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Friday, June 22, 2007 More Sloppy Headlines on Parkinson's Disease What's wrong with these headlines--one from HealthDay News and the other from ABC News Radio? First Gene Therapy Trial Effective Against Parkinson's and New Parkinson's Treatment A reasonable person would conclude that there's a new treatment involving gene therapy for Parkinson's disease. In fact, the study in question, which was just published in the research journal Lancet, was not even designed to show whether this alleged treatment is effective or not. It is merely a safety study of 12 people designed to show whether the experiment will clearly kill or otherwise injure potential subjects of future experiments. Now, everybody repeat after me, a safety study (technically called a Phase I clinical trial) is not a dosage study (phase II) or an efficacy trial (phase III). Phase I studies are the first baby steps of figuring out whether to even pursue this line of research in humans. Unfortunately, this gets glossed over time and again in general press reports. It's entirely possible that whatever suggestive hints of efficacy showed up in this incredibly limited trial were the results of the surgery used to implant the viruses that carried the target genes--and not the genes themselves. The implanting operation uses many of the same techniques as deep brain stimulation, which has already shown some benefits with respect to Parkinson's. I know, I know. Journalists typically don't get to write their own headlines. But this is playing with the hopes and fears of folks with Parkinson's disease and it's wrong. In addition, as the AP's Malcolm Ritter reported, the lead investigator of the Parkinson's study Dr. Michael Kaplitt has a financial interest in the company that is developing this so-called treatment. Clearly that's another potential source of bias and a further reason to remain wary about all the enthusiastic press. Source: MG Kaplitt et al. "Safety and tolerability of gene therapy with an adeno-associated virus (AAV) borne GAD gene for Parkinson's disease: an open label, phase I trial." The Lancet 2007; 369:2097-2105 Posted by Christine Gorman at 2:27 PM Rayilyn Brown Board Member AZNPF Arizona Chapter National Parkinson's Foundation [log in to unmask] ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn