Congress Expands Probe of Prescription-Drug Ads

House Committee Grills Major Pharmaceutical Firms

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WASHINGTON (AdAge.com) -- The House Energy and Commerce Committee, which has been scrutinizing direct-to-consumer drug advertising for Pfizer's Lipitor, along with Vytorin, jointly marketed by Merck & Co. and Schering-Plough Corp., is expanding its probe to more drugs.

Committee Chairman John D. Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., wrote Johnson & Johnson to question whether its ads for the cancer drug Procrit -- some of which feature the country's former surgeon general -- make unsupported claims that the patient's lifestyle will improve, while at the same time downplaying risks of the drug.

The committee also wrote to Amgen, questioning whether ads and marketing practices for Neupogen and Neulasta improperly push doctors to prescribe in tandem another Amgen drug called Aranesp for off-label uses.

'Serious risks'
"Millions of dollars have been poured into aggressive marketing campaigns, despite mounting evidence that these therapies pose serious risks," Mr. Dingell said. "These potentially harmful drugs are over-prescribed and widely used off-label, and it's time we evaluate the marketing practices used to push them."

Procrit and Aranesp are cancer drugs used to lessen the need for blood transfusions and treat anemia during chemotherapy. The letter said there are reports the drug class can cause increased risks of blood clots and death. But the committee indicated the drug was also marketed as a means to improve well-being and quality of life in cancer patients.

The letter questioned whether Procrit marketing was aimed at off-label uses and risks were played down. Some ads and posters for the drug featured Dr. Joycelyn Elders, former U.S. surgeon general.

"This Committee is concerned that J&J may have used misleading direct-to-consumer television and print advertisements for Procrit to help fuel excessive and dangerous off-label use of the drug, particularly in connection with unsubstantiated 'quality of life' claims," said the letter, which asked for information on the drug's marketing.

Suspicious link
Amgen did not directly market Aranesp to consumers, but the letter questioned whether the company's promotion of the product as a companion to Neupogen and Neulasta -- two drugs that did get advertised -- led to the off-label use.

Rep. Stupak warned that "patients are placed in danger when direct-to-consumer advertising highlights the benefits but not the life-threatening risks associated with a drug." He said the ads fueled off-label uses of the products that "exacerbate the risk to patients."

J&J said in a statement it had received the committee's request for marketing information and would cooperate fully. Amgen, which has suspended advertising for Neulasta, said it will work with Reps. Dingell and Stupak to provide information. The company also said that while it didn't believe its sales and marketing practices had encouraged off-label use of Aranesp, it had restructured its rebate and discount procedures earlier this year to avoid "even the appearance" of such concerns.
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