FDA Panel Places New Restrictions on ESA Drugs
3 CommentsBy Ed Silverman // March 13th, 2008 // 5:09 pm
A closely watched FDA panel meeting ends with not-such-great news for Amgen and Johnson & Johnson. The drugmakers can continue marketing their anemia meds for cancer patients, but the current use should be restricted over concerns the drugs can increase the risk of tumor growth and death. However, the panel decided against completely restricting use in cancer patients, which Wall Street feared might have happened.
The voting: By a 13-to-1 margin, the advisory committee decided the drugmakers should market their meds for use in cancer patients undergoing chemo. But the vote was 11-to-2 for restricing use in curative patients - those with early-stage cancer whose treatments may provide a cure. And the committee voted 9-to-5 in recommending the meds shouldn’t be used in patients with metastatic breast cancer, and neck and head cancer.
Assuming the FDA adopts the recommendation, sales for the drugs - Amgen’s Aranesp and Epogen, and Johnson & Johnson’s Procrit - are likely to drop sharply, although it would appear the stock prices had recently reflected today’s outcome. For more on this, read Adam Feuerstein’s column in TheStreet.com.
Matt
So, if you have cancer, using the drug will increase the risk of tumor growth and death?
Wow, the pharmaceutical industry’s PR machine combined with the consumer’s ignorance is a powerful combination that can result in death.
Stupid humans.
Gregory D. Pawelski
It’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
Past thread from lung cancer news forum about this problem:
http://lchelp.org/l_community/viewtopic.php?t=33475&highlight=
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!!!
Stratumseind Eindhoven
Stratumseind Eindhoven…
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