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29 March 2005, The Wall Street Journal
A14
(Copyright (c) 2005, Dow Jones
& Company, Inc.)
We regret to report that Kianna Karnes,
featured in last Thursday's editorial on the Food and
Drug Administration's fetish for the placebo-controlled
testing of cancer drugs -- "How About a `Kianna's
Law'?" -- died Friday night of complications from
kidney cancer. She was 44.
While it came too late to save Mrs. Karnes,
our reporting of her plight certainly generated a lot
of attention. Bayer and Pfizer -- developers of two
investigational drugs showing much promise for this
particularly deadly cancer -- both contacted her doctor
almost immediately to discuss the appropriateness of
providing the compounds. Mrs. Karnes's family was also
contacted by the FDA and told that the agency stood
ready to approve such treatment on an emergency basis.
All encouraging steps. But isn't it a
national scandal that cancer sufferers should have to
be written about in The Wall Street Journal to be offered
legal access to emerging therapies once they've run
out of other options?
The FDA's oncology division has proven
to be essentially incorrigible on this point in recent
years, so it's time for Congressional action mandating
that the agency use 21st-century science and statistical
methods to get these therapies to patients sooner. More
specifically, drug approvals could be based on large
trials open to all comers and analyzed with so-called
Bayesian statistics, as already happens in the FDA's
medical device division. (Yes, the agency at least recognizes
that studies involving, say, "placebo" defibrillators
would be beyond the pale.)
Mrs. Karnes's father John Rowe -- himself
a leukemia survivor -- plans intense Congressional lobbying
in the coming weeks, and he's had some interest from
Congressman Dan Burton's (R., Indiana) office in the
possibility of sponsoring a "Kianna's Law."
No doubt there will be others willing to sign on.
We'll keep you posted. Meanwhile, we'd
suggest that cancer patients looking for a constructive
way to make their voices heard -- and those looking
to educate themselves on the issue -- contact the Abigail
Alliance for Better Access to Developmental Drugs at
www.abigail-alliance.org.
(Copyright (c)
2005, Dow Jones & Company, Inc.)
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