In the most recent debacle over Merck’s Vioxx, Merck is accused of hiring a ghostwriter for a Circulation paper likely written to minimize issues linked to Vioxx’s safety. The Heart.org said well-known cardiologist Dr. Marvin Konstam of Tufts University Medical Center agreed to act as lead author in 2001. Claims just made in an Australian court allege the paper was written by Merck’s in-house scientists, a conflict of interest.
It is believed the Merck paper was developed in defense of an article published in the Journal of the American Medical Association (JAMA) that broke with news that Vioxx increased cardiovascular side effects, said The Heart.org. It took until 2004 for Vioxx to be globally withdrawn. “During the three years after publication of the Konstam manuscript, millions of patients around the world were prescribed rofecoxib by physicians who believed that the drug was safe. In this case, a ghostwritten article caused great harm to the public health,” said Dr. Steve Nissen of the Cleveland Clinic and author of the JAMA paper, quoted The Heart.org.
News of the scandal is surfacing in Australia amid a class-action lawsuit against Merck and its subsidiary, Merck, Sharp and Dohme, and following the Pharmaceutical Research and Manufacturers of America’s (PhRMA) issuance of “revised principles” on communicating clinical trial results, said The Heart.org, such as limiting author credits to those who actually made so-called “substantial” research contributions. Nissen told heartwire, “We must not view this situation as ‘old news.’ We had long suspected that this [Circulation] manuscript was ghostwritten, but definitive proof was lacking. These court documents finally confirm our suspicions,” quoted The Heart.org.
Of note, said The Heart.org, Konstam does not have specific expertise in meta-analyses or COX-2 inhibitors and was also apparently not first choice as lead author. The paper was originally rejected by JAMA for “fast-track publication” before being accepted by Circulation for publication, said TheHeart and, it seems that there was a connection between Konstam and the American Heart Journal—another publication possibility—which increased Konstam’s attractiveness in speeding up review processes.
The Australian reported that an email sent to the Federal Court as part of the class-action against Merck, by senior scientist Briggs Morrison mentioned concerns about the article’s peer review process, “I guess what I am saying is that the data appears to have been interpreted to support a preconceived hypothesis rather than critically reviewing the data to generate hypotheses.” According to Professor Jelinek, a witness involved in the case “… it is inappropriate for a pharmaceutical company to seek to release its own scientific content effectively disguised as independent research or commentary. In my opinion, the ghost-written material from Merck and MSDA … does not disclose that the content was written or directed by Merck or MSDA, and is, therefore, likely to mislead readers about the true nature or purpose of its contents.”
Vioxx is the target of a federal probe and numerous lawsuits following an analysis that linked it to over 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. After Vioxx was pulled, it was revealed that the U.S. Food and Drug Administration (FDA) tried to silence the drug expert heading that study via veiled threats and intimidation. In 2007, Merck agreed to settle most of its Vioxx claims for $4.85 billion. Last April, an analysis of court documents uncovered in the course of Vioxx injury lawsuits, found Merck employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies.
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