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PARKINSON'S NEWS Scientific Advisory Board Responds to Fetal Tissue Study Results January 16, 2003 In November 2002, Dr. Warren Olanow presented the results of a second major study of fetal tissue transplantation at the Seventh International Congress of Parkinson's Disease and Movement Disorders in Miami, Florida. Dr. Olanow reported that the procedure does not improve parkinsonian disability, and but does cause serious side effects in the form of increased involuntary movements, or dyskinesias. Dr. Olanow pointed out that his findings are consistent with the previous study of Drs. Freed, Fahn and colleagues.* The Scientific Advisory Board of The Michael J Fox Foundation for Parkinson’s Research has made the following observations: * The reported results of this study, conducted by lead researcher Dr. Warren Olanow, reaffirm our long-held belief that the welfare of patients must be paramount in all clinical research. Until researchers are reasonably certain that the medical dictum of “first do no harm” can be met, we believe that no further human clinical trials involving fetal tissue transplants ought to occur. * Still, important lessons may be drawn from this research. First, a well-structured, controlled, double-blind trial that uses placebos and examines patients long after initial treatment is critically important to assessing comparative results and moving science forward. Prior experimentation with transplants was, in general, not structured in such a controlled fashion, nor studied over such a long period of time. As a consequence, the findings were inconsistent and equivocal. Because this study was carefully planned, executed and documented over a longer period of time, researchers have a clear picture of the effects of fetal transplantation as currently performed, and road map to follow in determining why the procedure did not succeed. * Of particular interest to scientists is the fact that although brain scans showed that the transplanted cells appeared to function as anticipated researchers weren’t able to discern any measurable improvement in signs and symptoms of Parkinson’s disease in the patients studied. Further, many of the serious side effects occurred only many months after the treatment. Scientists are already at work using experimental models of Parkinson’s disease to determine why the procedure was not more efficacious, and why side-effects developed * Throughout history, every major scientific breakthrough has been preceded by much trial and error. To most scientists, failure has the potential to teach just as much as success. Indeed, the currently accepted therapy for Parkinson’s disease, the drug levodopa, at first produced terrible side effects (including severe nausea) which were overcome only by starting patients on very small doses and increasing them very slowly. When a promising new therapy fails to deliver the expected results, there is clearly a need for a sober reappraisal of every aspect of the original hypothesis. Yet we must keep in mind that often the result of such an assessment is progress rekindled. * With the goal of renewed progress and discovery in mind, The Michael J. Fox Foundation for Parkinson’s Research has planned a summit of experts in cell replacement therapy and other areas of Parkinson’s research scheduled to convene from March 24 to March 26. The goal is to develop a consensus on the key scientific questions raised by this study and to assess ways in which the Foundation can accelerate the progress of science in this area. *Olanow, Warren, MD, HYPERLINK "http://www.wemove.org/emove/article.asp?ID=510"No Symptomatic Benefit in Second Fetal Transplant Double-Blind Trial. Miami, FL: Movement Disorder Congress, 2002. --- Outgoing mail is certified Virus Free. Checked by AVG anti-virus system (http://www.grisoft.com). Version: 6.0.445 / Virus Database: 250 - Release Date: 1/21/2003 ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn