Testimony on Comparative Effectiveness Research

William Vaughan, Consumers Union

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On April 3, 2009, public testimony on comparative effectiveness research was given at a meeting of the National Advisory Council for Healthcare Research and Quality. The testimony represents the views of the presenter and not necessarily those of the Agency for Healthcare Research and Quality (AHRQ) or the Department of Health and Human Services (HHS).

The Council provides advice and recommendations to the Director, AHRQ, and to the Secretary, HHS, on priorities for a national health services research agenda.

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Delivered Via Electronic Mail

Comments on ARRA Comparative Effectiveness Research (CER) from Consumers Union

Consumers Union is the independent, non-profit publisher of Consumer Reports. We have used the results of CER from the Oregon Health and Science University's Drug Effectiveness Project to support our free Best Buy Drugs program, which helps consumers choose the most effective and safest brand and generic prescription drugs. We strongly support the ARRA provisions and hope for the future enactment of a permanent, all-payer CER trust fund.

In setting priorities for the use of the ARRA CER funds, we hope you will give priority to

1. Identifying and helping eliminate harmful health care disparities that impact ethnic and racial minorities;
2. Identifying areas where there is large scale off-label prescribing with no apparent scientific basis, and conduct research to determine whether that off-label use is appropriate;
3. Completing or strengthening data registries essential for determining safety and effectiveness, such as the cardiac devices registry;
4. Working with the FDA to make sure their active surveillance system of large medical databases created by section 905 of the FDAAA of 2007 (PL 110-85) is proceeding successfully;
5. Seeking out and providing a place of publication for the many high quality clinical trials and studies which have not been published (or were rejected) because they were not ‘positive' or ‘exciting' enough (thus bringing the science from these projects to light and off-setting the bias in trial publication toward dramatic, breakthrough studies. Seek out trials which were registered but for which no results have ever been reported, and try to bring their scientific contribution to light;
6. Considering research topics that include the evaluation of translation and presentation strategies for comparative effectiveness information.

We also hope that AHRQ will be a voice for ensuring that all of those involved in the CER process are free of conflicts of interest. The main reason taxpayer-funded CER is necessary is that the objectivity of industry funded trials and the way they are presented has, with good reason, become very suspect.

Finally, we hope that AHRQ will be supportive of including the consumer's voice in every specific medical research project. What consumers may want from a medicine (as we have found in the case of migraines) can be a very different end point than researchers assume.

Thank you for your consideration of these views.

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