DTCA

Year	DTCA Spending[3]
1989	$12 million
1990	$48million
1991	$58 million
1992	$156 million
1993	$166 million
1994	$242 million
1995	$313 million
1996	$595 million
1997	$844 million
1998	$1.17 billion
1999	$1.58 billion
2000	$2.24 billion
2001	$2.38 billion

The 1997 “Draft Guidance” has made DTCA of prescription drugs through television possible. But it remains to be seen whether or not this new source of information is resulting in a benefit for consumers. Many believe that DTCA does not in fact result in an informational benefit, but rather poses a potential problem in the interactions between physicians and patients.

A study conducted by Barbara Mintzes in 2003 examined the effects that DTCA has on prescribing decisions by physicians. The study consisted of a statistical comparison between a market where DTCA was legal, the United States, and where it was not, Canada . It found that in the United States twice as many patients requested advertised drugs than in Canada. Of these, 78% were filled by physicians. The physicians were then asked if they would have prescribed the same drug for a similar but different patient . Fifty percent responded with a certain amount of "ambivalence "replying that it was "possible" or "unlikely." Only 12.4% responded similarly when asked about prescriptions not requested for by patients.[4]

Mintzes and her colleagues conclude that: "more advertising leads to more requests for advertised medicines, and more prescriptions. If DTCA opens a conversation between patients and physicians, that conversation is highly likely to end with a prescription, often despite physician ambivalence about treatment choice.”[5]

An additional study conducted by the Journal of Family Practice examined the views of family physicians with regards to DTCA. The study found that 84% of physicians surveyed felt negatively about DTCA through television. Many of them cited “misleading biased views” within the ads as the reason for their negative feelings.[6] Seventy percent felt that DTCA was both not beneficial and that it had “pressured them to prescribe a pharmaceutical agent that they otherwise might not have chosen”.[7]

A 1999 article in American Journal of Law and Medicine, by Tamar V. Terzian claims that DTCA forces many physicians to appease confrontational patients with these ambivalent prescriptions. Physicians claim that, "pushy patients, prodded by DTC advertisements, pressed, wheedled, begged, and berated them for quick treatments. This scenario comes at a time when physicians cannot afford to lose patients, because their income is already constrained by managed care cost cutting."[8] In an increasingly competitive and financially burdened health market, DTCA may be resulting in pressure that is harming the patient-physician relationship.

The proponents of DTCA have argued that consumers benefit from additional informational content and that the current DTC ads stimulate conversations between patients and physicians. Mintzes agrees that DTCA helps stimulate conversations—in the form of prescription requests. But if the study’s findings are accepted, then it is hard to believe that a conversation that ends in a potentially unnecessary prescription is consistent with a benefit. After all, some of the 55,000 that have died due to the use of Vioxx may have started a conversation with their doctors and requested the drug because of DTCA. In addition their doctors may have filled those requests despite being ambivalent. The Mintzes study provides evidence that DTCA is affecting the prescription process in questionable ways, and the Vioxx case reminds us all just how important this process is.

The American Medical Association (AMA), the national professional organization for physicians, calls into question the benefit of DTCA in its online newspaper American Medical News. An article written in 2001 cites a “new tension” to the physician-patient relationship created by DTCA.[9] It states that DTCA often motivates patients to ask about drugs that they have seen advertised, and that sometimes “their questions provoke unpleasant confrontations.”[10] An additional article notes that physicians believe DTCA “chips away the time they have with patients by spurring unnecessary discussions.”[11] The AMA governing body itself has stated, “‘Currently, we do not know how DTC[A] affects the patient-physician relationship […] Many broadcast ads are misleading, using imagery to suggest effectiveness far beyond what clinical evidence supports.’”[12]

The FDA did its own study on DTCA in 2003 titled: “The Impact of Direct-to-Consumer Prescription Drug Advertising on the Physician-Patient Relationship.” The study was in agreement with current research that DTC ads present benefits more clearly than risks, and that patients were likely to get a name brand prescription filled if they requested it. It also claimed, however, that 40% of physicians believed that DTC ads had positively affected their practice.[13] The AMA and many physicians have stated that this data is not in line with physicians’ personal experiences because the sample of physicians used in the study contains too many specialists, whose specialization results in fewer abstract questions involving DTC ads from patients.[14] Dr. Richard Kravitz, an expert in the industry on DTCA, believes that the study should motivate the FDA to “resume its more aggressive stance toward review of the ads, and it should do what it can to encourage the pharmaceutical industry to do more education and less selling.”[15]

Despite this evidence, the effect that DTCA has on the prescription process is still debated. It does appear though that a majority of physicians feel skeptical about the overall benefit of DTCA. The drug companies and proponents of DTCA, once again claim that the benefit and intent of DTC ads is an increase in awareness and information for consumers.

But consumer groups are not in agreement with this assessment. Public Citizen is a national, nonprofit consumer advocacy organization aimed at protecting consumer interests. The group summed up the problem with DTCA well:

"Advertising by its very nature is all-too-often misleading. Its sole purpose is to sell by generating brand-name awareness […] by accentuating benefits and downplaying potential risks […] Consumers face enormous barriers to obtaining objective, comparative information about prescription drugs."[16]

The group also expressed concern about the effect that DTCA could potentially have on physicians, arguing that advertising can cause a biased influence on some physicians.[17] In 1996, Consumer Reports, the nonprofit watchdog magazine for consumers, stated that rules governing DTCA should not be relaxed, citing that the purpose of advertisements is to sell products—not inform consumers.[18]

In 1997 the FDA loosened the restraints on DTCA for the purpose of increasing the information available to consumers. Proponents are correct in arguing that more consumers are now aware of more drugs. But their knowledge of these drugs comes at a price: a lack of information. Consumers are told of a new drug’s potential through clever antidotes and expensive graphics, while the minimum required set of side effects is listed in boring, often medically complicated terms. Public Citizen notes that these ads do not portray objective information that can be used by the consumer to inform their medical decisions.[19] The whole list of side effects and proper usage is available in medical terms on the Internet or via phone. But if the FDA truly believes that the average consumer is quick to access this information, then it is seriously and irresponsibly overestimating the enthusiasm of the average person. The ads cause consumers to focus on the potential benefits of a drug. As a result they confront their physician with a biased view of the requested medication.

The fact is that DTCA complicates the critical patient-physician relationship and may create situations where physicians are pressured into to prescribing a medication that they may otherwise not have. It is safe to say, that if Merck had not spent millions of dollars on advertising Vioxx, fewer people would have asked their doctor for a prescription, and fewer doctors would have prescribed the medication. Next