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April 28, 2002

Brief Introductory Statement of the
Fibromyalgia Research Foundation:
"T4 Replacement Therapy: An Obstacle to
Recovery from Fibromyalgia"


Dr. John C. Lowe, President & Director of Research 
Jackie Yellin, Director of Education

Read by Lyn Mynott, Chairperson, Thyroid UK
to the Medical Advisory Board
for the All Parliamentary Group,
Fibromyalgia Association Conference,
Harrogate Conference Center, Harrogate, United Kingdom


We first want to thank Lyn Mynott for reading this official statement of the Fibromyalgia Research Foundation in our absence. We also want to thank all our other colleagues at Thyroid UK for providing educational information about the relation of fibromyalgia to hypothyroidism and thyroid hormone resistance. Our Foundation’s charter obliges us to provide educational information to patients, clinicians, scientists, and the public at large. We are proud to work with Thyroid UK in fulfilling this educational responsibility.

We have prepared a full written version of this official statement. Our colleague Karen Goodfellow of Thyroid UK has been kind enough to print copies of the full statement to be handed out at the Harrogate Conference. We also have posted a copy of these brief comments and the full statement at our website, www.drlowe.com. These comments are a brief summary of our full statement.

For the last 15 years, we have diligently studied the underlying mechanisms of fibromyalgia. Based on the results of our studies, we developed a treatment protocol that we call "metabolic rehabilitation." This protocol enables some 85% of fibromyalgia patients to fully recover and remain recovered.* Our research and our clinical experiences with fibromyalgia patients have led us to the following conclusions:

(1) Fibromyalgia is a set of symptoms and signs resulting from hypometabolism. (2) Most patients’ hypometabolism has multiple causes. (3) The most common and most potent cause of patients’ hypometabolism is too little thyroid hormone regulation, due either to hypothyroidism or partial cellular resistance to thyroid hormone. Other factors that commonly compound patients’ hypometabolism are a dysglycemic diet (one that causes blood glucose irregularities), multiple nutritional deficiencies, low physical fitness with subnormal skeletal muscle mass, sex hormone imbalances, and decreased adrenocortical reserve or frank cortisol deficiency. (4) We said that 85% of patients who go through our treatment program fully recover from their fibromyalgia. By "fully recover" we mean that they no longer meet the American College of Rheumatology (ACR) criteria for fibromyalgia, and that the patients are symptom-free and fully functional. These patients recover only when properly guided through a program of metabolic rehabilitation that comprehensively corrects the multiple causes of their hypometabolism. Proper guidance, which implies both safety and effectiveness, requires that: (a) most hypothyroid patients use a thyroid hormone product containing both T4 and T3 in a 4-to-1 ratio, and that thyroid hormone resistance patients use plain T3, typically in supraphysiologic dosages; and (b) clinicians adjust patients’ dosages according to objective measures of their tissue responses to thyroid hormone without regard to thyroid function test results. As we explain in our full statement, careful safety testing shows that our patients who recover with TSH-suppressive dosages of thyroid hormone do not suffer decreased bone density, acute adrenal crises, or cardiac arrhythmias.

Our clinical experience and research findings reveal the inimical impact of T4 replacement therapy on the population of fibromyalgia patients. Only rarely does a fibromyalgia patient improve with T4 replacement therapy. Most hypothyroid patients on  T4 replacement who consult us meet the ACR criteria for fibromyalgia; the symptoms of some patients are debilitating. Most of these patients fully recover when they abandon T4 replacement therapy and undergo comprehensive metabolic rehabilitation, including thyroid hormone therapy unguided by thyroid function testing. Our data indicate therefore that T4 replacement therapy is a major impediment to patients’ recovery from the symptoms and signs currently diagnosed as fibromyalgia. Most of our fibromyalgia patients recover when switched from T4 replacement to T4/T3 combination medicines or  T3 alone. They recover, however, only when their dosages are higher than replacement dosages of T4.

These findings have led us to several conclusions: (1) T4 replacement therapy generally constitutes under-treatment of patients, leaving them symptomatic; (2) T4 replacement therapy is thus a major cause of the continued suffering of patients whose symptoms and signs we currently diagnose as fibromyalgia; and (3) fibromyalgia will cease to be a widespread affliction when (a) mainstream medicine recognizes T4 replacement as a failed clinical concept and (b) abandons it in place of response-driven thyroid hormone therapy as practiced in the 20th century before TSH assays came into widespread use. In short, we agree with a conclusion of Dr. David Derry of British Columbia: Fibromyalgia, chronic fatigue syndrome, ME, and a variety of other so-called "new diseases" are a direct result of the imposition of the concept of T4 replacement on mainstream medicine and the patients it cares for. T4 replacement thus constitutes one of the most costly and health-devastating blunders in the history of medicine.

More succinctly stated: Thyroxine alone is comparatively ineffective for fibromyalgia patients. To recover, most must use either a T4/T3 combination (as in natural thyroid) or T3 alone. Patients need dosages that get them well without overstimulating them. Whether their TSH is normal, low normal, or suppressed during thyroid hormone therapy is entirely irrelevant and unimportant. Patients’ dosages must be kept below thyrotoxic amounts. But in that the TSH is not a reliable or valid indicator of tissue thyrotoxicosis, it should not be used, and clinicians should depend only on more direct measures of tissue thyrotoxicity. Restricting patients to the use of thyroxine, specifically to dosages that keep the TSH within the reference range, ensures that most will continue to suffer from fibromyalgia. Ignoring TSH levels altogether and titrating thyroid hormone dosages according to tissue responses enables most patients to recover.

*In most cases, patients remain recovered when they continue the practices that enabled them to recover, such as wholesome diet, nutritional supplementation, abstention from metabolism-impairing drugs, and hormone therapies appropriate for them. As might be expected, some patients do not continue one of more of these practices, and these patients typically experience recurrences of their symptoms and signs. When the patients fully resume the practices, however, their symptoms and signs usually again subside.


| Censorship by Some Members of Medical Advisory Board |
| T4 Replacement: Obstacle to Recovery from Fibromyalgia: Full Version |

We appreciate your continuing
support of our research

  

Thyroid Hormone Replacement Therapy:

Replacement therapy is a controversial approach to thyroid hormone treatment. It involves adjusting a patient's daily thyroid hormone dose so that it keeps his or her TSH within its reference range. For the last forty years or so, mainstream medical clinicians have prescribed only synthetic T4 (thyroxine) for patients. We call this approach T4 replacement. In recent years, some mainstream practitioners have begun prescribing very small doses of T3 along with T4. But the two hormones together (especially with the small amounts of T3  prescribed) are little-to-no more effective than replacement with T4 alone.

Studies have shown that T4 replacement is ineffective and harmful to many patients. (See Dr. Lowe's rebuttal to the British Thyroid Association; his critique of the false beliefs of Richard Guttler, MD; and his critique of four 2002 studies of T4 vs T4/T3 replacement.)

Nonetheless, most mainstream medical specialties (most prominently the endocrinology specialty) obstinately ignore those who bring the the scientific evidence before them. And continue to advocate T4 replacement as the treatment of choice.

Many critics point out the documented financial inducements to the specialties from drug companies that profit from T4 replacement. The critics say the inducements have two effects on the specialties: blinding them to the evidence against T4 replacement, and closing their eyes and ears to the suffering they cause by patients restricted them to replacement therapies.

Critics of T4 and T4/T3 replacement also argue that the approach ensures the sale of scores of millions of TSH lab tests each year. The sales financially benefit clinicians who order the TSH, labs that run the test, and Big Pharma, which manufactures the tests. Critics also argue that the ineffectiveness of replacement therapies causes a public health problems: it ensures that hypothyroid and thyroid hormone resistance patients will continued to suffer from symptoms of too little thyroid hormone regulation and associated diseases, such as high blood fats and hypertension. These continuing health problems of the patients ensure that  mainstream clinicians will prescribe Big Pharma's expensive patented drugs, keeping medical costs scores of billions of dollars higher than if the clinicians properly treated patients for their hypothyroidism or thyroid hormone resistance.

T4 Replacement as
the Root Cause of Fibromyalgia. Among the millions of thyroid patients subjected to thyroid replacement therapies are many fibromyalgia/thyroid patients. In fact, Dr. Lowe argues that ultimately, T4 replacement is the root cause of so-called fibromyalgia and many other "mysterious new diseases." Similar proposals have been registered by two of his colleagues, David Derry, MD, PhD and FRF's late research team member Dr. Richard L. Garrison. Dr. Garrison stated that the TSH has caused so much human misery  that it should be recognized as a modern medical disaster and abandoned as a diagnostic test. Dr. Lowe fully agrees with this opinion.