Drugs may need greater evaluation

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As drugs continue to be taken for longer periods of time, unexpected complications may arise that were absent from short-term clinical trials. Over the weekend, New York Times science journalist Gina Kolata reported on what happens when drugs cause problems they were originally developed to prevent, focusing on the risks associated with the now highly restricted diabetes drug Avandia, and bisphosphonates, a class of medicine used to treat osteoporosis. After post-market analysis revealed that Avandia is associated with an increased risk of heart failure, the drug was temporarily removed from the market in Europe and heavily restricted by the U.S. FDA last month. Bisphosphonates have also been under heightened scrutiny since the drugs have been linked to rare fractures of the thigh bone and degeneration of the jawbone.

These allegations concern Dr. Ethel Siris, osteoporosis expert at Columbia-Presbyterian Medical Center, because even though thigh fractures associated with bisphosphonate use are extremely rare, people might still turn away from the drug.

The benefits far outweigh the risks, ACSH s Dr. Elizabeth Whelan reminds us. The devastating effects of osteoporosis are well-known, including hip fractures, which often lead to loss of independence and are very common among the elderly. The drugs used to prevent and treat the disease have helped many more people than they ve hurt.

Ms. Kolata s article reminds Dr. Ross that we may not have our eyes on the prize anymore. Diabetic treatment is supposed to reduce the rate of diabetic complications including vascular disease, kidney disease and neuropathy not merely control blood sugar. Studies that show Avandia may increase the risk of heart failure illustrate a case of when a drug does the opposite of what it s supposed to.

So how can we determine how safe a drug which may be used for decades is when clinical trials only last a few months, or years? Dr. Jason Karlawish, a University of Pennsylvania ethicist, proposes the development of a national electronic drug database that would track the safety as well as all complications involved with drug use after market approval.

This sounds reasonable to me, says Dr. Ross. Collecting post-marketing data or requiring its collection to assess for unusual or unexpected toxicities seems like something that should be done.