Tysabri info

[HarryZ]

Hi Amelia,

You know Harry, the past is the past. Let's move forward and those that wish to take it are just venting their frustrations. At the moment, the FDA is the hold up.

I think you have to ask yourself why the FDA has slowed down the process and that I believe is obvious....they rushed the process first time around, got caught when PML showed up and ended up taking a lot of flack over the fast tracking of the drug. And all this happened at the worst possible time.....when Vioxx was the center of attention with its damage to many users who used a "FDA approved" medication.

Just as some people get tired of me criticizing Biogen/Elan's handling of Tysabri, I get tired of potential Tysabri users constantly criticizing the FDA for the current slow re-approval of the drug. (I'm not a fan of the FDA, either) They are simply covering their rear-ends the second time around.

Harry

[amelia]

And yes, if you think this Tysabri incident will change anything Pharms and the FDA do things, you will be wrong. Yes it is a bad thing and yes people die or get permantly sick because of it. But we live in a world of greed and that will only get worse as well.

[HarryZ]

Hi Amelia,

And yes, if you think this Tysabri incident will change anything Pharms and the FDA do things, you will be wrong. Yes it is a bad thing and yes people die or get permantly sick because of it. But we live in a world of greed and that will only get worse as well.

You are absolutely right...this won't change anything in the way big Pharma or the FDA operate. It will all blow over at some point and then everyone will wait for the next similar incident to take place. What was it someone said...if you want to look at what will happen in the future, just look at the past and you'll get a pretty good idea!

Harry

[Ronnie]

Hello again, Amelia and HarryZ and all!

I need something to look forward to. Christmas is nice, Summer is fun, but I would like to have something concrete and positive to look forward to. Or just different, I would welcome something different.

I felt that Tysabri did improve my eyesight. I felt freed from nightly or thrice weekly injections of mysterious refrigerated fluids, and I was happy that I didn't have bruises and new sunken injection sites. I could pretend to be nearly normal for awhile. It was comforting.

I am looking forward to the re-release of Tysabri, and I will welcome the new regimen. I will be responsible and monitor my condition, maintain a close contact with my neurologist, and try to remain objective. I will be a good girl.

Is it snake oil in the end? I hope not. But snake oil is better than despair.

Take care, everyone! Happy Summer!
Ronnie

[HarryZ]

Ronnie,

I can really appreciate your need for something positive to look forward to when it comes to trying to treat MS!! My wife has had the disease for 35 years now and we've gone through every "a cure is just around the corner" announcement during this time. Kind of difficult to get excited when the experts still don't even know what causes the disease.

I truly hope that Tysabri helps you and other MS patients. Time will tell but at least the users won't have to go through the many problems that the CRAB users have to endure on a daily basis. Perhaps by the end of the year, after Tysabri has been used for a number of months, we'll start to learn how effective it may be.

Take care.

Harry

[amelia]

I think the most positive thing about Tysabri is the people who have used it and had much improvement. Not a cure, but improvement. I know that some did not. But my guess is the ones that didn't see much improvement were those that MS doesn't get in the way of their every day life. That is mine and Gary's hope. Nothing else has given the hope of improvement.

[HarryZ]

Amelia

. I know that some did not. But my guess is the ones that didn't see much improvement were those that MS doesn't get in the way of their every day life. That is mine and Gary's hope. Nothing else has given the hope of improvement.

I'm not sure that I would agree with you on that guess. In the trials, Tysabri was used on patients who had mild cases of MS.

A study at St. Michael's MS Clinic in Toronto for patients who were experiencing an exacerbation and taking Tysabri showed no difference from those on placebo. And I don't think it was beneficial for those who had SPMS.

Harry

[amelia]

you are only looking at data Harry.
We had a DR from a MS clinic talk to our group recently. He had 10 patients on Tysabri. His opinion and practice was that he was giving Tysabri to many different stages of the disease. You of all people should know that what the data said and what was given did not come out the same. Right or wrong.

[HarryZ]

Amelia,

you are only looking at data Harry.
We had a DR from a MS clinic talk to our group recently. He had 10 patients on Tysabri. His opinion and practice was that he was giving Tysabri to many different stages of the disease. You of all people should know that what the data said and what was given did not come out the same. Right or wrong.

Well, if you take what was used for FDA approval, Tysabri was beneficial for mild, initial cases of MS. And that's all we "officially" have so far is what Biogen/Elan have given us and that, to the best of my knowledge, has never been peer reviewed.

Beyond that usage, Tysabri has not shown much if any benefit....at least from a clinical data point of view. As far was what the data stated and what was given....most of us can only speculate on this. And the speculation is based mostly on what we read and from what others have said. And comments from the "experts" have varied quite a bit, adding to the confusion.

Biogen used the data for approval and everything else for marketing and sales efforts. What is fact and what is "hype" we certainly don't know for certain....yet!

Now I can only presume that the doc who gave Tysabri to the 10 patients of different MS levels did so when the drug was available to everyone in January and February of 2005. Variable patients, to my knowledge, were not part of the trials. So I can presume at this point that he made his observations after only a maximum of two infusions.....enough to initially see some results but not even close the time required to give Tysabri a proper assessment.

Thinking that Tysabri will be available sometime this July, we'll have to wait until the end of the year before seeing any kind of trend for success or failure.

Take care.

Harry

[bromley]

Harry & co,

I think this story will run and run - it is complicated by the stats on reduction in relapse rates.

The CRABs reduce relapse rates by 30-30%
Tysabri by c.68%
Novantrone c.75%
Campath c.75%

I saw these stats last week in a UK MS Society journal called Research Matters. They seem to fit with the figures banded about in various research papers etc.

From what I have read, Novantrone is used in worsening RR or SP with relapses and has shown to provide some stability (and sometimes some improvement in disability). Campath is effective at reducing relapses and inflammation which, for those with RR, has led to stability and improvements in disability, but for those with SP, disability progression continued despite inflammation being suppressed (which showed that in SP the issue is not so much about inflammation or relapses, but the death of nerve fibres / cells).

The CRABs are not that effective at reducing relapses and I have seen no evidence reported of any improvements in disability. They claim to slow down disability but the jury is still out on this.

From the neuros I have spoken to about Tysabri, it is much better than the CRABs at reducing relapses / inflammation. But the risks have not been properly defined as it wasn't used for long enough to assess this. But as Harry suggests, Tysabri is only likely to be effective for those still experiencing relapses / in the inflammatory stage of the disease. But given its reported effectiveness, it might, like Campath and Novantrone, provide some stability and perhaps some improvement in disability.

The bigger question is whether suppressing relapses and inflammation for those at the RR stage can prevent them going to SP. This is what the Campath trials will hopefully show in due course (one way or the other). But I think many of the experts are coming to the view that even with heavy duty suppression of relapses and inflammation, other strategies are required - neuro-protection, repair etc.

My recent postings on the Bone Marrow Transplantation project showed that at the very extreme end (killing off one's immune system) it looks as if the disease can be halted and that repair (some) can take place. Not sure if this will ever be a common treatment approach, but as safety is improved it might be an option for some. The project does show that the immune system appears to be responsible for the damage (although not necessarily auto-immune damage). The real breakthrough will be when they identify the cells that do the damage etc. The more targeted treatments can be developed.

But coming back to Tysabri, in the short term, it might be the most effective mainstream treatment for those still experiencing relapses (but recognising that the risks have not been fully evaluated).

Ian

[HarryZ]

Ian,

The bigger question is whether suppressing relapses and inflammation for those at the RR stage can prevent them going to SP. This is what the Campath trials will hopefully show in due course (one way or the other). But I think many of the experts are coming to the view that even with heavy duty suppression of relapses and inflammation, other strategies are required - neuro-protection, repair etc.

A big question, indeed!

Taking Novantrone, Campath or the extreme, bone marrow/immune system replacement, can really shake up one's entire system. After all, these are heavy duty cancer treatments and they can cause many different changes in a person.

But from what I have read so far, the MS at some point in time, slowly continues to progress. But I believe you are so right in they have to figure out just what is causing this progression and somehow protect against it. And the researcher and/or company that finds that answer won't have to worry about their financial situation for a very long time!

Harry

[bromley]

Harry,

Taking Novantrone, Campath or the extreme, bone marrow/immune system replacement, can really shake up one's entire system. After all, these are heavy duty cancer treatments and they can cause many different changes in a person.

I agree that the cancer drugs can cause complications / changes (an avoidable death on the Campath trial), but one has to weigh this up against the possible changes caused by MS (a disease which at the end of the day eats away at your brain and spinal cord). The terms 'late stage MS' and 'end stage MS' are not ones that are easy to take. The pictures of Richard Pryor are a reminder of what may happen.

The fly in the ointment is that the neuros cannot give a prognosis. If they could say "your MS will be mild and you should be working / walking in 25 years time", then you might decide to not start any treatment. If they said "you will become severely disabled within ten years", then you might be quite happy to take a chance with the chemo drugs.

Dr Freedman has said that for those who have undergone the Bone Marrow Transplantation there are no MRI / clinical signs that the disease has returned. Of course time will only tell, so fingers crossed for those that have been through it.

Until they can work out what is happening with this disease, the sufferers are caught between a rock and a hard place. The situation is complicated when they publish research saying that benign MS may not be so benign. And terms like near-normal lifespan! Until they can come up with some answers, sufferers will have to continue to play Russian roulette - do you do nothing and see how it progesses? do you start on CRABs which seem to offer little benefit? do you go for chemo drugs which potentially can provide bigger benefits but also higher risks? etc etc.

This in many ways is a cruel disease which at the moment we cannot free ourselves of (for those with it). Tysabri, for all its faults (Biogen's handling of the PR etc) offers hope to some. I hope that it delivers some benefits for those who have been waiting for so long.

Ian

[Dunmann]

Just to add more fuel to the fire... Elan is thinking about increasing the price of Tysabri.


UPDATE 3-Elan, Biogen mull price rise for MS drug Tysabri
Thu May 25, 2006 9:17 AM ET

DUBLIN, May 25 (Reuters) - Biotech group Elan Corp. (ELN.I: Quote, Profile, Research) says there is scope to raise prices for suspended MS drug Tysabri and hopes along with U.S. partner Biogen to know more about the product's return to market before a June 28 deadline.

The Irish company (ELN.L: Quote, Profile, Research) and Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) would need to see the drug's final risk profile before setting a price, Elan Chief Executive Kelly Martin said on Thursday, citing price rises for rival multiple sclerosis treatments.

"Clearly there's headroom to raise the price," Martin told journalists after the company's annual shareholder meeting. "But we haven't finalised that."

Sales of Tysabri were suspended in February 2005 after three patients developed a rare brain infection, which led to two deaths. Elan (ELN.N: Quote, Profile, Research) has said it hopes to start relaunching the drug in the third quarter after receiving regulatory approval.

Elan stock was up 0.5 percent at 13.50 euros by 1230 GMT, slightly outperforming a flat Irish ISEQ index <.ISEQ>.

The shares soared in March after a panel of U.S. experts recommended Tysabri be allowed back onto the market subject to certain controls. The Food & Drug Administration (FDA) in the United States is currently considering the risk management plan for the drug and is due to reach a decision by June 28.

Martin said on Thursday he hoped there might be a judgment even before then given the pressure from doctors and patients wanting to use Tysabri.

"Elan and Biogen and the agency (the FDA) have indicated that if we can achieve clarity sooner than that we will do that," he said.

Tysabri is seen as key to Elan's future after a brush with bankruptcy in 2002. The company posted a smaller-than-expected net loss earlier this month and said it was confident that revenue from Tysabri would speed up a return to profitability.

"Elan's AGM message was optimistic on both timelines and pipelines," Jack Gorman, analyst at Davy stockbrokers, wrote in a research note. "Tysabri remains on course for US and EU launch in the second half of the year, with significant operating leverage as revenues expand."

In terms of Elan's pipeline of other potential new drugs, the company said it still hoped to reach a decision on whether to launch a final Phase III trial on the AAB-001 Alzheimer's drug, developed with Wyeth (WYE.N: Quote, Profile, Research), by the end of the year.

(Additional reporting by Claire Shoesmith)

[amelia]

Another thing about RR MS and SP MS. At the moment, all that I know in testing is that a DR says that your MS has turned into SP MS. Well how do they know exactly? Gary's MS was paralyzing him from the start severely, and then he went into a 8 year remission. This is before Betaseron was even approved. So DR's don't know what your MS will do. Although Gary and I can "read" his better now, it is still unpredictable for the most part. So it all comes down to NOBODY KNOWS ABOUT MS. No data is right for everyone. Just because it is 30% effective, is your MS the 70% that is not? or are you just going through a different phase of your disease? As I said before, I look at data, but that is not the "end product" for me. I like to read what others have experienced. As for the price, why not? They know how many people want it so they know they can get it. I have always been a disbeliever on the price of most medicines.

[Ronnie]

Dear Amelia:
I started Tysabri a few months after I finished my lifetime dosage of Novantrone. I had been taking Rebif while I waited for the Tysabri to become available, and I was able to get two doses of Tysabri before they yanked it.

I did notice improvement in my vision while I was on Tysabri. I did notice that the CRABs were not helping me as much as the Novantrone had been. I want to try Tysabri again, because it seemed to be working better than the Rebif or the Copaxone (which I am using now); and it was much easier on me physically. Novantrone was nasty for about a week each time I had a treatment, which was once every three months. Too bad I used up my lifetime amount! I feel quite tied down by the injection schedule for any of the CRABs.

Yes, I officially have SPMS, although I occasionally fill out questionaires with RRMS, more from habit than anything else. So maybe I won't get that much better results with Tysabri than I would with Copaxone. I can accept that. I realize that I only have my gut feelings that my vision was better, but as you all have pointed out, nobody has much more info than that anyway. We have some limited preliminary data. Good enough. I like trying new things, kind of like baking a new recipe of cookies or trying some exotic chicken salad occasionally-- it keeps life from getting duller, anyway.

So, I am still hoping...
Take care everyone!
Ronnie