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Aggressive promotion of new drugs, too often understating risks and overstating benefits, adds to the concern many of us have that people may not realize that, even with Food and Drug Administration (FDA) approval, there are serious uncertainties about the drugs’ benefits and harms. Researchers at Dartmouth College, therefore, did a survey to see whether people had too much faith in FDA approval and whether additional information could help them make better choices concerning new drugs.
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Aggressive promotion of new drugs, too often understating risks and overstating benefits, adds to the concern many of us have that people may not realize that, even with Food and Drug Administration (FDA) approval, there are serious uncertainties about the drugs’ benefits and harms. Researchers at Dartmouth College, therefore, did a survey to see whether people had too much faith in FDA approval and whether additional information could help them make better choices concerning new drugs.
On the first point, 39 percent of adults surveyed mistakenly believed that the “FDA only approves prescription drugs that are extremely effective,” and 25 percent mistakenly believed that “only extremely effective drugs can be advertised to consumers.” One-fourth mistakenly believed that the “FDA only approves drugs that do not have serious side effects,” and 17 percent mistakenly believed that “drugs that have serious side effects cannot be advertised to consumers.”
It was therefore somewhat reassuring that when provided additional information — the kind usually lacking in the massive advertising campaigns accompanying the introduction of new drugs — many more people were able to make better choices between drugs.
A theoretical pair of newly approved cholesterol-lowering drugs was presented to participants, one merely lowering cholesterol levels and the other actually preventing heart attacks in addition to lowering cholesterol. With no extra information provided, 41 percent of the participants chose the drug that only lowered cholesterol levels. That percentage fell to 29 percent when participants were told either that surrogate markers (lab tests, in this case) such as cholesterol “do not always translate into patient outcomes” or to ask for a drug shown to reduce heart attacks.
Similarly, those surveyed were presented with information about a pair of heartburn drugs: one just approved, the other approved eight years ago. With no additional information, 66 percent chose the newer drug, possibly reflecting the illusion that newer is better. But when told that it “takes time to establish the safety of a new drug” or to “ask for one with a longer track record,” the percentage choosing the newer drug fell to 47 percent. Both of these information-based changes were statistically significant improvements over decision-making based on information that often comes from advertising, without any help from outside sources.
Readers of Worst Pills, Best Pills News will recognize this kind of education in our reports on new drugs. One of several reasons for our opposition to the cholesterol-lowering drug rosuvastatin (CRESTOR) is that it is the only such drug other than fluvastatin (LESCOL) that does lower cholesterol but has not been shown to actually reduce heart attacks in people with previously elevated cholesterol levels.
Concerning evidence that newer is often not better, we have long urged readers to avoid using any new drug for the first seven years after its approval, unless it is a rare breakthrough drug in the treatment of some disease.
Too many of these newly approved drugs either have to be taken off the market or are the subject of new safety warnings, often in those first seven years after approval.
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