Drug ads target consumers

By EDMUND MEINHARDT

VIEW ON HEALTH

The relationship between patient and physician has changed dramatically over the last several decades.

In the past, patients described symptoms to a doctor who then recommended a course of treatment, which often included prescribing drugs. Patients rarely knew anything about these drugs before visiting the doctor. Sources of information were scarce. Enterprising patients could consult a thick tome called the Physician's Desk Reference, which could be difficult to understand for those without training in pharmacology. Most simply relied on their doctors' advice.

Things are different now.

Advertisements for prescription drugs are everywhere in the media, and patients routinely decide to ask for a particular drug before going to a doctor. In 2001, the Kaiser Family Foundation published the results of a survey which showed that 30 percent of adults have asked their physicians about an advertised drug. Of those, 44 percent said they requested and received a prescription for the drug.

This is no accident. Scott Gottlieb, M.D., Deputy Commissioner for Medical Scientific Affairs for the Food and Drug Administration from 2005 to 2007, said in April 2005 at the Annual Drug Forum that were are more than 12,000 medications on the market and Americans would spend an estimated $248 billion on them that year. The pharmaceutical industry spends billions on advertising, more than most other industries (the typical drug company spends more on product promotion than on research and development) and has found direct-to-consumer, or DTC, advertising to be a very effective marketing tool.

The pharmaceutical industry began pushing for DTC advertising in the early 1980s, but agreed to a voluntary moratorium until 1985, by which time the FDA had concluded it lacked the authority to prohibit it. Most DTC advertisements were in print form at that time because the FDA guidelines on presenting risk information were too cumbersome for radio or television spots.

That changed in 1997, when the FDA relaxed regulations, requiring only "major" risk information to be presented within the advertisements and allowed advertisers to direct consumers to other sources of information about risks, such as toll-free telephone numbers, Web sites or print advertisements. Suddenly, television was a viable medium for DTC advertising and the floodgates opened.

Proponents of DTC advertising say it is an essential aspect of patient education, enabling patients to actively participate in determining their course of treatment. Numerous surveys conducted by the FDA and others consistently show DTC results in improved communication between physicians and patients and an increase in doctor visits that result in the discovery of previously undiagnosed or untreated conditions.

But there are problems. Studies suggest DTC marketing may be driving up health care costs, frustrating physicians and resulting in ineffective care. Many physicians loathe DTC and complain that it lengthens patient visits. Some say it causes patients to seek unnecessary care. Even worse, some physicians blame DTC for making the patient-physician relationship less cooperative and more adversarial. Mistrust can seep into the patient-physician relationship when a doctor must defend the decision to deny a patient's request for a specific drug. Studies have also found that patients whose physicians refuse to prescribe specific drugs are likely to take their requests to other physicians in an attempt to obtain the requested drug.

The American Medical Association strongly opposed DTC throughout the 1980s, concerned that such advertising overemphasized benefits and downplayed risks and might encourage self-diagnosis and self-treatment. In the early 1990s, the AMA softened its position somewhat decided to accept DTC advertisements as long as they met certain guidelines.

A 2000 study published in the Journal of Family Practice found that print DTC advertisements were informative, but lacked important information about the conditions and treatment for which the drugs were used. Research presented at a 2003 FDA public meeting on DTC showed that television advertisements for drugs presented risk information in a manner which was difficult to understand or recall, or was sometimes even misleading. A follow-up presentation in 2005 by the same researchers showed that television ads could be modified to make risk information easier to understand and recall.

In June, the AMA crafted a new policy regarding DTC advertising. It calls for a better balance between the presentation of benefit and risk information and wants the FDA to pre-approve all DTC advertisements and impose a moratorium on DTC advertising for new prescription drugs while physicians become properly educated about them.

This could prove problematic, because the FDA isn't sufficiently staffed to take on the gargantuan task of pre-approving every DTC advertisement and negotiating a moratorium for every newly developed drug. Additional staffing would require more funding for the FDA, either through congressional appropriation or by imposing a prescription drug user fee, which could have a dramatic effect on health care costs.

In an attempt to short-circuit attempts to impose guidelines through legislation, the Pharmaceutical Research and Manufacturers of America developed a set of voluntary guidelines, which are remarkably similar to the AMA's policy.

Ronald Davis, M.D., president of the AMA from June 2007 to June 2008, said the AMA's policy also calls for additional research on DTC advertising to determine its effect on overall health outcomes, the patient-physician relationship and health care costs.

"My concern about DTC advertising is it may create heightened concern about symptoms beyond where that concern ought to be," Dr. Davis said. "It may also result in patients seeking more expensive or higher-risk-profile treatment than is necessary."

The legitimate business goals of the pharmaceutical industry can sometimes be in conflict with the patient-care goals of physicians.

"What we see in some areas of drug development is the manufacture of 'me-too' drugs," Dr. Davis said. "These are new drugs with not much advantage over similar drugs, but a slight tweak in the molecular structure might result in a minimal difference in efficacy or safety, and it is marketed as a breakthrough." Patients request the drug even though its benefits might not justify its exorbitant cost.

What's good for a drug company's bottom line isn't always good for the health care industry. Patients targeted by DTC advertising aren't usually the ones bearing the cost of the drugs their doctors prescribe. A 2002 Government Accountability Office report found that DTC drugs are among the best-selling drugs and that increased use, rather than price increases, accounted for skyrocketing spending on heavily advertised drugs. The same report showed that DTC advertising is used to promote drugs that are newer and more expensive or for which there is a mass market. Just 20 prescription drugs account for about 60 percent of total industry spending on DTC advertising, an estimated $4 billion last year alone.

The AMA concluded in a 2006 Board of Trustees report that DTC advertising is protected by the First Amendment and is unlikely to ever be prohibited, so the best course of action is to push for regulation while continuing to study its effects. Meanwhile, DTC advertising has gotten patients and physicians talking to each other like never before.

"We want patients and physicians communicating," said Davis. "But we want it to be fruitful communication."