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?
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
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!
20 Jul, 2006
FDA: "Migraine meds" risky when mixed with antidepressants
This is not surprising since the industry has tried to pass off its antidepressants as medication for migraines. News flash: combining too much of an antidepressant can make you crazy or make you die. Why don't people recognize serotonin syndrome more often (such as when you take an SSRI and have too much serotonin in your body)? There goes the low serotonin theory again!
FDA: Mixing migraine, depression meds risky
Wed Jul 19, 8:33 PM ET
WASHINGTON - People taking migraine drugs together with some antidepressants are at risk of a life-threatening condition, health officials warned Wednesday.
Serotonin syndrome can occur when migraine headache drugs called triptans are taken with antidepressants known as selective serotonin/norepinephrine reuptake inhibitors, or SSRIs and SNRIs. The syndrome occurs when the body has too much of the nervous system chemical serotonin.
Patients taking the drug combination can experience restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea, the FDA said.
Commonly prescribed SSRIs include Prozac, Zoloft, Paxil and Lexapro. SNRIs include Cymbalta and Effexor. Triptans include Amerge, Axert, Imitrex and Zomig.
The FDA asked the manufacturers of all three types of drugs to update their prescribing information to warn of the potential risk of serotonin syndrome.
Patients taking a triptan with either an SSRI or SNRI should talk to a doctor before stopping their medications, the FDA said.
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On the Net:
FDA health advisory: http://www.fda.gov/cder/drug/advisory/SSRI_SS200607.htm
