On May 2, 2007, the FDA announced its most misleading warnings to date about selective serotonin reuptake inhibitor (SSRI) antidepressants like Paxil when it said the drug makers would revise the current black box warning of increased risk of suicides in children and adolescents to include adults. The caveat -- only young adults ages 18 to 24. Apparently at the quarter century mark of 25 the increased risk no longer exists. An FDA advisory committee held a public hearing on December 13, 2006 to review drug company data that show SSRIs like Paxil to be associated with adult suicide. The commonly prescribed SSRIs in the United States include Prozac, by Eli Lilly; Paxil by GlaxoSmithKline; Zoloft by Pfizer; and Celexa and Lexapro by Forest Labs, along with various generic versions of the drugs.
Many of the world's leading experts on psychiatric drugs traveled to Washington to appear at the hearing, some of whom have spent years investigating the adverse events associated with SSRIs, to testify about the need to extend the back box warnings about suicide to all age groups.
Advocates and experts alike are outraged over the limited warning, which is widely viewed as another gift to the drug makers by the FDA.
Not only does the new warning label continue to minimize the adverse reactions of the antidepressants on the entire population but is now become a cheerleader for the psychiatric community. The FDA has made some seriously misleading statements that will lead patients and physicians into a false sense of security."
Critics say the nation's regulatory agencies under the Bush administration have evolved into a protection network for drug makers, in large part, because the industry has created a revolving door where top officials move directly from their government employment into high-paying positions with drug companies.
The latest evidence of this charge appeared in the media on May 4, 2007, with a press release by Prozac-maker Eli Lilly, announcing that Alex Azar II will be joining Lilly as senior vice president, who until February 3, 2007, was the Deputy Secretary of Health and Human Services and served as the chief operating officer of the largest civilian department in the federal government.
According to the Indianapolis Star, Azar takes over the Lilly post as seven states are suing the company, alleging that it promoted off label uses for Zyprexa, its top selling drug approved for schizophrenia and bipolar disorder.
Many other experts agree that safety decisions should not be based on drug maker studies. The research designs used by these studies are incredibly unfair and yet the FDA is allowing this system to continue.
Independent research investigations repeatedly find adverse events are much, much higher than the rates reported in the studies submitted to the FDA by the drug manufacturers.
The FDA's statement that scientific data does not show an increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicide is extremely misleading.
Critics also find this statement disturbing in light of other independent studies, including a study reported in the May 1, 2006, London Free Press, conducted at the Toronto's Institute for Clinical Evaluative Sciences, that identified suicides among older Ontarians, 66 and up, and found that for patients who were prescribed antidepressants in the six months before their deaths, the risk of suicide in the first month for those taking SSRIs like Paxil was nearly five times higher than for seniors taking older antidepressants called tricyclics such as Elavil.
Most patients with milder depression would get well if seen by a sympathetic physician or therapist and describes three side effects that have resulted from the SSRI controversy. Physicians seem to have lost confidence in their own ability to help patients without drugs.
The FDA just commissioned a series of three year studies to evaluate the adult suicide problem and by the time these studies are done and released, the bulk of the medications will be either off or going off patent.
Source: Evelyn Pringle - http://www.scoop.co.nz/stories/HL0705/S00440.htm
