The Vioxx Wall of Shame

The April 16 issue of Journal of the American Medical Association (JAMA) has an astonishing account of medical and research fraud, perpetrated primarily by Merck with the willing assistance of a number of biomedical researchers. What’s astonishing is not only that it happened, but that apparently this sort of thing goes on all the time, according to the accompanying editorial in JAMA.

The details reveal an extensive, systematic effort by Merck to shape and distort the research around its blockbuster drug Vioxx (rofecoxib). Merck ran its own trials of Vioxx, prepared the results for publication, and then recruited outside authors to be the lead authors, because (obviously) that would give the studies more credibility. We can assume they (Merck) intended to then describe each paper as “a study led by independent unversity researchers....” In many cases the authors had little or nothing to do with the study – they merely attached their name to the paper after the study was completed. In some cases, Merck paid the authors a consulting fee. Perhaps these scientists were simply padding their resumes, or perhaps they really believed that the studies were good science – but by allowing Merck to use their names in this fraudulent manner, these scientists undermined the integrity of the scientific literature. They deserve to be called out, so I’ve decided to create a Vioxx Wall of Shame and list their names in this post. All of these names can also be found in the article in JAMA by Ross et al., JAMA 299(15):1800-12.

The details only came to light because of the ongoing lawsuits against Merck on behalf of patients who might have been harmed by Vioxx. [Aside: for those who don’t know, Vioxx is a painkiller much like ibuprofen/Advil or aspirin.] The scientists who wrote the exposes in JAMA had access to numerous internal documents that normally would never see the light of day. So for example, Ross et al. found internal versions of a paper listing 9 Merck authors, with the first author left unspecified as “External author?” When the paper appeared, not one but three academic authors appeared as the first three authors, followed by 8 of the 9 Merck authors (one was removed for an unknown reason) – despite the fact that the final version was almost unchanged from the draft. This is just one of the smoking guns that show not only Merck’s deception, but also the unethical behavior of these scientists. These three authors are the first three names on the Vioxx Wall of Shame.

The Ross et al. study found 20 articles published on Vioxx by Merck, and in 16 out of 20, the first author is an external academic scientist. This despite the fact that for all the studies, a Merck employee was the author of the first draft of the manuscript. On those 16 articles, external authors were usually first, second, and third authors (sometimes all three) on the published version. This illustrates that the academic authors were likely motivated by academic “credit” they gain by appearing to lead these studies: the first author, and to a lesser extent the second and third authors, are generally regarded as the intellectual and scientific leaders of a study, and the first author gets the most credit for the publication. The problem is that they took credit for work they did not do.

Perhaps even more egregious is the practice of hiring outside companies to write the papers. Merck did this multiple times for Vioxx. The fact that such companies exist, and make a profit, is strong evidence that this happens all the time. For example, one company (Scientific Therapeutics Information, STI) wrote a paper and sent it to Merck with an email message in which they say that Merck needed to "invite" an author. In another case, STI describes an “independent” author who was “too busy” to make revisions to “his” article. STI wrote to Merck because they wanted to be paid more money for handing the revisions. Another company, Health Science Communications, sent a contract to Merck for $23,841 to write a manuscript including figures and tables, “journal-ready for author submission to journal”. One particularly damning STI document discloses their progress (in 1999) on writing 8 studies on Vioxx targeted at different journals: 7 of the 8 studies eventually appeared, all in the intended journals, and all of them with academics as sole author. Those authors appear in the Wall of Shame.

Vioxx Wall of Shame

Leon J. Thal, UC San Diego
Steven H. Ferris, NYU School of Medicine
Louis Kirby, Pivotal Reearch Centers
These three listed their names as the first 3 authors on a paper in Neuropsychopharmacology (2005;30(6):1204-15) despite having made few or no contributions to the paper.

William Garnett, Department of Pharmacy Virginia Commonwealth University, Medical College of Virginia. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. The paper was: Clinical implications of drug interactions with coxibs. Pharmacotherapy 2001;21(10):1223-32.

Noor Gajraj, Dept. of Anesthesiology, UT Southwester Medical Center. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. The paper was: Cyclooxygenase-2 inhibitors. Anesth Analg. 2003 Jun;96(6):1720-38.

Arthur Weaver, Arthritis Center of Nebraska. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. The paper was: Rofecoxib: clinical pharmacology and clinical experience. Clin Ther. 2001 Sep;23(9):1323-38.

Mark C. Hochberg, School of Medicine, University of Maryland. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. Paper: Treatment of rheumatoid arthritis and osteoarthritis with COX-2-selective inhibitors: a managed care perspective. Am J Manag Care. 2002 Nov;8(17 Suppl):S502-17. Dr. Hochberg gets extra credit for a later article titled “COX-2: Where are we in 2003? - Be strong and resolute: continue to use COX-2 selective inhibitors at recommended dosages in appropriate patients.” (Arthritis Res Ther. 2003;5(1):28-31.) I have to wonder if he wrote that one himself.

F. Michael Gloth III, Victory Springs Senior Health Associates and Johns Hopkins University School of Medicine. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. Paper: Pain management in older adults: prevention and treatment. J Am Geriatr Soc. 2001 Feb;49(2):188-99.

Thomas Schnitzer, Northwestern University Medical School.
Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. Paper:
Osteoarthritis management: the role of cyclooxygenase-2-selective inhibitors.
Clin Ther. 2001 Mar;23(3):313-326;

A. Mark Fendrick, Department of Internal Medicine, University of Michigan. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. Paper: Cost-effective use of NSAIDs: issues pertinent to coxib use in managed care. Am J Manag Care. 2002 Nov;8(17 Suppl):S529-41.

So that's the list. These scientists have authored many other publications besides their Vioxx work, and I have to wonder about their other studies. A scientist who will put his name on a paper at the behest of a drug company cannot be trusted to conduct objective science. The editors of JAMA (DeAngelis and Fontanarosa) called for these scientists and others like them to be “banned from publishing articles in that journal" and to be “reported to the appropriate authority (ie, medical school dean or department chair)” - a good idea, so I wonder if JAMA has reported the authors described in their own journal?

The JAMA editors also call for sanctions against the scientists who participate in these schemes. As the JAMA editors say in their editorial:

“Individuals, particularly physicians, who allow themselves to be used in this way, especially for financial gain, manifest a behavior that is unprofessional and demeaning to the medical profession and to scientific research.”

To some scientists, the JAMA revelations may come as no surprise. But to most of us, the behavior of Merck and of the scientists who colluded with Merck is shocking and reprehensible. Medical journals need to tighten their oversight, as do the employers (mostly medical schools and universities) of these authors. Quoting the JAMA editorial again: “When integrity in medical science ... is impugned or threatened ... patients, clinicians, and reearchers are all at risk for harm, and public trust in research is jeopardized.”

Finally, all of this is made worse by the fact that Vioxx does kill people, and Merck knew it, and they kept their own findings from the public. This is revealed in the other JAMA paper by Psaty and Kronmal from the same issue. Their investigation revealed that Merck's own internal analysis, in April 2001, "identified a significant increase in total mortality" among patients taking Vioxx versus placebo. Psaty and Kronmal show how selective reporting of results made Vioxx appear safe when it really isn't. They call for greater oversight of clinical trials and much greater scrutiny by journal editors and reviewers. We can start by calling out scientists such as those in the Vioxx Wall of Shame.