Moderna Therapeutics just reported that, based on early human trials, its COVID-19 vaccine is a staggering 94.5% effective at preventing infection. This is promising news for a nation whose public health and economy have been crippled by the pandemic. And it wouldn’t have been possible, especially this quickly, if Moderna hadn’t skipped animal testing red tape that is typically forced on pharmaceutical companies by the Food and Drug Administration before a drug can be administered to humans.
Back in March, the company’s chief medical officer Dr. Tal Zaks stated, “I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial.” Thankfully, the FDA listened to reason and allowed human studies to proceed. But this isn’t always the case.
Other promising COVID treatments may already be available too, if not for Depression-era FDA regulations that still force drug companies to pay for slow, expensive, and misleading tests on dogs and other animals before new medicines can come to market.
For instance, an experimental drug called tradipitant has shown promise for treating COVID-related pneumonia in human trials. This same drug was put on ice by the FDA in 2018, in the middle of human trials when the company behind it, Vanda Pharmaceuticals, refused to conduct unnecessary tests that would’ve involved force-feeding puppies the drug every day for nine months and then killing them, at an estimated cost of nearly $1 million. The impasse over the FDA’s dog-testing demands tanked Vanda’s stock price and left the drug’s future in limbo.
“By not changing its outmoded approach of forcing companies to conduct unnecessary tests on dogs, the FDA not only misses the opportunity to improve safety, but also pointlessly impedes the delivery of innovative new drugs to patients who need them,” said Vanda’s CEO, Dr. Mihael Polymeropoulos.
The government’s own data shows that over 90% of drugs that pass animal testing later fail in human patients because the drugs are either unsafe or ineffective. The failure rate is even as high as 99% for some diseases, such as Alzheimer’s. It is not mysterious why: Beagles are not furry people. More effective and efficient high-tech drug testing methods are available and being widely embraced by industry, but the FDA frequently isn’t allowing them to be used for regulatory decision-making.
This means that FDA bureaucrats are routinely sending drug makers down the wrong path, creating uncertainty for patients and shareholders. One economist recently wrote in the Financial Times, “Insisting on unreliable animal tests means patients, taxpayers, investors and many others will continue to suffer harm while potentially safe and effective drugs, even for COVID-19, collect dust on the shelf. It’s time to deregulate and give pharmaceutical companies the freedom to employ the best tools science has to offer.”
Taxpayers overwhelmingly agree. Polls show that 73% of Republicans and 66% of Democrats want the FDA’s dog testing mandate abolished.
Congress is taking notice and taking action. Freedom Caucus firebrand Scott Perry of Pennsylvania and DNC speaker Rep. Brendan Boyle of Pennsylvania have just joined forces to introduce the Alternatives to Animals for Regulatory Fairness Act. The AARF Act would ensure drug makers have the freedom to avoid wasteful testing on dogs and other animals and choose the most current and effective research tools available. In the upper house, Republican Sens. Susan Collins of Maine and Martha McSally of Arizona sent a letter to the FDA urging Commissioner Stephen Hahn to prioritize the regulatory acceptance of high-tech alternatives to dog testing.
Bottom line: FDA red tape is suffocating patients, puppies, and private industry.
Private industry, which has increased R&D and reduced animal testing, shouldn’t be required by government fiat to waste millions of dollars and precious time making puppies swallow and inhale experimental drugs in dead-end tests. So, let pharmaceutical companies test on dogs if they need to. Just don’t force them.
Alyssa Hackbarth is a member of the Board of Directors for the White Coast Waste Project. Anthony Bellotti is founder and president of the White Coat Waste Project.
