http://www.rttnews.com/1907975/abbot...e.aspx?type=qf

http://disability.ulitzer.com/node/2251066

http://www.wkyc.com/video/1503457318...-steady-relief

OK, so 40 other countries have approved this Duodopa -twin, but not the United State. Why, why, why?

Anybody know the scoop on this?

It is an intestinal gel form of carbidopa/ levodopa delivered via a peg-tube pump.
Peggy

Peg,

A few of us tried to put a petition to the FDA going on this and no one would sign it!

I had been waiting on this (as has Jim) because it means that applying for FDA approval is next step! With those amazing stats they darn well better approve it.

Here is a link with a bit more detail on clinical results * Seems to meet Safety and Efficacy here (in addition to the living proof we have had for the last 10 or so years from EEC)

http://www.news-medical.net/news/201...-congress.aspx
Laura

i'd sign it. good luck!

Sorry to be cynical, but this has not been approved, IMHO, because it is going to cost about $120,000.00 per year for each PD patient. Even is countries with nationalized or socialized medicine, whatever you want to call it, they ration it because of cost-you cannot get it unless you are so bad off that the cost to take care of you (in a nursing home/facility) is higher than what duodopa would cost. So even though it is available, very few people actually can get it, from what I have read. It's horrible, truly.

If you do a search and read posts by folks who live in countries where this is available, they qualify, but cannot get it because they are not yet "bad enough off", it becomes very clear why this is not yet approved here. Medicare/medicaid does not want to add this to its list of treatments, nor does any private insurer.

Am I missing the point here?

According to the article at:
http://disability.ulitzer.com/node/2251066
(thanks to Diego24 for this)
the results show a reduction of "off" time at 12 weeks of LCIG of 1.91 hours per day compared to levodopa-carbidopa IR tablets. Even ignoring the cost, this does not seem to me to be too spectacular, especially given its invasiveness.

Perhaps it's my type of Parkinson's, but I've always been confused by the use of "on" and "off" time as a measure of efficacy. When I have no drugs in my system I can still function. Some things I can do at a near normal pace (e.g. walking), other things I'm very slow at (e.g. dressing where I'm, perhaps, 10 times slower). After I've taken the drugs, there is very little improvement in the things I'm good at, but a big improvement in what I'm bad at (e.g. dressing goes from being 10 times slower to only 3 times slower). But in no way am I "normal": the motor symptoms, although reduced, remain; the tremor remains and the non-motor symptoms, such as constipation, remain. So, for me, the question is not really what is the "off" time?, what is the "on" time?; but, rather, what is the quality of the "off"? what is the quality of the "on"?

As far as LCIG is concerned the article says nothing about quality except in terms of dyskinesias: "off" decreased by 1.91 hours, "on" (by the definition given in the article, I think excluding dyskinesias) increased by 1.86 hours. This implies that dyskinesias increased by 0.05 hours.

The article goes on to describe treatment-emergent adverse events. These occurred in 95% of LCIG and 100% of tablet taking patients. But within these numbers are some that relate to LCIG only: complication of device insertion (51%), post-operative wound infection (17%) etc..

John

Our neuro expressed a lot of concern over the fact that the patient would be in control of administering how much duodopa they got. Just as there are patients who take too much sinemet (because they want to feel better, and then their judgement becomes affected and they can't stop), this could happen even more easily with a pump.

Not sure how they could fix that.

The doctor could enfore an upper limit on the pump; like a speed limiter on a car.