November 30, 2009

The Honorable Harry Reid
United States Senate
Washington, DC 20510

Re: Scientific Integrity in Health Care Reform (S.Amdt. 2786 to HR 3590)

Dear Majority Leader Reid,

As the Senate considers health care reform legislation, please ensure that provisions regarding scientific research are consistent with the scientific processes for peer-review and best practices. The compromise legislation (S.Amdt. 2786 to HR 3590) now being considered in the Senate includes a provision, Section 6301, that would subject research findings to review by non-scientists.  This provision could stifle science for political or other reasons.  Please remove this language to ensure that science remains independent and unbiased; the public's confidence in the government and in medical treatments is, in large part, built upon their trust in government funded science and scientists.

S.Amdt. 2786 to HR 3590 includes a provision that would establish a Patient-Centered Outcomes Research Institute (Section 6301).  The Institute would conduct research to improve information used by the medical community to make decisions on the prevention, diagnosis, treatment, and management of disease and medical conditions.  The Institute would fund comparative clinical effectiveness research conducted by federal agencies, academic, or private sector researchers.

Of concern, this section would require scientists to clear their research findings with the Institute before publishing their results in peer-reviewed, scientific journals.  Section 6301 would amend 42 U.S.C. 1301 et seq. to include Part D, Section 1181 (d)(2)(B)(iv), which would require that publications based on research funded by Institute grants "be within the bounds of and entirely consistent with the evidence and findings produced under the contract with the Institute".  If the Institute finds that the research a scientist is seeking to publish does not meet this requirement, it must bar the researcher from receiving research funding for a minimum of 5 years.

Subjecting research findings to administrative review prior to publication in a peer-reviewed scientific journal is unacceptable and violates the basic tenets of scientific best management practices.  The process of peer review prior to publication in a scientific journal allows the scientific community to maintain quality control of research.  Academic peer review is the best tool scientists have to ensure high standards for their professional work.  Review by non-scientists within the Institute opens the possibility of impropriety and the politicization of science.

Section 1181 (d)(2)(B)(iv) should be removed from the bill in order to preserve the scientific integrity of comparative-effectiveness research conducted or funded by the Institute.  Without a firewall between science and competing commercial or political interests, results disseminated by the Institute will be suspect and of little value to the medical community or patients.

The American Institute of Biological Sciences (AIBS) is a nonprofit scientific association dedicated to advancing biological research and education for the welfare of society.  Founded in 1947 as a part of the National Academy of Sciences, AIBS became an independent, member-governed organization in the 1950s.  AIBS is sustained by a robust membership of individual biologists and nearly 200 professional societies and scientific organizations representing the breadth of the biological sciences.  The combined individual membership of the latter exceeds 250,000 individuals.

Thank you for your consideration of our concerns.  If AIBS may provide further assistance to you on this or other matters, please do not hesitate to contact AIBS Director of Public Policy Dr. Robert Gropp at 202-628-1500.

Richard T. O'Grady, Ph.D.
Executive Director

Senator Max Baucus
Senator Christopher Dodd


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