----- 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

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