It is a common belief that drugs given the okay by the Food and Drug Administration (FDA) 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 warn experts. For example 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.
One reason for this trend and belief is the 1992 Prescription Drug User Fee Act (PDUFA), which now mandates that the FDA approve new drugs within 10 months of submission or face funding cuts. Such fast-tracking can compromise safety, as noted in a study published in the New England Journal of Medicine in March 2008. That investigation revealed that drugs funneled through quickly in order to meet PDUFA deadlines were five times more likely to get taken off the market because of safety issues after winning FDA approval. Such meds are also more likely to need dosage alterations and get slapped with a black-label warning post-FDA approval.
The latest survey involved a 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 said.
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…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.
Dr. Michael Carome, deputy director of Public Citizen's Health Research Group in Washington, D.C., also believes in encouraging consumers to view the medications they're prescribed with a more critical eye.
“Patients need to be aware that almost any drug has potential side effects," he said. "And for newly approved drugs there's often insufficient information about serious risks, some of which may have gone undetected during the approval process and won't be detected until they're used in the real-world setting on a wide-scale basis.”
His organization supports a “do-not-use-for-seven-years rule,” Carome said. “Unless a new drug is a breakthrough medication for a condition for which there were no previously good options, we recommend that people not take it for at least seven years.”
Harvard University's Daniel Carpenter, a professor of government, said “the term 'FDA-approved' gives patients a mental and emotional security about a drug.” But it's possible that people attach too much subconscious trust to this stamp of approval, he added. “So I'm in sympathy,” he continued, “with the policy recommendation that patients ought to be made aware, for example, that we know less about an FDA-approved drug that has been on the market for a day or a year than we do about drugs that have been on the market for five or 10 years.”
But how to get that message across effectively in real-world practice will need a lot more research, he said. Writing in the same journal issue, Dr. Deborah Grady, of the department of medicine at the University of California, San Francisco, recommended that the job of selecting the safer, better drug be left to properly trained clinicians.
Many consumers mistakenly believe new prescription drugs are always safer than those with long track records, and that only extremely effective drugs without major side effects win government approval, according to a new study.
A national survey of nearly 3,000 adults finds that about 4 in 10 wrongly believe the U.S. Food and Drug Administration approves only "extremely effective" drugs. One in 4 mistakenly believes the FDA allows only drugs that don't have serious side effects.
That means consumers "may not get the benefit from drugs they think they're getting, or they may expose themselves to more harm than they think" said study co-author Dr. Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice and the VA Outcomes Group
In truth, the FDA approves a new drug when its benefits outweigh any known risks. FDA approval doesn't mean the drug's benefits are large compared to drugs already on the market. And risks for some drugs appear only after they've been used by millions of people and long after FDA approval. For instance, Merck & Co. withdrew the FDA-approved arthritis pill Vioxx after its heart risks surfaced.
The new survey, appearing in Monday's Archives of Internal Medicine, revealed a partial solution to consumer confusion: Simply worded cautions can make a difference in which drugs people choose.
To test that idea, the researchers dreamed up two fictional drugs for heart disease and two for heartburn. The survey posed a question: Which drug would you choose?
Participants were told both heart disease drugs were free and both lowered cholesterol, but only one was known to reduce heart attacks.
Seventy-one percent of people chose the better drug that reduced heart attacks, when they were reminded in a warning the other one only lowered cholesterol levels. "It is not known whether it will help patients feel better or live longer," the warning said. Fewer people, 59 percent, made the better choice when they weren't given the added caution.
The make-believe heartburn drugs worked equally well and were free, consumers were told. The difference? One was approved by the FDA in 2009, the other in 2001.
This time, 53 percent chose the older drug when given a warning about the newer one. The caution said: "As with all new drugs, rare but serious side effects may emerge after the drug is on the market — when larger numbers of people have used the drug."
Fewer people, 34 percent, chose the older — and perhaps safer — drug when they didn't get that warning.
"One of the reasons doctors tend to prescribe newer, expensive drugs is there's a widespread perception that newer is better," said Dr. Michael Steinman of San Francisco VA Medical Center, who wrote a commentary about the study in the journal. "That's sometimes true, but many times it's not true. So much of what doctors learn about new drugs is somehow affected by drug company marketing."
The survey was conducted in 2009 by the Internet research firm Knowledge Networks, and has a margin of sampling error of plus or minus 2.4 percentage points. Participants were recruited using telephone and mail sampling and given free Internet access if they needed it.
Woloshin said simple cautions would help doctors, too, and should be part of drug advertising and labeling. He and co-author Dr. Lisa Schwartz have been working with the FDA to improve its guidance to drug makers on writing labels, he said.
They also are promoting the idea of drug fact boxes, similar to the nutrition fact boxes on packaged foods. The fact boxes, written in plain English, would tell consumers how well a drug works compared to other drugs and include side effects.
Last year's national health care law required the Department of Health and Human Services to report to Congress on the evidence for drug fact boxes. The department's report said it needed at least three more years to study the idea.
Drug fact boxes could help consumers and doctors, Steinman said, and patients can question their doctors about prescriptions. He suggested these questions for starters: "Is this drug recommended by the guidelines for my disease? Is there a drug that's equally effective but has a longer track record of safety? Has this drug been shown to help people like me live longer or feel better?"
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