Letter to U.S. Senator Harry Reid (Majority Leader) urging him to keep strong comparative effectiveness research (CER) language in the Senate health care reform bill

December 1, 2009

Majority Leader Harry Reid
United States Senate
Washington, DC 20510

Dear Majority Leader Reid:

Members of the Patient and Consumer Coalition strongly urge you to keep strong comparative effectiveness research (CER) language in the Senate health care reform bill.  We urge you to strengthen the safeguards in the current Senator Reid’s CER provision, by reducing or eliminating conflicts of interest from the companies that make medical products, including pharmaceutical companies, medical device companies, and companies that make diagnostic tests.

The goal of comparative effectiveness research should be to provide patients, physicians, and healthcare providers with the best available information to help assess the effectiveness of various treatments and therapeutics.  This cannot be done if the studies are influenced by companies whose products are being evaluated or conducted by researchers with financial conflicts-of-interest.

The Senate bill proposes the establishment of a non-profit “Patient-Centered Outcomes Research Institute,” and requires that the Governing Board include three members representing “pharmaceutical, device, and diagnostic manufacturers or developers.”

In a recent New England Journal of Medicine (NEJM ) article entitled, “Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform” well-respected health policy experts Dr. Harry Selker and Dr. Alastair Wood noted that “Embedded in the [Senate] legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research.”[1]

Comparative effectiveness research, if done scientifically and objectively, should save lives and improve medical care by reducing the use of ineffective treatments, including pharmaceuticals, medical devices; and inaccurate, unreliable, or potentially dangerous medical tests.  Objective comparative effectiveness research is urgently needed. Earlier this year, an Institute of Medicine report on the topic stated: “All too often, the information necessary to inform…medical decisions is incomplete or unavailable, resulting in more than half of the treatments delivered today without clear evidence of effectiveness.”[2]

We agree with the New England Journal of Medicine article’s statement that “a commercially driven review process is dangerous, irresponsible and likely to endanger public trust.”1 We urge you to improve the current CER provision by deleting the requirement that three members of the Governing Board must represent the pharmaceutical, device, and diagnostic manufacturers and developers; and instead require that the Governing Board members not have conflicts of interest that interfere with the goals of using comparative effectiveness research to determine the safest, most effective medical treatments.

Sincerely,

Breast Cancer Action
Community Access National Network
Center for Medical Consumers
National Consumers League
National Research Center for Women & Families
National Women’s Health Network
Reproductive Health Technologies Project
THE TMJ Association
Union of Concerned Scientists
U.S. PIRG
Woodymatters

The Patient and Consumer Coalition includes nonprofit organizations that represent patients, consumers, health care providers, scientists, researchers, and other stakeholders who believe that our nation’s health care will improve if based on the best possible objective evidence to support sound medical decision-making.

For additional information, contact Paul Brown at the National Research Center for Women & Families, (202) 223-4000 or pb@center4research.org


[1] Selker HP, and Wood, AJJ (November 18, 2009).  “Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform,” New England Journal of Medicine.

[2] Institute of Medicine of the National Academies (June 2009).  “Initial National Priorities for Comparative Effectiveness Research.”