Smoke Screen - How a Conflict of Interest Muddled the Debate on the Smoke-Free Initiative at the University of Michigan

As a physician, not being a big fan of cigarette smoking, I would have found little to criticize had anyone showed me the Smoke-Free Initiative at the University of Michigan, as promoted by the University President, Mary Sue Coleman. 

A Conflict of Interest: University President and Johnson & Johnson Board Member

It turns out, though, that this initative has provoked debate on that campus, not so much about its possible benefits and harms, but about whether the Ms Coleman's promotion of it had to do with a conflict of interest.  The debate broke out with an op-ed in the Michigan Daily:

It’s clear, then, that University President Mary Sue Coleman is the architect of the Smoke-Free Initiative, which will take effect in July of 2011. The initiative will prohibit smoking on all outdoor University property. Coleman and University administrators have been embarrassingly vague about why such a ban is necessary. Instead, they keep insisting that the smoking ban will improve public health.

Interestingly enough, the smoking ban may also improve Coleman’s salary.

That’s because Coleman isn’t just a college president. In her spare time, she moonlights as a businesswoman, sitting on the board of directors for major pharmaceutical company Johnson &  Johnson, as well as the Meredith Corporation, a magazine publisher. According to Forbes.com, her position at Johnson & Johnson netted her an income of $229,000 last year.

Among Johnson & Johnson’s many marketed brands are smoking cessation products like Nicorette and Nicoderm — products that University smokers will feel encouraged to use once smoking becomes unwelcome on campus in July 2011. Indeed, administrators have already announced that smoking cessation products may be offered at discounted prices to students who are trying to quit.

Obviously, this is a sizeable conflict of interest for Coleman. Even if her Johnson & Johnson salary didn’t actively influence her decision to ban smoking, it makes it substantially harder to take her at her word that the University needs this ban — especially when representatives of her administration can’t come up with a specific reason for it.

But Coleman’s corporate troubles run deeper than this. As the University’s College Libertarians pointed out in a press release this weekend, Johnson & Johnson has an affiliated non-profit group, the Robert Wood Johnson Foundation, which lobbies for the adoption of certain health-related policies through research and grant money. RWJF is notoriously anti-smoking, as its website explains: 'At the state and community level, we support advocacy for proven tobacco control measures, such as smoke-free air laws, funding of prevention and cessation programs and increases in tobacco taxes.'

While it’s no surprise that RWJF would fight for laws that restrict smoking and lead to increased use of Johnson & Johnson products, such an aggressive lobbying force should not hold financial sway over the president of a public university. Students, faculty and staff must be able to trust that their president is working in the best interests of the University community, not a profit-motivated corporation. Even the perception of a conflict of interest is embarrassing for this institution.

And then, in another op-ed in that paper:

Granted, some of Coleman’s reasons for the Smoke-Free Initiative are likely motivated by good intentions like lowering the University’s health care costs. But these justifications are severely compromised by her compensation from a corporation that will likely benefit from the smoking ban. Coleman sits on the board of directors for Johnson & Johnson, from which she earned nearly a quarter of a million dollars in 2009, and holds 11,159 shares of common stock, 10,777 shares of common stock equivalent units and 7,600 exercisable stock options in the company. Johnson & Johnson is the producer of a host of nicotine replacement products, including Nicoderm and Nicorette. Coleman explains, 'the University will offer free behavioral sessions and selected over-the-counter smoking cessation products to faculty and staff, along with co-pay reductions for prescription tobacco cessation medicines (and) discounts on tobacco cessation aids.'

In other words, under the proposed Smoke-Free Initiative, the University would subsidize products made by Johnson & Johnson. The University would purchase more nicotine replacement products, likely resulting in financial gains for Johnson & Johnson and, consequently, Coleman.

In reply, a letter by Dr Robert W Winfield, University of Michigan Chief Health Officer, asserted:

Some have raised concern about the appearance of a conflict of interest between President Coleman’s service on the board of directors of Johnson & Johnson, a company that produces some smoking-cessation products.

Simply put, there is no conflict. Prescription-only drugs for smoking cessation are generally considered the most effective and most widely used. Johnson & Johnson does not make any prescription-only smoking-cessation products.

A report of a meeting of the Michigan Student Association noted:

In a press release and columns in The Michigan Daily, members of the College Libertarians have identified Coleman as having an apparent conflict of interest due to her position on the board of Johnson & Johnson — a company that manufactures and markets smoking cessation products.

Kozack said if the allegations prove to be true, they could have large implications as Coleman is compensated for sitting on the company’s board.

He said the main reason for the resolution and the accusation of Coleman’s conflict of interest is that there is not enough information provided to the whole campus about the origin of the Smoke Free Initiative.

But in defense of President Coleman, the following appeared in the Michigan Capitol Confidential:

The University of Michigan's student newspaper - The Michigan Daily - wrote an opinion piece last week suggesting a conflict of interest involving University of Michigan President Mary Sue Coleman.

Coleman also earned a $230,000 salary in 2009 for sitting on the board of Johnson & Johnson. Alza Corporation, a subsidiary of Johnson & Johnson, markets Nicorette and Nicoderm, smoking cessation products.

Three ethics experts say Coleman is not in conflict.

'She is doing a public health service,' Peter Rost, a former vice president of Pfizer who has testified before Congress on the business practices of drug companies, wrote in an e-mail. 'The possible income by J& J from this campus is completely and utterly negligible and will have no impact on J&J income statement. Same thing if she opened public health clinic for depressed students and happened to sit on board of (a company) selling antidepressants. Conflict of interest should normally have some undue influence on either party. Since that is not the case I'm not troubled.'

Aine Donovan, the executive director of the Ethics Institute at Dartmouth College who teaches business ethics, said she didn't see a conflict.

'This is very reasonable,' Donovan said. 'Johnson & Johnson has a large range of products. This is a very reasonable position she is taking and it is a very laudable one.'

Timothy Keane, director of the Emerson Ethics Center in St. Louis, said it was 'a bit of a stretch' to say Coleman had a conflict of interest.

'Johnson & Johnson is not trying to set up shop and sell something to the University,' Keane said. 'They are not being a supplier to the University. It doesn't matter if you are a smoker or not, research indicates it is bad for you.'

A Hazy Debate

Smoke gets in your eyes. Maybe it should not be a surprise that once President Coleman's relationship with Johnson and Johnson was noted, opponents and proponents of the Smoke-Free Initative used arguments about that relationship to bolster their positions, rather than debating the smoking ban on its merits. The result, however, shows how conflicts of interest seem to always produce confusion, if not smoke and mirrors.

Most of the debate seemed to be about whether Ms Coleman would personally profit from the smoking ban, and if so, how much. For example, the second op-ed above argued, "the University would purchase more nicotine replacement products, likely resulting in financial gains for Johnson & Johnson, and consequently, Coleman." On the other hand, one expert quoted in the Michigan Capital Confidential argued that the income to J&J from the Michigan campus would be "utterly negligible," and another argued that "Johnson & Johnson is not trying to set up shop and sell something to the University."

On one hand, however much use of J&J nicotine replacement products there is at the University of Michigan, the amount is unlikely to change the profits of J&J, or the salaries or values of stock owned by its directors. On the other hand, J&J may not run a retail store at the University, but it is in the company's interest to sell more of all its products on university campuses, and everywhere else.

But in my humble opinion, the issue is not about the degree President Coleman's salary and assets derived from her position with Johnson and Johnson would be affected by a specific policy she may advocate. The issue is whether her judgments and decisions as President could be unduly influenced by her relationship with the company.

Definition of Conflicts of Interest


This provides a good opportunity to review a good working definition of conflict of interest as it applies to medicine, health care and health policy. Last year the Institute of Medicine published a thorough and well-balanced report, Conflict of Interest in Medical Research, Education, and Practice. It defined conflict of interest (p. 6):

Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....

Furthermore,

The severity of a conflict of interest depends on (1) the likelihood that professional decisions made under the relevant circumstances would be unduly influenced by a secondary interest, and (2) the seriousness of the harm or wrong that could result from such an influence.

But,

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

Thus, a conflict of interest should be seen as a situation which increases the risk of bad judgments or decisions, but does not necessarily cause them, much less cause a particular bad judgment or decision.  (Thus, it makes no sense to try to argue, as the experts did above, that because a person made a good decision, he or she does not have a conflict of interest.)

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

However, that she has such a conflict does not prove that any particular judgments or decisions were made badly because of it. Conversely, that particular judgments or decisions were made well does not disprove the existence of the conflict. 

So I beg to differ with all the experts cited in the Michigan Capital Confidential article.  On the other hand, while the President may have a conflict of interest, it is impossible to tell how or whether this influenced her particular decision to support the Smoke-Free Initiative.  Neither does it speak to the benefits or harms of such a policy.  The main effect of the President's conflict of interest seems to have been to muddle the debate about the policy.

Conflicts of interests' general tendency to muddle and confuse provide one argument for their elimination.  Another is that they may affect judgments and actions that are not so readily debated as, and more likely to produce bad results than smoke-free initiatives.  Maybe the hazy debate about the University of Michigan Smoke-Free Initiative will lead to a clearer discussion of whether academic and academic medical leaders should also be corporate leaders.

Failed Leaders of Citigroup as Leaders of Health Care

When we began this blog, I never dreamed I would do so much writing about finance and the financial services sector of the economy, but,... 

The Governance of Citigroup

The discussions and revelations generated by the global financial collapse/ great recession continue to provide insights into the ongoing health care crisis.  Let me start with a small item from the Dow Jones Newswire this week:

The California Public Employees' Retirement System said it opposes the re-election of two Citigroup Inc. (C) directors, in part because of their roles in the recent financial crisis.

The nation's largest public pension fund, which owns about 61.2 million Citigroup shares, plans to cast 'withhold' votes for board nominees Andrew Liveris, chairman and chief executive of Dow Chemical Co. (DOW), and Judith Rodin, Rockefeller Foundation president, at the annual shareowners meeting Tuesday.

Both served on the company's audit and risk committee before the financial crisis. During the crisis, the banking giant accepted a total federal government infusion of $45 billion, which it has repaid.

'It's time for new blood in the boardroom,' said Anne Simpson, the senior portfolio manager who heads the Calpers corporate governance program....

Let me back up a bit.

The near-failure of global banking giant Citigroup, prevented only by a massive US government bail-out, was one of the central components of the global financial collapse. We noted recently how Mr Robert Rubin, one of the key leaders of Citigroup was accused of "being asleep at the switch," "irresponsibility and misjudgment," and being a "very well paid boob" after his testimony at hearings by the committee investigating the collapse. We also noted his link to health care. As senior member of the Harvard Corporation, Rubin is one of six top stewards of the US' oldest and arguably most presigious university, containing one the country's most prestigious medical schools and teaching hospitals.

Although all those who were members of the Citigroup at the time it collapsed have not been hauled in front of the committee, there has been considerable discussion of their responsibility for the company's failures. For example, in 2008, soon after the government rescue of Citigroup began, the Wall Street Journal published an editorial:

"Citi never sleeps," says the bank's advertising slogan. But its directors apparently do. While CEO Vikram Pandit can argue that many of Citi's problems were created before he arrived in 2007, most board members have no such excuse. Former Treasury Secretary Robert Rubin has served on the Citi board for a decade. For much of that time he was chairman of the executive committee, collecting tens of millions to massage the Beltway crowd, though apparently not for asking tough questions about risk management.

Chairman Sir Win Bischoff has held senior positions at Citi since 2000. Six other directors have served for more than 10 years -- including former CIA Director John Deutch, Time Warner Chairman Richard Parsons, foundation executive Franklin Thomas, former AT&T CEO C. Michael Armstrong, Alcoa Chairman Alain Belda, and former Chevron Chairman Kenneth Derr.

When taxpayers are being asked to provide the equivalent of $1,000 each in guarantees on Citi's dubious investments, how can these men possibly say they deserve to remain on the board?

While other banks can claim to be victims of the current panic, Citi is at least a three-time loser. The same directors were at the helm in 2005 when the Fed suspended Citi's ability to make acquisitions because of the bank's failure to adhere to regulatory and ethical standards. Citi also needed resuscitation after the sovereign debt disaster of the 1980s, and it required an orchestrated private rescue in the 1990s.

Last year, as reported by Bloomberg,

Citigroup Inc. investors should vote against re-electing four of 14 board members, including John Deutch and Michael Armstrong, to improve management of the company’s risks, a shareholder advisory group said.

Deutch, former U.S. Central Intelligence Agency director, Armstrong, former AT& T Inc. chief executive officer, and Alain Belda, chairman of Alcoa Inc., should be opposed 'for poor risk oversight,' RiskMetrics Group Inc.’s ISS Governance Services said today. Xerox Corp. CEO Anne Mulcahy shouldn’t be re-elected because she sits on more than three boards, which may limit her effectiveness, the group said.

'The pattern of chronic oversight failure at Citi and the magnitude of the corresponding shareholder losses warrant removal from the board of directors most responsible for risk oversight,' RiskMetrics said in the statement.

Furthermore,

'Despite the fact that the board has many incumbent directors that have been successful in their respective fields and have been on the board for some time, their track record taken as a whole is dismal given that the company is currently surviving on federal assistance,' RiskMetrics said.

Rick Conrad, of the Seeking Alpha blog, thus berated the CEO of Citigroup at its 2009 shareholders meeting,

Mr. Armstrong, who has been a director since 1989 is no longer part of the Audit Committee, as of this year, continues his 'service' to our Company on the Nomination as well as the Compensation Committee. Much as this company has suffered under an illusion of prosperity, it appears to continue to suffer under an illusion of competence.

John [Deutch] has served on the Audit Committee of our Company since 1997 and hence, likely drank the Kool-Aid as to the Illusion of Prosperity.

I note that the audit and risk management committee has many members who, like Mr Deutch and MrArmstrong presided over this seemingly out of control disaster.

Andrew Liveris since 2005 on Audit

Ann Mulcahy since 2007 on Audit

Dr Judith Rodin since 2004 on both Executive and Audit Committees.

Overlaps Among Citigroup's Board and Health Care Organizations' Leadership
So there seems to be good reason to believe that the board of Citigroup at the time the firm collapsed were a collective example of inattentive goverance and poor stewardship. We have previously documented overlaps among poor governance and leadership of finance, and the governance and leadership of health care, suggesting that the poor leadership and governance of the latter may be in part a result of infection from the former. So I looked for overlaps among the Citigroup board and health care organizational leadership.

A list of the membership of the failed board comes from the 2008 Citigroup proxy statement.  The biographies provided therein, supplemented with some Google searching, produced the following overlaps:

- C Michael Armstrong - is also Chairman, Johns Hopkins Medicine, Health Systems and Hospital

- Alain J P Belda - was a Trustee and member of the Corporation of Brown University (including the Warren Alpert Medical School) (see link).  (He stepped down prior to 2009 at an unknown time.)

- Sir Winfried Bischoff, Chairman of the Board - is a director of Eli Lilly and Co.

- Kenneth T Derr - is a director of the University of California San Francisco Foundation.

- John M Deutch - no overlap found

- Roberto Hernandez Ramirez - no overlap found

- Andrew N Liveris - is a Trustee of Tufts University (including the School of Medicine and Tufts- New England Medical Center)

- Anne M Mulcahy - in 2009, was appointed to the Board of Directors of Johnson and Johnson (see link)

- Vikran S Pandit, CEO - is a Trustee of Columbia University (including the College of Physicians and Surgeons and Columbia University Medical Center)

- Richard D Parsons - is a Trustee of Howard University (including the College of Medicine and Howard University Hospital)

- Judith Rodin - is President of the Rockefeller Foundation

- Robert E Rubin - is a member of the Harvard Corporation (including Harvard Medical School and multiple Harvard teaching hospitals), and a Trustee of Mount Sinai Medical Center

- Robert L Ryan - was a director of UnitedHealth Group, is a Trustee of Cornell University (including Weill Cornell Medical College, and Weill Cornell Medical Center), and was a Senior Vice President and CFO of Medtronic

- Franklin A Thomas - no overlaps found

Summary

So in summary, of 14 board members, 2 are trustees of major medical centers (Johns Hopkins and Mount Sinai), 6 were or are trustees or equivalent of universities that include medical schools and medical centers (Brown, Tufts, Columbia, Howard, Harvard and Cornell), one is a trustee of such a university's foundation (University of California San Francisco Foundation), 2 are or would be board members of pharmaceutical corporations (Eli Lilly and Johnson and Johnson), one was a board member of a commercial managed care organization/ health insurance company (UnitedHealth), one was a former top executive of a medical device company (Medtronic), and one is the President of a large charitable foundation which historically has supported multiple medical and public health initiatives (Rockefeller Foundation).  Only 3 of 14 did not have a major leadership role of a health care organization.  

Most of these health care organizations have been involved with cases we have discussed on Health Care Renewal (see links above).

Given the seriousness of the failure of Citigroup, one has to wonder why so many of the directors who presided over it still have such influential positions in health care organizations?

As we have pointed out, as the world economy was driven to near ruin by "masters of the universe," some of the same also became leaders of academia and academic medicine in their spare time. Maybe this made sense 10 or 20 years ago, but why does it still make sense? On the other hand, now that we understand how bad the leadership of finance really was, it is a little easier to understand why the leadership of health care has become so bad. Iit seems reasonable to hypothesize that some of the problems of academia, and particularly the problems of medical academia, may have been at least enabled by leadership more used to working in an increasingly amoral marketplace than to upholding the academic mission.  The failures of the leadership and governance of finance thus suggest we need to re-examine the leadership of health care.

A Short, Pithy, Open Letter to the National Coordinator for Health IT Dr. David Blumenthal

Sent: Wednesday, April 21, 2010 7:17 AM
To: David.Blumenthal@hhs.gov
Cc: fschulte@huffpostfund.org; 'Ross Koppel'; 'Justin Starren'
Subject: Re: "As Doctors Shift to Electronic Health Systems, Signs of Harm Emerge"

Dear Dr. Blumenthal,

In the Apr. 20, 2010 article "As Doctors Shift to Electronic Health Systems, Signs of Harm Emerge" at http://huffpostfund.org/stories/2010/04/doctors-shift-electronic-health-systems-signs-harm-emerge#ixzz0ljMzNOzD you are quoted as saying that:

"... CPOE alert and decision support features make doctors better ... CPOE is critical to the success of the electronic health records initiative. We need to support it and make sure it happens. How fast and in what form remains to be seen."

I have written that our approaches to IT in medicine lack the scientific approach we use in medicine itself. The foundation of that approach is the use of evidence.

Yet the evidence base is increasingly shedding doubt on statements such as yours, including studies and articles I've been compiling at http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009 . This growing corpus of literature suggests these statements may be premature regarding the health IT experiment.

I also share a belief that HIT potentially holds great promise towards improving healthcare quality, safety and costs. However, my beliefs are based on my experiences developing such technology for highly specialized clinical settings, but specifically not based on my experiences with commercial HIT upon which your office is leading a multi-billion dollar spending frenzy. My experiences with that sector have been disappointing as I have repeatedly documented at the Healthcare Renewal blog of the Foundation for Integrity and Responsibility in Medicine.

As we enter the second decade of the 21st century this potential has been largely unrealized. Significant factors impeding HIT achievement have been false assumptions concerning the challenges presented by this still-experimental technology, underestimations of the expertise essential to achieve the potential benefits of HIT, and the current orthodoxies around leadership for this grand social reengineering experiment.

The enabler and driver of these factors has been a lack of critical thinking about the technology, about social informatics and its implications, and a marketing and HIMSS driven 'irrational exuberance.'

We really need to return to critical thinking and to a scientific approach to our evaluations and prognostications about HIT.

With that in mind, please show us the hard evidence, now, that would support such statements, or please stop making statements to an unwitting medical audience and public that "CPOE is critical to the success of the electronic health records initiative."

Such statements sound more and more like marketing, not the measured statements on experimental technology I would expect to hear from a Harvard physician-scientist.

-- SS

Another Echo of the Case of the Deadly Heparin - A Report on the Perils of Out-Sourcing Drug Production

In 2008, we published multiple posts on how heparin made as an "active pharmaceutical ingredient" in China under apparently primitive conditions, contaminated accidentally or deliberately, was sold in the US bearing the label of a large American pharmaceutical company.  Ultimately, many patients were sickened, or died.  A summary of our posts on the topic, in smaller type, is below.

Case Summary

- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.

- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.

- Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.

- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.)

- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible.  (See post here.)

- Hundreds of lawsuits against Baxter have now been filed, so far without resolution.  (See post here.)

Now, as reported to date only on the PostScript blog, a US government report on problems with active pharmaceutical ingredients made in China has appeared.

A new report (pdf) by the U.S. China Economic and Security Review Commission stresses the safety risks to Americans posed by pharmaceutical ingredients made in China.

According to the report, issued by a group that advises Congress on the economic and trade implications of U.S.-China relations, found that the U.S. is the number one destination for Chinese pharmaceutical raw material exports – a $2.2 billion business each year. The U.S. relies heavily on Chinese products not only for over-the-counter drugs but for active pharmaceutical ingredients (API) found in prescription drugs.

And the report makes clear that China has neither the will nor the systems in place to monitor its exports.

This begs the question that most of the coverage of the deadly heparin also begged.  Are American pharmaceutical companies so besotted with the need for cost-savings that they are willing to buy active pharmaceutical ingredients with unknown provenance overseas as if they were a pig in a poke?  If so, why do we allow company leadership to potentially sacrifice quality, and sell adulterated drugs just to enrich their bottom lines (and their executives' salaries)? 

Cerner - Fuqua School of Business 'Corporate Ethics 101' Paper and Website Disappear

On April 16 at "Healthcare IT Corporate Ethics 101: A Strategy for Cerner Corporation to Address the HIT Stimulus Plan" I wrote about a Duke Fuqua School of Business paper (apparently authored by a Cerner official) promoting a business strategy of regulatory manipulation to restrain the free market for HIT products.

The paper, and the Fuqua School of Business web page "Past Papers" on which the paper was promoted, have both disappeared as of this April 18 writing.

I have posted an image of the "Past Papers" page and updated my link to an archived copy of the paper, but the scrubbing of the Fuqua site and removal of the paper is interesting.

-- SS

Addendum Apr. 19 -

A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my academic site dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's.

If so, so be it. Who else might be on that blacklist, I wonder?

Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee

I have never before seen a document like the one entitled "Health Information Technology Basics", by the Institute for Health & Socio-Economic Policy, California Nurses Association and the National Nurses Organizing Committee. It is available at this link (PDF).

It is long but contains rather interesting views on the issue of health IT, management and clinicians (nurses).

I find the following passages of particular interest as they reflect views we express on this blog, and attack the notion of cybernetic miracles being wrought:

Skill is the ability, drawn from education and experience, to do something expertly. It can also be defined as the effective exercise of professional judgment in non-routine situations.

Following prescribed rules, as a machine would, makes an employee competent to perform tasks, but it doesn’t make the employee skilled. They can do their job as long as there are no surprises. But when something unexpected happens, the rules break down, and caring for patients means facing the unexpected every day. Only skilled health professionals can cope with the unexpected. To know what to do, they have to rely on their own judgment. The exercise of judgment is the essence of skill.

... Much health information technology is skill-degrading. As the work of health professionals becomes increasingly automated, they lose the ability to do their jobs without HIT. To make matters worse, they’re expected to keep pace with machines. They serve the machines rather than doing the more gratifying work of patient care, and ultimately they’re compensated less well.

And this:

Displacement [pf people by machines] is hard to spot because it’s unlikely to appear as a one-to one correspondence; that is, you probably won’t find a robot sitting in your colleague’s chair tomorrow. It’s more likely to happen piecemeal, over an extended period, and through attrition.

• The job of patient care will be redefined, privileging technical over clinical skills.
• The hospital will begin to hire more HIT specialists and fewer RNs.
• Functions performed in the past by health professionals will be fragmented and reallocated between machines and less-skilled employees.
• Increased technical efficiency will enable the hospital or HMO to expand without expanding its workforce.

And this:

Use of any hospital technology must be consistent with safe, therapeutic, and effective patient care. Health information technology is a complete unknown in this regard. It’s an enormous social experiment designed by computer scientists and implemented by hospital administrators. HIT hasn’t grown organically from the needs of patients but has been imported from other industries. Known as enterprise resource planning, it’s adapted from similar technology designed to manage business operations on a massive scale and already being used to run the world’s largest corporations.

Caring for patients isn’t business. It requires compassion, judgment, and advocacy. Because RNs have the moral right and legal duty to advocate for patients, they have to be able to override the automated decision-making of HIT designed to serve business interests.

RNs have to work collectively to control health information technology rather than trying to fix it. It’s important to recognize that tinkering can’t fix HIT because its primary purpose is to mechanize, or routinize, patient care. It’s designed to quantify the unquantifiable, to replace the patient with an imaginary statistical norm. High-quality healthcare can’t be mechanized because it depends on people—on patients and caregivers—and people are infinitely more complex and capable than computers can ever be.

Amen to that.

Read the entire document for a union-oriented view of health IT. It contains many truisms regarding HIT irrational exuberance and the control issues of the healthcare management class.

-- SS

If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers

In 2005 the RAND corporation ‘guesstimated’ figures for healthcare IT benefits based on existing, limited data sets (http://www.rand.org/pubs/research_briefs/RB9136/index1.html).

Their methods and results were contested, such as by the Heartland Institute (as here). Recent studies also put the RAND assumptions including those about flawless implementation and acceptance in serious doubt (as here).

Similarly, the often-quoted 2000 Institute of Medicine (IOM) report "To Err is Human" used several small studies to extrapolate a death rate due to medical mistakes at 98,000 per year. That report was challenged by medical informatics pioneer Clement McDonald, MD in a 2000 JAMA article "Deaths Due to Medical Errors Are Exaggerated in Institute of Medicine Report" here, PDF.

However, the refutation didn't stop anyone who could benefit from quoting such numbers from touting them, including those pushing healthcare IT. In fact figures such as these have been used as a bludgeon to affect national policy on healthcare IT.

If the benefits of HIT can be guesstimated, so can and should the dangers.

The true incidence of health IT-related medical errors, injuries and deaths from IT error, poor design, cognitive overload, clinical disruption, etc. is unknown. The Joint Commission in its 2008 Sentinel Events Alert advised that "There is a dearth of data on the incidence of adverse events directly caused by HIT overall" (as here).

As a thought experiment, presented here are some estimated corrective factors that might shed some light on the actual figures for HIT-related injuries and deaths "on the ground" when national, universal HIT deployment is achieved.

The thought experiment:

Jeffrey Shuren, MD, JD of FDA mentioned reports of 44 injuries and 6 deaths over 2 years that are likely the "tip of the iceberg" at the Feb. 25, 2010 HIT Policy Committee Adoption/Certification Workgroup on IT safety (http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html).

Ross Koppel, PhD at the same Feb. 25 IT safety conference opined that "We don't know 99 percent of the medication ordering errors that are made [due to difficulty in recognition, lack of proper studies and other factors - ed.]. If 100 percent of the known errors were reported, that would be 1 percent of the [true] total. But the data suggests that the maximum on voluntary reporting is about 5 percent. So 5 percent of 1 percent that is what we know is reported...."

Now, some estimated corrective factors:

• Due to a severe lack of awareness by physicians and healthcare organizations of FDA as a "go-to" organization to whom to report HIT-related medical errors and harm, let us assume FDA is privy to only 1/100 of the known injuries and deaths due to HIT (mostly reported locally). That's probably a conservative figure. Corrective factor = 100x

• Based upon figures from "Electronic Health Records in Ambulatory Care — A National Survey of Physicians", NEJM 359:50-60, July 3, 2008, let us roughly estimate that 10% of doctors/organizations are using HIT "meaningfully" (or better term, "in good faith") in 2010. Corrective factor for HIT-related errors that cause harm = 10x for universal use nationwide.

• Per Koppel, only a maximum of 5% of medication errors are voluntarily reported at all. Assuming similar figures for [medication and other] HIT-related errors that cause harm, corrective factor = 20x

• In approximating the actual number of HIT-related medication errors based on reported numbers, we would need to multiply reported figures by 100x per Koppel (since only 1% of HIT-related medication errors are recognized as HIT-related). However, from the JC Sentinel events alert figures from the United States Pharmacopeia MEDMARX database from 2006, only 1.25% (i.e., approximately 1%) of medication errors actually cause harm, so reported figures on medication errors require no corrective factor regarding patient harm (corrective factor for HIT-related medication errors that cause harm = unity = 1x).

• Although the learning curve never becomes flat in part due to clinician unfriendliness of the software, newcomers to HIT will for a number of years be more error-prone and experience more HIT-related adverse outcomes than experienced users and organizations. Conservatively assume a corrective factor = 2x.

Overall, that creates a corrective factor of 100 x 10 x 20 x 2 = 40,000

Multiply the FDA figures per year (22 injuries and 3 deaths) by this factor = 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved.

Merely multiply by 4,000 for a guesstimate of current figures at ~10% diffusion.

This assumes no major changes occur with regard to the technology's risks, such as via the accelerated interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering recommended by the National Research Council in their Jan. 2009 report on HIT (http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572), and via other studies and improvements that might be made.

The way this industry operates, however, e.g., as in my post "Healthcare IT Corporate Ethics 101", the National Research Council-recommended changes are unlikely in the near future.

While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events.

In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently.

-- SS