Drug maker, Merck & Co., has always characterized its conduct as above board and ethically appropriate among pharmaceutical companies.
“We employ rigorous scientific methods to design, conduct, analyze, and report results of clinical trials in the development of innovative drugs and vaccines, with a focus on meeting unmet medical needs and with an ethic that puts the interests of the patient first.”
That’s what the company says in a 2002 paper titled “ The practices of Merck & Co.
But what really goes on is another story.
Authors writing in this week’s issue of The Journal of the American Medical Association (JAMA) reveal how Merck manipulated dozens of publications to promote one of its products, ironically the painkiller Vioxx (rofecoxib).
Based on internal company documents revealed in Vioxx litigation, JAMA authors uncover how the company, without disclosing it, compensated ghostwriters who aren’t even doctors, to create articles for professional journals that have the potential to influence doctors and popularize drugs prescribed to the public.
In the 250 documents reviewed by the authors, Merck employees either working by themselves or in collaboration with a medical publishing company helped create the study on Vioxx.
They would then recruit academics or leaders in the medical field to lend their name as the lead author.
For scientific review papers, Merck would outline the plan for the manuscript then ghostwriters were hired from medical publishing companies, which typically pay about $20,000 per submission to the ghostwriter.
The scientist then recruited to be the named author would be offered “honoraria” for their participation.
This review in JAMA finds that among 96 published articles, 92 percent of clinical trials disclosed Merck’s financial support. But only half disclosed Merck’s involvement in the creation of the publication or whether the author had received compensation.
In another JAMA article in the same issue, the documents suggest the company’s control of the data allowed it to downplay the risk of death from Vioxx in patients with Alzheimer’s disease.
Vioxx was taken off the market in 2004 but not before it was linked to an increase in heart attack and strokes. The FDA says the drug lead to up to 139,000 heart attacks, 30-40 percent of them fatal.
Litigation followed and ultimately resulted in a $4.85 billion settlement against Merck to settle U.S. cases. The internal company documents were released as part of the settlement.
In 2002, the company reported on its practices “We believe that proprietary interest of the Company can be respected while observing objectivity and transparency in communicating clinical research results.”
Increasingly, doctors and academics are shying away from an asterisk next to their name indicating an “honorarium” has been paid. (See accompanying story)
One academic, Dr. Thomas Schnitzer of Northwestern University ‘s Office of Clinical Research and Training in an August 9, 2000 email to a Merck employee, says “I really do not feel it is appropriate to be paid for this type of effort” in discussing honorarium for an article.
An accompanying editorial in the same issue of JAMA says the practice impugns the integrity of medical science.
Catherine DeAngelis, Editor in chief of JAMA writes, “When integrity in medical science or practice is impugned or threatened - such as by the influence of industry - patients, clinicians, and researchers are all at risk sfor harm, and public trust in research is jeopardized."
The authors include Joseph Ross, MC, MHS of Mount Sinai School of Medicine who along with researchers from Harvard, Brown and Yale Universities were given full access to all of the data in the study.
Dr. Ross tells Bloomberg.com, ``The academic authors are supposed to be the most objective members of the team,'' said Joseph Ross of Mount Sinai, who led the analysis, in a telephone interview. `To have them involved in the very last stage, and give the impression that they've been involved from the very beginning, is distorting. This is not acceptable.''
"We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal,'' said Peter Kim, president of Merck Research Laboratories, in a statement.
In the recognition of full and fair disclosure, Dr. Ross and the other authors were compensated for their work as consultants at the request of the plaintiffs in the litigation against Merck & Co. #