Introduction: Understanding Our Approach and What the Words Really Mean

Understanding Health Information: A Guide for You

Health information is everywhere today. You see it on TV, read it in magazines, find it online, and scroll past it on social media. But just because something is printed or said in a commercial does not mean it is completely true. Sometimes facts are shown in ways that make them sound more dramatic or scary than they really are. Numbers can be used to prove almost anything — and sometimes they are used on purpose to mislead you.

A perfect example of this is the Women’s Health Initiative (WHI) study, which we will talk about later in this book. It is a great example of how health numbers can be twisted in ways that frightened millions of women away from treatments that could have helped them.

Before we go any further, it is important that you understand some key words and ideas used in this book. Some medical language can be confusing, and some information — even from doctors or TV commercials — can be misleading or even dangerous if you do not know how to look at it carefully.

To help you cut through all of that, we have gathered ideas from Dr. Milton Packer, a respected heart doctor. He teaches that true expertise is not just about memorizing facts. It is about asking good questions, challenging ideas that seem off, and always looking for the real truth. You do not need to be a doctor to do this. You just need to be informed enough to make smart decisions about your health. The best thing you can do is learn how to spot misleading information and ask the right questions.

Even healthcare professionals sometimes struggle to understand complicated medical reports or fast-talking TV drug advertisements. In this book, the term “healthcare providers” includes nurse practitioners (NPs) and physician assistants (PAs). When we say “physicians,” we are referring specifically to medical doctors (MDs) and doctors of osteopathy (DOs).

How Health Advertisements Have Changed

As a doctor with many years of experience, I have watched how health products are sold to the public change dramatically over time. Growing up in the 1950s, TV commercials mostly sold cigarettes, featuring famous characters like the Marlboro Man. Today, those same TV spots are filled with ads for prescription drugs — complicated medicines with names that are almost impossible to pronounce.

Many of these drug ads explain how a medicine works using words that most people — including many healthcare providers — do not fully understand. For example, you might see a commercial for Opzelura (ruxolitinib), a medicine for eczema (a skin condition that causes itchy, inflamed patches). The ad might say it “reduces itching fast” and is “steroid-free,” which sounds wonderful. But then, very quickly, a fast voice reads off a long list of warnings and side effects that most viewers simply do not have enough time to process.

The ad also mentions that the drug is a JAK inhibitor — but how many people know what that means? If you search online, you will find that JAK inhibitors work by blocking certain immune system enzymes — special proteins that control inflammation. These enzymes also show up in diseases like cancer, which is why some doctors already know JAK inhibitors from treating patients with blood disorders.

This raises an important question: Why is this drug being advertised to everyday people instead of only to doctors? Drug companies spend hundreds of millions of dollars on advertising. Understanding their motives can help you think critically about the messages you see and hear.

Cutting Through Misleading Information

The amount of medical and health-related content you see every day — on TV, online, and in social media — is overwhelming. Much of it is sensationalized — meaning it is written or filmed to grab your attention rather than to genuinely help you. This section will help you recognize misleading health claims, whether they come from TV drug ads, online articles, or social media posts.

We will also introduce a new way of looking at aging and chronic disease that shifts the focus toward better long-term health rather than just treating symptoms after they appear. This change in thinking — what doctors call a “paradigm shift” is all about understanding your body, asking the right questions, and making informed choices.

Our commitment to your well-being drives us to offer approaches rooted in the careful balance of scientific insight and personalized care. By the end of this book, you will feel more confident in recognizing misleading health claims, questioning media messages, and making informed choices that truly support your health and happiness.

Our New Way of Understanding Chronic Disease and Aging: From Tissues to Cells

Imagine your body is like a big building. The extracellular matrix (ECM) — a word that means the material between your cells — is like the building’s framework or scaffolding. It gives your tissues structure, strength, and support. Think of it as the walls, beams, and foundation that hold the whole building together.

For each individual room in the building — your cells — to work at their very best, the building itself must be solid and well maintained. In our approach, we begin by stabilizing this ECM (the tissue-centric view) before we focus on helping the cells inside work better (the cell-centric view). This means that if the framework is weak or damaged, even the best vitamins and supplements — what we call nutraceuticals — will not work as well, because the cells they are supposed to help are not properly supported.

To truly address the root cause of a problem — rather than just putting a Band-Aid on the symptoms — we first have to understand what set the stage for the problem in the first place. We use three simple words to describe this: antecedents, triggers, and mediators.

Breaking Down the Causes: Antecedents, Triggers, and Mediators

1. Antecedents — The Building Blocks That Set the Stage

What They Are: Antecedents are the background conditions — the things already present in your life long before any sickness or symptom appears.
Examples: Your genetic blueprint (what you inherited from your family), early life exposures, your family’s history of disease, and long-term lifestyle choices like diet, exercise habits, and how you handle stress.
Think of it this way: Antecedents are like the blueprint and materials used to build your house. If there were hidden weaknesses in the original design or building materials, those problems might not cause visible damage right away — but they make your house more vulnerable over time.

2. Triggers — The Events That Push Your Body Over the Edge

What They Are: Triggers are the specific events or changes that push your body past a tipping point — the thing that turns a hidden weakness into an actual problem.
Examples: Infections, surgery, very high levels of stress, exposure to toxins or chemicals, or dramatic changes in your eating habits.
Think of it this way: Imagine a heavy rainstorm hitting a building that already had a weak foundation. The storm (the trigger) causes visible damage — flooding, cracks, collapse — because the building was already vulnerable due to its flawed blueprint.

3. Mediators — The Internal Signals That Make Things Worse

What They Are: Mediators are the internal processes or biological signals inside your body that take a small spark and turn it into a full-blown fire.
Examples: Long-lasting inflammation (your body’s defense system staying on too long), imbalances in hormones, oxidative stress (damage from harmful particles called free radicals), problems with your immune system, and imbalances in the bacteria living in your gut (called dysbiosis). Technical terms you may hear include inflammatory chemicals called interleukins, such as IL-6, and tumor necrosis factor (TNF) alpha — these are the biological signals that drive inflammation.
Think of it this way: Once the storm hits the vulnerable building, mediators are like faulty repair systems that try to fix the damage — but instead of helping, they sometimes make things worse, causing ongoing problems or even structural collapse.

The Big Picture: Fix the Framework First, Then Optimize the Cells

In our approach, we believe that by first taking care of the health of your tissues — your ECM — you create a strong foundation for your cells. When the ECM is stabilized, it is as if you have repaired and reinforced the framework of your building. Only then can your cells fully benefit from nutraceuticals (special nutritional supplements) that help them function better and keep you healthy for the long term.

For example, if chronic stress or an unhealthy diet has already weakened your ECM, your cells may not be able to properly absorb or use nutrients. By fixing the underlying structure first — through lifestyle changes, proper nutrition, and following our protocols — you give your cells the best possible chance to do their job well and help reverse or slow down the development of chronic diseases.

To put it simply:

Tissue (ECM) Stabilization: Fix the building’s framework so that everything rests on a strong foundation. Use our protocols to address a destabilized ECM.
Cell Function Optimization: Once the structure is sound, focus on helping each cell work better through nutraceutical supplementation and other supportive therapies.
Understanding Your Causes: By recognizing your antecedents, triggers, and mediators, you can better understand why your tissues may become unstable — and how to restore balance and health.

Clarifying Terminology: What Do Those Study Numbers Really Mean?

With so much health information in today’s media, we are often hit with study results that quote statistically derived risk factors — numbers that can be very confusing and lead to completely wrong conclusions. For example, a study reported that taking aspirin daily doubles your risk of pancreatic cancer. Wow — no matter what other health benefits daily aspirin might have, that sounds terrifying enough to make anyone stop taking it immediately.

But wait. What you were just told is the relative risk — not the absolute risk — of aspirin’s connection to pancreatic cancer. Understanding the difference between these two ideas is one of the most important health skills you can develop. Let us break it down in plain language.

Absolute Risk vs. Relative Risk

Absolute Risk refers to your actual, real-world chance of developing a condition over a certain period of time. It is usually shown as a percentage or a simple fraction.
Relative Risk compares the risk between two groups — one exposed to a certain factor (like aspirin or hormone therapy) and one that is not. It is shown as a ratio or a percentage increase or decrease.

A Simple Example: Aspirin and Pancreatic Cancer

The lifetime risk of developing pancreatic cancer in the United States is approximately 1 in 59 (about 1.7%). If a study finds that daily aspirin users have a ‘doubled’ risk compared to non-users, that would mean their absolute risk might rise from roughly 1.7% to 3.4% which is about 2 in 59. — still a relatively small absolute change.

But the relative risk (RR) is doubled (a 100% increase) — because 2 in 59 is doubled 1 in 59 people.

This can be very misleading if it is not framed properly. While “doubling the risk” sounds alarming when you hear it in relative terms, the actual absolute risk remains extremely low — meaning the real-world impact on each individual person is very small. In fact, stopping daily aspirin based on this headline alone could be a deadly mistake when you consider aspirin’s proven ability to lower the risk of colorectal cancer and dangerous blood clots.

Why This Matters for Hormone Studies

Medical studies about hormones — including the infamous Women’s Health Initiative (WHI) — very often report relative risk, which can make findings sound far more dramatic than they really are. For example:

If a study says that hormone therapy increases the risk of breast cancer by 30%, that sounds very significant.
But if the absolute risk of developing breast cancer was 5 in 1,000, a 30% increase raises it to only 6.5 in 1,000 — a much smaller real-world impact.

How to Read Study Results Wisely

Always check the absolute risk. If a study reports a big percentage increase, find out what that actually means in terms of real numbers.
Consider the baseline risk. If something already has a very low risk, even a large relative increase may still mean a tiny actual impact on your health.
Weigh risks vs. benefits. Some medications or treatments may slightly increase one risk but offer significant benefits that far outweigh that small risk.

So, the next time you see a headline saying something “doubles your risk” or “increases risk by 50%,” stop and ask: are they talking about relative risk or absolute risk? The difference can make the numbers far less scary!

Real-World Examples of Absolute vs. Relative Risk

Example 1: Smoking and Lung Cancer

Absolute Risk: In absolute terms: if about 10 per 1,000 non-smokers develop lung cancer over their lifetime, smokers face rates of roughly 150–250 per 1,000 — a dramatic and real-world meaningful difference.
Relative Risk: Smokers have approximately 15 to 25 times the risk of developing lung cancer compared to non-smokers — one of the strongest risk relationships in all of medicine. This is a case where both the relative risk and the absolute risk are genuinely large and alarming, and where the public health message is appropriately urgent.

Example 2: Blood Clots and Birth Control Pills

In 1995, headlines screamed that birth control pills “double the risk” of blood clots.
Absolute Risk: Without the pill, 1 in 7,000 women develop blood clots per year.
Relative Risk: With the pill, 2 in 7,000 women develop blood clots — the risk doubles in relative terms, but the absolute increase is still very small.

Example 3: Processed Meat and Bowel Cancer

The lifetime risk of developing colorectal cancer is approximately 4–5% in the United States. Lifetime risk is a statistical estimate of the probability that a person will develop a specific disease at some point during their entire lifespan — typically from birth to age 85 or death, whichever comes first.

Relative Risk: A study found that eating 50 grams of processed meat daily increases bowel cancer risk by 18%.
Absolute Risk: If the baseline risk is 5 in 100, an 18% relative increase raises it to 5.9 in 100 — a small absolute change in reality.

Example 4: Heart Disease and Statins

Relative Risk: Statins (cholesterol-lowering drugs) reduce the risk of heart attacks(major cardiac event) by 22–25%.
Absolute Risk: If 10 in 1,000 people would have heart attacks without the drug, means about 7 in 1,000 will have heart attacks instead — a real and meaningful absolute benefit. Note: The actual benefit in absolute terms — how many heart attacks are actually prevented per 100 patients — depends heavily on individual baseline risk. In high-risk patients with existing heart disease, the absolute benefit is meaningful. In low-risk primary prevention patients, the absolute benefit per person is smaller, which is why individualized risk assessment is essential before starting statin therapy.

Key Takeaway: In many cases but not always Relative Risk (RR) can make changes sound dramatic. Absolute Risk tells you the real-world impact. Always check both when you are reading about a medical study!

What Is a P-Value? (And Why Should You Care?)

When scientists do studies to find out if something is really true, they use a number called a p-value. This number tells them — and you — how likely it is that their result happened purely by accident or by luck.

Here is a simple way to think about it:

If the p-value is small, it means: “This result probably did NOT happen by luck — it is real.”
If the p-value is big, it means: “This result might just be luck.”

The Number Rules for P-Values

A p-value below 0.05 means there is less than a 5% chance the result occurred by random chance alone — researchers call this ‘statistically significant.’ However, statistical significance does not automatically mean the result is large, important, or will be repeated in other studies. A small p-value tells us the result is unlikely to be a fluke, but it does not tell us how meaningful the result is in real life. Always consider effect size and clinical relevance alongside p-values Less than 0.05 (that means less than 5 out of 100) means the result is solid — we trust it.
The smaller the p-value, the more we can trust that the result is real and not just a fluke.

A Coin-Flip Example to Make It Clear

You flip a coin 100 times.
You expect roughly 50 heads and 50 tails just by chance.
But if you got 90 heads, that would be very strange — something must be unusual about that coin.
The p-value in that case would be very small — telling you that something real is going on, not just luck.

So a p-value is like a “luck meter”. A small p-value means the finding is probably NOT due to luck — it is likely real.

When reporting data on the effectiveness of the MD Matrix cream, based on animal studies (not human) the p-values for reducing inflammation were p < 1×10⁻⁸ — which means p < 0.00000001. In other words, there was less than a 1-in-100-million chance that the result happened by pure luck. The formal studies are described in my patent which is not the same as a FDA approved medication.

Here is how to picture that: 1×10⁻⁸ = 1 chance in 100,000,000. To give you a comparison: if you flipped a fair coin 27 times and got heads every single time, the odds of that happening are about 1 in 134 million — which is even smaller than 1 in 100 million. That kind of result tells us: “This almost certainly is not just luck.” The clinical observations in my office (not RCT) confirm that these p-values are highly predictive of MD Matrix cream effectiveness.

Our Goals for You: What Is “Optimal Health” and “Wellness”?

My goal in writing this book is to help you — the patient — achieve optimal health and wellness. But what does that actually mean? Let us break it down in simple, everyday terms.

What Is “Optimal Health”?

Optimal health means your body is running as well as it possibly can.
It is like having all your parts — your heart, lungs, muscles, and so on — working properly without any diseases or serious problems slowing them down.
Think of it as your body’s “best performance mode.”

What Is “Wellness”?

Wellness goes beyond just your physical body. It is about feeling good in your heart and mind too.
Wellness means you are balanced — not only free of physical illness but also feeling mentally and emotionally healthy and happy.
Imagine wellness as a big circle that includes your body, mind, and feelings all at once.

Feeling Healthy vs. Being Truly Well

Sometimes you might feel healthy because your body seems fine. You have no pain and no obvious sickness. But that does not always mean you are completely well. You might feel physically strong but still be stressed, sad, or constantly tired — and that affects your overall well-being too. You can look healthy on the outside but still be missing a piece of what it means to be truly well.

How Does Physical Fitness Fit In?

Physical fitness refers to how well your body can perform activities like running, lifting, or playing sports. It is about strength, endurance, flexibility, and heart health.
Optimal health is a broader idea. Your body is working at its best — not just physically, but also being free of disease. Being physically fit is one important part of optimal health, but it is not the whole picture.
Wellness takes things a step further by including your emotional and mental well-being alongside your physical health. You might be in great shape physically but still feel low or stressed — which means you are not entirely well.

Our aim is to look at everything — from how your body works at the cell and tissue level to how you feel in your heart and mind. Being physically fit is one part of feeling healthy, but to be truly well, you need balance across all parts of your life.

FDA-Approved Drugs vs. Off-Label Drug Use: What You Need to Know

What Is an FDA-Approved Drug?

The FDA — the government agency that oversees medicines in the United States — requires a very careful approval process before a drug can be sold to the public. When a company wants to get a drug approved, it must show the FDA that one specific dose of one specific molecule is both safe and effective for treating one specific condition. This is called a “one-size-fits-all” approach — and it is intentional, because it makes the testing process reproducible and clear.

But this approach also has a downside: it does not account for the fact that every person is different. Individual differences between patients are not built into the official approval process. In practice, doctors sometimes adjust doses for individual patients — this is called off-label dosing — but those specific adjustments were not part of the official controlled trial.

Here are some important facts about FDA-approved drugs:

Developing a single FDA-approved drug is extremely expensive — cost estimates range from approximately $1 billion to over $2 billion depending on the methodology used, which factors are included, and who funds the analysis
When a patient takes multiple FDA-approved drugs at the same time, the risk of experiencing at least one adverse (harmful) reaction increases: from about 27% with 3 drugs, to 34% with 4 drugs, and up to 41% with 5 drugs.
The FDA’s most serious safety alert is called a black box warning — it highlights serious or life-threatening risks. Post-market surveillance studies have found that a significant proportion of FDA-approved drugs — estimates vary from approximately 8% to over 20%, depending on the study, time period, and definition used — eventually receive new safety warnings or black box warnings after approval.

What Is Off-Label Drug Use?

Off-label drug use is very common in medicine. Studies estimate that up to 20-25 % of all prescriptions are for off-label use — meaning doctors prescribe FDA-approved medicines for conditions, doses, or patient groups that are not officially approved by the FDA. For example, off-label use is particularly common in oncology, neurology, and pediatrics where it may exceed 50–60%.

Common reasons for off-label use include:

There may be no approved treatment for a specific condition.
A drug may have shown effectiveness in studies but has not yet been officially approved for that use.
Some medications are needed in different doses or forms than originally approved.

Off-label practice often becomes the starting point for future research and eventually for officially marketing a drug for new conditions — this is called drug repurposing. A classic example is Sildenafil (Viagra) which was originally developed to treat angina (chest pain from the heart). During early clinical trials, participants noted a side effect of improved erections — leading to its 1998 FDA approval for erectile dysfunction. It was later approved under the name Revatio to treat pulmonary arterial hypertension — making it one of the most famous examples of drug repurposing in medical history.

An equally important example is Synthroid (levothyroxine), the most commonly prescribed thyroid medication used by traditional practitioners for decades — which was never formally approved by the FDA until the late 1990s. Between 1991 and 1997, there were ten recalls of levothyroxine tablets due to potency problems, leading to some hospitalizations. In 1997, the FDA ruled these were “new drugs” that needed formal approval — raising serious questions about consistency and quality control that had been overlooked for years, largely because of strong marketing campaigns.

Our off-label use of drugs is based on positive clinical outcomes spanning four decades and is backed by evidence-based medicine. We always carefully discuss the risks and benefits of any particular off-label drug based on each individual patient’s specific needs.

Understanding Hormone Terminology: Bioidentical, Compounded, and Pharmaceutical

What Are Hormones?

Hormones are natural chemicals made by your body. They work like messengers — they travel in your blood and send instructions to different parts of your body. Think of them as tiny, important notes that tell your cells what to do.

Hormones help control many vital functions, including:

Growth and Development: They help your bones and tissues grow.
Metabolism: They control how your body turns food into energy.
Reproduction: They guide sexual development and fertility.
Mood and Energy: They affect how you feel from day to day.

Hormones attach to special sites on your cells called receptors. Think of it like a key fitting into a lock — the hormone is the key, the receptor is the lock. This connection is what allows hormones to do their job.

Bioidentical vs. Synthetic vs. Natural Hormones

Bioidentical Hormones

Bioidentical hormones are designed to have exactly the same molecular structure as the hormones your own body makes. Modern medicine always emphasizes that Randomized Controlled Trials (RCTs) — carefully designed experiments — should be used to prove whether a drug or hormone works before it is used. But consider this: the hormones your own body makes have been tested and refined by the longest ongoing experiment in the history of life on Earth — evolution itself. That experiment has been running for millions of years, and no FDA-sponsored study can match it. Monetary gain is a major driving force behind the standard FDA approval model.

Bioidentical hormones can be made in two ways:

Pharmaceutical Bioidentical Hormones: Made in large batches by big companies, these come in set doses as pills, patches, or creams. They are very consistent and have gone through extensive testing.
Compounded Bioidentical Hormones: Made by a specially trained pharmacist just for you. They can be adjusted or mixed to the exact dose you need — especially helpful if the standard product does not fit your individual situation.

Synthetic Hormones

Synthetic hormones are man-made molecules that are “new to nature” — meaning they have molecular structures that do not naturally occur in the human body. DES (Diethylstilbestrol) is a powerful synthetic estrogen, and medroxyprogesterone (Provera) is a synthetic form of progesterone called a progestin.

Synthetic hormones became popular largely because of the FDA’s approval model, which encourages patented molecules — since natural, bioidentical hormones cannot be patented (though their delivery systems can). Because synthetic hormones have unique molecular structures that differ from the body’s own hormones, standard clinical laboratory monitoring of their blood levels is generally not part of routine clinical practice. Unlike bioidentical hormones — which can be measured using standard hormone assays — monitoring synthetic progestins like medroxyprogesterone acetate is not typically done in everyday clinical settings, making dose adjustment more challenging.

Natural Hormones

Natural hormones come from a natural source outside the body. A well-known example is Premarin, which is made from conjugated estrogens found in the urine of pregnant horses. As one doctor famously put it: “If you have hooves and graze on grass, then Premarin is right for you.”

What Does “Compounded” Mean?

Long before the FDA existed, pharmacies operated primarily as compounders — pharmacists mixed medications on-site using raw ingredients, preparing customized treatments for each individual patient. Large-scale, standardized mass-produced pharmaceuticals were not widely available. The U.S. Pharmacopoeia (USP), first published in 1820, helped set standards for drug composition, purity, and strength. The FDA became a regulatory agency with the 1906 Pure Food and Drug Act, and its powers expanded greatly with the 1938 Food, Drug, and Cosmetic Act.

When a medicine is “compounded,” a pharmacist mixes it up specifically for you — based on your doctor’s prescription. This might be needed because you require a different dose, or because a standard ingredient causes you an allergic reaction. This customized approach ensures your treatment fits your unique individual needs.

“What you put into your body matters — but just as important is how your body processes it. It is not only about the medication or hormone you take, but also about how your body breaks it down and uses it.”

Terminology Dealing with Results: Risk Reduction, Not Absolute Prevention

We intentionally use the term “risk reduction” rather than “prevention,” “treatment,” or “cure.” This distinction is fundamental because — given the complex nature of diseases like cancer — absolute prevention or complete cure remains beyond what we, or traditional medicine, can currently offer. Instead, our goal is to lower your risk by stabilizing the extracellular matrix (ECM) within your body’s tissues. In other words, we aim to create a healthier tissue environment that reduces the chances of abnormal cell behavior, while recognizing that many forces — including genetics, lifestyle, and environmental exposure — remain at play.

Destabilization of the ECM and Cancer Risk

One of the core concepts in our approach is understanding how destabilization of the ECM (discussed in Chapters 1 and 2) can increase cancer risk. Environmental pressures or nutritional deficiencies may disturb the delicate balance of the ECM, reducing its ability to regulate cell growth effectively. When the ECM becomes compromised, conditions may favor the uncontrolled growth of cells — a fundamental aspect of what traditional medicine calls cancer.

Our protocol does not target cancer in the conventional sense. Rather, it emphasizes the stabilization of the tissue environment — an approach aligned with the principles of Tissue Organizational Field Theory (TOFT) rather than solely focusing on cellular mutations, which is the view held by somatic cell mutation theory (SMT). In doing so, we aim to reduce the risk that destabilized tissues will create conditions that encourage abnormal cell behavior.

What Drives Our Approach to Risk Reduction

While we work diligently to stabilize your ECM and thereby reduce the risk associated with abnormal cell growth, our protocols are designed to lower risk — not to guarantee absolute prevention. This is a crucial distinction in setting realistic expectations. By focusing on risk reduction, we honestly acknowledge that while our protocol may lead to a healthier tissue environment, it does not provide complete protection against the unpredictable nature of chronic disease.

Key Points About Treatment Effectiveness

Cancer Risk Is Multifactorial: Cancer develops under the influence of genetics, environmental exposures, and lifestyle choices together. Our protocols can lower the risk of cancer development by contributing to a more stable ECM, but they cannot eliminate the risk entirely, since many contributing factors are beyond any single person’s control.
Biological Variability: Every individual’s body is unique. Factors such as your genetic makeup, immune system function, and overall health mean that responses to our protocols may vary. What works well for one person might produce different results in another — that variability is a natural part of any health approach.
Statistical Uncertainty: The effectiveness of any protocol is subject to variation. Random factors, measurement differences, and variations in how clinical studies are designed all contribute to a range of possible outcomes. Real-world evidence often reflects this natural uncertainty.
No Absolute Guarantees: Despite our best efforts to improve tissue health and lower risk, complete assurance of safety is not possible. For those who may already show signs of structural changes — such as polyps or other precancerous conditions — conventional medical treatments continue to play a critical role in your overall care.

Where Our Protocols Come From: Derivation and Justification

Our nutraceutical protocols are derived from peer-reviewed literature — research published in respected medical journals — and from observation-based clinical outcome studies gathered over many decades of practice. Innovations in our medical practice are based on biological individuality — the recognition that each patient is unique — which distinguishes our approach from many others.

Justification for using non-FDA pharmaceutical medications in an evidence-based way — specifically to address the condition of a destabilized extracellular matrix — can be found in the ACOG Committee Opinion Number 352, 2015, published by the American College of Obstetricians and Gynecologists (ACOG), of which I am a member. ACOG wrote:

“In clinical practice, physicians aim to benefit their patients by providing the best possible procedures and treatments. The desire to improve currently available practices has given an important impetus to the development of new medical knowledge. The notion of what is best or most appropriate evolves with time, ongoing research, and changing individual and societal values. Good clinicians constantly adapt and modify their clinical approaches in ways they believe will benefit patients. The introduction of such innovative interventions is guided primarily by the judgment of the individual physician, although professional organizations often advise and monitor.”

ACOG also stated: “Anyone who has treated patients understands that some patients do not fit into a classic pattern and that management requires the physician, in the best interest of the patient, to go outside of usual guidelines. When writing a guideline, the authors have to consider the usual patient with the usual findings who will respond in the usual way. In any bell-shaped curve of two standard deviations, 95% will be inside the curve, and 5% will be outside the curve. It is the management of these 5% that can be confusing and difficult. After four years of medical school and four years of specialty training, the physician can and should be able to make a decision for the best care of the patient that may not follow a guideline.”

In Summary: What This All Means for You

Our Approach: We focus on risk reduction by stabilizing an organ’s ECM — the supportive tissue surrounding your cells. An excellent starting example is the colon and rectum, whose ECM is clearly affected by our increasingly toxic modern environment. This proactive approach supports tissue health and reduces the likelihood of abnormal cell behavior — without making promises of an absolute solution. As you will see throughout this book, our ECM paradigm can be extended to every organ in your body. The colorectal surface gives us an excellent window into how environmental pressures can destabilize the ECM and contribute to disease.
What It Means for You: By understanding that our approaches are designed to lower risk rather than provide outright cures, you can appreciate how our protocol serves as one important part of a broader health strategy — one that also embraces conventional medical advice, especially when structural changes are detected.
Why This Matters: Clear terminology allows you to make informed decisions about your health. Recognizing that our language reflects a commitment to realistic, evidence-based care helps set appropriate expectations as we work together toward a healthier future.
How Our Approach Differs: Rather than targeting cells alone (cell-centric medicine), we target the tissue environment surrounding cells — the extracellular matrix or ECM (tissue-centric medicine). As defined in our introduction, a destabilized ECM is a condition, not a disease. The ECM stabilization protocols in this book address this condition and manage symptoms that may look like disease symptoms — especially those of the Four Horsemen of the Medical Apocalypse. This symptom management does not constitute treating, diagnosing, curing, or preventing any disease.

This foreword is meant to give you a transparent view of our strategy, the language we use, and the realistic expectations regarding clinical outcomes. Our aim remains to safely support your overall health while integrating our protocols with the best evidence-based practices in functional medicine — intertwined with traditional approaches.

Figure 1. The tissue-centric approach: stabilizing the extracellular matrix (ECM) creates the foundation for cellular health and reduction of chronic disease risk throughout the body.[FC1]

References

The following references support the information presented in this foreword and throughout the book.

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13. Petersen M. Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs. New York, NY: Farrar, Straus and Giroux; 2008.

14. Mick DJ, Ackerman MH. Critical care nursing for older adults: pathophysiology and related clinical interventions. Nurs Clin North Am. 2004;39(3):473-493.

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16. Soto AM, Sonnenschein C. The tissue organization field theory of cancer: a testable replacement for the somatic mutation theory. Bioessays. 2011;33(5):332-340.

17. Bhatt DL, et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006;354(16):1706-1717.

18. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA. 2002;288(3):321-333.

19. Fisher B, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998;90(18):1371-1388.

20. International Agency for Research on Cancer. Red Meat and Processed Meat. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol. 114. Lyon, France: IARC; 2018.

21. Collins R, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet. 2016;388(10059):2532-2561.

22. Vandenbroucke JP, Helmerhorst FM. Risk of venous thrombosis with oral contraceptives. Lancet. 1996;348(9033):972.

23. U.S. Pharmacopeial Convention. USP-NF: United States Pharmacopeia and National Formulary. Rockville, MD: USP; 2024.

24. Lasser et al. 2002, JAMA or Downing et al. 2017, JAMA Int Med.

25. JACC Heart Fail. 2019;7(5):391-393).

This document is for patient education purposes only and does not constitute medical advice. Always consult with your healthcare provider before starting or changing any treatment.

[FC1]This makes no sense

Forward to Dr. McWherter’s New Book!