Amgen, J&J; told to stop drug ads

Lawmakers have asked Amgen Inc. and Johnson & Johnson to suspend all consumer advertising of their anemia medications until after U.S. regulators complete their safety review.

In letters sent Tuesday to the chief executives of both companies, Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, also asked Amgen and Johnson & Johnson to cease financial incentives to doctors related to the anemia drugs and turn over documents related to promotion efforts.

The anemia drugs Aranesp and Epogen, made by Thousand Oaks-based Amgen, and Procrit, sold by New Brunswick, N.J.-based Johnson & Johnson, have come under increased scrutiny after clinical trials have raised questions about the drugs’ safety in certain cancer patients.

Lawmakers asked the companies to answer questions about the studies in question and the timing involved in reporting the suspensions to the Food and Drug Administration.

“We’re back into the era of oversight,” said analyst Ira Loss, who follows health policy for Washington Analysis, a research firm. “Does it lead to a hearing? Maybe. In the meantime, it’s putting pressure on these companies.”

Lawmakers asked Amgen and Johnson & Johnson to stop consumer ads and financial incentives for physicians until after an FDA advisory panel meeting in May “to determine what, if any, additional measures need be taken to protect the public from unnecessary risks to human life from these products,” Dingell said in the letters.

Studies have found that higher-than-approved doses of the drugs targeted by the FDA increased the risk of death, blood clots, strokes and heart attacks in patients with chronic kidney failure, the FDA has said. Excess doses led to rapid tumor growth in people with head and neck cancer.

The FDA’s Oncology Advisory Committee is scheduled to meet May 10 to discuss the studies.

Amgen and Johnson & Johnson confirmed receipt of the letters in telephone interviews Wednesday.

“Amgen will fully cooperate with the committee,” Amgen spokesman David Polk said. “Amgen is committed to patient safety. The well-being of patients is the company’s top priority.”

Amgen’s shares rose $1.17, or 2%, to $60.60. The shares have fallen 11% this year. Johnson & Johnson shares rose 15 cents to $61.22. The shares have declined 7.3% this year.

Aranesp is Amgen’s biggest-selling product, generating $4.12 billion for the company last year. Aranesp and Epogen together accounted for 47% of the company’s revenue in 2006.

Procrit, Johnson & Johnson’s version of Epogen, had $3.18 billion in sales last year. The company makes medical devices and consumer products in addition to pharmaceutical drugs.

Amgen has never used direct-to-consumer advertising to promote Aranesp or Epogen, Polk said. The company also said it didn’t offer financial incentives to doctors to boost prescriptions of the drugs.

Ortho Biotech, the unit of Johnson & Johnson that sells Procrit, stopped direct-to-consumer TV advertising two years ago, spokeswoman Stephanie Fagan said.

Before that, Procrit TV commercials in 2001 told consumers that the drug could boost their energy and provide “strength for living.” The camera showed a woman who at first was too tired to sew her daughter’s wedding dress dancing at the wedding thanks to Procrit, according to an article in the FDA’s consumer magazine.