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Ned, There may be nothing wrong with the use of sham surgery in clinical trials. It may indeed be necessary for determining if a treatment actually is effective. On the other hand, having holes drilled into the skull, incisions made in the scalp and being put under general anesthesia for several hours is not the same as taking a sugar pill. Researchers and doctors and bioethicists have all been surveyed on their opinions on the use of sham surgery, but no one has asked Parkinson's patients, as possible future clinical trial participants, about their viewpoints. That is why the Parkinson Pipeline Project initiated this informal survey. We recognize this is not a scientific study, but we hoped to learn about the viewpoints of informed PWP. We expect that in the near future more potential PD treatments will involve surgery - whether gene therapies or stem cell implantation - and sham surgeries are likely to be performed as part of the research study design. We think now is the time to identify potential problems and make sure ethical guidelines and safe procedures are in place that adequately protect subjects. We think informed consent documents need to be closely examined so that trial participants are fully informed about the risks and benefits of participating in trials and about the rights and responsibilities of clinical trial subjects and trial sponsors. Alternative study designs might also be developed that utilize less invasive techniques. For example DBS surgery was approved by the FDA without the use of sham surgery in controlled clinical trials. We need to educate ourselves about all the alternatives. The members of the Parkinson Pipeline Project encourage increased participation in clinical trials and we deeply appreciate all the PWP who have volunteered for trials and are leading the way towards better treatments and someday a cure for Parkinson's. If anyone would like to add their opinions to the Sham Surgery Survey, go to www.pdpipeline.org and click on the Survey under what's new. Thanks, Linda herman www.pdpipeline.org -- Ned Gardner <[log in to unmask]> wrote: Linda: As long as the PWP involved are aware that they are in a study and that this possibility exists that no surgy may take place what is the harm, they volunteered. How else can Can a study establish base lines and prove the true effectiveness of a procedure without first eliminating such things as hysterical responses and the placebo effect. Ned ----- Original Message ----- From: "[log in to unmask]" <[log in to unmask]> To: <[log in to unmask]> Sent: Monday, July 16, 2007 7:18 AM Subject: Survey of the use of sham surgery in clinical trials > Hi all, > As more Parkinson's treatments involving surgery move into phase II > clinical trials, (such as CERE120 and GAD gene therapies and Spheramine > cell therapy), we can expect increased use of sham surgery in clinical > trial designs. > As a placebo control, sham surgery means there will be some patients that > will undergo anesthesia, IV solutions, and surgical prep to undergo > anesthesia, will have to be placed on IV solutions, and be surgically > prepped, but will not receive the treatment under trial. No one other than > the neurosurgeon will know who receives the sham surgery. > > What is your view of the use of sham brain surgery in Parkinson's > research? > > To read more about sham surgery and reply to short survey being conducted > by the Parkinson Pipeline Project-- go to www.pdpipeline.org and click on > "Survey on Sham Surgery" (under What's New. ) Responses can be anonymous, > if you prefer. > > Thank you. We appreciate your opinions. > Linda Herman > > www.pdpipeline.org > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: > mailto:[log in to unmask] > In the body of the message put: signoff parkinsn > ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn