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Setting out methods to conduct comparative effectiveness research

Consumers Union's testifies before Institute of Medicine on framework for what medical treatments are most effective

March 20, 2009

National Priorities for Comparative Effectiveness Research

Consumers Union, the independent, non-profit publisher of Consumer Reports, deeply appreciates the opportunity to testify today.

You are beginning an historic moment in American health policy, where we finally begin a major scientific commitment to understanding what works best for most people in the world of healthcare.

While AHRQ and others have done excellent Comparative Effectiveness work on tiny budgets, the American Recovery and Reconstruction Act (ARRA) finally gives AHRQ, HHS, and the NIH some notable resources for comparative effectiveness work.

In the longer run, we believe more than the ARRA’s $1.1 billion is needed, and we support the kind of legislation that Senators Baucus and Dorgan, and Representative Stark and others proposed in the last Congress—an all-payer trust fund that would provide about $2.7 billion over ten years in additional CE research.
By setting the correct priorities for this initial $1.1 billion in research, you can help promote the passage of the above legislation and ensure the future of more robust, sustained CE.

We believe that CE can save America untold billions in health costs and improve the quality of care that patients receive. We have been using CE from the Oregon Health and Sciences University to provide our Best Buy Drugs service in about twenty drug classes. We have frequently seen that the scientific data shows that the most heavily advertised drugs in these classes are no better—and may actually be worse—than the lower cost alternatives. CE allows us to present this scientific information to America’s consumers—and without any government involvement—tell consumers what the prices of these drugs are, and thus to make a Best Buy recommendation, which a patient can and should discuss with their physician.

We believe this consumer empowerment work is an important element of why all Americans should support government funding of unbiased, scientific CE research.

Policy Priorities

Please consider prioritizing several common policy approaches to all CE work. These include:

1. First and foremost, in all work supported in any way by Federal CE funds, eliminate any conflicts of interest or financial relationships from the decision-making process. Decisions must be made by individuals free of any related recent or current conflicts.

2. Use CE to eliminate harmful racial and ethnic treatment disparities. We urge you to identify areas where there have been harmful disparities in treatment among various racial and ethnic groups and prioritize some research to ensure that CE can be used to help reduce such harmful differences. It is very important that future clinical trials give more attention to including and reporting on American ethnic and racial populations.

We all know there are disparities. We know the tragic history and why minority communities have been distrustful of good treatment in our society. Some have expressed fear that CE could perpetuate rather than eliminate these disparities. We believe, on the other hand, that CE is at long last a chance to identify areas of harmful differences where minorities consistently get care that is considered less than optimal and where we as a society can concentrate on ending these disparities.

Last year’s article in the Journal of General Internal Medicine by Dr. Somnath Saha and others entitled “Racial and Ethnic Disparities in the VA Healthcare System: A Systematic Review,” identified some areas of disparity. We urge you to concentrate significant CE research on (1) areas where disparities have been identified and combine it with (2) disease sectors where minorities are disproportionately impacted (such as renal failure), and (3) where one or more of the major treatments has little or no clinical trial data on the impact of the treatment on minority patients.

Focusing significant research on classes of treatment that meet these three criteria would help answer fears in the minority communities that CE could actually make matters worse, rather than better. It would fill in important clinical trial data and it would focus on how to ensure the best course of treatment for all our citizens, not just white males.

3) Include consumers at decision-making levels. Consumers understand comparisons and can inform the process in a variety of ways. We have found that researchers tend to ask questions they feel are most important rather than questions most important to patients. Creating conversations between the two result in better focused, helpful research. The time required to do this on the front end is more than made up for later in the process. Lets answer questions that are important to patients. For example, recent studies have shown that some women with breast cancer or patients with severe migraine have very different priorities than the physicians do—let’s give the patients’ priority better consideration.

4) Make the process accessible to the public at critical points. Assure both industry and consumers that the process is fair, open and balanced. Provide opportunities for input into the process. Doing so will allow all to have their opportunity to be heard.

5) Anticipate the need for updates at reasonable intervals. Fixed update intervals are rarely successful.

Research Priorities

1) Use CE to answer off-label (OL) questions: It has been estimated that 21 percent of all prescriptions are for off-label use, and that about 73 percent of those uses have no scientific justification. At the same time, the pharmaceutical industry continues to pursue off-label promotions despite enormous fines and penalties.

It would be wonderful, of course, if many of these off-label drugs were indeed effective or above average treatments, and it is important to put some of these OL theories to a scientific test. We urge you to identify several areas of the largest volume of off-label prescribing and bring some scientific evidence to such OL use.

2) Use ARRA CE funds to prepare for the use of the FDA’s coming Active Surveillance program: The FDA Amendments Act of 2007 (PL 110-85)’s section 905 creates an electronic medical database with hopefully 100 million records by the summer of 2012. We believe that the active surveillance of this database will provide quicker information on adverse events. For example, it was estimated that if this system had been in place, the problems with Vioxx would have been widely recognized in 4 or 5 months, instead of years. But it is also an enormous observational tool to identify areas where gold standard randomized clinical trial (RCT) should be undertaken to nail down important CE differences. It would be very useful to have software protocols developed and ready to take advantage of this database as it starts to roll-out over the next few years.

3) Use ARRA CE funds to develop a consensus on how to maintain the cardiac devices registry database: As the New York Times reported last month, limited financial support as well as ‘technical problems that make it hard to merge registry information with Medicare records, have undermined the registry’s utility.’ We hope that the $1.1 billion now available can be used to resolve these difficulties and lead to a dependable, all-payer system of keeping this vital data up to date.

4) Actively solicit already completed comparative studies that may not have been published because of negative results. Provide a peer reviewed publication process to evaluate these studies and make them available to the public and to researchers. Provide seed funding for peer reviewed publications that are free of industry financial relationships.

5) Create a process to monitor and report on the “trial registries” created by medical journals. Consider strategies that can expand and translate this important data for consumers and researchers.

6) Consider research topics that include the evaluation of translation and presentation strategies for comparative effectiveness information. Consumers may be confused by comparisons involving drugs and services they assume are superior because of industry information. What strategies most effectively provide balanced information?

7) Prioritize systematic reviews. Consumers believe decision making is based on evidence. We believe it would be helpful to know whether that is the case for the most common medical decisions.

8) Finally, Consumers Union has been working for the past five years to encourage the States to pass laws reporting hospital acquired infections. As data from Pennsylvania and elsewhere shows, such public reporting is helping bring down the rate of deadly infections (infections kill about 100,000 Americans annually or about one person every 5 minutes). The Annals of Internal Medicine (18 March 2008) editorialized in support of more CE research on the best ways to combat these deadly infections. Some Northern European nations are doing a much better job than we are in this sector, and good research on what works could quickly result in the saving of thousands of lives.

Thank you for your consideration of these views, as you start this historic mission.