What FDA Failed to Disclose 1991, 2006 Vera Hassner Sharav Alliance for Human Research Protection.

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Presentation transcript:

What FDA Failed to Disclose 1991, 2006 Vera Hassner Sharav Alliance for Human Research Protection

German regulators, 1986

“The data showed higher percentages of suicidality among fluoxetine patients than among tricyclic or placebo patients…apparent largescale underreporting” FDA Safety Review, 1990

1991, FDA withheld evidence Data submitted to FDA by Pfizer & GSK confirmed increased suicidal behavior in patients on Zoloft & Paxil. David Healy. Antidepressants and Suicide briefing paper, 20 June 2003

FDA Advisory Committee 1991 “Modifying antidepressant drug labeling could lead to reduction in antidepressant use, and this could damage public health.” Paul Leber, Director, FDA Neuropharmacological Drug Products Evidence ? or Marketing propaganda

UK, 2003 SSRIs “are contraindicated (not suitable) to treat depression in children and teenagers”

June, 2004 Spitzer suit is the first to call suppression of negative data illegal. New York Executive Law 63 (12) allows the attorney general to obtain restitution and damages from companies that make "any deception, misrepresentation, concealment or suppression" of material fact. October, 2004: FDA Black Box Warnings

FDA, April 2006 “the findings from this meta-analysis provide some reassurance regarding possible excess suicide risk…”

GSK, May 2006

FDA, December 2006 “studies or events in studies reported to the MHRA were not reported to the FDA.” “there were more completed suicides reported” to MHRA How reliable is the data? FDA: Clinical review: relationship between antidepressant drugs and suicidality in adults. Nov. 17, 2006:47

? UK, Gunnell, 2005 (n= 40,000 +): "An estimated 16 suicides, 172 episodes of non-fatal self harm, and 177 episodes of suicidal thoughts were reported" Gunnell, Saperia, Ashby. SSRI Suicide in Adults, BMJ. Feb FDA, 2006 (n = 100,000): Overall 8 suicides, 133 attempts, 10 “preparation,” 358 ideation

Zoloft suicides MHRA review (2005): Zoloft n= 7,169 Suicides = 4Suicide attempts =20 FDA review (2006): Zoloft n= 6,950 Suicides = 0 Suicide attempts = 7 FDA: Clinical review: relationship between antidepressant drugs and suicidality in adults. Nov. 17, 2006:42

Is FDA’s exclusion criteria legitimate? “This search should be strictly limited to adverse events that occurred…within 1 day of stopping randomized treatment.” FDA: Clinical review: relationship between antidepressant drugs and suicidality in adults. Nov. 17, 2006:54

FDA 2006 – “no treatment effect” “the pooled estimates of studies of the adult population support the null hypothesis of no treatment effect on suicidality.” Suicidal Behavior Age <25: RR = 2.30 ( ) Age : RR = 2.29 ( ) Age : RR = 1.75 ( ) FDA: Clinical review: relationship between antidepressant drugs and suicidality in adults. Nov. 17, 2006:44.

What the FDA presented to you A reassuring interpretation of selected data by the officials who have dodged the issue for 15 years, claiming it’s the condition, not the drugs.

What the FDA did not show you Evidence to support SSRI safety for any age group, any indication. A complete SSRI data analysis. Peer reviewed critical analyses by independent scientists who have been proven right. FDA has been wrong then, wrong now.