|Pharma company pawned its writings off to academically affiliated doctors. Source: American University at Cairo|
Clinical trial manuscripts related to Vioxx (rofecoxib) were authored by Merck employees, but attributed to academic investigators, who did not always disclose industry financial support, according to a case study investigation published April 16 in the Journal of the American Medical Association (JAMA).
“Authorship in biomedical publication provides recognition and establishes accountability and responsibility,” the authors noted. They wrote that the recent Vioxx litigation “provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation.”
Vioxx was approved for use as an anti-inflammatory drug in 1999, and became a blockbuster for Merck with annual sales of $2.5 billion. In 2004, the FDA ordered the painkiller off the market after an analysis of patients using Vioxx linked the drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.
Joseph S. Ross, MD, MHS, from Mount Sinai School of Medicine and colleagues reviewed court documents originally obtained during litigation related to Vioxx against Merck, as well as publicly available articles related to rofecoxib identified via MEDLINE. All examined documents were predominantly created between 1996 and 2004.
Ross and Kevin P. Hill, MD, MHS, from Harvard Medical School in Boston reviewed approximately 250 documents, the majority of which were Merck internal correspondence and publication reports, along with external correspondence between Merck and medical publishing companies.
For the publication of clinical trials, the researchers found documents describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to be authors. Recruited authors were frequently placed in the first and second positions of the authorship list, the authors noted.
The case study indicates that one draft of a Vioxx clinical study had yet to achieve an academically accepted author, so the document identified the lead writer as “External author?”
For the publication of scientific review papers, the researchers found documents describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts and recruiting external, academically affiliated investigators to be authors. Recruited authors were commonly the sole author on the manuscript and offered honoraria for their participation.
“It is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors,” an accompanying editorial in JAMA said.
Ross and colleagues found that among 96 relevant published articles, 92 percent (22 of 24) of clinical trial articles published a disclosure of Merck’s financial support, but only 50 percent (36 of 72) of review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company.
“This case-study review is based on documents from a single company related to a single medication. We cannot determine if the authorship pattern we observed for clinical trial and review articles related to rofecoxib also would be observed in articles describing other Merck products or the products of other pharmaceutical companies,” the authors wrote.
The authors also thought it important to clarify that Merck is most likely not the only pharmaceutical company to involve themselves in this practice. “Because Merck has traditionally characterized itself and its conduct as among the most ethically appropriate of pharmaceutical companies, perhaps the practices we observed are conservative in comparison with other companies within the industry,” Ross and colleagues wrote.
“We are hopeful that our findings encourage discussion of ways in which to improve the integrity of research. The medical profession and the pharmaceutical industry should agree that collaborations must be conducted with the highest standards,” the authors concluded.