Wednesday, January 25, 2006

Dodging Stones Thrown From Glass Houses: the JAMA Article on Conflicts of Interest

This week's JAMA featured a major article about addressing conflicts of interest that face physicians. (Brennan TA et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295: 429-433.) The article has already attracted a lot of media attention (e.g., see the New York Times, Washington Post, and Los Angeles Times).

Unfortunately, I believe that this article is much more notable for what it omits than what it says.

I will summarize its main points, and then comment.

Main Points

Conflicts of Interest Are Important-

Physicians' commitment to altruism, putting the interests of the patients first, scientific integrity, and an absence of bias in medical decision making now regularly come up against financial conflicts of interest.

The Most Important are Conflicts of Interest Involving Pharmaceutical Corporations and Device Manufacturers and Affecting Physicians -
Arguably, the most challenging and extensive of these conflicts emanate from relationships between physicians and pharmaceutical companies and medical device manufacturers

Academic Medical Centers (AMCs) Shall Police Such Conflicts-
To remedy the situation and prevent future compromises to professional integrity, academic medical centers (AMCs) must more strongly regulate, and in some cases prohibit, many common practices that constitute conflicts of interest with drug and medical device companies.

Specific Interactions Between Physicians and Pharmaceutical and Device Corporations Must Be Addressed -
The following list, while not exhaustive, indicates the interactions with industry that must be addressed: gifts, even of relatively small items, including meals; payment for attendance at lectures and conferences, including online activities; CME for which physicians pay no fee; payment for time while attending meetings; payment for travel to meetings or scholarships to attend meetings; payment for participation in speakers bureaus; the provision of ghostwriting services; provision of pharmaceutical samples; grants for research projects; and payment for consulting relationships.

Physicians Shall Not Receive Any Gifts from these Corporations -
All gifts (zero dollar limit), free meals, payment for time for travel to or time at meetings, and payment for participation in online CME from drug and medical device companies to physicians should be prohibited. A complete ban on these activities by eliminating potential gray areas greatly eases the burden of compliance.

Physicians Shall Not Get Pharmaceutical Samples -
he direct provision of pharmaceutical samples to physicians should be prohibited and replaced by a system of vouchers for low-income patients or other arrangements that distance the company and its products from the physician.

Hospital Formulary Committees Shall Exclude Those Health Professionals with Financial Ties to Drug Companies -
Hospital and medical group formulary committees and committees overseeing purchases of medical devices should exclude physicians (and all health care professionals) with financial relationships with drug manufacturers, including those who receive any gift, inducement, grant, or contract.

Corporations Shall Not Support Continuing Medical Education (CME) Directly, but Shall Give Money to a Central Repository at the AMC -
Drug and Device Manufacturers should not be permitted to provide support directly or indirectly through a subsidiary agency to any ACCME-accredited program. Manufacturers wishing to support education for medical students, residents, and/or practicing physicians should contribute to a central repository (eg, a designated office at an AMC), which, in turn, would disburse funds to ACCME-approved programs.

Drug and Device Manufacturers Shall Only Support Trainees' Travel by Giving Money to the Central Repository -
Pharmaceutical and device manufacturers interested in having faculty or fellows attend meetings should provide grants to a central office at the AMC. That office could then disburse funds to faculty and training program directors.

Physician Faculty Shall Not Serve on Industry Speakers Panels -
Faculty at AMCs should not serve as members of speakers bureaus for pharmaceutical or device manufacturers.

Physician Faculty Shall Not Publish Ghost-Written Articles -
Faculty should be prohibited from publishing articles and editorials that are ghostwritten by industry employees.

To Consult for Industry, Physicians Shall Have Explicit Contracts with Deliverables -
Because the process of discovery and development of new drugs and devices often depends on input from academic medicine, consulting with or accepting research support from industry should not be prohibited. However, to ensure scientific integrity, far greater transparency and more open communication are necessary. Accordingly, consulting or honoraria for speaking should always take place with an explicit contract with specific deliverables, and the deliverables should be restricted to scientific issues, not marketing efforts.

Industry Shall Give Research Grants and Contracts to AMCs -
To promote scientific progress, AMCs should be able to accept grants for general support of research (no specific deliverable products) from pharmaceutical and device companies, provided that the grants are not designated for use by specific individuals.

AMCs Shall Post Grants and Contracts on the Web -
To better ensure independence, scientific integrity, and full transparency, consulting agreements and unconditional grants should be posted on a publicly available Internet site, ideally at the academic institution.

My Comments

The paper starts out well, by highlighting the importance of conflicts of interest in health care.

Conflicts Involving Other Health Care Organizations

It first goes seriously wrong by limiting its concern to only conflicts of interest involving pharmaceutical and device manufacturers, and only conflicts of interest affecting physicians. Health Care Renewal, and other related sources have documented conflicts of interest involving nearly all kinds of health care organizations.

Most particularly, although they don't often make news any more, most physicians are acutely aware of the strong conflicts of interest posed by their relationships with managed care organizations. Much was written about this in the 1980s and 1990s when managed care became ascendent as a way to control health care spending. To summarize, I wrote this in 2003,[1]
Physicians, especially primary care physicians, are often exposed to incentives that conflict with professional values. 'Market driven health care creates conflicts that threaten medical professionalism.'[2] Managed care organizations, in particular, provided strong incentives to do less for patients, but at the risk of making physicians into 'double agents,' whose financial incentives are no longer clearly aligned with providing services, but may turn on holding services to some minimum level.'[3] Most primary care physicians feel pressure from managed care to limit referrals and see more patients,[4] and thus are concerned about conflicts of interest and failure to regard the patient’s interests as paramount.[5] Managed care organizations may employ a 'strategy of giving with one hand while taking away with the other, of offering consumers comprehensive benefits while restricting access through utilization review, [which] obfuscates the workings of the system, undermines trust between patients and physicians, and has infuriated everyone involved.'[6]

Conflicts Affecting People Other Than Physicians

Conflicts of interest affect not only physicians, but also others involved in health care, particularly the leaders of health care organizations. Again, my "Cautionary Tale" article, and the contents of Health Care Renewal provide many examples. Some recent ones include the cases at Roger Williams Medical Center, the University of California, and the University of Medicine and Dentistry of New Jersey (UMDNJ).

Furthermore, there have been many examples of leaders of health care organizations being willing to sacrifice physicians' core values at the alter of increasing the organizations' bottom lines. A recent one would seem to be at the University of Sheffield, where research leaders cautioned Dr Aubrey Blumsohn not to demand the data from his own research project, lest he offend the pharmaceutical company that was sponsoring that research. More systematic evidence was provided by the Mello study[7], (see post here), which showed that AMC leaders were willing to sign research contracts with commercial sponsors that allowed the sponsors, rather thant than the AMC faculty, to control how the research was done, and how and even whether its results were presented.

I agree that physicians should be held to high ethical standards that strictly limit their conflicts of interest. But these standards should restrict all conflicts of interest that could threaten physicians' professionalism. If payments from a drug company that could make physicians more favorably disposed to its products are bad, financial incentives from a managed care organization that tempt physicians to withhold care that could benefit patients are equally bad.

Furthermore, leaders of health care organizations, including executives and trustees of AMCs, should be held to equally strict standards.

The Commandments

The article sets forth what amount to a set of commandments. I actually agree with many of them, even though some are harsh. However, I disagree with those that forbid individual physicians from specific intereactions with drug and device companies but allow AMCS to have such interactions. As noted above, corporate money can sway leaders of AMCs away from their institutions' missions, just like such money can sway physicians from their professional values. Also, as implied above, lacking are any commandments dealing with conflicts involving organizations other than pharmaceutical and device manufacturers. In particular, there are no commandments relevant to conflicts involving managed care organizations or insurance companies. Furthermore, again as implied above, lacking are any commandments for anyone other than physicians.

Enforcement of the Commandments

Why are AMC managers better qualified than are physicians to enforce these ethical standards? Physicians already are held to strict ethical standards incorporated in their training, the oaths they swear, and the requirements for licensure they must maintain to practice. AMC executives, aside from the decreasing minority who are also physicians, are not held to any standards of training or licensure, or any particular code of ethics. Chervenak and McCullough found "there has been to date no ethical framework offered that academic leaders can use to identify, prevent, and responsibly manage the ethical conflicts that are inherent, but sometimes hidden, in being an academic leader." Also, "ethics is an essential but largely neglected tool in the AHC (i.e., AMC) leader's 'toolbox'...."[8]

This blog is full of cases of bad, conflicted, and sometimes frankly corrupt leadership of AMCs and teaching hospitals. Again, the most recent examples include Roger Williams Medical Center (the entire organization was indicted, its CEO was indicted and just fired), UMDNJ (the entire organization admitted to commiting crimes, and is now operating under federal deferred prosecution agreement, while its President was just fired). In the past year, we have also seen the CEO of Fletcher Allen Health Care convicted of federal conspiracy (see post here), ongoing stories of mismanagement at University of California-Irvine (see post here), King/Drew Medical Center (see post here) and at Westchester Medical Center (see post here), etc, etc, etc.

Yet, the JAMA article's policies would put AMC managers in charge of policing physicians' compliance with conflicts of interest policies. These policies would condemn a physician for accepting a $1 pen from a drug company because such a gift might affect his or her practice. However, the policies would tolerate a drug company sending millions of dollars to an AMC. How could one deny the possibility that receiving large amounts of money would affect the organization's decision making?

Instead, I suggest developing a broad set of principles about conflicts of interest, and generally about business ethics in health care, focused on all transactions with outside organizations with their own vested interests or agendas. These principles should apply to all who make decisions in health care, physicians, other health care professionals, and leaders of health care organizations. The details of the implementation of these principles could vary, so as to apply to the setting and role of each individual.

A Final Irony

Finally, it is ironic that the first author of an article on conflicts of interest apparently had an important, relevant conflict of interest that was not disclosed in this article. Dr Troyen Brennan, who is listed as a Professor at Harvard Medical School, just accepted a position as Medical Director of Aetna, Inc, the large, for-profit health insurance and managed care company (see Jan 19, 2006 articles in the Boston Globe and Hartford Courant). Brennan must have been in negotiation with Aetna during some phase of the writing of this article, yet his relationship to the company is not indicated in the JAMA article.

1. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14 (2003) 123–130.
2. Kassirer JP. Managed care and the morality of the marketplace. N Engl J Med 1995; 333: 50-52.
3. Shortell SM et al. Physicians as double agents: maintaining trust in an era of multiple accountabilities. JAMA 1998; 280: 1102-1108.
4. Grumbach K et al. Primary care physicians’ experience of financial incentives in managed-care systems. N Engl J Med 1998; 339: 1516-1521.
5. Feldman DS et al. Effects of managed care on physician-patient relationships, quality of care, and the ethical practice of medicine. Arch Intern Med 1998; 158: 1626-1632.
6. Robinson JC. The end of managed care. JAMA 2001; 285: 2622-2628.
7. Mello MM et al. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.
8. Chervenak FA, McCullough LB. An ethical framework for identifying, preventing, and managing conflicts confronting leaders of academic medical centers. Acad Med 2004; 79: 1056-1061.

Update (1/31/2006) - For a take on this in the inimitable manner of PharmaGossip, go here.

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