Bob, I've been shouting since last november, through a deafening silence, to all those mentioned, and more than a few other important people or agencies, I guess the wheels grind slowly........ good on the Scots for finally doing what the English didn't............. nice to see Steve Ford give voice to our concerns, I spoke to someone there on this issue a couple of weeks back......

Lindy

our culturally most respected paper didn't do a thing.........

[QUOTE=lindylanka;672301]Bob, I've been shouting since last november, through a deafening silence, to all those mentioned, and more than a few other important people or agencies, I guess the wheels grind slowly........ good on the Scots for finally doing what the English didn't............. nice to see Steve Ford give voice to our concerns, I spoke to someone there on this issue a couple of weeks back......

Lindy

Lindy,
You were shouting since November.. to all those mentioned. and more than a few other important people or agencies, and you spoke to Steve Ford, Parkie President, about these issues AND YOU DON'T MENTION THAT EVERY WORD THEY SAID ON THIS ISSUE WAS FROM YOU. All I am saying is, you made this happen. You infiltrated their system and once they heard you and understood you there was no way for them to reject what you said. As soon as I saw the headline, I said, this is what Lindy was working on for months... I heard a little bit about it here and there, that you were going in there and challenging a lot of important people to recognize in themselves that what was happening was wrong.
Lindylanka made this happen. There is no disagreement on that. As you say, you talked to all of them, and to more higher up. Going in there alone, fighting for us all. You got the message across.

http://industry.bnet.com/pharma/1000...-unacceptable/

Merck's Silence Over Parkinson's Drug Shortage Is Unfair and Unacceptable
By JIM EDWARDS at BNET
Merck (MRK)’s mysterious silence over the shortage of its Parkinson’s disease drug Sinement has provoked some high-profile critics. A Scottish member of Parliament and a U.K. Parkinson’s charity have both turned on the company, demanding an explanation and an end to the Sinemet drought.
The strangest thing, however, is Merck’s refusal to tell anyone what is happening with the drug, which is vital for anyone with the disease. It’s a position that is unfair to both doctors and patients.
Parkinson’s is a progressive and irreversible condition of the nervous system that leads to uncontrollable muscle tremors and difficulty in walking and coordinated motion. Actor Michael J. Fox suffers from it. If PD patients stop taking Sinemet their symptoms return and can worsen. Sinemet is a version of levodopa, also known as L-dopa, a drug that helps limit symptoms of rigidity and slowness.
Parkinson’s UK has begun a campaign to end the shortage. “We are yet to receive a full explanation,” the nonprofit says. It’s asking supporters to flood the email inbox of Merck’s medical director with calls for an end to the shortage. Here’s what Merck is currently saying about Sinemet.
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.
The statement appears to say that the shortage is Merck’s own fault. Merck makes clear that it’s not a regulatory problem, but says that it is to do with “the necessary timelines needed to obtain regulatory approvals.” Those timelines are predictable, so why did Merck fail to work around them? We don’t know. Merck has offered no explanation other than “a change in the source of supply,” which could mean anything but sounds like Merck is closing one factory and opening another, the type of move that might require a new set of regulatory approvals.
Merck’s statement also admits for the first time that some patients — and some “markets,” which is often a drug industry euphemism for “countries” — will “not get any” Sinemet. That’s a worse position than Merck has previously confessed to.
More importantly, Merck hasn’t yet felt the need to give patients any details about when and where the shortage of the drug will strike, and what percentage of full capacity the company is supplying, even though the situation is set to last through 2011. The shortage began last year. Parkinson’s patients are literally in the dark, hoping for the best. That’s just unacceptable.
And this isn’t just Merck’s fault — there’s no shortage in the U.S. in part because Mylan (MYL) makes a generic version of Sinemet. There’s no reason why Mylan can’t be asked to supply foreign countries with the drug (I’m sure they’d love the extra business) and yet there’s no sign of European authorities requesting that permission from the FDA.
Of course, if that were to happen Merck would lose what market share it has in those countries. Only a cynic would suggest that the two failures are linked …
Related:
• Drug Shortage Has Parkinson’s Patients in a Panic — and No One Can Explain It

http://www.pharmalot.com/2010/07/upr...28Pharmalot%29

Pharma Blog » 2010 » July » 06
Uproar Over Shortage Of Merck Parkinson’s Drug
By Ed Silverman // July 6th, 2010

Patient groups and politicians are demanding that Merck move faster to end an ongoing shortage of Sinemet, a widely used Parkinson’s treatment that the drugmaker says may not become available again until sometime in 2011. For the past few months, Merck has issued a statement blaming the problem on a change in the supply source and the time needed to obtain regulatory approvals, but not safety or quality issues….
The Parkinson’s UK group, however, is no longer willing to accept this excuse and has begun an online campaign to prompt Merck officials to do a better job of communicating the details and more effectively manage the ongoing problem). “Waiting until 2011 is simply not good enough,” says Parkinson’s UK chief executive on the group’s web site. “This shortage should end now.”
And Margo MacDonald, a member of the Scottish Parliament and a Parkinson’s sufferer, tells The Herald: “This news really does horrify me. This drug is supplied by NHS doctors so therefore I assume that there has to be some arrangement between the Health Department and the drug’s suppliers. “I think there might be room for some political questioning as to why this has been allowed to come about.”
Other formulations of the active ingredient are available, but the issue, for some patients, is that simply switching to another medication is a difficult adjustment due to differences in other substances - although, not the active ingredient - used to make those pills.
There has been speculation on the NeuroTalk forum that warnings about compulsive behavior, which have plagued another Parkinson’s drug, Boehringer Ingelheim’s Mirapex, appeared on the Sinemet labeling just as the shortage began, although this logic would suggest Merck yanked the drug to avoid the sort of lawsuits that have plagued Mirapex….

http://www.pharmatimes.com/UKNews/article.aspx?id=18147
PHARMA TIMES July 5, 2010

…..In a statement to the Association of British Neurologists, MSD warned that, because of the change in arrangements, which reportedly involve a switch to a single wholesaler, it is likely that “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”.

“Many countries are being asked to take reduced allocations so that Merck and MSD can supply product to patients in countries that have no or limited alternative treatment options”, the company said, but has not given any further clarification on the situation.

While other formulations of the active ingredient are available, it can take a long time for patients to find the combination of drugs suitable for them and get to grips with new dosing regimens or the timing necessary to treat symptoms of the disease most effectively, a spokesperson for the charity told PharmaTimes UK News online.

In addition, some people may experience side effects to new medication, as while the active ingredient is the same different substances can be used in different products to ‘bulk up’ the pill.

“The shortage of Sinemet has caused anxiety and deep distress for people who are already trying to cope with the impact of Parkinson’s,” said Steve Ford, Parkinson’s UK’s chief executive. “We’ve heard of cases where people with Parkinson’s are being told by their pharmacist that there is no Sinemet available so this means they have to look elsewhere. This is unacceptable,” he added.

http://www.parkinsons.org.uk/about_u..._campaign.aspx

PARKINSON’S UK

Campaign to end Sinemet shortage
We need people affected by Parkinson’s to contact the Medical Director at Merck to demand that the shortage of Parkinson's drug Sinemet ends now.
The worst thing is the uncertainty. The drugs are a lifeline so it's a real panic when they're not available.
Briony Cooke, person with Parkinson's
This shortage has caused anxiety and deep distress for people who are already trying to cope with the impact of Parkinson’s.
How you can help
Take action: Ask Merck what they're doing about the Sinemet shortage
Using our simple online form only takes a few minutes and can make a big difference.
What we want
We are asking Merck, the manufacturers of Sinemet, to:
• take greater responsibility for communication with people with Parkinson’s – such as taking part in an online questions and answers session on our forum
• clarify how they are managing the supply of Sinemet, how supplies will be released and where they will be sent to
• ensure that pharmacists are clear about the new way that Merck is distributing Sinemet through a single wholesaler
What we have been doing
• We initially contacted Merck for more information.
• As the calls to our helpline increased, we put information about the shortage on our website to inform people with Parkinson's and professionals.
• In partnership with the British Geriatric Society Movement Disorders Section and the Parkinson's Disease Nurse Specialist Association (PDNSA), we contacted Merck again to ask for direct communication with people with Parkinson’s. This included an invitation to do an online questions and answers session on our forum.
In Merck's reply they acknowledged that they have not done enough to communicate with people with Parkinson's. But they have not committed to any action as yet.
We have also been in contact with two parliamentarians, who will be asking questions in parliament about this shortage and what the Government is doing about it.

Remembering the Amgen GDNF Parkinson's volunteers

I put
my fingers
against
the glass

and I bowed
my head

and cried.

(The New Prophet Jeremiah said that)

I would like to say that this has been simmering in the UK for a while now, as more patients started to contact Parkinson's UK, and the campaign to end the shortage has got off to a flying start. I spoke to the campaign manager this morning, and as a result of that would urge anyone from the UK to join this campaign.

Go to:

http://www.parkinsons.org.uk

and follow the links.

If you have been personally affected by this please add it to the emai message that will go to Merck.

Parkinson's UK has been in talks today with Merck, and are pressing for an online meeting with patients, and an explanation for the shortage, and what they are going to do about it.

SUPPORT THIS CAMPAIGN! SPREAD THE WORD TO PATIENTS AND UK GROUPS..........

Lindy

Lindy,
I know you have been working at this for months, you got it simmering, and now it is boiling.
Is there any way for us outside the U.K. to e-mail our international support? Big Pharma works around the world and plays one country against another, whereas PWP have no world-wide alert system for mutual defence. Merck should hear from us around the world.