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Trial Subject’s Experience
During a web search for info on the progress of Biogen's Amevive
towards obtaining final FDA approval, I read Any
Amevive Trial Subjects Out There?
from Tiffany. In your
response to the author, you decried the dearth of any input from actual
test subjects. For what it's worth, I'll briefly recount my experience.
In January of
1999, I signed up for a six month test program conducted by a facility
affiliated with the University of California, Irvine Medical Research
Department. By that time in my life (I was 49, at the time) the disease,
which had first reared its abominable head fifteen years earlier as a
small, quarter-sized patch on the back of one calf, just above the ankle,
had progressed to a severe stage of heavy plaque build-ups on both arms
and legs (especially around the elbows and knees) and all across my lower
back and upper buttocks.
I had tried
most all the cortisone, UV, and over-the-counter remedies. All to no
program at UCI consisted of approximately 6 weeks of biweekly injections,
followed by six weeks of weekly injections, after which I continued to
come in for observation and blood testing on a semi-weekly until the six
months was up.
Here's a rough
timeline as to the results of the treatment:
I noticed little, if any improvement to my condition.
There was a slight reduction in the size and density of the affected
The rate improvement was astonishing!
Weeks 7-10: I
no longer had any apparent symptoms, anywhere on my body! Even the areas
that I had thought would be permanently discolored or scarred returned to
Believe it or not, I no longer even had a speck of dandruff!
three months of treatment, during which I experienced not the slightest
discomfort or side effects, the transition was truly amazing!
I was a free
man for the first time in over a decade! That July, I returned to the
beach in a T-shirt and shorts. After so many years spent prisoner to my
"disguise" clothing, the experience was one the happiest days of
remarkably, the drug continued to stave off any recurring symptoms until
well into the Spring of 2000, I was hoping against hope that I was
permanently cured. However, the cursed disease slowly began to re-manifest
itself and, by the end of the year, I was right back where I started!
following the progress of Amevive through the FDA approval very closely.
As soon as it's available, you can bet that I'll be one of the first to
demand it! Sincerely, -Art C.
Response: Thanks so much for
sharing this with us, Art. I’m
sure the folks at Biogen are going to be tickled.
I am. I’m thinking
very seriously about abandoning my (near valueless) place on the waiting
list (26,000) for Enbrel when Amevive gets final approval.
Depending on price, we might find a fight with the insurance
companies, but I know conscientious derms and the NPF are girding up to
help fight the fight.
For readers who
may not be up-to-date on this story: Amevive
(a.k.a. alefacept) is one of the
new biologic drugs (derived from living tissue rather than dead chemistry
— wow, what a lazy way to say that!) that has many flakers excited.
For more info on Amevive visit http://www.biogen.com.
And, for the latest news about the Amevive FDA approval process,