link @ FDA
On December 2, 2006, FDA was notified that Pfizer will suspend a large, Phase 3 trial evaluating the investigational cardiovascular therapy torceptrapib/atorvastatin (T/A) due to an increased rate of mortality (death) in patients receiving the combination compared to those receiving atorvastatin alone. With the T/A development program, as it does with all such development programs, FDA assured that Pfizer had the appropriate protections in place for patients participating in the drug’s development, including informed consent, a Data Safety Monitoring Board (DSMB) for its outcome study, and that the development program was done in a careful, stepwise manner.... (continues)
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2 comentários:
Entretanto podem sempre ler este "artigozito" do NEJM.
http://content.nejm.org/cgi/content/short/352/25/2573
Assim vemos como o rombo é grande para a Pfizer.
Mais uma vez a tal questão sobre quem deve realizar os RCT.
Vejam o último parágrafo do artigo do NEJM:
"The torcetrapib story suggests that we have become
too dependent on manufacturers as the predominant
source of our scientific knowledge about
the effects of medications. As Medicare prepares for
an increasingly unaffordable drug benefit, the best
way to contain that public expenditure will be to
commit a small fraction of those funds to support
such public-interest drug trials, fairly comparing
competing therapies (especially costly new ones)
with clinically realistic alternatives. With pharmaceutical
costs increasing faster than most other
health care expenditures, the nation requires studies
that will meet the needs of evidence-based prescribing
and not just the needs of the pharmaceutical industry.
It is not a question of whether we can afford
to pay for our own drug trials; it is increasingly evident
that we cannot afford not to do so."
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