Doctors in Medicare Fight Over Right to Prescribe
STEVE INSKEEP, host:
Hard to continue this show after that but we'll do what we can.
There is news elsewhere in the world, including this: Patients and doctors are staining against the federal government and it's Medicare rules. The question is whether the government should pay for some of the drugs that patients want.
NPR's Joanne Silberner has the latest in a series of reports.
JOANNE SILBERNER: It all started last spring when the Food and Drug Administration placed a black box warning on some popular anemia drugs. The labels warn against using the drugs in cancer patients with relatively mild anemia resulting from chemotherapy. The FDA says the drugs clearly shorten survival and speed the progression of cancer. In people with slightly worse anemia, the drugs might have the same effects.
To Barry Straube, Medicare's chief medical officer, the message was clear.
Dr. BARRY STRAUBE (Acting Chief Medical Officer, Centers for Medicare & Medicaid Services): We felt this black box warning was basically telling on colleges and doctors and us that there was some potential danger to the use of these drugs in cancer patients.
SILBERNER: So the agency decided not to pay for the drug in people with slightly worse anemia. That is when levels of a key blood component called hemoglobin are between 10 and 12. Medicare continues to pay in more severe anemia where the level is 10 or less. But manufacturers of these drugs and many cancer specialists say people with levels between 10 and 12 can benefit.
Joshua Ofman is a vice president at Amgen, which makes two of the anemia drugs - Aranesp and Epogen.
Dr. JOSHUA OFMAN (Vice President, Amgen): The FDA label acknowledges that a certain risks cannot be excluded, but they have clearly stated that the lowest dose should be use to avoid transfusion with an upper safety limit of 12, leaving some discretion for physicians to make those determinations based on their individual patient needs.
SILBERNER: The disagreement is over whether doctors should have that discretion. The FDA doesn't exactly endorse the drugs. Take Aranesp, for example. The FDA-approved package insert says that though the clinical study show the drug can lead to fewer blood transfusions, there's no proof it can improve symptoms of anemia, quality of life, fatigue or well being.
The manufacturers have hard on a slew of lobbyists to convince Congress that the Medicare payment rule needs to be changed back so that doctors can use their clinical judgment for that mid-level anemia. And they've reached out to doctors and patients through Web sites, encouraging them to lobby their legislatives.
Seventy-seven-year-old John Dale(ph) hasn't contacted his legislators yet, but he's pretty upset about the symptoms he suffered when his anemia fell into the mid zone.
Mr. JOHN DALE: I was - wanting to sleep. I feel asleep when I sat down. I was just generally, totally, chronically fatigued.
SILBERNER: He would have liked the drug option. As for the possibility that the drug might harm him:
Mr. DALE: It may well be that there could, but then so do a lot of other drugs that I take.
SILBERNER: His oncologist Wayne Keiser isn't happy about it.
Dr. WAYNE KEISER (Oncologist): I did feel and continue to feel extremely frustrated. I know we can help these people, and I believe, without substantial risk and yet we're not able to do this by the current guidelines.
SILBERNER: Medicare's Straube says if a doctor feels a patient really needs a drug despite the lack of evidence of benefit, there are options. Patients can pay for the drugs themselves, although at several thousand dollars where the doctor can get involved.
Dr. STRAUBE: Our policy allows doctors to appeal to our physical intermediaries and carriers who pay the bills and appeal in those cases.
SILBERNER: But that's something most doctors already burdened by insurance paperwork are loathed to do. They want the policy reversed. And several professional organizations have petitioned Medicare to change its mind including the American Society of Clinical Oncologist and the American Society of Hematologist. But so far, Medicare is sticking to its gums.
Joanne Silberner, NPR News, Washington.
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