February 7, 2014- By Steven E. Greer, MD
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.