I have just been told by a UK org that their understanding is that there is no shortage of the levo-carbidopa generic versions...... the problem is said to be at the regulatory end of things, though exactly where is unknown. From this is would appear that there is no problem with raw materials, and I understand that the places where madopar is used rather than sinemet are not affected.

I think it is time to ask questions higher up, there may not be anything that we can practically do about this, but we can ask the right questions, and try and ensure they go to the right people.

I think that it is very important that we are seen as concerned patient advocates, and not as scaremongers, but absolutely understand all expressions of concern, there is something quite wrong in the secrecy that surrounds drug manufacture and distribution. This is an essential drug, and there should be openness in the way patients are informed, and their physicians too. My guess is that many doctors, especially GP's will not be wholly aware of the implications of this.

Lindy

..."it is very important that we are seen as concerned patient advocates, and not as scaremongers"
The only scaremonger is Merck; in fact they are the only ones claiming there is a world-wide shortage; no one else has said so; and every three months they mail out letters to doctors and pharmacists saying that the situation is getting worse, but refusing to explain anything. The first wave of letters sent by Merck in Australia said that 50% to 80% of patients would have to be taken off sinemet; three months later, the second wave of letters said that all supplies of CR in Australia were cut off entirely.
In the U.K., Merck did three waves of scaremongering: the first was that CR was in shortage, the second downgraded to shortage to a total disappearance of CR; the third saying that other formats of sinemet were now also vaporizing into thin air.
Some members of my group buy sinemet in large quantities from India, (taking a risk on the quality); the salesman in India says that sinemet is easily available, and that his sales have gone through the roof. The only shortage, he says, is a shortage of Merck labels to put on the containers.
If the pharmaceutical industry is unable to provide us with the same boring drug that has been the Parkinson's "Gold Standard" for half a century, with cosmetic variations, the question is why. Is the shortage of sinemet caused by the incompetence and negligence of Pharma, or is it caused by viciousness and greed?
You can be sure no one will tell us. Unless, like the tiny Parkie group in Madrid, someone starts to prepare criminal charges against the perps. In Spain, they did not get the same series of scaremongering threats from Merck. In that country, the first letter from Merck said that there would be a shortage in Spain that would last a year and a half. But when PWP replied with a threat of pressing criminal charges against the individual managers responsible for this charade, sinemet was back in production in Spain within 3 days, and the product was being shipped within 2 weeks. So the second wave of Merck letters in Spain announced that the shortage was over, as Merck diverted supplies from other countries to buy their way out of the protests their first letter had set off. And after buying off Spain, they sent the new letters in the U.K., announcing that CR was totally gone and Regular is disappearing fast; the longer Merck works on the problem, the worse it gets.
For PWP, I think this is all an exercise in futility. It is worthwhile that we know about it, but our chances of changing it are about the same as if a few of us on this site get together to take down the Mafia. We don't have the resources to take down the Mafia.
Waste of time; as long as some drugs are sold at 96% gross profit margin, as long as Parkinson's drugs bring in three billion dollars a year, they are certainly not going to listen to us. We can wear ourselves out battling Big Pharma, but nothing will change until a fair percentage of Pharma executives find themselves locked in a prison, thereby providing a disincentive to treating sick people as cheap meat for their grinder.
May as well just go and live our lives - Big Pharma, like the Mafia, drug dealing, prostitution, etc. will still be there long after we are gone.
It would just make things so much easier for us all if Pharma could tell us straight what the price is and what we get for that price - as it is when dealing with prostitutes. They, at least, are honest about what they are doing.

Hi Bob,
I understand your position absolutely, and agree that we are notable to do much at all. Your picture of the situation in Spain shows exactly what needs to be done. Nevertheless it could not have happened that way if not for the support of the government, and for this reason I mentioned scaremongering.

To explain, the majority of PD patients are not informed or even engaged, and are passive recipients of treatment. We do not only represent the vocal minority, by default we also represent the majority, and their fears can be manipulated in many different ways. This thread is a very important discussion, it represents not only the information that we have accumulated on this, but also our feelings, and reactions to it. I am sure that it has in some way been scrutinized, it registers high on google searches. In some ways it is vulnerable to the fact that there are only a few of us keeping an eye on how this progresses - the way in which we discuss it matters.

Here in the UK we need to make our decision makers aware that this is happening, to open the discussion, there are many vulnerable people here. Our system is great for keeping the majority of people treated for the majority of conditions, the price we pay is that we do not have a consumer voice, and most people do not question the things that are done in their name. Most people will put side effects they experience from medication changes down to being part of their PD, or think it is progression, and some will spend many months adjusting. Or they could stop taking the substitute, they are not educated to know that they should not, that they could become very unwell....... This is a hidden layer of suffering that should not occur, especially among the very elderly and infirm, and I for one think that the politicians in charge of down-pricing agendas need to realize that this is not cost-efficient, it is not economic, and that they should have more of a handle on the strategies that drug companies are using across the EU region. And that there are patient groups who are looking at this........ and that further more it is something that is being tried on globally, to see how far it can be pushed....... how compliant different populations are.

We are on the same page, we want the same things, I would hate to think that our words might cause patients a sense of panic, it is not what is needed, for instance stockpiling sinemet in countries where it is freely available seems to be wholly unnecessary, and you report that there is a glut in India. The internet seems to bear this out, so why the regulatory problems, it needs to become visible......What is needed is more awareness of the games that are being played with our lives.......


Lindy

Lindy,
Thank you for your tolerance of my diatribes; it would be definitely you who should go to policy-making meetings about things such as this; not me. I would have a tendency to ask them just why they aren't in jail, and what did their mothers teach them about how to treat people, and whether or not there is a difference between right and wrong. The corporate bio-ethicists working for Pharma have so far pretty much concluded that the concept of "doing the right thing" was purchased by Quaker Oatmeal and so no longer applies to the general public. And the difference between right and wrong, after centuries of discussion, has finally been resolved: If wrong improves Q4 bottom line just in time for the annual executive bonuses, then wrong is the right choice, and therefore, the business philosophers are arguing, it is actually truly the right choice to do wrong.
The only value of my rantings on this site, is not the contents of what I write about Amgen GDNF or this Merck-charade, it is just that some of the Pharma lurkers, on this site and on my site, may slowly pick up the difficult concept that Big Pharma has committed grave strategic errors, and they have a credibility problem that keeps on growing, to the extent that throwing Pharma executives in jail is now openly discussed in meetings of mainstream political parties. The remarkable thing is how widespread it is.

Bob,
You do not ask anything that I don't ask!
Picked up a new batch of meds, in yet a different packaging.
We now have to deal with another set of corporate bods - it is even less likely we will be able to see where things are coming from. The windows into this industry are as transparent as mud......
Lindy

Bob, Please could you let me know anything you have on the Spanish experience, and how they managed things. I have been unable to find any links, and have initiated a discussion on this that at the very least raises concerns, and at best may help shed light. But I need to have some hards facts.

Thanks
Lindy

Need someone who speaks Spanish to get full story from Taray PD org in Madrid.
Best contact: Francisco Fernández Cimas
Vicepresidente
Asociación Nacional Parkinson TARAY

Feb. 17: Spain – rebel group of Parkies demand that their government take legal action against Merck, not civil lawsuits for damages… criminal charges.
Feb. 21: Merck suddenly starts to communicate. They can rip off supplies from other countries where they are not facing time in federal penitentiary. And the production problem? What production problem? Who every made you think there was a production problem?

(Rough translation by Google)

17 feb 2010
Dear Sir

DISINFORMATION FROM THE MINISTER OF HEALTH (Spain)
…The Minister of Health, Trinidad Jimenez, was asked what had happened to the Parkinson's drug shortage, to which the Minister failed to respond. The Minister must know what is happening as a person who has to ensure the health and welfare of the citizens of this country, some people with a neurodegenerative disease, incapacitating and disabling.
It seems very strange that the Minister is unaware of the situation when the National Association of People with Parkinson TARAY, after doing their own research on the 4th of this month comes in contact with the company in commercializing the drug MSD Spain (Sinemet) and they tell us they have no stock of the drugs and they are looking for a supplier they cannot restore the domestic market until 2011.
From this moment, our group has been in contact with the Department of Pharmacy who is in the same building as the Minister of Health, from whom we have had no response whatsoever. We also got in touch with the Spanish Agency of Medicines; after much stress tell us they have obtained a commitment by the MSD.
Gentlemen, these are not commitments, these are obligations that the company has to fulfill certain laws, which must have a minimum of stock and if they fail the law requires they be punished like any citizen, they are playing with the health of many people.
Who is to deceive, if the 4th of this month there is no medication in stock…., if they have the supplier of the active ingredient? How can already supply the market?
Not if you understand it but I do not understand anything and the Minister and the Federation of People with Parkinson’s being quiet as if nothing happened…

Muchas gracias
Atentamente
Francisco Fernández Cimas
Vicepresidente Asociación Nacional Parkinson TARAY
Manuel Serrano, 23
28300 Aranjuez (Madrid)

Spanish version (it was in many newspapers in Spain)(:
http://www.hispanidad.com/noticia.aspx?ID=134276

http://www.extremaduraaldia.com/cart...dad/96191.html

From PD website in Spain -
“This is the latest information that we control the company MSD”

Letter from Merck (MSD) in response:

Parkinson Association TARAY
Mr. D. Francisco Fernandez
Vice - Presidente
Asociación Nacional Parkinson TARAY
Manuel Serrano, 23
28300 Aranjuez (Madrid)

February 21, 2010

Dear Mr. Fernandez:

I am writing to inform you that thanks to the quick intervention of the Spanish Agency of Medicines and Health Products (AEMPS) belonging to the Ministry of Health and Social Policy, which has been evaluated with the highest priority the proposed new manufacturer for the active ingredient levodopa our product for Parkinson's disease Sinemet ® (carbidopa-Ievodopa), this manufacturer has been approved and we have begun to produce the active ingredient.

This good news will resolve partial or limited availability of
Sinemet previously announced in our country until 2011. Obtaining this
allow health approval in mid-March this year to start
levodopa product manufactured from the new source of supply.

As for the situation today and until you start available
medicine for the new manufacturer, we inform that standardization has been achieved thanks to divert supply to our country medicine from other countries in the European Union, although problems can still occur in submitting timely supply of Sinemet 25/100 mg PLUS until the situation has returned completely at the end of March.

We remind that in our country there are now other drugs
available with the same composition, exchangeable for the pharmacist, and patients may also consult with their doctors about these alternative treatments available in our country.

We will keep you informed about the full normalization of supply
product when we have new information during the month of March. Do not hesitate to contact us by phone for any clarification 913210843 relevant.

Sincerely,

Carmen Lopez-Lavid
Communications Director, MDS

In Spanish, (near the bottom of the front page):
http://www.aep-taray.org/portal/
That seems to have been replaced by a complaint about Mirapex being in shortage:
Escrito por Parkinson Taray Martes, 15 de Junio de 2010 00:00
Posible desabastecimiento de medicamentos en todo el territorio Nacional
Carta mandada al Ministerio de Sanidad, AEMPS y a las Consejerías Sanidad de todas las comunidades Autónomas
Estimado Señor Alfonso Jiménez: DIRECTOR GENERAL DE FARMACIA En una reunión mantenida con Usted la Presidenta de la Asociación Nacional de Enfermos de Parkinson Taray Mercedes Villalobos y yo Francisco Fernández le expresamos nuestro malestar por lo que estaba sucediendo con los mayoristas distribuidores de medicamentos en España, a lo que Usted nos contesto que estaban estudiando sacar una Ley o una normativa para que no pudieran quedar desabastecido el mercado Nacional, como Usted recordara de esto ya hace mucho tiempo, pues bien este problema no solo sigue ocurriendo con los distribuidores mayoritarios en España sino que ahora muchas farmacias en todo el territorio Nacional están pidiendo los medicamentos directamente a los Laboratorios, unas cantidades que oscilan entre 240 y 320 envases mensuales a lo largo del los últimos meses cantidades que es imposible que puedan suministrar en su demarcación, porque nadie se puede creer que puedan tener tal cantidad de Enfermos de Parkinson en su zona, según conversaciones con el propio laboratorio (que tampoco puede probarlo nos sospechamos que puedan estar sacando estos medicamentos a través de intermediarios fuera de España) lo que supondría un desabastecimiento del mercado Nacional, lo cual ya está empezando asuceder. (Me estoy refiriendo al medicamento llamado Mirapexin deBoehringer)
Señor Alfonso Jiménez a través del Ministerio o de la Agencia delMedicamento Ustedes pueden recabar esta información que las farmacias no le dan ni al propio Laboratorio de a quien suministran estos medicamentos, porque la situación puede agravarse considerablemente en perjuicio de los afectados de esta Enfermedad, Algunos Neurólogos ya les están llamando directamente al Laboratorio diciendo que está pasando que no tiene Miraprexin por que no lo suministran y el Laboratorio se ve impotente ante la situación acaecida, creo Señor Jiménez que de una vez por todas tanto a los Mayoristas como a las farmacias se les tenía que poner en su sitio, que el mercado Nacional es lo primero, por cierto yo creía que las Farmacias estaban única y exclusivamente para suministrar medicamentos a los pacientes no para lucrarse a costa de ellos.
El Laboratorio tiene una base de datos la cual a mi no me puede facilitar de todas las Farmacias Españolas que están pidiendo estas cantidades que le comento y a Ustedes como administración sí que se la pueden dar o Ustedes sí que se la pueden exigir, ellos están dispuestos a solucionar este problema lo antes posible por el bien de todos
Reciba un cordial saludo
Mercedes Villalobos
Presidenta Francisco
Fernández Cimas
Vicepresidente
Asociación Nacional Parkinson TARAY
C/ Manuel Serrano
nº 23Aranjuez 28300
MdridTeléfono 649192114
parkinson@aep-taray.org

Google translation:

Written by Parkinson Taray Tuesday, June 15, 2010 00:00

Possible shortages of medicines across the national territory

Letter sent to the Ministry of Health, AEMPS and Health Ministries of all the autonomous communities

Dear Mr Alfonso Jiménez: DIRECTOR GENERAL OF PHARMACY At a meeting with you the President of the National Association of People with Parkinson Taray Mercedes Villalobos Francisco Fernandez and I express our displeasure about what was happening with the wholesale drug distributors in Spain, You tell us what answer they were looking out a law or legislation lest they were cut National Market, as you remember this long ago, well this problem is not only happening with major distributors in Spain, but now many pharmacies across the country are asking for the drugs directly to the Laboratories, amounts ranging between 240 and 320 containers per month over the past months that it is impossible quantities to provide within its authority, because nobody can believe that they have so many Parkinson's sufferers in their area, according to conversations with our own laboratory (which we suspect can not prove that taking these drugs may be through an intermediary outside Spain) implying a shortage of domestic market which is already beginning asuceder. (I am referring to the drug Mirapexin deBoehringer)

Mr Alfonso Jiménez through the Ministry or the Agency delMedicamento You can take this information that pharmacies do not allow it at the same laboratory who supply these drugs, because the situation could worsen considerably to the detriment of those affected by this disease, some Neurologists and are calling them directly to the laboratory saying is happening is not that Miraprexin not supplied and the Laboratory is powerless before the situation occurred, I think Mr. Jimenez that once and for all as both wholesalers to pharmacies I had to put in place the national market is the first, by the way, I thought that pharmacy was solely to provide medicines to patients, not for profit at their expense.

The Laboratory has a database which I do not can be provided in all Spanish pharmacies are asking these quantities as you and I comment that the administration itself, or you can give that it may require, they are willing to solve this problem as soon as possible for the good of all

Yours sincerely

Mercedes Villalobos

President Francisco

Fernández Tops

But we will never have much in the way of hard facts, until criminal charges are pressed, search warrants issued, and a blizzard of subpoenas falls on Pharma world-wide. With Merck, they would not even tell Jim Edwards, of BNet (CBS news) where was it that they had a supply problem - that is "proprietary information" Merck says. And that's the point. GDNF is Amgen's "proprietary" interest. The three billion dollars a year we spend of levodopa and the agonists is immense cash cow for them.

I believe in free entreprise. I believe high profts in Pharma are excellent because it attracts more investment money. But any medical outfit that misbehaves towards us in such blatant ways does not deserve the job. Many of them should be fired. Some of them should be jailed. And before being given control over the needs of suffering and dying people, there should be some evidence that these people have at least some vague awareness of the difference between right and wrong, and they should have some desire to help sick people instead of just blackmailing them out of money. You know, society hesitates to hire child rapists to teach kindergarten. The police generally don't recruit bank robbers. Airlines are not supposed to hand the controls of a 747 with 400 people on board to a pilot who is too drunk to walk.

Scientists, doctors, pharma corps, and "corporate bio-ethicists" who believe that Amgen did the right thing to the 48 Parkinson's volunteers - those people should not be permitted to deal with Parkinson's patients or do Parkinson's research.

And, after half a century of cranking out a drug, suddenly they are incapable of making the drug for 18 months - well if they are not crooked they are most certainly wildly incompetent. I mean, you can't even transfer them to the toothpaste department because they would be no go good there either. So their licence to kill should be revoked. They are fired. They lost the contract. With our $3 billion spent annually on Parkinson's drugs, with the $200 million a year spent on Parkinson's research, we should go out to tenders and find a group that is competent to do the job, and that is not morally corrupt to the bottom of their souls.
I don't want that kind of medical people delivering my wife's baby, or taking my child's temperature. And so I sure don't want them having control over items we need in order to survive.
Pharma flunked. They are going to go down. It may take 30 years, it may take 300 years, but their way of treating sick people cannot last forever, and one day - maybe tomorrow, maybe in generations to come - they will be driven out of the health industry and not permitted back in.

If you have the science but not the human decency, then get the hell out of the health business.

Sorry to return to this once again but I got an e-mail about this:
The ladder of justice is supposed to have no top and no bottom. But it seems that the laws for some people are enforced, but not for others:

Old friend in Barcelona says that this is THE LAW in all countries of the European Union, but the law is never enforced except when a small Parkie org. in Madrid publicly demanded that the government enforce the law. Other than that, no public action is being taken anywhere in Europe, as far as we can see from the vantage point of isolated Parkie groups trying to decipher the latest information black-out engineered by companies that operate on a global scale. The law is not being enforced in Europe.

I do not even have a clue if there are similar laws in Canada or the U.S.A.

Quote from friend in Barcelona (works in medical industry)

Article 81 of European Directive, requires the maintenance of appropriate and continued supply of medicinal products by distributors.

Selling any medicinal product for human use without a licence constitutes a criminal offence.

The legislation requires that, where a manufacturer distributes any medicinal product manufactured or assembled pursuant to his licence, they must comply with a number of requirements.

The Regulations require that a holder of a permit must ensure the appropriate and continued supply of such relevant medicinal products to pharmacies and persons corresponding to retail sale so that the needs of patients are covered.

A manufacturer that failed to comply with the requirements could face regulatory action, their permit could be revoked, and they could face criminal prosecution.

The legislation requires pharmacists to make the care of patients their first concern.The pharmacist must exercise professional judgment in the interests of patients and the public and in doing so the pharmacist must be sure their professional judgment is not impaired by personal or commercial interests, incentives, targets or similar measures.

Dat’s da law, folks. Too bad we ain’t got no coppers to read them their rights.

http://www.heraldscotland.com/news/h...nald-1.1039229
by Russell Leadbetter
5 Jul 2010
Independent MSP Margo MacDonald has said she is horrified by news of a global shortage of a Parkinson’s drug and would raise the issue with Scottish health ministers.
….The Parkinson’s UK charity is demanding answers from Merck, over what it says is the ongoing shortage of the drug, Sinemet.
The charity says limited supplies of the drug are set to continue into next year and is asking people affected by Parkinson’s to join their campaign and write to Mercks’ medical director to urge an immediate end to the shortage.
It is also calling on Merck to take greater responsibility for communicating with Parkinson’s sufferers, to clarify how they are managing the supply of Sinemet
The charity’s chief executive, Steve Ford, said: “The shortage of Sinemet has caused anxiety and deep distress for people who are already trying to cope with the impact of Parkinson’s…
“People with Parkinson’s throughout the UK rely on Sinemet to treat their condition – Merck has a responsibility to them. Waiting until 2011 is simply not good enough. This shortage should end now.”
MacDonald, who herself has Parkinson’s…