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.
Showing posts with label ABIM. Show all posts
Showing posts with label ABIM. Show all posts
Thursday, April 24, 2014
Thursday, March 06, 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:
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,
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,
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,
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:
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.
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,
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
except as required for the purposes of continuing medical education.
- 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,
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.
Monday, March 03, 2014
The Plot of the CareFusion/ Dr Denham/ NQF/ ABIM/ Dr Cassel Case Thickens Even More - Current NQF and Previous ABIM CEO Found to be Long-Term Premier Inc Board Member, Resigns from that Board
The plot of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group case (as we previously entitled it) just will not stop thickening.
Background
To summarize the events up to our last post on the subject:
- The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice
- 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 and other health care 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 to prevent surgical site infection written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision
- The Department of Justice alleged that the standard was based on a journal article sponsored by Cardinal Health, from which CareFusion split, and which may have been manipulated by its sponsor
- NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs, established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy.
- Despite these efforts by the NQF to remove excess influence by Dr Denham, a specific recommendation to use ChloraPrep, specified by formula but not by name, did appear in another NQF standard, one for preventing central line infections; the NQF logo apparently appeared on at least one educational event run by Dr Denham that advocated the use of ChloraPrep; and CareFusion cited NQF support in at least one promotional brochure
- In retrospect, people who worked with Dr Denham on various health care quality and patient safety projects acknowledged they should have realized something fishy was going on.
- Senator Charles Grassley is now investigating
- Dr Christine Cassel, the CEO of the NQF, who had previous been the CEO of the American Board of Internal Medicine, was reported to be on the boards of directors of Kaiser Permanente Health Plans and Hospitals, a large non-profit health maintenance organization and hospital system, and Premier Inc, a for-profit hospital group purchasing organization. Both these organizations could be affected by the standards set by the NQF, and possibly by the certification standards set by the ABIM.
A Change in Course at NQF
At the time these conflicts were disclosed by ProPublica, , an NQF spokesperson and the NQF board chairperson suggested that the organization was well aware of these relationships, did not believe they were serious conflicts of interest, but chose to manage them by having Dr Cassel recuse herself from specific activities that could be construed as conflicts of interest. ProPublica quoted ethics experts who suggested that nearly all of Cr Cassel's activities at NQF could be involved in such conflicts, and hence such management would be inadequate.
Less than two weeks later, reports appeared that Dr Cassel will be resigning from the boards of Kaiser and Premier Inc. As reported by Joe Carlson writing in Modern Healthcare,
The story was also reported by ProPublica, and briefly with focus on California-based Kaiser, by the Los Angeles Times and the San Francisco Business Times.
But the resignations were just to reduce "distraction," as per ProPublica,
However,
Ms Darling did not explain how the issue had become so distracting as to lead to a disavowal of something of which one should be so proud.
Modern Healthcare also reported that the National Quality Forum will re-review the 2010 standards that recommended use of a CareFusion product and were written by a committee that included Dr Denham, who was alleged by the US Department of Justice to have taken kickbacks from CareFusion.
What About the American Board of Internal Medicine?
Before coming to the NQF in 2013, Dr Cassel was the president and CEO of the American Board of Internal Medicine (per the NQF press release announcing her appointment). In our last post on the subject, I raised the question of whether Dr Cassel could have had a conflict of interest related to her stewardship over Premier Inc while she was running the ABIM. However, at the time of the last post, there was nothing public about whether Dr Cassel had a role with Premier Inc or its predecessor organizations while she was the leader of the ABIM. .
Now, according to Joe Carlson writing in Modern Healthcare, it seems that Dr Cassel had been on the board of the privately held but for profit predecessor of the publicly traded Premier Inc since 2008, overlapping at least five years of her leadership of ABIM. Per that article, "Premier arranges for the purchases of products that could be affected by the NQF's patient-safety recommendations," and per the ProPublica article, Premier has an interest in what influences "practices adopted by medical providers across the country." As we wrote previously, the ABIM has a very substantial influence on health care. Physicians must pass its examinations to become certified as internal medicine specialists or sub-specialists such as cardiologists, gastroenterologists , etc. Recently certified physicians, and soon all certified physicians will have to participate in ABIM sanctioned "maintenance of certification" activities or risk being flagged as not adequately keeping with the board's concept of medical progress. So it would appear that Dr Cassel's long term stewardship of the predecessor of Premier Inc could have been just as important a conflict of interest for her as ABIM CEO as it appears to be for her as NQF CEO.
Summary
This case increasingly demonstrates how pervasive is the web of conflicts of interest that is now draped over all of health care. It also shows how important health care organizations seem to be lead by an overlapping, interconnected group of insiders. The same names appear again and again amidst the top hierarchies. The more ingrown the leadership of health care becomes, the more isolated it may be from the realities of health care for patients and health care professionals on the ground.
Specifically re the extension of this case to the American Board of Internal Medicine, to update what I wrote previously, in my humble opinion the current ABIM leadership needs to consider that Dr Cassel, its previous long-term CEO, had a conflict of interest involving her membership of the board of the private for-profit predecessor to Premier Inc from 2008 to 2013. Was this conflict disclosed to the ABIM board of trustees? If so, was there an attempt at management, and why was it not publicly disclosed? If the conflict was not disclosed to anyone, why not? If what was done conforms to current ABIM policies on conflicts of interest, should these policies be strengthened? If what was done did not conform to such policies, should their enforcement be strengthened?
To repeat, 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.
Background
To summarize the events up to our last post on the subject:
- The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice
- 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 and other health care 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 to prevent surgical site infection written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision
- The Department of Justice alleged that the standard was based on a journal article sponsored by Cardinal Health, from which CareFusion split, and which may have been manipulated by its sponsor
- NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs, established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy.
- Despite these efforts by the NQF to remove excess influence by Dr Denham, a specific recommendation to use ChloraPrep, specified by formula but not by name, did appear in another NQF standard, one for preventing central line infections; the NQF logo apparently appeared on at least one educational event run by Dr Denham that advocated the use of ChloraPrep; and CareFusion cited NQF support in at least one promotional brochure
- In retrospect, people who worked with Dr Denham on various health care quality and patient safety projects acknowledged they should have realized something fishy was going on.
- Senator Charles Grassley is now investigating
- Dr Christine Cassel, the CEO of the NQF, who had previous been the CEO of the American Board of Internal Medicine, was reported to be on the boards of directors of Kaiser Permanente Health Plans and Hospitals, a large non-profit health maintenance organization and hospital system, and Premier Inc, a for-profit hospital group purchasing organization. Both these organizations could be affected by the standards set by the NQF, and possibly by the certification standards set by the ABIM.
A Change in Course at NQF
At the time these conflicts were disclosed by ProPublica, , an NQF spokesperson and the NQF board chairperson suggested that the organization was well aware of these relationships, did not believe they were serious conflicts of interest, but chose to manage them by having Dr Cassel recuse herself from specific activities that could be construed as conflicts of interest. ProPublica quoted ethics experts who suggested that nearly all of Cr Cassel's activities at NQF could be involved in such conflicts, and hence such management would be inadequate.
Less than two weeks later, reports appeared that Dr Cassel will be resigning from the boards of Kaiser and Premier Inc. As reported by Joe Carlson writing in Modern Healthcare,
In continuing fallout from a recent conflict-of-interest scandal, National Quality Forum President and CEO Dr Christine Cassel is stepping down from two outside board of directors jobs amid questions about whether they created conflicts of interest for her.
Cassel, 68, has worked on the board of directors at Kaiser Permanente Health Plane and Hospitals since 2003, and has held board jobs with healthcare supplier and consultant Premier and its predecessors since 2008. She told the National Quality Forum board of directors on Wednesday that she is resigning both roles because they had become a 'distraction' for the NQF.
The story was also reported by ProPublica, and briefly with focus on California-based Kaiser, by the Los Angeles Times and the San Francisco Business Times.
But the resignations were just to reduce "distraction," as per ProPublica,
The Quality Forum said in a statement today that Cassel's decision to sever ties was voluntary.
'Although serving on these boards provided her with direct knowledge of many current issues in health care, as well as practices of good governance, the issue of her board involvement had become a distraction,' the organization said in a prepared statement.
However,
[NQF board of trustees chair Helen] Darling said she believed it was an asset to have Cassel aligned with such prominent organizations like Kaiser and Premier. 'It’s like saying you’ve got a Ph.D. from Harvard,' Darling said. 'This is something you’d be proud of.'
Ms Darling did not explain how the issue had become so distracting as to lead to a disavowal of something of which one should be so proud.
Modern Healthcare also reported that the National Quality Forum will re-review the 2010 standards that recommended use of a CareFusion product and were written by a committee that included Dr Denham, who was alleged by the US Department of Justice to have taken kickbacks from CareFusion.
What About the American Board of Internal Medicine?
Before coming to the NQF in 2013, Dr Cassel was the president and CEO of the American Board of Internal Medicine (per the NQF press release announcing her appointment). In our last post on the subject, I raised the question of whether Dr Cassel could have had a conflict of interest related to her stewardship over Premier Inc while she was running the ABIM. However, at the time of the last post, there was nothing public about whether Dr Cassel had a role with Premier Inc or its predecessor organizations while she was the leader of the ABIM. .
Now, according to Joe Carlson writing in Modern Healthcare, it seems that Dr Cassel had been on the board of the privately held but for profit predecessor of the publicly traded Premier Inc since 2008, overlapping at least five years of her leadership of ABIM. Per that article, "Premier arranges for the purchases of products that could be affected by the NQF's patient-safety recommendations," and per the ProPublica article, Premier has an interest in what influences "practices adopted by medical providers across the country." As we wrote previously, the ABIM has a very substantial influence on health care. Physicians must pass its examinations to become certified as internal medicine specialists or sub-specialists such as cardiologists, gastroenterologists , etc. Recently certified physicians, and soon all certified physicians will have to participate in ABIM sanctioned "maintenance of certification" activities or risk being flagged as not adequately keeping with the board's concept of medical progress. So it would appear that Dr Cassel's long term stewardship of the predecessor of Premier Inc could have been just as important a conflict of interest for her as ABIM CEO as it appears to be for her as NQF CEO.
Summary
This case increasingly demonstrates how pervasive is the web of conflicts of interest that is now draped over all of health care. It also shows how important health care organizations seem to be lead by an overlapping, interconnected group of insiders. The same names appear again and again amidst the top hierarchies. The more ingrown the leadership of health care becomes, the more isolated it may be from the realities of health care for patients and health care professionals on the ground.
Specifically re the extension of this case to the American Board of Internal Medicine, to update what I wrote previously, in my humble opinion the current ABIM leadership needs to consider that Dr Cassel, its previous long-term CEO, had a conflict of interest involving her membership of the board of the private for-profit predecessor to Premier Inc from 2008 to 2013. Was this conflict disclosed to the ABIM board of trustees? If so, was there an attempt at management, and why was it not publicly disclosed? If the conflict was not disclosed to anyone, why not? If what was done conforms to current ABIM policies on conflicts of interest, should these policies be strengthened? If what was done did not conform to such policies, should their enforcement be strengthened?
To repeat, 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.
Thursday, March 10, 2011
A New Venue From a Surprising Source to Discuss "External Threats to Good Decision-Making"
A new blog, entitled the Medical Professionalism Blog, signed on last week with a post emphasizing some themes that should be familiar to Health Care Renewal readers:
So, our new colleague in the blog-sphere raised the following questions:
Again, the importance of threats was emphasized, and concerns about conflicts of interest affecting physicians' professionals were implied. This blog will apparently have a unique focus which I hope will complement our approach on Health Care Renewal.
So we welcome The Medical Professionalism Blog to our blog-roll and look forward to some interesting content.
For a final twist, I need to note that this blog's authorship appears to be unique. The Health Care Renewal bloggers, and most of our blogging friends mostly seem to include, in no particular order: academic physicians, often tenured or retired (and thus able to speak more freely), other generally senior or retired academics, independent or retired practicing physicians, journalists, independent consultants, some whistle-blowers and others who once worked in the health care establishment, and some very anonymous bloggers in the belly of the beast. Thus, we are generally an very independent and iconoclastic, if a somewhat rag-tag lot.
However, the chief blogger on The Medical Professionalism Blog is Daniel Wolfson, who is Executive Vice President and Chief Operating Officer of the ABIM (American Board of Internal Medicine) Foundation, and the blog itself is a project of the foundation. Thus, this is a blog from the heart of the medical establishment, the powers that be, etc, etc. No other blog on our blog-roll comes from a current leader of such an organization. (One is written by someone who was a CEO of a major academic medical center/ hospital system, but who lost his job under controversial circumstances.)
It is truly refreshing to have a voice coming from the inside, so to speak, proclaim:
Furthermore,
Lately, we have not heard a lot of calls for vigorous debate and dissent from the medical establishment, the powers that be, etc, etc. In fact, the anechoic effect is how we describe how such debate and dissent has been suppressed.
So it appears the The Medical Professionalism Blog may be a real breath of fresh air. We hope it can truly inspire some discussion, especially open discussion of issues which used to be not what one was supposed to talk about in polite health care company. This could help advance the transparency which we have long been advocating.
There is an increasing focus on the sustainability of the U.S. health care system based on current cost trends. Predictions are for the health care system to consume 19% of the GDP by 2019. How did we get here?We have been underlining concerns that health care professionals' values, the mission of academic medicine, and truly evidence-based practice are under a series of threats. (For a recent, but already out of date list of threats to the academic medical mission, see this post.) It is nice to see that that others are now alarmed by these threats and looking for ways to counter them.
Some point to the overuse and misuse of health care services, inefficiencies and lack of care coordination. Others blame the lack of clinical evidence, primary care workforce and the external threats to good decision-making, such as a toxic payment system and the influence of pharmaceutical and device companies.
While there are many different ideas about what got us here and what should be done, there is wide consensus that physicians and other stakeholders must begin to develop new more effective and efficient systems of care and make wise choices that preserve our health care system’s sustainability.
So, our new colleague in the blog-sphere raised the following questions:
* What is the appropriate role of physicians and other stakeholders in preserving these resources?
* What behaviors foster and which threaten wise choices in medical decision-making?
* How can waste be removed from the system without sacrificing quality or safety?
* What system changes are needed to achieve better health care outcomes, reduce costs and improve the patient experience?
* What effect do the nature and performance of partnerships – clinician-patient, clinician-organization and clinician-society — have on professional behaviors and resource use?
Again, the importance of threats was emphasized, and concerns about conflicts of interest affecting physicians' professionals were implied. This blog will apparently have a unique focus which I hope will complement our approach on Health Care Renewal.
What we’re hearing from folks is the need to 'show me how' to answer these questions. Through analysis of promising practices, we hope to provide examples of what works – and what doesn’t.
So we welcome The Medical Professionalism Blog to our blog-roll and look forward to some interesting content.
For a final twist, I need to note that this blog's authorship appears to be unique. The Health Care Renewal bloggers, and most of our blogging friends mostly seem to include, in no particular order: academic physicians, often tenured or retired (and thus able to speak more freely), other generally senior or retired academics, independent or retired practicing physicians, journalists, independent consultants, some whistle-blowers and others who once worked in the health care establishment, and some very anonymous bloggers in the belly of the beast. Thus, we are generally an very independent and iconoclastic, if a somewhat rag-tag lot.
However, the chief blogger on The Medical Professionalism Blog is Daniel Wolfson, who is Executive Vice President and Chief Operating Officer of the ABIM (American Board of Internal Medicine) Foundation, and the blog itself is a project of the foundation. Thus, this is a blog from the heart of the medical establishment, the powers that be, etc, etc. No other blog on our blog-roll comes from a current leader of such an organization. (One is written by someone who was a CEO of a major academic medical center/ hospital system, but who lost his job under controversial circumstances.)
It is truly refreshing to have a voice coming from the inside, so to speak, proclaim:
The Medical Professionalism Blog was created by the ABIM Foundation to stimulate conversation and highlight best practices related to professionalism....
Furthermore,
Open for considerable debate is my belief that physicians’ engagement in quality, safety and the management of health care resources ultimately improves the care they give their patients and adds to their joy of work. I look forward to hearing your point of view, even if it’s a dissenting one.
Lately, we have not heard a lot of calls for vigorous debate and dissent from the medical establishment, the powers that be, etc, etc. In fact, the anechoic effect is how we describe how such debate and dissent has been suppressed.
So it appears the The Medical Professionalism Blog may be a real breath of fresh air. We hope it can truly inspire some discussion, especially open discussion of issues which used to be not what one was supposed to talk about in polite health care company. This could help advance the transparency which we have long been advocating.
Thursday, March 17, 2005
Are Older Doctors Dumber? - Reloaded
Joe Diaz and I published an e-letter about the Chourdry et al review of physicians' age versus performance. The e-letter was similar to what I had posted last month on this blog.
Coincidentally, or inspired by our letter, a whole host of other e-letters appeared, all sharply critical of the Choudry article. See all the e-letters here.
Some points that they raised were:
Coincidentally, or inspired by our letter, a whole host of other e-letters appeared, all sharply critical of the Choudry article. See all the e-letters here.
Some points that they raised were:
- that the authors of the Choudry et al review may have had conflicts of interest that affected their results, conflicts that were not properly disclosed
- publishing such an article, disparaging "older physicians with flimsy data," raises questions about the Annals' publishing policies at a time when older physicians are being driven out of practice early by malpractice insurance and reimbursement concerns
- the article will be used as justification for increasing mandatory re-testing of older doctors, as was advocated by ABIM leaders in an accompanying editorial, even though it provides no evidence that such testing would actually improve performance
- publishing the article without acknowledging its severe limitations could have grave "incalculable" effects on medicine and medical practice
Wednesday, February 16, 2005
Are Older Doctors Dumber?
The results of a systematic review in the Annals of Internal Medicine have created headlines around the US. Most, like this one from the Boston Globe (Greater Risk Seen With Older Doctors), suggest that older doctors are, well, dumber than younger ones. My wife, seeing the headline, and observing that I had progressed to a certain age, said this morning, "shouldn't you look into this one." So I did.
The study in the Annals of Internal Medicine [Choudry NK, Fletcher RH, Soumerai SB. Systematic review: the relationship between clinical experience and quality of health care. Ann Intern Med 2005; 142: 260-273] searched the literature search to find 62 articles that analyzed physician knowledge or performance according to the the physicians' age. Summaries of the 62 studies were broken down by study purpose: 12 involved written tests of knowledge; 17, adherence to guidelines or practice standards for diagnosis, screening, or prevention assessed by self-report, e.g., by surveys or interviews; 7, adherence to such standards assessed by chart audit; 5, adherence to guidelines or practice standards for treatment assessed by self-report; 13, adherence to guidelines or practice standards for treatment assessed by chart audit; and 7, directly measured patient outcomes.
The review did not screen out articles of poor methodologic quality, or rate the methodologic quality of any article. So it did not eliminate articles whose specific standards for physician performance were not evidence-based, such as tests of knowledge not related to the physicians' practices. Furthermore, it included articles regardless of their study architecture, age, sample size, patient selection criteria, whether and how they controlled for patients' characteristics, and effect size and its precision. Thus, this review's results could well have been biased by poorly designed or performed studies, and studies which are unlikely to generalize to modern physicians.
I did not have time to re-review every article, but a quick perusal made me more concerned that the most striking results showing older physicians performing worse were contributed by the methodologically weakest articles. For example, of the 13 articles that looked at adherence to standards for treatment by chart audit, only 6 showed what the authors called a consistently negative effect of increasing age. Of these,
Yet an accompanying commentary, [Weinberger SE, Duffy FD, Cassel CK. "Practice makes perfect" ... or does it? Ann Intern Med 2005; 142: 302-303.], hailed the article as showing that physicians "must embrace the concepts behind maintenance of certification, which provides an opportunity to prevent the outcomes demonstrated...." Since Choudry's review did not include any studies of recertification, I think this conclusion goes even farther beyond its data.
Even though physicians seem beset on all sides by powerful organizations, sometimes that stand to profit by reducing physician autonomy, I believe that our professional values mandate serious, ongoing examination of our own performance. (I have actually published a few studies which do just that.) However, the principles of clinical epidemiology apply to such studies just as they apply to studies of patients. We do no one any favors by rushing to negative conclusions about physician performance without examining the strength of the relevant evidence.
The study in the Annals of Internal Medicine [Choudry NK, Fletcher RH, Soumerai SB. Systematic review: the relationship between clinical experience and quality of health care. Ann Intern Med 2005; 142: 260-273] searched the literature search to find 62 articles that analyzed physician knowledge or performance according to the the physicians' age. Summaries of the 62 studies were broken down by study purpose: 12 involved written tests of knowledge; 17, adherence to guidelines or practice standards for diagnosis, screening, or prevention assessed by self-report, e.g., by surveys or interviews; 7, adherence to such standards assessed by chart audit; 5, adherence to guidelines or practice standards for treatment assessed by self-report; 13, adherence to guidelines or practice standards for treatment assessed by chart audit; and 7, directly measured patient outcomes.
The review did not screen out articles of poor methodologic quality, or rate the methodologic quality of any article. So it did not eliminate articles whose specific standards for physician performance were not evidence-based, such as tests of knowledge not related to the physicians' practices. Furthermore, it included articles regardless of their study architecture, age, sample size, patient selection criteria, whether and how they controlled for patients' characteristics, and effect size and its precision. Thus, this review's results could well have been biased by poorly designed or performed studies, and studies which are unlikely to generalize to modern physicians.
I did not have time to re-review every article, but a quick perusal made me more concerned that the most striking results showing older physicians performing worse were contributed by the methodologically weakest articles. For example, of the 13 articles that looked at adherence to standards for treatment by chart audit, only 6 showed what the authors called a consistently negative effect of increasing age. Of these,
- one was published 34 years ago, and included only 37 physicians;
- one, of treatment of depression, did not account for the severity of the patients' symptoms, and had a very small effect size (OR=1.12, CI 1.01, 1.24);
- one used a standard of care for inappropriate drug selection that might be debated;
- one used that same standard, did not adjust for patients' clinical characteristics, and had a very small effect size (OR=1.14);
- one was published 21 years ago, and used practice standards defined by consensus, not evidence; and
- one was published 20 years ago, included only 66 physicians, and again used practice standards defined by a panel, not evidence.
Yet an accompanying commentary, [Weinberger SE, Duffy FD, Cassel CK. "Practice makes perfect" ... or does it? Ann Intern Med 2005; 142: 302-303.], hailed the article as showing that physicians "must embrace the concepts behind maintenance of certification, which provides an opportunity to prevent the outcomes demonstrated...." Since Choudry's review did not include any studies of recertification, I think this conclusion goes even farther beyond its data.
Even though physicians seem beset on all sides by powerful organizations, sometimes that stand to profit by reducing physician autonomy, I believe that our professional values mandate serious, ongoing examination of our own performance. (I have actually published a few studies which do just that.) However, the principles of clinical epidemiology apply to such studies just as they apply to studies of patients. We do no one any favors by rushing to negative conclusions about physician performance without examining the strength of the relevant evidence.
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