Healthy Skepticism Library item: 326

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Publication type: news

Weiss R.
NIH Panel Backs Tighter Limits on Outside Income
The Washington Post 2004 May 7

Full text:

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.