Is departing from clinical guidelines always wrong?

Doctors are not car mechanics with a repair manual that must be followed.

Margaret Somerville | Nov 25 2016 | comment

On the second day of hearings before the New South Wales Legislative Council committee enquiring into the "under dosing" of cancer patients, the first witness was Dr John Grygiel.

Dr Grygiel was a St. Vincent's Hospital cancer specialist, who lost his appointment as a result of his "under-dosing" practice in failing to follow the clinical practice guidelines of recommended chemotherapy dosages.

The media have repeatedly referred to this a “scandal”. That's a damming characterization, so is that label justified?

A doctor's conduct can constitute ethical or legal wrongdoing in four ways:

* they commit a breach of ethics;

* their conduct is professional misconduct (conduct that it brings the profession of medicine into disrepute, which can result in penalties, including loss of a licence to practice medicine);

* it is medical negligence (malpractice), which is treating patients in ways that no reasonably careful and competent doctor with the required skills would treat them;

* in extreme cases, if the conduct shows "wanton and reckless disregard for human life or safety" it could even be criminal negligence.

So the question is whether, in not following the clinical practice guidelines, Dr Grygiel's conduct fell within any of these categories and what is the relevance of the clinical practice guidelines in determining that.

One of the members of the Legislative Council (MLC) repeatedly and aggressively asked Dr Grygiel why he had not apologised to his patients. That question might indicate that he does not understand the ethics and law governing the application of clinical practice guidelines, as it seems to assume that failure to follow the guidelines is automatically wrong doing, which is not correct.

In 1993, the Canadian Medical Association Journal asked me to write an article on this topic. It's currently my most accessed article worldwide, which indicates many people are uncertain and need to know more about this issue. So what is the relevant ethics and law?

Not the Ten Commandments

Guidelines are important and must be taken into account and given due weight, but they are guidelines, not absolute rules, not the Ten Commandments. Deviation from them can be unethical and give rise to legal liability, but so can applying them in certain circumstances, although probably much more rarely.

While the guidelines are guides, and doctors have a duty to inform themselves about them (their duty to keep up-to-date with current medical knowledge, which is an important requirement of competent medical practice), they also have an ethical and legal obligation to use good professional judgment. That means they may deviate from the guidelines, but such deviation must be able to be justified.

In considering whether such justification exists, we must keep in mind the old ethical mantra that "good facts are necessary for good ethics." Two sets of facts are relevant: those on which the guidelines are based and those of each of the cases of Dr Grygiel patients.

The facts on which the guidelines are based can have varying degrees of certainty and verifiability and the less the degree of that certainty and verifiability and of consensus among those drafting the guidelines, the less the strength of the guidelines. Dr Grygiel gave evidence that he spoke to one of the drafters and was told there had been difficulty reaching a consensus. I know that experience from having been a member of a committee trying to write guidelines for "vaginal birth after caesarean section" (VBAC) to guide decision making about allowing a trial of a vaginal birth for a woman who had previously had a child delivered by C-section.

We should keep in mind, also, that medical research and doctors are not always correct and, as a recent spate of withdrawal of published papers from leading scientific and medical journals on the basis of their inaccuracy attests, assessing the validity of medical evidence can involve subjective judgments. I am in no way suggesting that there was any intentional wrongdoing on the part of any member of the "cancer treatment guidelines" drafting committee, but doctors can also have their own biases.

Perhaps the most famous example is that of Halstead's radical mastectomy, a very mutilating and debilitating surgery for breast cancer, pioneered by Dr William S. Halsted, a renowned American surgeon at the beginning of the twentieth century. Despite evidence becoming available of far less damaging treatments giving equally good results in terms of life expectancy and effectiveness, the operation was used for over twenty five years, in contrast to almost all other surgical operations devised at the same time being refined several times or discarded entirely.

Medical historians have speculated why this occurred and the answers include that most surgeons "persisted in a blind faith in the operation designed by Dr Halsted, a Yale football captain who went on to become one of America's most illustrious surgeons."

A doctor’s primary duty is personal care of each patient

I cannot comment on whether Dr Grygiel's deviations from the guidelines were justified, as that depends on all the facts in each individual case and I do not know them. But I thought he sounded credible in justifying what he did to the Legislative Council committee. The short answer to the MLC's question to him, "Why didn't you apologise to your patients and their families?" is that you only apologise if you've done something wrong, and Dr Grygiel's explanation for the lower dose, at the least, threw that issue into question with respect to the dosage used.

Ethically doctors have "a primary obligation of personal care to each patient." Each word in that principle is important and deserves exegesis, but in the context of the present discussion the words "personal care" and what that requires is central. Clinical practice guidelines apply in general, but each doctor must apply them to each particular patient, taking into account all of that patient's circumstances and other relevant considerations.

Doctors are not car mechanics with a repair manual that must be followed. Medicine is both a science and an art and the art of medicine involves, on the doctor's part, the exercise of discretion. Such exercise is both a privilege and an obligation, but it is not unbounded. Rather, it must be undertaken within a matrix of ethical and legal requirements.

Among the most important of those requirements is to obtain the patient's informed consent to or informed refusal of the treatment protocol adopted or withheld, respectively. What that requires, in total, is complex and often involves nuanced analysis and decision making, but, most relevant for present purposes, the concept requires that patients be given all the information that would be relevant to a reasonable person in the same circumstances, which includes disclosing all treatment options reasonably indicated for the patient, and the risks, harms, benefits and potential benefits of all the options, including of refusing all treatment. In addition, patients' questions must be answered fully and honestly.

So Dr Grygiel should have obtained the patient's informed consent to the lower dose treatment. Whether or not he did is a question of fact, but if none of his patients chose the clinical guidelines protocol that would raise serious doubts about whether he did obtain the necessary informed consent. If he did not obtain it, he made an ethical and probably legal error, for which, as the MLC demanded he do, he should apologise.

Margaret Somerville is Professor of Bioethics in the School of Medicine at the University of Notre Dame Australia. Until recently, she was Samuel Gale Professor of Law, Professor in the Faculty of Medicine, and Founding Director of the Centre for Medicine, Ethics and Law at McGill University, Montreal. Her most recent book is Bird on an Ethics Wire: Battles about Values in the Culture Wars. This article was first published in the ABC’s Religion and Ethics section and is reproduced with permission.

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