Robert M. Califf, MD

I had the chance to commune with our cardiovascular practice last night.  It was a remarkable experience.

Almost 30 years ago, the practice of medicine at Duke Hospital was a one person individual effort.  Every doctor was a member of the Private Diagnostic Clinic (PDC), but beyond that each doc saw patients as an individual with a team that typically included students, house staff and fellows.  Harry Phillips and I found ourselves in the hospital every evening as I was developing the CCU as a place to intervene in the new era of reperfusion for myocardial infarction and Harry was busy building a cath lab practice. In those days, we would round on up to 30-40 patients a day, including every other weekend.  Being on call every other night and every other weekend was a great improvement in quality of life.  After a while we decided to join forces with the blessing of Joe Greenfield and we formed a 2 person group.  Within several years we were up to 5 as others joined in.

Now, of course, like most large academic and private practices we work in functional groups–general cardiology, EP, intervention, imaging, valvular and congenital, heart failure.  These groups have become integrated practices with multiple physicians, advanced practice providers (nurse practitioners, PAs) and staff.  We are closely aligned with the hospital units and clinic staff where we work.

Last night, Chris Granger and Kristin Newby, who head our general cardiology practice group, hosted a get together for many of the faculty, fellows, nurses, pharmacists, PAs and other associated staff.  The event was dominated by the dozens of children, direct progeny of their parents.  But the progeny of our training programs and educational system were equally evident.  Lloyd Smith, my Chair of Medicine at UCSF in 1978-80, gave a great lecture once on “Academic Progeny”.  His point was that academic medical centers are an amazing melting pot of people from all over who convene to learn and practice.  Most of these people move on to teach, learn, and practice elsewhere and some stay with us.  The influence one can have in this environment is remarkable.

Much of the conversation was about children, but we also talked about friends and colleagues who have recently left or soon will leave to spread aspects of our knowledge and culture elsewhere.  The same opportunity exists as we take in trainees and faculty from elsewhere.  We need to remind ourselves more often that our greatest impact in a place like Duke may be in the imprint we leave on people who go elsewhere.

I have been in numerous meetings recently about the impediments to device development in the US.  There is no question about the migration of device R&D out of the US with resultant loss of jobs on a fairly large scale.  My colleague Richard Stack, who is an emeritus professor and now runs a device incubator fund in the Triangle, has emphasized the fact that he would prefer to work in the US, but cannot afford to do it in the current environment.  On the other hand, the January 21st issue of the Lancet had a scathing editorial by Richard Horton on the lack of rigor in the UK and European system, and its effects on human well being of research subjects.

The middle ground here is elusive.  How do we encourage development of new technologies that require evaluation in human research participants?  It would be interesting to hear some new ideas.

There has been a slight upturn in people approaching me to express concern that anxiety levels are high among people affected by the leadership change in the DCRI, and more broadly, the impact on other components of DTMI.  Many cliches and aphorisms exist to capture the risk and opportunity of anxiety, so I will refrain from using one at this point.

Everyone should be assured that in numerous meetings with leaders and team members across the enterprise, no one has suggested a change in fundamental direction.  Indeed, we have been through our budget meetings with institutional leadership and several presentations–the major message is one of stability and acknowledgement of the successes of the organization.  If anything, the major motivation for change is coming from the continuing evolution of our environment, ranging from continued pressures on the NIH, to globalization and the opportunities derived from the ongoing divestment of R&D from large pharma.

Most recently, there is an uptick in national discussion about the need to change the clinical trials model from its current state to one in which electronic health records and patient-reported outcomes are used as the major source of data for trials with additional structured data as needed.  We hope the DCRI and other elements of DTMI will be leaders in this transition, which has been an increasing focus of our public private partnership with the FDA (Clinical Trials Transformation Initiative).

The institutional effort to find a replacement for Dr. Harrington continues, and I am hopeful that we will have a new leader during the month of March.  In the interim, Bob remains engaged as the leader and I have complete confidence in his loyalty to the well-being of the institution and the many people making a contribution across DTMI.  So, I continue to believe that turning anxiety into creative thinking and action will lead us to a better place.

On another note, if you have not been on the tour of the new Cancer Institute, I recommend that you do it.  Its a fascinating peak at where medicine is headed and should give our cancer patients and their families a first-rate place for caring treatment.

As I’m delving into the great things going on at DCRI as we look to the future, one that ties a lot of the effort together is the Center for Educational Excellence (CEE).  The concept that health care providers will need lifelong education after completing fundamental training and graduate medical education is not a new concept.  The question, of course, is “who should be responsible for this”.  What seems to be evolving is a complex maize of professional societies and academic institutions.  The older supposition that the medical products industry should provide education for healthcare providers has fallen into disfavor because of concerns about conflicted presentation of knowledge.

In addition to lifelong education, globalization is another key theme.  Interactive education using the internet and cell phone technology will almost certainly drive future continuing education.   The best materials for basic education will consolidate into a smaller basic set, but this will enable educational entrepreneurs to move from “Education 101″ to “Education 200 and beyond”–taking the basic material and making it much more interactive and specialized.

The third theme is the learning health system concept.  This idea, developed by the IOM, is a modern version of something started here by Eugene Stead in the cardiovascular database.  We can learn continuously from our experience if we collect, coded, analyzable data as part of our routine in healthcare delivery.

We are in a great position to weave these themes together to become an important part of a network that can provide practitioners with what they need to know to generate and consume evidence to enable the best choices for patients.  Our Duke-NUS School of Medicine, the Medanta Duke Research Institute, the Brazilian Clinical Research Institute  and the Duke-Kunshan University give us nodes in a virtual network, reaching the major global population.

At the core of all this, of course, is fundamental high quality and high integrity research and transformation of that research into knowledge that can drive better healthcare.  That will remain the core value of DCRI and its parent organization, DTMI.

I have received over 300 messages about the 60 Minutes segment.  The overall tenor has been very positive with expressions of support and hope that we can move on with a better institution because of the improvements that will result from our learning from this situation.  Many leaders external to the institution have sent messages of support and encouragement, with the most common comments relating to the importance of the fact that we have been open and transparent since recognizing the fundamental issues and the gravity of the situation.  “This is what great institutions do” seems to be the most common comment.

I have also heard a concern from both our internal community and the external world that we will breathe a sigh of relief and forget the root cause of the problems that led to so much public attention.  The TMQF principles are at the core: data provenance, adequate quantitative collaboration, accountability and open dialogue about issues beyond the individual lab and systems to deal with conflict of interest.  We need to assure both the internal and external world that we are following through with our commitments.  At the same time we need to recognize that there are complex issues in operationalizing these principles across an entire institution.  We are working on a plan for enabling our faculty and staff to follow our progress.  This blog will certainly be one source.

Finally, I have heard from some that there is still confusion about what exactly happened.  60 Minutes did a thorough investigation and I believe that they found that all of the important events were already publicly available.  I believe the whole story can be found on publicly available documents and the 60 Minutes story.  We are committed to continuing transparency as we move forward.

I have received many nice comments about the 60 Minutes segment representing a true effort to learn from mistakes and improve the organization. Dr. Dzau’s message this morning was on target. We need to continue to be transparent and share what we have learned with others.

The CBS 60 Minutes web site is touting a segment entitled “Deception at Duke”.  While this series of events is certainly a sad part of our institutional history, I hope the world will see an institution full of hard-working people, dedicated to advancing knowledge and care for our fellow human beings-an institution willing and able to look at its mistakes and learn from them.

Most importantly, I hope that our actions will embody our ambitions to be aggressive, but humble in our efforts to learn and apply and practice, especially being open to mid-course corrections!

60 Minutes

Story featured in Triangle Business Week

“Deception at Duke” featured on Duke Check

I continue to be impressed by the creative ideas coming from people inside and outside of the “DTMI family” with regard to the future.  Please continue to send messages with insights and concerns.

There is obvious tension between the desire to maintain what is special about DTMI and its major engine, DCRI, and the obvious importance of better integrating its efforts with the University and Duke Medicine.  The name “DCRI” has tremendous recognition now around the world and stands for excellence in collaborative clinical research.  We need to understand how to extend the support systems in DCRI to a wider group of faculty on the Duke campus.

In addition, we now have a rapidly expanding network of collaborators in many countries and a university that is dedicated to globalization as a key part of its educational mission.  With “bricks and mortar” in Singapore and soon in Kunshan, in addition to a joint venture in Delhi, we have a presence in Asia that will need to be developed with an effective strategy for bringing our talents to the region in a manner that fosters networking and collaboration.   This was the topic of an interesting conversation with President Brodhead yesterday, and I see our efforts as completely aligned with where the university is going.

The next several months should be a fertile time to revise our plans. Dr. Harrington will be with us and free to think without the constraints of operationalizing ideas and the leadership groups of our various entities will be charged with thinking through our best organizational approach and strategy for our research and education missions.

In preparing a lecture on accountable care, I was struck by the mandatory COI slide now that appears after the title slide.  People expect “relationships with industry”.  Isn’t it time we updated our understanding of this topic?  The medical products industry is only one of many industries involved in healthcare. In fact, doctors now are increasingly employees of  health systems that do billions of dollars worth of business.  These doctors, including our best academic centers, are typically heavily incented to deliver high cost and high tech care of unproven value to drive margins.  Increasingly, salaries are based on RVU’s with some adjustment for “productivity” and those who speak out against unnecessary expensive procedures come under pressure for impacting margin.  This is all understandable, because we all want a reasonable compensation plan and a margin must be generated to pay for our teaching and research efforts.

Consider the massive revenues of our large academic systems now: Pitt is > $12B, Partners > $9B, Hopkins > $7B.  It just doesn’t seem right for our faculty to be calling pharma “industry” when we are employees of very large companies by any standard!

Accordingly, for a lecture on organization of health care, my employment by Duke is the major conflict, not my consulting with the pharmaceutical and device companies.