Tag: clinical trials

In the "agreement for corrective action" against CAFE study coordinator Jean Kenney last week, the Board of Social Work cited Kenney's failure to respond to "alarming voicemail messages" from family members of Dan Markingson. Presumably, the Board is referring to a message left by his mother, Mary Weiss, which warned, "Do we have to wait until he kills himself or someone else before anyone else does anything?" The failure of Kenney and Stephen Olson to take the warnings of Mary Weiss seriously has been one of the most disturbing aspects of this case. In a deposition for the lawsuit filed by Weiss, Kenney was questioned about her response. Here is an excerpt. (The initial questions come from Gale Pearson, an attorney for Mary Weiss.)

Out here in Minnesota, where the snow is gently falling, many of us are hunched over our computers, puzzling over a document just posted by the state Board of Social Work. It concerns the death of Dan Markingson (or as the document calls him, “Client #1”). Markingson, of course, was a young man under a commitment order who was coerced into a profitable Seroquel marketing study at the University of Minnesota over the objections of his mother, and whose condition spiraled downward until he committed suicide.

For the past several years whenever a critical essay has come along examining the work of Irving Kirsch and his colleagues I have made an effort to examine the validity of the proposed arguments. Kirsch and his colleagues used the Freedom of Information Act to gain access to the unpublished trials of antidepressants and then pooled the clinical trial data – both published and unpublished ─ and analyzed it as a single data set. It is common for pharmaceutical companies to only publish those studies that find their products effective, and to withhold the negative studies, making it difficult to reach accurate conclusions by examining only the published data. Kirsch and his colleagues have reported that in the company sponsored clinical trials, the SSRIs only marginally outperform placebo, with the difference being statistically different but not clinically significant.

Everyone knows how muckraking is supposed to work.  An investigative reporter uncovers hidden wrongdoing; the public is outraged; and the authorities move quickly on...

Carl Elliott writes on the discrepancy between New Zealand's response to a research scandal - which lead to a national debate and dramatic reforms - and the silence following clinical trial scandals in the U.S.

Senator Charles Grassley is upping the ante on the controversy surrounding the Vertex pharmaceutical executives who cashed in on overstated clinical trial data --...