Misinterpreting the concept of “FDA drug approval”: A study

According to a new study, many people believe that the safety and efficacy of those drugs approved by the FDA is higher, which is why they get an okay.

To cite a popular example, in 2004, Vioxx –a painkiller approved by the FDA – was withdrawn from the market consequent to an increased heart attack and stroke risk associated with the drug use, as determined by long-term evidence.

As per the results of a new web-based survey of 3,000 people in the US, nearly 25% believed that only those drugs without any serious side effects receive FDA approval, while 39% of the population was under the impression that only “extremely effective” drugs are approved.

One of the study authors from White River Junction VA Medical Center in Vermont, Dr. Steven Woloshin, said that in reality, approval “just means that the benefits are judged to be greater than the harms. It doesn’t mean that they’re big and important.”

Subsequently, it is just up to the doctors and patients to decide upon certain drugs for any indications.
During the survey, the researchers presented the participants with 2 scenarios to understand whether educating patients about drug options would transform their concept regarding which drugs are the safest and most effective.
In one of the scenarios presented, patients were asked to pick between a hypothetical cholesterol drug that was shown to lower cholesterol and another that actually reduced the risk of a heart attack. The authors said that keeping all other factors constant, choosing the drug with a clear effect on a “bad outcome” (heart attacks) should have been the approach. However, that choice was exercised by only 59 percent of the participants.

In the second scenario, participants had an option to pick one amongst a newer or older heartburn drug, both of which had the same side effects and were equally effective. However, only 34% made a choice to pick the older heartburn drug.
The participants were then informed by the authors that newer need not necessarily mean better because researchers may not have had adequate time to review and evaluate safety concerns.

Woloshin said, “New often just means we know less about it… because it takes time for a drug to establish its track record.”

As per the report in the Archives of Internal Medicine, researchers stated that on hearing this, participants had a change of mind and performed better. The cholesterol drug with clear clinical benefit was chosen by 71% of the participants and the older version of the heartburn drug was picked by 53% participants.

Woloshin said, “We were happy that these very simple statements had an effect.”

According to researchers, although a simple explanation brought about a tremendous improvement, this would not be convincing enough for all patients to take an informed decision.

Woloshin made a few suggestions to educate people. To begin with, a one-page fact sheet created by the FDA could clearly detail the risks and benefits associated with each drug, including a prompt “new is not necessarily better.” He added that those abbreviated reminders could be reiterated on all drug advertisements on drug labels for the public.

In an email, an FDA spokesperson said that the study was not reviewed by the agency and therefore refrained on a comment, but also said that the FDA has publicly available information on “new and emerging drug safety issues.”

A commentary accompanying the study was documented by San Francisco VA Medical Center’s Dr. Michael Steinman who went on to say that patients should not shy away from consulting their physicians about treatment options and must not feel frightened about voicing their concerns.

He said, “Doctors are well trained in knowing about the risks and benefits of different treatments, but patients know themselves better than anyone else.”

“It’s important for patients to be their own advocates, to keep track of what’s going on… to ensure that they are getting the highest quality care that suits their needs,” he said.