Second time posting.....grrrr.

I would like to include an ethics component to our forum project, and consider us as watchdogs to a high degree. Many activities need watchdogs and are crossing ethcial lines. For example, why are paid consultants needed in addition to all the other professionals involved in clinical trials [like, for ex., I think Olanow was a consultant for the Cere 120 trial] Do these consultants get paid no matter what the result? I assume they do, and Olanow listed a conflict of interest for the Cere 120 trial. I would like his role defined and justified....a reasonable question.

Patients must be included in trial design - not where they are not informed - but where they are justified in asking questions about who is getting paid for what, who is setting end points, what can we do that is more productive with the placebo effect, why aren't they eliminating likely non-responders? And on and on.

Why are high paid consultants always needed instead of paying upfront for participant expenses? And the IRBs....the untouchables? We need to hunt them down and ask questions about them. This we can do.

Where is the follow up to all of the failed trials? Pipeline has been invited to submit an abstract for a poster presentation for the ASENT conference, a multi -group advocacy coalition. we are planning some in depth analysis of the failed clinical trials, which may extend back to immunophillins.

Any participants from failed clinical trials who would like to comment or have something to help us in this analysis are needed and would you please contact me here through pm or email me at plwitt8385@ aol.com to help us?

I don't know if we will hear a response from MJFF...I rather doubt it. But that shouldn't stop us from attempting to set up an email listserve, which we were planning anyway with those involved in their onlinepd research as a means to participate and ask questions. It's like sitting at the kiddie table at Thanksgiving dinner and I don't like that so much. But the patients "included" should not be the same patients that show up on all the boards and councils or those who are wealthy. There are some expert patients out here, or should they be referred to as "clients" or "consumers"?

I wish I could trust more. I understand that PD is not going to be easy to solve and may never be solved. But it can't be a racket; the practices involved in trial design are too suspect. Shutting out patients is going to create loss of hope. Patient groups also need to work together. There is an element of competition and attitude within patient groups as well. This is unacceptable and not welcome in the neurotalk group.

If one doesn't understand advanced PD and the feelings of paranoia or anxiety that sometimes accompany posts or reactions, they should not be working on this project, or possibly any PD projects. This is difficult enough; constructive criticism is welcome tho - necessary in fact.

If you agree, I'd like to call a meeting on Tuesday at 4 p.m. ET. Lee says that is breakfast time in Australia, but would having it later be too late for Europe? We have set up a yahoo room and could meet there. I' m done moving so am up for trying Skype if you all would like to. If we don't get enough people in yahoo we can have another chat here but they do get confusing. We could improve it by using all different color types per person and always addressing the person you are responding to. We could even try carrying on one conversation at a time, but that would take forever.

The private forum has not drawn much response, even tho it is the easiest to use. iF you would like to become a member of the private forum, pm me or ask publicly and we will add your name.

so Tues at 4 again, here unless we get a lot of yahoo sign ups ....rick's wiki and a registration are on the table, i think ethics should be incorporated and that a listserve should be on the table to participate in the fox online research forum...albeit it not without regrets at not being more included.

1. Let's try to come out of this next meeting with an action plan to begin immediately.
2. Let's get serious about claiming our rights to be involved in clinical trial design. I cannot in good faith recommend clinical trials at all until we are more involved in the design and patient rights are accepted and applied. Pipeline and others have written a bill of rights that is creeping at a snail's pace within PDF. Great things have come out of it and the training now being provided by PDF is exceptional. Now what can we do to get what we have written and trained for in motion. The time is now.
3. Let's weed out the breeches of ethics; the applying for 5 yr grants and using every second of the 5 yrs and then reapplying with inconclusive results. I don't plan on being cured. Those of you on fire for current research that are 10 to 15 years behind us in age and PD onset, you have time for a trial that begins today to possibly help or cure you; you have a sprinkle of trials already begun that statistically won't make it past phase 2.
4. I am not being negative. I'm realistically using all the logic I can muster to light a fire with what fuel we have left.

See you Tuesday at 4 ET unless someone has a better alternative, here again unless many sign up and want to use yahoo or skype.

http://health.groups.yahoo.com/group/ParkinsonsProject/

Thanks and don't ever under- estimate what just a few of us can accomplish,
paula

I have just posted this on the yahoo group board and thought it should be here too. I absolutely agree with Paula's suggestions regarding ethics, it should be up for discussion at this time - it will help form a framework for activity, and perhaps it would be useful to discuss how it could relate to the wider activity of the group.

Hi all,
I have started this thread in response to part of Paulas Ethics thread
on Neurotalk, in which she invites us to a further meeting this coming
Tuesday, with the hope that we can come out of the meeting with an
action plan.

I would like to suggest that before we come to that meeting maybe we
could consider the following (please slap me down if I am speaking out
of turn!).

1. That we formally constitute ourselves as a group. i.e. give
ourselves a unique name.

2. That we formally identify the areas of activity we will engage in.

3. That we adopt, as a means of introducing the group and its
activity, a mission statement that will encompass the things
identified in 2.

4. That we make a start on drafting a formal invitation to PWP's to
participate in the process that we have begun, either as active
participants in the work of the group, or as people interested in the
patient participation process.


To kick things off, I can I make a suggestion that we call ourselves
the International Parkinson's Disease Patient Participation Project or
IPDPPP for short. It is only a suggestion so ...... Please anyone feel
free to brainstorm this, rip it to shreds, or argue for or against it!

Best wishes to all
Lindy

just a reminder, if you want access to the pd project forum here on nt, you need to send a pm to docjohn. it is private, so non members can't see it.

could olanow's conflict of interest as a paid consultant on the cere-120 trial stem from the fact that he is on ceregene's scientific advisory board?

Hit icon accidentally - not sticking my tongue out at anyone ...lol

From the phase I article comes this:

" Conflicts of interest

That's all I know rosie.

---------------

Wanted to add here a couple of other things. lindy your ideas are welcome; I do not want to be considered the only leader in this group. My organizational skills are slightly impaired lol. All input welcome.

Also wanted to add that my posts are a combination of peoples' ideas and it might be misleading not to name them sometimes. The questions above that we have about trial design come from pipeliner discussions and some of the ideas from the group, such as referring to ourselves as clients or consumers and others come from discussions with Jaye. I do not want to give the impression that I come up with all of these thoughts - I'm just in the habit of relaying them.

Of course the solution to that would be for everyone to post their own ideas, but of course one can't make someone do that. So if i have offended anyone for posting an idea that came from them, please allow me to clarify that as a teacher, I am a sharer of ideas and was never really concerned about receiving credit. The world doesn't work that way tho, so I think I should clear that up. I'm going to try to name people more who come up with ideas unless it's something I don't feel they would want me to do, such as the Olanow source.

The Olanow bit doesn't have to mean anything bad. We live in a world of ethical blur and downright dishonesty and greed. Joe the plumber followed up on what Obama started; it was his right and responsibility to do so, even tho Obama may not have meant to hurt him in any way. As I've stated before, research has it's own indiscretions and it's our responsibility to watch them. By including us, maybe we wouldn't jump to the wrong conclusions.

paula

Seriously, how about a database tracking researchers connections to industry and specific trials? Done properly, I think we might find ourselves being paid a bit more attention. PDpipeline data and those past trials that just fizzled could be a start, And it could incorporate things that seemed so promising but then simply disappeared such as the atomization technology discussed under Ron's BBB thread or the info on methylene blue from a year or two ago.

thanks you Lindylanka,

your comments and proposed plan of actions are great. Hope I can be there at 1pm (Pacific time) on tuesday. I think first we should focus on what we want to do and what is ethical treatment from a patients point of view. For example, i am unsure where I stand on the issue of control group with placebo treatment, is it ethical to deceive ( a strong word, I agree!) a patient who is hoping for a miracle cure? Is there any other "control " we can come up with? I am questioning the protocols of scientific experimentation, because human life and quality of life is more important than papers, statistics and patents.

thanks
Girija

PS: Do you still want me to be there and give my views ?

Hi all,
I have started this thread in response to part of Paulas Ethics thread
on Neurotalk, in which she invites us to a further meeting this coming
Tuesday, with the hope that we can come out of the meeting with an
action plan.

I would like to suggest that before we come to that meeting maybe we
could consider the following (please slap me down if I am speaking out
of turn!).

1. That we formally constitute ourselves as a group. i.e. give
ourselves a unique name.

2. That we formally identify the areas of activity we will engage in.

3. That we adopt, as a means of introducing the group and its
activity, a mission statement that will encompass the things
identified in 2.

4. That we make a start on drafting a formal invitation to PWP's to
participate in the process that we have begun, either as active
participants in the work of the group, or as people interested in the
patient participation process.


To kick things off, I can I make a suggestion that we call ourselves
the International Parkinson's Disease Patient Participation Project or
IPDPPP for short. It is only a suggestion so ...... Please anyone feel
free to brainstorm this, rip it to shreds, or argue for or against it!

Best wishes to all
Lindy[/QUOTE]

See you tuesday, Girija!
I have questions myself, one of which is, where do we stand on patients who may not have IPD, but who are to all intents and purposes treated and defined as Parkinson's patients, and who may be even further out on a limb than we are in terms of the understanding of their condition............ and inclusion in all sorts of scientific and medical efforts....... there must be more than a few who visit here, or who will at some stage in progression have a dx re-assigned. I can off the top of my head think of at least one very notable member of this forum....

which just leads to more.........questions, I mean....

Lindy

Hi,
I'm a little shy to weigh in all this stuff, because mainly what I have to contribute is some vague-ish opinions and right now I just don't have the personal energy to be involved at an organizing-activist level, and bless you forever on this board who are taking this on - but I read your comments and have a couple of my own...

I was concerned when I read the latest "warnings" emanating from the "study" of websites that offer various kinds of stem cell or cell therapies directly to the consumer. This "study" was published in Cell Stem Cell Magazine lately, and could apply to other innovative therapies as well. My concern is that while I think risks of offered therapies are especially important to be researched and disclosed, this warning point of view and the whole Cell Stem Summit planned for 2009 has a kind of condescending tone to it. No patient or consumer voices seem to be included in the article mentioned above, nor in the advance planning for the summit. Everyone else but, in fact.

And the "concern" seems to be that patients won't get false hope, but I repeat again, hope is only hope. It's not a promise. And I have a right to hold any hopes I want to, understanding that caveat emptor, as is true with every treatment that's out there. I also feel I should have a right to get information directly and make my own decisions about whether or not I want to risk my money and body, and whether or not I want to believe scientists and scientific works and/or products that are not US or UK-based. When they say they only want to protect the consumer from spending money on something that doesn't ultimately work or has dubious or "unproven" results - meaning that it didn't get funded by a company for the double-blind study that would prove it viable as a profit-maker - well, I've been doing that for years (CoQ10, etc.) (not to mention for approved stuff that turned out to be clearly harmful - Vioxx, etc etc)

So I guess my concern is that the flow of information be kept accessible, so I can make my own decisions and choices when I want to, and not have it be ultimately controlled by bodies with unclear agendas. Honestly, I don't get why people are so upset about entities that are offering cures that possibly earn high profits from very sick people when our entire scientific research is now based on that - if it doesn't seem profitable, chances are it won't be researched. It seems like there's anger and resentment out there at what a truly free market approach really means, which is that someone can offer me a treatment that US scientists and corporations don't control, and I can make my own decisions about it, if I want to.

I understand our doctors' positions, too - they're essentially backed into a corner, and can only recommend what's been sanctioned officially - so for them, forget working by informed intuition, or any kind of original thinking or innovative treatment. Insurance won't pay for it, their reputations will be threatened and so on. It's complicated. I was struck by the section of Monkees in the Middle where the one doctor had a strong feeling that the design of the catheter was a little off, but restrained himself from suggesting the improved one he had already designed - that could have made all the difference in the outcome of this trial - because he didn't want to seem self-interested. Yet that could have been very valuable insight that maybe was the nail for which the kingdom was lost.