Use extreme caution when choosing to take prescription drugs because FDA approval of a drug doesn’t mean it has proven clinical benefits for patients, nor does it mean that all serious side effects are known. A new study published in the Archives of Internal Medicine provides insight on what information you need to know when choosing a drug, while calling attention to the critical need for caution because evidence shows the American public is significantly misinformed.
The U.S. FDA approves a drug when it believes the benefits outweigh the harms, but approval doesn’t mean the FDA believes the benefits are large or important. It also doesn’t mean that all side effects are known or that the drug has proven patient outcomes. For example, to treat cardiovascular disease and atherosclerosis, some drugs are approved based on a “surrogate outcome” such as lowering cholesterol, while others are approved based on a “patient outcome” such as reducing heart attack rates. The second drug that has been clinically shown to improve patient health and prevent heart attacks is the better and more effective choice.
The new study found that 39 percent of the population is not aware of the difference between a “surrogate” and a “patient” outcome, and they mistakenly believe that the FDA approves only “extremely effective drugs,” which is simply not true. Also, 25 percent believed the FDA only approves drugs without serious side effects—once again, not true! Rather, the side effects must be balanced by the potential benefits, but a primary concern with drugs that are newly approved is that not all side effects have been identified. Researchers note that “uncertainties are greatest in the first few years after approval” and that many drugs are approved based on a small test group (a few hundred to a few thousand individuals).
Giving patients information about what drug to choose was shown to help them make the best drug choice, such as one with proven patient outcomes rather than one with only surrogate outcomes. In the study, two heartburn drugs were offered to patients who received various levels of explanation about the drugs. One of the drugs was newly approved and one had been approved eight years earlier, meaning it had a significantly longer track record. Participants were then put into three “explanation” groups about the drug: a control group got no information; a “nondirective” group got a general explanation (“It takes time to establish the safety of new drugs”); and a “directive” group received the same explanation as the nondirective group with the advice to “ask for a drug with a longer track record.”
Researchers found that providing patients with explanations did help them make the better drug choice and that directive and nondirective explanations were equally effective. But, only 53 percent of the individuals who received the explanations picked the preferred older drug that has a longer track record. A disturbing 66 percent of the control group made the wrong choice, picking newer, less proven drug.
Researchers performed the same test using the cardiovascular health drugs with either surrogate or patient outcomes and had more promising results with 71 percent of the informed groups choosing the better drug.
Trust in the FDA and misconceptions about what FDA approval means cloud the American public’s ability to choose medications that will promote health and prevent disease in the most effective, let alone cost-efficient way. A model used in the UK that requires new drugs to have a black triangle next to the name of the drug for at least the first two years they are on the market is one solution. When making drug choices, understand that “new does not equal better” and that patient outcomes are preferable to surrogate outcomes.
Schwartz, L., Woloshin, S. Communicating Uncertainties about Prescription Drugs to the Public. Archives of Internal Medicine. September 2011. 171(16), 1463-1468.