AS BIG PHARMA STOCK SOARS, THIRD FDA ADVISER RESIGNS OVER APPROVAL OF ALZHEIMER’S DRUG
The doctor and panel member wrote that it "was probably the worst drug approval decision in recent U.S. history."
Backlash over the U.S.
Food and Drug
Administration’s controversial approval of a new Alzheimer’s drug grew
Thursday with a third member of an agency advisory panel resigning in
The latest resignation to hit the Peripheral and Central Nervous System Drugs Advisory Committee, as
came from Dr. Aaron Kesselheim, a Harvard Medical School professor.
action followed FDA’s “accelerated approval” announced Monday for
aducanumab, on which drug maker Biogen put an annual price tag of
$56,000. Administered as a monthly intravenous infusion, it’s
the first drug to treat Alzheimer’s disease that’s been approved in
nearly two decades—approval that came despite the panel’s recommendation
against it in light of lack of data showing efficacy.
In his resignation letter, Kesselheim wrote that it “was probably the worst drug approval decision in recent U.S. history,”
the last minute,” wrote Kesselheim, “the agency switched its review to
the Accelerated Approval pathway based on the debatable premise that the
drug’s effect on brain amyloid was likely to help patients with
The FDA erred in its approval, Kesselheim
New York Time
s, “because of so many different factors, starting from the fact that there’s no good evidence that the drug works.”
In a June 7
, the day of the FDA announcement, Kesselheim wrote that “Accelerated
Approval is not supposed to be the backup that you use when your
clinical trial data are not good enough for regular approval.”
Monday’s announcement was followed by a surge in Biogen shares.
Kesselheim’s departure followed the resignation of two other members of the advisory panel this week.
They included Mayo Clinic neurologist David S. Knopman, who
that he didn’t “wish to be part of a sham process.”
whole saga of the approval of aducanumab,” Knopman wrote in his
resignation letter, “made a mockery of the [advisory] committee’s
consultative process. While I realize that the committee is advisory,
the approval of aducanumab appears [to] have been foreordained.”
Washington University neurologist Dr. Joel Perlmutter also resigned and told
its was “due to this ruling by the FDA without further discussion with our advisory committee.”
is administered as a monthly intravenous infusion and is meant not to
stop the disease but slow the rate of a patient’s decline.
trials of the treatment, meant to be given to people very early in the
course of disease before they develop dementia, did not indicate it
helped at all. But the drug’s maker, Biogen, re-analyzed data and said
there was an indication it might help some patients. […]
Clinical trials of aducanumab were stopped in 2019 because they failed to show the drug was effective.
the drug’s maker, Biogen, re-analyzed the data and said it showed some
patients who got high doses of the drug had not improved, but had shown a
slower rate of decline than other patients.
When the committee met in November, it
at the time of “a huge danger in approving something that turns out not
to be effective,” citing “a risk of delaying good treatments and
effective treatments for more than a couple of years, for many years,”
Another panel member, Dr. Scott Emerson said, said at the November meeting, “I’m highly critical of the fact that the FDA presentation today was so heavily weighted to just giving the same conclusions that the sponsor did,” referring to Biogen.
Beyond the average $56,000 price tag per patient, there “will
probably be tens of thousands of dollars in additional costs for
screening and monitoring patients,” the
Tuesday. From the newspaper:
drug is all but certain to unleash a gusher of profits for Biogen—the
drug is expected to become one of the best-selling pharmaceutical
products in the world within a few years—as well as for the hundreds of
clinics expected to administer the drug.
Those billions of dollars in anticipated costs are likely to be shouldered largely by Medicare.
drug’s approval could drive up insurance premiums, according to
healthcare policy experts. And it could add new out-of-pocket costs for
some families that are already facing years of staggering costs for
caring for loved ones with Alzheimer’s.
from Kaiser Family Foundation released Thursday said that Medicare
recipients prescribed the drug could face co-payments of $11,500 for a
year, “which represents nearly 40% of the
$29,650 in median annual income
per Medicare beneficiary in 2019.”
Mobile Phone Users - Click 3 Dots Below to View Complete Page
AUTHOR: ANDREA GERMANOS
DATE: JUNE 12TH, 2021
BIO: Senior editor &a staff writer at Common Dreams