Wednesday, December 20, 2006

More on FDA and SSRI-Suicide Link

Look at the above table. On the left are data from the FDA showing an increased risk of suicide on active treatment. On the right are the current data that the FDA, upon which the recent FDA panel made its recommendations about the risks of SSRI treatment.

David Healy presented the above slide in his testimony to the FDA about a week ago. Below, I present some excerpts from his speech made that same day:

This study presented by FDA over 3 years ago shows a clearly increased rate of suicides on active treatment. There were more patients, suicides and trials in this study than in the material FDA have presented to this meeting, and this study included withdrawal suicides.

FDA got their 2003 problem to vanish by controlling for age, sex, and the location of the trial giving the results you see on the right.

But if age and sex were substantially imbalanced in these trials, then the studies must have been invalid.

Regarding study location, this year FDA cited lower rates of suicide in US placebo controlled trials but didn’t explain the finding. Are you aware US investigators have been jailed for entering fake patients into trials? Bogus patients get better on treatment but there is one thing a bogus patient does not do -- he does not commit suicide. Does this explain FDA’s findings? Or is the real answer even darker?

At the 2004 PDAC meeting, FDA did not have all the pediatric trials. I bet they don’t have all the adult studies I’ve seen. We know for certain that all of the 2003 material is not included today. Do you know why not? I know FDA do have the placebo suicide who was taking an antipsychotic, antidepressant and 2 benzodiazepines, but don’t know what they’ve done with him. Do you?”

Healy apparently concluded his remarks with this: “So Truth of Fiction? Well the FDA document and presentation are exceedingly strange and this might following Mark Twain suggest truth. But there is too much blatant manipulation of the data for that. We are left with fiction; perhaps the strangeness derives from the fact that we are missing a key element of a good fiction, namely the final line as to who is doing what to whom.”

For more on the magically changing FDA data on SSRIs and suicide, see my earlier post. Always keep in mind that sponsors were responsible for providing the data, and the sponsors have a history of manipulating the placebo suicide data to make placebo appear more risky. Not that one can entirely blame the sponsors, as FDA has been fully compliant with this manipulation of data. To see how rose-colored glasses have been worn when interpreting the SSRI-suicide data, see another earlier post, which also discusses some of Healy’s work.

There's more to be said about the FDA's handling of this data. Thanks to an anonymous reader for providing me with the chart and speech excerpts.

1 comment:

Anonymous said...

According to Dr. Irving Kirsch in Prevention & Treatment , “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.

Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

4) Miscoding suicidal events as "emotional lability", and homicidal events as "aggression" to hide suicidal events from regulators.

5) False attribution of suicide to the placebo arm.

6) Hiring ghost writers to make the medical articles more favorable.

7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

For more information and links see my Paxil, Prozac, and SSRI Induced Suicide Newsletter

Jeffrey Dach MD