BLOGSCAN - FDA don't need no smart old people 'round

We have posted numerous times about the requirement for seasoned expertise (the kind that only comes with age) in healthcare leadership.

FDA, CDC and other HHS agencies may have different ideas:

http://gooznews.com/?p=2194

Age Purge in FDA Press Office?
December 5, 2010
By GoozNews

FDA Webview (subscription required) reports that the new FDA associate commissioner for external affairs, Beth Martino, 31, a former Kansas aide to HHS secretary Kathleen Sebelius, has conducted a purge of senior specialists, all aged over 50, in her office and in the press office. The abrupt removals were made to make room for younger people closer to Martino’s own age, the trade journal reports. “She’s uncomfortable with people who know more than she does,” a source told FDA Webview.

Three of the displaced staffers, public affairs officers Elaine Gansz Bobo, 52, Dick Thompson, 65, a former Time magazine science editor, and Ira Allen, 62, a seasoned health care journalist, were offered the choice of being terminated as probationary hires for fabricated “incompetence” or resigning. Similar purges are reportedly occurring at other HHS agencies, including Centers for Disease Control.

Neither Martino nor FDA senior deputy commissioner Joshua Sharfstein, whose duties include chairing the FDA’s transparency initiative, responded to FDAWebview’s request for comment.

If this story is true, it is not only illegal age discrimination under the Age Discrimination in Employment Act of 1967 (ADEA), it is deleterious to the appropriate functioning of federal agencies charged with safeguarding public health - via talent mismanagement.

-- SS

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