Regulation of broadcast advertising for prescription drugs began in 1997 when the U.S. Food and Drug Administration issued draft guidelines, which were made final last August. The resulting deluge of advertisingnot just on television, but on bus shelters and in magazine, newspaper, and radio adshas prompted heated opinions from all sides of the debate.
Thomas W. Abrams is no stranger to the controversy. "Its a new area for all of us and it is something that we look at very closely," said Abrams, director of the FDAs Drug Marketing, Advertising, and Communications (DDMAC) division.
He recognizes that some doctors are uncomfortable with prescription drug ads and those doctors say they are put in the middle when they have precious little time to discuss drug ads with patients. "But on the flip side," he said, "the advertising can serve an educational function, educate the public about diseases that they were not aware of. Thats a good thing if patients are learning about a real disease."
Abrams acknowledged that direct-to-consumer (DTC) ads have risen dramatically, but stressed that "he is happy that FDA has been effective" in regulating the area.
"We watch these ads very carefully," said Abrams. "What we have found is that the most common violations are not adequately presenting risk informationnot presenting a candid representation of the risks of drugsand overextending who the drug is forover-promising for more than the indicated population."
FDA has four key requirements that direct-to-consumer advertising must satisfy. The ads must include an 800 number for information, a Web site address, a recommendation to talk to a doctor, and a reference to a magazine for additional information, Abrams said.
Abrams recognizes that some physicians think that the ads hurt the publics health. "I havent seen the data," he said, adding that FDA is "doing our own surveys" to see how the onslaught of DTC advertising affects the publics health.
Downsides Too
At the opposite end of the spectrum, Brian Strom, M.D., views DTC advertising as a step backward. Strom, professor and chair of biostatistics, epidemiology, and medicine at the University of Pennsylvania School of Medicine, minces no words on the issue. He considers DTC marketing "a disaster."
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And Strom considers the advertising as "directly contrary to good therapeutics and what we were taught in medical school, namely to use a relatively small number of drugs, get to know them well, and only go outside that range when you must. Now we are pushing to use whatever the newest drug is, to use lots of drugs, and often there is unclear data on drug interactions and adverse reactions," he said. "And with supplements," he added, "we have moved to a pre-FDA era."
A Point of Discussion
Russell Harris, M.D., though, takes a step back from both Abrams and Stroms position, seeing the ads as a vehicle for patient education. "I dont find it a problem," said Harris, associate professor of medicine at the University of North Carolina, Chapel Hill. An academic physician to a great degree, he said he uses the ads to help patients make informed choices about their medical care.
For example, "for some patients, in almost every visit, prostate cancer comes up. You have people like [New York Mayor] Giuliani saying everyone should get a PSA. You have got to address that concern," Harris said.
Yet even though Harris sees the promotions as a mechanism for discussion, he said he is often "not happy about the quality of the information that is out there. Bias is clearly there and you see that folks are enriching themselves from the advertising," he said.
Harris said that in discussions of prostate-specific antigen screening for prostate cancer, he strives for balance, making sure that patients understand that "it is possible to get hurt by tests. Most patients dont realize that when they opt for a PSA test, they are opening the door to an entire cascade of events, perhaps a transrectal ultrasound, a biopsy, surgery or some form of radiation, and that the exact benefits and risks are not yet known."
Questions of Balance
George Sawaya, M.D., however, doubts that the average person can "figure out if a screening test is going to work for me." He thinks patients have a much easier time, for example, linking allergy symptoms with drug relief. "However, when you think about screening, first the public would have to be able to grasp the overall benefit and harm of a particular screening toolalready a daunting concept," he pointed out.
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"These are marketed to consumers with the message that you dont want things to be missed," he said, adding "they prey upon the fears of the worried wellyet about half of all women in the United States who get cervical cancer have never had a Pap smear." Also disconcerting to Sawaya is what they do not disclose: "how many people will be dragged along as false positives." Advertising for ThinPrep (http://www.thinprep.com) and other new Pap tests on the Web uses this tack.
Flipping through ThinPreps Web site to a page titled: "A More Effective Pap Test?" the text reads: "As good as the Pap smear has been, theres still room for improvement. For example, when the doctor collects your cervical sample, did you know that only a small portion is smeared onto the slide? The rest of itup to 80%is thrown out with the collection device! That means you may have abnormal cells that could get tossed away before the lab has a chance to find them! Kind of defeats the purpose of the test, dont you think?"
Sawaya said that in regulating the marketing of screening tests, "I am not sure why it is not mandated for manufacturers to discuss the risks of false positives."
Good and Bad Ad Campaigns
But Diane M. Harper, M.D., associate professor of obstetrics and gynecology and family and community medicine at Dartmouth Medical School, Hanover, N.H., draws a distinction between good and bad ad campaigns.
"If the studies are done in an appropriate manner, with good randomized controlled trials, presented at professional society meetings" and marketed well at the same time, Harper sees "an upside." The upside she sees as giving patients "more knowledge in helping remove social stigma."
But Sawaya questions the value of this information. He said you have to balance informing patients about the very real likelihood that the information will worry patients, make them depressed or anxious, and strain relationships.
Marketing to the Sick
Cancer patients are yet another group that drug manufacturers are targeting. "A great example is direct-to-consumer marketing of erythropoietin for chemotherapy-related anemia," said Jerry Seidenfeld, Ph.D., associate director of Blue Cross/Blue Shields Technology Evaluation Center program, which is now studying the use of erythropoietin in cancer patients.
In some markets, ads picture a mother who is unable to sew a dress for her daughters wedding because she is on chemotherapy. Another ad shows a veteran unable to march in the Veterans Day parade. "These ads are fairly persuasive and create the impression that erythropoietinby itselfhas a strong likelihood of counteracting fatigue in all patients on chemotherapy," he said.
"Fatigue in cancer is multifactorial," said Seidenfeld. "There are many contributing causes, and you can change one factor without having an effect on fatigue overall." For example, he points out that that with chemotherapy, fatigue can be secondary to cachexia. "Only with rigorous evaluation of the drug will it become clear who benefits from erythropoietin ... and the problem of fatigue in cancer is only beginning to be addressed." Available data leave questions unanswered that would pinpoint where the most benefit is for using erythropoietin.
Some doctors question the value of marketing cancer drugs directly to patients. Said Seidenfeld: "DTC advertising has had a major effect in how patients make decisions about treatment."
Steven Woolf, M.D., professor of family medicine at Virginia Commonwealth University in Richmond, Va., commented: "[Erythropoietin] is a very expensive drugand cancer patients are very vulnerable. It is very difficult not to prescribe it when patients are bombarded with its benefit."
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