July 31, 2008
FDA Uses New Labeling Authority
The Food and Drug Administration has ordered Amgen and Johnson & Johnson to relabel their anti-anemia drugs Aranesp, Epogen and Procrit over the protests of both firms. The new label says therapy shouldn't be initiated until red blood cell counts fall below 10 grams per deciliter of blood and it will no longer include an upper bound of 12 g/dl, which had been tantamount to declaring the drugs safe at that level for which, as today's New York Times story points out, there is no evidence.
Why did it take since March, when an advisory committee recommended the changes, for the FDA to act? Despite authority in the last year's FDA reform law to order changes without company negotiations, Amgen had been pushing to exclude certain restrictions from the label change, specifically, including a ban on using the drugs for breast or head and neck cancers, which the advisory committee had also recommended. The companies won that battle.
Posted by gooznews at July 31, 2008 11:05 AM
For over a year now, regulators have been looking into suggestions that the EPO drugs (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.
At the 12th annual NCCN conference, an executive with United Health Group, pointed out that in reviewing records of patients who were prescribed the drugs, 44% of those patients had blood work-ups that would indicate they were not even anemic.
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.
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.
Amazing how they can apply differing standards for proof or benefit when profit is involved! The profit motive did influence some doctors' decisions.
"It's clear that these drugs were overused because 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.
Until this revelation, the drugs had a combined sales of over $6 billion a year. 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.
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.
Posted by: Gregory D. Pawelski at July 31, 2008 04:57 PM