t4 tags

We had a great Thyroid Patient Community Call Friday night on TalkShoe with John Voliva, RPh, the President of Hooks Apothecary in Evansville, Indiana. Hooks Apothecary is a compounding-only pharmacy that has been in existence for ten years and is a small and high quality family-owned business.

And with our current shortage of desiccated thyroid via the tablets we were used to, compounding pharmacies are a good alternative in the meantime. Here’s what we learned from Mr. Voliva:

1) Different compounding pharmacies will use different fillers. Hooks Apothecary, for example, uses powdered acidophiles, the “active culture” which helps replace the good flora in your gut and improves digestion.

2) Compounded desiccated thyroid can be more expensive for two reasons: they acquire smaller amounts of the powder as compared to the huge amounts obtained by a pharmaceutical like Forest, and it takes time to compound it.

3) A good compounding pharmacy will give you the Certificate of Analysis right when you ask for it, and you should ask for it. This Certificate will tell you how much T4 and T3 is in one grain..and it’s not always simply 38/9 mcg.  It could be 35/8.6 or 39/8.5 per grain…for example.   Find out because there are allowed deviations of 10 mcg +-.  A really good pharmacy will shoot for an even better deviation and will also produce that Certificate right when you ask for it, not a day later. To not receive that documentation right when you ask implies they really weren’t paying much attention to the deviation.

4) A compounding pharmacy will get better deviations when they create a 65 mg grain of compounded desiccated thyroid than when they create a 60 mg grain.

5) Top notch Compounding Pharmacies will be accredited by, or be close to completing the steps towards, the Pharmacy Compounding Accreditation Board.

6) Compounding pharmacies can’t make a desiccated thyroid trouche because of the problems with heat in the processing of the trouche.

7) Mr. Voliva feels it would be too easy to overdose with transdermal (on the skin) desiccated thyroid.

8 ) Compounding pharmacies, via their 5-6 distributors, get the powder from American Laboratories.  But not all compounding pharmacies will be as diligent as others to make sure the deviation is closer to 5%.

9) If the compounding pharmacy is getting their powder via the distributor PCCA (Professional Compounding Centers of America), you can be assured you are getting a good product.  Ask the pharmacist where they are getting it.

10) Compounding pharmacies generally have plenty of desiccated thyroid powder.

My apologies to a group of callers whose chat questions I wasn’t able to see. I have sent a question about that to Talk Shoe’s Customer Support to find an answer before the next Community Call. But on the good side,  the audio worked on everyone’s computer.

Need alternatives during this shortage time? Here are options you can consider.

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I have been driving all day, bringing my husband back home after serious hand surgery yesterday. And while I was away from the computer, I received the below via the Contact Me form of STTM, written by Mary Budinger for the Arizona Net News journal, September 16, 2009:

Dr. Mark Starr’s office team wanted to send over a portion of an article just written for an Arizona health magazine:

Desiccated thyroid from pigs is a bio-identical, complete hormone preparation, containing the entire spectrum of thyroid hormones including T4, T3, T2, and T1 that are in the human thyroid gland.

Current FDA approved thyroid medications include Synthroid, Unithroid, Levoxyl, and Levothyroxine (all only contain T4), and Cytomel (only T3). These hormones are synthetic and contain only a portion of the thyroid’s hormones.

Dr. Mark Starr of Phoenix, Arizona, said patients have called him, frantic that desiccated thyroid is unavailable. “It is so key to my practice, I have enough for my patients. So far, it appears that when supply catches up with demand in a few months, the shortage will be over.”

Dr. Starr is the author of “Hypothyroidism-Type 2.” He said synthetic thyroid acts energetically differently in the body. “All living things have a right spin, and synthetic medications have a left spin. The desiccated thyroid is better tolerated.”

Dr. Broda Barnes did a study that revealed a relative intolerance to a synthetic thyroid product containing T3 and T4 (Thyrolar). One-fifth of the patients who had done well on desiccated thyroid developed rapid heart beats and palpitations when switched to Thyrolar. Dr. Barnes also did a major research study on desiccated thyroid that involved thousands of patients over 30 years; it showed a 94 percent reduction in the number of expected heart attacks. This study is the subject of the 1976 book “Solved: The Riddle of Heart Attacks.”

Lipitor is the best selling drug in the world. But for the first half of the 20th century, desiccated thyroid was the standard treatment for high cholesterol. Elevated cholesterol and triglycerides are one of the myriad symptoms of hypothyroidism. Dr. Barnes’ book included a chapter entitled “The Demise of the Cholesterol Theory.” Desiccated thyroid normalized cholesterol and triglycerides in 95% of the patients Dr. Barnes treated. The 5% who had persistently elevated levels had no increased incidence of heart attacks. Desiccated thyroid therapy also resolved a long list of other hypothyroid symptoms such as fatigue, cold intolerance, joint and muscle pain, dry skin, inability to lose weight, headaches, and menstrual problems. One of the most important benefits that Dr. Barnes demonstrated in studies on both animals and his patients was that desiccated thyroid increases immunity and allows the body to fight off infections. As we come into swine flu season, this is particularly important.”

Dr. Starr, I love the way you put it: “All living things have a right spin, and synthetic medications have a left spin. The desiccated thyroid is better tolerated.” And that’s exactly why the website Stop the Thyroid Madness exists–patients all over the world have found out what a far better “right spin” treatment desiccated thyroid has been for them!  So we present this information, hoping that more and more patients can learn from the paths walked before them, and take this right into their doctors offices.

And about Thyrolar, which is a combination of synthetic T4 and synthetic T3:  we’re glad it exists. But…there have been numerous patients over the years who tried the combination of synthetic t3/ synthetic T4, and who then switched to desiccated thyroid. And they identically report on the NTH thyroid group that they got far better results from desiccated thyroid. That is powerful information.

And yes, Dr. Starr, we are looking forward for supply to catch up, because natural desiccated thyroid is a godsend.

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Join the Thy­roid Patient Com­mu­nity Call on Talk Shoe this Friday. UPDATE: the President of Hook’s Apothecary, a compounding pharmacy that serves Illinois and Indiana, will be in the chat to talk about compounding desiccated thyroid.

Also check out the post below concerning possible hints that we are closer to seeing more desiccated thyroid on our shelves?

*Want to be infor­med of these fringe web­site blog posts? Curious what’s on unprofessional Janie’s mind? Just use the Noti­fi­ca­tions on the left below the links.

* The extre­mely hip and sophis­ti­ca­ted STTM t-shirts are half price! I love sales!

I have been receiving emails this afternoon from concerned patients about the latest blog post by health writer Mary Shomon. Her post states that Major Pharmaceuticals has received a notice from the FDA to stop making desiccated thyroid.  And Shomon questions:  is this the beginning of the end?

I think it’s important to mention something that I remember reading, but can’t right now put my finger on, that the FDA can stop production of desiccated thyroid if a company has started making it AFTER the FDA came into existence, and require it to file a New Drug Application, since it is “new” to that company.  Forest Labs and RLC do not fall in that classification. They were around before the FDA came into existence.

I did find this article about Morphine, which implies that as long as a drug (like desiccated thyroid) has not changed since it’s inception, it can avoid the New Drug status. It states:

Under a grandfather clause, a drug marketed prior to the 1938 Federal Food, Drug, and Cosmetic Act, and labeled with the same conditions of use as prior to the Act, was not considered a new drug. These drugs did not require an approved new drug application, but many thought tacit FDA approval was implied. It’s the drug company’s burden to prove an assertion that its product is grandfathered. But FDA believes few drugs are entitled to grandfather status because many differ from previous versions in some respect (e.g., formulation, strength, dosage form, route, indications, intended population).

The above statement makes you pause about Armour, which WAS changed by Forest Labs. But I’m not at all sure RLC’s desiccated thyroid has changed at all, which can be good news for all of us.

Check out page 332 of Good Manufacturing Processes for Pharmaceuticals by Joseph D. Nally which also outlines the above issue of grandfathered drugs.

All in all, it’s downright MADDENING and INEXCUSABLE how the FDA would tell these generic pharmaceuticals–Major and Time-Cap Labs, to stop producing the medication when we already have a shortage.

Here is what the FDA states in their 2006 Compliance Manual, Section 7132c.02 titled Marketed New Drugs Without Approved NDA’s and under A: Reason for This Guidance, please note what I have italicized in their statement:

Manufacturers of drugs that lack required approval, including those that are not marketed in accordance with an OTC drug monograph, have not provided FDA with evidence demonstrating that their products are safe and effective, and so we have an interest in taking steps to either encourage the manufacturers of these products to obtain the required evidence and comply with the approval provisions of the Federal Food, Drug, and Cosmetic Act (the Act) or remove the products from the market. We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market.

To the contrary, the FDA has IN FACT adversely affected public health and has imposed undue burdens on consumers by these ridiculous actions!! A large body of those now on desiccated thyroid will tell you that being on anything BUT desiccated thyroid ruins their health and well-being. I am one.

Under III. FDA’s Enforcement Policy, they define two areas of concern: drugs with potential safety risks, and drugs that lack evidence of effectiveness. You and I know very well that the latter has been stated ad nauseum by the FDA and certain individuals, and yet THE EVIDENCE IS IN HUNDREDS OF THOUSANDS OF US who have switched to desiccated thyroid is ignored, as it the continuing symptoms representing lack of effectiveness in T4 meds!

You can continue reading this FDA Guidance policy and use the Comments to see what hits you, as well.

I have compiled the above fairly quickly, so if I have left anything out, or you can offer more clarification, use the Comments.

P.S. A recommendation: if you are very optimal on your current desicccated thyroid, I would recommend trying to decrease your dose every other day. For example. 4 grains, 3 1/2 grains, 4 grains, 3 1/2 grains, etc.  Not everyone can do this, but if you can, it will help draw out the amount of desiccated thyroid you do have without adversely affecting you. Again, this may only work for those who are quite optimal, and without adrenal fatigue or other issues.

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We always talk about pharmaceuticals who produce our desiccated thyroid medication pills like Forest Labs (Armour) and RLC Labs (Naturethroid and Westhroid). These are also the pharmaceuticals who provide these pills to the local pharmacies we use. But there is another important link in the chain that proceeds them: American Laboratories, Inc. (ALI)

ALI is a small processing company located in Omaha, Nebraska which was established in 1967 by Mr. Jack Jackson and Mr. William Phalen.  They have been making desiccated Porcine Thyroid Powder (which is an Active Pharmaceutical Ingredient, API) for over 40 years, as well as 200 natural biologically derived products such as Pancreatin and Pepsin, both digestive enzymes. Their mantra is “Building trust through quality products and service.”

ALI, as a leading manufacture and supplier of enzyme and natural dried products, is also probably the only North American company to make desiccated thyroid powder. And they will explain that it’s a long and difficult product to make, but they are committed to it.

This morning, I spoke with Kenny Soejoto, the Chief Operating Officer. He explained that supply and demand has been a critical issue, and ALI will be doing everything they can to provide the quality desiccated thyroid powder to pharmaceuticals that they always have. You’ll also see a Press Release come out later today from Kenny and ALI about the issue. I’ll add it below.

The supply and demand issue is outright due to the current patient revolution, represented by STTM and other fine groups and websites,  against the sole treatment of hypothyroidism with T4 meds like Synthroid by too many doctors….and in favor of desiccated thyroid as a far better treatment. Demand has grown, and perhaps it caught them by surprise. (That is my comment, by the way, NOT ALI’s.)

Even RLC Labs states that demand for Naturethroid (due to problems with the newly formulated Armour) has quadrupled in the past few weeks. And rightly so!  Thyroid patients around the world KNOW FIRSTHAND how much better desiccated thyroid treatment is over T4-only. And word is spreading.

So as we,  thyroid patients on desiccated thyroid, face a shortage the next few months, take heart that everyone is working hard to bring supply back to us.  Also see my post below concerning the bigger issue with Medco, and potential alternatives.

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Here’s the Press Release below, and it should calm any fears or panic:

August 19, 2009

To our knowledge, American Laboratories, Inc. is the only manufacturer in North America of Thyroid Products for use in Human Pharmaceuticals as an Active Pharmaceutical Ingredient. We have manufactured our Thyroid products for over forty years, and we understand the importance they have to our customers and ultimately the consumer patients. Today, as well as in the future, our Thyroid products will continue to be a strategic part of our business.

Through the years, the world-wide demand for our Thyroid products, as well as our human nutritional enzyme products has increased dramatically. Through careful planning and strict adherence to regulations set forth by the FDA, USDA and other government agencies, we have implemented plans to increase our production capacities. In addition, American Laboratories’ is working closely with our suppliers to help ensure a consistent supply of quality raw materials. We hope that you understand that the process to manufacture the active ingredient takes several months to complete.

Please be assured that we have placed our Thyroid production as our number one priority so that we can meet the demands of our customers.

American Laboratories, Inc
Omaha, Nebraska, USA

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Jessica Terry is an 18 year old student at Washington State high school in the Bay Area who had years of problems which doctors couldn’t figure out: vomiting, diarrhea, weight loss and stomach pains.  Doctors said she had irritable bowel syndrome or colitis, and said her intestinal tissue was just fine according to slides.

Yet, she just knew that wasn’t correct.

So she took some of her own intestinal tissue to her Biomedical Problems class, and voila…she diagnosed her own problem:  granuloma, and specifically, Crohn’s disease, an inflammation of her intestines.

Sound familiar??

Yup, thyroid patients have had to do the exact same thing–self-diagnose– for almost ten years because of continuing symptoms of hypothyroidism which doctors have routinely dismissed, pooh-poohed or blamed on something else.  It’s all been a horrific, wide-reaching and damaging 50 year medical scandal by the medical establishment upon thyroid patients.

And why has this calamity occurred? Because doctors have always been hoodwinked by their medical school training, continuing education and Big-Pharma-financed-research in believing that T4-only thyroxine medications like Synthroid, Levoxyl, Levothyroxine, Eltroxin, et. al. were from God Almighty, and the TSH lab test was just as holy.

And thanks to thyroid patients around the world who had the gall to use the internet and join patient groups, we figured out it’s all because those medications and labwork have not worked, and what has worked. Additionally, it was patients who discovered they had adrenal fatigue and/or low ferritin and how to treat it, and patients who have succeeded in beginning a wave of change around the world in the treatment and diagnosis of hypothyroidism (except for the UK, who has gone backwards to the dark ages).

You can read Jessica’s story first reported in the Sammamish Reporter,  and only recently reported to a wider audience in the Bay Area News newspaper. She also spoke to a CNN affiliate.

Thanks to Kem on NTH for informing me of this news.

P.S. Do ya think that any newspapers or major news outlets like CNN are going to finally get what a huge story thyroid patients have given them?? We’re still waiting……

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