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BMJ report seeks side effect disclosure

18-Oct-2004

Researchers writing in the British Medical Journal have argued that drug companies must disclose all adverse events encountered during drug development ahead of licensing.

They make their assertions in the wake of the withdrawal by Merck & Co of the painkiller and anti-inflammatory drug Vioxx (rofecoxib), which has been found to cause cardiovascular toxicity.

This event has left the medical community wondering whether the side effects with Vioxx are related to the drug alone or a class effect, which could implicate other big-selling brands such as Pfizer's Celebrex (celecoxib).

 

In the article, Paul Dieppe and colleagues at the Medical Research Council Health Services Research Collaboration, University of Bristol Single, UK, claim that Phase III drug trials are simply not big enough to detect relatively uncommon but important adverse events, which may affect large numbers of people once the drug comes into routine clinical use.

 

Further, the impact of undetected adverse events is likely to be made worse if widely-marketed new drugs are prescribed "haphazardly and rapidly" to large numbers of people, they add, noting that, within five months of Vioxx' launch, more than 42,000 patients in England had been prescribed it.

 

They also claim that the use of non-steroidal anti-inflammatory drugs (NSAIDs) for routine pain relief should be re-assessed.

 

To prevent further similar episodes, drug companies should be legally required to register all clinical trials and to make all data on serious side effects seen in clinical studies available to the public immediately after completion of the research. which will allow independent, timely and updated systematic reviews, say the authors.

 

They also call for phased introduction of new drugs in independent, large-scale, randomised trials before licensing, plus better postmarketing surveillance.

 

In addition, "clear cut financial firewalls between pharmaceutical companies and researchers performing systematic reviews and clinical studies," should be in place, they note.

 

"Although these measures will not be popular with pharmaceutical companies, they will limit the numbers of patients exposed to unknown hazards and provide robust and unbiased evidence on adverse events before a drug is fully licensed, " conclude the researchers.

 

The paper can be read in full here .

 

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