"Good Managers" And Complex Technological Projects - Recipe for Poor Results?

Once more on the topic of CIO’s and other health IT leaders lacking in solid healthcare informatics and clinical credentials, there’s this letter in today’s WSJ that I think says it all about complex technological projects, including (perhaps especially) healthcare IT.

Emphases mine:

Wall St. Journal
Letter to the Editor
Dec. 16, 2010

Manhattan Spirit for Cyber Defense

In “How to Fight and Win the Cyberwar” (op-ed, Dec. 6), Mortimer Zuckerman uses the analogy of the Manhattan Project to build the atomic bomb in World War II and suggests forming a “Cyber Defense Administration” (CDA).

We need to keep in mind how the Manhattan Project managed to succeed in achieving its objectives. The direction and top management of the project was by scientists like Robert Oppenheimer, who understood the scientific details of the project, and project director Gen. Leslie Groves, who made sure the scientists got what they wanted. This is not like any bureaucracy in the U.S. government today.

I would visualize a CDA more as a TSA- or EPA-type bureaucracy with a politically sensitive lawyer or bureaucrat at the top, and having to go down two or more administrative levels before you find the first Ph.D.-level computer scientists with a history of serious research and publications in computer/network security. The head of the CDA would probably be clueless about the computer science details and would have no basis for making rational decisions. This is a field where the devil is in the details, and to truly understand those details requires much more than bureaucratic and political skills.

Whoever created the Stuxnet worm that attacked Iran’s nuclear program’s computers probably was not managed by a bureaucrat, but by a team of very high-level scientists who clearly understood the details. Countries like China often have real experts running their organizations, not just politically smooth bureaucrats who go from job to job with a false theory that a “good manager can manage anything.”

In reality, especially in a field like cyber security, a good manager can only manage what he understands. Our bureaucrats will lose the cyberwar against scientists who understand the details.

Dallas Weaver

Huntington Beach, Calif.

It is a bureaucratic conceit to think that a "good manager" can manage major healthcare IT projects - or pharmaceutical companies - or anything else outside their core competencies.

This holds true even assuming, at best, that one of their "core competencies" is competency itself (warning: PDF on the Dunning-Kruger effect on illusory superiority).

-- SS

New York Times: Panel Set to Study Safety of Electronic Patient Data

New York Times author Milt Freudenheim has published an interesting article on health IT:

"Panel Set to Study Safety of Electronic Patient Data" (Dec. 13, 2010, link)

In the article Mr. Freudenheim presents various viewpoints on health IT safety and usability, and reports on an upcoming Institute of Medicine (IOM) Committee on Healthcare IT safety.

In general, the expressed viewpoints reported upon are consistent with the position in the Healthcare IT Ecosystem of those quoted. I wish to add some commentary to a number of those stated positions.

Mr. Freudenheim observes:

Taking a fresh look at such concerns, the Institute of Medicine created the Committee on Patient Safety and Health Information Technology to run a yearlong study and issue recommendations. The 16-member panel is meeting for the first time on Tuesday in Washington.

(This new IOM Committee is in addition to a 2009 study by the National Academies/National Research Council that concluded that "Current Approaches to U.S. Health Care Information Technology are Insufficient", which has largely been invisible. The IOM is the health arm of the National Academies.)

I would add that this Committee is at least a decade late. That it is occurring at all seems to be at the behest of a multitude of complaints and "blows of the whistle" from clinicians who increasingly depend (either voluntarily or by coercion) on this technology to provide safe care.

I would also add that it is my hope the IOM committee with not be overly politicized, considering the stated unconditional exuberance of the past two administrations towards health IT, and that a wide variety of stakeholders will be heard. (For instance, as a medical informatics specialist whose relative was injured as a result of HIT interference with care continuity, will I be allowed to testify?)

Mr. Freudenheim then relates the points of view of stakeholders.

In February, the F.D.A. said it had received 260 reports of malfunctions related to health information technology “with the potential for patient harm,” including 44 reported injuries and six reported deaths in 2008 and 2009. The malfunctions were reported voluntarily to the agency, mainly by hospitals.

“Because these reports are purely voluntary, they may represent only the tip of the iceberg,” said Dr. Jeffrey Shuren, a senior F.D.A. policy and enforcement official.

I'd written about this at "FDA on Health IT Adverse Consequences: 44 Reported Injuries and 6 Deaths, Probably Just Tip of Iceberg" where I noted:

This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters.

Healthcare IT irrational exuberance can perhaps be illustrated in statements such as this:

“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - 2005 HIMSS Summit

I also opined at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" that one could, as a type of thought experiment, extrapolate from these numbers to guesstimate the effects of universal health IT in the US. The results were startling, even if just an experiment:

[We might have] 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved ... 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.

Unfortunately, national policy has been set up to now on wishful thinking. As I stated, the IOM meeting is coming none too soon.

The NYT article then reports on a statement made by ONC Chair David Blumenthal:

“All options for assuring safety are on the table,” said Dr. David Blumenthal, the Obama administration’s national coordinator for health information technology.

Yet Dr. Blumenthal is clearly an adherent to unbridled exuberance about health IT. At "Science or Politics? The New England Journal and the 'Meaningful Use' Regulation for Electronic Health Records" I wrote:

... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

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.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

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.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. [Followed by a list of such literature just off the top of my head - ed.]

Dr. Blumenthal then appeals to authority:

Dr. Blumenthal said health information experts like Dr. Donald M. Berwick, the Medicare and Medicaid administrator, and Dr. Brent James, of Intermountain Healthcare, based in Salt Lake City, “agree that electronic health records will improve the safety of care.”

I am unaware of the expertise of Dr. Berwick and Dr. James in this domain, and the peer reviewed literature they've written that supports such a statement while soundly refuting literature written by other experts that indicates otherwise.

(Perhaps at Intermountain, custom systems that took decades to develop utilizing their Medical Informatics expertise do show safety gains, but such systems and the lessons learned building them are not easily portable to a country's worth of organizations and practitioners, especially under HITECH timeframes.)

Freudenheim then quotes Blumenthal as stating:

“At the same time, any time you change the world you create risks,” Dr. Blumenthal said in a telephone interview last weekend.

This sounds typical of utopian ideology. Yes, any time you change the world you create risks, but you should not attempt to change the world cavalierly and blindly to those risks. (That's the path the National Program for Health IT in the United States has been on, until the IOM meeting was called.) Idealists tend to believe the collateral damage that is caused by utopian experiments (e.g., communism) are a necessary sacrifice to achieve the utopia. Such values are both abhorrent and alien to medicine.

“We want to make sure that implementation is as safe as it can be and all safety benefits are realized.”

Blumenthal's been painted into a corner by tons of complaints on HIT safety; ONC must act, even if just putting on a show about safety considerations. If there were true concern for safety he'd recommend slowing down HITECH timelines until the industry gets its act together and our understanding of HIT usability, safety, and other issues is resolved; cf.: statements of HIMSS leaders on 'needing to be patient' for the industry to get healthcare IT right:

As I'd written about HIMSS admissions of health IT unsuitability to task at "NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education":

... What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

Further, from the NYT article:

He [Blumenthal] said that if the Institute of Medicine “concludes that regulation is an important part of this fabric of assuring safety, we will want to balance regulation and innovation as we do in every marketplace.”

That he even needs to make such a statement is likely revealing of biases on regulation, which seem aligned to the industry. To wit:

“The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive vice president of Epic Systems, which has built electronic records systems for Kaiser Permanente and other large health care and hospital groups.

There is a lack of evidence supporting such a statement (e.g., pharma has been regulated for decades, as is its clinical IT). The fact that NIST has just delivered Computer Science 101-level usability guidelines to the HIT industry in its recent report “NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records” to help solve the HIT unusability crisis also suggests that 30+ years of un-regulation did not facilitate ‘innovation.’

In fact 'unregulation' appears to have led to prima facie innovation failure and paralysis as far as usability is concerned.

Unusable health IT might as well not exist as far as clinicians are concerned. It is a menace to the safe practice of medicine. This is a first principle.

Per the NYT, the industry trade group HIMSS has gone mum:

The industry has recently avoided speaking out on a role for the F.D.A. In a statement for this article, the Healthcare Information and Management Systems Society, a Washington-based industry group, said only that it “supports the administration’s decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months.”

They are certainly not taking a leadership role on this issue. In my humble opinion they will allow regulation, only kicking and screaming and being dragged into it by force. Patients come second to profits - the only factor that will be "stifled" as vendors are coerced to make better products.

The NYT article goes on:

Last month, in protest of one common industry practice, the American Medical Informatics Association said “hold harmless” clauses in many purchasing contracts were unethical. The clauses typically absolve manufacturers of responsibility for any errors or misuse.

“We said we value innovation, but we don’t value it more than safety,” said Kenneth W. Goodman, a University of Miami bioethicist who headed an association advisory group on patient safety.

It took a lot of writing and politicking to get AMIA to this point as well, at least to express it openly (cf.: my efforts here).

Finally, with regard to the IOM meetings on HIT safety, there will be industry stakeholders in attendance such as CCHIT and EPIC.

I believe they should be held to scientific standards of delivery. If they deliver marketing-based spin, they should be called to present scientific evidence for their stance – and not just “positive” evidence. They should be made to refute “negative” evidence as well, not ignore it.

In summary, I welcome the New York Times bringing these issues to the public.

I also welcome IOM's entry into studying HIT safety. While a "Committee on Patient Safety and Health Information Technology" should have been convened years ago, it's better late than never. (Except for patients already injured or killed, of course.)

The results may remain as invisible as the aforementioned National Research Council study. I also doubt the Committee's findings will change hearts and minds. Idealism, profit motive, and irrational exuberance are hard to rectify.

But their effects on people's behaviors can - and should - be regulated.

-- SS

The Lancet Emphasizes the Threats to the Academic Medical Mission

We just discussed an important article in the Lancet calling for major global reforms of health care education.(1)  An accompanying editorial(2) argued for the critical importance of upholding the mission of higher education, because that mission is critical to human civilization:

Louis Menand has investigated the current role of the modern university in his startlingly powerful book, The Marketplace of Ideas. Menand argues that: 'The pursuit, production, dissemination, application, and preservation of knowledge are the central activities of a civilisation.' More importantly still, 'the ability to create knowledge and put it to use is the adaptive characteristic of humans'. The goal of the university is 'to make more enlightened contributions to the common good'.

The editorial argued strongly for the revitalization of the university's mission:

'It is the academic's job in a free society to serve the public culture by asking questions the public doesn't want to ask, investigating subjects it cannot or will not investigate, and accommodating voices it fails or refuses to accommodate.'

The education of doctors, nurses, and public health workers must seek to: strengthen the overall intellectual culture of a society; define principles for public aspiration; give life to and enlarge the best and most proven ideas of the age; refine the grounds for the private exchanges that take place in our lives; facilitate the exercise of political power; and enable professionals to detect what is important and discard what is irrelevant, accommodate oneself with others, have common ground between colleagues across societies, ask good questions and find the means to answer them, and have the resources to adapt to national and global circumstances. Some readers might recognise that these words are adapted from John Henry Newman's On the Scope and Nature of University Education.

In England, Newman argued for the university as a centre of intellectual liberty, a vital force for progress in society. Menand writes about the university as a 'zone of autonomy'. The importance of tertiary education as a means to advance health, reason, democracy, and justice needs to be rediscovered.

But arguing so forcefully for upholding the academic mission makes sense only if that mission is under threat. The Lancet editorial only briefly alluded to why this might be:

What this Commission argues for is nothing less than a remoralisation of health professionals' education. For decades, health professionals have colluded with centres of power (governmental, commercial, institutional, even professional) to preserve their influence. The result? A contraction of ambition and a failure of moral leadership.

While the original article by Frenk et al suggested that health professionals' education has shortcomings, it did not argue that the academic mission is threatened.  Although the message of the accompanying editorial is that the mission needs a strong defense, it did not clearly explain the extent of the threat to it. 

However, this blog, Health Care Renewal, is largely concerned with threats to health care's core values, including threats to the mission of academic medicine, largely from concentration and abuse of power.  The largest set of threats come from the ascendancy of financial goals amidst the commercialization of health care (mentioned briefly both in Frenk et al and the editorial).  We have discussed the nature of the threats in detail.  For example,

• Abandonment of traditional prohibitions of the commercial practice of medicine - In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts  here and here.
• Making money takes precedence over education -  A recent survey showing that more than half the faculty at multiple US medical schools felt they were valued more for how much money they brought in than their teaching or patient care abilities (here), confirming previous anecdotal reports (see here). 
• The medical school re-imagined as a biotechnology company -  In 2000, a Vice President of the American Association of Medical Colleges(3) wrote that research universities must respond to "societal demands that they become engines of economic development…."  Many universities now defend lax conflict of interest policies with similar arguments.  For more details, go here.
• Faculty become employees of industry - For numerous examples of this and other kinds of conflicts of interest, go here.  A survey by Campbell et al suggested that approximately two-thirds of medical academics get significant payments from industry.(4)
• Academics become "key opinion leaders" paid to market drugs and devices - Marketers regard "key opinion leaders" as salespeople who appear more credible because of their professional guise.  See anecdotal evidence here.  
• Control of clinical research given to commercial sponsors - A study by Mello et al showed how universities' grant administrators are willing to sign contracts giving commercial sponsors control over key aspects of human research studies.(5)  See post here. 
• Conflicts of interest allow manipulation and suppression of clinical research - Commercially sponsored research design, implementation, and dissemination are often manipulated to favor the sponsor's interests.  When such manipulation fails to produce favorable results, the results may simply be suppressed.
• Academics take credit for articles written by commercially paid ghost-writers - Such ghost-writing is often part of organized stealth marketing campaigns. 
• Whistle blowers are discouraged, or worse, and academic freedom is damaged.  Discussion of some examples of what may happen to whistle blowers is here.  The survey mentioned earlier (here) showed that about one-third of faculty fear they may be punished for speaking  out. 
• Leadership of academic medical centers by businesspeople - Ill-informed management may result from leaders who have no background or training in actual health care. 
• Leaders of teaching hospitals and universities become millionaires -  A recent example is here, and more may be found here.  Leaders of academic medical centers and the parent universities of medical schools often make more than $1 million a year in the US.  When such amounts are in play, executives may focus more on short-term measures that lead to even more pay than on upholding the mission. 
• Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - A recent example is here, and a summary of how we discovered this phenomenon in 2006 is here.   The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see here and here).
• Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, recently here, here, and here, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities.  Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance. 

So the threats are real and substantial.  However, their scope generally generally gets little attention.  Even when specific threats appear in the academic literature, their importance may be soft-pedaled, and their confluence with other threats ignored.  Of course, trying to discuss the full breadth and depth of these threats, as we endeavor to do on this blog, threatens in turn those who have personally profited from the current system.  Hence, we frequently cite the anechoic effect, the phenomenon that important threats to health care's core values are often just not discussed in polite company.

Therefore, we applauded the article by Frenk et al for concatenating some of the most important challenges to health care professionals' education, and we now applaud the Lancet editorial for emphasizing the threat to the academic medical mission.  We hope that these two articles, appearing in one of the most prestigious and well-read medical journals, will help to combat the anechoic effect.  Meanwhile, we will continue to blog about threats to core values in the hope that discussing them will lead to solutions.
References

1.  Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T et al. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world.  Lancet 2010; 376: 1923-1958.  Link here.
2.  Horton R. A new epoch for health professionals' education.  Lancet 2010; 376: 1875-7.  Link here.
3. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. Link here.
4. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Llink here.
5. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.  Link here.

"Health Professionals for a New Century": Calling for "Ethical Conduct," a "New Professionalism," and Improved "Stewardship" and "Social Accountability"

A major article just published in the Lancet urged global reform of health care education  [Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T et al. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world.  Lancet 2010; 376: 1923-1958.  Link here.]

The problems it recognized included

• "Pitifully modest" spending for health professional education, compared to overall health spending
• Health care systems that are "dysfunctional and inequitable," due in part to "commercialism in the professions," leading to "breakdown ... especially noteworthy within primary care, in both poor and rich countries."
• For profit medical education leading to "a so-called de-Flexnerisation process ... in which low-quality professional schools might be proliferating...."
• Health care corruption, e.g., "the Indian press has reported illegal payments by new private schools seeking accreditation...."

The solutions it advocated included
- Fostering "ethical conduct" by professionals, developing a "new professionalism," earning trust "steered by ethical commitment and social accountability."
- Improving "stewardship mechanisms, including socially accountable accreditation"

It is nice to be in such good company.  While the report was written in the subtle, diplomatic language of international public health, it was the only such authoritative report to appear in a widely circulated, highly respected medical journal that I can recall that was this direct about the seriousness of such problems.

In fact, not only is little spent on actual medical education within academic medical institutions, but faculty members are valued more for the money they bring in than for their teaching.  Commercialism in health care has been institutionalized in the last 30 years (for discussion of its history in the US, look here, here, and here.)  The Transparency International Global Corruption Report of 2006 asserted "the scale of corruption is vast in both rich and poor countries," yet has gotten almost no notice in medical, health care research, and health care policy circles.  In 2009, the US Institute of Medicine published a detailed report including fairly strong recommendations on Conflict of Interest in Research, Education and Practice.  The anechoic effect, however, has dictated that discussion of striking examples of mission-hostile management, conflicts of interest, and outright crime and corruption is simply not done, especially in medical, health care, or health policy venues and journals.  The 2006 TI and 2009 IOM reports have infrequently been cited, and their recommendations have widely been ignored.

I do hope that the appearance of a publication as authoritative as the article by Frenk et al leads to some soul-searching by the leaders of health care around the world.  They need to realize that despite the article's measured tones, the problems really are severe, and even more broad than the article implied.  We have discussed in detail how health care education (and all of health care) are hurt by concentration and abuse of power, by governance that lacks accountability, integrity, and transparency; by leadership that ignores the context, core values and mission, promotes self-interest and conflicts of interest, and sneers at ethics; and by results such as suppressed and manipulated research, deceptive and dishonest education (look here, here, and here for examples), stifling of academic freedom and whistle-blowers, then dissatisfied, burned out faculty (here), and finally the final common pathway of rising costs, declining access, and poor quality.  

It is heartening that the importance of our concerns has been corroborated in such a notable venue.  I hope this report gathers less dust than the 2006 Transparency International Global Corruption Report and the 2009 Institute of Medicine conflict of interest report.

I suggest that to truly reform health care education (and health care itself), we will have to attend to the sorts of problems we write about on Health Care Renewal.  On one hand, we will need to improve the stewardship, governance, and leadership of health care education itself, and reduce the pervasive conflicts of interest that ensnare the faculty.  On the other, we will need to make sure education prepares students to deal with these problems in health care at large.

It would be nice if the appearance of the Lancet article signifies that help will soon be at hand to tackle the huge amount of work that needs to be done, in the face of likely withering opposition from those who have enriched themselves from the dysfunctionality of the current system.  We at Health Care Renewal will continue to try to draw attention to these issues, accompanied I am sure by our fellow bloggers (as are listed in the right hand column).  However, a small group of voluntary "citizen journalists," and health care professional curmudgeons cannot solve this problem on our own. I hope we will soon have some more support.

ADDENDUM (14 December, 2010) - See also comments by Paul Levy on the Running a Hospital blog.

NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education

The National Institute of Standards & Technology (NIST) has published a guide entitled:

NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records

It is available free at this link in PDF: http://www.nist.gov/itl/hit/upload/Guide_Final_Publication_Version.pdf (hat tip to an AMIA colleague for posting the URL on an AMIA mailing list.)

The NIST was commissioned by HHS/ONC to study Health IT issues such as usability and report on them.

I find the publication both welcome, and pitiable.

As I started to read ch. 6, for example, I observed material that is suitable for undergraduate computer science instruction:

6. User-Centered Design Process in EHRs

User-centered design is a bedrock principle for creating usable systems and devices. [You don't say? - ed.] One of the most common reasons why systems are poorly designed is that designers and developers fail to engage users in appropriate ways at appropriate times. [Hear that, my young Paduan learners? - ed.] At its core UCD is a process that relies on systematic understanding of users and their environments, and iterative design and testing based on user performance objectives. (Details on usability testing are provided in Section 9.)

UCD has been shown to be effective in many fields. In aviation, for example, this method has been used to develop cockpit navigation displays for low-visibility surface operations. [22] By taking the limitations and capabilities of the flight crew into account, navigation errors have decreased by almost 100%. The adoption of UCD has also been shown to be effective in the design of personal computers. When working on a redesign of the laptop computer, a UCD process was employed. Users were asked to offer feedback about the current model and to offer input about ways to improve the current design. User-centered design was successful in increasing market share, brand equity, and customer satisfaction. [23] In fact, user-centered design has been elevated to an ISO standard. [24] UCD serves to engineer improved human performance into a system or device, and has been crystallizing for several decades as a design philosophy. [25]

While there is no singular model of UCD, the instantiations embody the following principles:

• Understand user needs, workflows and work environments
• Engage users early and often
  
• Set user performance objectives
• Design the user interface from known human behavior principles and familiar user interface models
• Conduct usability tests to measure how well the interface meets user needs
• Adapt the design and iteratively test with users until performance objectives are met

[HHS needs ONC to commission NIST to provide schooling for the HIT industry on these bons mots? - ed.]

As an iterative process, UCD is a cycle that serves to continually improve the application. For each iteration, critical points and issues are uncovered which can be improved upon and implemented in subsequent releases. An illustration of the UCD process is included in Figure 1.

"User centered design process in EHR's." Undergraduate-level computer science 101 instruction from NIST for the healthcare IT industry? (click to enlarge)

Here is Figure 1:

User centered design 101 (click to enlarge)

I might even have used this in teaching high school students about computer programming.

Readers can download the entire report at the above URL.

I find this publication, or, rather, the need for it to exist at all in 2010, remarkable. Absurd and an embarrassment, in fact. Master of the Obvious [1] material that apparently was not so obvious to this industry.

This is after all a multi-billion dollar industry making claims its products will "revolutionize medicine" and other exceptional claims (but without exceptional evidence). These claims have been pushed so hard that many tens of billions of dollars (with penalties) have been earmarked to either entice -- or coerce -- physicians and hospitals to use these products.

What has this industry, including vendors and highly paid management consultants and contractors, been doing, exactly, for the past thirty+ years?

What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

That HHS needs NIST to provide undergraduate level remedial teaching to the multibillion dollar health IT industry is a very poignant commentary indeed on the priorities of that industry regarding engineering rigor, talent management, attention to safety, and other factors affecting human lives.

These observations speak strongly to the need for regulation for this industry, for a talent management and trade association shakeup of major proportions, and most especially for an awakening of our government servants to exactly what the real situation is with respect to HIT on the ground.

12/14/10 addendum: it struck me that the Guide might need another chapter. I suggest a chapter entitled:

"Listening to informatics experts when they say your product will kill people, instead of firing them."

-- SS

[1] This was another pithy line from my early medical mentor, pioneering cardiothoracic surgeon Victor Satinsky, MD at Hahnemann Medical College.

On the Interconnectedness of the Leadership of Health Care Organizations: the Abbott Laboratories Case

We just posted about some misbehavior by Abbott Laboratories: a physician Abbott paid as a "key opinion leader" to help market its cardiac stents was accused of inserting stents in many patients who had no need for them; Abbott settled for over $400 million a lawsuit alleging the company defrauded Medicare and Medicaid; and it settled an unrelated suit for over $40 million alleging the company paid kickbacks to physicians for prescribing its drugs.  I thus thought it would be interesting to see how well paid are the corporate leaders who presided over these activities, and who are the board members who were supposed to be providing stewardship of this company.

According to the company's 2010 proxy statement, the five highest-paid executives were:

Miles D White, Chairman of the Board and CEO - $26,213,966 total compensation
Thomans C Freyman, Executive Vice President, Finance, and CFO - $9,561,227
Olivier Bohuon, Executive Vice President, Abbott Pharmaceutica Group - $5,232,589
Laura J Schumacher, Executive Vice President, General Counsel, and Secretary - $5,724,060
James V Mazzo, Senior Vice President, Abbott Medical Optics - $10,394,085

Now, let us turn to the company's board of directors.  Note that I looked for board members who also held leadership positions in other health care organizations whose interests may not be aligned with the corporation.  I also looked for those who held leadership positions in the discredited financial services corporation who helped usher in the global financial collapse.  (I  used similar methodolgy here.)

Abbott currently has 12 board members, including

• Robert J Alpert MD - Ensign Professor of Medicine, Professor of Internal Medicine, and Dean of the Yale School of Medicine.  He also "serves as a Director on the Board of Yale-New Haven Hospital."
• Roxanne S Austin - President and Chief Executive Officer, Move Networks Inc, and President, Austin Investment Advisors
• William M Daley -"Vice Chairman and Head of the Office of Corporate Responsibility and Chairman of the Midwest, JP Morgan Chase & Co."  He is the board of directors of  "Loyola University of Chicago and Northwestern University."
• W James Farrell - Retired Chairman and Chief Executive Officer of Illinois Tool Works Inc
• H Laurence Fuller - Retired Co-Chairman of BP Amoco, former chief executive officer of Amoco
• William A Osborne - Retired Chairman and Chief Executive Officer of Northern Trust Corporation and the Northern Trust Company.  He is "Chairman of the Board of Trustees of Northwestern University."
• Rt Honorable Lord Owen - Chairman of Europe Steel Ltd
• Roy S Roberts - Managing Director, Reliant Equity Investors.
• Samuel C Scott III - Retired Chairman,  President and Chief Executive Officer of Corn Products International.  He "currently serves on the board of directors of Bank of New York Mellon Corporation."  He also is on the board of "Northwestern Healthcare."
• William D Smithburg - Retired Chairman, President and Chief Executive Officer of Quaker Oats Company.  He is on the "board of trustees of Northwestern University."
• Glenn F Tilton - Chairman, President and Chief Executive Officer of UAL Corporation and United Airlines Inc.  He is on the "board of directors of Northwestern Memorial Hospital."
• Miles D White - Chairman of the Board and Chief Executive Officer, Abbott Laboratories, "is on the board of trustees of "Northwestern University." 

Of Abbott's 12 directors, seven have leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities (Northwestern University, its medical school and teaching hospitals, in particular, are stewarded by six Abbott directors). 

Two have leadership positions in  financial services corporations that were implicated in the global financial collapse.  (Note that JP Morgan Chase staffers helped to invent some of the kinds of financial derivatives widely viewed as causative of the collapse, but the firm itself did not fail. [See Tett G. Fool's Gold.]  Through TARP, the US government took preferred equity stakes in both JP Morgan Chase and Bank of New York Mellon.  [See Ritholtz B.  Bailout Nation. p. 222]) 

Two more are leaders of financial services firms.  All but one are current or former high-level hired executives (seven are or were CEOs), or chairpersons or co-chair persons of corporations (the one exception is a dean of a medical school.) 

Note how similar our findings were here to those found after our perusal of the boards of Genzyme and Medtronic (see post here).   So we find again that executives of health care organizations who preside over various questionable activities not only rarely pay any penalty, but usually become extremely wealthy in the process.

We also find how interconnected is the leadership of health care.  The boards and leadership of drug and device companies overlap with the boards and leadership of medical schools, teaching hospitals, and their parent universities. 

Yet, as we have noted before, there are obvious conflicts.  In particular, 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. 

On the other hand, drug and device companies are supposed to put making a profit for their share-holders first.  The directors of such companies, like the directors of all for-profit corporations, are supposed to show an unyielding loyalty to their companies' financial health and profits, although contemporary corporate directors have been accused of acting more like cronies of the hired management.  (See this post.)

Also, we note that the vast majority of people chosen as stewards of a given health care organization are current or former top hired executives of other corporations.  The board members, that is, stewards of health care organizations, to whom the top hired executives reports, are usually not people with large ownership interests in the organizations (in the case of public, for-profit corporations.)  For the most part, they also do not seem to be people with clearly demonstrated devotion to the values of health care, in particular, putting the care of individual patients first, and advancing health care teaching and research.  Instead, they seem to be people with the perspective of hired executives, who may be prone to putting the interests of hired executives, rather than patients, doctors, teachers, scientists or the public at large, first.

So here is another admittedly limited case study of the board of directors, that is, the ostensible stewards of a health care corporation, selected this time because of its history of ethical missteps, which showed  - that the leadership of health care organizations is incredibly interrelated, interlocked, incestuous.  Again, it appears that top leaders of various health care organizations may be more familiar with and identify more with each other, and with other hired executives and managers, than with their organizations, their organizations' missions, and their organizations' professionals, staff, students, clients, and patients.

So to repeat-

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.

Don't Worry, the Feds Say Your Medical Information Will Be Kept Absolutely Private

With the planned burgeoning of health IT nationally and the formation of information "exchanges", ensuring information privacy, confidentiality and security become paramount. Systematic threats to medical privacy, confidentiality and security could do significant damage to our Republic.

Yet, according to Modernhealthcare.com in "Looking to loosen privacy rules in Calif." (Dec. 7, 2010):

The head of a federal privacy and security advisory committee and a lawyer for a prominent consumer affairs organization are scheduled to press California officials this week to revise that state's health information exchange (HIE) guidelines [which have strong opt-in consent requirements -ed.] to conform to less-stringent federal privacy recommendations.

Joseph Conn, author of the article relates:

Deven McGraw, director of the Health Privacy Project at the Center for Democracy & Technology, a Washington think tank, and Mark Savage, a San Francisco-based lawyer for Consumers Union [McGraw is also an appointee to a prominent role in the federally charted HHS Health IT Policy Committee; see below - ed.], are to participate via telephone Thursday in a meeting of the California Privacy and Security Advisory Board [CalPSAB].

Here's the problem:

The CalPSAB advises the state's health secretary on healthcare privacy and security policy. Given the traditional leadership role that California plays in the healthcare industry, the board's recommendations could influence how patient consent is handled in electronic health information exchanges nationwide.

Why these recommendations? To satisfy the needs of the reckless rush to national health IT:

McGraw, a lawyer, is a member of the federally charted Health IT Policy Committee, created pursuant to the American Recovery and Reinvestment Act of 2009 to advise the Office of the National Coordinator for Health Information Technology at HHS. McGraw also serves on five work groups or subcommittees of the Health IT Policy Committee. She is chairwoman of its privacy and security workgroup and co-chairwoman of its privacy and security tiger team. [The name "tiger team" makes me wonder who's going to get mauled - ed.]

McGraw and Savage sent a letter Oct. 6 to California Health and Human Services Sec. S. Kimberly Belshe along with a copy of the tiger team's recommendations on privacy and security for health information exchange originally sent to ONC head David Blumenthal on Aug. 19. They also sent Belshe a 10-page "briefing paper" summarizing those recommendations and a follow-up letter Dec. 5.

The briefing paper urged California to "adopt a comprehensive framework of privacy protections such as that recommended by the tiger team." [I.e., that are less stringent than California's - ed.]

They threw a little fear into their recommendations:

The brief also warned that with the first stage of a federal IT incentive program beginning soon, without a consent policy in place, "California's privacy and security framework for patient health information cannot be completed." Furthermore, if that framework isn't completed, the brief asserted, "eligible providers cannot achieve the meaningful-use criteria and benefit from the substantial federal reimbursements."

In other words, "The feds have rushed you to such a point that you cannot possibly have enough time to seriously consider and put into place rigorous privacy regulation, so adopt our 'tiger team' recommendations (or you ain't gonna get money from the feds)."

This is not reassuring.

Among other issues, it seems another example, as in HITECH itself, of the Federal Government setting timelines and policies and using the "fear, uncertainty and doubt" (FUD) principle to manipulate and strong-arm the States into ceding their rights to regulate healthcare. Such Federal overreach seems to be common these days.

Only now, due to the nature of the data involved, this gets personal.

Listen to us, we're the Tiger Team!

Of course, there's always plausible deniability:

Officially, the ONC is not a party to the push by McGraw and Savage to leverage the federal tiger team's work in California, according to the ONC. Asked whether the ONC was aware of and supports the efforts of McGraw in California, spokeswoman Nancy Szemraj said, "We have no knowledge of this letter."

Again, not very reassuring or credible, considering:

1) as above, that McGraw and Savage sent a letter Oct. 6 to California Health and Human Services Sec. S. Kimberly Belshe along with a copy of the tiger team's recommendations on privacy and security for health information exchange originally sent to ONC head David Blumenthal on Aug. 19.

and:

2) McGraw's role on five work groups or subcommittees of the Health IT Policy Committee:

Health IT Policy Committee (A Federal Advisory Committee)

The Health IT Policy Committee will make recommendations to the National Coordinator for Health IT on a policy framework for the development and adoption of a nationwide health information infrastructure, including standards for the exchange of patient medical information. The American Recovery and Reinvestment Act of 2009 (ARRA) provides that the Health IT Policy Committee shall at least make recommendations on standards, implementation specifications, and certifications criteria in eight specific areas.

-- SS

Addendum Dec. 10, 2010:

This post generated a comment containing a significant logical fallacy, apparently from Harley Geiger, staff counsel of the CDT (Center for Democracy and Technology) which is one of the key actors mentioned in the Modern Healthcare story. The comment and my comment back can be seen in the comments section at this post.

If the comment was truly from Mr. Geiger, I would be even less confident than before that an organization whose staff counsel will not or cannot proffer a logically coherent argument will protect our precious freedoms.

-- SS

ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety

Number 5, that is.

The ECRI Institute is an independent, unbiased, evidence-based healthcare research, information, and advice provider. They have been in operation for more than 40 years and are one of only a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-Based Practice Center by the U.S. Agency for Healthcare Research and Quality.

I've cited their code of ethics at HC Renewal as a model of commendable healthcare conduct before:

Conflict of Interest - The Integrity of Independence

Remaining unbiased is difficult, if not impossible, when conflicts of interest are present. That is why we strictly enforce our conflict-of-interest rules and have carefully developed an environment that maximizes objectivity, productivity, and integrity of process.

We accept no grants, gifts, finder’s fees, or consulting projects from, and our employees are not permitted to own stock shares in, medical device or pharmaceutical firms. To make sure that is the case, we examine each employee’s federal income tax return after it is filed.

And, we accept no advertising revenues from any source.

(Full disclosure: I was a contributor on health IT issues to their 2008 book "Physician Office Fundamentals in Risk Management and Patient Safety.")

ECRI's most recent report is "The Top Ten Health Technology Threats to Patient Safety" for 2011 available at this link. Their Dec. 7 press announcement is here.

I'd mentioned an earlier edition of the report at my Sept 2010 post "Health IT: Danger" as was spoken about by Dr. Ross Koppel at Univ. of PA, but will present more detail here now that the 2011 report is available to the public.

I am citing the WSJ health blog on this report, as ECRI requests linking to their registration and downloading page for the full report, rather than direct dissemination, posting, or republishing of this work, without prior written permission:

December 8, 2010, 6:15 PM ET
The Top Ten Health Technology Threats to Patient Safety
WSJ Health Blog

By Katherine Hobson

For the fourth year running, the nonprofit ECRI Institute has put together a list of what it judges to be the top ten health technology hazards on which health-care facilities should focus their efforts.

The list in descending order of importance, doesn’t necessarily reflect the devices or problems with the most reported errors. That’s a factor, but so is “the severity of the problem, whether or not there’s a way to fix or mitigate the problem, and the high-profile” nature of the problem, Jim Keller, vice president for health technology evaluation and safety at ECRI, tells the Health Blog.

Among risks such as radiation therapy overdose and other dosing errors (#1), alarm hazards (#2), cross-contamination from flexible endoscopes (#3), high radiation dose of CT scans (#4), and luer misconnections (#6, misconnections of various infusion tubes), there's this:

#5 Data loss, system incompatibilities and other health IT complications: Problems with electronic-health records and other health IT systems can lead to problems including lost data, the need for repeat testing and even patient injury or death.

Then another obvious concern is raised:

While Keller says both he and ECRI support the push for digitized systems, the rush for federal incentives raises “concern that some of the kind of problems we are describing will be overlooked.”

It's not a "concern" to me, it's a fact.

So, here we have it:

An independent, nonprofit organization that for more than 40 years has been dedicated to bringing the discipline of applied scientific research to discover which medical procedures, devices, drugs, and processes are best, with unique ability to marry practical experience and uncompromising independence with the thoroughness and objectivity of evidence-based research, reports:

"Problems with electronic-health records and other health IT systems can lead to problems including lost data, the need for repeat testing and even patient injury or death."

The degree of risk is unknown (cf.: Joint Commission 2009 Sentinel Event Alert on Health IT Safety, PDF):

"There is a dearth of data on the incidence of adverse events directly caused by HIT overall."

This does not seem the best environment for the ethical, rapid diffusion of this technology nationwide, under penalty of loss of income and loss of Board Certification and even licensure for non-adopters.

For those of different ethics than ECRI, health IT is a literal cornucopia.

Addendum:

I note this comment from a nurse at the WSJ health blog story's comment section:

8:50 am December 9, 2010

The list was predictable, emanating from my observations as a registered nurse. It has become impossible to give patients care that they need. Corners are cut. It is easier for doctors to order scans than it is to examine patients. I would rather examine patients but the hospital requires that I click everything in to the electronic record, and [t]hat takes a long time. The reference to the CPOE is true. It is a nightmare because of the mistakes it promotes and it intereferes with communication disrupting my team’s care of the patient.

This must be one of those "anecdotal" reports that constitute a growing corpus of irrelevant "anecdotes", to be safely ignored because they were not obtained as part of a scientific experiment.

-- SS

Addendum Dec. 10, 2010:

From an earlier post of mine (of which I was reminded via a viewing from IP 150.148.0.#, FDA.gov, on a Google search on "health IT safety" this morning), we don't need to worry about HIT risks. ONC chair David Blumenthal said so:

... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.

-- SS

Abbott Laboratories and Pig Roasts, the "Philly Mob," and Legal Settlements

Help.... The health care muck is now being raked so fast I can't keep up.

Abbott Laboratories, Prolific Stenters, Pig Barbecues, Etc

In the last week, multiple media outlets picked up the story of the cozy relationship between Abbott Laboratories and a doctor now accused of implanting too many cardiac stents for too much money.  The essentials were, as summarized from New York Times, Wall Street Journal, and Baltimore Sun articles -

Dr Mark Midei was a prolific user of cardiac stents for patient with coronary artery disease (blocked cardiac arteries)

In the June deposition, Dr. Midei estimated that in 2005 — before research revealed that many stents were unnecessary — he performed about 800 stent procedures. Instead of dropping in subsequent years, however, the number of stents Dr. Midei inserted rose to as many as 1,200 annually, he estimated. In a 2007 internal document, Abbott Laboratories ranked Dr. Midei’s use of stents behind only five other cardiologists in the Northeast, including those at hospitals four and five times St. Joseph’s size. [NYT]

Therefore, hospitals sought him out

He had been one of the most sought-after clinicians in his region. Trained at Johns Hopkins University, he was a co-founder of MidAtlantic, a practice with dozens of cardiologists that controlled much of the cardiac business in Baltimore’s private hospitals. Dr. Midei was one of the practice’s stars. When MidAtlantic negotiated a $25 million merger with Union Hospital in 2007, the deal was contingent on his continued employment.

St. Joseph was so concerned about losing Dr. Midei’s business that the hospital offered a $1.2 million salary if he would leave MidAtlantic and join the hospital’s staff. [NYT]

However, it appeared he performed the procedures on patients who would not benefit from them.

The hospital engaged a panel of experts who reviewed 1,878 cases from January 2007 to May 2009 and found that 585 patients might have received unnecessary stents.

When asked to review the cases himself, Dr. Midei found far less blockage than he had initially, according to the Maryland Board of Physicians. The hospital suspended his privileges and eventually sent letters to all 585 patients. Hundreds of lawsuits against Dr. Midei and St. Joseph followed, including from patients treated well before January 2007. [NYT]

Nonetheless, Abbott Laboratories had been rewarding him for frequent use of their products

Word quickly reached top executives at Abbott Laboratories that a Baltimore cardiologist, Dr. Mark Midei, had inserted 30 of the company’s cardiac stents in a single day in August 2008, 'which is the biggest day I remember hearing about,' an executive wrote in a celebratory e-mail.

Two days later, an Abbott sales representative spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei’s home, according to a report being released Monday by the Senate. The dinner was just a small part of the millions in salary and perks showered on Dr. Midei for putting more stents in more patients than almost any other cardiologist in Baltimore. [NYT]

When his over-use was alleged, Abbott continued to use him as a key opinion leader.

Abbott responded to the controversy by hiring Dr. Midei as a consultant. 'It’s the right thing to do because he helped us so many times over the years,' an Abbott executive wrote in a January e-mail cited in the Senate report. [NYT]

Also,

After St. Joseph barred Dr. Midei from practicing there in May 2009, Abbott arranged consultant work for him, according to emails released by the Senate committee.

In December 2009, an Abbott senior vice president wrote in an email that he was 'very open' to having Dr. Midei do consulting 'to see how it might go—either getting the word out in China/Japan, medical or safety work.'

The following month, the Sun reported on the allegations against Dr. Midei and St. Joseph. According to the Senate report, an Abbott executive subsequently said in an internal company email, 'We recommend that we not use Dr. Midei in the U.S. at this time (the press is just too hot).'

Charles Simonton, the medical director of Abbott's vascular division, said in another email cited by the report that Dr. Midei should 'clearly avoid' the Baltimore area, but Dr. Simonton encouraged colleagues to 'please find key physicians or cath labs you'd like him to get in front of with our data.' Abbott wanted to hire Dr. Midei 'because he helped us so many times over the years,' yet another Abbott executive said in an email.

Dr. Simonton didn't return phone calls seeking comment.

Abbott sent Dr. Midei to Japan to promote the Xience stent, but bad publicity caused that trip to be cut short in late January, the report says. In total, Abbott paid the doctor $30,623 to help market the Xience, the Senate investigators found. [WSJ]

When the relationship was criticized, Abbott executives responded with threats, or were they jokes?

I called David Pacitti, vice president of global marketing for Abbott Laboratories' cardiac-plumbing division, to ask why he seems to want goons to beat me up in the newspaper parking lot.

'Don't you have connections in Baltimore?????' Pacitti e-mailed a subordinate regarding a January column I wrote on heart-artery stents. 'Someone needs to take this writer outside and kick his ass! Do I need to send in the Philly mob?'

Pacitti and other Abbott execs apparently don't care for suggestions that their expensive vascular devices often do patients little good and that a star Baltimore doctor took their encouragement to be 'truly outstanding' a bit too much to heart. [Sun]

Furthermore,

Pacitti didn't return my phone calls, but an Abbott flack got in touch on Monday.

'We sincerely apologize if this caused you any concern or distress,' the company spokesman said. Pacitti's comment, he said, 'wasn't meant to be taken seriously.'

Yeah, that's what King Henry II said after they whacked Thomas Becket. [Sun]

So here is a particularly vivid case showing how big health care corporations make "key opinion leaders" out of doctors apparently just because they use or prescribe a lot of the company's products, regardless of the doctors' expertise, or ethics.  As we noted before, "key opinion leaders" are seen by corporate marketing executives as fellow travelers or useful idiots (see posts here, and here). It again appears is that all that health care corporate marketers care about is selling product. Whether their pitches are honest or ethical is besides the point. Those who get in their way are treated with contempt, and maybe, just maybe are threatened with violence

The physicians who are flattered at being called "key opinion leaders," or "thought leaders" have got to realize that the marketers think they are chumps. If they think they are providing honest information, or education, they are deluded.

This case has already been widely discussed in the blogsphere.  See, in particular, posts by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and Larry Husten on the CardioBrief blog.

But if that were not enough, on the heels of this story came several more about Abbott Laboratories

Abbott Laboratories Settles, Twice

As reported by the Los Angeles Times, while Abbott was trying to hide Dr Midei overseas, it was also busily negotiating settlements of completely separate charges:

Abbott Laboratories and two other pharmaceutical firms agreed to pay more than $421 million to settle claims of defrauding Medicare and Medicaid in the latest in a string of nine- and ten-figure health care fraud settlements announced by the Justice Department.

The drug companies charged one set of prices to doctors and pharmacies but reported another set of inflated figures that were used as benchmarks by government insurers reimbursing health care providers. The spread, or difference, amounted to kickbacks to the companies' customers, according to Tony West, assistant attorney general for the Justice Department's civil division, who announced the settlements on Tuesday.

In particular,

Abbott, of North Chicago, Ill, agreed to pay $126.5 million to settle accusations that it charged the government inflated prices for products ranging from sterile water and saline solution to vancomycin, an antibiotic.

An Abbott spokesman said the company believes 'that we have complied with all laws and regulations' and settled the case to avoid 'the uncertainty associated with continued litigation.'

At least he did not threaten the Department of Justice officials with an attack by the "Philly mob."

But that is not all. The Wall Street Journal reported that Abbott had to make a second, unrelated settlement:

Separately on Tuesday, the Justice Department announced an unrelated $41 million settlement with Abbott subsidiary Kos Pharmaceuticals Inc. on charges that it paid kickbacks to doctors and other health professionals to encourage them to prescribe or recommend the cholesterol drugs Advicor and Niaspan.

As part of that settlement, Kos entered into an agreement that will allow it to avoid prosecution on criminal charges. 'These actions occurred prior to Abbott's acquisition of Kos in 2006 and Abbott has not been accused of any wrongdoing,' an Abbott spokesman said.

However, Abbott chose to acquire a company that allegedly chose to pay kickbacks of this sort. The apparent resemblance to Abbott's payments to Dr Midei in the case above are striking.

By the way, the Los Angeles Times article also noted previous black marks on Abbott's record:

Abbott also paid $614 million in civil and criminal penalties in 2003 to end a federal investigation of the company's marketing practices and Medicaid and Medicare reimbursements.

In 2001, TAP Pharmaceutical Products Inc., of Lake Forest, Ill., an Abbott joint venture, agreed to pay $875 million and plead guilty to a criminal charge of conspiring with doctors to overbill Medicare.

At the time, the TAP penalty was the largest health care fraud settlement in U.S. history, but it has since been eclipsed by at least two others.

So we once again illustrate how punishing wrong doing by fining large corporations, when the fines are just seen as a cost of doing business, in the absence ofany negative consequences on the real people who authorized, directed, or implemented the bad behavior fails to deter future bad behavior.

This remarkable confluence of cases suggest how rotten are the ethical foundations of even large and previously respected health care organizations. I imagine, though, that as long as these corporations richly reward their executives regardless of the ethics of their actions, and regardless of the long term effects on the organizations' reputations, and as long as their are no externally imposed negative consequences on these leaders, the practices will continue, and will get worse.

Health care costs keep rising, access keeps declining, quality gets worse. We moan and wring our hands, but as long as we allow the rot to worsen, and the muck to grow, expect these trends to continue until the whole smelly mess collapses of its own weight (with all those rich executives escaping to their mansions.)

If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy.

ADDENDUM (8 December, 2010) - See also comments by Maggie Mahar on the HealthBeat blog, David Williams on the Health Business Blog, and Paul Thacker on the Project on Government Oversight blog.

IMPEACHMENT: IT’S ABOUT THE INSTITUTION, NOT THE PERSON

IMPEACHMENT: IT’S ABOUT THE INSTITUTION, NOT THE PERSON

The impeachment trial of Judge G. Thomas Porteous of Louisiana this week was a lesson in civic ethics. The lessons of the Porteous trial apply to academic medical centers, professional medical societies, medical journals, and granting agencies like NIH.

The Porteous trial is a straightforward case of bribes, kickbacks and corruption involving a Federal judge. The most enlightening arguments came from prosecutor Rep. Adam Schiff, D-California, laying out the case for impeachment in the Senate. He gave a lucid presentation of the logic and the historical origins of the impeachment process. The key points are these: impeachment serves to protect the dignity, honor, and credibility of the office more than to punish the wayward office holder; and impeachment is a constitutionally sanctioned way to clean the Augean stables without necessarily having to prove criminal liability. It is sufficient to demonstrate that the bad actors have brought disgrace on their offices.

What this means for us in medicine is that legalistic charges and defenses are not the right way to go in exposing and ejecting bad actors from our field. In the highly publicized cases of ethical compromise over the past few years, our group disapproval, when there was any at all, generally has run on two parallel tracks. The first is legalistic, and it favors the bad actors, who flaunt their constitutional protections with the taunt, prove it. The second ground of disapproval is esthetic, based on the tackiness of the bad actors’ behaviors – regardless of technical legalities, what they do is an affront and an insult to professional standards and mores. When we look at how recent incidents in medicine actually played out, however, we see a disconnect. The bad actors have narrowed the debate to the first ground of disapproval, while forcing the second off limits. In this strategy, they have received conscious or unconscious assistance from the professional establishment. The focus has been on legal technicalities involving the bad actors rather on preserving the dignity and credibility of high offices in academic medicine.

For instance, when Charles Nemeroff was exposed by Senator Grassley for conflict of interest in his NIH grants, he came up with the contrived legalistic defense that his unreported payments from GlaxoSmithKline were for ‘CME-like’ presentations, and thus somehow exempt from disclosure. Nemeroff’s obfuscations finally collapsed of their own weight and Emory University took decisive action against him, even though they had sufficient evidence dating back at least 4-5 years. In the end, Emory had to go through the wringer to discipline Nemeroff, and the institution suffered grave damage to its reputation for a number of years as the price of delay.

For instance, when Thomas Insel, the Director of NIMH, assured Pascal Goldschmidt, Dean of the School of Medicine at the University of Miami, that Nemeroff was absolutely in good standing for applying for new NIH grants if he left Emory for Miami, despite a 2-year ban at Emory, he hewed to the letter of the law while disregarding its spirit in order to help his friend. Moreover, when Insel appointed Nemeroff to two new NIH Research Review Committees, he established beyond any doubt that he was intent on trying to help Nemeroff get back into circulation, and that he failed to grasp the gravity of the dishonor that Nemeroff inflicted on the field. This obtuseness on Insel’s part damaged the credibility and reputation of NIMH. To his credit, NIH director Francis Collins finally ‘got it’ and forced a review of the NIH ethics rules that had been entrusted to Insel.

For instance, when Pascal Goldschmidt, Dean of the School of Medicine at the University of Miami, claimed he had done due diligence in his recruitment of Nemeroff as chair of his psychiatry department in 2009, he focused on the legalistic aspects of Emory’s review of Nemeroff, while failing to understand the degree of negative publicity associated with Nemeroff’s name. He ended up hiring someone who is an object of ridicule, and he in turn is ridiculed by association.

For instance, when Stanford University learned of Alan Schatzberg’s boundary violations vis a vis his NIH-funded projects and his personal corporation, they first pushed back on legalistic technical grounds. Only later did the Stanford administration get the message by removing Schatzberg from his Principal Investigator role with NIH grants, and eventually appointing a new chair of psychiatry. Meanwhile, the public image of Stanford suffered.

For instance, when the American Psychiatric Association was warned that Alan Schatzberg was a problematic candidate for election as President of the association on account of his history of ethical compromise, they went ahead anyway and they have since had opportunity to regret that decision. Here again, the professional society appears to have lost sight of the ethical forest for the legal trees. The credibility and reputation of the APA have suffered because of the taint associated with Schatzberg’s presidency.

For instance, when the New York Times recently exposed the ghostwriting associated with the 1999 textbook of Charles Nemeroff and Alan Schatzberg, the so-called authors responded with typical legalistic defenses. They and the University of Miami and the American Psychiatric Association Press (the publisher) again lost sight of the ethical forest for the legal trees. This stereotyped, public relations driven response ignores the visceral and esthetic distaste most observers felt on learning about the collusion between the ‘authors,’ the professional writing company and the sponsoring pharmaceutical corporation. Even the defense that it occurred a long time ago fails. In the Porteous trial, the prosecution established that dishonorable events in an officer’s past are grounds for impeachment, whether or not they also occurred during the person’s time in office.

For instance, when Harvard Medical School planned a new CME program on psychopharmacology in mid-2011, they engaged a number of compromised academic speakers, including Nemeroff and Schatzberg. What the hell was Harvard thinking? I told the Course Director, Carl Salzman, that this amounts to pandering. He replied defensively that Nemeroff and Schatzberg are well regarded speakers and that he would ensure that they gave unbiased presentations. That’s not the point. The point is that they have done serious damage to our field, and for Harvard Medical School to give them top billing amounts to denial of the elephant in the living room. It’s collusion in service of their public rehabilitation. I told Dr. Salzman that his logic amounts to compartmentalized thinking. I might have added that Adolf Hitler gave a lot of great speeches that received rave reviews and that compartmentalized thinking was widespread in the nation of Germany between 1928 and 1945. Meanwhile, Harvard Medical School gets a black eye through its association with these compromised individuals. So do the other speakers who will be on the panel. Who needs this kind of taint? Dr. Salzman can defend Nemeroff and Schatzberg all he wants on specious legalistic grounds, but who cares? Harvard Medical School could use some moral clarity.

So, we come back to the impeachment trial of Judge Porteous. Impeachment protects the institution. When sleazebags get into positions of authority and trust they need to be dumped, and our professional and academic institutions need to have enough spine to dump them. At the very least, we don’t need to tolerate institutions like Harvard Medical School pandering to compromised academic bad actors. For shame.

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