AND SO IT BEGINS.
WITNESS A CRIME IN PROGRESS.

http://pduk.org/

Excerpts from the Forum on PDUK:
http://pduk.org/forum/index.php?topic=2425.0

Voices from the PDUK site in the United Kingdom. The British seem to have been the first to face the shortage, starting in mid-2009. The real world-wide shortages start next month.

You are told your disease has no known cause and no known cure.
You are told that sinamet can relieve the symptoms.
The drugs are powerful, brain altering, addictive.
You are told that there is no other treatment; for the past 50 years, levodopa has been the “Gold Standard”; various agonists are added on to the chemical soup in an effort to increase the effects of the L-Dopa and reduce the side effects, which can be as bad as the disease.
You are told that if you suddenly stop taking sinamet (“cold turkey”), it is as bad as withdrawal from cocaine addiction, and you could suffer severe and irreversible damage to your brain and the entire nervous system.
You are told that the drugs may no longer be available to you.
And you are told that stress makes your condition much worse.

AND SO IT BEGINS:
Hazel: …my dad has just started on Sinamet the lowest dose, and now we can’t get it, the chemist did have some of the sinamet plus so he has got them now, I hope we can get them next time, otherwise don’t know what he is going to do.
Radar : My pharmacist has put Sinamet on the order every day, but none has been forthcoming and she is now saying that she thinks that it is not being manufactured, which I find very hard to believe. I will run out of pills on Monday so am going to see my GP about an altenative, although goodness knows this is not the road I want to travel. Any news very welcome.
Skyhigh: It took my pharmacist 16 days last month (to get sinamet) (lucky I had enough spare) I took my latest one in last weds, went to pick it up today and was told its going to be at least another week, I too will run out before then…

Panda: …Last Saturday I spent an hour phoning round different pharmacies trying to get sinamet 62.5mg, I only had two days supply left. I must admit I went into panic zone… While phoning round the pharmacies I was surprised what little knowledge a lot of them have on PD. A few said can you go without meds for a few days?---I soon answered that one!

Panda:… often health care professionals and admin staff do not always realise that PD meds cannot be missed out for a few days.

My pharmacist just can't find sinamet and I am slightly concerned about what might happen when my current supply runs out. Any info very welcome.

Radar: …they were not able to supply Pat's Sinamet. They phoned round and have found another supplier and have ordered a large amount... They did find one box of 100 tabs, but as I have about 2 months supply in reserve, I decided to… leave the box for someone else in town that may be in trouble. ..there are 200 PD patients registered to our local medical centre and I am sure someone else will be on it.
Grizzly Adams:…it would appear that the furore is caused by the change in licence for the manufacture of sinamet. What is coming out is that in the year 2010-11 there will be a considerable shortage around the world in sinamet/+ which could have been averted by better management of the licence to manufacture handover. I read it as the previous manufacturer is carrying on until the last minute before the new licencee or whatever even starts to gear up to production… the new manufacturer says that there will be a priority system for those in most need how do you go about that? Everybody is a priority for such an essential medication. This situation was avoidable it seems. The neupro situation is dire in the states. I have spoken to neupro on a number of occasions and whilst they refuse to say anything about the withdrawal, it would appear that because no major pharma were granted a manufacturing licence [it was manufactured in Canada and imported] the US Govt responded to lobbying of an intense nature and banned the import of the drug [rotigotine]. I am in touch with a woman in South Carolina who tells me she has to pay $580 per box from a pharmacy in Israel. They are only £110 a box to the GP budget in this country. Talk about profiteering from people's misfortunes.
but as for sinamet it could be a rough ride,
Canada has just joined the EU and Australia with a warning about sinamet shortage. This time however it is for the generic......... what is going on? My last prescription for 100/25 was filled but contained rather a lot of partial clips, with bits cut off. Anyone else had delays or difficulty?

I would advise trying to build up a stock by putting your repeat request in a bit early. This has worked for us and we have about 3 months of PD meds in hand, just in case.

Lyn: Hi, I have just tried to get my repeat prescription of asilect and sinamet. My pharmacist has been unable to get the asilect and told me whilst he was having trouble getting the sinamet he was able to get me a months supply this time. Have only a few days supply of asilect left. I feel very vulnerable being so dependant on drugs that are in short supply but feel if we all stockpile them we could make the situation worse.
not sure what to do .
When one thinks about it a shortage of sinamet is fairly unbelievable considering it's a drug which needs taking continuously. I don't really understand the distributor's explanation.
Panda293: Pat has a repeat prescription list for his long list of tablets for many conditions including PD. We always put it in a few days before the next lot is due. Over time one builds up a small stock…
I do agree that is seems odd that such an important drug could be in short supply and I don't understand it either.

Carlyle Travist: My local chemist ran out of Sinamet so in order to meet my prescription they got in some supplies from elsewhere. I notice half the boxes are different from my usual. The dosage and main ingredients appear the same. I can't work out if the manufacturer is different as the distributor appears the same. Could someone tell me please if there has been a general change in manufacture and distribution and if so could this affect us physically in any way?

Carlyle Travist: … my wife tells me she can feel a difference in desired effect from each brand and does prefer one over the other. I have heard (though cannot give you a source) that generic drugs may have a 10% swing in efficacy - this statement from my PD support groups, over the years.

SF: The pharmacist didn't seem to understand my concern. I was carrying a walking stick so I expect she thought my brain had atrophied. However she was polite and gave me some of her time. I have heard that although the drug chemicals are the same, different manufacturers might use different binders etc which some people might be sensitive to.

CT… I had a problem w with the shape and colour of generic ropinirole tablets that made it all too easy to confuse them with Sinamet CR tablets. My pharmacist agreed with me,… she now dispenses Requip despite the prescription stating ropinirole. ..
am just a bit curious we are a country presumably larger in our
PD patient population than the UK yet we have so much Sinamet
and generic "Sinamet" that we almost can give it away for free.
It is also one of the least expensive medications ,when one pays
out of pocket for it costing us, for 90 (10/100 mg )pills about $25.US

The Sinamet CR is still in patent and of course expensive to purchase.

I find this excuse from the Merck company is not quite right just
in my uneducated opinion.

Are you all now expected to have a Carbi-dopa-Leva-dopa "black market"?

Something here stinks of fish and it ain't with the fish mongers.

CT

To be fair not all the examples in the post above refer to the current situation, some relate to an earlier shortage last year. The questions we are asking now should be to do with the current shortage where Merck is issuing advance warning that there will be a shortfall in supply.

Yes, the British had a trial run of the shortages in mid-2009. The world-wide shortages will kick in during March and April of 2010, and last for one year, or two years.
The quotes from the UK above are partly mid-2009, partly early 2010. I view the 2009 shortages in the U.K. as being the trial roll-out for the world shortage that is proclaimed for 2010 and 2011, with the exception that the shortage in the U.K. has so far been minor compared to the shortages that Merck is predicting -- some markets will be cut off entirely.
I believe the conversations above show the level of panic and confusion that might be set off around the world during the next year. And the extent to which Parkies, the ONLY market for the product, are completely absent from the process, not even being able to find basic information about a multi-billion dollar industry that exists only because of them, much less participate or at least be listened to when life-and-death decisions are being made.
Merck gave a cryptic warning to doctors and pharmacists, but not to PWP or their organisations. But the legal and ethical duty of Merck would have been to keep production of the drug going, by any means necessary, until they resolved their "supply problems". Who is the supplier who is cutting Merck out? Why? Was there no contract in place? At the very least, there has been some sort of massive failure of management, and lives and health and peace of mind have been put at risk, and yet there is no reply, no investigation, no complaint, except for some maverick Parkies in Spain.
It's the end of something and the beginning of something else for a lot of people.

Just because there are no answers yet, it does not mean the questions have not been raised - rather that there are cogs out there that are very slow to engage. So raise the question at the highest level wherever you are if you are concerned and/or affected. You are not going to get answers from the person manning the phones. It is best however not to overstate the case, if we want to be taken seriously. It is difficult enough to be heard anyway.

The questions are:
Where are the actual shortages occurring.
What reassurances are there that this will not happen again.
What measures are being put in place for vulnerable patients whose response to other medications is poor, or who find change of medication results in worsening health, or adverse effects.
Why has the shortage been allowed to occur.
Why is there no apparent communication between govt, orgs and pharmas to prevent such shortages.
What exactly has caused the shortage.
Is the shortage genuine.
Why haven't patients been advised of shortages.

Lindy

I have received several hundred e-mails about this. A few have asked if there is an independent lab that can verify the ingredients of sinemet purchased without prescription on the black market, or from the mail-order pharmacies that you find by googling sinemet shortage. One group of 10 Parkies wants to order a 6 month supply. In some countries, pills-by-post are illegal; in other countries, they are accepted. And there is extreme concern about the ingredients of no-name drugs.
I have no answer, except be ultra careful.
This illustrates the panic that some people are going through; some countries will receive no sinemet whatsoever for at least a year, starting next week. Substitute drugs should take care of most Parkies, but some fear changing medication; some fear having no drugs at all. Many are having difficulty getting an appointment with a doctor, as so many Parkies are calling for appointments, and any change of medication requires repeat visits to the doctor. The system is broken.
From the various health departments around the world, the silence is deafening.
I have received suggestions on impressive letterhead that all of this is none of my business, so someone else will have to speak if they are interested. I will report in if I hear news from additional countries, which is unlikely, as most PD orgs seem to be not at all perturbed - or even aware - that something strange is happening.
It's a problem that should be handed over to Crown Prosecutors.
And some day, the $3 billion a year we spend on PD drugs (world-wide) should give Parkies enormous purchasing power to dictate the market, as would be the case in any other industry. But I'm not holding my breath waiting for that. Finally, there should be scientific scrutiny of what happens to PWP and their health, around the world, as a result of this unique event. Check out the placebo effect and so on.
Best of luck to you all.

Might be a good time to investigate this. Available OTC in US. I think I recall Ron Hutton as using long term as well. Several clinical trials (doses to 1200 mg/day) on Medline with zero side effects other than the DK noted below and corrected with lower dose of Ldopa.

2: Clin Ther. 1988;10(6):664-71.

Clinical trial on the use of cytidine diphosphate choline in Parkinson's
disease.

Cubells JM, Hernando C.

Department of Neurosurgery, Centro Ramon y Cajal, Madrid, Spain.

Thirty patients with Parkinson's disease, treated with levodopa for the past few
years, concomitantly received 500 mg of cytidine diphosphate choline (CDPC)
daily for 30 days. Significant improvements in some of the neurologic signs and
in several electrophysiologic parameters measuring the traction reflex and the
active contraction were observed. A greater stability of therapeutic response
between doses of levodopa was also seen, although the incidence of dyskinesia
increased. In a second stage of CDPC treatment, also lasting 30 days, the dose
of levodopa was reduced by one-third, and the incidence of dyskinesia dropped to
its previous level, but the therapeutic response remained stable. Addition of
CDPC produced significant increases in plasma concentrations of dopa and
homovanillic acid, with no modifications in tyrosine or 3-O-methyldopa
concentrations. A significant increase in the number of lymphocytic dopaminergic
receptors also occurred.

PMID: 3064905 [PubMed - indexed for MEDLINE]

Rick

thanks! eXCELLENT Suggestion. it would be so wonderful to find natural/over the counter products and not to be at the at the mercy of big pharma.

thanks again
girija

USA wins gold in sinemet olympics

Gold: USA. American company based in New Jersey declared world-wide shortage; but USA not included in “world-wide”. No shortage in USA.
Silver: Canada and U.K. tied: minor shortages.
Bronze: Spain, Switzerland, Sweden – substantial shortages.
Disqualified: Kenya, Australia. Man in Nairobi reports no sinemet available; he had thought it was only Kenya, not elsewhere. Austrilia also said to be cut off entirely.
Is it because Americans pay more for drugs, and have more competition? World Health Org. reports that in Uganda, brand-name drugs cost 13.6 times more than something called “the international price reference; generics cost 2.6 times more. But no indication of who collects that extra money.
http://www.who.int/features/factfile...en/index3.html
Unable to find info about the other 135 countries where Merck sells product.
WHO lists levodopa as one of the 340 essential medicines that all member countries must have in stock. Scction 9 of the 16th revised list of essential medicines, approved in March 2009. Biperiden and carbidopa also on the list.
Multi-national drug companies deal with mere nations one at a time; Parkies have no international representation.

At Bob Dawson's recommendation I am posting a post I recently put on Patients Like Me (PLM). This was on a thread addressing the current global shortage of Sinemet, which (based on threads on PLM) appears to have affected PWP in the States also, althouhg not perhaps as severely as it is affecting PLP in other areas of the world. Wish I hada the answers and I hope that posting this may prompt a better explanation/discussion of this.

The post:

There appear to be 2 different aspects of this:

The first is that the company with the patent on Sinemet (I believe this is Merck) has decided to switch at least one element in its supply change for the ingredients for Sinemet. I have not seen any further explanation for this switch and whether the issue is one of quality control, or if the element(s) of the supply chain involved are deemed unreliable or insufficient or inefficient or whether there is some other issue. An answer to this might be enlightening and might help clarify whether the changes being noted in the supply and distribution of generic Carbidopa/Levodopa are in any way related to this disruption in the supply of Sinemet.

The second issue has to do with decisions as to how the existing supply of Sinemet is distributed (on both a local, regional, national and international basis). This issue is certainly amplified by the overall shortage of Sinemet (which appears to be global) but may also involve other issues that transcend this shortage and may involve the global supply of medications in general (not just this particular medication).

My personal opinion is that the distribution problem does not appear to explain the decisions that led to the global shortage. My personal opinion is also that I think it unlikely that Merck decided to create a shortage just to boost the demand (and their potential for profit) for Sinemet. My personal opinion is that there was most likely another reason for Merck's decision and I would like to know what that reason is.

While I would suspect that I would be supportive of Merck's decision to alter their supply chain like this, Merck may believe that it is in a situation where they would be better off keeping their reasons to themselves. In this respect, my opinion is that this does a disservice to the global Parkinson's community.

I join with those who would like to know of any other information as to the reasons for this situation.

Bill

Hi Bill,

what you say makes sense - as good as any. So we have a few suspicions, no orgs are on it to help that i know about, the letter to doctors is vague but clearly instructing doctors to use alternate meds available, thus proving that they are either stupid,[this is dangerous for some pwp and difficult for most] uncaring, or in someone's pocket.

Do you realize how silly we look speculating but expecting someone else to actually do it? Do it and we'll write the book. An excerpt of the book will soon be previewed to you and you can best figure out what you can do if anything, about this never ending bucket of bull **** we've been dealing with. No one is really caring about patients. We are doing that and it feels great.

we need to lay out the speculation so we can see it all and then check it out thoroughly, each take something to look up.

ok i can't tell anyone on this forum what to do.......these suggestions are for the ones who are in the right place at the right time.

peace,
paula