Tuesday, September 27, 2005

FDA Footdragging Attacked Re Prozac, Paxil

According to a story on U.S. Newswire, 125 medical practitioners have signed onto a joint letter to the U.S. Food and Drug Administration (FDA), renewing a call to take immediate action on issuing stronger warnings for antidepressant and stimulant drugs, as a 3-day protest rages by consumer groups demanding Glaxo recall its $950 million antidepressant Paxil. The same letter, sent to FDA Commissioner Lester Crawford in July, 2005 and signed by 20 doctors, was left unanswered by the Commissioner prompting many to accuse the FDA of bureaucratic foot-dragging and procrastination. Senator Charles Grassley, (R-Iowa) who has spent months investigating the FDA, said the agency "demonstrated a too-cozy relationship with the pharmaceutical industry," and that "the opportunity to name a new commissioner is a chance to take the agency in the right direction."

The doctors' letters join recent efforts by Dr. Ann Blake Tracy, Executive Director of the International coalition for Drug Awareness (ICFDA) and Mrs. Bonnie Leitsch, founder of "Prozac Survivors Support Group" (PSSG) in calling for immediate federal action to warn the public that antidepressants can not only induce suicidality in adult patients - but also acts of violence, pointing out that the U.S. FDA has known of these effects since a 1991 public hearing on antidepressant drugs. Prompted by a spate of recent incidents of mothers murdering their own children while taking antidepressants, Dr. Tracy said, "These are extremely dangerous drugs that should have been banned, as similar drugs were in the past. Federal investigations into the violence- inducing effects of these drugs are long overdue." Mrs. Leitsch added, "In 1991, there was evidence of 500 deaths associated with antidepressants presented to an FDA Psychopharmacological Drugs Advisory Committee hearing investigating Prozac. The FDA's failure to issue timely warnings then has led to more suicides, homicides, school shootings and mothers killing their own children."

Concerned doctors are also pushing for FDA reform and action under new leadership. 25 European countries recently warned that antidepressants should not be used in patients under 18 due to the suicide and violence inducing effects of the drugs and recent clinical studies linked ADHD drugs to hallucinations, violence, psychosis, and suicide. Dr. Julian Whitaker, M.D., and principal author of the letter says the overwhelming evidence of the dangers of these drugs makes further FDA procrastination unacceptable, "It is beyond debate that these drugs have extremely dangerous side effects and that the public is not being kept adequately informed about these dangers," states Whitaker, "It is our hope that the new Commissioner will take immediate and swift action to protect the public from these dangerous and too often deadly psychiatric drugs."

Fueled by $4.5 billion in direct consumer advertising, ADHD stimulant drug sales have quadrupled since 2000 while antidepressant sales have passed the $20 billion mark, prompting many to question how profit-driven vested interests may be involved in the FDA's failure to warn patients of the drugs risks. "With literally billions of dollars of profits at stake, we are not surprised when we hear stories of skewed clinical trials, suppressed study outcomes, pressure placed on reviewers, and a host of other abuses," stated Dr. Whitaker.

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