for full article see:
http://www.ctv.ca/servlet/ArticleNew...128?hub=Canada

sorce:CTV.ca News Staff

Date: Thursday Jan. 28, 2010 12:02 PM ET

Excerpts: "Health Canada is warning Canadians with Parkinson's about a shortage in a key medication used to treat the disease.

The generic medication Apo-Levocarb CR, in the 200mg/50mg strength, has been temporarily discontinued according to the manufacturer, Apotex Inc. No reason for the discontinuation has been given.

Apo-Levocarb is the generic version of Sinemet CR, which is owned by Merck Canada and distributed by Bristol Myers Squibb Canada. Sinemet CR tablets contain a combination of levodopa and carbidopa, also called levo-carb.

Bristol-Myers Squibb says the discontinuation of Apo-Levocarb has created a sudden new demand for their product and has caused a backlog....

The Parkinson Society of Canada says patients with Parkinson’s should not try to ration or stop their dosing of levo-carbidopa, noting that other forms of levo-carb are available.

“Stopping levo-carb suddenly for a prolonged period can result in worsening of Parkinson’s symptoms which in some cases can be severe and irreversible,” the society notes.
Patients and physicians can also call BMS Canada at 1-800-267- 0005."

Mentioned in this blog
http://parkinsonsfocustoday.blogspot.com/



and on looking at original post:

Apo-Levocarb is the generic version of Sinemet CR, which is owned by Merck Canada and distributed by Bristol Myers Squibb Canada. Sinemet CR tablets contain a combination of levodopa and carbidopa, also called levo-carb.

Bristol-Myers Squibb says the discontinuation of Apo-Levocarb has created a sudden new demand for their product and has caused a backlog....

Very curious about above as previous notices of shortage relate to brand name, not generic........ doesn't make sense.......

Same shortage of Sinemet has been announced across Europe and in Australia. Explanation: "supply problems". Right. It's the famous "Gold Standard" drug, the only treatment developed in the past 60 years, and suddenly companies that have been cranking out L-Dopa for decades have simply ceased production. Mirapex sells for a far higher price than L-Dopa.
Makers of Mirapex are being sued for billions, for not warning that the drug can cause compulsions and destructive addictions, to sex and gambling, etc.
There was some research, shakily and feebly stating that Mirapex causes these problems, but there was no research whatsoever saying that Sinemet caused the same problems.
Suddenly, just as the first warnings of a shortage of Sinemet were announced in Europe in late 2009, they started printing a warning on Sinemet, almost word-for-word the same as the warning for Mirapex, about these dangerous side effects.
Without any research whatsoever.
So, your plan to drop Mirapex but take Sinemet is no longer possible. They have suddenly been declared to be the same, and the cheap one may not be around all the time.
So you may as well stick with the Mirapex. Hey, the side effects have now been declared to be the same. EXCEPT that at the same time, they started stating on the Sinemet packages that Sinemet also causes melanoma. No announcement or anything, they just quietly slipped it in. Makes Mirapex look safer than L-Dopa in my eyes. And the link between Sinemet and skin cancer - did that just suddenly happen after 60 years?
So, it's back to Mirapex for you, at a cost that is about 500% higher than L-Dopa. There is a very plentiful supply of the expensive drug, but not the cheaper one. Because of "supply problems". Entire production lines of Sinemet have been shut down. All of a sudden. With no explanation.
So next time you decide to sue Big Pharma for something like Mirapex, you will have to think twice.. They hold the big end of the stick and they can retaliate enough to put the Parkies back in line, as Amgen did so successfully with the GDNF caper.
The Parkinson's Association of Canada has reacted fiercely: they sent out a press release warning Parkies of the cocaine-like withdrawal symptoms they may go through if they can't get enough drugs. They did not ask for any explanation of why L-Dopa, pushed as the only treatment for 60 years, suddenly has production lines shut down world-wide. No one has dared to suggest that this looks awfully like an artificially-created shortage. It certainly will drive up the price of Sinemet; it certainly will help hold up the sales of Mirapex and other agonists.
If this is a game of money and power, then some Big Pharma execs should be taken away in hand-cuffs, instead of merely being fined, such as the $2.3 billion fine for criminal drug dealing that Pfizer has to pay. They made huge profits on the illegal drug dealing, despite paying the $2.3B Their stock went up, because they proved that a few billion to pay for the damages is no problem for them. The fine was 1% of their sales.
If it is not a power game Big Pharma is playing, then executives would avoid jail time, but be fired for absurd incompetence and bad planning and reckless endangerment. A drug cranked out generically for 60 years, and now there is a world-wide shortage for the next 2 years? All of a sudden?
But these questions will not even be asked, much less answered. Big Pharma has shown again and again that they can get away with anything.
And they know that PWP have no vehicle that will fight back - or, in the case of the Canadian PD Association, even ask the question: why will there be a shortage of anesthetic in the operating rooms and a shortage of drugs for chemotherapy for cancer? Oh wait, wait, my mistake. They would never get away with that; the whole society would hunt them down. But a shortage of L-Dopa? Hey, watch out for the withdrawal symptoms, suckers! And there's plenty, plenty of Mirapex to go around, at 500% higher cost.
And you won't hear much about it, anywhere. About the two year shortage. "Supply problems." Says your drug dealer.

Canadians don't have as long to wait - the European shortage is through 2011. This will cause more selling of DBS and stalevo possibly. But i don't know anyone who hasn't eventually had mirapex wear off in efficacy. They couldn't take l dopa away for good...we would die of the DAWS only sinemet doesn't have a new name for it's withdrawal death or significant life threatening dependency. Hey let's see if we can name it......how about something real original like CLAWS? [C- arbidopa ; L - levodopa ; A for the end of the two previous words; W - withdrawal ; S - symptoms.

I think we should get to name something. It's what we would use to try to get some if we were denied...our claws.

We have to make noise, lots of it. Violet Green sent a story about two MD protestors who got arrested for something outside if where Obama was speaking..i skimmed it and don't know the details until I read it again. Now that is my kind of medical doctor.

I don't know how to retaliate other than to say we aren't going to participate in trials. How else do we really get their attention? Tell them no because trials can't be trusted and we'll stick with what we've got for treatments. For the advanced, there will nursing homes and IV drips once we start breaking bones.

Our bandido Bob is currently in a skilled nursing home recovering from a fall and a crushed elbow. He will be there for 3 months and doesn't know if or when he will be able to go home. Bob is a vibrant man with a keen mind and we miss him terribly at the book meetings. I need to call him and make sure they aren't giving him cholinesterase inhibitors with an anticholinergic. He is 78 but hardly demented.

regarding pharma:

The hard part is we are living in a fallen world. Business practices rule, which means money rules. Money is the root of all evil. It's not going to change. Pharma controls our foundations as well, which is why using patients is so sparing and limited. The heads of foundations are paid hundreds of thousands of dollars and control the research without patients. what do we have to show for it ?

Who cares? moral code has been irreparably compromised.

we must keep noisy; don't be afraid....like larry j said all the time,
"I fall down, I get back up. I fall down again, and get back up again.

Ignore the competition among foundations and rejection of patient involvement. We have to get past that, do the best we can with the orgs in which we are involved, but don't look for them to let you interact with actual research design.

We are going to get there on our own thru exposure of corrupt practices. Dr. Tony Lang and gang recently published an article and quoted the PD Pipeline Database as their first resource. Linda H. is the gatekeeper.
http://www.pdpipeline.org

Bob Dawson, did you know that Amgen has licensed their GDNF for a convection enhanced delivery? Originally, we heard that Amgen was going to provide GDNF for gene therapy and I couldn't understand how it became a gene. It hasn't come up in America yet .....amgen is getting a cut on it and we are assuming that someone finally came up with a suitable delivery system

The worry is that they will use people in early stages only in these gdnf trials, which is where the market is and increased chances of success? Are they morally obligated to provide treatments for all pwp....or do the authors of the fallen world have that in control and see the benefit of babyboomers dying off, not living longer.

just to show how communication should never be assumed, a friend in the Freed fetal study that recently was the subject of these two PDOR posts ad their corresponding articles, came to visit and hadn't yet heard about the recent findings and articles.
http://www.pdonlineresearch.org/resp...and-colleagues

http://www.pdonlineresearch.org/news...inical-benefit

When she got back to Canada, she wrote to Dr. Freed, who was the lead investigator of the study, and he responded with , "what have you heard?'

Lynda has much to offer through some intensive neuro imaging. She has subequently had a DBS , and they have difficulty calibrating her; are her fetal cells making her less in need of higher calibrations? Are they still there?

Dr. Freed said he had lots of positive data but didn't anyone tell him his study was being re-evaluated? He heard it from patients who learned it thru neurotalk posters and pd pipeliner emails

i feel beyond urgency, but am going down fighting for wrongs to be corrected for my family to not have to repeat any of this. Negotiating thru life without getting poisoned is tricky business. The same people who make the poisons, make medicines.....and have those who should be caring about us in their pockets.

NOTIFICATION ON LIMITED AVAILABILITY OF SINEMET® AND SNEMETCR® FROM LATE 2009
Close
This following information has been provided by Merck & Co., Inc to help answer any queries from EPDA members.
________________________________________
It is a world-wide shortage, hoarding has already begun, and there has been no explanation:
"I am writing to inform you of an expected supply interruption in SINEMET® (carbidopa-levodopa) and SINEMET CR® (carbidopa-levodopa controlled release). At Merck Sharp & Dohme Limited (MSD), we are working hard to help minimize the impact that this shortage will have on some Parkinson's patients and their physicians.
Starting in late 2009 and continuing into 2011 MSD will experience a significant global supply shortage of SINEMET and SINEMET CR. This temporary shortage is related to a change in the source of supply for the drug and the necessary timelines needed to obtain regulatory approvals for this supply change. It is important to note that this situation is not due to product quality or safety issues, nor is it due to delays on the part of individual regulatory agencies that approve this supply change.
To address the expected shortfall, Merck & Co., Inc. (Merck), our parent company, and MSD are taking action to manage available supply of these products through a process that primarily takes into account patient needs, as well as availability of alternative treatments (which exist in most markets), and contractual obligations. In accordance with our analysis, some markets will get their full needs met, many will experience a significant shortfall in their supply, and many will not get any supply of these products. "

This should be a matter for the criminal courts.

Dear Prescriber,

We write to inform you that Australia will experience a significant shortage in the supply of SINEMET CR starting in early 2010 and continuing into 2011. ... ..it is estimated that initially only 20-50% of patients will be able to receive uninterrupted supply..

We appreciate your management concerns for your patients, especially for those whose symptoms are difficult to control. Your assistance in enabling a limited number of patients to receive continued supply through this difficult period is greatly appreciated.

Notice of the shortage of SINEMET CR is being communicated to neurologists, geriatricians and general practitioners in the first instance. Pharmacies will be informed of the stock shortage in a separate communication

For further information, please contact our Medical Information Department on 1800 645 712.

Dr Troels Wolthers

Medical Director
® Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ, USA

Might this be relevant........

http://www.michaeljfox.org/newsEvent...cle.cfm?ID=529

And scroll to bottom to see connection........

"Earlier this month, Merck announced that it had licensed Depomed's AcuForm technology for a combination product with Januvia. Depomed is set to report three phase III trials in October of this year."


It is unclear if Depomed is actually doing phase III trials on a carbi/levo product, or if the phase III studies mentioned above are with other drugs using their proprietary AcuForm timed-release technology. If you look at their pipeline of new prducts using this technology, there are two or three others already in phase III trials. http://www.depomedinc.com

The fact that Merck has licensed that technology makes me wonder if they are already doing the phase III trial with the intent of abandoning Sinemet CR in favor of marketing this newer formulation. It would be a great excuse for jacking up the price of the drug.

Robert,

What you have said sounds plausible and likely if they are intending to market a new formulation of something that has been around and untouched for many years.

I agree we should be angry and express concern but I worry that boycotting research hurts us more than helps in the long run. I take CR but honestly like Lindy it more helps smooth out dopa peaks or spikes rather than gives me a longer duration.

One way we can speak is to not buy Sinemet. period. Hoarding is exactly what is expected. I've been toying with trying Zandopa (mucuna pruriens) and making my own capsules...now seems like a great time to do so. I know that this is not feasible for some, but it would be fantastic time to send the message that we are not enslaved by them; there are alternatives.

Laura