Amy Rick gave her permission to share. Bob Dawson where are you? I gave her the Spanish story....thanks for all your help and we need you to make noise again.
thank you!


Michael Rosenblatt
Executive Vice President
Chief Medical Officer
Merck WS3A-20

T 908-423-6446
F 908-423-1447
merck.com & Co. Inc.


December 20, 2010

Amy Comstock Rick, J.D.
Chief Executive Officer
Parkinson's Action Network
1025 Vermont Avenue, Suite 1120
Washington D.C. 20005

Dear Ms. Rick:

Merck (known as MSD outside the U.S. and Canada) is committed to providing you with
up-to-date information about our products. This letter is to inform you of a potential
temporary supply issue that may occur in the U.S. in early 2011 for SINEMET®
(carbidopa-levodopa) and SINEMET CR® (carbidopa-levodopa controlled release
tablets).

Currently, Merck manufactures SINEMET for supply in the U.S. and globally, and Bristol
Myers Squibb distributes the product in the U.S. At the end of this year, Merck will
regain the marketing and distribution rights to SINEMET in the U.S. Concurrently, Merck
has filed an application with the FDA to change the manufacturing supply source of
SINEMET from Merck to a new source, a process that requires regulatory approval. As a
result of these two events, a potential temporary supply shortage may occur in early
2011 across some of the dosages. This potential shortage is not related to any product
safety or quality issues.

Merck continues to work with the FDA on the manufacturing supply source change. In
the meantime, while we are not experiencing a supply shortage currently, we want to
ensure that you are fully informed so that if necessary, you can inform patients in a
timely manner and provide them with relevant information about potential short-term
alternative therapies, including availability of alternative generic equivalents, as
appropriate.

Merck understands how difficult it is for any patient who may not be able to receive their
usual medication. We also recognize that some patients may express concerns if their
physician switches therapy from a branded to a generic medicine. We encourage all
patients and caregivers who have questions about their treatment options to speak to
their health care provider.

Should a supply shortage occur, any patient, caregiver or health care professional in the
U.S. who has a question about the availability of SINEMET should contact the Merck
National Service Center at 1-800-NSC-MERCK.

Please be assured that Merck will continue to monitor this matter very closely and will
inform you as soon as we confirm any supply shortages. Merck is committed to acting in
the best interests of patients.

Sincerely,
Michael Rosenblatt, M.D.
Chief Medical Officer
Merck & Co., Inc.
One Merck Drive
Whitehouse Station, NJ 08889WS3A-20

They are committed to acting in the best interest of patients. This is the second year in which I've read of a potential shortage of Sinemet. The best interest of the patient is to keep a shortage from happening. They have the technology to continue making the medication while all the regulatory is sorted out. Who the hell are they kidding? That said, at least it's a standard practice in the U.S. to use the generic unless the patient or the doctor specifies otherwise. That should help with a possible supply shortage for those who have issues switching.

I forgot about that. i have never taken brand name sinemet - my doctors said i didn't need it...no difference. another fallacy. so there should not be a shortage. Thanks for the reminder!!

[QUOTE=paula_w;733897]Amy Rick gave her permission to share. Bob Dawson where are you? I gave her the Spanish story....thanks for all your help and we need you to make noise again.
thank you!

thank paula, i am still here but I had no new info about Merck and my health is going down fast, and then just as i was recruited by a person with PD to write about PD I got recruited recently to investigate some stuff about native people in the Arctic and so my dance magazine which became a Parkinson's magazine is turning into an Indian, Inuit, Sami magazine - i have a few more chapters to do about them as i will find out why the Killiniq got kicked off that island --- so there are chapters about native people with the headline still saying it's Parkinson's and dance, and actually to me it all looks the same -- such as, Merck may as well be running the Dept. of INdian affairs or vice-versa - they use a lot of the same methods and tell a lot of the same lies.
Here's what it looks like. Parkinson's? Dance? Midnight SUn? It started because in my Parkinson's group we are all supposed to go out and help people who do not have Parkinson's - or let's say one activity or one interest that does not directly involve PD but shows the world we are out there and we are equal.
Spam: this is the first chapter that is not about PD:
http://parkinsonsdance.blogspot.com/...hapter-32.html

The list of other chapters is on the right, for people with way too much time of their hands.
Paula when is your book coming out?

I'm very sorry to hear your health is deteriorating. But good for you for helping others. I learned a lot from reading Smila's Sense of Snow and The Shipping News. I'll never understand their ability to withstand the cold but it's their way of life and I hope you can help them.

We hope to publish the book sometime this year, are proofreading, editing, finishing the writing. Many details but everything is moving along very well.

There probably isn't anything we can do, but Amy is watching.

Thanks!

[QUOTE=paula_w

Bob Dawson - January 15, 2011 at 11:45 am
…”Amy Rick gave her permission to share. Bob Dawson where are you? I gave her the Spanish story….thanks for all your help and we need you to make noise again. thank you! Paula at Neurotalk, Parkinson’s Michael Rosenblatt Executive Vice President Chief Medical Officer Merck…”

Reply
•
I was already working on a story related to this, courtesy of Jim Edwards at b|Net Pharma. . . will report before too long. . .
Namaste
condor - January 15, 2011 at 12:00 pm

[url]http://anewmerckreviewed.wordpress.com/other-main-blog/[/url]

[QUOTE=Bob Dawson;735216][QUOTE=paula_w
By the way
I go to this link if I want to read a lot about Merck and how it has to change. Our secret agent man at Merck writes a lot about them and look at the amazing graphics -informative and funny and very well done. This guy is a pro.
Do go read him:
[url]http://shearlingsplowed.blogspot.com/[/url]

Hahahaha! Merck keeps switching the shortage from one country to another. The letter Paula posted says shortage in USA - but shortage ended in Britain! Remember when Merck listed the countries - they said no shortage in USA but Britain would have a long shortage
then Parkies hassled the UK government and it was dicussed in the House of Commons - and shortage is gone... but it showed up in the USA
In Spain, Merck diverted pills from one country to another; production in Spain started up within three days after Parkies demanded jail terms for the perps
No danger for USA - enough pills floating around at top dollar... but just the way Merck handles the secrecy about a drug that exists only because of us - just what exactly do they think they own?

Sinemet 'returns to full production'

Healthcare News
18/01/2011
Manufacture of Parkinson's drug Sinemet has returned to pre-shortage levels, giving hope to those with the disease.

The production of Parkinson's drug Sinemet will return to full supply in 2011, after a shortage of the treatment during the past year.

MSD UK has announced they are now back up to full speed, supplying at the same level they were before the shortage.

However, they have said that increased demand could be a problem as back-orders and extra subscriptions are completed.

Val Buxton, director of policy, campaigns and information at Parkinson's UK said that the inconvenience and stress caused by the Sinemet shortage made for a difficult 2010 for many with the disease.

"We hope that those affected can now look ahead to 2011 and no longer worry about availability of essential medication," she added.

This comes after researchers from the Netherlands recommended in the Lancet that doctors should ask patients whether they were still able to ride a bicycle when diagnosing whether they had atypical or standard Parkinson's disease.
http://www.barchester.com/Healthcare...on%27/376/4034

Who was I posting to exactly? lol I usually don't post on blogs where I don't know the owners, but it's just a few simple questions.

thank you bob - there is humor in your veins even when you aren't up to par - not that i'm saying you are not up to par..no hell no...lol. we all have good and bad days. a good MJF quote: "i have good and bad days everyday."

i could be persuaded (not that they care) to forgive merck if they produce with the small molecules.