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E-DRUG: Climate at US FDA

E-drug: Climate at US FDA
Below is an op-ed published by Sid Wolfe and I in the Washington Post about
a week ago.

Troubling Climate At FDA
By Peter Lurie and Sidney M. Wolfe
Wednesday, December 30, 1998; Page A19

 It's been a record-setting year at the Food and Drug Administration: The
agency has been forced to remove three drugs from the
market because of safety problems, more than in any similar period in its

 First Redux was removed for causing serious heart valve defects. Then off
came Posicor, which caused life-threatening drug interactions
and fatal heart problems, followed by Duract, which caused sometimes-fatal
liver damage.

In all three cases, the drugs did not represent a significant advance in
effectiveness over already-approved drugs. In all three
cases, significant safety concerns existed prior to approval.

Egged on by its sponsors in the drug industry, Congress has systematically
set about weakening a drug-approval process that for years ensured
Americans the safest pharmaceutical supply in the world.  But that is
changing; these days Rezulin, one of 11 drugs available in the United
States  to treat diabetes, stays on the market with impractical
requirements for 11 blood tests during the first year of use to prevent
liver damage, while Britain has had the good sense to ban the drug. So far
Rezulin has caused at least 33 deaths from liver failure.

The signs are that for many within the agency, morale is
at a low point. One of FDA's medical officers -- the physicians who
actually review new drugs  -- was forced to turn to the letters page of The
Post in August of this year to express his dissatisfaction with current
agency drug review practices. He was threatened with dismissal as a result,
although the agency backed off under pressure.

With this in mind, we decided to survey the medical officers to better
understand conditions inside the agency. To protect the medical officers'
confidentiality, we did not ask for their names or the names of the drugs
they had reviewed. Fifty-three medical officers (31 percent) responded,
which is more than respectable given the controversial subject matter. The
results were startling. Nineteen medical officers mentioned 27 drugs that
had been approved by the FDA in the past three years even though the
medical officer -- the person most familiar with all the data on the drug
-- opposed approval. It is likely that had more medical officers responded,
even more such drugs would have been mentioned.

Seventeen medical officers said that FDA's safety and efficacy standards
had declined in the past three years, with only six saying
they were higher. As one medical officer put it: "In the last two years, I
recommended that two drugs not be approved. They were both approved without
consulting me. This never happened before. In one case, the drug did not
meet the standards set up by the division, so they nullified the

 Even free and unfettered discourse, a central ethic in science, is
frequently abrogated in the current pro-industry environment at the
agency. The medical officers described an array of inappropriate
practices -- including phone calls from sponsors, pressure from Congress
and being prevented by their supervisors from presenting data critical of
particular drugs to FDA advisory committees. How can these committees
properly decide whether to recommend approving a drug when relevant data
are being suppressed inside the agency?

While the changes to the drug laws enacted in 1992 and 1997 may have
brought benefits for some people with life-threatening
diseases such as AIDS or cancer, these drug industry-inspired and approved
amendments will mostly serve to benefit the industry and its stockholders.
Some changes in FDA approval processes predate the most recent of these
legislative  changes, but the climate within the agency has now shifted
from a consumer-protective one to one in which success is measured in the
terms  favored by the industry. One medical officer stated that senior FDA
  "are mainly interested in counts of approvals and time to approval,and
not quality."
 Most of the new drugs being hurried onto the market in an
effort to appease Congress and the drug industry offer no benefit over
their predecessors. Some, like Redux, Posicor, Duract and perhaps many
more, ultimately will have to be banned, but only after scores of Americans
have been maimed or killed.

FDA officials repeatedly have asserted that speeded-up drug approvals and
other changes at the agency have not compromised drug approval standards.
But now many of those FDA physicians who know the drugs
best have spoken, and they have painted a vastly different picture.

It is time for Congress to admit that it has acted recklessly in pushing
FDA to loosen drug approval standards, and to act expeditiously to force
the agency to tighten  them.

Copyright 1998 The Washington Post Company

Peter Lurie, MD, MPH
Public Citizen's Health Research Group
1600 20th St., NW
Washington, DC 20009
Phone: (202)588-7781
Fax: (202)588-7796
Email: plurie@citizen.org

[It would be helpful to know (briefly) therapeutic claims and generic names
of these three drugs.  BS Co-Moderator]

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