Just one day after the Senate Health, Education, Labor and Pensions Committee (HELP) held a hearing on the importance of litigation for protecting patients from defective medical devices comes an incredible front page New York Times story that clearly illustrates one of the most important things about civil lawsuits brought against drug companies and others: forcing out information about health and safety hazards that might otherwise never come to light.
Such is the case with documents obtained by attorneys suing drug giant Wyeth, and subsequently delivered to the New York Times, which show what appears to be an epidemic of ghostwritten medical journal articles between 1998 and 2005, aimed at “backing the use of hormone replacement therapy in women.” (The link between HRT and cancer had been known for decades but drug companies kept pushing it, with the Times noting, “[I]n 2001, more than 126 million prescriptions for such drugs were written for women in the United States,” with sales totaling $3 billion).
What’s more, industry ghostwriting apparently didn’t stop there. As the Times revealed:
The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”
Said Senator Charles E. Grassley (R-IA), who late last year launched his own investigation in the practice, “Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling.”
The issue of promotional ghostwriting has also been linked to Merck’s infamous arthritis painkiller Vioxx, and Wyeth’s diet pills, Redux and Pondimin—all of which have since been pulled from the market due to the hazards they posed to patients.
At the Senate hearing yesterday, Chairman Sen. Tom Harkin (D-Iowa), said “No matter how diligently and effectively the FDA does its job, it simply cannot guarantee that no defective, dangerous and deadly medical device will reach consumers.” And this story provides at least one example of why.
There has been a lot of positive movement on this topic in recent months since the Times article was posted. The Institute on Medicine as a Profession has updated their vast online conflict of interest policy database to include the topic of ghostwriting. Many Academic Medical Centers have instituted strong policies against ghostwriting, just in the last few months.
View the database at http://www.imapny.org/conflicts_of_interest/search_policies
Posted by: Medical Professionalism | March 11, 2010 at 04:56 PM