More oversight needed on direct-to-consumer ads

The AMA testified that DTC ads should be subject to government preapproval and, in the case of new products, temporary advertising moratoriums.

Posted June 9, 2008.

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AMA President-elect Nancy H. Nielsen, MD, PhD, recently described direct-to-consumer prescription drug advertising as akin to looking at the world through rose-colored glasses. It's an apt observation. Now-ubiquitous television drug spots leave a stronger impression of medications' benefits than their risks.

Dr. Nielsen's comments came as the U.S. House Energy and Commerce oversight and investigations subcommittee held a May 8 hearing on DTC ads. The panel has been studying this type of marketing since January with the goal of determining whether further regulation is needed.

In the AMA's point of view, the answer is yes. Those rose-colored glasses need to come off.

Federal law requires drug ads to fairly balance information on benefits and risks. The Food and Drug Administration has the authority to review DTC materials before they are distributed for public consumption and to stop dissemination of a false or seriously misleading ad. But if the FDA doesn't get to the advertisement in time, which it usually doesn't, the spot can still air on TV. The FDA should pre-review and preapprove all DTC ads for drugs and implantable medical devices, Dr. Nielsen testified before the subcommittee.

The AMA also calls for a moratorium on DTC ads for newly approved products to provide adequate time for physician education. The length, to be determined by the FDA, would depend on various factors, including the level of innovation involved, the severity of the disease and the availability of alternatives.

The AMA generally supports disease-awareness ads that don't mention a specific drug or device. However, Association policy opposes product-specific DTC materials that don't meet its guidelines, including that the ads be educational, be accurate and balanced between risks and benefits, and encourage physician consultation.

The call for more federal action is strengthened by the enormous growth in drug company spending on DTC ads. It skyrocketed from $1.1 billion in 1997 to about $4.2 billion in 2005, according to Rep. Bart Stupak (D, Mich.), the subcommittee's chair. The nearly 300% increase dwarfs the 86% growth in spending on ads aimed at doctors and the 103% rise in research and development expenditures.

Findings presented to the subcommittee by a Duke University researcher demonstrate that these ads leave a stronger impression of drugs' potential benefits than their possible downsides. The product's pluses are repeated many times, and the language used to express them is easy to understand. Risks are typically presented in difficult-to-understand language.

The result: Consumers remember the positives and forget the negatives. As the AMA argues, this lopsided presentation trivializes the safety risks of drugs and devices.

Drug firms argue that DTC ads are a critical consumer-education tool that not only informs the public about medical conditions and drug treatment options, but also often destigmatizes ailments.

Two-thirds of the public agree that prescription drug TV spots educate people about treatments and encourage them to get help for medical conditions of which they might not have been aware, found a January 2008 Kaiser Family Foundation study of nearly 1,700 adults. But more than half of respondents said the ads do only a fair or poor job explaining medications' potential side effects.

The ads can be educational sometimes, but that does not change the reality that their objective is to promote products. Indeed, they are a potent marketing tool. Each dollar spent on DTC advertisements yields $4.20 in drug sales, Dr. Nielsen noted.

Armed with these marketing materials, patients sometimes walk into doctor's offices asking to be put on a brand-name drug. If the medication is inappropriate, this puts physicians in the awkward position of defending their medical judgment. This can strain the patient-physician relationship.

It also raises questions about the ads' impact on health care spending. Do they lead to wasteful expenditures on expensive brand-name drugs over less expensive, but equally effective, medications or behavioral adjustments? The AMA is calling for more research on the subject.

DTC drug ads are a big business. Given its pervasiveness and questions about its impact, the industry is one that warrants more scrutiny and better regulation.

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