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From
Medscape News

MedscapeWire
Placebo Surgery Gains Wider Acceptance
March 23, 2001

By Mindy Hung

The ethical dilemma surrounding placebo surgery has been eclipsed by the
controversial use — and
failure — of stem cell therapy in 2 Parkinson's disease (PD) studies.

News of the most recent setback in PD research was released on March 16
when the Genzyme
Corporation and Diacrin Inc. reported that in preliminary results from
phase 2 clinical trials, no
significant improvement resulted from implanting the fetal cells of pigs
into patient brains when
compared with subjects who received placebo surgery.

In the study, which will be presented at the 14th International Congress on
Parkinson's Disease in
July, in Helsinki, Finland, 8 of 18 patients had holes drilled into the
sides of their heads, but were not
given implants. Antibiotics, standard fare for transplant recipients, were
administered to all patients,
although those who had sham surgery were issued dummy anti-rejection drugs.

The ethics review board at Columbia-Presbyterian Medical Center in New York
declined to let their
investigators participate in the study because dummy antibiotics could not
be provided. The review
board deemed the antibiotics provided to all patients as unnecessary, and
possibly harmful.

The second recent PD study, conducted by Curt Freed, MD, and colleagues
from the University of
Colorado Health Sciences Center and published in the New England Journal of
Medicine on
March 8, was fraught with ethical controversy not because sham surgery was
conducted on 20 of
40 patients, but due to the fact that investigators used stem cells from
aborted human fetuses and
because older subjects receiving injections actually reported a worsening
of their conditions. The
cultured mesencephalic tissue triggered an overproduction of dopamine in 5
patients, causing them
to experience dystonia and dyskinesias.

Although the research into PD itself has been set back by these findings,
use of
placebo-surgery-controlled trials in neurologic research has become more
firmly established. Indeed,
the item received only cursory mention in editorial comments in the NEJM
and the mainstream
media.

Moreover, phony procedures have been seeing wider application across other
specialties. For
instance, interest in such methods by orthopaedists has been strong at
least as long ago as 1996,
when a study by J. Bruce Moseley, MD, and colleagues was published in the
American Journal of
Sports Medicine. Moseley and colleagues reported that subjects who
underwent a fake operation
had the same levels of relief from osteoarthritis as those who had received arthroscopy.

The American Association of Neurological Surgeons (AANS) and the Congress
of Neurological
Surgeons (CNS), the only medical organization with a policy statement on
the procedure, sanctioned
sham surgery in January 2000. They state, "in certain, specific
neurological conditions, the use of
'placebo surgery' may reduce investigator and patient bias in analyzing
treatment outcome and,
therefore, increase the likelihood that results of a trial will be
interpreted correctly."

In spite of the AANS/CNS endorsement of sham surgery trials as being more methodologically
rigorous, medical ethicists remain divided. In a 1997 editorial in the
NEJM, Ruth Macklin, PhD,
from the Albert Einstein College of Medicine in New York City, noted that
performing the
procedure for no other objective than to further an experiment violated the
principles of "first do no
harm."

The first findings on placebo surgery were published in the NEJM in 1959.
Leonard A. Cobb, MD,
operated on 17 people suffering from angina, tying the arteries of 8
subjects — a procedure known
as the Fieschi technique — and only making incisions in the 9 other
patients. The fake procedure —
now known as internal mammary artery ligation — proved as successful as the
real ones.

N Engl J Med. 2001;344:710-719.



Mindy Hung is an associate editor at Medscape.

MedscapeWire is edited by Deborah Flapan, an associate editor at Medscape.
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                                 Ray Strand
                             Prairie Sky Design
 -----------------(   on  the Edge of the Prairie Abyss  )---------------
                          when  the  sky  is  clear
                            the ground is visible

                     49/dx PD 2 yrs/40? onset/retired

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