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<DIV><FONT size=4><A
href="http://www.latimes.com/news/nationworld/nation/la-na-nih21apr21.story"><FONT
size=3>http://www.latimes.com/news/nationworld/nation/la-na-nih21apr21.story</FONT></A><BR>
<H4>THE NATION</H4>
<H1>Scientists Add Clout in NIH Fight</H1>
<H2>Agency researchers who oppose conflict rules hire lawyers who also serve the
drug industry.</H2>By David Willman<BR>Times Staff Writer<BR><BR>April 21,
2005<BR><BR>WASHINGTON — Scientists at the National Institutes of Health who are
fighting new rules that would end their financial ties to the drug industry have
hired, at a favorable rate, a law and lobbying firm that also represents the
companies. <BR><BR>The hiring has added firepower to the government scientists'
campaign, which already is getting results: Senior aides to NIH Director Elias
A. Zerhouni now are discussing whether to soften a requirement that employees
sell any stock they hold in a biomedical company, according to an agency
spokesman. <BR><BR>The divestiture requirement — scheduled to take effect in
October — was part of a package of reforms announced by Zerhouni on Feb. 1. The
new rules also immediately prohibit all NIH scientists from taking fees, stock
options or any other compensation from pharmaceutical or biotechnology
companies. <BR><BR>In an e-mail to NIH employees on Tuesday, a group of
dissident agency scientists said that it had "mounted a legal and government
relations campaign to challenge the new conflict-of-interest rules." <BR><BR>The
dissidents, called the Assembly of Scientists, contend that the new restrictions
impose unfair financial burdens on them and will harm NIH's ability to recruit
and retain top talent. In addition to rescinding the stock-divestiture
requirement, they want most agency researchers — including laboratory directors
and branch chiefs — to again be allowed to take consulting fees from the
companies. <BR><BR>The Washington firm they hired, Arent Fox, has ties to the
industry that has been employing the moonlighting NIH scientists as consultants.
According to its website, Arent Fox represents the makers of pharmaceuticals,
medical devices, and dietary supplements. One of its longtime clients is the
Biotechnology Industry Organization, which last year urged the NIH to allow
agency scientists to continue serving as private, paid consultants.
<BR><BR>Arent Fox attorneys earlier this month filed a petition asking the U.S.
Circuit Court of Appeals for the District of Columbia to review the new
conflict-of-interest rules, arguing that they were imposed before the scientists
had enough opportunity to comment. <BR><BR>Last week, Rep. Chris Van Hollen
(D-Md.) sent a letter to Zerhouni asking him to delay implementation of all the
new rules for at least three months. Van Hollen, whose district encompasses the
NIH complex in suburban Bethesda, is a former Arent Fox partner. He said
Wednesday that he began assisting the dissidents early this year before he
learned about the firm's involvement. <BR><BR>The chairman of Arent Fox, Marc L.
Fleischaker, said in an interview that his firm was providing lobbying and legal
services to the dissidents at a discount. He declined to elaborate, but said
that none of the companies that Arent Fox represents had paid for the firm's
services on behalf of the NIH employees. <BR><BR>Fleischaker said his firm was
seeking "a more reasonable conflict-of-interest standard which will not result
in the loss of current scientists or the inability to recruit future scientists.
We hope to do that through discussions and conversations…. And if we have to
litigate, we will." <BR><BR>The new conflict-of-interest rules stemmed from
revelations that hundreds of NIH scientists took fees and stock from the
industry totaling millions of dollars, and that most of the payments were hidden
from public view. The payments raised questions about the scientists'
impartiality in overseeing clinical trials or making public recommendations on
the use of new drugs or other commercial treatments.<BR><BR>In some cases, NIH
scientists worked for drug companies that directly benefited from their
recommendations to doctors and regulators. In other cases, agency scientists
appeared at public forums and commented on or endorsed treatments or drugs
without revealing that they were on the payroll of companies making the
products.<BR><BR>Zerhouni, working with the Office of Government Ethics and the
Department of Health and Human Services, announced the tougher rules after
months of public discussion during which comments were sought from NIH
employees. In the spring of 2004, a blue-ribbon committee appointed by Zerhouni
held public hearings. Also last year, four congressional hearings — one in the
Senate and three in the House — were convened to examine conflicts of interest
at NIH. <BR><BR>Yet two weeks ago, Zerhouni told a Senate Appropriations
subcommittee that he generally favored relaxing the new requirement that senior
agency scientists divest holdings of stock in individual companies. <BR><BR>Two
senators who led the hearing, subcommittee Chairman Arlen Specter (R-Pa.) and
Tom Harkin of Iowa, the panel's ranking Democrat, questioned whether the
stock-divestiture provisions would hurt the NIH's ability to retain talented
scientists.<BR><BR>"While I strongly support restrictions on outside
compensation, I'm concerned that the new regulations go too far," said Harkin,
who had praised the new rules when they were announced in February. "These are
too onerous. They've got to be redone, and they've got to be redone
soon."<BR><BR>Lobbyists from Arent Fox have been contacting officials on Capitol
Hill for the past month, seeking to dismantle earlier bipartisan support for the
tougher NIH ethics rules. In one conversation described by a congressional
staffer, an Arent Fox lobbyist asked if there had been any erosion in solidarity
between the chairman of the House Energy and Commerce Committee, Rep. Joe Barton
(R-Texas), and the panel's ranking Democrat, Rep. John D. Dingell of Michigan.
<BR><BR>Barton and Dingell were unified during congressional hearings last year
in condemning the conflicts of interest among NIH scientists and calling for new
restrictions. <BR><BR>Their investigative subcommittee examined the earlier
rules that allowed NIH scientists to go on drug company payrolls and accept
unlimited sums of money. More than 530 NIH scientists took consulting fees,
stock or stock options as compensation from biomedical companies from 1999
through 2003, according to records and interviews. <BR><BR>One NIH institute
director, for example, was allowed to continue taking consulting fees from a
biotech company even after the firm began winning research grants administered
by his government subordinates. <BR><BR>The committee also developed information
about dozens of additional paid arrangements in which NIH scientists made
consulting deals without getting required approvals from the
agency.<BR><BR>Within the last two months, the dissident NIH scientists have
sought through news articles and opinion columns to cast the new rules as
damaging to the agency. In a memo dated April 8, the agency scientists cited the
backing that their cause has gotten from the Washington Post. Within the last
two months, the newspaper has published two supportive editorials along with
several news articles. <BR><BR>In an April 12 memo, leaders of the NIH group
told colleagues that "all the good press we have had over the last few weeks
just did not happen. This has been the result of a lot of hard work by members
of the Assembly [of Scientists] in educating journalists about the realities of
the conflict of interest regulations."<STRONG> </STRONG><BR><BR>The Post's lead
reporter on its NIH articles, Rick Weiss, said Wednesday that his pieces "simply
reflect the reporting I've done." <BR><BR>The Post and other publications
reported on the planned or actual departures of three senior scientists as an
indication that the new rules were forcing out key personnel. Each of the three
has faced scrutiny recently for accepting income as industry consultants in ways
that overlapped their government roles. <BR><BR>Records show that one of them,
Dr. P. Trey Sunderland III, accepted more than $500,000 in consulting and
speaking fees from Pfizer Inc. from 1998 through 2003 without seeking permission
or reporting the income to the agency as required. At the same time that
Sunderland accepted fees from Pfizer, he led a study of Alzheimer's patients at
the NIH in which Pfizer collaborated. Sunderland has headed the NIH's geriatric
psychiatry branch.<BR><BR>Dr. Lance A. Liotta, a veteran lab chief, led the
NIH's collaboration with a Maryland company from 2002 to 2004 to develop a test
for early detection of ovarian cancer. During that time, Liotta accepted $70,000
in consulting fees from a competing firm with the permission of his NIH
superiors, according to federal records, interviews and sworn congressional
testimony. <BR><BR>The third NIH researcher, vascular-disease specialist Dr. H.
Bryan Brewer Jr., accepted about $114,000 between 2001 and 2003 from four
companies making or developing cholesterol medicines, according to NIH
documents. As part of his official duties as a branch chief at the NIH, Brewer
during that time helped draft national guidelines that urged more aggressive use
of drugs to lower cholesterol. Brewer had entered his deals with the companies
with the approval of NIH officials.<BR><BR>In recent months, Sunderland and
Liotta have come under investigation by the inspector general of the Department
of Health and Human Services, people familiar with the probes have said in
interviews.<BR><BR>One NIH executive — Dr. James F. Battey Jr., director of the
NIH's National Institute on Deafness and Other Communication Disorders — has
said that he intends to leave because of the more restrictive
rules.<BR><BR>Battey, who had not accepted any compensation from drug or biotech
companies, told the Senate Appropriations subcommittee that the new
stock-divestiture requirements would be too burdensome on his
family.<BR><BR>Battey, 52, requested an early retirement from NIH, which would
take effect in September. He has applied for the top staff post with the newly
created California Institute of Regenerative Medicine, and is seeking other
research jobs in California and Maryland.<BR><BR>Another physician, Dr. David A.
Schwartz, wrote to Zerhouni in March and said that the stock-divestiture
requirements might prevent him from honoring his acceptance of an offer to
become director of the NIH's National Institute of Environmental Health
Sciences. But in e-mailed responses for this article, Schwartz said he expected
to leave his medical post at Duke University to accept the NIH position.
<BR><BR>A recent study requested by Congress pointed out expected benefits from
turnover at the agency. The study, conducted by the Institute of Medicine and
the National Research Council and released in July 2003, recommended that all of
the NIH's institute and center directors be limited to either five-year or
10-year maximum tenures.<BR><BR>The study also said that "a healthy degree of
turnover in leadership is critical for sustaining the vitality…. It would
provide opportunities for leading scientists across the nation to leave their
positions for a set period to come to NIH as a form of public service to provide
effective scientific leadership to critical elements of the nation's biomedical
enterprise."<BR></FONT></DIV></BODY></HTML>