The Great 2009 Thyroid Shortage
Doctors, patients, and pharmacists have been caught off guard by the sudden disappearance of Armour Thyroid. Although there were rumors about a possible shortage of desiccated thyroid starting in 2007 and scattered shortages at certain pharmacies in 2008, Armour Thyroid did not disappear from the shelves until August of this year. Forest Laboratories in New York State, manufacturer of Armour USP Thyroid, is mum about why the natural supplement is no longer available. An estimated 2 million Americans use desiccated thyroid hormone, and its unavailability will leave them in the lurch scrambling for alternative supplies and substitution of synthetic thyroid hormone. Given the delicate nature of balancing thyroid-deficiency states, the need to titrate a dose upward or downward based on lab testing and symptoms, patients, physicians, and pharmacists will be scratching their heads trying to fix this problem.
Regrettably, other desiccated thyroid supplement manufacturers will not be able to pitch in. RLC Laboratories in Phoenix has run out of Nature-Throid and West-Throid, their proprietary brands of USP desiccated thyroid. Time-Cap Labs, which produced a generic form of thyroid, has been ordered by the FDA to stop production, according to a report by the American Association of Health Freedom (AAHF) dated September 2, 2009. American Laboratories, the supplier of raw material for the manufacture of Armour Thyroid, is also decidedly silent about why Armour Thyroid is unavailable.
The failure of manufacturers, suppliers, and the FDA to explain why Armour Thyroid and other brands of thyroid are no longer being made is maddening and has given way to conspiracy theories. Less than a year ago, one of the components of natural estrogen hormone compounding, estriol, was also made unavailable. However, this involved a component only used by compounding pharmacies. Why Armour Thyroid would be discontinued when it has been legally manufactured for more than 100 years suggests hidden regulatory activity by the FDA.
Mary Shomon, author of About.com's Guide to Thyroid Disease, has uncovered irregularities by Forest Laboratories.1 In addition to manufacturing Armour Thyroid, Forest makes Levothroid, a proprietary brand of levothyroxine (synthetic thyroxine, or T4). In other words, the same company that makes a natural form of thyroid makes the synthetic form. Given most Armour Thyroid users' unbridled enthusiasm for their use of a "natural" product, and their disdain for synthetic forms of thyroid such as levothyroxine, it probably would be disconcerting for most to learn that the same drug company makes both.
With the current economic climate placing tremendous stress on the bottom line, one would be rightfully concerned that a drug company may make manufacturing decisions based primarily on profit concerns. Why the manufacture of Armour Thyroid should pose economic constraints on Forest Laboratories is unclear, but clearly this company has a number of thyroid products under one roof and perhaps there is a lack of profitability. However, Shomon, the author of numerous thyroid books, including The Thyroid Hormone Breakthrough, has found a failure of Forest Laboratories to be truthful about another of its thyroid products.
Forest Laboratories also makes a proprietary form of thyroid known as Thyrolar, a combination of synthetic levothyroxine and l-triiodothyronine. As in the situation with Armour Thyroid, Thyrolar has suddenly become unavailable. Forest Laboratories issued a statement that Thyrolar is on "back order" because the product needs to be reformulated. The reason that the company offers for reformulating the product is that it has been ordered by the US Pharmacopoeia (USP) to meet new specifications for thyroid manufacturing.
It is true that the USP has required changes in manufacturing requirements for levothyroxine (T4); however, it is not true that the USP required changes for the manufacture of Thyrolar. When Shomon contacted Forest Laboratories to find out why this explanation was untrue, no one was willing to respond. Shomon points out other inconsistencies with Forest Laboratories' manufacturing of Armour. Earlier this year the formulation of Armour Thyroid was changed – the excipient content of cellulose in the tablet was increased, while the content of dextrose was reduced. No explanation has been provided for this change. Forest Laboratories has blamed a shortage of raw material for the reason why Armour Thyroid is not being made. American Laboratories will not verify such a shortage.
In another posting on Shomon's About.com Guide to Thyroid disease, she asks thyroid doctors what they would do if Armour Thyroid and all other forms of desiccated thyroid were to become unavailable.2 Shomon reminds us that at this time compounding pharmacies are willing to compound desiccated USP thyroid, although she worries that different pharmacies will prepare formulations of varying potencies despite labeling of equal dosage. Jacob Teitelbaum, MD, offers that doctors should make a best guesstimate of a comparable amount of levothyroxine (T4) and Cytomel (T3). David Brownstein, MD, suggests that if a patient were using ½ grain thyroid, he would prescribe 25 mcg of levothyroxine and 5 mg of T3. Kent Holtorf, MD, recommended increasing the T3 slightly compared with the T4. Hence, the experts have different opinions about what one should do if Armour and desiccated thyroid products do not return to the pharmacy.
It is unclear when Armour Thyroid manufacturing will resume. Let us hope that the transition to alternative forms of thyroid treatment will proceed smoothly with most patients.
Hoffer on Bipolar Disorder and Schizophrenia
When I started to examine and practice alternative medicine in the 1970s, I was schooled in the use of vitamin supplements and intravenous nutrients for the treatment of physical disorders. Working with intravenous ascorbic acid; chelation; and high-dose vitamins, minerals, and amino acids to treat acute and chronic disorders seemed like a reasonable extension of medicine and treatment with drugs.
At the same time that I was being introduced to these natural approaches to treating cardiovascular disease, arthritis, cancer, and inflammatory disorders, I was also introduced to the use of megavitamins and diet for the treatment of mental disorders. Treating depression and anxiety disorders did not seem to be beyond the purview of megavitamin therapy. What was eye-popping was the use of such treatment for schizophrenia. An organization in Seattle, the Well Mind Association, not only promoted such therapies but operated a clinic to permit practitioners to administer megavitamin prescriptions to schizophrenic patients. The association also arranged seminars and lectures for practitioners and patients to learn the theory and practice of megavitamin therapy.
Perhaps the most important teacher of megavitamin therapy for schizophrenia was Abram Hoffer, PhD, MD, who had spent nearly his entire professional career researching and writing about it. He just recently passed away, but he had not quit writing, even in his retirement. In this issue, we have the honor of presenting Hoffer's article "Bipolar Disorder and Orthomolecular Treatment," which had not yet been published. It offers his view of manic-depression, schizoaffective disorder, and schizophrenia. From Hoffer's perspective, these disorders pose diagnostic difficulties because psychiatrists do not look at these conditions as a continuum, with schizoaffective disorder an intermediary condition between manic-depression at one end and schizophrenia at the other. Hoffer thinks that Dr. Karl Menninger's systematic means of diagnosing psychotic disorders depended on examining four areas of "mental activity: perception, thinking, mood, and behavior." Hoffer wants us to look at the patient's perceptual dysfunction, and determine how the thinking is disrupted and what impact these factors have on creating inappropriate mood and misbehavior. Without correlating perception with thinking and mood, one can misjudge schizophrenia for manic-depression. More importantly, Hoffer found that the biochemistry of catecholamines, particularly adrenalin, determines the development of perceptual disorder in schizophrenia. The role of niacin and ascorbic acid in correcting disturbed catecholamine biochemistry is fundamental to Hoffer's treatment for each of these disorders.
Please read this very important article on bipolar disorder and schizophrenia, and then pass it on to your psychiatrist colleagues.
Jonathan Collin, MD
1. Shomon M. Why is Forest Pharmaceuticals lying about thyroid drug Thyrolar? and what else are they hiding? [web page] About.com Guide to Thyroid Disease. Sept. 16, 2009.
2. Shomon M. The Armour thyroid and Nature-Throid natural desiccated thyroid shortage in 2009 [web page]. About.com Guide to Thyroid Disease. Aug. 18, 2009.