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.

Turning Patients into "Dialysis Dollars"

As we have discussed in previous posts (here and here), prior to a US Supreme Court decision in 1975, physicians (and other professionals) were left free to set up and enforce their own codes of ethics. Until about 1980, the US American Medical Association (AMA) stated,

• "in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients"
• "the practice of medicine should not be commercialized, nor treated as a commodity in trade"

The Supreme Court decision was widely construed as meaning that any promulgation by US professional organizations of ethical regulations that constrained any economic practices of their members was a violation of anti-trust laws. Thus, in 1980, the AMA dropped their prohibitions against the commercialization of medicine, and nobody, it appeared, tried to change the anti-trust law whose provisions the court interpreted.

A vivid example of how physicians and patients may be caught in the cross-fires among health care corporations in this brave new era of commercialized health care was provided by a recent report in the Denver Post:

News that Fortune 500 company DaVita Dialysis is moving its headquarters to Denver socked its competitors like a punch in the gut.

To its rivals, the kidney-care giant is a bully armed with high-powered attorneys who use lawsuits as tools to intimidate.

DaVita executives counter that they are simply strong competitors — they act as aggressors only when doctors or nurses or other dialysis companies break promises and double-cross them.

Either way, a string of DaVita-filed lawsuits around the country — with two major battles boiling in Denver and Colorado Springs — shed light on the ruthless competition over dialysis patients in an industry that costs Medicare alone more than $8 billion per year.

For years, DaVita's competition in Colorado's two largest cities was almost nonexistent.

The mud began to fly last year when the second-largest group of Denver kidney doctors, called nephrologists, ended their exclusive affiliation with DaVita and partnered with a Massachusetts dialysis company entering the Denver market. Near the same time, the largest nephrology group in Colorado Springs dumped DaVita in favor of Liberty Dialysis, which recently opened two dialysis centers in the city.

DaVita quickly sued doctors in both cities, plus a nurse battling breast cancer who quit her job at a DaVita dialysis center and took one with Liberty.

The hostility between the companies is so intense, it's seeping down to the patients.
'With everything that is going on, you feel like you are becoming sort of a dialysis dollar,' said Julie Estes, a 53-year- old Colorado Springs woman who spends three days a week, four hours at a time, hooked to a dialysis machine in order to stay alive.

DaVita says it 'paid millions' in 1998 to the doctors of Western Nephrology in Denver to retain them as medical directors of six dialysis centers in the metro area for 10 years. The doctors signed non-compete agreements, promising not to join forces with DaVita rivals or steal any of the California-based company's nurses.

Patients are free by law to choose any dialysis center they want. But dialysis companies bank on the fact that snagging the most popular kidney doctors in town to serve as medical directors of their centers will bring in the most patients — and the most dollars.

Every dialysis center is required by federal law to have a medical director to oversee the care of patients and the water purification system used to flush toxins from the blood of people with failing kidneys.

It's a side job, separate from a nephrologist's practice, that some estimate takes only a couple of hours each week. Companies and doctors declined to say what salary comes with the job, but estimates range from $20,000 to $200,000 per year depending on the competitiveness of the market.

After 10 years with DaVita, when they believed the non-compete agreement was about to expire, Western Nephrology doctors began making plans to become medical directors of shiny-new American Renal Associates dialysis centers opening in Denver with a flat-panel TV and heated, massage chair at every dialysis station.

Four of the new centers are within 3 1/2 miles of existing Da Vita centers. The non-compete agreement that Western Nephrology doctors had signed for DaVita prohibited them from having relationships with competitors within a 35-mile radius.

DaVita contends in its lawsuit that it found out about Western Nephrology's 'secret campaign' because the dialysis company they were working with applied for Medicare billing numbers for five new centers in the Denver area.

In its counterclaim, American Renal Associates accused DaVita of violating federal antitrust law — the company had controlled at least 80 percent of the Denver market. DaVita lagged in updating its dialysis centers until competition was imminent, according to court records. And the claim accused DaVita of 'filing legal actions that are objectively baseless' merely as an 'anticompetitive weapon.'

"Ruthless competition," "lawsuits as a tool to intimidate," "double crosses," flying mud, patients who feel like "dialyis dollars," non-compete agreements, medical directors paid according to "the competitiveness of the market," "secret campaigns?" - is this any way to run a health care system?

As Dr Arnold Relman pointed out (see our previous posts linked above), through the 1960s there was some consensus that health care does not function like a pure market, partially because patients cannot function like steely-eyed consumers. They do not have enough information about the benefits, harms and costs of their possible choices. They have trouble understanding the ambiguity and uncertainty of the medical context. And most important, they may not be capable of the cold cognition the free market model requires, since they may be dealing with choices whose potential outcomes prompt extreme emotions, and in many cases, they may be too frightened, sick, or cognitively impaired to make fully rational choices. In particular, patients with end-stage kidney disease, requiring dialysis to maintain life, seem very different from some ideal, coldly cognitive consumers. So what in the world are they doing caught up in these sorts of disputes?

I submit that real health care reform ought to help physicians and other health care professionals renew their professionalism, and put the provision of health care (and health education and clinical research) back in the hands of people who view these activities as callings, not purely as ways to get rich. Meanwhile, when you are a patient, be prepared to be treated merely like a source of revenue.

PS - Please note that, as we have posted before, the new US "czar" for health care reform is a former member of the board of directors of DaVita.

A Window on the Unworkable Settings in Which Physicians Practice

The Annals of Internal Medicine just published an important problem that helps explain why our health care crisis is so intractable. (Linzer M, Manwell LB, Williams ES, Bobula JA, Brown RL, Varkey AB et al. Working conditions in primary care: physician reactions and care quality. Ann Intern Med 2009; 151: 28-36. Link here.)

The article arose from the MEMO (Minimizing Error, Maximizing Outcome) study. The study included an initial cross-sectional survey and then longitudinal follow-up of 422 physicians, roughly equal numbers of family practitioners and general internists, in 119 different ambulatory settings in New York City, NY, Chicago, IL, Milwaukee, WI, Madison WI, and smaller towns in WI. The surveys asked physicians about their work-flow and time pressure, the pace of their practice (from calm to chaotic), their ability to control their own work activities, and five aspects of organizational culture (emphasis on quality, emphasis on information and communication, trust, cohesiveness, and alignment of values between physicians and leaders.)

The results showed how bad the practice environment in primary care/ generalist practice has become. Some important points were:

- More than half of the physicians (53.1%) said they needed more time to do physical examinations, and nearly half (47.6%) for follow-up visits.
- Almost half (48.1%) described the pace of their offices as chaotic.
- Substantial majorities of physicians thought their workplaces' organizational cultures were deficient, if not hostile.
- Only 23.7% thought there was a high emphasis on quality.
- Only 28.2% thought there was a high emphasis on communication and information.
- Only 30.6% thought there was a great amount of trust.
- Only 33.9% thought there was high work place cohesiveness
- Only 14.2% thought there was great alignment between the values of leadership and physicians.

So, to summarize, many physicians thought they did not have enough time to take care of each individual patient. Most thought their workplaces were nowhere near calm, and nearly half thought they were chaotic. Few thought that their workplaces emphasized quality or communication and information, or inspired trust or cohesiveness. Very few thought that their leaders' values were aligned with their professional values.

This blog has focused on problems with the leadership and governance of health care organizations. We have discussed leadership that is:
–Autocratic, or “imperial”
–Insulated
–Uninformed about health care context, indifferent to health care values
–Incompetent
–Self-interested
–Conflicted
–Corrupt
We have shown that the governance of health care organizations may be:
- Unrepresentative
- Unaccountable
- Opaque
- Not Subject to Ethical Standards
and that such governance facilitates and enables bad leadership.

I submit that the study by Linzer et al suggests how bad leadership can make the settings in which physicians practice unworkable. It may be that some of the time pressure that physicians face is due to the perverse incentives built into their pay schedules (e.g., see this post), and bureaucratic demands of insurers and government agencies. A fast paced and demanding environment is one thing, however, and a chaotic envirnoment is another. What else would explain chaotic work environments other than bad organizational leadership? Futhermore, how could well lead organizations ignore quality, and fail to inspire trust and cohesiveness? How could good leaders inspire four-fifths of the physicians to say the leaders of their organizations did not value what they value?

This article strongly suggests that we cannot fix the health care crisis simply by changing financing mechanisms or money flows. We can only improve health care by improving the leadership and governance of health care organizations, and by rethinking the size and scope of health care organizations. The most crucial part of health care is what goes on between individual health care professionals and individual patients. Yet our system is composed of endlessly enlarging bureaucracies run by self-interested, often clueless, and sometimes dishonest, if not criminal leaders. This must change, unless we want this crisis to get much, much worse.

Why Did US Physicians Give Up Their Ability to Enforce Their Own Professional Standards?

In his recent review of Dr Ezekiel Emanuel's book, (Healthcare, Guaranteed: A Simple, Secure Solution for America,) Dr Arnold Relman, Editor-Emeritus of the New England Journal of Medicine, discussed the history of the deprofessionalization of American physicians.

The behavior of US physicians has been changed by the commercialization of medical care, and this too has increased costs. US medical practice has traditionally relied on fee-for-service, which has always given it some of the attributes and incentives of a business. However, the American Medical Association (AMA) maintained for many years that medical practice was a profession, not a business. The AMA's ethical guidelines therefore advised physicians to limit their income to reasonable earnings from the care of patients, and to refrain from advertising and from entering financial arrangements with drug and device manufacturers. Those restrictions were lifted after the US Supreme Court decided in 1975 that lawyers, and by extension members of other professions, including physicians, are engaged in interstate commerce and therefore must be subject to antitrust law (from which they had largely been exempt).(1)

This decision had an enormous effect on the medical profession, but its consequences have received relatively little public attention. Although the courts did not initiate the commercialization of medicine, they certainly accelerated it and gave it legal justification. In 1980, after medical organizations lost some costly antitrust trials, in which they were accused of such offenses as limiting doctor fees or denying staff privileges, the AMA changed its ethical guidelines, declaring medicine to be both a business and a profession. This lowered the AMA's barriers to the commercialization of medical practice, allowing physicians to participate in any legal profit-making business arrangement that did not harm patients.

Nearly a half-century ago, Stanford economics professor Kenneth Arrow, later a Nobel laureate, convincingly argued that medical care cannot conform to market laws because patients are not ordinary consumers and doctors are not ordinary vendors. He said that sick or injured patients must rely on physicians in ways fundamentally different from the price-driven relation between buyers and sellers in an ordinary market. This argument implied that, contrary to the assumptions of antitrust law, market competition among physicians cannot be expected to lower medical prices. And since physicians influence decisions to use medical services far more than patients do, the volume and types of services provided to patients—and hence total health costs—need to be controlled by forces other than the market, such as professional standards and government regulation. But Arrow's argument was largely ignored in the rush to exploit health care for commercial purposes that ensued after the passage of Medicare and Medicaid in 1965.(2)

Writing about the decline of physicians' professionalism in 2007 [ Relman AS. Medical professionalism in a commercialized health care market. JAMA 2007; 298: 2668-2670. [link here) ], Dr Relman had briefly alluded to the effect of the 1975 Supreme Court decision, (see our post here):

The law also has played a major role in the decline of medical professionalism. The 1975 Supreme Court ruling that the professions were not protected from anti-trust law undermined the traditional restraint that medical professional societies had always placed on the commercial behavior of physicians, such as advertising and investing in the products they prescribe or facilities they recommend. Having lost some initial legal battles and fearing the financial costs of losing more, organized medicine now hesitates to require physicians to behave differently from business people. It asks only that physicians' business activities should be legal, disclosed to patients, and not inconsistent with patients' interests. Until forced by anti-trust concerns to change its ethical code in 1980, the American Medical Association had held that 'in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients' and that 'the practice of medicine should not be commercialized, nor treated as a commodity in trade.' These sentiments reflecting the spirit of professionalism are now gone.

It seems to me that Dr Relman has elucidated one of the "missing links" that help explain the current sorry state of physicians' core values, and the broader continuing health care crisis. I am amazed that this bit of history seems to have been so thoroughly forgotten. Dr Relman did write about it before 2007, but in publications that few physicians and other health care professionals were likely to see. Other than Dr Relman, almost no one writing in the medical and health care literature seems to have interest in this issue. (It has been discussed in the Journal of Health Politics, Policy and Law, and the Stanford Law Review by M. Gregg Bloche, but these unfortunately also could have easily been missed by nearly all physicians and health care professionals.) So we have another example of the anechoic effect.

Yet in my humble opinion, every physician and health care professional ought to know that the profession once foreswore the commercialization of medical practice, but gave up on its ability to police its own conflicts of interest after the US Supreme Court decided that professionals are subject to anti-trust law.

But knowing this important bit of history raises more questions than it answers:

• The Supreme Court decision apparently involved interpretation of law, not the constitution. Therefore, why didn't organized medicine pursue a change in the law that would allow physicians to continue to enforce their traditional professional values?
• The Supreme Court decision was primarily directed at lawyers, not physicians. Since the decision, to my knowledge, the law profession has maintained strict rules about conflicts of interest. (For example, no legal CME is sponsored by corporations whose products they seek to have the attendees favor.) Why did the decision wreck physicians' but not lawyers' abilities to regulate their own conflicts of interest?
• The Supreme Court decision only affects US law. Why have physicians in other countries also abandoned their traditional values about commercial entanglements?
• Why did this application of US antitrust law have such significant effects during an era when antitrust enforcement in health care was generally declining? (Insurance companies and hospitals that dominate local markets have not feared antitrust enforcement.)
• Why did only Dr Relman and Prof Bloche seem to care about this up to now?

Inquiring minds want to know.... And answering these questions might bring us back on the path of true medical professionalism.

Hat tip to Merrill Goozner in the GoozNews blog.

References (from Relman)

1. Goldfarb v. Virginia State Bar, 421 U.S. 773 (1975).

2. Kenneth J. Arrow, "Uncertainty and the Welfare Economics of Medical Care," The American Economic Review, Vol. 53, No. 5 (December 1963).

Physicians' Unexpected Un-Helplessness: Executives Invited To Leave Nashville-Based Healthcare System

At "Physicians' Expected Helplessness" I wrote that:

I am going to coin a new term to describe what I have observed as a corollary to physicians' learned helplessness: "Physicians' Expected Helplessness."

I observed that "Physician's learned helplessness", an adverse effect of dysfunctional medical training and culture described here, had perhaps led to societal expectations of physicians being weak in defense of their profession and its patient-protective values, and "having a target pasted to their backs."

In a case of human bites dog - or perhaps, more to the point, doctors bite dogs - a physician revolt has led to the ouster of unpopular and apparently ineffectual executives including the CEO, COO and Chief of HR at a large healthcare system based in Nashville.

Two more executives leave Saint Thomas Health Services

By Getahn Ward
THE TENNESSEAN

http://www.tennessean.com/article/20090212/BUSINESS01/902120346

Two more executives have left Saint Thomas Health Services, continuing changes after physician leaders recently cast votes of no confidence in the management team.

The position of Bev Weber, chief operating officer for the Nashville-based four-hospital health system, was eliminated, spokeswoman Rebecca Climer confirmed late Wednesday. Angelle Rosata, chief human resources officer, also has left, Climer said.

Their departures follow last week's resignation of Chief Executive Jim Houser, less than two weeks after the no-confidence votes by medical staff leaders at three of the system's hospitals — Saint Thomas and Baptist in Nashville and Middle Tennessee Medical Center in Murfreesboro.

Doctors were concerned about a review of operations that they expected to include budget cuts and more centralized management of the hospitals. [Translation: even more mission hostile, autocratic leadership by non clinical bureaucrats -ed.]

Patrick Madden, who ran a Pensacola, Fla., hospital system for Saint Thomas Health's Catholic-run owner Ascension Health, began his role as interim CEO of the Nashville-based health system Tuesday.

"The elimination of the system-level COO position will allow for greater communication and interaction between the hospital chief executive officers and our new interim CEO and his leadership team," Climer said in a statement.

Weber, who joined Saint Thomas Health in May 2006, was an intermediary [and probable obstructionist - ed.] between Houser and CEOs of the system's hospitals. Doctors feared the hospitals would lose much of their authority under a proposed structure they believed was being considered as part of the review.

Weber was a target along with Houser of the no-confidence votes.

The COO position was actually eliminated due to the position serving as an apparent bottleneck between CEO and the medical staff.

It should be remembered - and made clear to "management" by physicians and other clinicians - that clinicians are the enablers of healthcare, whereas executives and near everyone else are facilitators of healthcare.

As such, when push comes to shove the physicians "own" the hospital (and could in an emergency provide a lot of services even if the hospital burned to the ground). However, they only can protect their own interests if they stand up for themselves and for medicine's core values. That also means abandoning quaint notions of "political correctness" and "inclusiveness" as the sole means of interacting with those who do not share those values.

This is a phenomenon that hopefully may set an example for other medical staffs beleaguered with mission-hostile management.

-- SS

Did Mrs. Jones receive her off-label failed spinal implant via excellent informatics data, or via a surgeon's visit to a prostitute?

In a story that leaves me at a loss for what has become of medical ethics, I read that Medtronic stands accused of, among other marketing tactics, inducing surgeons to use its spinal implant devices via kickbacks and outings to a now-closed Memphis strip club whose owners pleaded guilty to dancers engaging in acts of prostitution.

Apparently the devices were being used extensively for off-label uses, resulting in unexpected adverse events, some quite serious in nature.

I could not have made up this rather sordid story if I tried:

Wall Street Journal
Sept. 25, 2008

Lawsuit Says Medtronic Gave Doctors Array of Perks

(subscription required)

A lawsuit brought by a former Medtronic Inc. lawyer alleges the big medical-device maker gave surgeons a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in. The previously undisclosed allegations involve Medtronic's spinal-devices unit, which has $3 billion in annual revenue. The unit's business relationships with doctors who use its spinal-repair implants are being investigated by Sen. Charles Grassley and have been the focus of lawsuits by other former employees.

Sen. Grassley has been looking into whether inducements for doctors, like those alleged in the lawyer's suit, have led to what surgeons say is widespread off-label use of Medtronic spine products.

... Ms Kelley's [whistleblower Ami P. Kelley, a former senior legal counsel for the spine unit] lawsuit says kickbacks were "pervasive" and "the culture and way of doing business" at Medtronic. Sales staff, she said, "routinely took physicians" visiting the spine unit's Memphis headquarters to the Platinum Plus strip club, and picked up the tab for the dancers' services during "VIP visits." In 2007, Platinum Plus's owner pleaded guilty to charges related to dancers engaging in acts of prostitution, and the club has closed.

Ms. Kelley's lawsuit sought to recoup damages for the federal government, which prohibits companies from giving doctors inducements to use products covered by Medicare or Medicaid.

Her lawsuit and a separate one that also accused the spine unit of paying illegal kickbacks to doctors were the basis for a $40 million settlement deal between Medtronic and the government in 2006, according to the settlement document.

"VIP Strip Club" visits for orthopedic surgeons and neurosurgeons? I'm certain that only the most advanced scientific discussions between company and client occurred at such venues.

My questions are:

• Why would any physician allow themself to be taken by a vendor to a strip club? This is a questionable and unprofessional activity on its face, but in the context of vendor marketing to surgeons (presumably male), it is even more appalling. I personally would have rejected such an invitation out of hand as being sleazy and tawdry by its nature.
• Was there a genuine data-driven attempt to evaluate the off-label uses?
• What datasets were being collected by the company and the surgeons to support non-FDA-approved uses of the spinal implant devices?
  
• Who designed those datasets?

Not to mention:

• Did the wives and families of the surgeons know where their husbands and fathers were being taken on their "business trips to Medtronic?"
  

The names of the involved physicians are currently a closely-guarded secret:

The former Medtronic lawyer's allegations are contained in a 2002 suit filed in U.S. District Court in Memphis against Minneapolis-based Medtronic and 10 doctors. The lawsuit and other filings in the case remain sealed, except for a heavily redacted copy of the complaint, which contains none of the doctors' names nor specifics of the allegations.

Medtronic has refused repeated requests from the Senate Finance Committee's staff for an unredacted version. Sen. Grassley, an Iowa Republican, is the panel's ranking minority member.

... The Kelley lawsuit names several top spinal surgeons among the 10 doctor defendants and lists several others as receiving inducements.

The complaint clearly comes from the typical "disgruntled employee":

Ms. Kelley, who now works at another company, alleges she was dismissed by Medtronic after challenging improper payments.

One surgeon's name was apparently made available to the WSJ:

The suit says surgeon Jeffrey Wang, now director of the University of California at Los Angeles's Comprehensive Spine Center, "liked to be taken" to Platinum Plus and emailed Medtronic sales official Brad Hancock saying he was "looking forward to going" to the club with him.

Of course, UCLA has an air-tight explanation for this:

A UCLA spokeswoman said Dr. Wang, who isn't named as a defendant in the suit, "denies ever being entertained by Medtronic at the Platinum club" and doesn't recall sending any such email. If he did send it, she said, "it would have been done so in jest."

In jest? They mean to say, a top surgeon who claims he never went to the club, doesn't recall sending the email --- but if he did actually send it and simply forgot (meaning he would have known a vendor takes doctors on "VIP visits" to strip clubs / houses of prostitution but refused to go himself) then it was just a joke?

On the MedInformaticsMD scale of credibility, that rates about a 0.3 out of 10. It's not even good spin.

All is better now:

Medtronic declined to comment on the lawsuit's allegations. It said it has changed many business practices since the suit was filed, and is "committed to reform and transparency in the industry."

How reassuring.

Actually, not, considering the posts about Medtronic's practices on this blog here, here, here and here, among others.

Also not reassuring was the simplest Google news search on "spinal implant problem medtronic" which returns items like this:

Medtronic Will Settle Accusations on Kickbacks
New York Times - Jul 19, 2006
Medtronic was the subject of two lawsuits filed in Federal District Court in Memphis by whistle-blowers on the actions of its spinal-implant division, ...
All 14 related - Related web pages

Medtronic to settle with doctor over spinal implant invention.
Free with registration - Saint Paul Pioneer Press - AccessMyLibrary.com - Apr 23, 2005
Spinal implant devices are part of a division that accounted for 20 percent of Medtronic's $9.09 billion in total sales last year. In 1999, Medtronic paid ...
Medtronic to Pay $1.35 Bln to End Spinal Doctor... - Bloomberg
Medtronic to buy spine patents, ends legal battle - USA Today
Forbes - San Diego Union Tribune - All 22 related - Related web pages

Medtronic Sofamor Danek's Patent Infringement Lawsuit Begins.
Free with registration - Commercial Appeal - AccessMyLibrary.com - Jun 4, 2004
Medtronic Sofamor Danek and Dr. Gary Michelson are disputing patent rights over the Los Angeles surgeon's inventions in spinal implants, instruments and ...
All 2 related - Related web pages

Medtronic Must Pay Inventor $109 Million, Jury Says (Update3)
Bloomberg - Sep 28, 2004
28 (Bloomberg) -- A US jury told Medtronic Inc., the world's biggest maker of spinal implants, to pay at least $109 million to an inventor for violating ...
Medtronic Must Pay Inventor $109 Million, Jury... - Bloomberg
Memphis, Tenn., jury awards surgeon $110 million... - Commercial Appeal - AccessMyLibrary.com (Free with registration)
All 12 related - Related web pages

Medtronic Must Pay Surgeon $400 Mln Punitive Damages (Update2)
Bloomberg - Oct 12, 2004
Minneapolis-based Medtronic doesn't break out sales of spinal implants. The unit that includes spinal products, as well as ear-nose-and-throat devices, ...
Medtronic ordered to pay $400 million to Los... - Saint Paul Pioneer Press - AccessMyLibrary.com (Free with registration)
$400 Million Judgment Against Medtronic - New York Times
Los Angeles Times - Star Tribune - All 11 related - Related web pages

I'm not even going to attempt to dig any deeper. I fear I may lose my breakfast as a result.

However, hopefully Sen. Grassley and his staff will dig deeper.

A lot deeper.

It's hard for Medical Informaticists and others to help usher in an era of data-driven healthcare when we are competing with strippers and prostitutes for the affection of our surgeons.

-- SS

Addendum:

I am increasingly coming to believe the executive resistance I faced to development of an advanced, very fine-grained, still-used Invasive Cardiology Clinical Database (ICCD) at a major heart center in Delaware late last decade was not based on scientific issues.

This information system could show whether a new device or treatment was effective or not in short order, affecting valuable orders for devices. In fact, in its first year it saved almost $1 million in expense through just that means.

Interestingly, the resistance was from administration and IT, not the doctors, who were the true cheerleaders of the system. Reading the increasingly common stories about the way business is conducted by such companies, I do wonder if cardiac device companies could have been in bed with administration in some way.

Additional addendum 9/28/08:

UC leadership is certainly aware of this issue as well as this posting, after reading it via a Google search on the terms "Medtronic" and "stripper." From the HCRenewal tracking logs:

Domain Name: ucsf.edu ? (Educational)
IP Address: 169.230.242.# (University of California San Francisco)
ISP: University of California, Office of the President
Operating System: Macintosh MacOSX
Browser: Firefox
Time of Visit: Sep 28 2008 6:35:33 pm
Last Page View: Sep 28 2008 6:35:33 pm
Referring URL: http://www.google.co...r&btnG=Google Search
Search Engine: google.com
Search Words: medtronic stripper
Visit Entry Page: http://hcrenewal.blo...eive-her-failed.html
Visit Exit Page: http://hcrenewal.blo...eive-her-failed.html

Response from author of "The ADVANTAGE Seeding Trial"

In response to my earlier post "Merck scientific debate hits bottom" I received the following from one of the authors of the VIOXX seeding trial paper The ADVANTAGE Seeding Trial: A Review Of Internal Documents, Ann Intern Med 2008", Dr. David Egilman, MD, MPH.

I posted Dr. Egilman's opinions below at his request. My own thoughts follow.

Dr. Egilman also posted numerous documents to and from Merck's lawyer at this link. (The tone of some of those documents towards Dr. Egilman is particularly disturbing, such as the one here.)

------------------------------------------------------

From: David Egilman, MD, MPH
To: Healthcare Renewal

I am one of the authors of the "Seeding" paper.

Merck executive Dr. Jonathan M. Edelman, Executive director, Global Center for Scientific Affairs wrote:

There's no doubt that the ADVANTAGE clinical trial had a legitimate scientific purpose. That purpose was to assess the gastrointestinal tolerability of VIOXX compared to naproxen – a commonly used arthritis medicine with known tolerability problems – in the treatment of patients with osteoarthritis in a primary care setting, and for the first time allowed patients taking concomitant aspirin to participate.

Dr. Edelman's claim that ADVANTAGE was the first trial that permitted aspirin use with Vioxx is incorrect. Study 058, which was part of Merck's application for new drug approval submitted in November 1998, permitted the use of up to 325 mg of aspirin per day. ADVANTAGE only permitted up to 100 mg per day. Study 058 was a 30 week trial. ADVANTAGE was only a 12 week trial. Study 058 involved patients older than 80, comparing Vioxx to namebutone (another NSAID) and was completed in April 1998, about 10 months before ADVANTAGE enrolled a single patient. Study 078, the ghost-written Alzheimer’s trial also permitted aspirin, began in April 1998 and was scheduled to be completed by April 2000 before the end of the ADVANTAGE trial. More patients took low dose aspirin in the Vigor trial than the Advantage trial.

Further, ADVANTAGE was not designed to test the effect of aspirin on anything. Although aspirin was permitted, the examination of aspirin effects was not included as part of the study objective which Merck described: "[t]o assess the tolerability of rofecoxib (VIOXX) compared with naproxen for treatment of osteoarthritis." On the other hand, Merck Study 136 was designed to test the effects of concomitant aspirin and NSAID use. This study revealed that Vioxx offered no GI protection to low dose aspirin users who constituted the majority of potential Vioxx users.

By November 1998, when Merck sought FDA approval for an OA indication and three months before the ADVANTAGE trial enrolled any patients, Merck had already informed the FDA it had sufficient studies to prove Vioxx was efficacious for osteoarthritis patients. Merck's osteoarthritis trials (that it used to get FDA approval for use of VIOXX in osteoarthritis patients) had compared Vioxx to 3 other NSAIDS. The VIGOR trial, which tested Vioxx and naproxen in rheumatoid arthritis patients, started at the same time as ADAVANTAGE and used twice the dose of Vioxx than was used in ADVANTAGE. VIGOR was, therefore, a more valid scientific trial to determine relative safety of the two drugs.

This request for and subsequent approval meant that Merck could claim VIOXX was as effective for pain as naproxen. Beginning long before the Advantage trial Merck claimed Vioxx was safer than all NSIADS including naproxen.

While ADVANTAGE was the first study that compared Vioxx to naproxen in OA patients, Merck had completed trials comparing the two drugs in other pain patients.

It is for these reasons that the President of Merck Research Laboratories (MRL) Dr. Scolnick characterized ADVANTAGE as "intellectually redundant."

Merck wrote:

ADVANTAGE was a double-blind, randomized, controlled clinical trial with a legitimate scientific purpose designed to answer previously unanswered questions about the use of VIOXX in osteoarthritis in a primary care setting. It was not a seeding study.

Merck’s personnel called it a seeding trial internally but in an apparent effort to hide its true purpose wrote:

“I eliminated the reference to seeding. It may be a seeding study, but let’s not call it that in our internal documents.”

Merck apparently tried to make it look like a typical science-based clinical trial to mislead IRBs and journals. All seeding trials make some claim to some usually trivial scientific purpose. For example the question of whether or not Vioxx works better on people as a function of height is a scientific question. It is of course a trivial question. In this case Merck had studies that compared Vioxx to naproxen for pain control before the Advantage trial had started. Merck also had a larger trial that tested GI toxicity.

Merck wrote:

ADVANTAGE was important because although the earlier VIOXX clinical trial program provided extensive data on efficacy and safety, it did not include naproxen as a comparison Medication.

This is not correct. Merck had a study that compared Vioxx to naproxen for pain control before the Advantage trial started. This was presented to the FDA in the original New Drug Application and was published in October 1999.

Merck wrote:

The ADVANTAGE clinical trial was designed, conducted, analyzed, interpreted and published by the scientific department of Merck's U.S. Human Health (USHH) organization, Clinical Development (CDP), in conjunction with participating investigators. CDP was part of the Medical and Scientific Affairs department of USHH and was separate from the marketing department within USHH.

A more complete picture is:

USHH was the marketing division of Merck. It included sub-divisions including sales, marketing and a medical/scientific group called CDP. CDP performed “medical” studies that could be used by marketing to increase product sales. These studies were only conducted if favorable results could increase sales. They were not done to obtain new indications for drug use and Merck did not publish or provide the FDA with some of these studies (example 106).

Mr. David Anstice, a marketing executive with no apparent scientific training or background was the President of Merck's USHH division. In contrast Dr. Edward Scolnick, a physician/scientist of international renown, was the President of Merck’s research division which was called Merck Research Laboratories. Mr. Anstice the person ultimately responsible for the Advantage trial testified:

Q. I understand that. All I'm saying is, this is the study [Advantage trial] that was initiated and conducted by marketing, right?
A. Yes, by doctors in marketing.

A picture being worth a 1000 words I provide the Merck graphic for the organization of the Advantage trial:



Here is the power point description of marketing’s role in the Advantage trial:



While the marketing division of USHH set the study “objectives” CDP was in charge of the technical aspects of study implementation.

Further proof that ADVANTAGE served little scientific purpose is the fact that Merck had already claimed that Vioxx was safer than and as effective as all NSAIDS including naproxen prior to the initiation of the ADVANTAGE.

Merck did not rely on any ADVANTAGE results to make any claim about Vioxx efficacy or safety to the FDA. The lack of scientific purpose behind ADVANTAGE is demonstrated by the fact that Merck had withheld the ADVANTAGE results from its application to the FDA that requested a label change that would allow them to claim Vioxx was safer than naproxen. Merck only produced the results after the FDA made numerous oral and written requests for the safety data discovered during the trial.

Merck claims Advantage produced important scientific information:

In the end, ADVANTAGE showed a different gastrointestinal profile between VIOXX and naproxen that was unaffected by concomitant use of aspirin. This was an important medical result for physicians. In addition to measuring the GI tolerability of VIOXX, investigators also monitored patients for adverse events, which were required to be submitted to the FDA. Therefore, in ADVANTAGE, Merck was further evaluating any potential risks of VIOXX.

In fact the trial that Merck performed to test the effect of concomitant aspirin and Vioxx use (136) showed that aspirin use thwarted Vioxx’s GI advantage. (Gastroenterology. 2004 Aug;127(2):395-402.) The conclusion Merck reached based on the Advantage result was wrong precisely because Advantage was not designed to test this question. This conclusion was based on data mining.

Merck wrote:

We also want to underscore that the scientific purpose of ADVANTAGE was properly disclosed to physicians-investigators, participants, and institutional review boards, and Merck's business interests were clearly understood.

Merck never disclosed the marketing purpose of the trial which included the fact that Marketing “set objectives.”

Merck accuses the authors of "bias.”

In this open letter to the editors of The Annals of Internal Medicine, Merck would like to put in perspective the latest article by four authors who served as paid consultants to plaintiffs' lawyers in the VIOXX litigation against Merck. We are troubled by the biased article, which contains numerous inaccuracies, and wonder about the motivation behind this attack on Merck's scientific excellence and integrity.

Merck writes that the authors were “plaintiff witnesses” and “cherry picked” documents. As far as I know, all litigation ended about a year ago. None of the authors were paid on a contingency basis, the authors received no compensation from plaintiffs to work on the papers we have written and none of the authors are working on any Vioxx litigation at this time.

If money motivation equates to bias then it is Merck and its representatives who suffer from this problem. The same cannot be said of Merck or its representatives because while the authors have nothing to gain Merck’s future earnings depend, in some measure, on its reputation for honesty.

Merck does not explain how any theoretical bias impacted on the paper. They have not come forward with contradictory documents or testimony.

The authors agree that all the documents should be made public so readers can decide for themselves if we “cherry picked.” Merck, and Merck alone, continues to block the release of the documents.

Merck would not allow us to cite documents that showed that Advantage investigators were accused of fraud and at least one was convicted. Some of this data was deleted from the published paper but readers and editors were never informed of these problems.

It should be noted that eight Vioxx patients had heart attacks during the ADVANTAGE trial compared to one patient on naproxen. Merck never informed any of these patient volunteers of the cardiovascular risks of Vioxx before or after the trial although the informed consent stated that Merck would pay for treatment of drug related side effects. Unfortunately for some, this would have been funeral costs.

Merck wrote:

It is unfortunate that the authors and journal editors chose not to contact Merck before finalizing these publications. Had any of these individuals contacted Merck, factual errors could have been avoided.

I contacted Merck's main trial lawyer Ted Mayer and provided Merck an opportunity to comment on another paper related to the Advantage trial before it was submitted for publication. I did not send a pre-publication copy to plaintiff lawyers. Mr. Mayer provided comments and i included his comments in the final version.

Merck then complained about my contact to Mr. Mayer to Judge Higbee and requested that she sanction me for contacting their lawyer and then insisted that I make no further contact with them.

-- David Egilman

-----------------------------------------

My own thoughts on all of this are as follows:

The lessons of the Annals article are clear. The scientific community and the public are simply fed up with cavalier practices in the biomedical industry. While the article may affect remaining VIOXX litigation as pointed out here, it also should have an necessary "cleansing effect" on drug R&D.

It was not clinicians and scientists outside the industry who earned it the public's animosity. It was, and continues to be, the industry itself. As Roy Poses observed, there cannot be evidence based medicine if the evidence is distorted by commercial zealotry. I think the public recognizes this.

Further, marketing personnel have no place in pre-approval, pre-marketing scientific studies such as clinical trials. If they have a scientific role, it is perhaps in post-marketing studies, especially post-marketing surveillance for adverse effects. The latter is a function the pharma industry performs poorly.

Even in that latter domain, there must be honesty and transparency, characteristics with which the biases of marketing and its leaders (e.g., towards maximizing sales) may interfere.

Merck's responses to this new Annals article seem the antithesis of science. Instead, the responses appear to be right out of the political and legal warfare playbook (where logical argument prevails - except when presenting logical fallacy is to the advantage of the protagonists) ...

The response has been this:

• ignore the arguments and evidence [in this case, emails and documents from Merck itself],
  
• issue an ad hominem attack,
  
• issue slogans ("litigation in the name of science"),
  
• present a Red Herring as a distraction,
  
• issue accusations of bias,
  
• issue accusations of cherry picking,
  
• issue accusations of the authors taking evidence "out of context", etc.

and finally:

• produce no context or new evidence of your own, hoping the above tactics will make that unnecessary.
  

All that's seemingly missing are ... puppets.

Merck seems to expect the "courtesy" of being allowed to be a participant in any issues written about its conduct, as if the authors of this paper are its employees who under employment policies must permit any pubs they produce to be reviewed internally for approval. I believe the company's executives forget that their authority ends at the front gate.

It is also an odd and even arrogant request, especially considering the way the authors' evidence (Merck's own emails and documents) was essentially ignored in the responses, and the insinuations promulgated against the authors as serving plaintiff's lawyers -- which also implies that scientific integrity and the interest of patients is not their motivation.

As I mentioned in my earlier post, this is classic ad hominem and is insulting to authors in my opinion, as well as insulting to any clinician or scientist. Why would anyone want to provide a company that acts in this manner the courtesy of pre-publication involvement in investigative journalism?

Another issue I find interesting is noted in the limitations section of the paper where it is stated that:

... we did not identify, despite an exhaustive and systematic search strategy, documents detailing discussions between the marketing and research divisions, nor could we identify documents describing contracts between Merck and collaborating companies.

As well as the Annals editor's obervations that:

... despite the large body of documents searched by the authors, they discovered few details about exactly how Merck's marketing division carried out ADVANTAGE.

This is surprising. From an information science standpoint, it would not be unreasonable to believe there might be more related to this trial of a major drug in emails or powerpoints or other documents. This document sparsity could mean that the documents did not exist, but it also raises a speculative question about the document corpus produced in Discovery.

Could "inconvenient documents" have selectively been eliminated from the corpus of documents before it was released, and therefore not be present in the corpus of documents the authors searched? Could the documents the authors did find represent ones that were "missed" by some weeding out effort?

Finally, I believe the entire tenor of Merck's responses - ignoring evidence, stating the trial was "published in a peer reviewed journal" as a Red Herring and a justification of its legitimacy while ignoring Sox & Rennie's (the Annals editors) accompanying commentary Seeding Trials: Just Say "No" , belitting the authors, etc. - is very disturbing.

From "Seeding Trials: Just Say No":

No one told Annals the true purpose of ADVANTAGE. We learned about it when we received a letter to the editor from Dr. David Egilman, who was a consultant to the plaintiffs' attorneys in the civil suits against Merck. He had access to publicly accessible trial documents, which included Merck employees' e-mail messages that disclosed the true intent of the ADVANTAGE trial ... The article provides clear evidence that the intent of ADVANTAGE was to increase prescriptions of Vioxx (the study outcome of greatest interest to Merck seems to have been Vioxx prescribing rates) ... The documents do tell us that deception is the key to a successful seeding trial.

When I review NIH grant applications, if I suspect deception I will mention it to the study section leaders, and I can assure that if deception is verified higher up the chain, that application will not get funded (at the very least). I can also assure that legitimate medical journals do not willingly publish studies involving deception.

Merck's responses to the Annals article seem to represent a belief that the public (laypeople and physicians) are stupid and gullible.

This is not science, and is not a path to a return to the corporate greatness and respect that Merck once enjoyed and had earned.

Finally, a Red Herring of my own:



-- SS

Merck scientific debate hits bottom, keeps digging?

I find Merck Scientific Affairs executive Jonathan Edelman's op ed in today's Philadelphia Inquirer on the Vioxx "ADVANTAGE seeding trial" controversy to be mediocre spin control at best, if not deliberately misleading through selective omission of critical facts:

Taking Exception
Great value in clinical studies
Philadelphia Inquirer, Sept. 26, 2008

Your articles "Merck faces more criticism" (Inquirer, Aug. 19) and "Journal vs. the bad seed" (Aug. 20) drew the wrong conclusion.

The Advantage study was published by the Annals of Internal Medicine in 2003 after passing the journal's editorial and peer-review process that determined the study to be important new information for physicians. Dr. Harold Sox recently wrote in Annals that the way to identify a good clinical trial is to look at the importance of the scientific question it tries to answer.

This is the very same criterion that Annals and other medical journals use to select the studies that they publish and that Annals correctly applied in accepting the Advantage study five years ago.

Advantage was a randomized, controlled trial designed to address the scientific concerns of physicians, namely: the need to study Vioxx in osteoarthritis patients in the primary-care setting, in real-world conditions, and against a commonly used arthritis medicine, naproxen.

We are troubled by how easily the journal editors were persuaded by the conclusions of authors who were paid consultants to trial lawyers standing to profit from litigation.

[i.e., Hill et al, authors of the article "The ADVANTAGE Seeding Trial: A Review Of Internal Documents." Ann Intern Med 2008; 149:251-258 - ed.]

There is great value in conducting scientifically based clinical studies to address unanswered questions. We believe we acted appropriately in the Advantage trial, and stand behind our unwavering commitment to ethical conduct and scientific integrity.

Dr. Jonathan M. Edelman
Executive director
Global Center for Scientific Affairs
Merck Research Laboratories
Upper Gwynedd

The bulk of this op-ed, in fact, consists of a Red Herring and an Ad Hominem attack.

First, the Red Herring. The controversy is not about what the Annals published in 2003, it is not whether the science in the ADVANTAGE study was itself "good" in isolation of contextual (e.g., ethics and social policy) issues.

It is about what was written in the Annals in 2008, and the controversy over performing ADVANTAGE and other seeding trials, period -- which David Gorski at Science-Based Medicine so aptly describes as suffering from (at least) one major flaw, inherent deception:

... To boil it all down, here’s my perspective on why seeding trials such as this are inherently unethical, regardless of whether the clinical scientific question under study is worthy or the design of the trial can produce an answer to that scientific question. It all comes down to one issue: Deception. There is no way to carry out a seeding trial without deceiving virtually everyone involved below the level of study designers.

But I digress. Deception aside, it was not the words or the interpretations of the Annals 2008 authors that the ADVANTAGE trials were of questionable scientific value ...

Those words came from the head of Merck's own R&D division himself. The 2008 Annals authors are reporting the words of Merck's erstwhile head of R&D. Yet, Dr. Edelman failed to mention that highly important issue, as if it was irrelevant or immaterial. Politicians and biased journalists do this all the time - omit critical details to spin a story. It's one of the principles of effective propaganda.

From a physician/scientist, however, we expect better.

(I also note that Merck and other pharmas generally require careful vetting of materials released for publication. I assume the Edelman Inquirer op ed underwent internal peer review.)

From the New York Times:

In e-mail messages on April 7, 2001, to ... an executive vice president at Merck Research Laboratories, [President of Merck Research Labs] Dr. [Edward] Scolnick wrote that he was especially angry because the Advantage trial had no scientific purpose. In theory, Merck set up the trial to show that Vioxx caused fewer stomach problems than naproxen. But Merck had already demonstrated that with the Vigor trial, which tracked more than 8,000 patients for a year.

In pharma, the president of the research labs is usually considered "god" as far as new drugs are concerned. It was pointed out that Dr. Scolnick, largely seen as the #2 official in the company, worried that the ADVANTAGE study risked disclosing data to the Food and Drug Administration that could cause problems for Vioxx.

... [T]he reason we have resisted doing large marketing clinical studies is just this. It opens a lot of data to FDA that compromises the large clinically meaningful trials." Small marketing studies which are intellectually redundant are extremely dangerous," Scolnick wrote.

I find these statements by Merck's former head of R&D quite remarkable for many reasons, some stated in my earlier post here. In fact I completed several assignments for Dr. Scolnick and can state emphaically he was not someone easily challenged on scientific matters. He knew his stuff.

Dr. Edelman also omitted the following salient fact seen in the Annals editorial by Harold C. Sox, MD, Editor of Annals of Internal Medicine, and Drummond Rennie, MD:

No one told Annals the true purpose of ADVANTAGE. We learned about it when we received a letter to the editor from Dr. David Egilman, who was a consultant to the plaintiffs’ attorneys in the civil suits against Merck. He had access to publicly accessible trial documents, which included Merck employees’ e-mail messages that disclosed the true intent of the ADVANTAGE trial.

I note that it's unfortunate the Annals editors in 2003 did not have access to these remarkable statements and documents. This information, in fact, only saw the light of day due to the VIOXX litigation. I doubt Annals would have published in 2003 with such knowledge.

Now to the Ad Hominem in Dr. Edelman's op ed.

I find the Ad Hominem attack ("against the person") on the 2008 Annals authors, Drs. Hill, Ross, Egilman & Krumholz, disappointing (they were "paid consultants to trial lawyers standing to profit").

So what?

That is useless information in the context of their current article.

In an ad hominem attack, the character or circumstances of a person making a claim, or their actions, are impugned. This attack is taken to be evidence against the claim or argument the person in question is making or presenting.

This is an exceptionally poor form of argumentation, especially considering the current Annals article was based on an "informational infrastructure" consisting of plain-English emails and documents written by Merck officials themselves. They are available for examination at this link.

These documents, provided by the company itself under rules of legal discovery, do not appear to be taken "out of context" in any way. They appear to stand on their own merits.

The reason why an Ad Hominem (of any kind) is a fallacy is that the character, circumstances, or actions of a person do not in most cases have a bearing on the truth or falsity of the claim being made or the quality of the argument being made.

(The above explanation is from the Nizkor Project page on ad hominem attack, link. In the final example of ad hominem on the Nizkor page, substitute "lackey to the trial lawyers" for "lackey to the Pope" to better visualize just how outrageous the attack on the Annals authors is.)

Is this is the state of the art for Merck scientific debate, I ask?

If so, the company's leadership is in its ripe old age, dementia fast approaching.

If pharma wants to re-establish its credibility with physicians and patients, among others, it needs to start acting more like a concerned physician than a furiously spinning politician trying to "control the narrative."

Finally, as numerous examples on Healthcare Renewal demonstrate, there are those in prominent leadership positions in healthcare who never learned basic rules of logical thought or argumentation yet claim to proffer scientific or ethical truths, or selectively "forget" logic to advance their own agendas. At this point, I have no qualms about calling such people scoundrels.

Addendum:

I note the statement by Dr. Edelman in the Annals comments site at this link ("Merck does say no") that the 2008 Annals article by Hill et al constitutes "litigation in the name of science."

I'd opine that the article more resembles a rather straightforward exposé of probable smoking-gun internal emails and documents in the defense of science. "Investigative journalism" is an apt description.

As Roy Poses pointed out in the comments, evidence based medicine is impossible when the science is tainted in the name of commerce.

-- SS