[paula_w]

As you hear occasionally, we have been very busy, and for interested persons who can possibiy make it, the PAN forum is coming up in February, and they do give scholarships to attend ,if you apply, but it's first come first served.

I would recommend it for several reasons - if you want to know more just send me a private message. Here I will say that we are on the verge of what I honestly think is going to be a noticeable change in practices and policies, with patients being a necessary seat at the tables and roundtables with patients becoming routine.

I could scramble an egg neater than I posted this thread! Where am I ? lol I believe I left out a few Key words as they say.
SECOND UPDATE

We have been invited as PD pipeline project to write an article in the medical journal published by ASENT coalition about Ethics and Neuroscience or something similar and the journal is named Neurotherapeutics.

Parkinson Pipeline Project, after more than five years with no budget, has been getting some sponsorship ,which is a good motivator i guess as now everything is happening at the same time. PDF works with us closely as well - we've been having weekly meetings for years - we are so slow! lol - sometimes multiple meetings each week.
There are communications going on between board members and patients - and patient advocates [not just a philanthropist] are now on the PAN board. They are dealing with patients and trying to help us...

I'm tired of playing poker.

Here are some questions we'd like anyone who wants to - to please respond to some, or one or however many you choose,through private message here to Linda H. or Sheryl J, Carolyn, or me - here are a few more key words i left out = private messsage only if you choose not to post here! yikes

There are many questions, so it will be interesting just to see which questions interest you too.
and thanks if you respond.....

This is open to all. Anyone can voice an opinion about the questions, instead of "why did you volunteer"- think-" why would you volunteer?'. Clinical trial par t ipants of course can answer from the experience.

There's more but this is already a lot.
More tomorrow...paula
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Interview questions about Ethics in neuroscience
We need many quotes to weave in and out of the article. It's due by Feb. 15 th but we have two events before then and so it's really due by the end of Jan.

The entire journal is being devoted to this topic. We need you to speak.

Why did you volunteer? Was either access to treatment in the randomized study, or access to treatment in extended open label studies important to your choice? How did the access to new treatment incentive compare to the value of science in your decision? Or to what you would learn from the participation?

Did you get placebo? When unblinded, what did you think you got before unblinded? Did you experience change in symptoms, how long did changes last?

What was primary outcome? What was your change in baseline to follow up? How long were you tracked, did clinical improvements continue to increase, decrease or stay the same?

Were there other key measures. Were imaging or other markers used?. How did they change over time? Were you satisfied with the feedback and reporting to you of findings from your data, and with privacy of data?

Did the informed consent (IC) cover how you would be treated if the study was terminated early? Did the IC explain the risks? What were they? With respect to unknown effects of treatment? with respect to surgery? Was the placebo effect explained to you? And were you given any strategies to minimize placebo effects?

Did the sponsors of the study explain how you would benefit if the trial proved successful and how you may be harmed if there were problems with your treatment or with the overall study (for surgery was it explained that acceptance of this treatment would likely make you ineligible for future experimental trials?)

Would you be less interested in a study sponsored by a company with significant ethical violations (conflicts of interests)? Failure to disclose data to advance science or to monitor safety in community settings, failure to live up to agreements with patients about conditions in the study or with ongoing clinical tests.

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It's time to speak out. People are focusing on your future, which can only be made possib le thru clinical trial participation - except we aren't lab animals, we are human beings. The human element can no longer be kept in ignorance and treated with no compassion, as if it can be turned off in the participant. That's the difference between people and animals - we seem to be a tad more advanced than animals with the added components of intelligence and emotion.

[jeanb]

I hope everyone will respond.

Paula - i am emailing you, SherylJ and Carolyn with my trial experiences. Coming soon to your inbox...

[jeanb]

If you participated in this trial, I urge you to provide your input. Together we can make a difference.

[paula_w]

Thanks very much Jean!

I'll continue a little more rested and coherent this morning with why it is so important. We've been working for two years + on developing a clinical trial participant bill of rights, although it isn't actually a bill so we are referring to it as stake holder rights and responsibilities.

This has taken much consultation with other stakeholders, including organizations, researchers, academia, FDA, and pharmas.

The first roundtable on this issue is being held on January 24 in New York. The list of participants is more than we could hope for. So this, again, is one of our goals becoming a reality.

At the PAN forum, we wiil be presenting about these issues and showing a new database that has taken more than 5 years to finally be finished. It contains just about anything you want to know about treatments in development, beginning with its pre-clinical history. You can look at this database and get a good estimate at any present time about what could be available for you during your lifetime.

So once again, back to the article, it IS important. There is at least one poster who regularly challenges us about representing all pwps and doesn't feel we can or do. There is only one way to change that. Speak.

thanks for putting up with this yet again,
paula

[jeanb]

I'm hoping to inspire others to tell their clinical trial stories, so here is one of mine:

Why did you volunteer? Was either access to treatment in the randomized study, or access to treatment in extended open label studies important to your choice? How did the access to new treatment incentive compare to the value of science in your decision? Or to what you would learn from the participation?

I volunteered for several reasons:
1. this was a new treatment that could be neuroprotective. Pre-clinical trials on rats & monkeys showed that it slowed or toopped the progression of pd.
2. It was placebo controlled - while I desperately wanted to get the drug, I knew that even if I got the placebo, my participation would help all people with parkinson's … in the end
3. if the drug were neuroprotective, I had a 75% chance of getting it and bettering my condition.

Did you get placebo? When unblinded, what did you think you got before unblinded? Did you experience change in symptoms, how long did changes last?

I got the lowest dose of 3 doses of the drug: high, medium, low, and placebo.

My symptoms from the experimental drug were extreme fatigue, and occasional nausea. When not on the drug, the symptoms ended.

What was primary outcome? What was your change in baseline to follow up? How long were you tracked, did clinical improvements continue to increase, decrease or stay the same?

My pd symptoms continued to increase. I was tracked for 20 months. When I started, I was not on PD meds. I started on agonists during the trial. The symptom most troubling to me, which precipitated my starting agonists, was neuropathic pain. But my other pd symptoms progressed as well: stiffness, bradykinesia, tremor, balance

Were there other key measures. Were imaging or other markers used?. How did they change over time? Were you satisfied with the feedback and reporting to you of findings from your data, and with privacy of data?

SPECT scans were taken twice - once at the beginning and once after approx 20 months. The scans did confirm that I had pd. And they did show that the disease had progressed. I received copies of my scans, although they refused to give me a clinical diagnosis of my scans.

I also went through many many physical tests. At first, I was tested to make sure I was healthy enough for the trial (EKG, blood, fecal, mental). After being in the trial, I was regularly tested. Tests included: blood tests, EKG, fecal, UPDRS, mental, blood pressure, SPECT imaging,

Did the informed consent (IC) cover how you would be treated if the study was terminated early? Did the IC explain the risks? What were they? With respect to unknown effects of treatment? with respect to surgery? Was the placebo effect explained to you? And were you given any strategies to minimize placebo effects?

The study was stopped early - abruptly - with no warning. Patients learned this because the company posted the trial halt on their website one evening. Patients heard nothing for weeks. We did not know if we should continue on the study drug or if we should stop it. I was on schedule to travel 2000 miles for my second SPECT imaging scan, and no one knew if I should proceed or not (this included the study center doing the SPECT scans).

Early trial halt procedures were NOT covered in the IC.
The IC explained possible risks. The IC did not explain possible placebo effects.

Did the sponsors of the study explain how you would benefit if the trial proved successful and how you may be harmed if there were problems with your treatment or with the overall study (for surgery was it explained that acceptance of this treatment would likely make you ineligible for future experimental trials?)

I specifically asked if I would receive the study drug - if it were successsful - after the trial ended. The study nurse and trial doctor said it wasn't covered in the IC agreement, but they would make my sentiments known. My concern was if the drug were successful, and If I had been on the placebo or not on an optimum dose, after the trial ended I wanted to be given the dose that worked. I told them it was only fair because of my comitment and participation in the trial.

I received no promises or response of any kind. As it turned out - the trial failed. And the people on the drug actually saw their pd symptoms progress faster than the people who were on the placebo.

One of the unanswered questions for me is this: the initial people in the trial were allowed to take coq10 1200mg per day. By the time I started in the trial, participants were limited to taking less than 600mg of coq10 per day. What percentage of people on the placebo were also taking 1200mg of coq10 per day? Is that why people on the placebo did better than people on the trial drug?

I have asked but not gotten a reply.

Would you be less interested in a study sponsored by a company with significant ethical violations (conflicts of interests)? Failure to disclose data to advance science or to monitor safety in community settings, failure to live up to agreements with patients about conditions in the study or with ongoing clinical tests.

I absolutely would be less interested to take part in a study sponsored by a company with significant ethical violations - Specifically I would be very careful before I agreed to participate in an Amgen study. I believe the way Amgen treated its GDNF trial participants was shameful. They could have provided their participants compassionate use of GDNF, but AMGEN has steadfastly refused to do so.

[paula_w]

Thanks for taking the time to do that Jean. I remember your experience very well.

This morning, I spoke with one of the participants in the original fetal cell transplant study with Dr. Freed. She had the placebo, which meant she had sham surgery. She had a placebo effect for a few months, but it wore off and then she hoped she was on the placebo because she wasn't getting any better.

After a year, she was unblinded and learned she was on the placebo, but one participant had a heart attack and they weren't sure if it was related. She had to wait another year for the real thing.

She openly admits that she didn't do it just for science. Her PD was bad. In spite of sham surgery and a 2 year wait, she'd do it again. It bought her a few years of relief.

Jean was treated quite callously when the treatment was halted. They have to let their stockholders know first right? Think I heard that at the time. The less important people, including the doctors were told after the fact or maybe found out another way.

I believe Cephalon at least admitted they could have done it better - is that right Jean?

Thanks again,
Paula