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The March 28th edition of the OTTAWA CITIZEN, a well-known daily newspaper in Canada's capital contained a controversial article on a Parkinson's research study in the United States. The article with a Boston source reads as follows:- 'Patients suffering the advanced stage of Parkinson's disease are so desperate for a cure for the untreatable disease that they're willing to undergo fake operations. In an experiment that has raised ethical questions, half of the participants in a study of a possible new way to treat the disease will have holes drilled in their skulls but will not get the actual treatment. The study is aimed at testing the effectiveness of transpanting fetal brain cells from pigs 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 contol grooup gives scientists a basis for comparison and guards against the "placebo effect," whereby some patients feel better simply from receiving medical attention. Joan Samuelson, president ot the California-based Parkinson's Actioin Network, an advocacy group, said the mock operations are necessary to advance the cure. "We need to get a breakthrough as strong as is humanly possible and if that is what the reseaschers think is needed to advance science, we support that," she said. The fact that patients are willing to participate in the study-even if they get only a placebo operation-shows their desperation, said Ms. Samulson, who was diagnosed with Parkinson's 11 years ago at age 36. The study has stirred debate over the ethics of subjecting patiients to a "placebo" that is not just a sugar pill. "This is not just giving somebody a pill. This is really doing an operative procedure on somebody," said Dr. Prather Palmer, a neurologist at the Lahey Hitchcock Clinic who monitored a group of patients already implanted with the pig cells. The study is bing sponsored by Diacrin Inc. a Bostoo biomedical company. The U.S. Food and Drug Administration, the agency that will ultimately decide whether to approve the fetal pig cell therapy, encoouraged the researchers in their plans to use sham operations. The study will be done at Emory University in Atlanta, Georgia, and the University of South Florida in Tampa, Florida. Patients wil be recruited from those two institutiions., Columbia university in New York City and the Boston medical Center. Over the next few months, surgeons willl 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 wiill in the other operations. In what is known as a "double-blind" study, neither the patient nor the doctor who monitors progress will know who hs been impllanted with pig cells. Michael Egan, Diacrin's senior vice-president, said the risks are small and that the phoney 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 diseease. There is no cure for Parkinson's, which cauces tremors and stiff movement. Patients will be informed of the risks and willl be told beforehand they have a 50-50 chance to get the cell transplant later if the treatment proves effective. Whether cells are transpanted or not, most patients wil 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 ealrlier study on the safety of the procedure in which no patints went untreated, told th BOSTON HEARALD the clinic would not have agreed to the sham operation.. "There were ethical problms. There are risks involved," he said. "You can have a heart attack, or there can be an infectioin 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 cell 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 per cent on physical asessment tests taken one year after the operation. The patient who died suffered a blood clot unrelated to the operatiion. ' Ken Clements < [log in to unmask] > 64/2 ottawa CANADA