Oh my God, are we ever screwed.
I had no idea it was this bad.
Those first 2 paragraphs are essentially a Merck press release saying a lot less than nothing, and government feels "reassured"
It's over. No use continuing.
Parkies of the world, disperse. You are on your own.
We do not have any resources to even scratch the surface. Either some brave prosecutor presses charges, or else just forget about it.

I found some interesting data on Rxlist.com regarding the "long acting" Sinemet CR dosage form:

here is a quote:
from the pharmacology section of this link:
http://www.rxlist.com/sinemet-cr-drug.htm

What does this mean? It means that the "long acting" action is not really long acting, and that the CR is not going to work for some patients. I know in my experience at a huge nursing home provider, the CR form was often used 4 times a day for some patients who might also have immediate release also.
Bioavailability issues for this drug are very much different than for other drugs. And herein lies the basic problem.

If raw material were not available, then the immediate release would also be affected. It has the same raw material in them.
It is only the CR that appears to be affected, so I am leaning towards the poor product formulation, or control of the CR by the manufacturer who expects the Depomed form soon. The website for Depomed does not show phase III has started yet however.

So how do we question the company direct, formally?

If anyone knows how, or who would be best to do this then please post.
Personally I cannot see anyone giving a clear answer, there would be a prepared and obfuscating statement.

We are still not aware of how many people are actually experiencing a shortage, or being moved onto generics, or even more the viability of the generic producers. IF anyone can find out more about the status of sinemet/generic in terms of being classified as essential drugs, in any country, please post.

I would like to know more about the current manufacturer of the raw material or "active ingredient", and the new producer.

thanks
lindy

Since posting this I have found the info I wanted, or most of it to my third question, and it is oh so obvious.....

"So how do we question the company direct, formally?"

Process starts with a search warrant; then a court date.

anyone on the board that can accomodate this situation? I don't know what is going on anymore than the next person, but I'm ready to follow the yellow brick road and right now.

count me in and i hope i'm wrong
paula

I'm further incensed that we have no official warning, word, nada from our supposed advocacy organizations...NPF, PDF, EPDA, and the myriad Canadian groups. Really, the silence is deafening. Just what is that these people do when their Non Profit 501(C) status is approved, other than largely, overlap each other, and ignore us? If they all have such narrow agendas that not one of them has any insider connections to help us in such a basic endeavor as this, then what is the point?

Laura

They will issue a royal decree that it's a non-issue after a long period of time has gone by, and make us feel powerless, stupid, etc.

p

I guess the reason that US orgs have not got involved is because there is no announcement of shortage for the US.

I am not looking at this in a completely negative way.

The statement from the UK does clarify some things. It is not just a shortage created by changing from one manufacturer to another. It is a shortage caused by supply change in the raw material. That makes it more understandable in terms of licencing and getting past all the legislation.

The fact that there is legislation in place that creates dialogue and an information flow between government and pharmas is also good, the 'best practice' stuff that is talked about give some leverage against companies that do not fulfill their obligations, and creates the imperative to inform the DH in the UK, I understand that the EU countries also have similar legislation in place.

I am also encouraged that as an individual I was able to get any kind of answer, and had not expected more at this stage.

What I would like to establish now is whether both the branded and generic versions of levodopa/carbidopa and the similar drug Madopar and it's generic are classed as essential drugs, and if so where they are given this classification. If they are not classed as essential this is something that needs to be done and campaigned for as a matter of urgency. Given that if and when a cure comes it is likely to be in incremental steps that remove the causes and symptoms, rather than one all encompassing CURE that fits all patients, my guess is that levodopa will remain a useful drug for a long time. The best way to protect is it to ensure the way in which it is classified.

I am 100% for affirmative action in this matter. At this time we need to be building bridges, not tearing them down.

Lindy

Lindy,
I wish you the best of luck with your positive approach, Lindy. Hope springs eternal.
But for myself, I believe that when dealing with extremely wealthy and powerful billionaires who are either wildly incompetent or just clever scam artists, you have to speak softly and carry a big stick. Parkies have a big stick, but have no resources to swing it.
If Merck has no fear of being held responsible for the consequences of their acts, they will be toasting their own cleverness in the boardroom, today, March 1, the day of the official beginning of the "world-wide" shortage. It's Amgen GDNF all over again, and it is already over, Parkies have already lost, and that will not change, unless somewhere in the world, somewhere in the 140 countries that Merck supplies, there is a government prosecutor with police power to issue search warrants and lay charges. And you can be absolutely sure that Merck's lawyers envisioned all of that before sending out the first press release, and they are entirely prepared; for one thing, Merck is incorporated separately in many countries, so each one can say it was decided somewhere else.
I have seen this movie before and I know how it ends. My group of Parkies are splitting into semi-autonomous Mutual Defence Units of 3 or 4 Parkies in each, and we are going local; withdrawing from national or international Parkie activities; back to the PD Underground where we belong. The Mayor will get his pills, the ex-con on parole for armed robbery will not. We will obtain what we need for the ex-con, through India if necessary; or probably there will be no shortage in Canada, because Canada contributed to the scam by shutting down production after it became clear that Merck was engineering a shortage. Health Canada copies Merck's press releases and sends them out virually word for word.
It's a multinational political scandal, a medical outrage, and an ethical swamp. It makes me sick to contemplate it at all.
It's just another porn movie and my group is switching channels, because it is not even a good porn movie.
Best of luck; my PD group will stay away; we do not have the energy or the health to battle organised crime.

I searched online some more today about "patents"..

I found an Italian company back in 1989 had one patent for levodopa.
http://www.freepatentsonline.com/4826875.html
and
http://www.freepatentsonline.com/4962223.html

Then other patents more recently mostly for alternate forms...
http://www.wikipatents.com/US-Patent...d-uses-thereof

http://www.freshpatents.com/Extended...0070275060.php

This is a monumental task. Finding who owns what, and who employs who... etc.

I think having Lexis/nexis connectivity may help.
But I really stalled out after only an hour!
Patents are only the beginning... they can be licensed out or bought.

edit ...I seem to recall that Roche was the first in US to market Levodopa. It was called Larodopa.. so I looked it up:
http://www.roche.com/pages/facets/5/parkinson.htm

This is just a factoid to illustrate that the "path" of this drug maybe very LONG.