What does it mean when a drug is FDA approved? It means that a drug is safe and effective for use. The primary role of the FDA is to ensure that prescription drugs and medical devices are safe and effective. The FDA determines the safety and efficacy of a product by reviewing the results of clinical trials.
The FDA Doesn’t Conduct Their Own Studies
It’s important to emphasize that FDA does not test any drug or medical device. The FDA relies on studies conducted largely by the drug companies seeking to sell their product. As you may imagine the FDA approval process can lead to corporate shenanigans that result in injury. Vioxx was one of the most public examples of the system failing to protect us.
Vioxx was a pain reliever pulled from the market in 2005. Many lawsuits were brought claiming the drug caused heart attacks. During one such lawsuit it was found that Merck changed the rules for one of it’s key clinical trials. This change in rules excluded people who suffered heart attacks from the results of the trial. If these people were left in the study, it is likely that the FDA would be alerted to the heart attack issue. The FDA could then send out a safety alert and lives could have been saved.
Check out the New England Journal of Medicine Article regarding Vioxx:
On December 8, 2005, we published an expression of concern regarding an article by Bombardier et al. on the Vioxx Gastrointestinal Outcomes Research (VIGOR) study that was published in the Journal on November 23, 2000. Our expression of concern was prompted by evidence that the VIGOR article did not accurately represent the safety data available to the authors when the article was being reviewed for publication.
Read the rest of “Expression of Concern” on the NEJM website.