welcome to the organic green doctor blog

i am a family physician who was diagnosed with
early mild cognitive impairment(mci) amnestic type on december 21, 2010
this is a precursor to alzheimers disease
because of this diagnosis i have opted to stop practicing medicine
this blog will be about my journey with this disease
please feel free to follow me along this path
i will continue blogging on organic gardening, green living,
solar power, rainwater collection, and healthy living
i will blog on these plus other things noted to be interesting

Friday, November 13, 2020

alzheimers news-status of my biogens aducanumab


in the theory of what happens in alzheimers it is thought that first amyloid accumulates in the brain in the hippocampus then later tau proteins inside the brain cells unwind and get deposited in the brain as tau tangles
the body then develops an inflammatory response to this damage and this inflammatory response causes more damage
as the disease progress the damage get worse and worse

the goal is to stop the three step process before it happens

enter biogens aducanumab drug which is a monoclonal antibody against amyloid  derived from older folks who dont get alzheimers disease
this antibody is then made in the lab and give intravenously to patients

i entered the aducanumab study about 4 years ago
i received 18 monthly intravenous doses of placebo followed by 7 months of the high dose aducanumab before the study was halted
it was restarted this spring but was stopped again due to covid 19
we all are waiting to find out when the study will be reactivated

biogen applied to the fda for approval for its use of aducanumab in treating patients with alzheimers

their study showed when given the higher dose that i was on that
the amyloid seen on pet scans was removed
functional measurements of how patients functioned were improved or the rate of decline was slowed
memory testing showed the same thing
those with alzheimers should have a decline from year to year some faster than others
tau protein scans showed less tau tangles
inflammation in the brain was slowed down also

so there was slowing of the measures of the disease
patients and families and doctors noticed improvements

if you look at how aricept (donepezil) helps to slow down the symptoms of azheimers i dont know that it works better than aducanumab
yet its approved for use

in order for aducanumab to get approved for use by the fda
an fda advisory panel meets which it did last friday 
it voted to not recommend that aducanumab be approved by the fda for use in alzheimers disease
it cited costs and not effective enough as the major reasons for voting against aducanumab

now the fda panel that makes the final decision will decide some time between now and march
it could approve aducanumab for use
usually if the fda advisory panel doesnt vote for it then the full panel doesnt usually vote for approval

there are however powerful influencers in the alzheimers world who want this drug to be approved
one is the alzheimers association a big mover in the alzheimers world and who has a lot of political influence wants this drug approved

several well known alzheimers researchers support the approval of aducanumab for use against alzheimers
many have seen how it has slowed the disease down in their patients

it is possible the fda panel will approve it
it is possible that the fda panel may require biogen to do a longer 4 year study then they will decide on its approval
it is possible that the fda panel will say no and thats it

my guess is they will either approve it
and or
require a longer term trial 

so how does this affect me
if its approved i will receive it monthly 
if biogen has to do a longer clinical trial then i will be in that trial for whatever time the study lasts
hopefully i will find out monday when i go to ucla

what do i think the fda should do
i wrote a statement and submitted it to the fda advisory panel
i think they should improve it
i think it works as well as aricept (donepezil) does
i realize it wont cure alzheimers but neither does aricept or namenda or exelon or razadyne which are approved for use in alzheimers 

no matter what happens i will get at least 2-4 more years of treatment with aducanumab

ill take whatever i can get

whats the other options 

i see alzheimers as a terminal disease like a terminable metastatic cancer
if i dont die of a heart attack or stroke or cancer thats what i will die from 

we give palliative care to terminal cancer patients to slow down the disease lessen pain and give patients a few months or a few years longer to be with their loved ones

so why cant us alzheimers patients with a terminable disease not have access to a drug that might slow down the disease some

it can be the difference of seeing ms b eg graduate from kindergarten then graduate from elementary school then graduate from  junior high school then if im lucky graduate from high school

aducanumab might allow me to see more than one graduation

thats why it should get approved

the organicgreen doctor

1 comment:

  1. Yes, Let's hope pray and advocate for this approval.
    Love to all of the Nashes!