Healthy Skepticism Library item: 2357

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Mundy A.
Wall Street biotech insider gets No. 2 job at the FDA
The Seattle Times 2005 Aug 24
http://archives.seattletimes.nwsource.com/cgi-bin/texis.cgi/web/vortex/display?slug=gottlieb24&date=20050824&query=scott+gottlieb

Keywords:
Gottlieb FDA biotech

Notes:

Ralph Faggotter’s Comments: These has been an increasing tendency for governments to blur the boundary between the regulator and the regulated. The cosy relationship which seems to exist between the FDA and the pharmaceutical industry has been a source of great public consternation and comment in recent times.
Many regard this close relationship as the key to such large scale medication disasters as the unfolding Vioxx saga.
Therefore, many people were shocked by the appointment of Scott Gottlieb to the FDA straight from Wall Street.
The FDA is sending a depressingly clear practical and symbolic signal of stunning indifference to public sensitivities by this appointment.

Full text:

Headline story from Seattle Times, 24 August

Full text at:

http://archives.seattletimes.nwsource.com/cgi-bin/texis.cgi/web/vortex/display?slug=gottlieb24&date=20050824&query=scott+gottlieb

Wall Street biotech insider gets No. 2 job at the FDA

By Alicia Mundy
Seattle Times Washington bureau

Only a month ago, Dr. Scott Gottlieb was a Wall Street insider,
promoting hot biotech stocks to investors.

Now Gottlieb holds the No. 2 job at the Food and Drug Administration
(FDA), the federal agency that approves new drugs, oversees their safety
and affects the fortunes of companies he once touted.

Wall Street likes the appointment of Gottlieb, 33, who believes in
faster drug approval and fewer news-release warnings to the public about
potential side effects of drugs.

But some medical experts are shocked by his July 29 appointment, coming
at a time when the public is increasingly concerned about the safety of
popular medicines. In addition, the federal government has just begun
scrutinizing the growing financial ties between Wall Street firms and
doctors researching new drugs.

Gottlieb’s new job “further impedes the independence of the FDA,” said
Dr. Jerome Kassirer, former editor of The New England Journal of
Medicine. “Gottlieb has an orientation which belies the goal of the FDA.”

“I’ve never heard of anything like this,” said Merrill Goozner, a
director at the liberal Center for Science in the Public Interest.

“If he’s had dealings regarding companies whose products are up for
review at the agency, it strikes me as a potential conflict of interest.
You want a barrier between the regulated and the regulators. It’s
fundamental,” Goozner said

A half-dozen current or former officials at the FDA say they do not know
of anyone from Wall Street moving directly into such a high-level job at
the agency.

Until last month, Gottlieb was editor of a popular biotechnology
investor newsletter, Forbes / Gottlieb Medical Technology Investor.
Forbes touted Gottlieb’s stock-picking success on its Web site in mid-May:

“Special Offer: In the last few months, Dr. Scott Gottlieb recommended
two cancer cure stocks to subscribers that have already climbed 38%.
Click here for the latest report from Forbes / Gottlieb Medical
Technology Investor, ‘Three Biotech Stocks To Buy Now.’ “

Now, as one of three deputy commissioners, Gottlieb will help oversee
such major policies as the FDA’s fast-track approval process for drug
and biotech products, a priority for many Wall Street funds and the
pharmaceutical industry.

Gottlieb said he has cut his ties to Wall Street and discontinued his
newsletter. He doesn’t see a conflict between that work and his new role
as a high-ranking regulator……

…..When the FDA announced Gottlieb’s hiring last month, it noted
Gottlieb had been a practicing physician, a scholar at AEI and
correspondent for the British Medical Journal. The agency did not
mention Gottlieb’s stints as editor of the two popular biotech
investment newsletters or his work with Wall Street firms.