Pharmacies Label Armour Thyroid “Illegal” and Issue Therapeutic Warning


 

by Gary Pepper, M.D.http://www.dreamstime.com/royalty-free-stock-images-danger-sign-skull-symbol-image31277139

Early in May 2014 a patient being treated with Armour Thyroid (desiccated thyroid) for hypothyroidism reported that her pharmacy service would not refill her prescription for Armour Thyroid because it was an “illegal” drug. We were both very distressed to learn of this, but for different reasons. My patient was rightfully concerned that she might be receiving a wildly inappropriate medication, while I was concerned that I might not be able to prescribe a medication I knew to be extremely helpful and safe.

The notion that Armour Thyroid is illegal turns out to be a misrepresentation, but this could easily be the start of a rumor adding a new stigma to the use of this drug. Medicare’s decision to remove Armour from the list of medications it will pay for was the likely trigger for these developments. The Federal action was based on recommendations by national organizations such as the American Association of Clinical Endocrinologists (AACE). According to the AACE guidelines published in 2012, recommendation 22.4 states; “There is no evidence to support using desiccated thyroid hormone in preference to L-thyroxine monotherapy (Synthroid, levothyroxine, Levoxyl ed.) in the treatment of hypothyroidism and therefore desiccated thyroid hormone should not be used for the treatment of hypothyroidism. Grade D, BEL 4”. This recommendation was approved unanimously by the AACE panel of experts.

Aside from the scorn being heaped on Armour Thyroid by the AACE, there is also a widely repeated rumor that Armour is dangerous to people older than 65 years because it contains the hormone T3 which theoretically may over stimulate the heart.

The result of these policies is that not only has Medicare removed Armour from its list of approved drugs but commercial pharmacy services have followed suit. When explaining these restrictions to Armour prescriptions the pharmacy service reverted to the word “illegal” when summing up the situation for my patient. So there you have the origins of the plausible new rumor that Armour is an illegal drug.

Another example of how the commercial pharmacy services are responding to Armour Thyroid, is this “Therapeutic Alert” I received from CVS/Caremark pharmacy in regards to another patient’s prescription,

Therapeutic alert_pic-001

With all these agencies going to great lengths to eradicate Armour Thyroid as a reputable treatment for thyroid disease, one may wonder why I persist. The answer is after extensive experience and research I believe this drug to be extremely useful and safe for my patients and that these advisory agencies have failed to do their job in understanding the drug treatments they are responsible for.

The Therapeutic Alert I received offers 3 references in tiny font at the bottom as the authority supporting their warning. Reviewing the first reference from 2006 I found no statement or evidence that Armour Thyroid was hazardous in any way. In fact, the researchers state specifically there was no difference in side effects between conventional T4 treatment (Synthroid, Levothyroxine, Levoxyl) and treatments which contain T3, of which Armour is one. Therefore this research does not support the pharmacy’s contention that Armour is dangerous.  The other two articles referenced in the Therapeutic Alert are not research articles but are committees offering guidelines for thyroid hormone treatment which rely on the research article from 2006. We then have a cycle of misinformation perpetuated by experts who did not do their job of reviewing the scientific data.

The AACE guideline statement has similar flaws. It is stated that there is no evidence to support using Armour in preference to T4 treatment. There is no logic to conclude because of a lack of preference (superior performance?) that a drug should not be used. If that were true most of the medications on the market for treating hypertension or diabetes would be similarly black listed.

In fact, since 2012 when AACE formulated their guidelines there have been two studies indicating superiority of Armour over T4 treatment in the form of patient preference for this drug. The first study conducted by the NIH found that 50% of patients preferred Armour to T4 while only 19% preferred T4. No significant adverse reactions were noted. The second study conducted by myself and my colleague Dr. Casanova-Romero, showed that 80% of a group of hypothyroid patients preferred Armour to T4. No significant adverse reactions were noted. As of this date, editors of key medical journals including Endocrine Practice published by AACE, have refused to publish our data.

Based on these facts, I will have to disregard the Therapeutic Alert and AACE guidelines when appropriate as I hope to offer my patients the best possible therapy for their disease. I also hope my colleagues and I will not be stopped in these efforts but only public knowledge of this situation can protect prescribing doctors from censure.

If you would like to help, please email Dr. R. Mack Harrell, the new President of the AACE, VSkelly@aace.com , with the statement, “We respectfully demand better options for treatment of hypothyroidism. I support my doctor’s ability to prescribe Armour Thyroid. Repeal AACE recommendation 22.4. ”

(Dr. Pepper has no economic relationship with companies that produce or market Armour Thyroid)

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