The FDA & Drug Disasters - Are We Headed for More?

Here's a frightening quote: "Drug disasters are literally built into the current system of drug testing and approvals in the United States. Recent changes in the system have only increased the proportion of new drugs with serious risks."

Those words come from Donald Light, a sociologist who presented his paper, "Institutional Foundations of the Vioxx Disaster," at the American Sociological Association's meeting in August 2008. The anti-inflammatory (Cox-2 inhibbitor) drug Vioxx was pulled from the market in 2004 because of increased risk of heart attack, stroke and other serious health problems. The FDA estimates that the drug caused nearly 28,000 heart attacks and sudden cardiac deaths.

Light's paper criticizes 3 major aspects of the drug testing and approval process.

1. Comparing new drugs to placebos instead of to drugs currently in use. He found that only 1 in 7 new drugs is better than existing drugs. Meanwhile, 2 in 7 new drugs cause serious side effects. That means, compared to older medications, new drugs are twice as likely to hurt as they are to help.
2. Drug trials flawed because of who's chosen. Light says pharmaceutical companies often minimize side effects in trials by chosing people who are healthier than those who will actually take the drug. He says they exclude people who are older, less affluent, or have multiple health problems. The less healthy people who end up taking them are more likely to have adverse reactions than people in the studies.
3. The FDA is financially dependent on the agency it regulates. Light says the FDA is seriously under funded, which has made it depend on drug-company funding in order to function at all. In return for funding, the industry expects faster reviews, and Light says faster reviews have more than tripled the number of black box warnings (the highest level of side effect warnings) or withdrawals from the market.

This is another thing for which we need to hold our elected official accountable. These problems need to be in the spotlight on a national level, so we can first tackle funding issues and then move on to re-designing clinical trials.

It's also a very clear warning that we need to be informed and think very carefully about the drugs we take. I'll use Light's words once again:

"Based on our current system, the designation of 'safe and effective' on today's new drugs could be replaced with, 'apparently safe based on incomplete information, and more effective than a placebo.'"

Suggested Reading:

• Know what you're taking with About.com's Drugs A-Z
• Fibromyalgia Fact Sheet
• Chronic Fatigue Syndrome Fact Sheet