By Alan C. Milstein
The news about Zetia and Vytorin once again raises a major problem in the way the FDA allows drug companies to control the information about the clinical trials they conduct, often to the detriment to public health. Apparently, Merck and Schering-Plough had completed the trial which has just hit the media back in April of 2006. While analyzing the results of the 720 human subjects might have taken some time, the data hardly could have been as complex as the two companies claimed in explaining the continued delay in reporting the information which will undoubtedly cost them sales of their drugs.
Meanwhile, there was little reduction in the direct advertising the companies did for the products. We still repeatedly had to witness the actors pretending to be med students on rounds discussing the advantages of Zetia with their mentor and the cute morphing of Aunt Meg and hard-boiled eggs in the Vytorin commercials.
Merck, of course, faced similar criticism about delaying the release of clinical trial data about Vioxx. And all the major players in BigPharma faced tough questioning from Congress over their failure to report the results of clinical trials they conducted which revealed that SSRIs increased the likelihood of suicide and suicide ideation in adolescents while showing no efficacy in the treatment of childhood depression. A long-delayed Black Box warning was the result
This is not a new problem. A few years back, I was investigating the systemic and institutional failures which caused the death of 18 year old Jesse Gelsinger. The Recombinant DNA Activities Committee had previously rejected a call for a Gene Therapy Information Network which would house the adverse events of all gene therapy trials so other investigators and human subjects would have access to the information. A prior trial at a different institution had yielded results which might have predicted Gelsingers reaction to the adenovirus but had been marked proprietary by the research team. In an off the record conversation, Phil Noguchi, FDA Director of Cellular and Gene Therapy and a member of the RAC, told Jesses father and me that had the network been approved Jesse would not have been killed. A sobering thought, to say the least.
While that network is now in place, more needs to be done to make the clinical trial enterprise in this country transparent and to eliminate the ability of pharmaceutical companies to withhold or delay the results of their clinical trials. The companies will cry that millions are at stake. But those are of lives not just dollars.
Alan C. Milstein is a nationally recognized litigator in the areas of insurance law, products liability, bioethics and clinical trials litigation.