This Is MS Multiple Sclerosis Community: Knowledge & Support

Sou wrote I recently received Tysabri Infusion number 44. Before I started on Tysabri I considered the pros and cons and decided to go on the treatment. It was an informed decision and I am glad I am receiving the drug. It works for me. I appreciate that it doesn't work for everyone but no drug will ever work for all recipients and no drug is without risk. I do not live with the fear of getting PML. I have filed away the information about PML and the only times I think about it are when I am on TIMS or every 4 weeks when receiving my infusion and my neurologist brings me up to date with the numbers.

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The other risks were not mentioned, but let's stay to the PML risk.

Taking Tysabri does not render somebody immune to car accidents or death in general. It is an additional factor. And we are not speaking about death, but PML, which is equal or worse IMHO.

I don't like to comment the "fear mongerer" characterization. After all, I doubt that this trial failed to complete the number of participants because of some kind of "fear mongerer", somewhere in an internet forum called HarryZ, sou, mitsos, whatever.

And finally, there is the risk/benefit ratio to everything in this life. Even drinking water can kill you, but you have to take the risk or else you are dead for sure. Usually, it doesn't kill you but helps you remain alive.

Let us not blame the patients that are afraid of being to the trial. We can simply respect their decision. After all, it will be beneficial for the drug maker to go through a phase of self-criticism (is that word correct? My English...) and find out what went wrong.

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Shortest joke: "We may not be able to cure MS but we can manage its symptoms."

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Bob,

I don't think that the fear of PML with Tysabri users is disproportionate to other risks at all. And I feel the main reason for this is that we really don't know what that risk actually is.

Biogen has just told us that the risk for 2-3 year users has jumped to 1.5/1000. And this comes after being told from the same company for a few years now that the risk was 1/1000. That's a 50% increase! And this same company(like many drug companies) knowing full well the FDA would chastise them, promoted the drug in their marketing and sales plan by highly minimizing this PML threat. They received a cease and desist letter from the FDA which they shrugged off as the cost of doing business in the highly competitive drug market.

So what is the MS patient to think? Who is he/she to believe? Even the MS docs are far more cautious with Tysabri because of the unknown. Having MS is terrible enough without having to live with the constant unknown of using a drug like Tysabri. I believe that's what Sou may have alluded to.

Take care.

Harry

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Yes, that is right.

And when I am talking about criticism, I mean that Biogen should stand in front of the mirror and ask themselves: "Why don't MS patients trust us?"

This has nothing to do with the drug itself. Personally, I don't trust their methods. There is no conspiracy. I just disagree with the way their marketing team advertises the drug and the risks associated with it. I am sure that even if Tysabri were more dangerous than it already is but Biogen told always the truth and the data were more transparent, the trial would have already been under way, because people would have known the risk they were taking.

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Shortest joke: "We may not be able to cure MS but we can manage its symptoms."

Bob,

I see your point but I also don't think that anyone here is "terrorizing" MS patients! That's a pretty strong word to use for people pointing out concerns that I feel a potential Tysabri patient should be aware before making his/her decision to use the drug.

Yes, we are all aware of the "documented" info that Biogen has given us but as Sou also points out, Biogen isn't exactly a trusted company when it comes to the data it provides. Hec, a top neuro I know here told me a number of years ago that Biogen has a very poor reputation in this area and he was one of the Tysabri trial docs. Here we have one of the main players in MS medication and they can't be trusted by the medical profession testing their drug.. Pretty sad, isn't it?!!

Harry

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Bob,

My intention has always been and continues to be to provide MS patients with all the info that I have learned after following the disease for 45 years. I highly doubt that a potential Tysabri user would experience terror from what I have ever said about the drug.



Well, it's impossible to show figures from anyone are wrong when they guard those figures carefully. Let me turn this around back to you...would you trust a company who purposefully minimizes the risks of PML, knowing full well they are contravening FDA regulations in doing so? If they do that, why would you believe they are giving us accurate documentation?

I'm sorry Bob, but when a trial MS doc tells me that Biogen's data is not to be trusted and I've seen how Biogen introduced Tysabri, I will never trust what they tell MS patients. The almighty $$$ is far more important to them than the health of MS patients. That's simply my belief and opinion. If you want to cut them some slack then that is your decision and I will respect your opinion.

Take care.

Harry

I have no problem with their numbers (as long as they are constant) but with their methods. Just their METHODS. You can't just rush a drug to the market which is initially safe, then it causes PML when used with Avonex, then it causes PML rarely even alone, then it causes PML, alone, to 1 in 1000, then it causes PML to 2 in 1000 after 3 years, then... What else? It causes PML if your name has 4 letters but is not John? This is just ridiculous!

Regarding the trials, I don't really trust a product advertised for more aggressive MS tested in newly diagnosed with (relatively) low EDSS. Neither I trust a company not really interested in further investigating the rebound effect in larger trials.

What else should a company do so as not to trust them?

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Shortest joke: "We may not be able to cure MS but we can manage its symptoms."

Know 10 days before announcing it publicly that PML was discovered in the trial, have the executives sell their stock making millions (their chief lawyer was found guilty of insider trading)before making the announcement and then say the stock sale was pre-determined when it reached a certain level. (clearing their conscience).

Harry

LOL! So it seems that they are fully capable of making themselves look untrustworthy. They don't need "fear-mongerers" to help them.

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Shortest joke: "We may not be able to cure MS but we can manage its symptoms."