So many times people say, oh, but we cannot replace animal testing. Well, that’s what the cosmetic industry used to say 20, 30 years ago. It took the work of advocates and animal protection advocate organizations that forced the cosmmetics.
CEO and Co-founder of the Center for Contemporary Sciences, Dr. Aysha Akhtar M.D., M.P.H., was interviewed by Dr. Erika Gebel Berg Ph.D., Director and Science Editor of the Science Custom Publishing Group. This podcast interview was originally broadcasted and transcribed by the Science Podcast. The conversation included context around the historic achievement of the FDA Modernization Act 2.0 passed in 2022, the downside to animal testing, and the relevance of human biology-based methodologies for drug research and development.
The Center for Contemporary Sciences
The
FDA Modernization Act 2.0 is a historic achievement in
that the law passed on a unanimous vote across the political
spectrum, highlighting the recognition on both sides of the aisle
for the need to shift toward human-relevant R&D methodologies
Despite conventional animal testing, more than 9 out of 10 drugs and
vaccines that cross animal tests end up failing when tried in
humans. It’s the differences between human biology and animal
biology that are problematic for drug and therapeutics R&D
There are deeply entrenched cultural barriers that still exist within the scientific fields and within scientific journals as well that prevent the accelerated adoption of human-relevant methodologies
Complete Podcast Transcript
Erica Berg: Hello to our listeners, and welcome to
the sponsored interview from the Science AAAS Custom Publishing
Office, and brought to you by Michelson Philanthropies. I’m Erica
Berg, director and Senior Editor for Custom Publishing at Science.
Today I am delighted to welcome Dr. Aysha Akhtar, a leader in the
fields of animal ethics and neurology. We’ll be having a
conversation about how a recent law and advances in technology could
someday soon allow scientists to develop a new drug without lab
rats. Thank you so much for joining Dr. Akhtar.
Aysha Akhtar: Thanks so much for having me here,
Erica.
EB: Before we get started, I wanted to share that
I recently had the chance to catch up with Dr. Gary Michelson about
how this new law came to pass. In addition to the Michelson Medical
Research Foundation, he established the Michelson Center for Public
Policy, which advocates for increased funding for biomedical
research equity in higher education and animal cruelty prevention
working with federal officials. He helped secure the passage of the
FDA Modernization Act 2.0, which was signed into law in 2022. Here’s
what Dr. Michelson had to say about this historic achievement.
AA: “What made this particular piece of legislation
truly remarkable was that you had Rand Paul and Cory Booker, who are
sort of the bookends on the political spectrum coming together in
recognition of how important this was. And then I think the more
remarkable part that nobody believes when I tell them is it actually
passed on a unanimous vote. When you tell anybody it was a unanimous
vote in that year, they go, “No, it never happened.”
EB: It’s always nice when government works, isn’t
it? Aysha, my first question for you is about the FDA Modernization
Act 2.0. My question is, what does that law modernize, and why?
AA: Currently the Food and Drug Administration or
the FDA requires that all new drugs and vaccines have to be tested
on two animal species before the FDA allows them to move on to be
tested in human clinical trials. And so that was actually a
regulation that evolved from a law called the Federal Food Drug and
Cosmetic Act of 1938. The FFDCA of 1938 was in response to a couple
of problems that happened. There was a sulfa drug, an antibiotic
drug that the company wanted to make it sweeter, so it was more
palatable for children. In order to make it sweeter, what the
company did was they add ethylene glycol, which is antifreeze that
led to more than a hundred deaths, many of them, or most of them in
children. Basically, the sulfa drug situation led to this
requirement that all new drugs and vaccines have to be tested on
animals before they can be tried in humans and approved for the
market. So the Food and Drug Modernization Act 2.0 basically updates
that depression-era law by saying, yeah, if you want to do animal
testing, you can, but you can also use other more cutting edge, more
innovative, and more modern techniques in place of animal testing if
you want. So it catches up the law to the science.
EB: From a purely scientific perspective, what are
the downsides of using animal models to stand in for humans?
AA: We now know that despite the animal testing,
more than 9 out of 10 drugs and vaccines that cross animal tests end
up failing when tried in humans. There are many things that we share
with the biology of a rat and a dog and a non-human primate,
including chimpanzees, but it’s the differences between our biology
and the biology of these other animals that are causing the problem.
EB: I’m gonna switch gears a little bit now to talk
about the alternatives. I’ve done a bit of reading about the
technologies that are currently in development as replacements for
animal models, and they sound like they’re all straight out of
science fiction. Can you tell me about the leading animal
replacement technologies? Let’s start with organoids.
AA: Sure. I know they sound so fascinating, and if
you look at them at the images and the videos of them, they’re quite
cool. Organoids are basically miniature organs that you grow in the
lab using, for example, adult stem cells and they mimic the
physiology of that actual organ. They mimic the function, the
biology of that actual organ. You can use them also to test whether
a drug is going to be safe in that organ and whether a drug will
work in that organ.
EB: Another technology I read about is called organ
on a chip or animal on a chip or human on a chip. What can you tell
us about those?
AA: Right. So the organ on a chip goes even further
than the organoids because it’s in a setting that mimics the actual
setting of the organ in the human body. So a lung on a chip actually
breathes and functions like a major part of the actual lung in human
body. So one day what’s gonna happen, Erica, is that a researcher is
going to be able to take my cells and create my organs on a chip and
integrate them to create an Aysha body on a chip. You’re gonna be
able to take your cells and create an Erica on a chip so that they
can use your body on a chip to actually screen drugs to see if
they’re actually going to be safe in your body, and if they’re
actually gonna work against any of the diseases you may experience.
Erica on a chip someday. Okay. [chuckle]
EB: So the other bucket of technologies I was
reading about sort of away from the wet lab and into a computer.
What can you tell me about how far we’ve come and the uses of
virtual cells or virtual organs, virtual animals? Where are we with
those technologies and how do they work?
AA: You can call it a digital twin or a virtual
patient. And a virtual patient basically is capturing data from
multiple sources, which could be population data, clinical trial
data, electronic health records, and basically it combines multiple
different types of testing methods and data sources.
EB: What is the idea for how these technologies
would actually be incorporated into the drug development process to
replace animal models?
AA: So right now many of these techniques are being
used in the drug development process, but sort of alongside animal
testing, which quite honestly doesn’t make sense because these other
methods can so far outperform the animal tests and be such better
predictors of human outcomes than the other tests. I think what’s
gonna happen is that as the field becomes more and more comfortable
and confident and experienced with using these newer methods,
eventually they will replace the use of animals. Totally. And they
will be used to predict whether a drug will be safe and effective in
humans. As a matter of fact, we can actually use these technologies
one day to perform human clinical trials that are in the lab.
EB: What are the hurdles that are preventing
scientists from using these technologies to replace animal and I
guess human trials as well?
AA: Regulatory agencies still require animal
testing. So even though that law, the FDA Modernization Act does not
require animal testing for drug development, it still leaves the
decision-making ultimately at the hands of the Food and Drug
Administration. There’s regulatory barriers and there’s funding
barriers. There are also publication barriers. I’ve heard from
numerous scientists that are working on these more advanced
technologies that when they try to publish their results, they get
kickback from the scientific publication saying, “No, we want to
also see these results in animal experiments.” So there’s this
entrenched cultural barrier that exists within the scientific fields
and within scientific journals as well. So all of those barriers
still need to be removed.
EB: Aysha, are there success stories from other
industries that you can talk about and how they reduced their
dependence on animal testing?
AA: Yeah Erica, that’s a great question. So many
times people say, oh, but we cannot replace animal testing. Well,
that’s what the cosmetic industry used to say 20, 30 years ago. It
took the work of advocates, animal protection advocate organizations
that forced the cosmetic industry to change. Animal testing is
hardly done now for cosmetics.
EB: Aysha, is there anything else you’d like to
share with us today? We’re running low on time, but I just wanted to
give you one more opportunity to share insights with us.
AA: I think Erica just thank you so much for having
this conversation, for talking about such a needed topic. I would
just add that I’m really truly excited about where we’re headed in
medical science.
EB: Aysha, thank you so much for taking the time to
talk with me today. These are indeed exciting times to live and to
hope that the next big life-saving drug may not need to come at the
expense of animals. To learn more about the work that Dr. Akhtar and
her colleagues are doing, please visit contemporarysciences.org. Our
thanks to Michelson Philanthropies for making this conversation
possible. And thank you to Chris Connor for audio support. And
finally, thank you, dear listener, for spending this time with us.
AA: I think Erica just thank you so much for having
this conversation, for talking about such a needed topic. I would
just add that I’m really truly excited about where we’re headed in
medical science.
EB: Aysha, thank you so much for taking the time to
talk with me today. These are indeed exciting times to live and to
hope that the next big life-saving drug may not need to come at the
expense of animals. To learn more about the work that Dr. Akhtar and
her colleagues are doing, please visit contemporarysciences.org. Our
thanks to Michelson Philanthropies for making this conversation
possible. And thank you to Chris Connor for audio support. And
finally, thank you, dear listener, for spending this time with us.