the
number of new mothers being put on antidepressant drugs documented by the US FDA to cause
mania, psychosis, worsening depression, suicidal and homicidal tendencies would be...that's right...
the Scientologists. For no other American would possibly be concerned that the bill was originally
named after a new mother by the name of Melanie Stokes, who after being diagnosed with
postpartum depression, put on a cocktail of psychiatric drugs, hospitalized and then electroshocked-
in other words "treated" in the mental health system -- committed suicide.
Judging from his comments in this article, US Senator Robert Menendez of New Jersey apparently
cares more about revenue for the businesses in his state than he does about the Constitution or the
citizens who will be put in danger if this bill passes the Senate (most of the world’s pharmaceutical
companies are located in New Jersey). No attention has been paid in this article to those already
harmed by the New Jersey version of this PPD law, which has been used to justify the police-forced
transport of mothers to psychiatric hospitals.
The Melanie Blocker Stokes MOTHERS Act states that PPD is treatable if attended to with
medication. It provides grants to those who will help ensure that all women considered at risk for
depression (including pregnant women) are referred to mental health care providers and in some
cases, prophylactically drugged or hospitalized.
Pharmaceutical sales manager Melanie Stokes was abused to death in 2001 by our mental health
system with four successive cocktails of prescribed antidepressant, anti-anxiety and antipsychotic
drugs as well as electroshock. Following her fourth psychiatric hospitalization since her daughter’s
birth, Melanie jumped out of a 12-story hotel window in Chicago, leaving 3 1/2 month old Sommer
motherless.
Antidepressants have been proven to be no better than a sugar pill, and they carry a black box
warning for doubling suicidal behavior and thinking. They also increase the risk of psychosis for new
moms 1000%. It is an outrage that anyone would use Melanie’s name to attempt to pass a bill that
will undoubtedly kill more women and children.
Prior to the publication of Elise Young’s piece on The MOTHERS Act, I provided her numerous
resources:
• Lists of pharma-backed groups who support the bill, and the dollar amounts they received
from pharmaceutical companies
• Medical literature on the dangers and ineffectiveness of antidepressant drugs including the
risk of death and birth defects for babies exposed to them
• Contacts for the numerous groups and victims endorsing our fight to stop this bill
Dr. Ann Blake Tracy also called Elise Young prior to publication but Young was unable to spend
long on the phone and subsequently failed to include in this piece information about her
conversation with Dr. Tracy, or any of the resources that we provided to her other than the URL for
my website.
Lies were reported as facts on the sidebar of this article, such as that medication actually improves or
eliminates symptoms- and in the piece itself were quotations from Robert Menendez misinforming
the public about drugs, lies about the bill itself, and also insulting the opposition by calling our
arguments “wrong-minded.”
The fact that Scientologists oppose psychiatric drugs does not diminish the truth about the dangers
of antidepressants. Are the FDA and the researchers published in medical journals such as the New
England Journal of Medicine part of Scientology? After all, the FDA requires black box warnings on
antidepressant labels and ads, something that was not added to this article. And the NEJM published
previously suppressed information showing that antidepressants are ineffective! The Record’s
irresponsible publishing of this article as well as their failure to allow our movement even the right to
continue commenting on the piece online are like a slap in the face to all those lost to or harmed by
these drugs. I wonder whether the paper’s management have any journalistic integrity at all.
In 2004 I was prescribed Zoloft when only six days postpartum, for anxiety after my firstborn son
Isaac nearly died from choking at the age of three days. Instead of being helped by Zoloft, I was
plagued by constant drug-induced homicidal thoughts toward my baby beginning with a hallucination
of throwing him down the stairs. I loved Isaac so much that I would have rather sacrificed my own
life than live another day fearing I might hurt him. This was why I initially went to the ER after three
days on Zoloft, because I thought perhaps they could help me, and Isaac would not have to grow up
without a mother.
Instead I became an involuntary patient in the psychiatric ward for two days where I was forced to
continue Zoloft and nearly given a host of other drugs. By the end of my time on Zoloft five months
later I would constantly imagine murdering my cats, mom, husband, neighbors, baby, and then
committing suicide to finish it all. I eventually went against medical advice and tapered off the drug,
which resulted in my return to normal and saved me and my family from continuing pain and fear.
Doctors did not recognize that any of my problems were caused by Zoloft and their only
recommendation was to not have more children or stay on drugs indefinitely. My second son Toby
would never have been born if I had listened to their advice.
Toby and Isaac are worth every hour I spend fighting, and I hope and pray that when my children
grow up, they will not have to go to outrageous lengths to protect their families from bull like the
ridiculous excuses for medical care that I received, or from the outrageous human rights violations
and attempts to murder millions of innocents that we see from the sugar-coated MOTHERS Act and
its deceptive salespeople.
###
(original article at http://www.northjersey.com/news/nationalpolitics/18963399.html)
06 Jun, 2008
(PHARMA $$$$$$$$ BACKED LAW) Insanity in Law and Medicine: The MOTHERS Act - From Permissiveness To Force
http://www.uniteforlife.org/May6Press.pdf
May 6, 2008
Insanity In Law And “Medicine”… S. 1375 “The MOTHERS Act": From
Permissiveness to Force by Amy Philo, Zoloft Survivor; Website: www.uniteforlife.org
Contact: 817-793-8028 (cell), 214-705-0169 (home) email: amy@uniteforlife.org
In 2006, a newborn baby was taken from a family in Washington by CPS after reports that the mother gave birth at
home. The mother was ordered to take antidepressants and subsequently ordered not to breastfeed. Eventually the
family was able to get the baby girl back, and they fled the state. http://www.thecowgoddess.com/2006/07/05/
Another case of excessive state interference: A Novermber 10, 2007 blog entry discusses a case of a Nebraska family
whose child was taken by DCFS because the family refused a routine newborn screening test.
http://clarateaches.blogspot.com/2007_11_01_archive.html
A recent article in the New Jersey Star Ledger discussed the cases of two women who were escorted by social workers
and police to hospitals for psychiatric treatment after mentioning that they were depressed. Many New Jersey doctors
now fear they will have to hospitalize women indefinitely during cases of PPD. Certainly the pressure to treat with
drugs is greater now than it was prior to the state’s new PPD law. http://www.uniteforlife.org/ppdcriminals.htm
Sadly, one third of US women are already taking psychiatric drugs at some point during their pregnancies, according
to the ACOG. Fifty percent of pregnant women are never warned that there are risks for their babies when they take
antidepressants during pregnancy. There is a concerted campaign by groups who receive pharmaceutical funding to
promote the idea that the risks for unborn babies or nurslings is outweighed by the benefit the mother will receive
from taking a drug. However, as many have known for decades, this “benefit” scenario is impossible because high
serotonin causes severe mental and physical problems. (see: http://www.babywhys.org/serotonin%20syndrome.htm,
http://www.drugawareness.org/Ribbon/SSRIMeds.html, http://www.uniteforlife.org/#prenatal)
Whether it is the foster care system drugging the young and vulnerable, or PhRMA convincing the breastfeeding
community and OBGYNs that psychiatric drugs are safe for nursing and pregnant women, the evidence that these
drugs are ineffective makes any and every excuse offered about so-called disorders irrelevant. The very significant risk
of death to the unborn, newborn, and young innocents in our society – either from the toxic effects, or violence
induced by the drugs, is a risk we must not accept.
Dr. Erick Turner recently published the FDA-reviewed studies that drug companies suppressed for decades, and
combined them with the published data. This report proves that there is no benefit whatsoever to taking
antidepressants. (http://www.uniteforlife.org/plosnobenefits.htm, http://www.uniteforlife.org/doctorletter.htm,
http://www.uniteforlife.org/suppresseddata.htm)
Another study completed in Sweden proves that 80% of suicides committed by adults were linked to the use of
psychiatric drugs, particularly antidepressants and antipsychotics.
(http://ps.psychiatryonline.org/cgi/content/full/59/1/116-a,
http://www.transworldnews.com/NewsStory.aspx?id=33878&cat=10)
Despite the fact that there is no benefit over placebo for any antidepressant, many continue to push for expansion of
the market in the childbearing population. A nation of people getting legally high on drugs with similar action to
cocaine, LSD, PCP and methamphetamines is the only kind of climate that could ever support all of the insane
policies being promoted and enacted.
http://www.babywhys.org/serotonin%20syndrome.htm#drugsaffectingserotonin
The New Jersey law mentioned earlier is about to become the law of our land if we do not join forces and protest
vigorously to stop that from occurring. A tremendous amount of drug company money has been donated to many
groups who support proposed legislation called “The MOTHERS Act.” The MOTHERS Act (H.R. 20 / S. 1375)
passed in the House in October by a two-thirds majority and is currently in the Senate HELP Committee. S. 1375 will
institute universal screening of new mothers and require that any mother considered at risk for or showing warning
signs of depression or psychosis be referred to a mental health care provider and given “essential services.” The bill
treats “medication” as essential. It defines PPD as beginning any time in pregnancy. The MOTHERS Act provides
grants for nonprofit groups and others who will ensure compliance with the law. It will also divert tax dollars to the
development of new drugs and experimentation on minorities. This devotion to more research is ironic considering
that Eli Lilly has a derivative of Prozac sitting on its shelf which is considered safer than Prozac, less likely than
Prozac to induce suicide and self-harm, according to the patent application. They chose not to market this drug. The
MOTHERS Act also requires the use of the Edinburgh Postnatal Depression Scale (EPDS) to screen mothers. The
EPDS has been shown to triple the number of women “diagnosed” with PPD. Swedish scientists recently warned that
the EPDS is a completely unethical screening tool and should not be used at all.
Many women who use psychiatric drugs after being tagged by bogus screenings and frightened into compliance will
become homicidal or suicidal as a result of taking these drugs (the FDA warns that antidepressants double the rate of
suicidal behavior), and this could lead to forced hospitalization or involvement from CPS. It is not unlikely that
children removed from their homes under these circumstances will subsequently be drugged.
There are many groups pushing for the bill who stand to benefit financially if it does pass. These groups promote the
bill in spite of all of the known risks and the lack of any benefit to mothers. Massachusetts General Hospital (MGH)
conducted a massive year-long psychiatry symposium in 2007, which included 150,000 participants. For this they
received $825,000 from Eli Lilly for the first quarter of 2007 alone. The MGH website contains articles promoting
antidepressants and antipsychotic drugs to pregnant and breastfeeding women, a recent blog entry claiming that there
is no risk of heart defects for babies exposed to Paxil in pregnancy, and a request for people to sign a “petition”
supporting The MOTHERS Act. Despite this Paxil and heart defects “study,” the reality is that SSRIs and other
antidepressants are behind thousands upon thousands of cases of infant death via spontaneous abortion, stillbirth,
birth defects, preterm births, SIDS, homicide, and more. The FDA MedWatch Database lists the drugs suspected of
causing Transposition of the Great Arteries – a rare heart defect. Paxil is listed in approximately 66% of cases, and the
remaining cases are heavily linked with other SSRIs and serotonergic drugs. If there really were a low absolute risk of
a baby being born with a cardiac defect after Paxil exposure, then it would probably only be due to the fact that the
rates of spontaneous abortion and stillbirth are doubled with SSRIs, while preterm births are five times more likely.
http://www.uniteforlife.org/abortions.htm
Other drug company funded groups pushing to pass The MOTHERS Act include (this is by no means a full list):
• American Psychiatric Association - $412,331 received from Eli Lilly alone for the first quarter of 2007
• The March of Dimes - $7,500 received from Eli Lilly alone for the first quarter of 2007
• Mental Health America - $94,000 received from Eli Lilly alone for the first quarter of 2007 ($2500 for a
Legislative Education Day)
• Suicide Prevention Action Network USA - $10,000 from Eli Lilly alone for the first quarter of 2007
• National Alliance on Mental Illness (NAMI) - $544,500 from Eli Lilly alone for the first quarter of 2007
• The Depression and Bipolar Support Alliance – receives more than 50% of their overall funding from
pharmaceutical companies
Tragically, the bill is also promoted in honor of a pharmaceutical sales manager named Melanie Stokes, who
committed suicide, leaving her 3 1/2-month-old daughter motherless. Melanie was abused with electroshock and four
separate cocktails of different brands of antidepressants, anti-anxiety, and antipsychotic drugs. The antidepressant
drugs Melanie took increase the risk of PPP 1000%. She was put through numerous drug and dose changes prior to
her death. The FDA also warns that dose changes of psychiatric drugs lead to suicide and psychosis. Despite
Melanie’s use of antipsychotic drugs, proponents of the bill also claim that Melanie was not promptly treated for post-
partum psychosis.
To learn more about The MOTHERS Act, as well as homicidal and suicidal urges caused by the drugs, and about the
suffering of babies and children who are exposed in pregnancy and through nursing, please visit www.uniteforlife.org
and watch our playlist on YouTube at: http://www.youtube.com/view_play_list?p=366E5CDDFC2C4E04
Additional resources for preventing and treating PPD safely:
http://www.uniteforlife.org/MOTHERpress.htm#prevention
Please share our petition against The MOTHERS Act with others: http://www.thepetitionsite.com/1/stop-the-
dangerous-and-invasive-mothers-act
06 Jun, 2008
Preventable Infant Deaths and Abortion Rights Groups Pushing for MORE of them?
http://www.uniteforlife.org/paxilinfantdeaths.pdf
Some of the sponsors of the MOTHERS Act include abortion rights groups. While they certainly have every right to sponsor whatever legislation they want, this seems utterly inappropriate. Under what possible pretext would an abortion rights group want to have anything to do with a PPD law? This is completely ridiculous in light of the fact that antidepressants actually cause spontaneous abortions, stillbirths, and neonatal deaths. Visit the link above to learn more.
25 Feb, 2008
URGENT - UPDATE - SIGN THE PETITION TONIGHT
This is an update, we have a few hundred signatures but we can use more! I would love to see EVERY CHAADA member sign the petition!! If you wish, you can uncheck the box that says "It's ok to list my name" and your name will show up as "Anonymous" with your state.
I am faxing this to Senator Kennedy Tomorrow! The HELP Committee is considering this on Wednesday, Feb. 27! Please sign the petition!
If you want you can also share my video with others. I just made it today, and it tells my personal story as just one example of why the MOTHERS Act MUST be stopped.
The link for the youtube video is: http://www.youtube.com/watch?v=LQW23XCmOCw
The link for the petition is: http://www.thepetitionsite.com/1/stop-the-dangerous-and-invasive-mothers-act
The link for the contact information for all 21 senators on the Committee is: http://www.uniteforlife.org/mothersactupdate.htm#contact
When you call Clinton's office, tell them that this will determine how you vote in the upcoming primary. She is on the HELP Committee and has not yet taken an official position on this bill. Hillary's campaign office phone number is 703-469-2008.
Ask her to stand up to Obama and defeat it!
When you call Obama, ask him to WITHDRAW his support for the bill. Tell him you are aware that he knows about Paxil birth defects, and ask that he consider ALL mothers and STOP supporting this, and tell him your reasons:
Drugs pose a serious threat to moms and babies - FDA-confirmed doubling of suicide on antidepressants as well as "homicidal ideation" on many labels (such as Effexor which Andrea Yates was taking)
Drugs can kill unborn children (stillbirth, miscarriage, preterm birth, neonatal death, SIDS) and newborns or cause them to have serious defects like heart problems and PPHN which can be fatal. The rate is at least doubled if not higher on many drugs.
The government should never fund the development of a new antidepressant - that is pharma's job!
This is an invasion of privacy and if it's anything like Teen Screen (with 90% of subjects getting a psychiatric drug prescription) we are in for a huge disaster.
If you want to take a look at the studies, please read the press release and the links in the addendum at http://www.uniteforlife.org/MOTHERpress.htm
YOUR VOICE MATTERS!!! LET IT BE HEARD!!! OUR FUTURE IS AT STAKE LIKE NEVER BEFORE!!!
SAVE OUR CHILDREN!!! SAVE OUR MOMS!!!
15 Feb, 2008
PLEASE HELP US GET 1,000,000 SIGNATURES!!!
UPDATE: The senate is on break this week, the markup committee meeting could take place as early as next week. It is extremely important that we sign the petition, forward it, and also those who can, please go get the press release and send it around to any media contacts you have as well as the 21 senators on the HELP committee. If this bill passes through to the Senate and gets approved, we will have a dire situation on our hands!!!
http://www.thepetitionsite.com/1/stop-the-dangerous-and-invasive-mothers-act
PLEASE HELP ME GET AT LEAST A MILLION SIGNATURES TO SAVE MILLIONS OF LIVES FROM GOVERNMENT SCREENING AND GOVERNMENT-ENDORSED DANGEROUS ANTIDEPRESSANT DRUGS WHICH ARE GOING TO BE PUSHED ON NEW AND PREGNANT MOMS IF THE BILL PASSES.
PLEASE FORWARD THIS TO EVERYONE YOU KNOW.
http://www.thepetitionsite.com/1/stop-the-dangerous-and-invasive-mothers-act
THIS IS EXTREMELY URGENT AND EXTRAORDINARILY CRUCIAL FOR THE SAFETY OF OUR COUNTRY
Sincerely,
Amy Philo
URGENT! Sign the petition against the MOTHERS Act at http://www.thepetitionsite.com/1/stop-the-dangerous-and-invasive-mothers-act
STOP THE MOTHERS Act - A nationwide screening program for psychiatric disorders which encourages drugs to pregnant and postpartum women
URGENT - VISIT http://uniteforlife.org/MOTHERpress.htm and call the HELP Committee and HELP Committee Chair Senator Edward Kennedy TODAY! OBAMA is a cosponsor.
SAVE REBECCA MERHAV: http://uniteforlife.org/help%20rebecca%20now.htm
You have nothing to lose, but her life is in danger! Send a letter today and help Save Rebecca!
Also share these youtube videos to invite others to get involved:
"PROTEST to Free Rebecca Merhav" at http://www.youtube.com/watch?v=uuFFfm3N3Nc
"Borrowed Time" at http://www.youtube.com/watch?v=ozqWGQko8u8
12 Feb, 2008
URGENT - Details on Stopping the MOTHERS Act
http://uniteforlife.org/MOTHERpress.htm
Please visit the UNITE yahoo group to post any updates to the database about places you have faxed / emailed / called and responses you got! The URL is http://health.groups.yahoo.com/group/uniteforlife/
The link with contact information for the Senate Committee Members is http://uniteforlife.org/mothersactupdate.htm#contact or you can email amy@uniteforlife.org
Click here to download a word version of the file appropriate for faxing! (I made it in word for mac so depending on what program you use to open it, you may need to edit it a little bit to get rid of a few mysterious symbols and fix some of the spacing. It looks weird in Word Pad for Windows but may look fine in Word.)
See the url http://uniteforlife.org/MOTHERpress.htm near the bottom for more information.
UNITE / CHAADA / ICFDA / COPES Foundation Objection to the Proposed MOTHERS Act - Bill before Senate Puts Young Children and Mothers in Serious Danger
February 11, 2008
Contacts:
Amy Philo
amy@uniteforlife.org
214-705-0169 home, 817-793-8028 cell
www.chaada.org www.uniteforlife.org
Dr. Ann Blake Tracy, Executive Director of the ICFDA
http://www.drugawareness.org/home.html
atracyphd1@aol.com, 800-280-0730 direct
Camille Milke sarinasvoice@aol.com
505-269-2286 direct or 505-213-0999 fax (USA numbers)
www.copesfoundation.com, http://www.drugawareness.org/home.html
To the HELP Committee of the United States Senate:
For years, the March of Dimes has warned not to use meds while pregnant. Why now encourage mothers to take drugs?
Please register this extreme objection to the proposed MOTHERS Act (S. 1375) which is now before you in committee. It is my earnest hope that you will immediately defeat this bill in committee. The bill has been brought to you under the guise of ensuring safety or support for new mothers- however, nothing could be further from the truth.
The bill was originally proposed in response to the death by suicide of Melanie Stokes, a pharmaceutical rep. who took her own life by leaping from a balcony several stories off of the ground. Contrary to popular understanding it was not post-partum depression that killed Melanie, but the numerous antidepressant drugs she was taking, which the FDA confirmed doubles the suicide risk.
Nobody is suggesting that new moms do not ever experience mood swings, depression, or even psychotic episodes. The more important issue is what the effect of this bill will be and why nobody is addressing potential methods of prevention. Everyone knows how many young moms experience gestational diabetes, but who is addressing the even higher rate of gestational hypoglycemia, which often initially manifests as depression? This is a physical condition that is treated with diet and is exacerbated by antidepressants (which list hypoglycemia as a side effect).
To simply screen women for post-partum mood disorders and ensure that they get "treatment," we would be setting families up for the expectation of tragedy and increasing the chances of that actually happening when we refer them to medical "professionals" who are oblivious to the negative mind-altering effects of psychiatric drugs. A popular opinion among medical caregivers these days is that "post-partum mood disorders" must be a sign of an underlying biochemical imbalance and would be corrected with drugs.
Current drugs used on post-partum women include SSRIs, atypical antidepressants, and even antipsychotic drugs. These pose a significant risk to the immediate safety and health of women as well as their children and families. SSRIs carry a black box warning for suicide and the most popular one, Effexor (the same med. Andrea Yates was taking when she drowned her 5 children), has the words “homicidal ideation” listed as a side effect. Nearly every recent case of infanticide which has made news can be clearly linked back to a psychiatric drug. These drugs endanger babies and mothers.
Additionally, the drugs can be extremely addictive and also pose a risk to nurslings or babies exposed in subsequent pregnancies. Some babies have died from SIDS linked to exposure from pregnancy or nursing; others have experienced coma, seizures, GI bleeding, heart defects, lung problems, and many babies died before reaching full term or soon after birth.
The bill does not address the fact that studies show that biological agents (antidepressants for example) cited in the bill and already prescribed to pregnant women can cause congenital heart birth defects where children have had to undergo open-heart surgeries to correct this. Also, some babies are being born with organs outside their bodies, requiring immediate surgery.
In closing I want to re-emphasize the total lack of any real answer to post-partum depression posed by this bill. If we can prevent post-partum depression or support moms through it, or offer proven SAFE and EFFECTIVE natural alternatives to dangerous drugs, then we should. However we should never, ever become party to a pharmaceutical campaign to push drugs on the public. We will set ourselves up for disaster if we allow an invasion into the privacy of every family in the country and suggest to our most vulnerable citizens that they might be mentally ill.
We must do everything in our power to protect innocent children, and giving their mothers addictive drugs which pose a significant risk of causing suicide and violence does not protect anyone. It does cause the child to become addicted while still in the womb and sets up drug dependence which can be lifelong.
We still have no idea what effect most drugs have on developing brains. It might take decades for the impact on the developing brain to become apparent.
For information on the research pertaining to the risks of antidepressants and other treatments for new moms and their babies, details about the Melanie Stokes case (or you can read the letter by Dr. Ann Blake Tracy at http://uniteforlife.org/MOTHERSact.htm#drtracymothersact), as well as information on prevention strategies and safe, effective treatments for post-partum mood disorders, please contact us.
Sincerely,
Amy Philo
Founder, www.uniteforlife.org
Co-Founder, www.chaada.org
Camille Milke
Founder, www.copesfoundation.com
New Mexico State Director of the ICFDA (http://www.drugawareness.org/home.html)
Mother of a victim of psychiatric drug-induced suicide and grandmother to a now motherless child
Dr. Ann Blake Tracy
Executive Director of the ICFDA
http://www.drugawareness.org/home.html
Author of Prozac: Pancaea or Pandora? Our Serotonin Nightmare
=========================
Addendum
(available online: http://www.uniteforlife.org/MOTHERpress.htm)
Prevention and Alternatives Information from UNITE (www.uniteforlife.org):
I. Danger of drugs
A. Inducing suicide and homicide
http://uniteforlife.org/SSRIs%20and%20Suicide.html
http://www.drugawareness.org/home.html
www.ssristories.com
www.breggin.com
www.healyprozac.com
http://www.fda.gov/cder/drug/antidepressants/default.htm
http://www.fda.gov/cder/warn/2007/Effexor_XRPromo.pdf
http://www.fda.gov/ohrms/dockets/dockets/04n0330/04N-0330-EC16.html
http://www.fda.gov/ohrms/dockets/ac/04/slides/2004-4065OPH1_04_Bostock_files/frame.htm#slide0012.htm,
B. Addiction, subsequent pregnancies threatened, nurslings threatened: http://uniteforlife.org/breastfeeding.html http://uniteforlife.org/antidepressants%20in%20pregnancy%20articles.html http://uniteforlife.org/developing%20brains.htm
http://uniteforlife.org/health%20risks%20ssris.html
http://www.fda.gov/medwatch/SAFETY/2005/Paxil_DHCP%20Letter_Dec%202005.pdfhttp://www.fda.gov/medwaTCH/SAFETY/2002/Zoloft_USPI_rev4.pdf (See pages 17-18, Pregnancy paragraph - which states that an increase in stillbirths and newborn deaths occurred from pregnancy plus nursing exposure)
Note: despite claims of minimal exposure to nurslings by some health professionals, the data on "safety" of nursing a baby while taking SSRIs and antipsychotics is based on an extremely small sample (nevermind that serious adverse events have been observed even in the few studies actually done). For SSRIs the studies amount to a few dozen people, many of which were also supplementally feeding formula. The Zyprexa study purported to study only 7 nursing couples and only examined 6 children's blood. See http://uniteforlife.org/zyprexa%20objection.htm for more information on the risks of Zyprexa.
II. Prevention of Post-Partum Mood Disorders:
A. Avoid interventions in childbirth: HOME BIRTH or midwifery or otherwise natural childbirth statistically results in LESS PPD...
Mothers Can Avoid (Specifically):
1. Labor drugs, including pitocin which interferes with normal oxytocin stimulation of uterine contractions (oxytocin is the love hormone and sets off many chemicals in the brain associated with normal maternal bonding & protective behavior)
2. IVs with glucose water during labor which can lead to complications in the newborn like perceived excessive weight loss, hypoglycemia, thus creating "mommy guilt" from feeling as if she is unable to sustain her own baby's survival due to perceived inadequate milk supply and subsequent breastfeeding difficulty when baby is inevitably given supplemental feedings
3. Avoid epidural which can cause breastfeeding difficulties in the newborn and may be associated with mood problems (the anesthesia fentanyl in the epidural is derived from cocaine)
4. Avoid episiotomy which can lead to excessive blood loss and fatigue as well as significant pain leading to use of pain medications
5. Avoid restrictive dieting before / after childbirth which can cause preterm labor (not having enough calories and protein leads to low albumin and high blood pressure), low blood sugar and lack of energy
6. Avoid epinephrine, which is often necessary in labor because of fetal distress or maternal distress (trouble breathing, low blood pressure) which are side effects in both mom and baby from pitocin or other augmentation as well as epidurals. Epinephrine is synthetic adrenaline and has been linked to mental disturbances.
B. Post-partum period:
1. FOR MANY WEEKS MOMS WILL NEED: someone to help with meals, chores, child care, etc. Without that, women ARE FAR MORE LIKELY to feel "symptoms" of depression, anxiety, etc.
2. MOMS WILL NEED someone to help with breastfeeding if they are inexperienced or have problems. They can contact a La Leche League Leader or an IBCLC. Loss of breastfeeding is sometimes associated with PPD due to additional hormonal changes in moms, while breastfeeding itself is thought to ease PPD due to numerous factors.
3. MOMS (and families) WILL FEEL BETTER if they cosleep because they will be well-rested and breastfeeding will be easier. For safety tips on cosleeping moms can use common sense or write to amy@uniteforlife.org for more info. Contrary to campaigns by the Crib Manufacturers SIDS is actually more common in cribs.
III. Alternatives to Drugs:
1. Screen for underlying medical conditions such as Thyroid disorders, anemia, etc. and treat those as safely as is possible. Thyroid disorders such as hypothyroidism or hyperthyroidism (or both - postpartum thyroiditis) are quite common and can cause depression or anxiety.
2. Omega 3 Supplements (From Fish Oil, Flaxseed, etc.)
3. Exercise (although initially excessive exercise will not help a woman, after childbirth it is necessary to rest in order to recover, and not lose too much blood)
http://uniteforlife.org/exercise.html Medication shown to cause relapse, exercise MORE effective than antidepressant drugs
4. Some people feel that counseling is effective
5. Some people find alternative treatments effective, for example: chiropractic, homeopathy (even for PSYCHOSIS), accupuncture, energy work, etc.
6. MOMS can FIND A SUPPORT GROUP or helpful PERSON but NOT one that will push them to use drugs.
IV. Alternative Ways to Support American Families:
If the government really wants to help moms, why not educate on these common sense strategies, push for better maternity leave allowances, improve obstetric cooperation with midwifery, or promote paternity leave or leave for grandparents who can help new mothers during their time of need?
V. The Bill Violates Basic American Principles and Rights:
Mothers want time in PEACE and PRIVACY to be with their new babies to bond. They DO NOT need to be dragged off to an invasive and dangerous screening for mental problems. The power of suggestion alone is enough to scare a significant amount of moms and this invasion of privacy goes far beyond anything EVER imposed on the U.S. Public.
Furthermore, similar programs like Teen Screen have been a total failure with an 84% or higher misdiagnosis rate. The vast majority of these misdiagnosed students were referred to mental health practitioners and put on drugs.
==================
Additional Critiques of the Bill
==================
There is no language in the bill that protects thousands of mothers being erroneously screened and drugged with antidepressants that medical studies show cause birth defects and withdrawal symptoms, devastating families and driving up health care costs to treat these iatrogenic-caused conditions.
The bill seeks more appropriations to the National Institutes of Health to research postpartum depression but doesn't specify how the funds are to be used. For example, during the past 3 years, NIMH has already spent more than $10 million on 38 studies of PPD, yet the National Center for Complementary and Alternative Medicine lists no grants on its website for such research.
There is no language about the diverse medical opinion and studies about "post partum depression" and whether it exists as a mental disability or as a physical condition that can be treated by normal medical or alternative means.
While the bill promotes more research into the condition, it doesn't provide safeguards about this research and the effects of biological agents on the fetus--with studies suggesting that antidepressants may exert an impact on developmental processes of the embryo, and cause higher rates of premature delivery, low birth weight, admissions to intensive care units, and poor neonatal adaptation, including respiratory and feeding difficulties in infants.
The way in which the bill is currently worded could lead to thousands of suits as hundreds have already been filed concerning antidepressant use during pregnancy that has resulted in infants being born with a life-threatening lung disorder, PPHN and that between 10% and 20% of infants born with PPHN end up dying, even when they receive treatment.
11 Feb, 2008
URGENT PLEA FOR HELP - Save Rebecca Merhav
FOR IMMEDIATE RELEASE
February 11, 2008
An Urgent Plea for Assistance: UNITE / CHAADA Members Demand Immediate Release and Protection of Rebecca Merhav; Survivors and Activists Protest Cruel Experiments & Call For Restoration of Human Rights
Contact:
Amy Philo 214-705-0169 home or 817-793-8028 cell (USA numbers)
email: amy@uniteforlife.org
www.uniteforlife.org, www.chaada.org
Ben Merhav benjaminmerhav@hotmail.com
Camille Milke 505-269-2286 direct or 505-213-0999 fax (USA numbers)
email: sarinasvoice@aol.com
www.copesfoundation.com, http://www.drugawareness.org/home.html
The 265-plus individual members and affiliated organizational members of CHAADA (Children and Adults Against Drugging America), together with sister organization UNITE (United Non-Profits and Individuals for Truth and Ethics), call for the urgent assistance of all allies and human rights organizations, as well as individuals who defend human rights. It is imperative that all capable parties intervene on behalf of Rebecca Merhav (and her father Ben Merhav) to preserve her life and safety, and to achieve freedom and an end to psychiatric torture in her case.
Rebecca Merhav of Australia is the daughter of Benjamin Merhav. Rebecca's mother had her hospitalized as a teen when she became defiant and would not do her chores. Psychiatrists have placed a CTO or Compulsory Treatment Order on Rebecca and she has been forcibly "medicated" (drugged) for over 30 years. Despite the fact that Rebecca does not want to take drugs, and her father (a cancer survivor who used natural therapies to recover) wants her to be free from drugs, psychiatrists continue experimenting on her.
Rebecca has been subjected to Clozapine, the most dangerous of all "antipsychotic" drugs, and now she is being forced to take 400 mg of Seroquel daily and 75 mg injections of Risperdal every 10 days. She is being held in a clinic against her will to ensure she takes the drugs. Her chances of continued survival diminish with each passing day because these drugs have a proven risk of sudden death in addition to gradual deterioration of the body from the toxic effects of the drugs.
The right to life, the right to control over one's own choices, freedom to live in the place of one's choosing, freedom over one's own body - these are basic human rights that all people should expect to have. Rebecca has not posed any danger to herself or others or committed any crime, and despite the cruel and toxic drugs and incarceration which so often lead to hopelessness and despair, Rebecca's will to live has prevailed and enabled her to survive with hope of rescue. She has persevered through torture for 30 years. Prior attempts and pleas, petitions, and evidence of harm presented to the authorities have failed. Your assistance and expertise are therefore desperately needed.
Whether you normally reach out to help individuals, or prefer to address systemic issues by tackling larger organizations and issues, if we allow this torture of Rebecca to go on, what is to prevent this from happening to us, or to our own children?
Furthermore, solving this once and for all and freeing Rebecca will set a meaningful precedent, thereby increasing the chances that more victims can now be saved.
All those interested in offering their assistance can start by sending a letter to the following addresses as soon as possible:
To: s.wilkins@alfred.org.au
cc: lisa.neville@minstaff.vic.gov.au; jesse.martin@minstaff.vic.gov.au; hsc@dhs.vic.gov.au;
kuruvilla.george@dhs.vic.gov.au; benjaminmerhav@hotmail.com; amy@uniteforlife.org; sarinasvoice@aol.com
A proposed sample letter is available at http://uniteforlife.org/rebeccaletter.htm
For additional information please see: http://uniteforlife.org/help%20rebecca%20now.htm
To offer additional assistance, please use whatever non-violent means are available to you to ensure Rebecca's freedom and safety and achieve the cancellation of her Compulsory Treatment Order (CTO) and release from the psychiatric doctors' so-called care. You can write or call Amy Philo or one of the other contacts listed above if you require further information.
Tomorrow could be too late. Please act today.
Sincerely,
Amy Philo
Founder, www.uniteforlife.org
Co-Founder, www.chaada.org
Camille Milke
Founder, www.copesfoundation.com
New Mexico State Director of the ICFDA (http://www.drugawareness.org/home.html)
Mother of a victim of psychiatric drug-induced suicide and grandmother to a now motherless child
20 Jan, 2008
Former FDA Reviewer Breaks Silence on Suppressed Antidepressant Studies
Please see: http://www.uniteforlife.org/suppresseddata.htm and
http://news.yahoo.com/s/nm/20080117/us_nm/drugs_studies_dc
Note: Lilly and other pharma types have attempted to sidestep the negative attention by claiming that they have made all of their studies available on their websites. In one statement by Lilly it said that all studies since 1994 and all information on new drugs since 2004 have been listed on their website. However Prozac was not researched for FDA approval in 1994 or later. The studies for Prozac took place in the several years prior to its FDA approval in 1987. In 1985 Germany refused to approve Prozac due to the suicide risk.
Pharma is not going to get away with this much longer. A ban is the only logical next step. If the FDA will not do it, we must get our legislators and presidential candidates involved in the efforts to protect us from our would-be murderers at PhRMA.
http://news.yahoo.com/s/nm/20080117/us_nm/drugs_studies_dc
Unfavorable drug studies don't get into print: report
BOSTON (Reuters) - Nearly a third of antidepressant drug studies are never published in the medical literature and nearly all happen to show that the drug being tested did not work, researchers reported on Wednesday.
In some of the studies that are published, unfavorable results have been recast to make the medicine appear more effective than it really is, said the research team led by Erick Turner of the Oregon Health & Science University.
Even if not deliberate, this can be bad news for patients, they wrote in their report, published in the New England Journal of Medicine.
"Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health," they wrote.
The idea that unfavorable test results are quietly tucked away so nobody will see them -- sometimes call the "file drawer effect" -- has been around for years.
The Turner team used a U.S. Food and Drug Administration registry in which companies are supposed to log details of their drug tests before the experiments are begun.
"It tells you where they placed their bets before they saw the data," Turner said in a telephone interview.
Of the 74 studies that started for the 12 antidepressants, 38 produced positive results for the drug. All but one of those studies were published.
REWRITTEN STUDIES
However, only three of the 36 studies with negative or questionable results, as assessed by the FDA, were published and another 11 were written as if the drug had worked.
"Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome," said the authors.
For example, of the seven negative studies done on GlaxoSmithKline's Paxil, five were never published. The researchers found three studies for GSK's Wellbutrin SR, but the two negative ones never reached print.
There were five studies for Pfizer's Zoloft, but the three showing the drug to be ineffective were not published. A fourth study, ruled questionable by the FDA, was written and published to make it appear that the drug worked.
A Glaxo spokeswoman said the company posts the data from all of its trials, positive or negative, on the Internet.
"GlaxoSmithKline agrees that public disclosure of clinical trial results for marketed medicines is essential and fully supports registration of all trials in progress," she said.
"Pfizer is committed to the communication of results of all registered clinical studies, regardless of outcome. More specifically, we have committed to disclose clinical trial results within one year after study completion for all of our marketed products," Pfizer spokesman Jack Cox said in an e-mail.
Turner and his colleagues did not find out who was to blame for not publishing the studies. He said medical journals may have played a role by deciding they would rather publish favorable results.
"There's an expectation that if you get a positive result, that's what you're supposed to do, and if you get a negative result you have failed," said Turner. "The first impulse is to say, 'I was wrong. Maybe I should move on to something more interesting"' so the results may never get written up.
(Editing by Maggie Fox and David Wiessler)
20 Jan, 2008
URGENT ALERT - A CHANCE TO MAKE A DIFFERENCE
I am sorry that this is a last minute alert. If you get this more than once I apologize.
Camille Milke is the mother of Sarina Cuoco who committed suicide while on psychiatric drugs last November. You can check her website out at
http://www.copesfou ndation.com/
New Mexico State Senator Carraro has proposed a commission to investigate the link between antidepressants and suicide and make recommendations to the government based on their findings. To make sure that this commission is established, we should all submit a letter of support to Camille by tomorrow. Again, I apologize for the time crunch. This is your chance to make a difference.
I hope you will read more about this opportunity to help prevent future tragedies by reading about the plea for support of what will eventually hopefully lead to Sarina's Law at
http://www.unitefor life.org/ sarina.htm
Send your support letters to Camille Milke at sarinasvoice@ aol.com as soon as possible, by tomorrow (Monday). Camille is going to the Senate with the letters on Tuesday.
Those of you who may not know, psychiatric drugs increase the risk of suicide and this has been shown to be true for all categories of people taking drugs like SSRIs, from those who are healthy volunteers, to those taking meds for insomnia, misdiagnoses and missed diseases like Lyme Disease, thyroid problems, even ridiculous reasons like back acne and migraines or social anxiety.
They have also been demonstrated to be ineffective and are linked to homicide and school / mall / workplace shootings. You may think this is an issue that does not affect you but if you have ever gone out in public you have probably been near some potentially dangerous people who could be walking time bombs.
No parent should have to suffer through suicide of their child when it could have been prevented.
Camille knows that like so many others before her, her daughter Sarina was mistreated with drugs and led down a path to suicide that never would have occurred had she not taken psychiatric drugs. Unfortunately most parents and even their doctors have not been given access to the information that would allow patients to give informed consent for using these medications.
If you are not aware of my story, I am a living testament to the fact that these drugs are extremely dangerous and it is because I was not fully informed that I continued taking Zoloft for 5 months even though it was making me increasingly homicidal and suicidal whenever the dose was raised. Luckily I survived, but there are so many who do not.
Please do what you can and send in a letter of support, even if it is a short note.
EVEN IF YOU ARE NOT SURE THAT YOU UNDERSTAND OR BELIEVE THAT ANTIDEPRESSANTS CAN CAUSE SUICIDE, PLEASE CONSIDER SENDING YOUR LETTER FOR SUPPORT OF AN INVESTIGATION. AN INVESTIGATION WILL HELP US AS A SOCIETY TO GAIN UNDERSTANDING. THOSE TAKING THE DRUGS SHOULD BE ESPECIALLY INTERESTED IN GETTING ALL OF THE INFORMATION AVAILABLE ON THEM, AND IN UNCOVERING ANY INFORMATION THAT HAS NOT PREVIOUSLY BEEN DISCLOSED.
Anything you can do to help is appreciated. Please forward this alert.
17 Sep, 2007
Texas Mother Attempts Murder-Suicide while withdrawing from Bipolar Meds
Paragraphs 3 & 4 read:
"According to court documents filed in juvenile court, Green had been diagnosed with bipolar disorder."
"According to the woman's husband, Green had stopped taking her medication and over the last three weeks her condition had diminished. Adam Green had little comment about the day's court proceedings, and simply asked for prayer for his children."
Paragraph 10 reads: "Police would not confirm neighbors' accounts of the events or fire officials' earlier statements that Green put her daughters in a closet, poured gasoline on them and herself and set them on fire."
If this tragic case follows the usual scenario, then Alysha Green was given an antidepressant, became manic and/or psychotic, was diagnosed with bipolar disorder and then given an antipsychotic, a mood stabilizer, an antidepressant and an anti-anxiety medication. Withdrawal from any one of these toxic substances can be a nightmare, so withdrawal from this kind of drug cocktail is beyond description. Almost 3% of the population in the U.S. is now diagnosed with bipolar disorder [Pharmaceutical Business Review: Nov. 21, 2006]. Consequently, the dangers of the toxic drug cocktail for bipolar disorder, both while on it and while withdrawing from it, are enormous. Rosie
http://cbs11tv.com/topstories/local_story_260182659.html
CPS Gets Custody Of Girls Allegedly Set On Fire
Katherine Blake
Reporting
(CBS 11 News) HALTOM CITY A court hearing was held Monday to find out the fate of three little girls who were allegedly set on fire by their mother.
Police say 29-year-old Alysha Green admits to setting her children on fire.
According to court documents filed in juvenile court, Green had been diagnosed with bipolar disorder.
According to the woman's husband, Green had stopped taking her medication and over the last three weeks her condition had diminished. Adam Green had little comment about the day's court proceedings, and simply asked for prayer for his children.
A family member told CBS 11 News that only one of the three injured girls is conscious. Seven-year-old Adamiria is said to be awake and talking with family members. As of Monday afternoon 3-year-old Arianna was on life support with burns over 90-percent of her body. Doctors put the girl's 5-year-old sister, Alexandria, in a medically induced coma. She has burns over 57-percent of her body.
After the three girls were pulled out of a burning house, the scorched 7-year-old screamed, "Why mommy? Why mommy? Why did you do this to me?" said a neighbor who helped the girls.
As rescuers tended to the girls their mother told a fire investigator that she doused them with gasoline and set them on fire, neighbor Kevin Lopez said Monday, two days after the fire.
"She was crying and saying, 'I'm sorry' and she didn't know why she did it," Lopez told The Associated Press.
In 911 calls released Monday terrified witnesses could be heard at the scene. During one emergency call a woman can be heard screaming in the background.
Police would not confirm neighbors' accounts of the events or fire officials' earlier statements that Green put her daughters in a closet, poured gasoline on them and herself and set them on fire.
On Monday, a row of balloons, teddy bears, flowers and candles lay in the front yard of the wood and tan brick house. Someone placed a sign that read, "Get well soon; we are praying for you" by a front window. A doll house, small purple plastic car, pink scooter and pink bicycle were by the front porch.
On a boarded side window, soot was visible on the window sill and a faint odor of smoke was in the air.
Also Monday, Child Protective Services filed a lawsuit to get temporary custody of the children. The courts granted the request, which among other things gives CPS power to make decisions about the girl's treatment at Parkland Hospital.
"As the temporary managing conservator CPS certainly has the legal authority to be making medical decisions, but at this point they have clearly indicated that they expect the father to play the key role," said James Teel, Tarrant County Assistant District Attorney.
Green, who is also being treated for burns at Parkland Hospital, has been arrested on three counts of suspicion of injury to a child. If convicted of the first-degree felony, Green could face up to life in prison.
14 Sep, 2007
Merrill Goozner on SSRIs and Suicides
That Controversial SSRI Study
I finally got my hands on a copy of the study in the American Journal of Psychiatry that claimed that a recent increase in youth suicides can be tied to psychiatrists dialing back on their use of anti-depressants in the wake of a Food and Drug Administration warning in 2004 that the drugs may actually increase suicide idea formation in youths. The Centers for Disease Control in a separate report confirmed the trend, if not the conclusion.
What struck me in looking at the data was how small the change was (14 percent doesn't seem small, but look at the raw numbers). The rate went from 2.83 per 100,000 or 1,737 suicides in a population of 61.45 million youths 19 and under in 2003 to 3.23 per 100,000 or 1,985 suicides in a population of 61.47 million youths in 2004, according to the study. The CDC data covered young people up to age 24 and showed a smaller increase in 2004, going from 6.78 to 7.32 per 100,000 youths, an 8 percent uptick. The CDC did note that this was the largest percentage increase since at least 1990 when the CDC began tracking the data.
However, looking at either set of numbers, the 2004 rate remained in the relatively low range that it has been in since the late 1990s. Youth suicide rates began falling in 1988 when, some argue, illegal drug use among youths began declining and legal drug use (various forms of speed for ADHD and serotonin reuptake inhibitors or SSRIs for depression) began its long-term upswing.
Critics of anti-depressants say the real danger period when using these drugs comes when kids start taking them and when they stop taking them. As one put it today: Taking these drugs is like riding the space shuttle; the riskiest part of the journey is going up and coming down. That theory suggests that one year blip in response to a downturn in prescriptions may have been related to drug withdrawals.
In any case, a one year change in a curve's direction doesn't a trend make. The danger signal from anti-depressants in kids that were highlighted by Food and Drug Administration reviewers in 2004 came from controlled clinical trials. This study's broad conclusion, "If the intent of the pediatric black box warning was to save lives, the warning failed, and in fact it may have had the opposite effect," is based on a crude correlation based on a small one-year shift in broad population data.
The study's chief author was Robert D. Gibbons, a professor of psychiatry at the University of Illinois. His conflict-of-interest disclosure at the end of the study (not revealed in the Washington Post article) reported that he also provides expert testimony in product liability trials for Wyeth Pharmaceuticals, which makes Effexor, an antidepressant in the SSRI class.
It takes a lot for the FDA to ignore clinical trial results in favor of population-based studies like this one. FDA psychiatry drug chief Thomas Laughren was properly circumspect in today's Post: "FDA is obviously concerned about possible negative impacts of labeling changes but also feels a strong obligation to alert prescribers and patients to possible risks associated with the use of antidepressants." He added, "We will continue to monitor antidepressant use and suicide rates, and will take appropriate regulatory actions as new data become available."
Posted by gooznews at September 6, 2007 04:36 PM
14 Sep, 2007
Recent PhRMA Spin on Black Box Warnings actually based on Journal Publication written by Drug Company Consultants
In the explosion of information yesterday surrounding the use of antidepressants, suicides and Black Box warnings, there was a little noticed item. The study in the American Journal of Psychiatry was authored by eight people, two of whom have rather noticeable conflicts of interest.
The study, which received front-page treatment in The Washington Post, was co-authored by Robert Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago, who has served as an expert witness for Wyeth, the company that sells Effexor. And J. John Mann, a psychiatry professor at Columbia University, has received research support from Glaxo, which sells Paxil, and served as an adviser to Eli Lilly, which peddles Prozac and Cymbalta.
How do we know? These competing interests were noted at the bottom of the study, but not in the Washington Post story. Meanwhile, as we pointed out yesterday, the American Psychiatric Association has harshly criticized the FDA for placing the warnings on product labels, saying this scares away some docs and patients. The APA publishes the medical journal, by the way, which to its credit, listed the conflicts.
These conflicts don’t necessarily suggest the data or conclusions are incorrect - that’s worthy of a separate analysis and discussion - but given the drumbeat of info coming from the psychiatric community, these should have been reported by the Post. And the medical journal should have been widely and easily accessible to the media, which it wasn’t. Full understanding requires full disclosure, from everyone.
Haven’t taken our reader’s poll? Look here…
Hat tip to GoozNews
14 Sep, 2007
Experts Question Study on Youth Suicides
Paragraph 3 reads: "W
hile suicide rates for Americans ages 19 and under rose 14 percent in 2004, the number of prescriptions for antidepressants in that group was basically unchanged and did not drop substantially, according to data from the study. Prescription rates for minors did fall sharply a year later, but the suicide rates for 2005 are not yet available from the Centers for Disease Control and Prevention."
http://www.nytimes.com/2007/09/14/us/14suicide.html
Experts Question Study on Youth Suicide Rates
By ALEX BERENSON and BENEDICT CAREY
Published: September 14, 2007
Last week, leading psychiatric researchers linked a 2004 increase in the suicide rate for children and adolescents to a warning by the Food and Drug Administration about the use of antidepressants in minors. The F.D.A. warning, the researchers suggested, might have resulted in severely depressed teenagers going without needed treatment.
But the data in the study, which was published in The American Journal of Psychiatry and received widespread publicity, do not support that explanation, outside experts say.
While suicide rates for Americans ages 19 and under rose 14 percent in 2004, the number of prescriptions for antidepressants in that group was basically unchanged and did not drop substantially, according to data from the study. Prescription rates for minors did fall sharply a year later, but the suicide rates for 2005 are not yet available from the Centers for Disease Control and Prevention.
“There doesn’t seem to be any evidence of a statistically significant association between suicide rates and prescription rates provided in the paper” for the years after the F.D.A. warnings, said Thomas R. Ten Have, a professor of biostatistics at the University of Pennsylvania.
In the report published last week, the authors analyzed data on suicides and antidepressant use over several years in the United States and the Netherlands. They argued that drug regulators may have created a larger problem by requiring pharmaceutical companies to place warnings on antidepressants, scaring away patients and doctors. The F.D.A. warning label says that a potential side effect in young people is an increase in suicidal thoughts and behavior.
“The most plausible explanation is a cause and effect relationship: prescription rates change, therefore suicides change,” said Dr. J. John Mann, a psychiatrist at Columbia University and a co-author of the study.
But Dr. Ten Have and other experts, while noting that it may still turn out that a reduction in prescriptions is leading to increased suicides among young people, said that the new study neither proved nor disproved this. Instead, some experts say, the study illustrates why suicide trends are so difficult to understand and why this debate has been so polarizing and confusing.
In an interview, Robert D. Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago and the lead author of the journal article, acknowledged that the data from the United States that he and his colleagues analyzed did not support a causal link between prescription rates and suicide in 2004. “We really need to see the 2005 numbers on suicide to see what happened,” he said.
But Dr. Gibbons defended the paper, saying that when taken in the context of previous studies that linked falling antidepressant use to increased suicide rates, “this study was suggestive, that’s what we’re saying.”
Other experts, however, said that the problem with such studies is precisely that they are suggestive rather than conclusive and are open to interpretation. Suicides are rare and uniquely personal events that can be driven by many factors: worsening depression or other mental illnesses, breakups or job loss, lack of drug or psychiatric treatment, even easy access to guns.
In calling for the labeling change on antidepressants, F.D.A. scientists based their decision on data from drug makers’ clinical trials, considered the gold standard in medical research. Those trials have shown that young patients who took antidepressants were about twice as likely than those on placebos to report suicidal thoughts or attempts, though the numbers in both groups were small.
Yet none of the youngsters in the trials, most of which ran for no more than a month or two, actually committed suicide. And most psychiatrists with long experience using antidepressants in children say the benefits far outweigh any risk.
In studies of data collected before 2004, Dr. Gibbons, Dr. Mann and others found clear associations between prescription patterns and suicide rates. For instance, prescription rates for patients from ages 10 to 24 rose steadily in the 1990s, while the suicide rate in that age group fell 28 percent from 1990 to 2003, according to a government report released last week.
In another study, researchers at Columbia University, analyzing data from 1990 to 2000, found that for every 20 percent increase in the use of antidepressants among adolescents, there were five fewer suicides per 100,000 people each year. Psychiatric researchers have found similar patterns among some age groups in other countries, including Sweden, Japan and Finland.
But many uncertainties remain. While the suicide rate for adolescents has fallen over the last decade, it has remained largely unchanged for the overall population, though prescriptions for psychiatric medicines have risen sharply in all age groups. Adjusted for the demographic changes, about 11 Americans per 100,000 killed themselves in 2004, the same as in 1994.
Demographics can play a role: White people kill themselves about twice as frequently as African-Americans and Hispanics, so as the population becomes more diverse, the suicide rate ought to drop, all else being equal. And suicide rates also appear to be negatively correlated with economic growth, which was exceptionally strong from 1994 to 2000. Advances in medicine also mean more lives can be saved now.
With so many potentially confounding factors at play, interpreting the relationship between prescription rates and suicides is difficult, said Andrew Leon, a professor of biostatistics at Weill Cornell Medical College who has served on F.D.A. panels studying suicide risk and antidepressants.
“These kinds of studies are very important in giving us a sense of the rates of disease and death in a population and how those may correspond to other things,” Dr. Leon said. “But what they don’t do is tell us whether the two trends are directly related.”
More Articles in National »
28 Jul, 2007
SSRIs and Diabetes Drugs create endless opportunities for profit at drug companies, harm to patients
For the past two decades antidepressants have caused more diabetes than
anything we know of. The evidence is there to show exactly that. I know that the
atypical antipsychotics have been the drugs accused of that and rightfully so.
They are also serotonergic meds and can do the same, but most who take
antipsychotics do so because of the antidepressant- induced or antidepressant
withdrawal-induced psychosis they suffered previously. So the damage from the
antidepressant upon the pancreas has already been established BEFORE the
atypical antipsychotic is introduced. And once again I say clearly that these drugs
do also produce the same damage to the pancreas, BUT antidepressants are
getting off scott free and they should not be. With the introduction of the SSRIs
upon the market diabetes skyrocketed. The atypical antipsychotics only
continued that damage.
Anyway because of the propensity of these drugs to induce diabetes, it is
critical that you continue to be informed about problems arrising from
treatments for diabetes.
Below is an article discussing the potential risk to the heart by two
antidiabetic drugs in the same family of drugs, Avandia and Actos. Please never
forget that when a drug is in the same family it is because it is only a tiny
fraction away from being the same drug. To say one is less harmful than another
is absurd.
Of course none of us would be surprised to hear from Mary Anne Rhyne, the
company spokesperson for GlaxoSmithKline, the makers of both Paxil and Avandia
(see below). That statement is that of course, just as we continued to hear
from her about Paxil, their drug is "safe" in spite of all the evidence
against it - calling black, white and white, black - is that what the scriptures
mean when they speak of "soothsayers" ?
Ann Blake Tracy, PhD, Executive Director,
International Coalition for Drug Awareness
_www.drugawareness. org_ (http://www.drugawar eness.org/) and author of
Prozac:
Panacea or Pandora? - Our Serotonin Nightmare
and audio Help! I Can't Get Off My Antidepressant!
(800-280-0730)
____________ _________ _________ _________ ______
Not only did the drugs double the risk of heart failure, but the increased
risk was seen with both high and low doses, the team found.
"We know these drugs increase the risk, but we found the risk is more
substantial than suspected. This occurs at even the lowest dose and among young
patients."
Avandia (rosiglitazone) and Actos (pioglitazone) are from the same family of
diabetes drugs and used by more than 3 million diabetic patients across the
United States.
The current product label warns against using these drugs in patients with
more severe cases of heart failure. The label also warns that there is an
increased risk of heart failure if the drugs are used in combination with
insulin.
Singh's group, however, found that the risk wasn't limited to patients on
insulin, and it was present even among patients without any risk factors for
heart failure.
"Doctors should be aware of the risk," he said. "Patients who are on these
drugs and start developing symptoms of heart failure should see their doctor
immediately, and patients not on these drugs should look at alternatives. "
One expert believes that patients taking Avandia and Actos face not only an
increased risk of heart failure, but also a 43 percent increased risk of heart
attack.
"This hazard of heart failure is pretty well known for these drugs," said Dr.
Steven E. Nissen, chairman of the department of cardiovascular medicine at
the Cleveland Clinic. He noted that, in May, the FDA said it was going to
mandate a "black box" warning about heart failure risk on the labels of these
drugs.
On Thursday, Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, which makes
Avandia, responded to the new government review by saying the company
continued to believe Avandia was safe, the Times reported.
_http://news. yahoo.com/ s/hsn/20070727/ hl_hsn/twodiabet esdrugsdoublehea rtfailur
eriskstudy;_ ylt=Aiqwl8V_ oPEdtT77h5VtvV9a 24cA_
(http://news. yahoo.com/ s/hsn/20070727/ hl_hsn/twodiabet esdrugsdoublehea rtfailureriskstu dy;_ylt=Aiqwl8V_ oPEdtT77
h5VtvV9a24cA)
____________ _________ _________ ______
(http://us.rd. yahoo.com/ dailynews/ hsn/SIG=10r2efrk l;_ylt=Aumq1aU0l MdrlvwNjLEYTnm9j 7AB/*http: //www.healthday. com/)
Two Diabetes Drugs Double Heart Failure Risk: Study
By Steven Reinberg
HealthDay Reporter 2 hours, 19 minutes ago
FRIDAY, July 27 (HealthDay News) -- Patients taking either of the diabetes
drugs Avandia or Actos face twice the risk of developing heart failure compared
to people not on the popular medications, a new study finds.
This means for every 50 patients with type 2 diabetes taking these drugs, one
patient will develop heart failure within 26 months, according to the report
released Friday and published in the August issue of Diabetes Care.
"Both Avandia and Actos double the risk of heart failure," concluded the lead
author of the first study, Dr. Sonal Singh, an assistant professor of
internal medicine at Wake Forest University School of Medicine. "We know these
drugs increase the risk, but we found the risk is more substantial than
suspected. This occurs at even the lowest dose and among young patients."
The report follows a U.S. government review released Thursday that found
Avandia's heart risks are far higher than Actos'. That report sets the stage for
an advisory panel hearing Monday that will examine whether Avandia's
cardiovascular risks warrant a stronger warning label.
Avandia (rosiglitazone) and Actos (pioglitazone) are from the same family of
diabetes drugs and used by more than 3 million diabetic patients across the
United States.
The current product label warns against using these drugs in patients with
more severe cases of heart failure. The label also warns that there is an
increased risk of heart failure if the drugs are used in combination with
insulin.
Singh's group, however, found that the risk wasn't limited to patients on
insulin, and it was present even among patients without any risk factors for
heart failure.
The government study, by a medical and safety review team at the Food and
Drug Administration, found that patients are at much higher risk of heart
problems if they take Avandia, compared to patients taking Actos. Avandia is
especially hazardous to patients who are already on insulin, the report found,
whereas Actos users can take insulin as well without fearing cardiac side
effects, the New York Times reported.
That data could help decide whether or not Avandia remains on drug store
shelves, experts said.
"A critical question to be resolved in determining appropriate regulatory
action is whether the anticipated therapeutic benefit of rosiglitazone outweighs
the demonstrated cardiovascular risk," one FDA reviewer concluded according
to the Times report.
In the Diabetes Care study, Singh's team collected data on more than 78,000
patients taking either of the drugs. These patients were included in
previously published studies and in case reports.
Not only did the drugs double the risk of heart failure, but the increased
risk was seen with both high and low doses, the team found.
Heart failure developed in some patients taking lower doses than are commonly
prescribed. The average time for heart failure to develop was 24 weeks after
starting the drugs, the researchers found.
Heart failure wasn't confined to older patients. Twenty-five percent of the
patients who developed heart failure were under 60. In addition, both men and
women developed heart failure while taking the drugs, Singh noted.
Singh's group suspect that Avandia and Actos may boost heart failure risk by
encouraging fluid retention.
Current guidelines allow the use of these drugs in patients with early-stage
heart failure. "Based on our information, that may have to change," Singh
said.
Singh noted that there are alternative drugs available. "Doctors should be
aware of the risk," he said. "Patients who are on these drugs and start
developing symptoms of heart failure should see their doctor immediately, and
patients not on these drugs should look at alternatives. "
One expert believes that patients taking Avandia and Actos face not only an
increased risk of heart failure, but also a 43 percent increased risk of heart
attack.
"This hazard of heart failure is pretty well known for these drugs," said Dr.
Steven E. Nissen, chairman of the department of cardiovascular medicine at
the Cleveland Clinic. He noted that, in May, the FDA said it was going to
mandate a "black box" warning about heart failure risk on the labels of these
drugs.
That same month, Nissen published a paper in the New England Journal of
Medicine that found that Avandia increased the risk of heart attack.
Since then, the controversy has continued, with both sides weighing in.
On Thursday, Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, which makes
Avandia, responded to the new government review by saying the company
continued to believe Avandia was safe, the Times reported.
"Across the extensive data we have, the science shows no increase in
cardiovascular death, and does not support a difference in heart attack rates
between Avandia and the other most commonly prescribed oral antidiabetics, " Rhyne
told the Times.
On Friday, the company's director of clinical development, Dr. Andy
Zambanini, told HealthDay that Glaxo was "still in negotiation with the FDA about a
new warning label on heart failure, and we expect to release that information
soon."
Nissen believes that patients who are considering taking Avandia should
discuss the decision with their doctor. "It is important that the totality of
information be out there," he said. "But no patient should stop taking a
medication [only] because they read a news report."
Another expert contends that the two drugs are safe if prescribed correctly.
"The risk for heart failure with these drugs may be one in 50, but if you can
correctly identify who that person [at risk] is, you can safely treat the
other 49 and not hurt anybody," said Dr. Larry Deeb, president for medicine and
science at the American Diabetes Association.
Deeb believes the same holds true for the risk of heart attack.
The boost in risk of heart failure and heart attack does not warrant taking
these drugs off the market, he added.
"They fit into the armamentarium of diabetes drugs if used properly," Deeb
said.
More information
Learn more about diabetes drugs from the _U.S. Food and Drug Administration_
(http://us.rd. yahoo.com/ dailynews/ hsn/hl_hsn/ storytext/ twodiabetesdrugs doubleh
eartfailureriskstud y/23894444/ SIG=11873la1s/ *http://www.fda. gov/diabetes/ pills
.html) .
28 Jul, 2007
Scientists Aim to Treat Depression with Ketamine
From Dr. Ann Blake Tracy:
For all of you who have read my book, this article will be of little
surprise. To those of you who have not, it should be a wake up call. There is one
entire chapter of my book devoted to comparing the Prozac family of
antidepressants, the SSRIs, to PCP (Angel Dust) and discusses the shocking history of
PCP. It becomes very, very clear in reading this research how similar in action
PCP is to the SSRI and SNRI antidepressants and the new atypical
antipsychotics.
Not long ago I became aware that NIH was testing Ketamine (a drug in the PCP
family) for use in depression! This was not too shocking to me due to my
previous research into the similar action of the drugs. What was shocking to me
is that NIH still had not caught on to the obvious - these drugs are all
dissociative anesthetics, intended to anesthetize the patient yet have them
appear alert and functioning. The brain wave patterns in my book give a clear
visual of what is happening as well when you see the brain in a total anesthetic
sleep state and dreaming while appearing alert and associating with others.
I have continuously heard from patients coming off antidepressants, "I feel
as if I am coming out from under anesthesia."
They also continuously report that they have no memory of what has happened
during the period of time they were on the drug. One young woman said she took
Prozac her first year of college and had absolutely no memory of that year.
I remarked on how that was certainly a waste of lots of tuition money and she
quickly agreed but without any humor associated with it, only hurt and anger
for what had been robbed from her. Another fellow on Prozac for 5 years
started a new government position. He spent his first day in intensive training
only to return the next day with absolutely NO recall of the previous day or
anything he had learned. Training had to be started over again. Another on his
antidepressant for two years said that he feared learning what had happened
during that time because he did not know what he had done and what he had
not done, what was real and not real during that period of time. (And trust me!
No one would want to know what he had done!)
Is it any wonder that "amnesia" is listed as a "frequent" side effect of
nearly everyone of these drugs? How do you recall who you are or things that
happen while under anesthesia? It should not be expected and neither should it
be expected to hold someone legally or morally accountable for what they have
done while under anesthesia! It is absurd!
Now look at what they are saying at NIMH! First they talk about how similar
in action Ketamine is to antidepressants THEN they admit it is an anesthetic
in a higher dose than what they are using in these studies. No mention is
made of course that as the drug builds up you can expect that anesthetic effect
that comes from the higher doses - just as you get as antidepressants
accumulate. And that they go on to say:
"Today's antidepressant medications eventually end up doing the same thing,
but they go about it the long way around, with a lot of biochemical steps that
take time. Now we've shown what the key targets are and that we can get at
them rapidly," said Zarate. "Ketamine probably can't become the medication of
choice, but this research is leading to some very real possibilities for a
whole new generation of antidepressant medications. "
Now I hope you understood here what they are telling you . . . they are
hoping to find a way with these new drugs coming from Ketamine to anesthetize
you faster than the current antidepressants are doing. They are saying it takes
too long to reach that point with the current ones although I would disagree
because I see it happen very quickly with these medications.
And next they go on to say that Ketamine's use is limited "BECAUSE IT MAY
CAUSE HALLUCINATIONS DURING RECOVERY FROM ANESTHESIA" - EXACTLY WHAT
ANTIDEPRESSANTS CAUSE IN DISCONTINUATION FROM THEIR OWN ANESTHETIC EFFECT AS WELL!!
This is why the FDA has warned of psychotic breaks in abrupt withdrawal from
antidepressants and why so many get a diagnosis of "Bipolar" when they stop or
change the dose of their antidepressant. It produces hallucinations. So if
they limit the use of Ketamine because of its potential to induce hallucinations
in withdrawal, why don't they try limiting their prescribing of
antidepressants that by their own admission produce the same?!
Now, if there was ever any question, just know for sure that this study is
perfect proof that NIH and NIMH are completely out of their minds!!! Of all
the absolutely insane studies they could think of, this is it!! Ketamine is
just as deadly as PCP and should have been pulled from the market at the same
time PCP was pulled and labeled as completely unfit for human consumption. Yet
antidepressants - admittedly producing the exact same effect are some of the
most popular drugs on the market today!
Please help us to wake up society by sharing this information with all you
come in contact with and helping us with our new donation program to help
spread the educational information, wake up government officials, help people come
safely off their medications and become productive citizens again and help
those in need of help with court cases resulting from the use of these drugs.
Go to _www.drugawareness. org_ (
http://www.drugawar eness.org) and call Joe
Goates at 801-597-2669 to see how anyone aged 70 - 87 can help fund all of these
things for us at NO COST TO THEM WHATSOEVER and yet it will help us with
funding so that we can help those who so desperately need it at no cost to them!
If you or a loved are in need of help with withdrawal, rebuilding after the
use of an antidepressant, or a court case caused by these drugs have your
grandmother, grandfather, god parent, etc. come forward and sponsor their
donation in your behalf without it costing them one red cent! I never dreamed we
could find such a simple way to produce the funds we need to help turn this
nightmare around! If you need help quickly you must act fast as today is the
deadline or they may be able still Monday, to get your applications in. It takes
three weeks from that time. The next batch will be a couple of months away.
Sorry if this is reaching you late and you have needed the help sooner. We
have sent notices before and perhaps many of you did not understand how simple
a program this is.
This drug-induced insanity MUST be turned around NOW! Too many are dying
needless deaths and having their lives completely shattered for no reason other
than drug company greed. How often do we need to see these cases pop up in the
news like the doctor this past week in Seattle who made false bomb threats
while in unintentional withdrawal from his Effexor? (He forgot to take it on a
business trip and had been without it for a few days and Effexor has
horrible withdrawal due to the timed release nature of that drug.) Go to our website
at _www.drugawareness. org_ (
http://www.drugawar eness.org) and click on the
database of cases to read thousands of similar cases connected to these
drugs.
Ann Blake Tracy, PhD, Executive Director,
International Coalition for Drug Awareness
_www.drugawareness. org_ (
http://www.drugawar eness.org/) and author of
Prozac:
Panacea or Pandora? - Our Serotonin Nightmare
and audio Help! I Can't Get Off My Antidepressant!
(800-280-0730)
____________ _________ _________ _________ ______
By aiming new medications at more direct molecular targets, such as NMDA or
AMPA, scientists may be able to bypass some of the steps through which current
antidepressants indirectly exert their effects -- a roundabout route that
accounts for the long time it takes for patients to begin feeling better with
the conventional medications.
While ketamine appears to achieve this, it is an unlikely candidate to become
a new treatment for depression, because of the side effects it can cause in
humans, including hallucinations. It is approved as an anesthetic by the Food
and Drug Administration at much higher doses than those given in the study,
but its use is limited because it may cause hallucinations during recovery
from anesthesia.
"Today's antidepressant medications eventually end up doing the same thing,
but they go about it the long way around, with a lot of biochemical steps that
take time. Now we've shown what the key targets are and that we can get at
them rapidly," said Zarate. "Ketamine probably can't become the medication of
choice, but this research is leading to some very real possibilities for a
whole new generation of antidepressant medications. "
_
http://www.scienced aily.com/ releases/ 2007/07/07072413 0613.htm_ (
http://www.scienced aily.com/ releases/ 2007/07/07072413 0613.htm)
Source: _NIH/National Institute of Mental Health_
(
http://www.nimh. nih.gov/) Date: July 25, 2007 More on:
_Mental Health_ (
http://www.scienced aily.com/ news/mind_ brain/mental_ health/)
, _Depression_ (
http://www.scienced aily.com/ news/mind_ brain/depression /) ,
_Mental Health Research_
(
http://www.scienced aily.com/ news/health_ medicine/ mental_health/) , _Psychiatry_
(
http://www.scienced aily.com/ news/mind_ brain/psychiatry /) , _Disorders and Syndromes_
(
http://www.scienced aily.com/ news/mind_ brain/disorders_ and_syndromes/) , _Pharmacology_
(
http://www.scienced aily.com/ news/health_ medicine/ pharmacology/)
Experimental Medication Ketamine Relieves Depression In Just Hours: Points
To Targets For New Medications
_Science Daily_ (
http://www.scienced aily.com/) — A new study has revealed
more about how the medication ketamine, when used experimentally for
depression, relieves symptoms of the disorder in hours instead of the weeks or months
it takes for current antidepressants to work. While ketamine itself probably
won't come into use as an antidepressant because of its side effects, the new
finding moves scientists considerably closer to understanding how to develop
faster-acting antidepressant medications -- among the priorities of the
National Institute of Mental Health (NIMH), part of the National Institutes of
Health
Ketamine blocks a receptor called NMDA on brain cells, an earlier NIMH study
in humans had shown, but the new study in mice shows that this is an
intermediate step. It turns out that blocking NMDA increases the activity of another
receptor, AMPA, and that this boost in AMPA is crucial for ketamine's rapid
antidepressant actions. The study was reported online in Biological
Psychiatry on July 23, by NIMH researchers Husseini K. Manji, MD, Guang Chen, MD, PhD,
Carlos Zarate, MD, and colleagues.
"Our research is showing us how to develop medications that get at the
biological roots of depression. This new finding is a major step toward learning
how to improve treatment for the millions of Americans with this debilitating
disorder; toward eliminating the weeks of suffering and uncertainty they have
to endure while they wait for their medications to work," said NIH Director
Elias Zerhouni, M.D.
Almost 15 million American adults have a depressive disorder. During the long
wait to begin feeling the effects of conventional medications, patients may
worsen, raising the risk of suicide for some. Depressive disorders also
affect children and adolescents.
By aiming new medications at more direct molecular targets, such as NMDA or
AMPA, scientists may be able to bypass some of the steps through which current
antidepressants indirectly exert their effects -- a roundabout route that
accounts for the long time it takes for patients to begin feeling better with
the conventional medications.
While ketamine appears to achieve this, it is an unlikely candidate to become
a new treatment for depression, because of the side effects it can cause in
humans, including hallucinations. It is approved as an anesthetic by the Food
and Drug Administration at much higher doses than those given in the study,
but its use is limited because it may cause hallucinations during recovery
from anesthesia.
Both NMDA and AMPA are receptors for the neurotransmitter glutamate, one of
the chemical messengers that enable brain cells to communicate with each
other. The glutamate system has been implicated in depression recently, leading to
efforts to unravel its molecular machinery in search of abnormalities and of
better targets for antidepressant medications.
This focus on the glutamate system is a departure from the thinking that led
to currently available antidepressants, which are thought to relieve
depression through a lengthy trickle-down process of biochemical reactions that
affect the circuitry underlying depression.
The fact that NMDA and AMPA receptors are part of the glutamate system and
that targeting them directly led to such rapid, sustained relief of
depression-like behaviors in this study -- and that a single dose of ketamine did the
same in humans in the earlier study -- suggests that they are probably the key
targets for antidepressant medications.
"In any other illness of depression's magnitude, patients aren't expected to
just accept that their treatments won't start helping them for weeks or
months. The value of our research on compounds like ketamine is that it tells us
where to look for more precise targets for new kinds of medications that can
close the gap," said NIMH Director Thomas R. Insel, MD. "We're making
tremendous progress."
To conduct the new study, researchers induced depression-like behaviors in
mice; for example, the mice gave up after being forced to engage in hopeless
tasks, such as prolonged swimming. A dose of ketamine reversed the
depression-like behaviors for at least two weeks.
When the researchers gave the mice a substance that blocks the AMPA receptor
beforehand, ketamine was not able to reverse the depression-like behaviors.
The boost in AMPA thus appears to be a necessary ingredient for ketamine's
antidepressant effects.
In a related experiment, the scientists used two different compounds instead
of ketamine to try to block just one part of the NMDA receptor, an even more
precise target. These other compounds also reduced depressive behaviors,
suggesting that it may be feasible to develop other fast-acting antidepressants
without ketamine's side effects.
"Today's antidepressant medications eventually end up doing the same thing,
but they go about it the long way around, with a lot of biochemical steps that
take time. Now we've shown what the key targets are and that we can get at
them rapidly," said Zarate. "Ketamine probably can't become the medication of
choice, but this research is leading to some very real possibilities for a
whole new generation of antidepressant medications. "
Reference: Maeng S, Zarate Jr. CA, Du J, Schloesser R, Joseph M, Chen G,
Manji HK. Cellular mechanisms underlying the antidepressant effects of ketamine:
role of AMPA receptors. Biological Psychiatry, online ahead of print, July
23, 2007.
Note: This story has been adapted from a news release issued by NIH/National
Institute of Mental Health.
12 Jul, 2007
Bill on drug safety clears House
Bill on drug safety, FDA funding clears House
By Lisa Richwine Wed Jul 11, 9:06 PM ET
WASHINGTON (Reuters) - The U.S. House of Representatives voted on Wednesday to give the Food and Drug Administration more power over drugmakers as part of an effort to better protect the public from dangerous medicines.
The measure must be merged with a competing version that passed the Senate in May before it can go to President George W. Bush to sign into law.
The FDA could require post-approval studies of new prescription drugs or order additional warnings under the legislation, which passed the House in a 403-16 vote.
Companies that fail to follow FDA directives could face fines as high as $50 million. Running a false or misleading advertisement to consumers could draw fines of $250,000.
"This legislation strikes the proper balance between new drug safety regulations and measures, and ensuring consumers have the access to innovative prescription pharmaceuticals without undue delay," said Rep. John Dingell, a Michigan Democrat and chairman of the House Energy and Commerce Committee.
The new authority for the FDA was among provisions meant to improve the government's drug safety oversight, increase transparency of company clinical trials and raise the fees that manufacturers pay to help speed reviews of medicines and medical devices.
Lawmakers crafted the legislation in response to complaints about the FDA's handling of serious side effects seen after drugs hit the market. The agency was criticized as slow to act on signs of problems with Merck & Co. Inc.'s arthritis pill Vioxx, which the company withdrew in 2004, and other medicines.
Pharmaceutical companies and the FDA had proposed $393 million in fees for each of the next five years to speed agency reviews and help fund safety monitoring after approval.
Under the House bill, companies would pay an extra $225 million over five years specifically for post-approval checks.
The Senate bill differs from the House plan in part by capping fines at $2 million and setting lower drugmaker fees.
Lawmakers are expected to work out differences between the House and Senate versions before the current fees expire in September.
The drug industry has generally supported the bill. Pharmaceutical companies strongly favor extending the fees they pay the FDA because they help cut product review times.
12 Jul, 2007
Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature
See especially the Table at: http://medicine.plosjournals.org/perlserv/?request=slideshow&type=table&doi=10.1371/journal.pmed.0020392&id=5510
Article available at: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020392
Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature
Jeffrey R. Lacasse, Jonathan Leo*
Competing Interests: The authors declare that no competing interests exist and that they received no funding for this work.
Citation: Lacasse JR, Leo J (2005) Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature. PLoS Med 2(12): e392 doi:10.1371/journal.pmed.0020392
Published: November 8, 2005
Copyright: © 2005 Lacasse and Leo. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abbreviations: DTCA, direct-to-consumer advertising; FDA, Food and Drug Administration; SSRI, selective serotonin reuptake inhibitor
*To whom correspondence should be addressed. E-mail: jleo1@tampabay.rr.com
Jeffrey R. Lacasse is at Florida State University College of Social Work, Tallahassee, Florida, United States of America. Jonathan Leo is at Lake Erie College of Osteopathic Medicine, Bradenton, Florida, United States of America.
In the United States, selective serotonin reuptake inhibitor (SSRI) antidepressants are advertised directly to consumers [1]. These highly successful direct-to-consumer advertising (DTCA) campaigns have largely revolved around the claim that SSRIs correct a chemical imbalance caused by a lack of serotonin (see Tables 1 and 2). For instance, sertraline (Zoloft) was the sixth best-selling medication in the US in 2004, with over $3 billion in sales [2] likely due, at least in part, to the widely disseminated advertising campaign starring Zoloft's miserably depressed ovoid creature. Research has demonstrated that class-wide SSRI advertising has expanded the size of the antidepressant market [3], and SSRIs are now among the best-selling drugs in medical practice [2].
Given the multifactorial nature of depression and anxiety, and the ambiguities inherent in psychiatric diagnosis and treatment, some have questioned whether the mass provision of SSRIs is the result of an over-medicalized society. These sentiments were voiced by Lord Warner, United Kingdom Health Minister, at a recent hearing: “…I have some concerns that sometimes we do, as a society, wish to put labels on things which are just part and parcel of the human condition”[4]. He went on to say, “Particularly in the area of depression we did ask the National Institute for Clinical Excellence [an independent health organisation that provides national guidance on treatment and prevention] to look into this particular area and their guideline on depression did advise non-pharmacological treatment for mild depression” [4]. Sentiments such as Lord Warner's, about over-medicalization, are exactly what some pharmaceutical companies have sought to overcome with their advertising campaigns. For example, Pfizer's television advertisement for the antidepressant sertraline (Zoloft) stated that depression is a serious medical condition that may be due to a chemical imbalance, and that “Zoloft works to correct this imbalance” [5]. Other SSRI advertising campaigns have also claimed that depression is linked with an imbalance of the neurotransmitter serotonin, and that SSRIs can correct this imbalance (see Table 2). The pertinent question is: are the claims made in SSRI advertising congruent with the scientific evidence?
The Serotonin Hypothesis
In 1965, Joseph Schildkraut put forth the hypothesis that depression was associated with low levels of norepinephrine [6], and later researchers theorized that serotonin was the neurotransmitter of interest [7]. In subsequent years, there were numerous attempts to identify reproducible neurochemical alterations in the nervous systems of patients diagnosed with depression. For instance, researchers compared levels of serotonin metabolites in the cerebrospinal fluid of clinically depressed suicidal patients to controls, but the primary literature is mixed and plagued with methodological difficulties such as very small sample sizes and uncontrolled confounding variables. In a recent review of these studies, the chairman of the German Medical Board and colleagues stated, “Reported associations of subgroups of suicidal behavior (e.g. violent suicide attempts) with low CSF–5HIAA [serotonin] concentrations are likely to represent somewhat premature translations of findings from studies that have flaws in methodology” [8]. Attempts were also made to induce depression by depleting serotonin levels, but these experiments reaped no consistent results [9]. Likewise, researchers found that huge increases in brain serotonin, arrived at by administering high-dose L-tryptophan, were ineffective at relieving depression [10].
Contemporary neuroscience research has failed to confirm any serotonergic lesion in any mental disorder, and has in fact provided significant counterevidence to the explanation of a simple neurotransmitter deficiency. Modern neuroscience has instead shown that the brain is vastly complex and poorly understood [11]. While neuroscience is a rapidly advancing field, to propose that researchers can objectively identify a “chemical imbalance” at the molecular level is not compatible with the extant science. In fact, there is no scientifically established ideal “chemical balance” of serotonin, let alone an identifiable pathological imbalance. To equate the impressive recent achievements of neuroscience with support for the serotonin hypothesis is a mistake.
With direct proof of serotonin deficiency in any mental disorder lacking, the claimed efficacy of SSRIs is often cited as indirect support for the serotonin hypothesis. Yet, this ex juvantibus line of reasoning (i.e., reasoning “backwards” to make assumptions about disease causation based on the response of the disease to a treatment) is logically problematic—the fact that aspirin cures headaches does not prove that headaches are due to low levels of aspirin in the brain. Serotonin researchers from the US National Institute of Mental Health Laboratory of Clinical Science clearly state, “[T]he demonstrated efficacy of selective serotonin reuptake inhibitors…cannot be used as primary evidence for serotonergic dysfunction in the pathophysiology of these disorders” [12].
Reasoning backwards, from SSRI efficacy to presumed serotonin deficiency, is thus highly contested. The validity of this reasoning becomes even more unlikely when one considers recent studies that even call into question the very efficacy of the SSRIs. Irving Kirsch and colleagues, using the Freedom of Information Act, gained access to all clinical trials of antidepressants submitted to the Food and Drug Administration (FDA) by the pharmaceutical companies for medication approval. When the published and unpublished trials were pooled, the placebo duplicated about 80% of the antidepressant response [13]; 57% of these pharmaceutical company–funded trials failed to show a statistically significant difference between antidepressant and inert placebo [14]. A recent Cochrane review suggests that these results are inflated as compared to trials that use an active placebo [15]. This modest efficacy and extremely high rate of placebo response are not seen in the treatment of well-studied imbalances such as insulin deficiency, and casts doubt on the serotonin hypothesis.
Also problematic for the serotonin hypothesis is the growing body of research comparing SSRIs to interventions that do not target serotonin specifically. For instance, a Cochrane systematic review found no major difference in efficacy between SSRIs and tricyclic antidepressants [16]. In addition, in randomized controlled trials, buproprion [17] and reboxetine [18] were just as effective as the SSRIs in the treatment of depression, yet neither affects serotonin to any significant degree. St. John's Wort [19] and placebo [20] have outperformed SSRIs in recent randomized controlled trials. Exercise was found to be as effective as the SSRI sertraline in a randomized controlled trial [21]. The research and development activities of pharmaceutical companies also illustrate a diminishing role for serotonergic intervention—Eli Lilly, the company that produced fluoxetine (Prozac), recently released duloxetine, an antidepressant designed to impact norepinephrine as well as serotonin. The evidence presented above thus seems incompatible with a specific serotonergic lesion in depression.
Although SSRIs are considered “antidepressants,” they are FDA-approved treatments for eight separate psychiatric diagnoses, ranging from social anxiety disorder to obsessive-compulsive disorder to premenstrual dysphoric disorder. Some consumer advertisements (such as the Zoloft and Paxil Web sites) promote the serotonin hypothesis, not just for depression, but also for some of these other diagnostic categories [22,23]. Thus, for the serotonin hypothesis to be correct as currently presented, serotonin regulation would need to be the cause (and remedy) of each of these disorders [24]. This is improbable, and no one has yet proposed a cogent theory explaining how a singular putative neurochemical abnormality could result in so many wildly differing behavioral manifestations.
In short, there exists no rigorous corroboration of the serotonin theory, and a significant body of contradictory evidence. Far from being a radical line of thought, doubts about the serotonin hypothesis are well acknowledged by many researchers, including frank statements from prominent psychiatrists, some of whom are even enthusiastic proponents of SSRI medications (see Table 1).
However, in addition to what these authors say about serotonin, it is also important to look at what is not said in the scientific literature. To our knowledge, there is not a single peer-reviewed article that can be accurately cited to directly support claims of serotonin deficiency in any mental disorder, while there are many articles that present counterevidence. Furthermore, the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is published by the American Psychiatric Association and contains the definitions of all psychiatric diagnoses, does not list serotonin as a cause of any mental disorder. The American Psychiatric Press Textbook of Clinical Psychiatry addresses serotonin deficiency as an unconfirmed hypothesis, stating, “Additional experience has not confirmed the monoamine depletion hypothesis” [25].
Consumer Advertisements of Antidepressants
Contrary to what many people believe, the FDA does not require preapproval of advertisements. Instead, the FDA monitors the advertisements once they are in print or on the air [26]. Misleading content is frequently found in various DTCA campaigns [27]; hence, it is valuable to compare SSRI advertisements to the scientific evidence reviewed above. These SSRI ads are widely promulgated; hundreds of millions of dollars have been spent disseminating these advertisements, and one study found that over 70% of surveyed patients reported exposure to antidepressant DTCA [28].
The Role of the FDA
In the US, the FDA monitors and regulates DTCA. The FDA requires that advertisements “cannot be false or misleading” and “must present information that is not inconsistent with the product label” [27]. Pharmaceutical companies that disseminate advertising incompatible with these requirements can receive warning letters and can be sanctioned. The Irish equivalent of the FDA, the Irish Medical Board, recently banned GlaxoSmithKline from claiming that paroxetine corrects a chemical imbalance even in their patient information leaflets [29]. Should the FDA take similar action against consumer advertisements of SSRIs?
As just one example, the prescribing information for paroxetine, which is typical of the SSRI-class drugs, states, “The efficacy of paroxetine in the treatment of major depressive disorder, social anxiety disorder, obsessive-compulsive disorder (OCD), panic disorder (PD), generalized anxiety disorder (GAD), and post-traumatic stress disorder (PTSD) is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin. Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets” [30].
In other words, the mechanism of action of paroxetine has not been definitively established, and remains unconfirmed and presumptive (the prescribing information states that the efficacy of the drug “is presumed to be linked to potentiation of serotonergic activity” ([30], our italics added). Although there is evidence that paroxetine inhibits the reuptake of serotonin, the significance of this phenomenon in the amelioration of psychiatric symptoms is unknown, and continually debated [12,31]. Most importantly, the prescribing information does not mention a serotonin deficiency in those administered paroxetine, nor does it claim that paroxetine corrects an imbalance of serotonin. In contrast, the consumer advertisements for paroxetine present claims that are not found in this FDA-approved product labeling.
In order to determine whether these advertisements actually comply with FDA regulations, it is useful to consult the Code of Federal Regulations under which DTCA is regulated. The regulations state that an advertisement may be cited as false or misleading if it “[c]ontains claims concerning the mechanism or site of drug action that are not generally regarded as established by scientific evidence by experts qualified by scientific training and experience without disclosing that the claims are not established and the limitations of the supporting evidence…” ([32], our emphasis added]).
Stating that depression may be due to a serotonin deficiency is seemingly allowed, but, as stated in the regulations, only if the limitations of the supporting evidence are provided. In our examination of SSRI advertisements, we did not locate a single advertisement that presented any such information. Instead, the serotonin hypothesis is typically presented as a collective scientific belief, as in the Zoloft advertisement, which states that regarding depression, “Scientists believe that it could be linked with an imbalance of a chemical in the brain called serotonin” [33]. Consumers viewing such advertisements remain uninformed regarding the limitations of the serotonin hypothesis (reviewed above).
According to federal regulations, advertisements are also proscribed from including content that “contains favorable information or opinions about a drug previously regarded as valid but which have been rendered invalid by contrary and more credible recent information” [32].
This means that a disconnect between the evolving peer-reviewed literature and advertisements is not permitted. Regarding SSRIs, there is a growing body of medical literature casting doubt on the serotonin hypothesis, and this body is not reflected in the consumer advertisements. In particular, many SSRI advertisements continue to claim that the mechanism of action of SSRIs is that of correcting a chemical imbalance, such as a paroxetine advertisement, which states, “With continued treatment, Paxil can help restore the balance of serotonin…” [22]. Yet, as previously mentioned, there is no such thing as a scientifically established correct “balance” of serotonin. The take-home message for consumers viewing SSRI advertisements is probably that SSRIs work by normalizing neurotransmitters that have gone awry. This was a hopeful notion 30 years ago, but is not an accurate reflection of present-day scientific evidence.
The FDA has sent ten warning letters to antidepressant manufacturers since 1997 [34–43], but has never cited a pharmaceutical company for the issues covered here. The reasons for their inaction are unclear but seem to result from a deliberate decision at some level of the FDA, rather than an oversight. Since 2002, the first author (JRL) has repeatedly contacted the FDA regarding these issues. The only substantive response was an E-mail received from a regulatory reviewer at the FDA: “Your concern regarding direct-to-consumer advertising raises an interesting issue regarding the validity of reductionistic statements. These statements are used in an attempt to describe the putative mechanisms of neurotransmitter action(s) to the fraction of the public that functions at no higher than a 6th grade reading level” (personal communication, 2002 April 11).
It is curious that these advertisements are rationalized as being appropriate for those with poor reading skills. If the issues surrounding antidepressants are too complex to explain accurately to the general public, one wonders why it is imperative that DTCA of antidepressants be permitted at all. However, contrary to what the FDA seems to be implying, truth and simplicity are not mutually exclusive. Consider the medical textbook, Essential Psychopharmacology, which states, “So far, there is no clear and convincing evidence that monoamine deficiency accounts for depression; that is, there is no ‘real’ monoamine deficit” [44]. Like the pharmaceutical company advertisements, this explanation is very easy to understand, yet it paints a very different picture about the serotonin hypothesis.
Conclusion
The impact of the widespread promotion of the serotonin hypothesis should not be underestimated. Antidepressant advertisements are ubiquitous in American media, and there is emerging evidence that these advertisements have the potential to confound the doctor–patient relationship. A recent study by Kravitz et al. found that pseudopatients (actors who were trained to behave as patients) presenting with symptoms of adjustment disorder (a condition for which antidepressants are not usually prescribed) were frequently prescribed paroxetine (Paxil) by their physicians if they inquired specifically about Paxil [45]; such enquiries from actual patients could be prompted by DTCA [45].
What remains unmeasured, though, is how many patients seek help from their doctor because antidepressant advertisements have convinced them that they are suffering from a serotonin deficiency. These advertisements present a seductive concept, and the fact that patients are now presenting with a self-described “chemical imbalance” [46] shows that the DTCA is having its intended effect: the medical marketplace is being shaped in a way that is advantageous to the pharmaceutical companies. Recently, it has been alleged that the FDA is more responsive to the concerns of the pharmaceutical industry than to their mission of protecting US consumers, and that enforcement efforts are being relaxed [47]. Patients who are convinced they are suffering from a neurotransmitter defect are likely to request a prescription for antidepressants, and may be skeptical of physicians who suggest other interventions, such as cognitive-behavioral therapy [48], evidence-based or not. Like other vulnerable populations, anxious and depressed patients “are probably more susceptible to the controlling influence of advertisements” [49].
In 1998, at the dawn of consumer advertising of SSRIs, Professor Emeritus of Neuroscience Elliot Valenstein summarized the scientific data by concluding, “What physicians and the public are reading about mental illness is by no means a neutral reflection of all the information that is available” [50]. The current state of affairs has only confirmed the veracity of this conclusion. The incongruence between the scientific literature and the claims made in FDA-regulated SSRI advertisements is remarkable, and possibly unparalleled.
(See link for references)
12 Jul, 2007
FDA Considers Removing Black Box Warning on Antidepressants
http://www.pharmalot.com covers the pharmaceutical industry and is a fairly new service of the The Star-Ledger of New Jersey. Vote "Leave the Black Box warnings alone!" here:
That’s what Tom Laughren, the FDA official who oversees psychiatric drugs, says may happen if CDC data on suicides in 2005, which will be released at year’s end, is compelling. The potential flip-flop comes amid growing noise by some psychiatrists that the agency’s Black Box warnings in 2004 that antidepressants are somehow linked to suicide in youngsters may be scaring some docs, parents and teenagers.
As evidence, some psychiatrists cite a recent study in The Journal of American Psychiatry, which found the number of scrips for pediatric depression, ages 5 to 18, fell more than 50 percent between 2003 and 2005. At the same time, the number of teen suicides jumped a record 18 percent between 2003 and 2004, the most recent year for which data exist.
“If I had known how much the label would rattle parents, I wouldn’t have voted for it,” Gail Griffith, who was the patient representative on the FDA panel that recommended the warnings, tells Newsweek.
For his part, Laughren notes that the study reflected “only one year of data,” but updated CDC may be revealing. “If the rates are up again, it’s likely we’ll go back to the board of advisers,” he tells the weekly mag, which notes the FDA has repealed only one Black Box warning in its history, on the acid-reflux medication Prilosec, which was withdrawn in 2003. “But I wouldn’t rule it out,” he adds. “The evidence is very compelling.”
For the "rest of the story", see here: http://tinyurl.com/3yehvo
For more info, see here: www.psychsearch.net/child_suicides.pdf
About Pharmalot
Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, for the past 12 years. During that time, he has closely followed a variety of topics of concern to those who work for, and with, pharmaceutical manufacturers — drug development; mergers and acquisitions; regulatory oversight; safety and pricing controversies, and marketing issues.
Prior to joining The Star-Ledger, Silverman spent six years at New York Newsday and previously worked at Investor’s Business Daily, among other newspapers. He has a master’s degree in journalism from New York University and a bachelor’s degree in accounting from Binghamton University. Although tethered to his laptop, Silverman lives in suburban New Jersey with his wife, three children and one sizeable labrador retriever.
22,223 signatures against TeenScreen:
12 Jul, 2007
CHADD Fires Coordinator for talking about science
via email...
Why was Steve Plog fired by ChADD for talking about lab tests & nutrition?
My name is Steven Plog. In Jan of 2006, I served as the Las Vegas coordinator for ChADD
(Children and Adults with Attention Deficit Disorder). My position lasted just 30 days.
I'm 52 now, but at the age of 39 in a 30 minute interview with a psychiatrist recommended to me
by ChADD in Chicago, I was diagnosed by a visual evaluation as having "so-called ADD" and
given a prescription of Ritalin. Later I found out I was toxic and suffering from nutrient depletions,
not a neurotransmitter malfunction in my brain, that was diagnosed by simply talking to me.
ChADD claims to be a grass-roots support group for persons with “so-called” ADD, like me.
My firing for talking about nutrition proves that ChADD, in fact, is not a grass-roots group at
all, but is simply a front group for the psycho-pharmaceutical industry and drug companies,
working to forward their specific messages and increase profits.
I'm now founder of The Results Project
www.resultsproject.net a non-profit organization who
is dedicated to getting people a proper diagnosis using lab tests, not visual evaluations.
In Sept of 2005 Heather Rockow then ChADD Coordinator for Las Vegas came to my meeting
where I presented lab test for symptoms of hyperactivity, depression, mood swings, attention
span etc.(With information from the lab tests, nutrition is the next step, not drugs. FYI)
Heather realized I had better information and better science than she was being sent by
ChADD and joined my 4 month program to help her husband, who was on 7 prescription
drugs per day and had been for 20 years. Turns out he was high in toxic metals and suffered
from multiple delayed food allergies. Dr. Robert Ellsworth, the doctor who orders the tests
said that after looking at the lab results stated that none of these results could be treated
with drugs, in fact they would make them worse.
Later, Heather stepped down from ChADD and recommenced me for the position.
I became the ChADD Chapter Coordinator for Las Vegas on January 1, 2006. Thinking
that other ChADD Coordinators might want this information like Heather did I called ChADD
HQ and asked if I could put a full page, full color ad in their ChADD magazine for a full year
about nutrition and lab tests.They said, "No".
When I asked why, they said all of their magazines are donated, and only the donors get their
info published. Big Pharma, selling Ritalin, Adderall etc., is the donor.
I then asked if I could donate an alternative magazine that I fund and send to ChADD Coordinators
to distribute for free to parents with info on lab tests and nutrition just like the drug companies.
They said, "No".
When I asked why, ChADD contends that they only distribute information that has science behind it,
and nutrition has none. Zero, Zip, Zilch. I said, "What about the over 100,000 published research
papers in major medical journals like JAMA, New England Journal of Medicine,
www.pubmed.gov
of which many are by Nobel Prize Winners in Medicine?"
ChADD replied that the subject is closed for discussion and hung up on me.
Later they found out I was talking about lab tests and nutrition in my ChADD weekly meetings in
Vegas and terminated me as the Coordinator.
Ruth Hughes Deputy CEO of ChADD personally called me up to fire me. We talked for an hour and I
brought up multiple references such as:
American Naturopathic Medical Association (ANMA) (
www.anma.com)
American Association of Orthomolecular Physicians (
www.orthomolecular.org)
Institute for Traditional Medicine (
www.itmonline.org )
American Nutraceutical Association (ANA) (
www.ana-jana.org )
I told Ruth there's more proof from labs that nutrition works than there is proof that Lincoln was ever
president of the US. For an hour I brought up fact after fact that she couldn't dispute so she would
say; "We'll have to agree to disagree."
I also pointed out the ChADD Motto right out of their Coordinator Manual states:
"It is the philosophy of ChADD that persons seeking information, non-judgmental support and education
about AD/HD be able to participate in a setting which is non-discriminatory and promotes recognized
best practices." Link from Manual http://www.resultsproject.net/gfx/CHADD1.png When I asked, "Wouldn't lab tests recognized by the FDA, AMA and NIH as "best practices" qualify to
be presented to parents in an unbiased ChADD meeting?"
She said, "We'll have to agree to disagree."
When I asked if I could bring outside materials to the open meetings Ruth said, "No products can be
sold in ChADD meetings." I asked why then meetings I've been to in Orlando & Dallas had drug reps
in the meeting presenting?" Ruth said, "We'll have to agree to disagree," fired me and hung up.
Termination Letter: http://www.resultsproject.net/gfx/CHADD2.png
Last week I sent out an invitation to over 100 ChADD Coordinators across America after getting their
contact info from their website inviting them to my EXPO featuring speakers from top labs in the country.
This EXPO is open to parents, teachers, doctors and child advocates dealing with "so-called ADD"
What's Causing My Symptoms? http://www.whatcausedmysymptoms.com/ Sept. 14th Las Vegas.
(If you would like to attend the Vegas EXPO click the above link)
The invitation stated that as a ChADD Coordinator they could attend for FREE and then I gave them a
link with all the speakers. (
www.whatcausedmysymptoms.com/html/speakers.html )
These labs provide tests to measure sugar levels, food allergies, hormone levels, metal toxicity, nutrient
depletions, serotonin levels and anti-oxidants. These lab tests can point to physical causes for symptoms
such as bad memory, low attention span, hyperactivity, mood swings, anger, depression, fatigue,
restlessness, headaches, insomnia.
They also show that Ritalin, Adderall, Concerta & Prozac are not needed at all. Once the nutritional
deficiencies are addressed, most if not all of the symptoms disappear.
Their response? 100% turned me down and 5 threatened me for emailing them the invitation. Why would
100% of the people who supposedly care about children, not want to see evidence based solutions to
safely reverse a child's symptoms?
ChADD is a big supporter of TeenScreen another Big Pharma backed program that will have children
take a simple 20 question test and then if the laymen who scores it gets the score they want, that
child will be sent to a psychiatrist who will give them a visual evaluation with no lab testing and then
according to the latest study by,
J AM Academy Adolescent Psychiatry 2002; 41:123-130
"9 out of 10 new psychiatrist will be put those children on drugs."
ChADD is just another front group for Big Pharma, which uses psychiatry to sell unnecessary,
dangerous, mind-altering drugs to children. They have over 20,000 members who are being told
that lab tests are unreliable and a psychiatrist visual evaluation is science and the drugs are
for an unseen mental problem.
If your doctor looked at you and said you had cancer, would you believe the diagnosis?
Why then when a psychiatrist looks at you and says you need Ritalin, do you believe it?
11 May, 2007
NYT Analysis Looks at Psychiatrists Who Receive Payments From Drug Companies
Thursday, May 10, 2007
Prescription Drugs
NYT Analysis Looks at Psychiatrists Who Receive Payments From Drug Companies
The New York Times on Thursday examined how "the intersection of money and medicine, and its effect on the well-being of patients, has become one of the most contentious issues in health care" -- and "[n]owhere is that more true than in psychiatry, where increasing payments to doctors have coincided with the growing use in children of a relatively new class of drugs known as atypical antipsychotics." Drugs in the best-selling class of antipsychotics --
which includes Risperdal, Seroquel, Zyprexa, Abilify and Geodon -- are being prescribed to more than 500,000 U.S.
children "to help parents deal with behavior problems despite profound risks and almost no approved uses for minors,
" the Times reports.
The Times conducted an analysis of records in Minnesota, the only state that requires public reports of all drug company
marketing payments to doctors. The analysis found that from 1997 to 2005, more than one-third of Minnesota's licensed
The analysis found that from 2000 to 2005, drug maker payments to Minnesota psychiatrists increased more than sixfold to
$1.6 million.
During the same period, prescriptions of antipsychotics for children in Minnesota's Medicaid program rose more than ninefold, the Times analysis found. The analysis also found that doctors "who took the most money from makers of atypicals tended to prescribe the drugs to children the most often," the Times reports. Further, Minnesota psychiatrists who received at least $5,000 from manufacturers of atypicals from 2000 to 2005 appear to have written three times as many atypical prescriptions for children as psychiatrists who received less or no money. The analysis found that payments to individual psychiatrists ranged from $51 to more than $689,000, with a median of $1,750.
According to the Times, because the records are "incomplete, these figures probably underestimate doctors' actual incomes." The Times notes that "[n]o one has proved that psychiatrists prescribe atypicals to children because of drug company payments" (Harris et al., New York Times, 5/10).
11 May, 2007
Illegal Promoting of OxyContin by Manufacturer's Sales Force
http://www.fda.gov/medwatch/safety/2007/safety07.htm#OxyContinMedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals of criminal charges and civil liabilities brought against Purdue Frederick in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces. The manufacturer's sales force was trained to make false claims about the product to healthcare professionals, thereby, misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications. These practices falsely promote the product and may cause
health risks for consumers.
Read the complete 2007 Safety summary, including a link to the FDA Press
Release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#OxyContin
10 May, 2007
Antipsychotic Drug Use in Children - Pharmaceutical Funded Doctors
Fabrizio Costantini for The New York Times
Anya Bailey is among a growing number of children given antipsychotic drugs by doctors who are paid by the makers of those drugs.
“Trust me, I don’t make much,” she said. Drug company payments did not affect her study or her talks, she said. In a recent disclosure, Dr. DelBello said that she received marketing or consulting income from eight drug companies, including all five makers of atypicals.
Dr. Realmuto has heard Dr. DelBello speak several times, and her talks persuaded him to use combinations of Depakote and atypicals in bipolar children, he said. “She’s the leader in terms of doing studies on bipolar,” Dr. Realmuto said.
Some psychiatrists who advocate use of atypicals in children acknowledge that the evidence supporting this use is thin. But they say children should not go untreated simply because scientists have failed to confirm what clinicians already know.
“We don’t have time to wait for them to prove us right,” said Dr. Kent G. Brockmann, a psychiatrist from the Twin Cities who made more than $16,000 from 2003 to 2005 doing drug talks and one-on-one sales meetings, and last year was a leading prescriber of atypicals to Medicaid children.
The Reaction
For Anya Bailey, treatment with an atypical helped her regain her appetite and put on weight, but also heavily sedated her, her mother said. She developed the disabling knot in her back, the result of a nerve condition called dystonia, in 2005.
The reaction was rare but not unknown. Atypicals have side effects that are not easy to predict in any one patient. These include rapid weight gain and blood sugar problems, both risk factors for diabetes; disfiguring tics, dystonia and in rare cases heart attacks and sudden death in the elderly.
In 2006, the Food and Drug Administration received reports of at least 29 children dying and at least 165 more suffering serious side effects in which an antipsychotic was listed as the “primary suspect.” That was a substantial jump from 2000, when there were at least 10 deaths and 85 serious side effects among children linked to the drugs. Since reporting of bad drug effects is mostly voluntary, these numbers likely represent a fraction of the toll.
Jim Minnick, a spokesman for AstraZeneca, said that the company carefully monitors reported problems with Seroquel. “AstraZeneca believes that Seroquel is safe,” Mr. Minnick said.
Other psychiatrists renewed Anya’s prescriptions for Risperdal until Ms. Bailey took Anya last year to the Mayo Clinic, where a doctor insisted that Ms. Bailey stop the drug. Unlike most universities and hospitals, the Mayo Clinic restricts doctors from giving drug marketing lectures.
Ms. Bailey said she wished she had waited to see whether counseling would help Anya before trying drugs. Anya’s weight is now normal without the help of drugs, and her counseling ended in March. An experimental drug, her mother said, has recently helped the pain in her back.
09 May, 2007
The New York Times: Doctors Reaping Millions for Use of Anemia Drugs
A dirty little secret is finally exposed...
May 9, 2007
Doctors Reaping Millions for Use of Anemia Drugs
Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving
their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.
The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent
cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’
risks of heart attacks or strokes.
Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers —
total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over
the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall
business.
Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show
that at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million
worth of its drugs last year.
Yesterday, the Food and Drug Administration added to concerns about the drugs, releasing a report that suggested that their use might
need to be curtailed in cancer patients. The report, prepared by F.D.A. staff scientists, said no evidence indicated that the medicines either
improved quality of life in patients or extended their survival, while several studies suggested that the drugs can shorten patients’ lives when
used at high doses. Yesterday’s report followed the F.D.A.’s decision in March to strengthen warnings on the drugs’ labels.
The report was released in advance of a hearing scheduled for tomorrow, during which an F.D.A. advisory panel will consider whether the
drugs are overused.
The medicines — Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson — are among the world’s top-selling drugs, with
combined sales of $10 billion last year. In this country, they represent the single biggest drug expense for Medicare and are given to about a
million patients each year to treat anemia caused by kidney disease or cancer chemotherapy.
Dr. Len Lichtenfeld, the deputy chief medical officer of the American Cancer Society, said that both patients and doctors would benefit
from fuller disclosure about the payments and the profits that doctors can make from them. “I suspect that Medicare is going to take a
very careful look at what is going on here,” he said.
Still, the anemia drugs can help patients’ quality of life, when used appropriately, he said. “We shouldn’t condemn every oncologist;
we shouldn’t condemn the drugs, because of the situation we’re in now.”
Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from
pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in
their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors
receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for
the drugs, often at a markup over the doctors’ purchase price.
Medicare has changed its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined with
those insurance reimbursements, the rebates enable many doctors to profit substantially on the medicines they buy and then give to patients.
The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company’s drugs exclusively typically
receive higher rebates.
Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to use more medicine. Instead, the
rebates “reflect intense competition” in the market for the drugs, the company said.
Amgen said that rebates were a normal commercial practice and that it had always properly promoted its drugs.
“Amgen is dedicated to patient safety,” said David Polk, a spokesman. “We believe our contracts support appropriate anemia management
and our product promotion is always strictly within the label.”
Both companies’ stocks fell yesterday after release of the F.D.A. report. Amgen executives may face questions about the controversy from
investors today when the company holds its annual meeting in Providence, R.I.
Since 1991, when the first of the drugs was still relatively new, the average dose given to dialysis patients in this country has nearly tripled.
About 50 percent of dialysis patients now receive enough of the drugs to raise their red blood cell counts above the level considered risky by
the F.D.A.
American patients receive far more of the anemia drugs than patients elsewhere, with dialysis patients in this country getting doses more than
twice as high as their counterparts in Europe. Cancer care shows a similar pattern. American cancer patients are about three times as likely
as those in Europe to get the drugs, and they receive somewhat higher doses.
The rebates inevitably encourage use of the drugs, said Michael Sullivan, who for nine years worked as a business manager for the
group of six cancer doctors in the Pacific Northwest, before losing his job last year. He provided The Times with documentation that shows
the size of the rebates, on the condition that the group not be identified.
“Personally, I think rebates should go away,” said Mr. Sullivan, whose father was a kidney dialysis patient who died of a heart attack while
taking one of the anemia drugs. “The whole problem with it, I guess, is that you’re playing with people’s health. It’s not the same as buying
widgets.”
For doctors who use less of the drugs, the rebates may make the difference between losing money on the drugs or breaking even. Mr.
Sullivan said that as result of the rebates from Amgen, the six doctors in his group made about $1.8 million in net profit on the drugs they
prescribed.
Unlike most drugs, the anemia medicines do not come in fixed doses. Therefore, doctors have great flexibility to increase dosing —
and profits. Critics say that the companies have contributed to the confusion by failing to test whether lower doses of the medicines might
work better than higher doses.
“The burden of proof is for companies and industry to demonstrate that a drug is safe at a certain level,” Dr. Ajay Singh, an associate
professor at Harvard Medical School. Dr. Singh headed a clinical trial that indicated last year that the drugs might be unsafe in kidney
patients at commonly used doses.
Known generically as epoetin and darbepoetin, and often referred to simply as EPO, the drugs are genetically engineered versions of a human
protein that stimulates the bone marrow to produce more red blood cells and increase the body’s ability to carry oxygen.
Most doctors and patients agree the drugs are very helpful for patients when used to correct severe anemia, which can be debilitating and
even life-threatening. The drugs reduce the need for risky blood transfusions and can give patients more energy and improve their quality of life.
“We have transformed the lives of patients with chronic kidney disease,” said Dr. Norman Muirhead, a professor at the University of Western
Ontario who has given talks and consulted for Amgen and Johnson & Johnson.
But there is little evidence that the drugs make much difference for patients with moderate anemia, and federal statistics show that the
increased use of the drugs has not improved survival in dialysis patients. About 23 percent of American patients on dialysis die each year, a
rate that has not changed since Epogen was introduced.
Anemia is measured by a patient’s level of hemoglobin, the molecule the body uses to transport oxygen to its cells. Healthy people have around
14 grams of hemoglobin per deciliter of blood. Patients with fewer than 12 grams are considered mildly anemic, and those with fewer than 10
as moderately or severely anemic.
The labels on the drugs, as currently approved by the F.D.A., encourage doctors to aim for a hemoglobin level of 10 to 12. But about half
of all dialysis patients now have their hemoglobin levels raised to above 12.
Critics of the drugs say their increased use has been driven by profit. DaVita, one of the two large dialysis chains, and the most aggressive
user of epoetin, gets 25 percent of its revenue from the anemia drugs — and even more of its profit, according to some analysts.
Dr. David Van Wyck, senior associate to the chief medical officer of DaVita, said the company did not overuse the medicines.
Doctors determine how much to use, Dr. Van Wyck said. “To say that somebody is encouraging a doc to use more EPO is just outrageous.”
Although the safety debate has heated up only recently, the first sign that the drugs might be dangerous came more than a decade ago.
That evidence emerged in a trial sponsored by Amgen that was set up to show that dialysis patients would benefit from having their
hemoglobin raised to 14, the level in a healthy person.
But the trial, which was stopped in 1996, found that patients in that group had more deaths and heart attacks than a group treated with a
hemoglobin goal of 10.
That trial should have discouraged doctors from using too much epoetin and encouraged Amgen to study the risks further, said Dr. Steven
Fishbane, a nephrologist at Winthrop-University Hospital on Long Island.
Instead, use of epoetin continued to soar. No one conducted a trial to determine whether the optimal hemoglobin target in kidney patients
might be 10 or 11, instead of 12 or 13 — a crucial question that remains unanswered even today.
Dr. Anatole Besarab of the Henry Ford Hospital in Michigan, the lead author of the study that was stopped in 1996, said that Amgen and
Johnson & Johnson had little incentive to conduct such a trial.
Dr. Robert M. Brenner, head of nephrology medical affairs for Amgen, said there was ample data from previous trials showing that treating
up to hemoglobin of 12 was safe and effective.
Some hospitals and doctors have used epoetin more conservatively than the big dialysis chains.
Dr. Ronald A. Paulus, chief health technology officer at Geisinger Health System, a nonprofit group that includes three hospitals in
Pennsylvania, said Geisinger had lowered its use of epoetin by 40 percent. Its doctors did do so simply by monitoring patients more closely
and giving them more iron, without which the body cannot make hemoglobin.
Dr. N. D. Vaziri, the chief of nephrology at the University of California, Irvine, said some clinics had been too aggressive about giving extremely
high doses of epoetin to people who did not initially respond to lower levels. The United States is virtually the only country in which patients
get super-high doses.
“You create a toxicity situation,” said Dr. Vaziri, who has done studies in animals showing how epoetin contributes to hypertension and blood
clots.
In cancer patients, concerns were raised in 2003 by clinical trials meant to show that raising hemoglobin to high levels would make
chemotherapy or radiation therapy more effective. Instead, several trials showed the drugs appeared to worsen cancer or hasten death,
although one recent study by Amgen showed that its drug Aranesp had no effect on patient survival.
The conflicting studies are among the issues the F.D.A. advisory committee is expected to discuss tomorrow. Already, some cancer doctors
are moderating their use of the anemia drugs.
Dr. Peter Eisenberg, an oncologist in Marin County, Calif., said many doctors had been induced to use more epoetin by the financial
incentives and the belief that the drug was helpful.
“The deal was so good,” he said. “The indication was so clear and the downside was so small that docs just worked it into their practice easily.
“Now it’s much scarier than that,” he said. “We could really be doing harm.”
04 May, 2007
FDA expands suicide warning on 36 drugs but leaves out some drugs that act as SSRIs
via email:
As you should all know by now Wednesday the FDA finally issued the warning
we learned last December was on its way. That new warning now includes the
same warning of increased suicide risk for ages 18 -24 who take antidepressants
which was previously issued for those 18 and under who take antidepressants.
Following is a list of the 36 drugs warned of and a news article on this new
FDA warning that is two decades late in being issued. Keep in mind that this
list does NOT include all the drugs it should include. Many other
medications also work as Selective Serotonin Reuptake Inhibitors. One would be the pain
killer, Ultram or tramadol. Another would be the old antidepressant
Izoniazid, now being used as a TB medication.
Ann Blake Tracy, Ph.D., Executive Director,
International Coalition For Drug Awareness
Website: _www.drugawareness. org_ (http://www.drugawar eness.org/)
Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare
& CD or audio tape on safe withdrawal: "Help! I Can't Get
Off My Antidepressant! "
Order Number: 800-280-0730
_See the list of drugs that will now require the warning_
(http://www.fda. gov/cder/ drug/antidepress ants/default. htm)
Antidepressant Use in Children, Adolescents, and Adults
The U.S. Food and Drug Administration (FDA) today proposed that makers of
all antidepressant medications update the existing black box warning on their
products' labeling to include warnings about increased risks of suicidal
thinking and behavior, known as suicidality, in young adults ages 18 to 24 during
initial treatment (generally the first one to two months).
Current Information
* _FDA News_ (http://www.fda. gov/bbs/topics/ NEWS/2007/ NEW01624. html)
* _Draft Medication Guide for Antidepressant Drugs_
(http://www.fda. gov/cder/ drug/antidepress ants/antidepress ants_MG_2007. pdf)
* _Revisions to Product Labeling_
(http://www.fda. gov/cder/ drug/antidepress ants/antidepress ants_label_ change_2007. pdf)
* _Questions and Answers _
(http://www.fda. gov/cder/ drug/antidepress ants/QA20070502. htm)
List of Antidepressant Drugs with Medication Guides
Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/ amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/ amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl) Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/ fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/ amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)
_http://www.wthr. com/Global/ story.asp? S=6461352_
(http://www.wthr. com/Global/ story.asp? S=6461352)
Expert: FDA move on antidepressants justified
May 2, 2007 04:09 PM CST
_Rich Van Wyk_ (mailto:rvanwyk@wthr. com) /Eyewitness News
Washington - Eli Lilly and other antidepressant drug-makers are ordered to
put new warnings on the nation's most widely prescribed drugs. The _Food and
Drug Administration wants_ (http://www.wthr. com/Global/ story.asp? S=6458652)
labels rewritten to say the use of these drugs causes suicidal behavior in young
adults.
They're expanding on this warning for children using drugs like Eli Lilly's
Prozac: "In clinical studies, antidepressants increased the risk of suicidal
thinking and behavior in children and adolescents with depression and other
psychiatric disorders."
Young people college age and slightly older are being warned for the first
time that using antidepressant drugs increases the risk of suicidal thoughts
and behavior. After issuing the same warning for children and adolescents
three years ago, the FDA is expanding it to include patients 18 to 24 years old.
"I believe it is justified," said Amy Peck, assistant professor of Pharmacy
Practice and Drug Information at Butler University. "I think they are taking
responsible action and not taking these drugs off the market because
obviously the offer great benefit to some patients."
The Food and Drug Administration recommends the new warnings appear on 36
antidepressant drugs, including Cymbalta, Eli Lilly's second best-selling
product and Prozac, a former best seller.
In a statement supporting the FDA decision, the Indianapolis- based Lilly
says, "This step will help ensure that the millions of people with
depression.. .can make informed decisions while minimizing the fear and stigma associated
with depression."
The use of antidepressant drugs is staggering. Last year US pharmacies
filled 195 million prescriptions. IMS, an international health information
company, says antidepressants are the nation's most prescribed group of drugs.
New warning labels recommended by the FDA also include new information
finding the use of antidepressants pose no risks to adults older than 24 and
actually decrease the risks of suicidal behavior in patients 65 and older.
04 May, 2007
Disturbing Statistics: Psychiatric Drug Market within Medicaid Program
This article was accepted for publication in the Spring 2007 newsletter of the International Center for the Study of Psychiatry and Psychology (www.icspp.org). I'll have more details to add very soon. -- Ben
*Michigan Lawsuit Uncovers Psychiatry's Dark Secret: *
*Drug-Induced Movement Disorders in Young Children*
by Ben Hansen
Last month the New York Times exposed yet another example of unethical marketing practices by pharmaceutical giant Eli Lilly. The front page story, "In Some States, Maker Oversees Use of Its Drug," focused on Lilly's efforts to coerce Medicaid officials into placing Zyprexa on preferred drug lists in at least 25 states. Eli Lilly was caught in broad daylight with its hands in the "Medicaid cookie jar," yet the story behind the scenes is deeper than that.
For over a year I've been investigating Eli Lilly's subversion of Michigan's Medicaid program, and through a Freedom of Information Act lawsuit I obtained nearly a thousand pages of documents showing how Medicaid is being milked like a huge cash cow by the pharmaceutical industry. In July 2006 I alerted the New York Times to Lilly's antics in Michigan. I provided several key documents and solid leads to the reporter covering the story, Stephanie Saul. Overall I was pleased by the way Ms. Saul reported the Lilly/Medicaid
scandal, but there's another part of the story the Times didn't mention.
The purpose of my FOIA lawsuit in Michigan is not simply to embarrass one pharmaceutical manufacturer -- my aim is to gain access to data that will blow the lid off the entire psychiatric drug industry. This may be why the State of Michigan has fought me every step of the
way, beginning with my first FOIA request in November 2005. Instead of joining my attempt to shed light on Michigan's corrupt Medicaid system, the state attorney general's office has tried to block the release of the documents I've requested, even filing a motion to have my lawsuit thrown out of court.
Thankfully, a respected attorney has taken my case pro bono, and we're mapping a strategy to outmaneuver our opponents. The lawsuit, "Ben Hansen vs. State of Michigan Department of Community Health," boils down to a fight over the release of records which show a list of each patient's psychotropic drugs by drug NAME, not just by drug CLASS. For example, we know at least one Michigan Medicaid patient is currently on a total of 17 different psychiatric drugs, but the State of Michigan doesn't want us to know the names of the drugs in the 17-drug cocktail!
By the time the next ICSPP newsletter is published, I hope to report a successful outcome to this ongoing legal battle. For now I wish to share a sampling of the psychiatric prescribing data I've obtained so far. The numbers speak for themselves.
During a 10-month period from January 2006 to October 2006, MichiganMedicaid statistics show:
*100% increase in children under age 18 on 3 or more mood stabilizers.*
*100% increase in children age 6-17 on 4 or more psychiatric drugs.*
*79% increase in adults on 5 or more psychiatric drugs.*
*67% increase in adults on 3 or more psychiatric drugs.*
*49% increase in adults on 2 or more insomnia agents.*
*45% increase in children under age 18 on a benzodiazepine for at least 60 days.*
*45% increase in children under age 18 on 2 or more antipsychotics.*
According to Michigan Medicaid records from 2005, the top 5 psychiatric drug classes prescribed to *children under 5 years old* were:
1. Anxiolytics/Sedative Hypnotics (1,265 patients under age 5).
2. Antidyskinetics (972 patients under age 5).
3. Anticonvulsants/Mood Stabilizers (933 patients under age 5).
4. Sympathomimetics/Stimulants (408 patients under age 5).
5. Atypical Antipsychotics (322 patients under age 5).
The most recent data on children under age 5, from February to December 2005, shows a 100% increase in children under 5 prescribed antidyskinetics (also called antiparkinsonians) for movement disorders such as dystonia, dyskinesia, tics, and tremors. This is perhaps
the most disturbing statistic I've uncovered so far. If the same trend continued through 2006, it would mean the prescribing of antidyskinetics to children under 5 years old has *quadrupled* in the last two years!
If the increased prescribing of antidyskinetics is the direct result of an increase in the diagnosis and treatment of "mental disorders" in American toddlers, then we could be witnessing a public health disaster of monumental proportions. Drug-induced movement disorders in very young children areincreasing at an astonishing rate, yet little if any mention of this is reported in the news. Certainly this is not
something the pharmaceutical industry and its servant, the American Psychiatric Association, wishes to see publicized. It is the urgent task of organizations like ICSPP to uncover this dark secret and shine a light on it for the world to see.
*******
Ben Hansen is a psychiatric survivor and activist who serves on the MichiganDepartment of Community Health Recipient Rights Advisory
Committee. A member of ICSPP and co-founder of MindFreedom Michigan, Ben is also founder and president of the wickedly satirical Bonkers Institute for Nearly GenuineResearch. Visit his brilliant web site: www.bonkersinstitute.org
02 May, 2007
Breggin: The Spellbinding Effects of Psychiatric Drugs
Intoxication Anosognosia: The Spellbinding Effect of Psychiatric Drugsby Peter R. Breggin, M.D.
ABSTRACT Why do so many individuals persist in taking psychoactive substances, including psychiatric drugs, after adverse mental and behavioral effects have become severe and even disabling? The author has previously proposed the brain-disabling principle of psychiatric treatment that all somatic psychiatric treatments impair the function of the brain and mind. Intoxication anosognosia (medication spellbinding) is an expression of this drug-induced mental disability. Intoxication anosognosia causes the victim to underestimate the degree of drug-induced mental impairment, to deny the harmful role that the drug plays in the person's altered state, and in many cases compel the individual to mistakenly believe that he or she is functioning better. In the extreme, the individual displays out-of-character compulsively destructive behaviors, including violence toward self and others. Read the entire article here: http://www.breggin.com/spellbinding_psychiatric_drugs.pdf |
02 May, 2007
FDA expands antidepressant suicide warning to age 24
This is laughable considering the actual research has been swept under the carpet, but at least it's a broader warning than we had before. As we know, nobody is immune from the risk of the drugs, no matter the age. The part about elderly people being at decreased risk for suicide is also obviously a big lie.
FDA seeks antidepressant warning
By ANDREW BRIDGES, Associated Press Writer 15 minutes ago
WASHINGTON - Young adults beginning treatment with antidepressants should be warned about an increased risk of suicidal thoughts and behavior, federal health officials said Wednesday.
The
Food and Drug Administration proposed labeling changes that would expand a warning now on the antidepressants. The current language applies only to children and adolescents. The expanded warning would apply to adults 18-24 during the first month or two of treatment with the drugs, the FDA said.
The proposed labeling changes also would note that studies have not shown this increased risk in adults older than 24, and that adults 65 and older taking antidepressants have a decreased risk of suicidal thoughts and behavior, it said.
The proposed expanded warnings emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
"Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks," said Dr. Steven Galson, the FDA's drugs chief.
The proposed changes came with the endorsement of FDA expert advisers. Some experts have argued that the changes are overdue while others maintain they could keep drugs from those who need them.
Last month, a comprehensive analysis of antidepressants for children and teenagers found the benefits of treatment trump the small risk of increasing suicidal thoughts and behaviors in some patients. TheJournal of the American Medical Association study also found that risk is lower than what the FDA identified in 2004, the year the agency warned the public about the risks of the drugs in children.
01 May, 2007
Was drug reaction cause of Oroville man's actions?
via email from drugawareness.org Texas Director:
Dear Friends and Colleagues,
As of today, May 1st, 2007, there are over 1,600 documented cases posted on http://www.ssristories.com
Since I last reported to you on March 5th, 2007, there have been 66 new cases and 34 older cases added to the Website.
I am including an "older" case in this email. It involves the SNRI Effexor:
Paragraph 5 reads: "After examining Pursell, the doctor concluded he "fits the pattern of an individual whose thoughts and behaviors were temporarily beyond his capacity to control" due to an adverse reaction to the medication."
Paragraph 10 reads: "Letters to the court from several relatives and friends all depicted Pursell as caring and giving. They said they couldn't identify the young man who had accompanied a missionary couple to a Third-World country as a teen-ager with the person arrested for the bizarre series of Oroville crimes."
Paragraphs 12 & 13 read: "He had returned to his hometown of Oroville and was being treated for clinical depression last summer when he was prescribed a series of drugs, including 'Effexor', according to his lawyer."
"After examining him in his jail cell earlier this month, Kevin McCready, a San Joaquin County clinical psychologist, concluded that the defendant's 'obsessive behavior' was due to a reaction to the drug."
_________________________________________________________________
Was drug reaction cause of Oroville man's actions?
Chico Enterprise-Record (Chico, CA)
August 16, 2001
Estimated printed pages: 2
Was drug reaction cause of Oroville man's actions?
By TERRY VAU DELL - Staff Writer
OROVILLE - Did an adverse reaction to a prescription drug cause a former university football star to break into an Oroville bank manager's home and run up thousands of dollars in phone sex charges on her telephone?
That is the question a judge said Wednesday he wanted answered before sentencing Stephen Pursell.
Butte County Superior Court Judge Thomas Kelly ordered Pursell, 33, of Oroville to undergo a 90-day presentence diagnostic evaluation at a state prison.
In a report to the court, a defense psychologist said Pursell was taking the same type of anti-depressant medication which figured in the Columbine school massacre and the recent case of a Texas mother charged with drowning her toddlers in the bathtub.
After examining Pursell, the doctor concluded he "fits the pattern of an individual whose thoughts and behaviors were temporarily beyond his capacity to control" due to an adverse reaction to the medication.
Pursell was arrested in March after he admitted breaking into the Oroville home of Rebecca Castenada several times, out of anger at the branch supervisor for Sierra Credit Union over the loss of $120 Pursell said he placed into a night-deposit slot.
Prosecutors contend that although there were no bank records of such a deposit, the defendant stole the victim's credit card and used other personal information he obtained in the burglaries to create financial havoc in the couple's lives.
Castenada, who was in court for Pursell's sentencing Wednesday, reportedly told police the first inkling she had that something was wrong was when she and her husband received a bill in their name for some Internet purchases which they had not made.
Oroville Police reported that over the next few months, additional credit cards were applied for in the Castenadas name, money was removed from the couple's accounts, someone canceled their auto insurance, changed their cell phone to a more expensive plan and ran up more than $1,000 in bills to sex line on their home telephone.
Letters to the court from several relatives and friends all depicted Pursell as caring and giving. They said they couldn't identify the young man who had accompanied a missionary couple to a Third-World country as a teen-ager with the person arrested for the bizarre series of Oroville crimes.
A former administrator at the University of Arizona wrote the court that after a shoulder injury prevented Pursell from playing on the varsity football team, he had worked for awhile as a trainer and later in a Tucson, Ariz. nursery.
He had returned to his hometown of Oroville and was being treated for clinical depression last summer when he was prescribed a series of drugs, including "Effexor," according to his lawyer.
After examining him in his jail cell earlier this month, Kevin McCready, a San Joaquin County clinical psychologist, concluded that the defendant's "obsessive behavior" was due to a reaction to the drug.
"While many report tremendous benefit from taking such psychotropic drugs, some persons have been shown to have a high sensitivity" to the medication, which in some cases have produced "extreme and violent reactions," the psychologist stated.
The defense expert said Pursell told him he wasn't motivated by revenge, but rather "he had in his mind the idea that he could prove that the bank was responsible for the loss of his deposit by proving that he could compromise the security of the bank and the bank manager."
The defendant said his actions "make no sense to him now" and he is "extremely remorseful," added the psychologist.
In urging the court to place his client on probation, Pursell's lawyer, Michael O. Harvey, argued in writing that "the very drug that was supposed to help him cope with life ... transformed this young man into a Mr. Hyde."
Deputy district attorney Kelly Maloy said outside of court she was fully prepared to ask for the maximum sentence Wednesday, citing the "egregious" nature of the crime.
However, the prosecutor said she agreed with the court's decision to obtain a "neutral opinion" in light of the defense psychologists' findings.
(c) 2001, 2004 Chico Enterprise-Record. All rights reserved. Reproduced with the permission of Media NewsGroup, Inc. by NewsBank, Inc.
Record Number: 103121B563290AE9
01 May, 2007
The Drugs Don't Work, Warn Psychiatrists
The Sunday Independent (Ireland)
The drugs don't work, warn top psychiatrists
TOM PRENDEVILLE
A DAMNING indictment by the country's most eminent psychiatrists paints a picture of patients' lives being needlessly put at risk by a cocktail of dangerous drugs, and a profession which is in the back pocket of vested interests in the pharmaceutical industry.
"The psychiatric world has to be cleaned up - it's appalling. There are over 200,000 people on over-the-counter tranquilliser drugs," says Dr Michael Corry, a consultant psychiatrist. "In Ireland, there are 25,000 people on Zyprexa and 20,000 people on Seroxat. With Seroxat, there is a one-in-500 suicide risk. They get totally overwhelmed by a sense of disinhibition, and they literally feel they can't go on, and they kill themselves." Coincidentally, a damning Oireachtas report on the adverse side effects of pharmaceuticals, which was released last week, has come to more or less the same conclusions.
The report stated that "the influence of the pharmaceutical industry is unhealthy". It also called into question the relationship between the pharmaceutical companies and psychiatric doctors, who are financially rewarded in the form of payments for ghostwriting medical-research reports, get free travel, research grants and numerous other perks.
The all-party committee report also took a swipe at the widespread prescribing of psychiatric drugs. "Their [drugs] use in therapy represents unwarranted medical intervention in what are often normal emotional difficulties," said. "The side effects include behavioural disorders, physical illness, dependence and even suicide."
The report went on to say that some of the drugs "were of doubtful benefit" and that "where side effects are well known, they seem not to be appreciated or are ignored by prescribers".
The Oireachtas Committee is now calling for the setting up of a Patient Safety Agency.
Other senior doctors raise the issue of the use of drugs such as Clozaril, a widely used schizophrenia drug which can produce a litany of life-threatening reactions.
"It's a very dangerous drug - and it's not the only one," said Dr Corry, who runs the Dun Laoghaire-based Institute of Psychosocial Medicine. "It's an absolute scandal that the Medicines Board has licensed these drugs - surely they can unlicense them, seeing as we have clear irrefutable evidence they are dangerous?"
Professor Pat Bracken, consultant psychiatrist and clinical director of the West Cork Mental Health Service, says that many of the woes befalling psychiatry can be directly traced to the vast influence which the pharmaceutical industry now wields over the academic faculties that teach psychiatry - an influence gained through the doling out of vast research grants.
"There are growing concerns about the way in which the pharmaceutical industry has come to dominate psychiatry," he warns. "The profession should be independent and be seen to be independent. And if it is not, it is a concern for everyone."
01 May, 2007
Phony Diseases & Dangerous Drugs
http://www.newswithviews.com/Howenstine/james58.htm#_ftn2 IS PSYCHIATRY SCIENTIFIC AND DANGEROUS?
By Dr. James Howenstine, MD.
May 1, 2007
NewsWithViews.com
When you look below the surface at the specialty of psychiatry what you uncover is so ludicrous it is difficult to believe that it is really true. Prominent psychiatrists
from all over the world gather annually for a meeting at which new diseases are invented. There are no objective findings that establish the diagnosis of these
diseases. These new diseases are included in the Diagnostic and Statistical Manual of Mental Diseases. Potential new diseases are discussed at these meetings and new
diseases are voted in or out by a show of hands.[1] Among the new diseases are social anxiety disorder (everyone who is uncomfortable in a social setting has this disease) and mathematics disease (anyone who has struggled over a math problem has this disease). Gender identity disorder, passive-aggressive disorder, disorder
of written expression and sexual disorder are other examples of invented diseases that will follow the individuals tagged with these ridiculous diagnoses the remainder
of their lives. Naturally all these phony diseases have a psychoactive drug which supposedly ameliorates this disease.
This is laughable but it has serious consequences. When a child is diagnosed with depression the child is often placed on a potent SSRI drug. The manufacturer of
one of the leading SSRI drug knew for many years that the drug caused loss of the ability to control violent behavior thus increasing violence toward self (suicide)
and others (mass murders). This information was covered up because it would have hurt sales of the drug. Nearly every teen involved in the Columbine and Red
Lake mass murders was taking an SSRI drug. There is a fundamental flaw in a nation more concerned about sales of drugs than the welfare of it’s children.
An annoyed teacher is allowed to make a diagnosis of Hyperactive Disease. Hyperactive children are routinely given the very addictive drug Ritalin. More than
1.5000,000 children are taking Ritalin which is known to cause zombie like behavior, suppressed appetite, weight loss, serious addiction problems, retarded
growth, paranoid symptoms, auditory and visual hallucinations and insomnia. Public schools get financial rewards from the government for increasing the
number of students taking Ritalin and the number of children completing vaccine programs. Following a nutritious diet restricted in sugar content and colorants
but replete with vitamins and minerals goes a long way toward eliminating most cases of hyperactivity.
What is Teen Screen? Big Pharma has formulated a program that will eventually enable all citizens to be placed on psychoactive drugs. (Does this sound like Orwell’s 1984?) Just as the
indications for dangerous statin drugs get liberalized annually so that more persons qualify to be placed on statin drugs there are other programs steadily being used
to increase the number of children and adults taking unsafe psychoactive drugs for bogus psychiatric diagnosis. One such program is Teen Screen.[2] Without parental knowledge children are given questionnaires to fill out. The goal of Teen Screen is to do a “suicide survey” on every teen in the USA. This has to be a
marketing tool by the pharmaceutical industry to increase the number of persons using their products. The actual number of teen suicides is quite low
(less than 50 yearly out of 4,000,000 students in the state of Florida), about equal to the number of persons struck by lightning. These children will often be
placed on SSRI type drugs which actually do increase the risk of suicide. Among questions asked to 9 year olds and older are these:
Have you ever felt very nervous when you have to do things in front of people?
Have you ever worried before you were going to play a sport or game or do some other activity?
In the last 3 months have you thought of killing yourself?
Are you still thinking about killing yourself?
Have you ever tried to kill yourself?
Because there are no valid objective tests to establish a psychiatric diagnosis the evaluating psychiatrist has to decide which disorder label does an individual
patient best fit into. Psychiatrists have been forced to admit that drug therapies do not cure any of their disorders. Therefore when one drug fails to help a bogus
disease the dose must be increased and then a second dangerous drug may need to be added. This dangerous process is all often in the pursuit of a bogus disease.
Infectious Diseases Frequently Cause Psychiatric Symptoms This lack of any scientific method in diagnosing and treating patients often makes psychiatrists a danger to patients visiting them. Very few psychiatrists are
aware that infectious diseases often cause psychiatric symptoms. Infections that are well known to cause psychiatric symptoms include pneumonia, urinary tract
infection, sepsis, malaria, Legionaires Disease, syphilis, Chlamydia, typhoid fever, diphtheria, HIV, rheumatic fever and herpes.
Lyme Disease caused by the Borrelia burgdorfi spirochete can mimic every disease in the Diagnostic Manual of Psychiatric Diseases. The ordinary psychiatrist is
very unlikely to consider the possibility of bacterial, parasitic, fungi, yeast, mycoplasma infection when a patient has weakness, fatigue and depression. Yet these
symptoms may appear when the infectious organisms release neurotoxins that interfere with hypothalamic function resulting in hypothyroidism and adrenal
insufficiency. Mothers who have infection with Herpes Simplex Type 2 virus are 6 times more likely to have a child who later becomes schizophrenic, than mothers
without Herpes 2 infections. Acute infection with Toxoplasma Gondi can produce personality changes and psychosis including delusions and auditory hallucinations.
Johns Hopkins virologist Robert Yolken and Psychiatry Professor Dr. E. Fuller Torrey believe that toxoplasmosis is one of several infectious agents that cause most
cases of schizophrenia and bipolar disorder. Mental patients were found to have a 53.8% incidence of parasitic infections in a 2 year study conducted in the University of
Ancona, Italy involving 238 inpatient residents in 4 Italian psychiatric institutions.
In addition to the infections mimicking schizophrenia or maternal infections during pregnancy that predispose children to become schizophrenic there are many
other patients with symptoms compatible with schizophrenia. What are the factors producing these symptoms?
Schizophrenia The generally accepted conventional medical concept about schizophrenia is that the disease is caused by excessive levels of dopamine and that decreasing the levels
of dopamine improves patients with schizophrenia. The evidence for high levels of dopamine is poor[3] and Parkinson’s Disease like symptoms appear when patients are treated for dopamine excess. Since Parkinson’s Disease is known to stem from a dopamine deficiency, it is probable that drugs provoking these symptoms are
creating a lack of dopamine, not correcting an excess of dopamine.
Genetics must play a role in schizophrenia because 50% of patients have a family member with the illness. There are four genetic disorders seen with greater than
normal frequency in schizophrenic patients. All four of these genetic defects cause a higher than normal exposure to adrenochrome (an adrenaline metabolite) or
an abnormal sensitivity to the adverse effects of adrenochrome. One of the genetic advantages of schizophrenia is an unusual resistance to developing cancer
particularly lung cancer.
There has been a striking rise in the frequency of schizophrenia since the industrial revolution. The prevalence of insanity has risen sevenfold between mid 18th
century and mid 20th century. Genetic disease cannot occur in epidemics. Therefore, industrial societies must have factors that increase the body’s production of
adrenochrome or provoke the body to create adrenochrome. Three such factors are stress, excess sugar consumption and increased exposure to allergic substances.
Adrenochrome has hallucinogenic properties and is a potent neurotoxin that damages the thyroid gland by antagonizing the hormone triiodothyronine. Chronic
schizophrenics have permanent thyroid gland damage. Adrenochrome creates many free radicals, which produce oxidative stress. This eventually wears out the
antioxidant defense system producing deficiencies of glutathione peroxidase, superoxide desmutase, and catalase.
Assuming that adrenochrome produces schizophrenia, eight valuable therapies are suggested. Allergic reactions to the environment cause over-oxidation of
adrenaline. Therefore, measures to decrease allergic reactions from environmental stressors will be beneficial.
Genetic and environmental screening can improve selection of therapies that are likely to be helpful. Allergy testing to correct allergies decreases adrenochrome
production. A low sugar diet blocks the insulin spikes caused by excess sugar. Absence of these spikes prevents the subsequent adrenaline release caused by low
blood sugar values. Schizophrenics oxidize the released adrenaline from hypoglycemia and have worse symptoms.
Medical therapies using medication that quickly reduce the damaging impact of adrenochrome are valuable. High dosage of niacin or niacinamide, vitamin B1,
riboflavin B2, and ubiquinone (CoQ 10) all lower excessive adrenochrome levels with niacin seeming to be the most effective.
The adrenochrome antagonist, triidothyronine, is quite effective in treating schizophrenia particularly when used in the first six months of illness. All 80 schizophrenics
with less than six months of symptoms who were given 120 to 1200 mg of desiccated thyroid for 100 days recovered[4] unless they stopped the thyroid therapy. Schizophrenics are very resistant to thyroid medication and must be treated with high dosages.
Eating foods that contain tryptophane, which is converted into serotonin, is worthwhile because serotonin antagonizes adrenochrome. Such foods include beans,
cod, pork, soybeans, and cheese. Be certain these foods do not cause allergy.
All possible efforts to repair the antioxidant defense system are worthy. Glutathione can be given intravenously and n-acetyl cysteine raises glutathione levels. Schizophrenics with MTHFR C677TT genetic dysfunction have excessive levels of homocysteine and lack of methionine. These defects can be repaired with folic acid,
vitamin B12, pyridoxine, zinc, and trimethylglycine. Homocysteine accelerates brain aging and plays an important role in causing arteriosclerosis.
Brain atrophy may develop in chronic schizophrenia. These patients have low levels of glutathione peroxidase. Supplementation with the four substances needed
by the body to create glutathione peroxidase (selenium, cysteine, glutamine, and tryptophane along with intravenous glutathione) can be of great value. The
fish oil (eicosapentaenoic acid) also is able to reverse brain atrophy and should be given.
The eighth vital step to help schizophrenics is restoration of their self worth by helping them gain employment, respect and compassion. All this material about schizophrenia is from University of British Columbia History Professor Harold Foster’s valuable book, What Really Causes Schizophrenia?
Causes And Therapy Of Depression. Ten percent of persons visiting physicians in the USA suffer from depression. Many persons with depression have either undiagnosed hypothyroidism, are lacking
omega 3 fatty acids in their diet, or are deficient in vitamin D. The RDA for vitamin D, at 400 IU daily, is set far below needed levels. Everyone probably needs more
than 800 IU daily, and persons with depression or living far from the equator may benefit from 1200 IU or more daily. Correction of any of these three common
conditions may eliminate the depression.
Countries with the highest intake of fish have the lowest incidence of depression. Less than 1% of Japanese, who average 140 pounds of fish annually, have depression
whereas 6% of persons in New Zealand are depressed where they eat only forty pounds of fish annually. Fish contain abundant omega 3 fatty acids. Countries with
higher average fish consumption also have lower rates of homicide, bipolar disorder, depression, and suicide.
What Is Avea? Turmeric (curcumin) has long been used in Ayurvedic and Chinese medicine as an anti-inflammatory, to treat digestive disorders and liver problems and for
the treatment of skin diseases and wound healing. Curcumin stimulates the production of bile and facilitates emptying of the gall bladder. In animals curcumin
protects the liver, has anti-tumor action, reduces inflammation and fights some infections.
Avea is an extract from the root of Curcuma longa, commonly know as turmeric. Nutramedix has a proprietary formulation of curcumin that is more effective
than conventional curcumin because of special extraction and enhancement techniques.
The German Commission E reports that curcumin has no known contraindications, no known side effects and no known interactions with other drugs. In May 2005,
toxicology studies were completed on Avea at the University of Guayaquil, Ecuador. No toxic effects were seen even when the animals were given doses 160,000
times the equivalent human dose.
Patients suffering from depression often report relief from depression within a few hours to a few days after starting Avea. A 38 year old woman had been seriously
depressed for more than ten years despite therapy with several different pharmaceutical drugs. When started on her first dose of Avea she felt less depressed after
thirty minutes. The depression was gone in 24 hours but the therapy was continued.
The dosage of Avea is ten to twelve drops three or four times daily. Patients who respond rapidly to Avea should remain on this therapy for one to two months to
allow the body to reset neurochemical balances in the brain. Patients who have been taking SSRI drugs should slowly taper off SSRI therapy over many weeks if
they wish to terminate SSRI therapy.
We think that persons trying Avea for depression will be pleased with this safe rapidly acting therapy. Avea can be obtained from naturalhealthteam.com phone 1-
800-416-2806 and from nutramedix.com phone 1-561-745-2917.
What Is The Future For Psychiatry? My hope is that many persons will be able to avoid the use of the dangerous, poorly researched drugs provided by the pharmaceutical industry for use in
psychiatric conditions. Safe effective natural therapies .are available to treat schizophrenia and depression. Natural therapies will never become widely used
because of the pharmaceutical industry’s control over the media and their full support by U.S. government agencies(FDA, NIH,).
Psychiatry is a complete fraud and the problems caused by the drugs used(gastrointestinal bleeding, tardive dyskinesia, etc.) by these practitioners have, as usual,
been covered up or ignored. Making money for drug companies has taken precedence over careful scientific research searching for truth in the interests of piling
up bigger profits for an enormously wealthy industry.
At this time psychiatry is a very valuable asset for the pharmaceutical industry. Psychiatrists are busy writing prescriptions for drugs all day long. The prospects
for the future are even brighter, as more and more Americans of all age brackets are recruited by programs aimed at having every living man, woman and child
taking a psychoactive drug daily.
Why do the insurance companies pay for worthless pharmaceutical prescriptions while refusing to pay for curative natural therapies? Why should Big Pharma bother to
waste money doing careful scientific research when flawed dangerous drugs are not exposed by a watch dog media and there is no government agency the least
bit concerned about the health of the American people. Remember 90% of us are useless eaters that are targeted for removal by the elitists running the world.
The list of unexposed health scams is mind boggling (GMO foods, mercury amalgams, dangerous root canals millions done annually, chemotherapy drugs and
radiation to treat malignancies, widespread use of transfats in cooking, worthless soil thanks to government mandated nitrogen, potassium, phosphorus fertilizer
which omits sulfur a key nutrient, chlorine and fluoride in drinking water, mandated dangerous vaccines for children, statin drugs to lower cholesterol, bypass
surgery, aspartame, suppression of heparin burn therapy, ignoring Dr. Abram Hoffer’s safe effective therapies for schizophrenia, etc.). These problems are typical
of those occuring when a totalitarian government has taken complete control over a country. Truth has become irrelevant.
Last fall I took a vacation to visit intelligent relatives and friends. In my luggage were many copies of an article carefully documenting the irrefutable scientific
facts proving that 9/11 was an inside job. Not a single one of these relatives and friends believed this article. The U.S. media has done its usual superb job of selling
9/11. Joseph Goebbels has to be green with envy if he is receiving this type of information. The world is currently locked in a titanic struggle between good and evil.
The Bible warns us that the end times would be marked by deception and apostasy. We must all do as good a job as possible trying to avoid fraudulent operations.
Staying out of the dangerous drug pushing psychiatrist’s office is a good place to start.
Dr. James Howenstine is in need of proof reading assistance for the second edition of his book A Physician’s Guide To Natural Health Products That Work Vol. 2 707
pg. If you are qualified in this area please contact him at dr.jimhow@gmail.com or by writing Dr. James Howenstine, C/O Remarsa USA SB 37, P.O. Box 25292, Miami. Fl. 33102-5292
Footnotes: 1, Whitaker, Julian Fraudulent Medicine Health & Healing September 2006 Vol 16, No.9 pg 3-6
2, Kramer , Ken Crazy Makers Big Pharma Involved In Stealth Agenda With School Districts To Screen Teenagers For Mental Illnesses Without Parental Approval Crusader Dec/Jan 2005/2006 pg 5-6
3, Issa, F., et al A multidimensional approach to analysis of cerebro spinal fluid biogenic amines in schizophrenia: 1. Comparisons with healthy control subjects and neuroleptic-treated/untreated pairs analysis. Psychiatry Research, 52(3), 237-249
4, Danziger, cited by Hoffer, A. (2001). Thyroid and schizophrenia. Journal of Orthomolecular Medicine, 16(4), 205-212
01 May, 2007
Parkinson's / Tardive Dystonia and dyskinesias and drugs responsible
Parkinson Current Topics
Drug-Induced & Tardive Movement Disorders
by Gwen M. Vernon
Several have postulated that their diagnosis with Parkinson's was
preceded by adverse effects from taking different medications earlier in life.
This work is presented for education and research.
Lynn Schmidt-Speed. Section Editor
Knowledge of pharmacology is important to neuroscience nurses. Pharmacology Update is presented as a regular feature. Drug-induced movement disorders are discussed in this issue.
Questions or comments about this article may be directed to:-
Gwyn M. Vernon RN.MS, The Graduate Hospital, Parkinson's Disease and Movement Disorder Center, 1500 Lombard Street, Suite 900, Philadelphia, Pennsylvania 19146. (She is the coordinator).
Copyright American Association of Neuroscience Nurses 0047 2603/91/2303-0153 $1.25
J Neuroscience Nursing 1991; 23(3):183-187.
Introduction
Drug-induced movement disorders and tardive syndromes present a unique challenge for neuroscience practitioners. Our understanding of the patho-physiology of these iatrogenic problems has developed mainly through clinical observations, while treatment and prognosis in most cases are complex and less than optimal. This article discusses drug-induced and tardive movement disorders, risk factors, management and nursing implications.
Causative Agents
Movement disorders secondary to pharmacological agents represent a large number of extrapyramidal disorders seen by neurologists and psychiatrists in the outpatient setting.
Involuntary movements, including tremor, chorea, athetosis, dyskinesias, dystonia, myoclonus, tics, ballismus and akathisia, may be symptoms of primary neurologic disease or occur secondary to pharmacotherapy (Table 1). Drug-induced abnormal movement syndromes have been recognized since the 1950s, following the introduction of chlorpromazine (Thorazine) to treat schizophrenia.
The risk of developing a drug-induced movement disorder begins at the onset of treatment with an offending agent. Drug-induced syndromes may develop acutely, within hours or a few days, or sub-acutely, over several weeks. Yet others may develop after prolonged exposure to an offending agent. When a movement disorder develops six months or longer after exposure, the term "tardive" is used, implying a late or delayed onset.
Most of our understanding of the patho-physiology of movement disorders has developed from clinical observations of response to pharmacotherapy.[5] Tardive syndromes appear to originate from drug effects on the striatal dopaminergic system. Five classes of drugs are known to affect central dopaminergic systems: [5,15
Table 1
Movement Characteristics
Tremor Rhythmic. oscillatory movement categorized
according to its relationship to activity or
posture
Chorea Irregular, unpredictable brief jerky movements
Athetosis Slow, writhing movements of distal parts of
limbs
Dyskinesias Recessive abnormal involuntary movements
Dystonia Slow sustained, posturing or contractions of a
muscle or group of muscles
Myoclonus Rapid, brief shock-like muscle jerks
Tic Repetitive. irregular stereotype movements or
vocalizations
Bellismus Wild flinging or throwing movements
Akathisia Subjective sensation of restlessness often
associated with inability to keep still. Easily
confused with psychiatric symptoms such as
agitation, hyperactivity and anxiety
-----------------------------------------------------------
* Central stimulants that act as indirect dopamine
agonists such as amphetamine
* Levodopa, a precursor of dopamine
* Direct dopamine agonists such as bromocriptine
* Presynaptic dopamine antagonists (dopamine depleting
agents) such as reserpine
* Neuroleptics such as haloperidol (Haldol) or chlorpromazine (Thorazine), and other medications such as metoclopramide (Reglan) which antagonize or block central dopamine receptors
By far the most common cause of drug-induced and tardive syndromes are those that block or antagonize dopamine receptors, usually the neuroleptics.
Prognosis for the patient with a drug-induced movement disorder ranges from complete recovery to chronic, persistent movements, often resistant to therapy. Tragically, many patients develop these syndromes after insufficient consideration of the ever present danger of this adverse effect.
Neuroleptics and other drugs known to commonly cause movement disorders (Table 2) should be used cautiously and reserved for situations where the benefits outweigh the risks. Even then, short-term therapy of minimal therapeutic dosages should he the strategy employed.
While drug-induced and tardive syndromes can present with any of the involuntary movements; parkinsonism, dyskinesias and dystonia tend to be the most common.
Parkinsonian
Drug-induced and tardive parkinsonism resemble idiopathic parkinsonism, and are therefore characterized by tremor, rigidity and most commonly an extreme paucity of movement called akinesia. Ironically, tardive parkinsonism was recognized as a reserpine induced akinesia prior to our understanding of the importance of dopamine deficiency to the manifestations of idiopathic parkinsonism. Today, neuroleptic induced parkinsonism is the second leading cause of parkinsonism symptomatology following idiopathic Parkinson's disease.[9]
The mechanism of tardive parkinsonism appears to be the drug-induced opposition or blockade of striatal dopamine receptors. This results in a subsequent imbalance in the normal acetylcholine-dopamine relationship.[5]
While parkinsonism may begin within several days of treatment, it usually follows a more delayed or subacute onset with 90% of cases evidenced within three months.[1] Women appear to have a higher incidence than men. Overall the incidence of developing a drug-induced parkinsonism ranges from 5-60% depending on the type of neuroleptic employed.[7]
Drug-induced parkinsonism appears dependent on two variables, drug type and dosage. The relative dopamine receptor blocking activity varies between offending agents, however all patients have the potential for developing tardive parkinsonism if dosages are continually escalated.[15]
Additionally, research supports the hypothesis there may be subclinical deficits in the dopaminergic system related to normal aging or even preclinical Parkinson's disease which may contribute a significant risk for developing tardive parkinsonism.[1,8]
When drug-induced parkinsonism occurs, the offending medication should be reduced, withdrawn or changed to an agent with a lower propensity for causing this adverse effect. However, this plan is not always feasible because of the underlying psychiatric or medical illness. Anticholinergics, or more commonly, amantadine (Symmetrel) are used to treat symptoms in cases where drug reduction, withdrawal or alternative therapy fail. Routine use of anticholinergics in patients receiving neuroleptics is not suggested as prophylaxis as there is evidence anticholinergics may reduce therapeutic efficacy of neuroleptics.[11]
Moreover, adverse effects of anticholinergics such as hallucinations and confusion may exacerbate underlying psychiatric symptoms.
Tardive Dyskinesia
Following the introduction of chlorpromazine (Thorazine) in 1952, several researchers began to describe a complicated movement disorder following exposure to this drug. Lipsmacking, facial and lingual masticatory movements, trunk rocking and restless foot movements were some of the movements described.
Faurbye and his colleagues coined the term tardive dyskinesia and described it as a syndrome of abnormal movements following at least six months and often many years of neuroleptic therapy, hence, tardive or late onset.[4] Today, tardive dyskinesia is characterized by choreiform movements of the mouth, tongue, face, arms, legs and body, in order of decreasing frequency.[15]
Risk factors for developing tardive dyskinesia include:
* chronic neuroleptic therapy especially polypharmacy
* age greater than 40 years
* chronic schizophrenia
* institutionalization
* Females are more commonly affected than males.
Institutionalization is included as a risk factor because of long-term, high dose neuroleptic therapy frequently employed in chronic care facilities.
Indiscriminate use of anticholinergics may also increase a patient's risk for developing tardive dyskinesia by blocking the cholinergic system and thereby
enhancing dopamine hence creating a neurotransmitter imbalance.
Onset of tardive dyskinesia may be insidious or emerge as neuroleptics are being reduced or discontinued. This pattern theoretically is related to denervation-hypersensitivity phenomenon. It appears with prolonged receptor blockade by a neuroleptic, the receptors rebound, becoming supersensitized. Medication non-compliance such as running out of a prescription or undergoing sudden drug withdrawals and resumptions are a common cause of this denervation-hypersensitivity rebound phenomenon.
The best treatment for tardive dyskinesia is prevention. The indication for long-term neuroleptics must be well established and continually re-evaluated, with alternatives considered. Once tardive dyskinesia presents, a gradual reduction of the neuroleptic should be attempted in hopes of a spontaneous remission. Overall 60% of persons may improve, however it may take two or more years for a remission to occur.[6]
Drug interventions for persistent dyskinesias include low doses of benzodiazepines, dopamine antagonists and other dopamine depleting agents such as reserpine and tetrabenazine.
Frequently, patients prefer the neuroleptic be resumed as the effectiveness of other agents is often insufficient to bring a satisfactory level of relief from the abnormal involuntary movements. At best, the prognosis for patients with tardive dyskinesia is poor. Emphasis must be placed on prevention, appropriate use of antipsychotics and early recognition of this phenomenon.
------------------------------------------------------------
Table 2
Syndrome Drugs responsible
-----------------------------------------------------------
Postural tremor Sympathomimetica ++
Levodopa ++
Amphetamines ++
Bronchodilators ++
Tricyclic antidepressants ++
Lithium carbonate ++
Caffeine ++
Thyroid hormone ++
Sodium valproate ++
APDs (1) ++
Hypoglycemic agent ++
Anrenocorticosteroids ++
Alcohol withdrawal ++
Amiodarone +
Cyclosporin A +
Others
Acute dystonic APDs ++
reactions Metoclopramid ++
Antimalarials +
Tetrabenazin +/-
Diphenhydramine +/-
Mefenamic acid +/-
Oxatomide +/-
Flunarizine and cinnarizine +/-
Akathisia APDs ++
Metoclopramid ++
Reserpine ++
Tetrabenazine +
Levodopa & DA agonists (3,4) +
Flunarizine and cinnarizine +/-
Ethosuximide +/-
Methysergide +/-
Parkinsonism APDs ++
Metoclopramide ++
Reserpine ++
Tetrabenazine +
Alphamethyldopa +
Flunarizine and cinnarizine +/-
Lithium +/-
Phenytonin +/-
Captopril +/-
Alcohol withdrawal +
MPTP (2) +
Other toxins (Mn, Carbon disulfide
cyanide) +
Cytosine arabinoside +/-
Chorea,including APDs ++
tardive Metoclopramide ++
dyskinesis and Levodopa ++
orofacial Direct DA agonists (3) ++
dyskinesia Indirect DA Agoniets and other
Catecholaminergic Drugs (4) ++
Anticholinergics +
Antihistaminics +
Oral Contraceptives +
Phenytonin (T) +
Carbamazepine (T) +/-
Ethosuximide +/-
Phenobarbital (T) +/-
Lithium (T) +/-
Benzodiazepines +/-
MAO Inhibitors +/-
Tricyclic antidepressants +/-
Methyldopa +/-
Methadone +/-
Digoxin +/-
Alcohol withdrawal +/-
Toluene (glue) snifling +/-
Flunarizine and cinnarizine +/-
Dystonia, APDs ++
including Metoclopramide ++
tardive Levodopa ++
dystonia Direct DA agonists (3) +
(excluding acute Phenytoin (T) +
dystonic Carbamazepine (T) +/-
reactions) Flunarizine and cinnarizine +/-
Neuroleptic APDs +
malignant Tetrabenazine + AMPT +/-
syndrome Withdrawal of antiparkinsonian
drugs in Parkinson's disease +/-
Tics (simple and Levodopa +
complex), Direct PA agonists +
including Indirect PA agonists ++
aggravation of APDs +
pre-existing tic Carbamazepine +/-
disorders
Myoclonus Levodopa (T) ++
Anticonvulsants (5) (T) ++
Tricyclic antidepressants ++
APDs +/-
Others (6)
Asterixis Anticonvulsants (5) (T) ++
Levodopa +/-
Hepatotoxins (T) ++
Respiratory Depressants (T) ++
Others (6) (T) ++
++ = Well documented common or not infrequent
+ = Relatively we11 documented; uncommon
+/- = Not well documented or only sma11 number of cases in literature
T = Usually other evidence of drug toxicity present (including serum drug levels)
DA = Dopamine
1. APDs=antipsychotic drugs
2. MPTP=1-lMNethyl-4-Phenyl-1,2,3,6-Tetrahydropyridine
3. Includes: Apomorphine, Bromocriptine, Lisuride,
Pergolide, Others
4. Includes: Amphetamines, Methylphenidate, Amantadine,
Pemoline, Fenfluramine, Nomifensine
5. Includes most categories of anticonvulsant drugs
6. Includes wide variety of other drugs capable of causing
toxic encephalopathy
From Weiner WJ, Lang AE. Pages 600-602: Movement Disorders: A Comprehensive Survey. Futura Publishing Co., 1989. Reprinted with permission.
------------------------------------------------------------------------
Tardive Dystonia
Tardive dystonia, resembling idiopathic torsion dystonia, is characterized by contorting posture(s) of a muscle or muscle groups. Tardive dystonia commonly affects the face or neck, but may also involve the leg or trunk. Other drug-induced movement disorders including tardive dyskinesia, akathisia (a subjective sensation of restlessness) or myoclonus may accompany tardive dystonia, and have led many researchers to classify tardive dystonia as a variant of tardive dyskinesia. Unlike tardive dyskinesia, tardive dystonia is seen in children as well as adults. As many as 2% of psychiatric inpatients have been noted to have features of tardive dystonia.[16]
There are no known biochemical changes in idiopathic dystonia. However, it has been postulated through pharmacologic observation an alteration may exist in the cholinergic system.
Clinically, patients with tardive dystonia often respond to dopamine-depleting drugs or antagonists. However, if ineffective, patients should be offered trials of the pharmacological therapy used in patients with primary idiopathic dystonia.
Infrequent Drug-Induced Syndromes
Two other syndromes, although infrequently seen, warrant consideration because of their potential morbidity and mortality: acute dystonic reactions and neuroleptic malignant syndrome.
Acute dystonic reactions have been associated with all neuroleptics. Swett found an incidence of acute dystonic reactions in 10.1% of patients studied on a variety of antipsychotic drugs; males under the age of 30 were most commonly affected.[12] Acute dystonic reactions are frequently seen in the psychiatric setting, or bring patients in the community to the emergency room within hours or a few days after the initiation of therapy with a neuroleptic, metoclopramide (Reglan) or other potential drugs. Like idiopathic and tardive dystonia, the pathophysiology of acute dystonic reactions remains obscure.
Treatment for acute dystonic reactions includes withdrawal of the offending agent and parenteral infusion of an anticholinergic or antihistamine such as benztropine (Cogentin) or diphenhydramine (Benadryl) followed by oral anticholinergic therapy every 4-6 hours for the next 24-48 hours.
Neuroleptic malignant syndrome is the least common of the extrapyramidal adverse effects of neuroleptic drugs, but the most dangerous.[2]
Idiosyncratic reactions including fever, severe rigidity, tremor, autonomic instability and obtundation lead to pulmonary embolism, myocardial infarction and disseminated intravascular coagulation. Death occurs in 20-80% of the cases while gradual spontaneous resolution over 2 weeks occurs in the remainder.[15]
Infrequently, patients continue to exhibit involuntary movements including dyskinesia or parkinsonism upon recovery from the acute phase.
The pathological mechanism of neuroleptic malignant syndrome is uncertain, however, it is thought the neuroleptic blocking effects on striatal dopamine receptors result in severe rigidity and excessive heat production from severe muscle contraction.
Additionally, thermo-regulatory function maybe altered by central effects of the neuroleptics.
Life supporting care including provision of fluids and electrolytes, cooling and artificial ventilation may be required. Dopamine agonists and direct acting skeletal muscle relaxants such as dantrolene sodium have been used with fair to good results.[2]
Nursing Implications
Nurses in many settings are exposed to patients at risk for, or who suffer from drug-induced and tardive syndromes. Prevention of these complications is the best treatment.
Careful assessment of the need for antipsychotic treatment must be considered along with knowledge of the risk of a persistent, irreversible involuntary movement disorder evolving as a complication of neuroleptic therapy. Nurses are in a position to carefully discuss these risks and benefits with the medical team, patient and family.
Constant weekly monitoring for early detection of abnormal involuntary movements is an important role of the nurse. Education of the patient and family is of utmost importance, with emphasis placed on the goals of treatment, medication effects and potential adverse effects.
Compliance should be monitored and patients must be discouraged from sudden drug discontinuance, Additionally, comprehensive care including options such as day programs and counseling should be considered to assist in resolving or optimally managing psychiatric problems. Once a movement disorder develops, nurses must carefully monitor the patient, assess therapeutic alternatives
and provide reassurance and counseling for the patient and family.
Summary
Drug-induced and tardive movement disorders represent a large number of extrapyramidal disorders seen in neurologic practice. Iatrogenically induced, most commonly by neuroleptics, these disorders can be characterized by any abnormal body movement including tremor, chorea, athetosis, dyskinesias, dystonia, myoclonus, tics, ballismus or akathisia. Parkinsonism, dyskinesias and dystonia tend to be the most common. Management of patients with drug-induced or tardive syndromes is complex.
Prognosis is frequently poor as patients usually need the offending agent to manage their underlying psychiatric or medical problem. Neuroleptics and other drugs known commonly to cause movement disorders should be used cautiously and significant consideration of all risks and benefits measured
before initiating therapy.
Acknow1edgment
The author wishes to thank Matthew B. Stern, MD, for useful comments in support of this article, and Rita Verrilli for her assistance in the preparation of the manuscript.
References
1. Ayd Fa: A survey of drug induced extrapyramidal reactions.
J Am Med Assoc 1961; 175:1054-1060.
2. Caroff SN: The neuroleptic malignant syndrome.
J Clin Psychiatry 1980; 41:79-83.
3. Chase TN, Shur JA, Gordon EK: Cerebrospinal fluid monoamine catabolites in induced extrapyramidal disorders. Neuropharmacology 1970; 9:265-275.
4. Faurbye A, Rasch PJ, Peterson PB, et al:
Neurological syndromes in pharmacotherapy of psychosis.
Acta Psychiatr Scand 1964 40:10-27.
5. Klawans HL: The pathophysiology a drug-induced movement disorders.
Pages 315-326 in: Parkinson's Disease and Movement Disorders,
Jankovic J, Tolosa E (editors).
Urban and Schwartzenberg. 1988.
6. Marsden CD: Is tardive dyskinesia a unique disorder?
Pages 64-71 in: Dyskinesia: Research and Treatment,
Casey DE, Chase TN, Christensen AV. Gerlach J (editors).
Springer Verlag 1985.
7. Marsden CD, Tarsy D, Baldessarini RJ:
Spontaneous and drug-induced movement disorders in psychotic patients.
Pages 219-226 in: Psychiatric Aspects of Neurologic Disease, Benson DF, Blumer D (editors). Grune and Statton, 1975.
8. Rajput A, Rozdilsky B, Hornykiewicz O et al:
Reversible drug-induced parkinsonism: Clinicopathologic study of two cases. Arch Neurol 1982; 39:644-646.
9. Rajput AH. Offord KP Beard CM et al:
Epidemiology of parkinsonism: Incidence, classification and mortality.
Ann Neurol 1984; 16:278-282.
10.Singh MM, Kay SR:
A comparative study of haloperidol and chlorpromazine in terms of clinical effect and therapeutic reversal with benztropine in schizophrenia. Theoretical implications for potency differences among neuroleptics. Psychopharmacologia 1975; 43:103-113.
11.Singh MM, Kay SR: A longitudinal therapeutic comparison between two prototypic neuroleptics (haloperidol and chlorpromazine) in matched groups of schizophrenics.
Non-therapeutic interactions with trihexyphenidyl.
Therapeutical implications for potency differences.
Psychopharmacologia 1975; 43:115-123.
12.Sweet C: Drug induced dystonia. Am J Psychiatry 1975; 132:532-534.
13.Tolosa E, Alom J: Drug induced dyskinesisas. Pages 327-347 in: Parkinson's Disease and Movement Disorders,
Jankovic J. Tolosa E (editors). Urban end Schwartzenberg 1988.
14.Van Praag HM, Ifoif J: Importance of dopamine metabolism for clinical effects and side effects of neuroleptics.
Am J Psychiatry 1976; 133:1171-1176.
15.Weiner WJ, Lang AE: Movement Disorders: A Comprehensive Survey.
Futura Publishing Company, Inc., 1989
16.Yassa R, Nair V, Dimitry R: Prevalence of tardive dystonia.
Acta Psychiatr Scand 1986; 73:629-633.
01 May, 2007
Pot triggers psychotic symptoms
Next to last paragraph reads:
"We don't know the basis of paranoia or anxiety," said McGuire.
Hmm... why don't we see stuff like that more often in the news stories about all the "disorders?" How about one that says "We don't know the basis of anything but here are some drugs to treat you."
Doctors: Pot triggers psychotic symptoms
By MARIA CHENG, AP Medical Writer Tue May 1, 6:23 AM ET
LONDON - New findings on marijuana's damaging effect on the brain show the drug triggers temporary psychotic symptoms in some people, including hallucinations and paranoid delusions, doctors say.
British doctors took brain scans of 15 healthy volunteers given small doses of two of the active ingredients of cannabis, as well as a placebo.
One compound, cannabidiol, or CBD, made people more relaxed. But even small doses of another component, tetrahydrocannabinol, or THC, produced temporary psychotic symptoms in people, including hallucinations and paranoid delusions, doctors said.
The results, to be presented at an international mental health conference in London on Tuesday and Wednesday, provides physical evidence of the drug's damaging influence on the human brain.
"We've long suspected that cannabis is linked to psychoses, but we have never before had scans to show how the mechanism works," said Dr. Philip McGuire, a professor of psychiatry at King's College, London.
In analyzing MRI scans of the study's subjects, McGuire and his colleagues found that THC interfered with activity in the inferior frontal cortex, a region of the brain associated with paranoia.
"THC is switching off that regulator," McGuire said, effectively unleashing the paranoia usually kept under control by the frontal cortex.
In another study being presented at the conference, a two-day gathering of mental health experts discussing the connections between cannabis and mental health, scientists found that marijuana worsens psychotic symptoms of schizophrenics.
Doctors at Yale University in the U.S. tested the impact of THC on 150 healthy volunteers and 13 people with stable schizophrenia. Nearly half of the healthy subjects experienced psychotic symptoms when given the drug.
While the doctors expected to see marijuana improve the conditions of their schizophrenic subjects — since their patients reported that the drug calmed them — they found that the reverse was true.
"I was surprised by the results," said Dr. Deepak Cyril D'Souza, an associate professor of psychiatry at Yale University's School of Medicine. "In practice, we found that cannabis is very bad for people with schizophrenia," he said.
While D'Souza had intended to study marijuana's impact on schizophrenics in more patients, the study was stopped prematurely because the impact was so pronounced that it would have been unethical to test it on more people with schizophrenia.
"One of the great puzzles is why people with schizophrenia keep taking the stuff when it makes the paranoia worse," said Dr. Robin Murray, a professor of psychiatry at King's College.
Experts theorized that schizophrenics may mistakenly judge the drug's pleasurable effects to outweigh any negatives.
Understanding how marijuana affects the brain may ultimately lead experts to a better understanding of mental health in general.
"We don't know the basis of paranoia or anxiety," said McGuire.
"It is possible that we could use cannabis in controlled studies to understand psychoses better," he said. McGuire theorized that could one day lead to specific drugs targeting the responsible regions of the brain.
29 Apr, 2007
Virginia Tech & School Shootings tied to prescription drugs
The Modesto Bee
Role of antidepressants in killings needs review
By TY PHILLIPS
April 29, 2007
The murderous rampage that left 33 people dead at Virginia Tech has stirred countless emotions: sadness and anger, fear and hatred, grief and disgust.
When Dr. Ann Blake Tracy heard the details, she felt many of those same emotions. Yet there is one sentiment Tracy does not share with much of the rest of the world: surprise. As terrible as it sounds, after nearly 20 years researching links between violent crime, suicide and antidepressants, Tracy is surprised only that it doesn't happen more often.
Details continue to emerge about the lonely life of killer Seung-Hui Cho, who had a history of mental illness. Among Cho's effects, officials found prescription medications related to the treatment of psychological problems.
Though it's still premature to draw conclusions without toxicology results, these are the details Tracy, an author and the executive director of the International Coalition for Drug Awareness, expected from the moment she heard about the Virginia Tech shootings. In her experience, when it comes to investigating high-profile shootings, antidepressants are as common as the presence of loneliness, despondence and rage.
"I'm just so tired of seeing people die, I could scream," Tracy said during a phone interview. "It's happening daily in this country. It's so massive, it's just unreal. We've got so many school shootings now, I can't even begin to keep up with them all. And the reason is so incredibly obvious. You don't have to look at much to figure it out."
2006, Bailey, Colo. — Duane Morrison shot and killed a girl and sexually assaulted six others. Antidepressants were found in his vehicle.
2005, Red Lake Indian Reservation, Minn. — Jeff Weise shot and killed nine people and wounded five before committing suicide. Prozac.
1998, Springfield, Ore. — Kip Kinkel killed his parents, then went to school and opened fire in the cafeteria, killing two and wounding 22. Prozac.
1989, Stockton — Patrick Purdy used an assault rifle to spray bullets through a playground at Cleveland Elementary School, killing five children and wounding 29 people before he killed himself. Elavil.
'It's all so intertwined'
There are dozens of other examples of violence at schools and the presence of antidepressants, but the carnage hardly is limited to our campuses. Countless families have been destroyed around the world through homicides and suicides committed by adults on antidepressants.
In June 2001, Texan Andrea Yates drowned her five children under the influence of four psychiatric medicines, including Effexor.
In February 2004 in Polk Township, Pa., Samantha Hirt, hours after taking a pill for manic depression, set fire in a bedroom where her two toddlers were playing, closed the door and sat on a sofa watching television while the fire spread, killing both children. Effexor.
Other famous cases include the 1998 deaths of actor Phil Hartman and his wife, a murder/suicide committed by her (Zoloft); the 1999 home and office killing spree by Atlanta day trader Mark Barton (Prozac); the 1998 shooting deaths of four co-workers by Connecticut lottery accountant Matthew Beck, who then killed himself (Luvox); and the 1994 New York City subway bombing by Edward Leary, which injured 48 (Prozac).
The list (which can be found at www.drugawareness.org) encompasses hundreds and hundreds of cases.
"You start linking them together and looking at all the similarities and you say, 'Good grief, it's all so intertwined,'" said Tracy, who has appeared on programs including "20/20," "Dateline" and "60 Minutes" and served as a consultant on high-profile cases including Columbine and Andrea Yates. "I keep asking, 'When is somebody going to see this?' But we've been so brainwashed about drugs, we think legal means safe.
"Most people don't know LSD once was prescribed as a wonder drug. Most people don't know that PCP was considered to have a large margin of safety in humans. Most people don't know ecstasy was prescribed and sold for five years to treat depression. Few know that history of drugs, and I think that's our biggest problem. We're just not educated enough to have concerns."
Prozac nation, indeed
The Northern San Joaquin Valley certainly is not immune. Stanislaus County Coroner Kristi Herr, who has investigated hundreds of the county's 4,000 annual deaths, including many accidental overdoses of prescription medicines, said she regularly goes into homes of deceased people and finds medicine cabinets loaded with prescription medicines. Sometimes there are so many pill bottles that large garbage bags are needed to transport them all.
"It seems to me a large portion of our society is on antidepressants," Herr said. "That isn't based on statistics. That is just based on my experience of going into homes and evaluating the cases that come through here."
In 2003, then-Newman resident Lorraine Slater's 14-year-old daughter, Dominique, killed herself after being treated for depression with several antidepressants, including Celexa and Wellbutrin. As her depression and erratic behavior worsened, her doctor prescribed her a double dose of Effexor. Fifteen days later, she was dead. Her body later was found in the Delta Mendota Canal in Patterson, not far from the family's home.
"On the drug, she became more agitated, combative and restless," Slater said. "And she had never been like that before. It's like our daughter was on LSD. It was a real Dr. Jekyll and Mr. Hyde experience."
Shortly after Dominique's death, the FDA released a warning that one in 50 patients, or 2 percent, will experience an adverse reaction to Effexor, which can include suicidal thoughts.
Slater has become a consumer advocate working to raise awareness of possible dangers of antidepressants. On May 9, she will testify at a hearing at the state Capitol concerning a bill that would require drug companies to disclose results of all clinical trials.
"We're not against medication," Slater said. "We just want disclosure about results from their trials. In their internal memos, marketers are told to downplay the side effects, and a lot of doctors aren't aware of the real dangers.
"We're just saying these companies need to give the citizens they're supposedly trying to help the information about possible symptoms so people can make informed decisions. If their medicine is so good, what is there they have to hide?"
Arguments against link
Of course, the logical argument against tying violent crimes to antidepressants is that there are countless factors that motivate a person to commit a violent act.
And those who carry out these deeds often are people with mental illness, so the presence of antidepressants can be expected. These are solid points; correlation does not in itself mean causation. And there is no doubting that countless people have benefited from these drugs.
Still, as one looks at the details of violent crimes around the country, too often there is an array of antidepressants. At the very least, this is a topic that deserves greater scrutiny.
In early 2005, the FDA issued a warning that antidepressants can cause both suicide and violence. The agency also mandated a black-box warning — the most serious available — that states these drugs can produce side effects that include anxiety, agitation, panic attacks, irritability, hostility, aggressiveness, impulsivity and mania.
The FDA also has warned that abrupt withdrawal of antidepressants can produce suicide, psychosis or hostility.
Eli Lilly, which makes Prozac, repeatedly has denied claims that Prozac causes violence, even though the company's own documents acknowledge "nervousness, anxiety, self-mutilation and manic behavior" are among the "usual adverse effects" of the medicine.
It's the same Eli Lilly that has paid more than $1.2 billion to 28,000 people who claimed they were injured by the drug Zyprexa during the past decade, according to a Jan. 5 article in the New York Times.
Paying $1.2 billion over 10 years may sound like a lot of money until compared with the $4.2 billion the company made last year alone selling Zyprexa, which has been taken by 20 million people worldwide since its introduction in 1996.
Most antidepressant drugs, including Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro and Effexor, are known as selective serotonin reuptake inhibitors, which alter brain chemistry in an attempt to manage depression.
Serotonin, a neurotransmitter, is a chemical that facilitates communication within the brain, allowing one to experience happy feelings upon its release. Essentially, the antidepressant drugs prevent reabsorption of serotonin in an attempt to make the happiness experience last longer.
Mother of a monster
One of the former lead chemists at the National Institute of Health, whose work eventually led to the development of many antidepressant drugs, first spoke out against the drugs nearly 10 years ago.
"I am alarmed at the monster that Johns Hopkins neuroscientist Solomon Snyder and I created when we discovered the simple binding assay for drug receptors 25 years ago," said Dr. Candace Pert in the Oct. 20, 1997, issue of Time magazine.
She said Prozac and other SSRI (selective serotonin reuptake inhibitor) antidepressants may cause heart problems and affect the entire body, where the vast majority of serotonin is produced.
The medical profession "ignores the body as if it exists merely to carry the head around," said Pert, who's now scientific director of RAPID Pharmaceuticals in Potomac, Md. "These molecules of emotion regulate every aspect of our physiology."
A recent study by the Centers for Disease Control and Prevention found that half of all Americans take at least one prescription drug, and that antidepressant use has nearly tripled in the past decade. According to some estimates, 30 million Americans take antidepressants. FDA statistics show U.S. physicians issue more than 10 million antidepressant prescriptions each year to patients younger than 18. FDA-approved prescription drugs injure 2.2 million and kill at least 100,000 Americans each year, according to numerous published studies.
Some survive and forgive
Problem is, when antidepressants don't work as intended, the harmful fallout isn't limited to the user. The victims often are those within striking distance. They are people like Mark Taylor, who was sitting outside and reading a Bible when he was shot numerous times by Eric Harris at Columbine High School.
"The first one hit me in the back of the leg. That was the shotgun blast," Taylor said in a recent phone interview. "That was the most painful. And then I got hit several more times in the chest; the bullets went right through me. They tried to make sure I was dead. I laid down and pretended I was dead.
"I think Eric Harris, from the medication, didn't really know what he was doing. I don't really hold him responsible for it. Eric and Dylan were both taking medicines. They just didn't seem to have any reaction to what they were doing. They were having fun with it, laughing and enjoying it and having a good time. I feel that antidepressants were the cause of the Columbine shooting."
Taylor, now 24, travels the country and speaks about the importance of forgiveness. Since the Virginia Tech shootings, he has been besieged with interview requests. His interviews included an appearance on "The Morning Show with Mike and Juliet," a national Fox News Network program. The hosts invited Taylor because they wanted to hear from someone who had survived a school shooting, someone who presumably could offer insight to help other children survive such an incident.
"Forgiveness," Taylor told them, "that's how I survived it."
But Taylor said the show's commentators weren't much interested in his message of forgiveness. Instead, the show focused on interviews with FBI agents and police tacticians, who offered survival tips that we are supposed to use to arm our children as we send them off to school.
Is this what it's come to? Do we now simply accept that frequent school shootings are a part of today's society and prepare ourselves for when tragedy strikes? Too often, instead of working to find the cause of problems, we react to symptoms. That same kind of thinking is what has so many Americans taking antidepressants in the first place.
++
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27 Apr, 2007
Virginia Tech & Death By Drugs Video Now On Youtube
Please visit the following link:
http://www.youtube.com/watch?v=Ni0lK4Na6VY
Watch and share the video with everyone you can, so they can learn the truth!
27 Apr, 2007
Prescription safety act up for vote in Senate!
URGENT ACTION NEEDED FOR SAFER PRESCRIPTION DRUGS! CALL YOUR SENATORS TODAY!
Vioxx, Paxil, Zyprexa...drug companies knew their risks, but failed to tell the public. As a result, tens of thousands of Americans suffered or died from these medications.
A bill that would work to prevent these disasters from happening in the future and fix our nation's drug safety system is headed to the Senate floor for a vote EARLY NEXT WEEK…This new law would require drug companies to publicly disclose the results of their drug studies and would give the FDA more authority to require drug companies to perform follow up safety studies and make changes to a drug’s label when appropriate.
Right now drug company lobbyists are lobbying hard to weaken this bill. We need to make sure Senators don't propose or vote for any floor amendments that will strip the strong reforms needed to make drugs safer and give patients and doctors much needed information about hazardous side effects.
Call today and tell your Senators: “VOTE YES on Senate Bill 1082, the Food and Drug Administration Revitalization Act, and oppose any amendments that will weaken the bill.”
Use this link to find the contact information for your Senators (the drop-down menu of states at the top will find your two Senators). http://www.senate.gov/general/contact_information/senators_cfm.cfm
Here are some talking points:
· My name is ________ . I live in (your state) and I’m a constituent.
· I’m calling to ask the Senator to support Senate Bill 1082 when it comes to the Senate floor for a vote. I believe that Congress should pass strong drug safety reforms this session, so I urge that the Senator opposes any amendments that may weaken this legislation.
· It has been almost three years since the Vioxx disaster. Congress must make fixing our drug safety system a priority.
· Drug companies should be required to publicly disclose drug research and should be harshly penalized if they fail to perform post-market safety studies or withhold safety information.
· There is nothing in this legislation that would slow down the approval of important, life-saving drugs. Rather, it gives the FDA effective authority to ensure safety once drugs come to market. I hope I can count on the Senator to protect patient safety and support this bill.
Thank you for supporting this critical issue! Feel free to respond if you’d like to let us know you made a call(s) and/or to share any feedback.
Thanks again,
Meg Reeve
Campaign Organizer
Consumers Union
415-431-6747
www.prescriptionforchange.org
www.consumersunion.org
16 Feb, 2007
Young Children Diagnosed as Bipolar in Serious Danger from Medication Risks
Paragraph 2 reads: "Riley, the Hull 4-year-old who died of an overdose of psychiatric medications, was exceptionally young when she was diagnosed, just 2 1/2
. But among somewhat older children, the bipolar label has proliferated to the point that some psychiatrists now suspect the diagnosis may be sometimes misused, placing some children at unnecessary risk from the serious medications that usually follow."
Paragraphs 20 & 21 read: "Another possible factor in the increase of the bipolar diagnosis is the growing awareness among psychiatrists that
if they diagnose a bipolar child as being only depressed and prescribe antidepressants, the drugs could make the child dangerously worse, possibly even suicidal and psychotic."
"
Similarly, if a child has underlying bipolar disorder but is diagnosed as having attention deficit hyperactivity disorder and prescribed a stimulant, the symptoms could worsen, said Cambridge Health Alliance psychiatrist Nancy Rappaport."
http://www.boston.com/news/local/massachusetts/articles/2007/02/15/bipolar_labels_for_children_stir_concern/ Bipolar labels for children stir concern
Hull case highlights debate on diagnosis
Rebecca Riley's parents are accused of deliberately poisoning her with her prescription medication.
By Carey Goldberg, Globe Staff | February 15, 2007
The case of Rebecca Riley highlights a hot debate in psychiatric circles over the growing number of children who are diagnosed with bipolar disorder -- a battle centered largely in Boston but affecting the treatment of young patients nationwide.
Riley, the Hull 4-year-old who died of an overdose of psychiatric medications, was exceptionally young when she was diagnosed, just 2 1/2. But among somewhat older children, the bipolar label has proliferated to the point that some psychiatrists now suspect the diagnosis may be sometimes misused, placing some children at unnecessary risk from the serious medications that usually follow.
Others argue that many children are given different diagnoses, such as depression, when they should really be considered bipolar, a disorder that involves intense mood swings and hitting, biting, kicking, and screaming rages.
One thing is clear: In the past decade or so, the number of children diagnosed with bipolar disorder has risen dramatically. A study of mentally ill children in community hospitals, published last month in the Archives of General Psychiatry, found the proportion of children diagnosed as bipolar shot up from less than 3 percent in 1990 to 15 percent in 2000. Psychiatrists say the rate has continued to climb.
Why the increase? Psychiatrists at Massachusetts General Hospital were among those who spurred it. In 1995, they published research that contradicted the prevailing notion that bipolar disorder was exceedingly rare in children. Rather, they said, 16 percent of the children referred to their psychopharmacology clinic fit the diagnosis. Overall, that would mean perhaps 1 percent of all children may be affected.
"We support early diagnosis and treatment because the symptoms of this disorder are extremely debilitating and impairing," said Dr. Janet Wozniak , director of the Pediatric Bipolar Program at Mass. General. They "bring reckless and impulsive behaviors here and now and a long-term risk" for suicide, drug abuse, and crime, she said.
The psychiatric controversy is over diagnosing children before their teen years. There is virtually no scientific research on children younger than 6.
"Diagnosing and treating preschoolers is what I would call uncharted waters," Wozniak said, but research suggests the disorder often begins that early, and "it's incumbent on us as a field to understand more which preschoolers need to be identified and treated in an aggressive way."
Rebecca was prescribed an antipsychotic medication, a drug used to treat bipolar disorder in adults, and a blood pressure medication that is sometimes used to help hyperactive children sleep. She died in December. Her parents are charged with murder, and the Board of Registration in Medicine is investigating the role played by her psychiatrist, Dr. Kayoko Kifuji of Tufts-New England Medical Center.
Recent studies document a steep increase in prescriptions of anti psychotic drugs to children of all ages. That probably stems from the increasing diagnosis of bipolar disorder, said Wozniak, who gets about 90 percent of her research funding from the federal government, 5 percent from philanthropies, and 5 percent from companies that make psychiatric drugs.
Continued..."Still," she said, "the overall number of prescriptions is probably small relative to the number of children who need help."
The opposing camp, psychiatrists who want to define bipolar disorder more narrowly and sparingly, questions whether the disorder really affects so many children and whether the benefits of the diagnosis outweigh the risks of the drugs in many cases.
"Particularly over the last five to eight years, people like myself have become more alarmed at what we see as the misdiagnosis and the over use of medications," said Dr. Jennifer Harris , a clinical instructor at
Harvard University and supervisor at Cambridge Health Alliance. "I think clinical practice got way ahead of the science. . . . There are so many pressures -- some conscious, some unconscious -- to medicate these kids that I think clinicians jumped on this diagnosis way ahead of the evidence."
Harris and others point out that a diagnosis of bipolar disorder is considered more serious than attention deficit hyperactivity disorder or post traumatic stress disorder. A child diagnosed as bipolar thus tends to have much easier access to a range of help, from a spot in a therapeutic school to insurance coverage for hospitalization.
Another factor in the increased use of the diagnosis is the availability of new, potentially effective drugs, particularly anti psychotics and mood stabilizers. As the diagnosis gained popularity in recent years, so did prescriptions for powerful anti psychotic drugs such as Risperdal and Zyprexa -- which have been approved for use in adults, but are prescribed for children.
If there's a chance that a drug may calm down a dangerously out-of-control child and the drug is indicated for bipolar disorder, then it may make sense to diagnose the child with bipolar disorder, said Dr. George Dominiak , medical director of Westwood Lodge, a private psychiatric hospital in
Massachusetts.
"It's a tail-wagging-the-dog kind of thing," he said. "The treatments affect our observations and our labeling as well. "
Evidence has been mounting, however, that antipsychotic drugs can cause health problems, such as diabetes and significant weight gain.
"These are bad enough in themselves, but the concern is that if you have kids on these medications for extensive periods of time, then they may develop major medical problems as adults," said Dr. S. Nassir Ghaemi , director of the Bipolar Disorder Research Program at Emory University. (He has consulted for most of the drug companies that make the anti psychotics.)
Another possible factor in the increase of the bipolar diagnosis is the growing awareness among psychiatrists that if they diagnose a bipolar child as being only depressed and prescribe antidepressants, the drugs could make the child dangerously worse, possibly even suicidal and psychotic.
Similarly, if a child has underlying bipolar disorder but is diagnosed as having attention deficit hyperactivity disorder and prescribed a stimulant, the symptoms could worsen, said Cambridge Health Alliance psychiatrist Nancy Rappaport.
Further complicating the diagnosis: Abused or traumatized children can seem to have bipolar disorder when they are actually reacting to horrors in their lives.
Academic researchers have begun to make progress in refining the outlines of what constitutes bipolar disorder in children. But still, Rappaport said, the question of whether to diagnose a child with bipolar disorder can be "an agonizing clinical decision."
Carey Goldberg can be reached at
goldberg@globe.com
16 Feb, 2007
4-Year-Old Dead from Drug Cocktail, Parents Charged... Debate Over Children and Psychiatric Drugs
Paragraphs 3 through 5 read:
"Last week, prosecutors in Plymouth County charged the parents, Michael and Carolyn Riley, with deliberately poisoning their daughter Rebecca by giving her overdoses of prescription drugs to sedate her."
"The police said the girl had been taking a potent cocktail of psychiatric drugs since age 2, when she was given a diagnosis of attention deficit disorder and bipolar disorder, which is characterized by mood swings."
"The parents have pleaded not guilty, with their lawyers questioning whether the child should have been prescribed such powerful drugs."
http://www.nytimes.com/2007/02/15/us/15bipolar.html?hp&ex=1171602000&en=8c9cf594e7bae322&ei=5094&partner=homepage Debate Over Children and Psychiatric Drugs
![[]](http://graphics8.nytimes.com/images/2007/02/15/us/15bipolar_600.jpg)
Gary Higgins/Associated Press
Michael and Carolyn Riley were arraigned last week on charges related to the death of a daughter.
By
BENEDICT CAREYPublished: February 15, 2007
Early on the morning of Dec. 13, police officers responding to a 911 call arrived at a house in
Hull, Mass., a seaside town near Boston, and found a 4-year-old girl on the floor of her parents’ bedroom, dead.
She was lying on her side, in a pink diaper, the police said, sprawled across some discarded magazines and a stuffed brown bear.
Last week, prosecutors in Plymouth County charged the parents, Michael and Carolyn Riley, with deliberately poisoning their daughter Rebecca by giving her overdoses of prescription drugs to sedate her.
The police said the girl had been taking a potent cocktail of psychiatric drugs since age 2, when she was given a diagnosis of attention deficit disorder and
bipolar disorder, which is characterized by mood swings.
The parents have pleaded not guilty, with their lawyers questioning whether the child should have been prescribed such powerful drugs.
The case has shaken a region known for the excellence of its social and medical services. The director of the state’s Department of Social Services has had to defend his agency, which had been investigating the case before the girl’s death.
The girl’s treating psychiatrist has taken a voluntary, paid leave until the case is resolved. And New Englanders are raising questions that are now hotly debated within psychiatry, and which have broad implications for how young children like Rebecca Riley are cared for.
Tufts-New England Medical Center, where the child was treated, released a statement supporting its doctor and calling the care “appropriate and within responsible professional standards.”
Indeed, the practice of aggressive drug treatment for young children labeled bipolar has become common across the country. In just the last decade, the rate of bipolar diagnosis in children under 13 has increased almost sevenfold, according to a study based on hospital discharge records. And a typical treatment includes multiple medications.
Rebecca was taking Seroquel, an antipsychotic drug; Depakote, an equally powerful mood medication; and Clonidine, a
blood pressure drug often prescribed to calm children.
The rising rates of diagnosis and medication use strike some doctors and advocates for patients as a dangerous fad that exposes ever-younger children to powerful drugs. Antipsychotics like Seroquel or Risperdal, which are commonly prescribed for bipolar disorder, can cause weight gain and changes in blood sugar risk factors for
diabetes.
Some child psychiatrists say bipolar disorder has become an all-purpose label for aggression.
“Bipolar is absolutely being overdiagnosed in children, and the major downside is that people then think they have a solution and are not amenable to listening to alternatives,” which may not include drugs, said Dr. Gabrielle Carlson, a professor of psychiatry and
pediatrics at
Stony Brook University School of Medicine on Long Island.
Paraphrasing
H. L. Mencken, Dr. Carlson added, “Every serious problem has an easy solution that is usually wrong.”
Others disagree, insisting that increased awareness of bipolar disorder and use of some medications has benefited many children.
“The first thing to say is that the world does not see the kids we see; these are very difficult patients,” said Dr. John T. Walkup, a child and adolescent psychiatrist at the
Johns Hopkins University School of Medicine.
Dr. Walkup said that when drug treatment was done right, it could turn around the life of a child with a diagnosis of bipolar disorder.
Dr. Jean Frazier, director of child psychopharmacology at Cambridge Health Alliance and an associate professor at
Harvard, said that up to three-quarters of children who exhibit bipolar symptoms become suicidal, and that it is important to treat the problem as early as possible.
“We’re talking about a serious illness with high morbidity, and mortality,” Dr. Frazier said, “and for some of these children the medications can be life-giving.”
Still, most child psychiatrists agree that there are still questions about applying the diagnosis to very young children. Recent research has found that most children who receive the diagnosis are emotionally explosive but do not go on to develop the classic features of the disorder, like euphoria. They are far more likely to become depressed.
And many therapists have found that some patients referred to them for bipolar disorder are actually suffering from something else.
“Most of the patients I see who have been misdiagnosed have been told they have bipolar disorder,” said Dr. Bessel van der Kolk, a professor of psychiatry at
Boston University who runs a trauma clinic.
“The diagnosis is made with no understanding of the context of their life,” Dr. van der Kolk said. “Then they’re put on these devastating medications and condemned to a life as a psychiatry patient.”
Details about what happened to Rebecca are still emerging. A relative of her mother, Carolyn Riley, 32, told the police that Rebecca seemed “sleepy and drugged” most days, according to the charging documents.
One preschool teacher said that at about 2 p.m. every day the girl came to life, “as if the medication Rebecca was on was wearing off,” according to the documents.
Defense lawyers are also focusing on the question of medication. “What I want to know,” said John Darrell, a lawyer for Mr. Riley, “is how in the world you diagnose a 2-year-old and give her these strong medicines that are not approved for children.”
A lawyer for Rebecca’s psychiatrist, Dr. Kayoko Kifuji of Tufts-New England Medical Center, did not return calls seeking comment.
Some experts say the temptation to medicate can be powerful.
“Parents very often want a quick fix,” Dr. Carlson said, “and doctors rarely have much time to spend with them, and the great appeal of prescribing a medication is that it’s simple.
“To me one of the miracle of children’s brains is that we don’t see more harm from these treatments.”
Katie Zezima contributed reporting from
Boston.
13 Feb, 2007
Risk of Sudden Death with Geodon
Here is an example of a drug many psychiatrists enthusiastically prescribe for managing what is actually an adverse reactionary state caused by other meds including SSRIs. To decode any side effect terminology (or to help someone in a confused drug fog understand) go to an online medical dictionary such as http://www.kmle.com/ and look up the side effects. Then look up any terms in the definition that you're unclear on. This drug is one they'll prescribe if Pfizer's other miracle drug Zoloft sends you into a downward spiral that they like to call bipolar mania, or if you're really lucky - you can get schizophrenia!
WARNINGSIncreased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Geodon (ziprasidone) is not approved for the treatment of patients with Dementia-Related Psychosis (see BOXED WARNINGS). QT Prolongation and Risk of Sudden Death In the first phase of the study, the mean change in QTc from baseline was calculated for each drug, using a sample-based correction that removes the effect of heart rate on the QT interval. The mean increase in QTc from baseline for ziprasidone ranged from approximately 9 to 14 msec greater than for four of the comparator drugs (risperidone, olanzapine, quetiapine, and haloperidol), but was approximately 14 msec less than the prolongation observed for thioridazine. In the second phase of the study, the effect of ziprasidone on QTc length was not augmented by the presence of a metabolic inhibitor (ketoconazole 200 mg BID). In placebo-controlled trials, ziprasidone increased the QTc interval compared to placebo by approximately 10 msec at the highest recommended daily dose of 160 mg. In clinical trials with ziprasidone, the electrocardiograms of 2/2988 (0.06%) patients who received GEODON and 1/440 (0.23%) patients who received placebo revealed QTc intervals exceeding the potentially clinically relevant threshold of 500 msec. In the ziprasidone-treated patients, neither case suggested a role of ziprasidone. One patient had a history of prolonged QTc and a screening measurement of 489 msec; QTc was 503 msec during ziprasidone treatment. The other patient had a QTc of 391 msec at the end of treatment with ziprasidone and upon switching to thioridazine experienced QTc measurements of 518 and 593 msec. Some drugs that prolong the QT/QTc interval have been associated with the occurrence of torsade de pointes and with sudden unexplained death. The relationship of QT prolongation to torsade de pointes is clearest for larger increases (20 msec and greater) but it is possible that smaller QT/QTc prolongations may also increase risk, or increase it in susceptible individuals, such as those with hypokalemia, hypomagnesemia, or genetic predisposition. Although torsade de pointes has not been observed in association with the use of ziprasidone at recommended doses in premarketing studies, experience is too limited to rule out an increased risk. As with other antipsychotic drugs and placebo, sudden unexplained deaths have been reported in patients taking ziprasidone at recommended doses. The premarketing experience for ziprasidone did not reveal an excess risk of mortality for ziprasidone compared to other antipsychotic drugs or placebo, but the extent of exposure was limited, especially for the drugs used as active controls and placebo. Nevertheless, ziprasidone's larger prolongation of QTc length compared to several other antipsychotic drugs raises the possibility that the risk of sudden death may be greater for ziprasidone than for other available drugs for treating schizophrenia. This possibility needs to be considered in deciding among alternative drug products (see INDICATIONS AND USAGE ). Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including (1) bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong the QTc interval; and (4) presence of congenital prolongation of the QT interval. It is recommended that patients being considered for ziprasidone treatment who are at risk for significant electrolyte disturbances, hypokalemia in particular, have baseline serum potassium and magnesium measurements. Hypokalemia (and/or hypomagnesemia) may increase the risk of QT prolongation and arrhythmia. Hypokalemia may result from diuretic therapy, diarrhea, and other causes. Patients with low serum potassium and/or magnesium should be repleted with those electrolytes before proceeding with treatment. It is essential to periodically monitor serum electrolytes in patients for whom diuretic therapy is introduced during ziprasidone treatment. Persistently prolonged QTc intervals may also increase the risk of further prolongation and arrhythmia, but it is not clear that routine screening ECG measures are effective in detecting such patients. Rather, ziprasidone should be avoided in patients with histories of significant cardiovascular illness, e.g., QT prolongation, recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec. For patients taking ziprasidone who experience symptoms that could indicate the occurrence of torsade de pointes, e.g., dizziness, palpitations, or syncope, the prescriber should initiate further evaluation, e.g., Holter monitoring may be useful. Neuroleptic Malignant Syndrome (NMS) Tardive Dyskinesia A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients undergoing treatment with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, ziprasidone should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on ziprasidone, drug discontinuation should be considered. However, some patients may require treatment with ziprasidone despite the presence of the syndrome. Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with GEODON. Although fewer patients have been treated with GEODON, it is not known if this more limited experience is the sole reason for the paucity of such reports. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies, which did not include GEODON, suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics included in these studies. Because GEODON was not marketed at the time these studies were performed, it is not known if GEODON is associated with this increased risk. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug. PRECAUTIONSGeneral Rash In premarketing trials with ziprasidone, about 5% of patients developed rash and/or urticaria, with discontinuation of treatment in about one-sixth of these cases. The occurrence of rash was related to dose of ziprasidone, although the finding might also be explained by the longer exposure time in the higher dose patients. Several patients with rash had signs and symptoms of associated systemic illness, e.g., elevated WBCs. Most patients improved promptly with adjunctive treatment with antihistamines or steroids and/or upon discontinuation of ziprasidone, and all patients experiencing these events were reported to recover completely. Upon appearance of rash for which an alternative etiology cannot be identified, ziprasidone should be discontinued. Orthostatic Hypotension Ziprasidone may induce orthostatic hypotension associated with dizziness, tachycardia, and, in some patients, syncope, especially during the initial dose-titration period, probably reflecting its (alpha) 1 -adrenergic antagonist properties. Syncope was reported in 0.6% of the patients treated with ziprasidone. Seizures During clinical trials, seizures occurred in 0.4% of patients treated with ziprasidone. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. As with other antipsychotic drugs, ziprasidone should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, e.g., Alzheimer's dementia. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. Hyperprolactinemia As with other drugs that antagonize dopamine D 2 receptors, ziprasidone elevates prolactin levels in humans. Increased prolactin levels were also observed in animal studies with this compound, and were associated with an increase in mammary gland neoplasia in mice; a similar effect was not observed in rats (see Carcinogenesis ). Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro , a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients. Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time. Potential for Cognitive and Motor Impairment Somnolence was a commonly reported adverse event in patients treated with ziprasidone. In the 4- and 6-week placebo-controlled trials, somnolence was reported in 14% of patients on ziprasidone compared to 7% of placebo patients. Somnolence led to discontinuation in 0.3% of patients in short-term clinical trials. Since ziprasidone has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about performing activities requiring mental alertness, such as operating a motor vehicle (including automobiles) or operating hazardous machinery until they are reasonably certain that ziprasidone therapy does not affect them adversely. Priapism One case of priapism was reported in the premarketing database. While the relationship of the event to ziprasidone use has not been established, other drugs with alpha-adrenergic blocking effects have been reported to induce priapism, and it is possible that ziprasidone may share this capacity. Severe priapism may require surgical intervention. Body Temperature Regulation Although not reported with ziprasidone in premarketing trials, disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing ziprasidone for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration. Dysphagia Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. Ziprasidone and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. Suicide The possibility of a suicide attempt is inherent in psychotic illness and close supervision of high-risk patients should accompany drug therapy. Prescriptions for ziprasidone should be written for the smallest quantity of capsules consistent with good patient management in order to reduce the risk of overdose. Ziprasidone has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from premarketing clinical studies. Because of the risk of QTc prolongation and orthostatic hypotension with ziprasidone, caution should be observed in cardiac patients (see QTc Prolongation under WARNINGS and Orthostatic Hypotension under PRECAUTIONS). Laboratory Tests Patients being considered for ziprasidone treatment that are at risk of significant electrolyte disturbances should have baseline serum potassium and magnesium measurements. Low serum potassium and magnesium should be repleted before proceeding with treatment. Patients who are started on diuretics during ziprasidone therapy need periodic monitoring of serum potassium and magnesium. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec (see WARNINGS). Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Lifetime carcinogenicity studies were conducted with ziprasidone in Long Evans rats and CD-1 mice. Ziprasidone was administered for 24 months in the diet at doses of 2, 6, or 12 mg/kg/day to rats, and 50, 100, or 200 mg/kg/day to mice ( 0.1 to 0.6 and 1 to 5 times the maximum recommended human dose [MRHD] of 200 mg/day on a mg/m 2 basis, respectively). In the rat study, there was no evidence of an increased incidence of tumors compared to controls. In male mice, there was no increase in incidence of tumors relative to controls. In female mice, there were dose-related increases in the incidences of pituitary gland adenoma and carcinoma, and mammary gland adenocarcinoma at all doses tested (50 to 200 mg/kg/day or 1 to 5 times the MRHD on a mg/m 2 basis). Proliferative changes in the pituitary and mammary glands of rodents have been observed following chronic administration of other antipsychotic agents and are considered to be prolactin-mediated. Increases in serum prolactin were observed in a 1-month dietary study in female, but not male, mice at 100 and 200 mg/kg/day (or 2.5 and 5 times the MRHD on a mg/m 2 basis). Ziprasidone had no effect on serum prolactin in rats in a 5-week dietary study at the doses that were used in the carcinogenicity study. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unknown (see Hyperprolactinemia under PRECAUTIONS, General ). Impairment of Fertility Ziprasidone was shown to increase time to copulation in Sprague-Dawley rats in two fertility and early embryonic development studies at doses of 10 to 160 mg/kg/day (0.5 to 8 times the MRHD of 200 mg/day on a mg/m 2 basis). Fertility rate was reduced at 160 mg/kg/day (8 times the MRHD on a mg/m 2 basis). There was no effect on fertility at 40 mg/kg/day (2 times the MRHD on a mg/m 2 basis). The effect on fertility appeared to be in the female since fertility was not impaired when males given 160 mg/kg/day (8 times the MRHD on a mg/m 2 basis) were mated with untreated females. In a 6-month study in male rats given 200 mg/kg/day (10 times the MRHD on a mg/m 2 basis) there were no treatment-related findings observed in the testes. Pregnancy Pregnancy Category C In animal studies ziprasidone demonstrated developmental toxicity, including possible teratogenic effects at doses similar to human therapeutic doses. When ziprasidone was administered to pregnant rabbits during the period of organogenesis, an increased incidence of fetal structural abnormalities (ventricular septal defects and other cardiovascular malformations and kidney alterations) was observed at a dose of 30 mg/kg/day (3 times the MRHD of 200 mg/day on a mg/m 2 basis). There was no evidence to suggest that these developmental effects were secondary to maternal toxicity. The developmental no-effect dose was 10 mg/kg/day (equivalent to the MRHD on a mg/m 2 basis). In rats, embryofetal toxicity (decreased fetal weights, delayed skeletal ossification) was observed following administration of 10 to 160 mg/kg/day (0.5 to 8 times the MRHD on a mg/m 2 basis) during organogenesis or throughout gestation, but there was no evidence of teratogenicity. Doses of 40 and 160 mg/kg/day (2 and 8 times the MRHD on a mg/m 2 basis) were associated with maternal toxicity. The developmental no-effect dose was 5 mg/kg/day (0.2 times the MRHD on a mg/m 2 basis). There was an increase in the number of pups born dead and a decrease in postnatal survival through the first 4 days of lactation among the offspring of female rats treated during gestation and lactation with doses of 10 mg/kg/day (0.5 times the MRHD on a mg/m 2 basis) or greater. Offspring developmental delays and neurobehavioral functional impairment were observed at doses of 5 mg/kg/day (0.2 times the MRHD on a mg/m 2 basis) or greater. A no-effect level was not established for these effects. Labor and Delivery The effect of ziprasidone on labor and delivery in humans is unknown. Nursing Mothers It is not known whether, and if so in what amount, ziprasidone or its metabolites are excreted in human milk. It is recommended that women receiving ziprasidone should not breast feed. Pediatric Use The safety and effectiveness of ziprasidone in pediatric patients have not been established. Geriatric Use Of the approximately 4500 patients treated with ziprasidone in clinical studies, 2.4% (109) were 65 years of age or over. In general, there was no indication of any different tolerability of ziprasidone or for reduced clearance of ziprasidone in the elderly compared to younger adults. Nevertheless, the presence of multiple factors that might increase the pharmacodynamic response to ziprasidone, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period for some elderly patients. | |
13 Feb, 2007
Judge Blocks Zyprexa Documents & Lilly Attempts to Criminalize Gottstein
The simple fact is that this could be any of us that are trying to get the truth out and going against these giants. This could be me or you, or anyone of us.
I have always felt that if one of us is brave enough to stand up to this corruption in spite of the odds that all of us should make a cordon to cover that person.
I don't care who it is needing our help we must do what we can to assist them.
I feel strongly too, that this is why many people go along with stuff so nice and complicitly because no one wants to be there or is willing to stick with a person that is willing to put their neck out on the line to do the right thing to stop any of this once the heat starts coming down on them.
If there is any way that any of you all can I would appreciate it if you would try to get some funds to help out here. There is an address on the bottom of this that you can send it too.
Here is the Press announcement about this:
FOR IMMEDIATE RELEASE
February 13, 2007
Contact: Bruce Whittington
778-862-8847
Bruce.Whittington@ PsychRights. org
Judge Issues Permanent Injunction in Eli Lilly Drug Case
Congress Encouraged to Subpoena Zyprexa Papers
U.S. District Court Judge Jack B. Weinstein issued a permanent injunction today, barring mental health rights advocate and attorney Jim Gottstein, and expert witness Dr. David Egilman, from further distributing internal Eli Lilly documents concerning the drug Zyprexa. The documents were recently reported in the New York Times to contain evidence that Lilly downplayed the risks of Zyprexa, its best-selling drug, and trained its sales force to encourage doctors to prescribe the drug for non-FDA approved uses.
Last December, Gottstein, who is President and CEO of The Law Project for Psychiatric Rights, Inc. (PsychRights) subpoenaed internal Eli Lilly documents for a case involving forced drugging of a client. The documents were under a protective order as part of a massive products liability case, but the protective order also provided the steps by which the documents might be subpoenaed. Believing he had obtained the documents legally, and because of the importance of the information to patients, doctors, and the general public, Gottstein released the documents to the New York Times and others.
Zyprexa is big business for Lilly: last year’s sales of the drug amounted to $4.4 billion. Lilly sought and obtained an injunction against Gottstein and others to whom he had sent the documents--which Lilly claims contain "trade secrets"-- prohibiting them from disseminating the internal company files. By that time, however, the New York Times had begun publishing stories on the files. Soon thereafter, various versions of the files appeared on the Internet.
"This was not a conspiracy to harm Eli Lilly." says Gottstein. "The Court’s order sealing the documents provided for release of the documents in circumstances like these, and I made a concerted good faith effort to follow those provisions to the letter. If anyone truly intended to violate the sealing order, there would have been no reason to even subpoena the documents."
Judge Weinstein saw it differently, outlining other means in the sealing order by which the documents might have been obtained and choosing to continue the injunction against Gottstein. While the injunction also covers others who received the documents directly from Gottstein, but still have not returned them, Judge Weinstein refused to honor Lilly’s request to continue the injunction against various websites that had posted the documents, nor were the New York Times, or other news organizations who have the documents, named in the injunction.
In fact, as Judge Weinstein pointed out in today’s order, "There has already been sufficient revelation in the New York Times so that if Congress, the Food and Drug Administration, or the Federal Trade Commission wish to investigate or act they have grounds for doing so, subpoenaing protected documents as necessary for their purposes."
The most important issue, says Gottstein, is the right of patients and the public to know the truth about Zyprexa. "Zyprexa has killed and permanently sickened thousands of people who have taken it. The files show that the manufacturer hid vital information about the drug’s safety not only from patients, but also from doctors. The bottom line is patient safety." He continued, "Did I want to get this information in front of the public and the medical profession? Of course. Additional lives may well have been saved."
Today’s order releasing several people and websites from the temporary injunction does not take effect for 10 days, to allow time for Eli Lilly to file an appeal to try and keep them enjoined. Gottstein plans to continue to use mechanisms suggested in the order to obtain access to the documents for his clients. “My continued efforts to obtain the information legally are a testament to my respect for our legal system.”
Judge Weinstein’s decision, the New York Times articles, and other background information on the case is available on the PsychRights website at http://psychrights.org.
# # #
The Law Project for Psychiatric Rights is a public interest law firm devoted to the defense of people facing unwarranted forced psychiatric drugging and other forced psychiatric interventions. PsychRights is further dedicated to exposing the truth about these treatments and that the courts are being misled into ordering people to be subjected to damaging drugs against their will. Extensive information about this is available on the PsychRights web site: http://psychrights.org/.
You can also read this, which is where you will find out what you can do to help!
Judge Weinstein's decision today about the Zyprexa documents, at
http://psychrights.org/PR/2-17-07PRInjunctionRelease.pdf and the 78 page decision at http://psychrights.org/States/Alaska/CaseXX/EilLilly/MemorandumFinaJudgmentOrderInjun ction.pdf
The short of it is the court found Jim has engaged in an illegal conspiracy to violate the court's sealing order. We all should and must vigorously dispute this. This does not make much sense because if anybody had of wanted to violate the sealing order, there was no reason to issue a subpoena. Dr. Egilman could have given the New York Times reporter the documents surreptitiously and it probably would have been impossible to even find out how he got them. There will probably be an appeal.
It seems likely Lilly will seek financially ruinous contempt sanctions against Jim and even go after him for criminal contempt.
The International Center for the Study of Psychiatry and Psychology (ICSPP) has established a legal defense fund for him he will need all the financial support he can get to help fight this. You can find out about the legal defense fund at
I am asking that any of you that are able to will please send a donation to this fund to help Jim with this, he has done many good things for many people when he didn't have to. He has given me and others support to make it through the next day when he didn't have to. He did this because he believes in what he is fighting for and that is us, and that is to help us stop this coercion and force in psychiatric treatment as well. Be led by whatever you feel leads you here, if you pray please pray for him, if you can donate please send a donation. Jim did this for the right reasons, the public deserves to know the truth! Feel free to pass this on if you know of anyone that can help or would like to help with this, financially or any other way. Please feel as free in spreading this as you did in spreading the documents, and I appreciate anything that you do to help here.
In the struggle and thanks, Janie
Produced by a Psychogerontologist =the branch of science that deals with learning
some unidentified branch of advocacy or philosophical knowledge throughout the aging process
Janie Lee, M.Ed.
12 Feb, 2007
Newborn mice fed Prozac grow up depressed
I saw this in Discover in 2004, and could never find it after that when I needed it. So here it is. The writer of this article is obviously clueless as to the real efficacy (or lack thereof) of "antidepressants" as well as the harmful effects on people of all ages. But of all people who deserve protection, I'd say babies rank pretty darn high on that list, especially considering that their brains are still developing. At least here we have one more study that has somehow worked its way into the public domain despite its negative conclusions (in terms of drug company interests). Perhaps this will help prevent the drug companies from promoting their drugs as "SIDS preventers" as we have seen they are getting close to trying next.
Newborn mice given Prozac grow up depressed
a.. 17:00 26 October 2004
b.. NewScientist. com news service
c.. Philip Cohen
http://space.newscientist.com/article/dn6579
Mice treated with the antidepressant Prozac early in life grow into adults with emotional problems, a new report concludes.
Whether the drug has the same effect on people is unknown. But the result will add to the growing debate over what risks Prozac (fluoxetine) and similar SSRI drugs (selective serotonin reuptake inhibitors) pose for young children and unborn babies.
"If they really need these drugs, people should take them. They can be life savers," says Jay Gingrich, a psychiatrist at Columbia University in New York City, US, who led the research. "But it is a little bit alarming to find they might carry risks that aren't apparent until later in life."
Researchers began injecting mice with fluoxetine four days after birth until they were 21 days old. Nine weeks after their last injection, the adult animals were given a series of behavioural tests designed to assess their level of anxiety and depression.
The team found that rodents who received drug as newborns were more intimidated by new surroundings and moved more slowly to avoid painful shocks compared to controls. "They are more inhibited in novel situations," says Gingrich. "Extrapolating to people, we'd say the mice are showing symptoms of anxiety and depression or emotional problems."
Suicidal thoughts
"It's fascinating, " says Tim Oberlander, a developmental paediatrician at the University of British Columbia in Vancouver, Canada. "It suggests these chemicals can cause crucial changes in the developing brain."
SSRIs work by increasing the level of the neurotransmitter serotonin in the brain and can be extremely effective in treating depression. They have been widely prescribed and make huge amounts of money for the drug companies that sell them.
But the drugs have become the focus of some controversy. Recently, for example, GlaxoSmithKline was accused of withholding data from clinical trials, the results of which suggested that depressed children taking their SSRI drug Paxil (paroxetine) had more suicidal thoughts than placebo controls.
The use of SSRIs by pregnant women has been considered safe. For example, studies have shown that these women give birth to babies of normal weights, with unimpaired cognitive and language skills. But more recent research has suggested these medications may cause subtle neurological changes in the developing fetus.
Two years ago, for example, Oberlander and his colleagues reported that babies exposed to SSRIs in the womb were less sensitive to pain. And earlier in 2004, other researchers reported that SSRI-exposed infants had altered sleep patterns and a higher incidence of tremors. But it is not clear if these effects disappear soon after birth.
Difficult decisions
Gingrich's work suggests that even transient treatment with Prozac - and potentially other SSRIs - can have lasting, paradoxical changes. Even though the drug can treat depression in adult mice, it seems to trigger symptoms of depression in mice exposed to it as newborns.
"It suggests that the immature nervous system responds very differently than a mature one to the same drug," he says.
Even with this new evidence, pregnant women with depression still face a difficult decision over whether or not to take SSRIs, says Gingrich. Being depressed carries its own risks to babies since it can lead to poor care-giving and self-harm.
"It's important to assess for each patient whether there are non-pharmacological ways of addressing these emotional problems, while we try to get a handle on what the risks really are," he says.
Journal reference: Science (vol 306, p 879)
11 Feb, 2007
NAMI, Teen Screen and Class Action Suit against Lilly
Who is behind Suicide Screening of America's kids?
The National Alliance on Mental Illness (NAMI) - that's who!
Wherever TeenScreen is pushed, NAMI is there pushing it.
Wherever TeenScreen is protested, NAMI is there to defend it.
Who is behind NAMI?
Pharmaceutical companies promoting psychiatric disorders - that's who!
Photos, documents and videos are being compiled here: www.psychsearch.net/nami.html Bookmark that page for future reference or better yet, download all the material and blow it out on the net. And even better than that - get this information to your legislators and school board officials.
The latest document added? A federal lawsuit. Excerpts below.
Case 1:06-cv-00021-JBW-RLM
CLASS ACTION COMPLAINT AND DEMAND FOR JURY TRIAL
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
LOCAL 28 SHEET METAL
WORKERS on behalf of themselves
And other similarly situated
Thomas M. Sobol
David S. Nalven
Lauren G. Barnes
Hagens Berman Sobol Shapiro
One Main Street, 4th Floor
Cambridge, MA 02142
Telephone: (617) 482-3700
Jason Thompson
Ann Mandt
Charfoos & Christensen, P.C.
5510 Woodward Avenue
Detroit, Mi 48202
Telephone (313) 875-8080
Ronald Goldser
Timothy Becker
Zimmerman Reed
651 Nicollet Mall, Suite 501
Minneapolis, MN 55402
Telephone (612) 341-0400
Attorneys for Plaintiff
v.
ELI LILLY AND COMPANY
Defendant
I. INTRODUCTION
This is a proposed national class action on behalf of consumers and third party payors (self-insured employers, Taft-Hartley funds, non-profit and for-profit health insurers, all of whom bear the ultimate risk for prescription drug expense) against Eli Lilly & Company (“Lilly” or “Defendant”) seeking damages and other monetary relief by reason of Lilly’s wrongful and illegal marketing, sales and promotional activities for the atypical antipsychotic Zyprexa.
EXCERPT EXTRACTED FROM PAGES 73 – 75
7. National Alliance for the Mentally Ill (NAMI) Activities
192. Lilly also utilized a non-profit organization as a front to further its own purposes of increasing market share for atypical antipsychotics and other medications. Lilly’s funding and partnering with the National Alliance for the Mentally Ill (NAMI) in the late 1990s and early 2000s was designed to accomplish through a non-profit organization what it could not on its own: giving the appearance of independent analysis and a grassroots movement encouraging the use of atypical antipsychotics by state and private insurers. The scheme worked and Lilly certainly benefited from its significant donations to NAMI. Zyprexa was the leading antipsychotic in the world in 2000, capturing nearly 40% of the global antipsychotic market. A year later, Zyperexa was the sixth highest selling pharmaceutical product in the world, with $3.2 billion in sales.
193. NAMI is a national association of mental health organizations in every state and bills itself as “redacted from court record”. In reality, this not-for profit organization readily accepts donations offered by pharmaceutical manufacturers while “redacted from court record”.
194. Lilly has been the largest contributor among pharmaceutical manufacturers to NAMI, giving the organization approximately $2.87 million between 1996 and 1999.
195. Lilly “donations” to NAMI were not limited to money. In 1999, Mother Jones Magazine reported that Lilly executive Jerry Radke was “on loan” to NAMI as an executive. Also in 1999, Bob Postlethwait, a Lilly executive who headed the group that produced and marketed Zyprexa (and Prozac assisted NAMI Indiana in securing government funding for an executive director.
196. Lilly also provided funding for a variety of brochures and programs produced by NAMI highlighting the use of atypical antipsychotics. One such Lilly-funded brochure – “Understanding Schizophrenia” – produced by NAMI for patients and families of schizophrenics minimized the side effects of atypical antipsychotics such as Zyprexa. Another – the 2001 “Access to Effective Medications” brochure produced by NAMI National for legislators and paid for by Lilly – lays out a blueprint for nationwide NAMI lobbying of state governments to reduce or remove any limitations to payments for atypical antipsychotics, again down-playing the side effects of such drugs.
197. Using money from Lilly and other pharmaceutical companies, NAMI – both the various state-level association and the national organization – has effectively lobbied state and federal governments to increase spending on atypical antipsychotic drugs and to reduce restrictions on access to those pharmaceuticals, thereby protecting pharmaceutical industry profits through the guise of independent, grassroots advocacy. For example, between 1998 and 2000, Lilly gave NAMI Washington State $91,000. During that time, NAMI Washington State, in an effort led by NAMI lobbyist Brad Boswell, lobbied the state legislature for $1 million specifically for atypical antipsychotic drugs. Brad Boswell was Lilly’s Washington state lobbyist just prior to his assignment with NAMI Washington State. NAMI also join a suit initiated by the Pharmaceutical Research and Manufacturers of America (PhRMA) against the state of Michigan in order to increase physician access to higher cost pharmaceuticals – including atypical antipsychotics – under the state’s Medicaid program.
198. The U.S. Department of Health and Human Services Office of the Inspector General issued a report in 2002 warning that cozy financial relationships between non-profit advocacy groups and pharmaceutical companies – such as the one between NAMI and Lilly – which result in the generation of revenue for the pharmaceutical companies could be considered illegal under the federal anti-kickback statute.
11 Feb, 2007
Antidepressants not effective
via email:
We sent this out to you before and it has just come out on a google alert
again with perfect timing considering what has been hitting the headlines the
past few days - the black box warnings being blamed for an increase in teen
suicide because they say that prescribing of the drugs decreased after the
warning. But, did prescribing of antidepressants to children go up or down during
the period of time they are discussing. We will address that subject next.
Now, the question this study poses is, if the drugs do not show
effectiveness, why would not prescribing them lead to an increase in suicide among
children?
Dr. Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org and author of
Prozac: Panacea or Pandora? - Our Serotonin Nightmare
and audio Help! I Can't Get Off My Antidepressant!
(Order Numbers: Voice: 800-280-0730, Fax: 801-335-4727
or e-mail to atracyphd2@ aol.com with ORDER in
the heading)
Antidepressants are widely believed to be exceptionally effective
medications. The data, however, tell a different story. Kirsch et al. (2002a) analyzed
the data sent to the U.S. Food and Drug Administration by the manufacturers
of the six most widely prescribed antidepressants (fluoxetine [Prozac],
paroxetine [Paxil], sertraline [Zoloft], venlafaxine [Effexor], nefazodone
[Serzone] and citalopram [Celexa]). Their research showed that although the response
to antidepressants was substantial, the response to inert placebo was almost
as great. The mean difference was about two points on the Hamilton Rating
Scale for Depression (HAM-D). Although statistically significant, this
difference is not clinically significant (Jacobson et al., 1999). More than half of
the clinical trials sponsored by the pharmaceutical companies failed to find
significant drug/placebo difference, and there were no advantages to higher
doses of antidepressants. The small difference between antidepressant and
placebo has been referred to as a "dirty little secret" by clinical trial
researchers (Hollon et al., 2002), a secret that was believed by FDA officials to be
"of no practical value to either the patient or prescriber" (Leber, 1998, as
cited in Kirsch et al., 2002b).
In light of these data, what should be done in clinical contexts? Some have
suggested that antidepressants continue to be prescribed, even if their
effects are largely placebo effects. If nothing else, these agents can be used as
active placebos. Given the side effects of these medications, we suggest an
alternative approach. There are many interventions that seem to be as
effective or nearly as effective as antidepressants. These include physical exercise,
bibliotherapy and psychotherapy (Kirsch et al., 2002b). Psychotherapy has
the further advantage of demonstrated superiority to medications in long-term
comparative studies (Antonuccio et al., 2002). Given these data,
antidepressant medication might best be considered a last resort, restricted to patients
who refuse or fail to respond to other treatments.
http://www.psychiatrictimes.com/showArticle.jhtml?articleID=175802224
Antidepressants Versus Placebos: Meaningful Advantages Are Lacking
By Irving Kirsch, Ph.D., and David Antonuccio, Ph.D.
http://www.psychiatrictimes.com/print.jhtml;jsessionid=ABN3ZYUYMSJUYQSNDLRCKHSCJUNN2JVN?articleID=175802224&urlprefix=
Psychiatric Times September 2002 Vol. XIX Issue 9
(Please see _Counterpoint article_ http://www.psychiatrictimes.com/p020909.html by Michael E. Thase, M.D.)
(This is a preview of the Rumble in Reno II scheduled for Oct. 18. The
debate between Kirsch and Thase will focus on the issues highlighted in these
point/counterpoint articles. Brochures for this conference are available online
at -Ed.)
Antidepressants are widely believed to be exceptionally effective
medications. The data, however, tell a different story. Kirsch et al. (2002a) analyzed
the data sent to the U.S. Food and Drug Administration by the manufacturers
of the six most widely prescribed antidepressants (fluoxetine [Prozac],
paroxetine [Paxil], sertraline [Zoloft], venlafaxine [Effexor], nefazodone
[Serzone] and citalopram [Celexa]). Their research showed that although the response
to antidepressants was substantial, the response to inert placebo was almost
as great. The mean difference was about two points on the Hamilton Rating
Scale for Depression (HAM-D). Although statistically significant, this
difference is not clinically significant (Jacobson et al., 1999). More than half of
the clinical trials sponsored by the pharmaceutical companies failed to find
significant drug/placebo difference, and there were no advantages to higher
doses of antidepressants. The small difference between antidepressant and
placebo has been referred to as a "dirty little secret" by clinical trial
researchers (Hollon et al., 2002), a secret that was believed by FDA officials to be
"of no practical value to either the patient or prescriber" (Leber, 1998, as
cited in Kirsch et al., 2002b).
Previous reports of vanishingly small drug/placebo differences (Kirsch and
Sapirstein, 1998) were met with skepticism (e.g., Klein, 1998). In contrast,
the basic findings from this new meta-analysis have been accepted as accurate
(e.g., Thase, 2002). The dispute is no longer about the small size of the
average drug/placebo difference, but rather about how to interpret this fact and
what to do about it.
Various interpretive possibilities have been raised. One of the most popular
theories is that there may be a subset of patients for whom at least some
antidepressants are very effective, but that their relative lack of efficacy
with other patients masks effect (e.g., Thase, 2002). Specifically, whereas
mildly depressed patients respond to both drugs and placebos, more severely
depressed patients respond only to active drugs. The FDA data contradict this
hypothesis. Although severely depressed patients benefited more from medication
than mildly depressed patients due to a phenomenon known as regression toward
the mean, they also benefited more from placebo than their more mildly
depressed counterparts.
Of course, one can never rule out the possibility of undetected moderator
variables. But if there are hidden moderators, the overall mean difference
between drug and placebo (two points on the HAM-D) constrains the conclusions
that can be drawn from them. If the mean drug/placebo difference is greater than
two points for a subset of medications or patients, then it must be less
than two points for the others. For example, if the mean difference between drug
and placebo is four points for half of the patients (which is still a rather
small drug effect), then the mean effect of antidepressants on the other
patients must be zero, and if it is more than four points for half the patients,
then the medications must be interfering with responsiveness in at least some
others who would fare better on placebo.
Another popular hypothesis is that drug effects are more stable than placebo
effects, resulting in lower relapse rates. This hypothesis is also
contradicted by the data. A meta-analysis of relapse prevention trials published
between 1973 and 1990 indicated that 71% of the drug response was duplicated by
placebo (Walach and Maidhof, 1999). Kirsch et al.'s meta-analysis also examined
response to treatment as a function of the duration of the trial. The data
indicated that responses to both drug and placebo decrease over time. Contrary
to conventional wisdom, however, the correlation between duration of the
trial and response to treatment was higher for active medication (r=-0.84) than
for placebo (r=-0.62), suggesting a steeper decline in effectiveness for
active drugs than for placebo (Kirsch et al., 2002b).
In light of these data, what should be done in clinical contexts? Some have
suggested that antidepressants continue to be prescribed, even if their
effects are largely placebo effects. If nothing else, these agents can be used as
active placebos. Given the side effects of these medications, we suggest an
alternative approach. There are many interventions that seem to be as
effective or nearly as effective as antidepressants. These include physical exercise,
bibliotherapy and psychotherapy (Kirsch et al., 2002b). Psychotherapy has
the further advantage of demonstrated superiority to medications in long-term
comparative studies (Antonuccio et al., 2002). Given these data,
antidepressant medication might best be considered a last resort, restricted to patients
who refuse or fail to respond to other treatments.
Dr. Kirsch is professor of psychology at University of Connecticut and
former president of Division 30 of the American Psychological Association.
Dr. Antonuccio is professor of psychiatry and behavioral sciences at
University of Nevada School of Medicine, and director of and staff psychologist for
the stop smoking program at the Reno Veterans Affairs Medical Center.
References
Antonuccio DO, Burns DD, Danton WG (2002), Antidepressants: a triumph of
marketing over science? Prevention & Treatment 5:Article 25. Available at:
www.journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.
Hollon SD, DeRubeis RJ, Shelton RC, Weiss B (2002), The emperor's new drugs:
effect size and moderation effects. Prevention & Treatment 5:Article 28.
Available at: www.journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed
Aug. 2.
Jacobson NS, Roberts LJ, Berns SB, McGlinchey JB (1999), Methods for
defining and determining the clinical significance of treatment effects:
description, application, and alternatives. J Consult Clin Psychol 67(3):300-307.
Kirsch I, Moore TJ, Scoboria A, Nicholls SS (2002a), The emperor's new
drugs: an analysis of antidepressant medication data submitted to the U.S. Food
and Drug Administration. Prevention & Treatment 5:Article 23. Available at:
www.journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.
Kirsch I, Sapirstein G (1998), Listening to Prozac but hearing placebo: a
meta analysis of antidepressant medication. Prevention & Treatment 1: Article
0002a. Available at: www.journals.apa.org/prevention/volume-1/toc-jun26-98.html.
Accessed Aug. 2, 2002.
Kirsch I, Scoboria A, Moore TJ (2002b), Antidepressants and placebos:
secrets, revelations, and unanswered questions. Prevention & Treat-ment 5:Article
33. Available at: www.journals.apa.org/prevention/volume5/toc-jul15-02.html.
Accessed Aug. 2.
Klein DF (1998), Listening to meta-analysis but hearing bias. Prevention &
Treatment 1:Article 0006c. Available at:
www.journals.apa.org/prevention/volume1/toc-jun26-98.html. Accessed Aug. 2, 2002.
Thase ME (2002), Antidepressant effects: the suit may be small, but the
fabric is real. Prevention & Treatment 5:Article 32. Available at:
www.journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.
Walach H, Maidhof C (1999), Is the placebo effect dependent on time? A
meta-analysis. In: How Expectancies Shape Experience, Kirsch I, ed. Washington,
D.C.: American Psychological Association, pp321-332.
11 Feb, 2007
NY Times Slams Ely Lilly 3 times on Zyprexa Case
Two articles and now an editorial!
For the 3rd day in a row The NY Times is blasting the huge drug
maker Eli Lilly for its fraudulent marketing practices of the
psychiatric neuroleptic drug Zyprexa.
Two NY Times articles (one on the front page!) were followed by
today's stinging editorial.
Links to the text for all three NY Times pieces this week can be
found here:
http://www.mindfreedom.org/aff-spon/act/usa/psychrights/nytimes-vs-eli-lilly
or: http://tinyurl.com/vnvfw
The NY Times investigation credits attorney Jim Gottstein, founder
of PsychRights for providing their reporter with documentation of the
fraud (NY Times even included a great photo of a smiling Jim).
Congratulations Jim!
For info on how to submit a letter to editor or "op ed" to _The NY
Times_ see:
http://www.nytimes.com/ref/membercenter/help/lettertoeditor.html
MindFreedom International is proud that PsychRights is a sponsor
group, for more info on PsychRights see http://www.psychrights.org
Please forward this very good news!
================
Zyprexa
For more than a month the New York Times has run quite a number of pieces (including five in a row) about the formerly-secret Zyprexa files after PsychRights founder attorney Jim Gottstein leaked the files to NY Times journalist Alex Berenson. PsychRights is a sponsor group of MindFreedom International.
James B. Gottstein, a lawyer who represents the mentally ill, said the documents about Zyprexa’s side effects raised public health issues. [photo by Joshua Borough for The New York Times[
The NY Times obtained, examined and described the secret files about the neuroleptic psychiatric drug Zyprexa in this series.
Despite its widespread coverage of the secret files, the name of The NY Times has been conspiculously absent from any of the temporary restraining orders that Eli Lilly has requested so far from US Circuit Court.
