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here's what i think about it: scientifically, it would be wonderful to have perfect clinical trials, controlling for placebo effects and every other effect imaginable, exploring the effect in every possible subpopulation, and so on. but no clinical trial is perfect, so we shouldn't surrender the right of PWP to have their input in clinical trials that they will participate in. here's what happens if we adhere to this philosophy -- that nothing is wrong with sham surgery or, extrapolating, any sort of trial (drilling holes in skulls? inserting dud electrodes? injecting saline instead of stem cells?) as long as there is informed consent -- desperate *individuals* will sign up for trials hoping to be in the non-placebo group, but end up getting nothing beyond risky surgery and holes drilled into their skulls. is this what we believe in? it sounds like most here don't. one option that PWP, caretakers, and family members have is to lobby the FDA about sham surgeries. if the community makes it voice heard, these can be prevented, and i think this is completely reasonable. there will be some additional placebo risk, but if that's the a i also want to point out that, as i understand it, clinical trials are all approved by medical boards that are independent of the pharmaceutical companies, as well as the FDA. so there is considerable insulation from cruel trials, but apparently not enough to prevent unnecessary holes from being drilled in people's heads. though sham surgery sounds pretty unethical, the alternative is possibly exposing a larger population to surgery that doesn't work. e.g. if DBS didn't work better than a placebo but this wasn't picked up in a clinical trial, then a large number of people potentially would have been exposed to a dangerous surgery. but, i tend to think this may be an overblown risk when we're talking about neurosurgery and Parkinson's. the one situation that is pointed to is a case of arthritis where patients thought that a particular knee surgery was improving their condition, but this knee surgery is far less invasive than drilling holes in someone's head, and i think pain is much more prone to placebo effect than Parkinson's symptoms. On 7/17/07, 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