But a current spate of disquieting clinical trials involving louis vuitton handbags sale
drugs including Avandia (rosiglitazone) is prompting researchers to reevaluate
this reliance on surrogate markers (see 'Surrogates beneath suspicion'). "It's
been a watershed year," says Harlan Krumholtz, a cardiologist at Yale
University. "It's shaking assumptions about how we needs to be evaluating these
drugs."
Nobody is saying that surrogate indicators must be abandoned altogether.
Several well known drugs around the market right now, including the breast
cancer drug Gleevac (imatinib) and HIV fighting antiretrovirals, had been
approved depending on surrogate endpoints, and scandals are uncommon. "You do
not desire to deprive the public of a drug that possibly operates," says Arthur
Schatzkin, chief of nutritional epidemiology at the National Cancer Institute in
Bethesda, Maryland. "On the other hand, you do not desire to place one thing on
the market place which is dangerous. That is the type of thing that individuals
at the FDA [Food and Drug Administration] tear their hair out over."
One difficulty may be the struggle to show that a surrogate is causally
connected to illness out come, as an alternative to merely a correlate. Simply
because patients with flu have a fever, as an example, doesn't mean that
treating the fever will clear the infection. Absolute self-confidence inside a
surrogate needs comprehensive information of the pathways top to dis ease louis vuitton outlet uk
"The surrogate outcome would need to be involved in all pathways that could
possibly link the therapy towards the clinical outcome.
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