Pharma Expert Examines FDA Moves on Restricting Armour


Hank Frier has been involved with the pharma industry for a long time and helps us see through the news blackout in regards to the FDA actions on Armour. He is also suffering the same fate as many others in the U.S., having been successfully treated with Armour for many years, now forced to switch to other alternatives.

Hank writes:

I too have been switched back to Synthroid after several successful years of being on Armour. At this juncture it is too early to tell how this will impact me. Luckily, my physician had the foresight to also put me on Cytomel after I suggested this from my readings. The combination of Armour and Cytomel seemed to work quite well for me without any adverse events.

This next is my opinion so take it as such. I believe the makers of Synthroid (Abbott Ross) in an attempt to increase their sales of Synthroid put pressure on the FDA to require the makers of Armour to submit an NDA. It is a devastatingly poor tactic by Abbott Ross but typical of this industry.

It is unfortunate that the FDA is caught in the middle of this since by statute and law drugs must pass regulatory muster. Where the FDA has failed is in their lack of looking at the long past history of Armour, its lack of adverse events and its benefit/risk for those individuals that have been using this drug. As opposed to demanding an NDA from Forest Pharma they should have sat with them and reviewed the long history of this drug, the number of scripts written for this drug and even contacting those physicians/endocrinologists that have been prescribing it for their patients.

The only safety question in my mind is does Armour ingestion, a foreign protein, cause an immune response. This would have been reported by the medical profession if that were the case. Secondly, historically, large segments of the population have been eating pig and pig organ meats for generations without ill affects. The ingestion of a purified material from pig (Armour thyroid a protein) is probably benign. The FDA scientists should know this and counsel their legal staff as to the benign nature of the drug.

Hank

I too have been switched back to Synthroid after several successful years of being on Armour. At this juncture it is too early to tell how this will impact me. Luckily, my physician had the foresight to also put me on Cytomel after I suggested this from my readings. The combination of Armour and Cytomel seemed to work quite well for me without any adverse events.

This next is my opinion so take it as such. I believe the makers of Synthroid (Abbott Ross) in an attempt to increase their sales of Synthroid put pressure on the FDA to require the makers of Armour to submit an NDA. It is a devastatingly poor tactic by Abbott Ross but typical of this industry.

It is unfortunate that the FDA is caught in the middle of this since by statute and law drugs must pass regulatory muster. Where the FDA has failed is in their lack of looking at the long past history of Armour, its lack of adverse events and its benefit/risk for those individuals that have been using this drug. As opposed to demanding an NDA from Forest Pharma they should have sat with them and reviewed the long history of this drug, the number of scripts written for this drug and even contacting those physicians/endocrinologists that have been prescribing it for their patients.

The only safety question in my mind is does Armour ingestion, a foreign protein, cause an immune response. This would have been reported by the medical profession if that were the case. Secondly, historically, large segments of the population have been eating pig and pig organ meats for generations without ill affects. The ingestion of a purified material from pig (Armour thyroid a protein) is probably benign. The FDA scientists should know this and counsel their legal staff as to the benign nature of the drug.

Hank
hfrier@comcast.net
Hank Frier
1

Share this post

  • carolyn

    had Armour NOT RE-FORMULATED…I believe they would have been eligible for GRAS (generally accepted as safe) from years of benign usage.

    I sincerely believe that sombody in authority to cause a re-formulation, was “persuaded” to re-formulate for the express purpose of denying the GRAS rating further “down the line”………. Many people in high places have been eventually discovered to be swayed by bribes etc, and it is NOT UNHEARD of…………..alto I have no overt evidence…why would anyone re-formulate something that was so good and effective for so many years ….without an agenda to meet?……..

    Abbot brgged of a 157 million dollar profit in the last 3 month quarter…probably due to so many folks being forced to replace Armour dessicated thyroid with the synthetic????
    follow the money!!!

  • BJ

    I am a 50 year old female and have been taking Armour Thyroid for 12 years- I do not have a thyroid glad due to pregnancy induced Graves disease. I have tried over 20 pharmaceuticals to replace Armour Thyroid (including many pig compounded formulations) and nothing else can compare. I have tested these medications by blood-work and biofeedback. I do not know why Armour Thyroid is so different but it really is. I felt and tested the WORST taking Synthroid. If a person is not on the right thyroid medication for their chemistry the difficulties can be devastating to all aspects of their lives. It is especially hard for people without thyroid problems to understand this!!! Help!!!

  • mary

    Forest should just go back to making the original Armour before reformulation and insist that the medicine gets grandfathered status. ie. GRAS. My opinion is that the big Pharmas are causing the problem. The FDA should wake up to what is happening and consider all the millions of people that need Amour. One day the facts will emerge and some organization or individual is going to look really bad.