Healthy Skepticism Library item: 15986

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Mann M.
Other Probes Still On after State AGs Settle with Merck, S-P
GoozNews 2009 Jul 16
http://www.gooznews.com/node/3012

Full text:

Drug makers Merck and Schering Plough struck a $5.4 million deal yesterday with 35 state attorneys general to resolve an investigation into the companies’ lengthy delay in releasing negative results from the ENHANCE trial, which showed that ezetimibe combined with cholesterol-lowering simvastatin was no better than simvastatin alone. As previously discussed on Gooznews, the trial was completed in May 2006, but the results were not announced until January 2008.

During the lengthy delay, the companies engaged in aggressive direct-to-consumer (DTC) marketing of their two ezetimibe products, Zetia and Vytorin, spending $200 million on DTC marketing in 2007 alone, according to a study published last year in the New England Journal of Medicine.

The settlement extends the terms that Merck agreed to last year in its settlement with the states over its marketing of rofecoxib (Vioxx) to marketing of ezetimibe. According to a press release issued by the Illinois attorney general, the settlement requires the companies to:

Obtain preapproval from the FDA for all DTC television advertisements, and comply with FDA suggestions to modify the advertising;
Register clinical trials and post their results;
Refrain from ghostwriting articles for medical journals;
Reduce conflicts of interest for members of data safety monitoring boards; and
Comply with detailed rules prohibiting the deceptive use of clinical trials.

Drug companies are not required to submit DTC TV ads to the FDA for preapproval, although some companies do so voluntarily. Last year, an article in the Journal of the American Medical Association detailed how Merck engaged in ghostwriting of articles on rofecoxib.

As described in detail on the Shearlings Got Plowed blog, the settlement resolves only a small portion of the litigation and governmental investigations the companies face over their flawed handling of the ENHANCE trial.