Advances in medicine have increased Americans' good health, longevity and comfort — but increasing revelations about drug-company manipulation of research studies are not helping Americans' peace of mind.
Advances in medicine have increased Americans’ good health, longevity and comfort — but increasing revelations about drug-company manipulation of research studies are not helping Americans’ peace of mind.
Merck’s shenanigans with regard to its pain medication, Vioxx, are among the best-known, thanks to the drug’s 2004 recall and thousands of lawsuits. But two articles in this week’s Journal of the American Medical Association more clearly lay out the company’s duplicity with its trial data and with what appears to be shopping company-prepared research studies around for prestigious authors. Additionally, the journal’s top editors lay out an 11-point proposal for the medical community — physicians, researchers, drug companies and medical journals — to help restore public trust.
In the JAMA editorial, Catherine D. DeAngelis and Phil Fontanarosa lament such revelations hurt public trust in research and that “… manipulation of studies and misrepresentation of study results could not occur without the cooperation (active and tacit) of clinical researchers, other authors, journal editors, peer reviewers, and the FDA. “
In one article, University of Washington researchers, after sifting through court documents, lay out how the company changed calculations to hide a troubling death rate in some clinical trials to determine whether Vioxx could help people at risk of Alzheimer’s disease.
Richard Kronmal, who served as an expert witness for Vioxx plaintiffs, and lead author Bruce Psaty, who is not involved in the lawsuits, found Merck knew as early as 2001 that these patients were three times as likely to die as those taking a placebo.
In the other article, researchers led by Joseph S. Ross of the Mount Sinai School of Medicine in New York said they uncovered a troubling practice of ghostwriting. They assert the company hired writers or had company researchers pre-write articles and then found doctors to sign on as authors. Merck denies this practice, and at least one lead author told The New York Times he did his study’s heavy lifting.
The JAMA editors’ ideas are smart and shrewd. Other journals, not to mention other members of the medical community, should embrace them as well.