Friday, September 18, 2009

Health-Care Reform: A Center for Comparative Effectiveness Research is Redundant and Therefore Unnecessary

One legislative proposal for health-care reform in the US House of Representatives is to establish, through the Secretary of Health and Human Services in the Agency for Healthcare Research and Quality, a Center for Comparative Effectiveness Research (H.R. 3200: Division B, TITLE IV–QUALITY, Subtitle A–Comparative Effectiveness Research). This entity would be charged “to conduct, support, and synthesize research… with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically”. Furthermore, there will be an independent Comparative Effectiveness Research Commission “to oversee and evaluate the activities carried out by the Center [for Comparative Effectiveness Research]”. Moreover, the bill designates that funding will be allocated for and to be managed by the Center [“amounts in the Comparative Effectiveness Research Trust Fund (referred to in this section as the ‘CERTF’) under section 9511 of the Internal Revenue Code of 1986 shall be available, without the need for further appropriations and without fiscal year limitation, to the Secretary to carry out this section”]. It also establishes the fund (“For provision establishing a Comparative Effectiveness Research Trust Fund and financing such Trust Fund…”). Establishing these entities would divert precious dollars from and duplicate existing efforts.

Three critical comments about the proposed Center:
(1) Comparative Effectiveness is an alternate phrase for the existing medical practice of using Evidence Based Medicine in daily clinical decision making;
(2) The Center and attendant organizations will interfere with effective organizations presently in existence, e.g. the National Institutes of Health (NIH);
(3) Guidelines from the Center will be rigidly interpreted by Medicare and Medicaid personnel (based on near universal previous experience of physicians) with the egregious result of reducing patient-physician autonomy thereby negatively impacting our flexibility to manage patients on an individualized basis.

The NIH’s mission statement is quite clear –
“….[to realize its goals] the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research:
• in the causes, diagnosis, prevention, and cure of human diseases;
• in the processes of human growth and development;
• in the biological effects of environmental contaminants;
• in the understanding of mental, addictive and physical disorders; and
• in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists”.

Within NIH’s purview are the funding and overseeing of clinical trials (testing new treatments and procedures with sound and ethical research methods) and determining best treatments (outcomes research).

Other Existing Oversight
In addition to the NIH, independent professional medical societies (e.g. American College of Physicians-Internal Medicine, American College of Surgeons, American Psychiatric Association, American Academy of Pediatrics, et al) establish diagnostic, treatment and follow-up guidelines for specific diseases. Furthermore, these guidelines are based on best available evidence (equivalent to “comparative effectiveness”) and expert opinion.

So who is asking for the Center for Comparative Effectiveness Research? Other than the authors of the legislation, the answer is not all that clear. The request for this Center certainly does not emanate from physicians, scientists or research administrators. It appears that this legislation is nothing more than a further attempt at outside control of medical practice with the (un)intended consequence of reducing autonomy of patients, clinicians (practicing physicians) and clinical investigators. This reduction in autonomy will negatively impact our flexibility to manage patients on an individualized basis. How so? With guidelines for medical practice mandated by the Center more rigidly interpreted by Medicare and Medicaid (one size fits all approach), individual patient differences cannot be incorporated into clinical decision making. Think this doesn’t happen now? It recently happened to me regarding the cancer pain management of a patient of mine insured by Medicaid. It can only get worse with establishment of the proposed Center.

If there are gaps in existing (e.g. NIH’s) health-care missions, then rather than create another level of bureaucracy let’s make programs like the NIH more robust by expanding and solidifying its critical mission for Americans. Though a well-meaning proposal, establishing a Center for Comparative Effectiveness Research and its attendant organizations (Comparative Effectiveness Research Commission and Comparative Effectiveness Research Trust Fund) would duplicate existing efforts of successful programs, divert precious dollars from such work and reduce physician and patient autonomy.

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