Hearing to focus on direct-to-consumer ads for prescription drugs

May 8 2008

Officials for Pfizer, Johnson & Johnson, Merck and Schering-Plough on Thursday will testify at a House Energy and Commerce Oversight and Investigations Subcommittee hearing that Democrats hope will "lay the groundwork for future legislation to tighten controls on drug marketing," the Wall Street Journal reports.

According to the Journal, although Democrats last year "lost a fight over proposals to strengthen government regulations" of direct-to-consumer television advertisements for prescription drugs, recent concerns about ads for the cholesterol medications Vytorin and Lipitor and the anemia treatment Procrit have "given Democrats ... ammunition for a new battle" (Mundy, Wall Street Journal, 5/8).

The subcommittee will examine whether Merck and Schering-Plough in ads for Vytorin overstated the benefits of the medication, which a study released in January found no more effective than a treatment available in generic form in the prevention of accumulation of plaque on artery walls (AP/Boston Globe, 5/8). In addition, the subcommittee will examine the decision by Pfizer to feature Robert Jarvik, the inventor of the first artificial heart, in ads for Lipitor. The subcommittee earlier this year raised concerns that the ads could mislead the public because they portray Jarvik, who is not a licensed cardiologist, as a medical expert. The subcommittee also will examine the decision by J&J and subsidiary Ortho Biotech to continue to air ads that promoted Procrit as a treatment for fatigue -- a use for which FDA has not approved the medication -- despite repeated requests by the agency to revise the ads (Wall Street Journal, 5/8).

Witnesses from the American Medical Association, the Kaiser Family Foundation and other groups also will testify at the hearing (AP/Boston Globe, 5/8).

Comments

Subcommittee Chair Bart Stupak (D-Mich.) said, the "The issues with these ads aren't limited to the three campaigns we will examine in our hearing," adding, "But they serve as excellent case studies for problems prevalent in DTC marketing" (Loewenberg, The Politico, 5/7). According to Stupak, the hearing could lead to legislation to allow FDA to require revisions to DTC TV ads for prescription drugs before they air (Wall Street Journal, 5/8).

AMA President-Elect Nancy Nielsen, who will testify at the hearing, said that the group seeks increased regulations on such ads, with large penalties for violations. She added, "We have to recognize that direct-to-consumer adverting is primarily marketing, not education."

Such ads lead "people toward the newest and very often the most expensive treatment options," Drew Nannis, a spokesperson for AARP, which plans to submit testimony for the hearing, said.

Steven Findlay -- a health care analyst for Consumers Union, which supports a moratorium on such ads for two years after prescription drugs reach the market -- said, "DTC ads do promote a pill culture in this country. They foster a culture in which we think there is a pill for every ill" (The Politico, 5/7).

However, Pharmaceutical Research and Manufacturers Association Vice President Ken Johnson said such ads prompt patients to visit physicians and help "start important doctor-patient discussions about conditions that might otherwise go undiagnosed or untreated" (Wall Street Journal, 5/8).