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SGP-Antitrust3-sm The general blog following legacy Schering-Plough’s issues — and Merck’s inheritance of the same — through a 2009 bust-up/merger.

Do go look, if you are so inclined.

Namaste

12 Responses

  1. ________________________________________
    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 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
    __________________
    paula

    “Time is not neutral for those who have pd or for those who will get it.”

    http://neurotalk.psychcentral.com/showthread.php?p=734531#post734531

    (Where the above letter is printed.

    http://neurotalk.psychcentral.com/thread113354.html

    Started with Canada – most interesting part is further in about Spain, where the production of sinemet, to be scarce for one or two years, suddenly came back on stream in 3 days, and Merck diverted supplies from other countries./.. all because a Parkinson’s advocacy group was demanding that criminal charges be laid against individual Merck managers

    http://neurotalk.psychcentral.com/thread113354-10.html

    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.
    Spain: the mere threat of jail-time
    ________________________________________
    Update to postings number 48 and 49 in this thread.
    Earlier this year, Merck announces drastic cuts in supply of sinemet to Spain.

    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

    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

    • I was already working on a story related to this, courtesy of Jim Edwards at b|Net Pharma. . . will report before too long. . .

      Namaste

  2. So who has the sinemet now? And why couldn’t I ever get the brand name? Perhaps i wouldn’t be taking 2 regular 25/100s every 2 – 2/1/2 hours. Do doctors get penalized for recommending the brand name? Is it the insurance companies? I’m sure it is.

    We must exhaust all medication possibilities before checking into surgery.

    • I am still working on this one — but I did revise the dose, per your later correcting message.

      Namaste

  3. where can i buy sinemet plus? I used to buy this in spain and the formulation from there worked for us

    • I am sorry — but this site is not affiliated with Merck. You’ll need to call Whitehouse Station at 908-423-1000 –, to see if it is available anywhere on the globe.

      Namaste

  4. Where can I get the original ‘Brand’ name Sinemet?
    Who is the Manufacturer or distributor?
    Thanks, Christa

    christarodgers@live.com

    • Ask Merck, in Whitehouse Station, NJ — or ask your doctor — it is a prescription-only medication in the US. You need to speak to your doctor.

      Namaste

  5. Thank you, how do I delete — all done.

  6. where sinemet plus is available now? Update us

    • If you are in Spain, you’ll need to check with your local doctor. I cannot answer this for you.

      Namaste

  7. Merck you are really something else. The word is getting out about you and your lack of morals and all around lack of taking responsibility for adverse reactions caused by your drugs. Propecia has ruined many young mans lives and is still doing so today. What do you do about it? you hide the adverse effects for the last 15 years and keep them from your labels. people have become hypogonadal, lost penis size, testicular atrophy, severe depression, anxiety attacks, lost their jobs and wives and many other serious adverse side effects from this drug. You people are what’s wrong with America today, money hungry and will destroy anything even the innocent americans lives to make a few extra bucks and reach optimal bottom line sales numbers. There’s a special place in hell for merck employees and people who knew about these adverse side effects and didn’t do anything about it as far as letting the general public know these effects and leaving the drug on the market. You have even gone as far as deleting dr.s from blogs that have posted information about patients suffering from these side effects that do not go away after the drug is discontinued. you make me sick!

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