Democrats probe whether Amgen, J&J promotions increased unsafe anemia drug use

Democrats in Congress ratcheted up their scrutiny of marketing tactics used by Amgen and Johnson & Johnson to promote their anemia drugs, suggesting they encouraged overuse by doctors.

The blockbuster drugs have been under federal scrutiny for more than a year. Data showed the anemia drugs, Amgen's Aranesp and Epogen and J&J's Procrit, increase the risk of blood clots and death when prescribed at higher-than-recommended levels.

Advisers to the Food and Drug Administration said last month they should not be used in some types of cancer patients, though the agency has already bolstered their warning labels three times in the past year.

Reps. John Dingell and Bart Stupak, both Democrats of Michigan, issued letters to the companies Monday, suggesting their advertisements and promotional offers encouraged physicians to prescribe unsafe levels of the drugs. The lawmakers began investigating promotion of the drugs last year.

"These potentially harmful drugs are over-prescribed and widely used off-label, and it's time to evaluate the marketing practices used to push them," Dingell, who chairs the House Energy and Commerce Committee, said in a statement. Stupak chairs the Energy and Commerce Subcommittee on Oversight.

The pair requested J&J turn over all records of its print and television advertisements for the drug Procrit.

Dingell writes that these promotions may have fueled "excessive and dangerous off-label use of the drug."

Off-label uses are those that have not been approved by the FDA, though doctors are free to prescribe drugs as they see fit.

J&J has previously said it stopped advertising Procrit directly to consumers in 2005.

Some of the company's television advertisements showed anemia patients looking more vibrant and healthy after taking Procrit, suggesting it improved overall quality of life. Before last year's safety concerns emerged, many doctors would prescribe elevated doses of the anemia drugs believing it gave patients more energy.

FDA has since warned against that unapproved practice, stressing that Procrit and other anemia drugs are not proven quality-of-life enhancers. Rather anemia drugs are indicated to raise red blood cell levels so that patients do not need blood transfusions.

A company spokesman said J&J "received the letter and will continue to cooperate fully with the committee's request."

Amgen has never advertised its drugs Aranesp and Epogen to consumers, but Dingell and Stupak questioned whether special discounts offered to physicians encouraged over-prescribing of the drugs.

Like other drugmakers, Amgen has used discounts and rebates to promote higher sales. Some cancer experts contend such practices encourage overuse by doctors.

The company sells its injectable drugs to doctors, who administer them to patients in the office.

Amgen said in a statement that it restructured its rebate and discount program earlier this year, although it does not believe the practice "led to inappropriate or excessive off-label use."

Doctors had received higher rebates for ordering more vials of Amgen drugs. But the new system awards rebates based on what portion of the doctors' total drug orders are for Amgen products, the company said.

In their letter, Dingell and Stupak tell Amgen to hand over all contracts with physicians who received such discounts and asks the company how much money it made in connection with the practice.

A J&J spokesman said the company provides some rebates to hospitals that order Procrit, though they do not have to increase their orders to reap the savings.

Amgen's Aranesp and Epogen had combined sales of $6.2 billion in 2007, or more than 40 percent of the Thousand Oaks, Calif.-based company's revenue. Procrit had sales of $1.7 billion.

Shares of Johnson & Johnson rose rose 9 cents Tuesday to $65.99 in after hours trading, after closing at $65.90 earlier in the day. Shares of Amgen Inc. fell 32 cents to $41.84 in afterhours trading, after closing at $42.16 in regular trading.