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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BLOS is a Positive Black Swan for Health Care

BLOS could be a Positive Black Swan for Health Care.

If Black Swan in the title got your attention, then you are already familiar with Nassim Taleb’s work on Black Swans.  Beyond the financial sector, there is interest in predicting Black Swans in other sectors including Health Care.  What if the Black Swan for Health Care isn’t a digital product or novel class of promising drugs?  What if it’s a new, broad impacting asymptomatic disease that escaped the attention of medical researchers and the general public?  This potential Black Swan is Blood Oxidative Stress or BLOS.  An estimated 2/3 of adult Americans suffer from BLOS costing $1T/year in Health Care costs.  BLOS extends beyond the USA impacting Europe and many countries that adopted the Western Diet.

 

Blood Oxidative Stress may be the Black Swan for Health Care
BLOS could be the Positive Black Swan for Health Care.

What is Blood Oxidative Stress (BLOS)?

Blood Oxidative Stress or BLOS is a high percentage of blood cells generating reactive oxygen species (ROS).  Once induced to generate ROS, these blood cells generate it until replacement (about 1 week).  The high prevalence of BLOS in Western Countries suggests that the Western Diet may be the culprit.  One theory suggests that excessive dietary inorganic sulfur may lead to the proliferation of sulfate reducing bacteria (SRB) in the gut.  Many food preservatives and additives contain inorganic sulfur, which is common in the Western Diet.  In turn, these SRB have the potential to generate high amounts of sulfide in the gut.  Short bursts of sulfide production in the gut are thought to induce the ROS response in captive blood cells.

Can we measure BLOS?

Management of any process requires the ability to measure outcomes, which allows for the evaluation of methods to control the process.  BLOS is painless, which makes it difficult for physicians to observe in patients.  It’s one of the reasons that it escaped our attention.  However, flow cytometry measures BLOS, but it is not FDA approved and expensive.  An inexpensive, FDA approved method to measure BLOS will evaluate BLOS management strategies.  One approach for BLOS management involves lifestyle changes that focus on fitness and dietary changes.  Down the road, new drugs may target the ROS response in blood cells.  There are a few commercial test kits that measure the end products of Oxidative Stress, which may be useful for evaluating lifestyle changes right now.

Free Urine Oxidative Stress Kits for Diabetes Prevention Programs or Drug Trials

I proposed the use of the Urine Oxidative Stress test kit to improve Diabetes Prevention Programs and Clinical Trials.  In fact, I offered to purchase the Urine Oxidative Stress kit for a Diabetes Prevention Program.  This approach may improve the effectiveness of these programs by focusing on BLOS management instead of weight management.  I will extend this offer to any pharmaceutical company that wants to evaluate whether BLOS management improves the performance of a clinical trial.  What have you got to lose besides millions of dollars in another failed Phase2/3 clinical trial.  Send me an email, if there’s interest in partnering. 

Impact of BLOS as Black Swan for Health Care Industry

Eventually, BLOS will emerge as a major health issue and graduate to Black Swan status for the Health Care Industry.  Here is a list of the potential impacts of BLOS on Health Care and associated industries.

Health Care

BLOS management may reverse the damage caused by long-term, elevated BLOS or at the very least, prevent the progression of any health problems.  Healthcare facilities will offer BLOS management support.  The BLOS# test will become the “gold standard” of patient health, since it directly measures the causative agent of BLOS.  Urine oxidative stress and other oxidative stress tests measure the end products of BLOS, so they will not be used as a disease diagnostic.

Insurance

Health Care insurance costs should lower with widespread success of BLOS management to reduce the burden of expensive illnesses.  Don’t be surprised if you see new Life insurance policies that reward healthy policy holders that demonstrate BLOS management.

Wellness Programs

BLOS management may become the center piece of corporate Wellness programs, since BLOS impacts so many employees.  BLOS management will provide better guidance to employees on lifestyle changes needed to improve health.

Agriculture

Major change in the Food Industry to reduce or eliminate any component of the Western Diet that causes BLOS.  These changes in the Western Diet would continue the current trend of clean eating.  If inorganic sulfur is identified as the main cause of BLOS, then new food preservatives and additives will be needed.

Pharmaceuticals

Elevated BLOS probably impacts the efficacy of pharmaceuticals due to the oxidation of drugs and inhibited drug transport by ROS.  In addition, elevated BLOS may be the cause of the high rate of failed clinical trials due to the lack of control of BLOS.  Management of BLOS may improve the success rate of clinical trials.  Consequently, this would reduce the cost of pharmaceutical development and lower the retail price.  However, BLOS management may be effective at treating many illnesses.  This would eliminate the need for any current or new drugs in the pipeline.

BLOS may be cause of failed clinical trials
BLOS Management may be the key to improving the success rate of clinical trials.

BLOS is a Positive Black Swan for Health Care

The health care cost savings potential of BLOS management is enormous, which will result in both winners and losers in the Economy.

The Winners

The winners will be the folks currently suffering from elevated BLOS, who may look forward to much better health and a longer lifespan.  Worker productivity should benefit from this shift immediately.  Many workers in poor health miss time due to sick days and visits to their physician.  How many do not perform at their highest level due to poor health at the workplace?  Many retirees in poor health may regain their health and decide to return to the workforce.  This would also be a boon for the Economy in the form of an increase in the supply of Experience.

The Losers

The major losers will be companies, non-profits, academic institutions, and government agencies that fail to adapt to the new BLOS landscape.  The following table compares the commercial and industrial growth of BLOS products to previous shifts in medical history due to the recognition of a new disease.  Detection and measurement methods begin the wave.  Finally, with widespread knowledge of BLOS, it will be recognized as a Black Swan for Health Care.

BLOS spurs economic growth in healthcare and beyond
Short list of New Products based on BLOS Management

Skin In The Game

Taleb will be happy to know that I have “skin in the game.”  In addition to a couple of published research articles, I have a pending patent for a new method to measure BLOS.  My company, HemaGnosis, is developing this new BLOS# method.  All proceeds from my eBook sale and items sold in the BLOS World Store will be used to support BLOS Research.

 

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