NIH Dissident Scientists Hire Drug Industry Lawyers--Evidence of Journalistic Sh

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Fri, 29 Apr 2005 01:16:27 -0400

 

[sSRI-Research] LA Times: NIH Dissident Scientists Hire Drug

Industry Lawyers--Evidence of Journalistic Shilling

 

 

LA Times: NIH Dissident Scientists Hire Drug Industry

Lawyers--Evidence of Journalistic Shilling

 

 

Fri, 22 Apr 2005

 

http://www.ahrp.org/infomail/05/04/22.php

 

Pulitzer Prize winner David Willman of the Los Angeles Times, whose

investigative reporting first revealed the major covert conflicts of

interest among top scientists and administrators at the National

Institutes of Health (NIH), reports that a group of NIH dissidents who

oppose the new rules barring financial deals with biotech and

pharmaceutical companies, have hired a law firm to provide legal and

lobbying services on their behalf.

 

Willman reports that the firm, Arent Fox, has been lobbying

congressional leaders " seeking to dismantle earlier bipartisan support

for the tougher NIH ethics rules. " The dissidents call themselves " the

Assembly of Scientists, " their leader is NIH bioethicist, Dr. Ezekiel

Emmanuel.

 

The conflict of interest rules were adopted after the magnitude of

those conflicts were laid bare--first by the LA Times, then by

Congressional investigations:

 

" More than 530 NIH scientists took consulting fees, stock or stock

options [totaling millions of dollars] as compensation from biomedical

companies from 1999 through 2003. "

 

These investigations found 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. "

 

Willman's latest revelations add another layer of evidence and draw

the lines that connect the dots of the interlocking directorate that

appears to link the ethically challenged, greedy and arrogant NIH

scientists and the industry which is the source of their moral lapse,

is now revealed as their hired defender.

 

The LA Times reports that the NIH dissidents have hired a high-powered

law firm, Arent Fox, whose lobbying reach is to the congressional

leadership. 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. "

 

" 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. " Why not, given that the firm's more usual

billing is to the war chests of pharmaceutical giants who have an

interest in influencing the nation's biomedical researchers who set

the agenda for medical research and practice guidelines?

 

NIH scientists insist on having the best of both worlds-namely, high

paid prestigious positions at taxpayers' expense, while they engage in

private deals with corporate partners whose interests do not coincide

with the public interest. As a congressional committee accused NIH

scientists of wanting to have " the option of corruption. "

 

See: May 18, 2004: http://www.ahrp.org/infomail/04/05/18.php

May 3, 2005: http://www.ahrp.org/infomail/05/03/05a.php

 

Added to the unseemly conduct by NIH officials, the LA Times has

uncovered embarrassing evidence of unseemly journalistic shilling by

The Washington Post.

 

In 2004, the Washington Post Editorials called for tougher rules:

April: http://www.ahrp.org/infomail/04/07/06a.php

July: " Double Dipping at NIH "

http://www.washingtonpost.com/ac2/wp-dyn/A28128-2004Jul4?language=printer

 

But in February 2005, a front page headline in The Post announced:

" NIH Clear Most Researchers In Conflict-of-Interest Probe. " The report

lent credibility to an NIH self-investigation claiming: " as much as 80

percent of the seeming improprieties were actually the result of

errors by government investigators. " And an editorial said the rules

" threaten to harm the ability of the institutes to attract and retain

top scientists... " See:

http://www.washingtonpost.com/wp-dyn/articles/A45600-2005Feb22.html

 

Willman reports: " 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. "

 

" 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. "

 

" The Post's lead reporter on its NIH articles, Rick Weiss, said

Wednesday that his pieces " simply reflect the reporting I've done. "

 

Thus, the articles and editorials that followed the Post's lead

claiming that the tough conflict of interest rules will cause senior

scientists to leave NIH was planted by the dissidents.

 

First in the series: Stealth Merger: Drug Companies and Government

Medical Research December 7, 2003 See:

http://www.ahrp.org/infomail/03/12/07.php

 

See The Los Angeles Times Archives: The Price of NIH Credibility April

11, 2005; NIH Conflict Rule Is Eased for Interim Researchers March 17,

2005; Three Researchers in NIH Controversy Are Leaving March 10, 2005;

New Rules Will Cost Dissidents at NIH March 3, 2005; NIH Employees

Object to New Ethics Rules February 24, 2005; NIH Chief Calls for

Ethics Summit February 12, 2005; NIH Seeks 'Higher Standard' February

2, 2005; NIH to Ban Deals With Drug Firms February 1, 2005; The

National Institutes of Health: Public Servant or Private Marketer?

December 22, 2004; $508,050 From Pfizer, but No 'Outside Positions to

Note' December 22, 2004; Public Pays for Blood Expert's Advice, and So

Do Firms December 22, 2004; NIH Imposes Ban on All Outside Payments to

Its Employees September 24, 2004; NIH Is Pressured to Bar Drug

Industry Stipends August 6, 2004; NIH to Curb Its Scientists' Deals

With Drug Firms June 23, 2004; FDA Chief Launches Internal Inquiry of

Payments May 18, 2004; NIH Conflict Findings Left Out May 12, 2004;

Curbs on Outside Deals at NIH Urged April 9, 2004; Ethics Policy

Announced for NIH Officials March 2, 2004; NIH Directors No Longer

Drug Firm Consultants January 23, 2004; U.S. Scientists' Deals With

Drug Firms Under Review December 29, 2003;

 

Contact: Vera Hassner Sharav

212-595-8974

 

 

THE LOS ANGELES TIMES

Scientists Add Clout in NIH Fight

Agency researchers who oppose conflict rules hire lawyers who also

serve the drug industry.

By David Willman

 

April 21, 2005

 

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.

 

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.

 

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.

 

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. "

 

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.

 

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.

 

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.

 

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.

 

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.

 

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. "

 

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.

 

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.

 

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.

 

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.

 

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.

 

" 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. "

 

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.

 

Barton and Dingell were unified during congressional hearings last

year in condemning the conflicts of interest among NIH scientists and

calling for new restrictions.

 

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.

 

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.

 

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.

 

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.

 

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. "

 

The Post's lead reporter on its NIH articles, Rick Weiss, said

Wednesday that his pieces " simply reflect the reporting I've done. "

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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. "

 

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