Pontifications About Health Care Reform Written by Insiders Who Benefit from the Status Quo - Worse Than We Think

Perceptions that the US health care system is dysfunctional and needs major reform go way back.  A timeline from the Tampa Bay Times noted President Theodore Roosevelt's proposal for a national health service in 1912.  Nonetheless, as we have discussed endlessly, most attempts at reform failed, and health care dysfunction seems to be getting worse.

One big problem may be that we don't understand how much discussion of health care reform is driven by those who benefit from the status quo. 

A Personal Anecdote

When I began my academic career in 1983, I was often in the audience for talks about how to fix health care by people billed as experts.  Often these talks seemed oddly disconnected from the realities on the ground for a junior assistant professor with a lot of clinical and teaching responsbilities.  Worse, many of the solutions they offered seemed to entail greater burdens for health care professionals, with no obvious compensation other than the warm feeling that we would be benefiting society.  Who else these solutions might benefit was not discussed. 

One talk given a bit later stands out in my memory. On November 29, 2001, one Dr John W Rowe gave the prestigious Levinger Lecture at Brown University entitled "Good Health: Can we Afford It?" (referenced here, see items for 11/14 and 11/16)  As I recall, Dr Rowe spent considerable time scolding us hard working physicians for overuse of medical interventions leading to endless increases in health care costs, and promising more burdensome bureaucratic interventions to rein in our follies.  While promising more burdens on physicians, Dr Rowe did not dwell on how the resulting cost savings might benefit him in his role as CEO and Chairman of Aetna Inc.  Aetna had purchased the notoriously physician-unfriendly US Healthcare, and thus had become a big for-profit health care insurer already known for imposing bureaucratic burdens on physicians in hopes of decreasing their utilization, while increasing the company's revenues (look here).  Were Dr Rowe's pontifications really about improving health care for all Americans, or about justifying his previous management behavior, and perhaps supporting the price of his shares in Aetna? Why was Aetna's public relations given the patina of an academic lecture?

These days, health care professionals continue to be exhorted about health care reform.  Many such pontifications may be not so much about true health care reform as about preserving the fundamental status quo which has benefited and enriched so many insiders. The interests of the pontificators are often less obvious than those of Dr Rowe.  Maybe that is so why there has been so little real reform, and what little reform there has been seems to be under continuous attack.

Two Examples of How Hard It Is to Discover the Interests of Health Care Policy Pontificators

In the last few weeks I posted about two recent ostensibly authoritative pontifications.  One was about ways to address the worsening problem of physician burn-out (see this post). It was written by the CEOs of large, non-profit hospital systems, joined by the CEO of the American Medical Association.  The other was about a health care reform proposal from the prestigious National Academy of Medicine (see this post).  A rather uncritical article in the Washington Post hailed it as a "radical idea" because it was written by "doctors." In both cases, I was skeptical, mainly because many of the proponents had conflicts of interest, mostly undisclosed, that suggested they were already benefiting mightily from the current system.

However, it gets worse.  While I thought my posts were based on reasonable efforts to find undisclosed conflicts of interest affecting the authors of these exhortations, within a few weeks I realized I had missed one important item affecting each.  The lesson is that the web of conflicts of interest that ensnares the insiders who run most of US health care is even more complex and adherent than any of us realizes.

Dr John Noseworthy, Author of the Health Affairs Post on Reducing Physician Burnout: CEO of the Mayo Clinic, But Also Now Nominated to be a Director of Merck

Dr Noseworthy, CEO of the Mayo Clinic, was the lead author of a post in HealthAffairs about reducing physician burnout.  (Oddly enough, none of the proposed action items seemed to involve increasing physician autonomy by reducing the power of managers over health care professionals.)

Two weeks after Noseworthy and colleagues' post appeared, an article on the Minnesota Public Radio website reported that Dr Noseworthy has just been nominated to a seat on the Merck board of directors.  Presumably the possibility of this nomination had been known at the time the post was published.

I had previously written that two of the authors of the Health Affairs post were on corporate boards.  One, Dr Paul Rothman, was already on the board of Merck.  As corporate directors, they have fiduciary responsibilties to promote the revenues of their corporations.  Now it turns out there were at least three such board members among the health system CEOs who had pontificated to physicians about how to reduce their burn-out.

Yet the power of such health care systems, whose management is often mission-hostile, and who often put revenue ahead of physicians' professional values (per the shareholder value theory), is arguably a major cause of physician burnout.  Furthermore, Merck, in particular, has had its share of management misbehavior as demonstrated by a recent $830 million settlement for deceiving shareholders, a mere $5.9 million 2015 settlement for deceptive marketing, and multiple setttlements, cumulatively totaling more than $1 billion, plus one guilty plea for the historic deceptive marketing of Vioxx (see this post).

So to what extent are the authors of this pontification about reducing physician burnout (without really giving physicians much new autonomy) insiders benefiting from the status quo in health care?  It may be more than what we think, even now.

Mr Leonard Schaeffer, Author of National Academy of Medicine Article on Health Care Reform: Member of the Boards of Wahlgreen Boots, Quintiles, scPharmaceuticals, but Also Long-Term Director of Amgen

Mr Schaeffer was an author of the National Academy of Medicine article, now published online in JAMA, about health care reform.  (Oddly enough, none of the "vital directions issue areas" mentioned in the article involved real challenges to the power of large health care organizations, particularly for-profit corporations, or increased autonomy for health care professionals.)

The version of the article published online by the NAM did not include any explicit disclosures of conflicts of interest.  It did note that two authors were full-time employees of health care corporations, one was a consultant to health care corporations, one was a lobbyist for health care corporations, and one was on the boards of health care corporations.  The online JAMA version added more disclosures, but these were incomplete.  In my post, I noted that fully 13 of the 19 authors had major ties to large health care corporations, as employees, lobbyists, consultants or  board members.

In particular, Mr Leonard D Schaeffer was listed in the NAM version as simply affiliated with the University of Southern California, but I found was actually on the boards of Wahlgreens Boots Alliance, Quintiles Transnational, and scPharmaceuticals Inc.  That was still an incomplete picture of his conflicts of interest.

A ProPublica article from February, 2017 recounted how big pharmaceutical companies engaged Precision Health Economics to wage public relations campaigns to try to justify high pharmaceutical prices.  The article noted the following about Mr Schaeffer.  

Amgen has ties to all three founders of Precision Health Economics. Working for other firms, Philipson has twice testified as an expert witness for Amgen, defending the company’s rights to drug patents, according to his curriculum vitae. The other two founders, Goldman and Lakdawalla, are principals at the Leonard D. Schaeffer Center for Health Policy and Economics at USC, which received $500,000 in late 2016 from Amgen for an 'innovation initiative,' according to public disclosures. Goldman said the funds were unrestricted and could be used at the center’s discretion. Robert Bradway, the CEO and chair of Amgen, is on the advisory board of the university center, and Leonard Schaeffer, a professor at USC and the namesake of the center, sat on Amgen’s board of directors for nearly a decade.

With funding from Amgen, the Schaeffer Center hosted a forum in Washington, D.C., in October 2015 on the affordability of specialty drugs. Before a panel focused on the new cholesterol treatment, Goldman cautioned against lowering drug prices.

So Mr Schaeffer, in addition to his current board positions, turns out to have had a long relationship with Amgen.  Given that according to the 2013 Amgen proxy statement, Mr Schaeffer retired from the board with at least 28,277 shares of Amgen stock and options for 15,000 more, he may have current financial ties to the company. 

So once again, to what extent were the authors of the 2017 NAM report on health care reform (which did not challenge the influence of large health care corporations over the health of US citizens) insiders benefiting from the status quo in health care?  It may be more than what we think, even now.

Summary

Health care professionals, policy makers, and the public are constantly harangued by apparently unbaised experts about health care reform.  Yet many of these authorities are insiders who benefit from the status quo.  Many of their financial connections to the corporations that make the most money from the US commercialized health care system are not disclosed.  It may take considerable investigation to determine their involvement in a web of conflicts of interest that drapes over the US health care system.

Meanwhile, audiences should demand that those who lecture us about health care reform disclose all their financial conflicts of interest.  Any whiff of deception about their personal interests should suggest intense skepticism. 

True health care reform requires honest discussion of the issues.  Honesty in this case entails complete and detailed disclosure of the discussants' conflicts of interest. Until such honesty is the rule, be very, very careful about taking sanctimonious spiels at face value. 

Clinical Practice Guidelines: Still Conflicted After All These Years

Background: Untrustworthy Clinical Practice Guidelines

Since the 1990s, clinicians have been exhorted to follow clinical practice guidelines (CPGs) to improve their decision-making and patients' outcomes.  When Dr Wally Smith and I started teaching a short course (often at the Society for Medical Decision Making meetings) about changing physician behavior, we naively set out to improve decisions by increasing adherence to such guidelines.  We first thought that physicians' apparent shortcomings in guideline adherence were due to their lack of knowledge of the guidelines and the underlying evidence, and to their human cognitive limitations.

That approach, however, failed to yield ways to improve adherence.  After a while, it occurred to us that there might be other reasons physicians did not follow guidelines, including their lack of trust of the guidelines or the evidence supposedly incorporated within them.  We learned that integrity of  the clinical evidence base has been severely degraded due to the manipulation of clinical studies by those with vested interests, and the outright suppression of trials for which manipulation does not produce the desired results.

Furthermore, as we became less naive, we learned that the integrity of the guideline development process was also suspect, again due to the influence of those with vested interest.  No wonder physicians were suspicious of guidelines, and resisted adhering to them.

In 2011, the prestigious Institute of Medicine released a report on the development of  better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust.  Link here.)  We posted about that report here, but noted that it was receiving little other attention, an example of the anechoic effect.  The IOM report cited conflicts of interest (COIs) affecting the guideline development process as a major reason such guidelines might be untrustworthy, and suggested a variety of ways to reduce COIs affecting guidelines.

These included in particular:
- Guideline committee members should disclose their conflicts of interest in detail, and these should appear in the guidelines (Standard 2.1, 2.2)
- The number of conflicted committee members should be minimized, and in no case should be a majority of the committee (2.3, 2.4)
- Funders should have no role in guideline development (2.4)

This week, an original article(1) and editorial(2) in PLoS Medicine discussed how guidelines published since the report was produced addressed conflicts of interest.

Article Summary

Below I summarized the article, but presented results somewhat differently than did the authors.

Design

Campsall et al did a cross-sectional study of clinical practice guidelines that appeared in the US Agency for Healthcare Research and Quality (AHRQ) National Guideline Clearinghouse in 2012 from national or international organizations, excluding guidelines produced by organizations restricted to allied health professionals, guidelines produced by corporations, or guidelines that had no specific recommendations.  They obtained information from the guidelines, the organizations' websites, and surveys sent to the organizations.

Study Population

The study population was 290 guidelines produced by 95 organizations. The response rate for the surveys was 68%.  The organizations were primarily professional societies (67%) or disease advocacy groups (21%).

My comment is that therefore this study assessed guidelines mainly produced by non-profit organizations which ostensibly uphold health care professionals' values and/or primarily support patients' interests.

Industry Funding

63% of organizations reported receiving funds from biomedical companies.  (It was not clear whether the remainder denied receiving such funding, or provided no information about funding.)

My comment is that the majority of such ostensibly "do-gooder" organizations are nonetheless at least somewhat supported by commercial firms that market health care products, presumably mainly drugs or devices.

Conflict of Interest Policies

Please note that the authors provided results to emphasize the positive, for example, they provided the proportion of organizations which provided specific types of information about COIs or had particular policies to reduce COIs.  In most cases, I simply did subtractions to emphasize the negative.  Furthermore, the authors further emphasized the positive by choice of denominator, as noted below.

20% of organizations did not provide any information about conflict of interest policies, and 7% asserted the existence of such policies, but did not disclose them.  A majority, 55%, did not have disclosed policies that specifically dealt with with conflicts of interest affecting guidelines.

My comment is thus that a majority of these do-gooder organizations did not apparently even begin to address, at least in terms of clear, transparent written policy, the recommendations of the IOM report on trustworthy guidelines.

Measures to Improve Guidelines Trustworthiness by Decreasing Influence of Conflicts of Interest

The authors provided the number of organizations with disclosed policies that addressed particular issues of concern to the IOM in their report on trustworthy guidelines, but made the proportions of such organizations seem larger by using as a denominator the number of organizations that disclosed their entire policies, rather than the total number of organizations which produced the guidelines.

Therefore, they found that of the 60 (out of 95 total) organizations that fully disclosed their conflict of interest policies:
98% required committee members to disclose conflicts of interest;
90% required review of conflicts of interest before guideline publication; 
68% required that a majority of guideline committee members be free of conflicts of interest;
92% reported publishing committee members' conflicts of interest within guidelines;
78% did not allow direct industry funding of guideline development
82% did not allow industry participation in selection of committee members
67% did not allow industry to review guidelines prior to publication.

That all sound good, but consider what happens when one uses the total sample of organizations in the denominators.

Therefore, the article also found that of all 95 organizations that produced the guidelines of interest:

38% did not require CPG committee members to disclose conflicts of interest
43% did not require review of committee members' conflicts of interest prior to guidelines development
57% did not require that a majority of guideline committee members be free of conflicts
44% did not report publishing committee members' conflicts of interest within guidelines
48% did not report preventing direct industry funding of guidelines
51% did not report preventing industry participation in selection of committee members
61% did not report preventing industry review of guidelines prior to publication.

My comment is that thus the results suggested that substantial numbers of organizations that produced CPGs did not demonstrate that they were committed to measures that would improve guidelines trustworthiness by reducing the influence of conflicts of interest.

Disclosure of Conflicts of Interest Within Guidelines

Again, it was necessary to recalculate some proportions using the full population of guidelines reviewed as the denominator.

Of the 290 guidelines reviewed:
65% "included disclosure statements regarding direct funding and support"
37% specifically disclosed the absence or presence of direct funding from biomedical companies
However,
49% did not disclose committee members' financial relationships
99% did not disclose relevant financial relationships of the organization (that is, institutional conflicts of interest) that produced the guidelines as a whole

My comment is that substantial numbers of published guidelines were not clearly produced so as to increase their trustworthiness by reducing the influence of conflicts of interest on them. 

Did the Guidelines Follow the Organizations' Stated Policies?


The authors commendably provided information about whether the guidelines produced by organizations that disclosed conflict of interest policies followed those polices.  They found:

16% of organizations "that reported that committee member conflicts of interested were published in guidelines" produced guidelines that did not include committee members' COI disclosure

61% of organizations that "reported the majority of committee members must be free of conflicts of interest" produced guidelines by committees with majorities of conflicted members

6% of organizations that "reported that industry partners were not permitted to directly fund clinical practice guideline development" produced guidelines which disclosed such funding.

My comment is that thus even of the organizations that stated they had policies in place to improve the trustworthiness of the guidelines they produced by reducing the influence of conflicts of interest, they allowed guidelines to be produced that did not follow those policies.

Authors' Conclusion

Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry appear to be common. These relationships are important because they may influence, through guideline usage, the practice of large numbers of healthcare providers. We believe that to effectively manage conflicts of interest, organizations that produce clinical practice guidelines need to develop robust conflict of interest policies that include procedures for managing violations of the policy, make the policies publicly available, and disclose all financial relationships with biomedical companies.

Editorialists' Conclusion

The editorial by Bastian(2) was sharper in tone.  It included an observation that reinforced my confession of naivete above:

With hindsight, I think those of us encouraging better methodology for guideline development in the 1990s took the issue of disclosure of financial interests too much for granted. It seemed so self-evident, it got barely a mention even in national policy on guideline development

She also noted that the Campsall study did not address all the ways conflicts of interest can influence guideline development:

Stelfox and colleagues focus particularly on the organizational conflicts of interest of guideline producers and their policies. They examine the financial interests of the organizations, but not of the individuals employed within those organizations. This same blind spot is evident when it comes to policies about committee members; the financial interests of the organizations that individuals represent tend to be disregarded. Yet these can be substantial, including for patients’ organizations.

She noted that the failure of guidelines to report their developers' conflicts of interest is a continuing problem.  The rate of failure to report found by Campsall et al was

about the same rate that Taylor and Giles found in 2004 and Norris and colleagues found in 2010.

Finally, she emphasized that we are still a long way from having guidelines that health care professionals and patients can trust:

Guideline processes without adequate financial conflict management have to become unacceptable to a far wider circle. They need to become unacceptable to influential committee members, to the medical journals that lend so many guidelines additional standing and reach, and to the membership of the professional societies that produce them. Until that happens, for guidelines as for clinical research, it’s a case of caveat lector: let the reader beware.

My Summary

So should physicians trust clinical practice guidelines?  At least this article suggests they ought to be very very skeptical of them.  The IOM report meant to improve the trustworthiness of practice guidelines seems to be honored mainly in the breach.  The likelihood that any given guideline was produced so as to reduce the influence of conflicts of interest on it is low.  Even organizations that ostensibly put professional values and patients first in their efforts to develop guidelines seem to often be financially beholden to companies that want to sell drugs and devices.  Physicians and patients ought to be concerned that most new clinical practice guidelines may be as much about marketing commercial products as improving medical practice or patients' outcomes.

The current US presidential race has made it evident that we have a lot of disgruntled citizens, many of whom believe our system is rigged to favor the "establishment."  I suggest that the more we know about clinical practice guidelines, the more it appears that the health care system is rigged to favor certain parts of the "establishment," the big corporations that market drugs and devices, and their paid part-time hands within medical societies and patient advocacy groups who have turned these ostensibly idealistic, do gooder organizations into part-time marketing machines.

The huge and complex web of individual and institutional conflicts of interest that binds much of the health care system, the government, and industry may be good for the insiders, but is stifling improvement in our dysfunctional health care system.  True health care reform would first expose these conflicts, then reduce or better yet, eliminate them, and make health care more about helping patients and less about making money by marketing commercial products.

Musical Interlude

To dispel the darkness a bit, Paul Simon, "Still Crazy After All These Years," 1992 acoustic version:





References

1.  Campsall P et al.  Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry: a cross-sectional study.  PLoS Medicine 2016; DOI;10.1371/journal.pmed.1002029    Link here.

2.  Bastien H. Nondisclosure of financial interest in clinical practice guideline development: an intractable problem? PLoS Medicine 2016;  DOI;10.1371/journal.pmed.1002030  Link here.

Incoming President of IOM Outed as Member of Boards of Alnylam Pharmaceuticals, Medtronic and Pepsico

We just discussed how the new CEO of the National Quality Forum was revealed to be a member of the board of directors of Premier Inc, and discussed the implications of this apparently intense conflict of interest. 

Now another new leader of an influential non-profit organization dedicated to improving health and health care has also been shown to have major conflicts of interest.

All Hail the New President of the Institute of Medicine

In 2010, we posted about a student protest of the salaries of some top administrators at Duke University, including then Chancellor of Health Affairs Dr Victor Dzau, at a time when the university was undergoing financial difficulties.  We pointed out that Dr Dzau's income was further increased by compensation received as a member of the boards of directors of multiple corporations, and further that serving as a highly paid steward of health care companies like Alnylam Pharmaceuticals, Genzyme, and Medtronic appeared to be a major conflict of interest.  .  

Last week Dr Victor Dzau was hailed as the new president of the Institute of Medicine.  The simple version, in Modern Healthcare:

 Duke University Health System President and CEO Dr. Victor Dzau was named president of the Institute of Medicine, succeeding the longtime president, Dr Harvey Fineberg, the National Academy of Sciences announced Wednesday.

Dzau, whose six-year term will begin July 1, has done research in the area of treatment for high blood pressure and congestive heart failure and pioneered the use of gene therapy for vascular disease, the institute said in announcing the selection. Dzau served on the IOM Council from 2008 through 2013, Fineberg said in a statement.

'As a physician-scientist and leader in academic medicine, Victor has consistently demonstrated inspirational leadership, innovative thinking and multifaceted achievement. Now, all of us at the IOM, both members and staff, will benefit more fully from his leadership,' said Fineberg, who has served as president of the institute for 12 years.

Conflicts of Interest Barely Noted

Neither this article, the official Institute of Medicine press release, nor articles in the few media outlets that initially covered this new appointment on 19-20 February, 2014,, including the Boston Globe and the Charlotte News-Observer, noted Dr Dzau's positions on the boards of directors of Alnylam Pharmaceuticals, device manufacturer Medtronic, and sugary soft drink maker Pepsico.

However, Forbes blogger Larry Husten, was the first to publicly report these memberships, drawing on our 2010  post  on Dr Dzau's conflicts of interest as Duke Chancellor for Health Affairs.

Then a blog post on Modern Healthcare by Steven Ross Johnson added some more detail,

IOM spokeswoman Jennifer Walsh said in an e-mail that Dzau initiated steps to resign from his corporate board positions before Wednesday's announcement and that he has committed to severing the ties by the time he begins his six-year term in July.

It did not mention why the IOM press release and the initial news stories did not mention Dr Dzau's board memberships nor his intention to resign from them.  The IOM spokeswoman apparently did not discuss why Dr Dzau was going to resign his board memberships now, while he had maintained them as a member of the IOM Council from 2008 to 2013.

Since then, later on 21 February, a single mainstream media article, in Bloomberg, did address Dr Dzau's new job, his corporate board memberships, and his planned resignations, with emphasis on his break from PepsiCo:

The newly appointed president of the Institute of Medicine, which advises government leaders and policymakers on health issues, plans to resign from several corporate boards in advance of taking his new job—including one that might have created a sticky situation.

Among the companies that Victor Dzau will sever ties with is PepsiCo (PEP), according to Jennifer Walsh, a spokeswoman for the IOM. 'Dr. Dzau had already decided to step down from corporate boards before he accepted the position,' she says.

For Dzau, who’s leaving his position as chief executive officer of the Duke University Health System to head up the IOM, the PepsiCo relationship might have been a problem: Several of the company’s products are among those blamed for contributing to the obesity epidemic in the U.S. The Purchase (N.Y.)-based company is best known for its Pepsi soft-drink line and snacks including Fritos and Cheetos.

The IOM, which has identified solving the nation’s weight problem as a top priority, endorsed the idea of a soda tax in a report detailing the 'staggering toll' of obesity. The agency estimates obesity-related illness in the U.S. costs $190 billion a year.

The Bloomberg article mentioned his memberships on the Alnylam and Medtronic boards mainly in passing.

The Rewards of Board Membership


The Modern Healthcare blog post provided a list of recent compensation Dr Dzau received from his board memberships.

According to Pepsico's 2013 proxy statement, Dzau deferred his retainer of $66,667 for the year ending Dec. 29, 2012, in lieu of 944 units of phantom stock, where cash is paid at a future date in an amount equal to the market value of stock shares. Dzau also serves on the boards of Alynylam Pharmaceuticals (he was paid $50,000 and received option awards of $89,000 in 2013) and medical devicemaker Medtronic (PDF) (he was paid $80,000 and received stock awards worth $140,000 in 2013).

It did not mention whether he currently owns any stock, or the equivalent, in any of these companies. 


However, the most recent Alnylam, Medtronic, and PepsiCo proxy statements show Dr Dzau's considerable stock holdings in these companies.

- According to the 2013 Alnylam Pharmaceuticals proxy statement, he currently owns the equivalent of 90,000 shares today worth $8,070,300 at the current price of $89.67.
- According to the 2013 Medtronic proxy statement, he currently owns 9636 stock options and 15,200 deferred stock units for total holdings of 25,156 share equivalents today worth $1,450,495 at a current price of $57.66.
-  According to the 2013 Pepsico proxy statement, Dr Dzau currently owns the equivalent of  36,173 shares of Pepsico stock. today worth $2,830,537 given a current price of $78.25. 

The Bloomberg article provided a somewhat lower estimate of the value his PepsiCo stock holdings based on an otherwise unidentified 2 December, 2013 filing with the US Securities and Exchange Commission.  It estimated the value of his deferred stock units in Medtronic based on an April, 2013 disclosure, but did not list the stock options which appeared in the July, 2013 proxy statement.  It noted his membership on the Alnylam board but did not mention that he held any shares or the equivalent in Alnylam stock.

I cannot find anything public about what, if anything, Dr Dzau plans to do with these not inconsiderable stock holdings in health care and health related corporations.  

Note that as we posted in 2010, in its last proxy statement before it was acquired by Sanofi, Genzyme declared that Dr Dzau owned the equivalent of 75,137shares as of 2009, which in 2010 were worth approximately $5.3 million.  I cannot tell what Dr Dzau did with these stock holdings after the merger.  


Thus while there may be some confusion about this current holdings and their exact value, it seems clear that Dr Dzau has become a multimillionaire by virtue of his holdings of stock or equivalent from the three companies, a drug company, and medical device company, and a company whose products have apparent public health implications, on whose boards he currently sits, and possibly by virtue of his holdings in another drug/ biotechnology company on whose board he previously sat.  .  

The Intensity of the Conflicts

The acuity of the conflicts presented were the President of the IOM to continue sitting on these boards was emphasized by this description of the influence wielded by the IOM written in an article in the Durham (NC) Herald-Sun,

 Under the congressional charter of the National Academy of Sciences, the Institute of Medicine is recognized as a primary source for independent, scientifically informed analysis and recommendations on health issues.

Even though Dr Dzau will apparently exit his board memberships before he becomes IOM President, the IOM  has been providing such analysis and recommendations under the supervision of a Council member who had fiduciary duties to the stockholders of two pharmaceutical companies a medical device company, and company that makes sugar-laden soft drinks and snack foods.  It will continue to provide such analysis and recommendations under the supervision of a President who became a multimillionaire by virtue of the stock holdings he acquired through his board positions.


In 2006 we first discussed a newly discovered species of conflict of interest in health care, in which leaders of medical or health care organizations were simultaneously serving on boards of directors of health care corporations.  We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive.  It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]  Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management.  However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a pharmaceutical company or medical device company, could be very different and at odds with the mission of an academic medical institution or a non-profit ostensibly dedicated to improving health care quality.

Also, this case could be aggregated with that of Dr Cassel, the new CEO of the National Quality Forum (and former CEO of the American Board of Internal Medicine) who was found to be a member of the board of directors of Premier Inc, a for-profit hospital group purchasing organization.(see this post).  In my humble opinion, the issue here goes even beyond blatant conflicts of interest.  That top stewards of big for-profit health care corporations could simultaneously be  top leaders of influential non-profit organizations ostensibly dedicated to improving health and health care suggests that increasingly US health care is run by an insular group of insiders whose influence gets ever larger because of their collective power, not necessarily because of their dedication or ability to improvement of health care.  As reported by ProPublica about Dr Cassel's case,

Rosemary Gibson, an author and senior adviser to The Hastings Center, a research group dedicated to bioethics in the public interest, said she wasn’t surprised at Cassel’s outside compensation. So much money permeates decision-making in Washington, she said, that participants have become oblivious.

'The insiders don’t see it,' Gibson said. 'It’s like a fish in water.'

How Would Dr Dzau Respond to Criticisms of the Companies He Directs, and How Would His Responses Reflect on the IOM?

Even if  Dr Dzau were to resign from all three corporate boards, and sells all his stock holdings in the three companies, as previous board member he was responsible for the stewardship of these four companies for years. Therefore it would not be unfair for someone to ask him to address any questionable actions of those companies that affected patients' and the public's health.

For example, as we have discussed here, Medtronic has been involved in a series of recent misadventures, including most recently a settlement between multiple hospitals and the Us Department of Justice of charges that they allowed themselves to be persuaded by executives of Medtronic subsidiary Kyphon to inflate their billings for patients who had a Kyphon device implanted (look here),  and a Senate report that Medtronic manipulated articles in the medical literature to market another of its products (look here).

But the awkward fact is that Dr Dzau, as a board member of Medtronic, can be seen to be a steward of that corporation, and hence responsible for the its overall direction.  Even if he were no longer a board member, he cannot erase his responsibility for Medtronic activities that occurred on his watch.  Thus, Dr Dzau could easily find herself in the uncomfortable situation of having to defend and justify questionable past behavior by Medtronic while simultaneously wearing the hat of President of the IOM.  How that would play out is not obvious.

Summary

To date, the case of Dr Dzau as incoming president of the IOM and current board member of Alnylam Pharmaceuticals, Medtronic and Pepsico has received little attention, and therefore no ethics expert has gotten a chance to speak up in public about it, as they have about the case of Dr Cassel, the NQF, and Premier Inc.  So I will have to step in.

As I have said before,  Dr Joe Collier said, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."  [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.]  To reduce further unclear thinking and its consequences, we again urge that academic medical institutions, and non-profit organizations dedicated to improving patient care and public health forthwith begin real reductions of conflicts of interest affecting all those who make clinical or policy decisions.

The IOM ought to consider
-  Immediately disclosing conflicts of interest affecting all its members, staff, and leadership in a very clear and accessible manner
-  Beginning a gradual but complete phase out of such conflicts

Otherwise, we all ought to be concerned that the leadership of medicine and health care is increasingly in the hands of a small group of insiders, interchangeable executives who simultaneously or sequentially lead multiple organizations, and are likely to become more comfortable with the fellow members of this interlocking leadership than with ordinary health care professionals, patients and the public.   

What If the Institute of Medicine Wrote a Report and Nobody Followed it? - the Case of the Standards for Developing Trustworthy Guidelines

For over 20 years, clinical practice guidelines (CPGs) have been touted to improve health care quality and control costs.  Enormous numbers of guidelines have been developed, but with seemingly little impact on health outcomes.  While some of those leading health care organizations have predictably blamed individual practitioners for obstinately ignoring or challenging guidelines, there is increasing evidence that maybe the guidelines themselves are part of the problem.

 An Example of a Guideline that Apparently was Not Trusted

One example Dr Wally Smith and I have taught in our recurring mini-course on why physicians fail to follow guidelines (and otherwise appear not to practice in accord with others' wishes) is that of the guidelines on management of depression in primary care.  Most existing guidelines urge physicians to screen patients for (presumably mild-to-moderate) depression and treat them aggressively, with emphasis on the use of the newer anti-depressants.  These guidelines, in turn, were based on numerous published randomized clinical trials that showed that these drugs were safe and efficacious.  Yet multiple studies showed that physicians failed to follow these guidelines, and various attempts to improve their adherence did little.  So for years the assumption was that physicians at best experienced practical and system barriers to follow these guidelines, and at worst were ill-informed or irrational. 


However, information that came out gradually during the early part of the 21st century suggested that perhaps the problem was within the guidelines, not the health care professionals.  First, documents produced during New York Attorney General Eliot Spitzer's lawsuit against GlaxoSmithKline about the marketing of one of these drugs (Paxil, paroxetine) suggested that the company had suppressed clinical trial data that reflected poorly on the drug (See Kondro W.  Drug company experts advised staff to withold data about SSRI use in children.  Can Med Assoc J 2004; 170: 783.  Link here.)    These suspicions were later fleshed out  by consideration of documents further disclosed in litigation (e.g., see this post and its links).  Then several studies, most particularly that by Erick Turner and colleagues, showed that numerous trials of new anti-depressants had been suppressed, that is, never published (Turner et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358:252-260.  Link here).  When the results of these trials were added to those that were published, the efficacy of anti-depressants was no longer so clear.  So maybe the guidelines that physicians did not follow were not trustworthy, and should not have been followed in the first place.

Would IOM Standards to Improve Guideline Trustworthiness Help?

So in 2011, the prestigious Institute of Medicine released a report on the development of  better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust.  Link here.)  We posted about that report here, but noted that it was receiving little other attention, an example of the anechoic effect. 

A few weeks ago, an article appeared documenting a study meant to assess the the trustworthiness of clinical practice guidelines published soon after the IOM report.  Its title telegraphs the results. ( Kung J, Miller RR, Mackowiak PA. Failure of clinical practice guidelines to meet Institute of Medicine standards: two more decades of little, if any progress.  Arch Intern Med 2012.  Link here.)

Methods and Results

The investigators selected a random sample of 114 individual guidelines available during June, 2011 stratified by 26 clinical topics. The versions of the guidelines used were those archived in the National Guideline Clearinghouse (NGC) maintained by the Agency for Healthcare Research and Quality (AHRQ).


The goal of the study was to "examine adherence to the IOM standards" by guidelines published after the standards were published.  Actually, the study only assessed adherence to 18 of the 25 standards espoused by the IOM (because the remaining seven were "too vague and subjective to be analyzed.")

Furthermore, the criteria used to determine if a specific guideline met each of the three items above were rather lax:

In evaluating each guideline summary, care was taken to be as liberal as possible in considering that a standard was met when the individual guideline summary provided any information pertaining to that particular standard.

Nevertheless, using these lax standards to only evaluate adherence to 18/25 guidelines, the authors found that "the overall median number of IOM standards satisfied (out of 18) was 8 (44.4%) ....  Fewer than half of the guidelines surveyed met more than 50% of the IOM standards."

An examination of the details of the study's methods reveals things are even worse than that.

Analyzing the Study's Methods to Find that Things Are Worse Than They Seem

Review of the study's methods show that they provided a very optimistic view of adherence to the IOM standards.  As noted above, the study did not look for adherence to all of the IOM standards.  Moreover, those they did consider were simplified and made less rigorous.  For example, Standard 2 from the IOM on management of conflict of interest (COI) was:

  STANDARD 2
Management of conflict of interest (COI)

2.1
Prior to selection of the Guideline Development Group (GDG), individuals being considered for membership should declare all interests and activities potentially resulting in COI with development group activity, by written disclosure to those convening the GDG.
- Disclosure should reflect all current and planned commercial (including services from which a clinician derives a substantial proportion of income), non-commercial, intellectual, institutional, and patient/public activities pertinent to the potential scope of the CPG.

2.2
Disclosure of COIs within GDG
- All COI of each GDG member should be reported and discussed by the prospective development group prior to the onset of their work.
- Each panel member should explain how their • COI could influence the CPG development process or specific recommendations.

2.3
Divestment
- Members of the GDG should divest themselves of financial investments they or their family members have in, and not participate in marketing activities or advisory boards of, entities whose interests could be affected by CPG recommendations.

2.4
Exclusions
- Whenever possible GDG members should not have COI.
- In some circumstances, a GDG may not be able to perform its work without members who have COIs, such as relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the CPG.
- Members with COIs should represent not more than a minority of the GDG.
- The chair or co-chairs should not be a person(s) with COI.
- Funders should have no role in CPG development.

However, the study boiled all this down to three items:
-  COIs stated
-  Chair has COI
-  Co-chairperson has COI

Thus the study did not address standards requiring full and complete disclosure (not just some disclosure) of all COIs; consideration of how the COIs might influence the particular guideline; divestment of specific types of conflicts of interest, that is, financial investments, and cessation of participation in marketing activities or advisor boards; minimization of conflicts of all members of the committee; and barring of participation of funders in guideline development.

Even so, the guidelines assessed did a very poor job upholding even these few liberalized standards regarding conflicts of interest.  Of the guidelines assessed, less than half, 46.8% provided ANY disclosure of conflicts of interest.  Those written by sub-specialty societies were particularly opaque in this regard.  Less than one-third, 29.3%, provided any disclosure.  Thus the majority of guidelines assessed were not at all transparent about conflicts of interest affecting the guideline development process.

Furthermore, of the 46.8% of all the guidelines which made any disclosures of conflicts of interest, 71.4% admitted their chair people HAD a conflict of interest.  Thus, only (0.468 * [1 - .714]) = 13.3% provided assurance that they fulfilled the single requirement (from standard 2.4 above) that the chair person did not have a COI.  For the guidelines written by sub-specialty societies, by a similar calculation, only 12.2% provided an assurance that the chair had no COI.  (The proportions providing assurance that the co-chair people had no COI were even lower.)  Thus the vast majority of guidelines did not clearly follow two straight-forward standards for minimizing the effects of conflict of interest, that the guideline committee chair and co-chair should not have any relevant conflicts. 

Given the miserable results concerning even minimal adherence to some of the IOM report's conflict of interest standards, it is likely that almost no published guidelines from 2011 came close to fulfilling the full set of IOM standards.  Despite the best efforts of the IOM, it appears that guideline developers have not progressed at all towards providing trustworthy guidelines. 

Summary

An editorial (Shaneyfelt T. In guidelines we cannot trust.  Arch Intern Med 2012) accompanying the article by Kung and colleagues summarized its results thus:

The same problems that have plagued guideline development continue to plague guideline development; namely, their variable and opaque development methods, their often conflicted and limited panel composition, and their lack of significant external review by stakeholders throughout the development process.   As a result, the trustworthiness of guidelines is limited.

While guidelines may have seemed to be a promising method to improve health care in the early 1990s, they have failed to live up to that promise.  Shaneyfelt was not optimistic they would improve in the future:

I am not optimistic that much will improve.  No one seems interested in curtailing the out-of-control guideline industry.

On the other hand, in my humble opinion, it is not that on one is interested in better guidelines.  It would clearly be in the best interests of patients and the public, and of health care professionals who care about the quality of their practice and the outcomes of their patients to curtail that industry.  The issue is why patients', the public's, and professional's interests were ignored.

Neither Shaneyfelt nor Kung et al discussed why there has been so little attention to patients' and the public's health, and to health care professionalism in all this.  For a quick answer, we do not have to look far on Health Care Renewal. 


In fact, the IOM report on guideline development from 2011 was a serious challenge to the powers that be in health care.  In particular, it challenged the cozy relationships that had grown up among the organizations that undertook guideline development and the health care professionals on guideline panels on one hand and organizations that stand to gain were specific guidelines to favor their products, services, and agendas on the other.  The standards mandated transparency and honesty about conflicts of interest affecting guideline committees and the organizations which assembled them, and if upheld would have greatly reduced these relationships.

Now it turns out that the guideline standards have been honored mainly in the breach.  Of course, these standards, while increasing trustworthiness, would have cost a lot of medical societies considerable commercial funding, and would have cost a lot of health care professionals on guideline panels considerable personal wealth.  These standards would probably also have cost a lot of companies whose products and services were addressed by guidelines to lose revenue.  So it is not surprising that the IOM standards were ignored.  Their implementation would have cost too many people who are financially benefiting from the status quo too much money.  And these people, that is, leaders of professional societies dependent on commercial outside funding, health care professionals and academic used to financial support from commercial interests, and health care corporations are good at making sure their interests are not ignored, even if their interests conflict with those of patients, the public, and well-intentioned health care professionals.  

So, the flouting of the well reasoned IOM guideline standards adds one more reason for patients and the general public to distrust modern health care and all those who "deliver" it, even to distrust well-intentioned health care professionals who have not been able to distinguish themselves from their colleagues who are too happy to help commercial interests while taking commercial money.  If health care professionals want to regain the public's trust, they could do worse than publicly declaring their intention to show that their practice in the future will be guided by trustworthy guidelines based on clinical research evidence and knowledge of biomedical science, drawn up by health care professionals independent of commercial interests.

The Institute of Medicine Releases Reports on Practice Guidelines and Systematic Reviews Which Generate Few Echoes

Two days ago, the prestigious US Institute of Medicine released two reports on important health care issues, clinical practice guidelines and systematic reviews.  Systematic reviews of the relevant clinical research have been advocated by evidence-based medicine proponents as the appropriate basis for clinical and policy decisions.  Clinical practice guidelines have been advocated by many health researchers, policy makers, and clinicians as the best way to encapsulate the evidence to inform clinical and policy decision making.  Both reports suggested series of standards for how systematic reviews and clinical practice guidelines should be developed. 

These topics are of general importance to clinicians, health services researchers, and health policy makers.  The Institute of Medicine, part of the US National Academy of Sciences, is one of the most authoritative sources of opinion on medicine and health care.  Therefore, one would think that these reports would have gotten wide notice, and would hardly required Health Care Renewal to create some echoes.

However, a Google News search today produced only six "hits" relevant to these reports, including the original press release.  All are in specialized medical/ health care news outlets.  None are in the national media, and none are from major medical/ professional journals or societies. 

Let me suggest a theory about why these two major reports have generated so few echoes so far.  Let me quote from the summary of the report on clinical practice guidelines:

Most guidelines used today suffer from shortcomings in development. Dubious trust in guidelines is the result of many factors, including failure to represent a variety of disciplines in guideline development groups, lack of transparency in how recommendations are derived and rated, and omission of a thorough external review process. To be trustworthy, clinical practice guidelines should:
• Be based on a systematic review of the existing evidence;
• Be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups;
• Consider important patient subgroups and patient preferences, as appropriate;
• Be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest;
• Provide a clear explanation of the logical relationships between alternative care options and health outcomes, and provide ratings of both the quality of evidence and the strength of recommendations; and
• Be reconsidered and revised as appropriate when important new evidence warrants modifications of recommendations.
Additionally, as reflected in the committee’s standards for developing trustworthy clinical practice guidelines, guideline development groups optimally comprise members without conflict of interest. The committee recognizes that in some circumstances, a guideline development group may not be able to perform its work without members who have conflicts of interest—for example, relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the guideline. Therefore, the committee specifies that members of the guideline development group who have a conflict of interest should not represent more than a minority of the group.

So it seems that the report on clinical practice guidelines emphasized two issues highly relevant to Health Care Renewal, the need for transparency in guideline development, and the need to avoid conflicts of interest affecting the development process. The two first standards for guidelines are about transparency and minimization of conflicts of interest.  Similarly, the report on systematic reviews also included fairly tough standards to minimize conflicts of interest.

We on Health Care Renewal go on and on about the need to maximize transparency in health care, and particularly in health care leadership and governance, and about the need to disassemble the now pervasive web of conflicts of interest that has entangled health care.  However, as we know, these are not popular topics among the leadership of health care, which includes many individuals who have greatly benefited from lack of transparency and pervasive conflicts of interest.  We know these topics make these leaders, and many of those who report to, or work or associate with them very uncomfortable.

So unfortunately, I am not surprised that the two new and likely authoritative reports from the Institute of Medicine, despite that organization's prestige, have started off relatively anechoic.  It also unfortunately likely that they will remain relatively anechoic. 

In 2009, the IOM issued an authoritative report on conflicts of interest in medicine and health care which suggested fairly tough standards to decrease such conflicts and their influence (also see post here).  Since 2009, I just found 53 citations to that report in the medical literature using the ISI Web of Science, for a rate of 27/year.  In 1999, the IOM issued a report on medical errors, "To Err is Human."  Since then, it has received 1374 citations, a rate of 115/year. 

As we noted above, the topic of conflicts of interest seems to make the powers that be in health care very uncomfortable.  In contrast, "To Err is Human" was widely interpreted to mean that physicians make a lot of dangerous errors, and the best way to decrease them is to impose more controls by bureaucrats, managers, and executives (even if that was not its intent).  Thus, that report could be twisted to fit the talking points of the powers that be, and hence has been anything but anechoic.

So while Health Care Renewal is hardly a powerful tool for creating publicity, I thought we should try to get the word out about the new IOM reports on clinical practice guidelines and systematic reviews.  Every little bit helps.

Meanwhile, the deathly quiet reception these reports have gotten so far emphasizes the need to combat the anechoic effect.  As long as the powers that be can command billions of dollars to influence the health care conversation through their marketing, public relations, and lobbying departments, expect the discussion not to question what they do, and how they benefit from the status quo to the financial and health detriment of patients and the population.

We will not be able to truly reform health care until we can speak openly about what threatens health care values and what needs to be done about these threats.

New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which "exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a 'quality chasm'.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its "100,000 Lives Campaign" and, more recently, its "5 Million Lives Campaign."

Berwick's CMS gig is a "recess appointment": it was made during the Senate's July 4th recess period, without a formal confirmation hearing---although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama made the recess appointment in order to avoid a reprise of "last year's divisive health care debate." The president had originally nominated Berwick for the position in April, and Republicans have opposed "Berwick's views on rationing of care," claiming that he "would deny needed care based on cost."

A "Patient-Centered Extremist"

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described "Patient-Centered Extremist." He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the "professionally dominant view of quality of health care":

I think it wrong for the profession of medicine—or any other health care profession, for that matter—to “reserve to itself the authority to judge the quality of its work.” I eschew compromise words like “partnership.” For better or worse, I have come to believe that we—patients, families, clinicians, and the health care system as a whole—would all be far better off if we professionals recalibrated our work such that we behaved with patients and families not as hosts in the care system, but as guests in their lives. I suggest that we should without equivocation make patient-centeredness a primary quality dimension all its own, even when it does not contribute to the technical safety and effectiveness of care.

A new definition. My proposed definition of “patient-centered care” is this: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.

Does this mean that Dr. Berwick would also eschew professional, i.e., expert, judgment in favor of patients' wishes? In a word, yes:

Evidence-based medicine sometimes must take a back seat. First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.”

Dr. Berwick is not so naive as this opinion might suggest. He envisions a "mature dialogue" in such a case, and argues that "if, over time, a pattern emerges of scientifically unwise or unsubstantiated choices...then we should seek to improve our messages..." He also admits that there might be an occasional patient whose demands are so unreasonable that "it is time to say, 'No'." That exception, he argues, should not dictate the rule.

There are situations in which most civilized people would agree with Dr. Berwick's view of 'patient-centeredness'. In both the Health Affairs article and in his recent address to the 2010 graduating class of the Yale School of Medicine, he offered real examples of petty, arbitrary hospital rules causing unnecessary sorrow for patients and their loved ones. It is in such contexts that he makes a convincing case that health professionals ought to behave "as guests in their lives." In an interview for the New York Times, he argued:

We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated.

Nothing to disagree with there. To create that standard, moreover, would not undermine settled medical practice ethics---it would celebrate them, even as it rightly embarrasses the profession for having taken so long to do so.


Enter the Woo

Eschewing the scientific basis for modern medical practice, however, is another matter. In February of 2009, Dr. Berwick gave a 'keynote' address at the IOM and Bravewell Collaborative-sponsored Summit on Integrative Medicine and the Health of the Public. He shared the podium with Mehmet Oz, Dean Ornish, Senator Tom Harkin, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term "integrative medicine": literature emanating from the Summit characterized it as "preventive" and "patient-centered," whereas the only characteristic that distinguishes it from modern medicine is an inclusion of various forms of pseudomedicine.


I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions. I didn't bother to listen to his speech until the CMS appointment was announced a few days ago.

It is troubling, to say the least. Dr. Berwick did not argue, as he had in the NYT piece, that "If we doctors feel a person is going to make unwise choices, we have to take on the responsibility of being teachers, educators and informers." Rather, he praised his fellow speakers, most of whom were spouting nonsense, for their "reach" and "eloquence." He praised the IOM for its "glorious record...in pursuit of better designs in health care...traditional, allopathic curative care and now migrating into this distinguished and important new arena." He mentioned homeopathy and acupuncture, not to wonder why they should be promoted as effective, but merely to warn that they will fail---presumably in some economic sense---if they try to compete with each other for reimbursement.

Such language, and Dr. Berwick's very presence at the Summit, were a far cry from advocating "patient-centeredness." What they amounted to was a generous endorsement of pseudoscientific practices and of the socio-political movement that promotes them. Even granting some naivete on his part (he called himself "an amateur at this topic"), he must have known this. Such an endorsement, unlike tearing down the "technocratic castle," has ethical implications at least as profound as those that Dr. Berwick tacitly or explicitly relies upon to support his arguments for patient-centeredness.

"Physicians have no Immunity to Moral or Ethical Constraints"

The relevant medical ethics treatises (reviewed here) are in substantial agreement that it is unethical for physicians to prescribe scientifically implausible methods or to refer patients to other practitioners for the same purpose. They are also in agreement that it is unethical to prescribe a placebo to a patient while claiming that the treatment has specific biologic activity---a point that has been vigorously argued in the UK this year, with regard to homeopathy. These ethical tenets are not mere odes to nerdy, sciency thinking; they are matters of honesty and integrity---fundamental bases for ethical interactions between physicians and patients.

In 1983, philosophers Clark Glymour and Douglas Stalker published an article in the New England Journal of Medicine titled “Engineers, cranks, physicians, magicians.” They framed modern medicine as follows, comparing it to what was then called "holistic medicine" (the article is quoted extensively here):

Medicine in industrialized nations is scientific medicine. The claim tacitly made by American or European physicians, and tacitly relied on by their patients, is that their palliatives and procedures have been shown by science to be effective. Although the physician’s medical practice is not itself science, it is based on science and on training that is supposed to teach physicians to apply scientific knowledge to people in a rational way.

The practice of medicine in the United States and in other industrialized nations is a form of consultant engineering...

That statement is just as accurate now---even more so, in this era of Evidence-Based Medicine---as it was nearly 30 years ago, even if some might find the likening of medicine to engineering displeasing. Nor is it at odds with almost any definition of "patient-centeredness," other than one that presumes that the patient's desires trump the physician's ethics:

A physician engineer can act as consoler; nothing in either logic or social psychology forbids it. But certain combinations are impossible or extraordinarily unlikely. A physician engineer cannot honestly claim powers of magic or occult knowledge. The principles governing scientific reasoning and belief are negative as well as positive, and they imply that occult doctrines are not worthy of belief. Moreover, physician engineers have no immunity to moral or ethical constraints. On the contrary, they are by training and by culture enmeshed in a tradition of rational thought about
the obligations and responsibilities of their profession.

Dr. Berwick---if he really believes what his presence and words at the "Integrative Medicine" Summit imply---is playing with ethical fire. (If, as I hope, he doesn't really believe those things, he's playing with ethics of another kind). Will we begin to see pseudomedicine "integrated" into Medicare and Medicaid? That is certainly the expectation of those who observed Dr. Berwick's performance at the Summit, and who appear intent to hold him to his word.

KA

Two other blogs that have addressed this issue are:

Dr. RW: Not only evidence based medicine but science based medicine may take a back seat in Donald Berwick's vision for patient centered care

Dr. David Gorski: Dr. Donald Berwick and “patient-centered” medicine: Letting the woo into the new health care law?

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

Today we saw a new marker laid down in the arena called Conflict of Interest (COI). The Institute of Medicine of the National Academy of Sciences issued a report of its Committee on Conflict of Interest in Medical Research, Education and Practice. The report is comprehensive, even exhaustive, running to 353 pages. Gardner Harris in the New York Times today calls it “scolding,” “stinging,” and “damning.” The recommendations go well beyond any proposed in the recent past by medical schools or by other professional organizations. The NYT quoted David Rothman, president of the Institute on Medicine as a Profession at Columbia University: “With the I.O.M.’s endorsement, issues that were once controversial now are indisputable. Conflicts of interest in medicine are no longer acceptable.”

It will take some time for the field to digest the scope of the IOM recommendations. It will take even longer for the new standards to be implemented. For now, I offer just a few observations.

First, if the IOM hopes for maximum credibility then it might ought want to do some housecleaning. A few years ago I fired a shot across the bow of the IOM concerning COI. [Can the Institute of Medicine Review the FDA? Nature Medicine 11, 369 (1 April 2005) doi:10.1038/nm0405-369] Nothing much changed, and in the following years, national scandals erupted involving several of the issues I had highlighted. Prominent IOM members, who were well known to be poster boys for COI, were exposed by Senator Charles Grassley (R-Iowa). Their embarrassing behaviors included incomplete financial disclosures and noncompliance with NIH policy on financial conflict of interest. The exposés included Emory’s Charles Nemeroff and Stanford’s Alan Schatzberg. In both cases, administrative rearrangements have now been implemented. The case of Dr. Nemeroff has been referred by Senator Grassley to the Inspector General of the Department of Health and Human Services. It is perhaps no accident that Dean Claudia Adkison of Emory and Dean Philip Pizzo of Stanford were included as external reviewers of the draft IOM report. Their insights would have been invaluable.

Another ongoing embarrassment for the IOM is Lester Crawford. He was the FDA Commissioner who resigned abruptly in 2005 and later pleaded guilty to criminal conflict of interest. He had been charged with falsely reporting information about his stock holdings in companies he was in charge of regulating. He received a sentence of three years of supervised probation and a fine of about $90,000. He is now senior counsel with a health care lobbying firm in Washington, DC. The Institute of Medicine does not help its image by continuing the membership of such a compromised individual.

As the Emory-Nemeroff and Stanford-Schatzberg cases unfolded it appeared that the respective institutions had themselves contributed to the problems, either through inaction or through studiously nontransparent procedures on disclosure. Stanford, for instance, apparently did not require faculty members to report the proceeds of stock sales, and when challenged the university invoked on-line financial reporting services and SEC filings as a sufficient substitute. Not surprisingly, because Stanford didn’t know about Dr. Schatzberg’s realized gain of some $109,000 from sale of founder’s stock in his biotech start-up company, Corcept Therapeutics, this information was not reported to NIH.

Recommendation 4.1 One of the IOM’s recommendations applies particularly to the Stanford-Schatzberg case. Recommendation 4.1 addresses the boundary between academia and commerce in the case of research involving human subjects. Here is the specific language:

“Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14).

Last year I posted several times about this issue in the Stanford-Schatzberg case. It is gratifying now to see the IOM affirm the importance of the boundary. The activities declared off-limits by the IOM include not only “recruiting subjects; obtaining informed consent; assessing the clinical end points;” but also “analyzing data; or writing the results, conclusions, and abstracts for publications reporting the findings of the study.” (page 4-17). In Stanford’s earlier plan for managing the conflict and protecting the integrity of the research, Dr. Schatzberg was free to engage in the latter group of activities. Indeed, his hands were all over the project when it came to responding to scientific critiques, managing the climate of professional opinion, attacking and threatening critics, promoting his company’s interest through review articles and press releases, slipping unpublished and non-peer-reviewed commercial data into academic reviews, and generally conducting commercially slanted public relations through academic outlets.

When Stanford adopts the IOM recommendations, such activities will be blocked. As I stated last year, “Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be.”

We should congratulate the IOM committee members for their work, and we hope to see the field embrace their recommendations.

Bernard Carroll.

UPDATE 04-30-2009: The link provided earlier for the IOM report document is no longer operative. Here is where to go now for a copy of the report. This time it will cost you.

http://www.nap.edu/catalog.php?record_id=12598

Dr. Stossel Sounds Off

DR. STOSSEL SOUNDS OFF

Thomas Stossel, MD, Professor of Medicine at Harvard Medical School, has released another opinionated piece this week on academics’ conflicts of interest. It appears in this week’s British Medical Journal. Like his previous rants, this one combines tangentiality, circumstantial thinking, illogical thinking, false assumptions, smears, insults, and the demonizing of those with contrary opinions. Roy Poses did an excellent job of exposing Stossel’s rhetorical smoke and mirrors, so I will not belabor this point.

The central pathology in Dr. Stossel’s rant is his denial or minimization of current ethical problems in academic-corporate relationships in medicine. If he wishes to be taken seriously, he should familiarize himself with case studies of the corporate corruption of medicine. Contrary to Stossel’s assertion that these problems don’t exist, here is a link that describes the corruption of a major journal by key opinion leaders in cahoots with Pharma executives: http://hcrenewal.blogspot.com/2008/01/antipsychotic-drugs-for-depression.html . Every sleazy deceit in the book was in play here.

There are similar problems in continuing medical education events that are funded by drug and device corporations. See here: http://hcrenewal.blogspot.com/2008/01/variations-on-theme-of-sleaze.html

The main player in these unsavory instances is a member of the Institute of Medicine of the U.S. National Academy of Sciences. This individual is an ethical recidivist who has been outed multiple times for failure to disclose salient conflicts of interest; who was forced to resign the editorship of a major medical journal; and who was forced to retract false statements that favored his corporate clients (otherwise known as shilling). Dr. Stossel notwithstanding, the rest of us are appalled by such tastelessly venal spectacles at the highest level of American medicine. Is it any wonder that the likes of Dr. Stossel are viewed as challenged?