Medicare

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, pro­vid­ing this time a sum­ma­ry of the saga around the FDA approval of adu­canum­ab (Aduhelm) as a sup­posed treat­ment for Alzheimer’s Dis­ease, plus a range of time­ly research find­ings and resources for life­long brain health.

First, below are some key reads to nav­i­gate “prob­a­bly the worst drug approval deci­sion in recent U.S. his­to­ry” — Dr. Aaron Kessel­heim, the Pro­fes­sor of Med­i­cine at Har­vard Med­ical School who resigned rom the FDA Advi­so­ry Com­mit­tee in protest.

#1. Grow­ing back­lash against the FDA approval of unproven Alzheimer’s treat­ment Aduhelm, by Bio­gen:

“The Insti­tute for Clin­i­cal and Eco­nom­ic Review (ICER) believes that the FDA, in approv­ing adu­canum­ab (Aduhelm by Bio­gen) for the treat­ment of Alzheimer’s dis­ease, has failed in its respon­si­bil­i­ty to pro­tect patients and fam­i­lies from unproven treat­ments with known harms.”

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

“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.” — Dr. Sam Gandy, Pro­fes­sor of Neu­rol­o­gy and Psy­chi­a­try at the Icahn School of Med­i­cine at Mount Sinai, where he holds the Mount Sinai Chair in Alzheimer’s Research

#3. Can the con­tro­ver­sial FDA approval of Aduhelm back­fire and delay the dis­cov­ery of actu­al Alzheimer’s treat­ments? (Yes, it can):

“In short, while the amy­loid hypoth­e­sis has fal­tered, the approval of adu­canum­ab, which is based pri­mar­i­ly on this the­o­ry, sug­gests that the the­o­ry may once again dom­i­nate research, and could reduce the chances of find­ing more promis­ing treat­ments. For exam­ple, tau pro­tein, which also accu­mu­lates in the brains of Alzheimer’s patients — long before the amy­loid pro­tein does — has been shown to be close­ly asso­ci­at­ed with the cog­ni­tive impair­ment result­ing from the dis­ease … we must not inter­rupt research on bio­mark­ers and new ther­a­peu­tic approaches.”

#4. US Sen­a­tor Joe Manchin calls for a new FDA Com­mis­sion­er to replace cur­rent (act­ing) one who “has repeat­ed­ly ignored pub­lic health con­cerns and shown a dere­lic­tion of duty” over opi­oids and adu­canum­ab:

“I write today con­cern­ing the lack of per­ma­nent lead­er­ship at the Food and Drug Admin­is­tra­tion (FDA), and the con­tin­ued tenure of Dr. Janet Wood­cock as inter­im com­mis­sion­er. Just last week, the FDA grant­ed approval for Aduhelm (adu­canum­ab), a treat­ment for Alzheimer’s, despite its advi­so­ry pan­el vot­ing near­ly unan­i­mous­ly against its approval, with no pan­el mem­ber vot­ing in favor of approval”

(Let’s hope some­thing use­ful emerges from this very unhealthy FDA deci­sion. Quite dis­turb­ing, though, to notice the links between the opi­oid epi­dem­ic and the recent Aduhelm approval.)

#5. Health payers–including Medicare and Point32Health–to ques­tion Aduhelm pric­ing and its “rea­son­able and nec­es­sary” use:

“Under the broad label that FDA approved, the drug is avail­able to all Alzheimer’s patients, and the agency did not place lim­its on treat­ment dura­tion sug­gest­ing that patients could remain on the drug indef­i­nite­ly. We are trou­bled by reports that those fac­tors could lead the drug to com­mand “some­where between” the $37 bil­lion we cur­rent­ly spend on Medicare Part B and the $90 bil­lion we cur­rent­ly spend on Medicare Part D. This lev­el of poten­tial new spend­ing, par­tic­u­lar­ly for just one prod­uct with lim­it­ed evi­dence of clin­i­cal effi­ca­cy thus far, tests the program’s resiliency.”

The stakes could­n’t be higher.

Now let’s review oth­er impor­tant devel­op­ments in June.

#6. Debate: What is the role of finan­cial advi­sors and plat­forms in detect­ing and address­ing cog­ni­tive decline among old­er clients?:

” … big do-it-your­self invest­ing and trad­ing venues like Van­guard Group, Fideli­ty Invest­ments and Charles Schwab Corp. are strength­en­ing some of the ways they detect pos­si­ble signs of decline. Among oth­er things, all three firms check for clients’ dif­fi­cul­ty nav­i­gat­ing secu­ri­ty pro­to­cols or need for fre­quent pass­word resets. In such cas­es, a des­ig­nat­ed fam­i­ly mem­ber might be informed.

Van­guard also checks client-call record­ings for keywords—such as “con­fused” and “dementia”—that might sig­nal trouble.”

#7. Study in Chi­na finds that retire­ment may accel­er­ate cog­ni­tive decline, even for those with sta­ble income:

“While retire­ment schemes like the 401(k) and sim­i­lar pro­grams in oth­er coun­tries are typ­i­cal­ly intro­duced to ensure the wel­fare of aging adults, our research sug­gests they need to be designed care­ful­ly to avoid unin­tend­ed and sig­nif­i­cant adverse con­se­quences. When peo­ple con­sid­er retire­ment, they should weigh the ben­e­fits with the sig­nif­i­cant down­sides of a sud­den lack of men­tal activ­i­ty. A good way to ame­lio­rate these effects is to stay engaged in social activ­i­ties and con­tin­ue to use your brains in the same way you did when you were working.

In short, we show that if you rest, you rust.”

#8. The explo­sion of men­tal health apps rais­es sub­stan­tial opportunities–and tough ques­tions:

“Dig­i­tal men­tal health can be viewed as a way to extend the men­tal resources that we have,” said David Mohr, who directs the Cen­ter for Behav­ioral Inter­ven­tion Tech­nolo­gies at the North­west­ern Uni­ver­si­ty Fein­berg School of Med­i­cine. A step-care mod­el, for exam­ple, would allow patients with milder symp­toms to be treat­ed via tech­nol­o­gy while reserv­ing in-per­son care for patients who need some­thing more.

#9. Pre­scrip­tion soft­ware firm Pear Ther­a­peu­tics to go pub­lic via $1.6 bil­lion SPAC deal, har­ness­ing 3 FDA-autho­rized prod­ucts and 14 can­di­dates:

“Pear is one of nine com­pa­nies invit­ed to par­tic­i­pate in the U.S. Food and Drug Administration’s (FDA) Pre­cer­ti­fi­ca­tion Pilot Pro­gram. Pear has devel­oped and com­mer­cial­ized the first three FDA-autho­rized PDTs, has 14 prod­uct can­di­dates, and is scal­ing its plat­form for third-par­ty prod­uct dis­tri­b­u­tion oppor­tu­ni­ties. The Company’s three FDA-autho­rized prod­ucts, reSET®, reSET‑O® and Som­ryst®, address large mar­ket oppor­tu­ni­ties with more than 20 mil­lion patients suf­fer­ing from sub­stance and opi­oid use dis­or­ders and more than 30 mil­lion from chron­ic insom­nia, in the U.S. alone, respectively.”

#10. Don’t wor­ry, be hap­py: How exces­sive wor­ry­ing may influ­ence the rate of neu­rode­gen­er­a­tion:

“(Research find­ings) sug­gest that cog­ni­tive func­tion may need to be mon­i­tored close­ly in indi­vid­u­als with affec­tive dis­or­ders, as these indi­vid­u­als may be at par­tic­u­lar risk of greater cog­ni­tive decline.”

#11. Smarter cars are com­ing soon … : Eye-track­ing pio­neer Smart Eye acquires MIT spin-off Affec­ti­va to aug­ment dri­ver mon­i­tor­ing sys­tems and more

#12. And, much more: DARPA-fund­ed non­sur­gi­cal neu­rotech­nolo­gies push the fron­tier of brain-machine interfaces

Final­ly, a quick cog­ni­tive exer­cise. Giv­en the uni­ver­sal beau­ty of math, you don’t need to speak Span­ish to try this quick teas­er: Brain teasers en español: ¿cuál es el número que fal­ta en el cuar­to triángulo?

Wish­ing you a hap­py and healthy summer,

The Sharp­Brains Team