Avandia, Bisphosphonate Problems Point to Weaknesses in Drug Approval ProcessOct 18, 2010 | Parker Waichman LLP
Recent safety issues involving the diabetes drug Avandia and a class of bone drugs called bisphosphonates have some questioning the way drugs are approved for sale in the US. According to a recent New York Times’ news analysis, problems that have cropped up with Avandia, bisphosphonates and other drugs years after their approval have some calling for change.
Avandia was once one of the most popular diabetes drugs on the market. But in 2007, a black box warning – the US Food & Drug Administration’s (FDA) most serious safety warning – was added to Avandia’s label after a Cleveland Clinic study found it increased heart attack risks by 43 percent. Just last month, the FDA placed major restrictions on Avandia because of growing evidence that it is harmful to the heart.
Just last week, the FDA added warnings to the labels of Fosamax, Actonel and other oral bisphosphonates after studies showed long-term use of the drugs could be linked to a rare type of thigh fracture. The new warnings are ironic, considering that people with osteoporosis take bisphosphonates to prevent broken bones.
By the time these Avandia and bisphosphonate side effects became apparent, millions of people had been treated with the drugs. It’s impossible to know how many suffered heart attacks or fractures as a result.
The clinical trials required for drug approvals usually only last a few years, and are inadequate for detecting all of a medication’s potential side effects. Once their on the market, the FDA relies on doctors to report adverse side effects. Researchers then have to look at a variety of databases in order to spot trends.
“Here is a wide-scale institutional failure,” Dr. Daniel Carpenter, a government professor at Harvard University and an expert on the FDA, told The New York Times. “We have placed far more resources and requirements upon premarket assessment of drugs than on postmarket.”
Dr. Clifford J. Rosen, director of the Maine Center for Osteoporosis Research, expressed similar concerns.
“The basic underlying theme is that we don’t have good long-term safety indices for common chronic diseases that we are treating with major drugs,” he said.
According to The New York Times, Congress recently gave the FDA the power to require studies after drug approval, but the agency has used it sparingly. Both Drs. Carpenter and Rosen told the Times that they would like to see the FDA require large clinical trials after a drug is approved that would continue for years.
However, some see this as impractical. Dr. Jason Karlawish, a University of Pennsylvania ethicist, told the Times that he favored the development of a national electronic drug database that would reveal drug use and complications.