Outside the operating room—economic, regulatory, and legal challenges

A historical perspective: The more things change, the more they remain the same

By Paul A. Lombardo, PhD, JD

As a historian and a lawyer, I tend to look back to established precedents, a tendency that often leads to a conservative and cautious perspective. This kind of temperament is slow to reach sweeping conclusions, slow to push for change, and slow to believe that anything is really very new. This temperament is in stark contrast to that of the successful surgeon, who tends—again, speaking in stereotypes—to be aggressive, bold, courageous, pathbreaking, and, at the best moments, even heroic.

This contrast in temperaments may bring a different and perhaps helpful perspective to the task I have at hand—to look to the past for examples of ethical challenges in surgical innovation. In gathering these examples I was struck by how many of the foundational ethical issues that surgeons have faced over the years remain with us today.

CASE 1, 1649: ‘STANDARD OF CARE’ CONCEPT ARTICULATED

In 1649, an ordinance passed by the Massachusetts Bay Colony made it a crime to operate on a person without consent. It also stated that no person employed as a surgeon may perform any act contrary to “the known approved rules of the art” as laid out by one’s medical peers. The ordinance pointed out that this rule was meant not to discourage “the legal use of the skills of healers” but rather to inhibit those who might not be restrained from “the presumptuous arrogance of their own skill.”

This law mandated three things that are a foundation of what we think of as surgical ethics today:

• The notion of a standard of care (“the known approved rules of the art”)
• Peer review (the need to consult preoperatively with peers regarding that standard)
• Patient consent.

Interestingly, this ordinance was adopted at a time when most surgery was performed on visible pathologies or deformities, and elective surgery was all but unknown. Only about 150 years later did surgeons open a body cavity on a regular basis.

CASE 2, 1809: INNOVATION IN THE FACE OF CONDEMNATION

In 1809, Ephraim McDowell, a Kentucky surgeon, described the desperation of his patients as a motive for attempting a new procedure to fix a problem that was otherwise incurable. In his most famous case, McDowell reported visiting a woman some 60 miles from his home who thought she was pregnant but who actually had a large ovarian tumor. McDowell told her that there was no cure but invited her to come to his home if she were willing to undergo an experiment. He thought she would not make the trip, but, to his surprise, she arrived on Christmas Day in 1809.

As McDowell prepared for surgery, his nephew, who was a physician and his partner, argued that the procedure was a terrible thing to try. McDowell was also condemned from the pulpit by a preacher, who declared that the surgery was tantamount to murder if it failed.

While his patient recited psalms from the Bible, McDowell removed a 22-pound lump of tissue without anesthetic or antisepsis. The patient returned home about a month later and lived for more than 30 more years.

After having performed this oophorectomy procedure three times, McDowell deemed it less perilous than any other mode of treatment and the only certain cure for diseased ovaries. Later, surgeons in England who read about his work criticized McDowell for not explaining the operation sufficiently for others to replicate it, although he denied this charge.

In pioneering oophorectomy, McDowell did something quite innovative in the face of considerable professional and community opposition. Moreover, he took care to obtain patient consent and to include his patient in decision making.

CASE 3, MID-1800s: J.MARION SIMS AND ‘THERAPEUTIC MISCONCEPTION’

J. Marion Sims, considered the father of American gynecologic surgery, is famous not only for his technique as a surgeon but also for inventing several instruments, including the speculum. Yet he is criticized by historians and ethicists, primarily because he often performed experimental procedures on slaves, who probably were not in a position to give true consent. He kept patients as boarders for many months, doing a variety of experiments on them, and described in his writings how much pain his patients endured from his mistakes or from the prolonged operations.

Sims’ work is an example of “therapeutic misconception”: while he told his patients that he was going to cure them, he often had no idea whether he could. Thus, his patients believed that the operations were primarily for their benefit although he seems, as critical colleagues came to believe over time, to have sometimes been simply experimenting on patients who were uniquely vulnerable.

CASE 4, 1903: EARLY EXAMPLE OF MODERN INFORMED CONSENT

In contrast to the record of Sims, some 50 years later Dr. Franklin Martin described the painstaking approach he took to advising a patient who would undergo one of the first ovarian transplants, performed around 1903. Martin wrote:

I carefully explained to her the difficulties which we had to surmount…. I also clearly informed her that the operation must be looked upon entirely in the light of an experiment, and that she must be prepared to assume all responsibility with regard to failure in the outcome. Being a woman of unusual intelligence and one who was thoroughly in earnest in her efforts to regain her normal condition, these preliminaries were very easily settled.⁹

Without being required to do so, 100 years ago Martin went through a process equal to any informed consent disclosure that one might encounter today.

CASE 5, EARLY 1900s: A CALL FOR RESTRAINT IN EXPERIMENTATION

Around the same time, at the beginning of the 20th century, a surgeon writing in the Boston Medical and Surgical Journal condemned “over-confidence in the benefits to be derived from mechanical interference and an unrestrained enthusiasm for doing something tangible and heroic.”¹⁰ He urged his colleagues to “be brave enough to refrain from the mutilation and suffering caused by too late and hopeless operations.”¹⁰ He noted the habit of experimentation with new methods, arguing that advances in surgery led to a disproportionate focus on surgery as an art and too little attention to surgery as a science.

These arguments from a century ago make clear that today’s debates about the evidence required to move forward with innovative procedures are certainly not new.

CASE 6, 1913: COMPLEX INSTITUTIONAL MOTIVATIONS

In his 1913 book, The Modern Hospital: Its Inspiration, Its Architecture, Its Equipment, Its Operation, Dr. John Allen Hornsby wrote:

Benefactors of institutions, before giving their money, will want to know just what care the poor…are actually receiving at the hands of the institutions asking for their aid….Yet there must be a difference between the service given to a millionaire and a pauper, but that service should be wholly of the luxuries. The pauper need not have broiled quail and asparagus tips for dinner, and he need not have a private room with adjoining bath, with roses on every stand and the odor of perfumes scenting the room; but these extras should be the only ones that the man of millions should have that the pauper should not have; and patrons of wealth and refinement and of humanitarian instincts will give thousands annually to the institution where they know the poor are getting everything a rich man can get that is needful, where they will give begrudgingly a few paltry dollars to the institution that they know is neglecting the wants and welfare of the poor.¹¹

While this excerpt is notable for Hornsby’s eloquence in arguing for meeting a standard of care for the poor, it is just as notable for demonstrating how complex Hornsby’s motivations were. Not only should we care for the poor, but we have to do it right or the institution will not get money from the rich. In other words, “give the donors what they want.” Then, as now, it took large sums of money to run institutions, as well as to put new innovations in place. And then, as now, institutions had to grapple with complicated motives.

SAME ISSUES, NEW CONTEXTS

This historical review makes clear that the ethical issues we face today are not new. The foundational questions about the ethics of biomedical research as applied to surgery consistently revolve around consent, how thoroughly to inform patients, the use of vulnerable populations as research subjects, distinguishing between experimentation and therapy, and, of course, money and the best use of resources. Variations on these questions continue to loom for surgeons and other physicians.