What should consumers know about prescription drug advertisements? It seems the FDA thinks that Americans, first and foremost, need to understand the difference between a product-claim ad and a help-seeking ad.
At least, that’s the information highlighted on the main page of the new FDA website, “Be Smart About Prescription Drug Advertising: A guide for consumers.” We wrote last week about this site, which was created by the FDA and EthicAd, a non-profit with strong ties to the advertising and pharmaceutical industries.
Let’s look more closely at the site. It starts with the presumption that direct-to-consumer (DTC) ads “can provide useful information for consumers to work with their health care providers to make wise decisions about treatment.” Yet many in the medical community believe that DTC provides very little useful information and does more harm than good. This controversy should at least be acknowledged.
If you really want consumers to be smart about drug ads, perhaps the most important thing you could tell them is that the fact that a drug is advertised does not mean it offers important benefits.
In fact, the first question consumers should ask themselves about an advertised drug is, "how much does it work?" For example, if they see an ad for a sleeping pill they should ask: How much faster will I fall asleep if I take the drug?
There are any number of drugs that have been shown to provide little or no meaningful clinical benefit, including certain heavily advertised sleeping pills, cholesterol-lowering agents (for patients without heart disease), allergy treatments, Alzheimer’s drugs… the list goes on. But nowhere does the FDA/EthicAd site explain that advertised drugs may not be much good.
Yet one survey of consumers (reviewed here) found that 21 percent believed that only “extremely effective” drugs could be marketed directly to consumers. Other mistaken beliefs:
-43 percent believed that only “completely safe” drugs could be advertised directly to consumers, and
-22 percent thought that advertising of drugs with serious side effects had been banned.
Of course, no drug is “completely safe.” To effectively equip consumers to interpret DTCA would be to explain that the laundry list of side effects included in drug ads is really only meaningful if you know how serious each is, how likely it is to occur and, again, how to weigh that risk against the potential benefit. Not only that, but advertised drugs are generally new drugs, with risks that may not yet be fully known. The FDA/EthicAd site doesn’t provide this sort of discussion.
Another key question for consumers is whether another drug (or a non-drug treatment) might be better than the advertised one. A version of this question does appear on the FDA/EthicAd page of “Questions to ask yourself,” but it is number nine in a list and appears without any context or elaboration. Nor does the site say where one might look for this information.
Consumers should also know that when patients request an advertised drug, doctors are likely to prescribe it – even when it isn’t medically appropriate. And that there is much concern that drug companies use “help seeking ads” –ads that mention a disease, but not a drug – to convince some healthy people that they need treatment (think restless legs – a real, but rare condition).
Here’s another thing the website is missing: any critique of drug ad iconography. All those robust and handsome middle-aged actors cavorting on the beach? Drug ads sell with emotion, not information.
We hasten to say that it isn’t all bad. The site contains much good information, especially for advertisers seeking to avoid violations that could lead to fines. It also tells consumers how to flag an ad that doesn’t meet legal standards. Because, as the site explains, ads aren’t pre-approved: the FDA sees them about when they show up on TV. Print ads may not be reviewed at all. So consumers are mostly on their own.
(Thanks to Lisa Schwartz and Steven Woloshin of The Dartmouth Institute for Health Policy and Clinical Practice for useful discussions on this topic. Views expressed represent only those of the Prescription Project. )