Top U.S. lawmaker reprimands drugmakers over ads

By Susan Heavey Thu May 8, 1:08 PM ET

WASHINGTON (Reuters) - Pharmaceutical companies need to be more responsible in touting their products to consumers or else face tighter controls from Congress, a top U.S. Democratic lawmaker said on Thursday.

Rep. Bart Stupak, at a hearing to discuss specific ads by Pfizer Inc, Johnson & Johnson, Merck & Co Inc and Schering-Plough Corp, said television commercials in particular use deceptive techniques to push their products to potential patients and increase sales.

"It appears that we need to enforce significant restrictions on DTC (direct-to-consumer) ads to protect American consumers from manipulative commercials designed to mislead and deceive for the profit of pharmaceutical companies," said Stupak, head of the U.S. House of Representatives Energy and Commerce investigative panel.

The Michigan Democrat said Congress should consider whether ads promoting medicines should be allowed to continue to target consumers in the United States, the only country that allows such marketing except for New Zealand.

"Pharmaceutical companies should consider it a privilege to be allowed to air DTC ads in this country," he said, adding: "We should make sure that pharmaceuticals companies conduct themselves responsibly."

At the hearing, lawmakers focused on TV ads for Merck's and Schering-Plough's controversial Vytorin cholesterol drug that cited "food and family" as two sources of cholesterol and called on patients to consider medication if diet changes alone did not help.

Deepak Khanna, senior vice president and general manager of the companies' joint venture, defended the spots, saying they were reviewed by the U.S. Food and Drug Administration and were backed by research.

"The Vytorin advertising ... used an effective approach to educate patients about the importance of lowering cholesterol," Khanna said in testimony prepared for the hearing.

Merck and Schering-Plough ran the spots from September 2004 until January, when a study found Vytorin failed to keep arteries any clearer than Zocor, which is available as a cheaper generic. Print versions are still in circulation.

Stupak's panel is also investigating whether Merck and Schering-Plough withheld data from the Vytorin study.

Lawmakers also looked at ads for Pfizer's cholesterol drug Lipitor featuring artificial heart inventor Robert Jarvik, who had prompted some concern for appearing to be offering medical advice without being a practicing physician.

James Sage, a Pfizer senior director, defended the ads in an industry where companies cannot sell their prescription products directly to consumers. Such patient-targeted spots "motivate them to seek additional information ... consult their physicians ... and follow treatment plans," he said in prepared remarks.

Although ads for both drugs were suspended, several Republican lawmakers agreed with the companies, saying such commercials help prompt patients to seek therapy for their high cholesterol, a widespread chronic condition that can lead to heart disease.

Ranking Republican John Shimkus of Illinois said it was too soon for lawmakers to consider intervening, citing new powers granted to the FDA to crack down on drug ads that went into effect earlier this year.

"We gave the FDA power to act, and we haven't really given them time to really impose civil fines on false and misleading ads," said Shimkus, noting ads by the four drugmakers ran before the agency could use its new tools.

Thursday's hearing comes a week before the FDA holds its own meeting on direct-to-consumer ads.

Kim Taylor, president of Johnson & Johnson's Ortho Biotech Inc unit that makes Procrit, told lawmakers the company had worked closely with the FDA to develop ads for its anemia therapy that were "true, responsible and substantiated by scientific studies."

The ads ran from 1998 to 2005. Among other uses, Procrit is approved to treat anemia in cancer patients receiving chemotherapy, but Stupak said commercials touting it for "cancer fatigue" and as a way to improve patients' quality of life were off-base.

(Reporting by Susan Heavey, editing by Gerald E. McCormick)