[pegleg]

I am resolved to finding ways to better MANAGE PD this year. So much has gone by the wayside that I almost don’t see a cure in my lifetime (I turned 59 Nov. 15) - unless some things change.

I’m not getting any younger, but do not consider myself a senior citizen (except to get the AARP discounts – ha!). I try to keep my hair frosted or streaked (I am a natural blonde, but it’s hard to tell with all the gray now) and was thinking about getting an appointment. We were at my daughter’s tonight and my granddaughter (she’s 7) brought a friend over as I was attempting to have a conversation with my daughter. The little girls were pointing at my face and whispering something. When I inquired about what they were doing, my granddaughter said, “I was just showing her that you DO have eyebrows!” As they walked away, I heard them say something about “getting old.” .

I may not have eyebrows (that show up), but I do have Parkinson’s. And it is making me appear old before my time. My goals for this year are:

For 2010 - My Research Improvement Plan:

1) Build more PD awareness and drive home the fact that we are getting about 80 million baby boomers arriving at the “young” age of 60 – the average age most are diagnosed with PD,

2) Get more people to donate their brains (I made a complaint about not having a brain bank at my last clinical trial visit, and at this visit the sponsor had a “plan” attached to the informed consent - but it’s still just a plan – nobody’s tried it out yet), (can you believe there are large research facilities that do not deal in testing brain tissue from clinical trials they have administered?)

3) Work on the assessment tools used in PD research (Fix the flawed and subjective UPDRS (although they had to start somewhere) and totally throw out the Hoen & Yahr as part of screening protocol). Is there a software program or equipment that would help eliminate subjectivity? Also, do more research on why they use a 12-hour without meds protocol when it takes about 2 weeks for a full Sinemet washout).

4) Review recent “failed” trials (within the past 5-10 years) and make these companies meet some closer scrutiny as to why the seemingly positive Phase I turns sour in Phase II. (I was glad to see the follow-up on the fetal tissue (Feinstein) trials).

5) Fine-tune diagnostic tools or protocol used to label patients with “Parkinson’s.” Right now it’s using OBSERVED symptoms (which means mostly what the patient tells the doctor) and that pitiful Hoen & Yahr scale (you can go from 0 to 3 on a 5-pt. scale just because you have some gait and postural problems).

6) Take a look (a close look) at why sham surgery is required in PD research. We’re drilling into the one organ that controls ALL of our body systems and controls our emotional well-being, and we don’t even have a positively accurate way to diagnose that we have PD!

7) Jeez! I didn’t mean to make this the top 10 of the day, but my point is that we need to get some patient input into the things Parkinson’s research has accepted over the years.

Make this #7: What's the big deal about placebo effect? I know about all the serotonin levels and endorphins and touchy-feely emotions that doctors say apparently runs higher with PD patients. But if clearing up the placebo effect is so vitally important to having valid trial results, why aren’t we using neuropsychological results more often in trial analyses??? And are they questioning the day-to-day emotional highs and lows of patients when they come for trial visits? I can tell you they are not as I have been there and done that, and have talked with numerous others. We need to weight some areas to compensate for this “placebo effect” issue; like asking if the patient slept well the night before evaluation measurements are taken – or if they have been under stress since the last visit (financial and marital issues, job change, death in the family, etc.)

I am just saying if they are going to shut down trials that have had observable “improvement” of symptoms by crying “PLACEBO EFFECT” so often, let’s take the “Think thyself better” theory to its fullest limit.

I am going to keep my focus this year (my first New Year’s Resolution) on getting people excited about finding better treatments for Parkinson’s. (I’ll even throw a wish for a cure in there.) Many people in the world don't understand PD , and - sad to say -many in PD research do not either. So how can they learn more? Ask a patient!
Peggy

[SherylJ]

Peg, I think you are right on target with your Research Improvement Plan.
There is only one aspect that I think we need to be more proactive about.

You write "Many people in the world don't understand PD , and - sad to say -many in PD research do not either. So how can they learn more? Ask a patient!"

Waiting "to be asked" about PD is not a strategy that has benefitted patients thus far. I believe the onus is on us to open dialogs about how PD affects us, what we need, and how we expect to be treated. Too often we endure indignities with silence, conveying the message that our illness makes us less deserving of being treated with dignity and respect. In the words of Dr. Phil McGraw, "We teach people how to treat us." This must be our new mantra... our line in the sand.

[pegleg]

You are soooooo right! If we don't say what we want, we shouldn't expect anything to be done about it.

BTW, I learned a new word from you:

"ONUS

noun, plural o⋅nus⋅es. 1. a difficult or disagreeable obligation, task, burden, etc.
2. burden of proof. Compare onus probandi.
3. blame or responsibility"

I favor the "obligation" definition.

We all have our unique way of how to get others to listen to us, and one of the most often used it "the squeaky wheel gets greased." The squeaky wheel approach means the more noise you make, the more likely one will be heard or the more likely the squeaky wheel will be "fixed." But for some, that appproach is an instant turn-off because it tends to put them on the defensive. Sad to say, our U.S. political process works when we use the squeaky wheel approach.

I suppose you could call my approach the "Southern Belle surprise" approach. I guess you could say it's the opposite way of the squeaky wheel. I don't draw a line in the sand unless it's a major life or death situation - avoiding conflict at all costs. I'd love to have a little more "squeak" to my appeal, however.

Now you may be wondering what the surprise is in the Southern Belle surprise approach. There are times when I have had all I can take (and my blow-up threshhold is wide). I sometimes come to a point that I myself don't even have control of my outbursts. I usually end up having to apologize. (Blame it on PD lol) The surprise is that this Southern Belle becomes a mouthy and outspoken advocte.

One final comment. My advice to those of you wanna-be advocates. . . KNOW YOUR STUFF - take every opportunity you can to share your goals with others. Prove your credibility; build a reputation that you know what you are talking about. Sheryl and Jean are taking their message to the world andn the world is listening. Speak to both sides of an issue, and watch and listen to others who have been successful advocates.

Thanks for your input.

Peg

[SherylJ]

Peg, your point that we all have our unique way of how to get others to listen to us is a very important one. Different approaches work better in some situations and with certain people than others. Successful advocates understand this and send in the right team for the job.

Raised on the "squeaky wheel" philosophy, I never mince words. People always know where I stand, whether they agree or disagree with me. I could probably do with a little more honey in my approach, but as my Dad would say, "The tree is bent." This is why I love watching you weave the magic of your "Southern Belle surprise" approach.

Here's to a new year and a new decade... may it be all that we seek!

sheryl

[pegleg]

Sheryl quoted: "This is why I love watching you weave the magic of your "Southern Belle surprise" approach."

I wanted to clarify that the nice things I do are not always a facade for trying to wiggle my way into a situation (and I don't think you remotely meant to infer that). I try to treat others the way I would want to be treated. I often fail miserably, too. But southern Bells are raised to hhide their rreal feelings if they think it might cause conflict. Weird way of thinking, isn't it?

Did you have other additions to add to the Research Resolution plan?
Your input would be important to me.

[LindaH]

Peggy wrote::
“: What's the big deal about placebo effect? I know about all the serotonin levels and endorphins and touchy-feely emotions that doctors say apparently runs higher with PD patients. But if clearing up the placebo effect is so vitally important to having valid trial results, why aren’t we using neuropsychological results more often in trial analyses??? And are they questioning the day-to-day emotional highs and lows of patients when they come for trial visits? I can tell you they are not as I have been there and done that, and have talked with numerous others. We need to weight some areas to compensate for this “placebo effect” issue; like asking if the patient slept well the night before evaluation measurements are taken – or if they have been under stress since the last visit (financial and marital issues, job change, death in the family, etc.)

I am just saying if they are going to shut down trials that have had observable “improvement” of symptoms by crying “PLACEBO EFFECT” so often, let’s take the “Think thyself better” theory to its fullest limit.” (end of quote)

So many subseqquent studies cite this original fetal tissue study as “proof” that placebo controlled studies (including sham surgery) are absolutely required in PD clinical research. The original “failed” fetal tissue study (Freed etal) reported no difference in improvement between the experimental and sham groups.
So now that the long tern follow up data is avaialble – it seems the original trial might not have been a failure afterall. What impact will this have on how we vview the placebo effect in PD . Seems a reexamination is in order.

Also a reconsideration to the length of clinical trials, especially those involving cell and tissue tranplants and gene therapy.

[SherylJ]

I have one addition for the Research Resolution plan...

Improve clinical trial recruitment and retention
Much time and money is squandered on this, slowing progress toward discovery of improved treatments and even the cure. Fewer than 1% of people with Parkinson's participate in trials, far short of the number needed.

It's time to resurrect the patient-authored Declaration of Rights and Responsibilities of Clinical Trial Participants. We spent years writing and rewriting it and then allowed it to be locked away in a drawer somewhere. I believe that convincing the powers that be to use this document as a basis for designing and implementing clinical trials would improve recruitment and retention.
sheryl

[pegleg]

Linda - I believe we are onto something here. I wonder if it would make any difference if enough of us wrote to the NIH or FDA about re-examining these trials? Or should we pester the sponsors? I know we cannot just let it go. Any suggestions on this?

Sheryl - Trial recruitment and retention are absolute necessities in order to keep research for Parkinson's going strong. This is an area where nearly everyone can help. Even PD awareness will help recruitment and retention.

Thanks again.
peg

[violet green]

Peg,
One of your points was about donating our brains. After my recent photo driver's license failed to list me as an organ donor I started investigating how to specifically donate my brain. The information I found was daunting and I think I remember that there was no way to do so unless I had participated in a clinical trial.

Do you know of any simple ways to handle donating one's brain?

And another issue: folks often complain that not enough of us volunteer for clinical trials but as an 9 year since diagnosis PWP, there are few trials that my history, condition, location and medication fit the trial's requirements. That's something that I've rarely seen discussed. Then also, there's the control and trust issues that some of us may have difficulty ceeding to others (could that be me? lol, of course)

Katherine

[pegleg]

You have just made my day! My hope when I post here is to get people involved in (or should I say "In Charge of") their own healthcare.

We didn't ask to have Parkinson's, and we cannot make it go away (yet). But we shouldn't think of the disease as an inevitable ending, or we might as well lay down in the road and let an 18-wheeler run over us again and again.

We CAN do something about how our care is managed, and even be a part of the decision-making processes for promising treatments. No, you don't have to have a PhD or M.D., but note that I would never insult the professionals who dedicate their lives to caring for people like us; nor would I ever act as though I know MORE than they do about Parkinson's (but to use a Sarah Palin expression, "I betcha I know just as much about living with the disease!" My aspiration is to HELP them solve this puzzle.

There are people that frequent this forum that got started here by joining efforts already in place, or created their own. Now these folks are known and participate locally, in their state, nationally, and yes - even internationally!

But, Gosh! I'm sorry. You had questions about brain donations. You have to checck with facilities and institutioons to see if they have an established. I'll do more research and report back. I think the NPF has a progroam or once did.

Well, here's a good project for one of our many Parkinson's organizations. The Parkinson's Society in the UK had a "drive" for brain doonations:
http://www.medindia.net/news/More-Br...ns-63043-1.htm

It was quite successful. You only have a few hours that the tissue can be saved upon death, so it must be prearranged. Maybe we could form a group to check on this.. . and BTW they need HEALTHY brains, too! I imagine this could be added to driver's license (just like other organs donoations are done) and through your own Advanced Directives (formerly known as Living Willls). I'll come back with info (I hope) but any aspiring sleuth can do the same.

And you are right about not being "qualified" for many clinical trials. There is "Inclusion" and "Exclusion" criteria listed for any trial openn for recruitment. The sponsor and researcher generally want otherwise healthy participants (and they sometimes need people without PD as controls for the study).

Don't feel bad about not having entered a trial, BUT there are thiings like 23andme did not long ago (a genetic analysis - all you had to do was spit in a tube and mail it in). Did you see paula's Youtube ad for this? (Paula - can you post the link here?)
And NIH had a gene study for PWP that you could probably qualify for.

Here's two links to studies that are currently recruiting: (Linda, is our Pipeline database still accessible? I keep losing my password!)

www.PDTrials.org

www.ClinicalTrials.gov

You can search by condition (which starts under Neurology) and location, symptoms, etc.

Hope I've helped a little. Gotta go wash this gray away - and I wouldn't be caught dead in public without makeup! (Oops! probably a poor choice of words here)
Peg