http://www.thejournalnews.com/apps/pbcs.dll/article?AID=/20050927/OPINION01/509270318/1015
Reform the imploding FDA
(Original publication: September 27, 2005)
The all-but standing ovation given the news that Lester M. Crawford,
head of the federal Food and Drug Administration, resigned unexpectedly
last week is a measure of how much credibility that agency has lost
with the public and Congress.
It's been years of botched handling by the agency over too many drug
and health-safety issues to count, against a scary backdrop of hesitant
leadership and politics trumping science. The FDA's own advisory panels
have been repeatedly ignored, and there have been too many reports of
silenced scientists, let alone questionable policy-making, that seems
to have put pharmaceutical companies' interests well above patients'.
It is time for drastic overhaul and unimpeachable leadership at the
agency the American public is supposed to be able to count on for
guidance on drug, medical device and food safety.
Chief among the controversies that have raged since Crawford, a
veterinarian and expert on food safety, became FDA deputy commissioner
in 2002, then acting commissioner and finally commissioner two months
ago: the safety of pain killers like Vioxx, Celebrex and Bextra, which
were found early-on to increase the risk of heart and stroke; the
regulation of heart defibrillators and silicone breast implants; the
safety of adult antidepressants, their link to suicide, and their use
by teens and youths; and the latest, unacceptable delays and
politicization of over-the-counter emergency contraception.
The FDA's staff had concluded the latter drug was safe, but Crawford
wanted to look at whether distribution could be restricted to those 17
years of age and older. That prompted the resignation of the director
of the agency's Office of Women's Health, Dr. Susan F. Wood, earlier
this month, as well as outrage and widespread questioning of the
agency's scientific integrity.
An article in last week's New England Journal of Medicine was
especially critical. "The recent actions of the FDA leadership have
made a mockery of the process of evaluating scientific evidence,
disillusioned many of the participating scientists both inside and
outside the agency, squandered the public trust, and tarnished the
agency's image," it concluded.
Many in Washington cheered Crawford's departure. Said Sen. Charles
Grassley, R-Iowa, who has spent 18 months investigating the FDA: "In
recent years, the FDA has demonstrated a too-cozy relationship with the
pharmaceutical industry and an attitude of shielding rather than
disclosing information."
President Bush tapped Dr. Andrew C. von Eschenbach, head of the
National Cancer Institute, to temporarily head the FDA. After he names
a nominee, the Senate must confirm the new chief. Those are processes
that, under Bush, have taken many months. He took nearly two years to
replace Jane Henney, who quit as FDA commissioner in January 2001.
With Crawford's departure, some observers have said it is time to
change the process and do away with Senate confirmation. We disagree.
Given how discredited the FDA has become, it needs the oversight more
than ever.
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TC