Direct-to-consumer drug ads: Educational tool or sales booster?

You know the commercials. They are on television, radio, in newspapers and even on the Internet. What many have in common is the suggestion "Ask your doctor."

With annual spending for these direct-to-consumer prescription drug advertisements now in excess of $3 billion, it's clear that not only are they pervasive, but they also have an impact. Some estimates indicate that as many as 25% of Americans have, indeed, asked their doctors about a medication as a result of seeing an advertisement, according to the Kaiser Family Foundation.

Such statistics combined with firsthand practice experiences led delegates at last month's American Medical Association Annual Meeting in Chicago to take a wise step. They directed the Association to study the myriad ways these ads affect patient care and to consider strategies that could minimize their potential negative influences. A report on the findings will be presented at next year's Annual Meeting.

Getting to the facts will not be easy, but it is critical for determining how and if these ads should be used in the future. Since 1997, when the Food and Drug Administration relaxed its requirements for DTC prescription drug ads broadcast on television, debate and even controversy over this medium has been rampant.

Proponents say there are multiple benefits -- the ads reduce disease stigma, increase disease awareness, empower patients and encourage them to connect with physicians. Some even say they help promote compliance with physician-prescribed treatments.

But others see a much darker side.

Critics argue that the goals are not about public health. Instead, the DTC ads are simply designed to boost sales. By doing so, they unnecessarily increase health care costs and trigger overprescribing of expensive and potentially harmful medications.

In the past, the AMA has asked the FDA to fund and conduct research to resolve this difference in opinion -- to ascertain DTC ads' impact on the practice of medicine and patient well-being, with a particular focus on its impact on the doctor-patient relationship, health outcomes and cost implications.

But these crucial questions persist, and that's why the AMA action will provide much-needed insight.

AMA policy on direct-to-consumer advertising establishes criteria that, if followed by drug companies, would create disease-specific ads that educate consumers. The AMA stipulates that ads should offer a fair balance between a drug's risks and benefits. And it states that ads should direct patients to physicians. It is critical to the patient's best interest that the doctor-patient relationship be enhanced, not undermined.

That DTC advertising causes great concern within the House of Medicine is no surprise. The decision to scrutinize these ad practices resulted from six separate policy proposals at last month's meeting -- ranging from an outright ban to more moderate approaches. Physicians were passionate about both the harm they see and the complexities at stake.

But the timing of the AMA's inquiry could not be better because of activities taking place in other quarters.

On July 1, Senate Majority Leader Bill Frist, MD (R, Tenn.), called for a voluntary DTC advertising moratorium for the first two years a drug is on the market. He also requested a Government Accountability Office study of FDA regulation of prescription drug advertising as well as on related spending and consumer behavior.

On a different track, last month pharmaceutical company Bristol-Myers Squibb announced its own voluntary DTC communications code. As part of it, the company plans to wait a year after a drug is launched to advertise the product to consumers. Instead, that window of time will be used for physician education and feedback. Additionally, the Pharmaceutical Research and Manufacturers of America, the industry's trade organization, plans to release in the weeks ahead a voluntary code of conduct for DTC advertising.

If DTC advertising backers are right, consumer ads hold great promise to educate patients about diseases and potential treatments. Yet such claims warrant careful investigation.

By seeking answers now and developing a comprehensive knowledge base from which to devise strategies for the future, the AMA will play an influential role in efforts to define how and if this direct channel to the public should continue to operate.