"IF A PLAYFUL MOMENT turns into the right moment, you can be ready," Majority Leader Bill Frist quipped on July 1. His "playful moment," an echo of the slogan for Eli Lilly's erectile dysfunction drug Cialis, sobered quickly as Frist revealed his intent: He proposed a voluntary two-year moratorium on consumer drug advertising in an effort to cap spiraling health care costs and promote patient safety.
Frist attributes the recent surge in direct-to-consumer advertising (DTCA)--a marketing practice in which pharmaceutical companies target patients directly, as opposed to traditional pharmaceutical advertising aimed at doctors and hospitals--to a liberalization of drug advertising laws during the Clinton administration. This relaxation, permitting advertisements with fewer warnings of side effects, contributed to a 145 percent increase in pharmaceutical company spending on DTCA from 1997 to 2001. Exacerbating the effects on consumers of the sheer number of new ads is an understaffed Food and Drug Administration incapable of providing adequate oversight. As Frist notes, a division of 40 employees at the FDA is tasked with reviewing 40,000 "complex, medically sensitive advertisements." This deficiency leads to many ads running without formal review.
Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical industry's trade association, responded to Frist's proposal by announcing a set of voluntary "Guiding Principles" for its member companies. The principles include calls on member companies to refrain from airing new DTCA on television until the ads have been approved by the FDA, and to precede direct-to-consumer ads with greater efforts to educate health professionals about the new drugs. Though the principles are not mandatory, the Wall Street Journal reports that 23 companies have already promised to comply.
Frist welcomed PhRMA's announcement, but wished that their principles "would have gone farther and proposed a moratorium on DTC advertising of newly approved drugs." He maintained hope that "individual pharmaceutical manufacturers will seriously consider such a measure."
All of which raises the question: What benefits would a moratorium bring to health care that would justify limiting information to consumers?
DIRECT-TO-CONSUMER ADVERTISING is a double-edged sword. Against the advertising approach, Frist argues, are its potentially deleterious effects, including the creation of an "artificial demand" that results in an increased use of prescription medicines. He cites a recent report in the Journal of the American Medical Association which concluded that physicians are significantly more likely to write prescriptions for patients who ask for brand-specific antidepressants (requests frequently inspired by DTCA) than for patients making general requests for medication or no requests at all.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, believes that pharmaceutical companies "use misleading advertising . . . to sell more drugs by overstating the benefits and understating the risks." Citing an "85 percent decrease in FDA enforcement action between 1998 and last year," Wolfe considers increased congressional oversight of the FDA as the first step in reducing harmful ads. "Moratorium or no moratorium," Wolfe argues, "unless FDA starts enforcing the laws on direct-to-consumer and other prescription drug advertising, the industry will continue to violate the laws."
Frist notes that the increase in healthcare costs stems not only from an increase in the number of prescriptions filled but also from the nature of the drugs advertised. Newly released drugs, protected from generic alternatives by patent, are the most heavily advertised. While the development of new medications is laudable, the drugs that are advertised frequently convey no benefit over generic or other older alternatives. Such was the case with Nexium, the widely advertised "purple pill" for heartburn and acid reflux that made the news after the Pentagon removed it from its formulary. The Washington Post reported that Colonel James H. Young, director of the Defense Department's pharmacy programs, indicated that after reviewing 15 studies, a team of doctors and pharmacists concluded that there were "no significant differences clinically" between Nexium and four similar medications, but that "Nexium was far more costly."
In principle, higher prices for new drugs should temper demand, especially if effective alternatives are available. However, most consumers, instead of paying full price for medications, contribute only a small co-payment through their health insurance plans. Lacking incentive to shop around for cost efficient alternatives, consumers simply request the newer (and invariably more costly) versions they've seen in ads.
Frist also highlights the risk of widespread use of new drugs whose risks are not yet fully understood. He cites the unanticipated side effects of the anti-inflammatory drug Vioxx that went unnoticed by routine surveillance until after 93 million prescriptions had been written, a number largely the result of Vioxx's DTCA campaign. (Although some now dispute the risks of Vioxx relative to other anti-inflammatory agents such as Advil, including a recent panel convened by the Canadian government, Frist's logic in requesting the moratorium holds. His aim is to limit initial consumption of new drugs, lest dramatic and unforeseen side effects appear, as in the case of the "Fen-Phen" drug combination for weight loss.)
In its favor, direct-to-consumer advertising may inform consumers of both new treatment options for existing conditions and apprise them of the import of symptoms that might go unnoticed. In defending the practice, PhRMA cites a survey by Prevention Magazine and Men's Health which "found that 28 million patients talked to their doctor for the first time about a health condition after seeing ads." The apparent educational value of DTCA is also reflected in attempts by some nonprofit organizations to promote disease awareness, as in the American Stoke Association's ads targeting high-risk groups to inform them of the warning signs of stroke.
Furthermore, DTCA may weaken the "barrier of embarrassment" that restrains patients from seeking medical help. This barrier has been a significant cause of the under treatment of sexually transmitted diseases. In support of this argument, a survey by the health care research group Scott-Levin found that 34 percent of physicians noticed a significant increase in the number of patients diagnosed with herpes after an advertising campaign for a new drug against the disease.
In response to Frist's intent to help patients by reducing potentially harmful side effects, John Calfee, a resident scholar at the American Enterprise Institute, notes that a moratorium "retards the appearance of the benefits as well as side effects of that drug." Hence, if one accepts that the net effect of prescription drugs is positive, then limiting general usage seems unreasonable. Moreover, "if you're worried about unforeseen side effects, monitoring patients after a drug is approved is obviously most useful." Effective surveillance protocols would alleviate some problems of DTCA without eliminating its benefits.
Calfee also argues that insurance companies can continue to address cost-efficiency issues like those associated with Nexium. If appropriate generic alternatives to name-brand drugs exist, insurance companies can, within reason, choose to limit reimbursement for the latter. Calfee concludes that the risks that Frist presents are insufficient to proscribe direct-to-consumer advertising in light of its demonstrable benefits.
Finally, it is useful to note how the very idea of the moratorium brings into focus the problems in American health care. Even if the reduction of direct-to-consumer advertising might lower health care costs by reducing the demand for expensive new drugs, America's third party payer system provides little incentive for patients to routinely shop for cost efficient options. The prospective moratorium therefore treats a symptom, and not the root, of America's health care dilemma.
Eric Wasserstrum is an intern at The Weekly Standard.