Surgeons advised to consider the ethics of new procedures

Despite the appeal of an unapproved technique, a conservative approach usually is most appropriate.

BUENOS AIRES — In an era of medicine where technological advances occur rapidly, desire on the part of surgeons to treat patients with the newest procedure leads them sometimes to adopt techniques that have not been thoroughly evaluated in a clinical trial. Even when a new, seemingly efficacious approach seems best, Mauro Campos, MD, a professor of ophthalmology at the Paulista School of Medicine in São Paulo, warns that a tested and conservative one usually is better.

“The enthusiastic descriptions of new procedures at meetings or their premature, massive commercial advertisement historically have induced more sensible physicians to adopt certain therapies before their evaluation in a well-conducted clinical trial,” Dr. Campos told Ocular Surgery News. Dr. Campos cited thalidomide-induced birth defects, dangerous IOLs of the 1950s and a long history of failed refractive procedures.

Though the risks may appear minimal, Dr. Campos urges physicians to carefully review all other therapeutic options with their patients before recommending a procedure that has not been fully evaluated. A more conservative approach usually is a better option, he said.

“By taking a conservative approach, a surgeon will be allowing the newer, questionable procedure time to develop and time to be thoroughly tested,” he said. When an untested procedure is the only reasonable option, Dr. Campos said surgeons are obligated to consult colleagues to discuss its indications, limitations and if possible, to request their assistance during surgery.

Group discussion

There will be times when the newest approach is the only option, and when that is the case, Dr. Campos recommends a group discussion with colleagues prior to surgery.

“A group discussion of clinical cases is a great learning experience and particularly beneficial here,” he said. When discussed, new techniques, he said, should be evaluated with internationally accepted standards, not only those unique to a specific region. “Further, patients who understand the investigational nature of a new procedure are the best candidates.”

Dr. Campos said informed consent prior to undertaking an unapproved surgical procedure must include an in-depth discussion with the patient. The patient must be made to understand their specific condition or problem, the nature and goal of the proposed treatment, the risks and consequences of the proposed treatment, the probability of success, feasible alternatives and the prognosis.

“A detailed informed consent discussion will give the patient enough information for him or her to make an autonomous decision,” Dr. Campos said. The patient’s family also should be consulted, he said.

Managing desperation

Patients diagnosed with a sight-threatening condition are typically more willing than others to agree to a procedure that entails certain risks or is considered experimental. These patients, he said, are most vulnerable and must be dealt with most delicately.

“These patients are often weak and may be receptive to any option proposed by their physician,” he said. “The physician may be tempted to offer an unapproved technique, but the physician must remember that the recognition of a miracle may be short lasting and, if the therapy doesn’t work, it may have interfered with the success of a yet-to-be developed technique that could be available soon.”

Proving ground?

Because Latin American laws regulating the use of new medical equipment tend to be more liberal than in other parts of the world, there is a perception among some physicians that Latin America is a proving ground for untried surgical procedures.

After forming an affiliation with a local hospital, American and European physicians often are free to try new procedures that they legally may be prevented from undertaking at home. Clearly most foreign physicians working in areas with liberal regulations are interested in good medicine and patient safety — not in exploiting indigenous patients — but this practice still may create an ethical dilemma for cooperative Latin American physicians interested in new research but concerned about the possible dangers involved.

Dr. Campos advises would-be investigators not to try anything abroad they would not try at home.

“It is an internationally recognized ethical principal that a new drug, device or procedure should first be tested in its country of origin,” Dr. Campos said. “Before agreeing to cooperate with a foreign physician, a local physician should consult his or her national health agencies to ask for the special permits and necessary requirements for these practices.”

Dr. Campos said in Brazil, he has encountered cases where the work of a foreign physician, one invited there by the local medical community, led to negative repercussions.

Among Latin American nations, Brazil appears to be leading the way in preventing physicians — local or foreign — from using unapproved procedures. The creation of the National Health Council in 1998 to monitor medical practice has curtailed untested medical procedures. Dr. Campos said other Latin American nations are moving in that direction, but despite better policing, the use of untested procedures will remain a problem in both Latin American and other developing regions.

“The iatrogenic consequences of prematurely adopting unapproved practices will always be present in medicine due to the intense competition for market and leadership,” he said. “It is a difficult problem to solve because governmental agencies that regulate medical practice are always being pushed by physicians and companies to anticipate the approval of certain techniques that may produce less than acceptable results in the future.”

Dr. Campos presented a paper on ethical considerations in the use of new surgical techniques at the One Day Meeting on Presbyopia, held recently in Buenos Aires.

For Your Information:

Mauro Campos, MD, is a professor of ophthalmology at the Paulista School of Medicine in São Paulo. He can be reached at Paulista School of Medicine, Rua Botucatu, 822, São Paulo 04023-062, Brazil; +(55) 11-572-7713; fax: +(55) 11-573-4002; e-mail: mcampos@pobox.com. Dr. Campos has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.