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.

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.)

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

Wyeth, Ghostwriting, Dr. Joseph Camardo and a Big Liquor Store With a Little Grocery Department

Ghostwriting is a topic covered extensively at Healthcare Renewal, including at my post "Wyeth: Ghostwritten Papers Fake, But Accurate" here, Roy Poses' "Wyeth's Industrial Scale Ghost-Writing" here, and many others about Wyeth and other pharmas that can be viewed via this link: http://hcrenewal.blogspot.com/search/label/ghost writing.

A story in the Philadelphia Inquirer yesterday about Wyeth and ghostwriting brought to mind my medical school days at Boston University, in a metaphorical and rather negative way, regarding an oddity reflecting today's pharma industry.

In those years I lived next to Boston City Hospital on the top floor of a 29-story high rise at 35 Northampton Street, at that time one of the toughest and highest crime neighborhoods in the region if not the country (I was careful and lucky, and only got mugged at gunpoint once.) I had an excellent bird's-eye view of the urban decay in the area, reflective of ethical decay in the community.

35 Northampton St., next to Boston Medical Center (formerly Boston City Hospital)

Across the street from the high rise was an oddity - a very large liquor store named Blanchard's. Inside Blanchard's was a very small grocery department of all things. Have a snack with your booze! (I went in only twice; once to see what it was all about, and again during the Blizzard of '78 to get some needed food when all transit in the city was shut down and several feet of snow -- and neighborhood guns -- inhibited foot travel.)

The area has much improved in the past three decades, but according to Google street view the liquor store is still there:

In the 1970's "Liquor Land" was a large liquor store with a small grocery department named "Blanchard's." Click to enlarge.

Why does this odd store remind me of Wyeth, and more generally today's pharmaceutical industry?

Because that industry has turned from what used to be a biomedical research & development industry with decent ethics and a small marketing arm, to large marketing industry with poor ethics and a small R&D arm.

(Or, perhaps more accurately, a large marketing industry with poor ethics and a busywork section disguised to look like R&D. As a colleague noted in my post "Pfizer/Wyeth Merger And Sacrificing The Future: Laying Off Scientific Staff All Over The Place" here, a small fraction of prime scientist intellectual horsepower and time is actually spent on true R&D today, the rest wasted on feeding the bureaucratic corpulence that is the modern pharma research lab. He observed that "what we today call pharmaceutical R&D is in reality busywork disguised to look like R&D, in effect a well engineered, well managed, massively expensive failure.")

Here is what led to my "pharmas have become large marketing firms with a small R&D effort" metaphor. It was a story in the local newspaper on ghostwriting.

The glib quotes from Dr. Joseph Camardo, Wyeth's senior vice president of global medical affairs, on the practice of ghostwriting are simply stunning:

Philadelphia Inquirer

Ghosts in the medical machine

Was drug research infected by ghostwriters? With Paxil suit in court, a Chadds Ford firm says it was ethical.

Sun, Sep. 20, 2009

By Miriam Hill

Inquirer Staff Writer

When GlaxoSmithKline P.L.C. marketers looked for doctors to promote the antidepressant Paxil, they called the project CASPPER. The name was more than just an offbeat tribute to the friendly cartoon ghost. It was a wink and a nod to "ghostwriting," a questionable practice in which scientists put their names on research written by someone else, usually a writer paid by a drugmaker.

Ghostwriting critics say it disguises marketing material as scientific research.

Charges of ghostwriting have been lobbed against many companies in recent years, including Glaxo, Wyeth, AstraZeneca P.L.C., and Merck & Co. Inc., often arising in lawsuits from consumers claiming a drug hurt them.

... Documents released in connection with 8,000 lawsuits filed against Wyeth over Premarin and Prempro show that the company, which employs several thousand people in Collegeville, paid a medical-writing firm to produce articles from 1998 to 2005 that allegedly downplayed the risks of hormone treatment and emphasized benefits.

In 2002, researchers stopped a landmark federal study after finding that menopausal women who took certain hormones had an increased risk of breast cancer, heart disease, and stroke.

"Ghostwriting was used to sway physician opinions to favor hormone use as disease prevention long after that was a scientifically defensible position," Fugh-Berman [writer Adriane Fugh-Berman - ed.] said.

Joseph Camardo, Wyeth's senior vice president of global medical affairs, called Fugh-Berman's view "baseless." Medical opinion evolves, he said, and the papers in question reflected scientific understanding then. He also said the authors alone controlled the content and writing of the papers, though some did have outside help paid for by Wyeth.

"It's really being misrepresented as something we wrote and paid for that said what we thought it should say," Camardo said. "But the authors were not paid, and the authors had the final say."

... Studies on ghostwriting have suggested that anywhere from 8 percent to 75 percent of articles in medical journals may involve the practice.

Aside from the point I raised in my post "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?" here regarding possible severe contamination of the literature and therefore of "expert knowledge" as it exists today, Camardo's response raises a cornucopia of questions.

Regarding "Medical opinion evolves, he said, and the papers in question reflected scientific understanding then":

• Whose scientific opinion do they reflect, exactly?
• Does Camardo believe these ghostwritten papers, usually written by party "A" but with authorship claimed by party "B" (usually prominent academic physicians often nurtured by the industry into the role of "key opinion leaders", KOL's) are objective?
• Does Camardo actually believe most of the content comes from party "B" rather than party "A" in these papers?
  
• Does Camardo understand that paying a MECC (Medical education & communications company) or other firm to write scientific papers puts the author(s) of those papers in a conflict of interest position relative to the paying sponsor, injurious to objectivity?
• Is Camardo that naive to believe a paid writer would "diss" the holder of his or her paycheck?

Regarding "the authors alone controlled the content and writing of the papers, though some did have outside help paid for by Wyeth":

• Which authors is he referring to?
  
• The ghostwriters?
• Wyeth scientists?
• Academics claiming authorship?
  
• Was the "outside help" from Wyeth "authors" to the ghosts, or from the ghosts to Wyeth "authors", or from Wyeth to the academics claiming authorship, or what?
• Can Camardo produce statistics on what % of article content on ghostwritten articles Wyeth sponsored were written by the ghost vs. written by Wyeth scientists and/or the claimed academic author? If not, why not? And if not, why should any intelligent person not assume the papers are, say, 99% the product of the hired guns?

Regarding "the authors were not paid, and the authors had the final say":

• Again, which author(s) is he referring to?
• In terms of the ghosts, I assume they were not working for the MECC's for free.
• In terms of the academics and KOL's claiming authorship, they (maybe!) were not paid in money, but instead in the valuable academic currency of a publication in a major biomedical journal.
  

To claim the KOL's were "not paid" is disingenuous. In fact, I find his entire argument disingenuous, a play on words, PR "spin" completely callous to the needs for scientific objectivity, the advancement of science, and ultimately to patient's lives.

This is marketing, with poor ethics, in the extreme.

Being somewhat familiar with authorship issues as former Director of Published Scientific Information Resources and The Merck Index (of Chemicals, Drugs & Biologicals), 13th ed. at Merck Research Labs, I further pointed out in my post "Wyeth: Ghostwritten Papers Fake, But Accurate" here, that:

... in addition to the violation of accepted practices of authorship, such as specified by NIH and the International Committee of Medical Journal Editors, among others, such lucky authors [i.e., those who claim authorship of ghostwritten papers] get to "count" such papers in their academic portfolios, presumably also in violation of their own institutional policies and guidelines for fair attribution and intellectual honesty, e.g., here [Harvard - ed.]

These industry practices and Camardo's position may be based on:

• Ignorance of accepted practices of authorship of the NIH, the International Committee of Medical Journal Editors, and most academic institutions, or perhaps:
  
• Cavalier dismissal of these practices for pecuniary reasons.

Is Camardo informed and upfront? Inept? Disingenuous and dishonest? That is up to the reader to decide.

In my aforementioned post "Wyeth: Fake but Accurate" I'd also noted Wyeth attorney Stephen Urbanczyk acknowledging that the ghostwritten articles were part of a marketing effort. But he said that they were also "fair, balanced, and scientific." More spin.

This raises the following observation. It is said that you can judge people by the company they keep. I also believe that:

You can judge companies by the people they keep.

This raises the following very serious questions:

• Is the presence of a senior vice president of global medical affairs and a lawyer with such views on ghostwriting representative of the senior executive leadership's views on dissemination of biomedical scientific information?
  
• Is their presence reflective of the views of Wyeth's Board of Directors?

If so, then the objectivity of any article about Wyeth drugs is called into question, and physicians and patients should utilize Wyeth drugs (and literature on them) with great caution.

-- SS

Addendum: this from the Medical Ethics blog:

Recently released court documents in a lawsuit against drug giant Wyeth, thanks to a court action by the New York Times and PLoS Medicine, are now searchable at a University of California, San Francisco web site.

The Wyeth documents are the latest made searchable at the Drug Industry Document Archive, or DIDA, which archives the documents from several high-profile cases.

... The documents were first made available last month on the PLoS web site, but were not searchable and difficult to sort through. The DIDA site now make it possible to search for documents by name, type or content.

Also see "Ghostwriting: Why they do it" at that blog.

-- SS

UPMC Fouls Another One Off

It's almost World Series time in the US, so here's a baseball story, courtesy the Pittsburgh Business Times,

University of Pittsburgh Medical Center lobbyist Leslie McCombs used Pittsburgh Pirates baseball tickets purchased by UPMC’s insurance arm to entertain film executives and others to promote the creation of a state film tax credit, according to the State Ethics Commission.

The commission fined McCombs $5,025 for failing to promptly register as a lobbyist for Lions Gate Entertainment Corp. and omitting a daytime phone number in registering as a lobbyist for UPMC, according to a commission ruling reached on July 22. The confidential decision was disclosed Sept. 9 by The Associated Press.

McCombs, who works for UPMC as a consultant, received permission from UPMC President and CEO Jeffrey Romoff to lobby on behalf of Lions Gate, which she described in a February 2007 e-mail to him as the, 'largest independent producer and distributor of motion pictures and television in the country.'

Romoff cleared her work with Lions Gate after consulting with UPMC legal counsel and assured by McCombs in the e-mail that, 'UPMC signs will be prominently featured throughout the (‘Kill Pit’ television) series.'

Filming for the eight-part miniseries, which was renamed 'The Kill Point,' began in March 2007 in Pittsburgh. Gov. Ed Rendell signed the Film Production Tax Credit bill into law in July 2007, which provided for a 25 percent film tax credit to offset production expenses.

Also,

From 2005 to 2006, McCombs was director of public relations for UPMC Health Plan, a for-profit subsidiary of the nonprofit hospital network. She was then named senior consultant with UPMC’s government relations department.

The State Ethics Commission lists 18 baseball games where McCombs treated Lions Gate and government officials using UPMC tickets.

In addition, she attended a June 15, 2007, matchup against the Chicago White Sox with Rendell and his wife, Marjorie, and Romoff and his wife, Stefania, according to the commission.

It’s not clear from the commission report whose interests McCombs was representing at that game, but Rendell later reimbursed $960 for the tickets to the five games that he attended, which was returned to the health plan.

In 2007, UPMC Health Plan bought $61,440 worth of Pittsburgh Pirates tickets, which were available to employees of the insurer 'in the performance of their duties,' the report states. The sum included a $20,000 seat license.

So did you get all that? The director of public relations for the UPMC Health Plan, the managed care subsidiary of UPMC, a large academic medical center, lobbied the state governor for the enactment of a tax credit for television and movie production, partially so that the UPMC logo would appear in a television series, and entertained the governor using a few of the more than $60,000 worth of baseball tickets the medical center purchased for employee use. Amidst the complication, the public relations director violated state lobbying rules. None of these shenanigans had anything directly to do with health care, or medical education and research. The only conceivable advantage accruing to the institution would be the appearance of the UPMC logo in a television series. But most likely everyone had good times at the ball game.

This story again suggests that managers of health care organization are more focused on playing marketing and political games than on health care, and generally are more focused on benefiting themselves than upholding their organizations' mission. The amounts of money involved in this case may be small, but do not underestimate the collective effects on health care access, cost and quality of managers who have their eyes on the wrong balls.

UPMC has provided grist for the Health Care Renewal mill before, see earlier posts here, here, here and here.

"Seeking Justice for My Son"

At Healthcare Renewal we often write of the dangers of financial conflict of interest towards medical research and practice.

Here is a plea from a father of an 18 year old patient whose death became a cause célèbre against conflict of interest, only to then be swallowed up in the sea of silence known as the "anechoic effect." The plea is in our local newspaper, but deserves much wider attention:

Philadelphia Inquirer

Posted on Thu, Sep. 17, 2009

Seeking justice for my son

He died in a gene-therapy trial. Penn and the FDA should release the records.

By Paul Gelsinger

Ten years ago today, my 18-year-old son, Jesse Gelsinger, died at the University of Pennsylvania in a gene-therapy trial. Who is responsible? Could his life have been saved? Are other patients at risk? These questions have yet to be fully answered.

Jesse lived with a rare metabolic disease. The point of the research trial was to see if an adenovirus (a cousin of the cold virus) could safely deliver corrective genes to Jesse's liver. Instead, the adenovirus killed Jesse.

Jesse became the poster child for what not to do in human-subjects research. Neither he nor I was warned that, as the Washington Post later reported, monkeys had died in a prior trial. And the Wall Street Journal reported that the researcher who developed the adenovirus, James Wilson, had a seven-figure financial interest in the trial's outcome, as did Penn.

I stood by Penn, Wilson, and the two principal investigators, Mark Batshaw and Steven Raper, until I understood the extent of Wilson's financial ties and the extent to which Jesse was misled about the risks and efficacy of the therapy. I eventually sued and ultimately settled. The amount of the settlement was sealed; the documents were not.

The federal government also sued, claiming that the researchers blew through clinical stop signs in conducting the trial, ignoring evidence that Jesse was not well enough to receive the adenovirus and failing to sufficiently alert the Food and Drug Administration about severe incidents involving prior patients. The researchers disagreed, saying they had the discretion to proceed despite Jesse's test results, and that they had alerted the FDA. The government also reached a settlement, which restricted the researchers' activities for a period of years.

Before the government settled, I urged federal officials to make the documents they collected public. They refused, saying this is simply not done.

I believe a better understanding of what happened to Jesse could improve practices. So I gave the documents collected for my lawsuit to a law professor, Robin Wilson, who teaches at Washington and Lee University in Lexington, Va. They appear in her new book, Health Law and Bioethics: Cases in Context.

While they are incomplete, the documents show a chilling pattern. They show that a lot of good people inside Penn raised alarms about Wilson's financial ties from the get-go, but that Penn approved the deal anyway. The documents also show misleading disclosures to Jesse about the risks posed to him. For example, although animals died in prior trials, we were told that "animals have not shown toxic effects ... at the dosage of virus that is needed to transport the gene in this study."

I thought the lawsuits brought by me and the government would change research practices and the rules governing research. When I settled, real reform seemed likely. The Senate had held hearings, the FDA was investigating whether mistakes were made in the trial, and influential medical bodies such as the Association of American Medical Colleges had begun to examine disclosure practices and financial ties.

But, sadly, we have not yet learned enough from Jesse's death. The shroud of secrecy that envelops legal settlements has helped hinder reform. No one has publicly accounted for the mistakes that led to Jesse's death.

We don't know whether the FDA was misled or dropped the ball. We don't know whether the researchers' claims of efficacy had any basis in fact or were just wishful thinking. We don't know why Penn approved the deal despite warnings. And we don't know whether the researchers' decision to administer the virus to Jesse was reasonable or reckless.

Ten years ago today, my son died in a science experiment. A complete record of what the researchers and FDA regulators knew is the best precaution against future tragedies like Jesse's death.

I am asking that the University of Pennsylvania and the FDA finally do the right thing and release their records. If they did nothing wrong, let us see the proof. If they made a mistake, let us all learn from it and do better in the future. We owe it to Jesse to make his life and death mean something.

[Emphases mine - ed]

Other than stating that I strongly agree that these records should be released for others to learn from, I do not think additional commentary is necessary.

-- SS

Leadership by Those Who "Live Insulated from the Daily Travails of Ordinary" People; the University of Washington Example

On the University Diaries blog, Prof Margaret Soltan picked up on an article on the privileges now given to university leaders, using the example of the President of the University of Washington (which includes a medical school, academic medical center, etc). At a time when the university budget was being cut, President Mark Emmert refused to take a voluntary cut in his greater than $900,000 total annual compensation. This included a $12,000 car allowance and free use of the university mansion.

From the original article comes this key quote:

How could this happen? It happened for the same reason that Wall Street types, with acquiescence of their boards and public officials, saw no reason to make any personal sacrifice at a time when others are sacrificing greatly. The UW Board of Regents, as most others at public universities, is not made up of scholars and altruists. It consists mainly of governor-appointed businessmen, lawyers, and other high-income types who themselves live insulated from the daily travails of ordinary state taxpayers.

As Froma Harrop put it, the ethos among leaders of the finance sector now seems to be "heads, I win, tails, I'm bailed out." That ethos has now infiltrated the leadership of many kinds of organizations, perhaps because in many cases the Masters of the Universe from the finance sector now lead the boards of these organizations. The result may be leaders of academia more focused on enriching and empowering themselves than on their organizations' high-minded missions.

Biovail Settles, and a Judge Explains Why Settlements in Which Only the Organization Pays a Penalty Do Not Deter Bad Behavior

Last year, we posted about the guilty plea by the US arm of the Canadian firm Biovail to charges that it paid physicians kickbacks to prescribe a long-acting version of the drug diltiazam. This week, the plea was formalized, per Reuters,

A U.S. unit of Canadian drugmaker Biovail Corp (BVF.TO) has pleaded guilty to conspiracy and kickback charges, ending a case over its Cardizem hypertension drug, the U.S. Justice Department said on Monday.

Prosecutors said Biovail has been sentenced to pay $22.2 million in fines, formalizing an agreement reached last year. It also agreed to pay $2.4 million to settle civil claims. Both involved charges it improperly paid doctors and other prescribers up to $1,000 to recommend Cardizem.

When we originally posted about this case, we focused on the unprofessional behavior of the physicians who accepted the payments apparently in turn for prescribing. However, this is also yet another in a string of cases in which charges of unethical behavior by a large health care organization (a drug company this time) are settled by the company paying a fine, but not by any penalties accruing to any people at the company who authorized, ordered, or implemented the unethical actions. We have written about many such cases (see this).

Also this week, a US judge addressed another proposed legal settlement of an important parallel case in the world of finance, and how he ruled suggests what needs to be done to truly discourage unethical behavior by health care organizations. The background, summarized by the New York Times, is:

Giving voice to the anger and frustration of many ordinary Americans, Judge Jed S. Rakoff issued a scathing ruling on one of the watershed moments of the financial crisis: the star-crossed takeover of Merrill Lynch by the now-struggling Bank of America.

Judge Rakoff refused to approve a $33 million deal that would have settled a lawsuit filed by the Securities and Exchange Commission against the Bank of America. The lawsuit alleged that the bank failed to adequately disclose the bonuses that were paid by Merrill before the merger, which was completed in January at regulators’ behest as Merrill foundered.

Now consider some of the Judge's main points, and how they might apply to the many settlements of cases of unethical behavior of health care organizations. Per an editorial in the Wall Street Journal,

Judge Rakoff was having none of it. In a 12-page opinion, he tore into the SEC for ignoring its own guidelines and penalizing shareholders rather than the individuals who supposedly acted improperly. The settlement 'does not comport with the most elementary notions of justice and morality, in that it proposes that the shareholders who were the victims of the Bank's alleged misconduct now pay the penalty for that misconduct.'

Note that the settlement of nearly every health care case involved a payment by the organization, but none by the people who authorized, ordered, or implemented the unethical behavior in questions. In those cases involving public for-profit corporations, just like the current one, the shareholders were the ones footing the bill. In most such cases, the shareholders were also ultimately victims in that it was their money that ultimately paid for the bad behavior, just like in this case. So in those cases the shareholders, who were victims of the companies' managers' bad behavior, were penalized while the managers got off Scot free.

(In cases involving not-for-profit organizations, in parallel, one could argue that it was the organizations' line employees and other constituencies who were both the payers of the penalties and the victims of the conduct.)

Also,

As for the SEC's argument that this shareholder punishment will result in better management, the judge called it 'absurd.'

The judge also had little sympathy for the SEC's argument that it would be too difficult to pursue executives, since they had been guided by lawyers. 'If that is the case, why are the penalties not then sought from the lawyers? And why, in any event, does that justify imposing penalties on the victims of the lie, shareholders?' he asked.

In most settlements of parallel cases in health care, the relevant government agency usually suggested that the settlement will lead to better behavior by the organization. As we have noted before, the take-away lessons for managers was more likely that bad behavior will at worst lead to increased costs of doing business, but no penalties to the people involved. Such lessons would likely reinforce managers' decisions to behave unethically when doing so would benefit the managers themselves in the short run.

In parallel cases in health care, the relevant government agency has rarely explained why it did not pursue the managers who authorized or ordered the behavior, or the lawyers that advised them, for that matter. The current case suggests that there was no logical rationale for failing to hold the people responsible accountable, except...

[The judge said] broadly the deal 'suggests a rather cynical relationship between the parties: the SEC gets to claim that it is exposing wrongdoing on the part of the Bank of America in a high-profile merger; the Bank's management gets to claim that they have been coerced into an onerous settlement by overzealous regulators. And all of this is done at the expense, not only of the shareholders, but also of the truth.'

And it is likely in health care that previous settlements arose out of such a cynical relationship. The government agency got to claim it was exposing wrongdoing. The executives of the offending organization got to claim they were coerced into an onerous settlement by overzealous regulators. The main casualty was the truth.

Again, 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. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations.