Lessons from Vioxx litigation

The pharmaceutical industry, academia and government agencies need to work together to restore faith in drug development, say doctors in this weeks' British Medical Journal.

They argue that the recent litigation over the drug Vioxx, produced by Merck and Co. Inc., has highlighted the failings of the current system, which can be open to abuse.

Vioxx (rofecoxib) was introduced in 1999 as an effective, safer alternative to non-steroidal anti-inflammatory drugs (NSAIDS) for the treatment of pain associated with osteoarthritis. It was subsequently found that the drug increased the risk of cardiovascular disease (CV) and withdrawn from the worldwide market. Merck now faces legal claims from nearly 30,000 people taking Vioxx who experienced a CV event while taking the drug.

In the course of the litigation and in dealings with medical journals it was revealed that Merck had obscured critical data on the drug's toxicity, given a biased presentation of Vioxx research and had used ghost writers to author papers on Vioxx - which were published in a number of academic journals.

The authors argue that the Vioxx case is "bad news for industry, academics, journals and the public" but conclude that "its [Merck's] behaviour may not be any different from that of others in the pharmaceutical or biotechnology industry."

They say that academic medicine, industry, medical journals and government agencies must come together to define a set of principles governing drug development. They also call for new approaches to collaboration and development of drugs, including storing research data on independent academic sites - rather than with the pharmaceutical company, stricter scrutiny for research which has potentially immense financial implications and penalties for ghost-writing.

They conclude that "collaborations between academics, practicing physicians, industry and journals are essential in advancing knowledge and improving the care of patients. Trust is a necessary element of this partnership, but the recent events have made it necessary to institute proper systems that protect the interests of patients."

http://www.bmj.com