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:

• FDA Grants Accel­er­at­ed Approval for Alzheimer’s Drug (press release)
• Grow­ing back­lash against the FDA approval of unproven Alzheimer’s treat­ment Aduhelm, by Biogen
• Three mem­bers of the FDA advi­so­ry com­mit­tee have already resigned in protest. Here’s their rea­son­ing: Joel Perl­mut­ter, David Knop­man and Aaron Kessel­heim.
• What does a clear major­i­ty of the bio­phar­ma indus­try think of the FDA approval of adu­canum­ab? ‘Hor­ri­fy­ing’ ‘Dan­ger­ous’ ‘Con­fus­ing’ ‘Dis­as­ter’
• ‘Sim­ply unac­cept­able’: Alzheimer’s Asso­ci­a­tion blasts Bio­gen over the price of its new medicine
• Study chal­lenges the “seduc­tive” amy­loid hypoth­e­sis of Alzheimer’s dis­ease (AD)
• Cog­ni­tive train­ing, diet, exer­cise, and vas­cu­lar man­age­ment seen to improve cog­ni­tion even in peo­ple with genet­ic pre­dis­po­si­tion for demen­tia (APOE e4)
• Report: 35% of world­wide demen­tia cas­es could be pre­vent­ed by mod­i­fy­ing these 9 mod­i­fi­able risk factors