In high­ly un­usu­al op-ed, 3 ad­u­canum­ab ad­comm mem­bers again call on FDA to re­ject Bio­gen's Alzheimer's drug

Typ­i­cal­ly, when the FDA con­venes ad­vi­so­ry com­mit­tees for drugs or vac­cines, the out­side ex­perts of­fer their per­spec­tive, vote, and then the agency ei­ther lis­tens to them or not. And that’s where it ends. But the re­view of Bio­gen’s Alzheimer’s drug ad­u­canum­ab has been any­thing but typ­i­cal.

In a high­ly un­usu­al op-ed in JA­MA, three mem­bers of the ad­comm that re­viewed the drug last No­vem­ber again laid out their case for why the FDA should re­ject ad­u­canum­ab. Johns Hop­kins epi­demi­ol­o­gist Caleb Alexan­der, Uni­ver­si­ty of Wash­ing­ton bio­sta­tis­ti­cian Scott Emer­son and Har­vard bioethi­cist Aaron Kessel­heim spot­light­ed the con­flict­ing re­sults be­tween Bio­gen’s two piv­otal tri­als, the po­ten­tial safe­ty con­cerns those stud­ies turned up, and al­le­ga­tions that reg­u­la­tors may have com­pro­mised their ob­jec­tiv­i­ty by work­ing too close­ly with the com­pa­ny.

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