Masters of Health Magazine November 2022 - Page 63

Mainstream medicine preaches that it is sufficient to supplement only with T4; that the body will convert an appropriate amount of T4 into T3; and that T1, T2 and calcitonin aren’t needed. While this may be true for some hypothyroid patients, there are many others who get better only when they take NDT.

Compounded versions of NDT are crucial because pharmacies can individualize doses and delivery systems to meet individual patient needs. When thyroid glands are not functioning properly, they rarely stop producing hormones completely—they are producing the wrong levels of hormones. Doctors must determine how to correct these imbalances based on observed hormone levels in each patient. Additionally, hormone levels can fluctuate. This is why the one-size-fits-all FDA-approved options are not sufficient for many patients.

Note that compounded sustained-release T3 medications appear to be safe (for now) because they are made from a synthetic version of T3, not the natural version which is now considered a biologic and effectively banned from compounding.

Armour and other commercially available NDT products that are not compounded also appear safe for the time being, but that could change. Note that Armour and other brands of NDT are considered “grandfathered”; that is, they were in use before drugs were required to prove safety and efficacy and are allowed to remain on the market without adhering to those requirements as long as they are labeled with the same conditions for use. But the FDA has an “Unapproved Drug Initiative” to try to get these grandfathered drugs to go through FDA approval. In 2021, the FDA  released a Consumer Update on thyroid medications, essentially warning patients from taking natural thyroid because these products have not been reviewed by the agency for safety and efficacy. Clearly, these medicines are on the FDA’s radar, and it wouldn’t be surprising to see the agency move against Armour and other commercially available NDT products in the future.

Some patients get Armour and other products from compounding pharmacies because they are more readily available than at chains like CVS or Walgreens. This should not be interrupted for the time being. Armour and other commercially available NDT products are still legal; the threat is to compounded NDT products.

Compounding allows doctors to custom-fit thyroid medications based on what you need as an individual, whether it’s a specific dose not found in FDA-approved drugs, or a time-released version, different combinations of T3 and T4, etc. It’s hardly surprising, then, that studies have found many, many patients prefer natural thyroid to synthetic options.

In order to be made into a customized medicine, a substance has to meet one of three criteria. It must either:

1.      appear on an FDA pre-approved list (the Bulk Drug list);

2.      have a USP monograph; or

3.      be a component of an approved drug.

NDT has a USP monograph. So, what’s the problem? The FDA is now claiming that NDT meets the definition of a “biologic” (medications that come from living sources, like vaccines, monoclonal antibodies, etc.) because it contains thyroglobulin, an amino acid found in the pig glands used to make NDT. Biologics are not able to be compounded unless there is an approved biological license application (BLA), which is akin to a new drug application requiring clinical trials. The FDA is using a back-door method to ban medicines it has attacked for years.

This is, of course, absurd. Clinical trials cannot be conducted on compounded medicines given the highly varied and individualized doses and delivery mechanisms used. As explained above, this is the whole point behind compounded medicine, to customize medicines to meet individual patients’ needs. With this move, the FDA is in effect banning compounded NDT. What remains to be seen is how swiftly the agency will move to enforce this position.

We will return to this in subsequent coverage, but this is part of a years-long FDA campaign against natural thyroid. This stems from the fact that natural thyroid competes with Big Pharma’s FDA-approved T4 thyroid drugs, which include Levothyroxine and Synthroid.