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Join the Petition to Save Armour Thyroid


troubled

 

 

 

Armour Thyroid, used successfully to treat hypothyroidism for over 100 years, offers patients unique benefits not seen with synthetic thyroid preparations. Forest Labs, which has been the maker of Armour for many decades is about to be merged with Pfizer. Pfizer already manufacturers a synthetic thyroid hormone product, Levoxyl. Pharmaceutical industry dynamics require that in this type of merger the weaker of two competing products, in this case Armour,  will be eliminated without hesitation. Without Armour Thyroid the health and well being of many thousands will be jeopardized.

Join us in petitioning the responsible corporate executives to preserve the supply of Armour Thyroid to these vulnerable individuals.

http://www.ipetitions.com/petition/continued-supply-of-armour-thyroid

 

 

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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

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LA Falls Through a Crack in Our Health Care System and Finds Armour Shortage Crisis


LA lives in rural America and has no health insurance. After 30 years of effective therapy with Armour Thyroid she is unable to obtain this medication any longer. Her story is a sad reminder of just how far we need to go to provide meaningful health care to the citizens of this country.

LA tells her story like it is:

I knew nothing about this problem of non-availability of Armour Thyroid. I have been on Armour since 1978 and it has worked just fine. I had my annual prescription renewal in June and because I do not have insurance, I was able to get 200 pills at a time for a price break. I take 3 60 mg tablets a day and have been on this dosage for about 6 years, up from a previous dosage of 2 60 mg tablets. Today, 4 Nov 09, I went to pick up a refill that I called in a week ago. I was informed at the pharmacy that Armour Thyroid is no longer being made. Period. I took my last pills on 2 November so I have no medication at all. I have a call in to my doctor but he has not yet returned that call. We contemplated a switch to Synthroid a couple of years ago (for a variety of reasons, none of which are relevant here) but the doctor said it could be a very slow process of finding out exactly what dosage of synthetic hormone would adequately replace the natural Armour. At that time I had insurance that would have covered the lab tests required to determine the proper dosage. I am now without insurance due to the death of my spouse, and because of the hypothyroidism I am unable to obtain health insurance that is even remotely affordable. Therefore I can’t afford all the tests, all the doctor visits, all the rest of the hoopla that woudl go with switching medication. I’ve been fortunate so far that I’ve been able to keep my same doctor, and that he gives me a bit of a break paying cash for my once-a-year-visit, but he’s 60 miles away and I can’t even afford the trips back and forth if I have to start “nudging” a new medication. It’s bad enough to be without the medication for a while, but to think that it will never be available again? I honestly don’t know what to do.

I knew nothing about this problem of non-availability of Armour Thyroid. I have been on Armour since 1978 and it has worked just fine. I had my annual prescription renewal in June and because I do not have insurance, I was able to get 200 pills at a time for a price break. I take 3 60 mg tablets a day and have been on this dosage for about 6 years, up from a previous dosage of 2 60 mg tablets. Today, 4 Nov 09, I went to pick up a refill that I called in a week ago. I was informed at the pharmacy that Armour Thyroid is no longer being made. Period. I took my last pills on 2 November so I have no medication at all. I have a call in to my doctor but he has not yet returned that call. We contemplated a switch to Synthroid a couple of years ago (for a variety of reasons, none of which are relevant here) but the doctor said it could be a very slow process of finding out exactly what dosage of synthetic hormone would adequately replace the natural Armour. At that time I had insurance that would have covered the lab tests required to determine the proper dosage. I am now without insurance due to the death of my spouse, and because of the hypothyroidism I am unable to obtain health insurance that is even remotely affordable. Therefore I can’t afford all the tests, all the doctor visits, all the rest of the hoopla that woudl go with switching medication. I’ve been fortunate so far that I’ve been able to keep my same doctor, and that he gives me a bit of a break paying cash for my once-a-year-visit, but he’s 60 miles away and I can’t even afford the trips back and forth if I have to start “nudging” a new medication. It’s bad enough to be without the medication for a while, but to think that it will never be available again? I honestly don’t know what to do.
LAWHilton@yahoo.com
LA
1

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Armour Crisis Creates New Alliances


Good things can develop during a crisis situation. For me it was the eye opening experience I had this week by participating in The Thyroid Patient Community Call. The Thyroid Patient Community Call is a group internet telephone call hosted by Janie Bowthorpe, author of Stop The Thyroid Madness. During the 90 minute session I was able to interact with dozens of callers as well as Janie herself. Needless to say, Janie’s audience is mostly individuals who are deeply committed to maintaining Armour Thyroid as a treatment option and who are equally angry with the field of Endocrinology which backs the ban on dessicated thyroid hormone. I knew this audience wanted answers to some very tough and troubling questions. For a few days before the call I needed to review for myself just how this crisis developed, and how I became a lightning rod for the growing controversies. I believe this process was necessary and therapeutic.

Being a strong advocate of t4 plus t3 therapy and of Armour Thyroid, I was in sync with most of the topics being discussed on the call. What was hard for me was hearing the out pouring of stories describing how endocrinologists had alienated (infuriated) so many thyroid patients. How to explain but not excuse the inflexibility, wrong headedness and arrogance of a whole field of medicine on a topic central to its mission, my own field for the past 25 years? My head still hurts thinking about it. For those wanting to hear how this played out can visit Talkshoe.com which hosts these shows and follow the instructions for listening to past episodes of Janie’s show. Perhaps Janie can give more specific instructions by posting them here.

I came away from Janie’s session with a firm recognition that the field of Endocrinology is in serious need of a make-over. Imagine a Democrat walking into a room full of staunch Republicans and asking everyone to join him in a sensitivity training program. It is a lonely job.

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Obama Not to Blame for Armour Shortage, Says New Member


Will S., a new member of metabolism.com, offers these sensible comments on who to blame for the sad state of FDA oversight of prescription drugs like Armour Thyroid.

Will argues:

Gatekeeper: Just a suggestion to do a little more research on this situation before blaming it on Obama. It was several years ago, at the end of the Clinton and beginning of the Bush administration, that the FDA began to investigate and reveal that Armour Thyroid had never been officially approved by the regulatory agency. Membership on the FDA consists partially of highly paid executives that came from pharmaceutical companies. It makes sense that they have an interest in making sure that only the big pharmaceutical companies have the money to get their drugs approved. Situations like this are why we need health care reform now. Yes, you certainly can and should bring this issue to the attention of the current administration, but please place blame where it is due, as finger pointing in the wrong direction is unhelpful to those who are suffering.

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Tina Sends the NY Times a Heads Up Regarding the Armour Crisis


Tina has raised her pen (actually her keyboard) to bring greater visibility to the Armour Thyroid crisis. Tina addressed her comments to one of the editors at the NY Times who actually appears to have taken this seriously and passed the email on upward. Thank you Tina, from me and those who are struggling with this unwarranted interruption in their medical treatment.

Here is the email sent by Tina to the NY Times Editor

Dear Ms. Kolata: I am writing in regard to recent restrictions on the availability of alternative, though highly effective, medications for hypothyroidism. Dessicated thyroid generics (made from the thyroid glands of pigs), known as Armour or NatureThroid, help thousands of people who suffer from low-functioning thyroids. I was on Synthroid, a synthetic thyroid medication, for years, but still suffered from symptoms. It was only when I began using NatureThroid, which treats all four of the hormone levels affected by the thyroid (vs. Synthoid, which only treats one), that my symptoms cleared up. I can’t tell you what a relief it is to no longer feel agitated and inexplicably moody, nor to have my hair falling out, my skin dry, etc. But it is becoming harder and harder to find dessicated thyroid generics. Armour, which has been around for about 50 years, is virtually out of business. Apparently the shortage has to do with FDA documentation requirements (which is odd; why now?)!
. Meanwhile, the American Academy of Clinical Endocrinologists (AACE) is backing Synthroid, which makes big money for its manufacturers (i.e., Abbott Laboratories). I hope this captures your interest. I don’t know what I, or thousands of others who have found relief with dessicated thyroid generics, will do if they are no longer available. If you would like more information, it may be helpful to go to http://www.metabolism.com. Thank you very much for your attention, Tina Montalvo West Palm Beach, FL

ARTICLE REFERENCED (if any):
None

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Mele is Out of Armour and Out of Options


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


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

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Dr. L. Mallette’s Advice on Handling the Armour Shortage


Lawrence Mallette, M.D., PhD, reports to us on how the Armour shortage has effected his practice, and shares with metabolism.com his advice on how to handle replacement therapy. We appreciate Dr. Mallette’s comments.

Dr. Mallette Writes:

The shortage of Armour Thyroid and other brands of thryoid extract has devastated my office. We have received over 300 requests for changes due to the shortage. We can’t get the other work done!

Synthetic T3 (Cytomel) at a dose of 5 to 10 mcg a day, together with a balancing amount of Synthroid or Levoxyl does the trick for most patients. Only a few find a distinct improvement on Armour versus Cytomel as a source of the T3 supplement. The symptoms experience by 50% of Synthroid- or Levoxyl- treated patients usually do not derive from the Synthroid itself, but from the lack of T3 in those preparations. This is possibly going to be the only work-around, as I’ll not go back to Armour until we have an explanation from Forest Pharma.

I the Federal Government (FDA) responsible for this shortage. Likely. They are criminally neglegent in that case.

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Armour Thyroid Shortage a Nation Wide Problem


Samantha, Nurse Practitioner in New York reports on the effect the national shortage of dessicated thyroid products is having on health care in her area. My own experience is that the situation is getting worse here in Florida, as well. Nature Thyroid and Westhroid which we had hoped would replace Armour in this practice has also become unavailable. At this very minute our office administrator is calling every pharmacy and pharmaceutical mail order companies we have used, trying to locate a source of these products for this practice (8 endocrinologists who serve a large portion of South Florida). Switching people back to T4 because the desired dessicated thyroid medication is unavailable, seems unacceptable in the “best health care system in the world”.

I thought Samantha’s comments were vital to see:

Samantha writes:

I’m a nurse practitioner in NY, and find that our patients generally do better or Armour Thyroid than on the usual T4 products. As for Cale, it sounds as if he’s in love with BigPharma, but many conservative practitioners and dispensors abound, so take what he says with a grain of salt. I, several MDs and NPs and a DO of my acquaintance all use Armour Thy. ourselves, but have noticed a slight decrease in effectiveness since the reformulation. The real frustration is having to convert our patients back to Levothyroxine and Cytomel which many do not find nearly as helpful. Other brands such as wes-throid and nature-throid are now out of stock, (in our area) and so there is no real alternative. Some of our patients have even tried getting stocks from Canada, to no avail. When I last checked with Forest they had stocks of 120 and 360 dosages available, but most of our patients require much less. While I will still use Armour and prescribe it, when we can get it again – as will my colleagues mentioned above – we are thoroughly annoyed at Forest for the reformulation. Most people tolerated the product very well. Patients should not have to have their effective medication routines switched out from under them. No one wants to change horses mid-stream.

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