Intermune Executive Convicted of Fraud

From today's New York Times comes word of an unusual legal case,

In a verdict that could strike fear into pharmaceutical industry executive suites, the former head of a drug company was convicted of wire fraud Tuesday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug.

But the executive, W. Scott Harkonen, the former chief executive of InterMune, was acquitted by the federal jury in San Francisco of a related charge of off-label marketing itself, known as 'misbranding,' the Justice Department said.

The case was unusual because off-label marketing cases are often settled with the company paying a fine. It is rare for prosecutors to press charges against individual executives.

'Today’s verdict demonstrates that pharmaceutical executives will not be able to hide behind a corporate shield when they promote drugs using false or fraudulent information,' Thomas P. Doyle, a special agent in the Food and Drug Administration’s office of criminal investigations, said in a statement Tuesday.

InterMune’s drug, Actimmune, was approved for two rare genetic conditions. But the main sales of the drug, which peaked at $141million in 2003, came from an unapproved use: treating idiopathic pulmonary fibrosis, a scarring of the lungs that can be fatal.

InterMune conducted a large clinical trial testing Actimmune as a treatment for the lung disease. The drug did not achieve the goal of the trial, which was to improve lung function compared with a placebo. But InterMune found that if only the patients in the trial with mild or moderate disease were considered, those who got the drug lived longer than those who received the placebo. The company highlighted the 'survival benefit' in a news release, issued in August 2002. [Editor's note - if the primary study outcome was improvement of lung function, and the only 'positive' result was improvement of survival in one sub-group, that result may have been due to chance alone, due to multiple statistical comparisons. If one does analyses on multiple sub-groups and for multiple endpoints, the likelihood of finding a 'significant' result increases with the number of such analyses done.]

Prosecutors said the news release was part of a scheme to induce off-label sales of Actimmune, also known as interferon gamma, which costs about $50,000 a year.

[The company's attorney] Mr. Topel said interpretation of the clinical trial results was a matter of debate. 'One position in a scientific dispute has been criminalized — quite an astonishing thing,' Mr. Topel said in an interview.

Wire fraud carries a maximum sentence of 20 years in prison and a $250,000 fine. Dr. Harkonen, who remains free on bail, has not been sentenced.

A medical doctor by training, he was chief executive of InterMune from February 1998 until June 2003.

InterMune agreed to pay about $37 million in 2006 to settle charges related to Actimmune marketing. The company, based in Brisbane, Calif., also entered into a five-year corporate integrity agreement with the Department of Health and Human Services.

In 2007, a second big trial of Actimmune found that the drug did not prolong lives of patients with pulmonary fibrosis. Sales of the drug have dwindled year by year. [Editor's note - this suggests again that the result in the sub-group from the first trial might have been a false positive due to multiple comparisons.]

This case is unusual because it involved the prosecution of an individual who appeared to be responsible for the allegedly unlawful conduct. In most cases of unethical or unlawful conduct alleged on the part of health care organizations, at most it is the organization itself that has paid the penalty, usually in the form of a fine, sometimes accompanied by a corporate integrity agreement or deferred prosecution agreement. (See relevant posts here.)

We have argued that such penalties applied to corporations do little to deter bad behavior. A fine can just be a cost of doing business. The cost of the fine may diffuse across the whole organization. For public for-profit corporations, the fine may finally be paid by stockholders (through lower dividends or lower stock appreciation), employees as a group (through lower pay), and customers, clients, or patients (through higher prices). So the penalty may ultimately be spread over a large number of people, hardly any of which were actually responsible for the bad behavior. The few people responsible, who could include people who implemented, directed, or approved the behavior, usually have suffered no consequences. So what is to deter such people from again behaving badly?

So this case seems to be a step forward. One may argue whether off-label marketing should be illegal, but it currently is illegal. Corporate leaders who do not like this law ought to strive to change it, not violate it. If the law is to be upheld, when someone within a corporation implements, directs or approved illegal off-label marketing, then that person should suffer the consequences.

Malocclusion: Disease of Civilization

In his epic work Nutrition and Physical Degeneration, Dr. Weston Price documented the abnormal dental development and susceptibility to tooth decay that accompanied the adoption of modern foods in a number of different cultures throughout the world. Although he quantified changes in cavity prevalence (sometimes finding increases as large as 1,000-fold), all we have are Price's anecdotes describing the crooked teeth, narrow arches and "dished" faces these cultures developed as they modernized.

Price published the first edition of his book in 1939. Fortunately, Nutrition and Physical Degeneration wasn't the last word on the matter. Anthropologists and archaeologists have been extending Price's findings throughout the 20th century. My favorite is Dr. Robert S. Corruccini, currently a professor of anthropology at Southern Illinois University. He published a landmark paper in 1984 titled "An Epidemiologic Transition in Dental Occlusion in World Populations" that will be our starting point for a discussion of how diet and lifestyle factors affect the development of the teeth, skull and jaw (Am J. Orthod. 86(5):419)*.

First, some background. The word occlusion refers to the manner in which the top and bottom sets of teeth come together, determined in part by the alignment between the upper jaw (maxilla) and lower jaw (mandible). There are three general categories:

• Class I occlusion: considered "ideal". The bottom incisors (front teeth) fit just behind the top incisors.
• Class II occlusion: "overbite." The bottom incisors are too far behind the top incisors. The mandible may appear small.
  
• Class III occlusion: "underbite." The bottom incisors are beyond the top incisors. The mandible protrudes.
  

Malocclusion means the teeth do not come together in a way that's considered ideal. The term "class I malocclusion" is sometimes used to describe crowded incisors when the jaws are aligning properly.

Over the course of the next several posts, I'll give an overview of the extensive literature showing that hunter-gatherers past and present have excellent occlusion, subsistence agriculturalists generally have good occlusion, and the adoption of modern foodways directly causes the crooked teeth, narrow arches and/or crowded third molars (wisdom teeth) that affect the majority of people in industrialized nations. I believe this process also affects the development of the rest of the skull, including the face and sinuses.

In his 1984 paper, Dr. Corruccini reviewed data from a number of cultures whose occlusion has been studied in detail. Most of these cultures were observed by Dr. Corruccini personally. He compared two sets of cultures: those that adhere to a traditional style of life and those that have adopted industrial foodways. For several of the cultures he studied, he compared it to another that was genetically similar. For example, the older generation of Pima indians vs. the younger generation, and rural vs. urban Punjabis. He also included data from archaeological sites and nonhuman primates. Wild animals, including nonhuman primates, almost invariably show perfect occlusion.

The last graph in the paper is the most telling. He compiled all the occlusion data into a single number called the "treatment priority index" (TPI). This is a number that represents the overall need for orthodontic treatment. A TPI of 4 or greater indicates malocclusion (the cutoff point is subjective and depends somewhat on aesthetic considerations). Here's the graph: Every single urban/industrial culture has an average TPI of greater than 4, while all the non-industrial or less industrial cultures have an average TPI below 4. This means that in industrial cultures, the average person requires orthodontic treatment to achieve good occlusion, whereas most people in more traditionally-living cultures naturally have good occlusion.

The best occlusion was in the New Britain sample, a precontact Melanesian hunter-gatherer group studied from archaeological remains. The next best occlusion was in the Libben and Dickson groups, who were early Native American agriculturalists. The Pima represent the older generation of Native Americans that was raised on a somewhat traditional agricultural diet, vs. the younger generation raised on processed reservation foods. The Chinese samples are immigrants and their descendants in Liverpool. The Punjabis represent urban vs. rural youths in Northern India. The Kentucky samples represent a traditionally-living Appalachian community, older generation vs. processed food-eating offspring. The "early black" and "black youths" samples represent older and younger generations of African-Americans in the Cleveland and St. Louis area. The "white parents/youths" sample represents different generations of American Caucasians.

The point is clear: there's something about industrialization that causes malocclusion. It's not genetic; it's a result of changes in diet and/or lifestyle. A "disease of civilization". I use that phrase loosely, because malocclusion isn't really a disease, and some cultures that qualify as civilizations retain traditional foodways and relatively good teeth. Nevertheless, it's a time-honored phrase that encompasses the wide array of health problems that occur when humans stray too far from their ecological niche. I'm going to let Dr. Corruccini wrap this post up for me:

I assert that these results serve to modify two widespread generalizations: that imperfect occlusion is not necessarily abnormal, and that prevalence of malocclusion is genetically controlled so that preventive therapy in the strict sense is not possible. Cross-cultural data dispel the notion that considerable occlusal variation [malocclusion] is inevitable or normal. Rather, it is an aberrancy of modern urbanized populations. Furthermore, the transition from predominantly good to predominantly bad occlusion repeatedly occurs within one or two generations' time in these (and other) populations, weakening arguments that explain high malocclusion prevalence genetically.

* This paper is worth reading if you get the chance. It should have been a seminal paper in the field of preventive orthodontics, which could have largely replaced conventional orthodontics by now. Dr. Corruccini is the clearest thinker on this subject I've encountered so far.

Malocclusion: Disease of Civilization

In his epic work Nutrition and Physical Degeneration, Dr. Weston Price documented the abnormal dental development and susceptibility to tooth decay that accompanied the adoption of modern foods in a number of different cultures throughout the world. Although he quantified changes in cavity prevalence (sometimes finding increases as large as 1,000-fold), all we have are Price's anecdotes describing the crooked teeth, narrow arches and "dished" faces these cultures developed as they modernized.

Price published the first edition of his book in 1939. Fortunately, Nutrition and Physical Degeneration wasn't the last word on the matter. Anthropologists and archaeologists have been extending Price's findings throughout the 20th century. My favorite is Dr. Robert S. Corruccini, currently a professor of anthropology at Southern Illinois University. He published a landmark paper in 1984 titled "An Epidemiologic Transition in Dental Occlusion in World Populations" that will be our starting point for a discussion of how diet and lifestyle factors affect the development of the teeth, skull and jaw (Am J. Orthod. 86(5):419)*.

First, some background. The word occlusion refers to the manner in which the top and bottom sets of teeth come together, determined in part by the alignment between the upper jaw (maxilla) and lower jaw (mandible). There are three general categories:

• Class I occlusion: considered "ideal". The bottom incisors (front teeth) fit just behind the top incisors.
• Class II occlusion: "overbite." The bottom incisors are too far behind the top incisors. The mandible may appear small.
  
• Class III occlusion: "underbite." The bottom incisors are beyond the top incisors. The mandible protrudes.
  

Malocclusion means the teeth do not come together in a way that's considered ideal. The term "class I malocclusion" is sometimes used to describe crowded incisors when the jaws are aligning properly.

Over the course of the next several posts, I'll give an overview of the extensive literature showing that hunter-gatherers past and present have excellent occlusion, subsistence agriculturalists generally have good occlusion, and the adoption of modern foodways directly causes the crooked teeth, narrow arches and/or crowded third molars (wisdom teeth) that affect the majority of people in industrialized nations. I believe this process also affects the development of the rest of the skull, including the face and sinuses.

In his 1984 paper, Dr. Corruccini reviewed data from a number of cultures whose occlusion has been studied in detail. Most of these cultures were observed by Dr. Corruccini personally. He compared two sets of cultures: those that adhere to a traditional style of life and those that have adopted industrial foodways. For several of the cultures he studied, he compared it to another that was genetically similar. For example, the older generation of Pima indians vs. the younger generation, and rural vs. urban Punjabis. He also included data from archaeological sites and nonhuman primates. Wild animals, including nonhuman primates, almost invariably show perfect occlusion.

The last graph in the paper is the most telling. He compiled all the occlusion data into a single number called the "treatment priority index" (TPI). This is a number that represents the overall need for orthodontic treatment. A TPI of 4 or greater indicates malocclusion (the cutoff point is subjective and depends somewhat on aesthetic considerations). Here's the graph: Every single urban/industrial culture has an average TPI of greater than 4, while all the non-industrial or less industrial cultures have an average TPI below 4. This means that in industrial cultures, the average person requires orthodontic treatment to achieve good occlusion, whereas most people in more traditionally-living cultures naturally have good occlusion.

The best occlusion was in the New Britain sample, a precontact Melanesian hunter-gatherer group studied from archaeological remains. The next best occlusion was in the Libben and Dickson groups, who were early Native American agriculturalists. The Pima represent the older generation of Native Americans that was raised on a somewhat traditional agricultural diet, vs. the younger generation raised on processed reservation foods. The Chinese samples are immigrants and their descendants in Liverpool. The Punjabis represent urban vs. rural youths in Northern India. The Kentucky samples represent a traditionally-living Appalachian community, older generation vs. processed food-eating offspring. The "early black" and "black youths" samples represent older and younger generations of African-Americans in the Cleveland and St. Louis area. The "white parents/youths" sample represents different generations of American Caucasians.

The point is clear: there's something about industrialization that causes malocclusion. It's not genetic; it's a result of changes in diet and/or lifestyle. A "disease of civilization". I use that phrase loosely, because malocclusion isn't really a disease, and some cultures that qualify as civilizations retain traditional foodways and relatively good teeth. Nevertheless, it's a time-honored phrase that encompasses the wide array of health problems that occur when humans stray too far from their ecological niche. I'm going to let Dr. Corruccini wrap this post up for me:

I assert that these results serve to modify two widespread generalizations: that imperfect occlusion is not necessarily abnormal, and that prevalence of malocclusion is genetically controlled so that preventive therapy in the strict sense is not possible. Cross-cultural data dispel the notion that considerable occlusal variation [malocclusion] is inevitable or normal. Rather, it is an aberrancy of modern urbanized populations. Furthermore, the transition from predominantly good to predominantly bad occlusion repeatedly occurs within one or two generations' time in these (and other) populations, weakening arguments that explain high malocclusion prevalence genetically.

* This paper is worth reading if you get the chance. It should have been a seminal paper in the field of preventive orthodontics, which could have largely replaced conventional orthodontics by now. Dr. Corruccini is the clearest thinker on this subject I've encountered so far.

Diabetics on a Low-carbohydrate Diet, Part II

I just found another very interesting study performed in Japan by Dr. Hajime Haimoto and colleagues (free full text). They took severe diabetics with an HbA1c of 10.9% and put them on a low-carbohydrate diet:

The main principle of the CRD [carbohydrate-restricted diet] was to eliminate carbohydrate-rich food twice a day at breakfast and dinner, or eliminate it three times a day at breakfast, lunch and dinner... There were no other restrictions. Patients on the CRD were permitted to eat as much protein and fat as they wanted, including saturated fat.

What happened to their blood lipids after eating all that fat for 6 months, and increasing their saturated fat intake to that of the average American? LDL decreased and HDL increased, both statistically significant. Oops. But that's water under the bridge. What we really care about here is glucose control. The patients' HbA1c (glycated hemoglobin; a measure of average blood glucose over the past several weeks) declined from 10.9 to 7.4%.

Here's a graph showing the improvement in HbA1c. Each line represents one individual:

Every single patient improved, except the "dropout" who stopped following the diet advice after 3 months (the one line that shoots back up at 6 months). And now, an inspirational anecdote from the paper:

One female patient had an increased physical activity level during the study period in spite of our instructions. However, her increase in physical activity was no more than one hour of walking per day, four days a week. She had implemented an 11% carbohydrate diet without any antidiabetic drug, and her HbA1c level decreased from 14.4% at baseline to 6.1% after 3 months and had been maintained at 5.5% after 6 months.

That patient began with the highest HbA1c and ended with the lowest. Complete glucose control using only diet and exercise. It may not work for everyone, but it's effective in some cases. The study's conclusion:

...the 30%-carbohydrate diet over 6 months led to a remarkable reduction in HbA1c levels, even among outpatients with severe type 2 diabetes, without any insulin therapy, hospital care or increase in sulfonylureas. The effectiveness of the diet may be comparable to that of insulin therapy.

Diabetics on a Low-carbohydrate Diet
The Tokelau Island Migrant Study: Diabetes

Diabetics on a Low-carbohydrate Diet, Part II

I just found another very interesting study performed in Japan by Dr. Hajime Haimoto and colleagues (free full text). They took severe diabetics with an HbA1c of 10.9% and put them on a low-carbohydrate diet:

The main principle of the CRD [carbohydrate-restricted diet] was to eliminate carbohydrate-rich food twice a day at breakfast and dinner, or eliminate it three times a day at breakfast, lunch and dinner... There were no other restrictions. Patients on the CRD were permitted to eat as much protein and fat as they wanted, including saturated fat.

What happened to their blood lipids after eating all that fat for 6 months, and increasing their saturated fat intake to that of the average American? LDL decreased and HDL increased, both statistically significant. Oops. But that's water under the bridge. What we really care about here is glucose control. The patients' HbA1c (glycated hemoglobin; a measure of average blood glucose over the past several weeks) declined from 10.9 to 7.4%.

Here's a graph showing the improvement in HbA1c. Each line represents one individual:

Every single patient improved, except the "dropout" who stopped following the diet advice after 3 months (the one line that shoots back up at 6 months). And now, an inspirational anecdote from the paper:

One female patient had an increased physical activity level during the study period in spite of our instructions. However, her increase in physical activity was no more than one hour of walking per day, four days a week. She had implemented an 11% carbohydrate diet without any antidiabetic drug, and her HbA1c level decreased from 14.4% at baseline to 6.1% after 3 months and had been maintained at 5.5% after 6 months.

That patient began with the highest HbA1c and ended with the lowest. Complete glucose control using only diet and exercise. It may not work for everyone, but it's effective in some cases. The study's conclusion:

...the 30%-carbohydrate diet over 6 months led to a remarkable reduction in HbA1c levels, even among outpatients with severe type 2 diabetes, without any insulin therapy, hospital care or increase in sulfonylureas. The effectiveness of the diet may be comparable to that of insulin therapy.

Diabetics on a Low-carbohydrate Diet
The Tokelau Island Migrant Study: Diabetes

The Kelo Case Redux: Pfizer's "Nice Place" Ends Up Covered with Weeds

Four years ago we posted (here, here and here) about the controversial US Supreme Court decision in the Kelo case. Most discussion of the case at the time focused on individual property rights vs the power of the government to promote economic development, but the case had an important health care angle.

Briefly, the case centered on the taking of private property, including a house owned by Susette Kelo, by a not-for-profit organization, the New London (Connecticut) Development Corporation (NLDC) given the power of eminent domain by the New London city government. While the ostensible rationale for the taking was economic development, the action appeared to have been at the behest of Pfizer Inc, the world's largest pharmaceutical company, which had built a research and development facility in the city, and wanted a suitably upscale and sanitized environment for its workers.

As we previously posted, the NLDC's leadership had multiple conflicts of interest that involved ties to Pfizer. One board member was a Pfizer vice-president. The board president was married to another Pfizer vice-president. Pfizer wanted the part of New London that included Kelo's house made more attractive to complement its new research facility. The husband of the NLDC president had said, "Pfizer wants a nice place to operate. We don't want to be surrounded by tenements."

Kelo's and other property owners' protest of the taking went all the way to the US Supreme Court. As we posted here, the Court decided against the property owners by a 5-4 vote. Justice John Paul Stevens wrote for the majority that the city's "determination that the area was sufficiently distressed to justify a program of economic rejuvenation is entitled to our deference. The city has carefully formulated an economic development plan that it believes will provide appreciable benefits to the community, including - but by no means limited to - jobs and increased revenues." This majority opinion is important, because the Fifth Amendment to the US Constitution provides "nor shall private property be taken for public use without just compensation." Many had interpreted this provision to mean that eminent domain could only be used to take property for public use, e.g., to build a road or a public school, but not for private purposes, like building upscale waterfront developments.

The Associated Press just published an ironic follow-up.

Weeds, glass, bricks, pieces of pipe and shingle splinters have replaced the knot of aging homes at the site of the nation's most notorious eminent domain project.

There are a few signs of life: Feral cats glare at visitors from a miniature jungle of Queen Anne's lace, thistle and goldenrod. Gulls swoop between the lot's towering trees and the adjacent sewage treatment plant.

But what of the promised building boom that was supposed to come wrapped and ribboned with up to 3,169 new jobs and $1.2 million a year in tax revenues? They are noticeably missing.

What happened?

New London the city's prized economic development plan has fallen apart as the economy crumbled.

The Corcoran Jennison Cos., a Boston-based developer, had originally locked in exclusive rights to develop nearly the entire northern half of the Fort Trumbull peninsula.

But those rights expired in June 2008, despite multiple extensions, because the firm was unable to secure financing, according to President Marty Jones.

So that was the result of the economic development plan the Supreme Court majority termed "carefully formulated." The lesson seems to be that when government makes policy to favor individual corporations, the results are bad policy and little public benefit. Government leaders often seem willing to favor specific health care organizations, rationalizing their actions in terms of economic development or promoting health and health care. Doing so may benefit the corporations involved, but rarely individual or public health.

Although US local and national government officials have have increasingly practiced such corporate socialism, they have neglected their regulatory roles. Instead of picking winners and losers, government would do better to act like a combination of an honest policeman on the beat, deterring and punishing dishonest behavior, and in impartial referee, trying to make sure everyone is playing the game honestly. But no doubt government officials used to mingling with the corporate superclass would not be comfortable in the roles of honest cop or impartial referee.

Malpractices of the multitude revisited: "An outstanding job of educating themselves about clinical issues"

At numerous posts at Healthcare Renewal, we have pointed out what we feel to be a serious gap in the credentials of many in biomedical leadership roles.

The gaps are in the form of a near complete lack of any scientific or biomedical education and experience, except perhaps a high school chemistry and biology class or two.

We often receive comments back, usually from "anonymous" posters such as here to our opinions that this expertise gap impairs the judgment of such leaders on medical matters:

... No. I've met individuals with management training who do an outstanding job of educating themselves about clinical issues. And I've met individuals with clinical training who do an outstanding job of educating themselves about management and business issues.

I feel this "anyone can be an expert" sentiment is an important issue to bring outside of the comments section of our posts.

I raised probing questions in response to such messages here in my post "More On Healthcare Management By Domain Neutral Generalists: CIO's Running Hospital Pharmacies and Home Healthcare Divisions?"

Here are my most recent questions to the above anonymous medical self-education proponent:

Re: "I've met individuals with management training who do an outstanding job of educating themselves about clinical issues."

What, exactly, is it that individuals with management training who do an outstanding job of "educating themselves about clinical issues" are professionally or even reasonably qualified to do?

Could they pass medical boards?

Could they reasonably interpret a complex medical article in, say, The Annals, and make truly informed, wise decisions based on that reading?

Could they reasonably evaluate therapeutic alternatives in complex cases, say, someone with a new heart valve who's just developed fever and a lower GI bleed?

In an emergency could they provide medical care? (mot in the legal sense, just in the skills sense.)

If not, why not, and what do you mean by "outstanding job?"

In comparison, I have no MBA or formal business training (other than working for years in my father's pharmacy as a stocker and cashier) but did a good job managing a department of 50+ and a budget of $13 million for an international pharma, solving severe business problems that had been impairing R&D and managing my budget consistently to within 0.5% of EA.

Is there perhaps an asymmetry between medicine and business?

Finally, I ask:

What percentage of a typical medical training curriculum (such as for a Pharm.D. here or a physician here) can a person with a management background absorb through self-education, and is the medical training curriculum therefore irrelevant? Should we just go back to the days of self-trained practitioners? If not, why not?

The critically thought-out answers to these questions expose the territorial invasion of medicine by ill-suited outsiders and dilettantes quite well.

Echoing an observation I wrote about once before in my eight part series on mission hostile EMR's, but addressing it to medical administration where it also applies:

Medical administration reminds me of dentistry in its early days, especially when medical administrators lacking biomedical expertise refer to themselves as "medical professionals."

B.T. Longbothom, author of the second dentistry book published in the U.S. ("A Treatise on Dentistry", 1802), gave an excellent description in his preface of problems at the time. His observations apply to medical administration in our present age:

The word "dentist" has been so infamously abused by ignorant pretenders, and is in general so indifferently understood, that I cannot forbear giving what I conceive to be its original meaning: viz, the profession of one who undertakes and is capable not only of cleaning, extracting, replacing by transplantation and making artificial teeth, but can also from his knowledge of dentistry, preserve those that remain in good condition, prevent in a very great degree, those that are loose, or those that are in a decayed state, from being further injured, and can guard against the several diseases, to which the teeth, gums and mouth are liable, a knowledge none but those regularly instructed, and who have had a long, and extensive practice, can possibly attain, but which is absolutely necessary, to complete the character of a Surgeon Dentist.

Hardly anyone spoke out.

More than thirty years later, untrained practitioners were as prevalent as ever. One of the leading dentists of the time, Shearjashub Spooner, in his "Guide to Sound Teeth, or, A Popular Treatise on the Teeth" (1836) warned the public of a phenomenon I believe now applies to medical administration:

One thing is certain, this profession must either rise or sink. If means are not taken to suppress and discountenance the malpractices of the multitude of incompetent persons, who are pressing into it, merely for the sake of its emoluments, it must sink, - for the few competent and well educated men, who are now upholding it, will abandon a disreputable profession, in a country of enterprise like ours, and turn their attention to some other calling more congenial to the feelings of honorable and enlightened men.

I understand that point of view.

-- SS

Congress expects physicians to implement EHR's when they can't post a PDF on the web?

Congress expects physicians to implement EHR's and review patient histories in detail, when they can't even review their own bills before acting, and post a PDF on the web?

This has to be the lamest, most inept, and/or most patronizing Congress in history (with approval ratings to match, 16% as of Sept. 25 according to Rasmussen):

Washington Examiner
Baucus claims it's too difficult to put health care bill online
By: BARBARA HOLLINGSWORTH
09/24/09

A proposal by Sen. Jim Bunning, R-Ky., that would have required the Senate Finance Committee to post the final language of the $900 billion health care reform bill, as well as a Congressional Budget Office cost analysis, on the committee’s website for 72 hours prior to a vote was rejected 12-11.

... Chairman Max Baucus, D-Mont., himself admitted that “This probably sounds a little crazy to some people that we are voting on something before we have seen legislative language.” Indeed.

Baucus’ excuse - that it would take his committee staff two weeks to post the bill online – sounds a little crazy too.

This very same Congress is pushing physicians to implement EHR's under penalty of Medicare payment reductions, while they claim an inability to post a PDF or Word document online. Implementing EHR's is only several orders of magnitude more complex...

Or, perhaps the "inability" to post the text has to do with text that appears at pages 80-81 of the bill:

"Beginning in 2015, payment [under Medicare] would be reduced by five percent if an aggregation of the physician's resource use is at or above the 90th percentile of national utilization." Thus, in any year in which a particular doctor's average per-patient Medicare costs are in the top 10 percent in the nation, the feds will cut the doctor's payments by 5 percent."

As in the Washington Times:

This provision makes no account for the results of care, its quality or even its efficiency. It just says that if a doctor authorizes expensive care, no matter how successfully, the government will punish him by scrimping on what already is a low reimbursement rate for treating Medicare patients. The incentive, therefore, is for the doctor always to provide less care for his patients for fear of having his payments docked.

And because no doctor will know who falls in the top 10 percent until year's end, or what total average costs will break the 10 percent threshold, the pressure will be intense to withhold care, and withhold care again, and then withhold it some more. Or at least to prescribe cheaper care, no matter how much less effective, in order to avoid the penalties.

No metrics on quality of care, outcomes, patient satisfaction, or other aspects of the complex process of medical care are apparently involved. Just an "aggregation of the physician's resource use."

May I use the words "capricious and arbitrary" to describe this metric?

Now, we should ask:

• Is this what our government means by "data driven healthcare?"
• Do they realize the likely adverse consequences of such half-baked measures?
• Are those who would propose such a bill friends of patients, and friends of physicians?

Where have I seen this before? (How about: biomedical dilettantes helping impair R&D at a pharmaceutical company, now in sale mode due to a poor pipeline of new drugs, through cutting drug discovery resources on the simplistic metric of "cost per user per database?")

Ultimately, this Medicare strategy is the end result of allowing medical dilettantes (no matter how well they've "self educated" themselves about medicine) to control the playing field. It is a poster example of a perverse incentive in direct conflict with the obligation of physicians to provide the best care.

In the end, patients and physicians get screwed.

-- SS

GHOSTING MATILDA

The fall season is upon us and the markets are filled with advertising for Halloween, so our thoughts naturally turn to the recent stories of ghostwriting in medical journals. Here is a lighthearted take on that topic. This parody began on Margaret Soltan’s blog a few days ago, and it has just kept growing.

GHOSTING MATILDA

Once a jolly bagman signed on to some articles.
Corporate ghosts even promised him a fee.
And he sang as he watched and waited till they were in print,
These will be grand right up there on my CV.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
And he sang as he watched and waited till they were in print,
These will be grand right up there on my CV.

This month it’s Janssen, next it’s Bristol-Myers Squibb.
Wyeth and Lilly soon might want to talk to me.
Novartis might sign me up, also AstraZeneca ─
Soon I’ll be famous like that guy at Emory.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
Novartis might sign me up, also AstraZeneca ─
Soon I’ll be famous like that guy at Emory.

Up came an editor, looking for the telltale signs.
Ghost writing’s hard to cover up, you see.
And he found them in the documents: metadata do not lie ─
Bagman just sold his name and passed these off on me.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
And he found them in the documents: metadata do not lie ─
Bagman just sold his name and passed these off on me.

Up jumped the bagman, pointing fingers right and left,
You’ll never prove that I lied, said he.
I will say that underlings failed to send disclosure forms;
Let them be blamed instead, while I get off scot-free.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
I will say that underlings failed to send disclosure forms;
Let them be blamed instead, while I get off scot-free.

Out! said the editor, you’re now persona non grata.
So, too, the Dean and the Provost agreed.
Bagman’s ghost may be heard now, sighing in the library ─
Could have been grand right up there on my CV.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
Bagman’s ghost may be heard now, sighing in the library ─
Could have been grand right up there on my CV.

The Reappearance of a Ghost of Seasons Past

About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest. The early posts were here, here, here, and here. In this post, we summarized the case thus:

• Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) under a contract between P&G and the University.
• Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.
• Despite numerous requests, (like this one), P&G refused access to this data repeatedly.
  Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.
• Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially related to a graph shown to him that omitted 40% of patient data.
• Blumsohn objected to P&G arranging for papers and abstracts to be written by a professional writer, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.
• Eastell warned Blumsohn not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."
• After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including Eastell, medical school Dean Tony Weetman, University Vice-Chancellor Robert Boucher, and the Head of the University's Department of Human Resources, Ms R Valerio.
• Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then offered him a severance agreement if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.

So the case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research. Although Health Care Renewal, being US based, most often writes about such issues in the US, this case is a reminder that they are global. (Note that we posted more about this case in 2006, here, here and here, but since then it has not gotten much public attention.)

Last weekend the (UK) Guardian returned to it:

The Guardian has learned that one of Britain's leading bone specialists is facing disciplinary action over accusations that he was involved in 'ghost writing'.

The General Medical Council will call Professor Richard Eastell in front of a fitness to practice committee. Eastell, a bone expert at Sheffield University, has admitted he allowed his name to go forward as first author of a study on an osteoporosis drug even though he did not have access to all the data on which the study's conclusions were based. An employee of Proctor and Gamble, the US company making Actonel, was the only author who had all the figures.

Experts believe the practice is widespread in Britain.

In a letter published in the Journal of Bone and Mineral Research, which carried the original study, he stated: 'In the original paper one of the authors, a statistician working for P&G, Ian Barton, had full access to all the data.' The authors had full access to all the analyses of the data that they requested, he said – but those analyses were carried out by the company.

The letter, published in 2007, also acknowledged flaws in the study. A later independent analysis of the data 'identified some errors and poor practice', he wrote. The study was designed to show the strengths of Actonel which was in fierce competition with a rival bone-strengthening drug called Fosamax, made by Merck.

Eastell's paper concerned a study carried out on behalf of Proctor and Gamble, comparing the bone density of women prescribed Actonel with others who were not. Only the company knew which women were on the drug and which were taking something else.

Eastell's colleague, Dr Aubrey Blumsohn, wanted the codes which would say which of the patients who suffered fractures had been on the drug. The company refused. Blumsohn took his concerns to Eastell, but in a conversation which Blumsohn says he taped , Eastell said he was concerned that persistent requests might damage the relationship they had with the company. Eastell is said to have told him: 'The only thing that we have to watch all the time is our relationship with P&G. Because … we have the big Sheffield Centre Grant [from P&G] which is a good source of income, we have got to really watch it.' .

So, after four years, this case has generated an official hearing of sorts. The hearing is obviously late, and seemingly will only be devoted to only one aspect of this case (ghost writing). However, at least our friends in the UK are doing something. I cannot recall a single case that resulted in any serious consideration of imposing negative consequences on anyone who was accused of suppressing research, manipulating research, endorsing ghost-writing, or intimidating a whistle-blower. In fact, many of the more troubling cases have never resulted in any sort of public discussion either at the institutions at which they occurred, or at any organization with relevant regulatory, or even just moral authority. So the GMC hearing is at least a step forward. Two cheers for the British GMC, and none for US universities, academic medical centers, professional societies, and government regulators.

(If anyone can remind me of a case in which there was a public discussion at the relevant institution, or some public consideration of the case by a regulatory agency, professional society, or some group with moral authority, please remind me of it, and I would be happy to post about it.)

Another Fatty Liver Reversal, Part II

A month ago, I wrote about a reader "Steve" who reversed his fatty liver using a change in diet. Non-alcoholic fatty liver disease (NAFLD) is a truly disturbing modern epidemic, rare a few decades ago and now affecting roughly a quarter of the adult population of modern industrialized nations. Researchers cause NAFLD readily in rodents by feeding them industrial vegetable oils or large amounts of sugar.

Steve recently e-mailed me to update me on his condition. He also passed along his liver test results, which I've graphed below. ALT is a liver enzyme that enters the bloodstream following liver damage such as hepatitis or NAFLD. It's below 50 units/L in a healthy person*. AST is another liver enzyme that's below 35 units/L in a healthy person*.

Steve began his new diet in November of 2008 and saw a remarkable and sustained improvement in his ALT and AST levels:

Here's how Steve described his diet change to me:

I totally eliminated sugar, heavy starches, and grains. Started eating more whole, real foods, including things like grass-fed beef and pastured pork and eggs, began supplementing with good fats and omega-3 (pastured butter, coconut oil, cod liver oil). Ate more fruits and vegetables instead of refined carbs. Also completely gave up on the idea that I had to eat only "lean" meats. After my last results, the GI doc said that I wouldn't need the biopsy at all, that things were great, and that if I kept it up I "would live forever."

He did experience some side effects from this diet though:

My triglycerides also went from pre-diet measures of 201 and 147 to post diet 86, 81, and 71.

The added bonus, of course, was that my weight went from 205 pounds to 162 pounds and my body fat percentage from 24% to 12% in the matter of five months--all without the typically excessive cardio I used to try unsuccessfully for weight loss.

The liver is the body's "metabolic grand central station". It's essential for nutrient homeostasis, insulin sensitivity, detoxification, and hormone conversion, among other things. What's bad for the liver is bad for the rest of the body as well. Don't poison your liver with sugar and industrial vegetable oils.


* The cutoff depends on who you ask, but these numbers are commonly used.

How to Fatten Your Liver
Excess Omega-6 Fat Damages Infants' Livers
Health is Multi-Factorial
Fatty Liver Reversal
Another Fatty Liver Reversal

Another Fatty Liver Reversal, Part II

A month ago, I wrote about a reader "Steve" who reversed his fatty liver using a change in diet. Non-alcoholic fatty liver disease (NAFLD) is a truly disturbing modern epidemic, rare a few decades ago and now affecting roughly a quarter of the adult population of modern industrialized nations. Researchers cause NAFLD readily in rodents by feeding them industrial vegetable oils or large amounts of sugar.

Steve recently e-mailed me to update me on his condition. He also passed along his liver test results, which I've graphed below. ALT is a liver enzyme that enters the bloodstream following liver damage such as hepatitis or NAFLD. It's below 50 units/L in a healthy person*. AST is another liver enzyme that's below 35 units/L in a healthy person*.

Steve began his new diet in November of 2008 and saw a remarkable and sustained improvement in his ALT and AST levels:

Here's how Steve described his diet change to me:

I totally eliminated sugar, heavy starches, and grains. Started eating more whole, real foods, including things like grass-fed beef and pastured pork and eggs, began supplementing with good fats and omega-3 (pastured butter, coconut oil, cod liver oil). Ate more fruits and vegetables instead of refined carbs. Also completely gave up on the idea that I had to eat only "lean" meats. After my last results, the GI doc said that I wouldn't need the biopsy at all, that things were great, and that if I kept it up I "would live forever."

He did experience some side effects from this diet though:

My triglycerides also went from pre-diet measures of 201 and 147 to post diet 86, 81, and 71.

The added bonus, of course, was that my weight went from 205 pounds to 162 pounds and my body fat percentage from 24% to 12% in the matter of five months--all without the typically excessive cardio I used to try unsuccessfully for weight loss.

The liver is the body's "metabolic grand central station". It's essential for nutrient homeostasis, insulin sensitivity, detoxification, and hormone conversion, among other things. What's bad for the liver is bad for the rest of the body as well. Don't poison your liver with sugar and industrial vegetable oils.


* The cutoff depends on who you ask, but these numbers are commonly used.

How to Fatten Your Liver
Excess Omega-6 Fat Damages Infants' Livers
Health is Multi-Factorial
Fatty Liver Reversal
Another Fatty Liver Reversal

Why Have Governing Boards Forsaken Their Duties? - Ideas from Silverglate and Malchow

We have posted frequently about the governance and leadership of academic medical organizations. While one would think that health care organizations, and especially academic health care organizations ought to be held to a particularly high standard of governance, we have noted how their governance is often unrepresentative of key constituencies, opaque, unaccountable, unsupportive of the academic and health care mission, and not subject to codes of ethics. How the governance of organizations with such exemplary missions and sterling reputations got this way has been unclear.

Now there are new insights from the ongoing discussion of one of the most interesting and controversial cases of disputed organizational governance. We have often come back to the example of Dartmouth College, of which Dartmouth Medical School is a significant component. We most recently discussed here an ongoing dispute about the extent that the institution's board of trustees ought to represent the alumni at large, or instead, ought to be a self-elected body not clearly accountable to anyone else. (For our take on this complex case, start here and follow the links backward.) The latest development in the case is a lawsuit filed by Dartmouth alumni challenging an increase in the number of self-elected, or "charter" trustees, which they charged broke an 1891 agreement that established numerical parity between alumni-elected and charter trustees.

Soon after this lawsuit was filed, an important article by Harvey Silverglate (one of the founders of FIRE, the Foundation for Individual Rights in Education) and Joseph Malchow appeared. For those interested in the case, the article includes extensive detail, with multiple citations, on all the twists and turns of the case, and is very much worth reading. (See this post on FIRE's Torch blog for more background and discussion.)

However, the article also features extensive scholarship on governance of US not-for-profit institutions, focused on academic institutions (including medical academia), and with relevance to other not-for-profit or non-governmental health care organizations. In particular, the article sheds light on how the governance of such organizations has become so degraded.

First, Silverglate and Malchow summarized the duties of governing boards:

Traditionally, fiduciary duty [of the board of trustees] has been understood as having two components: the duty of loyalty and the duty of care. The duty of loyalty requires a fiduciary to act in a manner he or she reasonably believes to be in the best interests of the organization. The duty of care obliges directors to inform themselves of reasonably available information prior to making a business decision. More recently, courts have considered the duty to act in good faith [the duty of obedience] as a fiduciary requirement. This component, similar to the duty of care, is satisfied when a director makes informed decisions without conflicts of interest.

The question central to the dispute regarding Dartmouth governance is to what or to whom do fiduciaries owe their duty. Corporate directors have a relatively straightforward task of serving the corporation and its shareholders. In the case of a charitable trust, however, which generally does not have 'ascertainable beneficiaries who can enforce their rights,' the duty of fiduciaries is instead directed toward fulfilling or furthering the organization’s mission

So just to summarize, considerable discussion, scholarship, and I believe some some laws support the notion that the board of a not-for-profit organization is obliged to take reasonable care to make informed decisions free of conflicts of interest to uphold the organization's mission.

However, currently, many boards value deference to the organization's (usually hired) top managers and avoidance of internal conflict within the board more highly than these obligations:

Dartmouth, to be sure, is far from the only place where fealty to organizational leaders—and the notion of 'going along in order to get along' —has been placed before true fiduciary duty.

Silverglate and Malchow have some important ideas about how we came to this.

Not-for-profits became more like for-profit corporations:

During the 1980s, traditional nonprofit organizations supported by donations and governed by donors and volunteers became increasingly displaced by professionally staffed commercial nonprofits, supported by grants, contracts, and earned income, and governed by insider boards. The shift in governance was armored by progressively professionalized and entrepreneurial management, which was perceived to be more adept at control of the ebb and flow of funds in the American market.

Top hired not-for-profit executives assumed more power at the expense of other constituencies, including the professionals who did the work:

By the 1990s, with faculty power firmly institutionalized at colleges and universities, a notion that university presidents were bereft of power took hold. The AGB [Association of Governing Boards], in 1996, argued that university presidents needed to regain power with a pivotal document of its own: Renewing the Academic Presidency: Stronger Leadership for Tougher Times. Though this outlook was applied to varying degrees at colleges and universities, an imperative toward greater executive power in universities was thus established.

Presidential and professorial decision-making power, combined with the rise of the administrative bureaucracy in academia, have generally relegated trustees to a secondary role in campus affairs.

Attempts at reforming governance were inappropriately based on a for-profit corporate model, and particularly the need to project unity and avoid confrontation among the leadership trumped transparency:

Aligning academic boards with the cultural trends of increased critical oversight has obvious benefits, but some boards have moved to adopt the norms of for-profit corporate governance that are simply not applicable to the university context. Admittedly, this is a thin distinction when considered on a theoretical level. But in practical terms, misguided nonprofit reforms—some of which, upon close examination, actually violate an institution’s mission—are readily evident.

For example, some nonprofit boards have emphasized the adoption of formal nondisclosure pledges or confidentiality agreements that step well beyond nondisclosure of proprietary information. This is hardly uncommon in the business sector, where bottom-line strictures demand a certain degree of internal accord and non-transparency. And though there is evidence that nonprofit board directors have, from time to time, attempted to hush public dissent, only recently have dominant majorities of some nonprofit boards proposed and ratified binding pledges not to publicly air differences. According to a 2006 BoardSource publication, 'If a board member does not support a decision for whatever reason, [he or] she has a responsibility to remain silent or step down from the board.' (Recall the resignation offer made to Zywicki before his second term was denied.)

These directives, written in highly influential publications in the realm of university governance, disregard the important role that public discussion has on decision-making at universities and nonprofits in general. 'In the nonprofit context, nondisclosure agreements or the use of 'executive session' rules to curtail debates about policy and procedure depart from established norms. They shut down opportunities for public dialogue and for communication with other concerned and influential parties, including reporters,' nonprofit specialist Norman I. Silber wrote in the Oregon Law Review.

Emphasis on raising money rather than upholding the mission has lead to board deference to hired executives.

Fidelity to institutional leaders, rather than institutional mission, is now paramount in higher education, as deviation from accepted decisions is perceived as potentially shrinking the donor base. Administrators cringe at public disagreement; rather than focusing on the long-term likelihood that competing ideas will result in implementation of the fittest, they tend to focus on the short-term possibility that a particular alumni subset may be offended. This shortsighted outlook is not only an insult to the intelligence of alumni and other constituencies, but it is ultimately detrimental to the institution, as established ideas are enthroned and unchallenged. It is also based on false premises: as in the case of Dartmouth, there is no established correlation between public criticism and donor decline.

Boards are increasingly composed of executives of for-profit corporations, particularly in the finance field, who may grant the same deference to the organizations' leaders that they would like from their own board. That is, hired executives identify more with other executives than with the organizations they are supposed to be leading:

Judge Cabranes noted that trustees, especially business executives, tend to act toward university presidents as they wish their boards would act toward them—deferentially. And the phenomenon of board members believing they serve at the pleasure of the executive is what one nonprofit attorney and blogger, has termed 'upside down board.' The ascendance of the hedge-fund community, a peculiar province of graduates of elite institutions, has contributed to the prevalence of the upside down board....

The article suggests some issues that need to be addressed to make governance more accountable, transparent, ethical and honest. Boards need to be reminded of their duties, and that their loyalty should be to the mission, not the organization's executives, or the views of the board's majority. Transparency and open discussion are more important than projecting the (sometimes false) impression of unity. New board members should be chosen for their loyalty to the mission rather than their similarity to and congeniality with current board members.

I strongly suggest that anyone who cares about how health care organizations are run ought to read Silverglate and Malchow's full article. It should be required reading for current and would-be board members of academic and health care not-for-profit organizations (but I will not hold my breath waiting for them to read it.)

A "Safety-Net" Medical Center CEO Gets a Golden Parachute

From theBostonChannel.com comes this story on executive compensation in a not-for-profit health care organization,

Boston Medical Center – a financially troubled hospital – gave its outgoing CEO a one-time, nearly $3.5 million payment, in addition to her $1.3 million annual salary, Team 5 Investigates reported Friday.

Elaine Ullian, 61, has led the city’s major 'safety net' hospital for the last 15 years. She recently announced she will retire when her contract expires in January.

The hospital's financial situation is such that hospital leaders say it could face closure in the years ahead. It is currently suing the Executive Office of Health and Human Services over how it gets paid for treating poor and uninsured patients.

Team 5 Investigates discovered, in a review of the hospital’s financial filings with the state, that Ullian was paid $3,466,458 'in recognition of exceptional performance over a period of 15 years.'

The nearly $3.5 million bonus was on top of Ullian’s 2008 compensation of $1,348,504 including salary and benefits.

In a written statement to Team 5 Investigates, Ted English, the chairman of BMC’s board said that Ullian’s 'compensation is set by a committee of the Boston Medical Center Board of Trustees who consult with independent compensation advisors. It is based on her performance evaluation and measurable goals that are reviewed annually.'

'The Board considers Elaine Ullian to be one of the most competent and successful hospital CEOs in the country and believes she is primarily responsible for the success of Boston Medical Center over the past 15 years,' English's statement said.

Boston Medical Center was formed by the merger of University Hospital (the Boston University teaching hospital), and Boston City Hospital, the legendary municipal hospital. (Note: I served as an internal medicine intern and resident in the University Hospital program, and rotated through Boston City frequently.) Thus, as noted above, BMC is the city's primary "safety net" hospital for the care of the poor. BMC has for its mission:

We will provide consistently excellent and accessible health services to all in need of care regardless of status or ability to pay – exceptional care, without exception.

Such generous pay seems inconsistent with this mission and the organization's not-for-profit status. Such a golden parachute seems inconsistent with the current threats to its finances.

Any worry about the CEO's retirement finances should further be reduced by her ongoing part-time work on the boards of directors of three public for-profit health care corporations, Hologic, a medical device company specializing in "womens' health," ThermoFisher Scientific, a manufacturer of laboratory equipment and supplies for health care and research, and Vertex Pharmaceuticals, a biotechnology company focusing on small-molecule drugs. For her work as a director of Hologic, she received $304,698 in total compensation in 2008, and owned 40,000 shares or equivalent of common stock (per the company's 2009 proxy statement). For her work for ThermoFisher Scientific, she received $275,319 total compensation, and owned 61,068 shares or equivalent (per the 2009 proxy statement). For her work for Vertex Pharmaceuticals, she received $337,480 total compensation, and owned 79,500 shares or equivalent (per the 2009 proxy statement). As Robert AG Monks put it, corporate directors are supposed to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Therefore, Ms Ullian's directorships seem to pose conflicts with her primary employment as CEO of an academic medical center which must buy products used in womens' health, buy laboratory supplies, and implement basic and clinical research.

The BMC board chair's assertion that the CEO is "primarily responsible for the success" of the institution merits special comment. It seems obvious that the main determinant of the success of a medical center is the work done by its health care professionals and support personnel. A medical center cannot provide care, much less good care, without doctors, nurses, therapists and technicians, supported by supply, logistics, cleaning, maintenance, dietary, clerical, medical record, financial and yes, even health care information technology workers and systems (and if I left out an important group of support personnel, I apologize now.) The chair's assertion suggests the hubris central to the ethos of contemporary business managers, but is at odds with the clinical context. (Of course, if the CEO was primarily responsible for the organization's success, she should now shoulder primary blame for its current awkward financial situation, but such consistency may be the hobgoblin of minds too little to understand the gravitas of the C-level manager.)

A long time ago, in a galaxy far, far away, health care was a calling. Doctors once pledged to avoid all commercialization (see post here), and hospital directors or superintendents (not CEOs) did not earn riches, much less become "imperial." (See Ludmerer's Time to Heal.) But in the culture of wretched excess that spread from the financial world, hospital CEOs now seem to feel entitled to become wealthy, as they claim responsibility for all successes, while all failures are blamed on someone else. The current system has made hired managers into an ersatz aristocracy, entitled to fill their pockets while denying any responsibility for ever rising costs, declining access, poor quality and demoralized professionals. In my humble opinion, to achieve true health care reform, health care again must become a calling, lead by people who will put the mission ahead of the accumulation of wealth and power.

Physicians, Even Those Educated in IT and Informatics, Are Not "Real" IT People

I've been participating in the comment thread on the HisTALK heath IT industry news/gossip site at http://histalk2.com/2009/09/17/news-91809/ . At this time there are 40 comments - mine start at #4. (I've also archived the thread in Word format here.)

It's been quite interesting, demonstrating that many of the harmful attitudes of IT personnel about healthcare I observed more than a decade ago are still around.

An anonymous commenter under the title "Programmer" has been forthcoming with views I think are actually common in the health IT field about medicine, science, IT flaws and shortcomings, and physician involvement in HIT. I will let you read them for yourself at the above link.

Others have indicated in that comment thread and other threads that "Programmer" is an executive with a large HIT company, but I cannot confirm this.

Among other stunning views, this commenter exhibited:

• Serious errors in logic such as repeatedly and unshakably mistaking well-documented reports about known rates of IT project failure as a condemnation that all IT projects fail, perhaps reflecting a state of denial;
  
• Lack of understanding that in scientific fields such as biomedicine, conclusions generally should be supported by reasonable evidence, not "because I think so";
  
• Lack of understanding and dismissal of the value of the peer reviewed scientific literature on health IT, and further, a seeming inability or unwillingness to peruse the "references" section of scientific articles, a profoundly unscientific approach to the world;
  
• Dismissal of the written views of organizations such as the Joint Commission, US National Research Council, European Federation for Medical Informatics and others on HIT deficiencies;
  
• Perhaps most harmfully, dismissal of faulty conceptual and physical data models, inadequate workflow and cognitive support, and IT of poor user interaction design that presents a mission hostile user experience as a real problem in critical care areas such as Invasive Cardiology (specifically, in this case). Instead, this IT person dismissed physician dismay and rejection of such ill-designed and profoundly unusable IT as a mere "pissing contest" between IT and clinicians, consistent with narrow, territorial, paternalistic, indeed autocratic IT-centric views and a reversal of enabler (clinician) vs. facilitator (IT service provision) roles in patient care.

"Programmer" also attacks (from the perspective of arrogant ignorance) the "Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop" white paper drawing together the thinking at a workshop attended by over fifty informatics experts from all areas of medicine and technology. The role of the medical informatics expert itself, and other issues as well relating to reasons for HIT failure and difficulty are attacked and dismissed.

(If the person is a fake or "sock puppet", they're doing a mighty accurate approximation of my own uncomfortably-common observations in managing health IT and biomedical research IT projects while working with non-biomedical IT personnel, see cases here.)

The crux of the matter came out towards the end where "Programmer" maintains in Comment #28 that I am "just someone who likes to talk about IT” and he is a “real IT person.”

A "real IT person?" I've heard that before: this is the "doctors don't do things with computers" (including medical informaticists) type of comment I've heard face-to-face periodically from healthcare IT personnel since I entered the field in the early 1990's, and commented upon a decade ago here.

I've emailed Tim, the proprietor of the HISTalk site [mr_histalk AT yahoo.com], to inquire if this poster was real or just a provocateur.

Tim's response: "He's real and has been around for awhile, although lately he seems to be enjoying an escalated level of confrontation when he can create one."

I maintain -- based on personal experience and that told me by others -- that this person's views are not all that rare in the HIT vendor and hospital IS communities.

I also opine that thinking such attitudes can be dealt with by logical argument and persuasion is a belief itself lacking in rigor.

IT personnel of views as in the HisTALK comments thread represent an older culture of data processing, dating from the days of card punch tabulators that ran businesses prior to computers. It is a culture that has failed to mature with the times.

As I wrote here, the unimaginative, process over results, tight fisted control, bureaucratic data-processing culture of the business IT (management information systems) world is the lineal descendant of IBM's patchcord plug-panel programmed, card tabulating machines from which IBM made a large portion of their profit in the days before the electronic computer:

Hollerith Type III Tabulator with its control panel exposed. Photo: MNRAS, Vol.92, No.7 (1932). Click to enlarge.

Fortunately, such personnel and their designer-centric, as opposed to user- and work-centric philosophies are starting to become obsolete. This can be observed (as an example) via the mission of the iSchool consortium, of which my organization, the Drexel College of Information Science and Technology, is a member:

The iSchools are interested in the relationship between information, people and technology. This is characterized by a commitment to learning and understanding the role of information in human endeavors. The iSchools take it as given that expertise in all forms of information is required for progress in science, business, education, and culture. This expertise must include understanding of the uses and users of information, as well as information technologies and their applications. [the order of these priorities is pertinent - ed.]

Unfortunately, the data processing culture and its adherents are not becoming obsolete quite fast enough. There are still too many in the upper echelons of management, including health IT vendors, hospitals and pharmaceutical R&D environments.

Finally, IT personnel with such attitudes as displayed in the comments, from the lowliest programmer to the CEO and Board, have no place anywhere near where patient care is conducted, or where information systems serving clinical medicine are designed and built.

In line with other character types one encounters in healthcare that are often discussed on Healthcare Renewal, clinicians should not accommodate such IT personnel and these types of views.

-- SS

Addendum:

The final (at this time) comment, #40, left by the above commenter states:

#40 Programmer: If I decide to become a medical informatproctolicist, I’m going to specialize in sardonicology.

IT personnel of such views bring to life Lecia Barker's paper "Defensive climate in the computer science classroom":

“Defensive climate in the computer science classroom” by Barker et al., Univ. of Denver. Link here (subscription required). May help explain the control-seeking culture of IT personnel. As part of an NSF-funded IT workforce grant, the authors conducted ethnographic research to provide deep understanding of the learning environment of computer science classrooms. Categories emerging from data analysis included 1) impersonal environment and guarded behavior; and 2) the creation and maintenance of informal hierarchy resulting in competitive behaviors. These communication patterns lead to a defensive climate, characterized by competitiveness rather cooperation, judgments about others, superiority, and neutrality rather than empathy.

-- SS