David Healy made a submission to the FDA in February 2004. The Executive summary is below and the full paper can be read here:
The enclosed document arose from a direct invitation from Dr. Robert Temple, Director of the Office of Drug Evaluation I, of the Food and Drug Administrion, in the course of a meeting organised at FDA on February 3rd 2004. The meeting was focussed primarily on the issue of suicidality in children taking SSRIs. But this issue does not stand alone. It would appear that we have reached a crisis point in both the regulation of psychotropic drugs and perhaps all drugs and a crisis point in psychiatry and perhaps all of medicine. It will become clear from the material laid out here that most if not all of the supposedly scientific literature on giving SSRIs to children may be ghost-written. It also seems clear that FDA do not know basic things about the use of these drugs such as how many people are on the drugs.
This paper offers a model that for the first time gives an estimate as to likely numbers of people who have taken Prozac, Paxil and Zoloft since their launch in the US. From this it is possible to derive an estimate of the numbers of people who have committed suicide over and above the numbers who would have committed suicide had SSRI drugs never been marketed. This points to a figure of 21,000 excess suicides. It seems quite likely that when this model is in due course fed real figures from actually dead people, that this estimated figure will appear conservative.
One way out of the problem is outlined in this paper, namely to adopt a system that encourages consumer reporting of adverse events. The current crisis makes it clear that consumer reports are often considerably more accurate than physician reports.
The material laid out here gives rise to a series of questions for FDA:
In the light of Traci Johnson’s death on February 7th 2004, will FDA obtain Pfizer’s entire folder on the 1982 Hindmarch study in which healthy volunteers were given Zoloft, and make a statement as to whether data of this kind can indicate whether SSRIs can induce suicidality?
Will FDA undertake to obtain all of Glaxo SmithKline’s trials in children and make available an analysis of all the data in regard to suicidality and aggressive behavior?
In the light of the details below, will FDA comment on their characterization of the British approach to the question of the risk benefit ratio for SSRIs in pediatric populations as superficial?
Will FDA confirm that companies have inappropriately coded suicidal acts under the heading of placebo in trials of Prozac, Zoloft and Paxil in adults, and will the agency give a true set of figures for the suicidal acts on both active treatment and placebo in registration trials for adults?
Given that Paxil/Seroxat shows the greatest number of withdrawal syndrome reports to WHO for any psychotropic drug ever, and given that the full dimensions of this problem remain unknown, with the company changing its estimates as to the frequency and severity of the problem at regular intervals, will FDA outline exactly how a randomized withdrawal design could demonstrate these drugs work for either children or adults?
Given the abundance of evidence that physicians commonly increase the dose of SSRIs when faced with a patient not doing well on treatment, particularly during the early phases of treatment, what advice will FDA offer to doctors to minimize the risk of this happening inappropriately?
What will FDA do to remedy the incredible fact that Americans track the fate of parcels through the post 100 times more accurately than they track the death of children and adults on these drugs?
Specifically, in the light of the failures of physicians to report adverse events, will FDA consider an initiative begun by the mental health charity, MIND (UK) to foster consumer reporting of drug induced adverse events?