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Turned Down for Anti-CD11a Trial: Old Head Injury?
from Mike B.

Backstory:  Severe Relapse after Anti-cd11a (Xanelim) Trial

Hi, I think I'd mentioned in my first letter ]see Backstory, link above –Ed]  that I'm also a head-injury survivor (bad fall, going on 7 years ago).

My (former) derm had all kinds of research projects going, including such apparently unrelated things as blood-hypertension and sinus problems.  I'd been a volunteer subject for him WAY back, for Neoral [cyclosporine –Ed] — that's since been approved, at least in Canada, and of course is outrageously expensive while they recover the R&D costs.

So naturally he wanted me on one of the early stages of the Anti-CD11a work (sorry, Ed, I can never remember the "new improved" name).  This was back before they discovered that a half-strength starter dose seemed to eliminate most of the killer-headache problems they'd encountered in the earliest tests.

He later told me that Genentech had turned me down "because of your head injury."  To this day — and I constantly kidded him about it while I was still seeing him — it's not clear what the problem was.  Was I at risk of possibly more brain damage from it?  Or maybe they were afraid I’d throw their headache-incidence stats out of whack.

But my favorite guess is that they weren't quite sure I was competent to sign the consent-release agreement.  -Best, Mike B.


Ed’s Response:  Hah hah.  While your competency was surely not at issue, your statistical propriety probably was.  Headaches definitely did surface as an issue in an earlier phase of the anti-cd11a trials — see Anti-CD11a Trial Sparked 3-Day Migraine — and mixing prior brain surgery into the equation was probably deemed “asking for trouble,” hence you’re not a likely guinea pig. 

I can’t help but giggle, Mike, for as I prepare this for posting in the April-May ’02 update at FlakeHQ I’ve just seen a new TV commercial for Mike’s Hard Lemonade (“Mike” being completely coincidental, I’m sure).  This new commercial is the one where this fellow has grown a second, dwarfish, evil, ugly head, and this evil ugly head says, “I didn’t know Mike made a hard lemonade” and grins pruriently at the fetching feminine co-worker.  In the next scene two-heads and the co-worker are enjoying a Mike’s Hard Lemonade somewhere outside the office.  Anyway....

An update on cyclosporine.  Neoral was and is its initial product name by Novartis, the manufacturer.  But in the past couple of years a generic version has been approved and is offered by Eon.  As far as I know, it’s just called “cyclosporine.”  I used it for the last several months on the regimen.  The only (significant) differences are it’s cheaper, and it’s one helluva lot easier to get out of the packaging!  (Hey, when you’ve got severe nail psoriasis, that can be quite an issue!)

When/if anti-CD11a makes it into the drug catalogs it will probably be as “Xanelim,” at least at first.  The actual compound name (I guess it’s the compound name) is efalizumab (I know, sounds like the name of a Hittite demon-god).  Manufacturers involved in the trials (that I am aware of) are Genentech and Xoma (religious institutions that pay homage to Hittite demon-gods?).

Frankly, I’ve heard so many horror stories about the trials, it will be a long time on the market before I consider trying it.

All things considered, Mike, your old head injury may have come in handy.  Being turned down for this phase of the anti-cd11a trials might have been okay.  At least you’re still here, still making me laugh (brain-damaged or not).  -Ed

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