NIH to Ban Consulting Deals With Drug Firms – LAT / NYT

NIH to Ban Consulting Deals With Drug Firms – LAT / NYT

Tue, 1 Feb 2005

Thanks to the investigative reports by David Willman in the Los Angeles Times, shedding light on secret financial ties by sernior scientists at the National Instiutes of Health, the public gained insight into the corrosive nature of such conflicts on medical research and medical practice. The illusion that scientific integrity can be maintained in the presence of conflicts of interest was shattered, and so was public trust. The NIH is about to announce a ban on all outside consultancies by NIH staff.

Willman documented what were clearly pervasive, concealed financial conflicts of interest – including a myriad of financial deals with the drug and biotech companies by high ranking scientists and directors of NIH institutes. The scientists’ NIH affiliation had significant financial value for drug companies – the NIH affiliation lent the appearance of credibility and objectivity to the health care recommendations these scientists made because the public perceived them to be impartial.

But as the LAT revealed, NIH scientist published clinical trial reports that failed to disclose fatal events, and “scientists appeared at public forums and commented upon or endorsed treatments or drugs without revealing that they were on the payroll of companies making the products.”

These were not isolated instances, hundreds of NIH scientists have quietly taken millions of dollars in fees and stock options from biomedical companies while simultaneously drawing the highest government salaries. Most of the payments, as the LAT demonstrated, “were hidden from public view, raising questions about the scientists’ impartiality in overseeing clinical trials and in making recommendations to doctors for treating patients.”

Those revelations culminated in the imposition of a ban to prevent NIH scientists from working both sides of the street:

“All NIH scientists will be prohibited from accepting consulting fees, speaking fees and any other form of income from all biomedical companies, professional societies and other outside entities. The scientists must sell or otherwise dispose of any stock or stock options they hold in individual pharmaceutical or biotechnology firms.

On the other hand, the government employees will be allowed to accept paid outside positions as physicians at hospitals or in other clinical settings. They also will be allowed to accept fees in some circumstances from universities for teaching or writing and editing services. The number of NIH employees required to file annual financial-disclosure reports open to public inspection under the Freedom of Information Act also was to be expanded.”

“It returns NIH to where it should be in terms of the public’s confidence that the people who work for NIH are working for them, and not for some drug company or some biotech company,” said Dr. Philip R. Lee, who served presidents Lyndon B. Johnson and Bill Clinton as assistant secretary of Health.

Contact: Vera Hassner Sharav
212-595-8974

http://www.latimes.com/news/nationworld/nation/la-na-nih1feb01,0,5059199.story?coll=la-home-headlines

THE LOS ANGELES TIMES
NIH to Ban Deals With Drug Firms
Federal researchers will no longer be able to accept fees to consult for companies, officials say. The lucrative pacts have sparked ethics probes.
By David Willman
February 1, 2005, p. 1

WASHINGTON – Under a far-reaching reform to be announced today, all staff scientists at the National Institutes of Health will be banned from accepting any consulting fees or other income from drug companies, and the employees must also divest industry stock holdings, officials said.

The new regulations – drawn up by administrators from the NIH, the Office of Government Ethics and the Department of Health and Human Services – are aimed at halting lucrative deals that have led to conflict-of-interest inquiries at the government’s premier agency for medical research.

The changes exceed the partial and temporary curbs on outside income proposed earlier by the NIH director, Dr. Elias A. Zerhouni. Although the new rules could be reassessed after one year, officials familiar with the matter said they viewed the changes as permanent.

For the last decade, government scientists at the NIH have quietly been allowed to consult for biomedical companies under policies that defenders have said helped attract talented personnel to the agency. Hundreds of scientists took millions of dollars in fees and stock from industry. Most of the payments were hidden from public view, raising questions about the scientists’ impartiality in overseeing clinical trials and in making recommendations to doctors for treating patients.

In some cases, NIH scientists worked for drug companies that directly benefited from their recommendations to doctors. In other cases, scientists appeared at public forums and commented upon or endorsed treatments or drugs without revealing that they were on the payroll of companies making the products.

The Los Angeles Times in 2003 and 2004 revealed the existence of the deals – along with the secret policy changes that made them possible. Zerhouni appointed a blue ribbon panel last year to examine the NIH’s policies, and congressional leaders, citing the Times articles, asked him to provide details on all biomedical industry payments to agency scientists for a five-year period.

Four congressional hearings into conflict of interest at the NIH were convened last year, three in the House and one in the Senate.

Full details of the new and restrictive rules were held tightly on Monday by NIH officials. Those familiar with the changes, speaking on a condition of anonymity, provided these particulars:

All NIH scientists will be prohibited from accepting consulting fees, speaking fees and any other form of income from all biomedical companies, professional societies and other outside entities. The scientists must sell or otherwise dispose of any stock or stock options they hold in individual pharmaceutical or biotechnology firms.

On the other hand, the government employees will be allowed to accept paid outside positions as physicians at hospitals or in other clinical settings. They also will be allowed to accept fees in some circumstances from universities for teaching or writing and editing services. The number of NIH employees required to file annual financial-disclosure reports open to public inspection under the Freedom of Information Act also was to be expanded.

Two members of the House Energy and Commerce Committee, whose leaders sought the documents about drug company payments to NIH scientists, praised the new rules.

“NIH’s ethics requirements were appallingly lax – not at all what the public would expect from our nation’s premier research institution,” said Rep. Diana DeGette (D-Colo.).

In a written statement, Rep. Henry A. Waxman (D-Los Angeles) praised Times reporting and said “we need to restore integrity and trust in NIH. I am glad NIH recognizes it has a problem and is now beginning to address these issues.”

Word of the new rules also drew applause from other present and former officials.

“It’s a very, very salutary move,” said Dr. Philip R. Lee, who served presidents Lyndon B. Johnson and Bill Clinton as assistant secretary of Health. “It returns NIH to where it should be in terms of the public’s confidence that the people who work for NIH are working for them, and not for some drug company or some biotech company.”

Last month a deputy director of the NIH, Dr. Raynard S. Kington, said in an agency newsletter that investigations of potential conflicts of interest among agency employees were under way. Kington told the newsletter that “fairly soon, we’ll enter the penalty phase of these investigations…. Some employees have substantially violated rules and regulations.”

The Times reported Friday that, according to officials familiar with the matter, the inspector general’s office at the Department of Health and Human Services was investigating an Alzheimer’s disease researcher at the NIH, Dr. P. Trey Sunderland III. Records showed that from 1998 through 2003, Sunderland accepted $508,050 in consulting and speaking fees from Pfizer Inc. – without seeking permission or reporting the income to the agency as required.

Over the last year, Zerhouni had insisted that any employee who violated the existing conflict-of-interest rules would be held to account. But the NIH director also said repeatedly that he wanted most agency scientists to remain at liberty to moonlight for the companies because that would help “translate” scientific discoveries from NIH laboratories into useful medical products. However, no evidence of any such translations was presented throughout the congressional hearings, or during sessions convened by the blue ribbon panel.

Rigorous case-by-case screenings of ongoing or proposed moonlighting deals, Zerhouni said, would adequately safeguard against conflicts of interest. He appointed an ethics advisory committee last year to do just that, joining other agency efforts that NIH administrators said would “manage” conflicts of interest.

The Times reported in December 2004 that one of Zerhouni’s appointees to the ethics advisory committee, Dr. Harvey G. Klein, the top blood-transfusion expert at the NIH, accepted income from companies whose activities overlapped with his area of expertise.

The article, based on government and company records and interviews, reported that Klein from 1999 to last year accepted $240,200 in consulting fees plus 76,000 stock options from five companies active in marketing or developing blood-related products.

Klein said that other officials at the NIH approved all of his outside arrangements.

Zerhouni in the last year made several attempts to contain the controversy over the drug industry payments.

He first proposed to ban outside paid consulting for top-level NIH leaders – while allowing most of the agency’s 5,000 or more other scientists to enter into such deals.

In September, he proposed a one-year, NIH-wide moratorium on paid consulting, but it was never carried out.

Times researcher Janet Lundblad in Los Angeles contributed to this report.

To read previous Times coverage on the NIH, go to latimes.com/nih.

Related Stories

NIH Seeks Outside Inquiry of Scientist

January 28, 2005

The National Institutes of Health: Public Servant or Private Marketer?

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

Panel Wants Top Health Officials Off Drug Payrolls

May 7, 2004

Curbs on Outside Deals at NIH Urged

April 9, 2004

Ethics Policy Announced for NIH Officials

March 2, 2004

See also:
THE NEW YORK TIMES
February 1, 2005 p. A-15
Ban on Federal Scientists’ Consulting Nears
By GARDINER HARRIS

The National Institutes of Health and the Office of Government Ethics are expected to announce a ban today on private consulting arrangements between scientists at the institutes and pharmaceutical and biotech companies.

The ban comes in the wake of damaging revelations that some government scientists leveraged their positions at the institutes to gain lucrative consulting contracts with such companies, arrangements that sometimes overlapped with their government work.

Dr. Elias Zerhouni, director of the institutes, emphasized in an interview last year that only 369 of the institutes’ 6,000 scientists had consulting arrangements with such companies from 1999 to 2004. More than 80 percent of these scientists received $5,000 or less from outside consulting, Dr. Zerhouni said.

“I want to dispel the notion here that every scientist at N.I.H. has consulting arrangements with 10 companies,” he said in the interview.

Dr. Zerhouni had hoped for months to preserve scientists’ right to engage in some of these activities, saying a ban would turn the institutes into “a convent,” which, he said, was not in keeping with Congress’s insistence that its research lead to cures.

But a series of articles in The Los Angeles Times detailing the conflicts between some N.I.H. scientists’ public and private work and several hearings by the House Energy and Commerce Committee forced Dr. Zerhouni to retreat and finally propose late last year a ban on outside consulting activities. Since the ban was a change to government policies, it required approval from the Office of Government Ethics. That office is expected to announce today that it has approved such a ban.

Representative Diana DeGette, a Democrat from Colorado and a member of the House Energy and Commerce Committee, released a statement yesterday saying that the institutes’ new consulting guidelines would be “a major step toward restoring public confidence in our nation’s premier research institution.”

Studies show that researchers who accept money from private companies are less likely than others to share the results of their work with their colleagues. Such researchers are also more likely to focus on commercially applicable studies, said Dr. David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital in Boston.

Mildred Cho, associate director of the Center for Biomedical Ethics at Stanford University, said that academic researchers increasingly collaborated with drug and biotech companies, and that the growing number of consulting relationships between N.I.H. researchers and companies had simply reflected that trend.

“What’s different about this,” Dr. Cho said, “is that it involves the government, government research and government funding of research. That represents a crossing of a line that hadn’t been crossed before.”

The number of cases that have come to light so far are wide-ranging and include top-level administrators and working researchers alike.

Dr. Bryan Brewer Jr., for instance, is chief of the National Heart, Lung and Blood Institute’s molecular disease branch. In 2003, he wrote an article promoting the benefits of Crestor, a cholesterol-lowering medicine from AstraZeneca.

The article was published in a medical journal “supplement” that was paid for by AstraZeneca, and Dr. Brewer’s N.I.H. title was prominently displayed.

The article failed to mention potentially serious safety problems with Crestor.

In the interview last year, Dr. Zerhouni distanced himself from Dr. Brewer’s Crestor article, saying that it was a “marketing effort” and “a product-driven endorsement” that should be banned.

Dr. P. Trey Sunderland, a senior researcher at the National Institute of Mental Health, received more than $500,000 in consulting fees from Pfizer at the same time that he was collaborating with it in his government capacity of studying patients with Alzheimer’s disease. Despite rules requiring that government scientists disclose their consulting arrangements to the health institutes, Dr. Sunderland failed to make such a disclosure.

Dr. Zerhouni has described Dr. Sunderland’s case as “a way outlier” that is being closely investigated.

Private consulting arrangements between N.I.H. researchers and drug and biotech companies were relatively rare until the 1980’s, when they slowly started to grow. They grew quickly after Dr. Harold Varmus, who was the institutes’ director in the 1990’s, decided to lift the limits on outside income, and administrators loosened disclosure rules about these activities.

When the House began investigating, it asked Dr. Zerhouni to produce a list of agency researchers who were consulting for companies and the amounts they made. At first, Dr. Zerhouni said such a list would be impossible to produce. The committee asked pharmaceutical companies to disclose a list of their consultants at the agency. Finally, Dr. Zerhouni produced a list of consultants.

But the lists produced by the drug companies included dozens of researchers who had not been listed by the institutes. Dr. Zerhouni said some of those names were errors. But, he said, the agency is investigating “30 or 40” people whose outside consulting arrangements were unknown to the institutes, and among them is Dr. Sunderland.

Neither Dr. Sunderland nor Dr. Brewer could be reached. An institutes spokesman also declined to comment.

Copyright 2005 The New York Times Company

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