Testimony on Comparative Effectiveness Research
Raymond J. Baxter, Kaiser Permanente
Delivered Via Electronic Mail
Dear Sir or Madam:
Kaiser Permanente offers the following comments in response to the National Advisory Council for Healthcare Research and Quality's study to identify and recommend national priorities for conducting comparative effectiveness research to be conducted or supported with funds from the American Recovery and Reinvestment Act of 2009.
The Kaiser Permanente Medical Care Program (which offers services to the public under the Program's trade name "Kaiser Permanente") is America's largest private integrated healthcare delivery system. It comprises: Kaiser Foundation Health Plan, Inc. (and its local subsidiaries, collectively "Health Plan"), the nation's largest not-for-profit health plan; the nonprofit Kaiser Foundation Hospitals ("Hospitals"); and the Permanente Medical Groups ("Medical Group"), eight independent physician group practices that contract exclusively with Health Plan to meet the health needs of Kaiser Permanente's 8.7 million members in nine states and the District of Columbia. In addition to nearly all ambulatory and hospital care, most pharmacy, diagnostic and laboratory services are performed within Kaiser Permanente by Health Plan, Hospitals or Medical Group physicians and employees in Health Plan or Hospitals-owned facilities.
Kaiser Permanente applauds the decision of Congress to provide funding that could transform health care by advancing comparative effectiveness research, the outcomes of which could answer questions of effectiveness, safety, quality, affordability, access, and population health. We would also like to acknowledge AHRQ for its leadership and the foundation it has built with extensive infrastructure already in place: the Effective Health Care Program and its evidence-based practice centers, the DEcIDE Research Network, and Eisenberg Center. We urge AHRQ to build on that foundation, and to consider going further to designate and fund a few "national laboratories" in the model the Department of Energy has used for energy research.
America needs a greatly expanded national system for the post-marketing evaluation of the effectiveness and safety of medications, biologics, devices and vaccines as used in everyday clinical practice. Comparisons of alternative therapeutic approaches (e.g., of newer treatments vs. "usual care"; of newer surgical procedures vs. established procedures or optimal medical therapy) can provide significant benefits for all Americans by identifying practices that will improve clinical outcomes, advance public health, mitigate harm, and potentially provide cost-savings that can be redirected for other needed health and welfare services.
Kaiser Permanente can contribute to the national capacity to identify what works in health care, develop standards for systematic reviews of evidence, and methodologies for developing trustworthy clinical practice guidelines.
As the largest, private integrated system in the United States, Kaiser Permanente offers a continuous learning system that uniquely positions us to perform comparative effectiveness and safety research. Resources that we bring to the table include:
- Stable and diverse (racially/ethnically, socio-economically) membership of over 8 million individuals, across the United States, and the potential to link to larger family clusters for research through those individuals;
- A payment structure that distinguishes Kaiser Permanente from more traditional payment systems that provides strong incentives for in-plan use and virtually eliminates payment incentives that could influence care management decisions;
- Rich, longitudinal, clinical electronic databases that capture virtually complete health care delivery, payment, decision-making and behavioral data in detail to support primary, secondary and tertiary clinical care across inpatient, outpatient and emergency department settings;
- Kaiser Permanente's computer systems, which manage very large amounts of data, and Kaiser Permanente members' use of online tools at a rate of 45 million encounters per year;
- Planned expansion of databases to include genetic and environmental exposure data;
- Committed and experienced research community of full time investigators and hundreds of clinicians engaged in research;
- Sufficient numbers of individuals with diverse disease conditions, e.g., asthma, HIV, diabetes, rare conditions, etc. to provide statistically meaningful results; and
- External, well-established partnerships with traditional academic centers and research networks in which Kaiser Permanente brings unequalled value to the research collaboration.
For 40 years, Kaiser Permanente has taken advantage of its unique research environment to conduct drug safety research. In 1969, the Food and Drug Administration (FDA) funded a large study of surveillance for adverse drug effects. Since then, Kaiser Permanente has conducted drug, device and vaccine effectiveness and safety studies and with these, has developed and applied state-of-the-art research methodologies.
The following are just a few examples of Kaiser Permanente's experience in comparative effectiveness research, some of which were funded by and done in collaboration with AHRQ:
- Kaiser Permanente researchers have created the largest database ever to address the safety of maternal medication use during pregnancy, and potential effects upon the developing fetus.
- Kaiser Permanente researchers participated in the nation's largest post-marketing safety surveillance for vaccines, the CDC-funded Vaccine Safety Datalink (VSD) project.
- Kaiser Permanente's research includes studies on the effectiveness of:
- Venlafaxine versus other medications in the treatment of depression;
- Use of financial incentives to increase
- adherence with guideline recommended care in depression;
- Various anti-hypertensive agents as secondary-line therapy in hypertension;
- Drug-eluting versus bare metal stents in patients with coronary heart disease;
- Bariatric surgery versus usual medical therapy in obese patients with type 2 diabetes mellitus;
- Different diabetes treatment approaches;
- Treatment responses to darbopoetin versus epoetin, drugs used in cancer patients to treat anemia and increase hemoglobin levels; and
- Converting statin therapy from brand name Zocor to generic lovastatin.
More recently, Kaiser Permanente's researchers, physicians, and operational leadership have recognized the benefit to the communities we serve of pursuing research in comparative effectiveness and safety. Over the last year, Kaiser Permanente's research leadership has been developing a concept for a virtual center to study comparative effectiveness and safety, recognizing that such a center can capitalize on its unique ability to conduct in-depth studies of questions of drug, device and biologic safety and comparative effectiveness. The center would offer the potential for addressing these questions, translating the findings into the operations of our program, evaluating their impact and publishing and disseminating them back into the community for the benefit of all.
In conclusion, we appreciate the opportunity to contribute to the National Advisory Council's study to advise the AHRQ director and the Secretary of Health and Human Services on priorities for comparative effectiveness research. We would welcome the opportunity to discuss these matters with you further. If you have questions, please contact me at (510) 271-4664 (email: Raymond.J.Baxter@kp.org)
Raymond J. Baxter, PhD
Senior Vice President, Community Benefit, Research and Health Policy