Healthy Skepticism Library item: 16919

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Publication type: Journal Article

Selker HP, Wood AJJ
Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform
NEJM 2009 Nov 18;
http://healthcarereform.nejm.org/?p=2364

Abstract:

Much attention has been focused on the ongoing efforts in Washington to pass a health care reform bill. Comprehensive health care should reduce the use of ineffective and suboptimal medical interventions and investigations in order to improve medical care and reduce wasted expense. To do that effectively, we need data on the comparative effectiveness of therapies and medical tests, which unfortunately we currently lack.

Recognition of this lack of data has resulted in the inclusion of increased funding for comparative-effectiveness research (CER) in current versions of the health care reform legislation. However, there are significant differences between the approaches taken by the bill that emerged from the Senate Finance Committee, on the one hand, and the bills that came out of the Senate Health, Education, Labor, and Pensions (HELP) Committee and the House of Representatives, on the other. Although all versions include a trust fund that will provide approximately $600 million per year for CER, there is considerable controversy over how that money will be allocated and, most important, whether industry will have a part in controlling the allocation of the funds, the design of the studies, and decisions about which results can be published.

Although most observers agree on the value of funding CER, many are unaware that embedded in the legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research. In the currently proposed legislation, there are two general constructs for the conduct of CER. The Senate Finance Committee bill mandates the creation of an entirely new private–public research entity and, owing to industry lobbying, guarantees industry three seats on this entity’s 15-member governing board, as well as representation on its methodology committee (the relevant portion of the bill, which may be found at http://finance.senate.gov/press/Bpress/2009press/prb101909.pdf, begins on page 1129). This approach contrasts with that generally taken by science agencies in the United States, such as the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ), which have strict conflict-of-interest rules to ensure that science is free of inappropriate commercial influence. Unlike the Senate Finance Committee bill, the bill from the Senate HELP Committee and the versions developed in the House make the AHRQ responsible for CER, thereby recognizing and preserving the independence of the scientific process.

The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not “within the bounds of and entirely consistent with the evidence.” Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists – and their institutions, which receive the support for the conduct of research – to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome. This move would be a major retrograde step that would both inhibit the conduct of CER and call its integrity into question. In addition, because researchers and their institutions will seek to avoid such punishment, this provision is likely to result in prolonged arguments, taking place out of public view, regarding which data are acceptable to publish, thereby impeding and delaying publication. The American public, which would be paying for this research, deserves better.

CER that is performed carefully, with integrity, and free of commercial control is key to informing future health care decisions that will be important to all patients and their families. The results of such research must therefore be published freely and without intimidation or threats. Given the impediments built into the Finance Committee bill, it is important to clarify what we see as the minimum requirements for CER legislation.

First, funding for CER should be awarded by means of the peer-review system that has served U.S. science so well in the past. To substitute a commercially driven review process is dangerous, irresponsible, and likely to endanger public trust.

Second, the creation of a new, untested agency to oversee CER is likely to increase the administrative burden and cost and to delay the implementation of this initiative while a new agency and its infrastructure are created. Such a delay would be particularly unfortunate, given that other existing agencies, such as the AHRQ and the NIH, have shown expertise in both research review and funding. For some areas of research, other existing federal agencies, such as the Centers for Disease Control and Prevention and the Food and Drug Administration, have relevant expertise that could be tapped without the need to create a new agency.

Finally, the governance, design, and publication of CER must not be ceded to the industries that have a commercial interest in its outcome. Moreover, the responsibility for determining “medical appropriateness” for the purposes of insurance coverage should not be made by the same agency that is responsible for designing and funding CER.

If health care reform legislation does not promote CER that is free of the potential taint of commercial and political meddling, the public will have little confidence in the results of such research. This outcome would be extremely unfortunate, since such research has the potential to improve patients’ lives by leading to more effective medical care. The U.S. biomedical research enterprise has a long and storied history that has made it a model for other countries. It would be a tragedy if we were to squander its achievements for political expediency, in the service of short-term commercial interests. The current proposals for controlling CER in a manner unlike anything we have seen in federally sponsored biomedical research therefore should be rejected.