Tag Archives: FDA

Mele is Out of Armour and Out of Options


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Below, Mele describes her plight struggling to adjust to the disappearance of Armour from U.S. pharmacies. She discovered what was explained in my post, “Behind the Disappearance of Armour”. Forest Pharmaceuticals and Medicare are both responding in their own ways to the FDA decree that Armour Thyroid submit an application (NDA) as if it were any new drug seeking to come to market now. The FDA is charged with the responsibility to assure all prescription drugs in the U.S. demonstrate minimum levels of safety and efficacy. As a bureaucracy the FDA is unable (unwilling) to find a way to use the 50+ years of unblemished clinical experience unique to Armour, to satisfy this requirement. Rather than correct its own deficiency the FDA is forcing many thousands of hypothyroid patients on dessicated thyroid products to go through the difficult and potentially dangerous process of finding alternative thyroid hormone therapies. I am guessing that the FDA is receiving support for this policy from companies making synthetic t4 products and from medical organizations and their officers who receive funds from these same companies. Let’s not forget that Forest itself markets a generic t4 product, Levothroid, which will absorb some of the business lost by the withdrawal of Armour.

Mele submits her story to metabolism.com:

I’m just devastated. I could only get a seven day supply yesterday of Armour at Wal-Mart. They have no idea what the problem is and told me to come in Tuesday and they would have some again. I had no idea there was a problem again (last year’s nightmare made me assume everything would be ok after Forrest redid their manufacturinging plant) until I googled today.

I am 66 years old and have been on Armour Thyroid since I was 15 years old when I had a subtotal thyroidectomy for carcinoma. The only time I ever tried Synthroid was about 20 years ago when an endocrinologist convinced me that I was going to get osteoporosis if I continued using Armour. I only took it for two months, and when I walked into my family doctor’s office at the end of the two months, he took haveone look me and said “whWt is wrong? You are not you”. I wasn’t me anymore (and the blood tests he ordered confirmed that I was very low on T3 and barely in the normal range for T4). That was probably the most terrifying experience I have ever had. I had no idea how totally entwined my personality, and feelings of well being, are dependent on Armour. I still find it scary that “me” is a product of a drug I take and when I take a different brand, I am no longer me. I felt like a stranger in my own skin…weak, no sparkly, dramatic personality… instead dull feeling, acting and cobwebs in my brain. My family doctor said that he was putting me back on Armour immediately and slowly I began to feel like me again.

I’m terrified now. I am in the middle of trying to prepare for a very complicated (nothing is ever simple or easy medically for me) cataract surgery in another city that I have fly to repeatedly for the presurgical appointments. If I have to go on Synthyroid again…how can I deal with this other upcoming surgery? It can’t be put off as I can barely see to drive now.

Anyhow, I agree with others here that we have to organize and fight this. I find it very difficult to believe this is simply a shortage of the thyroid powder that Forrest is claiming is the problem. This is the FDA meddling, yet again, with patients very lives. I think I know an organization that will help us as they have fought bloody battles with the FDA for many years and have been victorious to a large extent. I am speaking of the Life Extension Foundation. I’ll be contacting them.

Two other things. For what it is worth, I have noticed no problems with the change in Armour but for the first time in many years, I have not done thyroid blood levels in two years. But I feel fine so I guess I don’t have the absorbtion problem some mention with the new formula. I have had hair breakage though which I have puzzled over and that could well be due to the formula change.

As for Medicare and Armour, I have had Medicare since a drunk driver hit me many years ago so I have had Medicare long before I turned 65. When Medicare Part D first appeared Armour was on the Medicare forumulary. That was in mid 2006. Armour was on the Medicare formulary in 2007 also. Beginning Jan 2008, Armour was removed from the Medicare formulary. My physician I did a lot of research, calling, letter writing, etc. about it. My drug plan was and still is from AARP/United Health Care. United Health Care is angry about the Armour situation. However, they cannot make a special exception to cover it when a physician asks them to do so (as mine did) because their hands are tied. They are required by law to allow ONLY drugs that are approved and on the Medicare formulary.

AARP/United Health Care covers ALL drugs on the Medicare formulary and by law cannot cover any that are banned from the Medicare formulary. Armour was banned in 2008. I called Forest about it and was extremely puzzled by their lacksidasical response. My physician wrote Forrest also and they sent back a reply that had nothing to do with the question about Armour being removed from the Medicare formulary. My physician learned later that his, and my, suspicions were correct. It was removed because the FDA told Medicare that they could not cover a drug that had not gone through the NDA I believe it is called…where a new drug has to undergo extensive clinical trials as per FDA regulations. We learned that the FDA was requiring Forrest to do this if they wanted Medicare coverage for Armour. Well, that is not possible. Forrest charges very little for Armour. Where are they supposed to get the money for the many years of clinical trials that the FDA has demanded? The FDA knew that demanding this would effectively kill Armour and that was their intent.

So, since Jan 2008, I have had to pay for a Medicare Part D plan that I can’t use because the only drug I take (unless I need an antibiotic or something short term) is Armour. Wat is worse, most health insurance companies follow the Medicare formulary so if Medicare no longer covers Armour then most insurance plans will not cover it either.

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Behind the Disappearance of Armour Thyroid


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After 50 years of exemplary therapeutic use and despite a large devoted following, Armour Thyroid and related dessicated thyroid generics have virtually disappeared from pharmacies in the U.S. An air of mystery with suggestions of conspiracy surround the shortage. The level of distress among Armour users confronted by their inability to obtain the medication, is extraordinary. Adding to the turmoil and confusion is the manufacturers’ continued reliance on flimsy and unconvincing explanations for their actions.

Several concerned individuals contacted the FDA for clarification of the Armour situation and received a prepared statement in response. A copy of the FDA’s letter explaining the government’s stance was posted to metabolism.com by an involved member. After studying the letter I believe I can offer a good explanation for the situation. The explanation, as I see it, is grounded in the fact that several thyroid medications such as Armour Thyroid but also including synthetic t4 medications like Synthroid, existed before the FDA was given full regulatory power. In 1973 the Supreme Court empowered the FDA to regulate the use of prescription medications in the U.S.. This meant that all prescription drugs would have to demonstrate to the FDA’s satisfaction, safety and efficacy for specific indications before pharmaceutical companies could promote the use of their drugs. Medications like Synthroid and Armour, already vital components of medical therapy for years before 1973 entered a grey area of legitimacy after that time.

Just a few years ago, I was astounded to hear from my pharmaceutical representatives that Synthroid faced being banned by the FDA since it never provided the FDA with the type of documentation of safety and efficacy that all modern medications had. After 30 years the FDA decided it wanted to rescind the right of the drug manufacturer to promote this medication which was considered safe and effective way before the FDA achieved regulatory power. What followed was a tense year during which the manufacturer of Synthroid went through the costly and bureaucratically intricate process needed for FDA approval, which it ultimately won.

What I believe is happening now is a similar scenario with Armour Thyroid and other dessicated thyroid products. What convinced me of this is the wording in the FDA letter which refers to Armour Thyroid as an illegal drug. The FDA has put Armour on its Most Wanted List and is intimidating the manufacturer (and prescribing physicians) by implying the law is being broken by continuing to make and use this drug. In the case of Synthroid, which enjoys the full support by the medical community and provides millions of dollars in annual sales the financial equation was a “no-brainer” in favor of putting the money into the process to gain approval.

Not so for Armour Thyroid which has been defamed by the American Academy of Clinical Endocrinologists (AACE) and who’s use is much more limited and far less profitable to the manufacturer. I can imagine that the pharmaceutical company has already done the math and decided that not making Armour makes more financial sense that to continue making the “illegal” product and going through the FDA gauntlet for approval.

Where does that leave the patients who depend on dessicated thyroid preparations and the physicians who prescribe it? With no way to force the manufacturer to make the drug or to make the FDA to back down on its stance my guess is that Armour and related products will simply cease to exist and alternative prescriptions will have to be written. Please remember, I am the messenger here and do not sanction or in anyway condone what I see as the most likely outcome of this predicament. Perhaps by recognizing the existing reality a strategy can be developed to prevent this outcome.

Gary Pepper, M.D., Editor-in-Chief. Metabolism.com

Unreasonable Standards by the FDA for New Diabetes Drug Approval?


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This post is the third in a series under the title: 2009. Another Troubled Year for Endocrinologists.

This year the FDA has instituted new standards for diabetes drugs coming up for approval. These new standards require that each new drug prior to approval must demonstrate the lack of any negative impact on cardiovascular (heart and blood vessel) health. While this may seem a legitimate requirement, in reality it requires thousands of patients be treated for many more years in research settings to acquire this information. So far three new diabetes medications from Takeda Pharmaceuticals, Novo Nordisk and Bristol Myers have all been put in limbo due to delays on their approval based on the new requirements.

I would point to the case of Avandia as an example of how difficult it is to prove that a drug has negative cardiovascular effects. In 2007 an alarm was sounded by several outspoken critics, whose analysis pointed to increased cardiovascular risk from Avandia. At that time Avandia was a key diabetes medication on the market for over 5 years with millions of individuals treated. Although the diabetes community remained split on the truth of these assertions major medical organizations such as the American Diabetes Association placed a virtual ban on the use of this medication and the FDA placed its highest “black box” level warning on Avandia use. At that time the FDA was criticized widely for allowing this supposed public danger to go unrecognized for so long. Many think that it is in response to this criticism that the FDA was forced to add the new much more stringent requirements on new drug approval.

Since 2007 however, a large V.A. study (the VADT study) and the 2009 RECORD study both found no evidence of cardiovascular risk with Avandia use. The belief is growing that the FDA was initially correct in allowing Avandia to come to market, although so much negative publicity has hurt the use of Avandia and led the FDA to take a highly defensive approach to new drug approval.

Some pharmaceutical executives believe the new FDA requirements will double the cost of bringing a new drug to market. Approval of several promising new diabetes treatments has already been stalled and the companies developing new medical therapies are beginning to move diabetes treatment to the back-burner. It is likely that it will takes years to reverse this trend, if a reversal is possible at all.

Gary Pepper, M.D. Editor-in-Chief, Metabolism.com