FDA Taken to Task, Again

By Amanda Gardner
HealthDay Reporter1 hour, 46 minutes ago

WEDNESDAY, Sept. 7 (HealthDay News) -- Once again, a leading physician
has wielded his pen in one of the world's most prestigious medical
journals to lambaste the U.S. drug approval process.

In this case, Dr. Jerry Avorn, of Harvard Medical School and Brigham
and Women's Hospital in Boston, writes that when it comes to the
requirements for approval of new drugs, the federal government allows
"a minimal standard that would be unacceptable anywhere else in
research."

Writing in the Sept. 8 issue of the New England Journal of Medicine,
Avorn likens the U.S. Food and Drug Administration to "a patient with
obsessive-compulsive disorder" who is "single-mindedly preoccupied"
with, essentially, asking the wrong questions.

The charge struck a chord with another longstanding critic of the
beleaguered agency.

"There has been a series of blatant problems," says Dr. Eric Topol,
chairman of the department of cardiovascular medicine and chief
academic officer of the Cleveland Clinic Foundation. "This is the worst
situation we've faced in decades at the FDA."

The FDA declined to comment on the article, agency spokeswoman
Christine S. Parker said.

Avorn, who is also the author of Powerful Medicines: the Benefits,
Risks and Costs of Prescription Drugs, focuses much of his argument on
so-called "lifestyle" drugs, such as those used to treat impotence or
arthritis pain.

While a weighing of risks and benefits is particularly important for
these drugs, Avorn notes the FDA generally does not require such an
assessment.

Topol says: "We could separate out lifesaving and lifestyle drugs, and
I think lifestyle drugs, unless they are having a tremendous impact,
which is rarely the case, they should be looked at in a different
light."

In his piece, Avorn goes back a few years to the weight-loss drug
dexfenfluramine (Redux), which became part of the fen-phen craze of the
1990s. That drug was approved by the FDA despite concerns that it might
cause potentially fatal pulmonary hypertension. It turned out the drug
did cause pulmonary hypertension in some patients, as well as cardiac
valvulopathy, valve problems that were an unexpected development. The
drug was withdrawn from the market within a year. It had been approved
because people taking it in trials lost an average of six pounds more
than people on a placebo, Avorn writes.

The FDA is now in the process of reviewing rimonabant (Acomplia), a
weight-loss drug of a different sort. In trials, the drug did induce
some weight loss, along with some withdrawals of participants from the
study because of neuropsychiatric and gastrointestinal disorders, Avorn
writes.

Avorn also criticizes developments in another "lifestyle" area:
insomnia.

Ramelton (Rozerem) was approved on the basis of trials that found
improvements over one or two nights only. Another study did not
demonstrate a benefit in patients under the age of 65, Avorn says.

And then there is the example of BiDil, recently approved to treat
congestive heart failure in black patients. That approval, Avorn
writes, was based on a subset of a larger study. A larger, controlled
study should have been conducted to assess differences between blacks
and whites before the drug was released to market, he notes.

Also, some lifestyle drugs, such as the controversial arthritis pain
medications Vioxx and Celebrex, were given fast-track review, Topol
points out. "Do we want to do that for lifestyle medicine? On the other
hand, there are those that prevent death. They're lifesaving. The FDA
doesn't partition in any way."

But the FDA should be able to exercise more authority, as it has by not
allowing companies to claim that osteoporosis drugs prevent fractures
if the trial only showed an increase in bone mineral density, Avorn
contends.

Avorn recommends that the agency ask questions that more directly pit
risk against benefit, assess how long the drug is effective, and how
the drug compares to current treatments.

If large pharmaceutical companies were to shift the balance of what
they spend (currently two-thirds for marketing and administration vs.
one-third on research and development), it might help ameliorate the
situation, he writes.

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