WASHINGTON (Reuters) - Pharmaceutical companies need to be more responsible in touting 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 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. “We should make sure that pharmaceuticals companies conduct themselves responsibly.”
Ruth Day, head of Duke University’s Medical Cognition Laboratory, told lawmakers that drug companies use a variety of tactics to highlight a drug’s benefits and downplay risks, including fast speech to visual effects.
For example, an ad for Schering-Plough’s allergy drug Nasonex featured a bumble bee that flew around as side effects were listed, but simply hovered when benefits were discussed.
“All of these wing flaps and wing flashes and sparkly things essentially divided the attention of the viewers ... and thus led to decreased knowledge” of possible risks, Day said.
At the hearing, lawmakers focused on TV ads for Merck and Schering-Plough’s controversial Vytorin cholesterol drug, citing “food and family” as sources of cholesterol and urged 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 backed by research.
“Our consumer research has consistently shown that the information about the two sources of cholesterol is getting through,” Khanna said.
Merck and Schering-Plough ran the spots from September 2004 until January, when a study found Vytorin failed to keep neck arteries any clearer than Zocor, which is available as a cheaper generic. Stupak’s panel is also investigating whether the companies 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, said ads are necessary because companies cannot sell prescription products directly to consumers. Such patient-targeted spots “motivate them to seek additional information ... consult their physicians ... and follow treatment plans,” he said.
Although ads for both drugs were suspended, several Republicans agreed with the companies, saying commercials prompt patients to seek therapy for their high cholesterol, a widespread chronic condition that can cause heart disease.
Ranking Republican John Shimkus of Illinois said it was too soon for lawmakers to intervene, citing new FDA powers 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.
The FDA reviews print and television ads and can send warnings or impose fines for false or misleading claims. Staff is limited, however, and the agency cannot review all ads.
A report by the Government Accountability Office released at the hearing found the agency still does not have a system in place to prioritize materials that need FDA review or keep track of which ads it had already reviewed.
Kim Taylor, president of Johnson & Johnson’s Ortho Biotech Inc unit, which makes Procrit, told lawmakers the company worked 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 featuring healthy- looking, energetic patients did not reflect the reality cancer patients face, including hair-loss and fatigue.
Additional reporting by Lisa Richwine, editing by Gerald E. McCormick; Editing by Andre Grenon
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