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cheerleader wrote:I think the damage of MS continues whether or not the immune system is ablated or not

Tysabri does not ablate the immune system.

I was thinking about doing this since last month and after this past week's events with Biogen, it's what I had to do.

He said that a minimum "drug holiday" would be three months since that's how long it takes to clear from your system. He also said he has no way of knowing if this will help or not and anyone who claims to know that it helps is wrong.

He also said that in one post trial evaluation, patients were given spinal taps and that the T cells were at zero even at six months post drug cessation. So we know it keeps doing what it does for a long time. Everyone will be different of course but I'm hoping I'll be about average in that regard.

He also spoke to me about Cladribine, an oral treatment that should be approved in the spring.

It has a long history since it's a chemo drug that has been used for 18 years, but the MS dose is much smaller and even safer. He said the side effects were negligible in the trials. So I'm thinking about that as a possible replacement therapy. It's hard to believe that a pill is so close to reality.

patientx wrote:

cheerleader wrote:I think the damage of MS continues whether or not the immune system is ablated or not

Tysabri does not ablate the immune system.

But it certainly restricts certain components of the immune system from functioning in a normal manner and when it comes to the JCV virus, the results can be nasty.

Harry

HarryZ wrote:

patientx wrote:

cheerleader wrote:I think the damage of MS continues whether or not the immune system is ablated or not

Tysabri does not ablate the immune system.

But it certainly restricts certain components of the immune system from functioning in a normal manner and when it comes to the JCV virus, the results can be nasty.

Harry

Absolutely.

In addition to more clear reporting about incidences of PML (and thus risk) I'd also like to know how the 19 or so patients who did not die from PML are actually doing. What treatment did they receive for PML compared to how well they are doing?

I'm just completing my 24th month on Tysabri. My neuro takes her patients off for a 6 month drug holiday after 12 months on the drug. So I'm coming up on my second "holiday" and not too happy about it. With the first holiday I felt great & full of energy for @ 3 months, had an exacerbation in month 4 (mild to moderate) and OK after that.

There is no agreement on these "holidays" or how long they should last. My neuro says Tysabri stays in the system 3 to 4 months. Some neuros think "holidays" can lessen drug efficacy.

I agree with leaning on Biogen. A customer relations person called me today to see how I am getting along. Glad I read these posts before I returned the call. I will definitely pass on the concerns about lack of reporting (translation:lack of caring about users lives) Now I'm pissed AGAIN.

It is problematic that Biogen is not more forthcoming in reporting information on PML cases and deaths. In an attempt to see the issues, I looked at business issues for Biogen. Here's some information.

For the quarter ending 9/30/2009, Biogen's profits increased about 36% thanks largely to the sale of Tysabri. Biogen made about $275 million in profits for that quarter and is expected to have profits of about $1 billion for the year. The profitability of Biogen very much depends upon Tysabri so, obviously, Biogen is anxious to avoid raising alarms about PML. At this time, about 46,000 persons use Tysabri for MS and Biogen would like to expand that number.

One analyst said that Biogen understates the incidence of PML. That analyst said that after 24 infusions, the rate of PML rises to 1/800.


Another issue is that the CEO at Biogen continues to cause a fair amount of flap. Last year, some shareholders at Biogen complained about his extravagant expenditures. For example, he uses corporate jets to fly home and each trip costs about $100,000 while a commericial airline ticket would cost about $1,000.

Shareholders are also complain that the CEO is unloading his Biogen stock and has pocketed about $60 million. Some shareholders believe the CEO no longer is interested in the longer term profitability of the company.

This sale of stock by the CEO is very interesting. It may mean that the CEO expects the bottom to drop out of the stock price for Biogen stock. This would happen if Tysabri turned out to be more dangerous than expected.

All in all, it looks like those with MS do need to be wary of Biogen, Tysabri and PML.

A related fact is the high cost of preventing relapses using drugs. One study showed it costs about $80,000 to $90,000 to prevent one MS relapses with drugs.

There is so much money at stake here. The pharmaceutical companies have powerful economic incentives to understate problems with the MS drugs.

Rebecca wrote:It is problematic that Biogen is not more forthcoming in reporting information on PML cases and deaths. In an attempt to see the issues, I looked at business issues for Biogen. Here's some information.

And some people think that I'm the only one who thinks that Biogen has no interest in MS patients' welfare and is only interested in increasing their profiits regardless of who stands in the way.


Harry

I read an article yesterday that said Biogen has decided to reinstate the monthly reporting of PML cases. I hope this was in direct response to all the calling and raising concerns!