Robert M. Califf, MD

We are working on a proposal for a cooperative agreement with CMS as part of their CMS Healthcare Innovations Challenge in which they are allocating $1B (yes that’s one billion dollars) to 3 year implementation efforts to meet the “triple aim” of improving healthcare, improving health outcomes and reducing costs.  Doing all 3 of these at the same time is a real challenge, as pointed out by a recent Federal report that found that so far, most efforts to meet the triple aim have improved healthcare and/or health outcomes, but they have increased costs!

Our system of fee for service is a real problem in that regard.  Consider that African American patients in our region have a very high rate of amputation due to peripheral arterial disease.  This, of course, is a source of expertise for our hospitals and vascular surgeons.  If you needed an amputation, you’d want an expert; to become an expert requires volume, and we’re producing volumes by failing in our efforts to treat diabetes effectively.  We also know that treating diabetes more effectively will involve an upgrade of outpatient service, including more home visits and follow-up by advanced practice providers (NPs, PAs).  These services are not well reimbursed and, on balance, lose money. Since many African American patients are less well off, the cutbacks in funding of Medicaid and Medicare impact this situation even more.  On the other hand, amputations make money!

It seems clear that we want to reduce amputations while maintaining the expertise that is so valuable to all patients from high volume procedural specialists.  This would require more centralization of procedures and a change in payment to enhance valuable outpatient services.  Or, it is likely that we will continue to reinforce a system that is associated with a decline in our national health status relative to other economically developed countries.

We have a team, including Dr. Susan Spratt, dedicated to reducing amputation rates, but I’ll bet they would be more successful if they were swimming downstream instead of battling the upstream currents!

I gave a lecture yesterday at Stanford on our efforts to create a learning health system.  When it came to the standard second slide (the one after the title slide that lists conflicts), I had a quandary.  People expect a list of medical products companies on this slide.  Indeed, we academicians insist on identifying ourselves as academicians, and understandably so, given our nonprofit mission.  We then discuss “industry” as if its a dirty word and write policies requiring a “rebuttable presumption” of guilt when we work together.

However, most medical products companies pale in comparison to our large integrated health system.  An increasing proportion of docs, and almost all academic physicians, are employees of such systems.  And almost all such systems heavily incent docs to do more high-tech, expensive procedures, many of which have unproven value.  At least the “medical products industry” is required by law to meet standards of evidence for advertising.  Compare that with ads for our big health systems!

So, pretending that we’re pure academicians when we work for the likes of Duke (>$3B), Hopkins (>$7B), Partners (>$8B) or Pitt (>$12B) seems a little odd.   And try pushing a reduction in use of procedures that generate margin and there will be negative pushback in many situations.  This is all understandable since we must have a margin in our nonprofits institutions to pay for teaching and research, but I believe we’d be better off to embrace reality rather than pretend that there is a sharp line between the industries.

So, I listed being an employee of Duke Medicine as my major conflict in the lecture.  I hope we’ll move toward more meaningful disclosures in multiple dimensions in the future.

As we are preparing a response to the CMS Healthcare Innovations Challenge, a well known issue is becoming clear.  Taking accountability for a geographically completed population is a very different issue than selecting a population of interest based on disease or insurance status or whether they come to your facility.  The “triple aim” of better healthcare, better health outcomes and lower cost sounds eerily like the well known slogan of project managers (better, faster, cheaper–can you really expect all 3?).

Consider a hospital and practitioners who wish to achieve excellent outcomes at a low cost in heart failure.  The likelihood of success is likely to be very dependent on the selection of a population that is well educated with excellent social support and a high level of  compliance.  In fact the selection of those types of patients will make the providers look good, while actually making the other providers in the geographic region look worse!

Perhaps this is what explains the paradox in cardiology that many of our best known heart centers (CCF, Duke, Hopkins, UAb) have terrible CV mortality and morbidity rates in their home counties.  This won’t be fixed until we are forced to be accountability for the entire population as far as I can see.

The confidential disclosure agreement (CDA): is it a way of conducting secret human experiments or a civil way to protect confidential information that could destroy the ability of companies to develop useful products to society?  In my role as Vice Chancellor for Clinical and Translational research I get to see the “outliers” when companies send CDA’s to Duke.  One of the most common issues is the struggle to have the chance to read a protocol to decide if we should participate in a study.  Our standard is to agree to confidentiality for 5 years, but yesterday we had a demand for 10 years of confidentiality from a company.

The problems with this are:

1. We have no way of controlling our faculty and other research personnel, especially after they leave the institution.  And the chances of a junior person still being here in 10 years is small.
2. A lot of people should read a protocol to make an informed decision about whether we should participate.
3. Society has spoken.  The genesis of the laws concerning ClinicalTrials.gov was concern that companies and investigators were doing their human experiments in secret.  Withholding information about study design or known toxicities of a drug or device will not pass the test of public scrutiny.

The one significant argument in favor of the CDA is proprietary chemical composition or other legitimate trades secrets about the “test article”.  It is unclear why this sort of information should be in a clinical protocol in the first place.

So I say, liberate clinical trial protocols!  End secret human experiments.  I’ll bet the vast majority of the public would agree.  We struggle to gain public trust—perhaps people who keep secrets from the public shouldn’t be trusted!

In the meanwhile, of course, we continue to sign CDAs that we can’t enforce in order to continue to be able to do the