On Thursday, October 25, Dr. Alex Tabarrok visited HFCC to discuss the question “Is the FDA Safe and Effective?” As the Director of Research at The Independent Institute and Associate Professor of Economics at George Mason University, Tabarrok believes that the FDA is “overly safe” when it comes to the drugs that go on market.
He began by passing around a sensor pad, a simple device that amplifies touch making it easier for women to diagnose themselves with breast cancer. Tabarrok then explains how the FDA classified this as a “high-risk device” simply because there was nothing else like it on the market.
According to Tabarrok, countries such as Great Britain, Spain, and Germany are more likely to approve a new drug or medical device than America. Tabarrok continued to explain his belief that once an industrial country approves a drug, the rest of the world should approve it within 90 days.
“If it’s good enough for the Germans, it’s good enough for me,” said Tabarrok.
He mentioned an “invisible graveyard” which describes a place filled with people who died because a drug which was not yet on the market.
“The FDA is much more concerned about Type One Errors because they are more noticeable in today’s society,” says Tabarrok.
An example he made of a Type One Error was “Little Timmy”. Timmy took his FDA approved medication and developed a rare side-effect and died because of it. According to Tabarrok, errors like these are very common in today’s society and are more likely to be heard of simply because of how noticeable they are.
He prolonged the argument that the FDA should focus more on Type Two Errors. Type Two Errors occur when people die because a new drug is not yet on the market, thus bringing the audience back to the invisible graveyard. He gave several examples proving this point including Thalidomide, which can cause birth defects in children. Thalidomide was banned by the FDA but later on it was discovered that it helps with leprosy and cancer.
Tabarrok continued to make the point that many of the drugs on today’s market are prescribed off-label, or for purposes they were not FDA approved for. Sometimes traditional therapies are unsuccessful in treating patients. When this happens, doctors and patients try new techniques such as using a drug for an unintended purpose.
The argument is then made that the FDA should focus more on post-market surveillance instead of pre-market surveillance. This means that instead of putting more time and effort into testing new drugs and thinking of worst case scenarios, the FDA should instead monitor the drugs after they are put on the market. Tabarrok argued that if this were to occur, more uses for medicines already on the market would be found and less people would end up in the “invisible graveyard”.
As his closing argument, Tabarrok stated, “I would like to see an FDA that helps patients and physicians make better decisions.”