“An experiment is ethical or not at its inception, it does not become ethical post hoc – ends do not justify means. There is no ethical distinction between ends and means.”
-- Henry K. Beecher, MD
New Engl J Med 274(24) June 16, 1966 pp 1354-1360.
“For the most part, doctors and civil servants simply did their jobs. Some merely followed orders, others worked for the glory of science."
-- John Heller, Director of the Public Health Service's Division of Venereal Diseases
The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African American men who thought they were receiving free health care from the U.S. government. The Public Health Service started working with the Tuskegee Institute in 1932. Investigators enrolled in the study a total of 600 impoverished sharecroppers from Macon County Alabama. Three-hundred ninety-nine (399) of those men had previously contracted syphilis before the study began, and 201 did not have the disease. The men were given free medical care, meals, and free burial insurance, for participating in the study. They were never told they had syphilis, nor were they ever treated for it. According to the Centers for Disease Control, the men were told they were being treated for "bad blood", a local term for various illnesses that include syphilis, anemia, and fatigue.
The 40-year study was controversial for reasons related ethical standards, primarily because researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease they were studying. Revelation of study failures by a whistleblower led to major changes in U.S. law and regulation on the protection of participants in clinical studies. Now studies require informed consent, communication of diagnosis, and accurate reporting of test results.
The Tuskegee Syphilis Study led to the 1979 Belmont Report and the establishment of the Office for Human Research Protections (OHRP). Importantly, it also led to federal laws and regulations requiring Institutional Review Boards for the protection of human subjects in studies involving human subjects.
Fast forward thirty-five years.
Could the new American Board of Internal Medicine (ABIM) mandate for participating in their Maintenance of Certification (MOC) process unilaterally imposed 1 January 2014 so they can maintain a publicly-reported maintenance of certification "status" be violating ethical standards set forth by the 1979 Belmont Report?
Let me explain why I think it does.
The increasingly complicated test- and survey-taking exercise called "Maintenance of Certification" has never been scientifically proven to improve physician quality. Our society's inability to agree on a definition of a "quality" physician (and how to measure those qualities) is part of the reason why this issue has never been studied. For instance, should we define a "quality" physician on the basis of his or her empathy, surgical skill, lack of complications, ability to recall facts or some combination of these or other attributes? The reality is, it is nearly impossible to adequately define a "quality" physician at the outset.
But the issue of maintaining "quality" health care delivery is critical to those paying for health care services (CMS and insurers, aka, "stakeholders"), especially now in this era of health care reform. Payers want to assure they receive the most value for their dollars spent in health care. Patients want to be reassured that they are receiving competent care by a physician, especially in a time where cost-cutting, deployment of unproven electronic medical systems, use of non-physician care-givers, and shortened physician training and work hours has occurred. Seeing an opportunity, the American Board of Medical Specialties (ABMS) and the ABIM stepped in to help the government define physician quality. Through the assurances of their leadership, the ABIM led "stakeholders" to believe that (1) quality is easy to measure (after all, they have a thorough testing "process") and (2) the responsibility for determining physician quality should rest with individual physicians. This leap of faith by government officials is similar to the Tuskegee era when government physicians were similarly obsessed with African American sexuality, believing that the responsibility for the acquisition of syphilis rested solely upon the individual.
Because the Maintenance of Certification process imposed by the American Board of Internal Medicine is unproven, it is, at best, an experiment that attempts to assure physician quality on patients without a defined hypothesis (what, really, does the ABIM test with the MOC process?) or informed consent. The issue of informed consent is critical, in my view, because the psychological, financial, and social consequences of NOT passing the test to doctors and their patients have never been evaluated.
|The "MOC Complex" at ACC2014 (click to enlarge)|
First, I learned that the pass rate this year (2013) for internal medicine specialists was 86%, and for cardiac electrophysiologists was 84%. This means that fourteen percent of internists and sixteen percent of cardiac elecrophysiologists did not pass their test. (We were assured that 97% "ultimately" pass, however, but no data were supplied to the audience to this effect).
The second thing I learned directly from Dr. Baron yesterday during the question and answer period was this: the ABIM has never studied the psychological, social, or financial impact that NOT passing the MOC process upon physician test-takers. This is not a small issue, especially if one considers that many hospitals are beginning to tie the ongoing Maintenance of Certification process to the issuance of hospital privileges to practice medicine. How could anyone trained in the ethics of scientific study and research permit such an egregious oversight to the protection of physicians?
From the 1979 Belmont Report:
The expression "basic ethical principles" refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.Let's examine each of these principles described in the Belmont Report in regards to MOC testing.
Regarding respect for persons:
Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.Today, physicians are "persons with diminished authority" in the certification and licensure discussion. The decision to invoke every-two-year testing was imposed by leadership of several physician organizations whose leadership have had strong ties to government agencies (including the Center for Medicare and Medicaid Services, a la Dr. Baron) without the approval of their membership. Further, the MOC process is already being used by some hospitals as a lever to dispense hospital privileges without proof that the MOC process assures physician quality, however might have been defined.
Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.Given the fact that the negative consequences of failing to re-certify in medicine are very real for doctors, failing to pass the ABIM's tests may, in fact, harm them. No attempt to minimize harm to physicians has occurred. No attempt has been made to warn physicians about the negative consequences of what might happen to them if they fail to maintain their certification in good "status." Worse still: not allowing physicians to practice medicine may actually harm, rather than benefit, the doctor's patients! The ABMS and ABIM have clearly turned a blind eye to this possibility.
Finally, in regards to the last critical element of the Belmont Report, justice:
Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.So who is served by the Maintenance of Certification process, really? Are patients? Doctors? Or the leadership of ABIM?
Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.
There are significant financial incentives driving the marketing of the ABIM's ongoing MOC process to America's physicians. From the ABIM's own 2012 Form 990 that I could retrieve, the ABIM earned $30,661,314 from their members for examination fees, $17,509,141 for Maintenance of Certification, and an additional $970,415 for exam development, supplying duplicate certificates, and re-scores of the examination. Of the total revenues reported by the ABIM in 2011 ($49,304,645) fully 48.6% ($23,937,881) went to staff salaries, other compensation, and employee benefits. Christine Cassels, MD alone (who served as President and CEO at the time), earned $786,751 that year and had her spouse's travel fees to meetings thrown in, too. It goes without saying that the leadership of these organizations have received salaries far higher than most of their physician members. Justice (as defined by the Belmont Report) can hardly be served when scales are tipped so heavily toward those of our own profession that stand to benefit so handsomely from this certification process.
It is time that doctors and patients understand exactly what has transpired with the foisting of the ongoing MOC process upon America's physicians. Just as the Tuskegee experiments in Macon County Alabama did years ago, well-meaning members of our profession have represented physician "quality" by their own standards that include the ability to perform a serious of test- and survey-taking exercises without responsibly admitting the harms this process might have on their colleagues and their patients. Like the serious breaches of ethical standards that occurred when doctors worked "for the glory of science" in the Tuskegee era, this unfortunate unproven experiment of MOC re-certification by the ABIM continues unabated without checks and balances.
It is time for this injustice against physicians to stop. Responsible physicians and their patients everywhere need to rise up and demand accountability by the ABIM for their ethical breaches that have occurred. The heavy marketing of the benefit of this process without acknowledging its potential harms is dangerous to both doctors and patients. Further, it is not okay to entrap physicians by making them pay for an unproven process that could destroy their social status and ability to earn a living.
To believe otherwise is about as unethical as it gets.
P.S.: Here's a link to an anti-MOC petition underway.