Dr. Silverstein and Dr. Poses in WSJ: "The Literature Is Hardly Pristine"

I have considered Dr. Roy Poses' Dec. 14, 2010 post "The Lancet Emphasizes the Threats to the Academic Medical Mission" (with its hyperlinks to source posts and articles) an excellent summary of many of the pathologies we address at Healthcare Renewal, especially with regard to the academic mission and the disruption of the integrity of the medical literature by commercial interests. His post is consistent with what might be considered our mission statement:

Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

The Wall Street Journal published the following letter to the editor authored by me today in which I cited and summarized Dr. Poses' accounting of the medical literature's ills.

Unfortunately, the print version cannot contain the hyperlinks as in the aforementioned source post, but I have included them in the reproduced letter below in [brackets]. They are worth reviewing, along with additional links at the aforementioned source post "The Lancet Emphasizes the Threats to the Academic Medical Mission":

April 8, 2011
Wall Street Journal
Letters to the Editor

The Literature Is Hardly Pristine

I find it unfortunate having to inform reader James Reichmann, (Letters, April 1) who prefers his physician to recommend only treatments proven in the "synthesized medical literature," that the very literature on which he wishes his life to depend may be tainted.

As Dr. Roy Poses points out on the Healthcare Renewal Blog, numerous factors common in today's culture can and do corrupt the literature.

The factors include but are not limited to: rampant commercialization of medicine [here, here, here and here], research universities with lax conflict of interest policies [here], faculty as de facto employees of industry through grants [here], academics paid to be "key opinion leaders" to stealth-market drugs and devices [here], control of clinical research given to commercial sponsors [here], conflicts of interest allowing manipulation and suppression of clinical research [here and here], academics taking credit for articles written by commercially paid industry "ghost writers," [here and here], whistleblowing discouraged [here and here], leadership of academic medical centers by business people [here] and medical school leaders becoming stewards (as members of boards of directors) of for-profit health-care corporations [here, here, here and here].

As for me, until the medical literature can be freed of these contaminants, I'd rather trust a well-trained personal physician's good judgment in my own medical care.

Scot Silverstein, M.D.

Drexel University

Philadelphia

I believe it's also worth reviewing my own views on the subject, that the degree of contamination of medical literature is unknown and may be unrecoverable, due to spread of the contaminant vectors to the "experts" who then propagate the disease.

See my Aug. 2009 post "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?" where I raise these questions.

At that post I suggest that while the damage might not be easily recoverable, the practices that lead to contaminated literature must be stopped going forward if true evidence-based medicine is ever to be a reality.

-- SS

4/12/2011 addendum:

Almost predictably, some anonymous person, this time over at the Respectful Insolence blog in commenting on a post there that attacks "naturopathic" medicine, proffered strawman arguments about my piece above in comment #26.

... So Dr. Silverstein thinks that the defects he cites (many of which have been revealed by and hotly debated within the scientific community) are ample justification for tossing out the entirety of research in favor of the sort of "clinical intuition" that's repeatedly been found false over the years

This binary, two-dimensional thinking is quite sad to read, if real. I'll be charitable in saying that the comment does have the "feel" of something contrived, such as received before from corporate sockpuppets.

-- SS

4/13 addendum:

The proprietor of Respectful Insolence assures me that "anonymous" quoted above is not a sockpuppet. My response was basically that before attacking non-anonymous authors by name on the web who in fact (as is clear from my writing here) share similar views on medical quackery, one should contact them first to ensure you truly understand their views.

(In my case, my view is that the "well-trained physicians" of good judgment I wrote of consider the literature critically but are not bound to it, in consideration of the unknown level of its commercialization-based contamination and the variability of individual patient situations. They treat the patient, not the guideline.)

-- SS

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. 

BLOGSCAN: The Place Where the Compass Spins

The 1 Boring Old Man blog is on a roll.  Read this summary post, see its amazing introduction below, then peruse the main page and the archives:

At the North Pole, the magnetic compass apparently spins at random, not knowing where to point. Is it because there�s no North? or is North everywhere? That�s the way I feel about this Atypical Antipsychotic story I�ve been preoccupied with for a couple of months. It�s like everyone�s walking around with a compass that doesn�t work any more. The Pharmaceutical Companies involved have forgotten what their products are used for. Many doctors seem to have forgotten why they became doctors. Whole industries have sprung up [Clinical Research Organizations, Clinical Research Centers, Medical Writing companies, etc] without being clear about what they�re even involved in. One has to move away from it all to avoid getting caught up in the confusion and becoming as blind as the other players. Once you get far enough away, it�s tempting to forget that it�s even there, that place where the compasses don�t work anymore.

The Lancet Emphasizes the Threats to the Academic Medical Mission

We just discussed an important article in the Lancet calling for major global reforms of health care education.(1)  An accompanying editorial(2) argued for the critical importance of upholding the mission of higher education, because that mission is critical to human civilization:

Louis Menand has investigated the current role of the modern university in his startlingly powerful book, The Marketplace of Ideas. Menand argues that: 'The pursuit, production, dissemination, application, and preservation of knowledge are the central activities of a civilisation.' More importantly still, 'the ability to create knowledge and put it to use is the adaptive characteristic of humans'. The goal of the university is 'to make more enlightened contributions to the common good'.

The editorial argued strongly for the revitalization of the university's mission:

'It is the academic's job in a free society to serve the public culture by asking questions the public doesn't want to ask, investigating subjects it cannot or will not investigate, and accommodating voices it fails or refuses to accommodate.'

The education of doctors, nurses, and public health workers must seek to: strengthen the overall intellectual culture of a society; define principles for public aspiration; give life to and enlarge the best and most proven ideas of the age; refine the grounds for the private exchanges that take place in our lives; facilitate the exercise of political power; and enable professionals to detect what is important and discard what is irrelevant, accommodate oneself with others, have common ground between colleagues across societies, ask good questions and find the means to answer them, and have the resources to adapt to national and global circumstances. Some readers might recognise that these words are adapted from John Henry Newman's On the Scope and Nature of University Education.

In England, Newman argued for the university as a centre of intellectual liberty, a vital force for progress in society. Menand writes about the university as a 'zone of autonomy'. The importance of tertiary education as a means to advance health, reason, democracy, and justice needs to be rediscovered.

But arguing so forcefully for upholding the academic mission makes sense only if that mission is under threat. The Lancet editorial only briefly alluded to why this might be:

What this Commission argues for is nothing less than a remoralisation of health professionals' education. For decades, health professionals have colluded with centres of power (governmental, commercial, institutional, even professional) to preserve their influence. The result? A contraction of ambition and a failure of moral leadership.

While the original article by Frenk et al suggested that health professionals' education has shortcomings, it did not argue that the academic mission is threatened.  Although the message of the accompanying editorial is that the mission needs a strong defense, it did not clearly explain the extent of the threat to it. 

However, this blog, Health Care Renewal, is largely concerned with threats to health care's core values, including threats to the mission of academic medicine, largely from concentration and abuse of power.  The largest set of threats come from the ascendancy of financial goals amidst the commercialization of health care (mentioned briefly both in Frenk et al and the editorial).  We have discussed the nature of the threats in detail.  For example,

• Abandonment of traditional prohibitions of the commercial practice of medicine - In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts  here and here.
• Making money takes precedence over education -  A recent survey showing that more than half the faculty at multiple US medical schools felt they were valued more for how much money they brought in than their teaching or patient care abilities (here), confirming previous anecdotal reports (see here). 
• The medical school re-imagined as a biotechnology company -  In 2000, a Vice President of the American Association of Medical Colleges(3) wrote that research universities must respond to "societal demands that they become engines of economic development�."  Many universities now defend lax conflict of interest policies with similar arguments.  For more details, go here.
• Faculty become employees of industry - For numerous examples of this and other kinds of conflicts of interest, go here.  A survey by Campbell et al suggested that approximately two-thirds of medical academics get significant payments from industry.(4)
• Academics become "key opinion leaders" paid to market drugs and devices - Marketers regard "key opinion leaders" as salespeople who appear more credible because of their professional guise.  See anecdotal evidence here.  
• Control of clinical research given to commercial sponsors - A study by Mello et al showed how universities' grant administrators are willing to sign contracts giving commercial sponsors control over key aspects of human research studies.(5)  See post here. 
• Conflicts of interest allow manipulation and suppression of clinical research - Commercially sponsored research design, implementation, and dissemination are often manipulated to favor the sponsor's interests.  When such manipulation fails to produce favorable results, the results may simply be suppressed.
• Academics take credit for articles written by commercially paid ghost-writers - Such ghost-writing is often part of organized stealth marketing campaigns. 
• Whistle blowers are discouraged, or worse, and academic freedom is damaged.  Discussion of some examples of what may happen to whistle blowers is here.  The survey mentioned earlier (here) showed that about one-third of faculty fear they may be punished for speaking  out. 
• Leadership of academic medical centers by businesspeople - Ill-informed management may result from leaders who have no background or training in actual health care. 
• Leaders of teaching hospitals and universities become millionaires -  A recent example is here, and more may be found here.  Leaders of academic medical centers and the parent universities of medical schools often make more than $1 million a year in the US.  When such amounts are in play, executives may focus more on short-term measures that lead to even more pay than on upholding the mission. 
• Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - A recent example is here, and a summary of how we discovered this phenomenon in 2006 is here.   The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see here and here).
• Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, recently here, here, and here, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities.  Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance. 

So the threats are real and substantial.  However, their scope generally generally gets little attention.  Even when specific threats appear in the academic literature, their importance may be soft-pedaled, and their confluence with other threats ignored.  Of course, trying to discuss the full breadth and depth of these threats, as we endeavor to do on this blog, threatens in turn those who have personally profited from the current system.  Hence, we frequently cite the anechoic effect, the phenomenon that important threats to health care's core values are often just not discussed in polite company.

Therefore, we applauded the article by Frenk et al for concatenating some of the most important challenges to health care professionals' education, and we now applaud the Lancet editorial for emphasizing the threat to the academic medical mission.  We hope that these two articles, appearing in one of the most prestigious and well-read medical journals, will help to combat the anechoic effect.  Meanwhile, we will continue to blog about threats to core values in the hope that discussing them will lead to solutions.
References

1.  Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T et al. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world.  Lancet 2010; 376: 1923-1958.  Link here.
2.  Horton R. A new epoch for health professionals' education.  Lancet 2010; 376: 1875-7.  Link here.
3. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. Link here.
4. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician�industry relationships. N Engl J Med 2007; 356:1742-1750. Llink here.
5. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.  Link here.

How the Fallacy of the "Perfect" Health Care Market Undermined Professionalism and Caused Health Care Dysfunction - in the New York Times

We began this blog way back in 2005 to discuss threats to physicians' values, especially from concentration and abuse of power.  Personal experience, and cases and anecdotes described by colleagues suggested that a dysfunctional health care system was making patients and physicians miserable.  Interviews with more physicians suggested pervasive threats to their values, many stemming from how leaders of health care organizations wielded their power.  

Threats to Professional Values

In a 2007 post, based on an article in JAMA by Dr Arnold Relman, I asserted that the notion that threats to physicians' professional values are a major cause of health care dysfunction was becoming mainstream.  Furthermore, Dr Relman's review of the history of the problem suggested that the rising power of for-profit health care corporations, for whom making money came before the health and safety of patients, was a primary culprit. 

Dr Relman has discussed the issue frequently (e.g., see this post).  However, despite occasional publication in some prestigious medical journals, his views seem to have gotten little traction. 

Arrow's Analysis: Is Health Care a Perfectly Competitive Market?

Amazingly, however, the issue has made it into the New York Times, in the form of two posts in the Economix blog by health economist Prof Uwe Reinhardt.  Prof Reinhardt started by resurrecting the classic article by "Nobel laureate economist Kenneth Arrow," which argued that health care's special context means that the health care market cannot be truly competitive.

First Prof Arrow reviewed the characteristics of a perfectly competitive market:

To lay down a standard to which to compare the health care sector, Professor Arrow explained first on what basis economists consider a perfectly competitive market for some good or service as 'maximizing human welfare,' an outcome economists describe as 'efficient.'

The crucial characteristics of a perfectly competitive market are (1) that all of the quality dimensions of the good or service traded in that market are accurately understood by buyer and seller; (2) that potential buyers have full transparency on the price they will have to pay per unit of that good or service; (3) that it is easy and relatively costless for potential sellers to enter and exit this market; (4) and that there are so many potential buyers and sellers that none individually can affect the market price of the thing being traded.

If those and some other conditions are met, Professor Arrow explained, then for any given initial distribution of income and wealth that market will settle down at a unique equilibrium, that is, a state from which no potential buyer or seller would want to move. This equilibrium has important attributes.

First, in what Professor Arrow calls the First Optimality Theorem of welfare economics, it can be shown that in this equilibrium the traded good or service is allocated among buyers in such a way that it would be impossible through any reallocation to make someone happier without making someone else less happy.

It is an allocation that economists call Pareto efficient, in honor of the Italian industrialist, economist and philosopher Vilfredo Pareto (1848-1923), who first proposed this criterion.

For any given initial distribution of income and wealth, economists declare the associated Pareto-efficient allocation of the thing being produced and traded to be 'welfare-maximizing' � hence the term 'welfare economics' for this type of analysis.

Second, and very importantly, in what Arrow calls the Second Optimality Theorem, he explains that if on ethical grounds society wished to distribute a good or service (for example, education or health care or food or beach houses) among people in a particular way � like egalitarian principles � it need not have government directly involved in producing or distributing that good or service.

In his second blog post, Prof Reinhardt summarized why health care cannot be such a competitive market. The problems are uncertainty and asymmetry of information:

This uncertainty has several aspects.

First, physicians may not agree on the medical condition causing the symptoms the patient presents.

Second, even if physicians agree in their diagnoses, they often do not agree on the efficacy of alternative responses � for example, surgery or medical management for lower-back pain.

Third, information on both the diagnosis of and the likely consequences of treatment are asymmetrically allocated between the sell-side (providers) and the buy-side (patients) of the health care market. The very reason that patients seek advice and treatment from physicians in the first place is that they expect physicians to have vastly superior knowledge about the proper diagnosis and efficacy of treatment. That makes the market for medical care deviate significantly from the benchmark of perfect competition, in which buyers and sellers would be equally well informed.

Uncertainty and asymmetry of information about the quality of goods or services being traded is not, of course, unique to the medical care market. It is ubiquitous in modern economies that trade in highly complex goods and services. We find these characteristics, for example, in financial transactions, including all types of insurance; in automobile repairs, in plumbing and even in the purchase of some consumer electronics.

Wherever asymmetry of information is present, there exists the potential for the better-informed market participants to exploit the ignorance of the less well informed. How society responds to this flaw in markets depends on the severity of its consequences.

In the market for electronic products, for example, the consequences appear to be regarded as trivial. A customer may be seduced into purchasing an excessively complex and expensive product, but society takes no action on this front. In finance, on the other hand, the consequences of asymmetric information can be severe, as we have been reminded once again in the recent financial crisis.

Professional Standards and Mission-Oriented Non-Profit Organizations to Remedy Market Imperfections
Prof Arrow suggested that how health care worked when he wrote his article, in 1963, could be partially explained as attempting to remedy the problems created by uncertainty and asymmetry of information.

Professor Arrow explained many of the nonmarket social institutions and regulations characteristic of medical care [at that time] that he had identified as 'attempts to overcome the lack of optimality resulting from asymmetry of information and the inability of competitive markets to allocate efficiently all of the risks inherent in health care.'

Pointedly, he said, 'It is the general social consensus, clearly, that the laissez-faire solution for medicine is intolerable.'

That was then and this is now.

The Rise of "Greed is Good"

The problem is, of course, that health care has changed a lot since 1963. In an interview with the Atlantic from 2009, Prof Arrow defended his basic analysis:

I think the fundamental questions are the same. I also think there are more problems in the market today than when I wrote the paper. But I think the basic analysis hasn't changed.

He also discussed how failure to heed it have lead to our current dysfunctional health care system:

The market won't work -- it doesn't work well in the health context. But something else supplements the market, and the thing I put stress on in the paper are the elements that put a non-economic influence on the market: professional commitments to provide a service, to engage in services that aren't self-serving. Standards of caring decided by non-economic actors. And one problem we have now is an erosion of professional standards. In a way there is more emphasis on markets and self-aggrandizement in the context of healthcare, and that has led to some of the problems we have today.

Furthermore, he commented on those who sold the idea, which today ought to be totally discredited, in my humble opinion, that health care could be a perfect market, and this market would make everything right:

Sometimes I think it's because of the Chicago School. I think there has been a general drift around the country towards the idea that greed is good. Look at Wall Street. All of these industries involve a professional element in which information is flowing. You're supposed to be constrained to be honest about it. I don't really know why. But there is now more of an emphasis on popularization, which does improve efficiency but can also lead to an erosion of professional standards. There was this idea that professional standards were a mask for monopoly power--a Chicago theory, which I believe came from George Stigler. I don't know if they were that influential, but they seemed to be saying a lot of things that people were taking up in practice. I'm not totally sure why these professional standards changed, but it's more than medical reasons.

So you do not need to take it from me, take it from a Nobel laureate economist.  It now seems clear in retrospect that a major characteristic of modern health care is how the "better-informed market participants ... exploit the ignorance of the less well informed."

Summary: What is to be Done?
We have been sold a real bill of goods that health care could function as an ideal market. That bill of goods has lead to the deprofessionalization and commercialization of physicians, the destruction of the basic values of health care professionals, and the rise of health care organizations that put making money ahead of patients' health, safety, and welfare. And in health care, the dominant slogan has become "greed is good." This is true of course, but only for the greedy.

True health care reform would help physicians and other health care professionals uphold their traditional values, including, as the AMA once stated, "the practice of medicine should not be commercialized, nor treated as a commodity in trade." True health care reform would put health care "delivery" back in the hands of mission-focused, not-for-profit organizations, which put patients' health, safety and welfare first.

These reforms, however, would certainly threaten the continuing wealth of a lot of people who have profited mightily from the current dysfunctional system. So do not expect them to be happy about even the discussion of them.