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Brooks Schuelke
Brooks Schuelke
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Did Merck Ghostwrite Vioxx Studies For Doctors? And Why Is That Important To Personal Injury Lawyers?

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According to an article published yesterday by the Journal of American Medical AssociationMerck was ghostwriting Vioxx studies for doctors.    The study’s authors reviewed over 20,000 pages of drafts reports of studies and came to the conclusion that:

When publishing their own clinical trials (designed, conducted, and sponsored by Merck), documents were found describing Merck scientists often working to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to collaborate on the manuscript as guest authors.

But the authors state that Merck may not be alone in this practice:

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. However, given the reported prevalence of guest authorship and ghostwriting among the most prestigious medical journals and that similar authorship patterns were identified using documents produced during litigation surrounding both gabapentin and sertraline, iit is reasonable to expect that the authorship practices observed in this case study may be used by other pharmaceutical companies as well.

On its face, this conduct is unacceptable.  The World Association of Medical Editors has described this type of conduct as dishonest and unacceptable and stated that it erodes the ethical foundation of medicine and medical research. 

But I think this story is significant to personal injury victims and trial lawyers for at least two non-obvious reasons.  First, this study demonstrates the value of litigation, not only as regulation, but also as a check on unsubstantiated assertions of wrongdoers.  The study was based on a review of studies and drafts of studies that were produced in the various Vioxx cases.  In the absence of pharmaceutical litigation, these studies would never have been scrutinized and this type of story would never come to light.  As the authors of the study wrote:

Nevertheless, access to industry documents through litigation presents a rare opportunity to explore the relationship between the medical profession and the pharmaceutical industry and has provided valuable insights and findings in the past.

More importantly, this story is important in the tort “reform” debate.  I have written about it time and time again, but this revelation is another indictment of the current administration’s continued push for preemption of state laws.  It is the administration’s position that any drug that is approved by the FDA (or product approved by the CPSC, etc) should not be subject to lawsuits based on state law.  At a time when articles are coming out weekly about the FDA’s (or other governmental entity’s) inability to regulate all of the drugs or products and with this revelation that pharmaceutical companies are likely misleading the government, it makes no sense to me to continue pushing for preemption.

For more on this story, you can read:

NYT: Merck Wrote Drug Studies For Doctors

Merck Press Release:  Merck Responds to JAMA

Pharmalot:  Vioxx Studies — Ghostwriters and Merck Sponsorship

Oklahoma City Injuryboard: JAMA Editorial Blows Whistle On Drug Companies

WSJ Health Blog: Ghost of Vioxx Still Haunts Merck

UPDATE:  Since my post, the following have posted good articles on this story:

Injuryboard national desk

Ethics for the Real World

Public Citizen’s Citizen Vox