NIH seeks regulation on research paid for by drug firms - three articles

Posted by Editor on February 6, 2005:

NIH to Ban Deals With Drug Firms
Los Angeles Times, February 1, 2005

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, Times Staff Writer

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.
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NIH Seeks "Higher Standard"
Los Angeles Times, February 2, 2005

Banning staff deals with drug firms will help set an ethical example, the agency director says.

By David Willman, Times Staff Writer

BETHESDA, Md. - The director of the National Institutes of Health, Dr. Elias A. Zerhouni, said that rules he announced Tuesday banning all staff scientists from taking drug-company fees would help the federal research agency set the highest ethical example.

Referring to the pervasive intermingling of pharmaceutical marketing with medical research nationally, Zerhouni said the time had come for the NIH to provide "at least one source of public health information in the country that can be completely trusted."

"We believe that we need to hold NIH and ourselves as scientists at NIH to a higher standard, because we do have national public health responsibilities," he told a news conference at the agency's headquarters.

The new restrictions, agreed on by Zerhouni and senior officials with the Office of Government Ethics and the Department of Health and Human Services, are intended to be permanent, he said.

According to a summary issued by the NIH, employees also would be banned from moonlighting for research institutions receiving NIH funds, for health insurers and for "related trade, professional or similar associations." And virtually all staff scientists at the NIH would be prohibited from holding investments in biomedical companies.

Zerhouni, 53, said that his endorsement of the restrictions marked a turnabout.

For the better part of the last year, the NIH director had fought against imposing an across-the-board ban on industry consulting, saying that the paid arrangements generally helped translate scientific discoveries into medical remedies for patients.

"I've changed my mind," Zerhouni said.

"I'm not confident that we can continue to pretend that we have a system that works," he told reporters. "We will never go back to the old rules - that's for sure."

Last year, Zerhouni supported banning only the most senior officials at NIH, including the directors of the agency's research centers and institutes, from moonlighting for pharmaceutical and biotechnology companies. The vast majority of the NIH's more than 5,000 staff scientists should be allowed to work for the companies, Zerhouni had said, because those employees did not have the power to dispense research grants.

In explaining his change of position, Zerhouni pointed to evidence brought to his attention over the last 14 months. He cited reports published in December 2003 by the Los Angeles Times as raising "real concerns" that prompted him last year to appoint an advisory committee focused on conflict-of-interest issues.

The 2003 reports, along with articles published by The Times last year, raised questions about NIH scientists' impartiality in overseeing clinical trials and in making recommendations to doctors for treating patients. The articles were cited by congressional leaders in their requests to Zerhouni a year ago for documentation of the drug industry payments to NIH scientists. Those and other records reviewed recently by The Times identified at least 530 NIH scientists who accepted fees, stock or stock options from biomedical companies from 1999 through 2003.

The scientists typically were required by the companies to sign confidentiality agreements as a condition of their outside employment, inhibiting their freedom to discuss related scientific matters with colleagues at the NIH. The compensation paid to the agency scientists totaled in the millions of dollars.

Zerhouni's support for the new restrictions drew bipartisan praise Tuesday.

"I want to commend Dr. Elias Zerhouni for taking a step that is both difficult and necessary," said Rep. Joe Barton (R-Texas), chairman of the House Energy and Commerce Committee, whose oversight and investigations subcommittee conducted three hearings last year into conflicts of interest at the NIH.

Barton added: "For the National Institutes of Health to do the complex work of thwarting disease and saving lives requires near-absolute public confidence in the people who conduct the research. If the notion that private gain is supplanting public service as the guiding light for health research, NIH's value to our nation will plummet."

Sen. Tom Harkin of Iowa, senior Democrat on the Senate appropriations subcommittee that oversees the NIH budget, said, "I welcome [NIH's] decision today to ban consulting deals between all of its employees and pharmaceutical and biotech companies. NIH's well-deserved reputation as the world's premier biomedical research agency was in danger of being tarnished as a result of recent revelations that some NIH scientists had flouted the agency's guidelines on preventing conflicts of interest."

The new rules will not prevent all paid outside activities.

According to Zerhouni aides, employees will still be allowed to teach courses at universities, write general textbooks and perform reviews for scientific journals. They will be allowed to work shifts at hospitals and to otherwise practice medicine part time. Agency employees could also accept fees for speaking to physicians at medical-education events funded by biomedical companies, if the money came in the form of an unrestricted grant and if the subject to be discussed did not overlap with the scientist's area of expertise at the NIH.

Zerhouni and other senior administrators declined Tuesday to discuss the status of internal conflict-of-interest investigations. The director says that "the cases concern a few dozen scientists."

Zerhouni told reporters that though the crackdown on industry payments had drawn mixed reactions from staff scientists, he had had no recent difficulties recruiting talented personnel.

Without referring to his predecessor by name, Zerhouni also suggested that the seeds of the NIH's difficulties with conflict of interest were sown in 1995, when then-agency Director Harold E. Varmus quietly lifted a range of restrictions on moonlighting in the industry. Varmus allowed all NIH employees - including institute and center directors - to enter into deals with drug companies and to accept stock and stock options as compensation.
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Los Angeles Times, January 28, 2005
NIH Seeks Outside Inquiry of Scientist

Agency ethics officials target an Alzheimer's researcher who accepted more than $500,000 from a drug company and did not report it.

By David Willman, Times Staff Writer

WASHINGTON- Ethics specialists at the National Institutes of Health have requested an outside investigation of an Alzheimer's disease researcher who accepted more than $500,000 from a drug company without seeking permission or reporting the income to the agency as required, according to government officials familiar with the matter.

In response, the investigations unit of the inspector general's office at the Department of Health and Human Services has opened an inquiry into the researcher, Dr. P. Trey Sunderland III, the officials said.

Among the circumstances being investigated is whether Sunderland's conduct violated federal conflict-of-interest law, they said.

The inspector general's office is empowered to subpoena documents and to question witnesses. It also may refer a matter for criminal prosecution to a local U.S. attorney's office or to the Justice Department.

Based on interviews and public records, the Los Angeles Times reported last month that Sunderland's paid services for Pfizer Inc. often overlapped with his government role. For instance, at the same time that Sunderland accepted consulting and speaking fees from Pfizer, he led a study of Alzheimer's patients in which the company collaborated.

In the spring of 1998, Sunderland's NIH staff began providing the company with samples of spinal fluid that the government employees collected from elderly patients who had visited the agency's research hospital in Bethesda, Md. The research collaboration with Pfizer spanned about five years.

Sunderland, 53, has focused at the NIH on finding ways to detect Alzheimer's disease before a patient develops pronounced symptoms. And Pfizer, along with a corporate partner, Eisai Inc., stands to gain billions of dollars in sales from the early-stage treatment of Alzheimer's.

The Times article last month reported that Sunderland also was a paid consultant to Eisai in recent years, according to information recently provided to the NIH by his attorney. The two companies jointly market a drug called Aricept, which is approved for treating the symptoms of mild to moderate Alzheimer's. The once-a-day pill generated worldwide sales of $1.6 billion in 2003, making it the top-selling Alzheimer's drug.

Sunderland endorsed the use of Aricept during a televised presentation at the NIH in September 2003. Viewers of the event, broadcast by C-SPAN, had no way of knowing about Sunderland's affiliation with Pfizer or with Eisai.

On more than 80 occasions from 1999 to June 2004, Sunderland was paid by Pfizer for speaking appearances at conferences in the U.S. and overseas, documents show.

Investigators are now examining whether Sunderland used vacation hours for all of his private appearances or whether he spoke for Pfizer while on government time, according to officials familiar with the inspector general's probe.

Sunderland's attorney, Robert F. Muse, declined to comment for this article. In a letter last month to the director of the NIH ethics office, Muse said Sunderland had not tried to hide his dealings with Pfizer or other companies.

"Dr. Sunderland has committed no unethical acts," Muse wrote. "His failures have been in the context of not keeping and filing proper paperwork."

Throughout the NIH, Muse wrote, the monitoring of financial relationships between the government scientists and their outside employers has been characterized by "indifference, lack of enforcement and administrative shortcomings."

Internal NIH e-mails show that Sunderland was aware of agency conflict-of-interest rules that could ban him from taking consulting fees from a company, like Pfizer, that maintained a formal research agreement with the NIH.

In e-mail exchanges in March 1999 that had not previously been made public, an NIH ethics officer, Olga Boikess, asked Sunderland about a lecture that he had delivered at a psychiatric conference. On March 23, 1999, Sunderland replied:

"I can tell you that I have no CRADA's or MTA's with any European pharmaceutical company, so there should be no possible conflict of interest."

CRADA is shorthand for "cooperative research and development agreement." An MTA is a material transfer agreement, an arrangement to exchange proprietary material or information.

In 1998, Sunderland's NIH staff had begun providing Pfizer with samples of the spinal fluids under terms of a material transfer agreement. Pfizer pledged to provide analyses of the samples.

Starting that year, and continuing through 2003, Pfizer paid Sunderland consulting and speaking fees totaling $508,050, records reviewed by The Times show. Related documents describe how Sunderland received fees from Pfizer as recently as June 3, 2004.

The NIH over the last decade has allowed employees who seek advance approval to enter into a wide variety of paid positions with pharmaceutical and biotechnology companies. However, NIH policies have consistently forbidden its scientists from accepting income from a company that is collaborating with their government laboratory.

Ethics specialists under the director of the NIH, Dr. Elias A. Zerhouni, requested the inspector general's investigation of Sunderland, according to the officials familiar with the matter, who spoke on condition of anonymity. A deputy NIH director assigned by Zerhouni to oversee ethics matters, Dr. Raynard S. Kington, has said that he is not at liberty to discuss the specifics of any internal review or investigation.

However, an in-house newsletter at the NIH this month, paraphrasing Kington, said agency officials were "investigating every case that has come to light of inappropriate outside activities at NIH." The newsletter quoted Kington as saying that "fairly soon, we'll enter the penalty phase of these investigations. … Some employees have substantially violated rules and regulations."

It has been nearly 13 years since an NIH scientist was prosecuted and convicted for an offense related to a conflict of interest. The scientist, Prem S. Sarin, repaid $25,000 to a German pharmaceutical company involved with AIDS research. A federal judge also sentenced him to two months of community service. He had faced a maximum sentence of about 20 years in federal prison, said his lawyer, W. Neil Eggleston.

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