The Right To Try Bill is a new Law, which offers hope for terminally ill patients interested in trying experimental drugs that passed Phase 1 safety standards from the FDA. While encouraging, the grim reality of experimental drugs is that a large majority fail in Phase 2/3 of Clinical Trials. This is despite Pre-Clinical experiments providing evidence that these experimental drugs work in animal models. Could variable levels of Oxidative Stress in humans cause some of this failure? If true, then there may be a simple way to improve the odds of an experimental drug working for Right To Try patients. This approach should also interest Big Pharma. An Oxidative Stress Test provides feedback on lifestyle choices for lowering Oxidative Stress. This approach should be used prior to using experimental drugs for better results.
Elevated Blood Oxidative Stress May Impact Clinical Trials
The primary source of Oxidative Stress in adult Americans is from blood cells, which we call Blood Oxidative Stress or BLOS. Although about 2/3 of adult Americans are thought to suffer from elevated levels of BLOS, medical researchers do NOT control it during Clinical Trials. Control in this context means minimizing BLOS during the clinical trial. But Big Pharma has been doing this for decades and this is the right approach for evaluating experimental drugs, right?
Simple Analogy of the Evaluation of a Smart Fire Extinguisher
A simple analogy can help people, even smart people that run pharmaceutical companies, see a problem clearly.
New Products Require Systematic Testing Before Going to Market
Let’s start with a small company that designed a smart fire extinguisher and wants to evaluate it before going to market.
Let’s start with a pharmaceutical company that designed a new drug to treat a hypothetical disease and wants to evaluate it and get FDA approval.
First Product Test is the Easiest Test
This smart fire extinguisher can be controlled via radio signal by an operator off-site. The company starts with a simple pre-market experiment where the smart fire extinguisher puts out a fire in a room. The company is blissfully unaware that the real-world has a larger number of fires with radio interference. So, they didn’t bother testing their product with radio interference.
The pharmaceutical company uses a pre-clinical experiment to demonstrate that the experimental drug treats an animal model with the disease. The animal model does not have BLOS.
Final Product Tests are the Most Difficult Tests – Real World!
With great results, the company decides to test their product in a real-world building. If it doesn’t work in a real-world building, then nobody will buy it.
With great pre-clinical results, the pharmaceutical company decides to test their product in humans (Phase2/3). If it doesn’t work in humans, then the FDA will not approve it for sale.
This trial involves real buildings with fires, but there is no effort to characterize the building. Now, it is obvious that more than half of the burning buildings also have radio interference. So, the fire extinguisher designed for ideal conditions is challenged by a fire in a building where radio interference is prevalent. Will it impact the effectiveness of the smart fire extinguisher? The smart fire extinguisher fails the test, because the off-site operator can’t control it.
The experimental drug fails in Phase2/3, because they didn’t control BLOS prior to the clinical trial.
Is Big Pharma Stuck On Stupid?
Don’t worry dear reader. Pharmaceutical ompanies will continue to spend billions of dollars to develop experimental drugs in the same broken way. Why don’t they consider a simple approach to control BLOS before Phase2/3 trials?
Should BLOS be of concern for Right To Try patients? Yes, BLOS is a continuous source of reactive oxygen species (ROS), which diffuses into tissue throughout the body causing havoc. High concentration of ROS (i.e., Oxidative Stress) impacts drug effectiveness in two ways: 1) oxidizes the drug into either non-functioning compounds or more dangerous compounds 2) inhibits drug transport.
Use Oxidative Stress Blood Test Before Trying Experimental Drug
A new Oxidative Stress Blood Test (BLOS#) is under development, but there is an alternative available right now. The simplest strategy for lowering Oxidative Stress requires the use of a Urine Test Kit, which measures the degree of Oxidative Stress in your blood via the urine. I provided several posts (free) on my blog on how to change lifestyle choices to reduce Oxidative Stress. Instead of reading all of my blog posts looking for answers, I compiled the best posts in my new eBook. This eBook provides guidance on how to use three lifestyle choices to reduce your Oxidative Stress.
Step 1 Evaluate Your Oxidative Stress
Determine whether you suffer from Oxidative Stress by using the Urine Test Kit.
Step 2 Review and Change Your Lifestyle Choices to Lower Oxidative Stress
Change your lifestyle and use the Urine Test Kit to determine whether your lifestyle changes lowered Oxidative Stress.
Step 3 Use Experimental Drug
Start the experimental drug and provide feedback to your physician and the Pharmaceutical company about your strategy to lower Oxidative Stress before using their experimental drug.
Big Pharma Should Embrace Oxidative Stress Blood Test
This strategy be of interest to Big Pharma, because it offers the potential to reduce the failure rate of experimental drugs. Pharmaceutical companies should use this as an opportunity to learn about how BLOS may impact their product. The simplest approach would be for a donation of my eBook and the Urine Test Kit to any Right To Try patient interested in trying to lower BLOS before using the experimental drug. With proper lifestyle choices, a person should be able to reduce BLOS in about 1-2 weeks. The Urine Test Kit is the key to ensuring minimal BLOS before starting the experimental drug. This approach could also generate results for Fast Track applications for experimental drugs that meet an unmet need.
As always, read my disclaimer and always consult with your physician before making any changes in your diet or fitness regime.
Click on the image below to download our Free Report on the Best Vitamin C Supplement for fighting Oxidative Stress.