"Possible sinemet cr shortage in Canada"
 

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."

also mentioned here........
 

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.

we have to hit bottom first
 

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.

many will not get any supply of these products.
 

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.

They are going to pick and choose who has been naughty and who has been nice
 

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

DM-1992, a novel sustained-release formulation of LevoDopa/Carbidopa
 

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

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

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

This is from the MJFF link Lindy gave
 

"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.

Respond by not buying it
 

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

Bewildered.......
 

I simply do not understand the logic of any of the explanations coming from Merck and their subsidiaries.

Why there is a shortage is not explained, why it should affect both branded and generic, why CR is singled out right now though the initial EU notice included all variations, and why it should be 'world wide'. There has been no implication of shortage of raw material, or problems with distribution, only a vague statement relating to 'source of supply' changes and 'timelines needed to obtain regulatory approvals' (world wide???) ......... but they KNOW that it is an essential replacement drug, not a palliative. Would they not have taken care to ensure a continuing supply if they were shifting production or some such? The more I see this story the less sense it makes.

And no comment ANYWHERE from any of the orgs that represent patients and/or their interests, though it has been announced on three continents.....

We are not just patients but consumers as well.

Perhaps patients are due some answers that make the real picture clearer.

I called Canada's only maker of Sinemet a company called Apotex, and they said that they have entirely halted production of Sinemet because they are "undergoing re-organisation" and because the market is flooded with cheap Sinemet from China and Canadian workers won't work so cheap. They claimed to be unaware that production lines have been closed in other countries, and the world-wide shortage will last two years - it was news to them that their production shut down at the same time as in other countries - who would have guessed? Oh, and they said they halted production and recalled what was on the shelves. True or not; makes no sense. A recall? Also said they might re-start production in a few months, but Health Canada takes a long time to approve.... new packaging? new production line?
If they are shutting down production in this obviously co-ordinated manner from country to country because of the flood of cheap Sinemet from China, then where is the flood? How is a world-wide shortage caused by a flood of cheap imports?
I called Health Canada and asked lots of questions and they said they would get back to me. They also did not seem to be aware that production is being shut down in places other than Canada. All at the same time.
What is needed is criminal prosecution to at least attempt to bring out the truth. If it is not actual gangsterism, at the very least it is criminal negligence causing bodily harm.
Get a huge population addicted to a drug without which they can't function, and then pull the plug on them. Zero explanation. Synchronized destruction of production in different countries is not something that can be blamed on China. Something else is going on, and what we need is police raids followed by energetic criminal prosecution. They do not fear billion dollar fines for criminal activity, they do not fear billion dollar pay-offs to silence people they injured: they just add it to the cost of the drug. The only thing they would fear would be prosecution for a series of crimes, such as reckless endangerment, criminal negligence resulting in bodily harm, racketeering, price fixing; with luck the withdrawal from the drugs will not actually kill people, otherwise, what was the title of that book....."None dare call it manslaughter." They fear nothing so far; facing 20 years in penitentiary might improve the accuracy of future press releases.
It would be wise at this point for Merck or one of the Parkinson's orgs to come forward with an explanation, or at least some new lies that have a bit more credibility than the old lies. It would be interesting to have an accurate time line about where and when and why the production of an essential drug was curtailed, and why it takes two years of people suffering before they can crank out the same addictive pills they have been selling us for half a century.
There is an element of information missing here. Something is not being said.. It's all very amusing until someone gets hurt.

Merck's letter to Australian doctors is iconic, a real collector's item: 50% to 80% of patients will be denied the drug that allows them to function.... who decides? Who gets the drugs and who does not? Triage time. Playing lifeboat. Ten people in a room, drugs enough for only two of them. Who decides who are the eight and who are the two? What criteria?
In the Australian letter, Merck asks the doctors to help out with the triage. But notice - nothing Parkie is consulted. Or informed. Our lives are on the line and we are not even part of the discussions. Somebody somewhere handed out this addictive drug like candies and then unilaterally pulled the plug, without consultation or information or conversation with the people who will suffer as a result. It's the same system as the Amgen GDNF caper. Now, like then, we are groping for information about decisions to cut us off from medication that allows us to walk down the street. Who is going to decide who gets cut off from the drug? That should be a public debate in every neurology department, and especially, in every Parkinson's organisation.
One way would be by drawing straws. A lottery. Highest bidder. No, it is going to be "who needs it most". But again, by what criteria? I need it more than you do, but your doctor has more pull. Who are the 8 who get thrown off the lifeboat to save the two - that should be decided in every Parkinson's group. At least as theater. Because what is going on is not right. Let the doctors come forward and explain exactly what criteria they are using to decide thumbs up or thumbs down. What are the regulations of this triage, and who is supervising the regulations? Health Canada? Or Merck? What are the criteria, gentlemen? Ten Parkies in a room and you got drugs for two. We want to hear you say what you are going to do.

Shortage in 2003!?

With a google search I just found that there was a Sinemet shortage in the US in 2003 as reported in the fall newsletter of the Parkinsons Disease Foundation:

"Sinemet and Sinemet CR

The Parkinson's Disease Foundation (PDF) has received numerous calls from patients who are unable to get hold of their Parkinson's medications, Sinemet and Sinemet CR, either at their usual pharmacy or elsewhere. Both medications, but particularly Sinemet CR, have been very hard to find in recent months.

PDF has contacted Bristol-Myers Squibb, the distributor, to determine why these medications have been unavailable to patients. Speaking with a company representative, we learned that: "The current shortage of Sinemet and Sinemet CR is due to manufacturing issues. Bristol-Myers Squibb is working with the manufacturer of the medicines to obtain an appropriate supply of both Sinemet and Sinemet CR."

The company reported that the manufacturing issues are being resolved and that both Sinemet and Sinemet CR are now being distributed. However, due to the backlog of orders, it is likely to be the end of 2003 before supply levels are fully normalized."

http://www.pdf.org/en/fall03_Sinemet

There was nothing else giving more detail about the events in 2003 or now.

organized wisdom found at PD neurotalk...
 

Health Canada called back. It is not their department. It has nothing to do with their mandate, their mission, their purpose, their jobs.
They will say nothing whatsoever about the sudden closing of Canada's only sinemet production; they will say nothing whatsoever about the fact that sinemet production is being curtailed around the world, with no explanation; they will say nothing about who is going to decide who gets the drugs or not, who conducts the triage and by what criteria; Health Canada has nothing whatsoever to do with any of this. They would not answer any question whatsoever. They said I could call the drug companies. Which I already did. Same as Health Canada. No information, no concern, no problem.
Health Canada 613-957-2988
(And this is socialized medicine. Hahahahaha!)
No doubt about it. We completely on our own.

What tangled webs they weave; seeking to deceive
 

The old song "Yes, we have no bananas" has been changed to "No, we do not have no bananas, yes we have some bananas." Bristol Myers Squibb has a monopoly on the Merck version of the Golden Standard of Parkinson's treatment. BMS returned my call (800-267-0005) today, and they said there is no shortage of sinemet in Canada.
BMS's own website still carries the public advisory sent out by Health Canada. Health Canada's website still warns of the shortage. It was broadcast on national news by CTV, Canada's largest TV network. The PD Association of Canada sent out a press release saying that going cold turkey on these drugs could cause "irreversible harm".
Apotex, the only Canadian producer of this drug for BMS, confirm to me that they have in fact shut down production of the drug.
BMS deny what they say on their own web page.
Health Canada refuses to talk and told me to call Apotex and BMS. Which I had already done.
Meanwhile the European Parkinson's Disease Association (EPDA) confirm that there will be drastic world-wide shortages for two years. Merck confirms that some markets will get full service, some markets will have reduced amounts of drugs, and some markets (countries) will have none at all.
So the triage is taking place on this, the first round of triage, at a national level. Canada has been selected to get its full dose. In Australia, every neurologist and every pharmacy has been told by individual letter from Merck that they must prepare to yank between 50% and 80% of their patients off the drug.
Which other countries will receive none at all has not yet been revealed.
Canada paid what to be on top of the list? What palm did Australia fail to grease? What type of countries - what income level - will be cut off entirely?
And then, the second round of triage, countries like Australia have to decide who should switch drugs or go off drugs and who should be given access to the newly-created short supply of the drug, as sinemet production factories belonging to different companies in different countries somehow all came to the conclusion that they should pull the plug on PWP.
I don't know which European countries are being put in Australia's category (play lifeboat - give the drugs to those who really deserve them, by criteria you do not reveal - a fun game of Russian roulette with a loaded pistol) and I don't know if the USA is going to be in the Canadian category ("what, me worry?"). And I really don't know which countries are being cut off completely. Is it by skin color, size of nostrils, or untraceable funds moving through Swiss banks? Maybe it's a video game they all play like Grand Theft Auto III, and they don't realize that Parkies actually exist in the real world.
No, no, no, it is actually not a conspiracy. They aren't bright enough to put together a conspiracy. It is just wildly extreme incompetence governed by greed and total disrespect for the laws of God, man, and nature.
Between Parkies and the Parkinson's Industry, this is the norm.. It's always been like this, so what are you whining about this time? Swallow your pill, sit in a chair, stare at the wall. Except that this time you don't get the pill.
And you thought your side effects were bad up to now!
Big Pharma is going to educate a LOT of Parkies on just how wonderful L-Dopa really is. They will have you on your knees begging for it.
But there is a "supply problem"; a little mistake in balancing supply and demand. Mathematical error perhaps, or as Apotex said, "re-organisation". Or their mule got busted at the airport. Sends the price way up.

In US, FDA says "no shortage"
 

Bob Dawson wrote:
"Which other countries will receive none at all has not yet been revealed.
Canada paid what to be on top of the list? What palm did Australia fail to grease? What type of countries - what income level - will be cut off entirely?"

I certainly can't answer Bob's questions but I wondered if the US distributors were involved in the "world-wide" shortage.

Upon the advice of a good doctor (my definition is one who listens and responds timely besides being knowledgeable), I wrote to the FDA Drug Shortages Group. They responded:

"Thank you for your email message. BMS markets the Sinemet and Sinemet CR for the US market and they have not reported any shortage to us. We are checking on supplies of their products and will let you know what they report. Please note that the US has several generic firms that also supply the same formulation of carbidopa and levodopa. Please let us know if your pharmacy is a having any difficulty obtaining the product you normally take and we can check but we are not aware of any shortage issues and have not had any reported to us for the US products. Thanks.

CDER Drug Shortage."

I'll report if I receive further information from them. Of course, they don't realize that the generic does not work for some of us.

In terms of motivation, the only thing I can surmise is that the drug companies may receive more money for the drug in certain countries and are providing it without shortages there. I've been told that even for generics, US patients pay more and therefore drug companies make more $ on drugs sold here.

Perhaps there are other reasons like transportation? And that's why by some reports, Canada and US have no shortage? Is it manufactured here? But I can't imagine that the transportation costs of sending small pills across oceans would inflate costs enough to create shortages in the rest of the world.

God save the queen
 

Thanks for going further and contacting the FDA. I thought it odd that the three countries receiving official notice of the shortage all have ties to the British crown. Probably no there, there, but odd nonetheless. I also ran across a study singling out the NHS in the UK as a culprit in the shortage that is underway there. It seems there is a medicine supply chain problem there. Sinemet is not the only drug in short supply.

How this expands to Canada and Australia beyond the crown connection, I'm not sure, unless they are linked via production and supply?

Lindy can you make sense of this?

Laura

No great loss....
 

Here in Australia my fellow parkinsonians who are prescribed sinemet cr can take the alternative madopar sr.
This is the first I've heard of a potential shortage so will let you know if it happens to others within our P.D. community.

Crown
 

Laura,
The original announcement by Merck was an EU wide announcement, that said there would be a 'world wide' shortage running from late 2009 through till 2011. We are unaware of what is happening in non-english speaking countries, or countries that have no socialized or insurance based health systems. I do not believe that this is a matter relating to ex british territory as the the notices relating to shortage appear to come from Merck and it's subsidiaries. It would seem likely at the moment that this is some kind of bidding up strategy that pharma is using. The possible connection to Britain is health service style, with Canada having something fairly similar to the UK, and Australia having something halfway between the US and UK model. If there is no real shortage, and this is bidding up, then surely there should be some kind of regulatory org, perhaps the WHO, with some kind of watchdog capacity. I am as stated in other posts, completely bewildered by this. At this time none of it makes sense.

While there are other levodopa based medications available the problem comes for those patients who are settled on a particular regime AND who have not found benefit from generic substitutes, OR who have great difficulties changing medications resulting in weeks of adjustment. Also for the elderly who may not be in charge of their own regimen of drugs, in whom any deterioration may not even be connected by their carers to a change in medication.

Down through the rabbit hole again.............

Britain: a call for a public investigation
 

Still no info about Europe, or South America, Asia, etc. In Britain, demand for an investigation:

• The Pharmaceutical Journal 2010; 284:41 (UK)

In mid-November, 2009, 10 major players in the medicines supply chain and the Department of Health issued joint guidance reminding stakeholders of their legal and ethical obligations to meet the medication needs of UK patients.
From the patient’s perspective, stock shortages are not just an economic matter. Out-of-stock medicines can lead, at best, to increased visits to pharmacies to complete the supply and, at worst, to increased adverse reactions. The PSNC quotes US research that finds that when alternatives are prescribed this can cause confusion and decrease compliance.

Taking the issue to a national level, the PSNC has also asked the Department of Health to impose information requirements on branded medicines manufacturers to support the ongoing monitoring of supply problems and has recommended that it should institute a review in conjunction with manufacturers, distributors and community pharmacy to consider what measures can be put in place to address supply issues.
It will be using evidence supplied by contractors of supply issues linked to changes in manufacturers’ distribution arrangements to support this. The Society, meanwhile, has written to the Secretary of State demanding a public inquiry.
.... it is still the view of the BAPW that there is a fundamental fragility in the supply chain, caused by a combination of factors, including just-in-time ordering, which has reduced the amount of buffer stock in the system, a reduction in the number of full line wholesalers, and a rise in the number of entrepreneurs in tune with foreign currency exchange rates.
He describes the medicines shortages that pharmacies see today — and which they may still see tomorrow — “as the price paid for the efficiencies that have resulted in cost savings for the NHS”.

Curiouser and curiouser
 

Sorry, didn't mean to make light of it by suggesting alternatives...I know some of us really only respond to the brand name variety and have very little room for tweaking drugs in an efficacious way.

I guess I'm going on the the omissions in this official notice. I don't see this notice anywhere on the US PD org sites and nothing from the FDA- they would surely issue some sort of warning. Maybe I overlooked something? Also checked the official PD org in France, as that's the only other language I can read with some fluency- no mention there either and they are on socialized system- though hardly an indicator of the entire pharma situation in the EEC. Maybe my suspicious nature wonders that they didn't term it "global supply shortage", whether true or not, to cover their *****? I see a legal team hard at work behind this.

I suspect what you say about the bidding may be true; largely, it seems mostly smoke and mirrors at this point - that is even more reprehensible than economics.

I know the EPDA has issued a statement and that there seems to be a buzz on the UK PD forum, has anyone been able to phone them for more info? Seems likely they would have an inside scoop of some sort...not that they would willingly share it!

Anyway, thank you for the clarification :)

Laura

I did find a little information on the Canadian shortage from Health Canada and the Parkinson's Society. The situation in Canada seems somewhat different than what was reported in Europe and Australia, and it was predicted to be resolved sooner. But the fact that these announcements of shortages all were made around the same time is suspicious. Still no real answers. If you haven't already seen these web pages:
Questions and answers
http://www.parkinsons-society.org/pd...etShortage.pdf
Health Canada update
http://www.hc-sc.gc.ca/ahc-asc/media...010_14-eng.php
Bristol Myers Squibb
http://www.bmscanada.ca/bms/news/imp...s/?imp_id=2601

Manufacturing of Apo-Levocarb CR
 

I called the company listed on the Health Canada web site:
Apotex Inc. has information on its generic product, Apo-Levocarb CR (200/50) on its website or call 1-877-427-6839.
http://www.hc-sc.gc.ca/ahc-asc/media...010_14-eng.php
The individual answering the phone maintained there is a shortage of their product only in the US--that inspection of their manufacturing site in the US did not meet FDA requirements and the sites were temporarily shut down. That there is no shortage in Canada and the manufacturing of the product for Canadians continues. This individual did shunt me to another phone number for which I received a prompt to "leave a message", which I did. Really surprised I have yet to receive a return phone call. I cannot vouch for the veracity of this person's explanation.
In additon , the phone # for Bristol-Myers Squibb listed in the article is a "non-working number".....
Will continue my attempts tomorrow. madelyn

Canadian shortage experience
 

2 weeks ago I had a prescription for APO levo/carb 200/50 to be renewed

NO APO product available...

Presription filled with brand name Sinement 100/25 with twice # of pills..

take care ,,, ken

Australia: shortage upgraded to none at all.
 

Update:
The Pharmaceutical Society of Australia has received updated advice from Merck Sharp & Dohme (MSD) regarding the supply shortage of Sinemet CR (levodopa/carbidopa). The supply situation is such that the distribution of Sinemet CR to pharmaceutical wholesalers has ceased until 2011. It is expected that the majority of pharmacies will not be able to fill prescriptions from March 2010 for approximately 12 months.
Pharmacists can assist by recommending all patients currently on Sinemet CR to make an appointment with their prescribing doctor as soon as possible to consider alternative arrangements.
Pharmacists with any queries can contact the MSD Medical Information group on 1800 645 712.

So, Aussies, consider your alternative arrangements. How about handing the whole problem over to the Crown Prosecutor? That would be an alternative.

DH Guidance UK
 

For reference relating to uk shortage and supply guidelines

http://www.dh.gov.uk/dr_consum_dh/gr.../dh_108527.pdf

Euphemism of the century...
 

Consider the alternatives?!? That's the best euphemism yet for "sorry, but you are SOL (s**t out of luck)"

I was thinking that if regular Sinemet too ceases production that maybe alternative arrangements means... they will offer on a free and temporary basis DBS surgery which may or may not work? Or maybe there is some sort of experimental brain transplant treatment they are wanting to try? a Russian black market? a Golden Ticket?

Any other grand ideas? My, oh, my what a world we live in. Sham surgeries and no gold standard which sucks when there is no silver standard to fall back on.

-Laura

the wonderful wizards.......
 

so are they giving the canadians what oz should be getting LOL this simply gets more and more bizarre............ but interesting that it should be cr that falls first, what is the next best to cr one wonders, what will all the complicit people prescribe, advise patients to take - that is of course if any of this is real - but maybe it will change prescribing habits yet - does anyone know if patients are actually experiencing shortage yet in oz, i keep wondering exactly when this hammer is going to descend..... and where....... and if..........

Todays news in UK
 

Patients miss out on treatment as drugs sold abroad

http://news.bbc.co.uk/1/hi/health/8516080.stm

quote:

The Royal Pharmaceutical Society of Great Britain says drugs manufacturers and wholesalers are limiting the supplies they send individual pharmacies.
This means that when pharmacists exceed their quota, they are having to spend hours negotiating for extra supply, which sometimes takes weeks to arrive.

It all just stinks..........

It sure sounds sinister to me. Have to womder if this type of manipulation of pharmaceuticals has been going on all along, and we were unaware.Something else is troublesome. On Oct 19,2009 the EPDA posted a news article about the shortages ...
"Starting in late 2009 and continuing into 2011 Merck Sharp & Dohme Limited (MSD) will experience a significant global supply shortage of SINEMET® and SINEMET CR® (carbidopa-levodopa controlled release)...."

Today, nearly 4 months later the BBC reports: "The Royal Pharmaceutical Society says urgent action is needed and that patients' lives are being put at risk.

It says UK pharmacies face increasing shortages of over 40 well-known drugs used to treat conditions like cancer, high blood pressure and epilepsy.

Ministers have promised an emergency summit into the issue.The problem seems to be caused by the weak pound which makes it more profitable to sell medicines abroad....

and "The Department of Health has promised an emergency summit next month to look into the issue. " http://news.bbc.co.uk/2/hi/health/8516080.stm

Just wondering why it wasn't until now that its being considered an emergency? What were those responsible for public health doing since the first annoncement?

smells like...
 

more creative chaos.

"All the world's a stage....we are the players.

Switzerland: thumbs down Swiss Parkies! You lose.
 

Switzerland will get a “very restricted” supply of BOTH sinemet CR AND the traditional sinemet; essentially L-dopa that has been the center of PD treatment for 50 years.
Press release from Swiss PD org.
Says Merck announced very restricted supply for Switzerland for 2010 too 2011.
Information IMPORTANTE
Pénurie de Sinemet® / Sinemet CR®
En raison d’un problème dans leur chaîne de production/livraison, la société
Merck Sharp & Dohme Ltd. (MSD) a annoncé qu’elle ne pourra livrer les
médicaments antiparkinsonien Sinemet® et Sinemet CR® que de façon très
restrictive et ce, du début 2010 à 2011.
Parkinson Suisse, case postale 123, Gewerbestrasse 12a, 8132 Egg,
Tél. 043 277 20 77, Fax 043 277 20 78, E-Mail: info@parkinson.ch

Meanwhile, back at head office, all is good:
WHITEHOUSE STATION, N.J., - According to an 8-K filing with the U.S. Securities and Exchange Commission, pharmaceutical giant Merck & Co. will cut about 15 percent of its workforce and eliminate approximately 2,500 vacant jobs.
The Whitehouse Station, N.J., company said layoffs will affect all areas of the company worldwide and should be accomplished by the end of 2012. Merck said it will achieve reductions by eliminating duplicative positions in sales, administrative and headquarters offices, as well as from the consolidation of manufacturing plants and research and development operations.
For its 2009 fiscal year Merck reported net income of $12.9 billion, or $5.65 per share, up 65 percent from the previous year. Revenue jumped 15 percent to $27.43 billion.

Be well. Merck loves you
 

Hello Switzerland and Australia ! Countries 141 and 142

About Merck from the company's Web site-

Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit www.merck.com.

Canadians won't have to worry - Medtronic has two new brain stimulators just introduced! (Now all of you get to your doctor and get scheduled for surgery, ya hear!)

One never knows what political games are played at the expense of patients, do they?

being intentionally sarcastic
Peg

Parkies in fantasyland
 

It would make a great sitcom. A group of Parkies constantly trying to figure out what exactly is going on.

WONDERland Bob! We're in it and doing it!!

Lindy

Parkieland by Milton Bradley
 

I was thinking, given the paradoxes and mysteries particular to the Parkie universe warrants a new board game. Really, the possibilities are endless:

-A space that reads "GO directly to DBS, do not pass Go"

-A "Get out of Dyskinesia Free" card.

-A space that reads "You've been misdiagnosed!" now lose six turns, then roll the die, lose one turn, head back to "Start all over again"

-A limbo space marked "Global Sinemet Shortage" where you sit until either you roll three snake eyes in a row or successfully pull off the other option of a Sinemet drug heist.

The list goes on. Seriously, has anyone considered trying to storm the Bastille so to speak? Why don't we take this public and protest, or write Michael Moore to pester the CEO of Merck until we have some real answers?!?

ok i
 

I have visitors, one with pd and her husband so we can't resist:

From a caregiver: "Lose turn, do not pass go, do not collect 5 billion dollars, serve five more years in parkieland."

and-

"Trial halted. Forfeit all future trials."

"Purchase medical consultants."

"Owner of medical consultants wants to buy a hotel."

"Free railroad purchase. 14 year lease."

"Global warming - limit drug supply to non British Commonwealth countries."
:cool:

paula