Oxidative Stress Blood Test Good for Patients and Pharma

How does Oxidative Stress Impact Clinical Trials?

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?

Oxidative Stress Blood Test could reduce the failure rate of clinical trials
Oxidative Stress Blood Test may be the key to improving the success rate of clinical 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.

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Learn How to Enhance Probiotics for Women and Men

Learn how to Enhance Probiotics for Women and Men by Reducing Oxidative Stress

Probiotics are found in supplements and food items with the promise of a health benefit.  However, the FDA has yet to approve any probiotic for the treatment of any human disease.  While animal studies provide evidence that probiotics may be an effective treatment for health problems, human studies always come up short.  There may be a simple explanation for this observation: Oxidative Stress.  Learn how to enhance probiotics for women and men by reducing and managing Oxidative Stress.

Oxidative Stress Selects Against Catalase Negative Bacteria

More than 2/3 of adult Americans suffering from elevated levels of Oxidative Stress, hence it may impact clinical trials.  Blood Oxidative Stress or BLOS is the primary source of Oxidative Stress.  BLOS is the continuous production of reactive oxygen species (ROS) by blood cells.  Blood Oxidative Stress is a problem for microorganisms that are catalase negative.  Some bacteria generate catalase to counter or neutralize ROS, which are the predominant molecules associated with Oxidative Stress.  So, elevated levels of BLOS make catalase negative bacteria vulnerable.

Bifidobacteria and Lactobacillus strains are the most popular probiotic strains used in a variety of supplements and food item.  However, both genera are catalase negative.  Consequently, if you suffer from elevated BLOS, then these probiotics may not provide any health benefit since they die in the gut environment.  This also suggests that management of BLOS will improve the performance of these probiotic strains.

Is there any hope for Probiotics?

Reduced levels of Oxidative Stress should improve the health benefit of your favorite probiotic.  A simple strategy evaluates lifestyle choices aimed at reducing Oxidative Stress.  An inexpensive Urine Oxidative Stress test kit is available to evaluate dietary choices.  I’ve combined my ebook and the Urine Oxidative Stress test kit with other products in a range of BLOS Hack Kits.

Infographic describing the components of the BLOS Hack Kits

This approach offers the potential for improving conditions for the probiotic bacteria to flourish in the gut.  I offer such a strategy in my new ebook.   Folks disappointed in the performance of their probiotics may want to read my ebook.

Why Probiotic Vendors Should Learn How to Enhance Probiotics for Women and Men

Finally, leading probiotic vendors should take note.  Which vendor will be the first one to setup a clinical study to evaluate whether BLOS management improves probiotic performance?  The strategy that I provide in my new ebook would add a negligible cost to a clinical trial.  Recently I suggested the same strategy for pharmaceutical companies and Right To Try patientsDiabetes Prevention Programs could also use this approach and focus on reducing Oxidative Stress instead of Weight.

It’s the Blood Oxidative Stress Dummies!

Click on the image below to download our Free Report on the Best Vitamin C Supplement for fighting Oxidative Stress.

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