Tysabri: 2 new cases of PML

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Postby mrhodes40 » Mon Aug 04, 2008 12:35 pm

I am with you Harry, I guess I am a henchman :wink:
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Postby Lyon » Mon Aug 04, 2008 1:22 pm

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Postby gwa » Mon Aug 04, 2008 1:35 pm

HarryZ wrote:Thought I would post this link to show the large activity of Biogen insider stock trading since July 21. Was it a co-incidence that this activity happened before the recent news of the 2 new cases of PML?

http://www.secform4.com/insider-trading/875045.htm




Pretty amazing coincidence, huh? Maybe the best way to see how a drug is doing is to keep a sharp watch on the SEC filings of the execs selling. Keeping an eye on their buying might be smart too.

gwa
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Postby rainer » Mon Aug 04, 2008 4:13 pm

Thought I would post this link to show the large activity of Biogen insider stock trading since July 21. Was it a co-incidence that this activity happened before the recent news of the 2 new cases of PML?

http://www.secform4.com/insider-trading/875045.htm


Bet you a milkshake you can't correspond most of those sales with any significant events at the company. Anyone who has ever bought and sold w/ insider trading indicators will tell you how overrated it is. My 2 pennies.

(actually that quote about insider buys on that page being more telling then sales is probably on the mark.)
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Postby HarryZ » Mon Aug 04, 2008 5:26 pm

I can see where you're coming from on this one Harry, but a lot of people seem to really do well on Tysabri.


And I have read that several have not done well on it. The unfortunate part is that Biogen will show prospective patients the good comments on the drug but not the "not so good" comments. I read on one forum today that a patient who started on Tysabri last month was not told about the dangers of the drug!!! Talk about professional irresponsibility by the doctor!

You or I might not feel that the crabs do anything useful and/or maybe we feel that Tysabri doesn't do anything useful, but it is and should be available as an option for intelligent people and it's not up to any of the rest of us to question the wisdom of someone who chooses to take it and it's not up to us to attempt to overstate the dangers in taking it until the facts are all in.


I won't disagree with you on that at all. It's up to the patient and his/her doctor to discuss the options and make an informed decision. The problem, however, like I pointed out above, is that the patient isn't always given all the information to make this "informed" decision.

I don't know for sure but it seems that, by a large degree, more Tysabri infusions have been done in the USA and Canada. With that in mind, what is responsible for the two confirmed PML cases being in the European union? Were both cases in the same area of Europe? Were they in the same country? Clinic?


Tysabri's use in Europe was delayed several months while the health care system over there decided on whether the cost vs benefit equation was worth it. I read that one patient was in Norway and the other in Sweden (I could be wrong on the second patient) You can bet that Elan is working very closely with the doctors involved to obtain as many facts as possible. And I'm sure they will use Biogen's marketing/sales people to try and counter any bad publicity about it.

Before jumping to ANY conclusions or laying ANY blame there are a lot of very important things which need to be answered, and the situation starts suspiciously because it seems to defy the odds.


Defy the odds?.....I don't think so. I have read that there are more suspected cases of PML out there involving Tysabri but I stress that this information comes from internet comments and not from substantiated facts. Only time will tell if this information is true or not. Don't forget, the discoverers of Tysabri said a couple of years ago that there were going to be many PML cases and associated problems with this drug as its use grew.

One thing is for sure.....the drug remains quite controversial and Biogen's competitors will ensure that this remains so!

Harry
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Postby CureOrBust » Tue Aug 05, 2008 3:15 am

I have been offered Tysabri, and have chosen not to go on this treatment due to the past posts regarding the "bounce-back" seen when people have come off it. As far as I understand, this has yet to be explained?

So in my eyes, PML is not its only concern.

As far as its effectiveness goes, we can argue about the effects on current users, but the phase III results peg it pretty high above interferon's.
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Postby Lyon » Tue Aug 05, 2008 1:09 pm

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Postby HarryZ » Tue Aug 05, 2008 6:30 pm

Boston Globe article wrote:The US label says one in 1,000 patients could potentially contract the disease. With it in mind that those in the US on Tysabri accepted a 1/1000 risk, everyone should freak out about what so far seems to have shown to be a 1/15,000 risk, and, realistically, a 0% risk among US patients so far?


Statistics are a tricky business and they can be used to say a lot of things. Quite some time ago on another MS forum, there was a fellow who knew a fair amount of them. He took the data from the CRABs and compared it to Tysabri and determined that Tysabri was about 12% more effective than the CRABs. Another chap who was a statistician, took the 1/1000 PML risk that was being thrown about and said because 3 patients out of 3000 ended up with PML, that DID NOT translate into a 1/1000 probability of risk. He said that there were many other factors that had to be figured into this kind of stat and the 1/1000 figure was very wrong.

I don't and never have felt that Tysabri is the greatest thing in the world. It's not. Tysabri is nothing more than a higher degree of immune suppression and immune suppression is a flawed and dangerous mode of operation against autoimmunity. Unfortunately, at this point suppression is the only medically accepted mode and, with that in mind, Tysabri is the most advantageous "legitimate" treatment and so far hasn't been proven to be more dangerous than the crabs.



I like your comment about "medically accepted mode". In reality, because the drug companies are pretty much the only people who can afford the huge costs of clinical trials, it is these very companies who have determined what is accepted in the world of MS medication. And we are now seeing the increased dangers of this kind of treatment.

Take care.

Harry
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