Rendering Unto Caesar - What the Abramson Family Cancer Research Institute vs Thompson Says About the Loss of the Academic Medical Mission

A case, reported by the New York Times as involving an intellectual property dispute, should create a lot of cognitive dissonance about the state of the academic medical mission.

Litigation Involving the Abramson Family Cancer Research Institute and Dr Craig B Thompson

Here is how the Times outlined the story:

The president of Memorial Sloan-Kettering Cancer Center in New York is in a billion-dollar dispute with his former workplace, a cancer institute at the University of Pennsylvania, over accusations that he walked away with groundbreaking research and used it to help start a valuable biotechnology company.

In a lawsuit, the Leonard and Madlyn Abramson Family Cancer Research Institute at Penn described its former scientific director, Dr. Craig B. Thompson, as 'an unscrupulous doctor' who 'chose to abscond with the fruits of the Abramson largess.'

In particular,

In the suit, the Abramson cancer institute, which has received more than $100 million from the philanthropist Leonard Abramson and his family, says that Dr. Thompson concealed his role in starting Agios, which has attracted investors with a potentially new way to treat cancer. The institute says Dr. Thompson’s actions deprived it of proceeds that could support future research, causing it damages that could exceed $1 billion.

So presumably the Abramson Institute is alleging that Thompson took its intellectual property and put it into Agios, and the Institute therefore wants compensation. Note that the Institute does not appear to be alleging either that Thompson was supposed to be its employee, but actually was working for Agios at the time he was supposed to be working for the institute; or that Thompson hid a a conflict of interest created by his financial relationship with Agios that could have affected how he fulfilled his professional responsibilities there.

Note further that certain other parties declared that they are not part of this dispute. These included Dr Thompson's current employer:

Sloan-Kettering declined to comment, saying it was not a party to the lawsuit....

These also included the University of Pennsylvania:

Susan E. Phillips, senior vice president for Penn Medicine, said that the suit had been filed not by the university but by the research institute, a separate entity. She said the university was investigating the accusations.

The nature of this dispute ought to generate several kinds of cognitive dissonance.

Protecting Intellectual Property vs Upholding the Academic Mission at the University of Pennsylvania

On one of its web pages, the Abramson Family Cancer Research Institute describes its history:

The Abramson Cancer center of the University of Pennsylvania provides each patient with exemplary care though a comprehensive team approach, personalized service, education and outreach, and nationally recognized cancer research programs.

The web page describes the institute as simply part of the larger University of Pennsylvania cancer center, which came to be named for the Abramson family:

Penn's Cancer Center was renamed in 2002 as the Abramson Cancer Center of the University of Pennsylvania, recognizing the Abramson family's $100 million commitment to support comprehensive cancer research and care.

Thus it seems that the Abramson institute is simply a piece of a traditional academic medical center.

The academic mission is traditionally described as the creation and teaching of knowledge. Thus, if an academic institution creates new knowledge, its should then disseminate it, not own it. Of course, in the US, since the Bayh-Dole act was passed, academic institutions were given the ability to patent their discoveries, and began to protect and sequester the knowledge they contained, rather than disseminating it.

In this case, however, one part of a large university and a large academic medical center seems to be concentrating entirely on its right of ownership of intellectual property, not the traditional academic mission. The fact that this dispute has lead to litigation suggests that the academic organization is now intent on protecting, rather than disseminating knowledge. The dispute appears to be between a commercial research company and its allegedly errant former hired manager.

The Abramson Institute: Part or Independent of the Academic Medical Center?  

A little more digging suggests that the nature of the Abramson institute is not as clear as is described in its web-page. A GuideStar search revealed that the institute is actually legally independent from the university. It filed its own 990 form (latest version, covering 2009-2010, here.)

The filing did list various entities, including the Clinical Care Associates of the University of Pennsylvania Health System, and the Trustees of the University of Pennsylvania as "related tax-exempt organizations."

However, this filing should create cognitive dissonance about what the underlying nature of the Institute? Is it part of the University of Pennsylvania and its medical center, or is independent but cooperating?

This dissonance is only enhanced by the ambiguous response of the University of Pennsylvania to the lawsuit. If the Institute is part of the University, then the University ought to be party to the lawsuit, it would seem.

This filing with the US government did underline the Institute's commitment to disseminating research. A description of its tax "exempt purposes" included:

Education - scientists at the Institute actively share their discoveries with the research community, physicians, and students.

As above, this statement of purpose appears not to fit with the filing of a lawsuit to obtain damages due to the alleged taking of intellectual property. If this really were the Institute's mission, would not they want the intellectual property liberated so it could be actively shared? The cognitive dissonance about the mission of the Institute and of the University versus the protection and sequestration of intellectual property is thus increased.

Upholding the Academic Mission vs Staying Uninvolved at Memorial Sloan-Kettering Cancer Center

As an aside, note that Dr Thompson is now not just working for Agios. In fact, he has been President of the Memorial Sloan-Kettering Cancer Center since 2010 (look here). Just like the Abramson Cancer Center, Sloan-Kettering is an academic medical center with the traditional mission of teaching, research, and patient care. Here is its mission statement:

As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs.

So one would think that people there ought to be concerned by allegations that its current president took intellectual property without authorization, and that he is "an unscrupulous doctor." If these allegations were to be proven false, they seemingly would represent a major, unwarranted slur on its and his reputation. If they were to be proven true, they would indicate that current leadership might not have the character to uphold the mission. Either outcome would be serious and have serious implications. However, at the moment, this noted academic medical institution has expressed neither outrage about possibly false accusations nor resolve to investigate the matter and then weed out any leaders not devoted to the mission.

Thus, the apparent intention of the leadership of Memorial Sloan-Kettering to stay uninvolved with this case ought to generate more cognitive dissonance.


Summary

The cognitive dissonances evoked by the case of the Abramson Institute vs Dr Thompson ought to inspire questions about what our academic medical institutions have become.  While they proclaim their devotion to research and teaching to improve health and health care, and advance science, they may increasingly act like commercial research organizations whose main goal is to generate increased revenue from products and services, and in this case, from intellectual property. 

It is hard to see how this emphasis on holding onto rather than disseminating new knowledge will be good in the long run for science, learning, or patient care.

We are now a good 30+ years into our ill-fated American experiment about the effects of turning medicine commercial and making health care a commodity. So far, it has yielded the highest costs in the world, but declining access, mediocre quality, and demoralized professionals.  Squabbling among top researchers and leading academic medical institutions over the ownership of intellectual property for the sake of revenue, not dissemination, is the latest symbol of the decline of our health care.

I can only hope that all the parties involved suddenly remember that they are supposed to be creating and disseminating knowledge, not just getting rich. 

Relieving Blocked Qi at the University of Pennsylvania

We posted a while ago about the new alliance between the prestigious University of Pennsylvania School of Medicine, and the Tai Sophia Institute, a local purveyor of complementary and alternative medicine.

The Chronicle of Higher Education recently reported (link here, requires subscription) that despite some vigorous internal criticism, the medical school and Tai Sophia remain together.

The Chronicle reported that the initial news reports of the alliance lead to a backlash, but one "limited to a handful of faculty members and alumni." Medical school officials back-tracked about the nature of the relationship with Tai Sophia, claiming it was a "partnership," not an alliance. "It was never meant to be a joining of the two schools, said Gail Morrison, Vice Dean for Education. Alfred P Fishman, a pulmonologist who is now the Director of Penn's Office of Complementary and Alternative Therapies, explained that the purpose of the "partnership" is to educate "students about an area that their patients are increasingly turning to. We think it would be a mistake not to prepare our students to critically evaluate what they're seeing." Furthermore, he noted that the purpose was not to teach how to do alternative therapies, but to "better understand how they work."

That last phrase, however, suggests that Dr Fishman believes they do work. Yet as we noted before, the Tai Sophia Institute seems to go beyond the data in promoting the effectiveness of its methods. Also telling was an anecdote described in the Chronicle.

Robert M. Duggan cradles the wrist of a second-year student at the University of Pennsylvania School of Medicine while another acupuncturist demonstrates how she would insert a stainless-steel needle into the student's scalp to relieve lower-back pain or lessen a migraine.
Sixteen medical students sit cross-legged on the floor, in rapt attention. 'If someone puts a needle in the proper place, I feel an immediate response in the pulse,' Mr. Duggan explains. 'It's like a light switch turning on.'
The students, many of them groggy from late nights of studying and hours of hospital rotations, discuss the ways in which the body, mind, and emotions are connected. Marc Hoffmann, another second-year student, recounts how a persistent lump in his throat disappared after he broke down from pent-up frustration and sadness.
Mr. Duggan's explanation - that the cathartic release of his crying relaxed his muscles and dislodged a blockage of qi, or life energy - makes sense to him. 'Maybe not as a medical student, but as a person,' Mr. Hoffmann says.
Lessons like this are taking place every week at Penn....

What was that Dr Fishman was saying about critical evaluation? In the anecdote above, the disciples of complementary and alternative medicine of the Tai Sophia Institute were telling the students what to believe, and the students were buying it. There were no critical thinking skills apparent.

When I was a fellow in general internal medicine at the University of Pennsylvania, I learned clinical epidemiology and critical assessment of clinical research. Now Penn students are taught about blocked qi. How far we have fallen.

More on the Alliance Between the University of Pennsylvania and the Tai Sophia Institute

The Associated Press has done a follow-up of the new relationship between the University of Pennsylvania Medical School and the Tai Sophia Institute, "an alternative medicine school." (See our previous post here.)
The new article quoted the leader of Tai Sophia, "the goal is that the Penn medical school graduates will be highly able to speak with patients about how to guide these things [acupuncture, herbalism] in overall care."
Furthermore, Dr. Alfred P Fishman, "co-director of the collaboration," noted, "today, we're moving away from being completely focused on preventing disease and toward looking at what it takes to [achieve and maintain] wellness... I think patient care will improve enormously."
In particular, the article reported that "cardiologists at Penn's Presbyterian Medical Center are working with Tai Sophia to integrate alternative therapies into traditional care for heart patients. The idea is to teach the cardiology staff how to develop personalized therapy plans - including everything from meditation and message to reflexology and aromatherapy - to decrease patient stress, pain and anxiety."
However, the article also included a riposte by Steven Barrett, who runs Quackwatch. Barrett charged that alternative medicine is not being accepted into medical schools because of good evidence that it works, but because "skeptical voices are squelched and 'administrators see it as a way to jump on the bandwagon and get grant money.'"
I wonder what sort of data exists on the benefits of reflexology or aromatherapy for patients with heart disease? I would bet not much. Quick PubMed searches did not reveal anything convincing. For Quackwatch's take, see their page on reflexology, and their page on aromatherapy.
I am still waiting for any rationale for the University of Pennsylvania's embrace of the Tai Sophia Institute that fits with the University's scientific mission.

University of Pennsylvania Allies with Tai Sophia Institute

The Philadelphia Inquirer reports that the prestigious University of Pennsylvania Medical School has announced a partnership with a local center for complementary and alternative medicine (CAM), the Tai Sophia Institute, and in parternship will begin to offer a masters degree in CAM.
The article quotes 86 year old Arnold Fishman, a pulmonologist, who has "enjoyed a long, achievement filled career in evidence-based medicine," advocating for the alliance, "my interest is: what are the new frontiers?" He further noted, "The message from consumers is quite clear." "Medicine cannot supply all that consumers feel they want."
But Robert Baratz, a skeptic about CAM, challenged this, saying the University is "attempting to capitalize on the so-called dynamics of the marketplace."
The Tai Institute's Institutional Values include

• "Operate from a declaration of oneness, a unity with all creation."
• "Make all judgments and decisions in the context and light of the seven (past 3, future 3, and present) generations."

The Tai Institute offers acupuncture and herbalist services. Its web-site states

• "Individuals using traditional acupuncture treatments often find relief from concerns including headaches, chronic fatigue, depression, allergies, back pain, digestive disorders, joint pain, sleeping problems, infertility, menstrual disorders and other symptoms."
• "Acupuncture is helpful for many concerns from headaches to joint pain. It has also been found effective for severe chronic conditions where pinpointing the cause has been difficult to determine. Those who receive ongoing treatment for maintenance and the promotion of good health have told us that they: • Tend to get sick less often and recover more quickly• Have improved stamina and vitality• Are better managers of their own health• See reductions in long-term health care costs and tend to visit physicians less often• Enjoy deepened more harmonious relationships with others "

The web-site presents no evidence to support these claims. I doubt they are well supported by data from well-designed randomized controlled trials. For a more skeptical view of acupuncture, see this page from Quackwatch.
Regarding herbal therapies, the Tai Sophia web-site states:

• "Botanical healing, used for thousands of years, is used specifically to support the healthy structure and function of the body. It works to promote vitality, balance, and longevity. "

Again, The Institute does not present evidence that, in particular, using herbs causes people to live longer. Although I will allow that some CAM remedies may turn out to have benefits that outweigh their harms, I see no reason to believe that this is true for any particular such remedy until it has been tested in well-designed controlled studies. I can see value in medical schools teaching students about patients' use of CAM, and performing well-designed research on CAM. However, the University of Pennsylvania's alliance with an Institute that seems to be a fervent, uncritical promoter of CAM seems at odds with the the scientific basis of medicine that medical schools, of all institutions, should uphold. I hope the University will come up with a clearer explanation for what it is doing than the purely consumerist approach described in the Inquirer's article.
[Full disclosure: I did a Kaiser Fellowship in General Internal Medicine at the University of Pennsylvania, where I got training in, among other subjects, clinical epidemiology.]

Upenn: Not What The Doctor Ordered

The University of Pennsylvania has penned an excellent article in JAMA (March 9, 2005): Role of Computerized Physician Order Entry Systems in facilitating Medication Errors , Koppel et al (free article). A summary of the article was in today's Philadelphia Inquirer ("Not what the Doctor Ordered"). The authors studied a CPOE system at the Hospital of the University of Pennsylvania operational from 1997 to 2004 -- and since replaced.

Many IT and workflow system-related problems are cited as causing a situation where information technology implemented with the best of intentions was actually causing error. Among the problems cited were "loss of data, time and focus when CPOE is nonfunctional ... crashes are common." "Inflexible ordering screens." "Viewing one patient's medications may require 20 screens." "lack of coordination among information systems [causing antibiotic renewal failure]."

These, among other issues cited, are simply stunning. I was involved in implementing the exact same CPOE system (TDS) at Yale-New Haven Hospital in 1992. It appears that hospital IT is truly an island, with inadequate cross-institutional problem-sharing or corporate memory.

These issues are depressingly reminiscent of similar clinical IT observations I documented via an Internet collaboration with other medical informaticists starting in 1998 at the website "Sociotechnologic issues in clinical computing: Common Examples of Healthcare IT Failure."

Here's an excerpt from the Philadelphia Inquirer article (registration required for full access):

Not What The Doctor Ordered
By Susan FitzGerald, Inquirer Staff Writer
Computerized prescription-ordering systems are promoted as the answer to preventing medication errors in hospitals, but a new study shows the technology also can cause mistakes.
The study at the Hospital of the University of Pennsylvania found that computer systems that allowed doctors to order drugs electronically, rather than writing orders, could lead to a variety of errors, including requesting drugs for the wrong patient or at an incorrect dosage. "What is supposed to be the great solution is itself
a source of errors," said Ross Koppel, a Penn sociologist who led the study.
While computerized systems "do offer some real protection," Koppel said, the study identified 22 types of medication errors that could result from the technology.

I penned a reply to the authors and to JAMA, which I reproduce here:

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Re: Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors” (JAMA, March 9, 2005)

Dear Dr. Koppel,

As a formally-trained Medical Informatics specialist formerly directing IT implementation in healthcare (Yale-New Haven Hospital, Christiana Care Health System after CIO Ward Keever's departure to HUP, and pharmaceuticals at Merck), I found the article “Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors” (JAMA, March 9, 2005) fascinating. Congratulations on an excellent and useful study.

I would, however, have liked to see a discussion of a critical element that I feel may be at the root cause of many clinical IT problems. The root issue I have in mind was hinted at in the statement “the researchers were not involved in CPOE system design, installation or operation.”

In my 1998 JAMA letter “Barriers to Computerized Prescribing” (JAMA.1998; 280: 516-517), I identified a lack of leadership by clinical experts, especially those with dual formal training in medicine and information technology (i.e., Medical Informatics), in the design, evaluation, acquisition, implementation, revision, and system life cycle processes in clinical IT.

Instead, these processes are customarily led by those of a Management Information Systems (business computing) background in both vendor environments and provider environments. By leadership I mean the direct control of resources, staffing, skill sets, personnel evaluation, and major decisions impacting the practice of medicine. Clinicians as “consultants who know something about computers” is proving an inadequate model for success of complex clinical IT, as your experience suggests. I submit that most, if not all, of the errors you observed from CPOE use had as a root cause an inadequate leadership expertise of the system designers, evaluators and implementers. These personnel did not have bad intentions, of course, but due to a basic misalignment of skillsets required for leadership in clinical IT the observed problems may result.

A stunning example of this phenomenon on a large scale was the recent $450 million hospital IT failure at the Bay Pines, Florida VA Hospital. Half a billion dollars was wasted due to the system designers and implementers admittedly not having sufficient understanding of hospitals and healthcare, a debacle detailed by the Google search http://www.google.com/search?hl=en&lr=&q=Bay+Pines+VA+hospital+computer+system+failure .

On a national scale, the UK’s multibillion dollar national electronic medical records initiative faces similar problems due to “lack of engagement by clinicians in the early stages of the programme” (“NHS joint IT chief resigns after six months in the job”, http://www.computerweekly.com/articles/article.asp?liArticleID=133699 ).

As Joan Ash, Ph.D. noted at Oregon Health & Science University in a 2003 study “Most hospitals don't use latest ordering technology” (http://www.eurekalert.org/pub_releases/2003-11/ohs-mhd112403.php ), "many information systems simply don't reflect the health care professional's hectic work environment with its all too frequent interruptions from phone calls, pages, colleagues and patients. Instead these are designed for people who work in calm and solitary environments … some patient care information systems require data entry that is so elaborate that time spent recording patient data is significantly greater than it was with its paper predecessors," the authors wrote. "What is worse, on several occasions during our studies, overly structured data entry led to a loss of cognitive focus by the clinician."

Calm and solitary environments, indeed.

How are CPOE and other clinical IT systems that ignore the healthcare workplace's realities finding their way into real products? How is this possible? While the workflow of the National Security Agency might be secretive, the realities of the medical work environment are certainly not. Who are the CPOE designers, exactly, and what are their backgrounds? How could investor dollars have been spent in such a fashion as to ignore the fundamental realities of clinical settings? How could IT companies have designed and implemented systems that "led to a loss of cognitive focus by the clinician" and created error?

Unfortunately, the answer to these questions is that design and implementation of CPOE systems and other clinical IT are being led by Management Information Systems business-computing personnel, who generally design and implement systems for "calm and solitary" business office environments, instead of those with both IT and clinical expertise such as Medical Informatics specialists.

I detailed a number of case studies of healthcare IT failures through inadequate leadership models by business computing personnel at my old website “Sociotechnologic issues in clinical computing: Common examples of healthcare IT failure” at http://home.aol.com/medinformaticsmd/failurecases.htm . You will likely find these cases of interest. The IT model of "If it's information, we do it" starts to fall apart and impede progress in such organizationally and sociologically-complex environments as medicine.

Clearly, clinical IT leadership models are defective and must be changed as an initial step before any of the recommendations you make in your article’s conclusion can be realized.

Sincerely,

Scot M. Silverstein, MD

Former faculty, Yale School of Medicine, Center for
Medical Informatics, Director of Clinical Informatics, Christiana Care Health
System, Wilmington, DE, and Director of Scientific Information Resources &
The Merck Index, Merck & Co., Inc.

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(In my letter to JAMA, unfortunately, I forgot to include perhaps the most stunning of recent, costly CPOE missteps, "Doctors Pull Plug on Paperless System" at Cedars-Sinai Medical Center in Los Angeles, AMA News, Feb. 17, 2003. An excerpt:


As I wrote above, It appears that hospital IT is truly an island, with little cross-institutional sharing or memory. I sometimes wonder if Gilligan's Island is not an inappropriate metaphor for this phenomenon.

The author's JAMA article is quite welcome as a start to closing the gaps in the world of clinical IT. These articles are all too rare; these issues are often highly whitewashed in the hospital IT press. There is also resistance to such articles from many quarters. However, either an organization is in control of its computing - and studies its IT issues and mistakes - or the IT is in control of the organization. That's an adaptation of the old UNIX adage "either you're in control of your system, or it's in control of you."

Those who oppose exposure of clinical IT's flaws, when the critique is geared towards learning and correction , are firmly rooted in a dysfuntional territorial mentality that has no place in a scientific field such as medicine. It may or may not have had its place in "data processing" shops of the past; however, such beliefs have no place in 21st century healthcare.

It must be remembered that hospitals exist so that clinicians can take care of patients, not so that IT personnel, staff and vendor companies can have easy computing jobs and lucrative contracts.

(Note: I worked with an IBM/370-165 mainframe in the past at the assembly language level. As I recall, the TDS CPOE system ran on an a mainframe successor to the 370's that was of utmost industrial reliability, and the software was accessed via character-based terminal emulators (e.g., VT100) running on PC's. How such a system can have "common crashes" is somewhat of a mystery to me.)

-- SS

"Cedars-Sinai Medical Center in Los Angeles turned off its computerized physician order entry system in January, after hundreds of physicians complained that rather than speeding up and improving patient care, it actually slowed down the process of filling their orders -- assuming those orders didn't get lost in the system ... Cedars-Sinai's decision was extraordinary but not unique. David Classen, MD, of First Consulting Group, says he knows of at least six other hospitals that have pulled paperless systems in the face of physician resistance and other problems ... "They poorly designed the system, poorly sold it and then jammed it down our throats and had the audacity to say everybody loves it and that it's a great system," [Cedars-Sinai physician user Dr. Dudley] Danoff said."