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Friday, January 8, 2010 — "AhhhCHUUU!"
Excuse YOU, Ed
I felt fine for Christmas, made it
to Wednesday with no thought that I might be getting
sick, started Thursday feeling out of it, ended Thursday
(New Years Eve) sick. I was medicated and sleeping three
hours before the Great Ball fell in Time's Square. I
hope everything went well.
I've had the seasonal flu shot.
I've had the H1N1 flu shot. I'm an "above average" hand
washer and constantly hygiene-aware (as I'm a care giver
for a disabled elderly in-law). In spite of these
virtues, I'm never surprised to be harboring the
nastiest things going 'round. One reason: my live-in
elderly in-law frequents an adult daycare — these are
generally understood to be microbial cesspools. And
another reason: I'm working on my seventh more-or-less
consecutive year as a user of biologic medicines for P —
which means my immune system has been compromised in
ways that are "not fully understood." I figure my
chances of NOT catching everything diminish
exponentially year by year....
All this by way of explanation for
this late posting.
What's New at
Mail ... a new
Sherry Sheehan poem ... and
more to come.
Friday, January 1, 2010 —
When the Fine Print Becomes Real Life
Every now and then an email
comes to FlakeHQ with the power of a steam roller.
It jerks me back in my chair, opens my eyes wide,
shortens my breath and brings sweat to the palms of
my hands. I received one of these on December 22nd.
It came as a comment to a blog post, but I hastily
wrote back to Mike S. and said it would have to be
the lead piece in this update's
I've titled Mike's email,
Believes Enbrel Caused His Leukemia. If you've
only a minute to spend here right now, by all means
spend it reading Mike's story.
Years ago I learned that no matter
the statistical significance or insignificance of the
number of adverse reactions to a drug under testing,
they must be reported to the FDA and are most likely to
end up in the fine-print disclosure statement that's
packaged with the drug. That knowledge muted my
sensitivity to some of the nastier potential
consequences. How threatening can some deadly disease be
if the risk is less than 1%? Well, the percentages don't
matter when the unfortunate victim draws closer to you —
or IS YOU.
Mike S. has acute lymphoblastic
leukemia, though it is currently in remission. This
disease is called "acute" because it is an extremely
rapid spreading cancer that starts in the blood but
metastasizes quickly. There are no clear initial
symptoms and the abnormalities in blood can be
attributed to a number of things. The only sure
way to conclude acute lymphoblastic leukemia is through
a bone marrow biopsy. [Wikipedia, "Acute Lymphoblastic
Leukemia."] The fact that ALL is not an easy diagnosis
to confirm means it takes time; at the same time, the
disease spreads so fast it can kill in weeks.
Fortunately for Mike S. the methods of diagnosing and
treating ALL have been refined and today the number of
fatalities among adults with ALL is 50% or less. Think
about that statistic. On the other hand, this comes from
Amgen's "Prescribing Information" about Enbrel...
"In the controlled
and open-label portions of clinical trials of
ENBREL, 9 lymphomas were observed in 5723 patients
over approximately 11,201 patient years of therapy.
This is 3-fold higher than that expected in the
general population. While patients with rheumatoid
arthritis or psoriasis, particularly those with
highly active disease, may be at a higher risk (up
to several fold) for the development of lymphoma,
the potential role of TNF-blocking therapy in the
development of malignancies is not known." page 20,
This quotation says a
3-fold increase in the likelihood of contracting a
lymphoma was demonstrated in the trials. However, those
who participated in the trials (psoriatics, arthritics)
may be at higher risk for lymphoma with OR WITHOUT the
use of a TNF-blocker like Enbrel. While this sounds a
little self-serving, it really is the kind of
observation that must be made in any scientific inquiry.
The implication is, the tendency for lymphoma among the
target population needs to be determined just as rigidly
as the trial outcomes. In other words, don't blame the
drug without considering other possible causes.
These are the issues,
anguishing as they are, that the FDA wrestles.
Meanwhile, people like Mike S. know what has happened to
them. We know that it could happen to us, too.
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