[pegleg]

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 is used. Patients will "go through the motions" of having real surgery, but the brain's dura will not be penetrated. This means there will be some patients that will undergo anesthesia, have IV solutions, have burr holes drilled into their heads, 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 a 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?" ) If preferred, responses can be anonymous.

Thank you. We need and appreciate your opinions.

Peggy
link:
www.pdpipeline.org

[Teretxu]

Originally Posted by pegleg

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 is used. Patients will "go through the motions" of having real surgery, but the brain's dura will not be penetrated. This means there will be some patients that will undergo anesthesia, have IV solutions, have burr holes drilled into their heads, 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 a 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?" ) If preferred, responses can be anonymous.

Thank you. We need and appreciate your opinions.

Peggy
link:
www.pdpipeline.org

I find this extremely shocking. I'm sure it's got to be illegal to drill holes in peoples' heads for no other purpose than to see "what happens". It's a life-threatening procedure and the competent district attorneys should start looking into this kind of voluntary malpractice, which is what it is.

[Suffolkchris]

Peggy

Are candidates for DBS made aware of this before hand?

Do you know roughly what percentage fall into this category?

At 3 years since dx I am hoping that DBS is a long way off or that other options will appear before I reach that point. But like Teresa & yourself I just cannot believe that Sham surgery happens!!

When my Neurologistic told me that longer term I was "lucky" because I would probably be an ideal candidate for DBS I guess I just buried my head in the sand and thought this is never going to be an option I would remotely consider. But then i watched a video on "You Tube" recently of PWP before and after GDNF treatment and got a bit more real about the situation.
I guess to use a Dickens analogy it's "The ghost of Christmas future".

Chris

[pegleg]

Thanks, Teresa and Chris. I had a feeling that most did not know that s ham surgery was going on. The Pipeline group's purpose is to watch out for the safety of patients in clinical trials. This is definitely a safety issue.

With the information we receive from this survey we hope to write an informative article concerning such practice. it may be absolutely necessary to do sham surgery, but we are looking for alternatives.

Please pass on the link for the s urvey to as many as you can - the results will be more accurate with more participating.

Thank! (and I will have to delay answering your questions about DBS, Chris. DBS truly IS a miraculous therapy, BUT it IS brain surgery.

Peggy

[AnnT2]

With research trials involving pills, it is not as dangerous to give some people the placebo, but is it ethical with invasive surgery? Are there other examples of this in the medical arena? Do they have studies where people with another diseased or defective organ are put into two groups, both of which have the surgery but one group does not have the organ altered or removed? Why can't they compare people having the cere120 therapy with a matched group (same level of symptoms, same age, ethnic background, same state of health otherwise, etc.)? After a period of time, compare progression of symptoms.
It seems to me that doing sham surgery is unnecessary unless they are just comparing safety of the operation, not efficacy. If the former is the reason for the sham, the people undergoing it should be so informed.
Ann

[aftermathman]

on the one hand, how can it be right to put someone through "sham" invasive and potentially dangerous surgery. I have no doubt the threat of "sham" surgery delays the release of drugs by slowing down trial recruitment.

On the other hand PD especially and GDNF in particular led to us having the placebo effect rubbed in our faces and how do we combat that without realistic double blind procedures. Also the drugs companies will doubtless want to be sure their product works (perhaps I am naive here) and double blind through sham surgery is a stringent test.

On balance, due to the infamous PD placebo effect I lean towards "sham" surgery as a necessary evil.

Neil.

[lou_lou]

dear peggy,
This is the main reason -
I do not support the Clinical trials,

people have died -had strokes -made blind, etc.
from the shameful practice of "SHAM SURGERY"

I believe in my heart -this is a trespass of the oath the doctors take -which say - "Do no harm!"

Originally Posted by pegleg

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 is used. Patients will "go through the motions" of having real surgery, but the brain's dura will not be penetrated. This means there will be some patients that will undergo anesthesia, have IV solutions, have burr holes drilled into their heads, 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 a 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?" ) If preferred, responses can be anonymous.

Thank you. We need and appreciate your opinions.

Peggy
link:
www.pdpipeline.org

[chasmo]

Originally Posted by Suffolkchris

Peggy

Are candidates for DBS made aware of this before hand?

Do you know roughly what percentage fall into this category?

At 3 years since dx I am hoping that DBS is a long way off or that other options will appear before I reach that point. But like Teresa & yourself I just cannot believe that Sham surgery happens!!
Chris

it does NOT occur with DBS here. There are no double blind studies going on that I am aware of in the USA.
Can't you opt out of any studies and get the real thing??
DBS is the ONLY treatment we have that is effective and AVAILABLE at this time.
It is unfortunate that double blind studies appear to necessary to prove the efficacy of new treatments.

Charlie

[steffi 001]

I am appalled by this !!! Yeah...we would line up for much of what is on offer,as an alternative to this sickening illness if we thought the worst side effects we would suffer might be a thumping headache or a double dose of nauseas...BUT THIS???
Undergoing the trauma of pre op nerves,preparation like coming off meds for two weeks,the worry to family and friends, the risk of paralysis and even death ...!!!!!

Sorry...can`t see much of a queue forming for this one.

Visited the Imperial War Museum last weekend...lasted 5 minutes in the Holocaust section...couldn`t take the horror of what I saw and read....experimental surgery on unsuspecting victims in the name of medical progress...? UH?

I rest my case.

[olsen]

It is my understanding if one's physician recommends DBS and one agrees, one in fact receives the "real" thing. If one enters a clinical trial in which the possibilities of a "sham" procedure or DBS being perfromed, one may indeed undergo brain surgery as a "sham" procedure.

all patients MUST be fully cognizant of the possibility a sham procedure will be performed. For someone like charlie, there was never a possibility of a sham procedure because he was not entered into a clinical trial....

I would not want to be on the receiving end of a sham brain surgery procedure--in terms of this type of clinical trial I would be part of the "precipitate"....