Title: Innovation or Research in Surgery
Author: Aaliyah Eaves-Leanos
Description: A plastic surgeon wants to bypass accepted standards for research on grounds that they stifle “innovation,” but he also stands to make a sizable profit using his innovative technique now, rather than waiting for it to be formally approved.
Keyword(s): plastic surgery research, innovation versus research, conflict of interest, randomized control trial
Based On: (Murphey, 2004, p. 25)
Additional Source Information: (Frader & Caniano, 1988)
Case: Dr. A is aboard certified plastic and reconstructive surgeon. He completed two surgical residences, one in general surgery and the other in plastics. Dr. A. did his plastics residency in Los Angeles (L.A.) under world renowned plastic surgeon to the “stars” Dr. X. After the residency was over Dr. A was offered a position in a large plastic surgery group in L.A. that was very lucrative but was considered a cosmetic surgery mill. Dr. A decided to return to his own small southern town to accept an appointment with the local University on the promise that the University would devote substantial resources to building up the plastic and reconstructive surgery department so that it became a regional leader with Dr. A at the helm.
Most of Dr. A’s work consisted of complex, difficult and time consuming reconstructive cases and on teaching. Dr. A found that he had no time for his personal life and he was becoming increasingly overwhelmed by the tremendous amount of stress to generate revenue for the University. The promises the University made to lure him back to the little southern city failed to materialize and Dr. A felt underappreciated and under compensated in his current position.
Dr. A decided to leave the University and open his own practice. Surprisingly, the small town had numerous “old money” families and beauty pageant contestants which led to an over saturation of cosmetic surgeons in the area. Dr. A found that he was not able to build his business on his stellar education alone; he realized that he would need to distinguish himself in some other way.
Dr. A ran into his old mentor Dr. X at the annual American Society of Plastic Surgeons (ASPS) meeting. Dr. X told Dr. A about this new method for performing the standard breast augmentation procedure, but confessed he was having difficulty with prospective infections in about one third of the patients he tried it on. Dr. A was eager to join Dr. X on a research project that would improve this new technique because it could give him a significant edge over his local competitors. Dr. X dismissed the idea of a formal clinical study because he was the kind of surgeon that resisted formal clinical trials on the grounds that his work was not well suited for that type of research.
Dr. X believed that a better way to ascertaining the value of a particular method was the practical application of it on a succession of good cases. Dr. X cited the fact that the clinical process is too lengthy, expensive, and burdensome, and in the interim other options can become available that may even make the finding in the studies obsolete for practical purposes. In fact, the medical community may adopt an “innovation” that is concurrently in a research trial with its efficacy still pending. Dr. X said surgeons will be more likely to evaluate it based upon peer custom and usage rather than wait for the conclusion of the clinical trial. His main complaint lodged against participation in clinical trials was that he did not want to feel locked in a trapped by a particular technique or strategy, he preferred autonomous decision making during surgery. Dr. X worried that while he was locked into the study protocol some other surgeon would find an improvement and steal the success from approach.
Dr. A felt conflicted because his University experience made him value research and the generalizable knowledge that flowed from such research. Clinical trials ultimately led to medical improvements across many specialties as a result of published studies. He also knew that Dr. X’s line of reasoning was the norm among surgeons, which caused the proliferation of surgical techniques throughout the medical community from informal innovations by specific surgeons rather than formally researched or fully evaluated techniques in clinical trials.
When Dr. A returned home he continued to ponder his conversation with Dr. X and the opportunity for personal recognition and business advantage he might gain by trying Dr. X’s new technique. Fortuitously, he was contacted by a new patient that wanted a breast augmentation that presented a unique problem for Dr. A. This particular patient had a very small frame and she exhibited an obsessive concern about the scars that might be visible after the surgery. Dr. A felt that Dr. X’s new technique would best minimize scaring for his patient’s body type. Dr. A felt that he had gained new knowledge and skills from his stint at the University focusing on micro reconstructive surgeries and may have found a way to reduce the potential for infections that Dr. X had experienced. Dr. A decided to test this idea on this new patient with the goal of making this his new technique provided it was successful.
Dr. A explained to the patient that the other “local” surgeons didn’t use his new technique and that he preferred the methods that L.A. plastic surgeons used. He explained to the patient that some patients had experienced post operative infections, and that there was a risk that she too would have to have additional medical care due to a post operative infection, but such risks are always possible with surgery. The patient said she didn’t care how he did it so long as he minimized the scars.
The surgery went extremely well, there was no post surgery infection and the patient was very pleased because the scars were practically invisible. Dr. A began to exclusively use this new technique and to advertise his “L.A. Style” procedure in the local women’s magazine.
- What benefit can be gained by allowing physicians to use the innovation exception to circumvent the requirement that all new medical treatments must undergo a formal research process?
- What is the potential harm in allowing physicians to use innovation instead of going through the formal research process?
- Is there any validity to the claims made by Dr. X regarding randomized clinical trials, and why or why were you not, convinced?
- Did Dr. A use a new untested medical treatment for his own professional gain and try to disguise it as an innovation? Were his actions fair and appropriate?
- A huge hurdle to implementing the Belmont Report’s recommendation that clinical innovations be formally studied as soon as practical is the reality that standards of practice within the medical community may get established faster than it is feasible to conduct the research. Would it therefore be acceptable to allow physicians’ observations regarding the efficacy and appropriateness of the innovation, as reported in a series of case studies, to fulfill the Belmont requirements?
Source: Murphy, T. (2004). Case Studies in Biomedical Research Ethics. Cambridge, MA: The MIT Press.
Saunders, C., Baum, M., & Houghton, J. (1994) Consent, Research, and the Doctor-Patient Relationship. In R. Gillon (Ed.) Principles of Healthcare Ethics. Chichester: John Wiley & Sons.