What FDA Failed to Disclose1991, 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. 2005

FDA, 2006 (n = 100,000):

Overall 8 suicides, 133 attempts, 10

“preparation,” 358 ideation

Zoloft suicides

MHRA review (2005): Zoloft n= 7,169

Suicides = 4 Suicide 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 adultpopulation support the null hypothesis of notreatment effect on suicidality.”

Suicidal Behavior

Age <25: RR = 2.30 (1.04 - 5.09)

Age 45 - 54: RR = 2.29 (0.73 - 7.14)

Age 45 - 64: RR = 1.75 (0.68 - 4.48)

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 selecteddata by the officials who have dodgedthe issue for 15 years, claiming it’s thecondition, 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.