White House says FDA is doing a "spectacular job" of protecting the public
From: betts (21sall_at_law.com)
Date: 12/20/04
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Date: Sun, 19 Dec 2004 23:45:16 -0600
December 19, 2004
White House Official Praises Drug Agency
By THE ASSOCIATED PRESS
WASHINGTON (AP) -- The federal drug safety agency is doing a
``spectacular job'' of protecting the public, the White House chief of
staff said Sunday. The assessment drew an immediate outcry from a
Senate critic who charged that government oversight under the Bush
administration has proved ``a catastrophic failure.''
The debate about the effectiveness of the Food and Drug Administration
comes days after the agency began advising doctors to consider
alternatives to Celebrex, the leading arthritis painkiller, for their
patients. A study had shown that the Pfizer Inc. medication increased
the risk of heart attack and strokes at high doses.
Pfizer said Friday it will leave Celebrex on the market, although the
same problems led Merck & Co. in September to withdraw from the market
its painkiller Vioxx, a Celebrex competitor.
``For millions of patients, Celebrex is the best option, or, in some
cases, the last option, to live a normal life with the pain and
inflammation of arthritis,'' Pfizer's chairman and chief executive,
Hank McKinnell, said Sunday.
Later Sunday, Pfizer said it would immediately stop advertising
Celebrex to consumers. The move covers television, radio, newspaper
and magazine advertising.
The FDA's acting commissioner, Lester Crawford, said Friday the agency
has ``great concern'' about Celebrex and a group of similar
medications, called cox-2 inhibitors.
The National Institutes of Health, which halted a study testing
Celebrex for cancer prevention, ordered a full review of studies
involving cox-2 drugs.
President Bush's chief of staff, Andrew Card, said, ``I don't know
that we need a commission. I would like the FDA to continue to do the
job they do.''
Appearing on ABC's ``This Week,'' Card said, ``I support the FDA. They
do a spectacular job. When you think about all of the new technologies
and the new drugs that are coming into the marketplace, and they have
to review them all to make sure that when they come into the
marketplace, they live up to the expectation of improving health
care.''
That the public is learning about drugs on the markets that ``may not
live up to those expectations is a testament to the FDA in how they do
their job,'' Card said.
But the top Democrat on the Senate Health, Education, Labor and
Pensions Committee charged that the administration's record ``on
protecting us from harmful prescription drugs is a catastrophic
failure.''
Sen. Edward Kennedy of Massachusetts said in a statement: ``We need an
FDA that looks out for the health of patients and not just the health
of the pharmaceutical industry. Lives are at stake, and the president
should put an FDA leadership team in place right away, with no ties to
the industry it regulates, and that's committed to reform.''
An internal FDA survey made public last week found that about
two-thirds of agency scientists are less than fully confident in the
FDA's monitoring of the safety of prescription drugs now being sold.
Also, more than one-third of those scientists had some doubts about
the process for approving new drugs.
The chairman of the Senate Finance Committee, GOP Sen. Charles
Grassley of Iowa, has suggested that an independent board of drug
safety may be needed to ensure the safety of medications after FDA
approval.
Pfizer's McKinnell defended the extensive research on Celebrex and
said several studies showed ``the risk with Celebrex is less than any
other treatment option and is even less than people not being treated
at all.''
He added, ``I'm not sure we really understand yet the relevance of
this new data.''
But David Graham, a whistle-blower who works in the FDA's office of
drug safety, said, ``The fact that the FDA says now that it's
concerned about Celebrex to me is a serious signal. I would be very
concerned.''
Graham, who appeared with the Pfizer executive on ABC after Card's
interview, contended the agency is ``more concerned with getting drugs
onto the market than it is with getting safe drugs onto the market.
And so rather than dealing with issues such as cardiovascular safety
with Celebrex or Vioxx or Bextra before approval, the FDA is willing
to allow the experiment to occur after approval.''
Bextra is Pfizer's other cox-2 inhibitor.
Graham testified before a Senate committee last month that the FDA
fumbled in its handling of Vioxx and had mishandled safety problems
with five other widely used drugs.
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