The Association of American Medical Colleges (AAMC) issued a press release announcing a new report, which “urges U.S. teaching hospitals to establish policies that manage financial relationships between physicians and industry so that they do not influence patient care.”
The report, entitled “In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making,” is the third and final report by the AAMC on managing financial conflicts of interest. The first two association reports focused on conflicts of interest in the research and medical education settings. The final report was carried out by a task force convened by the AAMC in 2009. The task force was comprised of a 20-member panel, which included senior leadership from the nation’s medical schools and teaching hospitals, and was chaired by Patrick J. Brennan, M.D., chief medical officer and senior vice president at the University of Pennsylvania Health System.
The task force carried out this report to provide guidance on how academic medical centers (AMCs) can identify, evaluate, and disclose conflicts of interest in clinical care. AAMC felt the need to create such guidelines because of “a growing body of research that has raised questions about the impact of compensation and financial incentives on the practice of medicine.” In particular, the report points to “recent Congressional inquiries into possible physician misconduct, scandals surrounding several widely used pharmaceuticals and their related clinical trials, and widespread public concern over health care costs” as reasons that have led to increased concern about the role of money in medicine. Conveniently, the report makes no mention of the simultaneous growth of research, which shows there is no bias in medicine from such money, and that such relationships are beneficial.
As a follow up to the report, the AAMC is now developing clinical scenarios that can be used by its members to help define their approach to addressing conflicts of interest in patient care.
Citing this so called “growing body of research,” AAMC claims that “the presence of individual or institutional financial interests in these relationships between AMCs and industry sometimes creates perceived or real conflicts of interests in patient care.” Such a claim is problematic for two reasons.
First, the authors suggest only that “sometimes” these relationships create “perceived or real” conflicts of interest. This kind of approach will chill collaboration and research between industry, physicians and AMCs because of what some fell is a small chance that such relationships may result in a conflict of interest. This approach only considers the risks of such relationships and not the benefits, and AAMC has no discussion of the harm done by disrupting physician-industry relationships.
Second, AAMC acknowledges that “partnerships between AMCs and industry are essential to innovation and create powerful collaborations that benefit all patients.” Since that is the case, how can they create and propose guidance that essentially makes it more difficult to keep, create, and maintain such partnerships? This kind of confusion between the significance of such collaboration is problematic.
While the report attempts to “address conflicts of interest in ways that protect patients overall and preserve the integrity of individual relationships between physicians and their patients,” the recommendations do not meet the goals set out by AAMC Chief Health Care Officer Joanne M. Conroy, M.D. Specifically, while the guidance may serve to “uphold the highest standards of professionalism,” the proposals hinder “principled relationships with industry that improve patient care,” instead of maintaining them.
Background
To address this issue, the report first defines a clinical practice conflict of interest as “a secondary financial interest that creates the risk that the primary duty to the patient and the delivery of optimal care will be unduly influenced by personal financial interests of the care provider or care provider institution.” Using this definition throughout its report, AAMC gave examples of relationships that have the potential for this conflict such as:
– The development of new drugs and devices;
– Discoveries in the basic science laboratories of academic medicine are licensed to companies for development, testing, and marketing;
– Faculty physicians and scientists who make patentable inventions can be compensated with royalties as can the academic institutions where the inventions were made; and
– Other relationships include consulting when faculty physicians, consistent with policies of their institutions, may enter into personal consulting agreements (which produce personal income for physicians and scientists) with companies to work in various phases of research or development projects that would not normally be undertaken in their academic roles.
The AAMC asserts the need for AMCs to explicitly address these relationships “through a well-defined and publicized institutional process,” which manages conflicts of interest in clinical care resulting from physician-related financial interests as well as those conflicts that result from the institution’s financial interests in products prescribed for its patients.
To support this idea, AAMC cites no new evidence about the claimed negative effects of industry-AMC relationships. Instead, the report claims that “the link between self-interest and the erosion of altruism has been demonstrated by multiple studies.” The only “studies” they point to is the Wazana study, which suggested that the relationships between industry and physicians appear to affect prescribing and professional behavior. But relying on this evidence is clearly flawed because the study has no information about “clinical care,” and explicitly says so.
They also try using recently completed neurobiology studies to support their claims that relationships with industry are conflicted. But to their own acknowledgement, AAMC recognizes that such research “is still an emerging area of scientific discovery, and studies have not yet been performed on physician-industry interactions and decision making.” So then how is it that AAMC suggests that “these studies reinforce the necessity for multifaceted solutions to interdict biasing influences” when the data they rely on is flawed and “still emerging,” and when evidence is neither extensive nor conclusive?
The report on clinical care also addresses the prevalence of industry funding that surrounds professional society activities, and recognizes that such programs are “now receiving appropriate critical review.” Moreover, some believe that transparency of funding sources in professional societies is an adequate response to combat any potential or perceived conflicts of interest.
Consequently, despite the fact that AAMC relies on weak evidence, that professional societies adequately address conflicts of interest, and that “many AMCs have conflicts of interest (COI) policies that govern research and corporate relationships,” the report offers recommendations because “only a small number of these institutions have adopted policies that define and address conflicts of interest in clinical care.”
Recommendations
Many AMCs “have detailed, explicit policies governing conflicts of interest in research as well as ones that ban or sharply restrict pharmaceutical and device company gifts, speakers bureaus, travel, ghostwriting, and the like.” AAMC however, felt that academic medical centers need guidelines for institutions to evaluate their own compensation systems to determine whether they influence physician behavior and conflict with the best interest of patients. As such, the report recommends that:
Compensation mechanisms of academic medical centers should be aligned with the best interests of patients. Specifically, the report calls on AMCs to determine whether their own compensation systems are based on incentives that are consistent with the values of medical professionalism and reflect the primacy of the patient’s best interests or if they adversely influence physician behavior and create conflicts.
AAMC claims that common compensation mechanisms (e.g. fee-for-service, managed care, etc.) each present “ethical dilemmas as well as conflicts of interest that are inevitable.” The problem with such an assertion is that the report acknowledges that “evidence does not clarify whether physician responses to these different systems are motivated significantly by personal financial considerations,” and that “evidence does not support clear conclusions” about such dilemmas or conflicts.
Instead of waiting for more research on this subject to gather clearer findings, which the report explicitly calls for multiple times, AAMC relies on psychological research (that probably uses no clinical care data) as an attempt to explain why COIs are “so insidious and difficult to combat.” Such research explains that “physicians who strive to maintain objectivity and policy makers who seek to limit the negative effects of physician-industry interaction face a number of challenges.” Since that is the case, why not address ways to overcome those challenges, instead of avoiding them, and telling doctors they are wrong? In overcoming such obstacles, we can ensure that these interactions are proper so that continued progress and innovation in science is maintained.
Medical societies should set standards of addressing their own relationships with industry, which the report acknowledges is already taking place. Though we wonder why the AAMC thought it was necessary to comment on medical societies, since they are not in their purview.
Academic medical centers should address their physicians’ financial relationships with industry in the context of the clinical care they deliver. To do so, the report recommends that AMCs establish mechanisms to identify physician-industry financial relationships and evaluate their potential for biasing the clinical practice of physicians and to eliminate, limit, or manage those that appear to represent a risk of bias. Such relationships will include the receipt of, or rights to receive:
– Royalties by physicians;
– Consulting or other services for industry by physicians; and
– Physicians’ ownership interest in related companies.
The report calls for special treatment in clinical conflicts of interest policies on royalties and the use of a patented item and income to the inventor, especially those derived by the institution or its physicians from sales of drugs, devices, or diagnostics used at that institution.
Also, AAMC acknowledges that ownership interests (e.g., stock, stock options, other ownership interests but excluding certain diversified mutual funds) should be included within the definition of those financial interests that must be disclosed and evaluated. They specifically ask for a distinction between ownership interests in publicly traded companies and those in privately held companies, especially start-ups, for purposes of triggering evaluation by a conflicts of interest official or committee.
Additionally, they call on institutions to set thresholds for physician reporting to their institutions and for institutional evaluation mechanisms to assess the reported interests, because no de mimimis standard would result in a huge volume of disclosures to evaluate and would diminish an institution’s ability to focus on those conflicts with the most potential to inject bias into the relationships with patients.
AAMC also asserts that institutions must determine under what circumstances an individual physician’s financial interest relating to particular drugs being prescribed or devices being used on a particular patient are such that they should be disclosed to the patient as well as the means for disclosure to the patient.
Lastly, clinical conflicts of interest policies should include provisions for consequences for failures to adhere to them.
Academic medical centers should address institutional financial relationships with industry in the context of the clinical care they deliver.
Academic medical centers should disclose the industry ties of their physicians to their patient communities as one method, though not the exclusive method, of managing actual and perceived conflicts of interest in clinical care. In particular, the task force recommended that all AMCs make available to their patient communities and the public information regarding:
– The industry relationships of their individual physicians;
– The value to society of such relationships; and
– A description of the institution’s efforts to mitigate bias resulting from such relationships.
AAMC also recommends that AMCs use uniform standards and definitions of categories of disclosure for those interests that are determined to be conflicts so that patients can better understand information across care-giving sources. As such, the report makes no recommendation over others for disclosure (e.g. web sites, brochures, etc.).
Academic medical centers should involve their patient communities in determining the manner in which financial relationships of its physicians and of the institution itself should be made available to patients. This proposal asks that AMCs help patients understand the benefits, risks, and management of bias resulting from the financial relationships of its physicians with industry. It also supports the IOM’s call for more research on conflicts of interest to help determine what information is useful to patients as well as in how it is presented to specific patient communities.
Interestingly, although disclosure may promote informed decision making; respect participants’ right to know; establish or maintain trust; minimize risk of legal liability; deter troubling financial relationships; and protect research participants’ welfare, “little is known about the effects of disclosure of conflicts of interest on patients.” As a result, AAMC asserts in agreement with the IOM report that “much more research is clearly necessary.” Despite recognizing this need, AAMC still asserts that “in the case of clinical care, physicians should be required to report to their institutions on an annual basis their personal financial interests that are related to their clinical practices.” Annual reports would also include updates when interests change during a reporting period.
The task force also recommends that institutions inform patients of the existence of their providers’ financial relationships that have been determined to be significant, make additional information about those relationships readily available to patients, and that the physician himself or herself should normally be required personally to make the disclosure to the patient and document the disclosure in the medical record.
AAMC Recommendations for an COI Police State
Such recommendations lead AAMC to call for a duly appointed institutional official or committee whose purpose is to evaluate the information reported and to determine if there is a significant conflict of interest in clinical care and, if so, to manage it or determine that it should be eliminated. For example, an institution policy could require:
a. Verbal disclosure to patient with documentation of disclosure in medical record
b. Corroboration by colleague of any prescription involving a product from the commercial entity
c. Corroboration by colleague documented in the medical record of any prescription involving a product from the commercial entity
d. Appointment of an oversight committee to monitor practice patterns
e. Transfer of patient care to another colleague
f. Cessation or modification of relationship with a commercial entity, if necessary51
AAMC then takes it one step further by citing a policy, which calls for the following if a “conflict” that is whatever they decide is a “conflict” is not resolved.
– Suspend the faulty members clinical privileges
– Withdraw professional liability insurance coverage for the faculty member
– Reduce the faculty members salary
– Take other actions
There is also a section of the report that addresses transparency of such disclosures, which recognizes that information on web sites “can be easily misunderstood or misused to suggest that all disclosed financial interests are relevant to all activities and constitute conflicts of interest.” Another problem with this kind of disclosure is the lack of uniformity among web sites that confuses patients and the general public. Consequently, as AAMC points out, this kind of transparency must be changed to explicitly and clearly show that “many interests disclosed through these Web sites have no relation at all to the clinical practice experiences or other professional activities of particular physicians, nor are they conflicts of interest.”
At the same time, AAMC also calls for establishing uniform standards of disclosure in terms of definitions of categories of information to be disclosed and the time periods that disclosures cover to reduce confusion and inadvertent discrepancies. Such proposals are important because “in the absence of broader context, there is no real opportunity for patients or the public to evaluate what the information means in relation to the entirety of the physician’s professional activities.” Disclosure must avoid presenting the interests in “isolation from the physician’s professional context because it makes it appear that all of these relationships are at best problematic and at worst proven sources of inappropriate influence, when in fact no such judgments have been made about any interests.” That is why “sites should provide information about the potential benefits and value of appropriately structured related interests.”
Uniform Disclosure
In the appendix the AAMC outlines the Cleveland Clinic’s design of a uniform disclosure form, this is the one recommendation that actually makes sense.
Physician Owned Hospitals
In an ever so slight self serving move, the AAMC devoted a whole section of the appendix on physician owned hospitals. This seemed odd, but then again a poke at the competition can go a long way. Physician owned hospitals that run residency programs may want to read this section which will allow them to re-think their relationship with AMC’s. The report any good that may come from a physician practice owning their own imaging equipment and labs, or a physician having an interest in a hospital which can be more efficient than non physician owned hospitals and focusing on the potential risks.
Discussion
Many of the proposals for AMCs “represent an enormous commitment of institutional resources, which some suggest could be put to better uses.” With regards to disclosure and transparency, “many institutions do not have the means to establish Web sites.” Moreover, even IOM noted that disclosure “could also have harmful consequences if physicians or researchers react by avoiding relationships that promote important societal goals and that are accompanied by adequate measures to protect objective judgment.”
Accordingly, calling for such changes now seems counterproductive considering “substantial efforts have already been undertaken by academic institutions, national associations, and professional and scientific organizations in developing and implementing appropriate standards of conduct and transparency.” As a result, many of AAMC’s recommendations are unnecessary, and will only hurt “the relationships they admit “foster discovery and innovation and improve the health of the public.”
The report is also problematic because there is no discussion of the harm done by disrupting physician-industry relationships, and there is no acknowledgement of the self-serving reports that cause medical education to be monopolized by AAMC institutions. Essentially, the report is written in a vacuum where all relationships are a conflict and all ways a physician personally benefits from the practice of medicine is a problem. How can AAMC state that “medicine’s ethical principles are autonomy, objectivity, altruism, and the avoidance of conflicts of interest,” when their own report is far from objective?
Like in all other reports there is a conformational bias in that they fail to recognize any studies or literature or even acknowledge that others may disagree with the their positions, and they hold to the conflict of interest framing bias that all relationships equal a conflict.
Unfortunately, this report will only lead more and more achievers to leave academic medicine. Those remaining will either have a desire to follow a strict religious system or control others in places of power. Discovery will eventually leave institutions forever under their scenarios. This kind of effect must be avoided because as AAMC acknowledges, “partnerships between AMCs and industry are essential to innovation and create powerful collaborations that benefit all patients.”
The recommendation on getting collaboration on scripts shows just how separated the committee members of this patient care report were to patient care. Can you imagine the paperwork and time wasting involved if every time a university physician used a drug or device (regardless they all come from a commercial entity, last we checked the government does not own this sector) you would have to get a second signature from another physician, and they would have to sign off on this in the medical record. Our already taxed system would completely break down under this proposed scenario.
All we need is for some oversight committee to constantly look over the shoulders of our physicians to ensure we are using the treatments that they deem necessary. In so far as a new oversight committee would be used for prescriptions, one wonders whether will be we be practicing medicine from prison under these scenarios.
Conclusion
Academic medical centers have a critical mission to deliver medical care to patients. Aiding in this mission, “partnerships among academic medical centers, their physicians and scientists, and the pharmaceutical, device, and biotechnology industries are essential to capture the fruits of biomedical research for the benefit of the public and to assure continued advancements in the prevention, diagnosis, and treatment of disease.” As AAMC further notes, “these partnerships lie at the heart of the innovation process and represent a powerful force for constructive collaboration to the ultimate benefit of society at large. The benefits realized by these partnerships validate the wisdom of public policies that have encouraged them for years.”
Accordingly, since “advances in medicine depend on a constructive partnership between academic medicine and the pharmaceutical, device, and biotechnology industries,” the time for academic physicians to stand up and say enough already is now.
This report belongs to the shelf like most other reports, it is however recommended reading. It serves as a blue print for the extreme control agenda is going to look like; if you work in academic medicine the picture looks bleak.