This Is MS Multiple Sclerosis Community: Knowledge & Support

Dear all,

I'd be grateful for your thoughts on the following questions:



(i) Tysabri data refers to a 67% reduction in cinical relapses. However, I have seen elsewhere that attacks occur more frequently than originally thought (remitting phase is a misnomer) - the sufferer may only notice one in ten i.e. experience a new symptom / return of old symptom etc. This can be shown by regular MRIs. Does the Tysabri data only relate to the relapses that are noticed by the sufferer?

[Apologies for using the term sufferer but I hate MSer - it sounds too cute for someone with a horrible disease']


(ii) A number of current drugs are claimed to have a beneficial effect on this disease e.g. minocycline and statins. However, many of these have been suggested for several years e.g. national conferences of ms societies from several years ago. Why is there never any progress in getting them on the list of approved ms drugs - their safety has been proved already? How much influence do the major drugs companies have over our national drug approval bodies or our governments?

(iii) There are a number of oral drugs in or going into phase III trials. However, it seems to take an eternity to get them onto the market - looking at 2008 for the first. If any prove very effective in just the first year of the Phase III trial - what would prevent me as a private citizen from signing a piece of paper to say I want to take them and I'm prepared to take the risks i.e. would not sue the company if I got ill / died? MS is about reducing damage early on (as much as possible) and even a month is a long time for an MS sufferer. Can the system be bypassed?

(iv) Numerous re-myelination studies are being funded to identify a possible treatment. I cannot visualise how this would work. How would the new myelin be of benefit if it sits over scar tissue?


Sorry for all the questions, but I want to give OddDuck something to do to cheer her up (but thoughts welcomed from others).


Bromley

Hi, bromley!

Ok...........I'll do my best to answer these, but some of them unfortunately don't have "good" answers, but your questions are excellent ones! (Be careful, you might end up finding yourself in my boat as a result of asking good questions - especially directly from the medical professionals. )

(i) Does the Tysabri data only relate to the relapses that are noticed by the sufferer?

That's the problem. Nobody knows. The data is way too "skewed" to make real heads or tails of it. And it depends on what you believe (if you are a doctor) about what is really happening progressively speaking, in MS. None of which has been proven. So, depending on which doctor you are speaking with and his "particular" beliefs regarding MS and how it acts, you'll get many numerous answers to this, none of which can be proven.

(ii) Why is there never any progress in getting them on the list of approved ms drugs - their safety has been proved already?

First, it's extremely difficult to buck the "system", and second, it all revolves around how much "money" can be made from the drug(s).

How much influence do the major drugs companies have over our national drug approval bodies or our governments?

bromley, you'd be shocked if you knew the whole story (speaking solely of the U.S.) Let's just leave it at right now, with the Republicans having control of the country, let's just say they have "lots" of influence. (And that's putting it nicely.)

(iii) If any prove very effective in just the first year of the Phase III trial - what would prevent me as a private citizen from signing a piece of paper to say I want to take them and I'm prepared to take the risks i.e. would not sue the company if I got ill / died?

Nothing could prevent you from indemnifying them from legal liability, but that would do nothing for their "profit margin" or "market share" or "stock prices", should someone get ill or die during one of their trials. So, there is more than one consideration that they look at here. Risk assessment in the situation as you suggest would prove itself to not be worth it in most cases.

Can the system be bypassed?

Not very easily. Hence why we have "unions" and legislative advocacy (and lawsuits). Their stronghold is extremely impenetrable.

(iv) How would the new myelin be of benefit if it sits over scar tissue?

Good question, bromley. Especially since it is not demyelination that causes disability in the first place. It is axonal damage (that often happens WITHOUT demyelination taking place at all). I believe the thought by "some" (who in my opinion are still a bit behind the current proven position regarding the pathogenesis of MS), is that if you remyelinate in time BEFORE the glial scar is formed, then you could prevent the axon from becoming damaged. But, as I said, that is still "assuming", which has since been proven to be a false assumption in many patterns of MS, that demyelination happens "first" before axonal degeneration. In progressive MS, that is not the case. So, in my opinion.......I'd say it's probably going to be a waste of money in the long run for MS, but will help some demyelinating diseases. There are other demyelinating diseases that are NOT Multiple Sclerosis.



Deb

OddDuck,

Thanks. I'm completely on your side with all of this. Research in relation to this disease is a joke - just look at the 160 trials which are currently on-going. Pretty much all of them are related to the immune system which may play a part, but might well be nothing to do with the start of this disease.

What about neuro-protection? If you look at the annual conferences of the national ms societies e.g UK ms society, every year they say that the next focus will be on neuro-protection (which I assume means protecting the nerves before they degenerate in total with resultant consequences for the myelin). But it never happens. Why? Because if they could do this and the immune system no longer got involved, the companies couldn't sell their very, very expensive drugs which are focussed on the immune system.

I seen some papers which suggests that axonal loss is not really strongly related to lesions. Why won't researchers start to think out of the box.


All the best

Bromlaey

bromley,

That's SO coincidental. I just used that VERY phrase yesterday in an email to the NMSS. To even quote myself, I was talking about MS researchers, and I said to the NMSS: "I was just trying to make the point that maybe people need to just think outside the box a bit more."

Great minds think alike, bromley!

Deb