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Category: fda

Washington spits in your face, anti-depressant problem, and the STTM book is now in German and Swedish!

The US Government is going to confiscate your meds sent from overseas!

Fall is in the US, but as you were enjoying your summer, it happened in a flash:  last July, President Obama signed into law the FDA Safety and Innovation Act (S. 3187). And that Act includes a section that might negatively affect your life as a thyroid patient if you are among those feel forced to get your life-saving natural desiccated thyroid (NDT) or related medications from overseas (because your doctor was too clueless to either prescribe NDT or give you enough thanks to the medical stupidity about the TSH lab test).

i.e. in Section 708, the US government now has the authority to destroy a package of personally imported drugs at their point of entry to the United States…even if you badly need them. And this potentially includes NDT like Erfa coming to us from safe, reputable Canadian online pharmacies by prescription! Or your T3-only from other places. Both the latter are unclear, but it’s a possibility.

And do you know why they state they are doing this?? For your “SAFETY”.  Janie’s eyes rolling here.  Can someone tell me how they know if a thyroid med from somewhere else is “unsafe” simply because it wasn’t made in the US?? Are US-made drugs SAFE??? Give me a break. Ask that of folks whose lives paid big prices because of side effects from our FDA-approved medications like Synthroid and many other NON-thyroid related drugs pushed upon us. It’s all a bunch of Big Pharma-influenced, greedy hooey, say thyroid patients.

Now as far as we know, this isn’t going to affect anything really soon. The US Secretary of Health and Human Services has up to two years to decide how to make the new law a reality. But it may happen far sooner than later in that time frame and I would count on it.

Says Lee Graczyk, RxRights Lead Organizer, “It’s critical for people to stand up and get organized to fight against this harmful regulation!”

Anti-depressant use and your adrenals: not a helpful connection for some

Sure, having depression is not fun and it’s understandable if you want to do something about it. My own mother had depression so bad thanks to her lifelong use of Synthroid that she used anti-depressants her entire adult life. This was long before we, as thyroid patients, discovered the strong connection between low T3 levels in the brain and depression (and a connection which all too many doctors miss!)

She also had an extremely “emotionally apathetic” personality, which I assumed was solely due to the electric shock treatment she had while in her early 40’s in an attempt to reverse the depression. But turns out her impassive and flat personality could have also been from the nasty side-effects of my mother’s long-term antidepressant use. i.e. while they made her “happy”, they also made her more dull, flat and detached. This has been reported by all-too-many patients

But now we are seeing the problems that anti-depressant use can cause for your adrenals. A study done in September 2011 titled Antidepressant use and salivary cortisol in depressive and anxiety disorders reveals that

  1. Tricyclics* flatten your cortisol awakening response
  2. SSRI users** had higher evening cortisol levels
  3. Most antidepressants are associated with distinct alterations of the HPA axis (hypothalamus, pituitary and adrenal feedback loop)

*A common form of Tricyclics is Elavil (Amitriptyline).  **Common examples of SSRI antidepressant (Selective serotonin re-uptake inhibitors or serotonin-specific reuptake inhibitor) include Lexapro, Prozac, Celexa, Paxil, Zoloft, etc) 

The alternation of your HPA axis is a common finding when you peruse several research studies. And it’s even more obvious when thyroid patients with adrenal fatigue start using the T3 Circadian Method. i.e. it can take longer to get the right response from the T3. ***Please note that this is simply providing information in the name of being informed patients, not a recommendation to get off your antidepressant!  Talk to your doctor.

(Speaking of mood issues, a study was done showing cherries help with mood. Who would’ve guessed. You can read about it here.)

The revised Stop the Thyroid Madness book is now in German and Swedish! 

You can read about the translations here and I included an autobiography of each translator!  Please do not comment asking if a particular language is coming. I’ll announce them when the day comes.  If you know someone in Germany or Sweden who could badly use the patient-to-patient information in this book, go here.

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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:

How are YOU doing with the current desiccated thyroid shortages?

Pills Spilled Shortages

(This post garnered a lot of attention, up to FIFTY comments just a few hours after it went up. People are very interested in sharing their experiences in coping with the shortages! See below and add your own.)

This year will go down in history as shockingly miserable for enlightened thyroid patients on natural desiccated thyroid.

First came a reformulation in the most popular brand–Armour by Forest Labs. Patients worldwide in groups and forums reported a serious return of their hypothyroid symptoms on this product. A huge disappointment.

Second came the production shutdown of the two generic makers of desiccated thyroid: Time Caps Labs and Major Pharmaceuticals. It’s the first step in the FDA’s compliance plan to corral all grandfathered-in drugs (drugs already in existence when the the FDA was created in 1938) and make them each prove the efficacy and safety of their medication via very expensive clinical trials. i.e. over 110 years of safe and effective use of desiccated thyroid is not enough for the FDA?? We are still waiting to see the outcome of that plan with RLC and Forest Labs.–the two who were actually in existence before 1938.

Third came demand being greater than supply and shortages. Because of informative patient websites like Stop the Thyroid Madness, Sheila’s TPA-UK, Lyn’s ThyroidUK, Stephanie’s Natural Thyroid Choices, some areas of about.com (and other good websites I don’t mean to miss here), plus many fine patient forums and groups, patients found out why they had continuing symptoms on T4 thyroxine, and demand for natural desiccated thyroid grew exponentially.

STTM then created a list of options for all thyroid patients until the shortages resolved themselves, and also created CDT (Coalition for Desiccated Thyroid) where patients could discuss alternatives in a supportive and factual atmosphere.

And we’ve seen some interesting experiences and comments:

The new Armour: One grain tabs started to appear on some pharmacy shelves the past month. Other pharmacies have still been waiting. Many patients appear to have switched to other alternatives, though. One gal still on it feels she is finding success by adding T3 to the amount of new Armour she is on. Time will tell if patients can ever find success with the newly formulated Armour, and most feel it’s a huge loss.

Naturethroid and Westhroid: Patients reporting on their switch to either of RLC Lab’s two identical products report doing well, having to raise it slightly or lower it slightly, or just not liking them at all. Others have had a hard time finding it on their pharmacy shelves, but have been seeing some appear in the last few weeks.

Erfa’s Thyroid from Canada: When it became clear that the FDA was allowing this excellent product to be shipped to patients, many switched and had their prescriptions faxed to a Canadian pharmacy. Prices at many of those pharmacy websites were doubled after prescriptions started to come in from the US. Most patient who stuck with it seem to love it, reporting you can do it sublingually, as well. A few haven’t been impressed, but were finding their former success by raising it.

Compounded desiccated thyroid: In spite of being a more expensive option, some patients found success with this. Others learned they preferred the filler to be Acidophiles. If not the latter, Microcrystalline Cellulose was preferred over Methyl Cellulose–the latter which appeared to lessen the effectiveness of the compounded thyroid.

Synthetic T4 and Synthetic T3: some patients switched back to the synthetic combination, but many report that it hasn’t been as effective as desiccated thyroid was.

Other options: Patients moved to OTC products like Nutri-Meds, etc, which can be much weaker. Others sought desiccated thyroid from other countries and have found success.

So I’d like to hear from all of you. Did you go back to synthetic T4? What desiccated thyroid did you switch to? What worked and why? What didn’t work for you and why? What product do you hope to switch to once you run out of your current meds?

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FDA’s Safe Use Initiative–think they will listen to our cries about T4-only meds?

EarplugsAs a thyroid patient who was profoundly harmed by the use of Synthroid and Levoxyl in the treatment of my hypothyroidism, and as an activist who sees this same harmful truth with potentially millions of other patients, I find this recent news interesting.

But you gotta wonder if they will be wearing noise reduction headsets and ear plugs…or not…when it comes to the scandal of synthetic T4-only medications. Will they?

Just today, the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) announced the Safe Use Initiative, “a program aimed at reducing the likelihood of preventable harm from medication use”.

Statements I gleaned from this initiative include:

1. Today, tens of millions of people in the United States depend on prescription and over”the”counter (OTC) medications to sustain their health–as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse.

2. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use.

3. Medications offer great benefit, but they come with risks. Whenever medications are not used optimally, risks of harm can increase significantly.

4. FDA proposes to identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm.

This initiative is actually far broader than what I gleaned above, and also involves self-abuse, exposure of dangerous medications to children, dire side effects, and more. Five areas are also specifically targeted: Consumer medication information (CMI), Medication dosing devices, Acetaminophen toxicity, Alcohol-based surgical preps, and Medications in vials. You can read more in the fact sheet.

But if the FDA is going to do their job with this initiative, or do their job overall, you have to wonder if they will listen to and include the problems associated with being treated with a T4-only medication as experienced by millions of patients worldwide. Continuing symptoms of hypothyroidism while on this inadequate treatment is widespread and damaging for many, causing hands reaching deep in pockets to pay for numerous doctors appointments, besides antidepressants, anti-anxiety meds, blood pressure meds, statins, cortisol meds for adrenal fatigue, and other medications which we would have never needed, and would have been preventable, if we had been on natural desiccated thyroid like Naturethroid or Westhroid in the first place.

Many patients on thyroxine, T4-only medications will also report actual hospital visits due to the side effects of a poor treatment.

In other words, thyroxine aka levothyroxine aka T4 treatment has been an unsafe and harmful treatment, causing millions to suffer unnecessary injuries and side effects for over 50 years of its useless and popular use. It fits the Safe Use Initiative. Or at the very least, it calls for the FDA to listen to patient experience with this lousy choice to treat hypothyroidism.

Listen to us, FDA. Listen and be wise.

P.S. See the blog post below about a genetic reason why so many do lousy on T4.

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