Bioprinted organ models, organ-on-a-chip models, “virtual humans,” advances in stem cells, and artificial intelligence applications have been developed to predict human responses to new drugs more accurately and more quickly. The benefit these methods offer is that they are based on human biology, not mouse or pig or other animal biology.
From every sector, the cry is being raised: “We can’t go back to the
way things were before the pandemic.” CEOs and politicians,
educators and entrepreneurs, health professionals and scientists,
all urge the importance of taking stock, adjusting, and learning.
One sector in which this must happen now is drug development, where
an 83-year-old rule requiring that drugs be tested in animals
impedes the development of life-saving medicines.
The 1938 Federal Food, Drug, and Cosmetic Act requires that every
drug be tested on animals — even though more than 90% of drugs found
to be safe and effective in animals fail during human clinical
trials, and even though safer and more effective methods of drug
testing have been developed since then.
If Robert Califf, the new director of the Food and Drug
Administration, and a bipartisan group in Congress follow through on
their promises, the animal testing requirement could be history.
In response to a written “Question for the Record” submitted by Sen.
Rand Paul (R-Ky.) during the Califf confirmation hearing, the
then-nominee wrote, “We are entering a new era of systems biology
with computational methods that enable a more efficient pre-clinical
and clinical development and evaluation approach to drug and device
development. I support the shift toward the use of non-animal
methods where scientifically supported, and if confirmed would work
to ensure the Agency continues its strong commitment to supporting
the 3Rs: to replace, reduce, and refine the use of animals in
studies.”
The FDA Modernization Act of 2021, initially introduced in the House
of Representatives and later in the Senate, is supported by a
bipartisan group of lawmakers that include Reps. Vern Buchanan
(R-Fla.) and Elaine Luria (D-Va.) and Sens. Paul and Cory Booker
(D-N.J.). This act would allow companies to use methods more
advanced than animal testing to examine a drug’s safety and
effectiveness.
The issue of requiring animal testing isn’t limited to the west side
of the Atlantic. The European Parliament adopted a resolution in
2021 — by a vote of 667 to 4 — to phase out animal testing.
Many alternatives to animal testing — cell-based assays, organ chip
systems, computer modeling, and the like — are already a trusted
part of the research establishment and are proving to be more
effective than animal testing in predicting whether drugs will work
and be safe in humans.
The delay in development and bringing new drugs to market caused by
animal testing aren’t just theoretical. Cyclosporine, a drug now
widely and successfully used to treat autoimmune disorders and
prevent organ transplant rejection, was delayed because it failed in
animal testing. No one really knows how many drugs have been
rejected for failing animal tests that may have proven to be safe
and life-saving for humans.
The development of vaccines for Covid-19 provides a powerful example
of how using alternative methods can speed development. It took just
63 days from the time the sequence of the virus was made known to a
human volunteer getting the first vaccine dose.
The rules were relaxed to speed along a process that normally takes
10 to 15 years, part of which is taken up with animal testing. Even
so, vaccine developers were required to do animal testing
concurrently to follow the law, though perhaps unnecessarily.
To be clear, the FDA Modernization Act neither limits nor forbids
animal testing. Instead, it merely lifts the requirement for animal
testing, which lets the FDA authorize the best testing methods —
animal or non-animal — to determine the safety and effectiveness of
new drugs and vaccines. It allows research to move forward with
testing that is more relevant to human health than animal testing.
Bioprinted organ models, organ-on-a-chip models, “virtual humans,”
advances in stem cells, and artificial intelligence applications
have been developed to predict human responses to new drugs more
accurately and more quickly. The benefit these methods offer is that
they are based on human biology, not mouse or pig or other animal
biology.
The use of test methods based on human biology could cut in half the
time to market for new drugs and reduce costs as much as five-fold.
During the Covid-19 crisis, government officials and scientists
brought urgency to the pandemic response, cut through organizational
red tape, and developed successful vaccines in less than a year. The
FDA and academic and biopharma researchers cannot, and should not,
go back to a pre-pandemic mindset when it comes to medicine and
research.
Gary K. Michelson is an orthopedic surgeon and founder and co-chair of the Michelson Medical Research Foundation and the Michelson Center for Public Policy. Aysha Akhtar is a neurologist, preventive medicine/public health specialist, and cofounder and CEO of the Center for Contemporary Sciences. Both organizations advocate for reduced animal testing.