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Thread: TOTAL PML CASES in MS PATIENTS ON TYSABRI

  1. #31
    Distinguished Community Member SalpalSally's Avatar
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    Wow, 9 in less than a month. That's a lot, isn't it?
    Love, Sally


    "The best way out is always through". Robert Frost







  2. #32
    Distinguished Community Member agate's Avatar
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    I'm not sure it's less than a month. I think the report comes out once a month but when it becomes available seems to vary.

    Nine new cases in a month is about par for the course.

    December 2011 - 12 cases
    November 2011 - 11
    October 2011 - 11
    September 2011 - 7
    August 2011 - 5
    July 2011 - 12
    June 2011 - 9
    May 2011 - 13
    April 2011 - 9
    March 2011 - 7
    February 2011 - 10
    January 2011 - 6
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  3. #33
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    Big article in my Saturday newspaper regarding Tysabri. "MS DRUG MAY DOUBLE ITS SALES". It was in the business section. It says that Biogen Idec and Elan won U.S. clearance to modify the label of their multiple-sclerosis drug Tysabri with new safety information that might double the treatment's worldwide sales.

    It is a lengthy article since Biogen is located in my area and increased sales could be a boon to this area where Tysabri is manufactured. They employ over 800 workers and last spring announced it was expanding their office space there to give existing workers more room and allow for future hiring.

    Anyway, it said in the article that as of February 2011, 102 cases of PML had been reported among 82,732 patients treated with Tysabri worldwide.

    The worldwide market for MS drugs, now $10 billion to $11 bllion could grow to $15 billion in 2016. Tysabri's share of the market, now about 10 to 13 percent may grow to 20 percent that year with the revised label.
    Last edited by Virginia; 01-24-2012 at 06:53 AM.
    Virginia

  4. #34
    Distinguished Community Member agate's Avatar
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    Virginia,

    It's strange that the figures they're citing are from nearly a year ago though. The total number of patients on (or who have ever been on) Tysabri is now 96,582, and the total number of PML cases is now 201....
    Last edited by agate; 01-24-2012 at 09:16 AM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  5. #35
    Distinguished Community Member Cherie's Avatar
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    I just received the new prescribing information for Tysabri (sent only to Medical Professionals). Basic changes in the new wording include addressing the following:

    1. Safety is not known after 2 years of dosing.
    2. Serious liver injury is showing up at rates higher than in clinical trials and when a patient is taken off the drug to stabilize the liver then it is reintroduced, the liver injury appears again showing a direct correlation between said injury and use of Tysabri.
    3. There is a stronger warning for prescribers to use Tysabri ONLY as a monotherapy and ONLY after a sufficient time of trial with the injectable medications has shown to not be of benefit.
    4. Infection rates (UTI, pneumonia, skin and bowel infections) are higher with prolonged use than had previously been reported.
    5. If JC Virus antibodies are present, it is strongly advised to take patient off Tysabri even if they have done well up to that point on the drug.

    This bulletin was issued solely to Prescribers in the USA. So I cannot imagine how the company will double its sales on this particular drug. However, there may be a new oral released in the coming 12-18 months that could increase sales and workforce.

  6. #36
    Distinguished Community Member SalpalSally's Avatar
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    Wow, Cherie, it sounds like the business side of Tysabri is trying to pull a snow job on us, huh....the skunks!!

    It can still be a dangerous drug and maybe even moreso, the longer you take it?
    Love, Sally


    "The best way out is always through". Robert Frost







  7. #37
    Distinguished Community Member Frog42's Avatar
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    You'd have a very hard time convincing me they care about anything other than profit. *mad


    Whatever happens around you, don't take it personally. Nothing other people do is because of you. It is because of themselves. -- Miguel Ruiz

  8. #38
    Distinguished Community Member Cherie's Avatar
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    The longer it is taken, the greater the risk not only of PML, but of Liver injury (disease) and the higher incidence overall of opportunistic infections.

    Vicky, I do think they care about profit but ultimately they care about patient safety. If they really thought this drug was not safe and the risks outweighed the benefit, I have every faith they would pull it from the market.

    I do not rely on business news to make my medical choices. And I do not invest in pharmaceutical companies based on pending drugs coming to market. While I was on Rebif and doing well, my husband owned some stock in the company but sold it when I began having problems.

  9. #39
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    Agate, I too wondered about the lapse in time when they cited the number of PML cases.

    Cherie, I think it might depend on the individuals making the decision as to when and if to pull the drug off the market. Many individuals might make an
    argument against it even if there was evidence that the drug was potentially harmful, while others might pull it. People, and this includes heads of companies
    have differing views on ethics and what is right and wrong.

    Also, you cited some very serious side effects aside from PML. I know that patients are given literature to read about these drugs, but I do think many
    of these people see the potential good that it might do and also many rely solely on what their Doctors say.

    The only really big difference my Neurologist and I have had was over Tysabri when it was brought back on the market. He approached me pretty strongly
    about taking the drug and I was already in my 60s. Also I had been taking Rebif for a long time and before that Avonex, so my immune system was definitely
    not that of a young person. When I balked and was afraid to do it he almost lost his temper. It is the only time I ever considered leaving him as a
    patient. I think he honestly thought that because it had been allowed back on the market it would be alright for me to take it. Also, he had gone in with
    the big Neurology practice here in my home town and they do testing for all of Biogen MS drugs. And one of the Doctors in the practice is a spokesperson
    for Biogen. Things in the business world are not always as they should be. This is just my opinion.

    Virginia
    Virginia

  10. #40
    Distinguished Community Member Cherie's Avatar
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    this is new information that was just published this week. Yes...many individuals will make a decision based upon the impact MS has on their life. And that is Quite OK. I think this new warning was designed to make the seriousness of the decision come home to roost so to speak. I think, if it were me and there were no other choices, I would make that decision to take Tysabri. Fortunately at this time and in this place that is not a decision I personally need to make.

    Blessings.

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