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Sorry about the length, but we have to get the info out ... Parkinson's study raises ethical questions Copyright © 1998 Nando.net Copyright © 1998 The Associated Press BOSTON (March 26, 1998 http://www.nando.net) -- In an experiment that has raised ethical questions, half of the participants in a study of a possible new way to treat Parkinson's disease will have holes drilled in their skulls but will not get the treatment. The study is aimed at testing the effectiveness of transplanting fetal pig brain cells into the brains of late-stage Parkinson's patients. Participants in medical studies are routinely divided into two groups -- one might receive a new drug, while the other gets a dummy pill, or placebo. This "control group" gives scientists a basis for comparison and guards against the "placebo effect," whereby some patients feel better simply from receiving medical attention. The Parkinson's study, though, has stirred debate over the ethics of subjecting patients to something more than just a sugar pill. "Striving for scientific accuracy is a commendable goal, but asking someone to have a hole drilled in their head for no purpose is putting science ahead of the subject's interest," Arthur Caplan, director of the University of Pennsylvania's Center for Biomedical Ethics, told the Boston Herald. The study is being sponsored by Diacrin Inc., a Boston biomedical company. The Food and Drug Administration, the agency that will ultimately decide whether to approve the fetal pig cell therapy, encouraged the operations as a way of providing a control group. The study will be done at Emory University in Atlanta and the University of South Florida in Tampa. Patients will be recruited from those two institutions, Columbia University and Boston Medical Center. Beginning over the next few months, surgeons will drill a nickel-size hole in the heads of 18 patients and implant 12 million fetal pig cells into the brain of each person using a long needle-like device. Eighteen other patients will get surgery but not cells. Small depressions will be drilled into their skulls, just above the ears. The holes, however, will not be drilled all the way through the skull, as they will in the real operations. In what is known as a "double-blind" study, neither the patient nor the doctor who monitors progress will know who has been implanted with pig cells. Michael Egan, Diacrin's senior vice president, said that the risks are small and that the phony procedures are the only way to measure the success of the transplants and determine whether they should be extended to the estimated 1 million Americans with the disease. There is no cure for Parkinson's, which causes tremors and stiff movement. Patients will be informed of the risks and will be told beforehand that they have a 50-50 chance of getting the real operation. Those who receive the mock surgery will be given the chance to get the cell transplant later, if the treatment proves effective. Whether cells are transplanted or not, most patients will be able to go home the next day wearing just a small bandage. Dr. Stephen Kott, a neurologist at Lahey Hitchcock Clinic in Burlington, which took part in an earlier study on the safety of the procedure in which no patients went untreated, told the Herald that the clinic would not have agreed to the sham operation. "There were ethical problems. There are risks involved," he said. "You can have a heart attack, or there can be an infection in the bone." But George Annas, a professor of health law and medical ethics at Boston University, said, "There's almost no question in my mind that you have to do something like this to get a valid control group." Besides, he added, "I'd be much more concerned about the people getting pig cells in their brains than people with just holes." In the first-stage study done on 12 patients at the Lahey Clinic, the 11 surviving patients improved 19 percent on physical assessment tests taken one year after the operation. The patient who died suffered a blood clot unrelated to the operation seven months later. Joan Samuelson, president of the California-based Parkinson's Action Network, an advocacy group, said the mock operations are necessary to advance a cure. "We need to get a breakthrough as strong as is humanly possible and if that is what the researchers think is needed to advance science, we support that," she said. The fact that patients are willing to undergo the trials -- even if they get only a placebo operation -- shows how desperate they are for a cure, said Samuelson, who was diagnosed with Parkinson's 11 years ago at age 36. The National Institutes of Health is funding a similar study using human fetal brain cell transplants, where half the patients receive mock surgery, the FDA said. Judith Richards [log in to unmask]