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Sabtu, 07 Mei 2011

"We're Only In It for the Money" - Big Businesses Pretending to be Medical Schools Discussed in Main-Stream Medical Journal

This is a first, the contention that medical schools are only in it for the money has appeared in a prestigious, main-line, large-circulation medical journal(1). The author started by noting that medical schools are now academic in name only.
US medical schools have evolved into big businesses that derive most of their income by providing healthcare services and securing extramural research grants. In 2009, for example, 53% of medical school revenues came from clinical services and 29% from extramural grants. By comparison, less than 4% came from tuition.

These big businesses disguised as academic institutions behave like other big businesses:
Academic medical centers vie for clinical market share through direct-to-consumer advertising. To increase referrals, they offer free continuing medical education that boost the visibility of their most profitable services to community providers. Physicians with MBA degrees are becoming increasing common at academic medical centers....

Then University of Utah cardiology professor Matthew Movsesian clearly asserted that faculty realize that they are only valued for the money they bring in:
It's worth noting that medical school faculty members perceive that their-revenue-generating activities are of paramount importance in the eyes of academic leadership. In a recent survey of US medical schools, 51% of respondents agreed that 'the administration is only interested in me for the revenue I generate'; a less extreme statement might have elicited [even] more widespread concurrence.

Emphasis on revenue generation by faculty is evident in the incentive plans that typically compensate clinicians in proportion to the billable services they provide. And researchers understand that their salaries for time spent on research must be paid, sometimes in full, from extramural grants.

Dr Movsesian implied who the main beneficiaries of this revenue generation are:
Executives at these teaching institutions are paid industry-level salaries.

All of this should be familiar to those who have been reading Health Care Renewal.  We first wrote about how medical school leaders mainly evaluated faculty by their revenue generation, and dismissed those who did not generate sufficient revenue as "welfare recipients," here in 2007.  We discussed the survey that revealed that medical school faculty realize their supervisors only value their revenue generation here in 2010.  But the first post was derived from an interview in the SGIM newsletter, and the survey noted above so far is only publicly available in an on-line abstract.  To my knowledge, the notion that medical schools have abandoned their primary mission of discovering and disseminating the truth in favor of making money, perhaps mainly for the benefit of their top leaders, has not heretofore appeared in a main-stream medical or health care journal.  So this new publication marks an important weakening of the anechoic effect.

Late in 2010, we discussed an important new report in the Lancet about the reform of global health care education(2)(see post here).  It hinted at some of the threats to the academic medical mission we have long discussed on Health Care Renewal.  An accompanying editorial stressed the need to uphold the academic mission, implying that it was in some way threatened, but again did not discuss what actually threatened it.(3)(See our post here which listed some of threats that should be considered.  The threats are reprinted in the box below.)  Now the peril to the mission of US medical, and by extension, perhaps global health care education has made it into polite discussion.  Maybe it is not too late to address threats to global health care education before the system collapses from its internal contradictions.

Threats to the Global Health Care Education Mission (the "Thirteen Plagues")

Health Care Renewal, is largely concerned with threats to health care's core values, including threats to the mission of academic medicine, largely from concentration and abuse of power.  The largest set of threats come from the ascendancy of financial goals amidst the commercialization of health care (mentioned briefly both in Frenk et al and the editorial).  


  • Abandonment of traditional prohibitions of the commercial practice of medicine - In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts  here and here.



  • Making money takes precedence over education -  A recent survey showing that more than half the faculty at multiple US medical schools felt they were valued more for how much money they brought in than their teaching or patient care abilities (here), confirming previous anecdotal reports (see here). 




  • The medical school re-imagined as a biotechnology company -  In 2000, a Vice President of the American Association of Medical Colleges(4) wrote that research universities must respond to "societal demands that they become engines of economic development�."  Many universities now defend lax conflict of interest policies with similar arguments.  For more details, go here



  • Faculty become employees of industry - For numerous examples of this and other kinds of conflicts of interest, go here.  A survey by Campbell et al suggested that approximately two-thirds of medical academics get significant payments from industry.(5)




  • Academics become "key opinion leaders" paid to market drugs and devices - Marketers regard "key opinion leaders" as salespeople who appear more credible because of their professional guise.  See anecdotal evidence here



  • Control of clinical research given to commercial sponsors - A study by Mello et al showed how universities' grant administrators are willing to sign contracts giving commercial sponsors control over key aspects of human research studies.(6)  See post here




  • Conflicts of interest allow manipulation and suppression of clinical research - Commercially sponsored research design, implementation, and dissemination are often manipulated to favor the sponsor's interests.  When such manipulation fails to produce favorable results, the results may simply be suppressed



  • Academics take credit for articles written by commercially paid ghost-writers - Such ghost-writing is often part of organized stealth marketing campaigns. 




  • Whistle blowers are discouraged, or worse, and academic freedom is damaged.  Discussion of some examples of what may happen to whistle blowers is here.  The survey mentioned earlier (here) showed that about one-third of faculty fear they may be punished for speaking  out. 



  • Leadership of academic medical centers by businesspeople - Ill-informed management may result from leaders who have no background or training in actual health care. 




  • Leaders of teaching hospitals and universities become millionaires -  A recent example is here, and more may be found here.  Leaders of academic medical centers and the parent universities of medical schools often make more than $1 million a year in the US.  When such amounts are in play, executives may focus more on short-term measures that lead to even more pay than on upholding the mission. 



  • Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - A recent example is here, and a summary of how we discovered this phenomenon in 2006 is here.   The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see here and here).




  • Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, recently here, here, and here, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities.  Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance. 




  • Reference
    1.  Movsesian M. Intramural conflicts of interest warrant scrutiny, too. Nature Medicine 2011; 17: 21. Link here.
    2.  Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T et al. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world.  Lancet 2010; 376: 1923-1958.  Link here.
    3.  Horton R. A new epoch for health professionals' education.  Lancet 2010; 376: 1875-7.  Link here.
    4. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. Link here.

    5. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician�industry relationships. N Engl J Med 2007; 356:1742-1750. Link here.
    6. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21. Link here.

    Title with apologies to the late Frank Zappa.

    Jumat, 08 April 2011

    Dr. Silverstein and Dr. Poses in WSJ: "The Literature Is Hardly Pristine"

    I have considered Dr. Roy Poses' Dec. 14, 2010 post "The Lancet Emphasizes the Threats to the Academic Medical Mission" (with its hyperlinks to source posts and articles) an excellent summary of many of the pathologies we address at Healthcare Renewal, especially with regard to the academic mission and the disruption of the integrity of the medical literature by commercial interests. His post is consistent with what might be considered our mission statement:

    Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

    The Wall Street Journal published the following letter to the editor authored by me today in which I cited and summarized Dr. Poses' accounting of the medical literature's ills.

    Unfortunately, the print version cannot contain the hyperlinks as in the aforementioned source post, but I have included them in the reproduced letter below in [brackets]. They are worth reviewing, along with additional links at the aforementioned source post "The Lancet Emphasizes the Threats to the Academic Medical Mission":

    April 8, 2011
    Wall Street Journal
    Letters to the Editor

    The Literature Is Hardly Pristine

    I find it unfortunate having to inform reader James Reichmann, (Letters, April 1) who prefers his physician to recommend only treatments proven in the "synthesized medical literature," that the very literature on which he wishes his life to depend may be tainted.

    As Dr. Roy Poses points out on the Healthcare Renewal Blog, numerous factors common in today's culture can and do corrupt the literature.

    The factors include but are not limited to: rampant commercialization of medicine [here, here, here and here], research universities with lax conflict of interest policies [here], faculty as de facto employees of industry through grants [here], academics paid to be "key opinion leaders" to stealth-market drugs and devices [here], control of clinical research given to commercial sponsors [here], conflicts of interest allowing manipulation and suppression of clinical research [here and here], academics taking credit for articles written by commercially paid industry "ghost writers," [here and here], whistleblowing discouraged [here and here], leadership of academic medical centers by business people [here] and medical school leaders becoming stewards (as members of boards of directors) of for-profit health-care corporations [here, here, here and here].

    As for me, until the medical literature can be freed of these contaminants, I'd rather trust a well-trained personal physician's good judgment in my own medical care.

    Scot Silverstein, M.D.

    Drexel University

    Philadelphia


    I believe it's also worth reviewing my own views on the subject, that the degree of contamination of medical literature is unknown and may be unrecoverable, due to spread of the contaminant vectors to the "experts" who then propagate the disease.

    See my Aug. 2009 post "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?" where I raise these questions.

    At that post I suggest that while the damage might not be easily recoverable, the practices that lead to contaminated literature must be stopped going forward if true evidence-based medicine is ever to be a reality.

    -- SS

    4/12/2011 addendum:

    Almost predictably, some anonymous person, this time over at the Respectful Insolence blog in commenting on a post there that attacks "naturopathic" medicine, proffered strawman arguments about my piece above in comment #26.

    ... So Dr. Silverstein thinks that the defects he cites (many of which have been revealed by and hotly debated within the scientific community) are ample justification for tossing out the entirety of research in favor of the sort of "clinical intuition" that's repeatedly been found false over the years

    This binary, two-dimensional thinking is quite sad to read, if real. I'll be charitable in saying that the comment does have the "feel" of something contrived, such as received before from corporate sockpuppets.

    -- SS

    4/13 addendum:

    The proprietor of Respectful Insolence assures me that "anonymous" quoted above is not a sockpuppet. My response was basically that before attacking non-anonymous authors by name on the web who in fact (as is clear from my writing here) share similar views on medical quackery, one should contact them first to ensure you truly understand their views.

    (In my case, my view is that the "well-trained physicians" of good judgment I wrote of consider the literature critically but are not bound to it, in consideration of the unknown level of its commercialization-based contamination and the variability of individual patient situations. They treat the patient, not the guideline.)

    -- SS

    Kamis, 06 Januari 2011

    Why Would Directors of Health Care Corporations Push for Bigger Pensions for Academic Administrators?

    We recently posted about 36 well-paid top executives in the University of California system, including leaders of medical schools, academic medical centers, and public health, who threatened a lawsuit if their pensions were not increased according to what they claim was a promise made to them in 1999.

    Riddle me this: why would a group of directors of for-profit corporations that provide health care goods and services. plus a director of a leading biotechnology trade group, and the director of a leading mutual fund family band together to support this demand, thus to push for bigger pensions for these top managers of the University of California system?

    Here is a list of the directors, and their corporations:

    -  Mark R Laret, director of Varian Medical Systems and Nuance Communications Inc, which provides numerous health care products 
    - Dr David Feinberg, director of OSI Systems, whose Spacelabs Healthcare subsidiary manufactures medical devices
    - Steven C Currall, director of Leadership in Medicine Inc, which claims to be a leading provider of intelligence about key opinion leaders (KOLs) in medicine and health care.  Its web-site asserts, "IF YOU NEED TO KNOW who are the most prominent, admired, and influential actors in healthcare, how they are interconnected, and why, you need our expertise.  Given how vastly complex are the relationships among providers, researchers, and other significant actors in healthcare, it is vital to focus on key opinion leaders (KOLs) at local, regional, and global levels, and to understand the ties among them."  (Note that we have often discussed how KOLs function as stealth marketers for pharmaceuticals and devices.)

    They joined:
    -  Robert S Sullivan, PhD - director of BIOCOM, whose web-site asserts it is the" largest regional life science association in the world, representing more than 550 member companies in Southern California."
    -  Richard K Lyons, director of iShares, a leading provider of mutual funds.

    The answer is simple.  All the corporate directors listed above are also members of the group of 36 litigious executives.  See their name on the list of 36 here in the San Francisco Chronicle.

    - Mark R Laret, director of Varian Medical Systems and Nuance Communications Inc, which provides numerous health care products, is also CEO of UCSF Medical Center.
    - Dr David Feinberg, director of OSI Systems, whose Spacelabs Healthcare subsidiary manufactures medical devices, is also CEO of the UCLA Hospital System
    - Steven C Currall, director of Leadership in Medicine Inc, which claims to be a leading provider of intelligence about key opinion leaders (KOLs) in medicine and health care, is also Dean, and Professor of Management of the University of California - Davis Graduate School of Management.
    Robert S Sullivan, PhD - director of BIOCOM, whose web-site asserts it is the" largest regional life science association in the world, representing more than 550 member companies in Southern California, is also Dean of the University of California - San Diego Rady School of Management.

    - Richard K Lyons, director of iShares, a leading provider of mutual funds, is also Bank of America Dean and Professor of Business, University of California - Berkeley Haas School of Business.

    Their inclusion within the larger group seems ironic, at best.  As corporate directors, they have outside income and have accumulated assets that will likely keep them out of poverty in their old age.  For example, Mr Laret had accumulated the equivalent of 37,168 shares of Varian, and was paid $267,300 a year for his services according to the company's 2010 proxy statement.

    Furthermore, for those who directly lead health care institutions, Mr Laret and Dr Feinberg, their memberships on the boards of health care corporations, which imply fiduciary responsibilities to the companies and their stock-holders, conflict with their duties as leaders of academic health care to uphold teaching, research and patient care.  Dean Currall's responsibilities to an organization which seems entirely dedicated to helping drug, device, and biotechnology companies turn health care professionals and academics into stealth marketers at least seems unseemly given that his school is part of a university which also includes a medical school and academic medical center. 

    Since our earlier post, it appears that the University of California president will not accede to the demands of the 36, as noted in the San Francisco Chronicle.  Their demands have continued to provoke outrage.  A recent discussion in Inside Higher Ed interviewed Emeritus Professor Helen Henry, a member of the University's Academic Senate, who posited:
    the debate as part of a fundamental philosophical disagreement within the university. The signatories to the letter, many of whom are based in medicine or management, have a different view of the university than faculty from other disciplines, she said.

    'I don�t think there�s any question but that there are these two different mindsets that are fighting for what the university should be. It�s transparent in this letter,' said Henry, a professor emeritus of biochemistry at the Riverside campus. 'They are running businesses. But there are those of us that don�t feel this is what the university should be.'

    'This is absolutely a manifestation of that clash between the people who see UC as their business � and the people who see UC�s mission as teaching, and research and service to the state. That�s a dual personality that the university always has to live with.'

    Five of the university leaders demanding higher pensions for themselves have responsibilities as directors of corporations that may conflict with their academic institutions' missions, while these corporate positions ought to insulate them from financial concerns about their retirement. This corroborates Prof Henry's notion that they see themselves as businesspeople whose role is separate from, and not necessarily supportive of the university mission.

    I disagree, however, with Prof Henry's implication that the University has to live with such a split among its leadership. People who lead academic institutions have a primary responsibility to support the academic mission. Their goals should not be to maximize profits, much less to enrich themselves. Letting academia, and academic medicine be lead by leaders out to make money and line their own pockets will lead to just that, but hardly better teaching, research, and patient care.

    Selasa, 21 Desember 2010

    High Heels, Short Skirts, and Recruiting Bone Marrow Donors

    Once again, you just can't make this stuff up.  Here is the New York Times description of new state of the art in recruiting donors for bone marrow transplant.
    On its face, it seemed reasonable enough: a bone marrow registry sending recruiters to malls, ballparks and other busy sites to enlist potential donors.

    But the recruiters were actually flirtatious models in heels, short skirts and lab coats, law enforcement officials say, asking passers-by for DNA swabs without mentioning the price of the seemingly simple procedure. And the registry, Caitlin Raymond International, was paying up to $60,000 a week for the models while billing insurance companies up to $4,300 per test.

    In New Hampshire, where prosecutors say thousands of people appeared to have provided swabs, the attorney general is investigating the registry�s marketing and billing practices. The registry is a nonprofit subsidiary of UMass Memorial Medical Center in Worcester, which said Thursday that it had stopped seeking donors in New Hampshire and using models altogether.

    James T. Boffetti, the state�s senior assistant attorney general, said the registry had hired models based on their photographs and had given them 'explicit instructions' to wear heels and short skirts.

    The recruitment seemed to be based more on in-your-face sex appeal than an appeal to altruism:
    'The models worked the crowds, if you will,' he said. 'We were told basically they would engage a lot of younger men with some sort of flirtatious thing: �Hey, don�t you want to be a hero? Come on, do this!� '

    What the models did not tell their, um, prospects was that apparent acts of charity would result in a hefty bill to the volunteers' health insurance:
    They got people to do this without telling them it could be a charge of $4,300 against their insurance

    To put that charge in perspective, as reported by Liz Kowalczyk in the Boston Globe:
    In the last decade, Massachusetts, New Hampshire, and Rhode Island became the only states where legislators mandated insurers pay for bone marrow testing.

    Nationally, most hospitals and other donor-recruitment organizations do not charge for the testing, said Michael Boo, chief strategy officer for the National Marrow Donor Program. The test typically involves a DNA analysis to determine whether the donor is a match for anyone on the bone marrow transplant waiting list.

    Boo estimates it costs the organization about $100 to test and recruit each potential donor, although he said that, as the largest bone marrow donor registry in the United States, the program gets a volume discount from labs for the DNA analysis. The organization has about 8 million registered donors. (The Caitlin Raymond registry has 185,000 potential donors.)

    But in New Hampshire, UMass Memorial charges self-insured employers, like the city of Manchester, that do not have a negotiated rate upwards of $4,000 per person for testing. It generally has charged insurers like Blue Cross and Harvard Pilgrim $700 to $1,500 person for testing, said James Boffetti, senior assistant attorney general in New Hampshire and chief of the consumer protection bureau.

    'We haven�t been able to get a clear explanation from UMass about the reasons for the costs,' he said. As for the unusual recruiting, he said, 'they�re doing it because they are making money on this test.'

    Finally, although the medical center sent initial bills for the tests to volunteers' insurers, sometimes the volunteers got stuck with part of the bill. As reported by National Public Radio:
    Marc Ferland, a 45-year-old father of two in Bow, N.H., stopped at a registry booth after giving blood at a Red Cross drive. A month later, he received a bill that said he owed more than $2,000 to cover the costs of the test. When he complained, the amount was cut to $760, which he paid out of a health care account offered by his employer.

    'When you take money out of my spending account, that's a cost to me,' Ferland said.

    So here is an almost unbelievable example of how the a culture of marketing gone amok has taken over an academic health care institution. It seems darkly humorous now that the UMass Memorial Medical Center includes in its stated values:
    Staff members of UMass Memorial Medical Center are committed to:

    * Excelling at patient-centered care
    Achieving patient-focused excellence through the highest standards of quality care, patient safety and patient satisfaction
    * Acting with integrity
    Dealing honestly, fairly and responsibly with each other
    * Respecting one another
    Valuing the contributions, ideas and opinions of our coworkers, colleagues, patients and partners
    * Contributing to the community
    Partnering with the community at large and with other health care and social agencies in meeting the health needs of the community
    * Improving through teamwork and systems thinking
    Working to continuously improve ourselves, our processes and our patient services through cooperation and thinking as an integrated health care system
    * Embracing accountability
    Holding ourselves, our coworkers and our leaders to the highest standards of performance

    Integrity? Partnering with the community? - maybe that is what some of the recruits were hoping for, in a sense.   Embracing accountability?  Maybe the new vision statement should be "a sucker is born every minute."

    Again, it would be funny if it were not so tragic.  Here we see a major academic medical institution debased into something that a Las Vegas casino might frown upon.

    As we have noted ad infinitum, however, previous attempts at health care reform have not dealt with how the "greed is good" culture of Wall Street, run by amoral financiers and fueled by cynical marketers, has taken over health care.  Until we get health care leaders who really do care about patients, and about the integrity of teaching and research, the show will go on.  Meanwhile, the suckers better watch out.

    Selasa, 14 Desember 2010

    The Lancet Emphasizes the Threats to the Academic Medical Mission

    We just discussed an important article in the Lancet calling for major global reforms of health care education.(1)  An accompanying editorial(2) argued for the critical importance of upholding the mission of higher education, because that mission is critical to human civilization:
    Louis Menand has investigated the current role of the modern university in his startlingly powerful book, The Marketplace of Ideas. Menand argues that: 'The pursuit, production, dissemination, application, and preservation of knowledge are the central activities of a civilisation.' More importantly still, 'the ability to create knowledge and put it to use is the adaptive characteristic of humans'. The goal of the university is 'to make more enlightened contributions to the common good'.

    The editorial argued strongly for the revitalization of the university's mission:
    'It is the academic's job in a free society to serve the public culture by asking questions the public doesn't want to ask, investigating subjects it cannot or will not investigate, and accommodating voices it fails or refuses to accommodate.'

    The education of doctors, nurses, and public health workers must seek to: strengthen the overall intellectual culture of a society; define principles for public aspiration; give life to and enlarge the best and most proven ideas of the age; refine the grounds for the private exchanges that take place in our lives; facilitate the exercise of political power; and enable professionals to detect what is important and discard what is irrelevant, accommodate oneself with others, have common ground between colleagues across societies, ask good questions and find the means to answer them, and have the resources to adapt to national and global circumstances. Some readers might recognise that these words are adapted from John Henry Newman's On the Scope and Nature of University Education.

    In England, Newman argued for the university as a centre of intellectual liberty, a vital force for progress in society. Menand writes about the university as a 'zone of autonomy'. The importance of tertiary education as a means to advance health, reason, democracy, and justice needs to be rediscovered.

    But arguing so forcefully for upholding the academic mission makes sense only if that mission is under threat. The Lancet editorial only briefly alluded to why this might be:
    What this Commission argues for is nothing less than a remoralisation of health professionals' education. For decades, health professionals have colluded with centres of power (governmental, commercial, institutional, even professional) to preserve their influence. The result? A contraction of ambition and a failure of moral leadership.

    While the original article by Frenk et al suggested that health professionals' education has shortcomings, it did not argue that the academic mission is threatened.  Although the message of the accompanying editorial is that the mission needs a strong defense, it did not clearly explain the extent of the threat to it. 

    However, this blog, Health Care Renewal, is largely concerned with threats to health care's core values, including threats to the mission of academic medicine, largely from concentration and abuse of power.  The largest set of threats come from the ascendancy of financial goals amidst the commercialization of health care (mentioned briefly both in Frenk et al and the editorial).  We have discussed the nature of the threats in detail.  For example,
    • Abandonment of traditional prohibitions of the commercial practice of medicine - In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts  here and here.
    • Making money takes precedence over education -  A recent survey showing that more than half the faculty at multiple US medical schools felt they were valued more for how much money they brought in than their teaching or patient care abilities (here), confirming previous anecdotal reports (see here). 
    • The medical school re-imagined as a biotechnology company -  In 2000, a Vice President of the American Association of Medical Colleges(3) wrote that research universities must respond to "societal demands that they become engines of economic development�."  Many universities now defend lax conflict of interest policies with similar arguments.  For more details, go here.
    • Faculty become employees of industry - For numerous examples of this and other kinds of conflicts of interest, go here.  A survey by Campbell et al suggested that approximately two-thirds of medical academics get significant payments from industry.(4)
    • Academics become "key opinion leaders" paid to market drugs and devices - Marketers regard "key opinion leaders" as salespeople who appear more credible because of their professional guise.  See anecdotal evidence here.  
    • Control of clinical research given to commercial sponsors - A study by Mello et al showed how universities' grant administrators are willing to sign contracts giving commercial sponsors control over key aspects of human research studies.(5)  See post here
    • Conflicts of interest allow manipulation and suppression of clinical research - Commercially sponsored research design, implementation, and dissemination are often manipulated to favor the sponsor's interests.  When such manipulation fails to produce favorable results, the results may simply be suppressed.
    • Academics take credit for articles written by commercially paid ghost-writers - Such ghost-writing is often part of organized stealth marketing campaigns. 
    • Whistle blowers are discouraged, or worse, and academic freedom is damaged.  Discussion of some examples of what may happen to whistle blowers is here.  The survey mentioned earlier (here) showed that about one-third of faculty fear they may be punished for speaking  out. 
    • Leadership of academic medical centers by businesspeople - Ill-informed management may result from leaders who have no background or training in actual health care. 
    • Leaders of teaching hospitals and universities become millionaires -  A recent example is here, and more may be found here.  Leaders of academic medical centers and the parent universities of medical schools often make more than $1 million a year in the US.  When such amounts are in play, executives may focus more on short-term measures that lead to even more pay than on upholding the mission. 
    • Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - A recent example is here, and a summary of how we discovered this phenomenon in 2006 is here.   The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see here and here).
    • Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, recently here, here, and here, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities.  Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance. 
    So the threats are real and substantial.  However, their scope generally generally gets little attention.  Even when specific threats appear in the academic literature, their importance may be soft-pedaled, and their confluence with other threats ignored.  Of course, trying to discuss the full breadth and depth of these threats, as we endeavor to do on this blog, threatens in turn those who have personally profited from the current system.  Hence, we frequently cite the anechoic effect, the phenomenon that important threats to health care's core values are often just not discussed in polite company.

    Therefore, we applauded the article by Frenk et al for concatenating some of the most important challenges to health care professionals' education, and we now applaud the Lancet editorial for emphasizing the threat to the academic medical mission.  We hope that these two articles, appearing in one of the most prestigious and well-read medical journals, will help to combat the anechoic effect.  Meanwhile, we will continue to blog about threats to core values in the hope that discussing them will lead to solutions.
    References

    1.  Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T et al. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world.  Lancet 2010; 376: 1923-1958.  Link here.
    2.  Horton R. A new epoch for health professionals' education.  Lancet 2010; 376: 1875-7.  Link here.
    3. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. Link here.
    4. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician�industry relationships. N Engl J Med 2007; 356:1742-1750. Llink here.
    5. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.  Link here.

    Senin, 13 Desember 2010

    "Health Professionals for a New Century": Calling for "Ethical Conduct," a "New Professionalism," and Improved "Stewardship" and "Social Accountability"

    A major article just published in the Lancet urged global reform of health care education  [Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T et al. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world.  Lancet 2010; 376: 1923-1958.  Link here.]

    The problems it recognized included
    • "Pitifully modest" spending for health professional education, compared to overall health spending
    • Health care systems that are "dysfunctional and inequitable," due in part to "commercialism in the professions," leading to "breakdown ... especially noteworthy within primary care, in both poor and rich countries."
    • For profit medical education leading to "a so-called de-Flexnerisation process ... in which low-quality professional schools might be proliferating...."
    • Health care corruption, e.g., "the Indian press has reported illegal payments by new private schools seeking accreditation...."
    The solutions it advocated included
    - Fostering "ethical conduct" by professionals, developing a "new professionalism," earning trust "steered by ethical commitment and social accountability."
    Improving "stewardship mechanisms, including socially accountable accreditation"

    It is nice to be in such good company.  While the report was written in the subtle, diplomatic language of international public health, it was the only such authoritative report to appear in a widely circulated, highly respected medical journal that I can recall that was this direct about the seriousness of such problems.

    In fact, not only is little spent on actual medical education within academic medical institutions, but faculty members are valued more for the money they bring in than for their teaching.  Commercialism in health care has been institutionalized in the last 30 years (for discussion of its history in the US, look here, here, and here.)  The Transparency International Global Corruption Report of 2006 asserted "the scale of corruption is vast in both rich and poor countries," yet has gotten almost no notice in medical, health care research, and health care policy circles.  In 2009, the US Institute of Medicine published a detailed report including fairly strong recommendations on Conflict of Interest in Research, Education and Practice.  The anechoic effect, however, has dictated that discussion of striking examples of mission-hostile management, conflicts of interest, and outright crime and corruption is simply not done, especially in medical, health care, or health policy venues and journals.  The 2006 TI and 2009 IOM reports have infrequently been cited, and their recommendations have widely been ignored.

    I do hope that the appearance of a publication as authoritative as the article by Frenk et al leads to some soul-searching by the leaders of health care around the world.  They need to realize that despite the article's measured tones, the problems really are severe, and even more broad than the article implied.  We have discussed in detail how health care education (and all of health care) are hurt by concentration and abuse of power, by governance that lacks accountability, integrity, and transparency; by leadership that ignores the context, core values and mission, promotes self-interest and conflicts of interest, and sneers at ethics; and by results such as suppressed and manipulated research, deceptive and dishonest education (look here, here, and here for examples), stifling of academic freedom and whistle-blowers, then dissatisfied, burned out faculty (here), and finally the final common pathway of rising costs, declining access, and poor quality.  

    It is heartening that the importance of our concerns has been corroborated in such a notable venue.  I hope this report gathers less dust than the 2006 Transparency International Global Corruption Report and the 2009 Institute of Medicine conflict of interest report.

    I suggest that to truly reform health care education (and health care itself), we will have to attend to the sorts of problems we write about on Health Care Renewal.  On one hand, we will need to improve the stewardship, governance, and leadership of health care education itself, and reduce the pervasive conflicts of interest that ensnare the faculty.  On the other, we will need to make sure education prepares students to deal with these problems in health care at large.

    It would be nice if the appearance of the Lancet article signifies that help will soon be at hand to tackle the huge amount of work that needs to be done, in the face of likely withering opposition from those who have enriched themselves from the dysfunctionality of the current system.  We at Health Care Renewal will continue to try to draw attention to these issues, accompanied I am sure by our fellow bloggers (as are listed in the right hand column).  However, a small group of voluntary "citizen journalists," and health care professional curmudgeons cannot solve this problem on our own. I hope we will soon have some more support.

    ADDENDUM (14 December, 2010) - See also comments by Paul Levy on the Running a Hospital blog.

    Senin, 06 Desember 2010

    Duke Divinity Students Protest Pay of Chancellor for Health Affairs

    This may be a first.  A small group of Duke University divinity students publicly protested the compensation given to some top university leaders, specifically including the Chancellor for Health Affairs.  According to the Raleigh-Durham News-Observer:
    Theo Luebke strolled the plaza outside Duke's Bryan Center on Thursday afternoon with a bucketful of apples and a tale of woe.

    'Come on! Everyone's in this together! Get your apples!' he exhorted students passing by during the lunchtime rush. 'With all the cuts we have around here and all the bonuses we have to give to the big guys, we need to raise all the money we can.'

    Luebke isn't really the Depression-era fruit peddler his costume suggested. Luebke and a couple of other Duke divinity students hawked apples, ostensibly to raise money for the university, while others dressed as paperboys distributed a mock newspaper railing against bonuses paid to top officials within Duke's healthcare system and investment company.

    For Duke workers whose pay has been frozen of late, the bonuses appear staggering.

    A couple of examples: Neal Triplett, president of the management company, received a $729,749 bonus on top of his $413,603 salary; Victor Dzau, chancellor of the Duke health system, got a $983,654 bonus, bringing his total compensation to more than $2.2 million.

    Thursday's skit, which mostly drew befuddled looks, was the third in a series mocking executive pay.

    It turns out these munificent compensation amounts were paid at a time when Duke is in some financial difficulty:
    In recent years, Duke has frozen pay and eliminated jobs in an attempt to pare its annual operating budget by $100 million.

    Nearly 400 workers have accepted buyout offers since early 2009. Their jobs were then eliminated.

    'During a time when the administration is saying we all needed to tighten our belts and make sacrifices...as it turns out, some of the folks who lost money for Duke were giving themselves bonuses,' said Amy Laura Hall, a tenured professor of Christian ethics. 'I think that's obscene.'

    I cannot recall a previous example of students demonstrating against the compensation of a leader of a medical school and/or university health care system.  Maybe these students have started something.

    In fact, we have frequently discussed executive compensation given by health care organizations that seems wildly out of proportion to the value of the health care they provide or the clinical value of their products.  Although compensation is even higher for executives of for-profit health care corporations, even leaders of not-for-profit organizations, including academic institutions, is now often in the millions per year range.

    Service on (Mostly Health Care) Corporate Boards

    Dr Dzau's compensation may appear even more extreme in the context of the money he brings in from outside work.  As Prof Margaret Soltan pointed out on the University Diaries blog, Dr Dzau also serves on multiple corporate boards.  The multiplicity of his outside work is not fully acknowledged in the most complete official biography posted on the Duke web-site, here, which only notes service on the Genzyme board.  In fact, he also serves on the boards of Anylam Pharmaceuticals, Medtronic, and PepsiCo.

    According to the Alnylam Pharmaceuticals 2010 Proxy Statement, Dr Dzau's compensation as a director in 2009 was $234,433.  In 2009, Dr Dzau owned the equivalent of 45,000 shares, worth $424,800 at today's $9.44 price per share. 

    According to the Genzyme 2010 Proxy Statement, Dr Dzau's compensation as a director in 2009 was $412,942.  In 2009, Dr Dzau owned the equivalent of 75,137shares, worth $5,312,937 at today's $70.71 price per share.

    According to the Medtronic 2010 Proxy Statement, Dr Dzau's compensation as a director in 2009 was $173,698.  In 2009, Dr Dzau owned the equivalent of 14,552 shares, worth $493,895 at today's $33.94 price.

    According to the PepsiCo 2010 Proxy Statement, Dr Dzau's compensation as a director in 2009 was $260,000.  In 2009, Dr Dzau owned the equivalent of 25,065 shares, worth $1,622,458 at today's $64.73 price per share.

    So, in summary, in 2009, Dr Dzau received  $1,081,073 in compensation to be a director of these four companies.  In 2009, Dr Dzau owned stock or equivalent in these four companies valued at $7,854,090.  He has become what most people would consider rich just from his work on these boards, in addition to the millions he has received from Duke.

    Conflicts of Interest and Other Questions

    So this raises even more questions.  The most obvious is how the good doctor has time to simultaneously fulfill his responsibilities at Duke and for the four corporations? 

    The next most obvious is why the university does not make a full disclosure of what appear to be severe conflicts of interest?  Anylam and Genzyme are biotechnology pharmaceutical companies.  Medtronics is a medical device company.  PepsiCo is a food and beverage company whose products affect nutrition and public health.  Dr Dzau's service on the board of each of these companies means he has fiduciary duties to each company, and is supposed to show unyielding loyalty to the companies' stockholders.  Of course, many business commentators have charged that most corporate directors are mainly chosen to be compliant with the top hired management's wishes, if not to be frank cronies of the management.  Even in the best case, showing unyielding loyalties to the stockholders of companies that make drugs, medical devices, and sugary drinks seems to be likely to influence a leader of an academic medical institution in ways that risk degrading the leader's responsibilities to uphold the institution's mission, i.e., to create severe conflicts of interest. 

    Dr Dzau has a fairly severe case of what we labeled as a "new species of conflict of interest" in 2006.  Concerns about such conflicts affecting university presidents, but not specifically chancellors or vice presidents for health affairs, appeared in the New York Times last summer (see post here).  Maybe some day student protesters will see such conflicts as a problem.

    However, should Dr Dzau make the usual defense of such conflicts, that they promote collaboration with industry needed for innovation, maybe Duke students or alumni might ask questions about the other side of the coin.

    The Other Side of the Conflict of Interest Coin

    Dr Dzau is supposed to be responsible for the stewardship of Genzyme.  We have recently posted about the company's seeming recent inability to make pure, unadulterated pharmaceuticals, and while exhibiting such inability to perform such basic functions, its payment of extremely lucrative compensation to its hired CEO.  Maybe someone could ask Dr Dzau what he thought about such actions, and whether he would take any responsibility for them?

    Dr Dzau is supposed to be responsible for the stewardship of Medtronic.  Medtronic recently settled thousands of patients' lawsuits that alleged injuries due to a faulty lead on one model of a Medtronic implantable cardiac defibrillator for over $200 million. Medtronic has been the source of several alleged conflicts of interest involving influential physicians (see posts about Medtronic here).   Maybe someone could ask Dr Dzau what he thought about such actions, and whether he would take any responsibility for them.

    Finally, a larger question is: is it good to have a leader of a medical school and academic medical center who has presided over such ethical lapses by health care corporations?  Let's see if anyone does get to ask Dr Dzau such questions. 

    Kamis, 02 Desember 2010

    Academic Medical Center Crime Wave?

    Every large group or organization has a few bad apples.  My web searches constantly turn up stories of individuals working in health care who behave unethically or commit crimes.  I do not generally discuss these cases on Health Care Renewal, since they seem unavoidable, and their sporadic appearance does not necessarily have anything to do with systemic problems in health care.

    However, in the last week, I noted four cases of rather exceptionally bad behavior by individuals working in large hospital systems, and the severity and proximity of these cases made me wonder if they reflect some new trend.

    Pennsylvania State University Faculty Member Charged with Rape

    As reported by PennLive.com,
    Former Derry Township, Dauphin County, doctor Dr. Robert L. Yarwood stands accused of using his position and influence to addict two of his patients to painkillers and raping them multiple times.

    Yarwood, 56, has been charged with more than 42 criminal counts, including rape and sexual assault, stemming from allegations made in 2008 by two women, ages 40 and 45.

    He is accused of giving narcotics to the women to 'exert psychological force,' said Fran Chardo, Dauphin County first assistant district attorney.

    'The case, speaking abstractly, is very disturbing because of the trust relationship between the patient and the doctor,' Chardo said. 'It�s a violation of trust.'

    In an interview with The Patriot-News, one of the women said she had visited Yarwood several times over the course of a year. He was prescribing her pain medication, which she eventually became addicted to. Then, she said, he raped her. 'I was paralyzed. I was in shock,' she said. 'I trusted him.'

    At the time of the allegations, Yarwood was an obstetrician and gynecologist at the Penn State Milton S. Hershey Medical Center, which he joined in the late 1990s. In August 2008, the medical center was apprised of the investigation and immediately suspended Yarwood from having contact with patients.

    $5 Million Embezzlement from Columbia University Medical Center

    As reported by the Wall Street Journal,
    A 48-year-old Bronx man has been arrested and charged with grand larceny for allegedly stealing nearly $4.5 million from Columbia University over the course of two months, authorities said Monday.

    George Castro is accused of adding a TD Bank account belonging to him as a payee in the Columbia University Medical Center's accounts payable system, netting payments of $3.4 million in October and $1 million in November, authorities said. Mr. Castro, whose relationship with the university is unclear, was arrested Wednesday.

    A law-enforcement official familiar with the case said Mr. Castro had $200,000 in cash in his possession when he was arrested and had withdrawn $140,000 the day before his arrest. According to a criminal complaint, Mr. Castro told investigators the money 'just appeared' in his bank account and that he had gotten 'greedy.'

    Duke Surgeon and Surgical Department Business Manager Accused of Embezzlement

    As reported by WRAL.com,
    A former Duke University surgeon and manager have been charged with stealing $267,000 from the university, police said Tuesday.

    Dr. Eric Joel DeMaria, 51, of 1101 Tacketts Pond Drive in Raleigh, and John William Cotton, 39, of 7228 Loblolly Pine Drive in Raleigh, were each charged with embezzlement of more than $100,000. Cotton also was charged with obtaining property by false pretense.

    Cotton was arrested last Wednesday, and DeMaria surrendered to police Tuesday morning. Both have been released on $25,000 bonds.

    DeMaria was director of Duke's bariatric surgery program, while Cotton was a business manager in the surgical department at Duke University Hospital, according to Michael Schoenfeld, Duke's vice president for public affairs.

    Office Worker Accused of Stealing $3.8 Million from Memorial Sloan-Kettering Cancer Center

    As reported by the New York Post,
    A former worker at Memorial Sloan-Kettering stole nearly $4 million from the cancer center in a massive scheme that involved ordering a boatload of unnecessary printer cartridges and reselling them, authorities said.

    The loot from the elaborate scam was used to fund a lavish lifestyle that allowed $37,000-a-year receiving clerk Marque Gumbs to move from a Bronx housing project to a luxurious Trump high-rise in the suburbs.

    Gumbs, 32 -- who was arraigned yesterday in Manhattan Criminal Court on charges of grand larceny and criminal possession of stolen property -- allegedly began his scheme in 2004 by ordering extra toner cartridges and reselling them.

    In one astounding stretch from October 2009 through August 2010, Gumbs ordered $1.2 million worth of toner that wasn't usable for any machine at the hospital, authorities said.

    His alleged ruse cost the hospital $3.8 million.

    Summary

    So here is the box-score. Reported in one week were three alleged theft/ embezzlement schemes with values from $267,000 to $5 million, and one alleged series of multiple rapes. The alleged perpetrators included two academic physicians (one in surgery, one in obstetrics-gynecology), two hospital staff, one in management, and a person with an unclear relationship to the hospital. All involved large, prestigious academic medical centers.

    So, again, maybe these were just coincidences. However, it may be that there is a real trend toward bigger and more spectacular thefts and embezzlements from big, not for profit health care institutions.  The most likely explanation is simply that the increasingly huge amounts of money flowing through such institutions attracts those who go to where the money is, and that the increased complexity of the bureaucracy of ever-growing health care institutions makes it easier to hide such thefts.  At least, this odd string of cases should prompt more questions about the conventional wisdom that it is good for health care organizations to grow ever larger. 

    However, just to be speculative, note that three of these incidents occurred at institutions whose leadership has attracted our attention before.  We discussed conflicts of interest affecting one Columbia academic leader here, and the prevalence of leaders of failed financial services companies on the New York-Presbyterian board here.  We discussed a leader of two of the firms most involved in the global financial collapse who was also the chairman of the board of Duke University here.  A quick skim of Memorial Sloan-Kettering's Board of Overseers (in its 2009 annual report) showed the presence of at least two leaders of failed financial services firms heavily involved in the global financial collapse (E Stanley O'Neal, former CEO of Merrill Lynch, and Sanford I Weill, former CEO of Citigroup).  The speculation is that as academic medical centers and hospital systems and their parent universities have increasingly been recipients of the "stewardship," and hence immersed in the culture of the financial services industry, particularly firms which contributed to the global financial collapse, the culture of health care became increasingly laissez faire, anything goes, wild, wild west, and so it got easier for the wrong people to be hired, and for the wrong people to pull off truly spectacular capers.

    I submit that the first criterion for being a trustee or director, and hence ostensibly a steward of an academic medical institution should be devotion to the mission of the organization, not size of one's contribution.

    Rabu, 01 Desember 2010

    American Medical Schools Are "Only In It for the Money" Say Their Faculty

    We recently discussed the plight of young medical faculty.  It appears that their plight is even worse than we imagined.

    Last month, an abstract was presented at the Annual  Conference on Research in Medical Education at the Annual Meeting of the Association of American Medical Colleges, in a session entitled "Your Career is More than Your Specialty."  The citation would be: Pololi L, Ash A, Krupat E.  Faculty Values in the Culture of Academic Medicine: Findings of a National Faculty Survey.

    The authors described a large survey, of over 5000 faculty at 26 US nationally representative medical schools, done as part of the National Initiative on Gender, Culture, and Leadership in Medicine (known as C - Change) project.  The overall response rate was good (53%).   Here are the striking results:
    51% agreed that 'the administration is only interested in me for the revenue I generate'; 31%; that 'the culture of my institution discourages altruism'; 31%, that other people have taken credit for my work'; and 30% that 'I am reluctant to express my opinion for fear of negative consequences.' Half perceived that the institution does not value teaching and 27% that it does not reward clinical excellence; Over half disagreed with the statement that their own values are aligned with those of the institution. Also, 30% had seriously considered leaving academic medicine and 46% their own institution, both in the prior year.

    These results show that US medical education is in moral crisis, and probably close to catastrophe.  These results should provoke shame and outrage, and cause widespread discussion. On the other hand, it is remarkable that they were allowed to see the light of day at all, given the persistent strength of the anechoic effect.  Pololi and colleagues obviously never got the message that one is never ever supposed to discuss such things in public.

    Instead of being about discovery and dissemination of knowledge, the fundamental mission of education, a majority of large sample of faculty surveyed says American medical schools are about making money.  Instead of putting teaching first, half of the faculty said their institutions explicitly do not value teaching. Instead of supporting free speech, free enquiry, and academic, a significant minority of faculty say that are afraid to speak out.

    It is no wonder that nearly half of the faculty are considering leaving.

    On Health Care Renewal, we have discussed evidence, mostly anecdotal, about the rot within the foundations of medicine and health care.  (Note, posts on conflicts of interest, often affecting medical school faculty and leadership, are here; we have posted about how academic medicine has often allowed suppression and manipulation of research;  posts on excessive compensation of health care executives, including those of academic institutions, not based on upholding the academic mission are here.)  Now it appears that the rot is so severe that the whole edifice is about to fall down.

    Our foolish transformation of the calling and profession of medicine into a business (see posts here and here)  at a time when businesses were taken over by the arrogance, greed, unscrupulousness, and amorality that lead to the global financial collapse will surely also lead to a global health care collapse if something is not done very soon.

    We need a new effort much bigger than but at least as influential as the Flexner Report to re-imagine academic medicine again as valuing teaching, learning, research and patient care, while regarding its financing only as the means to reach those ends.

    The Carnegie Foundation sponsored the original Flexner Report, and the Rockefeller Foundation then hired Dr Flexner to reform medical education (see Mitka M.  he Flexner Report at the century mark:  a wake-up call for reforming medical education .  JAMA 2010; 303(15):1465-1466. Link here.) Will anyone or any organization have the courage to sponsor a new, bigger, and likely much more contentious effort?

    Meanwhile, the academic leaders who have personally profited from and colluded with the transformation of the system into one that is only in it for the money should resign. The few remaining leaders will need to draw upon all their honesty, integrity, knowledge, and determination to rebuild the system.

    Finally, shame on all of us for letting us get to this place.

    With apologies to the late Frank Zappa and the Mothers of Invention.

    Kamis, 18 November 2010

    Who You Gonna Call? - How Should a Young Academic Respond to a Proffered Conflict of Interest?

    To prepare a workshop on conflicts of interest in health care, I wrote a case of a faculty member offered a proposition that might provide a conflict of interest:
    Consider a health care researcher called by a commercial health care corporation's marketing department. The department representative proposes paying the researcher as a consultant to write a scholarly article on a specific policy topic of interest to the company. The implication is that the article should be favorable to the interests of the corporation in this arena. The corporation would be delighted to give the researcher editorial and staff assistance in writing the article and getting it published.

    Who you gonna call?

    The researcher is concerned that getting this consultancy might be a conflict of interest. What organization (e.g., appropriate professional society, unit within his or her academic institution, other academic unit, independent not-for-profit organization or NGO, or government agency) should the researcher contact for support and help? Please give at least one specific example, (preferably including a URL), with a brief justification of why that organization might be helpful.

    I sent the case to a few hundred people on our combined mailing list, to see how they might answer.  Responses came from medical academics, with a sprinkling of practitioners, a journalist, and a well-informed lay-person.

    Sources of Information: Is It a Conflict of Interest?

    Nearly everyone thought it would be unethical for a young academic to be paid as a consultant to write a health policy review policy by a company with a vested interest in the subject, and with editorial and staff support coming from the company.

    I implied (but did not make clear) that the faculty member felt uncomfortable with the situation, was looking either for advice and information, or actual support not to accept a conflict of interest that he or she might have felt pressured to take on.

    People suggested some sources of information. Most appeared to be useful, but most also were specialized (by clinical specialty, directed at journal editors, directed only at conflicts related to pharmaceuticals, etc)  Those particularly worthy of mention include:
    - The Prescription Project's site on medical school conflict of interest policies
    - The World Association of Medical Editor's (WAME) site on conflict of interest in scholarly publication
    - The PharmedOut.org general resource site
    My personal preference for a single source of general information on COIs is the 2009 US Institute of Medicine report on same.  (I will add all these links to our side-bar, and note that there are some other relevant links there.)

    The IOM definition of conflict of interest is:
    Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.

    Primary interest include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients.
    So the offer in the above case clearly seemed to present a conflict. The situation presented in my case seemed to present the potential to violate the report's recommendations 5.1 that bans scientific publications "that are controlled by industry," or that "contain substantial portions written by someone who is not identified as an author...."

    Note, however, that even the IOM report seems not to question the idea that "collaborations between physicians or medical researchers and pharmaceutical, medical device, and biotechnology companies can benefit society � most notably by promoting the discovery and development of new medications and medical devices that improve individual and public health."  It has never been clear to me that collaboration requires payment by one party to the other, or that academic medical institutions ought to be developing drugs and devices (as opposed to discovering knowledge that commercial firms might later use to do so.) Furthermore, the IOM report, while it is moderately tough and comprehensive, did not recommend that detailed public disclosure of all relevant conflicts by all parties to them, or an outright ban on all of the sorts of conflicts that many might think are objectionable.

    Support to Resist the Proffered Conflict

    Suggested sources of help resisting pressure to assume an unwanted conflict of interest included local sources: mentors, grants and contracts offices, local conflict of interest/ ethics committees, compliance departments, and research officers. Some people thought their local versions of the above might be helpful. No person seemed sure that any of these options would clearly lead to support if the academic was being pressured by his or her academic superiors.

    However, I have big concerns about the availability of even these sorts of local support.  We know COIs are very prevalent among individual academics.  About 60% of all academics, and of department chairs have important conflicts according to two articles by Campbell et al.(1-2)  So it might be hard for the young academic to find a mentor or university officer who was not already conflicted.

    We also know that medical schools and academic medical centers see commercializing their discoveries as taking precedence over their traditional mission of seeking and disseminating knowledge, and providing and improving patient care and public health.  For example, in 2000, a Vice President of the American Association of Medical Colleges(3) wrote that research universities must respond to "societal demands that they become engines of economic development�."[caps added for emphasis] Furthermore,
    Academic medicine� finds itself struggling to create a precarious equipoise between the world and values of commerce and those of traditional public service�.
    Also
    In our capitalistic economy the pathway by which research invention becomes beneficial application is often totally dependent on venture capital, the availability of which commonly demands the active participation of academic inventors in the commercial venture; put simply, no participation, no money. It is this demand � that has driven the dramatic increase in medical faculty entrepreneurship.

    I have seen university conflict of interest policies that include such verbiage in their introductions. The impression is that most academic medical institutions now think that is their mission, maybe their overriding mission, to develop and commercialize drugs and devices.

    So it might also be hard for the young academic to find a local academic unit that is not affected by institutional conflicts of interest. Indeed, none of the people on our list was sure that their institutions had local authorities or units that could help the young academic in the case above avoid the proffered conflict of interest.

    A few people suggested external sources of support: e.g., a small medical society, an association of journal editors, a bioethics center. But they too were ambivalent about how helpful they might be. The small medical society would only be helpful for its few members, and the person who mentioned it doubted it could provide more help that citing its own COI policy. The journal editors and their organizations might only be helpful about how the proffered conflict might affect the ability of the faculty member to get the resulting study published. The bioethics center appeared to have heavy institutional conflicts of interest of its own. No one could suggest an independent organization likely to provide effective support to resist COIs to a wide spectrum of academics (or other health care professionals, etc)

    Summary

    So this exercise did reinforce one of the assumptions I made when writing the case. Young academics at most US (at least) institutions may have little local support for resisting the extant pressure to become conflicted. There are NO generally useful and effective external sources of such support.

    I would point out that with all its limitations, the IOM report still called on academic institutions to develop clear guidelines for COIs (3.1, 3.2); ban people with COIs from research on humans (that is, from all clinical research) (4.1); develop educational programs on COIs (5.2); participate in developing continuing medical education that is free of industry influence (5.3); set up a committee on COIs at the board of trustees level (8.1). It also called on the US government to promote research about COIs (9.2).

    As far as I can tell, that was all pretty much wishful thinking. Despite the prestige of the IOM, almost none of these recommendations have been implemented. (I have heard so far of one university that seems to have implemented watered down versions of some of the IOM recommendations in their own policy. I would love to be told there are more extensive implementations of these recommendations. If there are, please show me the specifics.)

    Furthermore, there seems to be no effective support for the reduction of COIs from accrediting organizations, professional societies, or foundations that fund health care initiatives. (Again, I would love to be told I am wrong, but if I am, show me the specifics.)  Of course, it appears that most professional societies get extensive support from commercial sources, particularly drug, device, and biotechnology companies, and their leadership often have their own financial relationships with for-profit health care corporations.  Foundations that support health care and medicine may have leaders with similar relationships, and may have endowments disproportionately invested in health care corporations.   

    Given the pervasive nature of personal and institutional COIs throughout health care, which we have documented on Health Care Renewal , I was saddened, but not surprised by the responses to my query. So many people and so many institutions are making so much money from their industry payments. They will nearly all have excuses so that they can keep accepting the money. Young faculty are unlikely to be able to resist the prevailing culture, especially when it affects so many of their colleagues and supervisors.

    I know that the people on our email lists are more aware of this than most. But we all should be saddened and ashamed that so little progress is being made.

    Will academic medical institutions ever again put seeking and disseminating new knowledge, and providing and improving patient care and for the public health ahead of trying to be ersatz drug and device companies?

    Will professional societies ever again put put their members' core values ahead of pleasing their corporate funders?

    Will health care foundations ever again put rescuing health care's core values ahead of bland projects meant not to offend health care corporate leaders?

    References


    1. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician�industry relationships. N Engl J Med 2007; 356:1742-1750. (link here)
    2. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. (link here)
    3. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. (link here)