Showing posts with label transparency. Show all posts
Showing posts with label transparency. Show all posts

Thursday, April 24, 2014

American Board of Internal Medicine Quietly Discloses Some Conflicts of Interest

We recently discussed the American Board of Internal Medicine's exceedingly weak conflict of interest policy.  This came to light after the board's previous president was revealed to have simultaneously served for years on the board of directors of a privately held for-profit hospital purchasing organization.

The susceptibility of ABIM leadership to conflicts of interest is particularly important because the board, in its role as the de facto sole source of credentialing for all US internists and internal medicine sub-specialists, sets what these physicians need to know to pass the certifying examinations. Conflicts of interest raise doubts about whether the examinations may be used to further commercial agendas and similar vested interests.

Furthermore, the ABIM has been willfully expanding its scope into "maintenance of certification," that is, into requiring physicians to engage in ABIM educational and evaluation activities to maintain their previously obtained certification.  They have been criticized in particular (e.g., here and here) for pursuing maintenance of certification in the absence of clear evidence that it improves physician performance or patients' outcomes.  Conflicts of interest affecting MOC raise further doubts that this "innovation" may also be about furthering commercial interests.

ABIM Begins Conflict of Interest Disclosure

Now it appears that the ABIM is beginning to disclose more about its leadership's conflicts of interest.  One of our scouts notified me that the ABIM web-site now provides disclosures for the members of its board of directors and officer, council, and executives.

There seem to be limits to these disclosures.  As far as I can tell,They do not reflect a change in the preexisting ABIM conflict of interest policy, which still calls for conflicts to be disclosed, but only to ABIM leadership, while they are otherwise kept confidential.  Nor were these disclosures accompanied by any further explanation that I can find.  The disclosures include multiple categories, consulting relationships, peer educational activities, promotional activities, grants, intellectual property, stock/option, gift/ donations, expert witness, leadership in professional organizations, and other, which are not otherwise defined.  It was not clear, however, whether the disclosures covered services on corporate advisory boards or boards of directors, or service as executives or founders of companies.  The time course of the disclosed relationships were not clear.  Finally, ttere are no disclosures about members of exam writing committees of sub-specialty board members

Nonetheless, the disclosures do give an idea of the scope of conflicts of interest affecting ABIM leadership.  Because the disclosures have not otherwise been publicized, I thought it would be worthwhile to summarize them here.

Prevalence of Conflicts

Of the 12 officers and directors, 8 disclosed relationships with for-profit health care corporations

Of the 15 council members (one of whom is also a director), 9 revealed conflicts.

Of the 12 executives, 5 revealed conflicts.

Thus, a majority of ABIM physician leadership, and nearly a majority of  ABIM executives disclosed conflicts of interest.

Nature of Conflicts

The conflicts were predominantly consulting relationships, grants, holdings of patents, or of stocks or options.  The conflicts of the officers, directors and council members primarily involved pharmaceutical, biotechnology and device companies.  Several officers, directors and council members had two kinds of relationships with the same company, for example, consulting relationships and grant funding.




It was striking that 15 companies had multiple relationships with officers, directors and council members.  All were large pharmaceutical, biotechnology, and device companies.  They were

AbbVie (1 consulting relationship 2 grants)
Amgen (1 consulting, 1 grant, 2 stock holdings)
AstraZeneca (3 consulting, 1 grant)
Bristol-Myers-Squibb (2 consutling, 2 grants, 1 stocks)
Celgene (2 consulting, 1 grant)
Gilead (1 consulting, 2 grants, 1 stocks)
Johnson and Johnson (1 consulting, 2 grants [one through Janssen], 2 stocks)
Eli Lilly (1 consulting, 1 grant)
Medtronic (2 consulting, 1 grant)
Merck (2 consulting, 2 stocks)
Novartis (2 grants, 1 stocks)
Pfizer (1 consulting, 1 grant, 2 stocks)
Roche (1 consulting, 2 stocks)
Teva (1 consulting, 1 stocks)
Millennium (1 consulting, 1 grant)

The officers, directors, and council members additionally had relationships with a vast number of companies, including in attempted alphabetical order: Abbott Laboratories, Agios, Allos, AllScripts, Arrowhead, Biocontrol Medical, Cephalon, Cephied, CorAssist, Cornovus, CVRx, Covidien, Dr Redy's Labs, Emergent Biosolutions, Express Scripts, Genentech, Gen-Probe, Hologic, Human Genome Sciences, Incyte,  ION(?), miRNA Therapeutics, Peluton Therapeutics, Pharmacyclics, Regeneron, Repros Therapeutics, Research to Practice (owned by AmerisourceBergen) Prime Healthcare, Rigel, Seattle Genetics, Sunesis, TG Therapeutics, UnitedHealthcare, Value Capture, Viamet, Ventrigen, Vertex, XCenda,  and ZS Pharma.

Thus, the conflicts of interest were extensive, and involved major health care corporations.

Summary

The American Board of Internal Medicine is to be congratulated for taking steps towards more transparency and honesty about conflicts of interest affecting its leadership.  However, the steps were baby steps.  Lacking still are definitions and time courses of the relationships disclosed, assurances of the completeness of disclosure of all relevant relationships, assurances that disclosure is now the policy going forward, and disclosures for members of committees and sub-specialty boards who are also very influential in constructing examinations and maintenance of certification activities.  These ought to be addressed.

The disclosures reveal that the conflicts of ABIM leadership were extensive.  While disclosure is good, disclosure does not assure physicians and the public that certification and now maintenance of certification are not influenced by marketing needs and other commercial interests.  In my humble opinion, the ABIM now ought to phase out, as quickly as possible conflicts of interest affecting those who make its policy, write its exams, and conduct its other activities that can influence physician behavior, decisions made for patients, and health policy.  Also, in my humble opinion, the ABIM ought to suspend its efforts to promote maintenance of certification until it has greatly reduced the conflicts of interest that may affect this effort.

Thursday, March 6, 2014

American Board of Internal Medicine Policy Condones Keeping Conflicts of Interest Secret

The latest complication of the CareFusion/ Dr Denham/ NQF/ Dr Cassel/ ABIM case was the revelation that the current president of the NQF, Dr Christine Cassel, after resigning her position on the board of directors of for-profit publicly held group purchasing organization Premier Inc, was found to have been on the board of for-profit privately held predecessor of Premier Inc since 2008 (see post here).  Before Dr Cassel was CEO of NQF, she had been the president and CEO of the American Board of Internal Medicine for 10 years.  So apparently she was on the board of the predecessor of Premier Inc for about five years while she was leading the ABIM.

This relationship appears to be as serious a conflict of interest for Dr Cassel in her previous role as leader of the ABIM as it was for her current role as leader of the NQF.  Since she had this conflict for so long as leader of the ABIM without public disclosure, it seems logical to ask whether she was a long-term violator of ABIM policy, and hence sort of a long-term rogue CEO?

To answer that, one needs to review the ABIM conflict of interest policy.

What Sort of Conflicts of Interest Does the ABIM Ban?

The official wording is:

It is the policy of the Board that Directors, Subspecialty Board and Committee members, consultants and other individuals involved in developing ABIM products will not be employed (as staff or as a consultant) at greater than fifty percent by a commercial entity, except in such instances where explicit exceptions to the policy have been made by the Board. Unless a compelling reason is presented for granting an exception, such individuals will be asked to resign their position of service to the Board.

Let us parse that a bit.  The policy applies to the leadership of the ABIM, Directors, Subspecialty Board and Committee members, consultants, and individuals involved in developing products, so it applies broadly.

However, conflicts are only banned when they exceed a 50% time commitment.  But the time commitments required by many sorts of relationships among physicians and health care corporations are ill-defined.  For example, in the initial public offering prospectus for Premier Inc, the public document that announced her membership on the new public company's board, there is no information about the time commitment required by this position.

Also, physicians can earn large amounts of money for relatively small investments of time.  For example, not only can members of boards of directors make hundreds of thousands of dollars for ill defined time commitments unlikely to approach 10% full time equivalent, but also, key opinion leaders acting as primarily marketing consultants can also earn hundreds of thousands of dollars for undocumented time commitments, and physicians can earn hundreds of thousands or millions of dollars from royalty payments from patent holdings that require no current work (look here for example).  So a physician could easily earn hundreds of thousands or millions of dollars from health care corporations without approaching a nominal 50% time commitment.  I suspect that this ban would apply to almost no one other than a full-time corporate employee.


Furthermore, the policy is not absolute.  Exceptions can be made for "compelling reasons," which are not further defined. 

This is thus a very weak element of the policy 

How are Conflicts of Interest that are Not Banned Managed?

The policy states,

Given that prohibition of all financial interest in commercial entities would excessively restrict the pool of eligible candidates for Board membership, the Board's policy to regulate conflicts of interest consists of disclosure, self-monitored (and Chair-overseen) abstention from participation in decision-making that relates to the conflict, and adjudication of potential conflicts of interest situations by the Conflict of Interest Committee of the Board of Directors.

Individuals (non-staff) involved in developing ABIM policy and products — ABIM Directors, Subspecialty Board Directors and Committee members, consultants, the President and relevant staff members will be requested at the time of their appointment and annually thereafter to execute a disclosure.

I would note that the rationale is highly questionable.  One often hears from apologists for conflicts of interest that all competent doctors are conflicted because health care corporations identify all the most expert doctors and hire them as speakers, consultants, etc (look here for example).  We have shown examples on this blog of some less than stellar individuals with extensive financial involvements with health care corporations.  For example, we have posted (here, here, and here) about physicians dubbed key opinion leaders by pharmaceutical companies who lacked board certification, had been subject to sanctions by state medical boards, had received warnings from the FDA, had lost hospital privileges, and had been convicted of crimes. On the other hand, there probably are quite a few smart, dedicated, expert physicians who eschew major financial involvement with health care corporations.

The policy goes on to state that for some individuals, the management would be recusal from participation in relevant decisions,

 Test Committees and other policy committees will be expected to discuss the conflict of interest policy, and to share relevant disclosures, with the expectation that committee members will disclose any significant actual or perceived conflicts and abstain from discussion where such conflicts exist. In the event that a potential conflict of interest situation arises about which explicit policy does not exist, the Conflict of Interest Committee of the Board will hear and judge the appeal.

Note that recusal may be inadequate management.  Committees tend to learn to get along with each other.  The views of committee members who have to recuse themselves may be well known, and may be supported by their fellow members even when their recused colleagues are not in the room.

Worse, the policy says nothing about whether higher level ABIM leaders even need to recuse themselves.  The recusal policy apparently only applies to committee members.  There seems to be no policy about management of conflict affecting

So the management of conflicts of interest proposed by the ABIM document seems to be rather minimalist.


Who Makes Decisions about ABIM Conflicts of Interest?

The policy states that disclosures will be made to,
  • President and Chair of the Board;
  • The chairs of the relevant Subspecialty Boards, Test-Writing Committees, and other Committees of the Board, members who serve on the relevant Boards and Committees, and staff working with the respective committees;
  • The Conflict of Interest Committee members and Conflict of Interest Committee staff,
As noted above,

adjudication of potential conflicts of interest situations[would be] by the Conflict of Interest Committee of the Board of Directors.

However, again it is not clear whether they can adjudicate conflicts affecting anyone other than test and policy committee members.  Furthermore, whether anyone oversees conflicts affecting members of the Board of Directors is not clear.

Thus it is not clear who, if anyone, manages conflicts of interest affecting the top ABIM leaders, particularly the CEO and members of the board of trustees.  This aspect of the policy seems ambiguous.

How are Conflicts of Interest Publicly Disclosed?

The short answer is they are not.  The relevant wording is:

Information that is disclosed will be kept confidential except to the
  • President and Chair of the Board;
  • The chairs of the relevant Subspecialty Boards, Test-Writing Committees, and other Committees of the Board, members who serve on the relevant Boards and Committees, and staff working with the respective committees;
  • The Conflict of Interest Committee members and Conflict of Interest Committee staff,
except as required for the purposes of continuing medical education.

Let me reiterate, conflicts of interest are NOT PUBLICLY DISCLOSED.  They are kept confidential, secret, hidden, opaque.  Only the insiders listed above may know about them.

We have been discussing the prevalence and severity of conflicts of interest affecting health care professionals and policy-makers, and institutional conflicts of interest affecting health care organizations for years.  Based on the principle that sunlight is the best disinfectant, many now agree that disclosure of these conflicts of interest is a necessity, although there is considerable discussion about whether the current movement to make conflicts of interest public will reduce their effects.  However, in my humble opinion, concealing conflicts of interest is inherently dishonest.   Yet that is the policy of the American Board of Internal Medicine.

Summary

So, while it appears that the former president and CEO of the ABIM had a severe conflict of interest generated by her membership on the board of directors of a privately held for-profit group purchasing organization, her failure to disclose it publicly did not violate ABIM policy.

The reason is that the ABIM policy on conflicts of interest appears to be extremely weak and ambiguous.  Worse, it condones keeping conflicts of interest secret, which to me appears inherently dishonest and unethical.

This is very disturbing given that the ABIM has great influence on medical practice and health policy, previously was regarded as prestigious and trustworthy, and has been expanding the scope of its activities to make it even more influential, e.g., by now requiring physicians to participate in periodic ABIM sanctioned or sponsored activities and take repeated ABIM exams to "maintain" their board certification.

In my humble opinion, if the ABIM wants to continue to be trusted as it has been in the past, it needs a wholesale revision of its conflict of interest policies, and meanwhile needs to completely make public in detail the conflicts of interest affecting individuals who lead it, make its policy, write its examinations, construct its educational and maintenance of certification activities, and produce its other "products."  The ABIM ought to consider suspending attempst to expand its influence, e.g., by intensifying its requirements for maintenance of certification, until it has disclosed all relevant conflicts and improved its conflict of interest policies.

As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. 

Thursday, January 23, 2014

Putting in the Ski Lifts - National Quality Forum Leaders Improve Conflict of Interest Policies in Response to CareFusion Case

The complex case that came to light with reports of a legal settlement by CareFusion of allegations that it paid kickbacks to promote its ChloraPrep product just got even more complex, but now also a bit more hopeful, and hence much more hopeful than most of the cases we discuss..

Background


As we noted yesterday, the CareFusion settlement seemed routine when it was first briefly reported in the media.  Then Modern Healthcare published a series of articles about its ramifications, the latest appearing today.

In summary prior to the latest article,
-  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative skin cleaning
-  the Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision

We noted that the NQF policy on conflicts of interest for its standard writing committees seemed somewhat weak.  The current (October, 2013) policy asks members to internally disclose conflicts and recuse themselves from " discussion of the applicable measure or measures, and in some instances competing and related measures."  However it does not ban members with conflicts, nor require public disclosure of conflicts.  We also noted that NQF has several board members who have full-time leadership positions with health care corporations, financial firms that invest in health care, or health care trade associations, and NQF received funding from pharmaceutical companies and their in-house foundations.  Thus NQF appears to have its own institutional conflicts of interest. 

So we thought that the case raised questions about how well NQF standards are protected from the influence of conflicts of interest, and whether they should remain so influential in the absence of stronger protections?

NQF Clarifies its Conflicts of Interest Policies

As reported by Modern Healthcare, it took only a day for the NQF to issue yet another press release to clarify its conflict of interest polcies.  In particular,

I n response to concerns that the community raised about the evidence base underlying Safe Practice #22 and Dr. Denham’s inordinate interest in this particular Safe Practice, NQF took the following steps in early 2010:
  • Severed its relationship with Dr. Denham who has not been involved in any other NQF work since March 2010;
  • Made a decision to refuse offers for financial support from Dr. Denham’s foundation, discontinuing a 2008 - 2013 grant agreement that had more than three years remaining ;
  • Determined that it would not enter into grant agreements where the funder is on the endorsement committee, even as a non-voting member;
  • Reviewed committee reports that Dr. Denham was involved in to be certain that he did not influence their outcome; NQF staff believe that he did not; and
  • Updated and enhanced its conflict of interest policy – in 2010 and again in 2013;

So NQF appeared to react ad hoc to concerns that Dr Denham was too avid about the use of a particular product.  Its response included strengthening its COI policy and banning one particular type of conflict, receiving funding from an organization controlled by a member of a standard writing committee.  However, as we noted above, the 2013 policy still has its weaknesses.  

Furthermore, an NQF executive volunteered to inform me that while the current written COI policy does not require public disclosure, in practice the organization requires public verbal disclosure of conflicts at the beginning of each committee meeting, and that the transcripts of these disclosures are available on the organization's website.  However, how to reach these disclosures is not obvious, and I so far have not been able to find the transcript that supposedly contains the disclosures for the meeting which Dr Denham co-chaired


Summary and a Few Optimistic Thoughts (Rare as They are for Us)

What I must say is now most unusual in the CareFusion/ Dr Denham/ NQF case is that NQF leadership, rather than  hunkering down in a defensive posture we have seen many other leaders adapt, seems to be trying to take steps toward addressing problems posed by conflicts of interest affecting its standard setting, guideline development, and quality assurance.  First, it is clear that NQF leaders did react to concerns about Dr Denham, and did somewhat tighten up their conflict of interest policies in response to them.  Second, it is clear that they are willing to listen to public questions and criticism, and at least consider further change in response to them.  They thus appear far more open than do leaders of many other organizations.

IMHO, NQF leadership is to be congratulated for this more transparent approach.  If only the leaders of other health care organizations would do as much. 

Since they do seem open to criticism and change, in the spirit of constructive criticism, I do hope that NQF leaders might also consider:
-  further strengthening their conflict of interest policy for standard setting committees, particularly by minimizing the number of committee members with conflicts, and banning individuals with conflicts from chairing committees, as per the IOM report on standards for trustworthy clinical practice guideline development
-  increasing transparency about conflicts of interest, particularly by making disclosures for all projects available without complex web searching
-  decreasing institutional conflicts of interest by refusing funding from health care corporations whose revenues might be affected by the content of standards and guidelines, and reducing conflicts affecting NQF board members and executives

Health care leaders who see transparency and reduction of conflicts of interest as important goals show us that true health care reform might actually be possible.

ADDENDUM (24 January, 2014 - I was told that many people may need an explanation of the title.  "Putting in the ski lifts" is a shortened version of an old college saying.  The location for the ski lifts was a place that is traditionally very hot, think fire and brimstone.  The phrase refers to an extremely improbably event.  Sorry about any confusion.   

Thursday, March 21, 2013

NYU Faculty Vote No Confidence in their President

Faculty at large American universities, in which most of the country's medical schools and teaching hospitals are embedded, are becoming increasingly concerned about the leadership and governance of their organizations, and whether the universities are putting their academic (and clinical) missions ahead of other concerns, like making money and rewarding top executives.

In January, 2013, we discussed a an informal, anonymous vote faculty at the University of Miami medical school expressing no confidence in their dean and his chief lieutenant.

The NYU No Confidence Vote

The faculty of a major component of another big US university have just openly voted no confidence in their president, and are raising questions about their board of trustees.  The setting was New York University.  Some background comes from a New York Times article this month:

 Embarking on an ambitious expansion at home, constructing a network of new campuses around the globe, wooing intellectual superstars and raising vast amounts of money, John Sexton of New York University is the very model of a modern university president — the leader of a large corporation, pushing for growth on every front.
 
To some within N.Y.U., Dr. Sexton is a hero who has transformed the university. The trustees have thanked him by elevating his salary to nearly $1.5 million from $773,000 and guaranteeing him retirement benefits of $800,000 a year.

But to others, he is an autocrat who treats all but a few anointed professors as hired help, ignoring their concerns, informing them of policies after the fact and otherwise running roughshod over American academic tradition, in which faculty members are partners in charting a university’s course.

'He has a very evangelical sense of purpose,' said Andrew Ross, a professor of social and cultural analysis, 'that does not extend beyond the concept that the university should be an entity of his own making.' 

'I think,' he added, 'when other administrations see that they say, Well that’s what leadership should be. And when faculty see that they say, That is not what university leadership should be. It’s the style of a maverick C.E.O.'

The debate over Dr. Sexton’s presidency will come to a head this week. The faculty of the university’s largest school, Arts and Science, has scheduled a five-day vote of no confidence. Given Dr. Sexton’s international stature, the vote may serve as the most important referendum yet on the direction of American higher education. 

President Sexton lost the no-confidence vote, as noted in another NY Times article a week later:

The vote, 298 to 224 (with 47 abstaining), took place via electronic balloting from Monday through Friday. Full-time tenured and tenure-track professors were asked to respond to the statement: 'The faculty of Arts and Science has no confidence in John Sexton’s leadership.' Voter participation was 83 percent.

Top Executives Usurp Power from Faculty

An op-ed in the NY Times by a leading dissenting faculty member further explained the issues.  He charged that the President ignored faculty concerns about an ambitious plan to expand the physical plant of the university:

How did Dr. Sexton lose the confidence of so many faculty members? By ignoring us. Of course, many professors everywhere feel overlooked by today’s generation of jet-setting university presidents. But we have very specific complaints: above all, Dr. Sexton has consistently refused to address concerns about plans to expand N.Y.U. offices and dorms into the part of Greenwich Village south of Manhattan’s Washington Square Park, where many of us live. 

This expansion plan is known as N.Y.U. 2031, indicating the year in which all the building will be complete. The very name told us that we’d be living on a construction site for a couple of decades.

Not surprisingly, this did not go over very well with many faculty members. We were also concerned about where the money would come from to pay for this expansion, as no business plan for the project has been made public.
Thirty-nine departments and schools passed resolutions last year against the 2031 plan. These resolutions were typically passed unanimously or nearly unanimously. And yet Dr. Sexton’s response was a deafening silence.
Academic Values, Particularly Academic Freedom and Free Speech Ignored

Furthermore, the faculty were concerned about plans to expand the university overseas to nations not known for their vigorous support of academic freedom and free speech:

 Many of us are also concerned with Dr. Sexton’s plans to expand N.Y.U. overseas, including branch campuses in Abu Dhabi and Shanghai, with inadequate faculty involvement or oversight. It is doubtful that faculty members would have chosen to build campuses in countries where academic freedom, and free speech generally, are so parlous

Executives Enriching Themselves at University Expense


Finally, the faculty were concerned about top university executives immodestly enriching themselves from the coffers of a non-profit university:

As the faculty vote approached, more trouble arose for Dr. Sexton in the form of news reports about lavish compensation for NY administrators.  The central but by no means sole figure in this scandal is Jacob J Lew, the Obama administration’s new Treasury secretary, who worked at N.Y.U. in the early 2000s for a salary that eventually reached $900,000, larger even than Dr. Sexton’s at the time. 

Mr. Lew received loans to buy a nice home, which apparently were largely forgiven. He also received a severance of some $700,000 when he left for a well-paid position at Citigroup. Severance? For someone who leaves voluntarily?

 Dr. Sexton himself is to receive a salary of more than $1.4 million this year, and a 'length of service' bonus of $2.5 million in 2015. (Full disclosure: the university gave me a set of mugs when I completed 25 years of teaching.) And he will receive $800,000 a year after he retires. 

Other top administrators make similarly extravagant salaries. Some experts believe there may even be something illegal in the way Dr. Sexton has rewarded them; N.Y.U.’s chapter of the American Association of University Professors has asked New York States’s attorney general to investigate. 

All of which raises a question for many N.Y.U. faculty members: Should administrators be able to enrich themselves like this at educational institutions? N.Y.U. is not a Wall Street firm, but a tax-exempt university that gets millions in taxpayer dollars, not least from student loans. In fact, our students have the highest total debt load of any university in the country. Rather than expanding, or paying huge salaries to top administrators, why doesn’t N.Y.U. do more to help its alumni pay off their debts?

Forsaking the Academic Mission

An article in Inside Higher Education underlined how the dispute is really about the mission of the university in this brave new corporate era:

As Rebecca Karl, an associate professor of East Asian studies and history recently told Inside Higher Ed, 'We’ve become very critical of the whole idea of ‘expand or die,’ which of course is a corporate maxim, but we don’t understand why it needs to become our maxim.'

Also,

 Mark Crispin Miller, a professor of media, culture and communication in NYU's Steinhardt School of Culture, Education and Human Development, who has been an outspoken critic of the Greenwich Village plan [said]. 'The fact is we see NYU as a school, we see our mission as educational. Sexton and the trustees who support him view NYU as a bundle of assets whole value they will apparently do anything to maximize on paper. We believe that this approach is destroying this university.'
By the way, maybe in retrospect the trustees' role should not be so surprising.  Back in 2011 we posted about a group of extremely rich corporate and finance leaders who attacked critics of their growing power as "imbeciles," among other terms.  Several of the individuals featured in the news article which inspired this post were trustees of New York University.  These included   Kenneth Langone and John Paulson.  A quick look at the list of current trustees shows that it includes  many top leaders of finance firms, including firms whose actions were alleged to have helped cause the great recession/ global financial collapse or have been subsequently accused of other financial shenanigans, e.g., Steven S Miller, a Vice President of JP Morgan Chase, and Maurice Greenberg (a life trustee), former leader of AIG, E John Rosenwald Jr (a life trustee), Vice Chairman Emeritus of JP Morgan Chase, and William R Salomon (a life trustee), honorary chairman of Citigroup.

Summary

In summary, the issues that inspired the no-confidence vote against the President of New York University appeared to be allegations that university:
-  administration usurped power, particularly from the faculty
-  administration used this power to put corporate priorities, like expansion for its own sake, and increasing short-term revenue ahead of the academic mission
-  administration took advantage of their power to enrich themselves
-  trustees, who are supposed to exert stewardship that ensures the university upholds its mission, instead aided and abetted all this

All of these should be very familiar issues to Health Care Renewal readers.  We have discussed the rise of generic managers of health care organizations, trained supposedly in general management skills, but not in health care, and indifferent at best to the values of health care professionals.  At times their power has gotten so great as to constitute a manager's coup d'etat.   We have discussed how managers of health care organizations often put short-term revenue ahead of all other concerns, sometimes called financialization.  In doing so, they may end up perpetrating mission hostile- management.  We have discussed how managers are able to command often outrageous levels of  executive compensation.   Boards of trustees, who are supposed to exert stewardship over the organization, and see that its leadership upholds its values, often come from management backgrounds themselves, and are at best clueless about, if not hostile to the mission. 

It is time for university faculty to defend their institutions' mission.  Students, alumni, and patients at academic medical centers, medical school clinics, and of academic health professionals ought to be equally fervent in support of the academic and academic health care missions.  Academic medicine needs to be lead and stewarded by people who understand that mission, value it, uphold it, and are accountable for that.  These leaders and stewards should eschew management fads, cronyism, and excess personal enrichment.

Maybe the vote of no confidence at NYU is a small step on the path back to the academic and academic medical missions.  But do not expect those who are enriching themselves in the current system to go quietly.

ADDENDUM - see also this post by Prof Margaret Soltan on the University Diary blog.

Saturday, February 2, 2013

A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream.

The Goldacre Version in the New York Times in 2013

In his op-ed, Ben Goldacre introduced it thus:

the entire evidence base for medicine has been undermined by a casual lack of transparency. Sometimes this is through a failure to report concerns raised by doctors and internal analyses, as was the case with Johnson & Johnson. More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good.

He noted that this problems was supposed to be fixed by the registration of clinical trials, and by changes in editorial policies at medical journals:

many in the industry now claim it has been fixed. But every intervention has been full of loopholes, none has been competently implemented and, lastly, with no routine public audit, flaws have taken years to emerge.

 The Food and Drug Administration Amendments Act of 2007 is the most widely cited fix. It required that new clinical trials conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day.  But in 2012, the British Medical Journal published the first open audit of the process, which found that four out of five trials covered by the legislation had ignored the reporting requirements. Amazingly, no fine has yet been levied. 

An earlier fake fix dates from 2005, when the International Committee of Medical Journal Editors made an announcement: their members would never again publish any clinical trial unless its existence had been declared on a publicly accessible registry before the trial began. The reasoning was simple: if everyone registered their trials at the beginning, we could easily spot which results were withheld; and since everyone wants to publish in prominent academic journals, these editors had the perfect carrot. Once again, everyone assumed the problem had been fixed. 

But four years later we discovered, in a paper from The Journal of the American Medical Association, that the editors had broken their promise: more than half of all trials published in leading journals still weren’t properly registered, and a quarter weren’t registered at all. 

Goldacre's conclusions were:

Withholding data not only misleads doctors and patients; it’s an insult to the patients who have participated in clinical trials, believing that they were helping to improve medical knowledge. 

Medicine routinely overcomes enormous technical challenges, and there is nothing complicated about the changes needed to prevent Johnson & Johnson, or Roche — or anybody — from withholding information.

Hear, hear!

Our Version, Starting in 2003

Note that 10 years ago, in 2003, in my article on American health care dysfunction that could have been only published in Europe, (Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Intern Med 2003 Mar;14(2):123-130.  Link here)  I noted that an important cause of this dysfunction is that:

the scientific basis of medicine is increasingly under attack.

The integrity of medical research has been violated by the deliberate suppression of its results.

At that time, I suggested one solution would be:

Medical schools and universities must re-affirm their support of scholarly work in the spirit of free enquiry,...

Furthermore, in one of our first posts on Health Care Renewal in December, 2004, in the context of the discovery of internal company documents (in this case, from Eli Lilly) that showed that information about the adverse effects of a drug (in this case, increased aggression associated with fluoxetine, that is, Prozac), we wrote,

The increasingly complex story of suppression of SSRI research seems to be part of a growing epidemic of suppression of medical research.
Let's say it again. Withholding data from clinical research is unethical because:
1. it breaks the promise to research subjects that their voluntary participation has scientific or social value, but undisseminated research has no value; (See Emanuel EJ et al. What makes clinical research ethical? JAMA 2000; 283: 2701-2711.)
2. it impedes scientific progress;
3. it prevents patients from receiving the best possible medical care.
But until this unethical behavior starts having negative consequences for its perpetrators, the epidemic of research suppression is likely to continue. 

Note the similarity to what Goldacre published in the Times yesterday.  You heard it here first.

Summary
To date we have published 102 posts with the label "suppression of medical research."  Obviously, Ben Goldacre's NY Times op-ed shows that suppression of research still rarely leads to negative consequences for its perpetrators.  Obviously, by making drugs, devices, and other health care interventions appear safer and more effective than they really are, suppression of medical research has lead to huge revenues for health care corporations, and has made many health care executives exceedingly rich, and many of the health care professionals and academic leaders who have enabled or implemented research suppression somewhat rich.  In the face of such perverse incentives, until we end the impunity of those who suppress medical research (and by the way, those who authorize, direct, or implement all sorts of other unethical, criminal and corrupt behavior we discuss on Health Care Renewal) things will not get better.  I can only hope that having this subject appear in a New York Times op-ed may lead to some real progress.

ADDENDUM (2 February, 2013) - see also comments on 1BoringOldMan blog. 

Tuesday, November 27, 2012

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.

Tuesday, November 20, 2012

Why Did the Global Fund Fire its Inspector General?

The Global Fund to Fight AIDS, Tuberculosis, and Malaria continues to struggle with the issue of health care corruption, an issue we noted here and here in 2011. 

Now as a news story in Nature put it,

It has been a rough couple of years for the Global Fund to Fight AIDS, Tuberculosis and Malaria, the world’s largest funder of international health programmes. Since its creation in 2002, the organization, based in Geneva, Switzerland, has channelled US$24.7 billion to delivering disease-control measures such as drugs, diagnostics and bed nets, saving millions of lives. But the global financial crisis has hit the fund hard, and its troubles mounted in 2011 when allegations of corruption among its grant recipients tarnished its reputation and alarmed donors.

Last week, the Global Fund tried to move on, announcing a new leader and unveiling major changes to its funding programme.
The Nature news story suggested that the troubles of the Fund all seemed so unfair.  After all,
the fraud allegations, ... [were] largely rehashed audits already made public by the fund itself. A retrospective audit published in July this year suggests that the allegations may have been overblown. It found that, in a sample of grants worth $3.8 billion that were awarded from 2005 to 2012 in 27 countries, just 0.5% of grant funding was lost to outright fraud. Experts say that figure is not exceptional for funding programmes in poor nations that often struggle with corruption.
Yet the Nature story suggested that the Fund's intrepid new later "could signal a fresh start, and has been broadly welcomed," leaving the impression that all things may turn out well.

Firing the Inspector General

However, the Nature story left out one nagging detail.  At the same time the Fund board announced the appointment of Dr Mark Dybul as its new director, it also announced that it had fired the Fund's Inspector General.  A report in the Financial Times only included,


It also dismissed John Parsons, its inspector general. Some directors believed Mr Parsons had been too outspoken in conducting public audits that sparked criticism of relatively small amounts of mismanagement and corruption.
The impression left was that Mr Parson was mainly guilty of rocking the boat.

The New York Times version, which started by recounting the hiring of Dr Dybul, also made it sound that Mr Parsons was generating too much bad publicity,

The fund also dismissed its inspector general, John Parsons, on Thursday, citing unsatisfactory work.


Mr. Parsons and Dr. Kazatchkine had privately clashed. Mr. Parsons’s teams aggressively pursued theft and fraud, and found it in Mali, Mauritania and elsewhere. But the total amount stolen — $10 million to $20 million — was relatively small, and aides to Dr. Kazatchkine said the fund cut off those countries and sought to retrieve the money. The aides claimed that Mr. Parsons, who reported only to the board, went to news outlets and left the impression that the fund was covering up rampant theft.

The fuss scared off some donor countries....
The AP version also cited the Board's accusation that Mr Parson's performance was "unsatisfactory," but included,

The inspector general's office is supposed to function independently. It was created in 2005 at the urging of the fund's biggest donor, the United States, which has contributed $7.3 billion to date.


The board held a contentious closed-door session with Parsons on Wednesday then deliberated into the night after he stormed out.

The board chairman, Simon Bland, and the head of its audit committee, Graham Joscelyne, each said they were unconcerned whether U.S. lawmakers might perceive the firing as an infringement on the office. Joscelyne would not elaborate on what Parsons did wrong but cited several reviews of him that were not disclosed.

In its latest 6-month progress report, Parsons' office said it had a growing caseload of 142 active investigations, up more than 70 percent from just two years ago.

Summary and Comment

We posted about the allegations of corruption at the Global Fund here and here in 2011.  At that time the scope of the problem was  unclear.  Now, at least according to the latest news report, it still is not clear.  On one hand, maybe no more than 0.5% of the budget was compromised.  On the other hand, would that caseload of 142 active investigations reveal more? 

Even less clear is the reason that Investigator General Parsons was fired.  The Board did not clarify what about his performance was unsatisfactory.  The AP report implies that doing too little was not the issue.  Most disturbing is lack of any mention of a possible replacement.

As we mentioned previously, the authoritative 2006 Global Corruption Report from Transparency International stated that corruption is a major global health problem.  Furthermore, Transparency International's IACC (International Anti-Corruption Conference) in Brasilia just wrapped up.  It's final declaration included,

We call on leaders everywhere to embrace not only transparency in public life but a culture of transparency leading to a participatory society in which leaders are accountable.


We call on the anti-corruption movement to support and protect the activists, whistleblowers and journalists who speak out against corruption, often at great risk.

It is up to all of us in government, business and society to embrace transparency so that it ensures full participation of all people, bringing us together to send a clear message: We are watching those who act with impunity and we will not let them get away with it.

Yet, corruption as a global health problem is still mostly ignored. In particular, global health aid programs almost never include pro-active measures to address corruption. In this case, the Global Fund, the world's largest source of such aid, was initially pushed into defensively addressing corruption, but now seems not to be so transparent about the problem. In my humble opinion, unless more transparency soon becomes evident, donors may continue to find reasons not to support the fund.


So the leaders of the Global Fund might want to consider becoming more transparent, and making some assurances that they are not out to get whistleblowers, including their own internal watchdogs.  At this point a more pro-active approach might be too much to ask for. 

Monday, October 1, 2012

Traits that "Define a Great Hospital CFO" - Honesty, Integrity, Accountability not Included

A recent article in Becker's Hospital Review entitled, "6 Traits That Define a Great Hospital CFO" [Chief Financial Officer] was most remarkable for what traits were not included.

The Six Traits

Based on interviews with a managing director of health care recruiting for a large executive search firm, and an experienced CFO of large hospital system, the included traits were:
- "Conviction," including "some type of conviction and confidence that their decision-making abilities will lead the hospital to great healthcare outcomes, a healthy population and — as a result — a more financially stable organization."
- "Nimbleness and flexibility"
- "Calm demeanor"
- "Willingness to understand the clinical aspects," in particular, the ability to "at least understand the [clinical] processes from a layperson's point of view, and the most effective CFOs have great working relationships with physicians, nurses, technicians and others."
- "Ability to think long term"
- "Sense of humor"

To be fair, I am glad to see expectations that hospital leaders, even chief financial officers, know something about clinical care, and that they have some sort of commitment to it. This seems to be in contrast to our frequent posts about how the leadership of health care organizations often seems ignorant and uncaring about the health care context and health care values. (However, the phrase above about conviction was not clearly worded. In particular, it did not explicitly suggest quality clinical care ought to be a higher priority than revenue, and could have been read to mean that good care is just a means to increase revenue.)

I am also glad that the article promoted long-term thinking. It also seems to contrast with concerns (e.g., here) about how health care leadership may put short-term revenue ahead of all other goals, also called "financialization." However, again, the article did not explicitly give long-term goals a higher priority than short-term ones.

What was Missing

However, what was more striking were the dogs that did not bark. In particular, transparency, honesty and integrity or even being law-abiding were not on the list of key traits for a CFO. This is particularly noteworthy given how often we have discussed bad behavior by large health care organizations, including various kinds of deception and dishonest behavior, as well as outright crime, such as fraud, bribery or kickbacks, etc.

Also, the list of important traits did not include responsibility or accountability.   This is also noteworthy given that rarely if ever have the leaders of these organizations taken any responsibility or paid any penalty for bad behavior occurring on their watches. Although may large health care organizations have made numerous legal settlements of accusations that include fraud, kickbacks, etc, the leadership almost never admitted wrongdoing in any of them, and almost never had to accept any financial penalty form the organization. This parallels how the US legal system has rarely sought to punish any leader of a large health care organization in such cases, suggesting that health care leaders now have developed impunity.

Given that the article appeared in Becker's Hospital Review, a leading publication for hospital leaders, its apparent cynicism about what once were considered indispensable characteristics of good leadership was disturbing.  It is also disturbing that at the time this was written, the only comment on the on-line version of the article, also the only comment to note this lack, was written by your this humble scribbler.

Summary

This may test some CFOs' sense of humor, but instead let me propose my hopes for better health care leadership. To truly reform health care we should seek reasonable leadership that draws on the collective knowledge and values of health care professionals, and that shows accountability, integrity, transparency, honesty, and ethics.  Not asking our leaders to be honest, ethical and accountable just enables the current dysfunction. 

Monday, May 21, 2012

The Case of the Vanishing Graduate Medical Education Funds

While primary care falters in the US, those who teach it seem to feel increasingly poverty stricken.  Now it appears that one reason for this is an amazing example of multiple failures of transparency and accountability.  Let me work through it, begging your pardon for a little bit of "inside baseball," medical education style.  The results suggest how we desperately need some medical disciples of Sherlock Holmes.

Background

My personal experience and increasing data suggests that most medical school faculty believe that their teaching is not valued by their institutions because teaching brings in no external funds.  In 2004, Dr Catherine DeAngelis, then the editor of JAMA, wrote "few medical schools provide adequate, if any, reimbursement for teaching time."(1)  (See this 2005 post.)   This seems absurd on its face, since what are medical schools for if it is not to provide teaching. 

However, there is evidence of this mission-hostile behavior.  In 2007, we quoted from a revealing interview with Dr Lee Goldman, Executive Vice President for Health and Biomedical Sciences at Columbia University,(2) who stated that "taxpayers," faculty who "generate more [money] than they cost," are valued most, and implied that faculty who focus on teaching are regarded as "welfare recipients," who bring in less external funding, and are valued least.  In 2010, we noted the results of a large-scale survey presented by Dr Linda Pololi in which 51% of faculty felt that the administration only valued them for the money that they brought in, and half felt that their institutions did not value teaching.(3)

Yet while faculty seem to believe that educational institutions receive little if any money to pay for teaching, it is not clear why the believe something so counter intuitive, and it is less clear what money actually goes to pay for medical education.

US Government Funding for Graduate Medical Education

However, several recent publications affirm that actually a lot of money goes towards one important form of medical education, yet the specifics of the money flows are shrouded in secrecy.  In the May, 2012, SGIM Forum, Dr Mark Liebow and colleagues summarized some of what is known about federal support of graduate medical education, that is, education of interns, residents, and other house officers.(4)  There are two streams of money that flow from Medicare to US hospitals:
Direct GME (DGME) payments help hospitals pay the salaries of residents, teaching faculty, and support staff. DGME is the product of three numbers: a per resident amount that varies by hospital, adjusted annually for inflation; the number of residents in the hospital (capped for each hospital at 1997 levels); and the fraction of discharges from the hospital that are Medicare beneficiaries. The Indirect Medical Education (IME) payment is a percentage amount added on to each DRG payment. The percentage is calculated via a complex formula (the only US statute containing an exponent!), where the key factor is the ratio of interns/residents to beds (IRB ratio).

These two streams are of considerable size:
Of the $9.2 billion Medicare paid for GME in 2010, $3 billion was for DGME and $6.2 billion for IME. The money is paid to hospitals sponsoring training programs rather than to the training programs or other hospitals where training occurs. While about 1,100 hospitals receive GME payments, 66% goes to the 200 hospitals that have the largest numbers of residents.

So, the 200 largest hospitals get about $2 billion in direct GME money (and presumably about another $4 billion in indirect money). This averages then to about $10 million DGME and $20 million indirect GME per hospital.

Thus, teaching, at least the teaching of interns, residents, and other house-staff does pay, and much more than trivial amounts. (Note that these amounts are not for teaching of medical students, which ought to be supported by other funding streams.)

Why then do faculty think that teaching does not bring in any money?

The GME Money Vanishes

An article by Dr Saima I Chaudhry and colleagues in the American Journal of Medicine begins to explain, although the explanations are found between the lines.(5)

First of all, while the graduate medical education money is paid by the government to the hospitals, the government does not publish what it pays to individual hospitals:
It has been previously reported that the amount of GME funding individual hospitals receive is not publicly reported by the Centers for Medicare and Medicaid Services,....

The government also does not hold the hospitals accountable for how they spend this money, nor for the quantity or quality of education they supply in exchange for it.

Remarkably, Chaudhry et al imply that that the people who run graduate medical education teaching programs also may not know how much money their hospitals receive from the government to fund their programs. The introduction to their article noted:
It is unclear how much program directors know about the amount and flow of DME funds to their programs. Program directors' beliefs about the transparency of funding to their programs, or their desire to influence how funds are distributed to them, also are unknown.

The article reported on a survey of internal medicine residency program directors which asked about "their knowledge of D[G]ME funding for their programs, the transparency with which funds are distributed to them, and their desire to influence this disbursement." The researchers sent surveys to 372 member programs, representing 97.1% of all US internal medicine residencies. They got 268 responses, a 72.0% response rate.

The main results were that only 159/268 (59.3%) of program directors had tried to find out how much DGME money their programs received, and of those, only 84 (52.8% of those enquiring, but only 31.3% of all respondents) actually knew how much money their programs got.

Of the 92 program directors who did not even try to discover how much money their programs received, approximately 21% said that "no one would tell me," 21% said that the "information would be inaccurate," 14% said they "don't know who to ask," and 2% were "afraid to ask."

Summary

US medical school faculty, especially those in primary care, increasingly feel pressured to perform activities that they perceive brings in money from external sources. They tend to believe that their own teaching somehow does not bring in any money, and that their careers will fail if they do not put more emphasis on other activities that the institution views as more profitable.

However, literally billions of US government dollars go to support the education of house staff, including the salaries of faculty who teach interns and residents, who probably are the majority of physician faculty. Faculty probably do not know this, because the government does not publish the amounts given to individual hospitals, nor demand of the hospitals any accountability for how they spend the money they receive.

Presumably, the top executives of each hospital know how much money the government gives them. Nonetheless, the majority of physician leaders of residency programs are never told these amounts, apparently because their hospital executives kept the amounts secret. Many of those educators who have tried to find out the figures were unsuccessful. Some did not even try to find out based on beliefs that their attempts would be unsuccessful, any amounts they discovered would be inaccurate, the people who knew the amounts were hidden, or that it would be dangerous to their careers to even try.

Thus billions of dollars of money flowing from the government to fund graduate medical education seems to have vanished in an amazing example of widespread deficiencies in accountability and transparency.

There are many people who blame government for many social ills. In this case, one can blame the US Congress for not writing a law that makes the money flows transparent and hospitals accountable for providing good educational value for the money provided. One can also blame the executive branch, particularly the Center for Medicare and Medicaid Services (CMS) of the US Department of Health and Human Services (DHHS) for not making the money flows and the values received for them transparent.

There are a few people, including this author, who also blame the leadership of health care organizations for many of the problems besetting health care. In this case, one can blame top leadership, presumably CEOs and chief financial officers (CFOs) of hospitals for hiding the amounts of money they receive from Medicare to finance graduate medical education. One can also blame the physician leaders of residency programs for not insisting that they know the true sources of financial support for their programs, obtain budgets that reflect this support, and recognition that their faculty really do bring in external funds for their teaching of house staff (and are thus valuable "taxpayers" in Dr Goldman's parlance.)

It is amazing that such amounts of money have been flowing for years mostly in secret. The secrecy has fueled incorrect, and in retrospect, bizarre ideas about the funding of medical education, and the value of medical educators to their institutions. This secrecy, in turn, has helped suppress the morale of medical educators, support the control of managers of health care professionals, and distort the flow of money within academic institutions and to compensation for certain favored individuals.

Would our dysfunctional health care system not be better off if we demanded transparency and accountability from its leaders?  In particular, the US government should make payments to hospitals for graduate medical education completely transparent, and develop a system to hold these hospitals accountable for how they spend the money.  Meanwhile, top leaders of hospitals receiving this money should make the amounts transparent, first to the people who are supposed to be doing the education that the money pays for, and to the public at large.  This would allow those running the relevant educational programs to develop reasonable and realistic budgets, to treat their faculty with respect, and to demonstrate what value they provide for the money received. 
The ongoing anechoic effect, and related deception and secrecy fostered by leaders in health care are major reasons our health care system is so dysfunctional, that costs are so high, and access and quality so poor.  True health care reform would ensure health care leaders put the mission before their personal enrichment, and act ethically with accountability, transparency, and honesty. 
References
1.   DeAngelis CD. Professors not professing. JAMA 2004; 292: 1060-1.  Link here.
2.  Goldman L, Halm EA.  A view from the top: general internal medicine from the perspective of a chair and dean.  SGIM Forum, April, 2007.  Link here.
3.  Pololi L, Ash A, Krupat E.  Faculty Values in the Culture of Academic Medicine: Findings of a National Faculty Survey. Link here.
4.  Liebow M, Jaeger J, Schwartz MD. How does Medicare pay for graduate medical education? SGIM Forum, May, 2012.  Link here.
5. Chaudhry SI, Khanijo S, Halvorsen AJ, McDonald FS,Patel K. Accountability and transparency in graduate medical education expenditures. Am J Med 2012; 125: 517-522. Link here.