Unhealthy Ethics? The Price of NIH Credibility_ Editorials: WashPost / Los Angeles Times

Mon, 11 Apr 2005

Compare and contrast two editorials that focus on the new conflict of interest rules that were adopted by Dr. Elias Zerhouni, director of the National Institutes of Health, to rein in the corrupting influence of the pharmaceutical industry on research.

“Before he laid down the law, staff scientists were accepting lucrative consulting fees and other deals with the very biomedical industries whose products they were supposed to be independently reviewing.”

Indeed, the restrictions were adopted after a large body of evidence was uncovered by the Los Angeles Times, two Congressional committees, and by The Associated Press. At least 530 scientists at the NIH were implicated as having significant financial ties, including consultancy fees, stock or stock options, in biomedical companies between 1999 and 2003.

NIH scientists were shown to have undermined the safety of human subjects of research and to have misrepresented the findings of research regarding products of companies with whom they had financial ties. The magnitude and consequences of NIH Scientists’ misconduct prior to the new rules, led lawmakers to accuse NIH leaders (who were dragging their feet) of encouraging “the option of corruption.” See:
https://ahrp.org/infomail/04/05/18.php

Contrary to the assertions by a group of vociferous dissident NIH staffers–whose cause has been taken up by The Washington Post– “the new rules don’t bar researchers from meeting with corporate scientists. Researchers also may accept up to $150,000 annually in royalties if companies license their discoveries and develop a product, though there are tough reporting requirements on the income.”

Critics of the new rules restricting financial deals with industry, claim they will result in “a brain drain.” But the few who will leave will be replaced by scientists who are not driven by greed. Their replacements are likely to be ethical, conscientious, and highly competent scientists who would seek out a center of research where scientists could maintain their integrity and independence–and be “free from the increasingly brazen control that biomedical industries are exerting over research.”

Inasmuch as the NIH is in the backyard (so to speak) of The Washington Post, it is difficult to understand why The Post has, not only failed to investigate research misconduct at NIH, but has taken up the cause of those opposed to the necessary restrictions on outside financial deals.

Contact: Vera Hassner Sharav
212-595-8974

http://www.latimes.com/news/opinion/editorials/la-ed-nih11apr11,0,7214981.story?coll=la-news-comment-editorials

THE LOS ANGELES TIMES
EDITORIAL
The Price of NIH Credibility

April 11, 2005

Elias A. Zerhouni, the director of the National Institutes of Health, is being battered by his own scientists and by Congress to ease the strict conflict-of-interest rules he imposed last month.

Zerhouni should stand them off. Before he laid down the law, staff scientists were accepting lucrative consulting fees and other deals with the very biomedical industries whose products they were supposed to be independently reviewing.

Protesting NIH staff scientists and members of Congress opposing the new regulations would have us think Zerhouni intends to bulldoze the agency’s 300-acre campus in Bethesda, Md., and turn it into a garment-district sweatshop. In fact, the new rules don’t bar researchers from meeting with corporate scientists. Researchers also may accept up to $150,000 annually in royalties if companies license their discoveries and develop a product, though there are tough reporting requirements on the income.

Zerhouni’s critics claim that the new rules will lead to a cataclysmic brain drain. Yes, a few people might leave. But the rules also should bolster the agency’s status as one of the few places where scientists can work with true autonomy, free from the increasingly brazen control that biomedical industries are exerting over research.

A Government Accountability Office study released two months ago found that the previous NIH policies “could call into question the quality and independence of federally funded research.” There could hardly be a better reason for change.

A few of Zerhouni’s rules, such as his prohibition on accepting prizes or awards of more than $200, may need slight softening. In other areas, they don’t go far enough.

The rules don’t apply to the non-staff scientists who receive the lion’s share of the agency’s money at universities across the country. Last month, after a Times editorial pointed that out, Zerhouni acknowledged the problem. We urge him again to act.

When university researchers apply for NIH grants, they should have to disclose any financial interests in the research they are proposing to conduct.

The applications are open to Freedom of Information requests, giving the public a chance to know of possible conflicts of interests in the use of federal grant money.

At Senate hearings last week, Sen. Tom Harkin (D-Iowa) sided with the complaining scientists and dangled a possible NIH budget increase in an implicit tit-for-tat for softer rules. That’s just strong-arming.

Zerhouni is trying to restore scientific credibility to an agency that had allowed one of its top scientists, P. Trey Sunderland III, to pocket half a million dollars from Pfizer Inc. even as he was evaluating Pfizer drugs for the NIH.

Would Harkin want to buy a drug for his family that was developed in this manner?

http://www.washingtonpost.com/ac2/wp-dyn/A28425-2005Apr5?language=printer

THE Washington post Unhealthy Ethics Wednesday, April 6, 2005; Page A18

WE DON’T NORMALLY find ourselves in the position of arguing that ethics rules are too restrictive. Then again, we don’t normally encounter ethics rules as overbroad, intrusive and unnecessarily punitive as those recently put in place by the National Institutes of Health. The NIH ethics rules needed to be tightened, especially in light of reports involving possible conflicts of interest by government researchers who also engaged in lucrative outside consulting work. But the new rules represent an ultimately self-defeating overreaction.

The latest illustration of this comes in an e-mail sent Monday afternoon to employees at one of NIH’s component institutes, the National Institute of Dental and Craniofacial Research. This guidance — misguided, as it turns out — tells all employees that they must submit forms in advance before engaging in any outside activities, paid or unpaid, “even if it seems obvious that they in no way impinge on your duties as a public servant.” It offers such examples as coaching a children’s soccer team, serving as a Girl Scout leader, tutoring Spanish, or moonlighting as a sales clerk or house painter. As the e-mail itself notes, “these reporting requirements seem extreme and wholly unnecessary.”

In fact, the e-mail got the new rules wrong, as red-faced NIH officials acknowledged yesterday. They cover only outside “employment,” so Girl Scout troops won’t be left leaderless. NIH officials have already asked the Department of Health and Human Services to carve out other broad exemptions for employment that has nothing to do with NIH activities. “We will not have people filling out a 16-page form to go coach basketball one night a month for $15,” Deputy Director Raynard S. Kington told us yesterday. “It’s just not going to happen. We aren’t quite that dense.”

To the extent that NIH is trying to take far-reaching rules and apply them in more sensible ways, it deserves credit. For example, the agency has already said that the broad new prohibition on holding more than a small amount of pharmaceutical or biotechnology stock — even in companies entirely unrelated to an employee’s field of research — won’t apply to NIH fellows, who come for just a few years of training and aren’t in positions of authority that could produce conflicts of interest. But the fundamental problem with the NIH rules remains that they sweep in, rather senselessly, all 17,500 NIH employees, instead of being narrowly focused on the far smaller group of people whose positions could be most susceptible to ethical concerns.

On Monday, as the mistaken e-mail was being circulated, a group of NIH employees filed comments with the Department of Health and Human Services and filed a court notice that they would challenge the rules. Their criticisms ought to be taken seriously. For example, under the rule, at least one-third of the NIH workforce — scientists at a senior-enough level that they have to file confidential financial disclosure forms, and those involved in dispensing grants — would be prohibited, along with their families, from holding any stock whatsoever in pharmaceutical or biotechnology firms, even if such holdings had no connection, however remote, to their work.

These rules are already taking a toll on NIH staffing: James F. Battey, chief of NIH’s human-stem-cell program and director of that agency’s deafness institute, cited the rules in announcing his retirement, and a Duke University physician has postponed taking the helm of the National Institute of Environmental Health Sciences. The brass at NIH and HHS should heed the lesson: Ethics rules that make no sense can be almost as damaging to an institution as rules that are too lax.

© 2005 The Washington Post Company

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