... In with the new? Can we really trust new drugs to be safe and effective, or is it better to stick to the tried and tested?(REPORT: New drugs)

Publication: Choice (Chippendale, Australia)

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COPYRIGHT 2005 Australian Consumers' Association

In 2004, VIOXX (rofecoxib), an anti-inflammatory drug used worldwide by millions of people (particularly arthritis sufferers), was voluntarily pulled from the market after a study demonstrated it increased the risk of heart attack. Rofecoxib belongs to the class of newer non-steroidal anti-inflammatory drugs (NSAIDs) known as Cox-2 inhibitors. They'd been developed to avoid the usual gastrointestinal side effects that older NSAIDs have. According to the drug companies, VIOXX and another new Cox-2 inhibitor, CELEBREX (celecoxib), reduced pain and inflammation while being easier on the stomach.

After the withdrawal was announced, Merck, the maker of VIOXX, said in a press release: "... we conclude that a voluntary withdrawal is the responsible course to take."

According to the Wall Street Journal, however, 2004 wasn't the first time Merck was aware of data linking VIOXX to heart problems. The newspaper reported that as far back as 1997, internal emails within the company showed it was aware of VIOXX's potential to increase the risk of "thrombotic events". Merck says these comments have been taken "out of context".

More evidence that VIOXX could cause cardiovascular harm came from a trial the drug company itself reported on in 2000. Known as VIGOR, the study was undertaken to prove VIOXX was better for the stomach than older, cheaper NSAIDs. Although this was confirmed, the trial also showed an increase in heart attacks for VIOXX users compared with naproxen (an older NSAID, sold as NAPROSYN and ALEVE).

Merck responded by presenting the (unproven) hypothesis that naproxen was perhaps cardioprotective--that is, VIOXX doesn't cause heart attacks, but naproxen prevents them.

WHAT THE FDA KNEW

The us Food and Drug Administration (FDA) was also aware of VIOXX's dangerous potential as far back as 2001. The regulatory body sent a warning letter to Merck, criticising it for minimising safety problems, for presenting the naproxen cardio-protective hypothesis as fact and for recommending VIOXX for unapproved uses. However, the FDA was extremely slow to take further action, and was publicly criticised by one of its scientists for its handling of the VIOXX case.

The FDA's Australian equivalent, the Therapeutic Goods Administration (TGA), introduced stronger restrictions on all Cox-2 inhibitors in February 2005....

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