Forwarded message from Dr. Lynn Shepler:Dpartment of Health and Human Services
Public Health Service
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Bethseda, Maryland 20892
March 1, 2005
Lynn Shepler, M.D., J.D.
[email protected]
Dear Dr. Shepler:
Thank you for your February 13, 2005 e-mail correspondence to Dr. Elias
Zerhouni, Director of the National Institutes of Health (NIH)
[[email protected]]
elias.zerhouni AT nih.hhs.gov.
, regarding conflict-of-interest issues and
Lyme disease research, diagnosis and treatment. Dr. Zerhouni has
referred your correspondence to the National Institute of Allergy and
Infectious Diseases (NIAID), the component of NIH that leads federal
Government research on Lyme disease. As the Director of the NIAID
Office of Ethics, I am please to respond.
The public has been invited to comment on the proposed Government
conflict-of-interest rule. The rule is part of regulations that
supplement the Executive Branch Standards of Conduct, issued by the
United State Office of Government Ethics (OGE). As their website notes,
OGE "exercises leadership in the executive branch to prevent conflicts
of interest on the part of Government employees, and to resolve those
conflicts of interest that do occur. In partnership with executive
branch agencies and departments, OGE fosters high ethical standards for
employees and strengthens the public's confidence that the Government's
business is conducted with impartiality and integrity." For more
information on the executive branch ethics program, please see OGE's
website at www.usoge.gov.
Public comments on the proposed federal conflict-of-interest rule are
due by April 4, 2005. If you wish to comment on the rule, which is
located in the Federal Register at 5 CFR Section 5501, your suggestions
may be sent electronically to [email protected]. [ ethics AT hhs.gov ] The subject line should
read "Comments on Interim Final HHS Supplemental Ethics Rule."
It might be of interest to you that an independent study by the
Government Accounting Office (GAO) reported on June 22, 2001, that
federal employees at NIH and other HHS agencies were in compliance with
ethics rules and regulations as they relate to the research and
treatment of Lyme disease. There is nothing to indicate that this
situation has changed within the NIH.
Current ethics laws do not extend the Government's authority to
regulate conflict-of-interest behavior to individuals not employed by
the federal Government. Therefore, oversight of compliance with the
proposed rule does not extend to scientific researchers at
universities. In addition, the Government does not control the behavior
of state medical boards towards doctors in their state or examine
conflicts of interest among board members. These are matters that must
be addressed by appropriate state authorities.
I appreciate your support for strengthening the ethics program at NIH
and hope the information I have provided is helpful.
Sincerely,
Arthur Bennett
Director, NIAID Ethics Office
[email protected]
bennettar AT niaid.nih.gov
[Tel(301) 594-1660, fax (301) 402-8178]
[Comment by LS: I suggest that people familiarize themselves with this
issue, and write letters or emails to Dr. Zerhouni, Director of NIH,
and Arthur Bennett. Per Mr. Bennett, emails should be addressed to
[email protected], and the subject heading should read: "Comments on
Interim Final HHS Supplemental Ethics Rule." Dr. Zerhouni's email
address is [email protected].
For background information, see the articles by David Willman of the
Los Angeles Times. For the quickest way to access these articles, go to
Google, click on "News" and search "David Willman."
Most significant for those suffering from Lyme disease is that the
proposed rules only cover the scientists in the intramural program at
NIH (i.e., those who are NIH employees), and it does not cover
scientists in the EXTRAMURAL program at NIH -- those who receive
research grants through NIH now and in the past such as Steere,
Barbour, and others, and, of course, those affiliated with the fake
patient advocacy organization, the ALDF, and individuals who hold
patents on Lyme disease antigens, and so forth. Note that Arthur
Bennett refers to the GAO investigation of 2001 that was called for by
Connecticut Senator Chris Dodd and the Lyme Disease Foundation, a
report which many of us know to have been a whitewash and an enormous
disappointment after so much work.
See, also, the report by Pamela Weintraub, "Conflicts of Interest in
Lyme disease" posted on the LDA website, and the recent books by Marcia
Angell, The Truth About Drug Companies, Random House, 2004; Jerome
Kassirer, On the Take, Oxford University Press, 2005; and Sheldon
Krimsky, Science in the Private Interest, Has the Lure of Profits
Corrupted Biomedical Research? foreward by Ralph Nader, Rowman &
Littlefield Publishers, 2003. Dr. Angell and Dr. Kassirer are former
editors-in-chief of the New England Journal of Medicine; Sheldon
Krimsky is professor in the Department of Urban and Environmental
Policy and Planning at Tufts University ]
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