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The committee of the US Food and Drug Administration (FDA) that advises on oncology drugs last week recommended new warnings on erythropoiesis stimulating drugs that are given to patients undergoing chemotherapy to counteract anaemia. Patients undergoing dialysis are also often given the drugs.
The committee said that such synthetic erythropoietins (also called epoetins or “epo drugs”) were associated with an increased risk of cardiovascular events and possibly of progression of cancer. It unanimously recommended new clinical trials.
The FDA committee's recommendations came only days after the New York Times published a story on its front page headlined “Doctors reaping millions for use of anemia drugs” (www.nytimes.com, 9 May) and the Wall Street Journal reported how Johnson & Johnson promoted epoetin alfa (www.wsj.com, 10 May “Suit details how J&J pushed sales of Procrit”).
In March the FDA called for a review of two drugs made by Amgen, darbepoetin alfa (Aranesp) and epoetin alfa (Epogen), and of Johnson & Johnson's epoetin alfa (Procrit) (BMJ 2007;334:495, 10 Mar doi: 10.1136/bmj.39146.387789.DB). Experts had questioned whether US doctors were prescribing the drugs in dosages that were too high (BMJ 2007;334:978-80, 12 May doi: 10.1136/bmj.39198.510347.AD). The review was held last week.
The FDA placed “black box” warnings on the drugs in March after a New England Journal of Medicine study reported a higher risk of death, heart attack, stroke, and hospitalisations for heart failure in patients who were not on dialysis but who were being treated to raise their haemoglobin concentrations (www.fda.gov/cder/drug/advisory/RHE.htm).
The New York Times article said that the drugs are top sellers, accounting for almost half of Amgen's revenue, and are the biggest drug expense of the federal Medicare health insurance programme for elderly people.
Were doctors given financial incentives to prescribe the drugs? Drug companies cannot pay doctors to prescribe pills that patients get from pharmacies. However, the New York Times reported: “Companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment . . . Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a mark up over the doctors' purchase price.
“The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company's drugs exclusively typically receive higher rebates.”
The Wall Street Journal reported a similar story in its article. Former Johnson & Johnson sales representatives said that the company had tried to increase sales of Procrit by creating “complex purchasing programs offering doctors discounts and cash rebates on Procrit, which could increase the doctors' profits.”
It also said that another Johnson & Johnson programme “offered hospitals an incentive to buy Procrit and shun Aranesp [and] discounts on purchases from across Johnson & Johnson's product line—including some huge-selling drugs and medical devices sold by different subsidiaries—if the hospital used Procrit at least 75% of the time when prescribing anti-anemia drugs.”
A spokesperson for Ortho Biotech, the division of Johnson & Johnson division that sells epoetin alfa, said, “None of Ortho Biotech's promotions are intended to have the effect of relating the prescription of epo drugs to the income of physicians or their practices. We encourage physicians to follow the guidance in the FDA approved label.”
Amgen had not replied to questions from the BMJ by the time it went to press. In the 9 May New York Times article Amgen said that rebates were a normal commercial practice and that it always properly promoted its drugs.