Psst…. The FDA Has A Secret

July 17, 2009

By Nicole Andriso:

side effectsEach year, pharmaceutical companies spend millions of dollars showing us how their drugs will make us feel better and take away our pain. While we’re all looking for the one drug that will change our life, we also know it probably has side effects. We expect that pharmaceutical companies are telling us everything we need to know about those side effects to help us make educated health decisions, but what if they’re keeping something from us?

Recently, the Food and Drug Administration has come under fire to disclose such information, particularly in cases where the product (drug or medical device) is suspected of seriously injuring or killing people. According to a June article in the New York Times, the FDA failed to inform the public that a popular heartburn drug was toxic to babies, or that a well-known pain killer increased heart attack risks by over 40%, or that some antidepressants increased suicidal thoughts and behavior in teens.

“Trade Secrets”

As part of any drug ad, the FDA requires pharmaceutical companies to disclose a drug’s potential side effects. What pharmaceutical companies are NOT required to disclose are specific results from the drug’s clinical trials, which often take place prior to the drugs hitting the market.  The FDA has long considered this information to be a “trade secret,” or commercially protected information, and is exempt from public release under the Freedom of Information Act.

According to the Wall Street Journal, consumers, doctors and scientists agree that more transparency is needed in the FDA, especially relating to FDA decisions about medicine and medical products. In response to these complaints , the Obama administration announced in June the creation of a new FDA task force. It was designed to recommend ways to reveal more information about the agency’s decisions and possibly disclose information about drugs and medical devices still under study.

What Should They Disclose?

The idea of creating this FDA task force has been in the works for a number of years.  Even though drug and medical device companies agree that the FDA has an obligation to explain decisions about drugs more thoroughly, they stress that not all information should be disclosed to the public. They have also criticized it, claiming that legitimate data surrounding the drugs and testing should not be disclosed to the public, including specific formulations of drugs or specific schematics of a medical device. It’s understandable that pharmaceutical companies to expect some protection against other companies copying their products, but they are already protected under numerous patent laws.

The big challenge for the new FDA task force is where to draw the line between pharmaceutical company profit, and how much information is too much? Leading the task force is Joshua Sharfstein, FDA deputy commissioner, and other top agency officials. According to a recent article in the New York Times, the task force will seek outside comment from both sides of the issue, and is scheduled to submit a written report to the FDA commissioner, Margeret A. Hamburg, in six months.

Right to Know vs. Profit

The drug commercials are unforgettable:  an attractive couple frolicking on the beach or a famous actress playing with her grandchildren. These ads are meant to grab our attention and tell us that the drug will make us feel like the people in the advertisement – better and carefree. But they are misleading patients by not telling the whole story behind the drug. Consumers have a right to know whether their drug of choice prompted suicide or caused a heart attack. While the pharmaceutical companies see each drug as more profit, the consumer sees each new drug as a chance at better health and a better life. There is no price tag high enough for that.