Healthy Skepticism Library item: 844

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Publication type: news

Wysocki B.
Some Scientists Say New Ethics Rules May Damage NIH
THE WALL STREET JOURNAL 2005 Mar 3

Full text:

The taxpayer-funded National Institutes of Health long has been a magnet for some of the world’s top scientists, drawn to its state-of-the-art laboratories, intellectual freedom, high-powered peers and good pay.

Now the federal government wants to treat these government employees more like, well, government employees. That is causing an uproar at the NIH, with some senior scientists predicting long-term damage to the organization’s recruiting and employee-retention goals.

The griping stems from stringent new ethics rules announced last month by NIH Director Elias Zerhouni to combat complaints from Congress and watchdog groups that some NIH scientists had lucrative outside activities that might be conflicts of interest. The new rules ban all 18,000 NIH staffers from consulting for the drug industry and other biomedical-related organizations. Dr. Zerhouni also announced that about 6,000 NIH employees would be barred from holding stock in pharmaceutical or biotechnology companies and must sell their current holdings. The rules restrict holdings of drug or biotechnology stocks by other NIH employees and sharply curtail honoraria.

While the rules are tougher than those that govern many federal employees, they are much like those that apply to people holding other sensitive federal jobs, such as scientists at the Food and Drug Administration.

Nevertheless, NIH scientists say they already are seeing the effect of the stricter rules. Elaine Jaffe, a section chief at the NIH’s National Cancer Institute, says she is struggling to hire a post-doctoral cancer specialist for a two-year fellowship. The candidate has consulting arrangements with a private company, which he might have to sever to join the NIH.

“He has multiple offers and needs an answer” as to whether the rules apply to him, says Dr. Jaffe, one of about 15 NIH scientists leading opposition to the new rules. She says she doesn’t want to recruit him on false pretenses but also doesn’t want to “sacrifice the quality” of new recruits. (NIH officials say they are “reviewing” whether the rules apply to post-doctoral fellows.)

The rules also have angered NIH lifers on a deeper level: Their pride is hurt. Internal NIH scientists — who have included five Nobel laureates — tend to want to be treated more like academic rock stars, not as functionaries in the bowels of the federal work force. To many of them, the rules reek of diminished status.

Even worse, the rules, which go further than previous restrictions imposed during the past few years, give many scientists the feeling they aren’t trusted. One rule: a ceiling of $200 on honoraria. The implication “is that I can be bought for $200,” says Edward Korn, chief of the laboratory of cell biology at the National Heart, Lung and Blood Institute and 50-year NIH veteran. “Many of us think it’s a personal insult.” Like many colleagues, Dr. Korn says he believes in tough ethics rules but thinks the new ones “overreach.”

An NIH scientist who is a leader of the opposition to the new rules, Ezekiel Emanuel, says he was forced to sell stock valued at $140,000 last month, noting that he can’t own, for example, General Electric Co. shares because it has a medical-imaging division. The tight rules apply “to my secretary, to the cleaning lady, to the electrician,” Dr. Emanuel says. “Rather than prevent conflict of interest, the rules take a meat cleaver” to outside activities and stock ownership, he adds. (Dr. Emanuel is the brother of Rahm Emanuel, a Democratic congressman from Illinois and former Clinton White House official.)

It isn’t the only gripe NIH scientists have these days. The NIH’s annual budget has reached a plateau after a five-year period in which it doubled to $28 billion. Its scientists also complain of a steady increase in what they call petty rules and bureaucratic procedures.

The tough ethics rules were designed to restore public trust in the NIH after months of revelations that some NIH scientists and officials enjoyed lucrative income from outside dealings with drug companies and others. In one case, a senior Alzheimer’s researcher received more than $500,000 from Pfizer Inc., which markets a leading drug to treat the disease. The scientist never disclosed the payments; the information surfaced after congressional investigators received voluntary disclosure of these and other payments from drug companies. In another case, an NIH scientist was working with a biotechnology company in an official capacity but also quietly was moonlighting at a competitor to that company.

Last summer members of Congress grilled Dr. Zerhouni in public and pressured him to tighten NIH ethics guidelines. Pressure also came from the Department of Health and Human Services, of which NIH is a part, and the Office of Government Ethics, which oversees ethics within the executive branch.

The tight guidelines mark a reversal of a mid-1990s strategy to loosen NIH ethics rules to put its researchers on a par with their peers at universities. That push was led by then-Director Harold Varmus, a Nobel laureate, who left in 1999 and now is president of Memorial Sloan-Kettering Cancer Center in New York. Under Dr. Varmus, the NIH boosted salaries by putting thousands of its scientists in a special, alternative pay category called Title 42 that allows top employees to earn as much as $200,000 a year, far above U.S. civil-service levels. Dr. Varmus also loosened restrictions on getting compensation from outside consulting activities, a perk routinely available to university scientists.

The potential competition from academia hasn’t faded. Dr. Zerhouni says he is alert to possible problems of recruiting and retaining talent and that is why the rules will be reviewed within a year and then possibly modified. He doubts the rules will produce wholesale exodus from the NIH but acknowledges the raw sentiments within the work force. “There is a sense of collective punishment” for the wrongdoing or dubious behavior of a few, Dr. Zerhouni says. “At a subliminal level, that makes them feel not only second class, but victimized and scapegoated.” The feeling is understandable but as government employees, Dr. Zerhouni adds, NIH personnel have to be held to a higher ethical standard than counterparts elsewhere.

It is uncertain whether the unhappy climate will lead to large-scale departures. NIH turnover rates have been falling since 2000 and for all their complaining, scientists may not be inclined to uproot their families and leave NIH’s leafy campus and the cutting-edge research that occurs there.

That said, some scientists warn that universities can be aggressive in their recruiting. NIH researchers are big draws, whether for their ability to help universities extract grant money from the NIH (about 80% of its budget flows to non-NIH scientists, mostly working at universities) or for the expertise they bring.

Albert Fornace, a star scientist at the NIH for 27 years, decamped last month to become a professor at Harvard School of Public Health, Boston. He says a number of factors prompted his departure, but the new ethics climate was an important consideration. “The ethics rules are irritating. I kind of feel you aren’t been treated as an adult, or even trusted,” Dr. Fornace says. “I think the NIH is a wonderful place to do research,” he adds. “You can do high-risk research.” He predicts, though, that recruiting and retention problems will mount. “I feel bad about NIH,” he says.