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【drug-news】安进贫血药频遭质疑和负面报道
new study in The Journal of the American Medical Association is adding fuel to the fire about Amgen's (Nasdaq: AMGN) and Johnson & Johnson's (NYSE: JNJ) anemia drugs, but I don't think investors should be that worried about the study.
Combining clinical trial data from multiple studies -- called a meta-analysis -- showed that Aranesp from Amgen and Procrit from Johnson & Johnson raised the risk of death in cancer patients by about 10%.
I'd liken this meta-analysis to the one recently performed on drug-eluting stents, which actually helped Johnson & Johnson, but hurt Boston Scientific (NYSE: BSX), rather than to Dr. Steven Nissen's meta-analysis that showed an increased risk of heart attacks in patients taking GlaxoSmithKline's (NYSE: GSK) Avandia. In the latter, the side effect was a relatively new finding, while this most recent analysis and the one for drug-eluting stents are basically regurgitating old data. In fact, the FDA already made the companies change their warning labels in response to data suggesting that aggressive use of the drugs could make cancer worse.
While the news is old, the companies aren't off the hook yet. An FDA advisory committee meeting on March 13 could result in recommendations to further restrict the use of the drugs in cancer patients.
In the worst-case scenario, the panel could recommend that the drugs not be used in cancer patients, but there's enough evidence that the drugs help reduce the need for transfusions to make a full curtailment doubtful.
It's more likely that the panel will recommend that doctors wait for patients to become more anemic before administering the drugs. That would take a bite out of sales since some patients wouldn't reach the new threshold, but won't do too much more damage than what's already been done.
Until the meeting next month, investors won't know how bad the damage (if any) will be, but a meta-analysis of old data isn't going to change the outcome of the meeting much.
http://www.forbes.com/2008/02/27/amgen-johnson-update-markets-equity-cx_cg_0227markets34.html?partner=yahootix Study Finds Death Risk From Anemia Drugs
Widely used anemia drugs sold by Amgen and Johnson & Johnson raise the risk of death among cancer patients by about 10 percent, according to a new analysis of previous clinical trials that is to be published Wednesday.
Health Guide: Anemia »The study is the first compilation of clinical trial data — called a meta-analysis — to show a statistically significant increase in the risk of death from the drugs, said Dr. Charles L. Bennett, a professor at Northwestern University and its lead author.
The Food and Drug Administration is planning to convene an advisory committee on March 13 to discuss whether to impose further restrictions on the use of the drugs, Aranesp from Amgen and Procrit from Johnson & Johnson, with cancer patients.
The Amgen drug Epogen, which is the same as Procrit but is aimed at kidney dialysis patients, will not be directly affected by the discussions.
Amgen said the study, being published in The Journal of the American Medical Association, provided little new information. “What he observes is the risks that we’ve already talked about that are in the label,” said Roger Perlmutter, Amgen’s executive vice president for research and development.
The F.D.A. ordered stronger warnings on the drugs’ labels last year, after a flurry of studies suggested that the products, if used too aggressively, could worsen cancer conditions or hasten death. And Medicare sharply restricted reimbursement for the drugs when used to treat anemia caused by cancer chemotherapy.
Sales of Aranesp, Amgen’s best-selling product, declined to $3.6 billion last year from $4.1 billion in 2006.
One option that analysts expect to be discussed at the meeting in March would be to bar the use of the drugs for specific types of cancer, like breast cancer and head and neck cancer. Another would be to delay treatment with the drugs until patients became more anemic than the current threshold, a change that would more closely match the Medicare reimbursement policy.
A third option, which many analysts say is unlikely, would be for the F.D.A. to no longer authorize the drugs’ use in treating anemia caused by chemotherapy. The drugs would still be allowed to treat anemia caused by kidney disease.
Jim Birchenough, an analyst with Lehman Brothers, estimated in a report on Monday that rescinding approval for chemotherapy-induced anemia would reduce Amgen’s sales of Aranesp by $1 billion a year. A change in the label to match the Medicare policy would cut them by $300 million.
The new analysis on death risk, which could play into the discussions on March 13, combines data from 51 clinical trials involving 13,611 patients. The study also found a 57 percent increase in the risk of blood clots in veins, a known side effect of the drugs.
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作者:admin@医学,生命科学 2011-04-17 05:14
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