The FDA and You (and EthicAd)
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. )
September 15th, 2008 at 1:10 pm
We noticed that Integrity in Science Watch got a different story from EthicAd executive director Michael Shaw, who told us last week that “EthicAd receives no funding from any company and is supported ‘mostly by contributions of individual academics.’”
http://prescriptionproject.org/blog/?p=194
But from today’s Integrity in Science Watch:
In an interview with Integrity in Science Watch, Shaw admitted his firm and other members of EthicAd’s board underwrite the group’s expenses, which enables it to donate its services to the FDA. “All members do work for industry; if not all, almost all,” Shaw said.
September 27th, 2008 at 9:19 am
Daily, particularly viewed on TV during prime time hours, pharmaceutical commercials frequent your TV screen. The commercials usually contain a drug involved in a large-market disease and the commercial is sponsored by a big pharmaceutical company. This is called direct to consumer (DTC) advertising, and health care providers in particular would prefer they did not exist.
Since 1997, when the FDA relaxed regulations regarding this form of advertising, the popularity of these commercials greatly increased. Now, the pharmaceutical industry spends around $5 billion annually on this gigantic media effort. Normally, the commercial airs within a year of the drug’s approval, which raises safety concerns and involves money spent that could be applied to greater uses, according to many. But, we are dealing with a corporation here.
The purpose of DTC ads is not education, in my opinion, as others have claimed. Any advertising of any type shares the same objective — to increase sales and grow their market — in this case, for a particular perceived medical condition or disease state. The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment for what may be an unconfirmed medical condition. The most interesting ones are for erectile dysfunction (ED) during primetime TV, with the real possibility of children watching. Further surreal is that these particular commercials seem to have ED sufferers portrayed as those who could probably run marathons, which is not realistic from a clinical perspective.
DTC advertising is also a catalyst for and similar to disease mongering. Disease mongering is the creation of what some believe to be medical flaws. It is illustrated by the drug companies through exaggeration and embellishments via various media sources as an avenue for propaganda — often seen with DTC advertising. Though the flaws may not be medical, the corporate creation of these questionable human ailments that do not require treatment, possibly, may be an attempt to develop a particular medical condition to acquire profit.
One of my favorite DTCs is the new indication for the use of an anti-depressant for a social disorder. This used to be called introversion, a term created by Dr. Carl Yung. It is a personality trait, not a medical disease. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators wish to grow the market for a particular, and possibly fictional, disease state. Then there is baldness treatments being advertised, as another example. Lifestyle meds are not treatment meds for illnesses, and should not be portrayed as such.
Also, DTC ads normally discuss a single treatment option when likely several treatment options exist for authentic medical disorders. This should be left to the discretion of the physician, as they assess your health, not your TV or another media source. That’s why most of the world does not conduct DTC advertising, with the exception of America and New Zealand.
Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professionals remains largely unregulated, yet apparently effective for the DTC creators. People are prone to believe what they see and hear, regardless of whether or not it is actually true. After viewing a DTC ad, many seek out a doctor visit and request whatever product that was advertised, which makes the doctor’s situation quite cumbersome. So the doctor and patient relationship is altered in a negative fashion since most DTC advertised drugs require a prescription.
Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world. Perhaps this will save some of our over-prescribing habits, which will benefit all of us in the long term. And the health care system can regain control of its purpose, which is far from financial prosperity.
Men of ill judgment oft ignore the good that lies within their hands till they have lost it.
— Sophocles
Dan Abshear
Author’s note: what has been written is based upon information and belief.