Logical Fallacies in Support of Payments for Board Members of Non-Profit Health Insurers

The kerfuffle over the huge golden parachute given the departing CEO of an ostensibly non-profit Massachusetts health insurer/ managed care organization continues to evolve (see posts here and here), providing some new insight into governance problems afflicting health care organizations. 

One of the issues that aroused initially aroused concern was that Massachusetts Blue Cross Blue Shield paid the members of its board of trustees substantial amount, an unusual practice for a non-profit organization.  Board members who feel they owe their pay to the CEO they are supposed to be overseeing might be particularly inclined to over pay that same CEO.

Nonetheless, the Boston Globe just reported that other non-profit Massachusetts health insurers were defending their payments to board members:

The state’s second- and third-largest health insurers said yesterday their board members have decided to keep paying themselves five-figure annual fees despite objections from the state attorney general and an inquiry into directors’ compensation at nonprofit health plans.

The rationales for these decisions were fascinating, amounting to four variations of special pleading, plus an appeal to tradition.

Special pleading: Our board members are experienced and independent

'Good governance is advanced by the recruitment and retention of experienced, independent, reasonably compensated directors,' Harvard Pilgrim said in its statement. 'In 2010, our board worked more than 2,000 hours.'

I doubt any non-profit organization would admit to not wanting experienced, independent board members,  but very few other non-profits pay their board members. Asserting that board members of the Massachusetts insurance companies especially deserve pay because of characteristics they share with other members of other boards who are not paid amounts to a special pleading.

The second statement seems just to be a simple exaggeration, since 2000 hours a year implies that the board members work there full-time (40 hours/week * 50 weeks = 2000 hours).  

Special Pleading: Our board members are skilled and experienced

Wellesley-based Harvard Pilgrim, however, said in its statement that board members 'apply their specialized experience and skills in the areas of medicine, accounting, finance and law, to support our company and its mission. Our board serves as responsible, independent fiscal stewards for our members’ premium dollars.'

Again, board members of all sorts of non-profit organizations could be described in similar terms. So using this as an argument for paying board members when members with the same attributes of other boards are not paid is another special pleading.

Special Pleading: Our boards have great responsibility

Tufts, based in Watertown, said its board believes there is 'an additional overlay of responsibility' for directors of a health insurance company.

'Unlike the directors of other nonprofits, they are subject to distinct regulatory considerations,' the Tufts statement said. 'Therefore, compensation for time, commitment and skill of top talent is a responsible approach for the oversight of an organization that provides health care coverage to hundreds of thousands' of members.

Of course, boards of hospitals have their own "distinct regulatory considerations," as do boards of academic institutions  Boards of hospitals are also responsible for the health of their patients and boards of academic institutions are responsible for the education of their students. So this is a third example of a special pleading.

Special Pleading: Our responsibility, our time, our effort
Appeal to Tradition: Our tradition is to pay directors

The history and tradition of nonprofit health plans is to pay [directors] in this state. These are people from various walks of life who bring a skill set. These are not political hacks. . . . It’s because of the responsibility, the time, the effort, and the work you have to put into it. It’s a lot of homework.

It is true that the four non-profit Massachusetts health insurers all apparently did pay their board members, although in many other states, members of the boards of non-profit health insurers were not paid. But in the absence of any further argument that Massachusetts organizations were right when the others were wrong, this amounts to an appeal to tradition.   The rest of this personal statement was again a special pleading. 

Summary

Board members of non-profit organizations generally are said to have three duties, as per BoardSource:
- The Duty of Care: "a board member owes the duty to exercise reasonable care when he or she makes a decision as a steward of the organization."
- The Duty of Loyalty: "a board member must give undivided allegiance when making decisions affecting the organization. This means that a board member can never use information obtained as a member for personal gain, but must act in the best interests of the organization."
- The Duty of Obedience: "The duty of obedience requires board members to be faithful to the organization's mission. They are not permitted to act in a way that is inconsistent with the central goals of the organization."

The notion that boards stewarding non-profit organizations, including health care organizations, have these core responsibilities seems to have become increasingly ignored and forgotten in an increasingly commercialized health care environment.  Simply fulfilling these duties should not be regarded as exceptional board service, and certainly not so exceptional as to require pay.  The fallacious arguments made on behalf of lucrative payments given to members of the boards of two of the more highly regarded non-profit health insurance corporations in the country indicate how low governance and stewardship of health care organizations has sunk.

Again, we need governance of health care organization by people who understand their fundamental duties, who are willing to be accountable, and who put their organizations' mission ahead of personal gain. 

Those who profess concern about the stewardship of health care need not go far to find examples of fundamental misconceptions about what such stewardship involves.  We need to restore core values of governance to our health care organizations. 

Post Title → Logical Fallacies in Support of Payments for Board Members of Non-Profit Health Insurers

Once More with Feeling: Another Defense of Conflicts of Interest Based on Logical Fallacies

Despite increasing recognition of the adverse effects of health care professionals' and health care institutions' conflicts of interest on health care, such financial relationships continue to have their prominent defenders.  The latest example was an article in Medscape General Surgery by Frank J Veith MD, entitled "Physicians and Industry: Fix the Relationships, but Keep Them Going."  Dr Veith is a prominent vascular surgeon who "received numerous awards and honors as a leader, outstanding teacher, and innovator in vascular surgery," according to New York University

We have noted before how defenders of conflicted professionals and professional societies often employ logical fallacies to support their arguments.  Some recent examples were discussed here, by a prominent ostensibly libertarian attorney and law professor; here, published in a well-known medical journal by the former director of "medical communications" for a large pharmaceutical firm; and here, by the president of a large medical society, published again in a well-known medical journal.

Dr Veith seems to be continuing that tradition. His approach emphasized frequent repetition of the same fallacious argument.

Straw Man: "Totally Interrupt All Doctor-Industry Relationships"

Dr Veith's main argument seemed to be with attempts to prevent physicians from having any relationships with industry, presumably including not just financial relationships, but professional collaborations or even personal friendships.  For example, he wrote about

a recent initiative to completely sever the relationship between industry and doctors has gained traction. This initiative has been supported by several states, including Massachusetts and Vermont, and universities, such as Harvard, Stanford, the University of Massachusetts, and the University of Michigan, which have enacted draconian laws or policies designed to separate doctors and industry and to interrupt any relationship between them.

Furthermore,

Even many individual physicians have sanctimoniously jumped on the bandwagon and written articles or opinion pieces attacking the evils of any relationship between industry and doctors, suggesting the severance of any such relationships.

Then later, Dr Veith wrote,

We should establish rules to prevent or minimize the abuses, but we should not totally interrupt all doctor-industry relationships. To do so is wrong-headed and would eliminate the many beneficial effects that accrue to medical care and society from these relationships. It would be throwing the baby out with the bathwater.

Finally, he concluded thus,

These will be far better solutions than completely eliminating all industry-doctor relationships.... Such safeguards will be better than the present trend for institutions and governments to enact strict measures to separate physicians from industry.

Despite making this argument at least four times, the problem is that Dr Veith provided no citations, much less evidence that such "draconian" policies have been enacted or even advocated.

There have been new policies on conflicts of interest suggested or adopted by some organizations. None, to my knowledge have been exactly "draconian."

For example, Harvard University does have a new policy on conflicts of interest. Maybe Dr Veith was referring to it above when he mentioned Harvard. However, in an interview about the new policy involving university leaders published in the Harvard Gazette, the Vice Provost of the University said,

The University is not designed to be an ivory tower isolated from the world. So the trick is to be able to have a robust system for affording faculty opportunities to engage with the commercial world and at the same time not threaten in any way their own fundamental integrity or that of Harvard.

That hardly sounds like a policy that completely severs all relationships between faculty and industry.
So Dr Veith's main premise seems to be based on a multiply repeated straw-man argument. He argued again and again against a policy that no one seems to be advocating. (And even I, as a hard-liner about conflicts of interest, have never advocated a complete interruption of all relationships of any kind between all physicians and all of industry.)

Appeal to Fear: You Will be "Blighted"

Perhaps just to spice things up, Dr Veith warned of the dire consequences of the "draconian" policies that no one was advocating:

Those institutions that choose such inquisitional approaches will be blighted and suffer competitive disadvantages.

Dr Veith had asserted multiple benefits of continuing relationships among physicians, health care institutions, and commercial firm. He presented no evidence to support his assertions, most of which can be questioned (see below). His warning that institutions will be "blighted" was based on his assertion that the stringent policy no one advocated would eliminate these unproven benefits, hence his warning of  something so severe as "blight" seemed to be an appeal to fear.

Ad Hominem: "Sanctimonious" Physicians Leading a "Witch Hunt"

As noted above, Dr Veith referred to anonymous physicians who "sanctimoniously jumped on the bandwagon," thus leading to

The initiative to separate industry from physicians and surgeons [which] has taken on the trappings of a witch hunt.

And again,

Their leaders should recognize this and resist the temptation to join the separation witch hunt....

My interpretation is that this was an implied set of ad hominems. Those who supposedly advocated the "draconian" policy were made out to be "sanctimonious" witch hunters. After just having seen "The Crucible," I could also argue that the use of the term "witch hunt," with its current extreme emotional references (apparently to a case in which presumably innocent people were hanged), amounted to an appeal to emotion and an appeal to fear.

Summary

I must admit Dr Veith's entire set of arguments was not completely based on logical fallacies.  However, the rest of his arguments hardly appeared even-handed.  He presented a series of assertions about the benefits of such relationships, including that they "foster innovation and development," that "industry-sponsored medical education helps to keep physicians informed about new developments," that industry sponsored education about devices prevents "difficult and dangerous" practices, and helps physicians use devices "better and more safely."  He provided no evidence in favor of these claims, and seemed to ignore arguments about the hazards of payments to physicians biasing their clinical practice, teaching and research.

I should also note that these arguments were made by a physician who appears to have his own personal financial relationships with industry.  In the Medscape article, Dr Veith "disclosed no relevant financial relationships."   However, as a member of the editorial board of Medscape General Surgery, Dr Veith "disclosed the following relevant financial relationships: Owns stock, stock options, or bonds from: Vascular Innovations, Inc."  Furthermore, the disclosure summary for the iCON2011 conference includes the following for Dr Veith, "Honorarium/Expenses: Cook Medical, Cordis, WL Gore, Medtronic." Finally, Dr Veith apparently runs the Veith Symposium, which in 2010 acknowledged the following commercial sponsors: Aastrom, Abbott Vascular, Aptus Endosystems Inc, Atrium, Bard Peripheral Vascular, Boston Scientific, Cook Medical, Cordis Cardiac and Vascular Institute, Delcath Systems Inc, Gore, Hansen Medical, Lombard Medical Technologies, Maquet, Medtronic, Organogenesis Inc, Sanofi-Aventis, St. Jude Medical, Tenaxis Medical, Triavascular, Vascutek Terumo.

So Dr Veith's article continues the tradition of defenses of physicians' and health care institutions' conflicts of interest based on logical fallacies and unbalanced and unsupported assertions.  Also, note that all the examples of such defenses we have discussed were made by people with their own financial relationships with drug, device, and/or biotechnology companies, although some of them disclosed these relationships.  I have yet to see a defense of such conflicts based on logic and evidence, or a defense of such conflicts made by someone who has absolutely no conflicts of his or her own. 

The currently prevalent relationships with health care corporations among academic physicians, researchers, and other decision makers and influencers in health care have been lucrative for them.  I have yet to see a coherent, logical argument that these relationships are good for patients, medical education, biomedical or clinical science, or public health made by anyone, much less someone who does not have such relationships.

I will note that the defenses of conflicts of interest begin to seem drearily similar.  Not only do they often use the same logical fallacies, but they repeat the same stale and unsupported arguments about the benefits of financial relationships with industry: that they foster "innovation," and that they provide better educational opportunities than unconflicted programs and educators.  We now know that the managed care industry has engineered stealth health policy advocacy campaigns that furnish talking points to "third parties" which may get caught up in the larger policy discourse (see posts here and here).  I wonder whether some such stealth health policy advocacy campaign by pharmaceutical, device and/or biotechnology companies seeded the discourse about conflicts of interest with some of the logical fallacies and unproven assertions that have become so familiar. 

We need to elevate our discourse about health care policy.  People involved in health policy discussions should at least disclose their conflicts of interest when making their points.  We should be very skeptical of  arguments and look carefully for the evidence and logic that supports them.  When we find that evidence and logic is lacking, be even more skeptical about who benefits from them. 

Post Title → Once More with Feeling: Another Defense of Conflicts of Interest Based on Logical Fallacies

Why I Shouldn't Read Non-Systematic Review Articles: Special Pleadings and Undercover Authors

I usually resist looking at non-systematic review articles in medical journals, but because the title interested me, and things seem to be getting slow this holiday season, prompted by an update email from the American Journal of Medicine, I looked at Ram CVS. Beta-blockers in hypertension. Am J Cardiol 2010: 106: 1819-1825. (Link here.)

The Ram Article in Praise of Vasodilating Beta-Blockers

The article focused on the results of meta-analyses:

Concerns have also been raised by meta-analyses in which β blockers were reported to have a suboptimal effect on reducing stroke risk and increasing the risk for new-onset diabetes compared with other antihypertensive agents.

The article discussed several meta-analyses in which beta-blockers, [a specific class of blood pressure lowering drugs] but mostly atenolol (mostly sold generically), usually combined with a diuretic, were compared with other antihypertensive drugs, usually including angiotensin converting enzyme inhibitors (ACEIs) and calcium channel blockers. But after discussing these comparative results, the author jumped to descriptions of another group of drugs which were not included in any of these comparative studies. This was the category of vasodilating beta-blockers, consisting of labetolol (mostly sold generically), carvedilol (Coreg, GlaxoSmithKline [GSK]), and nebivolol (Bystolic, Forest Laboratories. Based on physiologic studies of these drugs and trials in which they were compared with placebo, but not on studies which directly compared clinical outcomes of patients given these drugs or other kinds of antihypertensives, Dr Ram reached conclusions that they were a better alternative:

The review of the evidence provided herein confirms that there are valid reasons to question the utility of certain β blockers in treating hypertension. However, many of the perceptions about β blockers are derived from data obtained from studies of traditional agents or combinations of diuretics and β blockers. Evidence suggests, and the guidelines concur, that there are intrinsic differences among members of the β-blocker class. Indeed, the vasodilatory β-blockers, which have generally not been included in comparative meta-analyses, lower blood pressure to a similar degree as other antihypertensive drugs, may provide better central aortic pressure reductions than traditional β blockers, and are associated with neutral or favorable metabolic effects.

Special Pleading

Dr Ram's questioned the old-fashioned beta-blocker atenolol (perhaps only when added to a diuretic)  based on the results of meta-analyses which attempted to compare it to other drugs. Such meta-analyses could suggest that atentolol (again, perhaps only in combination with a diuretic) might be in some way less preferable than the other drugs to which it was compared. However, the meta-analyses did not address the vasodilating beta-blockers at all. Dr Ram concluded that they were preferable based on different kinds of and probably less definitive evidence. He did not seek to compare such studies done on the vasodilating beta-blockers to similar studies done on the conventional beta-blockers.  Thus it seems his conclusions were based on a double standard.

In the vocabulary of logical fallacies, this was an example of a special pleading:

Special Pleading is a fallacy in which a person applies standards, principles, rules, etc. to others while taking herself (or those she has a special interest in) to be exempt, without providing adequate justification for the exemption.

Here was more reason not to bother reading a narrative review articles to learn how to better practice clinical medicine.  They often are based on idiosyncratic, if not biased evidence used to support illogical arguments.

But having read so far, I wondered why the authors of this article were so happy to use a double standard as the basis of their arguments.

Undercover Author

Those paying attention may also now be wondering why I referred to the authors in plural, when the citation lists only one author. The clue is at the end of the article:

Acknowledgment

I would like to thank Tamalette Loh, ProEd Communications, Inc. (Beachwood, Ohio), for her editorial assistance and literature validation in the preparation of this report.

Sensitized as I have been to the many recent discussions of ghost-writing, I immediately wondered who Ms Loh is, and what sort of "editorial assistance and literature validation" she provided. So first I looked at what her company, ProEd Communications does, wondering if its business is to help syntactically challenged academics and professionals write better sentences and more organized papers.

The ProEd Communications web-site states:

ProEd Communications balances diverse perspectives—clinical, regulatory, marketing, and customer—to create compelling messaging to maximize a product's potential.

So it appears that ProEd Communications does not provide independent editorial services. Instead, it is a medical education and communications company (MECC) which works mainly to market its clients' products, and further, its clients are essentially only pharmaceutical companies:

Of the world's 50 largest pharmaceutical companies, ProEd has worked with 18 in the past 3 years and currently supports projects for 7 of the top 10 largest pharmaceutical companies, as ranked by MedAdNews (2008).

Furthermore, a few minutes on Google reveals that Ms Loh seems to specialize in papers on anti-hypertensives, particularly Coreg (carvedilol), one of the three drugs in the vasodilating beta-blocker group favored by Dr Ram. In fact, two other papers whose authors she assisted sounded hauntingly familiar.

Let me first display the quote above from the Ram paper:

Concerns have also been raised by meta-analyses in which β blockers were reported to have a suboptimal effect on reducing stroke risk and increasing the risk for new-onset diabetes compared with other antihypertensive agents.

Now see this quote from Frishman WH, Henderson LS, Lukas MA. Controlled-release carvedilol in the management of systemic hypertension and myocardial dysfucntion. Vasc Health Risk Management 2008; 4: 1387-1400.  (Link here):

However, concerns have been raised recently from hypertension meta-analyses regarding suboptimal outcomes with use of beta-blockers, specifically atenolol, compared with outcomes for other antihypertensive drug classes.

Also see this relatively similar quote from McGill JB. Optimal use of beta-blockers in high-risk hypertension: a guide to dosing equivalence. Vasc Health Risk Management 2010; 6: 363-372. (Link here):

Concerns about the use of β-blockers as first-line agents for hypertension have been raised because of a 2005 metaanalysis that found β-blockers do not significantly reduce
cardiovascular events, especially stroke, compared with other antihypertensive drug classes

Furthermore, read this discussion of Coreg by Ram:

Carvedilol is a nonselective β blocker with α1 receptor–blocking activity and no intrinsic sympathomimetic activity. Clinical data suggest that carvedilol reduces systemic vascular resistance in patients with hypertension.

Here is Frishman et al:

Carvedilol is a third-generation, vasodilatory beta-blocker that nonselectively blocks both the beta 1- and beta 2-adrenergic receptors.... vasodilatory beta-blockers can lower blood pressure by reducing systemic vascular resistance (SVR)

Both Frishman et al and McGill are very positive about Coreg.  Although the emphases of the three articles are different, they have organizational similarities.  Again, all three were written with the assistance of Ms Loh.

At the end of the Frishman article we again find:

The authors would like to thank Tamalette Loh, PhD, ProEd Communications, Inc.®, for her medical editorial assistance with this manuscript.

At the end of the McGill article we find:

Editorial assistance, specifically revisions to the final draft, was provided by Tamalette Loh, PhD, at ProEd Communications, Inc.®, whose services were also funded by GlaxoSmithKline. Dr Loh’s revisions were reviewed and approved by Dr McGill.

Note that now it seems that Ms Loh has a doctoral degree, of unclear kind. Note also that now it seems that GSK, the manufacturer of Coreg, funded Dr Loh's work on the McGill article.

Dr McGill further disclosed:

Dr McGill is a consultant for GlaxoSmithKline and a speaker for AstraZeneca and Forest Pharmaceuticals. Financial support for medical editorial assistance was provided by GlaxoSmithKline, Philadelphia, Pennsylvania.

Finally, in another article, about angiotensin converting enzyme blockers combined with diuretics to treat hypertension (Egras AM, Ram CVS. Reduced cardiovascular risk and healthcare expenditures with angiotensin receptor blocker/ hydrochlorthiazide. Am J Pharmacy Benefits 2010; 2: 127-135. Lin here. ), Dr Ram acknowledged:

Dr Ram is in the speakers’ bureau pool of Cogenix, ProCom, and Genesis, which manage medical education programs for Bristol-Myers Squibb, GlaxoSmithKline, and Novartis.

The series of articles above demonstrated a phenomenon I have not seen explored before. All articles were written with some sort of assistance from an employee of a MECC, perhaps partly funded by a company which marketed a drug which was the subject of all the articles. The assistance was openly acknowledged.  The three articles had some remarkable similarities not explained by an overlap among their listed authors.  This suggested that the ostensible editorial assistant they had in common was substantively involved in the content of the papers, that is, was truly an author. Her presence was not ghost-like. However, the substance of her contribution may have been downplayed.  So let's call her an "undercover author."  (If someone has a better term, please leave a comment to that effect.)

Summary

So the reasons I rarely read narrative review articles except to make teaching points about health care dysfunction are:
- They often are based on idiosyncratic, if not biased selections of data
- They may employ logical fallacies to make their points
- They may be written by people with conflicts of interest, that is, with financial arrangements with companies seeking to market products, particularly drugs and devices.

My conclusions for health care professionals are: be very skeptical of non-systematic review articles, look for evidence that they are parts of stealth marketing campaigns, and do not assume all conflicts of interest are disclosed and all authorship roles revealed.

My conclusions for journal editors are: strictly demand more complete disclosure of conflicts of interest, or risk losing the trust of your readers.

My conclusions in general: until we start to sweep away the pervasive web of conflicts of interest that is draped over medicine and health care, expect further discombobulation.

Post Title → Why I Shouldn't Read Non-Systematic Review Articles: Special Pleadings and Undercover Authors

There You Go Again: Richard Epstein Says "Conflict-of-Interest Rules Thwart Medical Progress"

Richard Epstein, a professor at the New York University and University of Chicago law schools, just authored a report on the perils of conflict of interest rules.  In his blog, "The Libertarian," he summarized his beliefs that strict conflict of interest (COI) rules and restrictions on pharmaceutical marketing "spell lower rates of innovation and slower dissemination of new products." 

Prof Epstein is extremely prominent.  The Manhattan Institute, of which he is a fellow, claimed, "Professor Epstein's influence is profound: he is one of the three most cited law professors in the United States and the most cited professor writing largely in private law." Thus, it is disturbing that it appears that his objections are based on a series of logical fallacies.  (Note that we critiqued a defense of certain conflicts of interest he made in 2007 here on similar grounds.)

Ad Hominem: Enemies of Capitalism

Prof Epstein implied that the people who advocate strong conflict of interest rules are enemies of capitalism and free markets.  For example, he wrote, "most of the modern critics of the drug and medical device industries start with the assumption that the profit-motive alone is sufficient to distort the behavior of all scientists and researchers."  Later, "the people who line up most strongly against drug and device companies often treat the phrase 'market forces' as though it embodies the worst things in life."  How he was able to read the minds of those who disagree with him is unclear.  Attacking proponents of strict COI regulation as anti-capitalists (and by implication, socialists or communists) appears to be an ad hominem fallacy.

Burden of Proof: Ignoring Evidence of Harms of COI, Asserting Evidence of Benefits

Prof Epstein argued that COIs rarely if ever leads to bad effects: "the number of instances of serious abuses of power in the drug and device industry, like in medical research itself, is small, relative to the huge number of interactions that have taken place." Thus, he ignored evidence that commercially funded research may be biased in favor of the sponsors' products.(1-4) On the other hand, he implied that financial relationships  among physicians and researchers and commercial firms that sell health care products and services are necessary for "rapid development and deployment of new pharmaceuticals and medical devices," and for "innovation" in the field, but provided no evidence for these points.  Thus, while ignoring evidence of the possible harms of COIs, he failed to provide evidence for their benefits.  By placing the burden of proof on those who disagree with him, while avoiding it himself, he invoked the burden of proof (or appeal to ignorance) fallacy.

Appeal to Common Practice: Scientists Wearing Multiple Hats

Prof Epstein asserted that strict COI rules would disturb what is now common practice.  They would threaten how "the best research scientists in universities ... wear multiple hats.  In addition to researching within the academy, they also offer consulting services to drug companies, or start businesses of  their own."  Academics may currently behave in this way, but that does not mean this behavior is optimal in any sense.  Thus, Epstein employed the fallacy of the appeal to common practice. 

Slippery Slope: Silencing Communication and Collaboration

Prof Epstein asserted that strict rules on COI would "prohibit the collaborative efforts that have long characterized standard practices [in research]."  Specifically, he asserted the rules could stipulate that "no scientist who sits on any Food and Drug Administration (“FDA”) review committee, or any hospital conflict of interest committee, should be allowed to have connections with the pharmaceutical industry."  Also, "collaborations between government and industry scientists on research projects of common interests should either be totally eliminated or heavily regulated."  Finally, he asserted, "free interchange of information within and across firm boundaries is best calculated to allow the sharing and coordination of vital information," but "strong conflict of interest regulation poses real threats to these dynamic interactions."

Yet rules about conflicts of interest generally refer to those generated by financial relationships, most often payments by commercial firms to academics, researchers or physicians.  Payments are not necessary for collaboration.  Researchers can communicate, share information, even work together without one party paying the other.  Warning of such dire consequences of regulations that have nothing directly to do with communication or collaboration amount to the slippery slope fallacy.

Appeal to Authority: the "Most Gifted Members of the Academy"


Prof Epstein noted above that it was the best researchers who consult for commercial firms or start their own firms.  Later, he stated, "the ablest scientists often have the most extensive outside practices."  In complaining about rules that limit the pay of faculty members for services on boards of directors of for-profit health care companies, he asked, "why crimp the behavior of the most gifted members of the academy who can also make major contributions to industry?"  Thus he seemed to agree with the arguments made by representatives of pharmaceutical and device companies that the doctors who they pay to speak, consult, or do research are the best and the brightest.  However, there is considerable evidence (e.g., see posts here and here), that such "key opinion leaders" or "thought leaders" are chosen because of their sympathy to the companies and their products, and their malleability.  In addition, there is evidence that medical schools now put more emphasis on ability to attract external funding than any other faculty characteristic in decisions about payment, promotion, and retention (see post here).  Prof Epstein's invocation of the need to honor the best and the brightest appears to be a variant on the appeal to authority fallacy. 

Summary

So here we have another example, by " one of the nation's most prolific legal thinkers, (according to the Manhattan Institute) of a defense of the prevalent conflicts of interest that affect academic physicians and clinical researchers.  Like many previous such defenses, it seemed to be mainly based on logical fallacies. 

Also, like many previous such defenses, it was made by someone with a history of his own financial relationships with health care corporations.  To his credit, Prof Epstein did disclose, "over the years, I have worked extensively with various groups in the pharmaceutical industry, but have done no such work in the past few years."  On the other hand, he did not disclose his previous relationships with eSapience, a company which once claimed it "shapes the debate on issues that intersect law, economics, and policy."  (See post here.)

The currently prevalent relationships with health care corporations among academic physicians, researchers, and other decision makers and influencers in health care have been lucrative for them.  I have yet to see a coherent, logical argument that these relationships are good for patients, medical education, biomedical or clinical science, or public health made by anyone who does not have such relationships.

By the way, Prof Epstein also complained about overly rigorous regulation of pharmaceutical marketing in the same blog post, but since this really seems to be a distinct topic, I will not discuss his arguments here. 

References

1.  Bekelman JE et al. Scope and impact of financial conflicts of interest in biomedical research: a systematic review.  JAMA 2003; 289: 454-465.  Link here.
2.  Lexchin J et al.  Pharmaceutical industry sponsorship and research outcome and quality: systematic review.  Brit Med J 2003; 326:  1167.  Link here.
3.  Jorgenson AW et al. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. Brit Med J 2006; 333: 782.  Link here.
4.  McGauran N et al. Reporting bias in medical research - a narrative review.  Trials 2010; 11: 37.  Link here. 

Post Title → There You Go Again: Richard Epstein Says "Conflict-of-Interest Rules Thwart Medical Progress"

Logical Fallacies in Defense of Million Dollar Babies

We recently posted about the latest example of generously paid health care leaders, million dollar plus hospital CEOs in the Baltimore area (here).  Such stories are appearing more often in the media, and increasingly generating skeptical, anguished, or angry responses. 

Defending Millionaire Hospital CEOs

So it should be no surprise that the defenders of rich hospital CEOs are starting to rally.  The Baltimore Sun published two letters defending the million dollar plus compensation received by many local hospital CEOs.  But what arguments they made.

First, let us examine in detail  the arguments made by Carmela Coyle, "president and CEO of the Maryland Hospital Association."  She opened with this description of hospitals as organizations:

Famed management expert Peter Drucker said that health care is the most difficult, chaotic, and complex industry to manage today, and that the hospital is "altogether the most complex human organization ever devised."

Indeed, hospitals are not your typical business. Hospitals are places where lives are saved. They ease pain and suffering. Hospitals are open every minute of every day, driven by a mission of caring and rooted in their communities. Hospitals do not close up and move on when economic times get tough. This requires extraordinary dedication, commitment, talent, and leadership. And hospitals are governed by trustees--independent leaders from the communities hospitals serve.

She then briefly described her version of how hospital CEO compensation is set:

The compensation for hospital executives is determined by those boards and compensation committees who follow nationally recommended practices for setting contract terms, evaluating CEO performance, reviewing salary comparability data, setting and approving compensation, and ensuring the process is free from conflict of interest.

Then she provided this extraordinary description of what hospital CEOs do:

Perhaps the more important look is at what these hospital leaders do day in and day out for Marylanders:

•Provide more than 88,000 Maryland jobs; most hospitals are the largest employers in their communities and they employ your friends and neighbors;

•Make health care available 24 hours a day, every day of the year, regardless of a recession, blizzards, physician and nurse shortages, or other obstacles;

•Bring you the latest technology and facilities so you, your family, and your neighbors can get the care they need, when they need it;

•Manage the uncertainties and vast change that health care reform will bring;

•Preserve your local hospital as the cornerstone of care in your community.

Hospitals are unique places, and it takes unique people to run them. Maryland is fortunate to have such leaders.

.

"Famed management expert Peter Drucker said...." - Appeal to Authority

Mr Drucker may be a management expert, but what expertise does he have in health care, medicine, or the health care environment?  I actually agree that the hospital environment is "difficult, chaotic, and complex" in many senses, but would assert that it is the health care professionals in hospitals (doctors, nurses, other clinicians, therapists, technicians, etc) who are most expert at and primarily tasked with responding to these complexities (see below).  I submit that the opening citation of Drucker is an example of an appeal to authority (chosen not because of his specific expertise in the relevant context.)

"Hospitals are places where lives are saved...." - Appeal to Emotion

Of course they are, and the general description of the hospital is true.  However, who is it who (rarely) save lives, (hopefully often) relieve pain and suffering, and provide continuous service "every minute of every day?" 

It is, glaringly obviously, the health care professionals listed above, admittedly assisted by a variety of staff who keep the lights on, make the food, clean the operating rooms, etc, etc.  The most removed from the actual clinical care are the managers.  The higher the managers are in the food chain, the less likely they are to have any contact with actual clinical care.  I submit that most CEOs deal mainly with C-level officers and vice presidents, and interact mainly with them, spread sheets, PowerPoints, and emails.  Given that hospitals do al these wonderful things, should not the support, credit, and frankly, pay go to those who actually do wonderful things, not sit in meetings and play with spread sheets?

I believe that this wonderful description of the hospital mission is mainly an appeal to emotion, designed to generate warm and fuzzy opinions about hospitals that make paying their detached top managers much more than the people who actually provide patient care more emotionally, but not logically palatable.

"And hospitals are governed by trustees...."
"The compensation for hospital executives is determined by those boards...."
- Begging the Questions and an Appeal to Common Practice

The description of how CEO pay is set merely describes a process, but does not explain why this process is likely to come up with the right result.  It begs questions about hospital leadership and governance that we have discussed often, including whether boards populated by people with little understanding of health care, sometimes including leaders of financial firms who helped usher in the great recession, and sometimes including individuals with obvious conflicts of interest are likely to make decisions about executive compensation that ultimately support the hospitals' missions.  It begs questions about the standards to which executive pay is compared, especially the phenomenon that all executives are above average (see this post).  The implication that because a process is in place that follows the usual practice, the outcome must be good amounts to an appeal to common practice. 

"what these hospital leaders do day in and day out...." -Appeal to Emotion and the Questionable Cause Fallacy

In one sense, this is just a more extreme version of the appeal to emotion used above.  Furthermore, the bullet points are really about what hospitals and their health care professionals and support staff, not what their leaders do.  It is the hospitals as organizations that provide jobs.  It is the professionals and support staff who make the health care available every hour of every day.  (Have you ever seen the CEO of a hospital caring for an acute patient at 2 AM?  LOL.)  It is the hospital that provides the technology and facilities.  It is largely the health care professionals who manage uncertainties. 

Suggesting that the few CEOs, sitting in their meetings and reading their spread-sheets, rarely directly interacting with health professionals, and virtually never actually involved in patient care, should get most of the credit for these good works insults the thousands of health care professionals who actually do the health care.  It also amounts to an example of the questionable cause fallacy: the fallacy is that because the managers are somehow associated with actual health care, they cause the health care to happen.  (Think how long a hospital could provide services if the health care professionals and support staff were to vanish.  Think how long a hospital could provide services if the managers vanished.)

The second letter to the Baltimore Sun was by the chairman and CEO of Yaffe & Company, Inc, apparently a firm that consults on executive pay.  This letter was even less to the point than that above.  I invite our readers to discover its logical fallacies.

Summary

For a while we have been writing an informal series of posts about how logical fallacies may be deployed to advocate questionable health policy arguments, usually in a highly self-serving manner.  Our most recent example was here.  Most of the examples seemed to involve defenses of financial relationships among doctors and medical academics and drug and device companies, often written by people who themselves have financial relationships with such companies. 

The question of huge compensation given to leaders of health care organizations, and related questions about the effects of their perverse incentives, impunity from negative consequences of their actions, status as a new aristocracy, etc on health care dysfunction are getting more attention in the media.  So it should be no surprise that the defenders of the pay and power of these leaders are appearing.  It probably, but regrettably should also be no surprise that the defenses are mostly illogical, and made by people with financial interests in continuing excess compensation for health care leaders.

Physicians, other health care professionals, those interested in health policy, and the public at large need to be continuously skeptical about health policy advocacy appearing in the media, especially by those who stand to personally gain from the results of the advocacy.

My just slightly tongue-in-cheek suggestion for a policy position that could address this issue would be mandatory training in logical and evidence-based thinking, specifically to include recognition of logical fallacies, beginning at least at the middle-school level for all Americans (and around the globe), reinforced for those in health care.  (See the Nizkor Project site for a useful catalog of logical fallacies.)

Post Title → Logical Fallacies in Defense of Million Dollar Babies

Everybody's Doing It - Health Care Leaders Appeal to Common Practice

There were two examples in the recent news about how health care leaders employ logical fallacies to advance their positions.

Caritas Christi / Cerberus

We posted recently about the proposed takeover of the not-for-profit Caritas Christi hospital system by the Cerberus Capital Management private equity firm. We proposed skepticism about the idea. For-profit hospitals have not been shown to provide better, cheaper, or more accessible care than not-for-profit hospitals. There is reason to worry that a private-equity firm would put margin ahead of mission. The Boston Herald interviewed Dr Ralph de la Toree, the current CEO of Caritas Christi, who would continue to run the health system after the takeover. Asked about the role of Cerberus,

De la Torre dismissed concerns that Cerberus’ executives - and their investments - may not jibe with Caritas’ social justice mission.

Cerberus investor J. Ezra Merkin, for example, is facing civil fraud charges because of his ties to disgraced money manager Bernard Madoff. Besides its failed Chrysler investment, Cerberus has also invested in companies, such as gunmaker Remington Arms, that some Catholics may not support.

De la Torre admitted Cerberus has a diverse portfolio and said most boards of local nonprofits have members who have made their money through questionable means.

The last sentence is a good example of the appeal to common practice. Basically, the logical fallacy is that because many do it, doing it must be good.

Although we are often critical of the cronyism of boards of for-profit corporations and not-for profit organizations, even I would not go so far as to suggest that most boards include people who have made money unethically. Regardless of the prevalence of this pheonomenon, however, boards of health care organizations should be composed of people of integrity and honesty who support the mission of the organizations.

Professor Uwe Reinhardt

We recently posted about how prominent health economist and public health care intellectual Professor Uwe Reinhardt of Princeton University has failed to disclose conflicts of interest when opining about health policy. A follow-up interview of Reinhardt on SFGate.com included:

I invite you to look at the Wall Street Journal [reporters] and see their list of boards.

I have no idea whether Wall Street Journal reporters fail to disclose their memberships on boards of companies relevant to the subject of their reporting. We have frequently discussed conflicts of interest and how they can influence medical care, teaching and research, and health care research and policy. I agree that  such conflicts are frequent, and often go undisclosed. Again, however, Prof Reinhardt seemed to be using an appeal to common practice. Just because others have failed to disclose conflicts of interest does not make such failure right.

Interested readers may want to review the interviews of De La Torre and Reinhardt to see if they can find other logical fallacies.

Note that we have frequently quoted Dr Joe Collier, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."  [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.] We have discussed examples of how conflicted people seem to easily resort to logical fallacies to defend their conflicts (e.g., see post here.)

I do not think it is too much to ask prominent health care leaders to use evidence and logic, not logical fallacies to make their arguments.

Those who do use logical fallacies are inviting even more skepticism about their arguments and the agenda behind them.

Post Title → Everybody's Doing It - Health Care Leaders Appeal to Common Practice

Logical Fallacies in Defense of Conflict of Interest: Innocent, or Deliberate?

Roy Poses' post "Again, Defending Conflicts of Interest with Logical Fallacies" and a similar piece by Dr. Howard Brody over at Hooked: Ethics, Medicine, and Pharma were written by them with no foreknowledge by me of their planning, writing, or posting. I state this up front, because I have a very important observation to add after reading them.

The name of the subject of those posts, Dr. Larry Hirsch, seemed immediately familiar to me, for good reason:

Dr Hirsch was an employee at Merck & Co from 1988-2006 and managed the Medical Communications Department [at VP level - ed.] for clinical research publications from late 2001 to mid-2006.

He was VP of Clinical Drug Development, Clinical Trial Registration and Publication, as per his LinkedIn bio.

I was Director of Published [i.e., scientific] Information Resources and of The Merck Index of Chemicals, Drugs and Biologicals in Merck Research Labs from mid 2000-late 2003.

The name stood out due to my recollections of meetings I attended with Dr. Hirsch. The topic was whether, and how, Merck clinical trials results should be made available to the public. Being knowledgeable in electronic health records and biomedical information management, my input was sought.

I am, as is Dr. Poses, quite sensitive to logical fallacies. In my case, this sensitivity arises from early medical mentorship under the aegis of Dr. Victor P. Satinsky, cardiovascular surgeon, inventor (of the Satinsky clamp and other heart surgery-enabling devices) and polymath, and leader of the Hahnemann Medical College and Hospital's NSF-funded summer science programs.

Dr. Satinsky stressed "critical thinking ... always ... or your patient's dead" to his students; most still probably recall those words, repeated time and again. He would cut down poor arguments and logical fallacy directly and even confrontationally when he encountered them.

I recall Dr. Hirsch making reasonable arguments about the issues in publicizing clinical trials data, both pro and con, and even more importantly I left the meetings with a sense that such matters were in able hands. Dr. Hirsh was well able to synthesize information such as I presented and make rational arguments in response. I did not sense a fool in any way, shape or form.

Hence, my surprise and disappointment in the logical fallacies observed and defined by Dr. Poses and Dr. Brody in Dr. Hirsch's Mayo Clinic Proceedings article regarding the effects of conflict of interest.

This raises a number of questions:

• Have Dr. Hirsch's personal feelings simply clouded his judgment over the conflict of interest issue, resulting in a somewhat hysterical tone and logical swiss cheese, the holes as catalogued by Drs. Poses and Brody?

• Alternatively, are the logical fallacies deliberate and purposeful, as is done in propaganda written to confuse the audience and steer them erroneously towards a point of view that is not in their own best interests? (Such behaviors, of course, depend on an elitist belief that the audience - in this case, physicians, regulators and the public - lacks abilities to detect such flaws, or put more bluntly, as Dr. Satinsky might have said, is stupid and gullible.)

• Although this is less likely, there's been enough ghostwriting going on in this industry that the following question must be asked: who, exactly, wrote the Mayo Proceedings article in question? Could it have been, or could there have been contributions from, an unattributed "communications specialist", i.e., a non-scientist skilled in political spin while less skilled in logical argumentation?

• Are the reviewers and editors of the Mayo Clinic Proceedings able to critically review submitted pieces and themselves perform the analysis that Dr. Poses has performed? As a peer reviewer for scientific publications myself, I would likely have opined that such a piece was unsuitable for publication in its present form due to its flaws in reasoning.

I do not opine on the answers to these questions, but I do feel great disappointment that they even need to be asked. Dr. Satinsky, one of many medical giants of the past, must be rolling in his grave.

-- SS

Post Title → Logical Fallacies in Defense of Conflict of Interest: Innocent, or Deliberate?

Again, Defending Conflicts of Interest with Logical Fallacies

The latest version of the argument that we are all getting too worked up over conflicts of interest in health care has appeared, this time in a scholarly, peer-reviewed journal. (Hirsch LJ. Conflicts of interest, authorship, and disclosures in industry-related scientific publishing: the tort bar and editorial oversight in medical journals. Mayo Clinic Proc 2009; 84: 811-821. Link here.) The major point of the paper seems to be that payments to physicians, particularly academic physicians by pharmaceutical, biotechnology, and device companies are necessary for medical progress, so instead of perseverating about them, we all should pay far more attention to the evil of payments made for expert testimony by physicians who serve as expert witnesses in litigation against such companies.

In the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody addressed this main argument, while dismissing the bulk of the article as merely "illogic and innuendo." I think that Dr Brody failed to grasp the educational opportunities that the Hirsch article presented. It offers a true cornucopia of logical fallacies, making it ideal teaching material for the sort of course in logic and evidence that should be taught in all our medical schools, but is not.

So let me use this "teachable moment" to address just some of the many logical fallacies that Dr Hirsch so enthusiastically employed, in order of their first appearance in his article.

Appeal to Ridicule

There is a politically correct herd mentality that ascribes to the concept that objectivity is forsaken by medical companies that seek profit (and by their employees) because of 'conflict of interest.'

Also,

These overt restrictions on researcher communications in today’s climate of political correctness on COI are causing more than policy debates among various stakeholders....

In both these examples, concerns about conflicts of interest are deemed mere "political correctness." Thus, this is an appeal to ridicule.

Yet today there is a McCarthyesque reaction to the term, conflict of interest, with an unstated presumption of guilt until proven innocent.

Here instead the term of ridicule is "McCarthyesque."

Straw Man Fallacy

There is a politically correct herd mentality that ascribes to the concept that objectivity is forsaken by medical companies that seek profit (and by their employees) because of 'conflict of interest.'

This single sentence employed two fallacies for the price of one. I would challenge Dr Hirsch to provide a credible example that any thoughtful figure in the conflict of interest discussion has dismissed the objectivity of all for profit health care corporations, and all of their employees. He apparently has constructed a straw man argument which he has attributed to his opponents, one that is either to strike down than their real arguments.

Appeal to Authority

Previously, the president of the Association of American Medical Colleges emphasized that the term indicates a state of affairs and not a behavior, that COIs are ubiquitous, and that despite their inaccurate portrayal by the media, COIs do not indicate the occurrence of any improper behavior, much less scientific misconduct, analogous to a state of potential energy

If he said it, was he right? Is he still right today? Obviously, because someone with a distinguished title expresses an opinion does not mean it is true. Thus, this is an appeal to authority. (Note: since the reference appended to this sentence appears to have nothing to do with the content of the sentence, it is not even clear that the authority in question made such a statement. Link here.)

Appeal to Common Practice

Publication bias (preferential publication of studies with positive outcomes vs trials with negative, neutral, or ambiguous outcomes) has been reported for more than 2 decades,....

Publication bias clearly extends to government- and nonprofit-funded research....

The thrust here was clearly that publication bias is common and has been around for a long time, so why worry? This is an appeal to common practice, which equates a statement that a pheonomenon is common with the assertion that it is reasonable, justified, ethical, optimal, etc.

Special Pleading

For the 2008 article that was critical of Merck’s authorship practices by Ross, Hill, Egilman and Krumholz, the entire disclosure statement was, 'All of the authors have been compensated for their work as consultants at the request of plaintiffs in litigation against Merck & Co, Inc, related to rofecoxib.' Only in the middle of the Comment (Discussion) portion of the article was it mentioned that the authors had served as paid expert witnesses for plaintiffs’ attorneys in rofecoxib litigation. The terse disclosure statement seems at odds with JAMA’s stated policy in its Instructions for Authors that financial COI disclosure must be complete. Regardless, the information provided hardly conveyed that, as of January 2007, Krumholz had received more than $300,000 for his consulting from plaintiffs’ attorney Mark Lanier (no relationship to Mayo Clinic Proceedings Editor-in-Chief William L. Lanier, MD), which only became public in a letter to the editor of BMJ that responded to a previous article critical of Merck by Krumholz et al.

Krumholz’ remuneration seems substantial until it is compared to that of another coauthor of the JAMA authorship report,16 David Egilman. Egilman has testified for Mr Lanier and other attorneys in more than 100 tort cases (nearly always for plaintiffs) for approximately 2 decades and, by his own estimate, has earned $20 to $25 million for such testimony.

[Note: this discussion appeared in the midst of a long tirade against the editorial policies and practices of JAMA, especially in relation to controversy about the drug rofecoxib (Vioxx), the now withdrawn Merck Cox-2 inhibitor. Dr Hirsch apparently was responsible for Merck's publication policies about this drug. Further note that there are major questions about whether the figures supplied by Dr Hirsch are correct. Appended to the post in Dr Brody's blog post is a categorical denial by Dr Krumholz that he was paid, as asserted by Dr Hirsch, over $300,000, and evidence against the assertions by Dr Hirsch about Dr Egilman's pay.]

While Dr Hirsch alleged that the disclosures by the authors of this article were incomplete, he did not compare them to the disclosures made by authors of other articles in JAMA. In fact, I have never seen an article in JAMA which included disclsoure of dollar amounts, and could not find any such disclosure in spot checks of the latest issue.

On the other hand, here is the disclosure Dr Hirsch made in his own article:

Dr Hirsch was an employee at Merck & Co from 1988-2006 and managed the Medical Communications Department for clinical research publications from late 2001 to mid-2006. He currently is employed at a medical device and technology company that has no financial interest in any matters related to rofecoxib or the resulting tort litigation involving Merck & Co. Dr Hirsch owns mutual funds with stock from a variety of pharmaceutical and device companies, including Merck, and some shares of Merck and other medical product companies.

He did not disclose dollar amounts connected with any of these activities. He would not name his current employer on the grounds that it has no interest in rofecoxib and related litigation. However, his article is ostensibly about the broader issues of conflict of interest, authorship, etc which may relate to the interests of Becton Dickinson, which currently employs Dr Hirsch in the capacity of Worldwide Vice President of Medical Affairs, BD Diabetes Care. He did not name the "medical product companies" whose shares he owns.

Thus, Dr Hirsch argued that Dr Krumholz and Dr Egilman were wrong not to disclose the details of their financial arrangements with plaintiffs' attorneys (setting aside the likely inaccuracy of Dr Hirsch's contentions about the specifics of these arrangements), even though the detail they provided in their disclosures was similar to that provided by other JAMA authors, and even though Dr Hirsch did not find it necessary to himself disclose in such detail. Thus, Dr Hirsch was advocating a double standard, and in this case, his argument amounts to a special pleading, since the standard he advocated for others was not the same he felt obliged to uphold.


Appeal to Fear

[standards regarding COI] are beginning to affect the willingness of prominent researchers to interact with industry in any manner that involves even minimal compensation for their time and efforts.

Also,

There are serious negative implications for the future of medical product development if top academic researchers are shamed into ceasing any type of compensated interactions with industry.

Dr Hirsch implied that medical progress would be greatly endangered if industry no longer paid practicing physicians and full-time academics to work on the side, and that such payments would no longer be possible were COI disclosure requirements to be made more strict. Such dire warnings, without evidence to support them, amount to appeals to fear.

Summary

So Dr Hirsch has provided yet another example of an apologia for conflicted physicians and academics based on a panoply of logical fallacies. We have offered several other examples of fallacious defenses of conflicts of interest, compiled here.

It is sad to see logical fallacies so cavalierly employed. There frequent, sometimes strident use in current health policy suggest the need to better train health care professionals in logic and the use of evidence.

I am still awaiting a defense of the sorts of conflicts of interest that we frequently discuss on Health Care Renewal that is based on logic and evidence, but it may be that no one can produce such a defense.

Meanwhile, we continue to recommend that at the very least, medical academics, medical academic institutions, and other health care not-for-profits or NGOs should reveal in detail what payments they get from companies selling health care products or services, and how these payments could relate to the companies' marketing or lobbying efforts. In the US, some such disclosure would be mandated by the proposed "Sunshine" legislation now being considered by the US Congress. (By the way, note that this problem is hardly confined to the US, and needs global, not just American attention.)

However, physicians (at least physicians in full-time private practice, academic positions, and employed by mission-oriented not for profit organizations) should go further, and consider whether receiving industry money is worth the ongoing damage it does to our professionalism and our professional reputations. Medical schools, universities, health care foundations, disease advocacy groups, and other health care not-for-profits and NGOs should also go further, and consider whether receiving industry money is worth the ongoing damage it does to their missions, and their institutional reputations.

Post Title → Again, Defending Conflicts of Interest with Logical Fallacies

Again, Logical Fallacies in Defense of Conflicts of Interest: a Rebuttal to Rothman et al Appears in JACC

Earlier this year, a remarkable commentary in JAMA suggested major reconsideration of the relationships among professional medical associations (PMAs) and health care corporations.(1) Because of the influence of PMAs on clinical care, education, research, and policy, Rothman et al suggested that these organizations sever most of their financial ties to corporations such as pharmaceutical, device, and biotechnology companies. The authors suggested that the only acceptable payments to PMAs from these companies are those for advertising in publications that is clearly labeled as such, and advertising exhibits in meetings, again that is clearly labeled. Furthermore, the authors suggested that people with current or recent (within the last two years) relationships with such corporations ought not to serve as officers or trustees of PMAs, and ought not to serve on program or practice guideline committees. Rothman et al thus suggested that professional medical associations return to their roots, to be advocates for their physician members, and those members’ core values, not marketers of drugs and devices, and promoters of the interests of health care corporations.

The Journal of the American College of Cardiology (JACC) just published the first rebuttal of Rothman et al to appear in a peer-reviewed journal, written by Dr Alfred A Bove, President of the American College of Cardiology (ACC), one of the more influential PMAs.(2) Dr Bove contended that there is nothing wrong with the current relationships among corporations and PMAs, and PMAs should be free to relate to health care corporations any way they want. Dr Bove also asserted that “the assumptions that lead to ... [Rothman and colleagues’] conclusions can be challenged on many fronts.” However, in my humble opinion, Dr Bove supported these contentions with logical fallacies, rather than evidence and logic.

Appeals to Authority, Fear, and Pity

Early on, Dr Bove used a striking set of appeals to authority. (Note that his relevant quotes below appear in italics.)

“There is no comment about trust or virtue as a characteristic of the medical profession.”

“We are not to be bribed by a cheap pen or a free lunch.”

“The authors' assumptions imply that physicians as a group are not responsible people, yet physicians are among the most responsible professionals.”

These appear to be appeals to the traditional authority of the medical profession. Dr Bove simply asserts that physicians are inherently virtuous and deserving of trust, and thus no one could question the virtue of the profession.

He then compounded these appeals to authority with a veiled appeal to fear.

“The authors' assumption that the worst behavior is the average behavior of all physicians insults the profession.”

As noted below, Rothman et al did not make this assumption, so the appeal in turn rests on a straw man argument. This appears to be an appeal to fear in that an “insulted” profession might be expected to take action, legal or otherwise, to avenge the insult. It also could be a form of an appeal to pity, in that the reader might be inclined to pity the poor “insulted” physicians.

Straw Man Arguments

The bulk of the editorial consisted of a string of straw man arguments. A straw man argument propounds a distorted, exaggerated, or misrepresented version of his opponent’s argument, and then attacks it, rather than his opponent’s actual argument.

“The sole source for support of PMAs could only come from government or foundation grants....”

Actually, Rothman et al included membership dues, and by implication, meeting registration fees, journal subscription fees etc as acceptable sources of support.

“The article implies that all physicians who receive support from industry will forever be biased to support the products of the related pharmaceutical or device company.”

Actually, Rothman et al seemed to assume that conflicts of interest might affect someone for up to two years, but not forever. Thus, they suggested that board members should be “conflict free for a 2-year period before assuming the position.”

[The Rothman article] “also implies that industry does not work for the best interests of patients or the better [sic] public good, but only for profit.”

Actually, Rothman et al stated “the pharmaceutical and medical device industries make important contributions to medical progress. Their role in the development and testing of new compounds and instruments is essential for the diagnosis and treatment of disease and disability.”

“First, to assume that physicians would not be responsible for providing the best care for their patients after being associated with an industry study or consultation is inappropriate. The authors cited isolated examples of errant physicians who received large sums of money from industry and then promoted their products. They presume that all physicians are represented by these few—that we all have a price.”

Actually, Rothman et al did not discuss any particular cases of “errant physicians.” What Rothman suggested was that gifts, even of “modest value,” can bias decision making, and that the receipt itself of the gift may itself be influential. However, if even modest gifts have some influence, it is logical that large financial transactions might have major influence.

“Society understands that reward drives innovation, so expecting a financial gain from a commercial medical enterprise is not wrong. In fact, it is the only way that new ideas will move from the laboratory to the public good. Using public funds for manufacture and distribution would add an enormous burden to government costs and, based on past experience, would be unproductive.”

Rothman et al were not remotely suggesting nationalizing the drug and device industries.

“If one of us has an idea for a new device and needs industry to help refine its design, fund its development and manufacture, and establish its value by animal and clinical studies, this process should be honored, not condemned. Will the government fund the development of the next new drug? Would the government have funded the development and manufacture of an implantable pacemaker?”

At the most, Rothman et al recommended not allowing physicians who are paid by companies in conjunction with their development work to serve as top leaders, and on certain committees of PMAs. They never broadly “condemned” physicians who work with industry to develop devices.

“Governments have not shown an interest in funding the development of new drugs and devices. Industry raises the funds, takes the risks, and should reap the rewards for its role in creating a better life for our patients.”

Actually, governments have helped development considerably by funding much of the underlying basic science research. Again, Rothman et were not remotely suggesting nationalization of drug development.

Summarizing the Arguments

So Dr Bove ended up by warning that the suggestions Rothman et al made about reducing institutional conflicts of interest affecting professional medical societies, and individual conflicts of interest affecting their leaders would “destroy the best of what we have in our science and industry,” that is, destroy biomedical and clinical science, and lead to nationalization of important forms of medical production. None of that was suggested or implied by Rothman et al. After positing this dire future, Dr Bove then asserted that professional societies ought to be entitled to money from industry limited only by their “professionalism.” Thus, “industry should be able to support unbiased programs aimed at educating physicians and other health care providers about the therapies available for the care of their patients. Professional societies should be able to receive unconditional educational grants to provide up-to-date information to their members on medical therapies.” Furthermore, “the proper relationships should allow us to work with industry and allow our professional societies to receive undesignated funds from industry to foster better patient care.” So, Dr Bove wound up where he started, asserting that doctors and professional societies are inherently virtuous, and thus should be trusted to do whatever they think is right, without any external scrutiny or accountability. Yet he never demonstrated the virtue of the ACC under his leadership, or of PMAs in general, or showed why they should be trusted.

Why did the president of one of the nation’s most important medical associations publicly make such poor arguments to support his organization's current financial relationships with health care corporations? I can only speculate, but there may be some clues found by looking at what is publicly known about the current relationships of the ACC and its leaders to health care corporations.

Publicly Disclosed Relationships Among the ACC and Its Leaders and Health Care Corporations

My sources for these clues were a report on the ACC web-site on its relationships with health care corporations (through 2007), and the form 990s that the ACC is and the highly related ACC Foundation are required to file with the US Internal Revenue Service. (The form 990s are publicly available from GuideStar with a free membership. The ACC form is here, the ACCF, here.)

Perhaps unsurprisingly, it turns out that the ACC gets a large proportion of its income from industry. In 2007, it acknowledged receiving $35,882,095.15 from industry. The largest categories of industry support were "promotional/quality program support," $12,664,650; "charitable contributions," $7,603,639; and "exhibits" at meetings, $7,318,807; and "educational grants," $5,084,600. The total revenues of the ACC (which include the ACC Foundation), were $94,560,000, so that industry support accounted for 38% of total revenue. These figures should be compared to the revenue the society received from membership dues (found on its 990 form), $11,995,056, and the income it claimed from its annual scientific session, $8,400,632. So to put it another way, the ACC got about three times as much money from industry as it got from its members' dues, and almost twice as much money from industry as it got from dues and its annual meeting combined.

So were the suggestions made by Rothman et al to be implemented by the ACC, it would stand to lose at least $28 million a year (given that in 2007, about $1 million of its industry revenue was from advertising , and about $ 7.3 million was from exhibits at meetings.)

The organization's lavish revenues have allowed it to pay its full-time managers very well. In 2007, its CEO received $534,452 in total compensation; its general counsel, about $394,000; and its CFO, about $336,000. It seems obvious that were the organization to foreswear industry revenue, the organization's top full-time managers would be unable to continue to live in the style to which they are now accustomed to.

In addition, the organization's form 990 reveals that it pays its supposedly voluntary officers and some of its trustees substantial amounts as well. In 2007, it paid its president $147,750; its president-elect, $80,000; its two immediate past presidents, $79,500 and $70,000; its vice president (at that time, Dr Bove), $63,751; its treasurer, $32,500; its secretary for the board of governors, $52,500; its board of governors chair-elect, $25,000; its immediate past board of governors chair, $25,000; and some trustees amounts from $1000 to $20,520.

To my knowledge, it is unusual for a professional society to pay salaries to its voluntary officers (as opposed to full-time, hired managers.) However, given that the ACC does, it seems that were the organization to foreswear industry revenue, its officers' personal income might be threatened to some extent.

Finally, Dr Bove has his own personal financial relationships with industry. Some were disclosed because of his role on ACCs Cardiosource editorial board, including "Consultant Fees/Honoraria: Insight Telehealth Inc,""Research/Research Grants: Astella Pharma, INC," and "Royalty Income: Elsevier." In addition, in a 2008 article(3), he disclosed receiving speakers fees from Medical Seminars, Inc, and serving as a consultant to Vasocom Inc. For a 2009 conference, he also disclosed "modest" equity interests in Cardiovascular Therapeutics, and Merck.

So, in summary, it seems that the ACC gets a very substantial portion of its revenue from health care corporations, and that were it to carry out the suggestions of Rothman et al, it would lose much of that revenue. Thus, it is not surprising that ACC leadership would take exception to Rothman and colleagues' point of view. This is not the first time that an ACC president has defeneded the organization's dependence on industry funding (see post here). However, as I said in that post,

My questions are how could a society which requires such a substantial proportion, 38% of funding from commercial sponsors ignore the preferences of the sponsors for particular topics and content areas? How could such a society dare to allow criticism of the sponsors, their products, or their activities? Knowing that the society is dependent on this level of support, could society leaders really hold industry representatives at arms' length? Knowing that industry supplies more than one-third of their salaries, would society staff really keep industry outside of some bureaucratic, but not concrete 'firewall?'

In addition, it now seems the ostensibly voluntary officers of the ACC may have a personal stake in the ACCs receipt of health care corporate funding, since it is the apparent policy of the organization to pay these officers five- and six-figure salaries. Dr Bove did not disclose this apparent conflict of interest, nor did he disclose his other personal financial relationships with industry. As we have noted before, people with conflicts of interest tend to have trouble making coherent, logical and evidence-based arguments for positions related to their conflicts. As Joe Collier wrote in the BMJ, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult. "(4)

In any case, a previous ACC president wrote about the importance of "disclosure" and "transparency" in dealing with conflicts of interest. Whether disclosure of conflicts is sufficient to manage them, at least Dr Bove could have done the courtesy of disclosing that he is actually a salaried employee of the ACC, and disclosing his personal financial relationships with industry so that readers could try to evaluate how these financial entanglements might have affected what he wrote.

Summary

In conclusion, the first published rebuttal of Rothman and colleagues' suggestions for ensuring the independence of professional medical associations from outside vested interests was not based on evidence, but on logical fallacies rather than clear reasoning, and failed to disclose its authors' relevant financial relationships. We will see if anyone can make a better attempt.

ADDENDUM (17 July, 2009) - see additional comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

ADDENDUM (22 July, 2009) - see this post on the Cardiobrief blog, which alludes to the post above, but also discusses an interesting response by the CEO of the ACC to the Rothman paper, and adds original commentary on larger issues.


References

1. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry. JAMA 2009; 301: 1367-1372. (Link here.)
2. Bove AA. President's page: relations with industry: thoughts on claims of a broken system. J Am Coll Cardiol 2009; 54: 177-179. (Link here.)
3. Somers VK, White DP, Amin R et al. Sleep apnea and cardiovascular disease: an American Heart Association/ American College of Cardiology Foundation scientific statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council on Cardiovascular Nursing. Circulation 2008; 118: 1080-1111. (Link here.)
4. Collier J. The price of independence. Br Med J 2006; 332: 1447-9. (Link here.)

Post Title → Again, Logical Fallacies in Defense of Conflicts of Interest: a Rebuttal to Rothman et al Appears in JACC

Attacking "Crusaders" Against Conflicts of Interest with Logical Fallacies

An editorial appeared in the latest edition of Nature Medicine that suggested "crusaders" are making much too much fuss over insignificant "competing financial interests." [Anonymous. A really serious conflict. Nature Medicine 2009; 15: 463-4]

The Editorial's Arguments

Instead of regarding all conflicts of interest as part of a "monolithic scourge," it suggested we should only attack them in two specific situations.

Bad Conflicts of Interest

The first is when it leads to falsification of research data:

If there is one reason we need to worry about CFIs [competing financial interests], it is because they could lead to misconduct whenever a researcher has a financial incentive to fabricate data. So, if a clinical trial goes ahead on the basis of fraudulent preclinical work or if a drug is approved on the basis of false clinical data, the problem is more profound than can be addressed by the declaration of a CFI. Researchers or clinicians who produce sham data to continue receiving funds from a company must be subject to severe disciplinary actions from their institutions and funding bodies.

The second is when it leads to withholding of data in certain circumstances:

Companies that conceal negative data from regulators to receive approval for their drug should face not only fines but also penalties as serious as criminal charges. In any case, the focus should move away from CFI declarations and toward exposing and punishing scientific misconduct.

Some Conflicts of Interest are Unavoidable

On the other hand, the editorial asserted that conflicts of interest are unavoidable in certain situations.

But even though a lot has been written about this subject, it is seldom acknowledged that not all CFIs are equally insidious and that some are even necessary for the success of translational research.

Scientists who share their expertise with a company and clinicians who agree to conduct a clinical trial have to be compensated for their work in the same way that every other professional ought to be rewarded for his or her labor. To suggest that they should make their contributions freely is disingenuous, and to argue that they should not get involved at all can only slow the development of new medicines.

Academic institutions and their employees must be free to benefit financially from the fruits of the advances made in their laboratories, either by independently developing them into products or by selling them to the highest bidder. In the US, the Bayh-Dole Act has protected this right for nearly three decades, and CFIs that result from a university's right to enact this policy should not raise eyebrows.

Bad Outcomes of the "Crusade" Against Conflicts of Interest

In addition, the editorial argued that because of excess attention paid to minor or unavoidable conflicts of interest, bad things may happen. Clinical trials would be discouraged.

However, the fact remains that clinical trials are very expensive, and only the pharmaceutical sector has both the incentive and the deep pockets to pay for them.

And innovation would be slowed.

A third issue that is rarely acknowledged is that the stridency with which the CFI crusaders fight financial interests has created a milieu in which pharmaceutical firms have increasingly less breathing space to conduct their business, leading to a further slowing of drug development.

Finally, the editorial exhorted:

Let us instead accept that most financial interests do not represent a conflict as a matter of course and that the influence of money is negative only if it leads to scientific fraud—the one infidel we need to burn at the crusader's stake.

Logical Fallacies and Inflammatory Rhetoric

It is discouraging to see such sloppy thinking and inflammatory rhetoric appear under the masthead of a prominent journal. How was the thinking sloppy? Let me count the ways, and explain the logical fallacies used by the editorial to support its contention.

Arguing that Conflicts are Unavoidable Using False Dilemmas and Appeals to Common Practice

The editorial suggests some conflicts of interest may be unavoidable, even necessary for the advancement of science. To do this, it provided a series of false dilemmas and appeals to common practice. A false dilemma is an argument that x and y are mutually exclusive, when they are not. An appeal to common practice is an argument that because something is common practice, it is necessary, moral, correct, or the only course possible.

The editorial argued that researchers would not work for free, implying that if drug and device companies could not pay researchers to perform clinical trials, no clinical trials would be done. This is a false dilemma, because it is based on the unstated assumption that there is no other possible source of payment for clinical trial researchers other than the companies whose products the trials evaluate. It may be true that it would be hard to get anyone to conduct clinical trials for free, but there is no law of nature that dictates that all clinical trials must be financed directly by companies whose products are the subjects of these trials, or that prevents clinical trials from being funded by government agencies and/or non-governmental organizations disinterested in whether the results favor one treatment or another. Such disinterested sponsors paying researchers would not create conflicts of interest.

The editorial argued that if academic institutions and their employees cannot benefit financially from "the fruits of the advances made in their laboratories," there would be no drug and device development. This is a false dilemma, because it is based on the unstated assumption that the only setting for drug and device development is academic institutions. There is no natural law, however, that restricts drug and device development to academic institutions, or prevents drug development to be done by drug and device companies, or by independent laboratories. The editorial also appended an appeal to common practice. Bayh-Dole may be the current law in the US, but it is hardly natural law.

The editorial argued that without the "deep pockets" of the "pharmaceutical sector" and device companies, no one would pay for clinical research. This was a repetition of the false dilemma noted above. There is no natural law that prevents government and non-governmental organizations from sponsoring clinical trials. The editorial again appended an appeal to common practice. Current laws and social conventions have made drug and device companies extremely profitable, but continuation of their profitability is hardly inevitable.

Red Herrings to Distract from Other Bad Effects of Conflicts

While the editorial identified two particularly bad kinds of conflicts of interest, it ignored other instances that could be equally bad. This was something of a red herring. Although the two examples of bad effects of conflicts of interest were undeniably important, they distracted from other bad effects which the editorial chose to ignore.

The editorial correctly identified falsification of data as bad, but ignored the entire catalog of ways in which clinical research studies can be manipulated to make them more likely to favor a sponsor's product. See our posts (here and here) and the links contained therein for multiple examples of such manipulation.

The editorial noted that concealing data from regulators in order to win drug approval is bad, but ignored all the instances in which data has been suppressed outside of the regulatory process to make drugs or devices seem more efficacious or less dangerous than they really are. See this link for some of our posts containing relevant examples. If it is bad to fool people who must make regulatory decisions, why is it not so bad to fool physicians and patients who must decide whether to use drugs or devices?

The editorial further ignored that conflicts that affect how research is conducted or reported may be linked to conflicts that affect how research is disseminated or used in decision making. The clinical researcher who is paid by a drug or device company to conduct a clinical trial may also be an academic physician paid by the same company as a consultant or through a speakers' bureau to give talks and presentations, and write review articles favorable to the company's product. If it would be bad for the researcher to falsify data to make the product look better, why would it be acceptable for the researcher to act as a huckster for the product while pretending to be a disinterested academic? See this link for posts discussing stealth marketing, and this one for posts discussing the use of key opinion leaders.

Ambiguity and Ad Hominem Attacks Inflating the Bad Effects of Fighting Conflicts

While the editorial minimized the bad outcomes of conflicts of interest, it resorted to ambiguity and inflammatory language to exaggerate what might happen were conflicts to be reduced.

Its most dire prediction of the results of reducing conflicts was that doing so would create a "milieu" in which "pharmaceutical firms have increasingly less breathing space." Literally, this statement was nonsense. Metaphorically, it did not make a clear argument that these highly profitable companies (and even more profitable device companies) could not survive in a "milieu" in which their products were tested by researchers which the companies could not influence. This was not clearly a logical fallacy, but just word-play presented a reasoned argument.

Given how prevalent political correctness is, repeatedly characterizing people concerned about conflicts of interest as "crusaders" is inflammatory indeed. Being called "pharmascolds" is one thing, but "crusader" in some circles is regarded as equivalent to racist, a nasty term to label those who promote the separation of clinical research and medical education from commercial interests. Thus, the editorial winds up with a rather nasty version of an ad hominem attack.

We have seen numerous examples of the use of logical fallacies in defense of conflicts of interest, often by authors who were themselves conflicted. It is especially sad to see the editors of a scholarly medical journal employ such logical fallacies in the defense of conflicts of interest.

ADDENDUM (11 May, 2009) - See also the comments by Dr Doug Bremner in the Before You Take That Pill Blog.

ADDENDUM (20 May, 2009) - For an example of how the term "crusader" has become politically incorrect in the US context, see this article in the Boston Globe.

Post Title → Attacking "Crusaders" Against Conflicts of Interest with Logical Fallacies