Will NIH Ban on Consulting Deals with Drug Firms Set an Ethical Example? LAT / NYT

Will NIH Ban on Consulting Deals with Drug Firms Set an Ethical Example? LAT / NYT

Wed, 2 Feb 2005

The Los Angeles Times, whose investigative reports about conflicts of interest at the National Institutes of Health, shook the foundations of NIH by prying open the vaults that contained secret deals between NIH scientists and the drug and biotech industry, resulted in a ban on all financial ties between NIH staff and the drug and biotech industry.

Today the LAT reports that NIH director Dr. Elias Zerhouni

“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.”

Given Dr. Zerhouni’s year long resistence to ending conflicts of interest at the NIH – as he derided calls for complete bans as “ivory tower” proposals “that flew in the face of the agency’s need to work toward cures” – both he and Dr. Varmus reflect the same culture. That culture of self-interest and entitlement contrasts sharply with the cultural climate in medical research when the polio vaccine was developed.

When Dr. Jonas Salk was asked about the patent rights to the vaccine, he replied:

“Who owns my polio vaccine? The people! Could you patent the sun?”

Today, scientists who have produced no medical breakthroughs nor improved the treatment of the sick, are in partnerships with the drug industry and biotech venture capitalists, patenting our genetic code for profit–without any demonstrable evidence of a societal benefit. These medical entrepreneurs at the nation’s premier academic medical centers have grown accustomed to expect that their status is a license for self-enrichment, disobeying laws and regulations that others must abide by.

If the professional medical associations and their institutes of ethics /bioethics will not take a position to stem conflicts of interest in medical research, as the director of NIH finally did, then taxpayers are likely to exert the power of the purse to rein in unbecoming conduct at academic research centers. Perhaps, that may restore a moral conscience to a once noble profession.

Contact: Vera Hassner Sharav
212-595-8974

http://www.latimes.com/news/nationworld/nation/la-na-nih2feb02,1,5273080.story

THE LOS ANGELES TIMES
NIH Seeks ‘Higher Standard’
Banning staff deals with drug firms will help set an ethical example, the agency director says.
By David Willman
February 2, 2005

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.

http://www.nytimes.com/2005/02/02/national/02ethics.html?oref=login

THE NEW YORK TIMES
Agency Scientists Divided Over Ethics Ban on Consulting
By GARDINER HARRIS
Published: February 2, 2005

New rules prohibiting outside consulting arrangements by researchers at the National Institutes of Health have been welcomed by some scientists, with the agency’s director saying that group has “said that we needed this.” But others, said the director, Dr. Elias Zerhouni, have threatened “to walk across the street” to work for organizations that do not have such a ban.

The rules, formally announced at a news conference on Tuesday, ban consulting arrangements by scientists at the agency and pharmaceutical and biotech companies.

“There’s no doubt that among the majority of the 5,000 scientists who never did anything wrong and never broke any rules, they see this as being taken into a tsunami of regulations,” Dr. Zerhouni said.

Dr. Sheldon Krimsky, a researcher at Tufts University who specializes in science policy and ethics, said the changes were welcome, albeit overdue. “Imagine if someone working for one of the economic agencies of government made a deal with a company involved in forecasting and gave them privileged access to government data,” Dr. Krimsky said. “It would never have flown, but somehow biomedical scientists got away with it.”

The rules, which will take effect in a few days, grew out of revelations over the past year that some of the agency’s leading scientists had lent their names to drug industry marketing efforts.

Under them, N.I.H. scientists will be banned from working in either a paid or an unpaid capacity for drug and biotechnology companies, health care providers, insurers, trade associations and educational institutions that apply for money from the agency.

The rules will also ban top scientists from owning shares in drug or biotechnology companies. Lower-level employees will be able to own as much as $15,000 in company shares. Gifts of greater than $200 will be banned. Scientists will be prohibited from accepting many academic prizes.

“Nothing is more important than preserving the public trust,” Dr. Zerhouni said.

Banning consulting arrangements between government scientists and private companies is the only way to avoid such conflicts, Dr. Krimsky said.

For much of last year, Dr. Zerhouni insisted that some N.I.H. scientists should be allowed to continue their consulting arrangements, not only to prevent them from leaving the agency for more lucrative jobs elsewhere but also because such arrangements sharpened their skills. He derided calls for complete bans as “ivory tower” proposals that flew in the face of the agency’s need to work toward cures.

But revelations that some agency scientists had lent their names – and thus the name of the institution – to drug industry marketing efforts made him change his mind, Dr. Zerhouni said. He added that less strict proposals that simply banned consulting by top agency administrators would not have stopped lower-level scientists from being “a marketing tool for the outside party.”

Dr. Zerhouni said the rules would remain in effect until the agency decided to change them. But some said that such a change was unlikely in the foreseeable future.

Among the cases that Dr. Zerhouni has condemned is that of Dr. Bryan Brewer Jr., chief of the National Heart, Lung and Blood Institute’s molecular disease branch. In 2003, Dr. Brewer wrote an article promoting the benefits of Crestor, a cholesterol-lowering drug from AstraZeneca. The article was published in a medical journal “supplement” 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. Dr. Zerhouni has described Dr. Brewer’s Crestor article as “a product-driven endorsement.”

Cases like Dr. Brewer’s were revealed in a series in The Los Angeles Times as well as in hearings held by the House Energy and Commerce Committee. The committee’s investigation uncovered 30 to 40 N.I.H. scientists who were consulting for drug and biotechnology companies but who had failed to inform the agency or get permission for these arrangements.

Dr. Zerhouni said that many of the cases were still under investigation, and that some of those employees could be disciplined. Sanctions could vary from counseling to dismissal, another official said.

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