Fourth PML case in 2008

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

Postby RuSmolikova » Wed Dec 24, 2008 1:20 am

marcstck wrote:...all Tysabri patients should have been on some sort of immunosuppressive or immuno modulating therapy before attempting Tysabri.


Let me note a little specification: the man from Sweden who developed PML in July 2008 has never had been treated before Tysabri...
http://www.aan.com/news/?event=read&article_id=5753
See:
"In the first case, a treatment-naive male was started on natalizumab after being diagnosed with an aggressive clinical course of multiple sclerosis."
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Postby RuSmolikova » Wed Dec 24, 2008 1:48 am

:?:
Last edited by RuSmolikova on Thu Dec 25, 2008 1:03 am, edited 3 times in total.
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Postby HarryZ » Wed Dec 24, 2008 7:43 am

Marstck,

Thank you very much for putting all of this into perspective. Your post was excellently written.

I'm sorry, but much of the information contained in the above statement is misinformed.


Unfortunately some of the Tysabri "cheerleaders" continue to write their messages with this level of misinformation.

If you take the time to read the PDF, I think that will become obvious.


Very obvious to most of us but apparently not to some!

Tysabri has indeed proven to be a very effective drug for many patients. That said, it has also failed many patients, and there are patients who claim that it worsened their condition.as with all pharmaceuticals


Exactly!! I don't see much difference in the results area than what MS patients have experienced with the CRABs albeit the administration of the drug is much easier. The cost? ....well we are all aware of the initial costs and the huge follow up costs involved. Again, the Tysabri "cheerleaders" see this drug as the saviour of MS patients world-wide....but it is anything but that!!

Take care.

Harry
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Postby HarryZ » Wed Dec 24, 2008 10:52 am

"In the first case, a treatment-naive male was started on natalizumab after being diagnosed with an aggressive clinical course of multiple sclerosis."


I can only assume that his neuro chose to use Tysabri out of desperation because the drug has proven to be ineffective for progressive MS or for patients experiencing an actual exacerbation.

There is so much unknown about Tysabri at this time and we continue to hear about new problems as each month passes.

Harry
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Postby RuSmolikova » Thu Dec 25, 2008 1:00 am

Does anybody know why there is a lack of information about another serious side effects (melanoma, severe liver injury…)
http://www.nationalmssociety.org/news/n ... px?nid=256

…and about a stage of people who have had to stop Tysabri?
http://www.sciencedaily.com/releases/20 ... 163524.htm
(See:)
„The participants developed more than three times as many brain lesions, or areas of damage in the brain that are a marker of MS disease activity, in the 15-month period after discontinuing the drug than they had developed before they started taking the drug.“

The probleme of Europe is that Tys can be indicated almost to everybody:
http://www.emea.europa.eu/humandocs/PDF ... -PI-en.pdf
(See page 9)
„…patients with rapidly envolving severe RRMS, defined by 2 or more disabling relapses in one year and with one or more Gadolinium enhancing lesions on brain scan or a significant increase in T2 lesion load as compared to a previous recent MRI.“

Who pays additional costs connected with TOUCH and TYGRIS programme? Is it Biogene? Or Elan??
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Postby HarryZ » Thu Dec 25, 2008 7:54 am

RuSmolikova wrote:Does anybody know why there is a lack of information about another serious side effects (melanoma, severe liver injury…)


The answer to this questions is very simple....making this kind of information readily available is a disaster for any drug company's' sales. In this case Biogen would be aware of the problems but would minimize them. Often a competitor company will be the one who discovers this information and ensure the public is made aware of it.

At the same time, Tysabri is under the microscope because of its past issues and severe problems, such as a PML death etc, and these issues are made public by the company. Having this kind of information released by other sources becomes a public relations nightmare for any drug company.

Who pays additional costs connected with TOUCH and TYGRIS programme? Is it Biogene? Or Elan??


The final costs are ALWAYS covered by the patient and his/her insurance company. If you can recall, just before Tysabri was re-approved by the FDA, Biogen/Elan raised its wholesale cost from just over $ 1800 to about $ 2300 per dose. How do you think they planned to cover the extra costs associated with the re-approval process?!!

Harry
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Postby superman » Thu Dec 25, 2008 1:56 pm

TOUCH program. This program is non existent outside of he US, another reason for the cases in Euro.
[/quote]

As a french arrogant (?) :wink: guy I can't let you say this.
I don't how it is exactly in the rest of Europe but here in France, Tysabri is prescribed under Touch program: monthly blood test, MRI each 6 months, HIV tests.... added to the fact our national health system covers its cost, which is NON existent in the US.
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Postby sou » Thu Dec 25, 2008 3:53 pm

Hi all.

I am not on Ty and don't intend to, but several friends of mine are. Same situation here in Greece. A ton of diagnostic tests every month and 100% of expenses, both for the tests and the drug itself, are covered by the state through public social insurance programs, too. Isn't the TYGRIS program the European equivalent to TOUCH?

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Postby RuSmolikova » Fri Dec 26, 2008 3:24 am

superman wrote:TOUCH program. This program is non existent outside of he US, another reason for the cases in Euro.


Thanks for your opinion, Superman. But I don´t believe that France would have an exception from the guideline of EMEA - which suggests TYGRIS program for Europe.
http://www.medscape.com/viewarticle/585512

As far as all the european PML patients have survived (2 Germans and one from Sweden), one could conclude that TYGRIS program catches PML far earlier than the TOUCH one. :?:

How is it out of France? Tysabri patients have tons of tests in Czech republic too, including MRI being repeated every 6 months. Furthermore patients have to pass psychological investigation every sixth month, too. It´s because "symptoms of PML can include changes in thinking, memory, and orientation leading to confusion and personality changes".

The Czech neuros will try to make few weeks of holidays in Tysabri treatment after 10 or 12 infusions, now. We´ll see if dr. Jung (in the end of http://www.medscape.com/viewarticle/585512) is right.
It looks like the Tys treatment is one continuous trial, doesn´t it? The trial paid by NHS, not by pharmaceutical company...
<shortened url>
Forgive me mentioning the revenue of Biogen/Elan, please. I can´t help myself - Czech NHS has to spend a lot of additional costs while there is not enought money for treatment of all patients who could benefit from DMD´s. In contrast of the rest of the world we can´t get the treatment after the first relaps. Despite the fact that early treatment is the most effective, the Czech patients have to wait till the sesond/the third relaps.
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Postby Loobie » Mon Dec 29, 2008 5:59 am

As I understand it, the TYGRIS is to start to try and develop a pattern of "markers" in people on Tysabri's blood. It's completely seperate from the TOUCH program. I am enrolled in both of them. Apparently they want to see if there are any trends with people who have the same good and bad reactions to the drug for future use. At least that's what they tell you! This shit is expensive as hell though. I have to pay over $400usd/month on my current policy.
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MS Tysabri PML JC BK and LPs

Postby yeb4432 » Mon Dec 29, 2008 7:38 pm

In patients on Tysabri whom do not develop neutralizing antibodies it is at least2.5x more effective than the ABCR drugs. This has been established though the trials that initially brought Tysabri to market in 2005. Patients that develop neutralizing abs to it will obviously get no benefit from it. The firdt teo studies that showed its efficacy did not remove these patients, so the recoded efficacy would then be under stated.


In terms of minimizing PML risks. Pould not recieve the medications are patients that are not immune competent shuch as patients with Advanced HIV, patients that have some aspect of a quantitative immunoglobulinemia. There are not patiens that have been "washed out" from the ABCRs or even Cellcept. These are patients that have had there immune systems suppressed at the level of the bone marrow with medications like Immuran,, Cytoxan, Methotrexate to a lesser extent.

The fear that someone being on an ABCR med before starting the Tysabri is not the issue. That is exactly what the "wash out period is for. No "wash out period would help someone that has a perminantly suppressed immune system (described above).

Tysabri is not contraindicated as first line therapy, it is "not clinically indicated" There is a very big difference. It is crazy and be playing with fire for a young person with a big cervical spine lesion to have another attack or two before moving up a more efficacious therapy, because by that time they may have sustained significant disability.

Even "the pdf" can not make the link between PML Tysabri and JC viremia. I think many on Tysabri off Tysabri with MS and without MS would be suprised to see the that many of us have the virus at suppressed levels. The question is what role either Tysabri or other previous described "immune suppression" plays in this.

World wide there has been what now? 400K infusions world wide of tysabri and how many cases of fatal pml and treated pml? For me its an easy decision, I'll take my chances with Tysabri.
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Re: MS Tysabri PML JC BK and LPs

Postby HarryZ » Mon Dec 29, 2008 9:26 pm

yeb4432 wrote:In patients on Tysabri whom do not develop neutralizing antibodies it is at least2.5x more effective than the ABCR drugs. This has been established though the trials that initially brought Tysabri to market in 2005.


Not that I have ever been a fan of the CRABs but Tysabri's trial data comes from its comparison to placebo, not versus any of the CRABs. The drug was trialed on very mild MS cases and thus the results looked very nice. I believe the only way one could effectively state that it was 2.5X more effective than any of the CRABs would be to run a head to head trial against any of them. It would be very interesting to see just what kind of data would come out of a trial of that nature.

Harry
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Postby yeb4432 » Wed Dec 31, 2008 11:38 pm

I stand corrected you are absolutely right. Me making that statement was not correct, as Tysabri is not and has not been compared against anABCRs. The BEYOND, BENEFIT, and PRISM trials all showed about ewual effectiveness across the ABCR meds. You can easily any of these trials online if you google them. These studies constantly documented the ABCR's effectiveness around 30%. T\

WHile Tsabri has not been compared head to head to the ABCRs I dont realistically think we can question its effectiveness over an single ABCR witf\h thePRISMs trial showing Tysabri's effectiveness to bearound 67% I dont understand why people refute this.

I am sorry about the confusion.

ope all is well and happy new year
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Postby sou » Thu Jan 01, 2009 4:14 am

Hi.

The trials do not conclude that Tysabri has 67% efficacy. They conclude that the treatment group had 67% less relapses than the control group. They conclude to nothing more and nothing less.

What you have to wonder is whether you demografically fit in any of these groups. I hate being told that Tysabri is 67% effective in MS in general. How many MSers fit into these groups? What happens if someone with MS who does NOT fit into these groups takes Tysabri? Is it proven that it is safe for him? In my opinion, no.

In Greece, everybody with MS has been prescribed Tysabri. AFAIK, Biogen hands 100 Euro per infusion to the doctor, plus bonus trips and laptops. I had been strongly pressed to take Tysabri, but after a long conversation with my doctor I was not convinced that it would be of benefit to me or that it would be safe, either. I am SP, not RR.

I have been studying for a master degree in bioinformatics. We have had a course about statistics. Data can be presented in many ways. Even that "67%" reduction could be plasmatic. I am not saying that Tysabri does nothing at all. I am saying that we can only see the one side of the coin. The company presenting only the one side and using marketing techniques like gifts to doctors is not a company to be trusted, in my humble opinion.

sou
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Postby HarryZ » Thu Jan 01, 2009 7:17 am

Sou,

I have been studying for a master degree in bioinformatics. We have had a course about statistics. Data can be presented in many ways. Even that "67%" reduction could be plasmatic. I am not saying that Tysabri does nothing at all. I am saying that we can only see the one side of the coin. The company presenting only the one side and using marketing techniques like gifts to doctors is not a company to be trusted, in my humble opinion.

sou


It is nice to see a response from someone like yourself who can see beyond what Biogen keeps on telling the MS patients and docs. Their marketing department is one of the best in the business when it comes to creating "hype" about their products, especially Tysabri. A few years ago my wife's neuro, who was involved in the Tysabri trials, told me that Biogen's information is simply not trusted in the world of MS medicine.

Harry
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