1. What FDA Failed to Disclose 1991, 2006 Vera Hassner Sharav Alliance for Human Research Protection
NJPIRG Law & Policy Center MAY 2006

2. German regulators, 1986
In Germany regulatory authorities immediately recognized the suicide problem .

3. FDA Safety Review, 1990
“The data showed higher percentages of suicidality among fluoxetine patients than among tricyclic or placebo patients…apparent largescale underreporting”
David Graham also reported excess suicides with prozac compared with placebo.

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

5. 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
FDA argued that a warning would frighten people.

6. UK, 2003 SSRIs “are contraindicated (not suitable) to treat depression in children and teenagers”
UK issues warnings for children FDA followed

7. 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

8. FDA, April 2006
“the findings from this meta-analysis provide some reassurance regarding possible excess suicide risk…”
FDA officials continue obscure the scientific evidence with false reassurance by failing to report suicides such as Tracy Johnson, a healthy volunteer.

9. GSK, May 2006
Sobered by NYS Attorney General lawsuit, GSK finally admitted the suicide risk extends to adults.

10. FDA, December 2006 “there were more completed suicides
“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

11. ?
MHRA, 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
FDA: Clinical review: relationship between antidepressant drugs and suicidality in adults. Nov. 17, 2006

12. 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
FDA knew a study was missing from its analysis. Why didn’t they get it?

13. Is FDA’s exclusion criteria legitimate?
“This search should be strictly limited to
adverse events that occurred…within 1 day of
stopping randomized treatment.”
Data from the period of greatest risk
when dose changes / withdrawal occurred was
excluded.
FDA: Clinical review: relationship between antidepressant drugs and suicidality in adults. Nov. 17, 2006:54

14. 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 = ( )
Age : RR = ( )
Age : RR = ( )
FDA: Clinical review: relationship between antidepressant drugs and suicidality in adults. Nov. 17, 2006:44.
FDA claims the findings “support for the null hypothesis.” No effect? when the treatment effect poses a possible 5-fold, even 7-fold risk! This demonstrates incompetence.

15. Relative Risk of Suicidal Behavior RRs>1 indicate increased risk with SSRIs v. pbo
<25
45-54
Graph of all possible confidence intervals showing the estimates are
not substantially different.

16. 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.

17. 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.
Don’t Collaborate in a cover-up
The report confirms that the risk is higher for suicidal behavior than ideation, and for SSRIs than other antidepressants, and for periods after discontinuing or decreasing the dose.
But the FDA studiously avoids analyzing these high risk domains.
At the least, Black Box warnings should include ALL ages, ALL indications—it’s the drugs, not the condition.