Article from yesterday's Chgo Sun Times

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

Article from yesterday's Chgo Sun Times

Postby scoobyjude » Fri Mar 03, 2006 6:58 pm

This is the second article in the last two weeks that the Sun Times has run on Tysabri and this woman. Thought maybe someone would be interested. The tone of the article seems doubtful but she is very much an advocate.

http://nl.newsbank.com/nl-search/we/Arc ... p_docnum=1
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Postby scoobyjude » Sat Mar 04, 2006 10:51 am

Sorry about the link being broken. I guess the Sun Times only lets you connect to their archives for a day. They don't make money that way I guess. So here's the article if anyone was interested and couldn't pull it up.


MS patients want return of drug that has serious risk: Tysabri's success hailed, but 1 in 1,000 will get brain virus


Publication: Chicago Sun-Times (IL)
Date: March 2, 2006
Author: Jim Ritter The Chicago Sun-Times
Section: News
Edition: Final
Page: 20
Word Count: 525

A $24,000-a-year drug called Tysabri looks like the best new multiple sclerosis treatment in years. Tysabri reduces the rate of MS relapses by about two-thirds, and might prove beneficial for rheumatoid arthritis and Crohn's disease.


But there's a small chance Tysabri could cause a horrible side effect. In roughly one in 1,000 patients, the drug unleashes a brain virus that can kill patients or leave them blind, paralyzed and unable to speak.

Tysabri was taken off the market last year after reports that three patients contracted the brain disease, known as PML. But now the manufacturer wants the U.S. Food and Drug Administration to bring the drug back, and three studies published today in the New England Journal of Medicine report there have been no additional cases of PML.

'BEST DRUG AVAILABLE'

MS patient Bartira Tiburtius of Arlington Heights desperately hopes the drug returns. She took Tysabri for 28 months as part of a study, and during that time she suffered no relapses.

But since the drug was pulled in February 2005, Tiburtius has suffered several MS symptoms, including balance problems and "horrible" fatigue.

The chance of getting PML, she said, "is a small risk I'm willing to take."

Tiburtius said she wants to have the right to decide her treatment, "and right now, Tysabri is the best drug available to improve my life."

Tiburtius belongs to MS Patients for Choice, which hopes to persuade the FDA to bring Tysabri back. Next week, an advisory committee to the FDA will consider the issue, and Tiburtius is among the patients scheduled to testify. If Tysabri does come back, the FDA likely would require stern warnings and perhaps occasional MRI scans to check for PML.

The largest MS advocacy group, National Multiple Sclerosis Society, has not taken a position for or against bringing Tysabri back.

About 400,000 Americans have MS. The disorder can cause a wide range of symptoms, including difficulty walking, slurred speech, tremors, bladder problems, vision loss and problems with memory, attention and problem-solving. Most patients do not become severely disabled.

MS apparently is caused when the immune system turns on the patient and attacks the protective coating of nerve fibers.

Tysabri prevents immune system cells from entering the brain and damaging the protective coatings. Unfortunately, the drug also might impair the immune system's ability to fight the virus that causes PML.

A DIFFICULT CHOICE

When Tysabri is used, "one in 1,000 patients will get a horrendous and usually fatal disease," said Dr. Larry Steinman of Stanford University, who co-discovered the drug. "The potential benefit and rare harm makes for a difficult choice that doctors and patients will have to enter into."

Steinman said he would recommend Tysabri only for patients who have had relapses and have not responded to other drugs.

Tysabri is given to patients intravenously once every four weeks. During the three months it was on the market, 5,000 patients took the drug and another 15,000 patients were waiting to begin treatment.

jritter@suntimes.com
Color Photo: Richard A. Chapman, Sun-Times / Bartira Tiburtius of Arlington Heights took the MS drug Tysabri for more than two years during a clinical trial. She says the drug's potentially deadly risk is one she's willing to accept.
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Postby amelia » Sat Mar 04, 2006 1:58 pm

When Tysabri is used, "one in 1,000 patients will get a horrendous and usually fatal disease," said Dr. Larry Steinman of Stanford University, who co-discovered the drug. "The potential benefit and rare harm makes for a difficult choice that doctors and patients will have to enter into."


I love how he KNOWS that these people WILL get PML. Gee, if that was the case, why weren't there more cases on PML?
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Postby HarryZ » Sat Mar 04, 2006 2:16 pm

I love how he KNOWS that these people WILL get PML. Gee, if that was the case, why weren't there more cases on PML?


Good point Amelia but I think these guys use the mathematical laws of probability when it comes to issues like this. And the numbers get determined from the trials. I think that's why at some point in our education they made us take statistics :)

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Postby JFH » Sun Mar 05, 2006 5:50 am

scoobyjude wrote:But there's a small chance Tysabri could cause a horrible side effect. In roughly one in 1,000 patients, the drug unleashes a brain virus that can kill patients or leave them blind, paralyzed and unable to speak.


So where did they get 1/1000? I'm guessing that they said there were about 3000 patients on the original trial and 3 got PML. But what you cant say from that is that the probability of anyone else taking TYSABRI getting PML is 1/1000. :) Doncha just love stats??
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Postby HarryZ » Sun Mar 05, 2006 6:40 am

John,

So where did they get 1/1000? I'm guessing that they said there were about 3000 patients on the original trial and 3 got PML. But what you cant say from that is that the probability of anyone else taking TYSABRI getting PML is 1/1000. :) Doncha just love stats??


Well, if you believe in math, stats and the laws of probability, you can say that there is a 1/1000 chance of someone else coming down with PML. Of course, a lot depends on what side of the fence you may be on when it comes to believing in stats....what do some people say...you can use stats to prove almost anything :D

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Postby better2gether » Sun Mar 05, 2006 3:05 pm

.
An question I would to see answered is
" Where is the risk in Tysabri MONO therapy in IMMUNE COMPETENT patients?"
IMHO, there is no proof there is a risk.
I found this letter from an M.D - Ph.D, to Jim Ritter, Reporter, Chicago Sun-Times,
on another message board.

" Dr. Mr. Ritter

Thank you for writing this article on Tysabri on today's Chicago Sun-Times. I would like to bring your attention on a few points regarding the article:

1 - The risk of PML on Tysabri is actually less than 1/1000. This is because the number was calculated by combining all the trial patients who were also on Avonex and other immunosupressants.
In the Tysabri mono therapy trial (Affirm trial), there was no single patient contracted PML for two years.
Plus there is really no reason to use combination therapy since monotherapy efficacy beat combination of Avonex plus Tysabri. If you put this in your article that would help MS patients more informed in making their decision and the public should realize the risk of PML on Tysabri is really less than the risk of taking asparin or driving a vehicle (1/2200 death).

2 - Dr. Steinman has a huge conflict of interest in making his comment about Tysabri since he is developing a competing product with Tysabri. He owns a biotech company in Ca.

Sincerely,

XXX XXX, M.D , Ph.D "
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Postby HarryZ » Sun Mar 05, 2006 3:37 pm

Better.

1. On the flip side...and there is always a flip side....Avonex has thousands and thousands of patient years behind it and there has not been one recorded incident of PML from it. Even James Mullen, CEO of Biogen stated that Avonex likely never had anything to do with the two patients getting PML. So was it the Tysabri alone or some strange result from the combination that resulted in the PML?

Also, the Crohn's patient who died from PML had quit all immunosuppressent drugs for a number of months before going on the Tysabri. And he got the PML after only a few infusions of the drug.

2. Dr. Steinman was the co-inventor of Tysabri. While he is working for another company in a competitive manner, he has stated from the very beginning that Tysabri has many risks involved with it. He was saying this even before the 3 patients ended up with PML.

And we don't know what doctor sent this letter or what affiliation he has with Biogen and /or Elan, if any.

I'm not trying to down play the return of Tysabri because it WILL be re-approved, albeit with strict conditions. I've been saying this for months. But I think it's fair to say that we just don't know all the answers about its connection to PML and it's going to take some time before we do.

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Postby JFH » Mon Mar 06, 2006 3:40 am

HarryZ wrote:Well, if you believe in math, stats and the laws of probability, ...
I do It was the principal component of my BSc (many years ago now) :)
HarryZ wrote:... you can say that there is a 1/1000 chance of someone else coming down with PML.
Sorry Harry you cant say that. The best you can say is that 1/1000 is an estimate of the chance of contracting PML because of Tysabri use. And that estimate must be surrounded with a whole bunch of stuff (confidence intervals etc etc) before you can make any inference.
HarryZ wrote:But I think it's fair to say that we just don't know all the answers about its connection to PML and it's going to take some time before we do.
But you're spot on there :)
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Postby HarryZ » Mon Mar 06, 2006 7:18 am

John,

Sorry Harry you cant say that. The best you can say is that 1/1000 is an estimate of the chance of contracting PML because of Tysabri use. And that estimate must be surrounded with a whole bunch of stuff (confidence intervals etc etc) before you can make any inference.


At this point in time, in the absence of any other data that exists from the trials, there isn't a number that the researchers can use other than what has been made available by Biogen. And that's 3 out of approx 1000 Tysabri users ended up with PML. From statistical analysis you are right in stating that several variables exist that can alter the real probability but why does this situation exist?.....because Biogen didn't spend the time needed to get it right in the first place!

So everyone who is writing articles and commentary about Tysabri will grab the only numbers that are kicking around and use them. Not accurate but it looks nice in print!

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Postby JFH » Mon Mar 06, 2006 10:59 am

Harry,

Of course the point I'm making is that one must be so careful using stats. Particulary when combined with common sense :!: How about this, recall Better2's post

better2gether wrote:In the Tysabri mono therapy trial (Affirm trial), there was no single patient contracted PML for two years.

So using the 3/3000 = 1/1000 chance of PML argument we get 0/600 = no chance of PML. Er, maybe but not a valid inference to make from this set of data. :)
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Postby HarryZ » Mon Mar 06, 2006 11:12 am

John,

So using the 3/3000 = 1/1000 chance of PML argument we get 0/600 = no chance of PML. Er, maybe but not a valid inference to make from this set of data. :)


I see your point....perhaps Biogen may hire Better as their statistician :)

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