[corp-focus] Dr. Gottlieb Is Not Happy

[robert weissman]

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DR. GOTTLIEB IS NOT HAPPY
By Russell Mokhiber and Robert Weissman
	
It was an uncomfortable moment.
	There they sat -- next to each other.
	Dr. Steven Nissen, chair of the Department of Cardiovascular Medicine 
at the Cleveland Clinic Foundation.
	And Dr. Scott Gottlieb, deputy commissioner for Medical and Scientific 
Affairs at the Food and Drug Administration (FDA).
	Next to each other they sat.
	Fidgeting.
	Nervous.
	Dr. Nissen and Dr. Gottlieb -- along with four others gathered to 
discuss the question: "Government Science Panels: Fair and Balanced?"
	The panel was moderated by a reporter -- National Public Radio's 
Snigdha Prakash.
	The panel was sponsored by the Center for Science in the Public 
Interest, which the day before had released a report -- Ensuring 
Independence and Objectivity at the National Academies.
	The report found that nearly one out of every five scientists appointed 
to National Academy of Sciences panels has direct financial ties to 
companies or industry groups with a direct stake in the outcome of the 
study.
	But Cleveland Clinic's Dr. Nissen said he wanted to go beyond the 
narrow topic the panel was brought together to discuss.
	Dr. Nissen wanted to address the bigger issue of the "imbalance of 
power between the FDA and industry."
	"The American people no longer trust the FDA to protect their health," 
Dr. Nissen said. "Patients are increasingly suspicious of drug therapy 
and sometimes reluctant to accept potentially life-saving medications. 
How did we get into this predicament?"
	Dr. Gottlieb squirms.
	The entire FDA budget for drug regulation is about $500 million and 
relies extensively on user fees, Dr. Nissen said. User fees are paid by 
drug companies seeking marketing approval and those with drugs on the 
market, and by law may only be used to fund the marketing approval 
process -- not FDA's other functions, like safety reviews of drugs 
already on the market.
	As a result, the FDA is financially indebted to the companies it must 
regulate.
	Forget about NAS and government agency panels.
	This is the elephant in the room -- the big conflict of interest.
	"Industry spends more than $48 billion on marketing, complete with a 
dazzling array of direct-to-consumer advertising touting the latest 
sleeping pills or even creating entirely new diseases like 'restless leg 
syndrome,'" Dr. Nissen said.
	We must adequately fund the FDA -- without user fees, Dr. Nissen said.
	And plus, the FDA needs new laws to strengthen its authority over the 
industry.
	Dr. Gottlieb fidgets.
	"Currently, the FDA must negotiate with industry to make even simple 
changes in drug labels," Dr. Nissen said.
	"When drug studies reveal toxicity or lack of efficacy, the FDA is not 
permitted to release the results and the findings are often not 
published, thereby denying patients and physicians access to vitally 
important safety information. Why has the FDA not sought to strengthen 
its regulatory authority?" Dr. Nissen asks. "Well, that brings up yet 
another conflict-of-interest problem, evident at the highest levels of 
the FDA."
	The FDA's Dr. Gottlieb nervously checks his Blackberry-like device.
	He doesn't like what he sees coming.
	Dr. Nissen starts at the top.
	"For years, we had an interim FDA Commissioner, Lester Crawford, who 
shortly after confirmation, abruptly resigns, apparently because he and 
his wife owned stock in regulated companies," he says.
	"Then the administration appointed Andrew Von Eschenbach as interim 
commissioner, creating another conflict,"
	Dr. Nissen says. "In his role as director of the National Cancer 
Institute, Von Eschenbach must seek FDA approval for human testing or 
approval of new cancer drugs, an obvious conflict."
	Dr. Gottlieb is not happy.
	"Even worse, the administration appointed Scott Gottlieb as deputy 
commissioner," Dr. Nissen says. "He came to this job with no regulatory 
experience, directly from Wall Street, where he served as a biotech 
analyst and stock promoter. Between them, Drs. Von Eschenbach and 
Gottlieb have whined incessantly about the need to speed drug 
development. So while the American people worry about the safety of 
drugs, the top FDA leadership tells us we need faster drug approval."
	Dr. Nissen speed reads through the remainder of his talk.
	FDA's Dr. Gottlieb is next.
	And he's still not happy.
	But he gets up and brushes off the criticism with -- I know nothing 
about what Dr. Nissen said -- I'll stick to the subject at hand and 
delivers my prepared remarks.
	In November 2005, the Boston Globe reported that Dr. Gottlieb worked 
for the public relations firm of Manning Selvage & Lee and had corporate 
clients that included Roche, the manufacturer of the antiviral Tamiflu, 
and Sanofi-Aventis, parent company of the nation's sole flu vaccine 
manufacturer.
	Other firms he was involved with, according to the Globe, included 
Inamed Corp., one of two companies seeking to return silicone gel 
implants to the market -- and VaxGen Inc., a California firm that won a 
$878 million federal contract to supply 75 million doses of anthrax 
vaccine for the nation's protective stockpile.
	During the question-and-answer period, we asked Dr. Gottlieb about Dr. 
Nissen's remarks and about the conflicts.
	We prefaced the question with some facts from a 2005 newspaper report.
	Dr. Gottlieb used to work at the American Enterprise Institute and he 
authored a column called the Forbes/Gottlieb Biotech Investor.
	And he had a blog called the fdainsider.com -- since shut down.
	Back in September 2005, the Daily Deal, a daily news outlet that covers 
Wall Street, warned that "watchdogs should keep an eye on Gottlieb's 
relations with former clients."
	"His recent writing is rife with potential conflicts," according to the 
report by Alex Lash of the Daily Deal. "For example in an AEI paper, 
Gottlieb cites VaxGen as a victim of political meddling. In a footnote, 
he adds that he did consulting work for the company. And his Forbes 
columns are tagged with similar warnings that he 'may own stock or 
consult with firms' affiliated with his coverage."
	So, what about it, Dr. Gottlieb?
	"I'm not going to dignify the whole question -- it's not really a 
question -- it's a statement," Dr. Gottlieb shoots back. "But I complied 
with every requirement that was put on me. And that's not what I came 
here to discuss. I came here to discuss how we can move the agenda 
forward at the agency in dealing with some of these difficult issues 
related to these kinds of perception problems. And we're doing just that."
	We wanted to ask a follow-up question about the perception problem, 
about Dr. Nissen's observation that the practice of having industry 
people like Dr. Gottlieb in positions of authority at the FDA is 
perpetuating the problem -- in fact is an integral part of the problem.
	But NPR reporter Prakash wouldn't allow the follow up.
	"I think we should move on," she says.
	That brought a little cheer to Dr. Gottlieb.
	But the rest of us shouldn't be happy.


Russell Mokhiber is editor of the Washington, D.C.-based Corporate Crime 
Reporter, <http://www.corporatecrimereporter.com>. Robert Weissman is 
editor of the Washington, D.C.-based Multinational Monitor, 
<http://www.multinationalmonitor.org>. Mokhiber and Weissman are 
co-authors of On the Rampage: Corporate Predators and the Destruction of 
Democracy (Monroe, Maine: Common Courage Press).

(c) Russell Mokhiber and Robert Weissman

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