Health-Care-Renewal: April 2009

BLOGSCAN - Accountable Academic Governance Under Threat

On The Torch blog, hosted by FIRE (Foundation for Individual Rights in Education), this post by Kyle Smeallie summarized the travails of "petition candidates" for the boards of trustees of two elite American universities (Dartmouth and Harvard). As we have noted, at most universities, the boards of trustees, the bodies ultimately responsible for upholding the universities' missions, are closed shops. At most universities, the boards appoint new members to replace departing ones, without input from alumni, parents, students, faculty or anyone else who might be considered constituents. Thus, at most universities, even though the boards are ultimately responsible for the stewardship of the institutions, and upholding the institutions' missions, practically, they are accountable to no one. At very few universities, there may be contested elections for a few board seats, and an opportunity for those outside the board, usually alumni, to place candidates on the ballot. However, even at those somewhat more enlightened universities, those candidates face an uphill battle. Thus, while Dartmouth and Harvard have somewhat more transparent, accountable, and representative governance than do most academic institutions, even that is under threat.

Another Key Opinion Leader Confesses

The Milwaukee Journal-Sentinel published another story in their series on physicians' entanglements with health care corporations. This one tells the story of a single university faculty member who was seduced by pharmaceutical companies, then eventually became disillusioned.

[Dr James] Stein, now a professor at the University of Wisconsin School of Medicine and Public Health, was a 29-year-old cardiology fellow in Chicago in 1994 when his faculty mentor asked him to fill in for him at a drug company-funded lecture to a large group of doctors.

It would be his first taste of life as a drug company speaker and consultant.

Stein got first-class airfare to Dallas. A limousine took him to a luxury hotel for the talk.

He walked off the stage, and a doctor from the conference handed him an envelope containing a $500 check.

'I got a pat on the back and he said, 'There's more where that came from, son.' I had no idea what that meant, but I went home and paid off part of my student loans,' Stein said in a presentation at UW this month.

Stein's first drug company talk led to more than a decade of work for drug companies before he gave it up for ethical reasons. Now he is speaking out.

Over the years, many of the big names in the drug industry would hire Stein to give speeches or serve as a consultant, eventually leading to fees of $2,000 to $3,000 per talk.

About a month after his first talk in 1994, Stein was asked by another drug company to give a lecture on cholesterol at a small hospital in Chicago, just as blockbuster statin drugs were coming on the market.

'I was really flattered because over and over again I was told that I was a future thought leader,' he said. 'I did my talk. I got a $750 honorarium and I was hooked.'

Stein said he now realizes that the speech at the hospital was just an audition.

'They wanted to know what I would say and how I would deliver,' he said. 'And I think they also wanted to know what I would say about their product.'

He joined speakers bureaus for several drug companies. It was a kind of badge of honor, he said. The more companies a doctor spoke for, the more highly he or she was regarded.

Stein, now 44, came to UW in 1996. Over the years, he would give talks and do other work for many of the top names in the pharmaceutical industry.

For instance, in 2005 Stein did work for six drug makers, according to a disclosure form filed with UW. That year, Pfizer paid him between $10,000 and $20,000 for four days of work as a speaker and advisory board member.

LipoScience, a firm that markets a cholesterol test, paid him $10,000 to $20,000 for four days of similar work.

Another firm, Schering-Plough, paid him about $12,000 for two days as a lecturer.

Although he said he had concerns about the propriety of his work, Stein said he was assured by his superiors there was nothing wrong with it as long as he did it on his own time. Indeed, they said it enhanced the reputation of the university.

And, he said, he considered himself an educator, not a salesman.

He said he tried to manage any conflicts of interest by disclosing who paid him, controlling the content of what he said and doing the work on personal time.

Things started to change rapidly beginning several years ago.

Drug companies began referring to the talks as promotional. They wanted him to use their slides; he refused. Then, medical journals and the lay press began printing articles questioning the ethics of the relationships.

A 2006 article in a Madison newspaper listed Stein as being among the UW doctors who reported the most money from the drug industry. Stein said he was embarrassed.

But, he said, he continued to try to manage his relationships with drug companies. He sent letters to patients disclosing his ties to industry. As of December 2006, he donated all the money from his talks to charity.

Why didn't he just stop doing the work?

He said he believed he could save more lives lecturing than by working in the emergency room. Stein said he saw no harm in being paid. But he admitted that giving the talks also made him feel important.

At the same time, new scientific articles suggested that it is impossible for doctors to be unbiased when they receive gifts or payments from drug companies.

'I have learned that human beings, physicians included, are incapable of recognizing bias in themselves, and even when you try not to be biased it is impossible to avoid it, especially when money is involved,' he said.

He said he came to realize that drug and medical device firms were no longer trustworthy partners in medical education.

He also said it has become obvious that patients have the least power and drug companies have the most power.

'I was wrong,' he said.

Stein said he stands by what he taught.

But, he added, 'I was naïve to think I was not influenced by the money and power of the drug and device companies.'

As of last December, he said, he stopped all drug company speaking and consulting other than bona fide research.

It is nice that a few commercially paid "key opinion leaders" have realized what they were really doing. Maybe, Dr Stein will follow in the footsteps of Dr Daniel Carlat, and try to atone for his previous role in drug marketing disguised as education. (See Dr Carlat's excellent blog here, and his now classic article, "Dr Drug Rep.")

This compelling narrative reinforces some points about relationships among physicians and health care corporations.

Health care corporations do not pay for nothing, and are not charitable organizations. If a company pays a physician to give talks, it is almost certainly because those talks will help market company products or services.

Pharmaceutical and device companies have argued that they only pay the best and the brightest physicians as speakers and consultants. But this story (and others, e.g. here) suggest that they recruit young physicians who seem to be malleable and likely to go along with the company line, and groom them to do marketing in the guise of education.

The company's money thus helps mold "key opinion leaders." Worse, at many medical schools, being a commercially supported speaker or consult was a badge of honor. Thus, faculty chosen by commercial firms as most tractable and sympathetic to the companies' viewpoints, came to be regarded as the best and the brightest.

Why getting money from commercial firms was regarded as indicative of honor and intelligence, rather than gullibility, naivete, or worse, is not clear. I wonder whether it correlated with increasing alignment of the leadership of medical schools with commercial interests, and domination of the very top leadership, that is, the universities' board of directors, by those formerly regarded as Masters of the Universe (but now often seen as stupid, arrogant, greedy, or even corrupt. See posts about how the boards of Dartmouth, Harvard, and Yeshiva were disproportionately populated by leaders of [faux] finance).

At any rate, this is truly a cautionary tale of seduction of academia into hucksterism.

Hat tip to Margaret Soltan at University Diaries.

ADDENDUM (30 April, 2009) - See also the comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.

Excess Omega-6 Fat Damages Infants' Livers

A nurse friend of mine sent me an e-mail a few weeks ago with a very interesting observation:

On the unit I work on we get lots of babies who have "short gut syndrome" due to a variety of causes who have to be on parenteral nutrition to supplement their nutrition while their GI system grows and hopefully heals fast enough. The big problem (among many) with TPN (total parenteral nutrition) is that it destroys the liver and kids get horribly jaundiced (which also causes brain damage) and often they die of liver failure or need a liver transplant before their GI system grows enough to take them off TPN.

Boston Children's has done some amazing work showing that this is largely due to the fact that the lipids part of the TPN was a soybean based oil so they started using Omegaven instead which is a fish oil based IV lipid solution. So far the results have been amazing and reversed the damage in lots of kids livers and prevented it in those started on Omegaven at birth.

Babies born with short gut syndrome can't absorb nutrients properly due to their unusually short small intestine. They're temporarily fed intravenously (total parenteral nutrition; TPN), until their intestines can develop enough to digest food normally.

The typical TPN formula contains soybean and safflower oils as the fat, both of which are over 50% omega-6 linoleic acid. Soybean oil also contains 7% omega-3 alpha-linolenic acid. You can't get the kids started too early on a "heart-healthy" diet!

The solution was to replace the vegetable oil with fish oil, which prevents or rapidly reverses the severe liver damage caused by TPN rich in omega-6 vegetable oils. I don't think this is a great solution, but it certainly beats vegetable oil. The ideal solution would be to replace the vegetable oil with a fat that approximates the composition of breast milk: mostly monounsaturated and saturated fat, with a little bit of linoleic acid, alpha-linolenic acid and long-chain fats such as AA and DHA. You could do this pretty easily with a mix of lard and fish oil; or palm oil and fish oil; or coconut oil, olive oil and fish oil. Breast milk composition varies with diet, and the amount of linoleic acid in the breast milk of Western populations is unusually high.

Excess linoleic acid, particularly when combined with excess fructose and insufficient omega-3 fat, is toxic to the liver. Modern Western nations are experiencing an epidemic of non-alcoholic fatty liver disease (NAFLD), which animal studies indicate is probably the result of replacing animal fats with polyunsaturated vegetable oils and increasing sugar intake (see links below for more detail). Fatty liver was seen primarily in alcoholics three decades ago. An estimated 1/4 of Americans now have NAFLD. It's the number one cause of liver damage in the U.S.

Where the liver goes, the rest of the body follows.

How to Fatten Your Liver
Nonalcoholic Fatty Liver Disease
The Liver: Your Metabolic Gatekeeper
More Liver Functions

Excess Omega-6 Fat Damages Infants' Livers

A nurse friend of mine sent me an e-mail a few weeks ago with a very interesting observation:

On the unit I work on we get lots of babies who have "short gut syndrome" due to a variety of causes who have to be on parenteral nutrition to supplement their nutrition while their GI system grows and hopefully heals fast enough. The big problem (among many) with TPN (total parenteral nutrition) is that it destroys the liver and kids get horribly jaundiced (which also causes brain damage) and often they die of liver failure or need a liver transplant before their GI system grows enough to take them off TPN.

Boston Children's has done some amazing work showing that this is largely due to the fact that the lipids part of the TPN was a soybean based oil so they started using Omegaven instead which is a fish oil based IV lipid solution. So far the results have been amazing and reversed the damage in lots of kids livers and prevented it in those started on Omegaven at birth.

UPMC as "Proving Ground" for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?

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.

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

Today we saw a new marker laid down in the arena called Conflict of Interest (COI). The Institute of Medicine of the National Academy of Sciences issued a report of its Committee on Conflict of Interest in Medical Research, Education and Practice. The report is comprehensive, even exhaustive, running to 353 pages. Gardner Harris in the New York Times today calls it “scolding,” “stinging,” and “damning.” The recommendations go well beyond any proposed in the recent past by medical schools or by other professional organizations. The NYT quoted David Rothman, president of the Institute on Medicine as a Profession at Columbia University: “With the I.O.M.’s endorsement, issues that were once controversial now are indisputable. Conflicts of interest in medicine are no longer acceptable.”

It will take some time for the field to digest the scope of the IOM recommendations. It will take even longer for the new standards to be implemented. For now, I offer just a few observations.

First, if the IOM hopes for maximum credibility then it might ought want to do some housecleaning. A few years ago I fired a shot across the bow of the IOM concerning COI. [Can the Institute of Medicine Review the FDA? Nature Medicine 11, 369 (1 April 2005) doi:10.1038/nm0405-369] Nothing much changed, and in the following years, national scandals erupted involving several of the issues I had highlighted. Prominent IOM members, who were well known to be poster boys for COI, were exposed by Senator Charles Grassley (R-Iowa). Their embarrassing behaviors included incomplete financial disclosures and noncompliance with NIH policy on financial conflict of interest. The exposés included Emory’s Charles Nemeroff and Stanford’s Alan Schatzberg. In both cases, administrative rearrangements have now been implemented. The case of Dr. Nemeroff has been referred by Senator Grassley to the Inspector General of the Department of Health and Human Services. It is perhaps no accident that Dean Claudia Adkison of Emory and Dean Philip Pizzo of Stanford were included as external reviewers of the draft IOM report. Their insights would have been invaluable.

Another ongoing embarrassment for the IOM is Lester Crawford. He was the FDA Commissioner who resigned abruptly in 2005 and later pleaded guilty to criminal conflict of interest. He had been charged with falsely reporting information about his stock holdings in companies he was in charge of regulating. He received a sentence of three years of supervised probation and a fine of about $90,000. He is now senior counsel with a health care lobbying firm in Washington, DC. The Institute of Medicine does not help its image by continuing the membership of such a compromised individual.

As the Emory-Nemeroff and Stanford-Schatzberg cases unfolded it appeared that the respective institutions had themselves contributed to the problems, either through inaction or through studiously nontransparent procedures on disclosure. Stanford, for instance, apparently did not require faculty members to report the proceeds of stock sales, and when challenged the university invoked on-line financial reporting services and SEC filings as a sufficient substitute. Not surprisingly, because Stanford didn’t know about Dr. Schatzberg’s realized gain of some $109,000 from sale of founder’s stock in his biotech start-up company, Corcept Therapeutics, this information was not reported to NIH.

Recommendation 4.1 One of the IOM’s recommendations applies particularly to the Stanford-Schatzberg case. Recommendation 4.1 addresses the boundary between academia and commerce in the case of research involving human subjects. Here is the specific language:

“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).

Last year I posted several times about this issue in the Stanford-Schatzberg case. It is gratifying now to see the IOM affirm the importance of the boundary. The activities declared off-limits by the IOM include not only “recruiting subjects; obtaining informed consent; assessing the clinical end points;” but also “analyzing data; or writing the results, conclusions, and abstracts for publications reporting the findings of the study.” (page 4-17). In Stanford’s earlier plan for managing the conflict and protecting the integrity of the research, Dr. Schatzberg was free to engage in the latter group of activities. Indeed, his hands were all over the project when it came to responding to scientific critiques, managing the climate of professional opinion, attacking and threatening critics, promoting his company’s interest through review articles and press releases, slipping unpublished and non-peer-reviewed commercial data into academic reviews, and generally conducting commercially slanted public relations through academic outlets.

When Stanford adopts the IOM recommendations, such activities will be blocked. As I stated last year, “Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be.”

We should congratulate the IOM committee members for their work, and we hope to see the field embrace their recommendations.

Bernard Carroll.

UPDATE 04-30-2009: The link provided earlier for the IOM report document is no longer operative. Here is where to go now for a copy of the report. This time it will cost you.

http://www.nap.edu/catalog.php?record_id=12598

Hospital Board Members with "the Juice" in New Jersey

We recently commented on the conviction of a state legislator charged with selling his influence to a powerful local medical center. NorthJersey.com has a follow-up on this story which shows how health care leaders are often members of the power elite, if not quite of the superclass, and how their machinations put this group's interests ahead of the mission of their health care organizations.

The General Overview

The trial of former state Sen. Joseph Coniglio, convicted in a bribery scandal involving Hackensack University Medical Center [affiliated with UDMNJ, which has had its own issues, e.g., here], exposed the hospital’s reach into the State House — and put a spotlight on the wealthy, influential men who serve as the hospital’s power brokers.

Hackensack’s board members have connections and political muscle that extend far beyond the hospital. At black-tie fund-raisers and dinners at board member Joseph Sanzari’s Stony Hill Inn, business — hospital and otherwise — is on the agenda.

Various board members help to underwrite Bergen County’s Democratic machine and powerful lawmakers in Trenton. They’re awarded many of the region’s public construction contracts. They have the network — and the money — to smooth over zoning issues for the hospital. Testimony at the trial this month showed they supported the hiring of Coniglio, who was convicted of steering millions in grants to Hackensack while on the hospital’s payroll.

'A political machine' is how Assistant U.S. Attorney Thomas R. Calcagni described the hospital as he told jurors about Hackensack’s relationships with former acting governor and Senate President Richard Codey, state Sen. Paul Sarlo, Coniglio and others during the trial.

Board Members' Self-Dealing

There are several results. One is that "some [board members] are also making money off the hospital." The article gave several examples of such conflicts of interest.

A few examples from the hospital’s federal tax filings for 2007, the latest available:

* Companies owned by Sanzari and Creamer are building a 975-car garage as part of the $135 million cancer center now under construction. Creamer was paid more than $475,000 by the hospital for construction services.

* The hospital paid more than $2 million to Progenitor Cell Therapy, a private stem cell research company owned in part by Ferguson; Dr. Andrew Pecora, director of the cancer center; board members Peter C. Gerhard, George T. Croonquist and Samuel Toscano Jr.; and the hospital’s chief operating officer, Robert C. Garrett.

* The hospital paid $2.5 million to lease space from Sanzari 2001, where board member David Sanzari — Joseph’s cousin — is a managing member with an ownership stake. It also spent $68,000 at the Marriott at Glenpointe hotel, which is owned by David Sanzari’s family.

* The DeCotiis law firm, one of the most influential in the state, made more than $1 million from the hospital. It is representing the hospital in the Coniglio case and guiding its campaign to reopen Pascack Valley Hospital in Westwood. During that time, Frank Huttle III, a partner, served on the board. He said Friday that he resigned recently.

* Universal Health, which operates a retail pharmacy at the hospital, received $200,000. At the time, Toscano was the company’s chief executive officer.

Political Influence Disadvantages the Competition

The membership of the hospital's leaders in the power elite could be used to advance the hospital against less-connected competitors.

The Coniglio trial served as a primer on the backroom politics of New Jersey, where certain grants, known as 'Christmas tree items,' were doled out based on who has 'the juice.' By all accounts, Hackensack mastered the game and loomed large in Trenton. From 2004 to 2006, the hospital received $17.4 million for its cancer center, an extra $9 million in charity care above the millions it was already getting and $250,000 for the Joseph M. Sanzari Children’s Hospital. A $900,000 research grant was awarded to the private stem cell firm at the hospital and $70,000 went for a seat belt study.

Those awards dwarf the grants given to Hackensack’s competitors.

Connectedness of the Hospital's Board Members

The article gave further examples of how connected were the board members, and how they used their connections.

At Hackensack, a few names — Simunovich, Ferguson, Sanzari, Creamer — keep showing up in influential roles on key boards. They serve as trustees of the Hackensack University Medical Center Foundation, the hospital’s fund-raising arm, as well as the hospital’s board of governors and Hillcrest Health Service System, the hospital’s parent corporation. Leading contractors and developers — Sanzari, Creamer and John C. Fowler — are on the building committee.

Simunovich is the former chairman of the board of governors and current chairman of the board of trustees for the Hackensack University Medical Center Foundation, the hospital’s fund-raising arm.

Governor Corzine did not reappoint Simunovich to the Turnpike Authority in 2007 after he was investigated by the State Ethics Commission; as chairman, he had voted on millions in public contracts that were awarded to Sanzari while he accepted free rides on the contractor’s private jet. Simunovich paid a $50,000 fine, which was not an admission of guilt.

'Mr. Simunovich’s actions do not reflect the standards demanded by the governor for those who serve in his administration,' Corzine’s then-spokesman Anthony Coley said.

Joseph Sanzari serves as first vice chairman, the No. 2 position on the hospital’s board of governors.

Sanzari is part owner of both the Stony Hill Inn in Hackensack and the New Bridge Inn in New Milford, popular hangouts for Bergen County’s political elite. Sanzari, his companies and employees have contributed more than $100,000 to political campaigns and political action committees in the past three years, according to data the company provided to state elections regulators.

Among his top employees is state Sen. Paul Sarlo, also the mayor of Wood-Ridge. Sarlo oversees billions in public spending as a lead member of the Senate Budget and Appropriations Committee. As chairman of the Senate Judiciary Committee, he also controls key appointments to state agencies that have awarded millions in contracts to Sanzari’s firms.

Sarlo, chief operating officer for Sanzari’s construction company, testified at the trial that he was largely responsible for getting the $900,000 grant for the hospital’s cancer center. He said he also lobbied Codey for the $9 million cancer center grant and played a role in the $900,000 grant for stem cell research at the hospital.

Conclusions

Hospitals often have sterling reputations within their communities as selfless organizations devoted to improving the health of the people. As we have noted, hospitals and other health care organizations have come to be run more often by people with managerial background than those with health care experience. Not-for-profit hospitals have boards of trustees who are supposed to exercise stewardship, making sure the organization upholds its mission. But as we have noted before, e.g., here, boards of health care and related organizations may put their own agendas ahead of the mission. Furthermore, boards of big hospitals and other health care organizations seem to be increasingly composed of the well-connected, often to the point that they can be regarded as members of the power elite, if not the superclass. There may be some short term benefits to having such people on the boards. In the long run, however, is it any surprise that their missions may give way to other interests?

Hat tip to University Diaries.

ADDENDUM (4 May, 2009) - Hackensack University Medical Center's response to the news story discussed above was apparently first to stop advertising in the offending newspaper, and ban its sales in the hospital. Another example, almost laughable, of a health care organization's leadership trying to shoot the messenger, and of how the anechoic effect may be generated. Hat tip to the Schwitzer Health News Blog.

BusinessWeek on Health IT: "The Dubious Promise of Digital Medicine"

While I would have used the title "The Dubious Promise of Digital Medicine When Led By Amateurs in the Health IT Industry", the following Business Week article is one of the better and more realistic appraisals of the current state of Health IT.

Business Week, April 23, 2009
The Dubious Promise of Digital Medicine
Chad Terhune, Keith Epstein and Catherine Arnst

Recommended reading for anyone interested in improving healthcare via information technology. (Full disclosure: MedInformaticsMD was a contributor to the article.)

I will be commenting in upcoming posts on the article's points and HIT industry's customary, self serving and unscientific counterpoints. The article's thrust is that a HIT remains an experimental technology with a mixed history, which like any societal-level experiment (HIT representing a form of social engineering) carries individual and public risk. The risk is that when misled, any social experiment can and will lead to serious unintended consequences, which in this case ultimately means patient harm.

The first counterpoint that struck me in the article was this one:

Allscripts CEO Glen Tullman [a non-clinician businessman and an advisor to the Obama campaign on HIT] ... compares the skeptics of health info tech to doctors who questioned the introduction of the stethoscope in the 19th century: "There have been Luddites in every industry."

This profoundly unscientific, ad hominem dismissal represents the poster example of what I call a cross-occupational invasion of medicine by the IT industry. The attitude represents the antithesis of medical and scientific culture.

It simpy dismisses with a wave of the hand a growing body of authoritative literature going back decades. A small sample of that literature can be seen here, and anyone in HIT is grossly negligent to dismiss, or worse, not to be aware of such findings. There's really not much more to say on this issue.

This is an example of the attitudes of HIT industry leaders who believe they will "revolutionize" medicine via IT. Health IT with appropriate leadership can do quite well for healthcare. In the wrong hands, I'm sorry to say, the opposite is true.

It is, in fact, Mr. Tullman and like minded others in the IT industry, who make similar statements about those with the ultimate responsibility and liability for patient care, physicians (as Koppel and Kreda point out, the vendors have none), who are the Luddites. They are Luddites through their dismissal of the best thinking in modern IT and in biomedical information science.

On second thought, it might be more accurate to say they leverage their Luddism and willful ignorance in an opportunistic manner. Caveat emptor.

-- SS

Nutrition and Infectious Disease

Dr. Edward Mellanby's book Nutrition and Disease contains a chapter titled "Nutrition and Infection". It begins:

There is general agreement among medical men that the susceptibility of mankind to many types of infection is closely related to the state of nutrition. The difficulty arises, when closer examination is given to this general proposition, as to what constitutes good and bad nutrition, and the problem is not rendered easier by recent advances in nutritional science.

Dr. Mellanby was primarily concerned with the effect of fat-soluble vitamins on infectious disease, particularly vitamins A and D. One of his earliest observations was that butter protected against pneumonia in his laboratory dogs. He eventually identified vitamin A as the primary protective factor. He found that by placing rats on a diet deficient in vitamin A, they developed numerous infectious lesions, most often in the urogenital tract, the eyes, the intestine, the middle ear and the lungs. This was prevented by adding vitamin A or cabbage (a source of beta-carotene, which the rats converted to vitamin A) to the diet. Mellanby and his colleagues subsequently dubbed vitamin A the "anti-infective vitamin".

Dr. Mellanby was unsure whether the animal results would apply to humans, due to "the difficulty in believing that diets even of poor people were as deficient in vitamin A and carotene as the experimental diets." However, their colleagues had previously noted marked differences in the infection rate of largely vegetarian African tribes versus their carnivorous counterparts. The following quote from Nutrition and Disease refers to two tribes which, by coincidence, Dr. Weston Price also described in Nutrition and Physical Degeneration:

The high incidence of bronchitis, pneumonia, tropical ulcers and phthisis among the Kikuyu tribe who live on a diet mainly of cereals as compared with the low incidence of these diseases among their neighbours the Masai who live on meat, milk and raw blood (Orr and Gilks), probably has a similar or related nutritional explanation. The differences in distribution of infective disease found by these workers in the two tribes are most impressive. Thus in the cereal-eating tribe, bronchitis and pneumonia accounted for 31 per cent of all cases of sickness, tropical ulcers for 33 per cent, and phthisis for 6 per cent. The corresponding figures for the meat, milk and raw blood tribe were 4 per cent, 3 per cent and 1 per cent.

So they set out to test the theory under controlled conditions. Their first target: puerperal sepsis. This is an infection of the uterus that occurs after childbirth. They divided 550 women into two groups: one received vitamins A and D during the last month of pregnancy, and the other received nothing. Neither group was given instructions to change diet, and neither group was given vitamins during their hospital stay. The result, quoted from Nutrition and Disease:

The morbidity rate in the puerperium using the [British Medical Association] standard was 1.1 per cent in the vitamin group and 4.7 in the control group, a difference of 3.6 per cent which is twice the standard error (1.4), and therefore statistically significant.

This experiment didn't differentiate between the effects of vitamin A and D, but it did establish that fat-soluble vitamins are important for resistance to bacterial infection. The next experiment Dr. Mellanby undertook was a more difficult one. This time, he targeted puerperal septicemia. This is a more advanced stage of puerperal sepsis, in which the infection spreads into the bloodstream. In this experiment, he treated women who had already contracted the infection. This trial was not as tightly controlled as the previous one. Here's a description of the intervention, from Nutrition and Disease:

...all patients received when possible a diet rich not only in vitamin A but also of high biological quality. This diet included much milk, eggs, green vegetables, etc., as well as the vitamin A supplement. For controls we had to use the cases treated in previous years by the same obstetricians and gynecologists as the test cases.

In the two years prior to this investigation, the mortality rate for puerperal septicemia in 18 patients was 92%. In 1929, Dr. Mellanby fed 18 patients in the same hospital his special diet, and the mortality rate was 22%. This is a remarkable treatment for an infection that was almost invariably fatal at the time.

Dr. Mellanby was a man with a lot of perspective. He was not a reductionist; he knew that a good diet is more than the sum of its parts. Here's another quote from Nutrition and Disease:

It is probable that, as in the case of vitamin D and rickets, the question is not simple and that it will ultimately be found that vitamin A works in harmony with some dietetic factors, such as milk proteins and other proteins of high biological value, to promote resistance of mucous membranes and epithelial cells to invasion by micro-organisms, while other factors such as cereals, antagonise its influence. The effect of increasing the green vegetable and reducing the cereal intake on the resistance of herbivorous animals to infection is undoubted (Glenny and Allen, Boock and Trevan) and may well indicate a reaction in which the increased carotene of the vegetable plays only a part, but an important part.

And finally, let's not forget the effect of vitamin D on infection resistance. Low vitamin D is consistently associated with a higher frequency of respiratory infections, and a controlled trial showed that vitamin D supplements significantly reduce the occurrence of flu symptoms in wintertime. Vitamins A and D are best taken together. Did someone say high-vitamin cod liver oil??

P.S.- I have to apologize, I forgot to copy down the primary literature references for this post before returning the book to the library. So for the skeptics out there, you'll either have to take my word for it, or find a copy of the book yourself.

Nutrition and Infectious Disease

Dr. Edward Mellanby's book Nutrition and Disease contains a chapter titled "Nutrition and Infection". It begins:

There is general agreement among medical men that the susceptibility of mankind to many types of infection is closely related to the state of nutrition. The difficulty arises, when closer examination is given to this general proposition, as to what constitutes good and bad nutrition, and the problem is not rendered easier by recent advances in nutritional science.

The high incidence of bronchitis, pneumonia, tropical ulcers and phthisis among the Kikuyu tribe who live on a diet mainly of cereals as compared with the low incidence of these diseases among their neighbours the Masai who live on meat, milk and raw blood (Orr and Gilks), probably has a similar or related nutritional explanation. The differences in distribution of infective disease found by these workers in the two tribes are most impressive. Thus in the cereal-eating tribe, bronchitis and pneumonia accounted for 31 per cent of all cases of sickness, tropical ulcers for 33 per cent, and phthisis for 6 per cent. The corresponding figures for the meat, milk and raw blood tribe were 4 per cent, 3 per cent and 1 per cent.

The morbidity rate in the puerperium using the [British Medical Association] standard was 1.1 per cent in the vitamin group and 4.7 in the control group, a difference of 3.6 per cent which is twice the standard error (1.4), and therefore statistically significant.

...all patients received when possible a diet rich not only in vitamin A but also of high biological quality. This diet included much milk, eggs, green vegetables, etc., as well as the vitamin A supplement. For controls we had to use the cases treated in previous years by the same obstetricians and gynecologists as the test cases.

It is probable that, as in the case of vitamin D and rickets, the question is not simple and that it will ultimately be found that vitamin A works in harmony with some dietetic factors, such as milk proteins and other proteins of high biological value, to promote resistance of mucous membranes and epithelial cells to invasion by micro-organisms, while other factors such as cereals, antagonise its influence. The effect of increasing the green vegetable and reducing the cereal intake on the resistance of herbivorous animals to infection is undoubted (Glenny and Allen, Boock and Trevan) and may well indicate a reaction in which the increased carotene of the vegetable plays only a part, but an important part.

Pension Fund Scandals, Payment Agents, "Chooch" and the Anechoic Effect

As we get closer to graduation season for most institutions of higher education, another story about the leadership and governance of higher education, involving an institution housing a prominent medical school, has come into view, albeit indirectly. Let me try to explain this complex story, which on its surface has something to do with the ongoing financial crisis, but nothing to to with academia, by quoting, as usual, from media coverage.

We start with an article from the New York Times last week:

The man leading the Obama administration’s efforts to restructure the auto industry has been described in Securities and Exchange Commission documents as having arranged for his investment firm to pay more than $1 million to obtain New York State pension business.

Although he is not named in the documents, a person with knowledge of the inquiry said the investment executive is Steven Rattner, co-founder of the Quadrangle Group, the prominent private equity firm.

The S.E.C. complaint, filed as part of an expansive state and federal investigation into corruption at the state pension fund, details the efforts of Quadrangle to gain business from the pension fund beginning in 2004.

The person who received most of the $1 million-plus payment has been indicted, accused of selling access to the fund.

Here are the details of allegations of how Mr Rattner interacted with intermediaries to get NY state pension fund investments into his company.

Investigators are scrutinizing the fees paid by investment firms to intermediaries who arranged deals with the $122 billion pension fund. While such payments are legal, they often raise questions about conflicts of interest and would be illegal if used to bribe public officials.

In a 123-count indictment issued last month, two aides to Mr. Hevesi were accused of selling access to the fund. The aides, Hank Morris, who was Mr. Hevesi’s top political consultant, and David Loglisci, the fund’s chief investment officer, have denied any wrongdoing.

The S.E.C. complaint, which was released Wednesday, describes steps undertaken by the Quadrangle executive to win $100 million worth of business from the pension fund in 2005. That amount accounted for nearly 5 percent of a Quadrangle private equity fund and helped the company raise money from other investment funds.

In October 2004, the executive met with Mr. Loglisci to seek the pension fund investment and Mr. Loglisci 'reacted favorably' and 'began taking the necessary steps to secure approval' for the investment, the complaint said.

Two months later, in December, the same executive met with Mr. Morris, who, according to prosecutors, was working in tandem with Mr. Loglisci to generate millions of dollars in fees from the investment firms, and within weeks had agreed to a deal to pay an obscure securities firm that employed Mr. Morris 1.1 percent of any money that the retirement fund invested with Quadrangle, as a placement agent fee. That worked out to $1.1 million, of which Mr. Morris received 95 percent.

The timing of the meeting with Mr. Morris was significant, the complaint indicated, because the Quadrangle executive had already met with Mr. Loglisci and would presumably not need a placement agent. In addition, Quadrangle had previously retained a separate placement agent.

The executive also met with Mr. Loglisci about a low-budget movie Mr. Loglisci was producing, 'Chooch.' Soon afterward, GT Brands Holdings, a company owned by one of Quadrangle’s private equity funds, made a deal to acquire the DVD distribution rights to 'Chooch,' an agreement that made the film’s producers nearly $90,000.

The Quadrangle executive called Mr. Morris after the distribution deal was closed, and told him of the deal’s 'connection to Loglisci.' Three weeks later, Mr. Loglisci 'personally informed the Quadrangle executive that the retirement fund would be making a $100 million investment' in Quadrangle, the complaint said.

Later, the Washington Post published an article which alleges possible conflicts of interest affecting Mr Rattner in his current position as "automobile czar,"

The questions around Quadrangle and Rattner follow others that came to light soon after he emerged as a candidate to lead the Obama administration's efforts to prop up Chrysler and General Motors.

Quadrangle was, at least indirectly, previously involved in a deal involving Chrysler's majority owner, Cerberus Capital Management, a private equity firm.

That connection has led some Chrysler investors to doubt whether Rattner can decide without bias how the government should aid Chrysler.

In the summer of 2007, Quadrangle purchased Dennis Publishing, the owner of magazines including Maxim and Blender. The estimated price was $250 million.

Quadrangle's new magazine company was renamed Alpha Media and it took a loan of $125 million, much of it coming from Cerberus.

A year after Quadrangle's purchase, the publishing company's profits began to plummet.

The company announced last month that it would cease publication of its Blender magazine. Quadrangle has written the Alpha Media investment down to zero on its books, and Cerberus, the company's major creditor, is now effectively in control of Alpha, a person familiar with the matter said.

This week, a NY Times article revealed that Mr Rattner and Quadrangle are facing a wider investigation, and may be a target of investor lawsuits:

Two months after Steven Rattner left Wall Street for Washington, his private investment company is facing a widening investigation into corruption in public pension funds — and fighting for its future.

As state and federal authorities examine Mr. Rattner’s dealings with the New York State retirement fund, questions are emerging about his efforts to gain business from several other public funds, including ones in New Mexico and New York City. His private investment firm, the Quadrangle Group, is moving to calm anxious pension managers, who have entrusted the firm with hundreds of millions of dollars.

Mr. Rattner, who is leading the Obama administration’s efforts to revamp the auto industry, has left his small but prominent firm in a bind. Because he was integral to Quadrangle, investors can try to withhold additional money that they have pledged to the firm now that he has left.

No charges have been filed against Mr. Rattner, who did not respond to e-mail messages on Tuesday, or against Quadrangle, whose executives declined to comment.

While Quadrangle’s funds have not suffered as much as some other private equity funds, its investors have suffered losses in other parts of their portfolios. Some of them might try to capitalize on the inquiry to avoid making good on their pledges.

Another crucial question, however, is whether money from one Quadrangle fund was used to lure investors to a second fund. That possibility that might expose Quadrangle to investor lawsuits.

Furthermore, a Washington Post article raised the question of a failure of honest disclosure:

Government officials are expanding their investigation of Quadrangle, the private-equity firm founded by the Obama administration's lead auto negotiator, as new details emerge about an alleged kickback scheme involving the New York state pension fund.

On Wednesday, the New York City Comptroller William C. Thompson Jr. said he is working with the state's attorney general, Andrew M. Cuomo, to determine whether the city's pension funds were 'intentionally misled or deceived' by Quadrangle's failure to disclose the use of a middleman who has since been indicted, Hank Morris.

New York City's comptroller on Wednesday said Quadrangle never disclosed that it had paid Morris fees in connection with the city pension funds' investment in Quadrangle. The city invested $85 million in 2005 and $40 million in 2006.

The city has a rule that use of placement agents must be disclosed, but that rule was implemented in 2008 and does not apply to the Quadrangle investments.

But as part of the due diligence for receiving the investment, Quadrangle said in writing at the time that it used only two placement agents, Monument Group and London-based Helix Associates, the comptroller's office said.

'We take any ethical lapses by our managers seriously and will consider any remedies available to investors,' Thompson, the city's comptroller, said in a statement.

In response to all this, New York state government officials decided to ban middle-men from influence over pension fund investment decisions, according to the Wall Street Journal:

New York state said its public pension fund, one of the nation's largest, would ban the use of middlemen to help private-equity funds and other investors secure its business.

The move marked a pivotal development in a burgeoning controversy that has grown from a local corruption probe to a broader examination of the tactics that investment firms used to win lucrative business from vast public pension pools.

In most states, charging placement fees is legal if they are disclosed as required. But potential conflicts of interest are rife, especially for officials with a legal obligation to make informed, well-intended decisions about how pension-fund money is spent. Lawyers say a gray area emerges when finder's fees are paid to individuals or firms that do little more than trade on their access to public-pension-fund executives.

Such alleged behavior is at the heart of the scandal unfolding in New York. The state attorney general and the SEC have accused a former top fund official and a political adviser of giving investment funds access to billions of dollars of state pension money, in exchange for kickbacks and other payments for personal and political gain. One such middleman already has pleaded guilty to securities-fraud charges.

Some officials across the country have expressed concern about so-called pay-to-play practices -- that is, paying to influence people who direct the investments of public-employee retirement funds. Pay-to-play can range from illegal kickbacks, which in some instances have led to jail time, to legal activities such as campaign contributions to elected officials on the boards of pension funds. Pension funds are especially vulnerable to such accusations because their boards are often populated by elected officials or people with limited financial experience who need to rely heavily on outside advisers.

New York state's comptroller, Thomas DiNapoli, said that in light of the allegations contained in the case brought by the state's attorney general and the SEC, 'the best way to restore the pension fund's reputation is to say we won't be involved with any transactions that involved placement agents.'

Meanwhile, several commentators raised questions about Mr Rattner's suitability to be "automobile czar."

David Rothkopf, the author of Superclass, dubbed Mr Rattner the "kickback czar" on the Foreign Policy blog,

Are you joking? The Obama Administration somehow thought that it was okay to give a pass to Steve Rattner? They thought it was okay to appoint a guy to a key job after he apparently acknowledged to them that he was under investigation for providing a million dollar payment to pension consultant in exchange for receiving an assignment to manage a big chunk of pension fund money for New York State?

They thought it was okay in the middle of a justified surge of global disgust with Wall Street to embrace a big time Wall Street player who is smart enough to be arguing the legal technicalities of the transaction but not smart enough to recognize that it might just seem to be sleazy, dubious and a gross disservice to the people who were depending on the State to use appropriate methods and metrics to find stewards for their retirement money?

They even thought it was okay when part of the deal involved payments to support a movie called 'Chooch.' (What’s worse than bad ethics and bad taste all wrapped up into one sordid exchange? The New York Post called 'Chooch' which scored an amazing 00 rating from Rotten Tomatoes “the kind of vanity project that gives amateurs a bad name.”) What's more they did all this while giving Rattner the job of auto czar for which he had no material auto industry experience? I thought the way high ethical standards worked was that you didn't just bar people convicted of crimes, you tried to weed out people who had done things that were wrong or contrary to the public interest.

On BlackStarNews, Edward Manfredonia wrote:

I believed Rattner’s efforts to take the Times private should have disqualified him from an appointment with the Obama Administration; especially the key post of trying to stabilize the collapsing auto industry.

The White House still insists that the Administration fully supports Rattner; that reminds me of Bush proclaiming backing for Don Rumsfeld when it was clear he should have been shown the door as defense secretary.

Here's why Rattner deserves the boot.

An even more egregious form of activity that what I previously covered has become public. Rattner, who has extensive ties to Bill and Hillary Clinton, has been identified in several published news reports as the Quadrangle Fund executive who paid $1.1 million to receive more than $100 million from New York State’s multi-billion dollar pension fund to manage. The manner in which the payments were made leaves no doubt that they were meant for 'pay to play', which is illegal in my opinion.

Not surprisingly, a NY Times editorial was milder, but did allow,

Mr. Rattner showed some bad judgment in the 'Chooch' deal, and the public has a right to expect more of him in his new, highly sensitive position.

It's an interesting story, with implications in many areas, and it has hardly played out. Anyone reading this far is probably wondering, however, what this has to do with leadership, governance, and ethics in health care. None of the articles quoted above mentioned anything related to health care, or academics for that matter.

Here is where I pull the rabbit out of the hat.

Steven Rattner, in fact, has an important leadership position relevant to academics, and to academic health care. He is a member of Brown University's Board of Fellows, the "upper house" in the university's bicameral board of trustees, called the Brown Corporation. Brown University includes the Alpert Medical School, and the Division of Biology and Medicine. (Full disclosure: I am an alumnus of the College at Brown, and of the Medical School. I am a former full-time Brown faculty member, and currently a voluntary Clinical Associate Professor.)

And thus the issue here is really about the anechoic effect. Even though this convoluted case raises issues about Mr Rattner's role at Brown analogous to the issues it raises about his role as "automobile czar," there has been to date not even any media mention of his role at Brown, much less discussion of its implications for the university, academic leadership and governance, etc.

To survey the local coverage, the Providence Journal has not published any relevant news stories so far. It did print an op-ed questioning Mr Rattner's suitability for the "automobile czar" position, which had to do with the lack of sympathy an "investment banker" might have for the United Auto Workers. The Boston Globe ran a story from the Washington Post about the case, but one that had nothing on the local, or the academic angle. The Brown Daily Herald published a two news stories (here and here) about Mr Rattner's appointment as "automobile czar," which did note he is a "corporation member," but has not covered the current controversy. I am aware of no recent open discussion, or any discussion at all of Mr Rattner as a member of the Board of Fellows, in light of the recent unpleasantness.

Thus, our local angle on the New York pension/ placement agents/ Quadrangle/ "Chooch" affair mainly demonstrates how at many academic institutions, it is simply not done to bring up issues that question leadership and governance, especially at the highest levels.

Parenthetically, we have posted many times, most recently here, about the leadership and governance of Dartmouth College. Some might have interpreted these posts as hostile to that institution. They were anything but. In fact, it has only been possible to discuss leadership and governance at Dartmouth so thoroughly because that institution is much more open about its leadership and governance than is the typical US academic institution. Half of the he Dartmouth Board of Trustees, as we noted, used to be elected by vote of the alumni. The alumni could nominate their own candidates for the Board, through a petition process. The successful attempt to decrease the overall proportion of elected Trustees sparked a tremendous amount of open discussion and debate. Issues of leadership and governance at Dartmouth seem to be frequently discussed in local publications, on blogs, and sometimes even in the national media. I suspect that a governance system at Dartmouth marked by more than average representativeness and accountability has lead to much more vigorous debate and discussion of academic governance and leadership than occurs at more typical universities. (Note that even after the "board packing," Dartmouth still has a larger proportion of alumni-elected trustees than does the typical university, and it is still possible for alumni to put people on the ballot via petition.)

Brown University, on the other hand, is lead by a Corporation most of whose members are appointed by the Corporation itself. While a minority (14 of 42) of the Board of Trustees (the lower house) of the Corporation are elected by alumni, to my knowledge, all the election candidates are hand-picked by the Brown Alumni Association, and there is no provision for petition candidates. Although a few fiesty students occasionally call for more light to shine on the Brown Corporation, (e.g., see here), for the most part, questioning the leadership and governance of the university is simply not done. Thus, Brown seems to be typical of most major US academic organizations.

However, more transparent, accountable, governance, clearly guided by ethical principles and the organization's mission might allow US academia, and academic medicine to address some of the problems that we too often have opportunities to discuss on Health Care Renewal.

The "Investment Bankers" Strike Back: A Dissident is Thrown Off the Dartmouth Board

We have posted frequently on the governance and leadership of academic medical organizations. While one would think that health care organizations, and especially academic health care organizations ought to be held to a particularly high standard of governance, we have noted how their governance is often unrepresentative of key constituencies, opaque, unaccountable, unsupportive of the academic and health care mission, and not subject to codes of ethics. How the governance of organizations with such exemplary missions and sterling reputations got this way has been unclear.

We have often come back to the example of Dartmouth College, of which Dartmouth Medical School is a significant component. We most recently summarized here an ongoing dispute about the extent that the institution's board of trustees ought to represent the alumni at large, or instead, ought to be a self-elected body not clearly accountable to anyone else. When we first addressed the dispute, we noted that the self-elected, or "charter" members of the board were mostly leaders in finance, and when they succeeded increasing the proportion of self-elected members, the additions were again, mainly from finance.

The latest development at Dartmouth is that the board, whose majority is now self-elected, is going to boot off one of the few members who was elected by the alumni at large after being nominated by petition of alumni. As described in an editorial in the college newspaper, The Dartmouth,

We were dismayed to learn of the Board of Trustees’ decision not to reelect Trustee Todd Zywicki ‘88 for a second term ('Board votes not to reelect Zywicki ‘88,' April 7). Even in the wake of Zywicki’s open letter to the Dartmouth community on Tuesday ('Zywicki ‘88 criticizes Board in open letter,' April 15), the Board has yet to provide the Dartmouth community with a sufficient explanation for the removal.

Since 1990, when the power to reelect alumni trustees was transferred from alumni to the Board itself, reappointment to the Board for a second term has generally been routine; Zywicki is the first trustee in recent history to be denied reelection.

Zywicki said in his letter that comments he made during an address at the John William Pope Center in October 2007 'might have been' one of the reasons behind the Board’s decision. In the address, Zywicki made a series of controversial and inflammatory statements, including calling former College President James Freedman 'truly evil.'

Assuming that no egregious act remains undisclosed (and there has been no indication that this is the case), Zywicki’s removal disregards the will of the alumni who put him on the Board, and contradicts the democratic manner in which alumni elect trustees.

Dissenting opinions are essential to the operation of any governing body. While Zywicki may have behaved unprofessionally, the public reprimand issued by the Board was sufficient punishment. It is one thing to reprimand a trustee for making statements against the College in a public forum, but to remove dissenting opinions from the boardroom is to undermine the will of the alumni who voted in support of those very views.

Further news coverage in The Dartmouth suggested a flawed process was used to get rid of Zywicki,

Trustee T.J. Rodgers '70, who like Zywicki was nominated to be a candidate for the Board via petition and was successfully reelected at the April meeting, compared the reelection process to a 'witch-hunt trial' and said it was 'an affront to due process' in an e-mail to The Dartmouth.

'[Zywicki] was ejected by a secret vote — he was not allowed to know the vote count or even the reasons behind his ejection,' Rodgers said in the e-mail.

Rodgers added that he believes the decision not to reelect Zywicki was 'an embarrassment for the Board.'

'The effect of Todd’s ejection has been to warn me and any other trustee likely to speak his or her own mind to watch our step,' he said in the e-mail.

Finally, Mr Rogers wrote his own commentary in The Dartmouth,

'Hang one, warn a thousand' says the ancient Chinese proverb. In its April meeting, the Dartmouth Board of Trustees hanged Todd Zywicki '88, thus warning the petition trustees — and any others tempted to express independent views — not to cross the party line. The Board’s action was coldly deliberate. The legal machinery by which it was achieved took two years to construct.

Every 20 years or so, when a majority of the alumni body decides that the College is ignoring a critical problem, it elects petition trustees to promote change. That tradition, a healthy method of governance that sets Dartmouth apart, goes back to 1891, when alumni were formally granted one-half of Dartmouth’s Board seats in return for financing the College.

[After Rogers' election,] Subsequently, the alumni elected three more petition trustees with views similar to mine: Peter Robinson ‘79, Todd Zywicki ‘88 and Stephen Smith ‘88. It was no accident that each of them was a university professor or scholar. The Board Majority, predominantly composed of investment bankers, could have benefitted greatly from the new trustees’ education-first viewpoint, but instead, we were treated as if we were attacking the College. We were actually called a 'radical cabal' trying to 'hijack' the College by the Board member whose seat I had taken. The petition trustees had successfully overcome the penny-ante counterattacks, such as denying us the ability to mail our petitions to alumni to request signatures, and raising the required number of petition signatures, so it came time for the Board Majority to fix the petition trustee 'problem' permanently.

First, the Majority Board members simply declared the right to double their number from eight to 16 without adding an equivalent number of alumni trustees, despite an Association of Alumni poll of 4,000 alumni, who responded in favor of alumni trustee parity, 92 percent to eight percent. Then, the Majority threw its weight and College funds into a campaign to remove the Association leaders who had sued the College for breaking the 1891 Agreement.

In the boardroom, the Majority rewrote the 50 year-old Trustee Oath into an oath of loyalty, which was designed, in part, to limit trustees’ ability to express dissenting viewpoints without the direct threat of being ejected from the Board. And finally — fatally for Todd Zywicki — the Majority installed a formal review process that judged trustees against the new oath on a line-by-line basis.

On the day of his trial, Zywicki was asked if he wanted to make a statement. He apologized again for his Pope Center speech and exited. In order to maintain the confidentiality of board proceedings, I cannot give details. However, I can say from personal knowledge that many of the statements made in that meeting about Todd Zywicki were factually incorrect, but Todd was not there to respond. In my opinion, all of the issues, including his speech, did not rise to the level of negating the votes of the alumni who elected Todd. Despite my objection, the vote — for the only time in my five years on the Board — was secret.

Todd Zywicki’s greatest achievement as a Dartmouth trustee may well be having the personal courage to force the Board Majority to take responsibility for a political lynching.

Since I started writing about the governance of health care organizations, I used the example of Dartmouth (again, really a university with a medical school as a major component) as an example of governance that was more representative and accountable than that of many other health care organizations. Most universities that contain medical schools, for example, do not allow alumni to vote on the membership of more than a few board seats, and most only allow them to vote for alumni candidates hand-picked by the administration, not nominated by alumni petitions. However, since I started writing about Dartmouth, it seems that the self-elected majority of its board has done its best to make the board less representative and less accountable. Furthermore, it seems that some of the board's self-elected members regard anyone who disagrees with them as an enemy of the institution. Thus, their attitude seems to be: "l'universite c'est moi."

However, the duties of boards of trustees include the duty to uphold the institution's mission, not the board members' personal whims.

When I first started writing about these issues, I was surprised to find that the majority of the Dartmouth's boards self-elected, that is, "charter" trustees were from the finance sector. Now, having seen poor, sometimes arrogant, greedy, or even corrupt leadership of that sector bring down the world economy, I ask again whether people brought up in that culture ought to be dominant among the leadership of higher education?

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