I just emailed a top neurologist - MDS - in the UK and asked if sham brain surgery is used in the UK in PD clinical trials.

I'll post any answer I receive.

Well i read your questions madelyn and thought "I wonder what they do instead?" " Why hasn't this come up before?"

That sham surgery doesn't happen in Europe was just a fact; I knew someone could tell me.

But, it's days later and i still don't know..so here is where we've gone with it.

We are talking with a leading patient advocate from the UK. He didn't know but now thinks they do sham there too. They had a placebo control group in the gdnf trials, including the UK.

A friend in the uK has heard sham surgery called barbaric. We are all meeting on Friday on Skype but we should be able to answer your question by then!

In the meantime, we are thinking there haven't really been any trials that require sham surgery in other countries; no one could do it with DBS. Did they have a sham group with duodopa? i know it was the FDA that required then owner Solvay to do clinical trials here with a placebo - now in progress - and it's been used in Europe for many years. Pro Savin calls for a "possible sham".

So the mystery has yet to be solved. We concluded that there just haven't been enough treatments tested there.

If you are from outside the U.S. and know whether or not your country does sham surgery in clinical trials would you please let us know?

Our scientists are adamant and could be convincing other countries.

It is safer and cheaper to find a way to use the placebo with sham being reserved for special cirumstances. Participation in trials would increase. How do you trust a person to drill holes in your head when you have entered into an agreement that could be a lie? Why do we allow the impossible task of lying to people? We make them lie. It shows incredible disrespect for the human psyche.

Do they have liar traiining? It 's not easy for some people. Doctors? I think it doesn't do much for their already scant communications to patients. madelyn you have started a chain reaction and possibly a protest that will be heard globally.

to be continued ....

Hi Paula, you give me too much credit--seems this very question has been considered before on a pdforum though am unable to find out if it was followed up. I do not know the forum, though suspect many here do:

http://www.parkinsons-information-ex.../msg00146.html

and in the listing of a reference from France, the topic is addressed, though is not discussed in the abstract. I do not have access to the entire article.

Neurosurgery at an earlier stage of Parkinson disease: A ... by WMM Schupbach - 2007 - Cited by 61 - Related articles
Sham surgery was considered unethical. Thus, assessments were not blinded. ... The sponsor (Medtronic Europe) approved of the protocol and provided the ...
www.neurology.org/cgi/content/full/68/4/267 - Similar

My quest continues. If sham surgery is not used in other countries, why is it considered ethical here? thought we didn't have enough surgery suites to accomodate ---oh yeah, forgot that was enough surgical suites to accomodate all the PD patients who could benefit from GDNF if proven successful, NOT those who could be persuaded to enter into a clinical trial. Major difference, that.

Olsen,
I took part in the discussion on sham surgery on the ParkinsnList in 2007. i believe this was in response to the first Pipeliner survey. I don't think there was further discussion after the postings you cited. The list member from France is very highly respected and provides much information on an international basis.

I have also seen the article on early dBS you cited. The trial was carried out in France. Here is the quote about sham surgery the control group:
" Patients
in the control group receiving medical treatment only were given
priority if they still wished to undergo surgery at the end of the
study. All patients gave written informed consent. The potential
risks of neurosurgery and alternative medical treatments for early
stage PD were fully discussed, several times, with all patients and
their spouses. The study was approved by the Ethics Committee of
the Pitie´-Salpeˆtrie`re Hospital, Paris. Sham surgery was considered
unethical. Thus, assessments were not blinded."

The information on this topic is scattered. I don't believe there are official regulations anywhere about whether or not sham surgery should be included in trial design. It seems to be more of an accepted or not accepted practice among the neurological establishment of the various countries where the trials are taking place. However, it is possible that in seeking fDA approval for surgical treatments developed outside the US , the sponsors and researchers might feel pressure to adopt U.S. practices.

It's surely a complicated issue - both in terms of the science and the ethics. There is much about the placebo effect and PD that we don't know yet, that is currently being assumed to justify the use sham surgery in clinical trials and as they usually conclude -- further study is needed . In the meantime, perhaps there are other options for designing trials with surgical placebo controls that are more ethical and better protect the rights and safety of the participants

Hi Linda, thank you for the information; I did not realize the site referenced was related to the survey. I wonder if the court systems enter into the question of sham neurosurgery. Can this be reduced to whether this Is an ethical question or is it a legal one? Madelyn

Olsen, keep the conversation going as it flows thru your thoughts...here's what worries me. The UK is also doing a survey on sham surgery for clinicians..so we'll have multiple perspectives to compare.

I don't know how many they've received yet, but he did say there are strong feelings at either end of the brainsettings timeline - pro and con sham surgery.

At this point , we are able to say we received the survey responses of a whopping 11 people. That's pitiful. You may not agree about the surgery and that's ok but please don't ignore it . People need to know to represent you. This is a timed situation with the meeting in Bethesda at NIH june 30th.

This is enough time to organize any possibilities, such as going there and videotaping anywhere we can. we are missing the point


Bottom line: if we don't say right now how we think about subjecting people to sham surgery...they will never even consider changing it..these men are just men, not the congress..and they are businesssmen so they are coming from two superiority complex filled communities and are prone to getting their way, having more money and therefore smarter, with no obligation to their patients emotionally or personally.

ok but what about just being competent and comunicate to completion???? maybe toss in a little thoroughness!!

i urge you to call them on this expensive and dangerous procedure on individuals who are already extremely ill. They ignore half of what can go wrong for that person, signed informed consent or not.

People walk into the doctors office and do what he suggests, completely unaware of us here online who could give them a more realistic picture.

ramble on....

They just completed a large trial - no sham surgery used. There was a delayed start. Some people had the operation straight away while the rest had to wait a year and were kept on medication and then operated on.

Jean

ummm getting curiousier and curiousier. who dreamed up the sham neurosurgery arm of clinical trials for PD anyway? because it is utilized in lumbar surgery, etc, would be a good thing for PD?

Well i just got back from my neuro and we had a good talk. He doesn't have an answer about sham surgery but did put a slightly different slant on it so advanced people this is a heads up:

He said they really need a way to show that the new treatment works better than what they already have. IF they don't do sham surgery, a case could be made that there is nothing else we can do for pwp and they are already initiating this effort. He puts no faith or interest in stem cells, feels gene therapy needs worked on. But they already have medicines that work and why don't you get a DBS? i told him i didn't want to have a stimulator and depend on it and many other reasons. He just nodded but we both had to agree there isn't anything out there and people need to be given the chance to not get it thru neuroprotection. He likes azilect and thinks it may be so.

The second point he made was unless there is an identifiable reason , namely toxin exposure, in the future all pd will be genetically identified. This doesn't mean we got it from our parents, but i remember in college they always said don't take LSD - it can change your chromosomes. Toxins are most likely the cause of the mutation of the genes.

He says he is seeing Alzhemiers patients get it in their 40s. He did not know gdnf is coming back. i told him i might get surgery for that.

So his overall opinion is what we would expect - he does not foresee a treatment in the near future.

But if he is hearing "the word on the street" that nothing else can be done for pwp and they are working mainly toward prevention, this has trickled down to the neuros in the trenches.This makesone of our only hopes....again...gdnf. [and cere 120 and other gene therapies].

it behooves every clinician in the business to report results as they happen with no stall for any unnecessary reasons on the results of these trials. If you want to be a famous scientist, why not be the most efficient and time saving/the one to apply it with urgency and cut the paperwork out wherever you can. Tell us the results right away as we advanced have very few options. GDNF trials, at least one using gdnf from amgen, are in the works. And Andy Grove is an ally....been working on delivery. this is one of our few chances to recover some. duodopa is so expensive and who knows what gdnf will cost. i can't think of that.

i got another presecription for Physical Therapy. if you can do this i highly recommend it , PT and a power smoothie and i almost have energy.

But we all knew this....didn't we?
paula

Paula,
I'm not too bright about these things, and i just discovered organized and figured-out physical body work about 2 months ago. Ten years late but better than never. I had always done lots of physical stuff, mind you. Everything from cutting firewood (nothing like a powerful chain saw a few inches from your skin to concentrate - tremors stop until the tree comes down); and also did extreme night-time forest hiking. But I never understood that there are some powerful methods out there; not just some massage thing or 6 kinds of herbal tea; but really well-practiced experienced experts - there are different methods and different schools of thought, as with anything, and everyone should choose the one that rings their bell. I fell accidentally into something called Continuum Movement and the teacher in Montreal is doing spectacular wonders for me. Everybody has to remember it takes a lot of dedication and time - pretend you are training for the Olympics. That's the only hope going now - no cure, but some stuff to help us be tough.
Meanwhile, back at the ranch, sham surgery is unethical and damaging. If they have to drill holes in people just to retain their objectivity, then a bit less objectivity is needed; or analysts who can remain objective without playing charades with half of the volunteers.
And, as you have said before on this site, "If the placebos are so good that they can't distinguish the results from the drugs or brain surgery, then just give us the placebos."