Recently, the FDA overwhelmingly refused to take Avandia, the diabetes drug, off the market, despite studies that showed increased heart attack as a very realistic side effect. Weaknesses in those studies were one of the reasons cited by the FDA for their decision. However, one of the solid conclusions reached was that Avandia does increase heart attack risk.

The FDA did suggest a “black box” warning, the most severe, to warn consumers about the risk. Further suggestions included discouraging joint use of Avandia and insulin, as this also increases heart attack risk. FDA experts also recommended that the drug be investigated further.

In early 2007, Avandia was the second highest grossing diabetes drug in the United States. An analysis of 42 studies showed that there is a 43 percent higher chance of heart attack risk with diabetic patients taking Avandia than those taking any other or no diabetes medication. Avandia is used to control the body’s blood sugar by increasing sensitivity to insulin. Before the studies, this treatment was commonly perceived to decrease heart risks already associated with diabetes. Diabetes affects more than 18 million Americans today.

Congress is in the process of overhauling the FDA’s decision, and points to the Avandia situation as evidence of the FDA’s inability to handle the safety risks of drugs that have been approved for the market.

In the case of Avandia, it appears that the FDA is too lax in dealing with hazards associated with certain drugs. Conversely, many poor countries around the world are not even close to lax with their policies surrounding drugs that should be deemed necessities. Morphine is one prime example, as a pain reliever. Countless poor countries find it extremely difficult to secure this drug even in the cases of uncontrollable cancerous tumors that cause excruciating pain. However, even in these cases, morphine is not allowed due to an intense fear of patient addiction.

Is the FDA too lax in their drug safety control policies? Are foreign countries not lax enough?

See the following articles for more information:
Avandia:
www.msnbc.msn.com/id/20036086/from/ET/
www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html

Morphine:
www.nytimes.com/2007/09/11/health/11pain.html
www.nytimes.com/2007/09/10/health/10pain.html