March 13, 2008
EPO Cancer Use Curbed, Not Eliminated
Amgen and J&J dodged a bullet today when the Oncology Drugs Advisory Committee voted 13 to 1 to allow continued but reduced use of red blood cell boosting drugs (EPO) for cancer patients undergoing chemotherapy.
But, the panel voted 9 to 5 against using Aranesp and Procrit in breast and head and neck cancers, where clinical trials have indicated cancer patients face higher risk of seeing their cancers progress if they use the energy-stimulating drugs.
It also voted 11 to 2 against using EPO in cancer patients who are likely to be cured. With 60 percent of cancer patients now living five years beyond diagnosis, that would seem to rule out the lion's share of patients undergoing chemotherapy.
The New York Times also reported that the companies proposed that "the label would say that anemia treatment should not start until a patient’s hemoglobin — the oxygen-carrying component of red blood cells — drop to 10 grams per deciliter of blood. Now physicians often start when hemoglobin drops below 11."
I'm surprised that the companies proposed this. Is it possible that there is more evidence coming that these drugs are causing harm to some cancer patients?
The ball is now in the FDA's court. Let's see if the agency follows through and puts "don't start EPO therapy until patients hit 10 g/dL" on the label. Yesterday, the FDA and the companies sent out a letter warning physicians not to let their patients go over 12 g/dL. Given the recommendation on the lower boundary, perhaps that should be lowered to 11 g/dL.
If they do take such action, it will be the ultimate irony. When the FDA approved EPO for the first time in the late 1980s, the agency set the target for EPO therapy at a hemoglobin level of 10 to 11 g/dL. Sometimes your first instincts are the right ones.
Posted by gooznews at March 13, 2008 07:39 PMIt's Still a Chemotherapy Concession!
Gee, could it be that increased numbers of red cells deliver more oxygen to the tumor cells and thereby increase their activity across the board, including with respect to invasion, proliferation, and metatstasis?
On one hand we're developing drugs to halt and reverse angiogenesis while on the other hand we're helping the tumor to obtain more oxygen with existing vasculature.
And nobody in charge foresaw that?
At the 12th annual NCCN conference last year, an executive with United Health Group, pointed out that in reviewing records of patients who were prescribed the drug erythropoietin, 44% of those patients had blood work-ups that would indicate they were not anemic.
Amazing how they can apply differing standards for proof or benefit when profit is involved! The profit motive did influence some doctors' decisions.
Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But 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. The anemia drugs are injected or given intravenously in physicians’ offices.
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.
"It's clear that these drugs were overused because we've seen sales drop so dramatically in the past year without seeing reports of people dying in the streets," said Dr. Charles Bennett, a professor at Northwestern University, who authored the most recent analysis of anemia drug risks.
http://www.businessweek.com/ap/financialnews/D8V8LIK00.htm
The problem is that few drugs work the way oncologists think and few of them take the time to think through what it is they are using them for.
It's still a chemotherapy concession. Although the new Medicare bill tried to curtail the 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.
When are they going to take physicians out of the retail pharmacy business and force them to be doctors again!!!