Is the Patient Centered Outcomes Research Institute Really More Industry-Centered?

One of the biggest reasons our health care system seems so dysfunctional is that clinicians and patients have great difficulty determining what might be the appropriate management of particular clinical problems.  Due to endless and sometimes deceptive marketing, conflicts of interest affecting health care professionals and academics, and manipulation and suppression of clinical research, making truly evidence based decisions that put individual patients interests first has become very difficult.  Instead, we may end up using excessively expensive, relatively ineffective, and more dangerous than anticipated drugs, devices, and diagnostic and therapeutic strategies, thus leading to poor patient outcomes and high costs.

Background - the Patient-Centered Outcomes Research Institute (PCORI)

One lingering hope has been that better clinical research, particularly focusing on the outcomes that are most important to patients (patient-centered outcomes), and comparing clinical strategies that may be widely used but poorly evaluated (comparative effectiveness research) would help dissipate the fog.  An attempt to promote such research in the US appeared in our recent health reform legislation, the Affordable Care Act.  It authorized the creation of the Patient Centered Outcomes Research Institute (PCORI).

However, as we observed, how good a solution this would be would depend on the details.  Our concerns were that PCORI, which is an independent although government sponsored institute, not a government agency, might be too beholden to "stake-holders" including the large organizations, device and pharmaceutical companies, insurance companies, hospital systems, etc, that already dominate health care and may promote their and particularly their executives' interests ahead of patients.

Recently, Merrill Goozner, the editor of Modern Healthcare, raised similar concerns,

there is the law's requirement for stakeholder boards to set PCORI research priorities. They must include representatives of researchers, clinicians, patients, providers, insurers, employers and industry. The interests of those groups are not the same. Priority-setting by stakeholder boards could turn into a prescription for steering clear of the most controversial, and therefore most significant, questions.

So,

There is no shortage of drug and device firms, specialty hospitals and medical specialty societies with a vested interest in leaving certain questions unasked or muddying the waters with methodological quibbles. They shouldn't be allowed to hijack or soften the agenda.

PCORI is now in operation, but has seemingly not gotten a lot of scrutiny. What scrutiny it has received as not allayed these concerns.

The PCORI Advisory Panels

Recently, the publication of the membership of four key advisory panels for PCORI got the attention of  Michael Millenson, blogging on the Health Care Blog.  He noted that initially the members of the panels were identified only by name and city of residence, without any information on their other affiliations or characteristics.  He suggested,

PCORI isn’t a church, where all are created equal in the eyes of God, but a politically created, politically governed, controversial dispenser of a very large amount of money that a host of interest groups would like to control. PCORI staff chose the panel members in part by looking at their affiliations, and those connections (or lack of them) should be an immediate part of the public record when the appointments are announced. By being vague, PCORI obfuscates political and power relationships and makes it more difficult for the public and industry stakeholders to either approve of or criticize those choices.

Eventually, PCORI did release somewhat more information on membership of these panels, on Addressing Disparities, Assessment of Prevention, Diagnosis, and Treatment Options, Improving Healthcare Systems, and Patient Engagement.  Mr Millenson was able to review the membership of one panel, and noted some strange anomalies in a comment to his original blog post. 

One panel member who supposedly represents "patients, caregivers, and patient advocates" had a full time position with a pharmaceutical company.  Another worked for a big consumer organization which is heavily funded by the pharmaceutical industry.

This raised concerns that PCORI may get guidance from people whose interests are actually different from those they are supposed to represent.

Therefore, I attempted to review the stated affiliations of all PCORI advisory panels.

Review of the what was made public about the membership of the advisory panels revealed several additional important anomalies.  Members said to be representing "patients, caregivers, and patient advocates" appeared to have positions working for organizations who might have their own, and different interests from the group they were supposed to be representing. 

Let me summarize the apparent anomalies by advisory panel.  In each case, in alphabetical order by panel,  I will list the panelists name, supposed representation, and affiliation, with my comments. 

Addressing Disparities

Monique Carter MS - Dallas, TX
representing: patients, caregivers, and patient advocates
affiliation: Senior Research Scientist, AROG Pharmaceuticals Inc

So this person would appear to be more of an industry (pharmaceuticals) representative.

Venus Gines, MA, P/CHWI - Manvel, TX
representing: patients, caregiver, and patient advocates
affiliation: Instructor, Chronic Disease Prevention and Control Research Center, Department of Medicine, Baylor College of Medicine

So this person appears to be more of a clinician, or health system representative

Doriane C Miller MD - Chicago, IL
representing: patients, caregivers, and patient advocates
affiliation: Director, Center for Community Health and Vitality, University of Chicago Medical Center

So this person also appears to be more of a clinician, or health system representative.

Carmen E Reyes, MA - Whittier, CA
representing: patients, caregivers, and patient advocates
affiliation: Center and Community Relations Manager, Los Angeles Community Academic Partnership in Research in Again, UCLA

So this person appears to be more of a health system representative.

Mary Ann Sander, MHA, MBA, NHA - Pittsuburgh, PA
representing: patients, caregivers, and patient advocates
affiliation: Vice President, Aging  and Disability Services, UPMC Community Provider Services

So this person appears to be more of a health system representative

Deborah Steward, MD, MBA - Jacksonville, FL
representing: clinicians
affiliation: Florida Blue

So in summary, this panel included five people who ostensibly represent patients, caregivers, and patient advocates but who actually work for large academic medical centers or health systems, and one who was there to ostensibly represent patients, caregivers, and patient advocates who works for a pharmaceutical firm.  (In addition, one person supposedly representing clinicians apparently works full time for a health insurance company.)

Assessment of Prevention, Diagnosis, and Treatment Options

Karen Chesbrough, MPH - Annandale, VA
representing: patients, caregivers, and patient advocates
affiliation: Scientific Program Administrator, Foundation for Physical Therapy.

Note that the stated mission of the Foundation for Physical Therapy is that it "supports the physical therapy profession’s research needs," and the foundation is funded in part by companies that make physical therapy devices and supplies  (look here).  Therefore, this person appears to be more of a representative of clinicians, or perhaps industry (devices).

Bettye Green RN - South Bend, IN
representing: patients, caregivers, and patient advocates
affiliation: Community Outreach Nurse and Associate Director of Advocacy, Alliance for Clinical Trials in Oncology, Saint Joseph Regional Medical Center

So this person appears to be more of a health system representative.

Debra Madden - Newtown, CT
representing: patients, caregivers, and patient advocates
affiliation: Clinical Applications Systems Analyst, Associated Neurologists

So this person appears to be more of a clinician representative.

Daniel Wall - Spencer, WI
representing: patients, caregivers, and patient advocates
affiliation: Analyst, Biomedical Informatics Research Center, Marshfield Clinic Foundation

So this person appears to be more of a clinician or health system representative

So in summary, this panel included four people who ostensibly represent patients, caregivers, and patient advocates but who actually work for health systems or clinician organizations, and one of the latter organizations appears to be heavily funded by the medical device and supplies industry.

Improving Healthcare Systems

Susan Diaz MPAS, PA-C - Jacksonville, FL
representing patients, caregivers, and patient advocates
affiliation: Physician Assistant in Liver Transplant, Mayo Clinic in Florida

So this person appears to be more of a clinician, or health system representative.

Anne Sales PhD-  Ann Arbor, MI
representing: patients, caregivers, and patient advocates
affiliation: Professor, School of Nursing, University of Michigan

So this person appears to be more of a clinician, or health system representative.

Jamie Sullivan MPH - Silver Spring, MD
representing: patients, caregivers, and patient advocates
affiliation: Director of Public Policy, COPD Foundation.

Note that the COPD Foundation receives support at least from "Boehringer-Ingelheim/Pfizer Inc. and Grifols" (look here).  .

So this person appears to be at least somewhat an industry (pharmaceutical) representative.

So in summary, this panel includes three people who ostensibly represent patients, caregivers, and patient advocates, two of whom actually work for large health system, and one who works for a foundation with significant pharmaceutical industry support.  

Patient Engagement

Stephen Arcona MA PhD - East Hanover, NJ
representing patients, caregivers, and patient advocates
affiliation: Executive Director, Outcomes Research Methods & Analytics, Department of Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation

So this person appears to be more of a researcher, and industry (pharmaceutical) representative.

Marc Boutin JD - Washington, DC
representing patients, caregivers, and patient advocates
affiliation: Executive Vice President and Chief Operating Officer, National Health Council 

Note that while the National Health Council claims to be an advocate for people with chronic disease and disability, its core membership includes "major pharmaceutical, medical device, health insurance, and biotechnology companies." and it receives considerable industry support.  For example, it disclosed contributions in the $100,000 - $300,000 range from Amgen, Astra-Zeneca, Eli Lilly, Novartis, Pfizer, and the Pharmaceutical Research and Manufacturers of America (PhRMA), and smaller but still significant contributions from other pharmaceutical companies and other industry associations.  So this person appears to be at least somewhat of an industry (pharmaceutical) representative.

Charlotte W Collins JD - Elkridge, MD
representing patients, caregivers, and patient adovcates
affiliation: Vice President of Policy and Programs, Asthma and Allergy Foundation of America

Note that while the Asthma and Allergy Foundation of America claims to be a patient advocacy organization, it disclosed financial support from many pharmaceutical, device, and health insurance companies, and from major health care systems

So this person appears to be at least somewhat an industry, health insurance, and/or health system representative.

Amy Gibson, RN MS - Washington, DC
representing patients, caregivers, and patient advocates
affiliation: Chief Operating Officer, Patient-Centered Primary Care Collaborative (PCPCC)

Note that the PCPCC has an executive committee that includes multiple pharmaceutical, device, and health insurance companies, and health systems.  So this person appears to be at least somewhat an industry, health insurance, and/or health system representative.

Julie Ginn Moretz - Augusta, GA
representing patients, caregivers, and patient advocates
affiliation: Associate Vice Chancellor, Patient- and Family-Centered Care, University of Arkansas for Medical Sciences

So this person appears to be more of health system representative.

Sara Triagle van Geertruyden - Washington, DC
representing patients, caregivers, and patient advocates
affiliation: Executive Director, Partnership to Improve Patient Care (PIPC)
(Note: this affiliation appears incomplete.  Sara van Geertruyden is listed as a current partner of Thorn Run Partners, a lobbying firm, with a major practice area in health care, boasting, "Thorn Run Partners offers one of Washington, DC’s most comprehensive, competent and effective health policy practices."


Note also that PIPC has membership that includes many specialty physician societies, and a steering committee that includes the Biotechnology Industry Organization, and PhRMA. 

So this person appears to be more of an industry (pharmaceutical and biotechnology) representative.

So in summary this panel includes six members who ostensibly represent patients, caregivers, and patient advocates, but who work for either patient advocacy organizations that get considerable industry support, or a health system, or a pharmaceutical company.  One person whose affiliation was listed as a patient advocacy organization also somehow appears to be a full-time lobbyist.  

Summary

While PCORI has set up advisory panels that seem to strongly emphasize representation of patients, caregivers, and patient advocates, a substantial fraction of the people who are supposed to provide this representation seem to work for patient advocacy groups with considerable industry support, or directly for industry or health care systems.  Some of them may work as clinicians or researchers, but many appear to have high level executive positions with these organizations.  One appears to be a full-time lobbyist at a firm that has a strong health care practice. 

Thus it appears that PCORI advisory panels actually may be as much about the interests of big health care organizations, including pharmaceutical and device companies, health insurance companies, and large hospital systems, as they are about patients, caregivers, or patient advocates.  

I am afraid my and Merrill Goozner's original fears that PCORI may end up being more about industry-centered interests than patient-centered outcomes may not be paranoid.  I do hope that PCORI leadership manages to put improving patients' and the public's health ahead of making industry executives happy. 

by Roy M. Poses MD, for Health Care Renewal