First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all

6 ways the FDA’s approval of Aduhelm does more harm than good (STAT News):

Like many peo­ple, I was shocked when the Food and Drug Admin­is­tra­tion ignored the advice of its neu­ro­log­i­cal drugs advi­so­ry pan­el and broad­ly approved Biogen’s new drug, Aduhelm, even for pop­u­la­tions nev­er includ­ed in the clin­i­cal tri­als to assess the drug.

I am not a casu­al bystander to this con­tro­ver­sial deci­sion. I am a physi­cian who has been treat­ing peo­ple with Alzheimer’s since 1982; an ear­ly researcher into the biol­o­gy of amy­loid, the brain pro­tein that Aduhelm tar­gets; some­one with a strong per­son­al fam­i­ly his­to­ry of demen­tia … As I for­mu­late my respons­es to my own patients, here are six recur­ring themes:

  1. Pull of desperation
  2. Elbow­ing aside exist­ing treatments
  3. Amy­loid reduc­tion alone is no help
  4. An unin­ter­pretable trial
  5. Tri­als and label­ing disconnect
  6. Cost and equi­ty issues

Bot­tom line. The FDA’s approval of Aduhelm rais­es more ques­tions and cre­ates more prob­lems than a new drug approval should. It’s time for gov­ern­men­tal, pro­fes­sion­al, and advo­ca­cy enti­ties to step in where Bio­gen and the FDA have failed and explain to patients, care­givers, and clin­i­cians how this drug is not the “new day” in the fight against Alzheimer’s dis­ease and needs to be approached cau­tious­ly, if at all. Read full arti­cle HERE, over at STAT.

News in Context:

About SharpBrains

SHARPBRAINS is an independent think-tank and consulting firm providing services at the frontier of applied neuroscience, health, leadership and innovation.
SHARPBRAINS es un think-tank y consultoría independiente proporcionando servicios para la neurociencia aplicada, salud, liderazgo e innovación.

Top Articles on Brain Health and Neuroplasticity

Top 10 Brain Teasers and Illusions

Newsletter

Subscribe to our e-newsletter

* indicates required

Got the book?