Incurable Me: Why the Best Medical Research Does Not Make It into Clinical Practice

Incurable Me: Why the Best Medical Research Does Not Make It into Clinical Practice

by Kenneth Stoller

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Overview

In Incurable Me, a maverick physician brings transparency to some of medicine’s most closely guarded secrets. As he establishes a link between commerce and medical research, K. P. Stoller also explains how to treat some of the most worrisome diseases and conditions afflicting humans today—including Lyme disease, brain trauma, dementia, and autism.
Dr. Stoller maintains that the best evidence in medical research is not incorporated into clinical practice unless the medical cartel has the potential to make large amounts of money promoting the results of the research. Stoller takes his provocative argument a step further, maintaining that if specific research conflicts with a powerful entity’s financial interests, the likely result will be an effort to suppress or distort the results. Stoller cites numerous examples, including corporate influence on GMO labeling and public health.
Stoller also explores how “revolving-door-employment” between the Centers for Disease Control and large pharmaceutical companies can affect research results—as well as our health. Written in an accessible style that is thoroughly appropriate for a lay audience, Incurable Me is a must-read for anyone interested in the state of modern medicine.

Product Details

ISBN-13: 9781510707986
Publisher: Skyhorse
Publication date: 09/27/2016
Pages: 216
Product dimensions: 6.00(w) x 9.10(h) x 1.10(d)

About the Author

K. P. Stoller, MD, completed his training at the University of California at Los Angeles School of Medicine in 1986 and was a practicing board certified-pediatrician for over two decades, focusing on brain-injured children and adults. Dr. Stoller’s area of expertise is functional medicine, also known as integrative medicine. He is chief of hyperbaric medicine at the Hyperbaric Oxygen Clinic of San Francisco and editor of Medical Gas Research. He has published numerous articles on using hyperbaric oxygen to treat brain injuries. He lives in the San Francisco Bay area.

Read an Excerpt

CHAPTER 1

The House of Lyme

"Most men cannot accept even the simplest and most obvious truth if it be such as would oblige them to admit the falsity of conclusions which they have delighted in explaining to colleagues, which they have proudly taught to others, and which they have woven, thread by thread, into the fabric of their lives."

— Leo Tolstoy (1828–1910)

Merely calling Lyme a plague doesn't do this pandemic justice.

Lyme disease ("Lyme") is unequivocally emblematic of how confused our society is and how compromised and incompetent our government agencies can be. It is right up there with building nuclear power plants on major subduction zone earthquake faults. Lyme is an unrecognized plague of vast proportions. It causes widespread damage to humanity. Lyme disease must come to the fore in the consciousness of all of us in order to end and prevent untold suffering for so many people.

It is possible to have empathy for the suffering of one or even a few individuals. It is not possible to take in the pathos of millions — that is just a statistic. And this plague involves millions.

It would certainly be nice if everyone could be given the secrets for curing Lyme disease and then treat themselves. The medical community in general isn't up to speed in its understanding about Lyme and can be almost as much of the problem as the bacteria. Then there is the societal disconnect from Nature, which is the problem beneath the problem. Regardless, for some ill people the potential complications of getting correctly treated can be so severe as to require both a medical coach and a caregiver. They must understand what to expect and how to receive help in what could be a rocky road to recovery. It is a nontrivial matter to get correctly diagnosed, and even more difficult to get correctly treated — even with all your support-system ducks in a row. This is a most difficult subject, but it is finally time for the light to shine on the house of Lyme.

MY HOUSE OF LYME

In 1989 I was living in a quaint, 1,200-square-foot Craftsman-style house in sunny South Pasadena, California. The house was a few feet away from an elementary school where some very old trees were cut down. I could never figure out why there were so many ticks in those old trees, but they abandoned ship and dropped into my backyard. They were very happy to find the six dogs I was living with at the time. The dogs brought in only a few hundred of the thousands of ticks that had left the tree.

A few hundred adult ticks were fairly easy to find, as they were huge — but I didn't find them all. Several were mature females, who, having fed well from my dogs, were more than ready to create another generation of ticks. In addition to their abdomens swollen with recent feasts of blood (some of it mine), the engorged female ticks also carried ripe egg sacs. These mothers soon birthed what seemed like millions of super-tiny, flesh-colored baby ticks, called nymphs.

It was one of those up-close-and-personal experiences that turned me into a temporary tick removal expert. I suppose that is when I may have become infected, but it would be a couple of decades before I tested myself and learned I was positive for Lyme disease. I will never know for certain where, on the timeline of my life, I became infected. I am an example of someone who had minor medical issues but was never severely ill because my immune system is strong. I never had a "die-off" reaction to occasional antibiotics. I might have died never knowing I had been infected — even if it were the Lyme spirochete bacteria infection that eventually killed me, for example, by (faux) Alzheimer's disease. Others are not so fortunate.

Ticks are front and center in this chapter because the main organism in the United States that causes Lyme, Borrelia burgdorferi, is usually spread by ticks. Most who get bitten do not remember being bitten, and while it is hard not to notice being bitten by a large adult tick, the tiny nymphs often escape notice and literally get away with murder. They also bite more people than the large adult ticks if for no other reason then there are more of them.

The infamous bull's-eye rash that some get when a Lyme-carrying tick bites them doesn't show up on everyone. My theory is it shows up on those individuals who already have Lyme disease, making the three weeks or so of a single antibiotic that their physician may prescribe them an unfortunate undertreatment. There is more than one way to treat Lyme, but three weeks of a single antibiotic is not the way, even if one was recently bitten and didn't have Lyme before that recent bite.

IS HYPERBARIC OXYGEN THERAPY THE PERFECT ANSWER FOR TREATING LYME?

I started treating Lyme disease patients soon after I opened a medical hyperbaric oxygen clinic in Santa Fe, New Mexico. In hyperbaric oxygen treatment, a patient receives oxygen under pressure as if he or she were a sailor in a submarine (see chapter 5). The Lyme spirochete bacterium is a facultative anaerobe, which means that although it tolerates oxygen, it really doesn't like it; in fact, enough oxygen will destroy the organism. How much is enough to destroy it? At least 160 mmHg (millimeters of mercury) pressure of oxygen — this is what we breathe into our lungs and a well-oxygenated bloodstream at sea level. But as oxygen filters deeper into our bodies, the actual oxygen saturation into the inner reaches drops significantly. By the time sea-level pressure oxygen gets into our bone marrow, the actual partial pressure has dropped to about 50 mmHg (mean pO2, or average partial pressure of oxygen) — about three quarters less oxygen than entered our lungs. There is even less oxygen reaching the synovial fluid inside our joints, and arthritis is a wellknown Lyme symptom (although there can be many, many other symptoms of Lyme disease).

Hyperbaric oxygen therapy for treating Lyme can run into the same problem as antibiotics — biofilm. At high enough pressures, however, oxygen does penetrate biofilm, which will be discussed shortly. The presence of latent or dormant persister organisms of the Lyme bacteria, however, is as much an issue for hyperbaric oxygen therapy as it is for antibiotics. These cells are so metabolically inert that they can't easily be killed because they are literally dead to the world. They are the undead, and they can wake up if they sense there is no longer any threat. Hyperbaric oxygen alone is rarely the full answer, but it could be a big part of the answer if it were a treatment that was accessible to the public under the direction of a physician who knew how to use it in the treatment of Lyme. (Treatment is discussed at the end of the chapter.)

"SHAMEFUL" LYME CONTROVERSY — DR. BURGDORFER

The whole subject of Lyme is steeped in controversy. For clarity, it is important to understand the back-story of this controversy. The disease is named after the town of Lyme, Connecticut, where the first documented cases in the United States were found in 1975. The organism causing the disease was isolated in 1981 by entomologist Dr. Willy Burgdorfer, who died at the end of 2014.

In the documentary film Under Our Skin (2008), Dr. Burgdorfer says, "The controversy in the Lyme disease research is a shameful affair, and I say this because the whole thing is politically tainted. Money goes to the same people who have for the last thirty years produced the same thing — nothing."

Lyme disease, if treated within a few days after a bite from an infected tick, is essentially curable with a single antibiotic (usually doxycycline for adults or amoxicillin for children) given for a few weeks. To be safe, it should be given for about eight weeks. However, there are more ways to get Lyme besides being bitten by an infected tick, and there is more than one Borrelia species that can be transmitted to humans. Lyme that is treated late or only partially, or that is chronic, can leave humans and animals extremely sick, often disabled, mentally ill, or dead.

DIAGNOSIS CONFUSION? OR PROFITS?

The problem with the Borrelia burgdorferi (Bb) bacteria, as well as the controversy, starts immediately with diagnosis. Bb and its brother, sister, and cousin species all can cause Lyme disease. Some are very virulent, such as Borrelia hermsii (for the sake of simplicity I am calling any infection with a Borrelia "Lyme disease"). The bacteria are elusive. They try very hard to leave the well-oxygenated bloodstream for less-oxygenated tissues, such as bone marrow, the synovial fluid in joints, or the brain. Except in the relapsing fever varieties of Borrelia that seem to hide inside red blood cells as well, in general Borrelia prefers to leave the blood because it favors living in less oxygenated tissues. It is agreed that testing blood for the organism itself is not always accurate or completely reliable. (See PCR testing below.)

Blood testing for indirect immune system responses to the particular species of Borrelia is the only recognized means of diagnosis. But this is inherently problematic, because the testing is calibrated to match only the Bb group — not any of the additional related relapsing fever Borrelia species. In the San Francisco Bay Area of California, for example, Borrelia miyamotoi is probably as common as Bb. The current testing procedure also produces results that vary with the (usually unknown) stage of the disease, as well as the fluctuating immune status of the patient.

In 1994, the CDC and FDA gave their blessing to the diagnostic protocol that continues to be used today in 2016 — a two-tier (two-step) diagnostic test based on measuring antibody response levels in blood. In the first step, called enzyme-linked immunoabsorbent assay (ELISA), antibodies responsive to a mixture of whole-cell Bb bacteria are evaluated — burgdorferi species only. Because some non Borrelia microbes share some of these proteins, a more refined second-step test, the Western Blot, was implemented. This detects a narrower, supposedly more specific, set of antigen proteins.

The most contentious part of this two-tier diagnostic standard — some refer to it as the Dearborn criteria — is that it eliminates two key Bb proteins from the Western Blot test: outer surface proteins A and B (OspA and OspB). But antibodies to OspA and OspB are sometimes the only biomarkers present in those who have late-stage disease.

Spirochaetaceae is the family of bacteria to which the spirochete Borrelia belongs. This phylogeny is still being explored and this diverse and pathologically dangerous group of organisms will undoubtedly grow as more discoveries come to the fore. They continue to corkscrew themselves into our bodies and under the radar of modern medicine despite the millions upon millions infected. The nameless Borrelia in the relapsing fever group is the organism Dr. Shah a (IGeneX Labs) nd I discovered in 2015. If it were up to me I would like to call it B shahnii.

The CDC deals with this confusion by saying that their standard for testing positive, on the now truncated diagnostic criteria, is to meet the benchmark for case reporting, not for diagnosis. That is, if a lab finds a patient to be positive by the abbreviated testing, the lab has to report it just as they would if one tested positive for a venereal disease. But tell that to Lyme-illiterate physicians and insurance companies who don't want to reimburse if a patient doesn't meet the CDC standard (meant only for reporting purposes). Insurance companies continue to find it expedient to use the CDC standard as the basis for denying treatment coverage for all cases except the ones that labs must report.

This is an example of a Western blot test for Borrelia in the relapsing fever (RF) group. The organisms in the RF group will not test positive using the criteria for the brugdorferii group with or without band 31 and 34 (which is shown) included in the band count.

THE TICK AND THE VACCINE

When LYMErix, the first approved Lyme vaccine, was given the green light by the FDA in 1998, Allen Steere, MD, was then chief of the Rheumatology and Immunology Department at Tufts School of Medicine in Boston. But even though Steere was in charge of the research that developed the vaccine, he seemed to have some reservations about LYMErix if given to individuals with the HLA-DR4 gene, which is present in roughly 30 percent of the population. Published in the journal Science a few months after the vaccine was approved, Steere's evidence revealed a striking resemblance between a portion of the OspA molecule and the human protein LFA-1. LFA-1 is an integrin. It joins important white blood cells, called T cells, with cells that the immune system must act against: presenting the immune system with molecules or antigens the immune system needs to do something about. LFA-1, however, is more than just Velcro. It helps activate and program the immune system. Steere's concern was that T cells primed to attack OspA related to Lyme would also attack human cells lined with the "molecular mimic" and continue their attack on normal cells lined with LFA-1 merely because they look like cells lined with Lyme-caused OspA even if the Lyme-caused OspA were gone. The OspA antigen was the Lyme disease vaccine. OspB was the envisioned component of next-generation vaccines.

That is the mechanism involved in many untoward reactions that other vaccines have as well. Something in the vaccine too closely resembles necessary proteins or molecules in the human body, and the vaccine causes the immune system to attack parts of the body it should not be attacking — another reason why so many vaccines are inherently dangerous for many people, especially young children, even if vaccines were "clean" (free of mercury, aluminum, human DNA from fetal cells, retrovirus, etc.).

So, the LYMErix vaccine caused immune-toxicity in many of those who received it — a phenomenon where the vaccine sets the immune systems of the vaccine recipients on fire. Some people who received the vaccine became very ill with Lyme symptoms against which the vaccine was supposed to protect.

But in addition to immune-toxicity, there was another theory. The vaccine was given to many individuals who had previously had Lyme disease and were assumed to have been treated completely, usually by a standard (inadequate) course of antibiotics. But upon vaccination, not only did all their old symptoms reappear, but also antibody counts to most of the bands in the Western blot test unexpectedly soared high — bands that have nothing to do with the OspA antigen.

In all likelihood, injecting the OspA antigen signaled Lyme persister cells to wake up. The previously infected Lyme patients, who thought they were free and clear of the illness, found themselves ill again with Lyme symptoms. Borrelia is not the only family of bacteria that create these metabolic dormant sleeper cells that wait for the right conditions to reactivate, but the presence of both biofilm and persister cells make treating Lyme a challenge for many.

Vaccine proponents and pharmaceutical companies were very upset that the vaccine trials were stopped in 2002, stating there was no justification for not continuing the trials.

Nevertheless, in the real evidence-based world, it meant the vaccine may have reactivated a latent infection that either remained undiagnosed or was not completely eradicated in the individual in the first place and had returned with a vengeance. In truth, the situation was likely a combination of the above reasons — setting off an immune-toxicity reaction and activating a latent infection. If the latter is even half the truth, it means there are far more Lyme cases out there than previously realized.

EVIDENCE-BASED MEDICINE VS. EMINENCE-BASED MEDICINE

The introduction to this book mentioned an article published in 2011, "Alzheimer's disease — a neurospirochetosis: Analysis of the evidence following Koch's and Hill's criteria," which is a meta-analysis, or literature review, of published studies on the autopsied brains of Alzheimer's disease (AD) patients. Spirochetes — the general spiral-shaped type of bacterium of both syphilis and Borrelia — were observed in the brain in more than 90 percent of AD cases. Bb was detected in the brain in 25.3 percent of the AD cases analyzed, and Bb was thirteen times more frequent in AD brains compared to control brains. The brains also had more than one species of spirochete — the infection was not just the cause of a single species of bacteria.

This bears repeating. Over 90 percent of AD brains had infections with multiple species of spirochetes, and over a quarter of these infections were Bb — the one particular species of Borrelia recognized as the main culprit in Lyme. That percentage does not drop to zero in the general population merely because most people are not diagnosed with AD. Kris Kristofferson, actor and country singer, has recently joined the ranks of those who are fortunate enough to find out that their misdiagnosed Alzheimer's disease is actually a Borrelia infection. What is the penetration of these spirochete infections in the general population? 20 percent? 40 percent? No one knows for sure, but it isn't zero. Why didn't this information set off alarms in all corridors of modern medicine?

(Continues…)


Excerpted from "Incurable Me"
by .
Copyright © 2016 Kenneth Paul Stoller.
Excerpted by permission of Skyhorse Publishing.
All rights reserved. No part of this excerpt may be reproduced or reprinted without permission in writing from the publisher.
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Table of Contents

Introduction: Normalized Failure vii

Chapter 1 The House of Lyme 1

Chapter 2 Dementia: Are We All Getting Dicofo(o)l'ed? 29

Chapter 3 The Dystopic War on Discernment, or Human Colony Collapse Disorder (Thanks for All the Fish!) 55

Chapter 4 Multiple Sclerosis and Inflammatory Bowel Disease, or what a pile of… 68

Chapter 5 Traumatic Brain Injury and Hyperbaric Oxygen Therapy 76

Chapter 6 Mercury in Medicine-Quacks, Quackery and Quacksalber 91

Chapter 7 The Religion of Jabism-A Special Chapter on Vaccines 123

Chapter 8 On Diagnosing and Treating Toxic/Infectious/Immune Encephalopathy and Other Chronic Illness 143

Conclusion 163

Notes 170

Acknowledgments 191

Index 192

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