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The 2009 FDA Ombudsman report, and why you need to contact the FDA

Good or interesting news is kinda slack right now.

But last week, the ombudsman of the FDA’s  Center for Drug Evaluation and Research (CDER), came out with their 2009 report that I found interesting. The Ombudsman are those who receive and impartially look at any communications from patients to the FDA about medications.

On the fourth page, you find this under the heading Drug Shortages: Desiccated Natural Thyroid does not have FDA approval and it’s availability became quite limited in 2009. Many consumers complained to the ombudsman because of their preference of desiccated natural thyroid as thyroid replacement medication over the FDA approved synthetic versions.

Of course, the above gives a potentially false impression that the shortages were due to the lack of FDA approval–and reasons for this stupidity concerning “FDA-approval” are explained here.

To the contrary, last years shortages may be explained by production issues with the North American producer of desiccated thyroid powder, as well as demand being greater than supply thanks to patients finding out about the superiority of desiccated thyroid over T4-only meds like Synthroid.  The STTM website and book is working, as are numerous good patient groups and forums!

But the above reveals that they are hearing thyroid patients speak.

So with this being a somewhat silent period, waiting to see when the FDA will require RLC (Naturethroid) to do ridiculously expensive clinical trials to prove what patients have already known for 110 years–that desiccated thyroid is safe and effective–it can be a GOOD time to continue communication with the FDA. How? By reporting YOUR EXPERIENCE AND PROBLEMS with T4 for their 2010 report next year. i.e. it will serve to cement why so many did call to state their preference. Here’s how:

If you had depression or other psychological issues while on T4, report it.

If you have rising cholesterol, low ferritin, and/or low B12 because of T4, report it.

If you had dry skin or hair, digestive issues, or aches and pains, report them.

If the quality of your life was lowered on T4, report it, outline it, detail it.

If you got adrenal stress because of being on T4, underscore that lousy truth to them.

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The FDA and their Transparency Initiative may interest some of you as thyroid patients

The FDA....In case you are interested, the following represents Phase 3 of the FDA Transparency Initiative, which could end up benefiting thyroid patients as we deal with the upcoming clinical trials for natural desiccated thyroid. The links at the bottom give more understanding, as well.

For Immediate Release: March 12, 2010

FDA Task Force Seeks Public Comments on Increasing Transparency With Regulated Industry

As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.

Posted in the March 12, 2010, Federal Register, the request for electronic or written comments has a deadline of April 12, 2010.

The FDA regulates products responsible for about 25 percent of the gross national product of the United States and the industries responsible for these products. Products regulated by the agency — biologics and blood products, human drugs, foods, medical devices, radiation-emitting devices, and veterinary medicines — are integral to public health and to the U.S. economy.

The agency formed an internal Transparency Task Force in response to the Obama Administration’s commitment to achieve “an unprecedented level of openness in Government.” The Task Force is developing recommendations for making information about FDA activities and decisions more useful, understandable, and readily available, while appropriately protecting confidential information.

The Task Force held public meetings in June 2009 and November 2009. Based upon input received thus far, the Transparency Initiative has been divided into three phases. The first phase, creating a Web-based resource called “FDA Basics” to provide information on commonly misunderstood aspects of the agency, has been completed. The second phase, improving FDA’s disclosure of information to the public, is underway and the agency intends to issue draft proposals for public comment soon.

The request for comment for the third phase follows a series of listening sessions with members of regulated industry in January 2010. Transcripts and summaries of those listening sessions are available at http://www.fda.gov/transparency and at http://www.regulations.gov.

For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:

  • Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements
  • The guidance development process
  • Maintaining open channels of communication with industry routinely and during crises
  • Providing useful and timely answers to industry questions about specific regulatory issues

Electronic comments may be submitted to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA—305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. All comments should be identified with docket number FDA—2009—N—0247.

For more information:

Senator John McCain–what in the HECK were you thinking?? Huh??

Now let me start this post by saying that Senator John McCain and Senator Byron Dorgan’s anti-supplement bill…yes, a dim-wit ANTI-supplement bill…was squashed for now because he backed down thanks to plenty of public protest.

And thank God, because it would have especially affected thyroid patients who have suffered thanks to Synthroid or other T4-only meds, and are working diligently to regain their health with their freedom in choice of important supplements, besides natural desiccated thyroid and T3.  Think selenium, iron, B-vitamins, Vit.  D, iodine, Grape Seed Extract, Isocort, St. Johns Wort, and a slew of other supplements we freely and wisely take to undo the damage done to us by our TSH-and-T4-worshipping medical establishment.

In case you didn’t know, McCain sponsored a bill called the The Dietary Supplement Safety Act (DSSA). It would have nullified the protection of supplements from the 1994 Dietary Supplement Health and Education Act (DSHEA). Those protected supplements are either those found in food without any chemical alteration, or those sold prior to 1994…i.e. it would somewhat stop the FDA from either banning those kind of supplements or reclassifying them as “drugs”.  And with the FDA being in a financial bed with Big Pharma, you betcha we would have seen those bans and reclassifications.

And what else might have happened? We would have lost our lower cost, safer, and more effective alternative to side-effect drugs. I have helped my husband lower his high cholesterol, high LDL and high triglycerides WITHOUT the nasty statins and WITH supplements.

I like how Dr. John C. Lowe put it in his latest newsletter:

We appear to have won this time around. But a price we must pay for continuing freedom in our health care choices is to keep our noses in the air. Before long, the stench of Big Pharma’s greed will waft down upon us again in the form of some legislator’s bill. When it does, we must pay another price to keep our freedom: that is to organize once again and deliver a resounding “No!” to Congress.

Want to read more about this?? Just google “mccain’s supplement bill” and get an eye-full.   And I hope to see you respond to this post with a list of IMPORTANT and LIFE CHANGING SUPPLEMENTS and how they are helping you.

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Are you from Europe and would like to see your own NTH group?? I’ve just started NTH EUROPE and if you live in Europe, you are invited to join.  Note that new groups can be slow to build, so put yourself on Daily Digest or Individual Emails and watch its growth.  We will be looking for level-headed moderators and your donation of good European information in the Files and Links.

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It ain’t for sissies: getting older and hypothyroidism (plus FDA says it did NOT tell pharms to stop desiccated thyroid)

Yup, we’re all heading in the same direction—being just a tad older every single year and getting that first mailing from AARP.  Yup.

And getting older increases the incidence of thyroid disease.

Even worse, those who acquire it at an older age are probably going to go through the same bunk and bull those younger have gone through–having depression, rising cholesterol, osteoporosis or ostepenia, weight gain, easy fatigue, couch potato syndrome, dry skin and hair, plus more—-all classic symptoms of undiagnosed or undertreated hypothyroidism.

But older folks are told it’s all just part of aging so here’s your latest tablet for your handy-dandy Wal Mart pill box.

I recently found a great blog by Pam whose Feb. 23rd, 2010 post is titled Older Women and Low Thyroid. She turned 65 in 2009 (and she looks a lot younger) and writes how she found herself with hypothyroid at a later age as well.  And Pam is WAY ahead of the game in her knowledge. She understands that most older folks are put on Synthroid (which can be a lousy way to treat hypothyroidism for many), that getting older means conversion from T4 to T3 can be more difficult,  that being on desiccated thyroid or T3-only just might be the better treatment, and you can get adrenal fatigue at an older age as well (thanks to poor treatment with T4, the TSH lab test, or being underdosed even on desiccated thyroid).

You can read Pam’s post here, as well as about the phone call from her friend who is 50 lbs overweight, has brain fog, is out of work, has no energy…and voila–is on Synthroid so it can’t POSSIBLY be her thyroid. Sad. In fact, what has happened to Pam’s friend is what I keep stating to those who feel they are just doing peachy on T4: watch out, because as you age, the truth about T4 will reveal itself!

Pam, I love your blog posts, and I’m going to hope to see more of those in the “venerable age range” be just as wise as you are!!

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FDA HAS MADE A STATEMENT ABOUT NATURAL DESICCATED THYROID: Just before I was going to plop into my bed for the evening, I checked my notifications to discover that right on the FDA website and their 2010 Drug Shortages page (3rd column up from bottom), it states: Forest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. BINGO. I’ve been waiting for this for months, because though websites and groups were formed last year as if we needed to “rescue” desiccated thyroid from being banned, I couldn’t join the fearful rally of a few because my gut was telling me something quite different.  And a few others, I discovered, had the same feeling.  And hooray! Our guts were right on!

Does this mean the FDA “gets it” about desiccated thyroid? Maybe, or maybe not. Yes, their timing WAS awful last year with Time Caps Labs, right when we were starting a shortage. And there does appear to be some kind of future requirement “proving” the safety and efficacy of dess. thyroid–two things we ALREADY KNOW from 110 years of safe and effective use. Duhhh on the FDA. But it’s FAR more hopeful now, and realistic, and will hopefully promote more reasonable thinking from now on.

Onward and upward, folks.

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Naturethroid is coming back in pharmacies all over the US! See the blog post below or here for information about  the “new” Naturethroid.

(If you are reading this via the Newsletter email notification, just click on the title of this blog post to come directly to the site where you can Comment).

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Here’s the skinny about the “new” Naturethroid: the good, the bad, and the curious

(A lot has gone on since this post below was first put up in 2010. So after reading the below, see what happened in 2017 here.)

As the one grain tabs of Naturethroid desiccated thyroid by RLC Labs are hitting pharmacy shelves again all across the nation here and there after the recent shortages and the sad reformulation of Armour,  and patients are starting to use the new Naturethroid, we are gathering some good information, both anecdotal and factual:

  • The typical smell of desiccated porcine is less intense with the new tablets. We have no idea why.
  • The tablets are now stamped with RLC on one side, and N over 1 on the other, whereas before you’d see just NT1 or a reference to the fact that Time Caps Labs (TCL) used to make Naturethroid for RLC Labs
  • The package insert is no longer inside the bottle but stuck on top of the cap
  • Lot number info used to be on the edge of the label running vertically, whereas now, it runs along the bottom of the label  under the ingredients.

One grain is still 65 mg, with the T3 content being at 9 mcg and the T4 content being at 38 mcg.  The T2, T1 and calcitonin still unmeasured.

There are filler/inactive ingredients which have changed:

  • Calcium filler has moved up from 16 mg to 17 mg (calcium binds thyroid, but you just take more. Don’t swallow it with milk, please.)
  • The old contained Magnesium, Potassium, and Sodium (each at less than 1 mg), whereas in the new, potassium is now removed
  • And here’s the best part: the old NT had Hydropropyl Methylcellulose–that’s the larger size cellulose structure which we know binds some of the thyroid hormones. Now, the new NT has Microcrystaline Cellulose, the smaller size. (Too bad we can’t see all cellulose removed!)

Below are the new NT fillers, which are identical to the old except for the cellulose change:

Carnaba Wax, Colloidal Silicon Dioxide, Dicalcium Phosphate, Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystaline Cellulose, Polyethylene Glycol (PEG)-400, Sodium Starch Glycolate, Stearic Acid.

Most all the above comes courtesy of Stephanie Buist, owner of the Iodine group on Yahoo and thyroid and adrenal patient and advocate.  Thank you, Steph!  You can read about the fillers here by scrolling down.

Oh and by the way, the new tablets are now scored. A helpful addition!

In patient groups, we are seeing a variety of experiences with the new Naturethroid.  Most folks seem happy with it so far, and even some report it seems a tad stronger than the old (the cellulose change may have caused that). Occasionally, someone will report problems, but they appear to be from underdosing or a potential RT3 problem which has arisen and needs treatment with T3-only.  Changing brands can also bring different reactions, so you have to wiggle the dosage around sometimes to find your sweet spot once again.

All in all, it looks good.

P.S. If you are reading this via the Newsletter Notification, just click on the above link to put yourself right on the actual blog post if you want to comment. Let’s gather all our experiences with the new Naturethroid.

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If you missed the last internet radio Thyroid Patient Community Call with Dr. Kent Holtorf, you missed a VERY good one. Thank you Dr. Holtorf for excellent information. But good news! All the shows are recorded.  Just go to the following link, scroll down, and you can click on any past interviews, including two with Dr.  John C. Lowe and a great one with Endocrinologist Dr Pepper–one of a rare breed of open-minded Endos.  (I’ve also stopped doing my long intro’s about me in the last two, figuring if someone wants to know, they can go to the About Me page, or read the Introduction in the book which has even more detail. lol.)

http://www.talkshoe.com/talkshoe/web/talkCast.jsp?masterId=62603&cmd=tc

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