2004: On not being a viable test subject

by Michael S. Kaplan, published on 2008/05/05 03:01 -04:00, original URI: http://blogs.msdn.com/b/michkap/archive/2008/05/05/8459651.aspx

Nothing technical in this one -- it is just one of those historical Multiple Sclerosis blogs....

I was recently asked if I had ever been involved in any multiple sclerosis studies. Funny someone would ask that....

A few years back I tried to get it on a multiple sclerosis drug study. I even blogged about things as I was being assessed (in a different blog, one that no longer exists -- long story, not very interesting; but I had like two readers rather than the 22 I have now, so....).

Anyway, here I will revive the relevant posts, and this is what the blog you are reading will try to do. :-)

Saturday October 30, 2004
posted by michkap at 1:11 PM
Title: it's just an experiment....

Well, actually it's a study. I am trying to join the NBI-5788 study, and so far it looks like they like me as a participant. It was kind of touch-and-go after having that "flush" reaction from Copaxone but they decided to take that as injection artifact (which most people think it is). The fact that I was willing to switch back to it from Avonex and that Jane supported the decision probably had a lot to do with the approval....

Of course, the obvious question is why I want to be in on a study. Right?

I am giving up almost a year with a drug with a known [statistically significant] chance of helping me. All in order to have 11 months of a drug that looks promising which there is a one-in-three chance that I will not even be taking due to the whole placebo thing.

So why do it?

Well, the whole CRAB thing kind of stinks, and it costs about $1000 a month or more. Antegren might stink less, but it will probably be $2000. LDN (Low Dose Naltrexone), the one all the doctors hate since there are no studies on it and it stinks too, though it only costs a few bucks. We need more options!

Now I don't per se mind Microsoft paying $12000 a year for the Avonex -- they can afford it. But in a weird way I do mind the drug companies getting the money. I'd rather they didn't since they so clearly are only in it for the money. So why not take as year off knowing that I will either be helping myself or helping others? Maybe even both!

And I am getting worse, no way around that. I may as well help try and make sure that some other people may do better in the future. No one will ever really know, but its a great legacy to be part of, even if (or maybe especially if) no one knows.

So, I'll keep my fingers crossed and hope Dr. Bowen okay's my participation in the NBI-5788 study.

Sunday, November 07, 2004
posted by michkap at 8:46 AM

Title: More on the experiment

So I get a call on Friday afternoon from the doctor who has been working to set up the study. She wants to talk about my MRI, so could I give her a call when I have a chance....

Of course she called my f***ing cellular instead of work phone, so I did not get the message until I left in the evening (it was late, like after 8pm).

Ah well, its probably to say I am not eligible for the study. Maybe too much chronic stuff on the MRI? It was kind of depressing to look at so I can imagine that being a problem. Oh well, I guess it may be back to the CRABs....

Monday, November 08, 2004
posted by michkap at 6:22 PM
Title: Not a viable test subject

Yep, the title says it all.... they turned me down. Nothing active on the MRI. Lots of scar, lots of lesion, but nothing special in the way of enhancement shows up with Gadolinium contrast added. So I will be back on Copaxone next week (it should show up tomorrow).

It didn't take them long, did it?

The weird thing was that even though my neurologist still had me classed as relapsing/remitting -- secondary progressive, I was not eligible for the study because there were no active lesions at the time that they were doing the screening MRI.

If the drug turns out to be useful then after FDA approval I would be a candidate to receive the drug, even though I was not considered a valid subject for the study on the drug's safety and usefulness. Meaning they might well have insufficient actual data on whether it was either safe or useful for me.

At the time I was just irked at the rejection. I felt like that hand from So Long and Thanks For All The Fish, the one that had been bequeathed to medical science, though after medical science had a chance to take a good look at it they decided to pass. I was back in the hands of the drug companies.

And then I talked to some friends of mine about these screening guidelines -- by only selecting ideal candidates for the study, the numbers in the study are more likely to look impressive. So the drug companies, who of course have the most to gain if the drug is certified safe and useful for people who they never tested safety/utility upon, push for studies with no borderline cases. And the doctors go right along with the agenda too.

There has got to a better way to do all this than the pharmaceutical companies have set up. Greed is a great motivator for money but not so great for health....

Of course I am cynical enough to doubt that anything short of a miracle ever could fix the situation. So just think of this blog as me venting. :-(


This blog brought to you by(U+2624, aka CADUCEUS -- and it is not by accident that it is sponsoring, if you know why without looking it up then I'll be impressed!)

# mdmhvonpa on 5 May 2008 7:53 AM:

Not good enough to be well ... not good enough to be 'sick'.


# Mike Dimmick on 6 May 2008 6:36 AM:

This bit was from memory:

The caduceus, a vine stick with two snakes wrapped around it, was the legendary staff of Hermes. That bit I know from a novel: Lindsey Davis' "Two for the Lions", where her hero, Falco, has to dress up as Hermes at one point so he can get himself into the gladiators' arena.

After looking it up on Wikipedia:

Hermes had several roles but one was as 'conductor of the dead' - this matches with the novel. The caduceus is often associated with the medical profession but strictly this is a mistake - it should be the Rod of Asclepius, which has only one snake (and no wings). (Asclepius was a mythological healer.) This appears in Unicode as U+2695.

In many countries in Europe, the Rod of Asclepius is used as a sign for a pharmacist/drugstore, where in the UK and I think the US a green cross is used.

I'm not sure whether your sponsoring character is similarly a misunderstanding or whether this was deliberate.

# Michael S. Kaplan on 6 May 2008 10:18 AM:

No, it wasn't a misunderstanding (though that part is amusing) and the exact reason is not in what you mention (though all of that is accurate) - there is another valid use of the caduceus that exists which is the reason for the sponsorship....

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