10 more PML infections, 4 more deaths in Tysabri MS patients

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

10 more PML infections, 4 more deaths in Tysabri MS patients

Postby MSUK » Fri Feb 18, 2011 12:55 am

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Biogen Idec Inc. disclosed 10 more cases of a rare brain infection among multiple sclerosis patients taking Tysabri, a medication it sells with Elan Corp, bringing the total number of affected patients to 95 as of Feb. 2.

The Weston, Mass., biotech company reported that four more of those patients have died, bringing the total to 20.

The cases of the infection--known as progressive multifocal leukoencephalopathy, or PML--are closely watched as the MS market becomes increasingly competitive.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905
MS-UK - http://www.ms-uk.org/
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Postby Vonna » Wed Feb 23, 2011 12:07 am

Just wanted to say thanks for posting these continuous updates. After finding out my friend has PML, and all she has been through, it's all I have had on my mind today...

It's so sad that Biogen continues to minimize the risk of PML.
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Postby HarryZ » Wed Feb 23, 2011 6:47 am

It's so sad that Biogen continues to minimize the risk of PML.


You have to understand the mindset of big pharma. Tysabri is Biogen's cash cow and while their customer numbers aren't anywhere near what they thought they would be, the drug is a major source of revenue. They have been slapped on the wrist by the FDA for minimizing PML risk in their marketing but apparently that is a necessary mode of action that a lot of pharmaceutical companies take.

The new corporate execs of Biogen are also placing the company in an attractive position for a buy-out and takeover. The better they can make it look, the more money another company will likely pay to purchase them. And that means a nice tidy personal stock profit for the execs.

I hope you didn't think that Biogen's upper management is interested in the health and well-being of MS patients. PML is considered collateral damage with Tysabri. Very sad but true.

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Postby Vonna » Wed Feb 23, 2011 1:04 pm

I am very well aware that it is all about the money.

Here is part of a statement on the CCSVI Worldwide Victory website that I made about Biogen and how they minimize the risk:

So, we have a company that brings in $1 billion annually off of Tysabri sales. Are we to believe this was an oversight on the part of Biogen? No way! This was strategically planned! After European regulators disclosed a much higher number of PML cases than expected, they devised a plan to convince the customer that benefit was greater than risk. Here in this conference call between Biogen and it's investors you can hear of this plan for yourselves: Feb. 9, 2010 <shortened url>


Biogen knew when they made the decision to produce this webcast that they would be in violation, but they didn't care. Over four months after the violation was said and done, they simply received a letter requesting they immediately cease the dissemination. Unbelievable!

From the Tysabri website:
_____

How many cases of PML have there been?

* In TYSABRI clinical trials, 3 cases of PML occurred (2 in MS trials, and 1 in Crohn's disease trials)
* The two MS patients who developed PML were taking TYSABRI and AVONEX at the same time. The one patient with Crohn's disease had a weakened immune system
* There have also been reports of PML in patients who have taken TYSABRI as a monotherapy since TYSABRI was reintroduced to the market in 2006
* The absolute risk for PML in patients treated with TYSABRI cannot be precisely estimated, for more information contact your healthcare provider.
_____

This too, is unbelievable! They don't disclose the statistics every month because they are concerned for the patient, they disclose the statistics because they must. The statement above, which is on their website, shows how far they are willing to go to cover the risk of PML.
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Postby HarryZ » Wed Feb 23, 2011 1:46 pm

Biogen knew when they made the decision to produce this webcast that they would be in violation, but they didn't care. Over four months after the violation was said and done, they simply received a letter requesting they immediately cease the dissemination. Unbelievable!


And some people have commented that my dislike of Biogen is sour grapes and not justified!!

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