The FDA Modernization Act & Alternative To Animal Testing

It takes nothing away from a human to be kind to an animal.

- Joaquin Phoenix

It's legal to torture animals, inject them with cancer and zillions of other diseases for the lifestyle choices humans make. 

Understand - dogs like Neo, cats like Fluffy and Garph are also tortured as part of this legality. 

This is the world we live in where "pursuit of happiness" is part of the declaration of independence. 

In 2024 even this FDA Modernization Act doesn't ban this legal torture but wants to reduce it (good step for sure). 

Animal testing doesn't work. To be clear to most humans who don't care about animals - these drugs don't cure you and it is harmful to you since testing was not done apples to apples (don’t trust me? read the side effects of every medicine we have under the sun) 

So why are we testing on animals? In Bill Clinton's famous phrase - because they can. 

Nobody gives a fuck about animals. But I am sure you give a fuck about you and your family so this is not good for you. Plus bad for shareholders too. 

I lost Max to cancer and my favorite Oncologist Azra Raza lost her husband to cancer. I read her a book few months after Max passed away (three part post here, here & here) and had a huge emotional impact on me. 

Now Dr. Pandora Pound sets out an argument against animal testing in here new book Rat Trap: The Capture of Medicine by Animal Research - and How to Break Free:

Like most people, I have friends and family who have suffered – or are suffering – from a common condition for which there is no known cure. Given that we are so technologically advanced – we can send people into space for months at a time! – why have we been unable to make significant inroads into our most common diseases? Why are there so few options for people with stroke and Alzheimer’s disease (AD)? Why, for some cancers, are we still using the same toxic drugs we used 50 years ago? 

At the beginning of her career in the 1970s, Azra Raza, from the Herbert Irving Comprehensive Cancer Center at Columbia University, treated acute myeloid leukemia patients with a toxic combination of drugs known as “7+3.” All she has to offer them today is the same noxious cocktail.

What went wrong? Why are the billions of dollars we pour into research not coming up with the goods? Well, let me share the argument I set out in Rat Trap: The Capture of Medicine by Animal Research - and How to Break Free. In short, I believe that much of the problem can be blamed on our reliance on animal models. Experiments on animals are justified on the basis that they produce benefits for humans, but can we honestly say – after decades of research using animal models of human diseases – that we have really benefited? 

Of course, there are cases in which animal use has been associated with medical progress, but surely a successful paradigm needs to get it right reliably and consistently. We often hear that 90 percent of drugs tested for safety and efficacy in animals go on to fail when tested in humans. But in some areas, the failure rate is even higher (it’s closer to 100 percent for stroke and AD, while for traumatic brain injury it is 100 percent) – and that’s after 70 years of trying. Animal models are simply not good at generating effective drugs for humans. Nor are animal tests able to reliably ensure the safety of medicine. If a test shows that a drug is not toxic in an animal, there is no guarantee that the results will be reflected in humans.

As 2022 drew to a close, President Biden signed into law the FDA Modernization Act, replacing a 1938 Act that mandated that all new drugs be tested on animals. In other words, the FDA is now able to consider data obtained from a wide range of research methodologies, including human cell-based approaches, such as organoids and organs-on-a-chip, in silico modeling, and AI. The new law doesn’t ban the use of animals, but it does recognize the limitations of relying on them in drug discovery and development. Organ chips can outperform animal tests in detecting drugs that will be toxic to humans, and experts claim they are capable of doing things that animal models have never been – and never will be – able to do. US companies now have the freedom to choose whatever method they consider most scientifically appropriate when developing and testing their new drugs.

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Now that the US regulator has acted, perhaps others, such as the EMA, will follow suit. There is certainly a great desire for change within Europe. In 2021, the European Parliament voted by a staggering 667:4 in favor of an EU-wide plan to phase out the use of animals in experiments. But if regulators don’t take the hint, perhaps shareholders will force change. Whether motivated by a desire to invest in ethical companies or companies that deliver greater profits, shareholders will find much to interest them in biotech companies that are developing human biology-based approaches. Such companies, by focusing on technologies that are directly relevant to humans, are likely to provide benefits to patients, improve public health, avoid harm to animals, and deliver larger dividends to shareholders. 

I want to see this legal torture end before I die but I don't want to be alive with the assistance of the drugs developed from this legalized torture.