Monday, September 14, 2009

Making Health Care More Representative and Accountable - the Example of the Thai National Health Assembly

On Health Care Renewal, we have often shown how the governance of health care organizations may be unaccountable, unrepresentative of relevant constituencies, opaque, and not subject to ethical standards. Conversely, we have repeated the need to make the governance of health care organizations accountable, representative, transparent, and ethical. Meanwhile, our US debate about health care reform seems to be driven by leaders of powerful health care organizations, while common citizens need to scream to be heard.

Maybe we could benefit from a lesson from another country. As reported in the Bulletin of the WHO, Thailand seems to have found a way to get ordinary citizens and members of civil society involved in a civil, organized health care discussion.

For Dr Suwit Wibulpolprasert, chairman of the committee organizing Thailand’s first National Health Assembly (NHA), which took place from 11 to13 December 2008 in Bangkok, opening up the debate on public health is an essential part of developing effective national policy. 'In the past, health policy has tended to be drawn up by politicians and officials,' Wibulpolprasert says. 'But the National Health Assembly is a forum for the public to pool views and initiate health agendas that truly address people’s needs.'

More than 1500 people attended the conference, the first of its kind to take place since the passing into law of the National Health Act of 2007, which also brought the NHA into existence.

A broad cross-section of Thai society was represented, including 178 delegations from government agencies and provincial authorities, the private sector and civil society. In addition, groups including stateless people living near the Myanmar border gave presentations at technical briefings for participants. Dr Kumanan Rasanathan, from WHO’s Department of Ethics, Equity, Trade and Human Rights, described the meeting as 'a very interesting exercise in participatory governance'.

The 12 topics that were up for discussion were distilled from more than 68, including such familiar ones as universal access to medicines and equal access to basic public health services. Also addressed were matters as diverse as agriculture and food prices in the current economic crisis and safe media access for youth and family – an agenda that included a proposal for addressing problems of children addicted to online games and television.

'The broad slate of topics reflects the intention to encourage input from everyone,' says Rasanathan, 'and improve public participation as well as intersectoral collaboration.' In other words, the assembly’s organizers actively encouraged the participation of stakeholders from outside the field of public health – from education, agriculture and industry, to name but a few.

'The Thais have adapted much of the machinery of the World Health Assembly [WHO’s supreme decision-making body] for their own context,' says Rasanathan, who noted that each of the 178 constituent groups had equal speaking rights. Briefing papers were produced and resolutions were passed on each of the agendas. As with WHA resolutions, these resolutions are not binding.

According to Dr Amphon Jindawatthana, secretary-general of the National Health Commission Office, once the resolutions have been adopted they are considered by the National Health Commission, which reworks them for ministerial review and possible inclusion in national policy.

Given the hurdles that still need to be cleared once a resolution is passed at the Assembly, one might be forgiven for dismissing the body as something of a talking shop.

This is a charge that Wibulpolprasert firmly denies. He is convinced that NHA-formulated resolutions will certainly lead to policy, and policy that is closer to the needs of Thailand’s 63 million people.


The 2009 Assembly will be held in December. Details can be found here.

I wonder if we would be having a more productive health care debate in the US if the way had been prepared by a US National Health Assembly? Maybe if the multi-million dollar a year leaders of health care organizations had to listen to the concerns of ordinary people, and some practicing health care professionals, a little common sense might penetrate into the bubble created by their superclass membership.

"A cadre of people who understand the science"

Here is a fascinating, spot-on exchange regarding biomedical information science between Bill Moyers on PBS and the new President of Dartmouth College Dr. Jim Yong Kim (link). My comments in [red italics]:

DR. JIM YONG KIM: My own particular take on it is that I think for many, many years, we've been working under the fantasy that if we come up with new drugs and new treatments, we're done. 

The rest of the system will take care of itself. In my view, the rocket science in health and health care is how we deliver it. And unfortunately, there's not a single medical school that I know of that actually teaches the delivery of health care as one of the essential sciences. 

In other words, what we've learned about organizations is that it is very difficult to get a complex organization, a group of people, to work consistently toward a goal. In the business world, if you don't do it well, the market gets rid of you. You go out of business. But many hospitals executing very poorly persist for a very, very long time. So my own view of it is that we have to rethink fundamentally the kind of research we do and the kind of people we educate, so that they'll think about the complexity of delivery as a topic that we can take on and study and learn about as a science. [And possess a broad and deep enough background to understand these issues at very fine-grained levels, which in my opinion includes a rigorous scientific background to start with - ed.]

BILL MOYERS: What do you mean, complexity of delivery?

DR. JIM YONG KIM: Well, just think about a single patient. So a patient comes into the hospital. There's a judgment made the minute that patient walks into the emergency room about how sick that person is. And then there are relays of information from the triage nurse to the physician, from the physician to the other physician, who comes on the shift. 

From them to the ward team, that takes over that patient. There's so many just transfers of information. You know, we haven't looked at that transfer of information the way that, for example, Southwest Airlines has. Apparently they do it better than any other company in the world. [I would add that the nature of such transfers and the complexity of the information itself is far simpler in the Airline business than in medicine, so this is not the best analogy - ed.]

BILL MOYERS: Computers?

DR. JIM YONG KIM: No, they have taken seriously the human science of how you transfer simple information from one person to the next. [Note how Dr. Yong Kim wisely dismisses computers as the solution, in favor of people. He does not suffer the syndrome of inappropriate overconfidence in computers - ed.] And in medical school, and in the hospitals that I've worked in, we've done it ad hoc. Sometimes we do it well. Sometimes we don't do it well. But what we know is that transfer of information is critical. Now to me, again, that's the rocket science. That's the human rocket science of how you make health care systems work well 

What we need now is a whole new cadre of people who understand the science, who really are committed to patient care. But then also think about how to make those human systems work effectively. We've been calling it, aspirationally, the science of health care delivery. And we do it at Dartmouth. 

30 years ago, one of our great faculty members, Jack Wennberg, started asking a pretty simple question. Why is there variation, for example, in the number of children who get their tonsils taken out, between one county in Vermont versus another? 'Cause one of his children was in school at one place. Another of his children were in the school in another place. 

And in one place, almost everyone had their tonsils out. And in another place, almost no one did. And of course, he found that there happened to be a doctor there who liked to take tonsils out and benefited from it. And he kept asking this question, you know, outcome variation. He called it the evaluative clinical sciences. And I think that's really the forerunner to what we're talking about in terms of the science of--

BILL MOYERS: Fancy--

DR. JIM YONG KIM: --health care delivery.

I can add that part of that "cadre of people who understand the [information transfer] science" exists, in the form of Medical Informatics specialists (e.g., as produced by these organizations and many others in the U.S. and worldwide). Understanding the complexities of information transfer also calls for understanding the clinical environment and, in my view, the biomedical science as well.

However, you might never know this via reading statements from some of the non-clinical HIT leaders such as "computers enable complexity" [as opposed to well-trained and experienced medical experts - ed.]

It is indeed unfortunate that most hospital ads seeking Medical Informatics expertise are for "Director level" positions with little control of resources, i.e., they are "Director of Nothing" roles, diluting the contributions of such experts in the highly politicized and territorial environment of a hospital IT department.

Unfortunately, most in hospital IT today are just repackaged business computing personnel of a management information systems (MIS) background whose lack of knowledge of these topics or cavalier attitudes about them has actually harmed the progression of health IT as a practical tool, as I've profusely documented on this blog (e.g., here) and at my educational HIT site here.

An example of just how difficult the "rocket science" of information transfer can be is this, from a psychiatrist:

I work on an acute psychiatric inpatient unit. We see each patient on rounds each day, write a note in the chart each day and bill each day. However, the nature of psychiatric units are that patients wander freely around the unit. Consequently, whenever I walk onto the unit, I often have interactions with one or more patients, just in the short distance between the door and the nursing station. Some of those are brief but still give me a sense of how they are doing at that point, other interactions involve brief questions from the patients, still others involve walking to the patients' room and sitting down to discuss a particular issue in greater depth with the patient and/or family.

Each of these involves a direct patient to clinician interaction and require that I exercise judgment (often a judgment that they're doing OK). Yet none of these are billable interactions and most are not documented.

I was aware of this from my own medical school clerkship in psych. The fact that these valuable interactions are largely undocumented (except in the physician's gray matter) merely shows that modeling the real world of healthcare into neat, tidy little containers of information is harder than modeling the inventory and sale of widgets, due to the complexities of healthcare. One more of those "EHR as panacea" exceptions ...

(And even the modeling of widgets isn't always done well. I went to my local MicroCenter last week seeking an EIDE-to-USB hard drive enclosure, to use the orphaned 80Gb hard drive I upgraded in my Mac Mini to serve as a Time Machine backup drive. Their inventory system showed they had a dozen on hand; nobody could find them, anywhere. A week later - yesterday - the same situation prevailed.)


Finally, a quibble. Later in the exchange Dr. Yong Kim makes the statement that "Right now, the physicians who are running these hospitals have never been trained. Most of them have never been trained in system thinking, in strategy, in management."

As most hospitals are not run by physicians, I'd have to disagree with that statement. It perhaps should be redirected to the non-medical businesspeople in the C-suite and on the hospital Boards who do run hospitals, to which I'd add "who have never been trained in biomedicine."

-- SS

Friday, September 11, 2009

More On Healthcare Management By Domain Neutral Generalists: CIO's Running Hospital Pharmacies and Home Healthcare Divisions?

Both Roy Poses and I have written on a plague of healthcare mismanagement and perhaps malfeasance in part due to leadership by domain amateurs, i.e., healthcare leadership profoundly lacking in biomedical education and experience.

Examples of recent posts about the risks posed by domain neutral biomedical leadership are:


"NY Times Proclaims Anyone Can Run a Health Care Organization with a Little Studying Up" (Poses)

"Health Care Leaders: Don't Know Much About Health Care" (Poses)

"On Optimal Expertise for Leadership in Biomedicine" (me)

"Informatics, or Infomagic? Health IT Cannot Flourish When Everybody is an Expert" (me)

and "Pfizer/Wyeth Merger And Sacrificing The Future: Laying Off Scientific Staff All Over The Place" (me).

I have also written of a cross-occupational invasion of healthcare by the IT profession, in the form of power and territorial grabs over clinicians with regard to the tools clinicians increasingly need in order to provide patient care.

These leadership inversions, where domain neutral personnel are viewed as best able to lead any endeavor as if the world consists of interchangeable, faceless resources following equally interchangeable processes, are due to attitudinal laxity and permissiveness on the part of medical leadership, a takeover of healthcare by those with primary pecuniary interests, and perhaps a lack of appreciation for the value of domain expertise as sign of a waning western culture.

In a recent hospital CIO interview, in this case of CIO Avery Cloud at New Hanover Regional Medical Center in Wilmington, NC, we see both of these elements - supportive views towards healthcare leadership by domain amateurs, and towards a cross-occupational invasion of healthcare by IT personnel - combined:

Q: Is that inherent in their background, though, when you’ve got a lot of folks who worked to move their way up through IT, which is the argument of “are you better off with someone who’s risen through the IT ranks”, or better off to get a visionary who just lets other people worry about the nuts and the bolts?

A: That’s an interesting debate. I’ll just tell you about me: I came up through the technical ranks. I hold an MBA, but more importantly, I have an affinity to business. When people ask me about me and my job, I tell them I’m a business person who just happens to know IT.

I’d like to think that I could run any of the departments in this hospital [wow - ed.] A good example is that nobody is surprised when the CFO runs the pharmacy department [i.e., nobody in this CIO's limited circles - ed.], or the CFO runs materials management. It should be no big surprise either that the CIO can do the same, or does the same [In fact, it likely would be a big surprise to many -ed.] A very good friend of mine in another hospital — he’s the CIO there — runs the pharmacy down there. Another friend of mine who’s a CIO runs the home care division [this is, in fact, stunning and should be a cause of great concern to healthcare regulators if true - ed.]

I'm sure CIO's would like to think that they could "run any of the departments in a hospital."

(How about: Legal? Risk management? Health Information Management a.k.a. Medical Records? Biomedical engineering? Nursing? Trauma? Diagnostic Imaging? Neurosurgery?)

The question is this: is this a realistic view? Or, is it an extreme form of hubris and the Dunning Kruger effect? Can they run complex departments far outside their core competencies optimally? Or will they more likely be running an area they know little about by the seat of their pants?

Further, do leadership roles in organizations such as NIH or the Centers for Disease Control call merely for an MBA and domain neutral backgrounds? If not, why not?

Why are hospitals exempt from a requirement for domain specific expertise in their leadership?

As to CIO's (and, for that matter, CFO's) running hospital pharmacies, let's show the knowledge gaps graphically by first exploring the prerequisite training of a typical Pharm.D. pharmacist:

Professional Degree (Pharm.D. Degree) Curriculum
Class of 2011, 2012, & 2013
(Admitted Fall 2007, 2008 & 2009)

First Year, Fall Semester

NBAN 301 Principles of Human Anatomy 3 credit hours
PSIO 743 Fundamentals of Physiology 5 credit hours
PHAR 700 Pharmacy as a Profession 1 credit hour
PHAR 701 Pharmaceutical Care Lab 1 2 credit hours
PHAR 702 Physical Pharmacy 3 credit hours
PHAR 703 Intro Pharmacy Practice Experiences 1 1 credit hour
PHAR 720 Patient Health Education 2 credit hours

Total hours 17 hours

First Year, Spring Semester

BIOC 531 General Biochemistry 4 credit hours
PHAR 708 Pharmaceutics 3 credit hours
PHAR 709 Immunology and Biotechnology 2 credit hours
PHAR 710 Intro Pharmacy Practice Experiences 2 1 credit hour
PHAR 711 Chemical Properties of Drugs 2 credit hours
PHAR 712 Pharmaceutical Care Lab 2 2 credit hours
PHAR 737 Disease Prevention and Health Promotion 2 credit hours

Elective 2-3 credit hours

Total hours 18-19 hours

First Year, Late Spring – after spring term concludes

PHAR 714 Introductory Community Rotation (2 weeks) 2 credit hours

Second Year, Fall Semester

PCOL 743 Pharmacology 1 3 credit hours
PHAR 715 Pathophysiology & Therapeutics 1 4 credit hours
PHAR 716 Chemistry of Drug Action 1 3 credit hours
PHAR 717 Intro Pharmacy Practice Experiences 3 1 credit hour
PHAR 723 Pharmaceutical Care Lab 3 1 credit hour
PHAR 727 Medical Literature Evaluation 2 credit hours

Elective 2-3 credit hours

Total hours 16-17 hours

Second Year, Spring Semester

PCOL 744 Pharmacology 2 3 credit hours
PHAR 719 Intro Pharmacy Practice Experience 4 1 credit hour
PHAR 724 Pharmaceutical Care Lab 4 2 credit hours
PHAR 725 Pathophysiology & Therapeutics 4 credit hours
PHAR 726 Chemistry of Drug Action 2 2 credit hours
PHAR 728 Pharmacy Management 2 credit hours

Elective 2-3 credit hours

Total hours 16-17 hours

Second Year, Late Spring – after spring term concludes

PHAR 729 Introductory Institutional Rotation (2 weeks) 2 credit hours

Third Year, Fall Semester

PHAR 730 Pathophysiology & Therapeutics 3 4 credit hours
PHAR 731 Biopharmaceutics & Pharmacokinetics 3 credit hours
PHAR 732 Non-Prescription Drugs 3 credit hours
PHAR 733 Pharmacy Systems 2 credit hours
PHAR 735 Pharmaceutical Care Lab 5 1 credit hour
PHAR 742 Intro Pharmacy Practice Experiences 5 1 credit hour

Elective 2-3 hours

Total hours 16-17 hours

Third Year, Spring Semester

PHAR 734 Pharmacy Law and Ethics 3 credit hours
PHAR 736 Pharmaceutical Care Lab 6 1 credit hour
PHAR 738 Outcomes Assessment/Quality Improvement 2 credit hours
PHAR 739 Therapeutic Patient Monitoring 3 credit hours
PHAR 740 Pathophysiology & Therapeutics 4 4 credit hours
PHAR 741 Clinical Pharmacokinetics 3 credit hours
PHAR 746 Intro Pharmacy Practice Experiences 6 1 credit hour

Elective 0-2 credit hours

Total hours 17-19 hours

Fourth Year

Students complete eight five-week experiences beginning in the summer preceding their fourth year. Students will have required experiences, such as ambulatory care and acute care, and elective experiences.

Students are required to complete at least 10 professional elective hours selected from an approved course list during their first, second, or third professional year and prior to fourth year experiential rotations. With the exception of Fall semester in the first professional year, one elective can be taken each semester of the didactic program. Electives are intended to complement the required curriculum and allow students to select courses based on professional interests. Students wishing to take electives during summer terms may do so after their first professional year on any of the campuses in the WVU system (Morgantown, Parkersburg, Potomac State, West Virginia Tech) provided the courses are selected from the list of professional electives or are deemed equivalent by the University. Students wishing to receive course credit for courses taken outside of the WVU system must have pre-approval by the Curriculum Committee.


Of course, even assuming no requirement for a Dissertation defense (which is a typical Ph.D. requirement), the candidate needs to take state and/or federal exams for licensure:

Licensure. A license to practice pharmacy is required in all States, the District of Columbia, and all U.S. territories. To obtain a license, a prospective pharmacist must graduate from a college of pharmacy that is accredited by the ACPE and pass a series of examinations. All States, U.S. territories, and the District of Columbia require the North American Pharmacist Licensure Exam (NAPLEX), which tests pharmacy skills and knowledge. Forty-four States and the District of Columbia also require the Multistate Pharmacy Jurisprudence Exam (MPJE), which tests pharmacy law. Both exams are administered by the National Association of Boards of Pharmacy (NABP). Each of the eight States and territories that do not require the MJPE has its own pharmacy law exam. In addition to the NAPLEX and MPJE, some States and territories require additional exams that are unique to their jurisdiction.


(I can add that the typical M.D. curriculum, such as at the medical school I attended, is even more rigorous. That is prior to the medical internship, residency, and postdoctoral fellowship(s) most physicians also must perform, where they become intimately familiar with the services of many hospital departments).

Now, let's explore the comparable pharmacy science/biomedical training of the typical hospital CIO or CFO (or CEO for that matter):


(This, of course, is the mathematical symbol for the null set.)

For comparison and contrast, see Roy Poses' post "What is Not Taught About Leadership in Healthcare" for the healthcare MBA curriculum at a prominent School of Management, namely Yale's. Dr. Poses observed:

... So what is missing? There seem to be two obvious areas that are not taught.

The first is health care. There are only two courses in this curriculum on "healthcare policy" and "healthcare management." ... The second area missing is ethics, particularly the business ethics of health care. There are simply no courses even remotely related.

In the first of my posts linked above I wrote:

... Those in charge [and who lack domain credentials -ed.] cannot see that which the domain specialist sees.

They cannot see because they lack the training, experience, and what is described as 'meta-competence' (in this brilliant article on competence [the Dunning-Kruger effect - ed.]) essential to seeing that which is obvious. Obvious, that is, to those who do not lack these characteristics. In addition, I've also observed that some lack the fundamental analytical abilities essential to understanding and managing the complexities of biomedical R&D.

Why those without domain expertise are in charge of organizations whose long term viability depends entirely on the most advanced and creative pursuit of biomedical 'miracles' [i.e., pharma - ed.] is another matter. I won't address this here, other than saying it reflects the adverse consequences of a bias that has evolved in management "science."

That bias is the belief that all the world consists of faceless labor resources performing easily definable processes upon interchangeable widgets, and that management can therefore be done by generic managers, exclusively. Some of the world is like that [i.e., fast food chains - ed.], but some isn't, such as biomedical R&D. [And clinical medicine as well - ed.]

Management in the absence of domain expertise in this industry is, in fact, mismanagement.

There is nothing here to spin, there is nothing to debate. There is nothing to discuss. This is a first principle.

Failure to accept this reality results in corporate failure.

These views apply to hospitals perhaps even more critically than to biomedical R&D. In hospitals, mistakes in judgment can result in great patient harm, and far more rapidly than in an R&D organization.

Finally, in the same CIO interview there's this:

Q: If you’re talking to your CIO peers, what would you tell them is the key to know that you need to have this done and the thoughts to entertain before they start?

A: I think, you know, customer’s king. The key is to evaluate the customer’s level of satisfaction with services being provided. You can’t do that without getting very involved and face to face with the customers. So that’s number one ... So I think that is really what IT leaders have got to strive for, the user viewpoint, the user view of the services that IT provides.

The fact that this "customer is king" advice seems to merit constant repetition among healthcare IT leadership circles, especially when the “customers” are clinicians with patient care obligations and responsibilities, should be a cause of deep reflection and introspection among those in HIT. At the very least, they need to ask themselves - and healthcare professionals need to ask them - "who are you, and what are your motives for stepping foot in our hospital?"

It is also such a fundamental first principal that its frequent repetition suggests typical hospital CIO's are not truly fit in 2009 to lead anything in healthcare where domain expertise and viewpoints are essential, healthcare IT included. Its need for frequent repitition - dating to many HIT publication I've seen since I entered the Medical Informatics field professionally in the early 1990's - suggests they don't truly recognize that the business of hospitals is taking care of patients, the clinicians being the enablers of that business, everyone else being facilitators. The known problems and failure rates of heath IT in hospitals is corroborative of that view.

Healthcare reform will certainly require healthcare leadership reform, and the first task of that reform should be a re-evaluation of expertise required to tamper with people's lives and well being in a hospital setting.

-- SS

Tuesday, September 8, 2009

The Lexapro Marketing Plan Was Meant to Promote Marketing (Surprise?)

Last week, Gardiner Harris writing for the NY Times noted that the US Senate Special Committee on Aging had made public part of Forest Laboratories' Fiscal Year 2004 Marketing Plan for the drug Lexapro (escitalopram oxalate), an anti-depressant. The document is available here.

Review of this plan revealed the marketing department's various activities, including activities that others might have believed were educational, scientific, or had some other high minded purpose.

Continuing Medical Education

Overall, one "promotional objective" was to "Maintain SRI category leadership in total number of medical education events (including CME symposia, speaker promotion, teleconferences, and peer selling programs)"

One "critical issue" was to "increase Med Ed efforts: more sponsorships of CME, increased level of speaker programs, maintain level of teleconferences and peer selling."

Under "Marketing Tactics" was a long section on "Continuing Medical Education." It covered various venues for CME such as internet/electronic CME, "sponsoring symposia at major meetings," "regional CME symposia" which would "serve a number of medical specialties," "sponsorhips of scientific sessions," etc

Production of Scholarly Articles

The "Publications" section of "Marketing Tactics" noted "publications will be geared toward psychiatrists, PCPs, .... Articles will appear in several formats, including original reports, review articles, and journal supplements."

Thought Leaders and Consultants

Under the "Continuing Medical Education" section of "Marketing Tactics," and then in the "Advisor Relations" section, there were numerous references to what "thought leaders" would do, including
- "present new data" at "symposia at major meetings"
- act "as advisors to Lexapro in order to obtain critical feedback and recommendations on educational and promotional strategies and tactics."
- sit on the "Lexapro Exectuive Advisory Board" to "keep our advisors apprised of the commercial development ... of escitalpram."
- sit on the "Primary Care Advisory Board" to "obtain critical feedback and recommendations on educational and promotional strategies and tactics...."

Role of Medical Centers

Under the CME section of "Marketing Tactics," we see that "academic health centers" would help develop "regional CME symposia."

Under the "Sponsorship" section are plans to fund the "Professional Relations Group in their mission of establishing mutually beneficial long-term relationships with appropriate professionals and associations." Specific plans included funding the Department of Psychiatry and Behavioral Sciences at Emory

Medical Societies

The "Sponsorship section" also noted that these relationships "will also provide the basis for advocacy development and issues management, and will establish an appropriate environment for commercial and policy activities."

Under the CME section of "Marketing Tactics, we see that "medical associations and professional societies" would help develop "regional CME symposia" Also in this section is the note that "smaller, more prestigious societis do not accept industry-sponsored symposia." So instead, "sponsorship of a study groups or plenary sessions is recommended. Marketing will work with the professional relations group regarding potential opportunities."

Appendix VII, "Professional Associations of Priority" noted funding provided for guideline development by a "collaboration between APA, AAFP and ACP" for "chronic depression in primary care practice;" by AAGP for guidelines for late-life depression; multiple guidelines developed by AMDA;

The appendix also noted that Forest supports ACNP "annual programming, and is a founding sponsor of it's newly created International College of Geriatric Pscyhopharmacology (ICGP)," is a "Corporate President's Circle Sponsor of AAFP," became a "corporate sponsor of ACP in FY03," became "a Corporate Sponsor of AMDA for the last few years,"

Also, it noted that Forest has "expanded its involvement" with APA for "lobbying of State Health Departments...."

Disease Advocacy Organizations

Also in Appendix VII, Forest was identified as a "Corporate Sponsor of NAMI," a "major Corporate Sponsor of NMHA," and a "major Corporate Sponsor of DBSA."

Summary

We have often heard from pharmaceutical, biotechnology, device and other health care corporations that they are only involved in education to disseminate accurate information for the good of society. We have often heard from physicians and academics who consult for such corporations that their advice is sought about clinical, scientific, and technical issues. We often hear from academic medical institutions, medical associations and disease advocacy groups that the money they get from such corporations does not influence the content of their educational and scientific work.

Yet here we see, in considerable detail, that in the case of one drug company's promotional efforts for one drug,
- The marketing plan from the marketing department paid for medical education as a "promotional objective," that is, to market, not to educate.
- Thought leaders and consultants were again paid by marketing to market, and sometimes to provide opinions about "promotional strategies" and "commercial development."
- Medical associations are funded by marketing "for commercial and policy activities."

This suggests that health care corporations develop financial relationships with physicians, academics, academic institutions, medical and professional associations, and disease advocacy groups to support marketing first.

This allows the corporations to advance marketing disguised as education, research, and other high-minded and apparently selfless activities by professionals, not-for-profit organizations, and dedicated inviduals. Such marketing, of course, is DECEPTIVE and DISHONEST. It also is in conflict with the professionals' ideals, and the missions of the medical and professional assocations and disease advocacy groups.

The physicians, other health care professionals, and not-for-profit organizational leaders involved may rationalize these activities as consistent with their mission and professionalism, but such rationalizations are at best self-delusion.

No one knows how representative the Lexapro marketing plans are of the marketing of other drugs, devices and health care services. The only way to find out would be to force many other corporations' marketing plans into public view. The Lexapro documents suggest that society would benefit if many more marketing plans were made public, but that such publication might generate a wave of revulsion about how deceptive marketing of health care goods and services has become, and the extent that health care professionals have betrayed their professional ideals, and academic medical institutions, professional and medical societies, and patient advocacy groups have betrayed their missions.

I submit that we will not truly reform health care without making the marketing of health care goods and services honest, getting health care professionals to give up their financial relationships with health care corporations to reclaim their professionalism, and getting academic medical institutions, professional and medical societies, and patient advocacy groups to give up their financial relationships with health care corporations to reclaim their missions.

See additional comments on how the marketing plan was meant to promote CME by Dr Daniel Carlat on the Carlat Psychiatry Blog.

A Solution To Pharma's Repeated Drug Offenses: Incarceration

Some straightforward common sense follows. No spin, no indirection, no excuses:

Pfizer has recently paid a $2.3 billion dollar settlement on civil and criminal charges that potent drugs were being improperly promoted (i.e., pushed onto unsuspecting physicians and patients) for uses not approved by the regulatory agencies responsible for such matters.

What is the real world meaning of these charges?

The meaning is that patients - the final consumers - were ingesting drugs that were not only not indicated, but held possibilities of harming the drug taker.

We have seen negative outcomes from these practices before in the form of, for example, children in whom improperly pushed antidepressants caused suicidal thoughts and actual suicide (the teenage daughter of a friend of my mother hanged herself after starting such drugs, resulting in a lawsuit that the parents ultimately won).

It demonstrates reckless and malicious disregard for others to tamper with people's lives in this fashion. Perhaps sociopathy is an apt description of such behavior. One wonders about the adverse consequences to patients of this latest round of pharma fraud.

Ultimately, those engaging in these practices (usually at the group director or VP level) are doing the following:

They are gambling with the lives and well-being of countless patients.

In some of these cases, patients will have been harmed; in others, patients will have died. In the former case, the perpetrators of the fraud are facilitators of the injury. In the latter case, the perpetrators are accessories to murder.

Fining a corporation is a nearly useless exercise, as ultimately the conversation in the executive offices and Wall Street will be about the cost of doing business, not about crimes or morals. Terminating perpetrating individuals is also not extremely effective in motivating reform, even if terminated with prejudice, if those terminated have already made their fortune.

(The $2.3 billion could have been used, in fact, as a war chest to reduce the need for layoffs during economic downturns, like our current one, were it not wasted in paying fines due to the behaviors of unscrupulous executives.)

The solution to this problem is straightforward. Deal with the individuals involved in the following manner:

Where the executives behind these abuses belong: jail


Time in jail for these executives is a needed remedy.

The following, however, is the situation we have:




This is inexcusable. Healthcare advocacy groups and relatives of those injured need to lobby for the solution proposed in the first picture: long, stiff sentences for those committing medical fraud and quackery by proxy in the form of these industry abuses.

Finally, the Pfizer scenario causes me to ask:

Is the leadership of this company competent to manage its operations? Or, is that leadership - for instance a CEO lacking science and biomedical education and experience - an "enabler" of the creative marketing for drugs -- creative advertising campaigns being seen as a virtue in his prior industry?

-- SS

Monday, September 7, 2009

Pfour Legal Settlements for Pfizer - Why is the Company "Recidivist?"

We recently posted about Pfizer's $2.3 billion dollar settlement with the US government (here), which we first mentioned six months ago (here). It is worth reviewing what we know about this settlement. We will start with quoted from the article by Gardiner Harris writing in the New York Times. We will also use quotes from other articles listed below:

A Big Settlement

(from the NYT)


The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.

It was the largest health care fraud settlement and the largest criminal fine of any kind ever.
The penalties include a very large criminal fine, an even larger civil fine, and a corporate integrity agreement (from the NYT).



Under the agreement with the Justice Department, Pfizer will pay a $1.3 billion criminal penalty related to Bextra and $1 billion in civil fines related to other medicines. In addition, a Pfizer subsidiary, Pharmacia and Upjohn, will plead guilty to violating the Food, Drug and Cosmetic Act for its promotion of Bextra. The company has agreed to sign another corporate integrity agreement that requires senior company executives to annually certify legal compliance and mandates that Pfizer post on its Web site many of its payments to doctors.
For Specific Unethical and Illegal Activities

The activities for which Pfizer incurred the penalties included marketing drugs for "off-label" indications for which the company did not have US Food and Drug Administration (FDA) approval, and other deceptive marketing practices (from the NYT).

The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain.

[Acting US Attorney for Massachusetts] Mr. Loucks, the prosecutor, accused Pfizer of aggressive marketing tactics.

'Among other things, Pfizer did the following: Pfizer invited doctors to consultant meetings, many in resort locations. Attendees expenses were paid; they received a fee just for being there,' he said. Such weekend getaways for doctors are still common throughout the drug and medical device industries.
Also, per the Newark Star-Ledger,



The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different from those the drugs had been approved for by federal regulators. Authorities said Pfizer's sales representatives often created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

The civil settlement covered Pfizer's promotions of Bextra, blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. The agreement with the Justice Department resolves the investigation into promotion of all those drugs, Pfizer said.

The government said Pfizer also paid kickbacks to market a host of big-name drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec.

Pfizer's Previous Unethical Behavior

Pfizer has previously been charged with unethical conduct, and the penalties it paid for this conduct did not seem to deter it (from the NYT).


It was Pfizer’s fourth settlement over illegal marketing activities since 2002.

'Among the factors we considered in calibrating this severe punishment was Pfizer’s recidivism,' said Michael K. Loucks, acting United States attorney for the Massachusetts district.

Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement — a companywide promise to behave.

Some more details of these settlements, from the Philadelphia Inquirer,


Repeat Offender: Previous Pfizer Settlements

April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.

October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.

On Health Care Renewal, we have posted about other instances of unethical behavior by Pfizer. Most recently, these included producing allegedly misleading direct to consumer (DTC) advertising about Lipitor (see post here), and conducting unethical research in Africa (see post here).

So it appears that Pfizer is, as the prosecutor put it above, recidivist. Why has the company repeatedly behaved unethically? One argument is that company executives have learned that the rewards of unethical behavior exceed its costs (thus, are responding to a form of perverse incentives.)

Perverse Incentives Favoring Unethical Behavior

The fines paid by Pfizer were not that large for a company of Pfizer's size (from the NYT).


While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.


In lieu of other punishments, the company's managers may just look upon paying fines as the cost of doing business. Per ABC News,



Industry insiders say drug companies often forgo legal considerations in favor of profit.

If companies, people or entities 'are able to make that decision and determine that there's an economic incentive to break the law, they'll break the law,' said Reuben Guttman, attorney for Glen Demott, a former Pfizer drug representative.

Change in a financially driven industry depends on whether a few billion dollars of penalty will affect the company's net profits or share costs. In 2008, Pfizer earned $48.3 billion in revenue.


Bloomberg commentator Ann Woolner said one reason the penalties have not been stiffer is that somehow the government views the company as too big to fail.



So how does Pfizer get away with civil settlements given its history? The penalties have ranged from hand slaps to a light punch in the gut, none of which have hurt the company enough for things to change. Last year Pfizer earned $8.1 billion on sales of $48.3 billion.

The New York-based company repeatedly winds up as the target of government accusations. Its misdeeds cost federal and state programs hundreds of millions of dollars, says the Justice Department, not to mention the human suffering that comes with taking the wrong drug in the wrong dosage.

But Pfizer is the pharmaceutical equivalent of insurance giant American International Group Inc., which was too interwoven into the global economy to be allowed to fail. Likewise, if Pfizer were convicted of a crime, it would face debarment from federal programs. And that would mean that Medicaid and Medicare patients would have to either somehow pay pocket for vital medicines the company produces or go without.

'You have to balance the desire, an appropriate desire, to punish the company against the harm to patients,' says attorney Kelton.


This begs the question about why no people, save for two relatively low level managers, no individuals paid any penalties. The unethical behaviors listed above must have been implemented by scores of line personnel, lead by mid-level managers. They, in turn, were acting at the behest of a hierarchy of managers and executives, culminating in "C-level" officers, lead by the CEO. Finally, these executives all reported, in theory at least, to the board of directors.

So almost none of the people responsible for the unethical activities paid any penalty. No individuals had to pay fines, or even lose their jobs, much less face criminal proceedings. Maybe the apparent ability of company personnel, starting with those in the trenches, all the way up through levels of management to the CEO, and thence to the board of directors to act with impunity has lead to a culture of amorality.

A Culture of Amorality

Some evidence that the culture of the company is pathologic comes from former Pfizer insiders charged that the comany's culture promotes unethical behavior (from the NYT).

John Kopchinski, a former Pfizer sales representative whose complaint helped prompt the government’s Bextra case, said that company managers told him and others to dismiss concerns about the Neurontin case while pushing them to undertake similar illegal efforts on behalf of Bextra.

'The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,' said Mr. Kopchinski


Also, per ABC News,



'At Pfizer, I was expected to increase profits at all costs, even when sales meant endangering lives,' Kopchinski said, in a statement. 'I couldn't do that.'

In light of the list of unethical behaviors documented above, that company leaders deny any big problems itself becomes a problem (from the NYT).

Amy W. Schulman, Pfizer’s general counsel, said that Pfizer had reformed — again.

'The reasons to trust Pfizer are because, as I have walked the halls at Pfizer, you would see that the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner,' she said.
Note that the majority of Pfizer employees may be ethical, but all it takes to accomplish unethical behavior is a few people in key leadership positions willingo to direct unethical activities to increase sales and profits, and for their subordinates to be willing to just follow orders.

Also, per a report in Bloomberg News, Ms Schulman added,

This gives us a very important opportunity to put final closure on the universe of material open items involving our U.S.-based operations.

This is a significant opportunity because it allows Pfizer to return its attention to the things that really should matter most to a biopharmaceutical company, which is the practice of developing innovative medications and bringing them to market in an appropriate fashion.

Summary: What is to be Done?

So will even a $2,300,000,000 settlement and yet another corporate integrity agreement make Pfizer or any other health care corporation act more ethically? I doubt it.

Remember, Pfizer may be a corporation, and thus be before the law a sort of pseudo-person. However, it is not really a person.

In this settlement, like others before it, it was people who implemented the behavior, made the decisions which lead to the behavior, and condoned the behavior. The people involved ranged from those in the trenches, through layers of management, to C-level executives, to the board of directors. In my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior.

Finally, I say again that we cannot improve health care until we address this sort of unethical behavior. As reported by ABC News,

'It won't make a dent if the conduct that led to the settlement is not addressed as part of health care reform,' said [Harvard Medical School faculty member Dr Jon]Abramson, who was the expert consultant for the plaintiff attorneys in the Bextra case in 2007.

'The real problem is this behavior is not isolated to Bextra nor Pfizer but in essence is the way the pharmaceutical industry expands the sales of its drugs,' Abramson said. 'Unless health care reform can address misrepresentations, withholding science and control claims made to consumers, Americans will continue to pay too much for health care that is not as effective and is expensive.'


PS - According to Bloomberg commentator Ann Woolner, one of the whistle-blowers in this case was a physician who noticed that a Pfizer drug representative was pushing him to use drugs off-label,

Pfizer Inc. sales folks had one tough customer in psychiatrist Stefan Kruszewski. He didn’t buy their pitch to prescribe the anti-psychotic drug Geodon to children, a use that hadn’t been approved by federal regulators.

Nor did he go for the so-called off-label uses they suggested, such as treating dementia in the elderly.

Kruszewski didn’t just say no. He went and checked the research and saw Geodon could have serious cardiac side effects not mentioned by the salesmen, who boasted of its relative safety, according to his lawyer, Brian Kenney. And he noticed that Pfizer was paying his peers to promote the drug to other psychiatrists.

But the worst for Pfizer was that Kruszewski didn’t keep it to himself. He found a lawyer, Kenney, who specializes in whistleblower cases, and they took what they had to the government.

So to all you physicians out there, this shows that you can succesfully blow the whistle on unethical practices by health care organizations. And you may even make some money doing so. Apparently several of the whistle-blowers in this case will get sizable payments under the US False Claims Act.

ADDENDUM (8 September, 2009) - See also comments by Alison Bass on the Alison Bass Blog, and by Dr Howard Brody on the Hooked: Medicine, Ethics and Pharma blog.

Friday, September 4, 2009

Captains Outrageous for Cape Anne's Health Care System

While on a brief vacation on lovely Cape Anne, Massachusetts, one of my daily automated Google searches provided an article of local interest. The person nominated to be CEO of the local hospital system had been at the center of controversy while in his previous position as leader of a hospital system in Cincinnatti, Ohio. When I got back, I put some relevant terms into Google, and lo and behold, came up with one of the more complicated and colorful, if unhappy stories about problems with health care leadership and goverance I have seen lately. So, to the tune of "lions and tigers and bears, oh my...."

Let me start with some background, and then to try to tell this story chronologically, noting issues as they came into public view. Northeast Health System is a regional hospital system in northeast Massachusets. It includes Addison Gilbert Hospital in Rockport, BayRidge Hospital in Lynn, and Beverly Hospital. Now bear with me through the amazing details.

Leadership Lacking in Transparency

The system's leadership seems to have recently inspired more than its share of controversy. Hints about the nature of the leadership problem appeared in an editorial in the Gloucester (MA) Daily Times in April, 2008.

Once again, Northeast Health System, the Beverly-based corporation that owns Gloucester's Addison Gilbert Hospital, is trying to have it both ways.

When it wants public support — including public money — it casts itself as serving the public. When it doesn't want the public looking into its affairs, it retreats behind the 'private corporation' wall.

That is not acceptable.

The latest example is Northeast's refusal to provide statistics on its diversion rate of patients from Addison Gilbert to Beverly Hospital during the past three years.


Although the editorial allowed that the diversion statistics might not prove to be that alarming, but


If there is not a problem here, the corporation is simply creating needless concern about it by its failure to be forthcoming.

Unfortunately, this is a continuing pattern for Northeast CEO Stephen Laverty, who apparently sees no problem with accepting subsidies of $500,000 from the state for two years running — subsidies secured in part through Tarr's efforts — but then ignoring reasonable requests for information about the corporation's operations, specifically as it pertains to Addison Gilbert.

Statistics on diversions should not be high-level trade secrets. Laverty must make Northeast more transparent.


Doctors Vote No Confidence

The pot really started to boil in May, 2008. At that point, as reported by the Boston Globe, its medical staff voted "no confidence" in CEO Stephen R Laverty:


In a private meeting, doctors at Beverly Hospital have taken a vote of no confidence in its chief executive, Stephen R. Laverty, citing frustration with his management.

The unusual step, made three weeks ago and acknowledged by hospital officials this week, was prompted by Laverty's alleged lack of communication and support in recent years, said several doctors who attended the April 29 meeting at the hospital.

'There's been a lot of cumulative dissatisfaction with how the physicians have been dealt with over a period of years in a variety of departments,' said Dr. Harriet A. Bering, an oncologist who was at the meeting. 'People had the same frustrations with incidents in which they hadn't been included in the decision-making process.'


A vote of no confidence, oh my. The article was not very specific about what lead to such an unusual step, but did note that doctors "accumulated grievances during Laverty's tenure. For instance, they said they were not properly consulted a few years ago when Beverly Hospital ended a successful cancer treatment program with North Shore Medical Center...." So this part of the story points to a hospital system management that does not see the need to communicate with and be transparent to dedicated health care professionals.

The Pregnancy Pact

In June, 2008, a story about a high school's unexpectedly high pregnancy rate and allegations that girls there entered into a "pregnancy pact" got international attention. The latter allegation was not proven, and although initial coverage did locate the story in Gloucester, MA (e.g., see the story in Time), the role of Northeast Health System was more obscure. Later we learned, in October, 2008, as reported in the Gloucester Times,


Addison Gilbert Hospital risked losing the state grant that pays for the operation of the Gloucester High School Health Center this spring when hospital leaders were reluctant to allow confidential access to birth control at the clinic, according to its former staff.

Debate about prescribing contraceptives erupted within a health center advisory board working on a response to the rise in teen pregnancies in Gloucester this year and turned public when the medical director and nurse practitioner resigned because representatives of Northeast Health Systems, the company that owns Addison Gilbert and runs the clinic, would not consider adding confidential prescription of contraceptives to the care offered.


A pregnancy pact, oh my. But this part of the story speaks to system management that seems unsympathetic to the concerns of its health professionals.

Nurses Vote No Confidence, and Allege a Punitive Culture and Intimidation; Vice President Accused of Art Theft

Also in October, 2008, the nurses also voted no confidence, again per the Gloucester Times in an editorial that provided more hints about the nature of the system's leadership problems,


Conflicts between Northeast Health System CEO Stephen Laverty and his subordinates are, unfortunately, nothing new.

By now, in fact, they have taken on a weary familiarity
. After persistent rumors of unrest, a group of subordinates goes public with their frustration and resentment of the CEO. This past week, it was the nurses union, with members at both Beverly Hospital and Gloucester's Addison Gilbert Hospital, that took a 'no confidence' vote in Laverty.

The union is now trying to pressure the board of trustees to fire him, saying Laverty has created a 'punitive organizational culture (with) ... oppressive management practices.' And a 2005 Beverly Hospital citation by OSHA, which surfaced along with the nurses' discontent, gives credence to that claim.

The nurses, of course, are not alone. This past April, it was doctors who took a no confidence vote. In 2006, the Massachusetts Nursing Association filed a formal complaint against Laverty for entering operating rooms unannounced to observe surgeries.

Yet, the response from Laverty is always the same — no response. And his spokespeople offer little more than vague references to 'challenges' and 'competing agendas,' concluding with how proud they all are of themselves.


The editorial allowed, "It's also true that, in any large business, especially one as competitive as health care, there are sure to be conflicts between management and labor." However,


Still, it has to concern the Northeast trustees that every time there is trouble or unrest, Laverty is at the center of it.

It should concern them that morale continues to sink under his style of leadership, which most subordinates agree is a mix of arrogance and intimidation. Effective leaders don't assert their authority by demeaning their subordinates. They lead by building people up, not tearing them down. They lead by inspiring, not breeding resentment.

The truth is, Northeast still inspires shaky confidence among Cape Ann residents for a variety of reasons, including the corporation's out-and-out refusal to share numbers regarding the number of ambulance transport "diversions" from Addison Gilbert to Beverly — and, more recently, Northeast's stewardship over Addison Gilbert's wonderful endowment of artwork.

The recent arrest of a former Beverly Hospital associate vice president — a reported friend of Laverty — on charges of stealing donated art and antiques worth more than $200,000 from the hospital, hardly inspires confidence. And public confidence is one of the most important assets any health care institution has, since its patients are entrusting their health and livelihoods to it.

At times like this, when the public starts asking questions about problems, Northeast officials tend to retreat behind the 'private corporation' wall. It is true that Northeast is not part of the public sector. But it regularly seeks donations from the public. It has received at least $1.5 million in state money, supposedly to support its services to the public, but somehow still finds enough money to pay Laverty well more than $600,000 a year.

The trustees surely should not take the nurses vote as the only credible word on Laverty. But they need to take it, along with other continuing conflicts, very seriously.


Another no confidence vote, a punitive organizational culture and oppressive management, arrogance and intimidation, and art theft, oh my. So here we have much more detail about bad management, punitive, oppressive, arrogant, and ruling by intimidation. We also have allegations of criminal behavior by top managers.

Wait, what was that, a vice president of the system arrested for stealing art from it? In November, 2008, the Boston Globe suggested Laverty's imminent departure, and added more about the art theft.


The current situation comes after years of increasing resentment between Laverty and hospital staff. His internal relationships at the hospital were also damaged by his longstanding association with Paul G. Galzerano, Beverly's former associate vice president for support services. Galzerano sometimes argued with staff members, according to longtime employees, and often threatened them based on his close association with Laverty, according to former nurses.

Galzerano, who left the hospital last year, was arrested in October by Groveland police, who alleged he stole paintings, a grandfather clock, and furniture from Beverly Hospital. The items were found in his home, according to police, who alleged they were stolen when the hospital was undergoing renovations. Galzerano could not be reached for comment yesterday.


Threats by allegedly an art thief, oh my.

Birthing Center Threatened with Closure

But Laverty's departure did not end the controversy. Also in November, 2008, the Boston Globe reported,


A proposal to cease all deliveries at the North Shore Birth Center in Beverly - one of only two hospital-affiliated centers statewide that offer natural birth options - has ignited a passionate protest from women across the region.

With a debate and potential vote by Beverly Hospital's board of trustees expected Tuesday morning, women have been picketing the hospital, circulating fliers, writing letters to board members, blogging and organizing on Facebook, where more than 500 members have already signed on to the campaign.


Service cuts, oh my. After the art work was stolen, the system decided to cut costs by reducing an apparently very popular service.

Specialty Service Cuts, Bed Cuts, and Board Conflicts


An eloquent letter to the Cape Anne Beacon in January, 2009, (and an abbreviated version in the Gloucester Times) by Ms Beverly Quint of Drumlin Road, Rockport, provided much more detail about the legacy of the leadership and governance problems at Northeast Health Systems:


Since November, I’ve heard a number of people say on line at the market, or greeting one another for coffee or waiting for a movie to start, 'Thank goodness he’s gone. Now we can get somewhere without the worry.'

At first I thought they might be talking about the presidential election, but it became clear that most of them felt that anyone leading the country at this time was not expected to perform feats of magic. Then I wondered if they were talking about Father Time, himself, the old guy with the flowing robe and the long beard. It has, in fact, been a year of plunging confidence and quiet desperation. No, people were talking of neither of these; people were and are talking about the exit of Stephen Laverty, the much-criticized CEO of Northeast Health Systems, the corporation that 14 years ago merged with Addison Gilbert Hospital, our community hospital.

I wish I could share my neighbors’ rejoicing at Mr. Laverty’s exit, but I am more worried than ever about the potential loss of our hospital, the lifeline for Cape Ann citizens, isolated as we are from the mainland, connected by two not-always-reliable bridges. Here’s why I’m more worried than ever:

When NEHS announced its merger with AGH, it declared that the merger would benefit both parties. Almost immediately, NEHS began to dismantle AGH, service by service. Nor has NEHS ever made available to the community a detailed accounting of its use of $2 million given by the state Department of Public Health for the protection of emergency surgical and anesthesiologist services at AGH. Here it should be added that NEHS has never given a detailed accounting to the community of other sums taken from AGH, in the form of income from investments, real estate and an art collection estimated at $4 million.

Having downsized AGH’s bed capacity by refusing to use the beds on Steele Two and having sent patients to Beverly for every or no reason and having closed several departments, what remains in Gloucester is a shell. Even as such, we can still call it our community hospital so long — and only so long — as it provides eight services all under one roof, eight services essential for retaining its license. Now even that status for AGH is at risk. And that is why I am more worried than ever. If those eight services go, we lose all — and now they are being plucked at by NEHS. We are at the tipping point, with or without Stephen Laverty.

Let me give you a few examples. One of the eight services essential to our hospital’s survival is the availability of a surgeon 24/7. Instead, NEHS, without announcing it, sends any patient whom they think might need surgery to Beverly Hospital. Till Jan. 1 of this year, we had only one general surgeon based on Cape Ann. Now, again without publicizing it, he will not be available on call for emergency services.

The same is true of anesthesiologists. Without publicizing it, NEHS has not recruited anesthesiologists for AGH, even as it has not recruited surgeons for AGH. This, despite the previously mentioned $2 million received from DPH for bolstering those specialties.

Availability of hospital beds is another of the eight essential services required for AGH to stay alive, but NEHS refuses to open medical-surgical beds on Steele Two, sending patients away from their families, over the bridge instead.

NEHS has also not made an effort to insist that specialists, such as pulmonologists, see hospitalized patients at AGH, but are insisting that patients, instead, be moved to Beverly. As a by-product, this means that patients’ family members — many elderly, many handicapped, many who do not drive —are deprived of a closeness, something that can be emotionally important to patients’ recovery.

For starters, the present board of trustees needs to be questioned on the very high percentage of trustees who are physicians and executives employed by NEHS.


Cuts in surgical and anesthesia services, cuts in beds, shifting of medical sub-specialty services, and conflicted board members, oh my. So whatever the management is doing, it is not increasing services. Also, Ms Quint's letter suggested that conflicted governance may be enabling bad management.

Can It All Be Blamed on the Previous CEO?

In another letter published only last month, in August, 2009, Ms Quint suggested that things had not changed much under an interim CEO,


Not only has the Board of Directors of Northeast ignored a petition by 8,000 Cape Ann residents begging Northeast to disclose its plans and make a commitment in writing. Not only has Northeast ignored a petition by Rockport residents at Town Meeting to be more interactive in commitment to this issue.

Not only has it ignored Rockport selectmen's request to report at regular meetings to which the public could have input
.

Not only has it snubbed overtures by state Sen. Bruce Tarr to meet regularly with his Task Force, it has systematically downsized, downsized, downsized Addison Gilbert.

Some of this has been ascribed to the particularly tyrannical nature of former Northeast CEO Stephen Laverty. Yet here is a most recent example that belies Mr. Laverty's personality as the supreme cause of the problems. On July 28, Dr. Henry Ramini, interim replacement for Mr. Laverty, spoke to Rockport selectmen on the status of Addison Gilbert. Did you know Dr. Ramini would be there? Nobody seemed to know.

Even the selectmen — one of whom, I understand, had been on vacation — seemed unprepared to publicize Dr. Ramini's appearance. What I later learned from people who happened to hear Dr. Ramini was that he is a much kinder, gentler appearing person than his predecessor. However, the content of his presentation was not particularly reassuring: He urged the town of Rockport to be nice to any future doctors who might deign to seek employment here.


Again, the suggestion is that there are systemic problems with governance and leadership

"An Ugly Set of Facts"

And that will bring us up to the story that my automated search produced. The candidate to be the new Northeast Health System CEO also has his issues. Per the Gloucester Times from August, 2009,


The man in line to become the next CEO of Northeast Health System is leaving behind a crumbling hospital system in Ohio that has been plagued by lawsuits and controversy.

Supporters of Kenneth Hanover say he does not deserve blame for the breakup of the Health Alliance, a $1.4 billion corporation that he served as president and chief executive officer.

But in two court decisions, judges ruled that the Health Alliance and Hanover failed to live up to a legal obligation to act for the benefit of two of its hospitals, improperly used 'enormous sums' of money to fight the lawsuit and gave bonuses to doctors to prevent them from working at those hospitals.

'The record is replete with evidence that the Alliance breached its fiduciary
to (The Christ Hospital),' Judge Ralph Winkler wrote in his decision last year for the Ohio Court of Appeals.

Considering the turmoil surrounding Laverty's tenure at Northeast Health System, it might seem surprising that the organization would replace him with a man with such a controversial background of his own.

The breakup of the Health Alliance became so acrimonious that the Ohio attorney general's office stepped in. In July 2007, in the midst of the legal battle, the chairman of Christ Hospital wrote a letter calling for Hanover to be replaced.

Monica Rimai, the interim president at the University of Cincinnati and a former Health Alliance board member, acknowledged that the lawsuit and the breakup constitute 'an ugly set of facts and we lost.'

Robert Weigel, chairman of Fort Hamilton Hospital, which is in the processing of withdrawing from the Alliance, said Hanover is "one of the smartest men I know." He also said Hanover has a forceful manner than can rub some people the wrong way.

"I have a lot of respect for his abilities and his thinking, but he can be tough to deal with," said Weigel....


An ugly set of facts about the new CEO, oh my. One wonders if the NEHS board had investigated its new CEO candidate's previous performance. On the other hand, maybe the board is most comfortable with CEOs that are "tough [for others] to deal with."

Pregnancy pacts, art theft, no confidence votes, punitive corporate culture, threats and intimidation, closed wards and clinics, slashed services, oh my. You just can't make this stuff up.

On a slightly more sober note, the curious case of Northeast Health Systems is a good example of how governance and leadership can go wrong, and the downstream effect on health services.

Reorganizing the colorful facts above, we seem to start with poor governance, possibly by a conflicted board (per Ms Quint). That board seems most comfortable with aggressive leaders who seem more intent on imposing their will on dedicated, professional staff, rather than working collaboratively, and hiding behind a veil of corporate secrecy, rather than providing the transparency appropriate for a not-for-profit organization whose mission is to to serve the community. Meanwhile, services of all kinds decline, while the community that once supported the organization now regards it with suspicion and alarm.

The current debate about health care reform has focused - to the extent it has focused on anything - on financing and insurance. As we have said many times before, we cannot fix the health care crisis simply by changing financing mechanisms or money flows.

We can only improve health care by improving the leadership and governance of health care organizations, and by rethinking the size and scope of health care organizations. The most crucial part of health care is what goes on between individual health care professionals and individual patients. Yet our system is composed of endlessly enlarging bureaucracies run by self-interested, often clueless, and sometimes dishonest, if not criminal leaders. This must change, unless we want this crisis to get much, much worse.

The title of this post is a weakly satirical bow to the Rudyard Kipling novel set partially in Gloucester, MA.