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9 June 2005, The Wall Street Journal
A16
(Copyright (c) 2005, Dow Jones
& Company, Inc.)
In the early 1990s largely as a response
to AIDS, Congress created accelerated approval for new
drugs. The process has been crucial in speeding breakthrough
treatments for other life-threatening diseases, too,
especially cancer. So it's distressing that some Members
of Congress apparently want to stop the process in the
name of scoring a few political points against drug
companies.
The latest headline seeker is Democrat
Ed Markey of Massachusetts, a senior member of the Energy
and Commerce Committee, which oversees the Food and
Drug Administration. He's released a report that's received
respectful media attention alleging a "conspiracy
of silence" between the FDA and drug companies
about accelerated approval. He claims the companies
are reneging on their commitments to complete post-approval
studies of their drugs, meaning "the public will
never know if the products that they believe are safe
and effective are no better than sugar pills or may
be even dangerous to their heath [sic]."
And what new examples do Mr. Markey and
his staff produce to support this claim? Amazingly,
none. They complain that AstraZeneca's lung-cancer drug
Iressa has been shown in post-market studies to confer
little survival benefit on most patients. But this was
known when Iressa was approved in 2003, as was the fact
that for 10% or so of cancer patients the drug can be
a real lifesaver.
The Congressional scolds also single out
Tysabri, an effective multiple sclerosis treatment that
was withdrawn from the market this year after studies
showed the possibility of a rare but fatal side effect.
But so what? Medicine has always been about trial and
error. Neither of these are examples of what the study
purports to demonstrate: dangerous or ineffective drugs
that have remained on the market because of industry's
failure to fulfill its study commitments.
The most important thing to understand
is that drugs never go straight from accelerated approval
to drugstore shelves, where "consumers are being
misled," as the study suggests. Accelerated approval
is by definition limited to drugs for serious and unmet
medical needs, where treatment will always occur under
the close supervision of a physician. And no oncologist,
to stick with the Iressa example, is under any illusion
about what the drug can and cannot do.
As for the companies' alleged failure
to complete post-market studies, it's worth noting that
in fact such studies have been completed for more than
half the drugs that have received accelerated approval
since 1992. Many of the non-completed studies are for
drugs approved in the past few years, for the simple
reason that there hasn't been enough time.
Finally, what delays exist are mostly
the fault not of drug companies but of the FDA. That's
because the agency remains wedded to an outdated paradigm
that considers the placebo-controlled trial to be the
"gold standard." But of course seriously ill
patients aren't likely to volunteer for a trial -- where
they'd risk getting a sugar pill -- once a drug is on
the market. If the FDA wants to facilitate post-market
trials, it should embrace new statistical models that
will allow studies to be conducted without the need
for placebo groups and sugar pills.
Mr. Markey's report does nothing to address
this genuinely serious issue, and neither does his companion
piece of legislation aimed at forcing the FDA to get
tougher on drug companies. The exercise looks like a
stunt to grab some media attention, albeit at the expense
of desperately ill patients who need faster access to
developmental drugs.
(Copyright (c)
2005, Dow Jones & Company, Inc.)
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