[Vision2020] 04-21-05: LA Times: Agency researchers who oppose conflict rules hire lawyers who also serve the drug industry.

[Art Deco]

http://www.latimes.com/news/nationworld/nation/la-na-nih21apr21.story

THE NATION
Scientists Add Clout in NIH Fight
Agency researchers who oppose conflict rules hire lawyers who also serve the drug industry.
By David Willman
Times Staff Writer

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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