Government mulls tightening drug DTC advertising

Drug makers spent $5.4 billion last year on direct-to-consumer advertising, according to the market research firm Nielsen Monitor-Plus. That’s a fivefold increase in the decade since rules about the disclosures required in television ads were changed, allowing drug makers to more easily air commercials. But now, lawmakers are saying that the ads gloss over risks and may cause overprescribing of expensive medicines.

According to Duke University professor Ruth Day, who spoke in front of House Democrats last month at a hearing titled “Direct-to-Consumer Advertising: Marketing, Education or Deception?” about the subject, 80 percent of viewers can recall benefits mentioned in TV drug ads, while only 20 percent successfully recall side effects.

Over the past two months, members of the House have been investigating DTC ads and the impact they have on consumers. Rep. Bart Stupak, D-Mich., head of the Energy and Commerce Subcommittee on Oversight and Investigations, said “Congress needs to decide whether the United States should continue to be one of two countries in the world that allow DTC ads, and if we continue to allow such advertising, whether any further limits to DTC ads should be required. It appears that we need to enforce significant restrictions on DTC ads.”

The American Medical Association, testifying at the hearing, endorsed the proposal that the Food and Drug Administration should review and approve all direct-to-consumer ads for new drugs before they are aired on television. Nancy H. Nielson, president-elect of the AMA, told the House subcommittee that most AMA members don’t like direct-to-consumer advertising of prescription drugs but that they had become a fact of life and may be protected by the First Amendment. The best approach to deal with these ads, Nielson said, would be an FDA review prior to broadcast in order to guarantee that no unwarranted claims were made and that risks and benefits were fairly presented. The AMA said that, “A moratorium should be placed on ads for newly approved drugs until doctors are educated and regulators have signed off on the messages.” Stupak said Congress should consider new restrictions on ads.

In particular, House investigators are focused on four drug makers: Merck and Schering-Plough for marketing of their cholesterol drug Vytorin; Pfizer for using a doctor who does not practice medicine in their ads for their cholesterol drug Lipitor; and the anemia drug Procrit by Johnson & Johnson.

Merck and Schering-Plough were targeted for not releasing the results of their ENHANCE trial, which showed that their cholesterol drug Vytorin did not reduce plaque buildup in arteries compared with one of the ingredients in the drug Zocor alone. The companies, even while withholding the information, continued to aggressively market Vytorin to consumers.

Pfizer senior director James Sage defended his company’s role in using Dr. Robert Jarvik, the physician featured in the company’s Lipitor ad. While Jarvik isn’t a practicing physician, he did help design the first artificial heart.

“Although not a practicing physician, he has devoted his entire career to medical science related to the human heart,” Sage said. “An important objective of the Jarvik advertising campaign for Lipitor was to highlight the importance of diet and exercise in reducing cardiovascular risk.”

Sage, and officials from the other companies, all testified that they submitted the ads to the Food and Drug Administration for comments. Sage noted that Pfizer had made several changes to its ads for Lipitor, including weakening claims about its ability to lower cholesterol compared with other drugs.

Kim Taylor, president of Johnson & Johnson’s Ortho Biotech, which makes Procrit, defended commercials that suggested the drug could relieve fatigue with chemotherapy. Stupak challenged her on this, noting that the drug was approved for chemotherapy-associated anemia, not fatigue per se.

Two weeks after the hearing, Stupak and Rep. John Dingell, DMich., went even further by writing a letter to the chief executives at Merck, Pfizer, Johnson & Johnson and Schering-Plough to voluntarily limit DTC ads for their drugs Vytorin, Lipitor and Procrit, including withholding any ads for new products for two years until certain studies are completed.

“To date, we have not received adequate assurances that the leading pharmaceutical companies share our commitment to providing consumers with accurate information about drug therapies,” Dingell said in a statement.

Included in the letter sent out to the pharmaceutical companies by Stupak and Dingell was a recommendation that the companies add the FDA’s toll-free MedWatch phone number to their advertisements.

Kassy McGourty, spokeswoman for Johnson & Johnson’s OrthoBiotech unit, said the company received the letter and would cooperate with the committee. The other three companies have yet to comment on the letter.

In relation to the last request by Dingell and Stupak, Congress has asked the FDA to study whether adding the toll-free number, which is required in print ads for prescription drugs, would be an effective way to learn about harmful side effects.

This follows a request by Congress made just days before the letters were sent out to the pharmaceutical companies asking the FDA to speed its efforts in forcing drug companies to include safety-reporting information in television and radio ads. FDA spokes-woman Rita Chappelle said the FDA would look at the panel’s recommendations and incorporate them into the design of a study. Once complete, the next step would be to issue regulations and obtain Congressional approval, she said. No quick fix, “It could take some time,” Chappelle said. “It could take a couple of years.”

This news came as a disappointment to some consumer advocate groups that may have been looking for a quicker response. “We want to make sure that this information gets into TV ads sooner, not later,” said Elizabeth Foley, a policy advocate for Consumer Union, who testified before the panel back on May 16. “We want to figure out if there is a way for the FDA to shorten the time it takes to do a study on this proposal.”

Another issue that should be looked at is whether or not consumers understand how to report side effects. While the FDA does have a method for consumers to report a drug’s adverse side effects, most patients, according to a Consumer Reports survey, report side effects to their doctor, while only seven percent report them to the FDA.