The FDA's in­sid­er re­view on ad­u­canum­ab was all about pol­i­tics, not sci­ence, and it threat­ens pa­tients and the bio­phar­ma in­dus­try alike

The FDA de­serves ku­dos for draw­ing a line in the sand over their re­view of Covid-19 vac­cines. They’ve made it clear — af­ter deep skep­ti­cism be­gan to ap­pear fol­low­ing the de­ba­cle over con­va­les­cent plas­ma — just what they will need to see be­fore hand­ing out an EUA, thus sav­ing the agency’s rep for en­forc­ing stan­dards es­sen­tial to main­tain­ing pub­lic trust in drugs.

That same in­tegri­ty, though, has gone miss­ing from the FDA’s stance on Bio­gen’s Alzheimer’s drug ad­u­canum­ab. De­spite a sta­tis­ti­cal analy­sis that high­lights the con­flict­ing na­ture of the Bio­gen $BI­IB da­ta, a post hoc dump­ster dive op­er­a­tion to find sup­port­ive da­ta and a move to shine up small co­hort re­sults as back­up proof of ef­fi­ca­cy, the FDA di­vi­sion re­spon­si­ble for Alzheimer’s chose to en­dorse adu for use among mil­lions of pa­tients.

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