Over the past decade, some two dozen cancer drugs have been given
"fast track status" by the FDA in hopes of speeding experimental
drugs to patients, particularly those facing terminal illnesses,
even if these drugs don't help them live longer. This accelerated
approval process is now being questioned more vigorously by a growing
group of health professionals. Their concerns:
An analysis of clinical trials of 26 fast-track drugs by a Northwestern
University professor found, with many cases, only a few dozen patients
were actually helped by them. Even worse, 25 percent of these accelerated
cancer drugs on the market for less than 18 months have produced
serious side effects.
Although the FDA mandates follow-up studies of those fast-track
drugs, two-thirds of those tracked in the study haven't fulfilled
this requirement. Moreover, the federal agency has yet to rescind
an approval even when any of those few follow-ups were disappointing.
One FDA official argues finding entirely safe cancer drugs using
this fast-track method is far more of "a balancing act,"
and probably isn't achievable. Additionally, they must be given
in high doses to be effective at all. Even though these accelerated
drug approvals may have helped some patients, experts say, they
shouldn't be considered "blank checks" that absolve drug
makers of their responsibilities.
USA
Today March 10, 2005
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