Sixty-nine year-old runner and Alzheimer's patient Bill McKay hopes the new Biogen drug will get his life back on track, but his doctor cautions patients not to look to Aduhelm as the holy grail.
For 69-year-old Bill McKay, the FDA’s approval this week of Biogen's controversial Alzheimer’s drug offers hope that the veteran of 29 marathons can keep on running.
“Let's work on just being healthy and trying to extend my life as far as it will go.” His wife Jill is hopeful the treatment will prevent her husband, who is in the early stages of the disease, from getting lost along the way.
“That's a big worry for me.
I work full time and so I'm not home during the day, and he goes out for a run.
I wonder, am I going to get that phone call?
‘Bill should have been back 45 minutes ago, and we don't know where he went.’" Bill McKay already qualifies for Biogen's drug, called Aduhelm - the first new treatment for Alzheimer's in nearly two decades and the first to target a cause of Alzheimer’s by removing amyloid plaques from the brain.
But the drug’s approval comes with major asterisks: in two large clinical trials, Aduhelm showed a benefit in one but not the other, and a panel of outside experts said the data failed to prove that the medicine works.
And some trial patients experienced potentially dangerous brain swelling.
It’s why his doctor, Michigan neurologist Cara Leahy, is adamant about cautioning patients not to look to Aduhelm as the holy grail.
"So, there is going to be a lot of important education that we discuss with patients with a realistic idea of what this medication is and what it is not, so to make sure that patients understand this is not a cure, that we are hoping that it has some ability to slow down the progression for patients, but that the learning about this medication is ongoing.” The FDA has required a post-approval trial to demonstrate that Aduhelm does in fact slow cognitive and functional decline, but that could take years.
Its price tag?
Roughly $56,000 per year - although it’s not yet clear yet how much the drug will cost patients like Bill McKay, most of whom will be covered by Medicare.
Despite questions about the drug’s effectiveness and cost, the McKays have gone ahead and scheduled an appointment with Dr. Leahy for next week.
[BILL MCKAY]: “I certainly want to be active and certainly be part of my family life - and be a plus to the general population in this area and anywhere else I could be of service to.” More than 900 medical centers will start intravenous infusions of the drug in as soon as two weeks.
Latest Weight-Loss Drug , Faces Shortages .
The United States Food and Drug Administration
(FDA) says that high demand has left the latest
weight-loss drug, Zepbound, in short supply.
'Newsweek' reports that the Eli Lilly product
is expected to experience limited availability
through Q2 of 2024 as surging demand has
outpaced the manufacturer's expectations.
We have experienced
an unparalleled surge in
demand for our type 2
diabetes and obesity medicines, Eli Lilly spokesperson, via 'Newsweek'.
We recognize this situation may
cause a disruption in peoples'
treatment regimens and are
working with purpose and
urgency to help meet
the surge in demand, Eli Lilly spokesperson, via 'Newsweek'.
The FDA said that Novo Nordisk's weight-loss
drug, Wegovy, is also experiencing a
widespread supply shortage with no end
in sight for the drug's limited availability.
By the year 2030, 'Newsweek' reports
that the weight-loss drug market is
expected to grow to about $100 billion.
We expect our investments
in manufacturing and supply
capacity to progressively increase
production of our medicines
throughout 2024 and beyond, Eli Lilly spokesperson, via 'Newsweek'.
Over the past year, manufacturer Eli Lilly
has already seen share prices rise over 102%.
The company has announced plans
to expand operations to meet increased
demand for its incretin products which are
used in the firm's diabetes treatments. .
Incretin mimics gut hormones
that regulate blood sugar
while also suppressing appetite
Credit: Wibbitz Top Stories Duration: 01:30Published
Experts' Tips on Taking, Supplements as Sleep-Aids.
'Time' recently spoke with experts regarding
over-the-counter sleep aids and whether they
can really help someone with insomnia.
'Time' recently spoke with experts regarding
over-the-counter sleep aids and whether they
can really help someone with insomnia.
Melatonin has become a popular
supplement in recent years for being
a safe and effective sleep aid.
According to a 2023 study by the American Academy of Sleep
Medicine (AASM), nearly two-thirds of people in the
United States have tried using melatonin to help them sleep. .
It’s not something that is generally
harmful or toxic, which is probably
why people are tempted to take
more when a little bit doesn’t work, Dr. Milena Pavlova, neurologist at Brigham and Women’s
Faulkner Hospital and an associate professor of
neurology at Harvard Medical School, via 'Time'.
'Time' points out that supplements, such as
melatonin, are not regulated by the
U.S. Food and Drug Administration.
Similar to melatonin, over-the-counter antihistamines
like Benadryl have become a popular sleep-aid due to
containing doxylamine, which causes drowsiness.
However, doxylamine also comes
with a number of side effects,
including a potential hangover the next day.
The big problem with antihistamines
is they can make people extremely
groggy and really impair cognitive
function the next day, Dr. Indira Gurubhagavatula, professor of medicine
in the division of sleep medicine at the
University of Pennsylvania, via 'Time'.
While antihistamines can induce
drowsiness, they don't normally
result in quality, restorative sleep.
Experts suggest eliminating things that prevent healthy sleep, like alcohol and caffeine, while also incorporating physical activity into your daily routine.
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA to Outlaw Soda Ingredient , Already Banned Around the World.
Brominated Vegetable Oil (BVO) has been used as an emulsifier in various products
since the 1930s, ScienceAlert reports. .
Countries such as India, Japan and nations within
the European Union have banned BVO for years.
California also outlawed it in 2022.
Studies have indicated that BVO builds up in fat tissue when consumed and prevents iodine from properly functioning within the thyroid. .
BVO has also been linked with heart and behavioral problems, ScienceAlert reports. .
Recent toxicology studies prompted
the Food and Drug Administration (FDA)
to propose banning BVO in November.
The proposed action is an example of how
the agency monitors emerging evidence
and, as needed, conducts scientific research
to investigate safety related questions, , James Jones, FDA deputy commissioner
for human foods, via ScienceAlert.
... and takes regulatory action when the
science does not support the continued
safe use of additives in foods, James Jones, FDA deputy commissioner
for human foods, via ScienceAlert.
Over the years many beverage makers
reformulated their products to replace
BVO with an alternative ingredient, and
today, few beverages in the US contain BVO, James Jones, FDA deputy commissioner
for human foods, via ScienceAlert.
The FDA's BVO reclassification will still need to
go through a review process before completion.
James Jones, FDA deputy commissioner
for human foods, said that regulations
for authorizing other food additives are
currently being reviewed by the agency...
... in order to automatically block
the approval of ingredients known to
cause cancer in animals or humans
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Warns These , Cinnamon Brands , Could Contain Lead.
NPR reports that the Food and Drug Administration
has issued an advisory that several brands
of cinnamon could potentially contain lead.
The six brands impacted by the advisory are: , La Fiesta, Marcum, MK, Swad,
Supreme Tradition and El Chilar. .
These brands are commonly on sale at
discount stores and were found to contain
between 2.03 and 3.4 parts per million of lead.
The FDA said that while no illnesses have been
linked to the products, it has recommended
a voluntary recall of the cinnamon brands.
It is important to note that the lead
levels found in the ground cinnamon
products listed above are significantly
lower than lead levels in cinnamon in
the recalled apple sauce pouches
removed from the market this past fall, FDA statement, via NPR.
The FDA added that the impacted products , "could be unsafe for prolonged use.".
NPR reports that long-term lead exposure
in children can lead to slower development,
brain and nervous system damage,
as well as behavioral and learning problems.
According to the CDC, while adults
can experience similar impacts, higher
amounts of exposure are necessary.
The FDA said that "historically, lead chromate has
been illegally added to certain spices" to increase
their weight and enhance their color, "which
increases the monetary value of the adulterated spices." .
FDA's leading hypothesis
remains that this was likely
an act of economically
motivated adulteration, FDA statement, via NPR
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Approves Marketing , That Cites Yogurt's Ability , to Reduce Diabetes Risk.
NBC reports that the Food and Drug Administration
has decided that food makers can advertise
that regularly consuming yogurt could
reduce the risk of Type 2 diabetes.
NBC reports that the Food and Drug Administration
has decided that food makers can advertise
that regularly consuming yogurt could
reduce the risk of Type 2 diabetes.
The decision comes following a 2018 petition from
Danone North America, which owns major yogurt
brands Dannon, Activia, Wallaby Organic and Silk. .
The decision comes following a 2018 petition from
Danone North America, which owns major yogurt
brands Dannon, Activia, Wallaby Organic and Silk. .
The petition sought to have the FDA allow the
company to market yogurt's ability to reduce
the risk of Type 2 diabetes without objection.
On March 1, the FDA confirmed that
it would not oppose the marketing
campaign, while including some caveats. .
Those caveats include that the marketing must
note that evidence is limited to eating two cups,
equal to three servings, of yogurt per week. .
NBC reports that Danone's petition is
part of a standard process which the
FDA calls "qualified health claims.".
While these claims do not require the FDA's
approval, companies often petition the
agency to define the specific language
necessary to avoid making false claims.
The petition reportedly cited yogurt's nutrient
profile of proteins, vitamins and low sodium.
The petition also cited studies which have supported
the link between regularly consuming yogurt and
reduced risk of diabetes and related conditions.
The petition also noted that
the evidence supports the health
effects of yogurt as a food rather
than related to any single nutrient
or compound and thus is
independent of fat or sugar content. , FDA announcement, via NBC
Credit: Wibbitz Top Stories Duration: 01:31Published
Newly-Discovered Gene Variant , Could Help Prevent or Treat , Alzheimer's Disease.
'Newsweek' reports that scientists have uncovered
a genetic variant that has the potential to reduce
the odds of developing Alzheimer's by as much as 70%.
The discovery could reportedly lead to new methods to
effectively treat or prevent the disease which impacts
approximately 5.8 million people in the United States alone.
Some genetic variants have been found to have an
association with an increased likelihood of developing
the disease, while other variants offer protection. .
A team from Columbia University found that
genes involved with the production of fibronectin
play a crucial role in developing Alzheimer's.
Healthy individuals usually only have fibronectin present
in small amounts along their blood-brain barrier, while
those with Alzheimer's have much higher quantities.
It's a classic case of too much
of a good thing. It made us think
that excess fibronectin could be
preventing the clearance of [abnormal
protein clumps] from the brain, Caghan Kizil, co-leader of the study and professor of
neurological sciences at Columbia University's Vagelos
College of Physicians and Surgeons, via 'Newsweek'.
The team believes that methods aimed at reducing
fibronectin could play a crucial role in developing
new treatments and preventative measures. .
Anything that reduces excess
fibronectin should provide some
protection, and a drug that does
this could be a significant step
forward in the fight against
this debilitating condition, Caghan Kizil, co-leader of the study and professor of
neurological sciences at Columbia University's Vagelos
College of Physicians and Surgeons, via 'Newsweek'.
Our findings suggest that...
we may be able to develop new
types of therapies that mimic
the gene's protective effect
to prevent or treat the disease, Caghan Kizil, co-leader of the study and professor of
neurological sciences at Columbia University's Vagelos
College of Physicians and Surgeons, via 'Newsweek'.
The Columbia University team's
findings were published in the
journal 'Acta Neuropathologica.'
Credit: Wibbitz Top Stories Duration: 01:31Published