Quote:
Originally Posted by lady_express_44
As far as the ratio of PML cases they are "admitting" too, I'm not sure how they can make such a claim.
A very large % of that 35,000 have not been on Tysabri for 18+ months, but the "acceptable" PML ratio was determined on the basis that those “who received a mean of approximately 18 monthly doses of Tysabri" . . . "it was estimated that the incidence of PML was 1 case per 1000 patients over 18 months”.
http://www.pubmedcentral.nih.gov/art...medid=18360634
At that point they were suspicious/hopeful that the PML cases occurred only because of combined therapy, but unfortunately we know that those same people in the trials may have gotten it from Tysabri alone now ...
Last I heard, there were about 9,500 people (which isn't a mean, but the only # we have to work with) who are (or have been) on Tysabri for 18+ months. That is a cumulative number, which includes all the people that were on Tysabri in the trials, plus since the trials.
From what we've been told publically to date, there were 3 cases of PML in the trials, 2 in Europe, and now one in the US. Hence, the ratio should be now be closer to 6:9500 (or 1:1583).
They can't add in the people who've been on just a few doses to determine the current ratio 2:35,000 . . . when the original "estimation" of acceptable PML cases was based on an average of 18 doses. 
They also can't include the number of people in the trials who were on 18+ months (giving a total of 9500). . . but then drop counting the three PML cases from the trials because a few weren't on monotherapy when they got it.
Cherie |
These are commercial users of Tysabri. These are patients who have been on Tysabri since it was returned to market. Of the three people in the ORIGINAL trials before Tysabri was withdrawn from market, NONE of them were on monotherapy and TWO of them didn't have MS.
Of the three patients who have been reported to have been diagnosed with PML since Tysabri's return to market in 2006:
One patient had a TEN year history of azathioprine. That's not monotherapy. Imuran stays in your system. I cannot remember how many months it was before he started Tysabri. The fact remains that he WAS on Imuran prior to Tysabri, his neuro had him continue the Tysabri infusions despite his having problems and also administered steroids on top of that, as if treating a relapse without checking into it first.
One patient was treatment naive...NO treatment for MS at all. That is the one whose diagnosis of PML is in question at this time.
The US patient was treated with methotrexate with her last treatment 4 months before Tysabri. No further information is available for her due to the laws in the US concerning privacy. That's not monotherapy. Methotrexate stays in your system.
I am talking about commercial patients as stated in Biogen's own press release of their third quarter returns.
http://www.biogenidec.com/site/news-...PR_2008_36.htm
Scroll down to "Revenue Performance" and it says as of September 30, 2008 there are 35,500 patients worldwide. In the US there are more than 19,500 patients on Tysabri commercially. There are more than 15,300 patients rest of world on Tysabri commercially. In global clinical trials there are more than 700 patients. Cumulatively in the combined clinical trials and post marketing settings there are more than 48,000 patients who have been treated with Tysabri, of those patients 18,000 have been treated for at least one year and 9500 have been treated for more than 18 months.
That was September 30th. The run rate at this point for Tysabri is around 325 per week worldwide signing up. That is straight from the rep's mouth. That would make it a conservative estimate now of 37,500+ patients commercial use worldwide.
Of those patients only one can truly be considered monotherapy. We were not talking exact stats. I was reporting on a seminar and what was said there. That is where that figure comes from.
Of the 3 people who were diagnosed with PML prior to Tysabri being withdrawn, we have debated that to death. One was a Crohn's patient who died from what was diagnosed with astrocytoma. They dug that patient up and changed the diagnosis to PML. The patient was on immunosuppressants. The second patient was also in a combo trial with avonex and Tysabri. That patient is alive. The third patient, Anita Smith-combo trial with avonex and tysabri- was misdiagnosed with MS and died from PML.
Monotherapy...ONE patient, with a questionable diagnosis of PML at this point.
Deaths from PML...TWO, one with Crohn's and a history of immunosuppressants, one in a combo therapy trial who was misdiagnosed with MS, both from before withdrawal.
I am not sure what you want here Cherie. Do you want to argue what was said at a seminar in a conversation? I had a witness to what was said. Do you just want facts and figures? Go hunt them down. I have a full time job, along with many other things going on in my life. I've got thousands of pages of studies and information on Tysabri. I don't have time to go through every page to debate with you over stats.
I've been involved with this drug for many years. I have done my homework. The fact remains that hundreds of people are benefitting
from it. I am sure we will hear more about PML and I am sure a lot of people will decide not to take Tysabri and that is their choice.
As with each of the other DMDs for MS, it was a learning curve or did you forget that? Each one of them came out and people screamed about what the side effects were and what they could do to you. OMG, you could DIE from them!! Well guess what? People are injecting them into their bodies now regularly. Yet with every one of them, the future could NOT be predicted. Nor can the future be predicted with Tysabri.
Improved quality of life, no relapses for 19 months and counting, vision back to normal, no new lesions, no enhancing lesions, large lesions reduced or gone, no further progression, once a month infusion vs. a shot every day, other day or week, I'll stick with Tysabri, thanks.