REPORT CARD RESULTS
Public Citizen
American Autoimmune Related Diseases Association (AARDA)
Drug Companies: Abbott Laboratories, Forest Laboratories and King Pharmaceuticals
Dairy Queen
Endocrinology Researchers
America's Doctors
Holistic/Alternative Medicine Community
American Academy of Clinical Endocrinologists (AACE)
U.S. Food and Drug Administration (FDA)
Larry Ladd, Perchlorate Activist
Drug Companies, Attorneys for the Synthroid Class Action Lawsuit
PDF Printer-friendly version of 2004 Thyroid Disease Report Card
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The Endocrinology Research Community
Grade: C
Okay, at least the researchers are actually researching quality of life issues for thyroid patients. This is something to be grateful for, because most endocrinology researchers are only excited about diabetes, or they couldn’t be bothered with studying practical, real-life issues related to the thyroid, and instead are pumping out stuff like “Cytotoxic T Lymphocyte-Associated Molecule-4 Polymorphism after Antithyroid Withdrawal.” So the publication in 2003 of a number of studies that looked at the impact on people’s symptoms of combination T4/T3 therapy for hypothyroidism, versus levothyroxine (T4 only), were promising.
The research community got our hopes up, only to let us down...hard.
Two studies, published in the October 2003 issue of the Journal of Clinical Endocrinology & Metabolism (JCEM), both claim to show that combining thyroxine (T4) and T3 is not superior to T4 alone for the treatment of patients with hypothyroidism. One 15-week study looked at 40 hypothyroid patients with depressive symptoms and determined that T4/T3 combination therapy did not improve either mood or personal sense of well being. A second study compared a combination T4 and T3 therapy with T4 in a 20-week double-blind, random order, crossover trial of 110 hypothyroid patients. Half the patients received T4 therapy for 10 weeks and then T4 and T3 therapy for 10 weeks. The other half of the subjects received the combination therapy first. Once again, the researchers found no significant benefits for combination therapy compared to T4 alone.
Then, in December of 2003, the Journal of the American Medical Association (JAMA) published another study, which looked at 46 patients with hypothyroidism resulting from autoimmune thyroid disease (Hashimoto’s Disease). In the JAMA study, the two groups of patients either continued to receive their current synthetic T4 dose or received 50 µg less of their current dose of T4 plus 7.5 µg of T3, twice daily. The synthetic T4 doses of patients in both groups were adjusted to keep patients at so-called “normal” thyroid levels, according to blood tests. After four months, there were no differences in body weight, blood pressure, or lipid levels between the two groups of patients after this four-month study. Additionally, no significant differences were observed in any of the standardized tests that assessed hypothyroidism symptoms or mental function.
Are you detecting a trend here? All these studies set out to contradict the findings of Drs. Bunevicius, Prange, and colleagues, who since 1999, have published three separate research studies that have supported the use of T3.
Levothyroxine therapy is big business (Synthroid is one of the top three selling drugs in America, and a highly profitable drug sold at high markup as well), and anything that will take away business from the levothyroxine manufacturers has got to be a threat, so it's no surprise that research studies are setting out to prove that levothyroxine should be the only game in town. And doctors, reading these new studies with less than a critical eye, are likely to go along with the findings.
But should they? No, say many thyroid patients, and the experts who treat them, who believe that the studies are seriously flawed, for a variety of reasons.
The Wrong Amount of T3 Was Used -- According to Dr. Ken Blanchard, author of What Your Doctor Doesn’t Tell You About Hypothyroidism, both studies suffer from incorrect amounts of T3. According to Blanchard, both the JCEM and JAMA studies used too much T3. Says Blanchard: "...any T4/T3 study that does not give T4/T3 in about a 98%/2% T3 T4/T3 ratio and does not give T3 in time-release form will not come close to reproducing normal thyroid physiology.”
They Contradict Clinical Experience – According to holistic practitioner Roby Mitchell, MD: "...we only have to look back at all the prospective, randomized, double blinded, placebo-controlled trials 'proving' that hormone replacement with Premarin and Provera would reduce heart disease, Alzheimer's and didn't cause breast cancer. No clinician who routinely uses T3 therapy would buy either of these studies read or unread as they just don't match up with clinical experience. That's the first criterion for establishing the validity of any study...If monotherapy with T4 was universally effective, there would be no driving force behind the addition of T3."
The Dosages and Timing of Dosing Were Not Optimized -- Chronic Fatigue, fibromyalgia and metabolism expert Jacob Teitelbaum, MD has felt that the failure of these types of studies is that instead of adjusting the thyroid therapy dose to what feels best, the doctors often used a "one size fits all" approach. Teitelbaum believes that more T3 needs to be used, or possibly the natural desiccated thyroid drug rather than the synthetics, for optimal results. According to Dr. Teitelbaum: "Sadly, it seems the researchers did not consult with physicians experienced in the use of this approach. They would have noted: (1) Use an ~ 4:1 ratio of T4 to T3( not 10:1) (2) adjust the dose to that which feels best to the patient, while keeping the Free T4 level in the normal range (3) If one type of thyroid does not work adequately, try another (their study posits that only one "brand" of shoe is best for everyone instead of asking the key question - "Did one form work best for some patients and the other type for others?") (4) Do some patients benefit from split dosing (eg, twice a day) while some do fine with once a day? (5) Are there other components of the natural thyroid that also result in a better outcome (6) For those who still respond poorly, what other problems are being missed?"
Normal Range Used is No Longer Normal -- Blood levels of T4, T3, and TSH were maintained in the normal range in the majority of patients in this study. However, this study does not take into account that after the study was completed, new guidelines were issued indicating that the target TSH range should be maintained between 0.3 and 2.0-3.0, rather than .5 to 4.6-5.0. Patients in the study typically had TSH in the 2.0-2.5 range throughout treatment. Some patients, however, do not achieve optimal thyroid hormone replacement results unless the TSH level is in the lower end of the normal laboratory range, i.e., between .5 and 2.0.
Study Size is Too Small -- None of the studies included a large number of patients. Compared to the estimated 27 million-plus Americans with some form of thyroid disease, sample sizes of 20, 50 and 100 are really absurd. They certainly aren’t large enough to be statistically valid or applicable. Would doctors change treatments for diabetes or heart disease based on studies of 20 or 50 people?
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Back to the drawing board, researchers. And your first stop before you embark on any more misguided research efforts is to sit down and LISTEN to the doctors who are actually working with and successfully treating thyroid patients. Don’t talk to the endocrinologist who sees his patients once a year for 10 minutes, has his nurse take blood for a TSH test, and sends the patient away in tears, feeling sick and miserable. Talk to the doctors who have healthy, satisfied patients who are living well with their thyroid conditions. Find out what protocols those doctors are using, and test THOSE protocols, using the latest lab standards.
References:
Clyde, Patrick W. e. al. “Combined Levothyroxine Plus Liothyronine Compared With Levothyroxine Alone in Primary Hypothyroidism: A Randomized Controlled Trial” Journal of the American Medical Association. 2003;290:2952-2958
Walsh et. al. "Combined Thyroxine/Liothyronine Treatment Does Not Improve Well-Being, Quality of Life, or Cognitive Function Compared to Thyroxine Alone: A Randomized Controlled Trial in Patients with Primary Hypothyroidism," The Journal of Clinical Endocrinology & Metabolism, Vol. 88, No. 10 4543-4550
Sawka, A. et. al. "Does a Combination Regimen of Thyroxine (T4) and 3,5,3'-Triiodothyronine Improve Depressive Symptoms Better Than T4 Alone in Patients with Hypothyroidism? Results of a Double-Blind, Randomized, Controlled Trial," Journal of Clinical Endocrinology and Metabolism, JCEM 2003 88: 4551-4555
Bunevicius R, Jakubonien N, Jurkevicius R, Cernicat J, Lasas L, Prange AJ Jr. "Thyroxine vs thyroxine plus triiodothyronine in treatment of hypothyroidism after thyroidectomy for Graves' disease." Endocrine. 2002 Jul;18(2):129-33.
Bunevicius R, Prange AJ."Mental improvement after replacement therapy with thyroxine plus triiodothyronine: relationship to cause of hypothyroidism." Int J Neuropsychopharmacol. 2000 Jun;3(2):167-174.
Bunevicius R, Kazanavicius G, Zalinkevicius R, Prange AJ Jr. "Effects of thyroxine as compared with thyroxine plus triiodothyronine in patients with hypothyroidism." N Engl J Med. 1999 Feb 11;340(6):469-70.
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