The issue of sham surgeries has been debated my medical ethicists for the past several years. Essentially to answer part of Jean's questions, the subjects were told that they would receive either the sham surgery or the fetal tissue implant (both procedures explained). Those who received the sham operation were told that if the study produced benefits, they would be eligible for the real surgery in a year.
Now the problems:
Is it ethical to subject individuals to general anesthesia, holes drilled in the skull, and a cannula inserted but no tissue injected with no benefit for the sake of scientific rigor? None of the above are without risks most notably from the anesthesia or from infection.
Some of the sham operations have not inserted the cannula but have only gone so far as the anesthesia and the drilling of nickel sized holes. Same ethical concerns as above but now the benefit of the sham operation has been compromised. So now the problem is both ethical as well as scientific.
Finally, in a couple of the studies where the follow-up treatment has been promised to placebo patients, the treatment has been postponed for a least two years if not indefinitely due to the deaths of some of the transplant subjects.
So are we looking down the slippery slope with this research or have we already started to tumble?
Linda
Jean Edwards wrote:
Hi all: In experiments involving placebos, what are all the subjects/participants told? I was reading about a medical procedure reported in newsweek regarding surgery to relieve symptoms of Parkinson's disease. Some of the participants received the real operation; others a sham operation. Researchers found that those receiving the sham operation "benefited almost as much as those who had fetal cells implanted in their brains." Again, what are the subjects told? And.. I wonder what happens if the patients who receive the sham operation find out it was a sham. Thanks in advance to those who reply. JL Edwards
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Linda M. Woolf, Ph.D.
Associate Professor - Psychology
Director - Gerontology
Coordinator - Holocaust and Genocide Studies
Center for the Study of the Holocaust, Genocide, and Human Rights
Webster University
470 E. Lockwood
St. Louis, Missouri 63110
http://www.webster.edu/~woolflm/
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