The numbers were laid out in a special article tracking spending on DCA by the pharmaceutical industry since 1994.2

Led by Dr Meredith B Rosenthal (Harvard School of Public Health), the authors gathered data from an independent consulting company used by both the pharmaceutical industry and regulatory agencies and a media reporting company that tracks advertising campaigns in television and radio. They then compared spending on DCA to spending on total promotional efforts and sales from 1994-2000.

Annual spending on DCA for prescription drugs tripled between 1996 and 2000, from $0.8 billion in 1996 to $2.5 billion in 2000. Most of that increase has been in television advertising, which rose more than 7-fold in that time, from $0.22 billion to $1.57 billion. However, the authors note that promotions that went directly to physicians (journal advertising, free samples, etc.) consistently accounted for more than 80% of promotional spending.

Rosenthal's group also pointed out that DCA is concentrated almost exclusively on a small number of drugs. In the year 2000, for example, the 20 drugs receiving the most DCA accounted for 58.8% of all DCA that year. Spending on a specific product, or even a specific class of therapeutics, fluctuates extensively over time, and within a given class of therapeutics, spending on specific products is inconsistent.

The authors note the "relatively moderate emphasis on direct-to-consumer advertising by the pharmaceutical industry contrasts with the apparent degree of concern about it among physicians and policy makers." They attribute the high concern to the rapid growth of such advertising, the fact that drug costs are the fastest growing component of the health-care budget, and physicians' fears that they are being bypassed and the doctor-patient relationship disrupted.

The authors stress certain weaknesses in their data that must be taken into account when analyzing the findings. Elements of the promotional budgets of pharmaceutical companies were unavailable to them, most importantly the costs of spending on meetings and events. They point out it is impossible to determine the magnitude of the promotional effect of studies. Despite these limitations, they feel that their qualitative conclusions about the increased rate of DTC spending, in proportion to that spent directly on health professionals, are valid.

In the first editorial, Dr Sydney Wolfe (Public Citizen Health Research Group) argues that DCA is intruding on the otherwise laudable trend of more active patient involvement in healthcare.3 Wolfe writes that, "confusion arises when commercially driven promotional information is represented as educational."

Citing articles from medical marketing magazines, Wolfe's main contention is that advertising is inherently misleading and attempts to tap emotional response from patients. According to Wolfe, any educational benefit which may occur from advertising is incidental to the main purpose, selling more product.

Wolfe states that a ban on DCA would violate the First Amendment and therefore recommends stricter control of misleading advertising by the FDA. However, Wolfe points out that the FDA is understaffed for this purpose, and that while spending on advertisements has gone up, the number of warning letters and notices of violation of advertising regulations has gone down, from 139 in 1997 to 79 in 2000.

The education of patients - or physicians - is too important to be left to the pharmaceutical industry, with its pseudoeducational campaigns designed, first and foremost, to promote drugs.

Wolfe calls for both stronger enforcement and increased educational programs by entities such as the NIH and the FDA. "The education of patients - or physicians - is too important to be left to the pharmaceutical industry, with its pseudo-educational campaigns designed, first and foremost, to promote drugs," Wolfe concludes.

In the counter-editorial, Alan F Holmer, JD, argues that DCA of drugs strengthens the health care system by engendering doctor-patient discussion, and empowers the patient against other financial incentives that might influence a physician's treatment decisions.4

Holmer takes exception to the argument that DCA bypasses physicians, since all advertisements encourage the patient to discuss the drug with their physician, who remains the final gatekeeper to prescription. He also cites surveys that show if a patient demands a given drug, they receive something else about half the time. Pharmaceutical companies recognize the physician's importance, Holmer stresses, pointing out that companies aim the majority of their advertising dollars at physicians, not patients.

Holmer also observes that many new drugs, such as statins, are underused by doctors according to most reports, and that advertising may help remind patients to comply with prescriptions they have received.

Holmer argues for DCA as a tool of patient empowerment, writing that, "There are payment incentives that are linked to patterns of prescribing and dispensing of medications, formularies that are typically structured at least partially on the basis of financial considerations, and variable cost-sharing arrangements with patients for certain types of medicines." According to Holmer, DCA helps to balance these other financial incentives by providing information to patients. "It is surprising that the transmission of FDA-regulated information to consumers has engendered controversy," he concludes.

In his editorial, Drazen offers a final piece of advice for physicians.

"Most important, we need to remind our patients that what they see and hear in the mass media is simply advertising," Drazen writes. "Although advertising does inform patients, it should not be confused with medical advice given in the best interest of the patient by a learned intermediary."