NEW YORK (Reuters Health) - A review of industry documents from the litigation surrounding Vioxx, the arthritis pain reliever that was withdrawn from the market by Merck, Inc. in 2004, reveals that clinical trials and review articles published about the drug were often written by company employees or other unacknowledged authors, while an academically affiliated investigator, who may have had little involvement with the study or who did not always disclose sponsor-related financial support, was listed as the primary author.
Vioxx, also known generically as rofecoxib, is a pain reliever and anti-inflammatory drug approved by the U.S. Food and Drug Administration in 1999. The drug was considered particularly useful because it provided the effects of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, without causing the gastrointestinal side effects also seen with NSAID.
By 2004, enough reports associating the drug with a significant increase in heart attacks and strokes were received that it was withdrawn from the market. Since then, there has been considerable controversy and along with the lawsuits, questioning how long Merck had been aware of these potentially fatal side effects and how the drug was able to received FDA approval.
"This case-study review of industry documents related to Vioxx demonstrates that Merck used a systematic strategy to facilitate the publication of guest-authored and ghost-written medical literature," lead investigator Dr. Joseph S. Ross, from the Mount Sinai School of Medicine, and colleagues report in the Journal of the American Medical Association.
Ross' team evaluated the guest authorship and ghostwriting related to Vioxx by reviewing court documents and medical literature. The court documents were generated primarily between 1996 and 2004. Roughly 250 documents were included in their review.
For the clinical trials, their findings indicate that Merck researchers often prepared the manuscripts and then sought out academically affiliated investigators to collaborate as guest authors. These recruited authors were then frequently listed as either the first or second author, indicating that they lead or provide guidance for the study.
