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I guess it’s a step in the right direction that Pfizer has actually come forward to publicly admit these unsatisfactory intermediate endpoints, right? We have alarming industry examples where negative results like this have instead been buried from regulators and, worse, unsuspecting patients.

Consider, for example, companies like GlaxoSmithKline, whose internal reports (revealed during court trials last fall) clearly showed what they themselves described as “an alarmingly high number” of birth defects linked to GSK’s antidepressant drug Paxil as far back as 1998. But even with those concerns, that report was never turned over to the FDA, and “the alarming language” was deleted from the report. This was two years before Glaxo drug reps launched the CASPPER medical ghostwriting campaign to get physicians on their routes to lend their names to Paxil-friendly industry-written journal articles – none of which mentioned the little matter of birth defects. More at: https://ethicalnag.org/2009/09/24/paxil/

I really appreciated your website – keep up the good work at MDiTV.
cheers,
C.

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Notably, the same day that video was posted, Pfizer announced it would withdraw the cancer drug Mylotarg (Gemtuzumab Ozogamicin for Injection) because further study showed it didn’t live up to the expectations created by studies that relied on intermediate endpoints.

In 2000, Mylotarg won accelerated approval from the FDA based on trials showing it increased the remission rates among certain patients with acute myeloid leukemia (AML). However, the FDA required follow-up studies, which recently revealed that patients receiving Mylotarg didn’t actually live any longer… while they sometimes suffer serious side effects.

It’s one more example of why we need to watch out for the pitfalls of putting too much faith in intermediate or surrogate endpoints when interpreting medical research results.

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