This Is MS Multiple Sclerosis Knowledge & Support Community

on CCSVI in Multiple Sclerosis Facebook page....cheerleader has some links to articles pertaining to different companies rushing to get approval for oral drugs.....perhaps the big push is on because of CCSVI. I think they know people are sick and tired of the injectable drugs and maybe they hope this will appease some of them.....might be enough to keep them on drugs and deflect some of the attention away from CCSVI....if these drugs are approved with their high rate of side effects, then there is definitely something wrong with the FDA or whoever approves them....makes the drugs available now seem pretty good....

jackiejay wrote:....if these drugs are approved with their high rate of side effects, then there is definitely something wrong with the FDA or whoever approves them....makes the drugs available now seem pretty good....

My husband has been a part of a trial for an oral drug for almost 4 years now and has been taking the medication in various doses that entire time. Is there something we should know about side effects? The two he's experienced over the last few years have been very mild, such as slow to heal from illness and reduced lung capacity, though the latter hasn't affected him that he's noticed.

I have no clue what the pills are (or will be) called. Right now they're just his name and a number.

best not to ask me..you already know my opinion of the 'T' man

I am participating in a double-blind trial for oral cladribine. I am either on the placebo or the drug doesn't work, as I still had two new lesions in six months since I was on the drug.

Cladribine has some of the same risks as Tysabri (i.e. PML), though lower percentages (likely due to the oral formulation versus IV). Frankly, the best I have felt is when I started taking minocycline in addition to everything else.

Minocycline is an antibiotic with particularly strong anti-inflammatory properties. It is also (more than any other cycline drug) VERY EFFICIENT at iron chelating. Hard to tell which property of the drug is making the most difference right now.

These oral drugs you speak of are a good thing. They are at the VERY least options.

BooBear wrote:I am participating in a double-blind trial for oral cladribine.

One thing I only recently learnt about this one is that when injected, it is actually a chemo therapy drug to treat hairy cell leukemia! http://en.wikipedia.org/wiki/Cladribine

Cure, that is correct. Same drug; just an oral formulation.

Boobear if you pop down to your local GP and ask for a lymphocyte count (I think thats the white blood count) and a liver function test that will probably tell you whether you are on the placebo or real thing.

Low Lymphocytes and I would imagine some raised liver enzymes would indicate you are on the drug.

I get blood tests every month or so as part of the clinical trial. I have not gotten the tests outside of the trial, but that is a good idea.

I guess I haven't been particularly motivated to find out, since the drug has not slowed down my progression any. But an interesting thought nonetheless! Thanks!

JackieJay your post makes no sense. The oral drugs you are referring to have been going through clinical trials for years and have proven to be effective. I highly doubt that it is because of CCSVI.

it doesn't seem like they are rushing them through?....even though there seems to be some troubling statistics of serious side effects....perhaps the media is exaggerating the side effects, I'm not sure....they have been known to get things wrong.

jackiejay wrote:it doesn't seem like they are rushing them through?....even though there seems to be some troubling statistics of serious side effects....perhaps the media is exaggerating the side effects, I'm not sure....they have been known to get things wrong.

Who's doing the rushing? Both Fingolimod and Cladribine have undergone multi-year, multi-center trials. And the decison by the FDA to fast-track their reviews for both drugs was made before CCSVI was on most people's RADAR screen. (As an aside, the fast-track decision means the FDA would expedite the process up to the review, but does not mean they will necessarily make a hasty decision.)

Both drugs do have nasty side effects, but the fact that these are being discussed would indicate they aren't being covered up.

BooBear wrote:I am participating in a double-blind trial for oral cladribine. I am either on the placebo or the drug doesn't work, as I still had two new lesions in six months since I was on the drug.

Cladribine has some of the same risks as Tysabri (i.e. PML), though lower percentages (likely due to the oral formulation versus IV). Frankly, the best I have felt is when I started taking minocycline in addition to everything else.

BooBear,

Are you still in the Cladribine trial? I thought the phase III trial had wrapped up?

If you have concerns about progression, etc., I would suggest discussing these with the trial doctor and/or nurse. They should give some advice as to what to do. You can drop out of the trial at any time, no questions asked.