The Boards Who Ought to be Accountable for the Misbehavior of Health Care Corporations

I recently posted about the multiple conflicts of interest affecting a university health sciences leader.  While he was supposed to be running a medical school and an academic medical center, he was also responsible for the stewardship, as a board member, of three health major health care corporations, and a food and beverage corporation (whose products have bearing on nutrition and public health.)  .

This one case suggested how pervasive are conflicts of interest affecting the people at the top of health care leadership in the US, and also how such conflicts may be associated with problems for all the organizations involved.  The story originally came to my attention because students were demonstrating against the lavish compensation given the health sciences leader at a time of university cutbacks, suggesting that university leaders were paying more attention to their own enrichment than to the mission of the university.  At the same time, one of the corporations which he was stewarding (Genzyme) had to shut down a factory because the extremely expensive drug it was producing was found to be impure and adulterated, while its CEO continued to be compensated lavishly.  The other corporation (Medtronic) had to settle litigation accusing it of manufacturing defective products for hundreds of millions of dollars, while its CEO again continued to be compensated lavishly. 

So I thought it might be interesting to see who are the other stewards of these troubled corporations.  I consulted the official biographies of their board members from their 2010 proxy statements (Genzyme here, Medtronic here).  I looked for board members who also held leadership positions in other health care organizations whose interests may not be aligned with the two corporations of interest.  I also looked for those who held leadership positions in the discredited financial services corporation who helped usher in the global financial collapse.

The specifics of what I found follow.

Genzyme

Genzyme had 10 directors in 2010.  The following directors had relationships of interest:

-  Douglas A Berthiaume is "Chairman of the Children's Hospital (Boston) Trust Board, a member of the Children's Hospital board of trustees, and a Trustee of the University of Massachusetts Amherst Foundation."  Children's Hospital is a teaching hospital.  The University of Massachusetts includes a medical school. 
-  Robert J Bertolini "retired from Schering-Plough Corp following its merger with Merck & Co in November, 2009."  Schering-Plough was a large pharmaceutical company now combined with Merck to form an even larger company.
-  Gail K Boudreaux "has served since May 2008 as an Executive Vice President of United Health Group Incorporated."  Also, "she serves on the board of directors of America's Health Insurance Plans...."  UnitedHealth is one of the US' largest health insurance/ managed care corporations.  Incidentally,it has frequently misbehaved, as can be seen in this set of posts.  AHIP is the health insurance corporations' trade associations.
-  Robert J Carpenter "is Chairman of Hydra Biosciences Inc... He is also a trustee of the Immune Disease Institute, a non-profit institute affiliated with Children's Hospital in Boston...." 
-  Charles L Cooney "is a director of India-based Biocon Limited, a biotechnology healthcare company."
-  Victor J Dzau MD (discussed in the earlier post) is "Chancellor for Health Affairs and President and Chief Executive Officer of Duke University Health System...."  He "sits on the board of directors of Pepsico Inc, Anylam Inc, Medtronic Inc, and the Duke University Health System."
-  Senator Connie Mack III is "Chairman Emeritus of the parent board of the H. Lee Moffitt Cancer Center and Research Institute...."  He also is director of "EXACT Sciences Corporation and Moody's Corp."  EXACT Sciences is a biotechnology company that develops diagnostic test technology.  Moody's Corp is a financial ratings agency whose lax ratings of financial derivatives, perhaps arising from conflicts of interest produced by payments from the producers of the derivatives, have been implicated as a major cause of the global financial collapse.
-  Richard E Syron was from "January 2004 to September 8, 2008 ... Chairman and Chief Executive Officer of the Federal Home Loan Mortgage Corporation, commonly referred to as Freddie Mac...."    Freddie Mac as bailed out and taken over by the US government when he departed, or was forced out.  Freddie Mac, was a "government-sponsored enterprise," (GSE) one of another group of companies whose enthusiastic participation in securitizing dubious mortgages was implicated as a major cause of the global financial collapse.
- Henri A Termeer (CEO of Genzyme) is a "director of Massachusetts General Hospital, a board member of Partners HealthCare, and a member of the board of fellows of Harvard Medical School." 

So the box score for Genzyme's 10 directors: six have leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities (some such institutions are lead by more than one Genzyme director).  Seven have leadership positions in other drug, device or biotechnology corporations.  One have leadership positions in health insurance/ managed care corporations.  Two had or have leadership positions in discredited financial services corporations that were implicated in the global financial collapse.

Medtronic

Medtronic had 11 directors in 2010.  The following directors had relationships of interest:

- Richard H Anderson "was Executive Vice President of UnitedHealth Group Incorporated."  As above, UnitedHealth is a health insurance/ managed care corporation.
- Victor J Dzau (see above) is "Chancellor for Health Affairs at Duke University and President and Chief Executive Officer of the Duke University Health System."  He is "a director of Alnylam Pharmaceuticals Inc, ... PepsiCo Inc, and Genzyme Corporation." (See discussion above.)
- James T Lenahan "served as President of Johnson & Johnson from 2002 until June 2004...."  He is "director of Telecris Biotherapeutics Inc, Alton Pharma Inc and Imacor Inc."  Johnson & Johnson is a large drug, device, and biotechnology company.  Telecris, and Alton Pharma are biotechnology pharmaceutical companies.  Imacor is a medical device company.
- Denise M O'Leary "is a director of Lucille Packard Children's Hospital and Stanford Hospitals and Clinics."  Also, "she was a member of the Stanford University Board of Trustees from 1996 through 2006, where she chaired the Committee of the Medical Center...."
-  Robert C Pozen is "an advisor to Gelesis Inc."  Gelesis is a biotechnology company.
-  Jack W Schuler "has been a director of Stericycle Inc since March 1990...."  He is a "director of Quidel Corporation and Elan Corporation plc...."    Stericycle company disposes of medical waste, including that produced by medical devices.  Quidel is a biotechnology and (medical diagnostic) device company.  Elan is an multinational biotechnology and pharmaceutical company.

So the box score for Genzyme's 11 directors is: Two have leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities (some such institutions are lead by more than one Genzyme director). Ten have leadership positions in other drug, device or biotechnology corporations. One has a leadership position in health insurance/ managed care corporations. None had or have leadership positions in discredited financial services corporations that were implicated in the global financial collapse.

Summary

Just to summarize the sorts of conflicting interests these relationships suggest. 

Teaching hospitals and medical schools are supposed to provide unbiased teaching, including about issues relevant to drug and device corporations, such as choice of diagnostic strategies and treatments, and relevant health policy.  They are supposed to perform unbiased research, including research that evaluates drugs and devices.  They are supposed to provide the best possible patient care at a reasonable cost, which relates to choices of and prices paid for drugs and devices. 

Other drug, device, and biotechnology corporations may be producing, or developing products that compete with those of the index corporations.

Health insurance companies ostensibly try to control costs and improve quality in part by reducing excess utilization and bargaining down prices of drugs and devices. 

So this limited case study of the boards of directors, that is, the ostensible stewards of two health care corporations, selected because they have a common member who is the leader of a large medical school and academic medical center, and which both have histories of poor management or ethical missteps showed  - that the leadership of health care organizations is incredibly interrelated, interlocked, incestuous. 

This gave an example of how pervasive are the conflicts of interest that affect all kinds of health care organizations.  Companies that ought to be competing have interlocked directors.  Companies that ought to be negotiating at arms length have interlocked directors.  Not-for-profit academic medical institutions have leaders who are also directors of companies whose drugs their patients may take, whose devices their patients may receive, whose insurance their patients may buy, and whose products and services they may teach about and evaluate through clinical research and policy research. 

This also gives an example of how the failed culture of finance may be linked to the culture of medicine and health care.  Some of the stewards of health care organizations were also the stewards of financial services corporations whose reckless, if not arrogant, greedy and amoral leadership is widely believed to have caused the global financial collapse and our ongoing economic problems. 

Finally, this suggests how top leaders of various health care organizations may be more familiar with and identify more with each other than with their organizations, their organizations' missions, and their organizations' professionals, staff, students, clients, and patients. 

What is to be done?

I strongly believe that there needs to be much more investigation, academic, journalistic, and perhaps legal, of the identity, nature, and culture of the leaders of health care, and their relationships.  A few bloggers cannot do it all.  Obviously, the anechoic effect mitigates against medical and health care academics looking into their own leaders.  However, failing to understand who is leading our march to the brink of health care failure ought not to be something such academics would want on their conscience.

Finally, and obviously, health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment.  Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. 

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.   

Duke Divinity Students Protest Pay of Chancellor for Health Affairs

This may be a first.  A small group of Duke University divinity students publicly protested the compensation given to some top university leaders, specifically including the Chancellor for Health Affairs.  According to the Raleigh-Durham News-Observer:

Theo Luebke strolled the plaza outside Duke's Bryan Center on Thursday afternoon with a bucketful of apples and a tale of woe.

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

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

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

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

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

It turns out these munificent compensation amounts were paid at a time when Duke is in some financial difficulty:

In recent years, Duke has frozen pay and eliminated jobs in an attempt to pare its annual operating budget by $100 million.

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

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

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

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

Service on (Mostly Health Care) Corporate Boards

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

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

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

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

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

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

Conflicts of Interest and Other Questions

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

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

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

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

The Other Side of the Conflict of Interest Coin

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

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

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

VCU President Rao's Previous Code of Silence

We recently posted about the code of silence imposed by Virginia Commonwealth University President Stephen Rao on his staff.  It turns out now that this was not his first exercise in imposing a code of silence. Before he was at Virginia Commonwealth University, Rao was President of Central Michigan University.  Central Michigan Life just reported:

While serving as CMU president, Rao required all office employees to sign a similar confidentiality agreement stating all names, places, dates or incidents that happened in his office were not to be shared with anyone or discussed outside the office.

'I understand that the information and all files, letters, projects, telephone calls and anything relating to the work performed in the President’s Office and in my capacity as an employee is highly confidential,' stated the agreement, which was obtained through a Freedom of Information Act request. 'I understand that it may not be discussed with anyone outside this office who does not have a need to know, which includes any other CMU employee, as well as my family members, friends, etc.'

The CMU confidentiality agreement extended past any employee’s tenure at CMU, stating that the contract must not be broken past the term of employment. If an employee were to break the confidentiality agreement past employment, possible consequences included personal liability and potential lawsuits.

Note that just as was the case in Virginia, this agreement placed employees at risk not only of losing their jobs, but of being sued were they to violate the agreement.

By the way, while Central Michigan University does not include a medical school and academic medical center, as does VCU, it does have, and therefore the previous agreement affected the operations of multiple health related programs (see here) including allied health, health administration, physical therapy, and psychology.

As we wrote previously, such a code of silence subverts the university's central mission, and directly opposes the transparency I believe is necessary for good governance in health care.  The discovery of this previous confidentiality agreement at CMU suggests that such agreements may not be rare in health care. 

We have long discussed the anechoic effect in health care, how certain topics and issues are just not to be discussed, especially those that might embarrass or oppose the personal interests of health care leaders.  We have postulated that the effect operates through fear of offending supervisors, colleagues, or those who provide one's pay.  It may be, however, that the anechoic effect has been codified through confidentiality clauses.  As noted above, such codification can mean whistle-blowers may risk lawsuits as well as job loss and ostracism.

If there are other codes of silence operative in health care, I hope that sunlight soon shines upon them. 

That sunlight may cause such codes to shrivel is suggested by President Rao's rescinding of the code at VCU soon after it was made public, as reported by the Richmond Times-Dispatch:

With the board of visitors meeting yesterday to evaluate his performance, Virginia Commonwealth University President Michael Rao rescinded the confidentiality agreements he required employees working in his office to sign.

Rao sent employees a letter Wednesday that said the confidentiality agreements were intended "to protect the privacy of my family, particularly my children, in my home."

'The confidentiality agreements have been the subject of recent scrutiny and criticism and, unfortunately, have been misinterpreted in terms of what I sought to be accomplished by these agreements,' he wrote. 'I sincerely regret any undue burden or ill will that these agreements may have caused. Therefore, I have decided to withdraw all such confidentiality agreements.'

Such codes ought to be perceived as unethical, and perhaps should be made illegal.  Meanwhile, though, the anechoic effect continues.

Annals of Electronic Information Security

At The Hill, former House Speaker Newt Gingrich raises a good point about the leak of hundreds of thousands of diplomatic cables and other private information:

"You have a private first class who downloads a quarter million documents, and the system doesn't say, 'Oh, you may be over extended?' I mean, this is a system so stupid that it ought to be a scandal of the first order," Gingrich said.

Regardless of which administration(s) are responsible (these systems probably took many years to reach their current form), one wonders if commercial EMR's suffer from the same oversights.

-- SS

Professors at Harvard and Nottingham Medical School (UK): Are we repeating the UK's clinical IT failures in the US?

In the opinion piece "Don't Repeat the UK's Electronic Health Records Failure" (Huffington Post, Dec. 5, 2010), Dr. Stephen B. Soumerai, Professor of Population Medicine at Harvard Medical School and Dr. Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK share familiar themes on health IT.

These themes will be especially familiar to HC Renewal readers and to my students and other readers of my Medical Informatics teaching website.

The professors wrote:

Fueled by the economic stimulus passed by Congress in 2008 [The ARRA a.k.a. "American Recovery and Reinvestment Act" and the HITECH legislation it contained - ed.], the federal government has embarked on a controversial $30 billion program to induce doctors throughout the country to adopt electronic health records (EHRs) by 2014. The purpose is to create an interconnected system of electronic health records to improve safety and reduce medical costs.

But the United Kingdom has spent the last 6 years working on the same idea, and it's proven to be a colossal failure -- so much so that the government is drastically cutting its program. What happened to their plan? Should we be paying attention before rushing ahead with our own?

My response to that question is clear, such as at my Nov. 2008 post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and the followup Jan. 2009 post "I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" where I wrote:

$50 billion a year is big money that might be better spent elsewhere - such as providing care for the poor and for disadvantaged children - until we know how to get HIT right.

I suggest it may be best not to go all-out for HIT under the current paradigm. It is my belief, in fact, based on the above issues [UK and US issues - ed.] plus a chronic influx of HIT difficulty and mismanagement stories I hear from colleagues, ex-colleagues, recruiters, etc., that healthcare organizations not contractually obligated should consider a postponement of plans to purchase clinical IT (i.e., systems for direct use by clinicians such as EHR's).

This postponement should last at least until the issues that lead to ineffective and counterproductive HIT can be better understood and corrections initiated in the industry.

The professors further write:

In 2005 the United Kingdom embarked on the largest investment ($18 billion) in health information technology in the world. Yet despite expectations that the system would increase efficiency and reduce medical errors, their efforts neither improved health nor saved money -- in fact in some cases, they may have led to patient harm.

Britain's government-run medical system is obviously different from our complex public-private insurance system. [I had written that a smaller, socialized healthcare system should be far easier to automate than our own in the US - ed.] However, its electronic health record project bears an uncanny resemblance to the program President Obama is starting.

They then delineated a number of problems:

Too large and ambitious: The UK project tried to accomplish too much, too fast, attempting to digitize health records for the whole population in a period of four years. This massive undertaking is years behind schedule and has delivered only a fraction of what it promised. Despite all the money poured into the system, the vast majority of hospitals in the UK still don't have integrated electronic health records.

Why? The reasons sound familiar:

... Because non-clinicians developed the system, the electronic forms they designed have little to do with how doctors treat patients -- making it unworkable for many physicians. As the Chair of the British House of Commons Public Accounts Committee recently stated, "This is the biggest IT [Information Technology] project in the world and it is turning into the biggest disaster."

The "biggest IT disaster in the world" is not an honor I wish to see repeated in the U.S.

On another familiar problem:

Too dependent on commercial, proprietary companies: Rather than create one system and beta-test it, the UK government depended on four companies to build the system, two of which quit or were fired for missing deadlines. So the health records were never developed in the south of England. The computer software was secret and proprietary. There was no accountability to the public, and the vendors did not provide enough technical support to clinicians having trouble using the records.

The resulting software errors and crashes caused missing or incorrect clinical information and sometimes threatened patient safety, for example by causing surgical delays and the cancellation of hundreds of operations.

The inquiring mind would want to know about actual patient injuries and deaths that likely resulted from such problems...

The professors observe:

If a country like Britain -- which already has a national health system and is a fraction of the size of the US -- had so many problems with electronic health records, imagine the problems America would face.

This sounds like my comments in a public comment letter of March 9, 2010 to HHS/ONC (Re: RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology") where I wrote, among many other things:

... We ignore the UK experience at our peril, an experience in a medical environment smaller and far more government-controlled than our own.

... I believe that a rushed National Program for HIT in the United States will suffer the same fate as the aforementioned National Programme for IT in the UK, and perhaps even a worse fate as the UK’s socialized medicine system is certainly a smaller, more homogeneous and more controllable testbed environment for experimenting with HIT.

The professors relate:

Even our partial adaption of electronic health records is causing problems. Over the last couple of years, doctors and hospitals have reported to the FDA dozens of medical injuries -- including six deaths and preventable heart attacks -- caused by problems related to computerized health records such as software errors and unreadable computer screens. Some errors resulted in drug doses that were 10 times higher than intended. FDA officials called this the "tip of the iceberg."

I wrote about the FDA's findings here, and conducted a "thought experiment" regarding what those numbers might extrapolate out to in my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

They continue:

... More than 50 medical organizations, including the AMA, have called on the Secretary of Health and Human Services to delay the program. In response, the administration delayed some of the required health IT functions, but kept the same 2014 deadline.

Indeed. They are courting disaster in my opinion, both clinically and financially, as I wrote in a Feb. 2009 Wall Street Journal letter to the editor entitled “Digitizing Medical Records May Help, but It's Complex”:

Dear WSJ,

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

The professors then note:

How do we avoid the UK's failure? The administration or Congress should slow down the program and delete those parts of the legislation that fine doctors for not using this technology. There's no need to have this system in place by 2014. Instead, we should conduct rigorous studies of the cost-effectiveness of electronic health records systems before mandating their use. Rather than force doctors to choose from dozens of commercial software products developed in secret, we should take a hint from the non-commercial sector, such as the Veterans Administration, which uses "open-source" coding so people can work collaboratively to continuously improve the system.

Slowing down the program and performing rigorous studies of HIT before wide scale rollout are themes I raised, among other places, in my Dec. 2009 post "Tensions and Paradoxes in Electronic Patient Record Research: Critical Thinking on Health IT" where I wrote:

In conclusion, I believe this literature review supports the notion expressed in other studies and opinion pieces here and elsewhere that we really need to SLOW DOWN the current HIT stampede, largely promoted by the HIT industry lobby. We need to take the appropriate time to better understand how to "do HIT well" before plunging in as if we actually know what we're doing

as well as at my Oct. 2009 post "Washington Post Article: Electronic medical records not seen as a cure-all" where I wrote:

... The literature is indeed conflicting, and the need for rigorous scientific study has never been more essential considering the commitment of tens of billions of dollars towards health IT. The time for story telling, marketing based on opinion, name calling, leap-of-faith extrapolations of light year dimensions, and other forms of pseudoscience and non-science are over. The time for objective study is now.

The professors conclude:

The Obama administration wants government programs to be based on evidence of effectiveness. Simply following the lead of "IT believers" and salesmen without the requisite evidence will repeat the UK's failures. Now is the time to proceed carefully, consider existing research and the British experience, and chart a more rational course into the digital age of medicine.

I do not know if these two professors were familiar with my writings, but I am happy to see these themes (once treated as verboten and as grounds for marginalization by the HIT industry) increasingly going mainstream.

Patient well being - which includes you, dear readers - depends on that.

-- SS

Is Healthcare IT a Solution to the Wrong Problem?

In a study published in the Nov. 25, 2010 New England Journal of Medicine entitled "Temporal Trends in Rates of Patient Harm Resulting from Medical Care", Landrigan N Engl J Med 363;22, it was found that medical error rates were not dropping:

In a study of 10 North Carolina hospitals [from January 2002 through December 2007], we found that harms remain common, with little evidence of widespread improvement. Further efforts are needed to translate effective safety interventions into routine practice and to monitor health care safety over time.

Unfortunately, I don't believe that the article differentiated between computerized hospitals and paper-based ones. Nor were the subject hospitals selected on the basis of computerization or non-computerization:

We conducted a retrospective study of a stratified random sample of 10 hospitals in North Carolina ...

... All acute care North Carolina hospitals listed in the American Hospital Association (AHA) database except those providing exclusively pediatric, rehabilitation, or psychiatric care were eligible for selection for the study. These hospitals were stratified according to the AHA’s definition of the facility as small, medium, or large; urban or rural; and teaching or nonteaching. The number of hospitals that underwent randomization for inclusion in each stratum reflected the proportion of national discharges from that type of hospital. If an invited hospital declined to participate, another closely matched hospital was randomly invited to participate in its stead.

While the extent of EHR/CPOE and other clinical IT adoption was not measured, some of the hospitals studied would likely have adopted and/or been using clinical IT in various capacities during the study period. The IT might have been expected to contribute to lower error rates over time.

Although that is admittedly speculation, there is a more important point to be made.

Many of the identified errors seem to have little to do with record keeping, but instead with human factors.

From the New York Times article "Study finds No Progress in Safety at Hospitals" covering the NEJM article:

... Landrigan’s study reviewed the records of 2,341 patients admitted to 10 hospitals — in both urban and rural areas and involving large and small and teaching and nonteaching medical centers ... Among the preventable problems that Dr. Landrigan’s team identified were severe bleeding during surgery, serious breathing trouble caused by a procedure being performed incorrectly, a fall that dislocated a patient’s hip and damaged a nerve and vaginal cuts caused by a vacuum extraction device used to help deliver a baby.

The findings were a disappointment but not a surprise, Dr. Landrigan said. Many of the problems were caused by the failure of hospitals to use measures that had been proved to avert mistakes and prevent infections from urinary catheters, ventilators and lines inserted into veins and arteries.

The chart of "harms" in the article, both those deemed "non-preventable" and those deemed "preventable" reads like a textbook of medicine, e.g.:

Cardiac arrest, shock, myocardial ischemia, acute respiratory failure, acute renal failure, hemorrhage, thromboembolic venous event, hematoma, pancreatitis, ileus, stroke or intracerebral hemorrhage, withdrawal symptoms, catheter-related bloodstream infection, urinary tract infection, surgical-site infection, clostridium difficile colitis, surgical anastomosis failure, wound dehiscence, failed procedure, unplanned return to surgery, fetal neonatal complication associated with delivery, hypothermia, pressure ulcer, catheter complication, etc.

It seems unlikely a missing or illegible chart was the cause of many of these adverse events. (In fact, the study was done retrospectively from the patient charts.)

Thus, expectations for major quality improvements in healthcare from the hundreds of billions spent on health IT might be vastly overstated based on false assumptions about the causes of adverse events.

Many of the above adverse events seem not highly amenable to correction via cybernetic information retrieval systems. They might be amenable, though, to improved nursing and ancillary staffing (perhaps I should say 'elimination of understaffing'), decreased work hours, improved CME, and better supervision of trainees ($100's of billions of dollars being spent for IT would surely buy a lot of those items).

What I found striking was this:

“A third of the errors in the intensive care unit disappear when residents work 16 hours or less,” Dr. Landrigan said, although he noted that senior residents often work longer hours.

That being the case, health IT that created heavier workloads and cognitive overload of residents already struggling under sleep deprivation might actually increase the risk of error.

It would seem national healthcare IT may be a 'solution' to the wrong problems in 2010.

We perhaps should better be focusing on human problems not amenable to cybernetic intervention before we start a national medical IT experiment, in the hope that major changes will somehow be effected by the magic of computers.

-- SS

Health Insurers Sanctioned, Fined

It has not been a good few weeks for big US health insurance companies.  First was a report (e.g., per the Wall Street Journal) that three companies had been suspended from selling Medicare Advantage plans:

The U.S. government's Medicare program has ordered three health insurers--Universal American Corp. (UAM), Health Net Inc. (HNT) and Arcadian Health--to stop marketing to and enrolling new members in their Medicare Advantage health and prescription-drug plans, saying the companies violated regulations.

In particular,

Universal American was told to stop marketing to and enrolling people in its Medicare Advantage plans effective Dec. 5. The action doesn't affect current members or the enrolling of beneficiaries in the company's stand-alone Medicare prescription-drug plans.

Health Net had to suspend the marketing of and enrollment in its Medicare Advantage plans and stand-alone Medicare prescription-drug plans as of Friday, as the government said the company's conduct poses a 'serious threat' to enrollees. The sanction doesn't affect the status of current enrollees, however.

In a letter Friday to Theodore Carpenter, head of Universal American's Medicare Advantage business, the Centers for Medicare and Medicaid Services alleged the company has a 'longstanding pattern of prohibited marketing practices targeted to highly vulnerable populations in violation' of federal law and guidelines as well as contractual terms with CMS.

Universal American is a 'chronic poor performer' with respect to the regulations, according to CMS, which said the company's agents engaged in aggressive sales tactics and abusive behavior, and misled or confused beneficiaries or misrepresented the plan.

The agency's letter to Health Net government-programs executive Scott Kelly said the company's conduct 'poses a serious threat to the health and safety of its enrollees,' as a result of the company's 'intractable failure to provide its enrollees with prescription drug benefits in conformance" with laws, guidelines and contract terms.' CMS cited a 'history of non-compliance.'

Then, the state of California fined and ordered restitution from multiple companies, as reported by the San Francisco Chronicle:

State regulators Monday fined seven of California's largest health insurers nearly $5 million for systematically failing to pay doctors and hospitals fairly and on time.

The California Department of Managed Health Care issued the fines following an 18-month audit in which investigators looked at a small but statistically significant sample of claims. The investigation found the plans were paying on average about 80 percent of the claims correctly, far below the legal threshold of 95 percent.

'Our clear and consistent message is that California's hospitals and physicians must be paid fairly and on time,' said Cindy Ehnes, director of the Department of Managed Health Care, which is charged with regulating the states' health maintenance organizations, or HMOs.

In addition to the fines, the companies must pay the doctors and hospitals restitution that is expected to run into the "tens of millions of dollars," Ehnes said. The plans will also be required to come up with a plan to correct the problem and submit to future audits.

Failing to pay providers properly makes it tougher for them to survive in the struggling economy, Ehnes said. 'If providers are not paid, patient care and access suffer,' she said.

Regulators fined Anthem Blue Cross and Blue Shield of California $900,000 each. United/PacifiCare was fined $800,000 and Kaiser Foundation Health Plan and Health Net were both hit with fines of $750,000.


The fines for Cigna and Aetna were $450,000 and $300,000, respectively, for a total of $4.85 million.

Please note that some of these companies have become "frequent flyers" on the Health Care Renewal blog.  Anthem Blue Cross in California is a subsidiary of WellPoint. WellPoint, in particular, just appears again and again on Health Care renewal.  A list of all posts about that company is here, and see this post for a list of past ethical and management missteps.  Health Net appeared in both stories above, and appeared on Health Care Renewal here.  Posts on Aetna are here.

Having been writing for this blog now for several years, I am struck by how often the conduct of particular health care organizations has been discredited, without any discernible effect on the organization's leadership or course.  It is particularly striking how the attention paid and pay given to the leaders of some health care organizations contrasts with the public record of their organization's bad behavior.

In particular, contrast the long catalog of misbehavior by WellPoint, noted above, with the enormous earnings of the company's CEO (more than $13 million in 2009), and her status as a prominent speaker on health care policy (see post here). 

In the laissez faire, anything goes, wild, wild west economy of today, spearheaded by the financial service companies that lead us to the global economic collapse, it seems that ethical leadership counts for nothing.  This is bad when it applies to the leadership of financial services, whose bad leadership can cost us all a lot of money.  It is worse when it applies to health care, whose bad leadership can cost us our health and our lives.

As I have said ad infinitum, to really reform health care, we will need to get accountable, ethical, transparent leadership of health care organizations.

When Robo-Medicine Replaces Dr. Welby, Watch Out

At "The Trouble With Robo-Lending", WSJ, Nov. 13, 2010 Amir Bhidé wisely notes, contrary to the seductive memes of statistical model religionists, that:

"High-touch gave way to high-tech. Statistical models that took no heed of specific circumstances replaced the bankers' on-the-spot judgments"

and that:

"Robo-lending and the securitization it facilitates lead to the misallocation of capital and economic instability."

Wait until "Robo-Medicine" hits, where on-the-spot judgments about medical care get replaced with statistical models of treatment, for example, in the form of electronic medical records-hosted "decision support" based on "comparative effectiveness research."

We apparently have not yet learned our lessons from the financial crisis regarding statistical legerdemain in fields where statistics should never replace human judgment. It's only money.

However, the fundamental truths within the adage "there are three kinds of lies: lies, damned lies, and statistics" will become exceedingly and painfully clear from the medical mayhem that results when Robo-Medicine replaces Dr. Welby.

-- SS

Academic Medical Center Crime Wave?

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

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

Pennsylvania State University Faculty Member Charged with Rape

As reported by PennLive.com,

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

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

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

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

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

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

$5 Million Embezzlement from Columbia University Medical Center

As reported by the Wall Street Journal,

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

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

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

Duke Surgeon and Surgical Department Business Manager Accused of Embezzlement

As reported by WRAL.com,

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

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

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

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

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

As reported by the New York Post,

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

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

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

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

His alleged ruse cost the hospital $3.8 million.

Summary

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

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

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

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

"Unreasonably Dangerous" Heparin

It is time for an update on the case of the deadly contaminated heparin sold by Baxter International, which has received much less attention than seems warranted given its human costs (81 lives).  How the heparin was contaminated, and how the contaminated heparin ended up being sold as a US Food and Drug Administration approved American product are still unknown.  Despite the fact that the outcome of this case were so bad, it received disproportionately little attention when it was first made public, and now seems to have become nearly anechoic.

Case Summary 

Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.  (For a more detailed summary of the case, look here, and for all our posts on this topic, look here.)

Civil Cases Plod Forward
If there is any ongoing official investigation of this case, it has not been made public.  Civil cases filed by patients allegedly injured by the heparin, or by relatives of patients who died allegedly from the heparin, seem to be proceeding at a glacial pace.  However, there is one development in one set of civil cases worthy of note.  As reported two weeks ago by Alicia Mundy in the Wall Street Journal:

A state court in Illinois has granted a partial summary judgment to two plaintiffs suing Baxter International Inc. over contaminated blood thinner, saying that some of the company's heparin was 'unreasonably dangerous.'

The suit involves tainted imported heparin ingredients from China that caused a public health crisis in 2008, and were linked to more than 80 deaths in the U.S. and many other serious allergic reactions.

Some 300 cases nationwide against Baxter and its main ingredient supplier, Wisconsin-based Scientific Protein Laboratories LLC, were consolidated in Chicago in Cook County Circuit Court.

Both companies have said that they weren't negligent and weren't responsible for the deadly reactions among patients.

The Illinois judge's ruling, dated Wednesday, involved a motion for partial summary judgment that named only Baxter. The motion was filed on behalf of two plaintiffs in the consolidated cases, one of whom died.

The ruling cites statements by Baxter's corporate quality vice president and the president of the company's medication delivery division that the heparin was defective.

Baxter argued in its defense that a jury should address the question of whether a product is 'unreasonably dangerous.' The company noted that the two Baxter executives who agreed in depositions that the heparin was defective aren't doctors or scientists. However, Judge Jennifer Duncan-Brice wrote that the issue before her wasn't whether heparin actually caused the death or injury to the plaintiffs, but just whether the product was, as a matter of fact, contaminated.

The most basic responsibility of a pharmaceutical company is to produce pure, unadulterated product.  As the current director of the US Food and Drug Administration wrote in this week's New England Journal of Medicine, the agency's "modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law, more than a quarter of a century in the making, that prohibited interstate commerce in adulterated and misbranded food and drugs."  However, in the 21st century, drug companies are increasingly failing to produce unadulterated products, and the FDA is having increasing difficulty assuring patients that the drugs they take meet even the most basic safety standards. 

I submit that corporate cultures increasingly influenced by the arrogant, greedy, amoral leadership of the financial services industry that lead us to the brink of another depression are also leading us to the brink of a poisonous era in health care.  Corporate leaders intent on cutting costs, and paying themselves as much of the resulting proceeds as possible, may see quality and safety as just another cost cutting target.  Corporate leaders brought up in the culture of finance, but untrained and inexperienced in engineering, science, and medicine find it all too easy to ignore quality and safety and focus on the bottom line.  (It is ironic that in the quote above, Baxter International's attorneys made light of the judgments of the company's own executives because they are not physicians or scientists.)

Meanwhile, society seems to have been so mesmerized by the mantra that laissez faire capitalism will lead to miraculous "innovation" that we do not even attend to instances in which it lead instead to death.

As we have said until being blue in the face, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.


To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).

BLOGSCAN - This Book is Haunted

We have posted quite a bit about ghost-written articles, that is, ostensibly scholarly articles appearing in medical and health care journals with apparently prominent authors that were really written mainly by medical writers hired by companies to market particular products, usually drugs.  Now we hear of a case of a ghost-written book.  Our fellow bloggers have covered this well.  See posts here and here by Professor Margaret Soltan in University Diaries, and here on Inside Higher Ed; here by Dr Daniel Carlat on the Carlat Psychiatry Blog; here by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog; and here by Alison Bass on the Alison Bass blog.  Ghost writing is often an important component of stealth marketing schemes, and serves not only to deceptively market products, but to deceptively increase the influence and prestige of the "key opinion leaders" who enable the practice.  Be skeptical about the medical literature, and particularly skeptical by any academic who seems to have written more articles than would be humanly possible.

ADDENDUM (2 December, 2010) - As suggested by the comment below, see also posts here and  here on the 1BoringOld Man blog.  Also see an additional post by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

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

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

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

The authors described a large survey, of over 5000 faculty at 26 US nationally representative medical schools, done as part of the National Initiative on Gender, Culture, and Leadership in Medicine (known as C ‐ Change) project.  The overall response rate was good (53%).   Here are the striking results:

51% agreed that 'the administration is only interested in me for the revenue I generate'; 31%; that 'the culture of my institution discourages altruism'; 31%, that other people have taken credit for my work'; and 30% that 'I am reluctant to express my opinion for fear of negative consequences.' Half perceived that the institution does not value teaching and 27% that it does not reward clinical excellence; Over half disagreed with the statement that their own values are aligned with those of the institution. Also, 30% had seriously considered leaving academic medicine and 46% their own institution, both in the prior year.

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

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

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

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

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

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

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

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

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

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

The Economist, Information Privacy, Microsoft, and Technological Determinism: An Online Debate

At The Economist, an online "debate" entitled Health 2.0 has been posted (link). It poses a debate between two experts.

In this case, the debate is between Peter Neupert, Corporate vice-president, Microsoft Health Solutions Group, vs. Deborah Peel, MD, Founder, Patient Privacy Rights and leader of the Coalition for Patient Privacy.

The readers are asked to vote upon whether they agree or disagree with this statement:

This house believes that any loss of privacy from digitising health care will be more than compensated for by the welfare gains from increased efficiency.

Note the phrase "will be."

Readers are also permitted to post comments.

My response was as follows:

30/11/2010 19:16:26 pm

Dear Sir,

The premise of this entire debate is logically fallacious, in fact begging the question.

This statement implies proven or inevitable "gains" from health IT. This is far from certain.

Health IT such as electronic medical records systems and computerized order entry systems (CPOE) remain highly experimental medical devices. They are unregulated devices as well. Their effects on medical care can be toxic, and patients are exposed to these effects without informed consent. The "gains" attributed to them are increasingly doubted in a growing body of literature.

See

"Common examples of healthcare IT difficulties" at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/

and

"2009 a pivotal year in healthcare IT"
at
http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc...

for exposure to some of this literature.

In essence, management information systems and other business computing-derived approaches, customs and traditions for software design, development and lifecycle have proven ill suited in healthcare. Clinical computing and business computing are conflated; yet, they are two fundamentally different subspecialties of computing.

Further, medicine is a scientific discipline, yet the approach to IT in healthcare has been nearly devoid of science and critical thinking.

Sacrificing privacy for a dream that may or may not be true is not good social policy.

In the aftermath of the latest Wikileaks disclosures, a scientific approach - such as assertions about the beneficence of IT in healthcare not being made without strong, robust scientific evidence and without consideration of the downside evidence not being proferred so freely - would be a fine start.

S. Silverstein, MD
Drexel University
College of Information Science and Technology
Philadelphia, PA USA.

I found the position of Peter Neupert (Corporate vice-president, Microsoft Health Solutions Group) defending the motion particularly concerning:

Consumers must trust that the organisations they are engaged with are accountable and will respect—and protect—the privacy of their data.

"Must trust?"

I find this remarkable in the context of repeated violations of "trust" I've noted at this blog such as at my posts:

• "Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue?",

• "Networked, Interoperable, Secure National Medical Records a Castle in the Sky?",

• "Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?",

• "Medical data breach of the week - but your EMR data is secure, trust us, we're IT experts",

• "Insurers Test Data Profiles to Identify Risky Clients",

• and others.

Neupert's view is especially paternalistic and naive in the context of Wikileaks repeatedly and recently leaking hundreds of thousands of supposedly secure documents, stolen from U.S. intelligence by at least one known person and probably others. If the Pentagon and U.S. intelligence cannot keep information secure, how can lowly hospital IT departments?

The moderator's initial comments are also disturbing:

... Supporters argue that health information technologies have advanced to the point that such [security] concerns are vastly overblown. After all, do not financial data flow freely and with little incident over digital systems? On this argument, any loss of privacy will be more than offset by efficiency gains. In arguing for the motion, Peter Neupert of Microsoft, a software firm, insists that digital medicine must be centred on the patient—rather than, say, the doctor or the insurer, as is often the case today [this 'centered on the patient' meme sounds good, but what exactly does it mean? - ed.] —and that medical information must be as mobile as the patient. If that is the case, he argues, it is not merely the efficiency of health systems that will improve but also the value of health care—and perhaps health outcomes too.

MR VIJAY V. VAITHEESWARAN
Correspondent, The Economist

Note the statements of absolute certainty - "will be more than offset by efficiency gains", "will improve", etc. They remind me of the statements made in the NEJM by the Director of ONC, Dr. David Blumenthal, as I wrote at "Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records":

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

On that I had commented:

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. I note the lack of footnotes showing the source(s) of these statements.

The meme of technological determinism, that computerization in medicine is synonymous with, and will deterministically provide "improvements", no matter what the evidence, is quite concerning coming from a company as profoundly large and influential as Microsoft.

Further, the complete omission of consideration of the adverse clinical consequences (let alone mere information breaches) that may occur along the way to cybernetic utopia in healthcare is very disturbing. These are experimental medical devices, are unregulated, and are used without patient informed consent. Yet the IT industry seems to opine as if these systems are only to be used on experimental lab rats.

These systems produce "legible gibberish" of no clinical use to clinicians, but take clinician time to generate through distracting "clickorrhea." For example, just the placement of an IV and fluid infusion generates a half page of nonsense:

Actual "legible gibberish" from an ED EHR report, major health IT vendor. Half a page on how an IV was started and a saline infusion given. (How many distracting clinician mouse clicks did it take to produce this?) Click to enlarge.

Addendum 12/8/10 - From "Hidden Malpractice Dangers in EMRs", Steven I. Kern, Esq., Medscape.com:

Too Much Information

... Pages of repetitive documentation can be more time-consuming to review than brief, handwritten notes. When important information is embedded in paragraphs of boilerplate, it can easily be overlooked. The chance of missing critical data increases.

Overlooking important information is, of course, a significant cause of malpractice. A positive finding embedded in a string of negative findings can easily be missed.

Ironically, my relative was injured as a result of EHR-related disruption not long ago. Further, just the initial two and a half weeks of hospitalization generated more than 2,800 laser printed pages of "legible gibberish" (which cost just under $1000 to obtain; Kinko's should only have it so good).

A fellow physician I know well related:

From: [redacted name of MD]

Good Lord! I am so sorry to see this and hope your Mom gets better. You must be furious.

May I add to the cacophony? My wife went to [another local hospital's] ER for emergency transfusion. Their Emr displayed someone else's info under her name & SSN. Had I not been there she would have received incorrect treatment.

My wife went to [yet another hospital] for hip replacement. After surgery, while she slept off her anesthesia, a nurse came in and started injecting her. I asked and learned it was insulin. I stopped the nurse (with difficulty). My wife's not diabetic. Her screen showed someone else's orders. Had I not been there she might have died.

So keep up the good work... please!

[redacted name of MD]

How many other patients have been injured or killed as a result of EHR's?

In fact, we really don't know how many adverse events related to EHR's occur. As the Joint Commission itself admits in its Sentinel Events Alert #42, Safely implementing health information and converging technologies: "There is a dearth of data on the incidence of adverse events directly caused by HIT overall." I further wrote on this issue in a paper "A Dearth of Data on Unintended Consequences of Healthcare IT" here.

Is this a proper environment for national rollout of these clearly experimental medical devices, one should ask?

The memes of technological determinism and health IT "white-as-driven-snow" beneficence seem as difficult as vampires to eradicate.

Yet if this technology is to achieve the benefits of which it is capable via remediation of current IT industry customs, traditions and practices, these memes must be challenged and defeated.

Regarding health IT in the real world, reality matters.

-- SS