the university of alabama is doing a duodopa trial with the first four people open label. so the first 4 are getting the drug for sure. the rest is blinded. i don't know if all centers are doing open label and blinded. if not, that would justify the travel to alabama i have been told the first surgery , open label, went very well.. that leaves 3 more open label to go ....at alabama, so ask the other centers if you call about it.

let us know if there are others doing open label will you please?


thank you,
paula

Surely these are known drugs, (Levadopa), why years of research and "blind testing".

God, this situation stinks when we wait years for a different delivery mechanism for a 40 year old drug to be tested.

Why not provide Duodopa to all, today, whats the worst that can happen.

I will attempt to provide an update on UK status following my neuro meeting 11/09.

Neil.

'THOU SHALT NOT APPROVE DRUG iN TRIAL WITHOUT PLACEBO" , sayeth the FDA and most of the other medical profession in the USA.

thanks neil, for letting us know how the real world is doing with this.

paula

Duodopa is cleared as a treatment in the UK. It is very expensive though, $60k dollars a year for the drugs alone, then add in the aftercare, monitoring etc and add on $150k. So tough to justify however the PWP it has treated tend to be those about to go into a nursing home where Duodopa becomes cost effective versus the cost of the home. Apparently if being considered by a Neuro, Duodopa "makers" bring their own Accountant to meetings !!

Still looks very effective end stage treatment according to the Neuro.

Hope this helps,
Neil.

Just reviewing the info out there on clinical trials and use of this treatment. I was surprised to find that this delivery system is given only afterDBS has been eliminated as a possibility for the patient. OK, I get that a pump infusion system requires surgery and is invasive, but we're supposed to try brain surgery first? Hmmm...guess I don't see how giving someone free reign with wires inside my head is less invasive than installing a pump through my small intestine.

Also, why the exorbitant cost? I think both research and clinicians agree that smaller, steady doses of levodopa is actually better for us as it mimics natural processes vs. the nasty on-off effects and dyskinesia. Why wouldn't this therapy be offered as an alternative to DBS? I don't understand why you would need be ready to enter into a nursing home to be eligible. It seems to me that Solvay is missing an opportunity to market this differently, or are there simply too many complications wherein people cannot tolerate the treatment?

Laura

I believe the reason it has been considered for pwp about to enter a nursing home is that the cost benefit of Duodopa versus nursing home is easier to argue.

I cannot understand why the drugs are so expensive, l-dopa is pretty cheap, liquid l-dopa aka Duodopa seems to cost "$ large". Is this an example of a company pricing themselves out of the market ?

Why it should be considered only after dbs is a mystery to me. I agree I would take nearly anything over brain surgery. I wonder if there is a vested interest lobby for dbs among companies and Neuros who perform dbs !!

To me this highlights the struggle to get drugs to market. We go through a never ending round of trials possibly only to find the company's pricing model is off the pace due to the costs of drug delivery to market. Then we have to lobby the medical profession to move away from their existing pet company / product to consider the new alternative.

Makes you wonder how anything for PD gets to market (oh hang on, thats probably why nothing has for 40 years). I wish I had more answers.

Take care,
Neil.

Why can't the duodopa be approved instead of the brain surgery?

They drilled my head and I'm still taking 1500 mg of levodopa a day! I'd much rather have the pump!! And why the heck is this treatment which is so effective being squandered on those in nursing homes! Think of those that this could help get back on their feet and be productive with a lot of life ahead of them, NOPE I cannot see how this is more expensive than brain surgery-perhaps in the long run (drug costs,etc) but come on, initially?? I smell a rat!! I'm up way too late and tommorrrow is another day. Let''''s face it this healthcare thing is never going to be fixed. It's too dollar hungry with special interests. Nite ya'll.

I have been in the study since March 2009. I live in Ohio and just wanted to jump in and say that this system really works! I noticed that there seems to be some concern about infection at the port site. I have had little problem with this. A port is a port. Simply keeping the site clean and not snagging your port on something and jerking it are the two most important items. I am now in the second year of treatment. I was not in a blind study. I got the drug from the first. I only have to see my neurologist every six months and life is great.

Dan

My husband is one of two who have participated in the open label trial at Medical College of Geogia in Augusta. He underwent surgery in September, 2009. Had the reported infection at PEG site - very severe. Had to have additional surgery to remove infection and properly place the peg. Duodopa is great. Much less fluctuation and much less dykenisia.