I don't know if this says much or not, but we have to have a translator to read the article:

Rev Med Suisse. 2009 Aug 26;5(214):1650-5.

[Management of Parkinson's disease in 2009]
[Article in French]

Maertens de Noordhout A.

Service universitaire de neurologie, Hôpital de la Citadelle, Bd du 12e de ligne, 4000 Liège, Belgique. al.maertens@chu.ulg.ac.be

The cause of Parkinson's disease remains unknown and no cure or prevention exists so far. Levodopa remains by far the most potent symptomatic therapy, but induces side-effects such as motor fluctuations and abnormal movements, which can somewhat be counterbalanced by optimizing levodopa plasma levels or acting at receptors level with long half-life dopamine agonists. In severe cases, functional surgery with deep brain stimulation can be offered. Some non-dopaminergic symptoms like dementia, freezing, postural instability or dysautonomia do not respond to dopaminergic drugs and need special care.

PMID: 19772196 [PubMed - indexed for MEDLINE]

1% of ?????? We don't even know how many people anywhere have PD!!!


-Laura

I've quoted that stat for too long!

Better stated: fewer than 1% of the estimated number of people thought to have PD in the US participate in clinical trials.

I'd be curious to learn if we asked every pwp that we know personally or in our support group(s) including polling this board, what % were identified to have been trial participants. And of those who participated, how many had participated more than once. Personally I think that the 1% number is high because of the people who have participated in trials multiple times... And if that is true:

1. the % participating is lower than 1%
2. do we have a truly representative population participating in our trials?

peg,

i'm actually responding to both of your posts since i last read the thread.

i can understand the "not responding to dopaminergic therapy," especially with the autonomic system. I would be even more inclined to understand and agree if the words "no longer responding" were used, and you offered a sensible hypothesis..which is, do we know what an advanced patient who has never been on dopamine or survived going off of it looks like? Well the researchers better race to the l-dopa deprived countries to find some before Merck gets there with the UK's sinemet.

But as a person so clearly described in your post with your theory who is dependent on this medication and miserable on it at the same time, and last but not least, one who pays all the professionals an outrageous sum of money every month for insurance, services and medication - approx. $1500 a month -

I get frustrated. Your theory rings true in many ways.
I'm not sure who they is either....it's more like who isn't part of "they"?

paula

But I'm still having trouble understanding what the motive of the drug company could be. With as many baby-boomers as there are, why would they want to reduce the number of consuming units by eliminating the older (more advanced) ones?

If money is their motive, (and that's hardly a tough sell) I cannot understand how their financial gain is boosted by reducing the pool of consumers.

?????

I want to reply to both of you. Pam - you first. I think that the "shortage" is to force patients to "buy generic." This is the way that I've seen social medicine work. And this thought is strictly my opinion, but I also think this way of coertion is created by an agreement of the government who insures its people and pharmaceutical companies.

Has anyone noticed that you don't hear big Pharma yelling very loudly about healthcare reform? I believe they will come out smelling like a rose. If this is true, research will suffer greatly. There will be no need for the competitioon now seen, and we will take what they give us to take.

Paula - I have Medicare (at present you get this automatically the 3rd month after being declared "disabled" by the Social Security Administration. You remember that Medicare did not pay zilch until recently, when SS recipients could take an optional Part D to covero medications.

Private insurance policies (and I kept my Blue Cross/Blue Shield (BC/BS) of Tennessee from my "state" employment with the school system) was a must unless you wanted to take your meds or eat (which hhas actually been the case for some). And we are looking to change my "extra" policy to a Supplemental. We pay nearly $400 a month premium for my coverage. Although it is excellent coverage - and I rarely have to pay anything but the deductible each year - we can meet those deductibles (co-pays) shortly into the calendar year. I regularly see a Primary Care Physician (PCP), a neurologists, a rheumatologist, an orthopedist, an ophthalmologist, a urologist, and a gynecologist. (WHEW!) There are others I see on a referral basis. AND my out-of-pocket deductible paid thus far for 2009 (that's just MY co-pays) is $1,642 !!!!!!

Something has to give. I don't havea the choice to "get better." If we let this healthcare bill go through as is, I can PROMISE you that those with advanced will not have the care they need for a decent quality of life. (Let me go pull out that OpEd that I couldn't get anyone to publish earlier in the year)
Peg

pam,

Thus the creation of new markets, like non-motor and nondopaminergic, which isn't a bad thing if it produces something. Of course that's just an opinion and a cynical one for sure.

My question is.....what evidence are all these changes based on?

Merck [dispensor of sinemet in europe] is partnering with Addex on a new market of drugs and delivery which is non-dopaminergic. I hope it works. i would like to trust it, but things change so quickly...companies are sold, etc etc.......

http://www.addexpharma.com/press-rel...-merck-co-inc/

paula

Jean,

No worries on the quote; I'm simply annoyed that with so many advocacy groups on our behalf, this is all they can present? Just expressing my frustration on the lack of data on us.

I think that what you present as questioning just how this small group can truly represent a cross-section of 'us' is one that also needs to be addressed in research design. Who oversees the standard data design anyway? Is it the American Academy of Neurology?

Laura

Thanks, Linda. You are a wealth of information. I still cannot seem to get real excited about that alert. I think they nicked my brain during this last surgery lol

Laura -
There is an IRB required at each facility doing research (Institutal Review Board), a requirement of the Federal Drug Administration (FDA.) Defined on the ClinicalTrials.gov site:

INSTITUTIONAL REVIEW BOARD (IRB): 1. A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin. 2. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.

The people chosen to be on the board must meet certain criteria, but you know how politics plays into local communities. This would be good to know (how they are selected). I do know that patients on the board are rare. I find that strange, but it's that way with most efforts FOR patients; they aren't represented. For some of us "seasoned" trial participants, we could help write clinical trial protocol, and possibly prevent many of these missed endpoints for promising research that is sitting halfway done on some institute's shelf in the back room. (sigh)

I'll look for a good website that gives more detail, but for starters here are a few very good ones:

PDTrials - www.pdtrials,org

Parkinson's Pipeline Project - www.pdpipeline.org

The National Institutes of Neurological Diseases & Stroke (NINDS), sponsors a site called ClinicalTrials.gov This link has good information:
http://clinicaltrials.gov/ct2/info/understand

And here are the major types of trials done (from the ClinicalTrials.gov site). I bold typed the two that I feel we need to work on the most:


What are the different types of clinical trials?

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.Screening trials test the best way to detect certain diseases or health conditions.

[B]Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

my 2 cents worth in reference to early onset PD patients and the drug/tropic factor trials: one would think the most healthy who have not been on anti PD meds for a long length of time should be the group for whom a quick and robust response would obtain. And that it would be easier to determine what is the trial drug effect vs after effects of drugs that were taken formerly by older patients who have been on therapy. WIth $$$ constraints, getting a drug to trial, obtaining quick, robust results SHOULD help fast track the drug (if it proves effficacious). I'm with Jean--I think testing for 3 different groups is a place to start to determine who benefits most, though that means a much larger number of participants, more time, and thus, more $$$$. With my trust in the insurance industry, my concern with this approach is that if the drug is found to be efficacious for early stage PD,and the drug and or delivery system is very expensive, the insurance cos could refuse to pay for its use in those who are not in early stage because it has not been tested.