Merck & Co’s Vioxx has been put back in the spotlight following articles published in the Journal of the American Medical Association which claim that the drugmaker used ghostwriters to draft studies on the now-withdrawn painkiller and then recruited academic experts to put
their names to them. It is also claimed the firm downplayed the mortality risks associated with Vioxx in Alzheimer’s patients.
The first JAMA article noted that recent litigation related to Vioxx (rofecoxib) “provided a unique opportunity to examine guest authorship and ghostwriti
ng”, practices which it says “have been suspected in biomedical publication but for which there is little documentation”. A review of 250 documents reveals that Merck worked independently or with publishing companies to prepare manuscripts but then asked outside experts to be first or second a
uthors on the published studies. Documents were found describing Merck marketing employees developing plans for manuscripts,
The second JAMA article claims that Merck may have misrepresented the risk-benefit profile of Vioxx for patients with Alzheimer’s disease. Lead researcher Bruce
Psaty wrote that in April 2001, the firm conducted “high-quality analyses that identified a three-fold increase in the risk of death for patients taking Vioxx compared with placebo.” However, he claims indicated that the drugmaker did not provide this information to the US Food and Drug Administra
tion until 2003.
The New Jersey-based drugs giant has responded by saying that many of the points in the JAMA articles “are false, misleading or lack context”. Peter Kim, president of Merck Research Laboratories, said the firm is “disappointed that such false and misleading stat
ements…from trial lawyers have made their way into a medical journal”.
He added that “the allegation that Merck misrepresented mortality data from our Alzheimer’s studies is just plain wrong,” and in terms of the ghostwriting issue, he said “we have explicit policies governing the authors
hip of papers…and we take those policies very seriously”. He added that “the outside authors of the papers about Merck’s clinical trials referenced in the JAMA article were intimately involved in the studies.”
Nevertheless, another article in the journal, by JAMA editor-in-chief Catherine DeAngelis and executive deputy editor Phil Fontanarosa, states that “the profession of medicine, in every aspect – clinical, education, and research – has been inundated with profound influence from the pharmaceutical and medical device industries. This has occurred because physicians have allowed it to happen, and it is time to stop”. The two articles focus on Merck, the authors note, but “but make no mistake, the manipulation of study results, authors, editors, and reviewers is not the sole purview of one company”.
They concluded by saying that “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 for harm, and public trust in research is jeopardised”.
