Van Hollen Concerned about Effect of New NIH Disclosure Rules

Van Hollen Concerned about Effect of New NIH Disclosure Rules

Washington, D.C. - United States Representative Chris Van Hollen (D-MD) sent the following letter to Dr. Elias Zerhouni, Director of the National Institutes of Health.


Dr. Elias Zerhouni
Director
National Institutes of Health
1 Center Drive
Room 126, MSC0148
Bethesda, MD 20892-0148

Dear Dr. Zerhouni:

I am writing with respect to the application of the new conflict of interest regulations for NIH employees. As you know, my Congressional district is not only home to the NIH campus but to thousands of its employees.

The National Institutes of Health are one of our nation's greatest assets. It is essential that we uphold the trust the American people have placed in NIH. The public must remain confident that NIH employees are protecting the public interest. That is why I support strong ethics rules designed to prevent conflicts of interest.

I believe that some of the newly published rules - while well intended - are not carefully targeted at conflicts of interest. The rules should be drawn to apply to employees who have a conflict of interest without imposing unnecessary hardships on those who do not. I am very concerned that a "shotgun" approach to this issue will make it more difficult for NIH to attract and recruit the first-rate employees who are essential to ensuring NIH"s continued success.

I understand that you have stated that, over the next year, you will be analyzing the effect of these rules on the ability of the NIH to attract and retain employees. In my view, that period of review is too long. Employees are being required to abide by the divestiture requirements within the first 150 days of implementation. The effects on these employees, therefore, will be immediate. I would urge you to consider any adjustments to the rules in the short-term, rather than over the next year. The recent disclosure that investigators have cleared the majority of alleged wrongdoers of any impropriety also argues for reviewing some of these rules - which were drafted in response to that alleged wrongdoing -- sooner rather than later.

My major concerns about the new regulations include the following:

1. The regulations concerning stock divestiture in pharmaceutical, biotechnology and
medical device companies apply to all NIH employees, not just those involved in
performing and publishing biomedical research, awarding grants, or making policy.
Although the rules are less onerous for those employees who are not required to
file financial disclosure reports in that they can have individual holdings up to
$15,000, the divestiture rules apply to numerous employees who have no contact
with the areas likely to create potential conflict. The rules apply, for example, to a
clerk in the personnel department and to librarians, and to their spouses and
dependent children. They also seem to apply to temporary employees, including
medical residents and research fellows.

2. Long-time employees with investments that are now deemed "prohibited holdings"
may suffer financial loss due to the requirement to divest immediately. Even if the
rules are deemed to be reasonable as applied to future investments by current
employees or to new employees, it seems unfair for current employees to take a
financial loss, especially those employees who were never in violation of any ethics
rules. While it may be possible to postpone taxes on capital gains with a certificate
of divestiture, there is no relief for someone who will suffer a capital loss.

3. The rules being applied to scientists at NIH are not applicable to scientists at other
government agencies. This raises a basic issue of fairness, as it appears that NIH
employees are being subjected to onerous restrictions not imposed on similar
positions in other agencies.

4. Outside scientists who review NIH grant applications from other outside scientists or
who review the performance of NIH intramural scientists may well have conflicts of
interest, but are required only to complete disclosure forms. This is inconsistent
with the requirement that NIH intramural staff divest, rather than to disclose as their
counterparts do.

5. The regulations went into effect immediately upon publication, with the comment
period of sixty days running concurrently with the implementation of the rules. This
procedure precluded any public discussion of the regulations, including from
Members of Congress, prior to their taking effect.

Many of my constituents believe that NIH employees are being punished for the wrongdoing of a few and that less onerous regulations could be conceived that would deal with the crux of the conflict issue. Their concern, it appears, is a real one in terms of the effects that these new rules might have on the ability of NIH to recruit new employees at all levels, especially since stock divestiture applies not only to potential employees but to their spouses and dependent children. Retention of current scientists may be detrimentally affected as well.

Although no system of regulations may be foolproof, the deleterious effect of these rules on the ability of the NIH to recruit and retain the caliber of scientists required by its special mission is of great concern to me. While past abuses need to be dealt with and avoided in the future, a system of regulation that allows NIH to continue to attract and retain the finest employees in order to fulfill its mission is of the utmost importance.

I would appreciate your thoughts on adjustments that may be made to these rules and, particularly, the time frame in which they may be made.

Sincerely,



Chris Van Hollen
Member of Congress

http://www.house.gov/apps/list/press/md08_vanhollen/NIHDisclosurerelease.html