New “research” claiming antidepressants don’t cause suicidality in children is fraudulent

von freakoutcrazy

by altmentalities

He’s a “research scientist.”  A published author.  A professor of psychiatry.  An honored faculty member at the University of Chicago.

And he’s recently published one of the most dishonest and fradulent bits of “research” I have ever seen.

In his newest article, “Suicidal Thoughts and Behavior with Antidepressant Treatment: Reanalysis of the randomized placebo-controlled studies of fluoxetine and venlafaxine,” published yesterday in the Archives of General Psychiatry, he claims to have proven…

(drumroll please)

SSRIs do NOT cause an increased risk of suicide in children.

In spite of all of the following…

  • the FDA’s 2004 analysis of 9 selective serotonin reuptake inhibitors [SSRIs] and numerous Adverse Drug Reports [ADRs], and their subsequent insistence on black box warnings for all SSRIs about the risk of suicide in children and young adults taking these drugs…
  • the independent research of numerous others
  • the testimony at congressional hearings and the overall abundance of anecdotal data from families who will never be whole again because a loved one not predisposed to suicide suddenly committed the act in a violent and brutal way after beginning SSRI “therapy” (Here are a few people’s stories, shared during a congressional hearing in 1991.  There are many, many more)…
  • the data from the drug companies’ own trials [see below] …

…Gibbons boldly declares that “no evidence of increased suicide risk was observed in youths receiving active medication [SSRIs].”

I heard it this morning on NPR’s Morning Edition.  Hundreds of thousands of other Americans did, too.

And it is a deadly falsehood.

Let me be quick about this, because time is of the essence.  If even one child’s physician does as Gibbons urges and …

[reassess] the risk-benefit estimation for using antidepressants for major depressive disorder in all ages…

– Gibbons, in his Archives of General Psychiatry article

… a life could be lost, and that’s no exaggeration.  Because the fact of the matter is

SSRIs DO increase the risk of suicide in children

(and adults, too, for that matter), and pharmaceutical companies have known itfrom the very beginning.  This is true of multiple companies, but it is very well documented in the case of Eli Lilly.

They’ve known it all along

1. From the beginning, Eli Lilly executives noted Prozac’s (fluoxetine) propensity to cause agitation, aka akathisia, which research suggests is the causative factor in SSRI-related suicides.  It was recognized that akathisia put trial participants at increased risk for suicide.  This internal memo from the late 80s (later obtained by Peter Breggin through the “Freedom of Information Act”) is rather instructive:

Some patients have converted from severe depression to agitation within a few days.  In one case the agitation was marked and the patient had to be taken off the drugs.  In future studies, the use of benzodiazepines [tranquilizers]to control agitation will be permitted.
– Ray Fuller, “inventor” of Prozac, in internal Eli Lilly memo

Permitted by Lilly, not the FDA, I might add.

Which brings me to my next point…

2.  Lilly introduced the use of tranquilizers during the clinical trials to counteract the agitating and stimulating effects of Prozac.  This, of course, is not allowed by FDA regulations.

And furthermore:

After Eli Lilly submitted all of its clinical trials to the FDA, the agency’s evaluation showed Prozac to have little or no benefit, especially when the illegitimately tranquilized patients were removed from the clinical trial data… Instead of throwing out the bogus trials, negating any possibility of Prozac being approved, the accommodating federal agency allowed the tranquilized patients to be counted as if they were legitimate participants in the drug trials.  Then, and only then, did the clinical trials demonstrate effectiveness for Prozac – and even that was marginal at best.

– Peter Breggin, in Medication Madness, chapter 18: “Drug Companies on Trial”

But there’s more…

3.  Lilly routinely masked suicide and suicidal ideation in the clinical trials by calling it something else

An Eli Lilly internal memo written in 1990 (again obtained by Dr. Peter Breggin through the FOIA) reveals that Lilly researchers openly acknowledged employing this tactic.  From Claude Bouchy, a German employee, to Leigh Thompson in the United States:

Finally, on a very simple and non scientific basis, I personally wonder whether we are really helping the credibility of an excellent ADE [Adverse Drug Event] system by calling “overdose” what a physician reports as suicide attempt and calling “depression” what a physician reports as suicide ideation…Of course by the end of the day we will do what we are told to do…

– Eli Lilly employee and Prozac research Claude Bouchy in 1990 [emphasis added]

So, Lilly researchers routinely labeled suicidal ideation as “depression” in their adverse event reports during the clinical trials.  Remember that as you read this:

From my FOIA inquiries to the FDA, I had found that the initial drafts of the Prozac label had listed “depression” and “abnormal thoughts” as two of the three most commonly reported adverse reactions

– Peter Breggin, in Medication Madness, chapter 18: “Drug Companies on Trial” [emphasis added]

Let me get this straight: Lilly researchers were instructed to mask incidents of suicidality and suicidal ideation by calling them “depression.”  And then “depression” was reported as one of the top 3 adverse effects of Prozac?

Interestingly, at least one Lilly researcher could not escape the ethical and moral consequences of this action.  In a second 1990 memo, Bouchy expressed these sentiments:

I do not think I could explain to the BGA [German regulatory agency], to a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicide ideation.

– Eli Lilly employee and Prozac researcher Claude Bouchy in 1990

5.  And, when all else failed, Lilly just threw out the suicide data altogether.

In 2005, several more Eli Lilly documents were forwarded by an anonymous source to a highly esteemed medical publication, the British Medical Journal. The most damning of all of these, from 1985, was an internal analysis of one of the early Prozac placebo-controlled clinical trials that showed a significant increase in suicide attempts for the subjects taking Prozac.

12 suicide attempts were found in the Prozac group, compared to one in each of the control groups (one control group received placebo; the other received a tricyclic antidepressant).  The company’s hired research consultants simply decided to throw out six of the 12 suicide attempts.  Of course, this still leaves a 6:1 ratio between Prozac and control groups’ incidences of suicide…

Why am I telling you all this?

First, it is proof that even Lilly’s very biased trials, even her own paid “researchers,” could not hide the fact that Prozac does indeed increase the risk of suicidality amongst the people who take it.

And, second, because Gibbons reports in his article that he used 3 datasets, one of which was

The “complete longitudinal data for RCTs [randomized control trials] of fluoxetine hydrochloride conducted by Eli Lilly & Co.”

In other words, his assertion that “there is no evidence of increased suicide risk … in youths receiving active medication [SSRIs]” is based on the faulty data described above. In fact, he proudly boasts that he used “all industry trials of Prozac!”

This study avoided the problem of publications being biased in favor of positive clinical trials by examining all industry trials of fluoxetine and venlafaxine.

– Gibbons, in his Archives of General Psychiatry article

Gibbons claims that from the combined 3 datasets (including the Prozac clinical trials) “there were relatively few suicide attempts and suicides (a total of 20 attempts and 2 suicides in 21 patients among 9185 patients across all age cohorts and drugs).”  But we know from just the few snippets posted above that in one study of one drug [Prozac] 12 suicide attempts were recorded.

The numbers simply do not add up.

Revealingly, Gibbons goes on to report that:

An additional 6 suicidal events were identified from AERs [Adverse Event Reports], 4 attempts and 2 suicides… of the 2 suicides one was by an adult receiving fluoxetine and the other was a geriatric patient receiving placebo.

– Gibbons, in his Archives of General Psychiatry article

Very well.  But how many “overdoses” were there?

Funny—he doesn’t say.

A little more on Gibbons

As it turns out, he’s been advocating for the use of antidepressants in children for a long time.

Even after the FDA released its black box warning in 2004 regarding this class of drugs’ propensity to cause suicidal ideation in children, Gibbons was arguing for continued, widespread prescription of these drugs.

In his 2007 Psychiatric Times article, “SSRI Prescribing Rates and Adolescent Suicide: Is the Black Box Hurting or Helping?,” (which draws almost exclusively on data from another “scholarly” article of his with equally dubious origins) Gibbons loudly proclaims:

The effect of the black-box warning has been to lower antidepressant prescription rates, which in turn has resulted in more untreated depression and a corresponding increase in suicide rates for children and adolescents. The FDA sought to improve treatment of depression, but an overall decline in diagnosis and treatment of depression implies that the black-box warning did not achieve this goal, and the decline is consistent with the possibility that the black-box warning has had the opposite effect.

– Gibbons (2007) “SSRI Prescribing Rates and Adolescent Suicide: Is the Black Box Hurting or Helping?”

Did I mention his “proof” for this assertion has dubious origins?

As the New York Times reported about a week later, the study Gibbons cited (his own) was – plain and simple – fraudulent.

While suicide rates for Americans ages 19 and under rose 14 percent in 2004, the number of prescriptions for antidepressants in that group was basically unchanged and did not drop substantially, according to data from the study.

“There doesn’t seem to be any evidence of a statistically significant association between suicide rates and prescription rates provided in the paper” for the years after the F.D.A. warnings, said Thomas R. Ten Have, a professor of biostatistics at the University of Pennsylvania.

– from the 2007 NYT article “Experts Question Study on Youth Suicide Rates

Gibbons did do some fancy maneuvering in an attempt to rebut this critique of his “work” about a year later – which fell flat, it seems —  but it is beyond the scope of this article to follow the trail much further than we already have.

In Conclusion…

Gibbons has a history of publishing academic articles based on faulty datasets.  He also has a history of drawing false conclusions from those faulty datasets.

In other words, he just makes shit up.

And it’s all in support of his favorite cause: getting kids to use antidepressants, and getting physicians, parents, and everyone else to re-evaluate “the risk-benefit estimation for using antidepressants.”

You know what?  I agree with him.  Let’s all evaluate the “risk-benefit estimation” together, shall we?

What are the risks of allowing Lilly and other SSRI producers to run their clinical trials in such a blatantly immoral and fraudulent fashion? 

What are the risks of allowing pharmaceutical companies to hide, for years, the overwhelming evidence that SSRIs cause suicidality? 

And what are the benefits of letting one man – with a proven track record of fraudulent research in the service of pharmaceutical companies – re-open the debate on what is essentially a dead (and deadly) issue?

Antidepressants cause suicide and suicidal ideation in patients of all ages, children included.

End of story.

And no fanciful, fraudulent “meta-analysis” of the faultiest clinical trials ever conducted is going to change that.

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