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.

http://organizedwisdom.com/Sinemet_Dosage

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.

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.

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.

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

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.