2004 TPA-UK Letter Sent to all UK Endocrinologists and BTA
In July 2004 TPA-UK sent the following letter to all endocrinologists in the UK along with a copy of the MHRA letter referred to indicating that, contrary to the BTA stance, desiccated thyroid preparations are in fact able to be prescribed in Britain.
ARMOUR THYROID AND PORCINE THYROID EXTRACT FOR THYROID REPLACEMENT THERAPY
I am enclosing a copy of a letter received from the Medicines and Healthcare Products Regulatory Agency regarding the prescribing of thyroid extract to patients for whom the UK licensed synthetic thyroid hormone (Levothyroxine) is not suitable.
Medical practitioners are consistently being asked why thyroid extract is not being prescribed for patients unable to tolerate T4. Typical responses are Desiccated thyroid is an unreliable preparation in terms of active thyroid constituents and there is no adequate quality control for these preparations. Others believe that the synthetic is the only medication which provides steady hormone levels.
However, what tends to be overlooked is that there are patients who cannot tolerate T4 alone and, as a result, continue to be extremely unwell.
Many medical practitioners believe that the above information refers to Armour Thyroid. This is not true, as can be evidenced in the enclosed explanatory letter from the MHRA.
Armour Thyroid is authorised by the FDA as medicine that is standardised to the specification of the USP. The MHRA has not objected to the importation of medicines, provided that they are FDA authorised prescription medicine products, standardised to the USP, and that they are for the treatment of patients with thyroid diseases, for whom the UK licensed synthetic thyroid hormones are not suitable. Consequently, these products can be made available to those people who need them, subject to their being prescribed by a doctor.
Armour Thyroid and several other thyroid medications were grand fathered in when Congress passed the Kefauver-Harris Drug Efficacy Amendments of 1962, to tighten control over drugs. Before marketing a drug, firms had to prove safety and effectiveness for the products intended use. The requirement was applied retroactively to 1938, when the FDC Act was passed. Pre-1938 drugs were allowed because they were generally recognised as safe and effective, provided no evidence to the contrary developed. Too much evidence to the contrary developed concerning the levothyroxine products and the FDA decided none of them was generally recognised as safe and effective, so the levothyroxine products lost their grand fathered privilege and had to go through the NDA process. Armour thyroid retains its grand fathered status since no evidence to the contrary has developed concerning its safe and effective status.
If you would be interested in supporting a NICE technology appraisal, I would be very grateful if you would let me know.
Armour Thyroid is a registered trademark of Forest Laboratories, Inc.