According to an article published by The Associated Press on December
5, 2019 Biogen’s scientists issued a preliminary report on their new data
analysis of their Alzheimer’s disease (AD) medication, aducanumab. This is the medication that was in a Phase
III clinical trial that was ended in March due to poor results but, after new data
came in after the trial ended, was then promoted by Biogen as being effective.
Biogen’s presentation received very mixed reactions from scientists
at an Alzheimer’s conference in San Diego, California on 12/5/19. According to the A.P. article, scientists
were “sharply divided over whether there’s enough evidence of effectiveness for
the medicine to warrant federal approval.”
The new data released that day indicated that “the drug made only a very
small difference in thinking skills in one study and none in the other.” A.P. reports that independent experts said
that “the new analyses were done on partial results, and with methods not
agreed upon at the outset, making any conclusion unreliable.”
Some scientists cheered the new results and some judged them
insignificant. “Questions arose about
the size of any benefit. The drug did
not reverse decline and it only slowed the rate of it compared to the placebo
group by 22% in one study. Yet that meant
a difference in only 0.39 on an 18-point score of thinking skills.”
As I’ve written many times before, the currently FDA-approved AD
medications have been shown to be effective for only about 50% of the people
who take them, and then only for up to a year or two at most. But, sadly, once doctors place their AD
patients on these expensive medications, doctors are reluctant to ever remove
their patients from these meds … even
though there is absolutely zero research to indicate that these meds have been
or still may still be effective. The
result is that too many caregivers and AD patients continue to pay a lot of money
year after year for AD meds that I refer to as “expensive bottles of hope” when
that money could be much better used for day care, respite opportunities, or to
help pay for home or institutional care.
I sincerely hope that, if this is the best new data Biogen can
present to the FDA in support of their application to market aducanumab, the
FDA resoundingly says no to marketing at this point. If Biogen scientists think their data
suggests promise, then let them conduct new year-long Phase III clinical trials
with proper supervision. That is the
only way to demonstrate effectiveness. Scoring
one point more on a test of thinking skills is no reason to add yet another
expensive bottle of hope to the market.
