Merck’s Ghost Story

Once again the pharmaceutical industry has demonstrated it has more in common with Hollywood than healthcare.

First Pfizer (PFE) used a stunt double in their now discontinued Lipitor commercials featuring Dr. Robert Jarvik. Now Merck (MRK) has taken a cue from celebrities who employ ghostwriters to author their books.

Two articles appearing in today’s issue of JAMA (Journal of the American Medical Association) show Merck’s deceptive practices concerning its anti-inflammatory drug Vioxx that it pulled off the market in 2004. Merck faces a pending legal settlement of $4.85 billion to compensate 47,000 plaintiffs involved in the class action lawsuit.

It was through the plaintiffs’ lawyers combing through piles of documentation that they discovered instances where Merck’s consultants or employees in their marketing department would write studies showing Vioxx in a favorable light, and then recruit academic researchers to attach their name to it. The first JAMA article describes Merck’s ghostwriting concerning Rofecoxib (Vioxx). Reading the article’s introduction shows that Merck is not the first to ghostwrite research papers. In one instance, a draft of a Vioxx study Merck had Scientific Therapeutics Information (described as a specialist in the development of scientific literature), prepare a manuscript that was awaiting the name of a well known researcher to “author” it. Merck compensated researchers with “honoraria” for agreeing to serve as authors. These payments ranged from $750 to $2500. Merck paid Health Science Communications, a health marketing communications company, $23,841.00 to provide a 20-page review manuscript for a cardiology conference. Merck also contracted the company to prepare review manuscripts for nephrology and primary care audiences.

The second JAMA article describes how Merck misrepresented clinical trial numbers reported to the FDA. Merck wanted to promote Vioxx for use in slowing the progression of Alzheimer’s disease. In fact, the results of two Merck-sponsored trials showed that Alzheimer’s patients taking Vioxx were three times more likely to die vs. patients on placebos. Studies showing Vioxx causing increased deaths from heart attack and stroke prompted Merck to pull Vioxx off the market.

Dr. Catherine DeAngelis, JAMA’s Editor-in-Chief, outlines in her editorial steps that medical publications need to take to ensure all the authors involved in medical studies are disclosed, their contributions to the study, and any compensation received.

As time goes on, we are witnessing more and more of these so-called “lifestyle” drugs, medications taken for an issue that may or may not ever occur, as a “preventative.” Whether it’s hormone replacement therapy, statins, restless leg, attention deficit disorder, purple pills, etc., one thing has become crystal clear. The longer a person takes one of these types of drugs, the greater the chance that medication will cause adverse side effects - sometimes creating the very disease the drug was supposed to help prevent.

Related Post: “Merck & Schering-Plough: More Nails in Vytorin’s Coffin”

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