Logical Fallacies in Defense of the European Society of Cardiology's Lenient Approach to Conflicts of Interest

The European Society of Cardiology just published its recommendations for interactions between medical societies and industry.(1)   The report emphasized the supposed benefits of industry relationships and funding, and suggested few restrictions on current practices.  Like other defenses of leniency towards conflicts of interest, its arguments seemed to rest on a series of logical fallacies.  

Wonderful "Innovations ... Through Productive Collaboration" - Appeal to Belief and the Fallacy of Division

The report made several arguments about the benefits of professional - industrial interaction.  These included:

In recent decades, cardiology has been a fast-moving medical speciality. Many advances have come from basic and clinical research conducted by universities and by pharmaceutical and medical device companies. Innovations have been realized in part through productive collaborations between clinicians, academia, and industry. Such links are essential and need to be encouraged and supported by appropriate investment if medical progress is to be sustained.

The notion that interactions between physicians and industry is a source, perhaps the most important source of wonderful "innovations" is often used to justify the sorts of interactions, involving payments by industry to academia and physicians, that are now prevalent. In this report, this first appears as an assertion without any evidence to justify it.

Later, the report noted:

The Association of American Medical Colleges has stated that there are benefits from effective partnerships between industry and academic medical centres.

This statement came with a citation, to a 2008 report entitled "Industry Funding of Medical Education."(2) This AAMC report, in turn, contained many similar assertions, e.g.,

An effective and principled partnership between academic medical centers and various health industries is critical in order to realize fully the benefits of biomedical research and ensure continued advances in the prevention, diagnosis, and treatment of disease.

However, the AAMC report also failed to cite any evidence in support of these assertions.

There are two major problems with these assertions, which form the foundations of both reports. The first is they do not seem to have a clear evidence base.

While the notion that current research efforts marked by substantial interaction between physicians, academia and industry are producing wonderful innovations is appealing, what evidence there is suggests that clinically important innovation is rare. For example, I quote a 2009 review of global drug discovery by Light(3) on whether new drugs represent advances over older treatments:

the best evidence of clinical quality comes from systematic efforts to assess therapeutic advantage and adverse effects compared with existing drugs. A detailed analysis of therapeutic quality in new drugs over the past twenty years found that 14 percent of all new chemical entities are either therapeutic breakthroughs or substantially superior to existing medications. Likewise, a comprehensive review of all new drugs approved between 1989 and 2000 in the United States concluded that 14.8 percent were new chemical entities that provided significant clinical improvement, and a Canadian review board concluded that 10.7 percent of new chemical entities in 2000–2004 did so.

Thus while many new drugs are introduced, only a few introduced recently were chemically unique or had effects different than older treatments.  I would argue that most of these will prove not to be truly clinically innovative, in that good clinical research will not show that they produce substantial improvements in clinical outcomes without major adverse effects for a good number of patients with not uncommon problems.  (It is not hard to think of really important innovations developed before the era of major industry-academic-physician interactions: antisepsis for surgery, anesthesia for surgery, antibiotics, hormone replacement therapy with insulin, thyroid hormone, etc, smallpox vaccination, polio vaccination, etc, etc)  However, it is actually very hard to think of more than a handful of new drugs or devices discovered in the last 20 years which were that hugely innovative.  (The closest might be multi anti-viral drugs used to treat HIV, and Gleevec for chronic myelogenous leukemia.)  If there has been very little really important innovation in the last 20 plus year era of enhanced industry-academic-physician interactions, these collaborations could not have produced tremendous innovation. 

So the report's arguments rests on an assertion that is not clearly justified, and which appears to be at best a huge exaggeration. Resting an argument on a belief that is not further supported by evidence amounts to a obvious logical fallacy.  It is an appeal to belief.

Furthermore, while both reports emphasize physician-industry collaboration or interaction, there are many ways interaction or collaboration can occur without involving substantial payments by the latter to the former. It is possible for two people or organizations to work together without one paying the other.  Yet both reports use the broad assertions about interaction and collaboration to justify interactions and collaborations in which industry makes substantial payments to physicians or academic institutions. This appears to be an example of the fallacy of division, that is, an unjustified assertion that "what is true of a whole must also be true of its constituents."

CME Would Wither if Financing Were Reduced, and Industry is the Only Possible Source of Such Money - A Slippery Slope and a False Dilemma

The ESC report made the argument that without industry funding, CME would wither. For example,

Should Europe choose to follow the strategy proposed in the USA, severing links between industry and medical societies, CME could be severely compromised. Relying completely on public funding is not a viable option for Europe at the moment. The removal of industry support for medical associations would be followed by increased fees and reduced attendance at congresses especially by clinical trainees and young fellows. It is the view of the ESC that in the absence of alternative funding, or until alternative funding is identified, maintaining links with industry is appropriate....

The argument is that CME would fail if financial support for it would be reduced, and that industry is the only possible source of financial support at the current level. The notion that CME must inevitably fail if financing of it were reduced is a slippery slope fallacy, that is, a statement that a inevitably causes b when such inevitability is not proven. Why could not adequate CME be done at a lower cost, even if the result were less luxurious? Furthermore, the notion that industry is the only source of funding is a false dilemma fallacy. In fact, there are other possibly sources of funding. Given that physicians are among the world's best paid professionals, why could they not pay for their own CME?

"Conflicts of Interest are Unavoidable and ... They Cannot Be Abolished" - False Dilemma

The third major argument on which the report bases its recommendations is encapsulated above, and was buttressed by:

The risk of bias in medical education is not restricted to activities that are supported by industry. It can affect any type of scientific communication, even an educational meeting organized independently by a university or medical association.

Underlying these assertions seem to be extremely broad definitions of bias and conflicts of interest, coupled with unwillingness to see a distinction between trivial and serious varieties of each. This again appears to be a false dilemma. The distinctions should be between no conflicts, trivial conflicts, and serious conflicts, not between no conflicts and any conflicts, even if trivial.  This also could be called an example of how "the perfect is the enemy of the good."  Even if perfectly preventing all conflicts of interest is impossible, does this imply that preventing serious conflicts of interest is not worthwhile.   

Summary

We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples here, here,  here, and here.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.

So we add to our ongoing series how, based on a series of logical fallacies, the European Society of Cardiology provided a series of recommendations that allowed nearly any kind of relationship among CME speakers and selection committees and industry, as long as the relationships were disclosed.  The only relationships banned were those "which would represent a significant conflict of interest" for the Chairperson of a Congress Programme Committee.  Similarly, the only stipulations for the society's cardiology journals were that interests affecting editors and editorial board members must be declared, and board members and reviewers should decline reviews of manuscripts "relating to topics, drugs, or devices, in which they have significant commercial of academic interests."  The rules for guideline committees were somewhat more rigorous, but "receipt of consultancy fees or fees for lecturing would not debar an individual from being a member of a committee but must be fully disclosed."

It is discouraging that the web of conflicts of interest that currently enmeshes much of academic medicine and many medical professionals is so heavily defended.  It is more discouraging that its defenders include so many prominent academics and practicing physicians.  It is more discouraging that so many well trained people resort to logical fallacies to make their arguments, and do so in prestigious scholarly journals.

Our continuing series about how logical fallacies are used to support the status quo and the powers that be in health care suggests, if nothing else, that health care professional education ought to include courses in logic.

Finally,  in 2011, I noted, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  Last month, however, I discussed how the leader of one of the most acclaimed US medical schools made an argument in support of conflicts of interest based on logical fallacies,  Now we have just seen such arguments made by the leaders of European cardiology.  The new paper suggested that disclosure is the best way to manage conflicts of interest.  True to this belief, the paper included a disclosure section that took up an entire journal page.

It seems likely that number and magnitude of ongoing commercial interests so disclosed may have influenced the content of the position paper.  Yet while it may be unsurprising, it is most disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care.

The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA(4):

Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.

True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals, others who make decisions about patients' or the public's health, and academic health care institutions. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

References
1. ESC Board. Relations between professional medical associations and the health-care industry, concerning scientific communication and continuing medical education. Eur Heart J 2012; 33: 666-674. Link here.
2. Association of Americian Medical Colleges. Industry Funding of Medical Education. Washington, DC: AAMC, 2008. Link here.
3. Light DW. Global drug discovery: Europe is ahead. Health Aff 2009; 28: w969-w977. Link here.
4. Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link here.

Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care.  Recently, I argued that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles.  In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts here and here)  These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation.  Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

However, defenses of conflicts of interest continue to appear regularly.  The latest example, which incorporates an important twist, appeared in yesterday's Wall Street Journal.  It was in the form of a "Boss Talk"  interview with a leader of a major health care organization (whose identity we will discuss later.)

The title of the interview indicated that the interviewee was not "worried about industry ties" of academia or of health care professionals.  Conflicts of interest were clearly its main focus.  For example, it began,

Many universities are wringing their hands over the increasing coziness of medical schools and their corporate partners.

Then it stated that the interviewee:

has no such qualms.

The defense of this lack of qualms was heavily based on logical fallacies.

Biased Sample or Hasty Generalization

The main reason for this lack of concern appeared to be complete disregard of the more serious kinds of conflict of interest briefly described above. The interviewer asked:

What are the trickiest conflicts of interest to navigate?

The answer was:

Surgery is particularly challenging. Let's say you're a physician and you come up with a new hip replacement. You invented it so you're going to make a lot of money. But if you're going to do my surgery, I want you to put in the device you think is best. How do you separate that, when the person is the inventor and the great technician?

This may be tricky, but is arguably not the most tricky kind of conflict of interest.

The trickier example of the key opinion leader hired as a salesman was not raised by the interviewer or the interviewee. Such a case was graphically revealed by testimony of the aborted TMAP trial which implicated the former state mental health director as hired by Johnson and Johnson subsidiary Janssen to "promote ­Risperdal as a safe and effective medication." (See this post.)

Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There have been  documented instances (e.g., see posts here and here) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post here).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

Perhaps the interviewee was unaware of these issues.  Whether due to ignorance or deliberate avoidance, failing to consider the full spectrum of conflicts of interest, and specifically ignoring those with the greatest likelihood of adverse effects, appears to be a logical fallacy in this instance.  If deliberate, it appears to be reasoning from an (intentionally) biased sample, if not, it appears to be a hasty generalization.

The interview also included a few other choice logical fallacies that went unchallenged by the interviewer.

False Dilemma

The interviewer asked:

What do you tell professors who won't work with drug or biotech companies?

The response was:

I think that's a huge mistake. If you're a professor now, and you want to get your discovery to society, you either need to start a company or work with a company to commercialize a product.

Of course, in the "good old days," academic researchers got their "discoveries to society" simply by publishing them. Developing and marketing products based on their discoveries, while worthwhile undertakings in their own rights, were not considered part of the academic mission. Professors could still do this, if their goal was not to get rich. Yet the Bayh-Dole act allowed academic institutions to make money from their professors' discoveries, and the rush to commercialize the university has been on ever since. So while professors and academic institutions who are motivated mainly by money might not consider just putting the knowledge they discover in the public domain, that course remains possible, just not so lucrative.

The assertion that the only way to get a "discovery to society" is to start or work with a company is simply false, and using this assertion in an argument appears to be an example of a false dilemma.

Straw Man

The interviewee worked another argument into the same paragraph:

When professors have told me they won't work with companies anymore because they feel they'll have this scarlet letter, I think: 'Wouldn't that be sad if all the best scientists and clinicians won't work with companies because the public has said they're evil?'

I doubt that any of even the most vociferous critics of the conflicts of interest that now befog health care have claimed that those involved are evil, much less that they are have successfully convinced the whole public at large that anyone who "works with companies" is evil. Implying that this would be the result of criticism of conflicts of interest does not appear to be supported by evidence, and is probably flat wrong. Asserting it here appears to be an example of the straw man fallacy.

Summary

So the Wall Street Journal has added to our collection of defenses of conflicts of interest that seem mainly to be based on logical fallacies. 

We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples here, here,  here, and here.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.

In 2011, I noted, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  The interview discussed above, however, was a person who has such power.

The interview was with Dr Susan Desmond-Hellmann, the relatively new Chancellor of the University of California- San Francisco, who was just named one of the "25 most influential people in biopharma."  She has recently been advocating a change of direction towards commercialization for her campus, one of the most prestigious health care oriented universities/ academic medical centers in the country.  She previously justified this redirection again using logical fallacies (look here). 

She also appears to yet another advocate for conflicts of interest who has her own conflicts.  As we noted here, Dr Desmond-Hellmann had little academic experience before she became Chancellor, but had worked her way up in the corporate pharmaceutical world, leaving her position as President for drug development at Genentech after it was taken over by Roche. 

As we noted previously, even after that, Dr Desmond-Hellmann apparently has not completely left the corporate world.
- A web-site for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009."
- In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Last year, the company made an agreement with Teva to market over-the counter medications (see this Reuters article). Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's 2011 proxy statement, she appears to be in line to collect over $250,000 a year in compensation for this position.

It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.  Yet while it may be unsurprising, it is very disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care.

The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA [Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link here.]

Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.

True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals and others who make decisions about patients' or the public's health. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

More Tales of the Hospital CEO Compensation Bubble

The hospital CEO compensation bubble continues to grow. As the year draws to a close, I have found another set of stories about outsized payments to health care executives.  While their repetitive features suggest the magnitude of the issue, they featured some twists on the usual justifications given for large compensation packages. Presented in order of the size of the compensation package.....

Maxis Health System, Pennsylvania

The Scanton Times-Tribune reported:

Mary Theresa Vautrinot, president and CEO of parent company Maxis Health System, earned a little more than $464,000 in salary and other compensation, according to 2010 tax forms filed by the hospital.

These days, compensation under a half a million dollars may not seem like all that much, but it should be viewed in context. Maxis Health Systems actually actually owns only one hospital, Marian Community Hospital. In 2010, that hospital, already small, shrunk further,

In January 2010, the 70-bed hospital scaled back operations to just 35 beds. For the past six months, Marian Community Hospital has had about 20 inpatients each day.

Now it will close:

Last Monday, parent company Maxis Health System announced the Carbondale hospital's impending closure, citing ongoing financial pressures and a dwindling patient population

$464,000 seems like a lot of money to run a tiny hospital under "ongoing financial pressure" into bankruptcy. This seems like another example of pay for poor performance.

Summa Health System, Akron Children's Hospital, Akron General Health System, Ohio

In a survey of local hospital CEO compensation, the Akron Beacon-Journal noted,

Children’s President and Chief Executive William Considine received compensation and other benefits totaling $1,560,659 in 2010.

Thomas J. Strauss, president and chief executive of Summa Health System, received a total compensation and bonus package worth $1,408,062 last year.

For Akron General, 2010 was a year of leadership transition, with a former, interim and current leader all receiving executive pay.

Alan J. Bleyer, who retired as the hospital’s leader in 2009, received $677,267 in compensation. Michael Rindler, a national health-care consultant who was interim chief executive and continued in a consulting role through the year, made $983,744.


Vincent J. McCorkle, who took over as president and chief executive on July 1, 2010, received $568,605 in total compensation last year.

Lest anyone think that these hospitals were paying their CEOs a lot of money,

Nonprofit hospital executives could make substantially more if they worked in for-profit industries, [Ohio Hospitals Association spokesperson Mary] Yost said.

'A million dollars certainly is a decent package, but it’s not the highest thing that these people could command,' she said. 'We’re blessed that there are people who want to work for a nonprofit that has the mission of serving its community and they’re not just in it for the money.'

Only within the protected world of top executives would $1 million a year seem only a "decent package."  The stock defense of lavish executive pay is an appeal to common practice, i.e., the pay is justified because so many organizations pay their executives similar amounts.  This version of the defense lacked even the common accompanying assertions that the particular executives are so brilliant and hard-working that they would be assured of a high market price.

Furthermore, let us consider another comparison.  Consider the following data,

Summa’s revenue exceeded expenses by $31.7 million, for an operating margin of about 3 percent.

Akron General Medical Center’s revenue exceeded expenses by about $8 million, resulting in an operating margin of 1.7 percent.

Parent company Akron General Health System posted a loss of about $1 million on revenue of $854,207, according to IRS filings. The health system's filings reflect investment income and the costs of providing health screenings to the public, not hospital operations, Akron General spokesman Jim Gosky said.

Revenue at Children’s exceeded expenses by about $35.3 million for a 7.4 percent operating margin.

These data implied that the CEOs of Summa and Childrens' each received compensation equal to about 5% of their organization's total operating margins. The two people who acted as CEO at Akron General received together an amount that was larger than their system's operating loss, so had they been paid $1 million less, their system would have broken even. In this case, the newspaper found no one to quote who would assert that the former CEOs' performance was so good as to command that much of the hospital's excees, or the latter CEO's performance was so good as to be worth putting the hospital system into a deficit.  

Mercy Health Systems, Wisconsin

The Janesville, Wisconsin Gazette published a story about one CEOs response to previous reporting of his compensation,

Javon Bea saw the August article in a Madison newspaper that questioned the salaries of area health care leaders.

Bea, the president and chief executive officer of Janesville-based Mercy Health System, was singled out for receiving considerably more than hospital executives in Madison.

The article was based on 2009 tax filings, which show that Mercy paid Bea $3.6 million in total compensation. That included compensation of nearly $2 million and deferred pension payments of just more than $1.6 million.

The newspaper reported that the national average was $630,000 and included base salaries, bonuses, pensions and other benefits.

Many stories of executive pay have shown leaders who make many times other employees' compensation.  In this case, however, a CEO tried to assert that he did many times other employees' work.  Bea defended his salary by arguing he did the work of at least three, perhaps six people:

Bea said the Madison newspaper story compared executives at individual operations to him, an executive of a system that has three hospitals and 61 other facilities in 24 communities in southern Wisconsin and northern Illinois.

'To equal the job description of the CEO of Mercy Health System, you'd have to (add together) the salary of the CEO of DeanCare insurance, the salary of the CEO of Dean Clinic and the salary of the CEO of St. Mary's Hospital,' Bea said. 'And then you'd better throw in the chief operating officers at all three.'


Bea said Mercy doesn't have COOs and that he does that work.

Mr Bea did not explain how he found enough time in a 24 hour day to do the work of three to six people.  This seems to be a particularly hyperbolic version of argument that the executive is so brilliant and hard-working as to command such a high market price. Perhaps Mercy does not have CEOs or COOs of individual hospitals, but its 2010 Form 990 (from Guidestar here) documents that it has ten vice-presidents who each make approximately $200,000 to over $375,000 a year. Why Mr Bea would need to do the work of three or six people when he has so many other well-executives around to help was not clear.

Furthermore, Mr Bea came up with an apparently unique justification for his high pay, that its source was some sort of magic money that did not add to health care costs,

Bea said his salary has no effect on health care costs or the premiums MercyCare subscribers pay each year. He likened his salary to capital costs, which he also said don't affect what patients are charged.

John Cook, Mercy's chief financial officer, said Medicare, Medicaid and private insurance companies don't pay providers based on the costs of capital improvements or salaries, which in Bea's case is determined by a board of directors that works with national consultants and attorneys.

'My salary isn't going to affect your health care cost,' Bea said.

Maybe Mr Bea needs a second opinion from another CFO. His compensation appears to come from the hospital system's budget, per its 990 form, so it affects hospital costs as much as any other expense of the same amount. Furthermore, it is well known that hospital systems negotiate payment rates with private insurers, and that larger systems with more market power may negotiate higher rates.  Finally, it is also well known that different hospitals collect different amounts from government insurance programs for patients with apparently similar problems.  Thus, the notion that executive pay has no effect on health care costs, and the implication that it somehow comes from a magical place outside of the budget, seems to be an entirely new rationale for huge executive compensation.  From a psychological standpoint, it appears to be based on wishful or magical thinking.  Another way to look at it is as a logical fallacy, a special pleading, an assertion without a clear basis that the usual rules or principles do not apply.

Montefiore Medical Center, New York-Presbyterian Medical Center, and Others, New York, New York

A brief article in the New York Post focused on the bonuses given to some local CEOs,

Dr. Kenneth Davis, the head of Mount Sinai hospital and medical school, raked in a $1.2 million bonus in 2010, and Michael Dowling, the CEO of the North Shore-LIJ Health System, got $1 million. Louis Shapiro, president of the Hospital for Special Surgery, got a $1.5 million bonus and $992,215 salary.

Some CEOs also got a housing allowance, car and driver, and first- or business-class air travel.

Montefiore Medical Center in The Bronx paid CEO Steven Safyer $1.4 million plus a $359,845 bonus. The hospital also put $2.2 million into Safyer’s retirement fund, which he can take only when he leaves.

In addition,

The highest total compensation — $4.3 million — went to Dr. Herbert Pardes, the retiring head of New York-Presbyterian Hospital, who got $1.7 million in salary, a $1.9 million bonus and $648,686 as “other” compensation.

The Post found someone to provide the usual rationale,

Brian Conway, a spokesman for the Greater New York Hospital Association, defended the packages.

'Hospital CEO compensation reflects their myriad responsibilities, the complexity of running a medical center, and the national market for their talents,' he said.

That was a quick one-sentence summation of the "market" and "brilliant, hard-working" arguments.  Note that, as usual, no justification of why the particular people involved should be considered particularly brilliant or hard-working, and no comparison of their dedication or brilliance to that of lesser paid hospital employees was supplied.  Note also that CEO compensation is usually determined not by the market, but by a biased benchmarking process, see post here. Note further that this process almost never includes comparisons with employees who are not CEOs, nor includes explicit comparison of particular CEOs dedication, brilliance, etc with either that of other CEOs or other employees.



Premier Health Partners, and Others, Cincinnati, Ohio

The Middletown (Ohio) Journal reported,

Jim Pancoast, president and CEO of Premier Health Partners, the parent organization of Atrium Medical Center in Middletown, had the highest pay in 2010 of information available to date from that year. Pancoast collected about $4.6 million in 2010, most of which is a lump sum paid out through a supplemental executive retirement program.

The year before saw someone get even richer compensation,

Kettering Health Network’s former Chief Executive Officer Frank Perez and UC Health’s former CEO Kenneth Hanover topped the list in 2009, with each receiving more than $2.6 million.

Frank Perez’ total reportable pay in 2009 of more than $5.5 million included a more than $4.5 million lump-sum, taxable retirement payment.

Ron Seifert, executive compensation practice leader for the health care practice at Hay Group, supplied the usual rationale,

'No one, including the boards of these organizations, denies this is a lot of money. But what they’ll tell you is this takes a special leader,' he said. 'They come with a price tag.'

As is also usual, why the particular leader should be considered so special, particularly in comparison to other lesser paid hospital employees,  was not specified..

Northwestern Memorial Healthcare System, Chicago, Illinois

Last but not least, we address the compensation given Dean M Harrison, the CEO of Northwestern Memorial Healthcare System, as discussed in an editorial in FierceHealthFinance, entitled, "The problem of 8-figure hospital paychecks and near-poor patients." In summary,

Harrison was paid an astonishing $10.2 million in 2010, the result of a $7.5 supplemental retirement fund payout.

The ire this generated, so unlike the tone in the typical news article about executive compensation,  is worth quoting:

There are hundreds of nonprofit hospital CEOs like Harrison, compensated with millions of dollars while their institutions throw a few bread crumbs to the poor living in their service areas. Many these institutions spend more on CEO pay than charity care.

Alan Sager, a professor of health policy and management at Boston University, recently told Crain's Chicago Business what a lot of healthcare pay and governance experts dare not say: 'There's an enormous sense of self-entitlement among CEOs. It started in the for-profit corporate sector, but it has sloshed over into the non-profit hospital world.'

I worked up some talking points for Northwestern Chief Financial Officer Peter J. McCanna that he can bring to the next board meeting, although I'm guessing he won't do so. For those CFOs actually willing to rock the boat, these bullet points work for practically any large urban hospital in the country:

• Dean Harrison's 2010 compensation was approximately 170 times that of a charge nurse on their feet 12 hours a day. Does Dean Harrison work 170 times harder?

• Dean Harrison's compensation was approximately 20 times that of a cardiac surgeon performing 300 to 400 high-revenue procedures a year. Does Dean Harrison provide 20 times the benefit?

• Dean Harrison's compensation could be used to cover the first 10,000 uninsured patients who come through the emergency room each year. Which would provide a greater benefit to the hospital and community?

• The purpose of a supplemental retirement plan is to ensure its recipient maintains a reasonable standard of living past their working years. Given the tens of millions of dollars Dean Harrison has already received during his career and the six-figure pension and high five-figure Social Security income he is guaranteed upon retirement, will the $7.5 million payout actually accomplish its goal? Or will it merely be gravy for his heirs?

He concluded,

Meanwhile, if your hospital has a single patient who works hard, will be bankrupted by the bill they receive, and no one on your staff has walked them through every step of a charity care claim, that is where some imagination and original thought is sorely needed.

Too much money in some places, and not enough in others. Someone needs to announce that the buck stops here. And start moving around all the other bucks.

Summary

In a health care system with ever rising costs, declining access, and stagnant quality, we no longer can tolerate the perverse incentives generated by unaccoutanably high compensation to top executives. As long as top executives continue their sense of "self-entitlement," and can continue their current management practices reinforced by ever rising pay checks, expect poor leadership to undermine any attempts to improve health care.  Tired repititions of the usual rationales, that the CEOs are brilliant and hard-working, and that their compensation is mandated by the market do not make these rationales true.
We need health care leadership that has compassion for the increasing hardships that their patients have to endure, and that puts doing the right thing for patients' and the public's health ahead of self-interest.

A Logical Fallacy Affecting Selection of Panelists on an FDA Advisory Committee

An old argument used to defend against criticisms of conflicts of interest was just employed in a disturbing context. 

Expert Removed from FDA Advisory Committee for Having an Opinion

As first reported on the PharmaLot blog, and later by the Newark Star-Ledger, a panelist was just disqualified from voting on a US Food and Drug Administration (FDA) panel for having previously expressed an opinion about the safety of the drug up for re-evaluation.  Per the Star-Ledger,

Federal drug regulators have notified Sidney Wolfe, one of the nation's leading advocates for drug safety, that he would not be permitted to join a committee of experts asked to review new dangers associated with a group of birth control pills, including Bayer Healthcare's top-selling Yaz.

The Food and Drug Administration scheduled a meeting Thursday of two advisory committees — one on drug safety and risk management and the other on reproductive health drugs — after new information emerged on the safety of oral contraceptives containing the synthetic hormone

Why Was Dr Wolf removed from the committee?

The agency recently learned that Public Citizen, a non-profit consumer advocacy organization, had placed one of the contraceptives, Bayer’s Yasmine — a predecessor to Yaz — on its list of 'Do Not Use Pills' in 2002.

'He did not volunteer this information,' said agency spokeswoman Erica Jefferson. 'It was brought to our attention.'

The FDA offered Wolfe two options: He could present information to the advisory committee like other members of the public or he could sit on the committee, participate in the discussion but refrain from voting.

Logical Fallacy: False Dilemma

We frequently post about conflicts of interest affecting health care decision-makers.  It is now clear (e.g., look here) that leading health care academics often have significant financial relationships with drug and device companies and other health care corporations which could potentially influence their clinical research, clinical teaching, health policy recommendations, or direct patient care.  These relationships are frequently defended, often with logical fallacies used by those who themselves have conflicts. 

One common argument is based on the assertion that conflicts of interest are ubiquitous and everyone is conflicted.  Therefore, if one were to ban people with conflicts from responsible positions, there would be no one left to fill these positions, so such a ban would be untenable.  This seems to be an example of the false dilemma.  It is often employed by people who themselves have conflicts of interest.

One way to make it appear that everyone has conflicts of interest is to broaden the concept of conflicts of interest to "intellectual conflicts of interest."  Doing this facilitates the assertion that everyone who has an opinion on a subject has a conflict of interest, so this argument implies that all sentient beings have important conflicts.  This argument would make equivalent a doctor who would not use a particular drug because his or her reading of the clinical research literature about this drug suggests its benefits do not outweigh its harms, and a doctor who advocates using the drug, and is paid $100,000 a year by the marketing division of the company that makes this drug as a marketing consultant. 

The decision to prevent Dr Wolfe from voting on this committee seems to be based on this logical fallacy. As Dr Wolfe said,

In his statement, Wolfe said if intellectual conflict of interest means being informed and subsequently having opinions on a drug, then 'many more members of advisory committees would have to be excluded.'

'For members of a scientific and technical advisory committee, possessing information and expert views on matters within the purview of the committee is not a conflict of interest,' Wolfe wrote. 'To the contrary, qualified experts are likely to have developed views on a variety of subjects based on their professional experience.'

As Larry Husten wrote on the CardioBrief blog,

do we really want to choose advisory committee panelists who have never expressed opinions about the topics they are reviewing? Are we reaching the point where potential FDA panelists will be required, like Supreme Court nominees, to have avoided any discussion of all important issues at every point in the past?

Thus they point out the absurdity of banning people with "intellectual conflicts of interests," that is, with relevant opinions, as if they had real conflicts of interest. (But wait for someone to argue that if Wolfe were allowed to serve, it would be unfair to ban anyone with financial conflicts of interest from serving.)

What is most distressing about this case is that the sort of fallacious arguments usually employed by the conflicted to defend conflicts of interest are now being employed by leaders of government agencies, who are supposed to not have their own conflicts, and to serve the people, and in this case, to be dedicated to improving the health and safety of the population and of individual patients.

Every fallacious argument made in support of financial conflicts of interest affecting health care decision makers suggests we need to do more to combat such conflicts.  At an absolute minimum, all such conflicts should be fully disclosed in detail in any context in which they possibly could influence medical research, medical education, clinical care, or health policy.  Furthermore, we need to work towards ending as many such conflicts as possible.  A good starting point would be the recommendations made by the Institute of Medicine committee reports on conflicts of interest, and clinical practice guidelines.

See also comments by Merrill Goozner on the GoozNews blog.

ADDENDUM (9 December, 2011) - In response to comments below, see two posts by Dr Howard Brody in the Hooked: Ethics, Medicine, and Pharma blog on the problems with the concept of "intellectual conflict of interest" - here and here.

ADDENDUM (9 December, 2011) -  See further discussion by posted by Dr Brody today here.

Magical Thinking on Health IT from ModernMedicine.com

Annette M. Boyle, MBA has an article in the journal ModernMedicine.com that exhibits a severe form of fallacious thinking, approaching magical thinking. It's this type of thinking that gets patients injured and killed:

Health information technology: Better in long term despite short-term safety risks

Publish date: Nov 23, 2011
By: Annette M. Boyle, MBA

Responding to a new report that says health information technology (HIT) is creating some short-term safety issues, technology experts say physicians should remember one immutable fact: The new systems are far less dangerous than the old paper-based systems still in use in many practices.

Consider that first paragraph in light of the second:

Although the magnitude of the problem remains unknown, “serious errors involving these technologies—including medication dosing errors, failure to detect fatal illnesses, and treatment delays due to poor human-computer interactions or loss of data—have led to several reported patient deaths and injuries,” the Institute of Medicine (IOM) said in a news release.

So, "technology experts" proffer that a technology where the "magnitude of the problem remains unknown" are "far less dangerous than the old paper-based systems still in use in many practices."

Because they say so, right?

Wrong.

This is why "technology experts" need to be kept on a very short leash. They cannot think logically, even regarding such a simple issue such as this.

They claim as an "immutable fact" (that "physicians should remember") a comparison that has very little data underlying it? This is risible, shameful, patronizing in the extreme, insulting, and an example of the dangers of the invasion of medicine by computer technicians and salespeople.

The only "immutable fact" is, if you don't know the magnitude of risk, because it's - ah - unknown, you cannot (or should not) make statements about that very magnitude of risk. (This is K-12 level logic, and more towards the "K" than the 12.)

Actually, the evidence for significant risks beyond paper - far beyond paper - come from incidents like I've described on this blog. A very recent example is my Nov. 4, 2011 post "Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet."

Doctors are not in the habit of leaving off suffixes for slow release or long acting drugs (e.g., XR, SR), but a few lines of code can - and did - affect thousands at just one healthcare system. This was a potentially lethal error. Health IT can greatly amplify risk in a manner that paper simply cannot.

People who proffer gross illogic in medicine need to do society a big favor and simply remove themselves from any roles that affect medical care, patients, and medical ethics. If they know better, and are simply spinning their statements to promote sales, the need for such individuals to be distanced from healthcare is even more acute.

If they don't clean up their act, either way, they may find themselves on the defendant's witness stand, where such illogic will be ripped to shreds by plaintiff's attorneys.

-- SS

Logical Fallacies to Support Putting a Major Academic Medical Center into the Contract Research Organization Business

Two uncritically positive biographical features on UCSF Chancellor Susan Desmond-Hellmann MD appeared within the last two weeks, one in the New York Times, suggesting the game is afoot.  That game appears to be the Chancellor's new strategic direction for the university. 

A New Strategy for "Increasing Collaborations" with Industry

Per the NY Times, the university has just made a huge investment in bricks and mortar,

the school’s gleaming new building for stem-cell research and its enormous new waterfront campus, Mission Bay, which is becoming a medical and biotech empire.

Now, perhaps to pay for it,

Dr. Desmond-Hellmann hopes to supplement the usual sources of income like patient fees, grants and tuition by increasing collaborations between the university and the biotech companies that have sprung up in the Bay Area — many of them spinoffs from research that began at the university.

Dr Desmond-Hellmann described the general direction thus:

Her vision for the university is to make it 'the world’s pre-eminent health sciences innovator.' That means 'unparalleled' care for patients, brilliant faculty and staff paid enough to stay and fast translation of scientific discoveries into treatments.

That seems worthwhile, if quite a bit vague.
Making "Collaboration," "Innovation," and "Translation" More Explicit

An article in Xconomy sounded similar themes, but was more explicit. First, Dr Desmond-Hellmann said,

I’m sticking my neck out there and saying the world is changing very quickly, and yet our aspiration at UCSF is to be a world leader in health science innovation

So it is time to jump on the bandwagon,

The old way of doing things doesn’t really work anymore.

But the Xconomy article was more explicit about what sort of changes she envisioned, what innovation she had in mind, and what "translation" means in this context:

Often, some of the best research ideas would get handed off from academia to a company at a very raw stage of development. But few venture capitalists are funding startups at this early stage of development these days, and Big Pharma R&D has always tilted more heavily toward D than R. The economy has put more pressure on companies to tilt that balance even further away from research, and more toward late-stage development that has a chance to bear fruit in the near-term.

Universities need to recognize this is how things are. If they want to truly translate their innovations into products that help patients, they will have to carry the research a little further downfield themselves. Some Big Pharma companies have already shown they are willing to sponsor this kind of on campus work at UCSF and elsewhere.

So,

Working in collaboration with pharma companies is definitely a part of the future of advancing health, Desmond-Hellmann says. Financially, these deals are small potatoes, and aren’t going to close any budget gap. Even if UCSF researchers made a breakthrough cancer drug that generates billions of sales per year, it would likely only throw off a royalty stream to the university worth a few million a year—nice, but not exactly a big deal for a multi-billion-dollar institution.

Instead, the collaborations are about improving the flow of basic research through development. Pharma companies need new products to preserve and grow their bottom lines, and they aren’t doing so hot at inventing them on their own. When budget cutters ask questions about how taxpayer dollars are spent on campus, academic centers need to be able to say something like, 'We discovered a breakthrough drug that helps people live longer, better lives,' instead of just 'We got a cool paper published in Nature.'

Just to underline that,

Big Pharma R&D operations, rich as they may be, are feeling the same pressure to make cuts as universities. What’s needed now are the creative partnerships, where someone knowledgeable about the whole process (like maybe a Desmond-Hellmann) steps in and finds a way to more seamlessly bring together these two factions around what they have in common.

And the brave new world is almost here already,

UCSF has struck a number of creative partnerships with companies like Pfizer, Sanofi, and Bayer, which are being closely followed at other universities. UCSF has also found a way, with the help of some big-time philanthropy, to break ground on two ambitious projects—a $1.5 billion hospital complex and a $200 million neurosciences research facility in the Mission Bay district. There in the same neighborhood, the university has also continued to support QB3, an incubator where academic scientists are starting companies that test whether their ideas just might have what it takes to become new drugs, devices, or diagnostics.

So let us try to make Dr Desmond-Hellmann's new direction clear: what she meant by innovation and translation was doing contract research and development for big pharma and big biotech. The goal is not just to discover new knowledge, but to develop new products.  That should bring in a lot of money, which can pay for all sorts of fancy new buildings.

A New Direction Supported by Logical Fallacies

The problem is, as I hinted above, the arguments for this new direction were mainly based on logical fallacies.
Begging the Question

Note that the key argument in support of turning the university into a pharma/ biotech research and development shop was, "if they [universities] want to truly translate their innovations into products that help patients," they must develop those products themselves.  This begged these questions:
-  Should they want to develop products?
-  Why are they the only ones who can do so? 

These questions were never asked in either article, perhaps because their answers are obviously "no."  Universities' missions are to discover and disseminate knowledge.  Developing and marketing products are not part of their missions.  Furthermore, there are lots of corporations that ought to be able to develop and market pharmaceuticals and devices outside of universities.

Appeal to Common Practice/ Bandwagon

Another argument in favor of Dr Desmond-Hellmann's radical new plan was "universities need to recognize this is how things are," in that "the old way of doing things doesn't really work anymore." This is an example of two logical fallacies, the appeal to common practice, and maybe the bandwagon fallacy more so. An assertion is made that the world is changing, the change cannot be stopped or even questioned, so we all just have to climb on the bandwagon.

Straw Man and Begging the Question (Again)

The Xconomy article also noted:

Some academics sneer at this late-stage research/early-stage development work. It’s a cultural attitude Desmond-Hellmann wants to change. 'There’s a technical competence in taking a discovery from a lab and turning it into a medicine. It’s embarrassing that people don’t honor that technical competence. You sometimes hear it called 'applied' or 'obvious' or some other pejoratives. But it’s my expertise. I do take that personally. There is a technical competence. It needs to be understood, put into curriculum, and valued.'

Here Dr Desmond-Hellman seemed to be using the straw man fallacy, by setting up unattributed arguments against her cause that she could easily refute.

Meanwhile, however, another question she begged was what exhibiting such technical competence has to do with the mission of the university. As we will discuss further below, the mission of a university is to discover and disseminate knowledge. "Technical competence" may be required to do so, but exhibiting technical competence per se is not the goal. (Consider: if the university had faculty members who were competent amateur automobile mechanics, would it fulfill the mission to establish a university automobile repair business using these faculty members' technical competence?)

Another implied begged question was: if this competence ought to be a subject taught at the university, how would the need for such teaching require the university to do contract research and development for industry?

Appeal to Authority

Both articles also seemed to try to support Dr Desmond-Hellmann's ideas by emphasizing first that she had "a stunningly successful career in the pharmaceutical industry," perhaps so described because her "years in pharmaceuticals left her, by her own account, 'very, very wealthy," (It did allow that at the end of her career at Genentech, after she had become president of product development, "her compensation (base pay, stock and other payments) was more than $8 million a year. She also owned hundreds of thousands of shares of Genentech stock, worth $95 a share.")

Also, despite her apparent membership in the top one percent of the population in terms of income, the Times article took pains to note "she is so nice," and again, "she's a very nice person."

So the implication is that because she is successful, rich, and nice, her arguments and ideas must be correct.  This seems to be an appeal to authority.
Questions That Should be Asked

Neither the author of the NY Times article nor the author of the Xconomy article sought to ask her any of the questions that were begged, or to otherwise raised by Dr Desmond-Hellmann's grand plans.  So let me try.

How Does Becoming a Contract Research Organization Fulfill the University's Mission?

However her new plans are described, they entail hiring out the university's facilities and faculty to develop new products, drugs and perhaps devices. Yet the university's mission is to discover and disseminate knowledge. How will proprietary research and development fulfill that mission? 

In fact, there are reasons to worry that the new focus on for-hire drug research and development will undermine the mission.  Any new knowledge produced is likely to be labelled trade secrets. Faculty who work as drug and device development contractors will not be teaching students. Students caught up in drug and device development will be working for big corporations, possibly without pay, and without any ownership of anything they may discover in the process.

How Will the Resulting Institutional and Individual Conflicts of Interest be Managed?

If the university becomes dependent on being paid for drug and device development, can university faculty remain unbiased teachers and researchers? Will they not feel pressured to show favor to the products, policy goals, and leadership of the corporations that are paying them?

Why Would Faculty and Students Want to Participate in a Contract Research Organization Cloaked in Academic Robes?

Will faculty want to be labelled as contract workers? What will that do for their academic credibility? Will students want to be educated by people beholden to specific corporations and corporate projects?

Should Patients Want Care from a Contract Research Organization?

How will they be confident that the drugs they are prescribed and the devices used in procedures they undergo are not chosen because their doctors and nurses feel beholden to the corporations that make them?

Summary

UCSF's new multimillionaire ex-biotechnology executive Chancellor seems determined to push the university into a much closer relationship with the drug, device and biotechnology industry. In fact, she seems to be advocating that the university should become, in effect, a contract research organization to service this industry. So far, this radically new direction seems to be provoking no questions, much less dissent, even though the public justification for it was apparently based on a string of logical fallacies.

However, it is not clear how taking one of our major academic medical centers in this commercial direction will not harm, much less benefit its mission.

For 30 odd years in the US we have been making health care more commercial, and have to show for it the world's most expensive but hardly the world's best health care system. This increasingly inaccessible system which provides care of uncertain quality has made the one percent who run it very rich.

Those of us in the 99 percent need to question how making it even more commercial will do any of us any good.

Post-Script: You Can Take the Executive Out of Biotech, But You Can't Take Biotech Out of the Executive

When Dr Desmond-Hellmann first become UCSF Chancellor, we questioned how someone steeped in the culture of commercial biotechnology could distinguish that culture from the academic mission? (You heard that question here first.)  The answer now seems to be that her current ambitions substantially blur the academic mission with the pursuit of money and commercial success.

Maybe one reason for this blurring of distinctions is that Dr Desmond-Hellmann apparently has not completely left the corporate world.
- A web-site for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009."
- In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's 2011 proxy statement, she appears to be in line to collect over $250,000 a year in compensation for this position.

It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.

ADDENDUM (5 November, 2011) - As per Reuters,

Consumer products maker Procter & Gamble Co and Israeli drugmaker Teva Pharmaceutical Industries Ltd on Thursday gave details of a joint venture they have created to sell over-the-counter medicines.

The joint venture, which was initially announced in March, will combine Teva's expertise in drug marketing with P&G's expertise in branding to expand their presence in the $200 billion consumer healthcare industry.

So P+G is becoming more of a health care company, increasing concerns about how her position as a director of the company, which gives her fiduciary responsibility for its finances, may influence her in her role as Chancellor.

Using Logical Fallacies to Scold "Pharmascolds"

I first became dimly aware of how dysfunctional health care had become in the US after seeing, up close and personal, a case of attempted suppression of medical research because its content offended vested interests.  (See "Academic Freedom and the Corporate University" by Jennifer Washburn here.)  We have since blogged frequently about suppression of research, other threats to free speech and academic freedom in health care, and the larger anechoic effect, which undermines discussion of many of the threats to core values in health care.

A Case Illustrating "How Academic Orthodoxy is Enforced?"

Thus, I am always on the lookout for new cases which illuminate these issues.  So a recent post on the well-known Forbes blog site by David Shaywitz, identified only as a "contributor," caught my attention:

an elite coterie of self-righteous academics seek not to level the playing field but to dominate it, imposing their particular world view on everyone else. Of course, conservatives, among others, have long alleged this is the true nature of American colleges– where tolerance and open-mindedness is said extend from the left all the way to … the far left. But we now have the opportunity to see this play out at the professional level as well.

This sounds somewhat familiar. The FIRE (Foundation for Individual Rights in Education) web-site boasts a huge case file of attacks on free speech in academia. Most of them did not involve professional schools, or academic medicine in particular. Note, however, that FIRE is avowedly non-partisan, and while many attacks they deplore seemed to be on the free speech of those on the right, quite a few were also on those on the left.

So what was the nature of this illuminating case?

Those who wonder how academic orthodoxy is enforced in practice need look no further than the response to a recent lecture given at Case Western University by Dr. Tom Stossel, the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women’s Hospital, where he is also an attending physician. (Disclosure: Stossel was an academic colleague of mine back when I was in Boston, and we have co-written a number of commentaries over the years; we also coined the term, Pharmascolds.)

Stossel’s lecture, from what I’ve heard, was well-attended — so good for him. But the real news was the three sentence email received by members of the Case Western faculty prior to Stossel’s lecture — a nastygram sent by a colleague at the neighboring Cleveland Clinic.

Subject line: 'Re: Medicine Grand Rounds — Tuesday September 13th' (i.e. Stossel’s talk).

Body of the email (in full): 'This guy is an embarrassment to the medical profession. Can’t believe you would have him provide Grand Rounds. Your trainees deserve better.'

Enforcement or Just Argument?
Unless there is more too it, however, this case would not seem to fit in the category of attempts at suppression of free speech or academic freedom. After all, the folks from FIRE often note that the best response to speech or writing with which one disagrees is more speech or writing. The case above seems to involve two people who disagree, Dr Stossel, and whoever wrote the email. Disagreement is what free speech is all about. Per the FIRE web-site section on free speech:

Freedom of speech is a fundamental American freedom, and nowhere should it be more valued and protected than at America's colleges and universities. The 'marketplace of ideas' upon which a university depends for its intellectual vitality cannot flourish when students or faculty members must fear punishment for expressing views that might be unpopular with the public at large or disfavored by university administrators.

For this case to be an example of someone trying to "enforce academic orthodoxy," there needs to be an action, or at least threat of an action to silence one of these two people, or to punish one of them for what he or she already said.

So I looked for the next part of this case. But there appears to be a problem. There is no more to the case than what appears above:

And there you have it — watch and learn kids! - here’s how A-list academics do it, in three steps and three sentences.

So Mr Shaywitz appeared to be arguing that somehow the email sent about Dr Stossel is a threat to free speech. However, unless the email came from some academic official who could punish Dr Stossel or his audience at Case Western University, the threat to free speech is not apparent.

So we need to find out who wrote the three-sentence email, and whether he or she had the power to enforce his or her opinions as orthodoxy.  Who wrote the email?

The author of this email? Dr. Steven Nissen, perhaps America’s most quoted Pharmascold.

Dr Nissen is Chief of Cardiovascular Medicine at the Cleveland Clinic. Although he appears to have an appointment at the Case Western Reserve Medical School, the chair of cardiovascular medicine there is Dr Dan Simon. Maybe Dr Nissen did not agree with Dr Stossel, but there is no obvious way he could "enforce" his dislike, or otherwise turn it into "orthodoxy."

Dr Stossel's speech may be obnoxious to Dr Nissen. And Dr Nissen's written email may be obnoxious to Dr Stossel, and to Mr Shaywitz. However, neither side has enforced its orthodoxy on, or suppressed the speech of the other.

Logical Fallacies

Relativist Fallacy
If Dr Nissen could enforce orthodoxy by merely writing an email, then Dr Stossel presumably could do so by giving his talk, and Mr Shaywitz could also do so by publishing his post. Implying that only Dr Nissen, with whom Mr Shaywitz disagreed, enforced orthodoxy appears to be an example of the relativist fallacy, the fallacy that a claim may be true for others, but not for the person making it.

Thus the central premise of the blog post appeared to be based on a logical fallacy.  This suggests one should be highly skeptical that the goal of the published work was really the defense of free speech. 

Straw Man Fallacy

It did begin with a paean to free speech that even FIRE staff might like, but then posed an interesting contrast:

When you think about the arguments raised by the Pharmascolds, critics who worry about university/industry interactions, constriction of academic freedom is typically cited as a key concern. To the Pharmascolds, industry represents an inherently corruptive influence on students and trainees, and threatens to impose a restrictive and biased world view upon them.

While this 'Pharmascolds as defenders of academic freedom' narrative has certainly enjoyed considerable traction (likely related to the enabling role of journalists in this dynamic), there’s another competing narrative to consider.

It appears that Mr Shaywitz really does not agree with the "Pharmascolds," a group in which he believes Dr Nissen fits.  Mr Shaywitz did not explain who the Pharmascolds other than Dr Nissen are. He did not provide evidence in support of his summary of their views.  So, at least in this blog post, the Pharmascolds appear to be straw men, and Mr Shaywitz thus appeared to be using the straw man fallacy to support his argument.

A Second Relativist Fallacy

Moreover, Mr Shaywitz did not try to challenge the truth of the "Pharmascolds'" supposed views. Rather, he offered a "competing narrative." That is a surprising form of argumentation for someone who seemed to be appealing to conservatives. The notion that there is no truth, only competing narratives, is straight out of post-modernism, a school of thought with which conservatives rarely identify. Mr Shaywitz's casting of his argument as a better, but still "competing narrative," thus appears to be another use of the relativist fallacy.

So this extraordinary blog post in Forbes appears to be less a reasoned defense of free speech and academic freedom and more an attempt to once again discredit the "Pharmascolds," and hence to discredit anyone who is skeptical of the influence of pharmaceutical companies and other commercial vested interests on academic medicine. But like the last attempt to mock the "Pharmascolds," this one was based on primarily on logical fallacies.

Summary

We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples here, here, and here.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.
I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts.  While David Shaywtiz was identified only as a "contributor" on his Forbes post, and as an "adjunct scholar" on the version on the American Enterprise Institute site, his profile on the Forbes site notes that he really is Dr David Shaywitz, trained as a "physician-scientist," who now "works at a biopharmaceutical company in San Francisco." His own blog identifies him as "currently Director of Strategic and Commercial Planning at Theravance, a publicly-held drug development company in South San Francisco."  So perhaps Dr Shaywitz disagrees with the "Pharmascolds" because their skepticism may be perceived as threatening the vested interests of Dr Shaywitz's company? Perhaps the campaign against the "Pharmascolds" is yet another example of stealth health policy advocacy by those with vested interests that might be threatened by skepticism about ties among physicians, academic medicine, and industry?

Physicians and the public need to stay extremely skeptical about much of published health policy advocacy, particularly when the arguments appear illogical, or the interests of the advocates are not clear.

Academic Medicine Deploys a Logical Fallacy to Avoid Disclosing Inconvenient Truths

We recently discussed a simultaneous retreat from aggressive regulation and enforcement applied to big health care corporations by US government agencies.  Now a story published by Bloomberg (currently available without a subscription here on PharmaGossip) showed that the push for less disclosure of relationships with industry that generated conflicts of interest for academic medicine came not from industry, but from ... academic medicine:

The lobby for Harvard University and other research institutions drove the Obama administration to weaken draft rules for scientists to disclose potential conflicts of interest, according to U.S. records and watchdog groups.

In particular,

Universities objected to draft rules in a letter to NIH and in meetings with officials at the White House Office of Management and Budget, approver of the final version, said Carrie Wolinetz, associate vice president for federal relations at the Association of American Universities that represents 61 research universities.

Also,

The letter was co-signed with the Association of American Medical Colleges, American Council on Education and Association of Public and Land-Grant Universities.

The one example of the universities' reasoning to justify their objections to greater disclosure of conflicts of interest was striking.

Wolinetz’s organization wrote in the letter that 'there is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity.'

Recall that the disclosure to which they objected would be by federally funded researchers, and of financial relationships with organizations that had vested interests related to the particular research projects. The Institute of Medicine's landmark report, "Conflict of Interest in Medical Research, Education and Practice,"  stated:

Disclosure of financial relationships with industry is an essential, though limited, first step in identifying and responding to conflicts of interest.

One could also argue, as did Senator Grassley, (see here) that disclosure is owed to the tax-payers who support the research.

On the other hand, I do not think anyone would argue that disclosure and the ill-defined "management" proposed by the NIH would be sufficient to guarantee "objectivity and integrity" of the research.

In fact, the IOM report called for going far beyond disclosure.  Specifically, it called for banning most conflicts affecting most clinical research:

researchers should not conduct research involving human participants if they have a financial interest in the outcome of the research

This goes far beyond what the original NIH revision of its conflict of interest rules mandated. However, I am sure that banning such relationships was the last thing that the AAU and AAMC wanted.

So the academic institutions' argument seems to be a variant on the false dilemma logical fallacy. If the only alternative to doing nothing about conflicts of interest is disclosure, and if disclosure is really a poor solution to the problem, than perhaps doing nothing makes sense. However, if disclosure is just a necessary first step, as the IOM asserted, then it is a first step that should be taken in preparation for other steps to come.

Note that the academic institutions' argument also seems to be a version of what has been called the Nirvana fallacy, or the perfect is the enemy of the good fallacy. That is, if what one can do does not result in Nirvana, then one should do nothing.

Finally, in this case the academic medical institutions' argument seemed too extreme even for their pharmaceutical industry supporters. As the Bloomberg article reported,

Researchers have been lax making financial disclosures and there’s been an absence of oversight, said Peter Pitts, president of the Center for Medicine in the Public Interest, a nonprofit research institute in New York. 'When you don’t properly disclose, you give the impression that you’re trying to hide something.'

Institutes should instead disclose all financial interests without trying to judge whether they are conflicts, Pitts said.

As we have discussed previously, Peter Pitts' main occupation has been as a leader in public relations for the pharmaceutical industry. He is currently a senior partner, director, global regulatory & health policy for Porter Novelli. Even though we have previously criticized Pitts for deploying logical fallacies in support of industry positions, in this case the academic medical institutions' argument was too much for him to support.

So we have come this far. Universities are ostensibly about finding and disseminating the truth. Yet universities' academic medical subsidiaries now deploy illogic to avoid revealing particular truths that they find uncomfortable, and which might raise questions about relationships with industry that are increasingly lucrative. Universities seem now willing to jettison their mission to make more money.

True health care reform would require academic medicine to put its mission ahead of its revenues.

From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things

A poster who wishes to remain anonymous, a Senior Clinician in the state of Victoria, Australia, added this comment to my March 2011 post on 'anecdotes.' (That post was entitled "Australian ED EHR Study: An End to the Line "Your Evidence Is Anecdotal, Thus Worthless?".)

He makes a critical point I think has gotten lost in the HIT domain (emphases mine):

Anonymous August 15, 2011 9:26:00 PM EDT said...



Anecdote and Medicine.



We are actually talking about two different things here.



1. Anecdotal reporting of a new and potentially exciting finding in Medicine is NEVER a reason to widely implement a new treatment or procedure. It represents the lowest category of evidence in any systematic review In any orthodox system of medicine in the developed world a new intervention would not be ratified or re-imbursed without EXTENSIVE study in Randomised trials - ie the mandatory three phase trial arrangement for new drugs.



2. Anecdotal reporting of side effects/failure for an implemented treatment is a crucial part of any risk management strategy within a healthcare setting. Individual incident reporting of harmful events AND near misses is crucial to help organisations (and regulatory agencies) understand where risks to patients and staff are to be found. A root cause analysis can then be undertaken and corrective measures introduced and their subsequent impact assessed. The process of 'closing the audit loop' is required or no reduction in risk can be verified. This is separate from the regular audit cycle which each Department should apply to aspects of its work, usually reviewing a particular intervention in rotation.



In the above debate the pro e-Health lobby find themselves mis-interpreting both definitions.



They support the positive anecdotes for the adoption of Electronic Health Records WITHOUT proper randomised evidence being available and they decry the anecdotes of negative experiences of implemented systems that in reality represent episodes of incident reporting.



It appears the over-exuberant proponents of e-Health in general and for everything, need to attend revision courses in research methodology and risk management... [a fascinating observation - ed.]



nb Irony of irony;



Victoria now has State-wide implementation of risk management software which for all healthcare staff is the obligatory reporting mechanism for all incidents and near-misses.



The system is so user unfriendly and time demanding virtually none of the busy hospital doctors I have spoken to access the system, even though 'training' has been undertaken. The system has been widely condemned at our Medical Staff Committee.



Victoria has recently congratulated itself for a fall in annual number of critical incidents occurring in public hospitals!



I will leave it to you to work out how such a positive risk management statistic could be generated in a healthcare system working near capacity with increasing year on year demand for its services...

Per these observations:



A critical distinction that seems to have become lost, even among the Medical Informatics academic elite (see, for instance, my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture"), is the distinction between research observations on the one hand, and risk management incident reports on the other.



It seems a form of erroneous thinking or logical fallacy.



The lost distinction between research methods and risk management methods, that require very essential, very different consideration of "anecdotes", and the conflation of the two types of "anecdotes", are brilliant observations.



Finally, the loss of consideration of the distinctions between the two different types of "anecdotal reporting" is part of what I have termed the lack of the rigor of medicine itself in HIT.



-- SS