I was to visit my endocrinologist for a follow up on January 19, 2006. I had been researching the usage of Armour and had not been able to find any scientific evidence as to why Armour would not be good for thyroid cancer patients. The information I had gathered was that cancer patients needed to maintain a TSH level of .1 or below. The websites I visited sponsored by endocrinologists spouted information on how the potency was not consistent therefore it was not reliable. There was no information so substantiate these claims either. A review of the FDA website revealed that Armour had bee recalled only one time in over 100 years of usage.
From the FDA's Website:
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
May 11, 2005
05-19
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
_______________________________
PRODUCT
a) Armour Thyroid (thyroid tablets, USP), 30 mg.,
Rx only, packaged in 100 tablet bottle containers.
Product label contains NDC 0456-0458-01 (FOREST).
Recall # D-217-5;
b) Armour Thyroid (thyroid tablets, USP), 60 mg.,
Rx only, packaged in 100 tablet bottle containers.
Product label contains NDC 0456-0459-01 (FOREST).
Recall # D-218-5;
c) Armour Thyroid (thyroid tablets, USP), 120 mg.,
Rx only, packaged in 100 tablet bottle containers.
Product label contains NDC 0456-0461-01 (FOREST).
Recall # D-219-5.
CODE
a) Lots 034052, 035064, 035066, 036171, and 036456;
b) Lots 034053, 034488, 035065, 035997, 036500, 040423;
c) Lots 034051, 035067, 035995, 035996, 036499, 042018.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH, by letter on April 12, 2005.
Manufacturer: Forest Pharmaceuticals, Inc., Earth City, MO. Firm initiated recall is ongoing.
REASON
Subpotent: Product may not maintain potency throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE
58,544/100 tablet bottles.
DISTRIBUTION
END OF ENFORCEMENT REPORT FOR May 11, 2005
###
After finding the Armour recall information I decided to look into the track record of the T4 only synthetic hormones such as Synthroid. I found a less than stellar track record. My research revealed that in August of 1989, Knoll Pharmaceuticals recalled 21 lots of Synthroid for reasons of low potentcy during stability studies. In 1991, Knoll recalled 26 subpotent lots of Synthroid and in February and other lots in June. Investigations for a Synthroid manufacturing plant led to citations for deviations from GMP: two in April 1991, and nine in December 1992. Knoll also distributed sub potent Synthroid during 1990, 1991, and 1992.
In a release from the FDA they summarized:
"The history of potency failures ... indicates that Synthroid has not been reliably potent and stable. Furthermore, Knoll's use of an overage [in potency] that has not remained consistent over the years suggests that Synthroid has stability, potency, and consistency problems. Although you [Knoll] claim that Synthroid has been carefully manufactured, the violations of current good manufacturing practices discussed above indicate that Knoll has not always manufactured Synthroid in accordance with current standards for pharmaceutical manufacturing." 1
As I began to dig even deeper I found that the apparent reason for the endorsement was the strong financial relationship of the makers of Synthroid, Knoll Pharmaceutical, with the American Association of Clinical Endocrinologists (AACE). The AACE website until the recent redesign referenced the support of Knoll Pharmaceutical. One the leading endocrinologists in thyroid cancer research at a university who touts Synthroid as the only solution is also being funded by Knoll Pharmaceuticals. Is this is conflict of interest? I think it is. Many patients are left sick and debilitated for the sake of money. I am a person that relies on good solid scientific research and I was not finding anything to warrant the warnings about Armour.
During this time of research I learned of the importance of Free T4 and Free T3 levels in the body. I had been taught since my diagnosis that the only relevant number was the TSH – Thyroid Stimulating Hormone. As I read more I learned that the T3 hormone was the metabolic hormone. This was the active form of the hormone that is converted from T4. When an individual has a normal functioning thyroid approximately 20% of the needed T3 comes directly from the thyroid and the rest is converted from T4 as necessary. What was my body doing I wondered since I did not have a thyroid. Could this be the reason why I struggled to lose weight and stay warm, among other things?
1 Food and Drug Administration. Letter to Knoll Pharmaceutical Company, April 26, 2001.
