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Lessons from Vioxx litigation

July 02, 2017

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 It was subsequently found that the drug increased the risk of cardiovascular disease (CV) and withdrawn from the worldwide market.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."

bmj

In addition to their large body size, linemen face other challenges that put them at increased risk of cardiovascular disease. Often injured, they develop arthritis and persistent joint problems, which make exercise increasingly challenging, if not impossible. As they age, football players can't exercise easily because their old injuries bother them more, said Dr. Roberts. They're also used to eating large amounts of food, a habit that is difficult to break after they retire, he said.

Dr. Roberts has learned that weight management following football is very important; players who were large and lost weight tended to do better, from a health perspective, than those who were not so large while playing but then put on weight.

"Highlighting that some football players are at higher risk for cardiovascular disease is a great way to bring attention to an important health topic," said Barry Katzen, M.D., founder and medical director of Baptist Cardiac & Vascular Institute. "And football players aren't unique. Cardiovascular disease is the country's number one killer, and some 50 million Americans have metabolic syndrome, which increases their risk of heart disease. Anyone who has health issues such as excess abdominal fat and high blood pressure needs to be aware that they are at risk for heart disease and should consult a doctor about lifestyle changes and treatments, many of which are minimally invasive."

Considered the premier meeting on endovascular therapy, ISET is attended by more than 1,200 physicians, scientists and industry professionals from around the world. The meeting pioneered the use of live cases to promote the multidisciplinary treatment of vascular disease. ISET is presented by the Baptist Cardiac & Vascular Institute, Miami.

The Living Heart Foundation (Little Silver, N.J) is a nonprofit organization established in 2001 to combat cardiovascular disease and provide risk stratification for cardiac, pulmonary, and metabolic conditions through on-site screening and integrated health programs.

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