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|Anti-CD11a Trial Sparked
from Kelly Z.
Hi Ed: The last time I wrote you was about 4 months ago stating that I would be starting the Anti-CD11a drug trial and keeping a journal of the events [see Achieving Clearance Re-invented Her Self-esteem].
To give you a background how the study worked: I received 1 shot per week for 12 weeks with examinations each week. After 12 weeks I went back into the pool and it was determined whether I had received meds or placebo. The last 3 months I received no shots. EucerinŽ was the only lotion that could be used and they supplied me with all I needed. They took a preliminary photo of my worst spot (my butt) as well as whole body pictures (no face).
Well, after being in the study one week, I was removed from the study at my request. They’d briefed me on all the known side effects — but they hadn’t expected what happened to me. I was the first person in the study to end up with a 3-day migraine.
I really thought I was going to die, my head hurt so bad. I missed work, spent 5 hours in the emergency room because doctors wouldn't prescribe over the phone, and spent 3 days sleeping thanks to Vicodin [hydrocodone bitartrate and acetaminophen -EdD]. The FDA was hunting me down to get as much info as possible. That's the really bad news.
The merely bad news is that I actually received the drug and not the placebo and it actually did work. About 2 days after I received the shot, I noticed some thinning of my patches. Nothing went away completely because I immediately came off the drug — but there was definitely a change. The Derm in charge of the study asked if I was sure about the change. (After 20 years with this, I think I would know.) The thinner lesions lasted about 1 week and then I flared. God, I just knew that was going to happen.
It's now 4 months after the shot and I am finally done with the "study." My derm suggested I join another study, which floored me. I’ll stick with my PUVA and take my chances there. At least I know PUVA’s side effects. The best thing out of the whole study is I finally found a doctor who knew how to prescribe bath PUVA. My real derm doesn't seem interested in getting me that info.
Well, it's freezing here in Chicago, and I am getting tanner every day. Got to love that. Back to work. -Kelly Z.
Ed’s Response: Thanks for sharing your drug trial experience with us, Kelly. What a frightening experience! As unfortunate as this experience was for you, I’m thankful that you shared it with us because we sometimes forget that drug trials are risky. We can’t imagine doctors — Hippocratic oath and all — actually encouraging us to do something that may hurt us, but the whole point of drug trials is to determine a drug’s safety before it is "approved." Logically, the whole concept of drug trials embodies risk. That we don’t hear more bad stories is a testament to the care that goes into planning and executing the trials, and perhaps the speed with which researchers react to unanticipated side effects. (Or, as Hollywood would sometimes have us believe, a testimony to the greedy intent of drug manufacturers who hide their failures in cages in dank basement dungeons.) I can imagine how your quick and severe migraine blind-sided all the researchers involved in the trial.
FlakeHQ correspondent Stealth also had a less-than-satisfactory experience as a trial subject for Anti-CD11a. He relates his experience (that did not include any violent side-effect) in Retrospective on Long-Term Methotrexate and Cyclosporine Therapies.
Let us know how the bath PUVA works for you, Kelly. According to the National Psoriasis Foundation booklet on PUVA, in bath PUVA you immerse in a tub of psoralen-laced water and then get exposed to the UVA light within 15 minutes. This is less time than is required for oral psoralen (75 to 120 minutes between taking the pills and receiving the light). Also, this could be a good alternative for folks who cannot tolerate the oral psoralen.
It’s your turn, Kelly, to have a real good run with the PUVA, get clear and stay clear for at least several months. Regrettably there is no GI Bill for wounded veterans of FDA Drug trials! -Ed