PCORI and the COI Polloi

  • by: |
  • 02/13/2014

Conflict of Interest (COI)? Only for thee but not for PCORI.

From the pages of Current Medicine:

Industry conflicts arise at PCORI threatening any real comparative effectiveness research

The Patient Centered Outcome Research Institute (PCORI) was created by the PPACA “ObamaCare” law in 2010. Well-funded with approximately $3 Billion over ten years, the mission was, among other things, supposed to be to conduct comparative effectiveness research (CER) that would determine whether costly therapies are any better than cheaper alternatives.


The rise of CER has been one of the most feared developments by the drug and device industries. To avoid powerful lobbying efforts that could have resulted in de-funding and the death of PCORI before it got started, the institute steered away from even hinting at conducting CER. Now, almost four years later, PCORI is finally funding CER research. However, critics, such as former White House Director of Office of Management and Budget, Peter Orzag, say that the money spent by PCORI on CER is still not enough.

Meanwhile, a leading doctor in charge of PCORI research strategies, Harlan Krumholz, MD, a cardiologist at Yale, helped create The Yale University Open Data Access project, or “YODA”, and is the Principal Investigator. The YODA mission is to make clinical trial data more open and accessible to researchers.

Medtronic was one of the first corporations to pay YODA to analyze clinical data on the spine fusion growth factor product called InFuse. Recently, Johnson and Johnson (JNJ) signed up as the next large corporate client of YODA.

The drug and device industries have long been adept at muting the regulatory influences of healthcare agencies, such as the FDA, AHRQ, and CMS, using a variety of tactics. The “golden revolving door” hires former government regulators into lucrative jobs at JNJ, etc. Also, academic medical center “institutes” designed to keep the industry honest then become corrupted by accepting industry funding.

Since Dr. Krumholz is the senior clinical decisionmaker for both the Yale YODA, and the ObamaCare-created PCORI, conflicts of interest would arise if the industry began funding YODA. For examples, PCORI could be conducting CER on the various hip implant products and conclude that the JNJ DePuy device is no better than a less costly hip implant, or a Medtronic coronary stent might be found by PCORI research to be harmful and ineffective. But if Medtronic and JNJ began to pay millions of dollars to Yale’s YODA, then Dr. Krumholz would have a significant biasing force against initiating any CER at his other job, PCORI, that might harm sales of JNJ or Medtronic products.

In a brief interview with Dr. Krumholz about how he is managing these conflicts of interest, he replied, “Right – (there is) no direct connection (between YODA and PCORI research)– just a potential COI. All I can say is that it is disclosed. And I note that PCORI has people with different relationships. And that most of what PCORI does is in public view so people can assess for themselves.”.

Dr. Krumholz is correct in pointing out that many other members of the PCORI executive team and board have reported conflicts of interest accepting financial support from drug and device companies. We will have more on that in future reports.

The Executive Director of PCORI, Joe Selby, MD PhD, did not reply to our emails in time for this publication.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog