Is the FDA taking desiccated thyroid off the market?

by Mary Budinger — 

The shortage of natural desiccated thyroid began a year ago when the sole American supplier changed the manufacturing process that turns the thyroid glands of pigs into powder. This caused shortages for both major suppliers of desiccated thyroid, Forest (Armour Thyroid) and RLC Labs (Nature-Throid and Westhroid).

Forest recalled a large portion of Armour Thyroid due to stability concerns and back-ordered everything. RLC Labs was also having quality-control problems. Armour was then reformulated — reportedly the dextrose was decreased and the cellulose increased. Numerous patients, however, reported that the taste of the new tablets was repugnant and that their hypothyroid symptoms returned.

Meanwhile, Time-Cap Labs, Inc., producer of a generic version of the brand-name drug Armour, was ordered by the FDA last June to stop production. The FDA decided to classify the company’s product, available for more than a century, as an unapproved new drug, which requires a new drug application. Time-Cap Labs stopped production, and much speculation and confusion followed. Patients of the “Save Natural Thyroid Coalition” called the FDA’s consumer information line (888-463-6332) and got many different answers. No one knows if the FDA will require all natural desiccated thyroid drugs that are still on the market to go through the new drug application process.

RLC Labs said, “… [we are] fully committed to supplying patients with a quality product. We will see this through.” It is unclear when or if Forest will begin producing Armour thyroid.

Desiccated thyroid (from pigs) are bio-identical, complete hormone preparations, containing the entire spectrum of thyroid hormones including T4, T3, T2 and T1 that are located in the human thyroid gland. Current FDA-approved thyroid medications include Synthroid, Unithroid, Levoxyl and Levothyroxine (all contain only T4), and Cytomel (only T3). These hormones are synthetic and contain only a portion of the thyroid’s hormones.

Dr. Mark Starr of Phoenix said patients have called to tell him that desiccated thyroid is unavailable. “It is so key to my practice, but I do have enough for patients. So far, it appears that when supply catches up with demand in a few months, the shortage will be over.”

Starr is the author of Hypothyroidism-Type 2. He said synthetic thyroid acts energetically differently in the body. “All living things have a right spin, and synthetic medications have a left spin. The desiccated thyroid is better tolerated.”

Dr. Broda Barnes conducted a study that revealed a relative intolerance to a synthetic thyroid product containing T3 and T4 (Thyrolar). One-fifth of the patients who had done well on desiccated thyroid developed rapid heartbeats and palpitations when switched to Thyrolar. Barnes also did a major research study on desiccated thyroid that involved thousands of patients over 30 years. It showed a 94 percent reduction in the number of expected heart attacks. This study became the subject of the 1976 book, Solved: The Riddle of Heart Attacks.

Lipitor is the best-selling drug in the world, but for the first half of the 20th century, desiccated thyroid was the standard treatment for high cholesterol. Elevated cholesterol and triglycerides are one of the myriad symptoms of hypothyroidism. Barnes’ book includes a chapter entitled “The Demise of the Cholesterol Theory.” Desiccated thyroid normalized cholesterol and triglycerides in 95 percent of the patients Barnes treated. The 5 percent who had persistently elevated levels had no increased incidence of heart attacks. Desiccated thyroid therapy also resolved a long list of other hypothyroid symptoms such as fatigue, cold intolerance, joint and muscle pain, dry skin, inability to lose weight, headaches and menstrual problems.

One of the most important benefits that Barnes demonstrated in studies on both animals and his patients was that desiccated thyroid increases immunity and allows the body to fight off infections. During flu season, this is important.

Mary Budinger is an Emmy award-winning journalist who writes for complementary and alterative medicine. 602-494-1999.

Reprinted from AzNetNews, Volume 28, Number 5, Oct/Nov 2009.