Raymond J. Baxter, Kaiser Permanente
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.
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)
Sincerely,
Raymond J. Baxter,
PhD
Senior Vice President, Community
Benefit, Research and Health Policy
Kaiser
Permanente
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