Minding The Pharm

USA Today: Avandia safety debate shows flaws in FDA drug monitoring. USA Today (7/9) editorializes, “Since 2005, evidence has mounted that the blockbuster diabetes drug Avandia [rosiglitazone maleate] might increase the risk of cardiovascular complications — including heart attacks, one of the major causes of death among diabetics.” Yet, “the drug is still on the market, and scientists still are battling over its safety.” This “prolonged battle leaves nervous patients in the lurch — and renews questions about whether America’s medication safety watchdog, the Food and Drug Administration, is effectively monitoring drugs after they’ve been approved for sale. As with Vioxx [rofecoxib], the popular painkiller pulled off the market in 2004, the FDA has lagged several steps behind independent researchers.”

Florida Lawyers

Healthcare experts and federal regulators knew that the use of Avandia created a greater risk of heart attacks by as much as 43% way back in 2007, but recommended to the FDA that it stay on the market. Why?

When it comes to drug safety, they say, you can’t make an omelet without breaking a few eggs.

One key problem with the FDA’s drug-approval process is that a much greater emphasis is placed on the effectiveness of a medication than on its safety. “Only the grossest, most commonly occurring things will show up in clinical trials designed to determine efficacy,” said Sydney Wolfe, director of health research for the advocacy group Public Citizen.

Suppose a drug saves 3 people and kills 1 person… is that a good reason to keep it on the market?

See David Lazarus at the Los Angelas Times