Dr Bernard Carroll has posted several times, most recently here, about shenanigans by "key opinion leaders" in psychiatry whose apparently academic writing and speeches have conveyed messages in line with the marketing agendas of drug and device companies, while they downplayed or concealed their financial ties to these companies.  Lately, Dr Carroll noted how the current director of the US National Institute for Mental Health (NIMH), Dr Thomas Insel, has defended Dr Charles Nemeroff, whose recent move to the University of Miami let him shed sanctions imposed by Emory University for his failure to disclose conflicts of interest while he was there. Dr Carroll wrote, "For the past three months, Insel has been trying to put some distance between himself and Nemeroff, but the public isn’t buying it. I have called his statements disingenuous...."

Dr Carroll is on vacation, so in his absence, I note the following from a brief article in the Chronicle of Higher Education:

The director of the National Institute of Mental Health, Thomas R. Insel, has softened his denial of a mutually helpful relationship with Charles B. Nemeroff, a university researcher found to have repeatedly collected undisclosed corporate payments. In an update to his official blog posting, Dr. Insel said his initial denial of job assistance from Dr. Nemeroff 'may be viewed as misleading,' and acknowledged that Dr. Nemeroff served in key positions related to Dr. Insel's hiring by Emory University.

This seems to corroborate Dr Carroll's skepticism. I wonder what other statements by Dr Insel, or Dr Nemeroff for that matter, ought to be "viewed as misleading?"

We have said repeatedly that commercially sponsored "key opinion leaders" are really part-time drug marketers disguising themselves as academics or distinguished practitioners. The deceptions inherent in these roles seem to lead to a certain habitually elastic approach to the truth.

Medical academics and practitioners will need a renewed commitment to honesty and transparency if they want to regain the respect of an increasingly skeptical, if not cynical public.

Last year we posted about the seemingly incongruous choice of a wealthy biotechnology executive with little academic or practice experience to run the prestigious University of California - San Francisco, a health oriented university housing a respected medical school.  We wondered whether her corporate background would make it difficult to uphold the university's academic and patient care missions.

In line with our concerns, Duff Wilson, writing in the New York Times, reported:

When Dr. Susan Desmond-Hellmann was named chancellor of the University of California, San Francisco, last summer, she took over a medical institution focused on world health generally and tobacco control in particular.

But she forgot one thing in adjusting to her new role: personal stock holdings listed last year in the range of $100,000 to $1 million in Altria, owner of Philip Morris USA, the maker of Marlboro cigarettes. Altria has been blamed for thousands of deaths and repeatedly criticized by the Center for Tobacco Control Research and Education at the university.

Last week, a day after The New York Times inquired about the Altria stock, Dr. Desmond-Hellmann and her husband, also a doctor, ordered it to be immediately sold and imposed 'values screening' on their personal investments.

Experts on tobacco control were aghast:

Dr. Stanton A. Glantz, director of the university’s tobacco control center, said he was unaware of Dr. Desmond-Hellmann’s Altria stock, which was contained in a university filing but not made public until now, after a public records request by a former student who passed it on to The Times.

“I do find that kind of shocking, but at least she got rid of it,” Dr. Glantz said on Monday, adding that Dr. Desmond-Hellmann had been very supportive of the center.

Dr. Kenneth E. Warner, dean of the school of public health at the University of Michigan and a national antitobacco leader, said, “I find it frankly a bit appalling that the chancellor of a major medical center would have held such stock. It strikes me as unthinking, frankly.”

We should give Dr Desmond-Hellmann credit for selling her Altria stock as soon as its connotations were made plain to her. (And at least she was not on the board of a tobacco company, to our knowledge, as was one former president of a university and large health sciences center.)

However, this little incident underlines the clash between the culture that dominates large health care corporations and the mission of medical schools and academic medical centers. In the last 30 years, academic medicine has rushed to embrace the reigning corporate culture, not to mention corporate money. I submit that this embrace has been at the peril of the fundamental academic and patient care missions.

Academic medical leaders need to promote better patient care, and honest, responsible teaching and research. To do so, they may have to give up some of the glitz, glamor, and cash proffered by industry. If they do not make this sacrifice, they risk losing the trust of an increasingly skeptical, if not cynical public.

The vast amounts spent in the US on health care have not translated into access for many patients, consistently excellent quality of care, and signiticantly improved outcomes. While we spend all this money, the primary care and generalist practitioners on the front lines are increasingly embattled and disgruntled, and their numbers are rapidly thinning. One problem may be the pattern of fees paid to physicians. Fees paid to physicians not only influence costs directly, but provide incentives for physician decision making about what tests and treatments patients receive. We have posted several times, most recently in February, 2009, here, about how the US Medicare system sets fees paid to physicians.

Since health care reform is now a hot topic in the US, there has been increasing discussion of the plight of primary care and generalist practitioners, but little consideration of how it arose. What we wrote in February was (with updated links):

As we have discussed, the US Medicare system determines what it pays physicians using the Resource Based Relative Value System (RBRVS). This system determines the pay for every kind of medical encounter according to a complex formula that is supposed to account for physicians' time and effort, physicians' practice expense, and the cost of malpractice insurance. The components of physicians' effort assessed are, in turn, technical skill and physical effort; the required mental effort and judgment; and stress due to the potential risk to the patient.

To keep the system, which was started in 1990, current, requires addition of new kinds of encounters, which means encounters involving new kinds of procedures, and updating of the estimates of various components, including physicians' time and effort. To do so, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee (RUC). The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are secret, as are the proceedings of the group.

This opaque and unaccountable process has resulted in increases outstripping inflation in fees paid for procedures, while fees paid for "cognitive" medicine, i.e., for primary care, and for services that involve diagnosis, management of acute and chronic disease, counseling, coordination of care, etc, but not procedures, have lagged inflation. The effects of the RUC have been amplified by the unexplained tendency of commercial managed care and health insurance to track the RBRVS system when making their own payments to physicians.

For further details about the RUC, see these posts on Health Care Renewal  and important articles by Bodenheimer et al,(1) and Goodson.(2) By the way, why the US Center for Medicare and Medicaid Services (CMS) relies de facto exclusively on the RUC to control the RBRVS system, and why the AMA made the RUC into a secret organization apparently beholden only to the organization's proceduralist members are unanswered questions.

The next month, Dr William L Rich III, and Dr Barbary Levy, the Chair and Chair-Elect of the RUC, wrote me a letter to "point out several blatant inaccuracies within your blog entry that severely misrepresent the nature and work of the AMA / Specialty Society RVS Update Committee (RUC)." They then asked me to "retract or correct the inaccurate statements within the aforementioned blog immediately." However, the letter did not specify the supposedly inaccurate statements within the blog post. So, my email response noted that "the letter contains no detail about the alleged 'inaccurate statements.' If you define them, we will certainly consider your views." I never got a reply to this message, therefore thinking the matter to be closed, and I saw at that time no reason to make the exchange public.

Apparently, the matter was not closed. A few days ago, two anonymous comments were appended to the post. They stated that my letter had appeared on the AMA web-site, here. So it is now public. The comments did not say, and I have so far not been able to find out when the letter was posted, and what its context is within the AMA web-site, including any indication that I had already replied to it in private.

Despite these irregularities, however, given that the AMA apparently has chosen to make the letter public, I believe I ought to respond publicly.

"Blatant Inaccuracies?"

Dr Rich and Dr Levy wrote:

We would like to take this opportunity to point out several blatant inaccuracies within your blog entry that severely misrepresent the nature and work of the AMA / Specialty Society RBRVS Update Committee (RUC). We request you retract or correct the inaccurate statements within the aforementioned blog immediately.

First, as I noted above, the letter never specified which of my statements the letter writers considered "blatant inaccuracies." If there are any specific statements of fact in the post above (or any other post I write) that can be shown to be inaccurate, I will correct or retract them. However, I do not believe the letter by Dr Rich and Dr Levy demonstrated any particular statements of mine to be blatantly inaccurate.

The Obscurity of the RUC Membership

The letter stated:

The RUC does not operate in the shadows.

One of my major criticisms of the RUC was that it is opaque. Before I wrote my first post on the RUC, I tried to determine its membership by searching the AMA web-site, easily available AMA publications, and the web. I could find lists of past members, but no current list. In addition, I asked RUC staff by email whether they could provide me the list, or an easy way to access it. They would or could not do so, and the highest ranking staffer I contacted wrote, "we do not give out the RUC members' contact information. We attempt to shield the RUC from lobbying by industry or others." Only after these inquiries did I dub the RUC membership "secret."

Dr Rich and Dr Levy suggested that it is not quite secret. It stated that "a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide." This publication is available from the AMA here for a mere $71.95. However, the book is not on the web, or in my local or university library, and I have no other way to easily access it.

Additionally, although the letter stated, "any individual may solicit AMA staff directly or a specialty society to learn the names of the members of the RUC," the letter was not accompanied by any communication from AMA staff containing this information.

Thus, to date, I still do not know who the members of the RUC are. If the letter authors had wanted to show that the membership of the RUC was not meant to be obscure, they could easily have sent me the list with their letter, appended a copy of the pages of the book which contained the list, or asked their staff to provide this information. They chose not to do so. So, while the RUC membership may not be exactly secret, it remains obscure, only barely public, and relatively inaccessible.

The Secrecy of RUC Proceedings

Furthermore, to support its contention that "the RUC does not operate in the shadows," the letter stated that

any individual may attend a RUC meeting upon: (1) the invitation of and notification by a relevant specialty society; (2) an express invitation by the chair of the RUC; or (3) the approval of a written request to attend; and a review of conflicts and potential conflicts of interest.

This does not mean that RUC meetings are open, or that their proceedings are public. Instead, as Goodson(2) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review."

The letter also personally invited me to attend "the next meeting of the RUC, which will take place April 23-26, 2009 in Chicago." In retrospect, this invitation did not appear serious, since it was never repeated or expanded after my email reply to the March letter.

Nor did the invitation include any assurance that I could make anything about this meeting public. I had learned from a previous RUC attendee who will remain anonymous that attendees are obligated to sign non-disclosure agreements. Signing such an agreement might jeopardize my further ability to write anything of substance about the RUC. Furthermore, making all meeting attendees sign non-disclosure agreements effectively makes the meeting secret.

The RUC and Primary Care

Dr Rich and Dr Levy asserted that:

Your publication irrationally and unreasonably paints the RUC as the perpetrator of all physician payment policies that have negatively affected primary care.

Furthermore, they argued that the RUC has been good for primary care and cognitive practice:

The RUC has made several recommendations that positively benefit cognitive and non-procedural physician specialties.

My opinions about the RUC's influence on payments to physicians, and the decline of primary care and generalist and cognitive practice are hardly original. My previous posts were clearly based on evidence and discussion from references 1-4. Let me summarize these arguments, using direct quotes from these references, which perusal of the original articles would reveal are not taken out of context.

Primary and generalist practice is threatened by the current payment system.

From Bodenheimer et al(1):

Incomes of primary care physicians are well below those of many specialists, and the primary care–specialty income gap is widening.

... the lower income of primary care physicians is a major factor leading U.S. medical students to reject primary care careers.

Primary care practice is not viable without a substantial increase in the resources available to primary care physicians.

From Goodson(2):

Medicine's generalist base is disappearing as a consequence of the reimbursement system crafted to save it—the resource-based relative value scale.

Current reimbursement incentives substantially favor procedures and technical interventions and offer financial advantages for expensive care, thereby encouraging specialty services.

The continued and sustained incentives for medical graduates to choose higher-paying specialty careers and for those physicians in specialty careers to increase income through highly compensated professional activities have been associated with the dwindling of the generalist workforce. The lack of incentives for medical graduates to choose generalist careers in internal medicine, family medicine, and pediatrics has had a profound effect on the workforce mix and, ultimately, US health care expenditures.

The RUC has been the major influence on the physician payment system leading to these problems.

From Bodenheimer et al(1):

In summary, the RUC process favors increases in procedural and imaging reimbursement for 3 reasons: specialty society influence in proposing RVU increases, the specialist-heavy RUC membership, and the desire of RUC specialists to avoid increases in evaluation and management RVUs. With their ability to create new codes and influence RVU updates, many procedural specialists can influence fees in a way that observers find to substantially overvalue procedural and imaging services. Moreover, high fees may encourage physicians to increase the volume of profitable services, leading to even higher income gains and greater spending growth.

From Goodson(2):

The RUC has powerfully influenced CMS decision making and, as a result, is a powerful force in the US medical economy. Furthermore, by creating and maintaining incentives for more and more specialty care and by failing to accurately and continuously assess the practice expense RVUs, the decisions of CMS have fueled health care inflation. Doing so has affected the competitiveness of US corporations in the global market by contributing to years of double-digit health care inflation that have consistently increased the costs of manufacturing and business in the United States over the last decades.

The current mechanism fails to provide sufficient checks and balances and is skewed and dysfunctional.

The resource-based relative value scale system originally developed to achieve full value for cognitive services currently threatens the sustainability of the generalist base. As a result, a large portion of the population will lose access to the continuous and personalized care provided by generalist physicians whose repertoire of clinical skills and interventions coupled with access to specialty and diagnostic services are essential for ensuring efficient and effective health care delivery.

Dr Rich and Dr Levy are entitled to their opinions, but I would argue that there is considerable evidence and opinion suggesting that the current dysfunctional physician payment system is a major cause of the decline of primary care and cognitive practice, and simultaneous rise in health care costs and decline in health care access in the US. Furthermore, there is also considerable evidence and opinion suggesting that the RUC has singular responsbility for the dysfunctionality of the payment system and how it is skewed in favor of procedures as opposed to cognitive services and primary care.

Summarizing: the Opacity of the RUC, and its Negative Effects on Primary Care and Cognitive Services

So, I stand by my statement that the RUC process is opaque. Instead of saying "the identities of RUC members are secret, as are the proceedings of the group," I would be willing to now say, "the identities of the RUC members are obscure and difficult to ascertain, and the proceedings of the group are secret." That is not much of an improvement.

If the RUC leadership wants to make its membership transparent, all it needs to do is post it on the web. If it wishes to make its proceedings transparent, all it needs to do is publish them as well. If it makes such changes, I would happily and publicly applaud them.

If the RUC leadership wants to show that their members are not influenced by individual conflicts of interest, transparency about the committee's membership would inspire more trust than making the information as obscure as possible.

Furthermore, there may be more reason to be concerned about the effects of institutional rather than individual conflicts of interest on the RUC. Most RUC members appear to represent specialty societies. Rothman et al claimed that industry funding of professional medical societies is "pervasive."(5) If the RUC leadership wants to show that their committee as a whole is not affected by institutional conflicts of interest of its specialty societies, it ought at least to disclose the relationships of those societies and their leaders with companies that stand to profit from increasing utilization of the specific services whose use is influenced by the incentives which the RUC largely determines.

Finally, if there is a "wedge between cognitive and procedural specialties" it was driven a long time ago, particularly by a payment system that progressively favored the latter over the former, and by a bureaucratic burden that fell disproportionately on the former. But blaming the messenger is a time-honored, if not necessarily honorable tactic.

References

1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here.
2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. Link here.
3. Ginsburg PB, Berenson RA. Revising Medicare's physician fee schedule - much activity, little change. N Engl J Med 2007; 356: 1201-1203.
4. Newhouse JP. Medicare spending on physicians - no easy fix in sight. N Engl J Med 2007; 356: 1883-1884.
5. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA 2009; 301: 1367-1372. Link here.

Earlier this year, a remarkable commentary in JAMA suggested major reconsideration of the relationships among professional medical associations (PMAs) and health care corporations.(1) Because of the influence of PMAs on clinical care, education, research, and policy, Rothman et al suggested that these organizations sever most of their financial ties to corporations such as pharmaceutical, device, and biotechnology companies. The authors suggested that the only acceptable payments to PMAs from these companies are those for advertising in publications that is clearly labeled as such, and advertising exhibits in meetings, again that is clearly labeled. Furthermore, the authors suggested that people with current or recent (within the last two years) relationships with such corporations ought not to serve as officers or trustees of PMAs, and ought not to serve on program or practice guideline committees. Rothman et al thus suggested that professional medical associations return to their roots, to be advocates for their physician members, and those members’ core values, not marketers of drugs and devices, and promoters of the interests of health care corporations.

The Journal of the American College of Cardiology (JACC) just published the first rebuttal of Rothman et al to appear in a peer-reviewed journal, written by Dr Alfred A Bove, President of the American College of Cardiology (ACC), one of the more influential PMAs.(2) Dr Bove contended that there is nothing wrong with the current relationships among corporations and PMAs, and PMAs should be free to relate to health care corporations any way they want. Dr Bove also asserted that “the assumptions that lead to ... [Rothman and colleagues’] conclusions can be challenged on many fronts.” However, in my humble opinion, Dr Bove supported these contentions with logical fallacies, rather than evidence and logic.

Appeals to Authority, Fear, and Pity

Early on, Dr Bove used a striking set of appeals to authority. (Note that his relevant quotes below appear in italics.)

“There is no comment about trust or virtue as a characteristic of the medical profession.”

“We are not to be bribed by a cheap pen or a free lunch.”

“The authors' assumptions imply that physicians as a group are not responsible people, yet physicians are among the most responsible professionals.”

These appear to be appeals to the traditional authority of the medical profession. Dr Bove simply asserts that physicians are inherently virtuous and deserving of trust, and thus no one could question the virtue of the profession.

He then compounded these appeals to authority with a veiled appeal to fear.

“The authors' assumption that the worst behavior is the average behavior of all physicians insults the profession.”

As noted below, Rothman et al did not make this assumption, so the appeal in turn rests on a straw man argument. This appears to be an appeal to fear in that an “insulted” profession might be expected to take action, legal or otherwise, to avenge the insult. It also could be a form of an appeal to pity, in that the reader might be inclined to pity the poor “insulted” physicians.

Straw Man Arguments

The bulk of the editorial consisted of a string of straw man arguments. A straw man argument propounds a distorted, exaggerated, or misrepresented version of his opponent’s argument, and then attacks it, rather than his opponent’s actual argument.

“The sole source for support of PMAs could only come from government or foundation grants....”

Actually, Rothman et al included membership dues, and by implication, meeting registration fees, journal subscription fees etc as acceptable sources of support.

“The article implies that all physicians who receive support from industry will forever be biased to support the products of the related pharmaceutical or device company.”

Actually, Rothman et al seemed to assume that conflicts of interest might affect someone for up to two years, but not forever. Thus, they suggested that board members should be “conflict free for a 2-year period before assuming the position.”

[The Rothman article] “also implies that industry does not work for the best interests of patients or the better [sic] public good, but only for profit.”

Actually, Rothman et al stated “the pharmaceutical and medical device industries make important contributions to medical progress. Their role in the development and testing of new compounds and instruments is essential for the diagnosis and treatment of disease and disability.”

“First, to assume that physicians would not be responsible for providing the best care for their patients after being associated with an industry study or consultation is inappropriate. The authors cited isolated examples of errant physicians who received large sums of money from industry and then promoted their products. They presume that all physicians are represented by these few—that we all have a price.”

Actually, Rothman et al did not discuss any particular cases of “errant physicians.” What Rothman suggested was that gifts, even of “modest value,” can bias decision making, and that the receipt itself of the gift may itself be influential. However, if even modest gifts have some influence, it is logical that large financial transactions might have major influence.

“Society understands that reward drives innovation, so expecting a financial gain from a commercial medical enterprise is not wrong. In fact, it is the only way that new ideas will move from the laboratory to the public good. Using public funds for manufacture and distribution would add an enormous burden to government costs and, based on past experience, would be unproductive.”

Rothman et al were not remotely suggesting nationalizing the drug and device industries.

“If one of us has an idea for a new device and needs industry to help refine its design, fund its development and manufacture, and establish its value by animal and clinical studies, this process should be honored, not condemned. Will the government fund the development of the next new drug? Would the government have funded the development and manufacture of an implantable pacemaker?”

At the most, Rothman et al recommended not allowing physicians who are paid by companies in conjunction with their development work to serve as top leaders, and on certain committees of PMAs. They never broadly “condemned” physicians who work with industry to develop devices.

“Governments have not shown an interest in funding the development of new drugs and devices. Industry raises the funds, takes the risks, and should reap the rewards for its role in creating a better life for our patients.”

Actually, governments have helped development considerably by funding much of the underlying basic science research. Again, Rothman et were not remotely suggesting nationalization of drug development.

Summarizing the Arguments

So Dr Bove ended up by warning that the suggestions Rothman et al made about reducing institutional conflicts of interest affecting professional medical societies, and individual conflicts of interest affecting their leaders would “destroy the best of what we have in our science and industry,” that is, destroy biomedical and clinical science, and lead to nationalization of important forms of medical production. None of that was suggested or implied by Rothman et al. After positing this dire future, Dr Bove then asserted that professional societies ought to be entitled to money from industry limited only by their “professionalism.” Thus, “industry should be able to support unbiased programs aimed at educating physicians and other health care providers about the therapies available for the care of their patients. Professional societies should be able to receive unconditional educational grants to provide up-to-date information to their members on medical therapies.” Furthermore, “the proper relationships should allow us to work with industry and allow our professional societies to receive undesignated funds from industry to foster better patient care.” So, Dr Bove wound up where he started, asserting that doctors and professional societies are inherently virtuous, and thus should be trusted to do whatever they think is right, without any external scrutiny or accountability. Yet he never demonstrated the virtue of the ACC under his leadership, or of PMAs in general, or showed why they should be trusted.

Why did the president of one of the nation’s most important medical associations publicly make such poor arguments to support his organization's current financial relationships with health care corporations? I can only speculate, but there may be some clues found by looking at what is publicly known about the current relationships of the ACC and its leaders to health care corporations.

Publicly Disclosed Relationships Among the ACC and Its Leaders and Health Care Corporations

My sources for these clues were a report on the ACC web-site on its relationships with health care corporations (through 2007), and the form 990s that the ACC is and the highly related ACC Foundation are required to file with the US Internal Revenue Service. (The form 990s are publicly available from GuideStar with a free membership. The ACC form is here, the ACCF, here.)

Perhaps unsurprisingly, it turns out that the ACC gets a large proportion of its income from industry. In 2007, it acknowledged receiving $35,882,095.15 from industry. The largest categories of industry support were "promotional/quality program support," $12,664,650; "charitable contributions," $7,603,639; and "exhibits" at meetings, $7,318,807; and "educational grants," $5,084,600. The total revenues of the ACC (which include the ACC Foundation), were $94,560,000, so that industry support accounted for 38% of total revenue. These figures should be compared to the revenue the society received from membership dues (found on its 990 form), $11,995,056, and the income it claimed from its annual scientific session, $8,400,632. So to put it another way, the ACC got about three times as much money from industry as it got from its members' dues, and almost twice as much money from industry as it got from dues and its annual meeting combined.

So were the suggestions made by Rothman et al to be implemented by the ACC, it would stand to lose at least $28 million a year (given that in 2007, about $1 million of its industry revenue was from advertising , and about $ 7.3 million was from exhibits at meetings.)

The organization's lavish revenues have allowed it to pay its full-time managers very well. In 2007, its CEO received $534,452 in total compensation; its general counsel, about $394,000; and its CFO, about $336,000. It seems obvious that were the organization to foreswear industry revenue, the organization's top full-time managers would be unable to continue to live in the style to which they are now accustomed to.

In addition, the organization's form 990 reveals that it pays its supposedly voluntary officers and some of its trustees substantial amounts as well. In 2007, it paid its president $147,750; its president-elect, $80,000; its two immediate past presidents, $79,500 and $70,000; its vice president (at that time, Dr Bove), $63,751; its treasurer, $32,500; its secretary for the board of governors, $52,500; its board of governors chair-elect, $25,000; its immediate past board of governors chair, $25,000; and some trustees amounts from $1000 to $20,520.

To my knowledge, it is unusual for a professional society to pay salaries to its voluntary officers (as opposed to full-time, hired managers.) However, given that the ACC does, it seems that were the organization to foreswear industry revenue, its officers' personal income might be threatened to some extent.

Finally, Dr Bove has his own personal financial relationships with industry. Some were disclosed because of his role on ACCs Cardiosource editorial board, including "Consultant Fees/Honoraria: Insight Telehealth Inc,""Research/Research Grants: Astella Pharma, INC," and "Royalty Income: Elsevier." In addition, in a 2008 article(3), he disclosed receiving speakers fees from Medical Seminars, Inc, and serving as a consultant to Vasocom Inc. For a 2009 conference, he also disclosed "modest" equity interests in Cardiovascular Therapeutics, and Merck.

So, in summary, it seems that the ACC gets a very substantial portion of its revenue from health care corporations, and that were it to carry out the suggestions of Rothman et al, it would lose much of that revenue. Thus, it is not surprising that ACC leadership would take exception to Rothman and colleagues' point of view. This is not the first time that an ACC president has defeneded the organization's dependence on industry funding (see post here). However, as I said in that post,

My questions are how could a society which requires such a substantial proportion, 38% of funding from commercial sponsors ignore the preferences of the sponsors for particular topics and content areas? How could such a society dare to allow criticism of the sponsors, their products, or their activities? Knowing that the society is dependent on this level of support, could society leaders really hold industry representatives at arms' length? Knowing that industry supplies more than one-third of their salaries, would society staff really keep industry outside of some bureaucratic, but not concrete 'firewall?'

In addition, it now seems the ostensibly voluntary officers of the ACC may have a personal stake in the ACCs receipt of health care corporate funding, since it is the apparent policy of the organization to pay these officers five- and six-figure salaries. Dr Bove did not disclose this apparent conflict of interest, nor did he disclose his other personal financial relationships with industry. As we have noted before, people with conflicts of interest tend to have trouble making coherent, logical and evidence-based arguments for positions related to their conflicts. As Joe Collier wrote in the BMJ, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult. "(4)

In any case, a previous ACC president wrote about the importance of "disclosure" and "transparency" in dealing with conflicts of interest. Whether disclosure of conflicts is sufficient to manage them, at least Dr Bove could have done the courtesy of disclosing that he is actually a salaried employee of the ACC, and disclosing his personal financial relationships with industry so that readers could try to evaluate how these financial entanglements might have affected what he wrote.

Summary

In conclusion, the first published rebuttal of Rothman and colleagues' suggestions for ensuring the independence of professional medical associations from outside vested interests was not based on evidence, but on logical fallacies rather than clear reasoning, and failed to disclose its authors' relevant financial relationships. We will see if anyone can make a better attempt.

ADDENDUM (17 July, 2009) - see additional comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

ADDENDUM (22 July, 2009) - see this post on the Cardiobrief blog, which alludes to the post above, but also discusses an interesting response by the CEO of the ACC to the Rothman paper, and adds original commentary on larger issues.


References

1. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry. JAMA 2009; 301: 1367-1372. (Link here.)
2. Bove AA. President's page: relations with industry: thoughts on claims of a broken system. J Am Coll Cardiol 2009; 54: 177-179. (Link here.)
3. Somers VK, White DP, Amin R et al. Sleep apnea and cardiovascular disease: an American Heart Association/ American College of Cardiology Foundation scientific statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council on Cardiovascular Nursing. Circulation 2008; 118: 1080-1111. (Link here.)
4. Collier J. The price of independence. Br Med J 2006; 332: 1447-9. (Link here.)

Three months ago, we discussed the controversy at the University of Michigan about the university president's position on the board of directors of the big pharmaceutical, medical device and medical supply company Johnson and Johnson as a potential conflict of interest that could have influenced her decision to make the campus smoke-free. (Johnson and Johnson makes drugs to aid in smoking cessation.) I argued that by the Institute of Medicine definition, President Coleman did have a conflict of interest, and while it was not possible to tell whether it influenced the smoke-free decision, the issue with conflicts is that they constantly raise the possibility of undue influence on decisions.

Now this issue has made it to the big time. New York Times reporter Duff Wilson, wrote in the Times' Prescriptions Blog

The University of Michigan medical school became the first in the nation last month to say it would refuse any funding from drug companies for its continuing medical education classes. The decision could cost it as much as $1 million a year, but it was worth it, the medical school dean said, for education to be free from potential bias.

At the same time, Mary Sue Coleman, president of the entire University of Michigan, sits on the board of directors for the pharmaceutical giant Johnson & Johnson. Last year, the company paid her $229,978 — roughly half in stock and half in cash — for attending a limited number of meetings, corporate filings show.

Conflict of interest? Conflict of policies? If the med school and mere professors could be tainted by drug money, what about the university president?

She says no. Responding to questions on Ms. Coleman’s behalf Monday, Kelly E. Cunningham, a spokeswoman for the university, said the president satisfied the policy by disclosing her outside work. Ms. Coleman has never had to recuse herself from any discussion or action at the university because medical purchasing and investment decisions are so remote from her, Ms. Cunningham said.

'The same is true at J&J,' she added. 'There has never been a discussion or decision at the board level that involved something related to the UM. But, of course, if there were, she would recuse herself.'

The story was picked up by the Detroit Free Press, which reiterated the official line that President Coleman's role on the Johnson and Johnson board did not pose a conflict:

A student group at the University of Michigan is calling on President Mary Sue Coleman to resign from her seat on the Johnson & Johnson board of directors, saying it's a conflict of interest.

But Coleman has no plans to resign, and university officials say her role on the board is not in conflict with university operations. Last year, she earned nearly $230,000 for her board duties. Coleman's U-M salary is about $550,000.

'It's essential that U-M have a voice and interact with the business world,' said Rick Fitzgerald, a U-M spokesman. 'She thinks it's her duty to understand what the commercial world is doing.'

So, as I did last time, let us turn to the Institute of Medicine's definition of conflict of interest (in a health care context) found in its report, Conflict of Interest in Medical Research, Education, and Practice.

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 interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....

I asserted then that President Coleman has a conflict of interest. Her primary interests as President of a university are to uphold the university's academic mission, and as President of a university that includes a medical school, a school of public health, and an academic medical center, also to uphold the integrity of patient care and public health practice. Her secondary interest as a member of the board of directors of a public, for-profit corporation is her fiduciary duty to that corporation and its stockholders, which means she must "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Such unyielding loyalty to the shareholders of a pharmaceutical and medical device company clearly creates a risk of influencing judgments or actions that could affect the corporations' sales or operations, economic or health policy, or the general environment in which it operates. Many of the judgments of or actions performed by the leader of a medical school, public health school, and academic medical center could so so, and are thus at risk of being so unduly influenced.

As the IOM report said, though,

a judgment that someone has a conflict of interest does not imply that the person is unethical. Such judgments assume only that some situations are generally recognized to pose an unacceptable risk that decisions may be unduly influenced by considerations that should be irrelevant.

However, note that the sorts of decisions that may be influenced by a conflict of interest go beyond just those that involve the specific secondary interest causing the conflict. So the University spokesperson's statement that the president would recuse herself from any decision at the university that directly involved Johnson and Johnson, but that no such decision has ever been necessary, missed the point.

Meanwhile, the university's insistence that the president's part-time position at Johnson and Johnson is justified by the need to "have a voice and interact with the business world" rings hollow. There are many ways a president could do that which do not involve getting corporate pay (and for "unyielding loyalty"). It rings especially hollow at a university that has identified corporate funding for continuing medical education as an unacceptably bad conflict of interest.

But then again, conflicts of interest are known to create confused thinking, and such confused thinking is likely to be prevalent at an institution that has one set of rules for the little people, and another for the top leaders.

Maybe this story in the New York Times will lead to some discussion about whether it is good for academic medical institutions to tolerate this previously "new species of conflict of interest" (as we termed it in 2006).

We have frequently discussed the anechoic effect, how it is just not done to discuss certain topics, particularly those related to the adverse effects of bad (ill-informed, incompetent, self-interested, conflicted, or corrupt) leadership and bad (opaque, unaccountable, mission-hostile, unethical) governance of health care organizations. We have discussed many possible causes of the anechoic effect, but one particularly obvious cause is the silencing of dissenters and whistle-blowers.

Three recent stories illustrate old and new tactics to reinforce the anechoic effect.

A Classic Case - ValleyCare Medical System Nurse Fired

From the San Francisco Chronicle,

An Alameda County jury awarded more than $344,000 in damages this week against ValleyCare Medical System for refusing to rehire a Castro Valley operating nurse who claimed the hospital was retaliating against her for complaints she made about patient safety issues, including concerns about surgical equipment left inside patients.

Kristeen Klaas, a 15-year veteran at ValleyCare and a registered nurse for more than 30 years, sued the hospital system, which has services in Pleasanton and Livermore, after she quit in distress in May 2008 and hospital managers failed to respond to her request to be rehired days later.

The 54-year-old Klaas, who now works at Alta Bates Summit Medical Center in Oakland and San Leandro Hospital, had brought numerous safety complaints about the Pleasanton hospital to the attention of ValleyCare's management over the two years prior to her resignation.

Klaas complained about a fellow nurse who brought a dog into the operating team's break room and jumped rope with an electrical cord in the operating room, as well as a surgical technician who brought a rifle into the operating room office to sell. She also complained that a tip of a surgical instrument went missing during a surgery and was never found, and that an instrument was left in a patient because the hospital did not have a formal policy of counting instruments after surgery.

She also accused a supervisor of forging her signature on a performance evaluation after she refused to sign an evaluation that was backdated to comply with state regulations.

Here is the tactic allegedly used to silence the whistle-blowing nurse:

On her last day on the job, Klaas got permission from her supervising nurse to leave work because she was in distress after a colleague, the subject of three of her complaints, screamed at her.

'She realized, for the patient's safety, she couldn't continue to go forward that day in the operating room because she was so upset,' he said.

But then a supervisor called her at home and accused her of leaving without permission, prompting Klaas to resign, he said.

This is the classic, rather blunt way to do it: just make the would-be truth-teller's job experience so miserable that she quits.

Now we will present two examples of a more subtle approach, one directly from health care, one at least from a sphere with major health care implications.

A New Approach: A Contract Preventing Communication "Inimical" to a Pharmaceutical Company's Business

This case was documented by a personal narrative by Marc Lipsitch, a Professor of Epidemiology and the Harvard School of Public Health, published in the Chronicle of Higher Education,

I received a request from a large pharmaceutical company to assist in the design of a clinical trial, and the proposed terms seemed to require that I sign away my right to criticize the product. One provision would prohibit me from entering into 'any agreement or relationship to render services as ... adviser or consultant to, any other individual, firm, or corporation that would be inimical to or in conflict with' the aspects of the company's business covered by the agreement. Another would forbid me to engage, in any capacity, directly or indirectly, in "any business," with or without compensation, relating to the class of products under discussion—not just for the term of the contract, but for the year after as well. Those provisions could restrain me from providing candid advice to a regulator, a government official, or the editor of a peer-reviewed journal about the class of products on which I was consulting, even if the advice were based on publicly available information. I objected to those terms, as did a colleague who was offered the same arrangement.

Prof Lipsitch also noted that government research funding agencies and universities may not provide any protections to their faculty against such agreements. He also noted that the contract he was asked to sign was not one of a kind:

Discussions with my colleagues suggest that the problem is not limited to one pharmaceutical company ....

We and many others have frequently discussed the conflicts of interest that may be generated by physicians or health care academics having financial relationships with industry. The Institute of Medicine's definition of conflict of interest (in a health care context) found in its report, Conflict of Interest in Medical Research, Education, and Practice, 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 interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....

Thus the concern is that a faculty member,for example, who is paid to consult for a drug company might tend to favor the company, its products, or policies to its advantage in his or her clinical teaching, scholarly talks and writing, or public policy opinions. That might happen even if the consulting work is technical or scientific and not directly related to the particular topic about which communication might be influenced.

However, the situation described by Prof Lipsitch is much worse. Were he to have signed the contract, he would have been constrained by this legal agreement from writing or saying anything "inimical to or in conflict with" the company's business.

Last week, a similar, but more wide-spread example surfaced (pardon the pun) in a domain that is at least related to health care.

Another Version of the New Approach: the BP Consulting Contracts Making Any Communication Between the Company and the Consultant Confidential

Originally reported by the BBC,

The head of the American Association of Professors has accused BP of trying to 'buy' the best scientists and academics to help its defence against litigation after the Gulf of Mexico oil spill.

'This is really one huge corporation trying to buy faculty silence in a comprehensive way,' said Cary Nelson.

The BBC has obtained a copy of a contract offered to scientists by BP. It says that scientists cannot publish the research they do for BP or speak about the data for at least three years, or until the government gives the final approval to the company's restoration plan for the whole of the Gulf.

It also states scientists may perform research for other agencies as long as it does not conflict with the work they are doing for BP.

And it adds that scientists must take instructions from lawyers offering the contracts and other in-house counsel at BP.

Here are some examples of the wording of the contract as obtained by the BBC about confidentiality.

Confidentiality. All communications (including non-public information disclosed in such communications) between you (and your agents), BP Attorneys and/or other BP representatives in the course of your performance of the BP NRDA Services are deemed to be incidental to the rendering of legal services and are to be privileged and confidential. You shall maintain a strict confidentiality of such non-public communications and information unless or until a person from whom you are authorized to take instructions informs you in writing that this restriction is no longer applicable to any particular non-public communications and information. In the event you are required to disclose such privileged and confidential non-public communication and information by an order entered by a court or by similar judicial process, or by a judicial or administrative subpoena, you shall notify a person from whom you are authorized to take instructions as soon as practicable, and you are required to cooperate with BP if BP decides to seek relief from such required disclosure, including commencement of a legal or administrative proceeding to prevent or limit disclosure of such privileged or confidential information.

Here is the description of those from whom the signer of the contract must take orders.

Instructions. You agree to take your instructions only from me, from other lawyers in my firm, from Brian Israel or other lawyers in the Arnold & Porter law firm, and from Donna Ward or other in-house counsel at BP (collectively 'BP Attorneys').

Note that the contract defines privileged, confidential information as any communication between BP and its representatives and the contract signer. Thus, to make something confidential, all BP would have to do is mention it in a communication. It appears that this would allow BP to render off-limits any topic it chose. Also, since by the same mechanism, it appears that the contract itself, once signed, would also become privileged and confidential.

Summary

I submit that ideally medicine and health care ought to be a very transparent calling. Physicians are obliged to keep confidential the information disclosed to them by patients, enabling the patients to trust physicians sufficiently to provide them the accurate information needed for optimal care. However, it is hard to think of much other information or communication in health care that ought to be kept secret, (other than the processes used by commercial firms to manufacture drugs or devices.)

Yet as health care becomes more of a business and less of a calling, businesspeople's proclivity to keep as much as possible secret to avoid giving any advantage to a competitor has become more influential. Furthermore, those leading big organizations have realized that it is easier to maintain their power if they can keep their mistakes, if not misconduct secret. So businesspeople's proclivity to mount overwhelming legal defenses of their interests may lead to persuading or fooling people who might be inclined to delve into such mistakes and misconduct to sign contracts to keep them silent through confidentiality clauses, requirements to protect privileged or proprietary information, non-disparagement clauses and the like. The result will be better coddled self-interests, but more opacity that is inimical to good patient care, teaching, research, and public policy discussion.

To truly reform health care, we need more transparency. To produce more transparency, we need constraints on contracts that inhibit needed clinical, teaching, research and public policy communication.

Meanwhile, as my father, who was an attorney, done told me: "don't sign a contract you don't understand, and don't sign a contract giving away any right you need to keep."

In January, 2009 we posted about how the CEO of Blue Cross Blue Shield (BCBS) of Massachusetts and of Partners HealthCare, made a secret oral agreement that BCBS would pay Partners at a higher rate than that given to other hospitals.

Why BCBS would want to pay so much to this one hospital system was never clear. Partners does include some extremely prestigious hospitals, including the Brigham and Womens Hospital, and the Massachusetts General Hospital, ("Man's Best Hospital" in the House of God), but there are some other very prestigious teaching hospitals in Boston that were not blessed by BCBS' largess.

We speculated about one possible cause: the leadership of the two organizations may have felt they had more in common with each other than with the constituencies of their own organizations. A few leaders of each organization had direct ties to the other. Many leaders of both organizations were simultaneously leaders of finance, the same sector that has brought us what is now called the Great Recession. Leadership of both organizations had conflicted loyalties. The organizations' CEOs at the time, and many members of their boards had divided loyalties and apparent conflicts of interest. For example, Jack Connors, the chair of the Partners HealthCare board, is also the Chairman Emeritus of marketing communications company Hill, Holliday, Connors, Cosmopoulos Inc, whose clients include pharmaceutical and pharmacy benefits manager CVS / Caremark, and is also a member of the board of directors of Covidien, a medical device company.

The Boston Globe just published a report that Mr Connors had even more intense conflicts that had not heretofore been made public.

He's chairman of New England's largest healthcare company, and that position atop Partners HealthCare has tested the limits of Jack Connors's considerable corporate dexterity.

Though he has no background in medicine, Connors has been Partners' chief overseer, champion, and its most public face for 13 years.

[One board member] is the cofounder and chairman emeritus of Partners' advertising firm. That would be Jack Connors. And that potential point of conflict has been disclosed....

But to the chagrin of some former board members, never brought up for board review was Connors's stake in a leading medical education firm whose sale in 2004 made Connors a very wealthy man.

Nor has the board notified public officials of Connors's ownership of a fledgling home healthcare firm that has directly solicited Partners' hospitals for business.

Connors and top Partners officials defended the decision not to publicly disclose Connors's potential conflicts, saying that because Partners did not directly contract with either of Connors's firms there were no conflicts to report. Connors also defended his right to be an entrepreneur in the healthcare business while also chairing Partners' board, and strongly denied ever using his position for personal or financial advantage.

The larger company, M/C Communications, grew to become the biggest commercial provider of continuing education to physicians in the decade between its inception in 1994 and when Connors sold it in 2004. It profited hugely from an exclusive commercial relationship it maintained with Harvard Medical School, whose faculty teach at seminars the company holds. Partners' signature institutions, Massachusetts General Hospital and Brigham and Women's Hospital, are major teaching affiliates of Harvard Medical School.

In addition, M/C Communications benefited financially from millions of dollars in sponsorship revenue paid it from major pharmaceutical firms eager to play to this professional audience.

Connors said he was under no obligation to disclose his ownership of M/C Communications to the Partners board. He said that while there is an 'affiliation' between Harvard Medical School and the two Partners hospitals, there is no formal contract between them.

Connors said he informed Partners executives of his ownership of M/C Communications, and that they determined it did not warrant disclosure to the full Partners board.

'There is no contract between Partners and Harvard,' Partners said in a statement to the Globe.

Connors made a name for himself as an executive with Hill, Holliday, Connors, Cosmopulos, the Boston advertising company that he helped found and guided throughout a long career. Less well known is that he made most of his fortune from M/C Communications, which he sold to Bain Capital for $450 million in 2004.

The sale was the largest of a private healthcare-related company in Massachusetts that year, according to TM Capital Corp., an investment banking company. Connors, who led an investor group that bought the firm outright for $13 million in 2000, made about $250 million from its sale.

After his 2004 windfall, he founded a company that helps elderly patients readjust to life at home after a hospitalization.

That company, Dovetail Health, has - Connors acknowledged - solicited business from hospitals owned by Partners. And Connors confirmed that after Dovetail executives failed to convince Blue Cross Blue Shield of Massachusetts to contract with the firm, he personally spoke to the giant insurer's president, Cleve L. Killingsworth, on Dovetail's behalf. Partners and Blue Cross Blue Shield regularly negotiate over $2.5 billion worth of medical business a year.

Connors acknowledged in an interview that it might have appeared 'inappropriate' to some for him to pitch Killingsworth. But he said the conversation stemmed from a shared belief that new ways must be found to reduce frequent return trips of elderly patients to the hospital. More recently, however, he said he does not believe his approach to Killingsworth was inappropriate.

So let's try to recap this.

While Jack Connors has been chairman of the board of Partners HealthCare, the largest and most prestigious hospital system in Massachusetts, he also ran an advertising agency that did business with Partners, and has been on the board of Covidien, a medical device company. Both of these relationships he disclosed to his fellow board members, although no one seemed troubled by them.

However, while a Partners board member, Connors was also the founder, and ultimately profited very handsomely from the sale of M/C Communications. M/C Communications apparently begat M/C Holding Corporation, which in turn owns M/C Communications and Pri-Med Institute LLC. M/C Communications now describes itself as " established in 1994 and has become a leading provider of medical education event management solutions for health care professionals and others around the globe." M/C Communications runs Pri-Med, which is described thus: "Pri-Med is a platform for science and medicine that includes meetings, resources, online, and new media tools designed to meet the information and education needs of today’s practicing physician." Pri-Med markets itself to industry, presumably the pharmaceutical, biotechnology, and device industry, "Sixty percent of doctors’ offices restrict rep access, making it more challenging than ever to get in front of your customers. But with Pri-Med, you get to meet clinicians in a professional environment where they seek you out. More than 66% of attendees say they come to Pri-Med events to meet you, industry representatives." So Connors' company was a medical education and communication company (MECC), which provided what appeared to be educational programs to physicians that in fact were also sold to the health care industry as marketing opportunities.

So Partners HealthCare, which includes two of the world's most prestigious teaching hospitals, has been run by the boss of a MECC? Say it ain't so.

Not only did Connors own a company that had an exclusive contractual relationship (as described above) with the Harvard faculty who staff the main Partners HealthCare hospitals, that company was engaged in marketing the products of sponsoring drug and device companies disguised as education. Finally, Connors denied that this presented any kind of conflict of interest, because Partners HealthCare has no explicit contract, just an "affiliation" with Harvard Medical School.

Finally, just to ice the cake, Connors' latest venture is a home health care company that did business with Partners, and tried to do business with BCBS, spearheaded by Connors' direct conversations with the BCBS CEO.

Jack Connors thus seems to have just become the latest poster boy for leaders of health care organizations who put their personal financial interests ahead of their responsibilities to those organizations, and function as a power elite whose collective interests trump those of the constituents of the organizations they run.

Quoting from BoardSource, the main duties of the leader of any US not-for-profit are:

Duty of Care

The duty of care describes the level of competence that is expected of a board member, and is commonly expressed as the duty of 'care that an ordinarily prudent person would exercise in a like position and under similar circumstances.' This means that a board member owes the duty to exercise reasonable care when he or she makes a decision as a steward of the organization.

Duty of Loyalty

The duty of loyalty is a standard of faithfulness; a board member must give undivided allegiance when making decisions affecting the organization. This means that a board member can never use information obtained as a member for personal gain, but must act in the best interests of the organization.

Duty of Obedience

The duty of obedience requires board members to be faithful to the organization's mission. They are not permitted to act in a way that is inconsistent with the central goals of the organization. A basis for this rule lies in the public's trust that the organization will manage donated funds to fulfill the organization's mission.

By leading companies that did direct business with Partners and its staff, and failing to disclose that he was doing so to his fellow Partners board members, Connors appeared to have violated the Duty of Loyalty.

By running a MECC that helps drug and device companies market to physicians in the guise of education, using faculty from the academic teaching hospitals that he lead, Connors seems to have mocked the mission of the academic hospitals within Partners, and thus appeared to violate the Duty of Obedience.

This episode certainly does suggest that health care, and the organizations involved in this case, are lead by an "old-boy network," as one person interviewed for the Globe article suggested. More than just an old-boy network, they seem to be lead by chummy members of the power elite whose collective personal interests supersede the missions of the organizations they are supposed to steward. When this happens, is it any surprise that health care becomes less accessible, more expensive, and of lower quality?

Yet challenging the power elite that are increasingly revealed as controlling much of health care seems to be something that one cannot talk about when discussing health care reform. However, failing to address this problem will likely doom any effort, no matter how well intentioned, to improve health care.

Hat tip to and see comments by Alison Bass on the Alison Bass Blog.

ADDENDUM (3 June, 2009) - See also comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.

In the US, many important health care organizations are not-for-profit organizations. Many US medical schools, and other health educational institutions, along with their parent universities are not-for-profit. (Essentially all the exceptions are supported by local or state government.) The majority of US hospitals and hospital systems, including academic medical centers, are not-for-profit. Some managed care organizations are not-for-profit. Medical and professional societies, health care advocacy groups, health care charities, and a variety of other groups are not-for-profit.

Not-for-profit health care organizations here have hardly been immune from leadership and governance problems. We have discussed numerous instances of ill-informed, conflicted, and even corrupt leadership of these organizations, and underlying problems with their governance, which may be unrepresentative of key constituencies, unaccountable, secretive and opaque, and not subject to clear ethical rules.

There may be some major changes coming, however, affecting leadership and governance of all US not-f0r-profit organizations, including health care organizations. The US Internal Revenue Service (IRS) has long required that not-for-profits that exceed certain minimums file and make publicly available certain information on a form 990. Relatively recent forms from most US not-for-profits are available online from Guidestar.org. The old forms provided for some minimal transparency. They displayed, for example, a list of the filing not-for-profit organization's trustees, and the salaries and retirement plans given to their five highest-paid employees.

The IRS has revised the forms starting with those to be filed in 2009, which will reflect 2008 data, so as to markedly increase organizational transparency. The actual forms can be found on this IRS web-page, and a discussion of key points can be found here on the GuideStar.org web-site.

For the first time, the forms will include information about certain aspects of leadership and governance.

Leadership Conflicts of Interest

The new form 990 will require each organization to establish the "independence" of the organizations' trustees, directors, officers, and key employees. Independent individuals would be those without any direct or indirect business relationships with the not-for-profit organization; without any relatives with such business relationships; and who were not serving as an officer, director, trustee, key employee, partner, or member of an organization doing business with the not-for-profit organization. The relationships preventing individuals from being independent would have to be documented.

It is likely that perusal of such information on the new form 990 would reveal to some extent the degree the organization's leaders are conflicted. Up to now, it has been very difficult to get information about conflicts affecting the leadership of health care organizations. We have reported numerous cases of seemingly high-level conflicts affecting leaders of not-for-profit health care organizations. It is likely that such conflicts affect the ability and inclination of leaders to uphold their organization's mission, that is, to fulfill their duty of obedience.

Leadership Compensation

The new form 990 will ask for detailed information about the total compensation given to officers, directors, and trustees, key and the five most highly paid employees, and former officers, directors, trustees, key and most highly compensated employees who continued to receive substantial amounts. This will include not only reportable and other compensation, but whether anyone received unusual compensation such as first-class or charter travel, companion travel, tax indemnification for gross-up payments, discretionary spending accounts, housing allowance or residence for personal use, payments for business use of personal residence, health or social club dues or fees, and personal services (e.g., maid, chauffeur, chef). Also, the form inquires about severance packages and supplemental non-qualified retirement plans.

Up to now, little information about the compensation of not-for-profit leaders beyond base salaries, contributions to employee benefit plans and deferred compensation, and expense allowances and the like was available. Clearly, while not reaching the stratospheric levels enjoyed by top leaders of for-profit health care corporations, some leaders of not-for-profit health care organizations have come to be paid enough to make them rich. It is possible that some now regard their positions as first a pathway to wealth, rather than a calling to improve the health of society, or to advance medical education or science. Furthermore, it is possible that some leaders have been receiving additional compensation which has made them even more wealthy, while particular "perks," like staffed houses, chauffeured cars, and first-class travel, has isolated them from the patients, clients, and/or students they are supposed to be serving.

Organizational Policies

The new form 990 will ask whether the organization has a written conflict of interest policy, and if so, how compliance is monitored and enforced, and a written policy to protect whistle blowers.

Summary

In my humble opinion, the IRS' new form 990 could make substantial improvements to the transparency and accountability of not-for-profit health care organizations. Review of form 990's filed starting this year could provide important information about conflicts of interest affecting organizational leaders, whether they have been distracted by new-found wealth, or decoyed by luxurious perks, and whether their organizations have clear policies meant to maintain certain ethical standards.

However, while the IRS will mandate that such information becomes available, it is not clear what it will do about the information so revealed. Additionally, the wealth of information that will be provided could easily bury the few watchdogs, including the Health Care Renewal bloggers, that have been trying to monitor the governance and leadership of health care organizations.

However, the new information provides an important opportunity to other people concerned about these issues. For example, perhaps some health professionals have concerns about how their alma maters are lead and governed. Maybe they will peruse the new information provided, and then try to use it to make their alma maters more accountable. It is at least possible to be optimistic.

What Is to Be Done?

If you are concerned about a particular not-for-profit health care organization, you can prepare for the availability of more information from the revised form 990 in several ways, by searching for already publicly available information. You can peruse older form 990s, which at least provides the names of trustees and officers, and officers' and key employees' salaries.

In addition, the web makes it possible to identify some conflicts of interest affecting current leadership. For example, try first entering each leader's name, surrounded by quotes, into Google, to look for biographical information that could reveal conflicts. Next, try searching on the name plus terms like "board of directors," "board of trustees," "consultant," or "advisory board," which may uncover some additional conflicts. If you find anything of concern, consider making it more public.

Remember, the best way to improve health care leadership is to hold it accountable to an activated public, preferably strongly infused with health care professionals who want to uphold their professionalism.

This week, the Associated Press reported on yet another way health care corporations may keep information that reflects poorly on their products out of public view. The story involved fungal eye infections that particularly afflicted users of a specific contact lens cleaning solution:

More than 700 lens wearers in the United States and Asia say they were exposed to a potentially blinding infection known as Fusarium keratitis while using ReNu with MoistureLoc, a new-formula multipurpose solution for cleaning, storing and moistening soft contact lenses.

Sometimes, the damage was irreparable. Seven people in Florida, Maryland, New York, Oregon, Tennessee and West Virginia had to have an eye removed. At least 60 more Americans needed vision-saving corneal transplants.

The U.S. Centers for Disease Control and Prevention confirmed 180 cases in 35 states from June 2005 through September 2006, when the agency's dedicated surveillance stopped, according to Dr. Benjamin Park, a CDC epidemiologist. CDC continued to hear of sporadic, unconfirmed cases in the months after MoistureLoc was withdrawn, Park said.

'Surveillance usually captures the tip of the iceberg and sometimes it captures a larger tip than other times,' Park said in an interview.

Among out-of-court settlements reached in May was a potential bellwether case brought by Andrea Martin, a Broadway actress and comedienne whose eye was scarred. In Colorado, a corneal transplant ended a race-car driver's career. In Baltimore, a chimney-sweep business owner who lost an eye got hooked on painkillers.

Leading eye doctors and government scientists concluded that MoistureLoc, launched in 2004 with novel disinfectant and moisturizing ingredients, was the only lens solution that contributed to the outbreak. Yet the mechanics of how it caused the problem are still not fully clear.

AP alleged that Bausch and Lomb kept the cases out of public view by using a previously unknown (at least to me) strategy:

Contact lens maker Bausch & Lomb Inc. had an overriding reason for going private in 2007: It wanted to handle a devastating recall of its flagship lens cleaner, its chief executive said, 'without a lot of outside distraction.'

Over the past year, away from the glare of public scrutiny, the optical products company has quietly settled nearly 600 fungal-infection lawsuits — with dozens more individual claims yet to be resolved. The cost so far: Upward of $250 million.

With some fungal lawsuits still unresolved, the prospect of Bausch & Lomb's health care nightmare being aired in court has not entirely faded — which heartens some lawyers and doctors.

'The truth has been very carefully buried, and it appears to have been buried going back to the beginnings of the outbreak,' said Dr. Arthur Epstein, who was chairman of the American Optometric Association's contact lens and cornea section during the highly publicized crisis.

'All settlements were predicated on silence about the clinical findings and blame and so forth. My hope was that what actually happened would become part of public record in a courtroom. That way, we'd be able to learn from it and move on and make sure it never happened again.'

When Bausch & Lomb was acquired by private equity firm Warburg Pincus for $3.67 billion in October 2007, Chief Executive Ronald Zarrella said the deal would allow the company 'to pursue the growth path we were on ... without a lot of outside distraction.'Zarrella retired last year.

'hey can do all this out of the public eye — guys like me aren't sitting there scrutinizing the financial impact of every single settlement,'said analyst Jeff Johnson of Robert W. Baird & Co. in Milwaukee. 'you can completely focus on your brand and on doing what's right by the patient.'

So, if I understand this correctly, after Warburg Pincus took the company private, it was no longer required to file certain reports with the US Securities and Exchange Commission (SEC), including reports that would have had to acknowledge the multiple settlements the company made of cases alleging adverse effects of its contact lens solution. What is striking is the allegation by the AP that "taking the company" private was a strategy meant to conceal the settlements of these cases, (rather than a strategy implemented to fulfill other aims, which had the side effect of diminishing reporting of these cases' results.)

Again, I am hardly an expert, but relatively opaque private equity firms like Warburg Pincus seem to have become increasingly influential in the US economy, and to have an increasing role in health care. In 2007, we had posted how private equity firms running nursing homes, including Warburg Pincus, seemed to contribute to the opacity of their operations. More recently, we posted about how leaders of private equity, and of other kinds of firms in the finance arena, seem to also increasingly be leaders to which medical schools report.

One final note... A quick tour through the Warburg Pincus website reveals how involved the firm is in health care. The firm claimed that as a "direct equity investor in healthcare for more than 30 years, Warburg Pincus has invested more than $4 billion in approximately 120 healthcare companies." Furthermore, the firm seems quite intertwined with the leadership of academic medicine. It has a Life Sciences Advisory Board, of which three of four members are current leaders in academic medicine. The most prominent, Dr Michael Rosenblatt, Dean of the Tufts University School of Medicine, did not disclose this relationship in several versions of his biography published on the university web-site. (See the Tufts administration version here, and the Tufts Medical Center version here.)

Oh, what a tangled web we have weaved in health care, a web that continually frustrates transparency and makes it hard to figure out who was responsible for what when things go wrong.

Hospitals as a "Proving Ground" for tests of unproven health IT - upon children?

At my post "BusinessWeek on Health IT: The Dubious Promise of Digital Medicine" I began to discuss the responses made by health IT vendors and organizations regarding HIT problems and defects, raised in a very serious April 23, 2009 BusinessWeek article on these issues.

In this post I address the following claims regarding UMPC and a controversial Dec. 2005 article by a UPMC physician in the journal Pediatrics ("Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System", Yong Y. Han et al. -- my comments on this paper at that time were at this link).

BusinessWeek wrote:

... [HIT vendor Cerner] faced more questions over its technology at the University of Pittsburgh Medical Center (UPMC). In 2005 researchers there [i.e., Han et al. - ed.] found that at the university's Children's Hospital [note that this is a Children's Hospital - ed.], patient deaths more than doubled, to 6.6% of intensive-care admissions, in the five months following the installation of a computerized order-entry system. The research on child patient deaths at the University of Pittsburgh found a "direct association between [computerized records] and increased mortality," according to an article published in December 2005 in the medical journal Pediatrics. Digital technology slowed treatment in several ways, the researchers concluded. One example: Doctors and nurses in the intensive-care unit were accustomed to ordering medications and tests while a sick child was en route to the hospital.

The Cerner system required that orders be submitted only when the patient arrived, costing crucial time. The authors of the Pediatrics article acknowledged that their work clashed with other studies showing that digitization decreases errors and shortens hospital stays [but also is consistent with another body of literature (examples here) that Health IT vendors and others with conflicts of interest simply ignore, as per my numerous HC Renewal posts on the issue. Pharma should only have it as good - ed.]

G. Daniel Martich, chief medical information officer at UPMC, says the Pediatrics study was flawed. Factors other than the installation of computers, such as the centralization of pharmacy services, also disrupted care, he emphasizes. The problems identified in the 2005 paper have all been resolved, Martich adds. "There were workflow issues," he says. "We learned the hard way because we were pioneers." Over the long run, he says, technology has helped decrease mortality rates and cut medication errors in half at Children's Hospital since 2003 .

Again, I emphasize we are considering the healthcare of children in this matter.

Here are my observations and questions:

• Why is the 2005 paper simply being dismissed? This is not a scientific approach to the peer reviewed literature, especially where the deaths of children are concerned. I believed in 2005 and believe now that the red flags raised by this paper may have been "brushed under the carpet" too rapidly. See my 2005 post on the matter.

• The implication that the Cerner CPOE was uninvolved in the increased mortality would itself require a very careful observational study to ferret out the exact contributions of its deficits and that of the "centralization" of pharmacy services and other factors. Has such a study been performed and peer reviewed, and has a rebuttal been posted by the original study's authors? Can such a prospective study even be performed after the fact?
  

• While CMIO G. Daniel Martich claims "the problems in the 2005 paper have all been resolved" [wait - I thought the paper was flawed, yet it illustrated problems now resolved? - ed.], how can patients be assured of this? Where are the studies that show the issues have all been resolved?

• Does the damning commentary by the UK's former NHS HIT Director Richard Granger, stories such as patients going untreated for months at a time related to Cerner Millennium Care Records Service ("If NPfiT were a jumbo jet heaven help 747 flyers"), an equally damning report in Jan. 2009 on Cerner's EHR products (i.e., "Millenium") as reported by the UK House of Commons Public Accounts Committee, and the impact on the UK's £12.7 billion national Health IT project suggest a systemic problem needing investigation?

Martich also makes the fantastic claim that "we learned the hard way because we were pioneers."

Pioneers?

Pioneers in what, exactly?

As a former NIH informatics fellow and then former CMIO myself more than a decade ago, it seems more likely UPHS (as well as the children and their parents, and the pediatricians who held the ultimate responsibility per Koppel and Kreda's Hold Harmless paper in JAMA) learned the "hard way" because the organization ignored the work of the pioneers.

There is literature going back fifty years on the challenges of health IT as mentioned in my many posts at HC Renewal, such as here.

I began my informatics postdoc in 1992-4 working on CPOE implementation at Yale-New Haven Hospital. I'd learned lessons from the writings of others who'd experienced CPOE difficulties years before that, such as (emphases mine):

Massaro TA. Introducing physician order entry at a major academic medical center. I: Impact on organizational culture and behavior. Acad Med 1993;68:20–5. [PubMed]

Summary: In 1988 the University of Virginia Medical Center began implementation of a medical information system based on mandatory physician order entry. The implementation process was much more difficult than expected. The program experienced considerable delays, and cost much more than was originally estimated. Although there were some legitimate questions concerning the user-friendliness of the new technology, these were less significant than the cultural and behavioral problems encountered. The new system challenged basic institutional assumptions; it disturbed traditional patterns of conduct and forced people to modify established practice routines ... The author describes the problems that occurred and the organizational behaviors on which they were based, analyzes the lessons learned, documents the progress that has been achieved, and outlines the challenges that remain. The center's experience provides insight into the issue of technology-driven organizational transformation in academic medical centers. Recommendations for successful introduction of similar agents of institutional change are presented.

and

Massaro TA. Introducing physician order entry at a major academic medical center: II. Impact on medical education. Acad Med 1993;68:25–30. [PubMed]:

Summary: The introduction [in 1988] of an information technology (IT) system that mandates order entry by physicians had significant and often unexpected effects on medical education at the University of Virginia Medical Center. The system was deactivated briefly after the introduction of laboratory ordering, and frustration with the pharmacy ordering pathways provoked a major confrontation between the residents and medical center management. Changes in responsibilities, patterns, and priorities of work introduced by the system also contributed significantly to the general dissatisfaction. These issues had not been thoroughly considered in the planning stage, but it was only after accommodation was made to these changes that integration of the technology into routine practice could proceed. The author emphasizes the importance of extensive involvement and leadership of attending physicians in the planning and implementation of such a system. He presents a set of recommendations to those considering similar IT initiatives and wishing to reduce the disruptions that may accompany their introduction. With time and experience, however, the housestaff have adjusted to the system and developed facility in using it. Much of the dissatisfaction was derived from the perception that "doctors spend too much time on the computer." In fact, less than 10% of the physicians spent more than an hour each day. However, a small group of residents on call for the busier services were sometimes at the computer for more than four hours each day.

The entire thirty year old field of Social Informatics spells out the dangers of unintended consequences, and books such as Lorenzi and Riley's "Managing Technological Change: Organizational Aspects of Health Informatics", which contains enough information to have allowed avoidance of the issues in the 2005 paper, was first published in 1994.

My website on HIT difficulties would have helped avoid these issues as well, and it has been online and nearly unique (and the top hit on queries on 'healthcare IT failure' - click here - and similar) for a decade. Did anyone in this CPOE project do such a search, read it, and perhaps query its author about the material [of course not - ed.] before spending tens of millions of dollars and putting patients at risk?

In other words, was true due diligence performed? Considering this was a Children's Hospital, one would have expected extraordinary levels of due diligence.

Pioneers learning the hard way? No. It seems this medical center was a pioneer in ignoring the lessons of the past. I believe a simpler explanation of the difficulties in this CPOE project might be that, like many HIT projects, the project was mismanaged.

Perhaps Dr. Martich meant UPMC were pioneers in this particular new CPOE system. As in this article in the Pittsburgh Tribune:

The University of Pittsburgh Medical Center is taking another step in a quest to commercialize new medical technology.

UPMC on Monday signed a three-year deal with health care information technology provider Cerner Corp. to develop and market medicine-related technological advances. Both parties will contribute $10 million in cash, services and intellectual property to the effort.

The deal is a smaller version of an April 2005 deal between UPMC and information technology behemoth IBM.

As is the case in the IBM deal, UPMC will serve as a built-in proving ground for jointly developed technologies and products, with Cerner marketing the products and UPMC awarded a share of profits.

"Proving ground?"

I cannot believe I am reading such a claim. A hospital and patients, as I have written before, are not a learning lab for HIT vendors. The appropriate "proving ground" for new medical technology is the controlled clinical trial where participants (in this case, patients and healthcare professionals alike) have freedom of choice whether or not to participate, and a chance to give (or deny) consent after being fully informed of potential risk.

Were patients or their parents asked to give consent to the use of HIT (such as here)? Were they even aware they were serving as subjects of a "proving ground?" Likewise for clinicians?

It should be kept in mind that in this "proving ground" (i.e., experimental) situation we are dealing with children. Using a hospital as a "proving ground" for unproven HIT on unconsented or coerced subjects (e.g., children, their parents, and the doctors themselves) probably amounts to battery at the very least, is consistent with violations of fiduciary and Joint Commission safety standards, and I am concerned about it representing human rights violations as well.

In view of the recent Koppel and Kreda paper in JAMA on "hold HIT vendors harmless" and "defects gag" clauses, this entire arrangement seems incredibly disturbing at the very least.

I also believe the conflict of interest represented by a healthcare organization partnering with a vendor to "commercialize new medical technology" on unconsented subjects while sharing profits is a horrendous development, for as I stated, the appropriate settings for such practices are properly conducted, impartial clinical trials. The potential for abuses in the current arrangement seems uncomfortably high.

My sentiments seem aligned with IOM's recommendation 4.1 and others on Conflict of Interest as pointed out by fellow HC Renewal blogger Bernard Carroll at this post:

Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14).

One wonders if the individuals involved in the CPOE project had unreported conflicts of interest with the HIT industry. Perhaps, as in pharma, this needs to be explored.

Han's 2005 article in Pediatrics suggesting children died as a result of the "experiment" should probably be further explored on the basis of the issues I raise above. I also note Han is no longer at UPMC; perhaps his treatment after publication of this article should also be investigated.

In Dec. 2005 on this blog I wrote:

... This study is dealing with children, of course, and is perhaps a flag that much more detailed study of these systems, especially in socially-sensitive environments such as pediatrics, need to be performed.

For if this study's findings are not just due to serendipity and do reflect some underlying causation, the medical, ethical and legal issues could be enormous.

I stand by that assessment.

Finally, putting the camera to my statement that medicine is suffering a cross occupational invasion by the IT industry, in Business Week the picture below appeared of a handsome and proud physician in his office:

Cerner CEO Neal Patterson

Oh, wait...

That person is not a physician nor does he have any medical experience of which I am aware. He is the CEO of the Cerner HIT company.

This picture is the future face of medicine, and it will not be the brightest of futures if this cross occupational invasion continues unopposed by those of a scientific and biomedical mindset much longer.

I really do believe it is the time for a Congressional investigation of these issues, and strong consideration of FDA regulation of health IT, a precedent set long ago in the pharmaceutical industry.

-- SS

Addendum: I note in Dr. Martich's bio an impressive list of medical credentials; however I find formal Biomedical Informatics and/or computer science training lacking. This is not to attack the person, but the culture of HIT, as this scenario is common in HIT and represents what I refer to as "amateurs" running health IT.

I use the term "amateur" not derisively, but in the same sense that I am a radio amateur (albeit licensed after examination at the Extra class and in the "old days", when 20 WPM morse code proficiency was also required). I am not a telecommunications professional. While I have excellent skills in telecommunications theory, hardware, antennas, and operations, I would not consider myself even remotely qualified to, say, run a strategic telecommunications project for a large organization.

In medicine, I always believed education was critical. I may have been mistaken.