Misunderstanding of drug approval common: study

Many people believe that drugs given the okay by the Food and Drug Administration are safer and more effective than they have to be to win approval, according to a new study.

Especially in the first few years after a drug becomes available, researchers note, there are still questions about how well it will work and whether it will have any serious side effects.

In one well-known example, the FDA-approved painkiller Vioxx was pulled off the market in 2004 after longer-term evidence showed that it may increase the risk of heart attack and stroke.

In the new web-based survey of close to 3,000 people across the U.S., one quarter said they believed the FDA only approves drugs without serious side effects, and another 39 percent believed that only “extremely effective” drugs get approval.

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,” said Dr. Steven Woloshin, one of the study’s authors from White River Junction VA Medical Center in Vermont.

After that, it’s up to doctors—and patients—to make drug decisions for specific cases.

The researchers also questioned survey participants on two specific scenarios to see if educating patients about drug options could change their views on which drugs are safest and most effective.

In one scenario, patients had to choose between a hypothetical cholesterol drug that had been shown to lower cholesterol and another that decreased the risk of a heart attack. All other things being equal, picking the drug with a clear effect on a “bad outcome”—heart attacks—is the way to go, the authors said. However, only 59 percent of people made that choice.

In the other case, participants could choose between a newer or older heartburn drug that worked equally well and had the same side effects. Just 34 percent picked the older heartburn drug.

The authors then gave participants a short statement including the idea that newer isn’t always better, because researchers may not have had enough time to investigate safety issues.

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

After hearing that, the participants did better. Seventy-one percent took the cholesterol drug with clear clinical benefit, and 53 percent picked the older, thoroughly vetted heartburn drug, the researchers report in Archives of Internal Medicine.

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

But while that’s an improvement, the researchers say, a simple explanation may still not be enough for many patients to make informed choices.

Woloshin suggested a few things that could help educate patients. First, he said that the FDA could create a one-page fact sheet clearly stating the harms and benefits of each drug, including the reminder that “new is not necessarily better.” Those reminders, in abbreviated form, could also go on all drug advertisements for the public and on drug labels, he added.

An FDA spokesperson said in an email that the organization had not reviewed the study and so could not comment on it, but added that the FDA has publicly available information on “new and emerging drug safety issues.”

Dr. Michael Steinman from the San Francisco VA Medical Center, who wrote a commentary accompanying the study, said that patients should be encouraged to talk with their doctors about treatment options, and to not be intimidated about bringing up their concerns.

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

“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.

SOURCE: Archives of Internal Medicine, online September 12, 2011.