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FDA Attacks Natural Thyroid Millions Depend On

We have learned that Time-Cap Labs, producer of a generic version of the brand name drug Armour, a natural and bioidentical thyroid replacement, has been ordered by the FDA to stop production. The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug.  Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product.  The purpose?  Presumably to protect the profits of other, inferior drugs that have been FDA approved.

According to statistics by the American Association of Clinical Endocrinologists and other medical organizations, approximately twenty-seven million Americans have a thyroid disorder.  Thyroid consumer advocate Mary Shomon projects that 2 million of these patients take either Armour Thyroid or a generic equivalent.

Armour and other "whole" natural thyroid preparations (including Westhroid and Nathroid as well as Time-Cap Lab’s Thyroid) are bio-identical, complete hormone preparations, containing 'T4', 'T3', 'T2' and 'T1' in the same proportions made by the human thyroid. The FDA approved preparations Synthroid (T4), Cytomel (T3), and Levethyroxine (T4) include bio-identical molecules, but are not complete or totally bio-identical as they do not contain 'T2' or 'T1'.  It’s no wonder so many people feel much better with the balanced natural products that have been available for generations.

As famed physician Dr. Jonathan Wright observes:  “Natural thyroid has never killed or severely harmed anyone since its first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.” Source-American Association for health freedom. September 1, 2009.

Major Pharmaceuticals has put out a press release saying that they've been forced to shut down production of all natural desiccated thyroid drugs, a treatment for hypothyroidism that has been in use for over a century. Major received notice from the FDA that their complete line of desiccated thyroid drugs can no longer be manufactured, and that the FDA is pulling the designation that allowed them to sell these drugs. Major is also saying that the FDA is requiring that all manufacturers that wish to continue manufacturing submit an NDA or ANDA (New Drug Application or Abbreviated New Drug Application) for approval.

Desiccated thyroid drugs were in use in the early 1900’s, and already on the market when the government regulatory groups to oversee medications were formed, so they never went through the new drug application process. Biotech, Time Cap Labs, and Major are no longer manufacturing natural desiccated thyroid drugs. RLC and Forest are now the last makers of natural desiccated thyroid drugs in the U.S., and their products are unavailable or in short supply in throughout the nation. Source Mary Shomon:  About.com August 26, 2009

The FDA has shut down production and distribution of natural thyroid drug options by three firms: Biotech, Major, Time Cap Labs. Two other major manufacturers/distributors now have long-term backorders for their bioidentical hormone products, which include Armour, Nature-Throid, and Westroid. The uncertainty about the future of natural thyroid drug options has led patients and practitioners to form a new coalition designed to help protect your right to choose, under the banner "Save Natural Thyroid." They’ve also formed a Save Natural Thyroid Facebook Group to strategize and help keep thyroid patients informed. If you or anyone you love uses bioidentical hormones, you may want to join this group to keep up on the latest updates.

What do I do if I can no longer gain access to Armour thyroid from my local pharmacy?

Contact your local Naturopathic Doctor, schedule an appointment with them and after they review your health history and blood tests they will be able to prescribe the compounded equivalent of Armour thyroid for you. Compounded Armour thyroid comes in grains just like the original but is in capsules instead of tablets.

If you have been on Armour and and have felt good on it do not let your doctor try to put you on Synthroid, the synthetic form of thyroid hormone. Most patients who do well on Armour do worse on Synthroid. Here at our clinic we prescribe Armour thyroid daily and work with our local compounding pharmacy to provide you with the best quality natural hormone.

How do You Know if Your Thyroid is Not Working Properly?

Fatigue is the most common sign of an underactive thyroid, followed by depression and muscle weakness.

Other common signs of hypothyroidism include:

• Changes in your weight and appetite, especially unexplained
• Difficulty losing weight despite proper diet and exercise
• Forgetfulness
• Sensitivity to cold, especially in the winter, this is a big one
• Dry, rough or scaly skin, and dry, tangled hair, another important one
• Hair loss, particularly from the outer part of your eyebrows
• Brittle nails

The most common conventional way physicians diagnose hypothyroidism is with a thyroid stimulating hormone (TSH) test. The range for acceptable thyroid function is between 0.3 and 2.05. In my experience, most adults with levels over 2 have hypothyroidism. Let me repeat this as it is easy to overlook: BE CAREFUL, as most physicians will dismiss your TSH results as “normal” because they will be using outdated, and very broad reference ranges. If your TSH is above 2.0, then it is highly likely your thyroid is not working as it should.

Treatment Options for Hypothyroidism

What I have observed over the years is an interesting phenomenon. You can typically tell if a physician is a natural medical doctor, or at least oriented in that direction, by the type of thyroid hormone they prescribe. Natural medical physicians nearly exclusively prescribe natural hormones, and conventional  physicians typically prescribe synthetic versions like Synthroid and Levothroid. It’s important to realize that early intervention can successfully restore your thyroid function. If you’ve had your thyroid gland surgically removed, however, you have no choice but to keep taking thyroid hormones for the rest of your life. When it comes to thyroid hormones, you have two major options: synthetic or natural. One of the most commonly used is Synthroid, a synthetic hormone. Another common T4 hormone preparation is Levothroid. I rarely recommend using those, as most people cannot effectively convert the T4 in synthetic thyroid preparations to T3 which is the active form of the hormone.

If you’ve been on synthetic hormones for an extended period of time, say 10 to 20 years, the likelihood of you being able to wean yourself off the hormones is limited and most people I have treated were unable to do it. But if you’re newly diagnosed, or have not been on synthetic hormones for very long, I strongly recommend Armour Thyroid or a natural thyroid preparation – a natural porcine thyroid extract, which provides not only T3 and T4, but also T1 and T2, which will help normalize your hormone response. The fact that the FDA may now severely limit, or eliminate this option is distressing, as it is clearly the best option for many people.

Research Confirms the Superior Benefits of Natural Armour Thyroid

An important study published in 1999 in the New England Journal of Medicine (NEJM) showed the benefits of natural Armour thyroid compared to the synthetic Synthroid drug. They found that patients with hypothyroidism had greater improvements in mood and brain function when receiving Armour thyroid rather than Synthroid (thyroxiine). The researchers also detected biochemical evidence that thyroid hormone action was greater after treatment with Armour thyroid, because the patients who were on Armour thyroid had significantly higher serum concentrations of sex hormone-binding globulin.

Source: Mercola.com