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Old 11-27-2006, 05:28 PM #1
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Originally Posted by Harry Z View Post
I'm afraid I will have to respectfully disagree with you on the Crohn's patient who was indeed on a monotherapy with Tysabri. He had stopped using Infliximab 20 months earlier and hadn't used Azathioprine for 8 months. He was in generally good health (other than from the typical symptoms from Crohn's which he endured for 28 years) and went fishing and hunting.

The JC virus only appeared in his blood during his monotherapy Tysabri use between Feb-June 2003. In one NEJM article, the reps from Biogen/Elan state they asked the physicians who controlled the trial to review his case while in their own article, the physicians say they informed Biogen/Elan first, after knowing about the 2 MS patients who contracted PML!

The family of the Chron's patient was never originally informed about the cause of his death although the Biogen/Elan and the docs knew and stated such in the NEJM article. The family was informed by their doc in April 2005 and then told about the PML cases. The family ran up against roadblocks from the trial docs and Biogen/Elan when they asked to review the all the medical files. When they finally succeeded in being able to do so they were told "try not to make a big fuss about this"!!

This is another reason why I don't think we are being told everything by Biogen/Elan and the docs when it comes to Tysabri and PML. Biogen/Elan have been hanging their hat on the fact that PML did not occur in any monotherapy with Tysabri. The Crohn's patient situation looks like this isn't likely the case.




Have you noticed that the talking heads who were so visible prior to Tysabri's re-approval have disappeared? Maybe, once there was no chance of queering the re-approval, the hired guns lost interest in the "safety profile" of Tysabri? You seem to be the last guy carrying the banner.
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Old 11-27-2006, 07:52 PM #2
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Have you noticed that the talking heads who were so visible prior to Tysabri's re-approval have disappeared? Maybe, once there was no chance of queering the re-approval, the hired guns lost interest in the "safety profile" of Tysabri? You seem to be the last guy carrying the banner.
I'm guessing the reason some of them aren't around anymore is because there isn't too much say about whether Tysabri is going to get re-approved. I stated from the very beginning, after the drug was originally pulled, that the FDA would re-approve the drug because there is simply too much money at issue here.

Exactly the same thing happened over on the ThisIsMs forum after Tysabri got its original approval...only in the opposite way. A few other people and I continually stated at that time that Tysabri was a potentially dangerous drug and that a great deal of caution had to be followed when using it. I can't count the number of times some readers called us "Tysabri bashers, fear mongers and hidden agenda people over the course of about 4 months. And then, out of the blue, Biogen pulled the drug after PML showed up. All of a sudden these people disappeared and the name calling stopped...wonder why?

And I somehow doubt that we have heard the end of the problems with Tysabri. This drug plays with the immune system too much and there is simply too much unknown about it at this time.


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Don't forget the gushingly negative comments of competing Big Pharmas.
Won't disagree with you on that one...but in the Big Pharma business, these competitors are ruthless when it comes to bashing one another. Not surprising when billions of dollars are on the line!!!

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IMO, the efficacy and safety of Tysabri is no less than its competitors, and its potential to provide relief is far greater. I think the number of patients already enrolled is a testament to their confidence.
Afraid I can't agree with you on the safety of Tysabri at this time....even Biogen admits they don't know any long term effects on the drug. As for the efficacy, it really doesn't take much to beat the record of the CRABs, does it?

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Old 11-28-2006, 06:28 AM #3
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I'm guessing the reason some of them aren't around anymore is because there isn't too much say about whether Tysabri is going to get re-approved. I stated from the very beginning, after the drug was originally pulled, that the FDA would re-approve the drug because there is simply too much money at issue here.
The "talking heads" I was referring to are not the denizens of these boards; they are the "experts" trotted out by Teva and the other drug companies whose drug sales stood to suffer if Tysabri was approved.; all those doctors on their payrolls, via lucrative "research grants", who carried on so, as well as the columnists who seemed to consistently "get it wrong". Why are they all silent now? If this was really about safety, why would they stop talking?

IMO, it was all about money...you're right. You just have the identity of the bad guys wrong.
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Old 11-28-2006, 09:40 AM #4
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Rex,

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The "talking heads" I was referring to are not the denizens of these boards; they are the "experts" trotted out by Teva and the other drug companies whose drug sales stood to suffer if Tysabri was approved.; all those doctors on their payrolls, via lucrative "research grants", who carried on so, as well as the columnists who seemed to consistently "get it wrong". Why are they all silent now? If this was really about safety, why would they stop talking?

These "paid experts" by Teva, Serona and Burlex are no different than those from Biogen/Elan. Before Tysabri even got into general use the first time around, Biogen sponsored a web cast in Philadelphia which featured a host (he could have worked "Let's Make a Deal" with his antics) and a panel of "experts" in front of an audience of specially invited medical guests.

Talk about watching a circus of promotion by Biogen...big time marketing at its best!! All of these big pharmas have marketing/sales departments which spend millions on promoting their drugs to the docs and public. But don't for one minute think that Biogen's competitors have gone away. All of these people lurk in the background, waiting for the one event or incident that they can pounce on order to make the "other guy" look bad and perhaps get back a percent or two of that lucrative MS medication market....those 2% can translate into $ millions!! And with Tysabri, it isn't "if" something will happen, it's "when" something will happen.

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IMO, it was all about money...you're right. You just have the identity of the bad guys wrong.
Biogen/Elan are no different than the other people in this area...they just happen to have the latest MS drug out there. When these other pharmas come out with something else, the shoe will be on the other foot and Biogen will be doing exactly the same thing as these other guys are doing now. It has nothing to do with interest in MS patients but everything to do, like you said, about the money!!

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