update on Tysabri--August 2013

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

update on Tysabri--August 2013

Postby cheerleader » Thu May 23, 2013 8:32 am

According to e-healthme, a reporting site which is based on reports by the FDA and self-reporting of actual patients, on May 22, 2013--
90,168 people reported to have side effects when taking Tysabri.
Among them, 665 people (0.74%) have died.
http://www.ehealthme.com/ds/tysabri/death
359 people are currently reported to have PML.
http://chefarztfrau.de/?page_id=716

But there have been more Tysabri deaths documented, linked to antibody reactions, lethal relapses after withdrawal, and cancer. These are not included in the PML numbers. We honestly do not know how many pwMS have died because of Tysabri.

Patients are now tested for the JC virus before beginning therapy. But many do not realize that just because you are JC- does not mean you will remain that way. It is possible to become JC+ after beginning treatment.
Illustrating the need for follow-up testing, Bloomgren and colleagues noted the case of one patient whose initial blood sample was negative for JC virus antibodies. Another sample taken 13 months later was positive and the patient developed PML a few weeks later.

http://www.medpagetoday.com/clinical-co ... osis/32743

I've been reading about this online, as people who believed they were JC-, are now testing JC+ and are having to terminate Tysabri infusions. They are experiencing a rebound of the immune system and ending up worse off than they were before.

A lethal MS relapse after Tysabri withdrawal
http://www.ncbi.nlm.nih.gov/pubmed/23100404
more on the Tysabri rebound effect--
http://ms.about.com/od/treatments/a/The ... Effect.htm

Another problem is that PML looks like an MS relapse. It is very hard to tell the difference until a brain biopsy is taken after death. Because PML doesn't always show up in blood or CSF tests.

The patient developed subacute onset of bilateral blindness following his 44th dose of natalizumab (Tysabri). Ophthalmologic examination was normal, the brain magnetic resonance imaging was not suggestive of PML, and cerebrospinal fluid analysis did not reveal the presence of JCV DNA. The patient was subsequently treated for a presumed multiple sclerosis relapse with high-dose corticosteroids. Two weeks after his 45th dose of natalizumab, he developed hemiplegia that evolved into quadriparesis. Repeated magnetic resonance imaging and cerebrospinal fluid studies were diagnostic for PML. Postmortem histopathological analysis demonstrated PML-associated white matter and cortical demyelination.

http://www.ncbi.nlm.nih.gov/pubmed/23338729


Diagnosis of PML can be confounded in patients with multiple sclerosis (MS) if new demyelinating lesions develop, and the sensitivity of existing diagnostic tests is less than ideal. In the case presented here, four samples of cerebrospinal fluid were negative for JC virus DNA by polymerase chain reaction, yet brain biopsy eventually proved positive by immunohistochemistry.

http://www.ncbi.nlm.nih.gov/pubmed/23252596

To those who have other options, please talk to your doctors before beginning this drug.
I put together this info for my husband, when his neuro was pushing Tysabri--even though he was doing well, with no inflammation, relapses or MS progression.
Many doctors use scare tactics and make promises of restored health to get patients to sign up for these infusions.
But there is no research showing that MS progression is altered by Tysabri.

please be well,
cheer
Last edited by cheerleader on Sun Aug 11, 2013 12:11 pm, edited 1 time in total.
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http://ccsviinms.blogspot.com
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Re: update on Tysabri--May 2013

Postby Loriyas » Thu May 23, 2013 1:39 pm

Thank you Cheer
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Re: update on Tysabri--May 2013

Postby cheerleader » Thu May 23, 2013 3:32 pm

more than welcome, Lori-
really, really tough stuff. Coincidently, this story came out in Bloomberg News right after I posted.
"MS Patients chose death risk with potent drug treatment"
http://www.businessweek.com/news/2013-0 ... ent-health
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Re: update on Tysabri--May 2013

Postby HarryZ » Fri May 24, 2013 6:07 am

Hi Cheer,

From the first time this drug appeared, I've always said that it was dangerous and was going to cause a lot of problems down the line. Biogen marketed it as the savior for MS patients around the world and have always downplayed the nasty dark side of the drug. They are in business to make money and if there is some collateral damage to MS patients along the way, that's life when over a $ billion dollars in revenue is involved.

Of course, I was told I had an agenda and held a grudge against Biogen. The name calling and nasty comments came in by the dozen. Like yourself, I have always told potential Tysabri users to learn all they could about this medication before deciding to use it or being pressured by their neuro to start on it immediately.

You always hear benefit vs risk but now the real risk is surfacing and it isn't nice.

Harry
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Re: update on Tysabri--August 2013

Postby cheerleader » Sun Aug 11, 2013 12:11 pm

NEW--August 2013.
Researchers are now discovering the JC Virus activated by Tysabri in neurons of the gray matter in people with MS. The virus does not just show up as a demyelinating disease in white matter. It is creating gray matter atrophy--literally, death of neurons. This brain tissue loss can be seen on MRI.
http://www.ncbi.nlm.nih.gov/pubmed/23868420
http://www.ncbi.nlm.nih.gov/pubmed/23913509
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Re: update on Tysabri--August 2013

Postby HarryZ » Mon Aug 12, 2013 5:59 am

cheerleader wrote:NEW--August 2013.
Researchers are now discovering the JC Virus activated by Tysabri in neurons of the gray matter in people with MS. The virus does not just show up as a demyelinating disease in white matter. It is creating gray matter atrophy--literally, death of neurons. This brain tissue loss can be seen on MRI.
http://www.ncbi.nlm.nih.gov/pubmed/23868420
http://www.ncbi.nlm.nih.gov/pubmed/23913509


Hi Cheer,

Dr. Lawrence Steinman, one of the co-inventors of Tysabri, initially urged the FDA not to approve this drug based on what he thought was going to happen in the long term safety problems of this drug. Biogen told him to stop bad-mouthing the medication and others claimed he was saying this because of his involvement in other MS research. Now we see how right he was and just how the dangers of Tysabri continue to escalate.

Harry
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Re: update on Tysabri--August 2013

Postby cheerleader » Mon Aug 12, 2013 9:02 am

HarryZ wrote:Hi Cheer,

Dr. Lawrence Steinman, one of the co-inventors of Tysabri, initially urged the FDA not to approve this drug based on what he thought was going to happen in the long term safety problems of this drug. Biogen told him to stop bad-mouthing the medication and others claimed he was saying this because of his involvement in other MS research. Now we see how right he was and just how the dangers of Tysabri continue to escalate.

Harry


Dr. Steinman is still out there, warning about Tysabri. Biogen asked him to "tone down" his message--here's the NY Times article from 2005 on this topic.
http://www.nytimes.com/2005/03/01/busin ... ed=1&_r=2&

---but he still gives presentations at universities on the "fatal flaw" of Tysabri.
http://www.iom.edu/~/media/March%2028-2 ... einman.pdf

I wrote about this topic, and detailed Dr. Steinman's concerns in the past, when Tysabri flew thru the FDA approval process with a 12-0 vote. I also give updates on the drug here: https://www.facebook.com/notes/ccsvi-in ... 1616067211

I cannot believe this is being prescribed as a first line medication for those newly diagnosed. Every day, I get comments and messages thru my Facebook page, with stories of young patients being diagnosed with PML, turning JC positive and having terrible relapses after stopping Tysabri, and the horrific deaths of loved ones. It is heart-wrenching. No one told them the risks, they were scared into taking the drug because they didn't want to "be in a wheelchair" (even though 60% of pwMS will be ambulatory their whole lives.) Their doctors give them the worst case scenario to sign them up for infusions, and because these are new patients, they haven't had time to research anything for themselves. tragic.
cheer
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Re: update on Tysabri--August 2013

Postby HarryZ » Mon Aug 12, 2013 9:11 am

I cannot believe this is being prescribed as a first line medication for those newly diagnosed


Cheer,

Biogen has been known to offer great "incentives" to docs who rx this drug to their MS patients. It doesn't seem to bother them one bit of the dangers involved here. Then again, what do I know...I must have an agenda against big pharma and Biogen :-D

Harry
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Re: update on Tysabri--August 2013

Postby NHE » Mon Aug 12, 2013 4:36 pm

An absolute risk reduction in disability progression of 12%.

    Image


This is a brain on PML.

    Image


My question, is a 12% absolute reduction in disability progression worth the risk?
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Re: update on Tysabri--August 2013

Postby cheerleader » Mon Aug 12, 2013 8:36 pm

Dr. Steinman said no, it's not worth the risk, NHE. Thanks for that chart. It's illuminating.

I just found this tonight....ehealthme is an independent site which compiles FDA adverse reports on drugs. According to their site, as of August 4, 2013 2582 people have PML from taking Tysabri.


http://www.ehealthme.com/ds/tysabri/pro ... phalopathy

seriously...where is the outrage?
cheer
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Re: update on Tysabri--August 2013

Postby HarryZ » Tue Aug 13, 2013 5:05 am

seriously...where is the outrage?
cheer


Mind boggling, isn't it?

A German website shows the total Tysabri PML related cases as 377. Now we see the real number! Like I've said in the past, Biogen's marketing department does a great job of sweeping negative data about Tysabri under the proverbial carpet. Amazing what a company can do to protect their immense income for such a dangerous drug.

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Re: update on Tysabri--August 2013

Postby erinc14 » Wed Aug 14, 2013 6:47 am

a few years after I was diagnosed I got the impression that there was little symphony for pwms.
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Re: update on Tysabri--August 2013

Postby cheerleader » Sun Aug 18, 2013 9:45 am

New---PML risk numbers

It's becoming more common.

With more than 115,000 patients globally treated with natalizumab for longer periods of time, that estimate is 1 per 330. In patients who test positive for antibodies to JCV, have a clinical history of immune suppressive treatment before natalizumab, and have received more than 24 doses, the number of PML cases is 1 per 90.


http://www.ncbi.nlm.nih.gov/pubmed/23925759
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Re: update on Tysabri--August 2013

Postby HarryZ » Sun Aug 18, 2013 5:52 pm

With more than 115,000 patients globally treated with natalizumab for longer periods of time, that estimate is 1 per 330. In patients who test positive for antibodies to JCV, have a clinical history of immune suppressive treatment before natalizumab, and have received more than 24 doses, the number of PML cases is 1 per 90.


http://www.ncbi.nlm.nih.gov/pubmed/23925759[/quote]

I can recall a while ago when some readers really had some nasty things to say to me when I stated that Tysabri was going to be a dangerous drug in the long term. Was reminded that the risk of PML was only 1:1000 and that I was being an alarmist and trying to scare people. Hmmm....what's scary is a 1:90 risk and the problem continuing to escalate.

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