October 26

Suicide Rate Unchanged in 10 Years–JAMA / AMA Considers Stand Against Warning Labels on Antidepressants

Suicide Rate Unchanged in 10 Years–JAMA / AMA Considers Stand Against Warning Labels on Antidepressants

Thu, 9 Jun 2005

A major report in the Journal of the American Medical Association shatters all claims about the effectiveness of antidepressants as a treatment for the prevention of suicide. A comparison of the suicide data in the US between 1990-1992 and 2001-2003, by two Harvard led surveys is a stunning reality check. [1] The evidence is compelling:

“No significant changes occurred between 1990-1992 and 2001-2003 in suicidal ideation (2.8% vs 3.3%; P=.43), plans (0.7% vs 1.0%; P=.15), gestures (0.3% vs 0.2%; P=.24), or attempts (0.4%-0.6%; P=.45), whereas conditional prevalence of plans among ideators increased significantly (from 19.6% to 28.6%; P=.04), and conditional prevalence of gestures among planners decreased significantly (from 21.4% to 6.4%; P=.003).” At the same time, treatment increased dramatically:

“the enormous increase in treatment of emotional problems in the decade between the 2 surveys did not reduce the disparities in risk of suiciderelated behaviors.”.

“Despite a dramatic increase in treatment, no significant decrease occurred in suicidal thoughts, plans, gestures, or attempts in the United States during the 1990s.”

This major government sponsored study surveyed 9708 (English speaking) people aged 18 to 54 years compared the suicidal behavior data from the 1990-1992 National Comorbidity Survey (NCS) and the 2001-2003 National Comorbidity Survey Replication (NCS-R).

“There are approximately 3000 suicide ideators per 100 000 population and 500 suicide attempters per 100 000 population in the United States each year compared with only 14 suicide completers per 100 000 population. No statistically significant differences were found between the NCS and the NCS-R in the 12-month prevalence of any of the 4 outcomes: suicidal ideation suicide plans, suicide gestures.”

Try as they did, the authors could not explain away the evidence that antidepressants have failed to demonstrate their effectiveness as suicide prevention treatments:

“It is not clear how to interpret the finding that suicide-related behaviors did not decrease when treatment increased dramatically. Completed suicides decreased by about 6% during this period. The increase in treatment might have played a part in this trend, although county-level analysis shows no overall association between amount of treatment, as indicated by per-capita number of antidepressant prescriptions, and the suicide rate.35 If increased treatment did play a part in the decrease in the suicide rate, then why did we not see a comparable decrease in suicide-related behaviors?”

The authors acknowledged that their findings are corroborated by “other information” which “argues against the possibility that the increase in treatment prevented an increase that would otherwise have occurred in suicide-related behaviors. Specifically, randomized controlled trials find only modest effects of treatment in reducing suicidality, even with optimal regimens.”

The media’s failure to report these these important findings to the public may be an indication of the media’s financial dependence on drug company advertising.

AHRP calls for a moratorium on all screening for depression intitiatives which are falsely promoted as suicide prevention interventions. TeenScreen disseminates false information and leads to increased prescriptions for antidepressants. Inasmuch as there is absolutely no scientific-medical evidence that screening children for premumed mental disorders will benefit children, TeenScreen should be off limits from America’s schools.

A news report in the Chicago Tribune (below) reveals that the American Medical Association is seriously considering adopting a resolution proposed by a contingent of the American Psychiatric Association (APA) calling for the AMA to take a position AGAINST the FDA required Black Box warnings on antidepressant labels about the increased suicide risk for children prescribed an antidepressant.

“Those behind the proposal say it is designed to combat a recent, rapid decline in prescriptions” for children. Medco reported a 10% decline in prescribing SSRI antidepressants since disclosure of the suicide risk.

Perhaps this is the most appalling indicator confirming that the medical establishment has become a servant of the drug industry (much like pimps).

The fact that the scientific evidence has failed to demonstrate that antidepressants offer any benefit greater than placebo for children, and the fact that SSRI’s pose a twofold increased suicide risk for children and adolescents, is apparentlhy of no concern to the 35,000 psychiatrists who oppose the warnings.

This irresponsible move should disabuse those who had the illusion that either the AMA or the APA is concerned with enhancing the practice of medicine, once regarded as the healing profession. The AMA sells its list of doctors to the pharmaceutical industry–in the year 2000, the price was $20 million. [2] This list helps drug companies track doctors’ prescribing habits so that sales representatives can tailor their marketing pitch to individual doctors.

Organizations such as the AMA and the APA are primarily (solely) lobbying organizations for doctors and the drug industry: their goal is to ensure that both drug companies and doctors make a lot of money. Since writing prescriptions increases profits for drug manufacturers and increases income for doctors, the AMA and the APA promotes prescription drugs and jealously guards doctors’s exclusive right to prescribe–even if the drugs are lethal and ineffective.

1. Trends in Suicide Ideation, Plans, Gestures, and Attempts in the United States, 1990-1992 to 2001-2003 Ronald C. Kessler, PhD, Patricia Berglund, MBA, Guilherme Borges, PhD, Matthew Nock, PhD, Philip S. Wang, MD, DrPH. JAMA. 2005;293:2487-2495

2. Stolberg, SG and Gerth, J, “MEDICINE MERCHANTS / Tracking the Doctors,” The New York Times, November 16, 2000, at: http://www.nytimes.com/2000/11/16/science/16PRES.html?printpage=yes

Contact: Vera Hassner Sharav

Chicago Tribune
AMA to consider stand against warning labels on antidepressants

CHICAGO – (KRT) – The American Medical Association will consider taking a stance against a controversial Food and Drug Administration decision to add stiff warnings about antidepressant use among teens and children at its conference in Chicago this month.

Those behind the proposal say it is designed to combat a recent, rapid decline in prescriptions and ensure children and adolescents are getting proper treatment for depression.

But critics predict confusion will reign if the nation’s largest doctor’s group opposes the FDA and declares the agency has been too stern on antidepressants – especially during a time the agency is under criticism for lax oversight of drug safety.

Last fall the FDA ordered drug makers to place the highest warning, a so-called “black box” label, on antidepressants after a public outcry and government hearings in which some parents said they believed the drugs played a role in their children’s suicide. The new label warns of increased “suicidal thinking and behavior” in children and adolescents being treated with antidepressants.

Since the FDA began reviewing widely prescribed drugs such as Prozac, Zoloft, Paxil and Celexa antidepressant usage is down more than 10 percent among patients under age 18, according to a study by Medco Health Solutions Inc. The pharmacy benefit company found usage down 16 percent for the same age group in the fourth quarter, “traditionally the time of the year when antidepressant use peaks,” the Medco study said.

The decline concerns Dr. David Fassler, who is on the board of the American Psychiatric Association and is a voting AMA delegate representing the American Academy of Child and Adolescent Psychiatry.

“Are the right kids getting the right treatment?” said Fassler, adding that he didn’t feel the decision was supported by available scientific data. “I worry that it will reduce access to effective and appropriate treatment for children and adolescents suffering from depression.”

Fassler’s group, the 36,000-member American Psychiatric Association, is among those concerned about the affects of the black-box warning. The large organization could have some clout with the AMA’s 543-member policy-making House of Delegates when it meets the week of June 19 in Chicago to discuss the proposal, one of dozens the group will consider. The House represents nearly 250,000 doctor members of the AMA.

Though the resolution’s prospects are unknown, some observers say it is irresponsible of the AMA to even consider the proposal.

“For the AMA to move on this issue is irresponsible and confusing,” said Dr. Sidney Wolfe, director of Public Citizen’s health research group. “It is extraordinarily demeaning to both doctors and patients that a black box warning, that would lead to safer use of the drugs, is not a good idea. The black box warning is an attempt to balance out the known risks with the benefits of the drug and decrease the chance of a patient having an adverse reaction.”

A black box warning does not prevent doctors from prescribing a certain medication. It highlights risks and typically makes physicians think twice about using the product.

Any move to water down the labeling or eliminate the black box warning is sure to meet stiff opposition from some doctors, particularly pediatricians who fought for the new warnings last year.

“I think the black box warning is very reasonable and factually correct, and I don’t see any reason to change it,” said Dr. Thomas Newman, a pediatrician and University of California at San Francisco professor of epidemiology and biostatistics. He was on the FDA advisory panel that recommended the agency add the new warning labels.

Reached Wednesday, two of the largest makers of antidepressants, Pfizer Inc., the maker of Zoloft, and GlaxoSmithKline Plc. the maker of Paxil, declined to comment on the proposal before the AMA.

The drugs certainly have support among the medical profession, particularly in the field of psychiatry. And a report from the AMA’s Council on Scientific Affairs recently completed a report concluding that the FDA should re-evaluate the impact of its decision.

“This product labeling should not be interpreted in such a way that would decrease access to patients who might benefit from these drugs,” the report said.

The AMA forum could lead to a more unified voice among doctors regarding the controversial use of antidepressants among children, some doctors said.

“Are the right kids getting the right treatment?” Fassler asked. “That is where we need to place the emphasis.” Others, meanwhile, say parts of the AMA report advocating additional studies will also be a valuable exercise to put before the FDA.

“The FDA should evaluate the impact of the changes that it makes,” said University of California-San Francisco’s Dr. Newman. “The FDA takes actions with certain goals in mind and it would be a good idea for them to evaluate whether they accomplish the goals they were intended to accomplish.”

If doctors support the idea, it would be a tug in the opposite direction for the FDA – an agency recently criticized for not being vigilant enough in ensuring the safety of drugs after they hit the market in the wake of the withdrawals of pain medications Vioxx and Bextra.

Merck & Co. pulled Vioxx from the market last fall after a study found it increased a patient’s risk of heart attack and stroke. In April, Pfizer pulled Bextra, because of similar concerns, as regulatory scrutiny heightened. The FDA reportedly knew of heart risks from Vioxx years before.

June 7, 2005
Suicide rate unchanged in 10 years

Despite a dramatic increase in the psychiatric treatment of emotional disorders during the past decade, there has been no decrease in the rate of suicidal thoughts and behavior among adults, according to a highly respected federal survey.

People who attempt suicide were far more likely to be treated, especially with antidepressants such as Prozac, Paxil and Zoloft, in 2001-03 compared with 1990-92. But the rates of suicidal ideation, gestures and attempts remained essentially unchanged, said researchers from Harvard Medical School and elsewhere, who recently published their findings in the Journal of the American Medical Association.

The striking finding may have several explanations, they said: Reductions in suicidal behavior as a result of treatment might be offset by increases in such behavior triggered by the drugs in some people — the Food and Drug Administration last year warned of such effects in children, but has not said the problem affects adults.

It is possible suicidal behavior would have increased without the growth in treatment, or that patients got inadequate treatment. It also is possible antidepressants are not good at reducing suicidal behavior, even when prescribed correctly.

The analysis was based on a recent survey of 9,708 adults and a comparable survey in the early 1990s. It was primarily funded by the National Institute of Mental Health.

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