Genasense - after the fact subset analysis is not compelling evidence

[Guest guest]

Genasense failed to achieve the primary goal(s)/ endpoints the researchers (and

drug company) set for themselves ahead of the clinical trial. By slicing and

dicing the data after the fact, in a small subset of the patient cohort, they

drew statistically iffy conclusions that served their argument.

As some wag once put it, after the fact sub-set analysis is like shooting at a

barn, then painting bulls-eye around the bullet hole, where ever it happened to

be. Hardly compelling " proof " .

Careful patient advocacy requires that we be able to tell the difference between

marketing hype of companies with clear financial interests and cases where

regulatory hurdles are keeping back a truly valuable drug from the patient

community. Genasense is hardly a good example for getting the patient community

mobilized.

: I agree with you that compassionate use programs need to be expanded. I

STRONGLY disagree with you that Karl is some kind of a FDA stooge because he has

been a patient advocate representing our needs and viewpoints on FDA panels. He

is perhaps the single voice of reason that has knowledge, credibility and lack

of vitriol in his rhetoric going for him - this patient community is lucky to

have him as our advocate.

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> Sure Karl, I understand the point you make about bias.

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> Irregardless, we don't have approval of Genasense after an inordinate length

of time.

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> ~chris

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> -> Hi Be aware that the link is to a business perspective, which could

well be biased -

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