How FDA Avoided Finding Adult Antidepressant Suicidality

Peter Breggin, MD
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Doctors often tell patients that antidepressants can only cause suicidal behavior in children and not in adults. Many publications also make the same claim. The false claim is based on the FDA-approved Black Box Warning for antidepressants that warns about an increased rate of suicidality in children, youth and young adults taking antidepressants, but not in adults over age 24. The Black Box Warning specifically summarizes, “Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.”

The studies that the FDA relied upon for adults over age 24 were dismally flawed and untrustworthy compared to the ones used for children. According to the FDA at the 2006 hearings:

Due to the large number of subjects in the adult analysis, almost 100,000 patients, the adjudication process was left as the responsibility of the sponsors [the drug companies] and was not overseen or otherwise verified by the FDA. This is in contrast to the pediatric suicidality analysis in which the FDA was actively involved in the adjudication (p. 14).”

In addition, the FDA also announced at the 2006 hearings on antidepressant-induced adult suicidality that it did not require a uniform method of analysis by each drug company and an independent evaluator as required with the pediatric sample.

Thus, the FDA was comparing somewhat good apples (the pediatric studies) to rotten apples (the adult studies), while making them seem comparable. The child studies showed that antidepressants can cause suicidality — the adult studies (after age 24) showed nothing other than FDA collusion with the self-serving drug companies. As I have described in my books and scientific articles, drug companies routinely manipulate their data on suicide to avoid any causal connection to their drug (see for example my 2006 paper about GSK and Paxil).

In the case of Eli Lilly, here are two memos by employee Claude Bouchey (pages 2 & 3 of document) written to the hierarchy of the company in which he expresses guilt and shame about changing official investigator reports of Prozac-induced suicide attempt to misleading terms like “overdose” or “depression.”

Ironically, the FDA controlled and monitored the original pediatric studies precisely because the drug companies on their own failed to find any risk of antidepressant-induced suicidality in any age group. Why would the FDA assume these same self-serving drug companies, left on their own again, would spontaneously begin for the first time to conduct honest studies on the capacity of their products to cause adult suicidality?

Furthermore, even in the rotten-apple adult studies, despite the drug company’s manipulations, Paxil (paroxetine) turned out to be causally associated with increased suicidality in depressed adults in an internal FDA review of the data. As a result, in 2006 the FDA then forced the maker of Paxil, GlaxoSmithKline (GSK), to write a “Dear Doctor” letter to all healthcare providers confirming the Paxil/suicidality causal link in adults.

In April 2006, the FDA also made the drug company put a warning in its Full Prescribing Information (label or package insert) about the risk of Paxil causing suicidality in adults with depression; but GSK convinced them to drop it in subsequent years. The warning appeared in the Physician’s Desk Reference (PDR) only once in 2007.

Meanwhile, there are many studies showing that antidepressants do cause suicidality and suicide in adults.

Next time you hear someone say that the FDA studies only showed increased suicidality in children and young adults as opposed to adults, remember that the adult studies, unlike the pediatric studies, were not controlled, monitored or validated by the FDA. This is one more example of the extremes the FDA will go to in order to protect drug companies and their often lethal products.

It was bad enough to find out that antidepressants cause suicidality in children. The drug companies and their minions complained mightily. The FDA and the drug companies were not going to allow a repetition of sufficiently unbiased studies that might conclude that adults are also vulnerable to antidepressant-induced suicide.

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12 COMMENTS

  1. I appreciate the point you are trying to make, Dr. Breggin, and I heartily agree that studies of antidepressant drugs in adults have been fatally distorted by drug-company control. But the same applies to the pediatric studies!

    We would be terribly naive to think those studies were “monitored and controlled” by FDA, or that they were “somewhat good apples” compared to those awful adult studies. The most famous example is the infamous Study 329, which proclaimed Paxil to be safe and effective for adolescent depression. The multiple layers of deception imposed by drug company control, with direct complicity of leading academic experts, was not fully exposed until 2015 — and the article has still not been retracted.

    Mad in America has a treasure-trove of articles on Study 329 and related studies, which are an instruction manual in all the tricks of the trade used by GSK to defend a profitable product:

    https://www.madinamerica.com/?s=329

    The pediatric warning was not achieved by FDA vigilance and quality control. It was achieved by a coalition of brave parents and a few good experts who would not shut up. We had better learn that lesson and hang on tightly to it. The American psychiatric establishment is on a campaign to repeal that warning, just as was done with the suicide warning on Chantix.

    • a couple years ago, I was meeting with my Doctor. He and I were fairly new to working together. I brought a 3-page printout of a good article discussing “Study 329”. The Doc had never heard of it before. Shortly after, the hospital where the Doc worked terminated my medical care via an anonymous (unsigned) email! Also, the same hospital closed their child, and then adult psych units, after they fired the psychiatrist. The parent company/hospital also has a contract to provide psychiatrists & psych nurses to the State mental hospital. So far, they have FAILED to provide the staff levels they contracted to provide! I hope Dr. Breggin lives to see the end of psychiatry. It’s 21st century Phrenology, with neurotoxins. Breggin’s “Toxic Psychiatry”, which I read in the early 1990’s, probably saved my life, as it helped me get out of the clutches of the local CMHC. Sadly, I still see its’ “drug zombies” shuffling down the street, on disability, helpless, dysfunctional, and grossly over-medicated. When I was on both Zoloft and Wellbutrin years ago, now, all the drugs really did was make me *think* *about* suicide a lot. But I was NOT “suicidal”. these psych drugs are FAR MORE DANGEROUS, far less effective, and far less necessary that the psychs are willing to admit. Dr. Breggin is an exception which proves the rule: Psychiatry is a pseudoscience, a drug racket, and a means of social control. It’s 21st century Phrenology with potent neuro-toxins.

  2. I’ve found it odd for well over a decade that doctors would believe a pill could know the difference between a 24 year old adult and an older adult. Although according to my medical records my psychiatrist didn’t even know the difference between my head and a different part of my body, nor did any doctor I dealt with know that an opioid and an antidepressant were mind altering drugs – the doctors believe they’re “safe meds.” I had no idea doctors were so ignorant and/or unethical. Glad they are not all so stupid and/or lacking in conscience, thanks for pointing out the scientific fraud Dr. Breggin and Johanna.

  3. For some reason, I’ve been unable to place a longer comment here in which I report the New England Journal of Medicine’s (NEJM) failure to correct a misstatement about the number of suicides uncovered in a 2009 FDA meta-analysis of unpublished antidepressant studies.

    NEJM ran a column in 2014 in which Dr. Richard Friedman, psychiatrist and New York Times columnist, claimed there were no suicides reported in the meta-analysis. (Stone et al., 2009, in BMJ). There were eight, with an odds ratio of 2.1 that characterized an association of completed suicide with antidepressant use that narrowly missed statistical significance. (The confidence interval, .41 to 10.99, left little chance that the actual odds ratio was below 1.0).

    I notified the journal, by email, of the mistake and of a second one, which was an incorrect citation for the misstatement made by Dr. Friedman. My corrections were acknowledged by email, but have not been published. Dr. Friedman made the same misstatement in the New York Times in 2015. That publication published my correction.

    (It’s the software that runs this site, not an editor, that’s preventing my full comment from appearing here on MIA. Here’s hoping this one makes it through.)

  4. I have more respect for the Mexican drug cartels then the psychiatric medical mafia, at least those guys don’t sneak around playing corporate psycho games pushing their products as safe.

    Who is worse the dope dealer down town selling to adults who want to get high or the corporate- snakes who use crooked studies and put Legos stamped Risperdal in pediatricians offices ?

    Gangsters have much more honor then those corporate snakes and Washingtons crooks empty shells posing as humans who have zero.

  5. ….“Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.”…

    I think If this statement is “rigged” – the people responsible should face prosecution as anyone else would.

  6. Given their long history of research cherry picking and illegal misrepresentation of outcomes in the name of corporate profits, we should expect no less from Big Pharma on the issue of anti-depressants. As noted in “Psychiatry Under the Influence – Institutional Corruption, Social Harms, and Prescriptions for Change” [Whittaker and Cosgrove], these bad actors don’t relent even when they’re caught and fined hundreds of millions of dollars. They simply pass on the fines in price hikes. Until entire Boards of Directors are tried, convicted and thrown in jail for fraud and as accessories to negligent manslaughter, I seriously doubt that much will change.

    Thanks for another insightful article, Peter. I look forward to interviewing with you again on your show.