02-22-2023 Primetime Living - Flipbook - Page 28
28 A Special Advertising Section of Baltimore Sun Media Group | Wednesday, February 22, 2023
Understanding clinical studies,
continued from page 8
afraid. People are overwhelmed when
they have cancer. Their lives are already
turned upside down, so they don’t always
want to opt for something different.
“There’s also an anecdotal benefit to
taking part in a clinical trial. They seem to
do better than others. Were they in better
shape when they began? It’s unknown.
But they have better outcomes in general
and they are followed for years after the
trail is completed. Maybe this is just by
virtue of participating in a trial and getting
the extra attention.”
Trials take place for a variety of reasons. Drug companies want approval for
new medications or for different applications. For instance, some medications
are used in what is termed “off label.”
That means it was found to be effective
for a condition different than what was
originally intended. Then there will be
new trials so it can be added to the label.
Trials also look for treatments that are
better tolerated and as effective as the
established standard.
Werner talks about her patients.
“There’s a motivation to participate. It
could be they’re interested in maybe
something better, something that’s scientifically different, or maybe they’re
being altruistic. I think it’s great. When
you find something that advances care in
the future, it’s great. And when you help
that individual patient, that’s great. It’s
exciting to be involved.
“We see changes in oncology all the
time. There was one case, a patient with
triple negative breast cancer – a cancer
that tends to grow and spread faster,
has fewer treatment options, and tends
to have a worse prognosis (outcome)
– when, two days prior to our meeting,
a new medication was approved, so it
completely changed her treatment.
“If I could change one thing about
clinical trials,” Werner states, “they
would be more inclusive, especially with
our aging population. We are trying to
increase diversity in participation across
all trials.”
The Baltimore Longitudinal
Study of Aging (BLSA)
Running since 1958, the NIH National
Institute on Aging’s (NIA) Baltimore
Longitudinal Study of Aging is America’s
longest continuous study of normal
aging, and it has no intention of stopping. It is a well-known data resource
for studying the aging process over
the lifetime. Today, the BLSA is worldrenowned, having generated thousands
of scientific papers and made major contributions to our understanding of what it
means to get older.
Luigi Ferrucci, M.D., Ph.D., scientific
director at NIA and BLSA’s lead researcher, is a geriatrician and an epidemiologist
who conducts research on the causal
pathways leading to progressive physical
and cognitive decline in older persons. In
September 2002, he became the Chief of
the Longitudinal Studies Section at NIA.
We spoke about the impact the BLSA
has had on geriatrics.
“The BLSA is such a unique study,”
Ferrucci starts, “you can’t imagine how
many people have gone through it. The
only way to study aging is to have
people joining a study and then evaluate
them at regular intervals for long time.
Younger and older people have gone
through different experiences in their
lives, for example the oldest were young
during the time of war. So, for someone
who is 80, there wasn’t enough food or
clean water. The BLSA is very valuable
because some of the participants have
been in the study for more than 50 years.
“When participants join the study,
they are healthy. How do we define
healthy? We use 42 specific criteria to
define ’good health’ When they develop
problems, it could be due to environmental and physical changes. For their
annual checkups, we do blood tests, a
complete physical, magnetic resonance
imaging (MRI) of the brain, CT scans
(computed tomograpy) of lower extremities – it takes three full days.
“Then there is the data. We collect
a lot of data. That enables us to create
trajectories of health, so not only do we
know how they are now, but we also
have a timeline of their health. Then, as
they develop diseases, there are clear
indications of the future. Because these
changes are detected in the individuals
and we have all the biological samples,
we can identify those who are declining
and what caused it.
“Here’s an example: Each of us goes
to get check-ups because we want
to know how we’re doing. The doctor
checks our blood pressure, looks at our
heart, looks at test results for blood and
urine. In reality, you know that things
are happening in the body. The metric
we use allows us to detect those aging
faster even though there are no physical
manifestations. We tell their doctors, and
that person decides what to do.”
It’s fascinating to know that this study
has been going on for 65 years, providing substantive information about the
aging process, even during the pandemic. During that time, the BLSA staff
did not quit. All those involved teamed
up to develop and administer two telephone surveys. This was done not only to
track BLSA participant experiences with
COVID and maintain contact safely during quarantine, but also to collect data on
previously overlooked earlier life experiences and health-related conditions.
“Fortunately, few participants contracted COVID, but all experienced
social, behavioral, and/or psychological
effects ranging from severely negative to
generally positive,” Ferrucci continues.
“Participants with high personal mastery
– an enduring personality trait of belief in
one’s ability to control important things in
their life – demonstrated the least negative impact from COVID-related restrictions. You can read a comprehensive
review of these findings online.”
Ferrucci is refining the design of the
BLSA to focus more on normal aging
and the development of age-associated
frailty. “We are now also trying to understand the biological mechanisms that
cause aging. We already know that we
don’t age at the same rate. There’s your
biological age versus your chronological
age. But in the future, you’ll go to your
doctor, and she will say, ‘Your mitochondria are now acting badly, so here’s what
we can do to make sure you age at the
proper rate.’”
Ferrucci is referring to senolytic
drugs, a class of pharmacological agents
that eliminate senescent cells. “In biology, senescense is a process by which a
cell ages and permanently stops dividing
but does not die. These (senescent) cells
remain active and can release harmful
substances that may cause inflammation and damage to nearby healthy cells.
Senescence may play a role in the development of cancer and other diseases,”
according to www.cancer.gov.
What this means is there are cells in
our body that no longer function as they
should. Senolytic drugs, a single dose
given by mouth, clear the bloodstream
of senescent or “zombie” cells.” They
also boost a key protein. Some of the
drugs are highly targeted so they kill
the senescent cells and don’t harm the
neighbor cells.
“Right now,” Ferrucci says, “there are
ongoing clinical trials of senolytic drugs
looking to reduce the problems of aging.
We will know results in a few years, and
it’s something that’s becoming true.”
Should you participate?
The BLSA is ongoing. As such, it is
recruiting participants. To participate in
the BLSA study, visit www.nia.nih.gov/
research/labs/blsa/join-blsa.
NIH conducts clinical research trials for many diseases and conditions,
including cancer, Alzheimer’s disease,
allergy and infectious diseases, and neurological disorders. For other studies,
you can visit ClinicalTrials.gov, search for
studies and trials taking place near you,
and learn whether or not it is recruiting
additional participants. If you have the
opportunity and are comfortable joining,
great. As Dr. Werner states, “Don’t ever
feel like you don’t have a choice. You do.
Always.”
Should you decide to join a study or
trial, know that your contribution is valuable and valued. It’s another way we can
all give back.