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http://www.nationalpost.com/news.asp?s2=world&s3=specialreports&f=990427/2527815.html

April 27, 1999

If phony operations help why not just do them?
Surgery as placebo: Deceiving patients is viewed as being ethically
wrong

Sheryl Gay Stolberg
The New York Times

In 1939, long before high-tech drugs came along to treat the chest pain
known as angina, an Italian surgeon named Fieschi devised a simple
technique. Reasoning that increased blood flow to the heart would ease
his patients' pain, he made tiny incisions in their chests and tied
knots in two arteries. The results were spectacular. Three quarters of
all patients improved. One third were cured.

Two decades later, the National Institutes of Health paid Dr. Leonard A.
Cobb, a young cardiologist in Seattle, to conduct a novel test of the
Fieschi technique. Cobb operated on 17 patients. Eight had their
arteries tied; the other nine got incisions, nothing more. In 1959, the
New England Journal of Medicine published his findings: The phony
operations worked just as well as the real thing.

That was the beginning of the end of the procedure, known as internal
mammary artery ligation; within two years, it became a footnote in the
medical history texts. It was also the beginning and the end,
apparently, of sham surgery in North America. By the early 1970s, an
ethics revolution had transformed human experiments, and the idea of
surgery as placebo was unthinkable.

Unthinkable until now. Sham surgery is on the rise -- to the horror of
some doctors who say it is immoral and to the delight of others who say
it is time to apply the same rigorous scientific standards to surgery as
to the rest of the medical profession. And with it comes a host of
thorny questions.

The results of the first sham brain surgery study were reported last
week in Toronto by a team of neurologists. Forty people with Parkinson's
disease participated. Each had neurosurgery: four tiny holes, drilled
through the forehead into the skull. But only half got the injections of
fetal cells that might have repaired their damaged brains; the others
got nothing. One year later, three members of the placebo group said
their symptoms had improved.

The study has drawn praise from officials at the National Institutes of
Health -- who paid for it -- and criticism from other quarters. "A
placebo is truly inert and harmless," said Dr. Arthur Caplan, the
bioethicist at the University of Pennsylvania. "This is not a placebo.
It is a phony surgical operation."

Despite Caplan's protests, there are similar studies under way, in part
because the U.S. federal government is requiring them and in part
because new, less invasive, surgical methods make them feasible. Two
other groups researching Parkinson's are running sham neurosurgery
tests. A Rhode Island biotech company, Cytotherapeutics, is using phony
operations to study a treatment for cancer pain that inserts analgesic
capsules into the fluid at the base of the spine. In Houston, the
Department of Veterans' Affairs is sponsoring a program to see if
arthroscopic surgery, a common treatment for knee injuries, works for
osteoarthritis.

"If we so well accept a placebo in medicine trials, drug trials, why
don't we accept it in surgery trials?" asked Dr. Nelda Wray, chief of
general medicine at the VA Hospital in Houston. "My hope is for us to
critically think about the risk of the placebo, and if we can reduce it,
we should think about doing placebo trials before we disseminate
surgical procedures."

The placebo effect in medicine is well-documented. The word is Latin,
from the Catholic prayer for the dead, meaning "I shall please." In
centuries past, doctors used placebos to placate problem patients. "You
gave them something to send them away happy," said Anne Harrington, a
medical historian at Harvard University. Experts estimate that 30% of
all patients getting placebo treatment today improve.

The effect is profound in such disorders as Parkinson's, where patients
have good days and bad, and in those diseases where pain is common. And
it is likely to be especially powerful in an intervention as dramatic as
surgery, said Dan Moerman, a medical anthropologist at the University of
Michigan at Dearborn. "There is probably more need for placebo tests in
surgery," he said, "than in other areas of medicine."

The common wisdom in ethics circles is that in routine healthcare,
intentionally deceiving patients is wrong. But the debate over sham
surgery raises the question: If phony operations can help people, why
not just do them?

"That," said Dr. Wray, the Texas knee researcher, "is an important
point. What to do with it, medicine is going to have to decide."

Copyright © Southam Inc.
--
Judith Richards, London, Ontario, Canada
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