WEATHER WATCH
Drug-testing on puppies: new report asks for alternative testing at FDA labs
FDA IN SILVER SPRING, MD Source: 7NEWS

A new report details experiments are being done on puppies to develop new drugs for humans under the watchful eye of the FDA.

White Coat Waste Project, a D.C.-based tax-payer watchdog group, wants the FDA to fund more research into developing alternative testing.

Read the entire report here: WCW: Broken Bureaucracy

“Have you been able to determine if the FDA is just behind the times or what is the reasoning for this?” asks 7News I-Team Reporter Scott Taylor.

The reason is nearly a century old law states that new drugs have to be tested on animals and then humans and because this law was written in the 1930’s it doesn’t account for new technology that can replace animal testing that is outdated and the FDA itself admits it fails 95 percent of the time to predict what happens in people,” says Justin Goodman with White Coat Waste Project.

White Coat claims up to 20,000 puppies and dogs a year are abused or killed in FDA-sanctioned experiments.

Justin Goodman with White Coat Waste Project speaks with 7News I-Team investigator Scott Taylor.

It looked at almost 200 new drug applications submitted to the FDA.

Some pharmaceutical companies like Vanda Pharmaceuticals, based in the District, are refusing to launch experiments with the FDA that would end up euthanizing dogs.

“We see time and again that companies are being forced to poison puppies as young as a week old. Force them to ingest massive overdoses of experimental drugs. In some cases, some companies are taping the dog’s mouths shut,” adds Goodman.

The FDA won't answer our questions on camera but did email the following response:

"To clarify, the FDA requires that an FDA-approved medical product must be demonstrated to be safe and effective. The FDA does not mandate that human drugs be studied in dogs.

Generally speaking, as the principal agency responsible for the protection of public health, the FDA plays a critical role in new drug and vaccine discovery. The FDA, specifically the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), ensures that safe and effective drugs, vaccines, and other biologic products are safe, effective, and available to support and improve human health in the United States. While the FDA often advises the regulated industry on approaches that may be taken to address the scientific, regulatory, and statutory considerations to obtain marketing approval for a proposed drug product, the regulated industry is ultimately responsible for designing, conducting, analyzing, and then submitting to the FDA scientific studies (i.e., humans, animals and in vitro) to support a demonstration that a proposed drug is safe and effective for the intended use. As a result, even though early FDA involvement is encouraged, the FDA is not always involved in the design of animal studies, which are typically designed very early in the development program. If, however, completed studies are ultimately submitted in support of a marketing application for a drug, the FDA generally will review the studies that are submitted.

While the FDA is committed to doing all that it can to reduce the reliance on animal-based studies, there are still many areas where animal research is necessary because the current state of science does not support the replacement of all animal studies with non-animal methods. Current non-animal methods cannot always predict effects that occur in highly complex interacting systems (such as the human body). Additional research is necessary before alternative methods can be used routinely for addressing such complex issues. It is also worth noting that without the use of animals, it would be impossible to gain some of the important knowledge needed to prevent human and animal suffering for many life-threatening diseases. Animal research has played an important role in advancements such as preventing polio, eradicating smallpox, and identifying new cancer treatments. Animal research today continues this important role. For example, animal studies have been highlighted in contributing to the expedited development of treatments and vaccinations for COVID-19. We understand and share concerns that animals be involved in research only when there is no other way to fulfill an important public health objective. And, when these studies are necessary, the animals involved in research must be cared for under strict, humane guidelines.

Regarding your question on vaccines, please see the FDA Decision Memos for each of the FDA-authorized vaccines, which include information on, and results of the animal studies conducted for each FDA-authorized COVID-19 vaccine: Pfizer BioNTech, Moderna, and Janssen. It is important to point out that the animal studies used in the development of a safe and effective vaccine (e.g., which generally/often are only administered once or twice) significantly differs from the animal studies often used in the development of a drug that may be administered more chronically. This is, at least in part, because the potential risks associated with one or two exposures to a substance is fundamentally different from something that may be administered daily for a long period of time.

The FDA is committed to doing all that it can to reduce the reliance on animal-based studies. The FDA has already taken significant steps to reaffirm and strengthen our commitment to replacing, reducing, and/or refining animal studies, often referred to as the “3Rs,” and support the development and use of alternative methods (such as assays and technologies like organs-on-a-chip). We’ve formed the Modeling and Simulation Working Group to accelerate the adoption of modeling and simulation tools in product development and evaluation; initiated the Toxicology Working Group, which has developed a roadmap for integrating emerging predictive toxicology methods and new technologies into regulatory safety and risk assessments; and initiated the Alternative Methods Working Group (Advancing Alternative Methods) to support the advancement of new technologies as alternatives to animal testing. CDER has recently published a review of its efforts to support the 3Rs in carrying out its health mission mandate. The FDA also participates in the Interagency Coordinating Committee on the Validation of Alternative Methods.

These are just some of the many FDA initiatives underway to reduce reliance on animal studies. The FDA will update our progress on alternatives in real-time for our stakeholders on our website."

A new bill in Congress called the Alternatives to Animals for Regulatory Fairness Act is asking that the Feds give drug companies the freedom to avoid any dog testing and use more productive testing methods.

Earlier this year, lawmakers on Capitol Hill in a letter requested an investigation into the FDA as they're concerned about its failure to develop alternatives to animal testing.

"Science has come a long way and there are now better ways to assess the safety of drugs than conducting deadly experiments on puppies that are detailed in White Coat Waste Project’s troubling new report. Current law fails to account for newer, modern approaches to drug development that do not involve testing on dogs or other animals. I am proud to lead the Alternatives to Animals for Regulatory Fairness Act to modernize FDA rules to allow the use of more humane, economical, and effective testing alternatives. Especially when animal tests often poorly predict human outcomes, there is no reason we need to require them," says U.S. Congressman Brendan Boyle (D-PA).

“It is unnecessary and cruel for the FDA to mandate animal testing on dogs when there are other, better alternatives available. I am proud to sponsor the AARF Act to put an end to needless animal testing and allow drug makers to pursue humane solutions for testing that will improve animal welfare while also saving valuable time and money," adds U.S. Congressman Fred Keller (R-PA).

Americans For Medical Progress, which supports animal research, says:

Animal studies have and continue to play a critical role throughout the entire health research process. Research in animals helps us understand how living systems work. It helps us identify the factors behind countless diseases that impact both humans and animals. It also provides important information utilized to develop candidate treatments and cures that when successful, go on to be used in doctors’ offices and veterinary clinics around the globe.

Americans For Medical Progress adds:

"On top of that, animal studies are also vital for ensuring the drugs we take and give to our loved ones are safe. The FDA’s drug review process is internationally respected for its thoroughness and deep commitment to safety. As a result, drugs are rarely recalled or pulled from pharmacy shelves. This tremendous level of success is due, in great part, to safety studies in a variety of animals, including dogs. Contrary to animal rights claims, no existing technology is sophisticated enough to replace all animal studies and mimic an entire living body along with its countless functions. Furthermore, a variety of species must be studied because different animals align with human health in different ways. For example, humans and dogs can suffer from similar forms of cancer and therefore new treatments can benefit both species.

Everyone, especially scientists and physicians who dedicate their careers to fighting disease, supports efforts to reduce the need for animal studies. And in some select areas, animal research is no longer needed. However, because the stakes are so high, this is a slow and careful process that must be led by sound science. Timetables should be set by health experts, not by lobbying groups or those willing to place their own personal agendas above the health and welfare of the public.

The current pandemic has repeatedly demonstrated the critical need for animal studies. Animal research helped scientists develop safe and effective vaccines in record time. The groundbreaking use of mRNA snippets to fight the coronavirus - an approach used in both the Pfizer and Moderna vaccines - was developed years ago in animal studies. Animal research also demonstrated how the virus spreads, helping us prevent transmission. Studies in animals over several decades gave us the previously FDA-approved drugs that we are now using to fight the disease in infected patients. At the same time, animals are helping us develop new and better therapies so we can save even more lives."

Doctor Paul Locke, an award-winning scientist with Bloomberg School of Public Health at John Hopkins University says emphasis needs to be placed on alternative testing.

"If we don't invest in that research and make it a priority it just isn't going to happen fast enough and that is going to be bad for animals," says Dr. Paul Locke with John Hopkins University’s Bloomberg School of Public Health.

It's going to be bad for public health protection and it’s not going to get us the sort of drugs that we need for 21st-century public health protection.

Read the full letter to the FDA from members of Congress, below: 

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