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 will start screening for trials aat Cleveland Clinic (OH) this month

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.

My husband is participating in the Duodopa trial at MCG in Augusta, GA. He had the surgery in September 09 and did have the problem with leaking at the peg site which did lead to a very serious infection and he became septic. He was in the hospital for 24 days. We almost lost him. The drug works great but he is still struggling to regain his weight and strength after the long hospital stay.

It is my understanding the pegs and tubing are different from the pegs and tubing normally used in the US. Our doctors agreed that Solvay should either change the pegs and tubes or train our US gastro doctors about the differences. It seems like a simple solution but I continue to hear of these same problems again and again. If they know there is a problem, why don't they just address it??!! It is so frustrating.

My husband has had great success with Duodopa. The continuous infusion has greatly reduced his fluctuations and dykenesias. I just pray that get this approved quickly because we can surely see the great benefit it would be to so many people suffering with PD.

[QUOTE=Stitcher;566120]I had a doc from the University of South Florida, Tampa, say that there were a lot of issues with infection at the site. I can only hope that this problem has been resolved.



Unfortunately I don't believe the problem has been resolved. There is a problem with our surgeons being unfamiliar with the different peg and tubing and apparently Solvay has been slow to either change the tubing or further train our doctors. My husband is in the study and had surgery in September 09 to insert his peg. He got a serious infection, requiring additional surgery to repair and correctly place the peg along with removing the infection. He became septic and came very close to dying. He was in the hospital for 3 1/2 weeks. The drug is great but the procedure needs to be perfected. Seems that the solution is simple -- but Solvay hasn't responded very well.

[QUOTE=Dianne G;622585]Thank you so much for this valuable information. It is upsetting that Solvay does not see the immense marketing opportunity in its system. If it could work out the kinks, and perfect the tubing mechanism and get a handle on cost, they could have a potentially huge market for those who need more continuous dopamine delivery (that is the majority of us at some point). This could really be either an intermediary treatment between meds and DBS or an viable altemative to DBS. I wonder why they do not "get this"?

Sorry to hear that your husband ended up with such a serious reaction and infection. I am glad to hear that he has rebound and gains benefit from the system. Will he be able to continue treatment after the trials are over?

Laura

[QUOTE=Dianne G;622585]Thanks for the information: My wife is to start a clinical trial with this on the 22'nd of Feb 2010, next week. I will ask if the tubing has been changed or if the problems still exist. I would hope that the problem has been corrected. She currently has a lot of off time and we are looking forward to an improvement without the DBS. Will let you know next week how it goes.
Thanks again
Cmeender

i'm just reading this thread - got behind. Thanks for all the information from trial participants and family. I hadn't heard about it only being used if a DBS is ruled out.
Dianne, i'm so glad it was all worth it! what a nightmare.....

cmeender, wishing you all the best.

the drug companies sink to new levels all the time. They put you through the ringer and completely disregard the punishment and emotional/psychological consequences of the trauma, let alone the near death experiences.

after all that, it better work!
please keep us posted.
paula