Nobody has retracted or apologized for a study that was an academic disgrace—but a marketing coup for GSK—which may well have caused untold numbers of deaths, suicide attempts and irreversible anguish to myriad families. Can we stand idly by when we’re told that it “accurately reflects the honestly-held views of the clinical investigator authors who do not agree that the article is false, fraudulent or misleading.”? What is the current market value of the honestly-held views of people who tell lies?
The UK Times reports that pharmaceutical companies are actively lobbying to limit the release of clinical trial data to the public. Rather than limiting results and data to medical journals, new transparency initiatives are pushing for making the information publically available. The push for transparency comes in the wake of the reanalysis of the Study 329 data on paroxetine (marketed as Seroxat and Paxil), which found that the industry study had misconstrued its results.
If someone were to ask the surviving authors of Study 329 the question: “Knowing what you know now, if you had to do it over, would you agree to participate in that study again?”, many would probably say no. Study 329’s problems started to surface right after it was published. Several doctors wrote letters to the JAACAP Editor with probing questions, mostly centred on the psychiatric side effects of paroxetine, and the measures used to claim its efficacy in treating adolescents. The authors responded and the questioners did not pursue their concerns further. Except one. Next week, fourteen years and two months after it was published, it is about to take yet another hit, when the Restored version is published.
In addition to hosting the Panorama programs and The Famous Grouse history of Study 329, Study329.org has a comprehensive timeline on the origins of concerns about the SSRIs and the risk of suicide, initially with Prozac and subsequently with Paxil/Seroxat. The hope is to provide a comprehensive repository for anyone who wants to study SSRIs, RCTs, and Study 329 in particular.