In a new twist to the ethical issues Merck Inc, faces over Vioxx (rofecoxib), the company’s one-time best seller that was pulled from the market in 2004, because it became closely associated with patient heart attacks, some argue that the company hired writers to fashion the medical publications that their scientists are believed to have written. Many of these publications claim to be based upon the same scientific evidence which supposedly documented the safety of the drug in order to obtain approval from the US Food and Drug Administration (FDA).
Ghostwriters and Vioxx researchIn what seems to be deceptive maneuvers to many people in both the medical and the publishing fields, Merck acknowledged that it has been known to hire outside professional writers to develop research-related documents that eventually get published under the name of reputable leaders in the medical community. Critics are expressing doubt about the validity of the research and about the actual involvement of the scientists listed as authors of the papers. One especially galling example is that of the paper being developed as solid academic research but the lead writer is listed as “External author?”

Dr. Joseph S. Ross, of New York’s Mount Sinai School of Medicine, came across the apparently ghostwritten research studies while reviewing documents related to lawsuits filed against Merck. Because Ross has served as plaintiffs’ consultant in some of the legal cases, he had access to the millions of documents Merck supplied plaintiffs’ legal teams.

Merck has agreed to pay $4.85 billion to settle claims in tens of thousands of lawsuits filed by people who once took Vioxx or their surviving families.

Merck officials claim the practice is not uncommon throughout the pharmaceutical industry and that Ross’s conclusion that the authors named in these publications don’t actually participate adequately is false. Merck’s claim is seconded by Dr. Steven H. Ferris, a psychiatry professor at New York University, who is himself listed as author on a Merck publication suspected of being ghostwritten. Ferris describes Ross’s accusations as egregious and false.

An editorial published in the Journal of the American Medical Association (JAMA) puts forth the question of whether Merck might have deliberately manipulated dozens of seemingly academic published documents in order to promote Vioxx under false pretenses.

Dr. Catherine D. DeAngels, editor of JAMA, says that journal published a Vioxx study in 2002 that is now in question. This particular article did list a Merck staff scientist as lead author but ghostwriters were involved, too. DeAngelis considers it a dishonest move that the work of the ghostwriters were not fully disclosed when the document was submitted for publication.

Saying she feels the journal has been scammed, DeAngelis suggests than an even less desirable practice is when a for-profit company hires a for-profit writing firm to produce scientific research studies and then finds a doctor willing to endorse it before publication.

In about 96 journal publications, Ross and his colleagues discovered internal Merck documents and e-mail messages pertaining to clinical study reports and review articles, some of which were developed by the company’s marketing department, not its scientific department. In others, there is little evidence that the authors recruited for the report made substantial contribution to the research itself.

Some of the authors listed in the Merck study reports of concern deny their lack of involvement or question the true nature of ghostwriting. One neurologist, originally listed as “External author?” and then listed as Dr. Leon J. Thal, of the Unviversity of California, San Diego, in the final draft died a year ago in an airplane crash.

The journal Neuropsychopharmacology published the Thal paper on Alzheimer’s disease in 2005. Citing prohibitions against the practice of substituting a well-known doctor’s name to research conducted by others, the journal’s current editor, Dr. James H. Meador-Woodruff, plans to investigation the allegations.

Merck officials said on Tuesday that even when outside authors are listed for publication, they are in fact involved in the research process as well as the drafting and final review of any paper which bears their names. They also admitted that professional writers have sometimes been hired to develop drafts early on but the final work belongs to the doctor named as author. Merck lawyer James C. Fitzpatrick says this practice doesn’t necessarily mean the final product doesn’t reflect the listed author’s opinion of the work.

The Ross article includes a review of companies in the business of medical writing, including Scientific Therapeutics of New York. Ross’s research uncovered one of their memos to Merck dated 1999 in which the status of eight separate reports was mentioned.

One of those eight reports was targeted for publication in JAMA. When it was completed, it was indeed published in JAMA in January 2002. At publication, the paper listed two outside academic physicians acting as co-principal investigators and the lead author was identified as a Merck employee. There was no mention of the role Scientific Therapeutics played in writing the paper.

The JAMA editorial notes that editors of these journals bear some responsibility by allowing companies, such as Merck, to manipulate their publications.

Putting Merck in even more hot water is a second article in Wednesday’s JAMA that is based on some of the same documents Ross reviewed. Written by Drs. Bruce Psaty and Richard A. Kronmal, both of the University of Washington, the paper claims Merck was not fully candid when submitting data for review by the US Food and Drug Administration (FDA) during the time before Vioxx was recalled.

Calling the Psaty/Kronmal analysis misleading, Merck says the FDA knew of cardiovascular risks linked to Vioxx and was involved with on-going discussion of the matter with Merck.

Source: NYT