The FDA advisory committee voted 13-1 on March 13, 2008 to recommend that anemia drugs sold by Amgen and Johnson & Johnson still be available for cancer patients.
But the panel also said the drugs shouldn’t be given to patients who are receiving potentially curative treatments — a recommendation whose effects could be “quite significant,” analyst Eric Schmidt of Cowen and Co. told the WSJ.
For about a year now, regulators have been looking into suggestions that the drugs, sold under the brand names Aranesp, Epogen and Procrit, might increase the risk of death and fuel the growth of tumors. But much of that evidence comes from studies in which patients were treated more aggressively than the drugs’ labels recommend.
The FDA has said there is now mounting evidence of documented effects on survival, tumor progression and thrombotic events which require a reassessment of the net benefit of this class of drugs.
The drugs, known as ESAs, have combined sales of over $6 billion a year. The panel also endorsed a proposal that Amgen has backed that would require an unusually stringent informed consent procedure for cancer patients who receive the drug.
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!!!