Is Tysabri available in Canada?

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

Is Tysabri available in Canada?

Postby Mary » Wed Feb 09, 2005 5:53 pm

Does anyone know if Tysabri is available in Canada? I did a search on Health Canada but haven't come up with anything...

Thanks.
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Re: Is Tysabri available in Canada?

Postby HarryZ » Wed Feb 09, 2005 6:21 pm

Aylish,

aylish wrote:Does anyone know if Tysabri is available in Canada? I did a search on Health Canada but haven't come up with anything...


Tysabri has not been approved by Health Canada as yet and per my conversation with a MS Neurologist in December, it likely won't be until sometime later this year. The main reason, he stated, was because Health Canada wanted to review the two year data on the trials which won't be available until April or May.

Harry
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Re: Is Tysabri available in Canada?

Postby HarryZ » Mon Feb 14, 2005 9:25 am

Aylish,

I unfortunately heard news today that because of several problems encountered with Tysabri in trials conducted at the MS Clinic in Calgary, this drug may not get approved in Canada for a couple of years now.

Health Canada is likely going to wait until many patients in the US use the drug for some time before granting approval.

Harry
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Postby Arron » Mon Feb 14, 2005 2:04 pm

Harry, do you know what kind of problems were encountered?
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Postby bromley » Mon Feb 14, 2005 3:30 pm

HarryZ,

MS is, as you have said on many occassions, a lousy disease. Those suffering from it live in hope that some day some treatment will be available which can alleviate the suffering. Tysabri, on the first year evidence, appeared to show that it was more effective than the CRAB drugs and avoided the need for daily / weekly injections. The number of sufferers who have sought to get on this drug shows the level of desperation.

I am all for freedom of information / the truth etc but this needs to be balanced with the desperation felt by many with this disease. However, almost everyday, you post on Tysabri and the underlying thread seems to be that the trials data was dodgy, rumours that people have died etc etc.

Please don't pull out loads of my quotes and say Bromley said this ... I didn't say that. But have some sensitivity to those who are desperate to get on the best treament they can - which at the moment appears to be Tysabri. The rumours you hear may turn out to be true, but until this is the case, let those trying this treatment do so without the added fear that all these unproved rumours bring with them.

I know you mean well and I know that your wife has suffered from MS for many years - but I'm not sure you understand the impact of some of your posts

Bromley
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Postby HarryZ » Mon Feb 14, 2005 5:38 pm

Arron,

Arron wrote:Harry, do you know what kind of problems were encountered?


What I was told today was there were problems with "side effects" and "complications". The report originated on the MS Cruise that took place last week and was given by a person employeed by the MS Clinic, Foothills Hospital, Calgary, Alberta, Canada.

I attempted to get the email address today of the person who gave this report but was not able to actually speak to anyone at the clinic. I was able to determine that the person does indeed work there and has been involved as a MS Professional for some time.

I will attempt to get this info and post it for the readers.

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Postby HarryZ » Mon Feb 14, 2005 6:22 pm

Bromley,

MS is, as you have said on many occasions, a lousy disease. Those suffering from it live in hope that some day some treatment will be available which can alleviate the suffering. Tysabri, on the first year evidence, appeared to show that it was more effective than the CRAB drugs and avoided the need for daily / weekly injections. The number of sufferers who have sought to get on this drug shows the level of desperation.


Do you not think that following MS research for decades and watching my wife suffer with this disease for many years, gives me some idea of how desperate many MS patients may be?

I am all for freedom of information / the truth etc but this needs to be balanced with the desperation felt by many with this disease. However, almost everyday, you post on Tysabri and the underlying thread seems to be that the trials data was dodgy, rumors that people have died etc etc.


Please don't shoot the messenger...I only repeat what I have been told or have read. Believe me, I don't make any of this information up. As for the "rumors of people that have died"....I wasn't going to post anything on that issue but since you have brought it up, I asked for confirmation about it and was told that indeed, it DID happen. The situation is going to be discussed at the AAN conference later this month so I guess we'll have to wait until then to find out what the details were.

And you mention balance...well, how many messages have you read on the Tysabri thread that are word for word press releases by Biogen that have been posted here? I fortunately know some people who are MS Professionals and have a different perspective of what is going on with Tysabri. I feel that the readers of this forum should be entitled to see "the other side". Now if you believe that balance is fair, then you should not be objecting to what I have been posting.

The rumors you hear may turn out to be true, but until this is the case, let those trying this treatment do so without the added fear that all these unproved rumors bring with them.


Are you saying that the possible concerns about Tysabri should be totally ignored by MS patients and they should not be told about them? I knew absolutely nothing about these latest concerns that happened at the Calgary MS Clinic trials and only today was told about them.

I know you mean well and I know that your wife has suffered from MS for many years - but I'm not sure you understand the impact of some of your posts


Yes, my concern has always been about the well-being of the MS patient and everything that goes along with that. But at the same time, I will not "hide" information about Tysabri or any other MS medication that indicates something else other than what the makers of these drugs tell us. I have read widely differing opinions on Tysabri, some coming from neuros who have both been involved in the trials. And I ask myself, how can there be such disparity about the same drug?

I firmly believe that the patient MUST know as much information about a particular medication BEFORE he/she decides to use it. Sometimes this information is not what the patient wants to hear but does that mean that he/she is not entitled to hear about it? I give a lot of credit to the readers of this forum and their ability to decide what they want to believe and what they choose not to. And I will say it again.....I do not make this information up for any kind of sensationalism. If I discover at some point in time that what I wrote was wrong, I will be the first one to let the readers know.

Bromley, I'm not writing this message in a confrontational mode or tone but trying to be as objective as I can. I hope you and the other readers understand this.

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Postby HarryZ » Tue Feb 15, 2005 9:56 pm

Arron,

Today I was able to obtain the email address of the MS nurse at the Calgary MS Clinic. I asked her if she could elaborate on the Tysabri information which she gave to a group of MS Professionals.

Let's just say that the answer I got had little or nothing to do with the question I had asked. It was a very polite generic answer which indicated to me that since she had no idea who I was, I certainly wasn't going to be given any details, period! I mistakingly thought that the details of this information would be public knowledge since it was shared with many others but I was obviously wrong.

So other than what I wrote earlier, that's all the detail I can provide....concerns about some side effects and complications and Health Canada likely going to wait many months before considering approval.

If I come across anything else, I'll let you know.

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Postby Mary » Wed Feb 16, 2005 9:08 am

Hi Harry

Thanks for responding...I'll keep watching to see what happens with Health Canada and Tysabri treatment.

Aylish
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Postby Chilcotin » Mon Feb 21, 2005 11:40 pm

This article appeared in the Vancouver, British Columbia, Canada newspaper called "THE PROVINCE" this morning. It is about Tysabri in Canada.





New drug gives hope for MS sufferers
Results 'very good' for those with relapsing form of the disease

Don Harrison
The Province


February 21, 2005


Paulette O'Leary is a big-time skeptic. She refuses to be a drug company spokeswoman, despite her own success and the potential of financial benefit.

But even with those caveats, the Toronto woman wants fellow sufferers of multiple sclerosis to do some serious research about the drug Tysabri (formerly called Antegren).

And while she acknowledges that there aren't any miracle cures for the crippling neuromuscular disease, O'Leary knows that, so far, the drug has made her life better.

"I was on the first trial for one year," said the 35-year-old former risk- management analyst, "and it worked amazingly."

The O'Leary story mirrors data just released after the second year of a worldwide trial of Tysabri.

It showed that for those with the relapsing form of the disease, subjects on the drug showed a 42-per-cent reduction in the risk of their disability progressing. As well, there was a 67-per-cent drop in clinical relapses over two years.

Neurologist Dr. Virginia Devonshire is an associate professor at the University of B.C., one the continuing Tysabri trial sites. The UBC MS clinic associate likes the results.

"The [Tysabri] efficacy is very good," said Devonshire.

So good, that as well as UBC patients staying with the drug trial, others will switch to the monthly injected Tysabri.

O'Leary, who loved to be active, was first afflicted with bouts of leg paralysis in high school. But when she received her definite MS diagnosis on her 28th birthday, that life was gone.

"Now I can walk about 50 metres with a cane," she said, "then I have to sit down for 20 minutes."

Tysabri is currently not available for sale in Canada, but O'Leary is so convinced of its usefulness that she had been paying up to $4,000 for flight, hotel and the monthly drug treatment at a clinic in Cleveland.

However, the financial burden became too great on her and her husband and the trips recently stopped.

Now she hopes Health Canada's review of the drug will take the positive trial data as evidence the drug is good and safe.

"It keeps away [my] acute MS episodes," O'Leary said, "and my leg is a little stronger."

donharrison@png.canwest.com

© The Vancouver Province 2005








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MS sufferer, doctor praise wonder drug

Postby better2gether » Thu Feb 24, 2005 2:57 pm

.
MS sufferer, doctor praise wonder drug

Wed, February 23, 2005

MS sufferer, doctor praise wonder drug

By BRETT POPPLEWELL

CLINICAL TRIAL results are offering promising news for Canadians living with multiple sclerosis. Tysabri, an experimental new drug administered to patients intravenously once a month, was approved in the U.S. in November and is being reviewed for marketing application by Health Canada.

"I hope it will be on the market soon," said Dr. Suzanne Christie, a clinical neurologist with the Elizabeth Bruyere Health Centre.

Christie has been overseeing the clinical trial of the new drug on some of her patients and is happy with what she has seen.

Beth Parish, a computer programmer with the federal government, was first diagnosed with the disease in 1996 after suffering from a MS attack that left her temporarily debilitated.

She is one of 12 local MS patients taking part in the trial of Tysabri and said thanks to the drug, she's been able to continue working.

'I'VE HAD NO ATTACKS'

"I started the drug in October 2004, and since then I can tell you I've had no attacks, minor or major," she said.

Results from a two-year global trial of the drug have shown a 42% reduction in the risk of disability progression among patients.

The same trial saw a 67% drop in the rate of clinical relapses and a severe reduction in inflammatory lesions on the brain.

"Based on the results, I think Tysabri will most likely be the first line therapeutic choice among MS patients," added Christie.

MS is a chronic degenerative disease that affects approximately 50,000 Canadians.
The disease causes the body's immune system to repeatedly attack the protective covering of nerves in the brain and spinal cord. The attacks cause progressive damage and result in physical and mental incapacitation.

"The fact that Tysabri has been shown to be safe and effective over two years against both relapses and progression is very good news for people with MS," the MS Society of Canada said in a media release.

"The MS Society ... has been closely monitoring the therapy's review status and looks forward to a positive decision from Health Canada as soon as possible."

http://www.canoe.ca/NewsStand/OttawaSun ... 1-sun.html
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Tysabri promising, MS Society official says

Postby better2gether » Sun Feb 27, 2005 4:18 am

.
Sat, February 26, 2005


MS drug raises hopes

Tysabri promising, MS Society official says

By PAUL TURENNE, STAFF REPORTER


There might be some good news on the horizon for people with multiple sclerosis. A new drug that might slow the progress of the degenerative disease is raising the hopes of everyone from doctors to the MS Society of Canada.

The preliminary results of a two-year clinical test for Tysabri, a drug manufactured by the pharmaceutical company Biogen Idec, were released last week with promising news.

According to Biogen, the trial demonstrated the drug can reduce the number of relapse attacks by two-thirds, as well as reducing by 42% the risk of disability progression. Both those things mean patients will have more control over their bodies and will likely be in less pain as the disease progresses more slowly.

WAITING FOR APPROVAL

"From what we've learned so far from this drug, it does look promising," said Norm Velnes, executive director of the MS Society of Canada's Manitoba Division. "This has gone through all the clinical trials. What we're waiting for now as a society is for Health Canada to approve it for use in Canada."

Jirina Vlk, a spokeswoman for Health Canada, said proprietary rights to the drug prevent her from disclosing where it is in the approval process and could only say that Tysabri has not yet been approved.

But Andrew Gomori, a Winnipeg-based neurologist who does some work at Health Sciences Centre's MS clinic, said he's hoping the drug -- released in the U.S. last November -- could hit Canadian pharmacies within a year.

"I'm sure when it comes out a lot of people will want to go on it," he said.

Tysabri is different than the other four MS drugs on the market, said Gomori. Not only does it work differently but it only needs to be injected once a month, whereas the existing drugs must be injected anywhere from once a week to once a day.

Gomori, who did some blind patient testing during the study, said he is hopeful about the drug but is waiting to see the full report before jumping for joy. He expects the full report in the spring.

http://www.canoe.ca/NewsStand/WinnipegS ... 7-sun.html
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Re: Tysabri promising, MS Society official says

Postby HarryZ » Sun Feb 27, 2005 7:11 am

Gomori, who did some blind patient testing during the study, said he is hopeful about the drug but is waiting to see the full report before jumping for joy. He expects the full report in the spring.



This is EXACTLY why Tysabri has not been approved by Health Canada as yet. They want to review the data properly before they consider approval and that is the process that should be followed. They are not swayed by Biogen's elaborate press releases.

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Relentless

Postby MeadowStream » Sun Feb 27, 2005 8:23 am

Despite the overwhelming evidence from clinical trials and anecdotes from MS sufferers, you continue to use innuendo to attempt to cast a shadow over Tysabri. You are relentless and one must wonder why...
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Re: Relentless

Postby HarryZ » Sun Feb 27, 2005 6:10 pm

Meadow,

MeadowStream wrote:Despite the overwhelming evidence from clinical trials and anecdotes from MS sufferers, you continue to use innuendo to attempt to cast a shadow over Tysabri. You are relentless and one must wonder why...


I'm just reflecting what a number of MS professionals who have a different opinion have stated about Tysabri. I don't know how much you read other MS forums but although you may find this hard to believe, there are other readers out there who are much more adamant about exercising caution with Tysabri than I am. I just read one particular thread over on Brain Talk on this very issue.

This isn't innuendo, Meadow!! When I asked my wife's neuro about Tysabri (and he was involved in the trials) he was far from enthusiastic about the drug and felt it wouldn't be much use other than early, mild cases of MS. There have been several comments from forum readers who state that their neuros aren't advising the use of Tysabri until more data is available. Others feel no need to change their patients who are doing fine on another medication.

Maybe after the trials have been published and peer reviewed and several MS patients have used Tysabri outside of the clinical trial atmosphere, Tysabri may turn out to be a very good drug in the battle against MS. But until that happens, Meadow, I won't get influenced by Biogen's very slick marketing and sales presentation and all the wonderful press releases that they have put out. I prefer to read the reports by independent scientists who have a totally neutral approach to this and aren't tied to Biogen. And there are many others who feel this way.

I don't have any special agenda, game plan or ulterior motive against Tysabri. I'm simply very cautious when it comes to these powerful drugs given to MS patients. I've seen far too many friends of mine who have become worse off with their MS after taking the CRABs....the same CRABs that were pushed by their makers and many MS docs...and the same docs who are now throwing the CRABs out the window and stating their patients should be taking Tysabri because the CRABs are just not very good!!!

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