The Ethics of Surgical Innovation

George L. Spaeth, MD, Philadelphia, PA, USA

Ethics is considering whether behavior is good or bad, right or wrong. Determining whether something is 'ethical' then requires an agreed-upon standard of good or right as opposed to bad or wrong, related to behavior. The confusions, uncertainties and difficulties attendant to considerations of ethics are the consequence of the difficulty in establishing that standard against which behavior is to be judged. Different groups, including physicians, governments, pharmaceutical companies, street gangs and families have their own codes of behavior. Etiquette, whether related to how one behaves at a ball for socially prominent people, a dinner at the White House introducing a school friend or ordering a beer at the local bar, concerns itself with whether actions are right or wrong according to the code of etiquette used as the standard at the ball, the White House, the school or the bar. Etiquette and ethics are different only in that ethics deals with thinking about what it is that makes something right or wrong, whereas etiquette concerns itself primarily with observance or non-observance of a particular code of behavior. Determining whether surgery is 'ethical' requires thinking about whether that surgery is good or bad, right or wrong.

Determining whether surgery is ethical requires, first, establishing what one believes to be right or wrong, good or bad. It is here where considerations of ethics usually get confused or messy, because there is no universally agreed-upon standard of what is good or bad, even when considering a field as miniscule as surgical behavior. Perhaps the Golden Rule, that is, act towards others as you wish them to act towards you, comes closest, but there are readily-apparent, exceptions to that approach. For example, regarding surgery, some individuals wish to be deeply anesthetized during their surgical procedure, whereas other individuals prefer having no anesthesia whatsoever. The Golden Rule is obviously subjective, and subjective approaches will vary.

The standard method of determining whether something is medically ethical is considering whether it is 'in the best interest of the patient'. If that is the Gold Standard for surgery, then innovative surgery is rarely ethical, because innovative surgery is, by definition, experimental, and the outcomes of experiments are not able to be predicted accurately, and are not always good; it is rare for a new surgical procedure to work well when it is in its initial developmental stages.

 Another approach is to consider whether the surgery respects the three fundamental tenants of medical ethics: enhancing autonomy, being beneficial (not harming) and being just and fair.

Autonomy demands total openness. But surgical investigators stand to benefit in many ways: the prestige of developing a new procedure, the financial gain from performing surgery and having patients referred to them, the development of economically beneficial relationships with industry, and the advancement of their professional and academic careers. These conflicts - and others - lead to biases that cloud their judgment about the true value of the procedure they are developing.

Regarding beneficence, it is possible that a new procedure might offer certain advantages over one already in existence, but it is often the case that the new procedure may be more damaging; the surgery developed by Cushing to remove a pituitary tumor killed the initial patients, the initial intraocular lenses 'killed' the eyes into which they were placed, and the early results of phacoemulsification were worse than with the then available techniques.

It is not fair to the patient to encourage him or her to have a procedure that honestly is not as good as the developer believes or hopes. The difficulty of being truly open with one's patient when discussing a new surgical procedure, of the real possibility for a result less satisfactory than already obtainable, as well as the need to follow a strict, standardized protocol, making individualization difficult or impossible, leads many surgeons to avoid performing new procedures because of appropriate ethical concerns that they will not be acting in the best interest of their individual patients. But there is another face to the third aspect of medical ethics, specifically justice. Medical advances only occur when efforts are made to improve on already available technology and to develop new knowledge. If one assumes that the development of improved patient care is a 'good thing', then there is a responsibility to develop new technology and new knowledge. Note, however, that the only appropriate justification for this is the, at least relative, certainty that there will be an actual improvement in patient care. Some of the projected advantages of a new surgical technique may come at the cost of significant disadvantages. Consider phacoemulsification, which resulted in improved vision in comparison to intracapsular extraction, but which increased the cost of care markedly, and was not feasible in many parts of the world.

1. Do not lie
   The 'ethical' aspects of surgical innovation can be extraordinarily convoluted. However, when one considers the matter of the appropriateness of surgical innovation from the point of view of common sense ethics, deciding what is 'right' is actually fairly straightforward. At the heart of virtually every system of ethics is the belief that it is wrong to lie. A lie is not an untruth, but rather an attempt to deceive. For example, telling a patient that 'the old surgery has complications' is true, but when there is no following comment that 'the new surgery also has complications', the first sentence, while true, is a lie because it is an intent to deceive; the surgeon's intent is really to convey to the patient that the old surgery is not safe and the new surgery is. And that is a lie. So, the first principle is, 'Do not lie'. Because we are all prone to biases, being honest requires being evaluated, which means appropriate records must be kept, which need to be open for evaluation by anybody who wishes to review them. Proprietary, secret procedures are appropriate in the world of business, but not in a profession which has as its primary goal the benefit of those on whom the procedure will be performed, not the benefit of those developing it.
    
2. Acknowledge bias
   Perhaps the characteristic that most distinguishes the most recently developed primates, such as man, from all other species, is the ability to deny. Often those most convinced they are unbiased are those with the most biases, including the extremely serious delusion that they are free of bias. Denial and bias prevent us from recognizing that we are deceiving ourselves or others, that is, that we are lying. Denial and bias are promoted by self-interest of any kind. The second principle, then, is be aware that no one can evaluate his or her own work, projects or sense of honesty with total validity, especially when that person (or group) benefits from the project: financially, academically, emotionally, professionally or spiritually. It is prudent to be highly skeptical of one's own work, and to submit it to a critic. It is also important to remember that those reviewing the work have their own biases.
    
3. Follow the Code
   Physicians derive a major portion of their power from their association with the medical profession. From that association they receive their knowledge, their skills, and the public's approbation by being licensed to practice. Every act that physicians do in which they are recognized as being a physician carries with it an obligation to act according to the rules of the medical profession. Those rules are designed to have physicians act scientifically and in the best interest of their patient. The third rule then is that for surgical innovation to be ethical it must follow the rules of the profession. These rules, such as Hippocratic Oath and the Code of Ethics of the American Academy of Ophthalmology, are readily available. Every physician who practices as a physician is obligated to know those rules and to follow them. A surgical trial that is not well designed, and is not scientifically based, is not ethical. While pilot studies are necessary, those developing a new surgical procedure must evaluate that procedure in a properly-designed controlled trial, usually comparing it against the procedure currently considered the gold standard. To continue to perform experimental procedures which have not been tested appropriately is unethical.
   Finally, there is nothing inherently unethical about acting in one's own self-interest. Acting to promote one's own selfinterest, however, is unethical when that fact is not recognized by the person acting and not disclosed to others. Nor is self-sacrifice necessarily ethical. The ultimate goal is to act in a way which is a win for everybody: those on whom the new surgical procedure will be performed, those designing the procedure and implementing its use, and society at large, which may benefit from a method that results in improved health.