[Ip-health] Critics Top Shortlist for FDA Head

[Riaz K Tayob]

Snip:

One is Dr. Sharfstein, who successfully pushed the FDA last year to
block drug makers from selling over-the-counter cough and cold medicines
to small children. The other is Steven Nissen, 60, head of
cardiovascular medicine at the Cleveland Clinic. Dr. Nissen's questions
about the safety of two popular drugs, the diabetes medicine Avandia and
the anticholesterol pill Vytorin, have hit their makers' sales hard and
given him a platform to criticize the agency that approved them.
---

As a medical student at Harvard University in 1997, Dr. Sharfstein wrote
the New England Journal of Medicine to complain that Pfizer was offering
free alcohol and billiards games to doctors in Boston while promoting
its products.
---
As a Waxman staffer, Dr. Sharfstein helped get a bill passed amid a
Republican majority that reversed an FDA decision allowing the makers of
colored contact lenses to classify them as "cosmetics." A number of
people suffered blindness after wearing the lenses. The bill
reclassified them as medical devices.


* DECEMBER 12, 2008

Critics Top Shortlist for FDA Head
Baltimore's Sharfstein, Cleveland Clinic's Nissen Have Tangled With Industr=
y

By ALICIA MUNDY

WASHINGTON -- A doctor who once denounced Pfizer Inc. for holding a
marketing event in a pool hall is leading President-elect Barack Obama's
team formally assessing the troubled Food and Drug Administration,
boosting his chances of becoming the next FDA commissioner.

* Health Blog: Who Is Joshua Sharfstein?

Joshua Sharfstein, now head of the Baltimore Health Department, has
tangled with the pharmaceutical industry on several occasions and would
likely lead the agency to get tougher on drugs. Companies might benefit
from his strong support of childhood vaccinations, however.

Several other candidates remain in the running for the top FDA post, and
no decision appears imminent.

Dr. Sharfstein, 39 years old, is a former staffer for Rep. Henry Waxman,
the California Democrat who recently won the chairmanship of the
powerful Energy and Commerce Committee. Dr. Sharfstein visited the FDA
several times in recent weeks and discussed controversies involving the
agency, according to people familiar with the discussions. He declined
to comment on any current or future involvement with the FDA.


Joshua Sharfstein, health commissioner for the city of Baltimore, holds
up data listing examples of adverse reactions to over-the-counter cough
and cold medicines for children, at a joint meeting of the
Nonprescription Drugs Advisory and Pediatric Advisory committees of the
U.S. Food and Drug Administration, Oct. 18, 2007.


Congress is investigating many FDA issues, such as its approval of some
blockbuster drugs that had to be withdrawn or re-evaluated for safety
reasons. The agency is also under bipartisan fire for its handling of
contaminated milk products and a widely used blood thinner that were
imported from China.

The FDA commissioner's spot may prove among the most hard-fought of the
new administration, with members of Congress from both parties promoting
their candidates in letters and talks with the transition team. The
pharmaceutical industry's lobby donated about $10 million to Democrats
this election, breaking a heavily pro-Republican giving pattern.

Drug companies particularly worry about two contenders for the top job
whose crusading has affected FDA policy and corporate bottom lines.

One is Dr. Sharfstein, who successfully pushed the FDA last year to
block drug makers from selling over-the-counter cough and cold medicines
to small children. The other is Steven Nissen, 60, head of
cardiovascular medicine at the Cleveland Clinic. Dr. Nissen's questions
about the safety of two popular drugs, the diabetes medicine Avandia and
the anticholesterol pill Vytorin, have hit their makers' sales hard and
given him a platform to criticize the agency that approved them.

People close to the industry have been floating the names of other
candidates to run the FDA -- including Janet Woodcock, a senior official
at the agency -- who are seen as less likely to carry out a thorough
overhaul of the FDA. Some Democratic aides have suggested Ms. Woodcock
as a possible interim chief while a permanent leader is vetted.

As a medical student at Harvard University in 1997, Dr. Sharfstein wrote
the New England Journal of Medicine to complain that Pfizer was offering
free alcohol and billiards games to doctors in Boston while promoting
its products.

The New York pharmaceutical giant's ad for the event urged doctors to
"rack 'em up and toss 'em down." Pfizer responded to the journal that
its slide presentations at the pool hall "provided useful medical
information to attendees," but conceded that it "created a poor impression.=
"

As a Waxman staffer, Dr. Sharfstein helped get a bill passed amid a
Republican majority that reversed an FDA decision allowing the makers of
colored contact lenses to classify them as "cosmetics." A number of
people suffered blindness after wearing the lenses. The bill
reclassified them as medical devices.

Dr. Nissen outlined in a speech this week specific changes he wants at
the FDA. He said the agency should more often require companies to prove
their drugs save lives, rather than merely show they achieve some
presumed beneficial goal. For example, Avandia lowers blood sugar but
has been linked to heart attacks.

"The ultimate purpose of that drug should be to prolong life. So, isn't
that what we should be measuring?" he said in an interview. Dr. Nissen
also said too many medicines are put on a fast track for FDA approval as
ostensible life savers, even though they aren't that important. He has
called for complete transparency in the agency's interactions with
industry and criticized it for sometimes delaying public disclosures of
potential dangers based on corporate claims that "proprietary
information" is at stake.

However, Dr. Nissen has also suggested giving early limited-term
approval for truly life-saving and innovative drugs, an idea industry
supports.
=97Easha Anand contributed to this article.

Write to Alicia Mundy at alicia.mundy@wsj.com

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