Monthly Archives: September 2009

Theresa Points Out the Cardiac Dangers of Thyroid Hormone Deficiency


Theresa is concerned that failure to fully treat hypothyroidism can lead to complications including heart disease. Thank you Theresa for your informative post:

Theresa posts the following:

I find it odd that on all the thyroid forums I have seen, not one mentions the risk of cardiovascular fatality due to under medication of hypothyroidism.

In 1988 I had radioactive iodine ablation therapy and was euthroid for 8-years. Diagnosed in 1996 as hypothyroid. Prescribed Synthroid and have never felt well.

On Synthroid, my TSH, Free T3, and Free T4 are in the normal range, with a myriad of continued hypothyroid symptoms… My new doctor ordered a Reverse T3 test. All levels look ok except my Reverse T3 level is 399 pg/mL. The Reverse T3 reference range: 90 to 350 pg/mL.

Due to the prescribed non-treatment (Synthroid) of my hypothyroidism, I have become deficient in Vitamin B12, B6, Folate, and Vitamin D. All of which are required for cardiovascular health. The result is that my homocysteine levels are off the charts.

The high sensitivity C-reaction protein test (hs-CRP) test measures homocysteine (inflammation of arteries). The high-sensitivity CRP test (hs-CRP) is done to find out if you have an increased chance of having a sudden heart attack or stroke.

http://www.webmd.com/a-to-z-guides/c-reactive-protein-crp?page=2

Inflammation can damage the inner lining of the arteries and make having a heart attack more likely. Multiple studies now show that elevated C-reactive protein (CRP) levels are correlated with increased risk of cardiac events and mortality.

CRP Levels: Low Vitamin B and Elevated Homocysteine:

http://www.doctorsofusc.com/services/health-tips/heart-attack-risk

There is a correlation that the lower the vitamin B levels the higher the homocysteine levels. High homocysteine levels are linked to damage to the arteries, which can cause atherosclerosis and thrombosis.

http://www.doctorsofusc.com/services/health-tips/heart-attack-risk

There is also a link between low Vitamin D and cardiovascular disease.

http://www.sciencedaily.com/releases/2008/07/080714162515.htm

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Join our Weight Gain Forum and Share Your Comments with Our Experts


Ask your question today! Here is what other members have been saying:

  • i am 22 years old 6 feet tall and way 120lbs i have a 27″ waist with a 31″ inseam and a 30″ chest i can count my ribs in the mirror from aprox
  • my friends have been bugging me about my high metabolism saying that i am gunna get fat when i am older because they think that some of the worlds “largest” people had a high metabolism
  • Hey, I have had a normal/high metabolism for my whole life and now it is suddenly slowing down. I have never eaten healthy and I loath exercise of any type

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Sarah Maria, Offers a Peek Inside Her New Book on Restoring Positive Body Image


Love Your Body, Love Your Life
5 Steps to End Negative Body Obsession and Start Living Happily and Confidently
By Sarah Maria
Published by Adams Media
November 2009;$14.95US/$17.99CAN; 978-1-60550-153-6

Eating Disorders. Steroids. Plastic Surgery.

We’ll do anything to look better — and yet we still feel bad about how we look. Self-loathing has reached epidemic proportions. But there is a way to end self-destructive thoughts and behavior. In Love Your Body, Love Your Life, noted body-image expert Sarah Maria presents her proven five-step plan anyone can use to overcome negative body obsession (NBO). She helps you:

Commit to change
Identify and detach from negative thoughts
Discover who you really are
Befriend your body
Find your purpose
Love your body, love your life
Complete with exercises, case studies, and testimonials, you can learn how to stop obsessing over food and your body and achieve permanent peace with both. You’ll banish NBO forever, and feel healthy, radiant, beautiful, and desirable — every day!
Author Bio
Sarah Maria, author of Love Your Body, Love Your Life: 5 Steps to End Negative Body Obsession and Start Living Happily and Confidently, is the founder of Break Free Beauty (www.breakfreebeauty.com), a company dedicated to helping people love and accept their bodies and discover the beauty that they already are. She is a body-image excerpt, speaker, and coach who speaks and writes on the topics of body image, self-esteem, health, success, and spirituality. Her mission is to empower people of all ages, races, and body sizes to embrace the bodies they have been given and learn to love themselves so they can live their dreams. She has studied and trained with many well-known spiritual and self-help teachers, including Deepak Chopra and physician Dr. David Simon, the co-founder and medical director of the Chopra Center for Well-Being in Carlsbad, CA. She lives in Carlsbad, CA.

For more information please visit: www.amazon.com

Reviews
“Read this book and you will discover that there is only one beauty, and you are that.”
–Deepak Chopra

“In traditional cultures, the most powerful healers are those who have learned to heal themselves. Sarah Maria’s personal journey to loving her body and her life offers a proven path for those seeking a healthy, conscious relationship with their bodies.”
–David Simon, MD, The Chopra Center for Well-Being

“There are countless women and men who suffer unnecessarily because they don’t like their looks. Sarah Maria reveals that there is a way to feel great no matter what and she offers powerful tools to help you feel beautiful regardless of your current shape or size. Read this book and you will begin to love your body.”
–Marci Shimoff, New York Times bestselling author of Happy for No Reason and featured teacher in The Secret

“Sarah Maria has created a most practical, step-by-step journey for healing Negative Body Obsession. Following these steps awakens the inner healer in the heart of the reader and truly unfolds the inner treasures of joy, love and bliss.”
–Vasant Lad, BAMS, MASc, Ayurvedic Physician, the Ayurvedic Institute, Albuquerque, NM

“Powerful, honest, and elegantly written. An amazing concept that goes beyond the idea of self-love and taps into the notion that one’s love equals one’s peace.”
–Ira M. Sacker, MD, eating disorders specialist, international expert for more than thirty-five years, and bestselling author of Dying to be Thin and Regaining Your Self

The Surprising Truth About Weight Gain, Body Image and Eating Disorders
By Sarah Maria,
Author of Love Your Body, Love Your Life: 5 Steps to End Negative Body Obsession and Start Living Happily and Confidently

So much has been written on the topic of weight gain, eating disorders, and body image, and, by all appearances, the problem is getting worse. Statistics show that 95% of women dislike their bodies and their physical appearance, and now this rampant dissatisfaction has extended to men as well. Once thought to be the focus of teenage girls, studies are showing that eating disorders are increasingly prevalent among middle-age adults, and even beyond.

Is this gnawing discontent unreasonable? With obesity numbers reaching staggering proportions, you may very well think disgust with one’s physical appearance is a normal, and perhaps even a healthy problem to have, if it helps people change their diets and their lifestyles. Then, of course, there is the advent of ever-new disorders, such as pregorexia (compulsively restricting food intake during pregnancy, which impairs the healthy development of the fetus) and orthorexia (an obsession with eating healthy, organic foods).

Is there any solution to this ever-growing and ever-present problem? Or are we doomed to be a population condemned to ever-expanding waistlines, and an ever-increasing obsession with how we look and what we eat?

There is a way to end these ailments, whether you are overweight, or have a distorted view of your body, or find yourself obsessing when you need to order non-organic. Yet, contrary to popular opinion, the solution doesn’t come from solving the problem, per se. Rather, the solution comes from seeing the problem as an opportunity.

Now wait — before you silently yell obscenities at me (What do you mean my life-long affliction with food and with my body is an opportunity?!), and stop reading this article immediately — stay with me for just a second — give me a moment to explain what I mean.

As long as you consider your struggle to be a problem, you reinforce your belief that there is something wrong with you that needs to be fixed. If you are overweight, and especially if this has been a life-long or at least a long-term challenge, you probably have a story or two about what is wrong with you. It might sound something like this:

“I am lazy.” “I just like food too much.” “I can’t stay away from sweets.” “I have no self-control.”

“I am a fat slob — I will never have the body I want.”

Depending on your particular disorder, your story might also sound something like this:

“I must be thin.” “I will hate myself if I gain weight.” “I wish I had her body.” “If I eat, I will get fat.” “I must exercise all the time or else I will gain weight.”

Now, in the beginning stages of body-image struggles and eating disorders, you may convince yourself that you do not have a problem, that everything is fine, and that you are perfectly normal. Yet after living in the mental hell described above for a while, you start to get a sneaking suspicion that something might be wrong. You get the notion that maybe you are not living with all the peace, tranquility, and love that is possible.

At this stage, you become convinced that you have a problem and are in need of a solution. You come to believe that something is inherently wrong with you. You know that there is more to life, that you are capable of something great, but you are stuck in a web of pain and suffering, not sure which way to turn.

In my experience, having healed myself of a negative body image, eating disorders, and obsessive-compulsive behavior that lasted for well over a decade, I have found the following to be utterly transformative:

Your greatest struggle, your deepest pain, your most desperate confusion, holds the keys to your transformation. The secret is in shifting how you look at your problem. Instead of seeing it as a problem, consider it an opportunity. Now, it is up to you to discover the opportunity. It is easy for others to point out a problem to you, but you alone can uncover and in fact create an opportunity out of your adversity. Every challenge holds the keys to unlimited blessings; you need only become aware of your ability to transform your reality, and then stay open and alert to possibilities that come your way.

According to eastern wisdom, we all have within us the ultimate guru or teacher. This teacher is always with us, always calling us to discover our true greatness, our inner-being, that part of ourselves that is magnificent, grand, and wondrous, that part of ourselves urging us to live our very best life.

Unfortunately, very few of us learn how to listen to this inner-teacher as children. As we go throughout life, we lose our connection to ourselves, becoming increasingly tossed to-and-fro by the challenges and adversities of life. Our life becomes a mess of problems and adversities.

These problems, whatever form they take, are opportunities in disguise. They are calling you home. The challenges you face grab your attention. When you don’t listen, you find yourself stuck in a seemingly disastrous web of suffering, possibly unable to stop eating despite the health risks of your weight, unwittingly starving your own child because of your insecurities, refusing to eat after your recent divorce, or whatever form your particular suffering takes.

Yet you always have a chance to return home. You always have the opportunity to dive within yourself and connect with this inner-teacher. No matter how much pain and suffering you are experiencing in any moment, you always have the choice to stop, close your eyes, look within, and seek to discover the seeds of opportunity that are latent in your current adversity.

So whether you, yourself, are struggling with excess weight, an eating disorder, a negative body-image, or any other problem, or if a friend or loved one is struggling, here are a few simple steps to help you connect with your inner-guide an unleash the opportunity that will transform your adversity into a great blessing:

1. Consider the possibility that your problem, whatever it is, holds the seeds to opportunity. Just being open to this possibility will create a shift inside of you.

2. Take the time to go within. There is no substitute for diving deeply within yourself. As the teacher Krishnamurti once said, “In oneself lies the whole world, and if you know how to look and learn, the door is there and the key is in your hand.”

Traditionally, going within is accomplished through the practice of meditation. There are many different styles to choose from — the key is to make meditation a regular part of your daily routine. Regular meditation yields tremendous health benefits, both physically and psychologically, and it also helps you tap into your inner wisdom.

3. Find a teacher, guide, or a coach who can help you explore your internal landscape. When you are at the beginning stages of getting to know yourself, when you are beginning this path of spiritual and personal inquiry, a teacher, coach or guide is extremely valuable. This person could be a psychologist, a spiritual teacher, a yoga instructor, or a life coach. Look for someone who understands where you are coming from and a person to whom you feel a connection. Often this emotional bond is the most important component in getting you the assistance you need.

Remember always: you can transform any adversity into opportunity. Your greatest pain and greatest challenge can be your greatest gift to yourself and to the world. Dive within and discover the keys to create a body and a life of your dreams.

©2009 Sarah Maria, author of Love Your Body, Love Your Life: 5 Steps to End Negative Body Obsession and Start Living Happily and Confidently

Author Bio
Sarah Maria, author of Love Your Body, Love Your Life: 5 Steps to End Negative Body Obsession and Start Living Happily and Confidently, is the founder of Break Free Beauty (www.breakfreebeauty.com), a company dedicated to helping people love and accept their bodies and discover the beauty that they already are. She is a body-image excerpt, speaker, and coach who speaks and writes on the topics of body image, self-esteem, health, success, and spirituality. Her mission is to empower people of all ages, races, and body sizes to embrace the bodies they have been given and learn to love themselves so they can live their dreams. She has studied and trained with many well-known spiritual and self-help teachers, including Deepak Chopra and physician Dr. David Simon, the co-founder and medical director of the Chopra Center for Well-Being in Carlsbad, CA. She lives in Carlsbad, CA.

For more information please visit www.amazon.com

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Armour Draws Laughs During Year’s Biggest Meeting of Thyroid Doctors


I am reporting to you from this year’s meeting of the American Thyroid Association now taking place at the opulent Breaker’s Hotel in balmy Palm Beach, Florida. Cushy job if you can get it, I’d say.

Not a lot of laughs during the typical lecture at this three day meeting of the world’s experts on thyroid diseases and treatment but I did hear a few guffaws, giggles and snorts today during the single lecture devoted to using combination t4 and t3 therapy for treating hypothyroidism. The speaker on this topic, Dr. Michael McDermott a Professor of Medicine and Pharmacy at the University of Colorado, was actually significantly more open minded about using combination t4/t3 therapy then speakers from previous meetings on the same topic. He prefaced his comments by acknowledging that about half of patients treated with synthetic t4 continue to experience symptoms typical of thyroid hormone deficiency. What, if anything, doctors are to do to help their patients in this situation appears to still mystify the experts.

The laughs came when Dr. McDermott polled the audience of professionals about their opinions regarding treatment of a hypothetical hypothyroid patient with normal thyroid function blood tests continuing to complain of symptoms suggestive of thyroid hormone deficiency. The speaker put up a slide with 5 or 6 treatment options which the audience then voted on. Although a good portion of experts here gave a philosophical shrug of the shoulders by not choosing any of the options, it was reassuring to see a significant portion of the audience agreed with the statement that some hypothyroid patients appear to improve when t3 is added to traditional t4 treatment. This is far short of a strong endorsement of combination therapy but I would say it is a least a nod to those of us who routinely make use of this treatment option. The laughs and giggles came when the next to last option was read to the audience, proposing that Armour Thyroid was the best choice of treatment in this case. The last choice, that this type of patient should see a psychiatrist also got a few chuckles.

Not much more about dessicated thyroid treatment was mentioned after this curt dismissal but Dr. McDermott expressed his opinion that Armour Thyroid was a poor choice for treating hypothyroidism because it contains too much t3 and that synthetic t3 should be used exclusively if combination therapy was attempted. No one seemed aware that as of this month Armour Thyroid and similar dessicated thyroid medications were no longer available in the United States.

Despite the disturbing aspects of the first part of Dr. McDermott’s lecture he did end with some exciting ideas that I will soon be reporting on. The main idea he reviewed is that a genetic defect may cause resistance to t4 treatment in hypothyroidism. Those with the genetic defect would require the addition of t3 to achieve a healthy thyroid balance and elimination of the symptoms of hypothyroidism. I am sensing that this may be a breakthrough in thinking about why some people require combination therapy with t4 and t3. If so, endocrinologists will be forced to reconsider their reluctance/refusal to provide combination therapy for treatment of their symptomatic and dissatisfied hypothyroid patients. More to come on this breakthrough in my next installment.

Gary Pepper, M.D.

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Tony Kingkade Clarifies Armour Dosing Issues


Our pharmacist member, Tony Kinkade provides a precise explanation of the issues created by apparent differences in milligram (mg) dosages of dessicated thyroid.

Tony writes:

Armour Thyroid…is it really 60 mg? Actually, it’s 64.8 mg. The apothecary weight system was used in pharmacy back in the old days and has been replaced by the metric system. 1 grain is a weight measurement that is equivalent to 64.8 mg. Armour Thyroid is really 1 grain. However, depending on the person or manufacturer, 1 grain can be expressed as 60, 64.8 or 65 milligrams. If you are on 1 grain Armour Thyroid, you are really on 64.8 mg, but the stock bottle says 60 mg (they are allowed to do that). So one manufacturer will express 1 grain as 60 mg and another as 65 mg. Why not use 64.8 mg? They can. They just choose to round up or down for simplicity. And…manufacturers can vary a bit on either side of the true weight and still be compliant to FDA rules.

Don’t fret over it.

Remember, there are fewer strengths of dessicated thyoid available than levothyroxine has. So dosing precision isn’t the same. 1/2 gr to 1 gr to 1 & 1/2 gr (30 mg to 60 mg to 90 mg) for dessicated thyroid are much larger jumgs than 75 mcg to 88 mg to 100 mcg to 112 mcg to 125 mcg to 137 mcg to 150 mcg for levothyroxine.

Armour Thyroid…is it really 60 mg? Actually, it’s 64.8 mg. The apothecary weight system was used in pharmacy back in the old days and has been replaced by the metric system. 1 grain is a weight measurement that is equivalent to 64.8 mg. Armour Thyroid is really 1 grain. However, depending on the person or manufacturer, 1 grain can be expressed as 60, 64.8 or 65 milligrams. If you are on 1 grain Armour Thyroid, you are really on 64.8 mg, but the stock bottle says 60 mg (they are allowed to do that). So one manufacturer will express 1 grain as 60 mg and another as 65 mg. Why not use 64.8 mg? They can. They just choose to round up or down for simplicity. And…manufacturers can vary a bit on either side of the true weight and still be compliant to FDA rules.

Don’t fret over it.

Remember, there are fewer strengths of dessicated thyoid available than levothyroxine has. So dosing precision isn’t the same. 1/2 gr to 1 gr to 1 & 1/2 gr (30 mg to 60 mg to 90 mg) for dessicated thyroid are much larger jumgs than 75 mcg to 88 mg to 100 mcg to 112 mcg to 125 mcg to 137 mcg to 150 mcg for levothyroxine.
kingkade@san.rr.com
Tony Kingkade
1

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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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Soon to Be Married, Smoking or Over-eating are Melissa’s Choices


Melissa looks back to realize that smoking or over-eating are habits dominating her life. Soon to be married she wonders if anyone can offer a helping hand in her effort to control her weight. Can a weight loss pill be the answer?

Melissa writes:

I’ve been obese for most of my life…however at the age of 17 I started smoking casually which later turned into a full time addiction…between 18 and 19 I was partying all the time, smoking two packs a day, rollerblading like crazy, running the streets at night with friends, and dropped 80lbs by barely eating anything but drinking lots of mt. dew and alcohol. By 21 the weight started to come back on… I quit smoking at 23 and my metabolism slowed wayyyyy down. Recently I had a glucose/thyroid test done. Everything is in the normal range. Although my thyroid is on the low side of the “normal” range. I know the thyroid regulates the metabolism. I’m currently 266 lbs and a full time teacher. I’m getting married in 10 months and want to drop weight fast. Is there a weightloss drug out there that can increase metabolism without giving me the jitters. I’ve decreased portion sizes already and in a few weeks I’ll be getting a treadmill for the house. Please help a blushing bride to be.

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Support My Letter to the New York Times


In an effort to expand public awareness of the crisis created by the shortage of Armour Thyroid, I drafted a letter to the New York Times detailing the situation. My thought was to make as many people as possible aware of the situation hoping to create pressure on the FDA and Forest Pharmaceuticals to resolve their impasse.

So far it looks like the Times has rejected my letter. If we can get enough emails sent to letters@nytimes.com , with the wording “Please publish the letter: FDA Plays a Dangerous Game with Patients Well Being, by Dr. Gary Pepper”, maybe we can get the letter or some form of coverage published. Please take a minute to help out. The more supportive emails sent, the better.

Thanks and let’s work together toward a positive outcome to this crisis. I’ll be posting here regarding any progress.

Gary Pepper, M.D.

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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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