FDA Sides With Medicare In The EPO Drug Fight
2 CommentsBy Ed Silverman // October 17th, 2007 // 6:23 pm
The agency sent a letter to Pete Stark, a congressional Democratic, last week endorsing restrictions decided last July by the Center for Medicare and Medicaid Services on the use of Amgen’s Aranesp and Johnson & Johnson’s Procrit in cancer patients undergoing chemo.
The letter comes amid a growing debate in Congress over those restrictions. Amgen, in particular, has been lobbying pretty hard to undo the restrictions, which limited usage due to tumor growth and increased mortality. And the lobbying has started to pay off. Earlier this month, a bill was introduced in the House to role back the restrictions. The drugmakers have been getting help, by the way, from the American Society for Clinical Oncology, the American Society of Hematology and US Oncology, a treatment center company.
Meanwhile, several consumer-interest groups - Center for Medical Consumers; Center for Science in the Public Interest; Consumers Union; National Research Center for Women & Families; National Women’s Health Network; TMJ Association, and US PIRG - wrote members of Congress today, urging them to vote against the bill that would undo the Medicare restrictions.
As Merrill Goozner, who runs the Integrity in Science Project for the Center for Science in the Public Interest, writes on his blog: “Who put Congress in charge of medical decision making? If ASCO has a complaint about CMS payment policy, it should provide evidence to the physicians at that agency who made the decision.”
Hat tip to GoozNews and the Health Blog
gpawelski
Over at gooznews, he tells us “Who put Congress in charge of medical decision making? If ASCO has a complaint about CMS payment policy, it should provide evidence to the physicians at that agency who made the decision,” which is in line with the FDA label.
The FDA told Congress that the Medicare rules are “generally consistent” with the FDA’s label for the drugs, known as ESAs, and in line with “the available data and the published scientific literature. The FDA current labeling advises that hemoglobin not exceed 12 g/dL. It considers this to be an upper safety limit for EPO dosing, not a target for therapy.
The FDA also says that there is no evidence that pharmaceutical EPO results in improved survival, tumor control, health-related quality of life at any hemoglobin level in cancer patients undergoing chemotherapy. Pharmaceutical EPO was approved based on its effectiveness in reducing the need for red blood cell transfusions.
http://invivoblog.blogspot.com:80/2007/10/fda-sides-with-cms-in-epo-battle.html
http://www.house.gov/stark/news/110th/letters/20071012-esa.pdf
gpawelski
What Do We Do About The Anemia Drug Controversy?
Most doctors and patients would agree the drugs are very helpful for patients when used to correct “severe” anemia, which can be debilitating and even life-threatening. The drugs reduce the need for somewhat risky blood transfusions and can give patients more energy and improve their quality of life.
”These are drugs that were presumed to be entirely safe, given for supportive care and to improve quality of life,” not to actually treat cancer, said Dr. Eric Winer, director of breast oncology center at the Dana-Farber Cancer Institute in Boston. ”So any concern that they could shorten someone’s life are taken quite seriously.”
There is little evidence that the drugs make much difference for patients with “moderate” anemia. Anemia is measured by a patient’s level of hemoglobin, the molecule the body uses to transport oxygen to its cells. Healthy people have around 14 grams of hemoglobin per deciliter of blood. Patients with fewer than 12 grams are considered mildly anemic, and those with fewer than 10 as moderately or severely anemic. The labels on the drugs approved by the FDA encourage doctors to aim for a hemoglobin level of 10 to 12.
Critics of the drugs say their increased use has been driven by profit. According to Dr. John Glaspy, director of UCLA’s Outpatient Oncology Clinic, one complicating factor is that oncologists make significant revenue buying cancer drugs from manufacturers and charging patients a higher price for receiving the drugs in their offices. That profit motive could influence some doctors’ decisions.
Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, told UPI last year that “probably more than a billion dollars is spent on erythropoietin each year, which makes it one of the most expensive cancer drugs.” A six-month course of treatment can cost more than $10,000 per patient.
After this issue had started to be reported, U.S. Oncology took an 8-10 million dollar hit in its first-quarter SEC report last year, including reduced pre-tax income due to lower use of anemia drugs. They also were handicapped by CMS stopping the Medicare Demonstration Project which paid chemotherapy providers $130 per report, per infusional-chemotherapy recipient, on a patient’s level of nausea, vomiting, pain and fatigue, something that Congress found out that they were supplying free of charge anyway.
A continuance of the Medicare Demonstration Project would have exacerbated existing economic and clinical problems instead of resolving them by increasing the temptations for physicians to overuse injectable drugs and promise to aggravate the economic problems Congress attempted to fix with the new Medicare law.
A New York Times article reported last year that Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. However, 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 markup over the doctors’ purchase price.
Although the new Medicare bill tried to curtail this kind of drug concession, private insurers still go along with it. What needs to be done is to remove the profit incentive from the choice of drug treatments. Let’s take physicians out of the retail pharmacy business and force them be doctors again!