Center for Medical Consumers to the FDA: Rein in Those Deceptive Ads
The FDA is currently rethinking its guidelines for corporations that advertise their prescription drugs and medical devices to consumers. Don’t think that the regulatory agency has your best interests at heart. For one thing, the FDA cannot screen the ads for accuracy before they are unleashed upon the public, nor does it have the staff to track all the print and broadcast ads after the fact. The new guidelines currently under consideration by the FDA are just as wimpy as the old ones. The FDA can only provide guidance to the drug and device industries thereby living up to its reputation as a toothless tiger.
In a perfect world, one where the FDA actually served the public’s interest, these ads would be abolished altogether. That’s never going to happen. Here’s the Center for Medical Consumers’ pie-in-the-sky recommendations that the FDA is unlikely to follow:
- Make those entrepreneurial radiologists hawking whole-body scans and heart scans reveal the risks in their ads. They should be made to identify the radiation doses involved, as well as the high likelihood that scans will lead to unnecessary biopsies and detection of a type of cancer that would have remained dormant. As things stand now, a company can advertise any outrageous claim about, say, its digital mammography or scans with impunity as long as the brand name of the equipment is not revealed in the ad.
- Include the rate of effectiveness in all ads. Only about 10% of all drug ads currently address this important issue; the rest give the impression that everyone benefits from the product. To get FDA approval, a drug must prove to be better than nothing (i.e., a placebo). Let the public know how much better.
- Stop telling us that drug advertising is a good form of consumer education. Ads are designed to sell a product, not to provide balanced information. That’s why you see so many ads devoted to new, i.e., expensive, “me-too” drugs (think: Celebrex and Vioxx, Prilosec and Nexium, Lipitor and Zocor). That’s why you see little in the way of education— just a few promising words in the headlines like power and strength.
- Abolish all “disease awareness” ads. They masquerade as public service announcements because no drug is named. This type of ad is all about selling fear of a disease, the need for testing, and drumming up customers for lifelong drug therapy. Merck, maker of the osteoporosis drug, Fosamax, provides a classic example: “Osteoporosis—could you be at risk…. ask your doctor whether a bone density test is right for you.”
- Don’t allow companies to advertise diagnostic or screening tests to the public without proof that the new technologies are better than the old. Ads touting the expensive Pap screening technology called ThinPrep are a case in point. Such promotional activities have raised the cost of Pap testing without improving the accuracy of finding cervical cancer. To gain FDA approval, the maker of ThinPrep (and any other screening technology) has to prove only that it could find cancer, not that it is any better at finding cancer than the standard Pap test.
- Be straight with the public about the limits of FDA testing requirements. Each ad should have a disclaimer, such as: To be approved by the FDA, a drug has only to be proven safe and more effective than a placebo, not better than older drugs prescribed for the same condition. The drug trials required for FDA approval typically last eight to 12 weeks.
- Require the drug companies to list a few of the most common and most serious side effects in the body of the ad. Print ads are currently mandated to include the misnamed “brief summary” in tiny type on the reverse side of the ad. Anyone who reads the entire brief summary—and not many people do—will appreciate the concept of befuddling the public with too much information.
- Speed up the process for pulling a misleading ad. The FDA usually waits for someone to complain about a misleading ad. Then the agency takes too long to remove it, according to a report from the U.S. General Accounting Office. What’s more, there is no penalty. Corrective ads are rare, though deception is not. We were cheered to see the recent corrective ad for Pravachol, the cholesterol-lowering drug. Its maker, Bristol-Myers Squibb, had to run full-page ads in such publications as The New York Times and Parade, stating that Pravachol “has not been proven to help prevent stroke in people without heart disease. Pravachol is proven to help prevent stroke only in people with coronary heart disease.” [Note: Though most ad complaints come from a competing drug maker, according to an FDA spokesman, the Bristol-Myers Squibb lie was found by FDA staff.]
Our suggestions to the FDA were made last month in a letter written in response to the agency’s request for comments on its guidance to industry. We do not have high hopes that they will be taken seriously given the current political climate. (Political contributions from the drug industry totaled $29 million in 2002.) The FDA’s hands are tied by a Congress unwilling to release the necessary funds or rein in the pharmaceutical industry. Meanwhile, drug costs continue to rise, much of it because advertising promotes the most expensive new drugs, not necessarily the safest or best drugs.
Maryann Napoli, Center for Medical Consumers(c)