The Elephant-Sized Flaw in Large Clinical Trials

Imagine you’re like me and have a genetic variation in your D2 Dopamine receptor code which makes some aspects of “executive functioning” difficult. (I was always the last one to finish my lab work in Chemistry, Biochemistry, and General Physics — though I got the highest final score in Physics Lab, so I’m not claiming to be stupid.)

Anyway, you’ve got this D2 challenge in your brain, you do some reading and discover that organic velvet bean powder has L-dopa that might help you with things like working faster through cookbook recipes.

You buy some velvet bean powder, try it and, wow, you’re not only more efficient, your mood improves.

You should feel ecstatic, right?

But no, you’re vaguely suspicious because you’re a medical doctor. Professors and attendings have warned you that anecdotal evidence is worthless, and the placebo effect is ready and waiting to make a fool of you. 

To avoid embarrassment, you decide you need a double-blinded, prospective clinical trial with a large number of test subjects and proper randomization. Anything less would be rubbish.

Fortunately, this is not a problem. You’re also a multi-billionaire who can fund a complete drug trial.

Of course, you didn’t get rich by ignoring opportunity. You plan to make money with these velvet beans. 

Knowing that your problem starts with genetic D2 variation, common sense tells you to study a few thousand people who have the same genetic makeup.

But what about your target buyer? A businessperson looks there first.

From that perspective, you want the FDA approval to apply to as many people as possible so you can hand out genetically modified velvet bean pills to the broader public and make more money.

You therefore choose the typical mainstream experimental design: Thousands of unselected participants taken in randomly and then randomized and blinded into trial and control groups. You’ll also blind the people administering the bean pills and placebos so no one can fault your study.

Ten years and 1.2 billion dollars later, the trial ends and the stats come back from the math geeks, those rare professionals who honestly understands statistics and can manipulate them dishonestly.

Despite their efforts, they bring you bad news. There is no statistical evidence that your patented velvet bean extract improves executive functioning or mood.

Rats!

You go home and glare at your dog, then apologize with an organic carrot.

If you publish the paper, the entire world of mainstream MD’s, those smart women and men who don’t read the scientific literature or think for themselves because they’re too busy and frightened of lawsuits – those dedicated, exhausted people will hear from their educators, the drug reps, that velvet beans are rubbish. “This is just another example of the functional medicine quacks peddling snake oil.”

But you take organic velvet bean powder every day, it’s made a real difference. In the kitchen now, you’re turning out Molten Lava Cakes faster than the famous TV chefs. You feel more grounded and calm, too.

What should you do?

It’s obvious, isn’t it? Common sense tells you to go back and do a clinical trial using people with the D2 receptor issue, testing the organic velvet bean powder that works for you, not the GMO stuff your lab cooked up for megabucks.

Unfortunately, this common-sense approach rarely if ever happens in the real world. Negative studies like this are routinely published, and the mainstream fails to see the elephant-sized flaw in their assumptions: the human population is vastly more diverse than previously known at the genetic and biochemical level.

Genetic diversity is relevant to every branch of medicine because single nucleotide polymorphisms (genetic SNPs), like the one that affects my D2 receptors, create a huge diversity in disease susceptibility at the root-cause level, as well as a myriad of diversity in personal strengths and weaknesses within every system of the body.

From the central nervous system to the skin, genetic SNPs are the rule, not the exception. And science has hardly begun to uncover them all or understand their complex interplay across systems.

I have another common genetic SNP that reduces my ability to “detoxify” caffeine by about 60%.

With this knowledge, I’ve lowered my caffeine intake from several double mochas a day (at the VA Med Center years ago), to two cups of green tea per day. This reversed an unbearable sensation of vascular congestion in my legs. (n=1)

I also have a SNP that makes me inefficient at converting beta-carotene to vitamin A, a few SNPs that increase my need of several B vitamins for adequate methylation to keep my homocysteine levels down, and numerous others that I won’t bore you with. But despite all my SNPs, I’m still quite healthy for 63 year-old man.

The thing is, genetic SNPs are so common, you yourself almost certainly have at least one, more likely a handful. So it’s irrational for researchers to lump you into a huge unselected “normal” population when they’re testing something. And it’s misinformed and lazy for MD’s, however busy they are, to ignore your SNPs and follow cookbook-official protocols when treating you. They need to read more broadly and act with integrity even if it costs them.

Genetic diversity is why functional medicine, imperfect as it is, will become central to mainstream medical care someday. The establishment will change the name from functional medicine to something they haven’t already disparaged.

Currently, they say functional medicine is not evidence-based. In some ways that’s true.

But when it comes to reversing chronic disease rather than just controlling its progression, functional medicine is more evidence-based than mainstream medicine because it uses personal genetic data that the mainstream ignores.

Moreover, it understands the elephant-sized flaw in the mainstream’s large clinical debunking trials. 

Morrill Talmage Moorehead, MD

Photo by Rafael on Unsplash


This man could save your life.

Einstein began as an outsider. If today’s gatekeepers had run the journals in 1905, Einstein’s “miracle year” papers would have been rejected because he wasn’t employed and controlled by a university.

After he pulled the ripcord on space and time, Einstein faced rejection by his peers. That’s said to be the single most depressing thing that can happen to a person.

Physicists called him a mathematician. Mathematicians called him a physicist.

When the Nobel Committee finally realized his new-fangled universe wasn’t going away, they awarded Einstein the Nobel Prize for a fairly concrete paper he wrote on the photoelectric effect. With narrow minds, they passed over his impossibly radical discoveries — the flexibility of time and space, the equivalence of mass and energy, and the gravity of General Relativity.

To be fair, all of us have sacred-cow beliefs that we “know” are accurate beyond question. The Nobel Committee of the early 20th Century wasn’t so different from the rest of us.

But today, science’s devotion to skepticism has become a reflex for protecting certain key dogmas and assumptions that are felt to be “proven,” when in fact, some of them are not even testable.

An example would be “scientific materialism,” an assumption that is mistakenly considered to be foundational to science.

It’s the belief that the universe is composed of matter and energy alone. Nothing else. Therefore all information in our heads or in our DNA, as well as our sense of personhood are ultimately derived from matter and energy through random interactions that have accidentally created in us an “illusion of consciousness” with a sense of purpose which, like everything else about us, doesn’t actually exist except as a cruel and false illusion.

Scientific materialism, if anyone thinks about it, is as untestable as the assumption that intelligent consciousness is somehow at the foundation of the Universe and is the one thing that can’t be divided into mindless components.

Either way, the assumption is a choice that most of us make subconsciously without knowing when we made it.

Especially the highly educated people — we swim in a sea of scientific materialism. Like fish, we don’t focus much on what we’re swimming in until an outsider’s net hauls us into an unfamiliar world where air replaces the thing we’ve assumed was unchangeable.

So no one should be surprised that an outsider has hauled mainstream medicine up in his net.

This time it’s Ivor Cummins, an engineer with no medical background — the perfect outsider.

Listen to this guy, now. His speech could easily save your life if you can understand and remember it in full detail…

Cummins is teaching the medical establishment the shocking truth about two of today’s top killers, heart disease and type 2 diabetes. He tells us that…

  • Type 2 diabetes (including “pre-diabetes”) causes the vast majority of heart attacks (MI’s).
  • Between 49 and 65 percent of adults in the US have type 2 diabetes or “prediabetes” (which is a fairly unscientific division).
  • Testing insulin response (not glucose) for five hours after a glass of glucose gives the most accurate and info-rich diagnosis of type 2 diabetes (and “prediabetes”), as well as a uniquely valuable MI-risk predictor.
  • A $100 scan of the heart’s arteries (a coronary calcium scan) performs far better at determining MI risk than the various cholesterol measurements we use today in the US.
  • Improving your insulin response to sugar (by limiting carbohydrates, which reverses insulin resistance) prevents heart attack (MI).
  • Simply grinding up healthy food into powder causes an unhealthy insulin response in lab mice. The same thing probably applies to humans, but who would you ask to fund the study, C&H Sugar?

Why is an engineer able to put the vast and complex medical literature on heart disease and diabetes together logically, while the entire medical establishment can’t do it?

  1. Ivor Cummins is an unbiased thinker who personally faced a high risk of fatal heart disease despite his quite “healthy” lifestyle.
  2. As an engineer, he specialized in fixing novel problems within various complex systems. MD’s don’t have “complex systems analysis” as a specialty.
  3. Medicine is divided into specialties and subspecialties that cater to the info limits of the human mind. Busy MD’s struggle to stay current within their own specialties and rarely if ever do an exhaustive literature search outside their own narrow focuses, let alone doing an original analysis on a broad literature review outside their given specialty.
  4. Money influences the medical literature more than we care to admit. In the same way biased news is easily created by a bias selection of news stories, so modern medical science is hindered by an unbalanced selection of things to be studied. For instance, imagine there’s a plant in the rainforest that cures a disease. Scientists are unlikely to obtain funding to discover the plant and far less likely to find a grant large enough to cover the huge costs of the randomized, blinded trials required to show its worth to the FDA. Why no funding? Because a wild plant cannot be patented. This fact alone has created a gigantic bias in mainstream medical literature. The result is a multi-billion dollar industry of over-the-counter “dietary supplements” that go permanently untested and unapproved by the FDA.

If Ivor Cummins message doesn’t save your life, he does offer you another gift… the wisdom to refrain from shouting down the outliers in your fields of expertise. The wisdom to listen respectfully to those who “couldn’t possibly” be right because you already know the truth.

The greatest scientific, political and spiritual breakthroughs of history have come mainly from outsiders who were free of the mainstream dogmas and assumptions of their time.

Morrill Talmage Moorehead, MD


Ending Alzheimer’s Disease

The End of Alzheimer’s, by Dale Bredesen, MD, is finally out. I’ve been waiting for this forever. All the details of his protocol are now available to the public!

This book may save your mind and the minds of your loved ones. Buy it. Read it. Loan it to your doctor. 🙂

Clinical studies using Bredesen’s ReCODE protocol are showing breakthrough results in patients with mild to moderate Alzheimer’s Disease as well as pre-Alzheimer’s. Over 200 patient success stories exist, many are breathtaking. In each case, the disease was well documented before treatment.

Bredesen’s ingenious basic science research on Alzheimer’s Disease has been published in peer-reviewed journals for 28 years, yet strangely his successful clinical protocol papers have received a cold shoulder from the medical establishment.

Is this because Bredesen is going after causes while mainstream medicine is interested only in masking symptoms? No. It may seem that way sometimes, but the truth is much more interesting.

It boils down to a rigid devotion to traditional experimental design which insists that each component of any therapy must be studied separately. Yes, rarely the medical gatekeepers will make an exception and study two medications simultaneously for certain diseases, but the moon has to be just right for such madness.

Historically this monotherapy approach has worked fairly well for diseases with single causes, but it creates a roadblock to clinical research on complex diseases such as Alzheimer’s.

Though the evidence against monotherapy for Alzheimer’s Disease is a billion-dollar wasteland of failed clinical trials, medical authorities cling to their linear way of thinking, blindly following the sacred tradition of scientific fundamentalists throughout history who have uniformly obstructed all major paradigm shifts with their flawed scientific beliefs and assumptions.

In the case of Alzheimer’s Disease, the belief is simple: if you don’t isolate one thing at a time, you’ll never know exactly what that one thing does in isolation.

Brilliant deduction. The assumption, though, is that knowing what each thing does in isolation should always be the ultimate goal of science and medicine.

This is narrow reductionism – dissecting a thing with the mistaken belief that answers can only be found in the parts.

But as Emerson said, “Foolish consistency is the hobgoblin of small minds.” Sometimes the destruction of a forest cannot be prevented by focusing only on the trees.

In medical science, understanding a system as a functioning whole in both disease and health is more central than reductionism to the overall goal, which is saving patients’ lives.

Bredesen’s protocol is doing exactly that, as documented in peer-reviewed journals.

Disease complexity is why monotherapy experimental design has made no significant progress against Alzheimer’s Disease. This is a disease with at least 36 to 50 different “things” that can go wrong in various combinations that cause the mind to fail. The numbers and mixes of partial causes differ from one patient to the next, but three broad categories have emerged: Inflammatory, atrophic and toxic.

All three produce the same pathognomonic plaques and tangles under light microscopy, so pathologists consider Alzheimer’s a single disease, and drug companies target amyloid with their failed monotherapies.

It’s not as simple as they assume.

Clinically testing Bredesen’s therapies for each of the 36 to 50 causal elements in isolation, if it were possible and fundable (which it’s not), would take many decades and result in falsely negative and/or equivocal outcomes. This is because:

1. Each component of Bredesen’s protocol reverses only a small fraction of the 36 to 50 disease-promoting processes, and those processes are not uniformly distributed in the Alzheimer’s population. So any one of them tested in isolation would not likely have enough overall effect to achieve statistical significance. It’s like firing a shotgun one pellet at a time expecting to stop a serial killer in your bedroom. Stupid, right? Bredesen’s total protocol (tailored to each patient with lab tests) is needed to reverse mild to moderate Alzheimer’s Disease.

2. The synergistic effects of therapeutic components are foolishly eliminated by linear monotherapy-biased experimental design. Keep red and green separate and you won’t discover yellow.

Ignoring Bredesen’s work, as the orthodox mainstream currently prefers to do, is the moral equivalent of physical abuse to Alzheimer’s patients.

The mechanisms producing Alzheimer’s Disease take decades to produce symptoms, so when memory loss or difficulty with word-finding shows up, the disease has already been silently progressing for decades. The earlier you treat it, the better your chances for complete reversal. The worst thing you can do is wait for early symptoms to progress.

If you know anyone with subjective cognitive decline or mild to moderate Alzheimer’s disease, do them the biggest favor of their lives. Read Dale Bredesen’s breakthrough book for yourself and share your knowledge. Maybe the person you care about won’t be fooled by the supercilious, confident, sophisticated-sounding monotherapy zombies who feel they must watch their patients die while waiting for a prescription pill from a drug company.

Sorry, that sounds harsh. But people are dying in the worst imaginable hell while a scientifically documented breakthrough is ignored. It’s astonishing!

The problem is that most MD’s are too busy to read extensively and learn how to distinguish good science from unsubstantiated claims. So they blindly listen to authorities who have the power to take away their licenses.

In medical school, we studied our lecture notes and books with virtually no impetus to learn to critically evaluate journal articles. We had one brief class in statistics.

Anyway, here’s a video interview of Dale Bredesen discussing the groundbreaking, unprecedented results of his ReCODE protocol. Enjoy!

Learning the truth is always fun, and…

“It’s fun to have fun, but you’ve got to know how.” – Dr. Seuss.

Morrill Talmage Moorehead, MD
Retired Pathologist, science fiction writer, and novel content editor.

(I have no conflicts of interest to report and no personal acquaintance with Dr. Bredesen.)