Kansas and Missouri senators can help leave outdated animal drug testing in the past

Our nation’s public-private partnership that has guided formulation, testing and delivery of drugs to patients — from cancer treatments to pain medications to neurological problems — is badly in need of a reboot. The FDA Modernization Act — which would eliminate an archaic animal testing model and allow for the use of 21st century, human-based biological testing methods — would help us get there. Two U.S. senators from our region serve on the Senate Health Committee. Kansas Sen. Roger Marshall, who is a physician, has already co-sponsored this important legislation. I urge Sen. Jerry Moran to follow suit, as well as Missouri Sens Roy Blunt and Josh Hawley.

When the Federal Food Drug and Cosmetics Act was enacted in 1938, animal models seemed like the best proxy for drug developers to study how therapeutics might perform in humans. But with decades of analytics banked from common experience and reams of data, we now know that animals don’t perform very well in forecasting the human reaction to drugs. A remarkable 90% to 95% of drugs that pass animal trials fail during human clinical trials due to toxicities not predicted by animal tests or because of lack of efficacy.

The animal testing paradigm hasn’t dramatically helped our ability to cure the worst afflictions that cause suffering and death. Despite billions in funding for animal research into Alzheimer’s disease and cancer over decades, the failure rate in drug development remains around 97% for cancer and 99% for Alzheimer’s.

Differences in genetics and physiology among species can change the way a drug is metabolized by the body. As a result, the predictive value of using animals for toxicity testing is far from optimal. The intent of the 1938 requirement for animal models was to keep toxic drugs from harming patients. Yet, statistics show that these animal tests are flawed and misclassify many toxic compounds as safe. Our Kansas-based institutions, if they are liberated from a federal mandate to use an 84-year-old modality, could do even better in contributing to salutary public health outcomes for our nation.

That’s precisely why nearly 200 medical, patient advocacy, pharmaceutical and animal protection professionals have come together to promote a change in the law. The animal testing mandate is outdated, and the bipartisan FDA Modernization Act would lift that mandate. Introduced by Sens. Rand Paul and Cory Booker as S. 2952, and by Reps. Vern Buchanan and Elaine Luria as H.R. 2565, the legislation was included as a rider to a larger package of FDA reforms and passed the full House 392-28. It was also included in the Senate version of the legislation and passed out of committee. Both chambers are in negotiations to reconcile the language of the two packages, and it would be an unjust outcome if the FDA Modernization Act does not survive that process.

FDA still operating under Depression-era mandate

Non-animal methods that are superior to animal testing already exist. In a recent study, for example, researchers assessed the performance of 780 human “liver-chips” — in vitro simulations of liver tissue — across a set of 27 known toxic and non-toxic drugs. The study demonstrated that a liver-chip from biotech company Emulate was able to correctly identify 87% of the tested drugs that caused drug-induced liver injury in patients, despite having passed through animal testing, which failed to flag these adverse effects. An economic value analysis in that same study estimated that liver-chip testing could generate $3 billion in savings annually for the pharmaceutical industry due to increased research and development productivity.

Until and unless the Federal Food Drug and Cosmetics Act is changed, putting these alternatives to use isn’t an option because the Food and Drug Administration is bound by a Depression-era statute mandating animal testing. Additionally, the FDA Modernization Act maintains FDA discretion in working with drug developers to authorize the best testing methods, whether animal or non-animal in nature.

To encourage this kind of discovery and problem-solving, the United States must tweak its laws governing safety and efficacy testing, allowing drug sponsors to submit human-relevant non-animal data and find better ways to do lifesaving work. The FDA Modernization Act would serve as a trigger for catalyzing meaningful progress in modern science.

Our federal lawmakers from Kansas and Missouri can play an instrumental role in allowing Congress to move this vital policy forward to benefit patients, physicians, industry, and animals.

David Wiebers lives in Overland Park. He is emeritus professor of neurology at the Mayo Clinic in Rochester, Minnesota.