NIH Panel Recommendations Fail to Resolve Conflicts of Interest

NIH Panel Recommendations Fail to Resolve Conflicts of Interest

Date: Fri, 7 May 2004

Following the disclosure by the Los Angeles Times (December 2003) that “NIH officials now allow more than 94% of the agency’s top-paid employees to keep their consulting income confidential,” Congress demanded full disclosure and an overhaul of NIH policies to prevent conflicts of interest. “We know that there are financial relationships at all levels, not just at the top, and the taxpayers deserve to know the extent of those relationships,” Congressman Henry Waxman said.

A blue ribbon panel appointed by NIH director, Dr. Elias Zerhouni, released its report, recommending a complete ban on NIH employees accepting company stocks or stock options, and a prohibition on directors and deputy directors from accepting funds from industry. However, the panel would allow NIH scientists to continue to moonlight as industry consultants for up to 400 hours, and permit them to supplement their salaries by an additional 50% from industry. Furthermore, the panel would allow NIH scientists to keep the nature of those contracts secret–thereby preventing any verification of their activities.

How could the NIH panel fail to grasp that industry’s undue influence has undermined the safety of human subjects, the integrity of medical research and the scientific literature? Probably, because the panel reflects the culture of entitlement that has taken root at the NIH, and within the academic research community generally. This panel skirted the issue of harm done by not interviewing any of the victims of NIH research in which conflict of interest was a factor. They listened only to scientists who want to continue to moonlight while enjoying their full salary, benefits, comfort and prestige of federal employment at NIH.

To restore public trust and ensure that public health policies are not established on the basis of tainted reports, it is essential that scientists who receive public funds, disengage from ANY financial ties to industry. Lack of independence has impeded the scientific process. Scientists who have received payment from pharmaceutical companies have misrepresented research findings by concealing evidence of adverse effects and reporting inflated benefits of drugs. See: http://www.latimes.com/news/nationworld/nation/la-na-nih7dec07,1,7108097.story?coll=la-home-headlines

The scientific method requires open, free exchange of scientific findings, access to complete data without concealment of negative findings–so that such findings may be validated independently. But the recommendations by a panel composed of research stakeholders only partially address the underlying corrosive conflicts of interest. The NIH-appointed panel appears to endorse the notion that it is possible to be “a little bit pregnant.”

Dr. Zerhouni stated: “I can’t stand having the appearance of conflict or uncertainty in our rules that lead to a loss of trust in what we do.” But he has failed to comply with Congressional “requests to identify all of the agency scientists who have accepted payments from industry in recent years, and the circumstances surrounding those arrangements.”

Clearly these matters will be resolved only by independent citizens-not by stakeholders in medical research. Congress would do well to apply Ronald Reagan’s maxim: “trust but verify.”

Contact: Vera Hassner Sharav
Tel: 212-595-8974

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http://www.latimes.com/news/nationworld/nation/la-na-nih7may07,1,5334051.story?coll=la-home-headlines

THE LOS ANGELES TIMES May 7, 2004 Panel Wants Top Health Officials Off Drug Payrolls By David Willman,

BETHESDA, Md. – Senior officials at the National Institutes of Health should be barred from accepting income of any kind from drug companies, a panel examining conflict of interest at the agency recommended in its final report Thursday.

The long-anticipated report of the Blue Ribbon Panel on Conflict of Interest Policies places the greatest pressure to date on NIH Director Elias A. Zerhouni to toughen agency policies. The report urged Zerhouni to adopt the recommendations “as quickly as possible.” Zerhouni appointed the 10-member panel in response to articles in the Los Angeles Times in December revealing that NIH employees had accepted hundreds of payments from drug companies totaling millions of dollars, and that more than 94% of the top-paid NIH employees were not filing public income-disclosure reports.

The panel also recommended that nearly all of the 5,000 or more career scientists at the NIH be prohibited from accepting stock or stock options as compensation. “This is needed to assure the continued, deserved public confidence in the extraordinary work of NIH,” the report concluded.

However, the panel said that most career NIH scientists should be allowed to accept company consulting fees and should not be required to publicly disclose such payments – a position that is likely to draw questions next week at a congressional hearing into NIH’s relations with industry.

Zerhouni did not say whether he would embrace the recommendations. The NIH director told reporters Thursday that he wanted to meet “one more time” with the panel. Zerhouni is already under pressure to enact changes. The inspector general at the Department of Health and Human Services is investigating the conduct of several NIH employees, according to people familiar with the inquiry.

Both the inspector general and the General Accounting Office, the investigative arm of Congress, are examining NIH ethics policies. And the House Oversight and Investigations Subcommittee has scheduled for Wednesday the first of what are expected to be at least two hearings this spring into drug company payments to NIH employees. Just before the blue-ribbon report was released, the subcommittee’s chairman said the NIH had not complied with requests to identify all of the agency scientists who have accepted payments from industry in recent years, and the circumstances surrounding those arrangements. Rep. James C. Greenwood (R-Pa.) said that he complained to Zerhouni by phone Tuesday. “I told him I thought we’d been slow-rolled and stonewalled,” Greenwood said in an interview. “As far as I’m concerned, widespread reluctance to divulge this information is the message in and of itself.”

A senior Democrat on the subcommittee, Rep. Henry A. Waxman of Los Angeles, said that, contrary to the blue-ribbon panel’s recommendations, the NIH should require far-reaching public disclosure of any payments from drug companies. The blue-ribbon report, he said, “doesn’t appear to go far enough.” “We know that there are financial relationships at all levels, not just at the top, and the taxpayers deserve to know the extent of those relationships,” Waxman said.

When Zerhouni appears before the House subcommittee Wednesday, he is to be joined by the two men he appointed to co-chair the blue-ribbon panel: Bruce Alberts, president of the National Academy of Sciences; and Norman R. Augustine, retired chairman of Lockheed Martin Corp. Both Alberts and Augustine lauded and thanked the NIH staff for its assistance in the panel’s work. Their goal, the co-chairmen said, was to “do no harm,” while making recommendations to strengthen the agency’s handling of conflicts of interest. In explaining why they proposed a complete ban on employees accepting company stocks or stock options, Augustine and Alberts said such compensation could prompt people to become unduly concerned with a company’s financial success.

Of the NIH scientists now employed as paid consultants to industry, roughly 25% of them have been paid in such securities, Augustine said. The panel reported that 120 NIH scientists as of this month have active consulting deals. Zerhouni noted that as of late January, the total stood at 228 scientists. He acknowledged that some employees could be waiting for the agency’s policies to be resolved before resuming outside employment.

Under the panel’s recommendations, outside pay would not exceed 50% of the employee’s government salary, and the employees would devote no more than 400 hours a year to such outside arrangements. The scores of NIH officials who would be barred by the new recommendations from receiving compensation from companies would be the directors of the agency’s 27 research institutes and centers, plus all deputy directors, officials who direct research on humans, scientific directors and officials responsible for dispensing NIH grants. “Because of the public and national leadership roles played by senior NIH officials, financial relationships with industry may have the appearance of giving preference to certain private interests over the public’s interests or of giving preference to one private interest over another,” the report said.

The panel recommended that senior employees at the NIH begin filing annual income-disclosure reports that were open to public inspection. Zerhouni early this year ordered at least 93 additional officials to begin filing the public disclosure reports. But the panel declined to endorse such disclosure for many other NIH employees. Instead, the panel called for increased “internal disclosure” by NIH employees of outside income. Such disclosures would be exempt from the Freedom of Information Act, keeping payments to employees from drug companies locked from public view.

As an alternative to banning paid deals with industry or requiring far wider public disclosure, the panel saluted Zerhouni’s recent formation of an ethics advisory committee, composed of senior agency officials, which evaluates employees’ requests to engage in paid deals with drug companies and other entities.

Augustine and Alberts said that they feared that an agencywide ban could impede hiring or retaining the best scientific talent; that they wanted the NIH’s policies to be consistent with those of major universities that allow faculty to moonlight; and that consulting for industry could help translate scientific discoveries into beneficial health treatments or products.

Representatives of the NIH distributed advance copies of the blue-ribbon report Wednesday to members of Congress. One, Sen. Edward M. Kennedy (D-Mass.), said the panel’s “thoughtful recommendations will help NIH make certain that its integrity is untarnished by financial conflicts of interest.” Kennedy termed the report an “urgent call for positive change,” saying, “Congress has a responsibility to give Dr. Zerhouni and NIH the strong support they need to implement these essential reforms.”

Others greeted the report less enthusiastically. If Zerhouni continues to embrace drug-company consulting payments for NIH employees while resisting full public disclosure, the public will be ill-served, said Michael S. Josephson, a lawyer in Los Angeles who specializes in ethics and conflict-of-interest policy.”We need to try to prohibit those kinds of relationships which under the best of circumstances can create an appearance of impropriety,” Josephson said, adding, “Disclosure provisions are cumbersome, but they’re required of all kinds of government officials, because experience has taught us that the ‘trust us’ rationale is not reliable.. Transparency is the most effective antidote.”

Much of the specific conduct detailed by The Times would be prohibited under the changes recommended by the blue-ribbon panel. For instance, two senior-level officials, Dr. Stephen I. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and Dr. John I. Gallin, director of the NIH Clinical Center, accepted hundreds of thousands of dollars in industry consulting payments. On Thursday, Zerhouni noted that both Katz and Gallin, whose federal salaries were $200,000 and $225,200, respectively, ended their involvement with the companies after publication of the articles in The Times. Both officials have said that their outside deals were approved by others at the NIH. The blue-ribbon panel’s report said that the group “did not investigate specific allegations or review individual cases under investigation elsewhere.” The report did not elaborate.

C 2004 The Los Angeles Times

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http://www.washingtonpost.com/wp-dyn/articles/A6825-2004May6.html
The Washington Post
NIH Panel Backs Tighter Limits on Outside Income
By Rick Weiss
May 7, 2004 A-31

High-level employees at the National Institutes of Health should be subject to greater limitations on the amount and type of compensation they receive from pharmaceutical and biotechnology companies and should be required to disclose more details about those arrangements than under current rules, a blue-ribbon panel on NIH conflict-of-interest policies has concluded.

But saying the nation has much to gain from NIH’s ability to attract top scientists to its ranks, the panel — appointed by NIH Director Elias A. Zerhouni — also called for fewer restrictions on earnings from outside teaching, writing and speaking engagements. The panel also asked Zerhouni and Congress to work together to find new mechanisms by which top scientists could be offered higher salaries.

The 109-page report, published in draft form yesterday www.nih.gov/about/ethics_COI_panelreport.pdf), is the first of several to be released in the coming months focusing on conflicts of interest at the agency. Spurred by news media allegations last fall that NIH scientists were becoming unduly influenced by lucrative outside arrangements and subsequent congressional inquiries, investigations have been launched by the Department of Health and Human Services inspector general, the Office of Government Ethics, and the General Accounting Office.

The panel, co-chaired by Bruce Alberts, president of the National Academy of Sciences, and Norman R. Augustine, executive chairman of Lockheed Martin Corp., was not asked to look at specific allegations. The goal was to assess NIH rules for avoiding and disclosing potential conflicts and recommend improvements. The panel found a complicated and inconsistent patchwork of regulations and practices that had evolved over more than two decades. “These rules are widely misunderstood by some of the very people to whom they are intended to apply,” the panel concluded, “thereby creating uncertainty as to allowable behavior and adversely affecting morale.”

One of the more glaring problems involved the growing number of scientists hired under “Title 42” — a provision that allows specialists to be paid more than the standard federal pay grade allows. Because of arcane legal language, such employees have been exempt from filing the detailed financial disclosures required of many workers who earn less.

At the same time, the panel found that under current rules, NIH scientists are too often precluded from talking about their work at scientific meetings or in other public settings — and have even understood, albeit sometimes incorrectly, that they are not allowed to accept professional awards — a situation that has left some feeling divorced from the larger scientific community. “These are important — even essential — activities for NIH scientists . . . part of the tradition of science” that help make public service worthwhile, the panel said.

Growing pressure to transform basic research discoveries into cures has necessitated more collaborations with industry, the panel concluded, which increases the risk of real or perceived conflicts of interest and a loss of public confidence. Yet the best preventive for such perceptions, full financial disclosure, can drive top scientists to the private sector, the panel said.

Ultimately the panel recommended that NIH senior managers and others who have a say in how grant money is distributed should be banned from consulting for drug or biotech companies or paid academic consultancies. For those who do consult for industry or academia, outside earnings should not exceed 50 percent of their base salary (100 percent for health practitioners performing patient care) and no one source should account for more than 25 percent of their NIH salary. Moreover, no NIH employee should be compensated for outside work with stock options — forms of remuneration that the panel said have too much long-term growth and influence-peddling potential. And employees should not spend more than 400 hours a year on outside work, except for writing.

A few recommendations would require rule changes or legislation, including one that would allow compensation for teaching and speaking engagements at currently restricted venues and another that would beef up the extent of financial disclosure. Zerhouni, who praised the report as “very thoughtful and very thorough,” said he would weigh the recommendations carefully with an eye toward implementing them, “the sooner the better.”

“I can’t stand having the appearance of conflict or uncertainty in our rules that lead to a loss of trust in what we do,” Zerhouni said. The proposed changes, he predicted, “will make a huge difference in how the public relates to NIH and the way NIH functions.”

Zerhouni has already made policy changes to boost financial disclosure from nearly 100 previously exempt employees. Former NIH director Harold Varmus, under whose direction some conflict of interest rules were loosened in 1995 — a time, he said, when government was less “sophisticated” about the issues — said he generally supported the report. “I’m happy they endorse the idea that outside activities are an essential component of being an NIH scientist and the salary scale has to be competitive with the outside world,” said Varmus, now president of Memorial Sloan-Kettering Cancer Center in New York.

The Association of American Medical Colleges released a statement urging speedy adoption of the recommendations “to sustain and strengthen the public’s essential trust” in the NIH.

C 2004 The Washington Post Company

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