On May 10, the FDA held an emergency meeting of its Oncologic Drugs Advisory Committee to discuss the anemia drugs that supposedly help people cope with chemotherapy. But several recent studies were halted prematurely because these drugs—Epogen, Procrit, Aranesp—caused an increased death rate, cancer progression, deep-vein blood clots and heart damage (see last month’s newsletter). Ultimately, the FDA advisory committee asked for better studies and voted to put more stringent warnings on the labels for these drugs, known collectively as EPO. Unfortunately, few doctors ever read warning labels (one in ten, according to one survey), and the FDA has no authority over how they prescribe drugs.
As is often the case with drugs found to be risky long after they came on the market, the future of EPO comes down to money. There are huge financial incentives for oncologists to overprescribe EPO. Amgen and Johnson & Johnson, makers of EPO, sell their drugs directly to doctors and thanks to rebates (a.k.a. kickbacks) from the drug companies, many oncologists are making a fortune.
That was made clear the day before the FDA meeting in a front-page New York Times article entitled, “Doctors Reaping Millions for Use of Anemia Drugs.” A former business manager for a six-oncologist practice in the Pacific Northwest provided the Times with documentation showing that the six doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year. (The whistle-blower was crucial to this article because drug companies and the oncologist-recipients of their largesse do not want to make public the amount of the rebates.) The rebates are available for cancer drugs other than those self-administered by the patient, and they are in addition to the reimbursements doctors get from Medicare and private insurers.
Normally, the FDA steers clear of drug costs, sticking solely to safety and efficacy issues, but the Times article loomed over the FDA meeting. When the advisory committee discussed how to inform patients of the adverse effects of EPO, one oncologist said it should be left to doctors. But another committee member Otis Brawley, MD, head of Atlanta’s Grady Hospital, objected. “The problem is at my hospital doctors get $1200 for every dose they give patients. And they don’t have to sign conflict-of-interest statements like we do,” he said, referring to the FDA requirement that each committee member reveal any financial ties to drug companies prior to participation.
Another oncologist on the committee expressed fury about the uncertainties regarding the safety of the doses currently in use. “Yes, we have a burning question: Are these drugs killing people?” asked Silvana Martino, MD. “What are the doses that are reasonable and appropriate?”
The misleading EPO advertising aimed at the public would never have come up at this meeting were it not for consumer advocates. Five advocates attacked Johnson & Johnson’s ads for Procrit, which fraudulently sold the drug as the cure for chemotherapy-induced fatigue in an ad campaign that ran from 1998 to 2005. They pushed the FDA to force Johnson & Johnson to mount a corrective ad campaign because there is no proof for its claim.
There is no proven quality-of-life benefit for EPO. The drugs were initially approved as a safer alternative to blood transfusions for a chemotherapy-induced drop in red blood cells. But transfusions are not as risky as they were 15 years ago when the first EPO was approved. One basic question lingered: What is the purpose of this drug class?
Answers will take years, but Wall Street reacted immediately. Within days of the FDA meeting, Amgen shares dropped more than 15%.
© Maryann Napoli
