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----- Original Message ----- From: "archier" <[log in to unmask]> To: <[log in to unmask]> Sent: Sunday, July 22, 2007 9:23 PM Subject: Re: Survey of the use of sham surgery in clinical trials > 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. > Archer: Thanks for your thoughtful response. Would you deny the sham surgery to those it has made great improvements in their lives? I don't know how many people in these studies have had holes drilled in there heads to no avail, what I do know is that more than other disorders PWP respond most favorably and in larger numbers. I am not purposing this as a treatment modality but to use this information when judging all new procedures by subtracting say (I'm guessing)15-20% from the favorable outcomes due to the placebo effects. Ned ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn