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May 21, 2007 at 05:14:14

FDA Protects SSRI Makers With Misleading Suicide Warning

by Evelyn Pringle     Page 2 of 5 page(s)

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"Azar supervised all operations of the HHS, including the regulation of food and drugs," the press release said, and agencies under his direction included, among others, the FDA.

Azar follows in his former partner, Daniel Troy's footsteps in defending the drug industry. While Troy left his position as chief counsel at the FDA to work for a law firm representing drug companies, Azar (also a lawyer) went straight to the drug industry itself.



At Lilly, Azar will be responsible for "public relations, governmental affairs, public policy planning and development, external and internal communications, corporate branding and community relations."

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.

"Like other pharmaceutical companies," the Star points out, "Lilly also faces an array of public policy challenges, including criticism that it is too cozy with doctors and regulators."

There is one positive to be noted, at least Troy and Azar are no longer pretending to be protectors of the public health.

Experts say the suicidality risk applies to all SSRI users. "The simple truth is that antidepressants cause suicide in all age groups," according to psychiatrist, Dr Peter Breggin, a court-certified expert on SSRIs, and author of "The Anti-Depressant Fact Book."

"Dragged kicking and screaming into admitting that children and now young adults are at risk for antidepressant-induced suicidality," he says, "the FDA continues to evade reality."

"If the relatively insensitive drug-company rigged short clinical trials pick up suicidality in any age group," Dr Breggin says, "it's almost a certainty that they are causing actual suicides in all ages."

Many other experts agree that safety decisions should not be based on drug maker studies. "The fundamental problem continues to be that the FDA is basing their decisions on studies that are designed and paid for by the very companies that make these drugs," said Dr Timothy Scott, author of, "America Fooled: The Truth about Antidepressants, Antipsychotics and How We've Been Deceived."

"It is a case," he says, "of the fox guarding the chicken house."

"The research designs used by these studies," he notes, "are incredibly unfair and yet the FDA is allowing this system to continue."

"Dishonest research designs," Dr Scott says, "do not give an honest assessment of the physical or the psychological dangers of long-term antidepressant use."

"Independent research investigations," he states, "repeatedly find adverse events are much, much higher than the rates reported in the studies submitted to the FDA by the drug manufacturers."

For over a decade and a half, Attorney Menzies points out, SSRI makers have enjoyed enormous financial benefits from their manipulations of the clinical trial data and the FDA continues to ignore all evidence aside from data provided by the drug companies. "The FDA is ignoring," she says, "independent analyses conducted by scientists in the field, as well as historical and foreign regulatory actions dating back over 20 years."

Ms Menzies states that clinical trial data from before SSRIs were even approved, signaled the suicidality risk. Documents obtained in litigation show that as early as 1984, Eli Lilly was aware of an increased risk of suicidality with Prozac.

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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DOB -- September 20, 1940. Became active in civil rights and peace movements in 1962. Active in socialist and antiwar movements -- 1963-69. Active in Gay Liberation from 1969 to present.
rhalfhillDOB -- September 20, 1940. Became active in civil rights and peace movements in 1962. Active in socialist and antiwar movements -- 1963-69. Active in Gay Liberation from 1969 to present.

IT'S WONDERFUL NOT TO BE DEPRESSED!

   Even though my case is only one case and one of the first falacies we learn about in elementary logic is hasty generalization, I find it extremely dificult, in fact virtually impossible, to believe that prozac could have such a dramatic effect in my case and the assertions in this article, despite all the studies it cites, could be true.  I've suffered from chronic depression since the age of ten (I will be 67 in September) and it got worse as I got older.  The older antidepressants, that this article claims to be so much better than the present ones, did not have much effect.  It was only after I started taking prozac that I noticed much benefit,  Post prozac, it's wonderful not to be depressed!

   This year, prozac finally stopped having any effect and I had to switch to sertraline.  Within days, I experienced the same dramatic lifting of depression.

   If the effect on me of prozac and sertraline is due to the placebo effect, then it is hard to explain why I did not experience the same placebo effect when the older antidepresants were prescribed.

   And I am disgusted and fed up with white coated pontificators who sit behind desk and spout ineffectual, platitudinous "talk therapy."

R. W. H.

by rhalfhill (3 articles, 0 quicklinks, 0 diaries, 270 comments) on Monday, May 21, 2007 at 2:50:36 PM
 

 

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