An expensive clotting drug approved to treat hemophilia has become extremely popular in hospitals to stem bleeding during cardiac surgery, cerebral hemorrhage, trauma, liver transplants, and prostate removal. Yet another massive analysis of 64 studies of such "off label" uses of the drug, recombinant factor VIIa (rFVIIa) has found no evidence that it prolongs life and, in some cases, it causes embolism dangerous. "The stakes are high here in terms of results and costs of patients," says study leader Veronica Yank, a clinician at Stanford University in Palo Alto, California, who specializes in research on prevention.
in a second paper, Yank and her colleagues have shown that in US hospitals in 08, 97% of the use of rFVIIa, which costs $ 10,000 per dose and is made by Novo Nordisk of Bagsvaerd, Denmark, was off-label. It is legal for doctors to prescribe drugs off-label, but Jerry Avorn, a clinician at Brigham and Women's hospital in Boston, who co-wrote an accompanying editorial, said hospitals have a responsibility to act on these results. and if they do not? "If I were a lawyer's responsibility, I find it interesting," says Avorn.
The Food and Drug Administration of the United States approved rFVIIa in 1999 as an "orphan drug" for use in hemophiliacs who have developed immune responses against other blood clotting factors, the most common already available. The surgeons soon began to use it in many different contexts, including combat, with little evidence of efficacy. Several studies have warned about the widespread use of the drug's label, but none was as comprehensive as the two new documents, which will be published tomorrow Annals of Internal Medicine .
As Avorn notes in his editorial, there is "reason to wonder how the use of an obscure recombinant coagulation factor marketed exclusively to hematologists became so widely used." Novo Nordisk officials denied they improperly promoted off-label use of rFVIIa, but concerns about "financial arrangements" between the company and the army of the United States led the Defense Ministry to launch an investigation January 2010 is still ongoing. company officials stressed in a conference call with stock analysts that the doctors of the uS military have used the drug at their own discretion and in February 2010 "we have not been the product marketing at the Ministry of Defence. "Avorn says he has no direct knowledge of the company's marketing practices." But I think it is useful that the question was asked how it is got to be such a popular approach, "he said.
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