The FDA is taking a easier said than done look at anemia drugs for people beside cancer

On May 10, the FDA held an emergency meeting of its Oncologic Drugs Advisory Committee to discuss the anemia drugs that supposedly relief people cope near chemotherapy. But several recent studies were halt prematurely because these drugs--Epogen, Procrit, Aranesp--caused an increased death rate, cancer progression, deep-vein blood clots and heart injury (see last month's newsletter). Ultimately, the FDA advisory committee asked for better studies and voted to put more stringent warning on the labels for these drugs, set collectively as EPO. Unfortunately, few doctors ever read warning label (one in ten, according to one survey), and the FDA have no authority over how they prescribe drugs.

As is often the valise with drugs found to be risky long after they come on the market, the adjectives of EPO comes down to money. There are huge financial incentives for oncologists to overprescribe EPO. Amgen and Johnson & Johnson, makers of EPO, vend their drugs directly to doctors and thanks to rebate (a.k.a. kickbacks) from the drug companies, many oncologists are making a fortune.

That be made clear the day formerly the FDA meeting surrounded by 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 within 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 ultimate year. The rebates are available for cancer drugs excluding those self-administered by the patient. The rebate are in enclosure to the reimbursements doctors get from Medicare and private insurers.

Normally, the FDA steers clear of drug costs, sticking solely to sanctuary 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 gone to doctors. But another committee member Otis Brawley, MD, come first of Atlanta's Grady Hospital, objected. "The problem is at my hospital doctors procure $1200 for every dose they give patients. And they don't own to sign conflict-of-interest statements like we do," he said, referring to the FDA requirement that respectively committee member reveal any financial ties to drug companies prior to association.

Another oncologist on the committee expressed fury about the uncertainties concerning the safety of the doses currently within use. "Yes, we have a burning query: Are these drugs killing race?" asked Silvana Martino, MD. "What are the doses that are reasonable and appropriate?"

The misleading EPO selling aimed at the public would never have come up at this dialogue were it not for consumer advocate. Five advocates attacked Johnson & Johnson's ad for Procrit, which fraudulently sold the drug as the cure for chemotherapy-induced fatigue in an ad drum up support that ran from 1998 to 2005. They pushed the FDA to force Johnson & Johnson to mount a corrective commercial campaign because near 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 cell. But transfusions are not as risky as they were 15 years ago when the first EPO be approved. One basic grill lingered: What is the purpose of this drug?

Answers will bear years, but Wall Street reacted fast. Within days of the FDA meeting, Amgen shares dropped more than 15%.