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:

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. 

3 comments:

Steve Lucas said...

The sin of omission.

Steve Lucas

james gaulte said...

"What is legitimate for Jove is not legitimate for the Ox." Does (did) the leadership of ABIM consider themselves so ethical that it would be unnecessary to report any possible conflict of interests?

Anonymous said...

Not to mention that she was making more money than Walter White serving a largely honorific position as president of the 'non-profit' ABIM.