Pharmaceutical Industry Leaders Defend Direct-to-Consumer Advertising

During a hearing of the House Energy and Commerce Committee Oversight Subcommittee on Thursday, executives from Johnson & Johnson, Pfizer and a joint-venture between Merck and Schering-Plough defended TV prescription drug advertisements that lawmakers have claimed potentially misled consumers, the AP/Houston Chronicle reports.

Democratic members of Congress to date have been unsuccessful in passing legislation that would prohibit direct-to-consumer ads in the first three years after a drug is approved. They have "intensified their scrutiny of the drug industry, energized by a recent discovery" that Merck and Schering-Plough continued to advertise the cholesterol drug Vytorin after a study showed it is no more effective than a lower-cost generic drug, the AP/Chronicle reports.

Lawmakers are expected to propose similar legislation later this year (Perrone, AP/Houston Chronicle, 5/8).

The panel is focusing on three discontinued advertising campaigns that were "designed to deceive and mislead" consumers, Subcommittee Chair Bart Stupak (D-Mich.) said (Cohen, Newark Star-Ledger, 5/9).

Stupak and House Energy and Commerce Committee Chair John Dingell (D-Mich.) asked Schering-Plough Vice President Deepak Khanna why the company continued to air ads for Vytorin after the study was completed in January 2006. Results were not released until January 2008.

Stupak said, "Many consumers may not have taken Vytorin had they been aware of the study results."

In response, Khanna said, "I saw a vigorous debate over the quality of that data," adding that the company "took steps to make sure the data was there and meaningfully analyzed before its release" (AP/Houston Chronicle, 5/8).

Lawmakers questioned J&J representatives about ads for the drug Procrit, manufactured by J&J subsidiary Ortho Biotech, which promoted the drug as a treatment for "cancer fatigue" that would improve the "quality of life" for patients, the Star-Ledger reports.

FDA had not issued approval for such a use.

Stupak said, "This was clearly an instance of off-label marketing practice that is prohibited by FDA."

Ortho Biotech President Kim Taylor said, "Statements in the advertisements regarding the benefits of Procrit were true, responsible and substantiated by scientific studies" (Newark Star-Ledger, 5/9).

The panel also looked at Pfizer's ads for the cholesterol drug Lipitor, which featured Robert Jarvik, inventor of the first artificial heart, as a spokesperson, despite Jarvik not having a license to practice medicine.

Democrats on the panel said Jarvik is not qualified to give medical advice, even though he went to medical school (AP/Houston Chronicle, 5/8).

James Sage, a Pfizer marketing executive, said Pfizer and Jarvik are "confident that the statements included in the ads fairly represent the scientific data about Lipitor" (Newark Star-Ledger, 5/9).

Dingell requested that the drug company executives adopt new standards for marketing, but all three said they did not have the power to do so.

Dingell said, "Maybe we need to have another hearing with someone who can really speak on behalf of the companies," adding, "Perhaps the company presidents would be able to respond in a more helpful fashion" (AP/Houston Chronicle, 5/8).

Nancy Nielsen, president-elect of the American Medical Association, said DTC drug ads are "neither balanced nor educational."

Ruth Day, a researcher at Duke University, noted that consumers rarely have a complete understanding of the risk warnings included in ads.

Government Accountability Office representative Marcia Crosse testified that FDA does a poor job of overseeing the growing number of DTC drug ads.

However, Rep. John Shimkus (R-Ill.) said Congress last year established standards for drug ads and gave FDA permission to fine drug makers for airing misleading ads. He added that rules to implement the law are being written (Newark Star-Ledger, 5/9).

"It's all about politics, not advertising," John Kamp, director of the Coalition for Healthcare Communication, said. He added, "They hold a hearing so they can pretend their guys would do a better job of running the agency than the Republicans" appointed by President Bush to run FDA (AP/Houston Chronicle, 5/8).

PBS' "Bill Moyers Journal" on Friday is scheduled to include a discussion with former New York Times reporter Melody Petersen about her recent book on the history of prescription drug ads ("Bill Moyers Journal" Web site, 5/9).