This Is MS Multiple Sclerosis Knowledge & Support Community

Attached is an article on Tysabri written by a UK consultant neurologist.

The focus of the article is about the risks with fast-tracking therapies.

The author correctly (in my view) points out that EAE is a pretty useless model of MS. He also highlights the need for neuro-protective agents.

http://c.moreover.com/click/here.pl?j468373541&w=464753



Harry Z - a late Christmas present from me to you

I think the biggest problem with the tysabri debacle has been Biogen / Elan not disclosing all of the potential risks of the drug. There have been a number of people here who have said that the companies certainly SHOULD have been aware of the potential risks associated with the drug. If that is true, then they should have disclosed the risks to potential trial participants.

Having said that, if drug companies fully disclose all known risks about an experimental treatment, then the patient can make an informed decision. If patients are in a position to make fully informed decisions, then I am absolutely in favour of fast-tracking the clinical trial process and that doesn't just apply to the FDA, it should be around the world.

Fast-tracking trials and being vigilent about potential adverse side effects are separate issues. Maybe we need INCREASED safety monitoring to go along with fast-tracked trials.

My full disclosure: I'm biased, I just want a cure sooner.

Dear all,

Apologies - this morning the link provided access to the full article but it now does not. In addition to charging us for expensive drugs they now charge to see articles about the safety of the drugs.


Ian

Try this link, http://press.psprings.co.uk/bmj/february/ac416.pdf

Interesting stuff.

Thanks Ptwo - this is the same article.

Dr Chaudhuri doesn't seem to be a fan of Tysabri.

At the end of the article he says 'Short term solutions for a chronic disease like multiple sclerosis are not likely to be effective, and PML resulting from treatment with natalizumab should be taken as a signal to change the way we treat this disease'.

I'm quite happy for medics to question the safety and effectiveness of treatments, but some pointers to other ways to treat this disease would heve been useful.

This Tysabri fiasco is likely to run and run. When I was dx in May 2004 the MS nurse said that there was a really effective treatment in trial (then called Antegren). But as usual nothing is straightforward with this disease -triallists died, the drug was suspended, a year later trials are to resume, in March the FDA will consider whether the drug can re-enter the market. Doctors like Dr Chaudhuri publish a report saying the drug is high risk and not particularly effective.... There never seems to be a happy outcome for those with this disease who just want better treatments!

Came across as a credible objective view until I read this:

Relapse rates are not continuous but discrete numbers, and fractional relapse rates are meaningless. Results of the AFFIRM trial indicate that without treatment (and associated risk of side effects) a patient would experience only one extra relapse in 16-18 months. Although the statistics of these trials may seem impressive, there is no half or three quarter relapse in a patient's life.

Ian,

Harry Z - a late Christmas present from me to you

I always knew you were a nice guy and wouldn't forget about me at Christmas

That article pretty much sums up my attitude towards Biogen/Elan and Tysabri. What really gets me is the way that Biogen marketed Tysabri for a year or so before it got approved. Obviously a very carefully planned promotion of a terribly expensive drug that as we found out, got approved much too quickly!

Biogen/Elan dangled a lot of carrots in front of MS patients for many months and then pulled the plug, leaving thousands in limbo. Needless to say, Act II of this "play" is about to unfold within a few months and I sure hope that MS patients don't get "burned" again!

Harry

Ian,

Here is a recent article about Thomas Bucknum, the Biogen chief lawyer who thought he made millions on the Tysabri fiasco.

http://www.counterthink.org/017810.html

Kind of gives one a nice feeling to know that the top execs at some drug companies are so interested in the health of MS patients!!

Harry