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Is the FDA Poised to Ban a Century-Old Natural Remedy?

September 19, 2009 | 101,466 views

thyroid, bioidentical hormones, FDA, hormonesMajor 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.

 

Dr. Mercola's Comments:

Mary Shomon is the about.com thyroid expert, and she is one of the leaders in the field. In this article, she raises the warning flag about a very important issue for many people – the potential elimination of bioidentical hormones from the market.

She is enormously popular and has about 70 percent of the traffic that comes to my site. If you have any thyroid condition her site is an absolute must. She is my go-to thyroid expert, and I frequently call her to get advice in this area. She has my absolute highest endorsement as one of the most knowledgeable people on thyroid issues out there.

I am in the process of reviewing her new book, The Menopause Thyroid Solution: Overcome Menopause by Solving Your Hidden Thyroid Problems, and hope to have that up soon. I am sure it will receive my highest rating, as I have yet to review a book she wrote that wasn’t the best in its field.

So far, there are more questions than answers, but one thing is for sure: the FDA’s withdrawal of the designation that allowed these drugs to be sold has patients worried across the U.S.

As reported by Mary, the FDA has already shut down natural desiccated thyroid drug production and distribution 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 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.

Mary and I have had strategic discussions on the next step to preserve this important resource, but it is very unclear how we can direct the efforts.

I actually called the FDA on September 9th and talked to a senior health advisory officer. She told me she could not be quoted, but that she was personally unaware of any FDA meetings that were scheduled on this. Then she put me on hold for 15 minutes. When she came back she identified me as Dr. Mercola, even though I never said I was a physician. So she clearly looked me up.

Then she told me that I would have to call the FDA Press area for an official position, and that there actually could be a meeting being planned, but it wasn’t currently on the FDA website.

They are obviously highly secretive about this and not willing to let the public know what is happening, but I assure you that Mary and I are working on this together, and will bring you a plan as soon as we figure one out.

Thyroid Disease Affects Many

Your thyroid is a small butterfly-shaped gland in your throat area that contains thyroglobulin protein, which binds to iodine to form hormones, which in turn influence essentially every organ, tissue and cell in your body. Two key hormones produced by your thyroid are triiodothyronine (T3) and thyroxine (T4). These hormones help oxygen get into cells, and make your thyroid the master gland of metabolism.

If too much or too little thyroglobulin protein in your thyroid binds to iodine, too many or too few hormones will be produced.

Hypothyroidism is the condition where your thyroid produces too few hormones and account for some 80 percent of all people with thyroid disease.

Hyperthyroidism is the reverse problem, where your thyroid is overactive, producing too much thyroid hormone.

Thyroid disease, if left untreated, can lead to heart disease, infertility, muscle weakness, osteoporosis and, in extreme cases, coma or death, yet it’s estimated that half of the cases in the United States, about 15 million people, remain undiagnosed.

If you have certain symptoms, which I will review below, there’s a good possibility -- especially if you are a woman – that you might be one of these individuals.

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 3.04.

In my experience, most adults with levels over 3 have hypothyroidism, and many with levels from 1.5 to 3.0 seem to benefit from thyroid support.

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 reference ranges.

If your TSH is above 1.5, 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. About the only time I find it helpful is for people who are sensitive to Armour Thyroid or for those who have been on synthetic hormones for many years when the benefit for shifting appears to be minimal.

I also do not recommend Cytomell, which is a T3 hormone preparation, although it can be used in conjunction with the others to help balance out your hormones.

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 – 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.

Lifestyle Strategies for Normal Thyroid Function

Prevention is always the best alternative, and there are simple strategies that can help you maintain good thyroid function. The following lifestyle changes address the root cause of an under-functioning thyroid:

  1. Eat a healthy diet, following a nutrition plan that is right for your nutritional type, and avoid processed and refined foods.

  2. Avoid brominated foods (which includes most commercial bakery products and some flours), and other sources of bromine. When you ingest or absorb bromine, it displaces iodine, and iodine deficiency is a major cause of thyroid problems.

    Bromine is an insidious toxin that is used in a very wide variety of foods, beverages and other products you may be using on a regular basis. For more information, please read my report on this issue.

  3. Make sure you’re getting enough selenium and iodine, which provide the raw materials for your thyroid gland to work better.

  4. Get plenty of omega-3 fats from high quality sources like krill oil. A variety of studies and physiological principles suggest that omega-3 fat in doses of 3-5 grams per day would be helpful in restoring thyroid function.

  5. Avoid unfermented soy, because soy isoflavones can wreak havoc on your thyroid.

    Kaayla Daniel's groundbreaking book, The Whole Soy Story: The Dark Side of America's Favorite Health Food is a powerful exposé that reveals its many health dangers, including its detrimental impact on thyroid function. Clearly, if you want to keep your thyroid healthy, you’ll definitely want to avoid unfermented soy products of all kinds, including soy milk.

  6. Get a sound night’s sleep, in complete darkness.

  7. Address your emotional stress. The vast majority of people's thyroid glands become impaired as a result of weak adrenal glands. The thyroid gland tries to compensate for this and eventually just gives up and stops working.

    Adrenal impairment is frequently due to emotional stress, and unless you have these previous emotional challenges resolved, there is little likelihood of recovering your thyroid function without hormonal replacement.


[+] Sources and References

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