fda tags

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:

• March 12, 2010 Federal Register Notice
• FDA Transparency Task Force Web Page
• FDA Basics Web Page
• FDA Transparency blog: http://fdatransparencyblog.fda.gov/2010/03/final-phase-of-the-transparency-initiative-we-want-your-ideas.html
• How did we get to where we are with the FDA’s actions towards desiccated thyroid today? Go here.

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).

When the shortages hit the United States for natural desiccated thyroid in 2009, we all had to figure out which way to turn, since the 110-year-old natural desiccated thyroid has been a far, far better treatment for our hypothyroid state than levothyroxine T4-only such as Synthroid, Levoxyl, Eltroxin, Oroxine, etc.

Additionally, Armour thyroid by Forest Labs was reformulated in early 2009, and patients worldwide reported a return of symptoms as well a stress on their adrenals.  So patients started an exodus away from Armour.

Luckily, the FDA loosened restrictions and allowed us to order the Canadian brand by Erfa Canada Inc, called simply “Thyroid”.   Erfa’s Thyroid proved to be an excellent desiccated thyroid for most, especially if they raised high enough once again to rid them of symptoms.  And since it contains sucrose, patients have been able to do it sublingually–a method which is not necessary for benefits, but is preferred by many.

I gathered a list of known Canadian online pharmacies, which you can view on the Options for Thyroid Treatment page.

And just recently, I sought opinions from patients about the pharmacies they have used:

Universal Drugstore aka Canadian Pharmacy Online: This pharmacy received the greatest kudos from US patients and with the best prices.

• Awesome – good prices and fast, friendly service. Will call your drug store and get your Armour script transferred.
• Faxed my prescription and it was mailed the next day. I believe it took a week and a few days to arrive to Florida.
• Great customer service, easy ordering, and was cheaper than paying the co-pay with my insurance. It takes about 10 to 14 business days to get your prescription, according to the company, but mine came sooner than that and it was the holiday mail rush season!
• Rapid service, excellent customer service, email reminders to refill, coupons
• They had the best price and were very professional and efficient.  My order arrived within ten days.
• I paid $43.25 for 200 60 mg pills
• Online forms were easy. I faxed my prescriptions and received my Thyroid in twelve days for $7 shipping

Pharmacies Online:

• Easy to register and the customer service was excellent. I faxed my prescription. A pharmacist called me to see if I had any questions. I paid $45.63 including shipping for 100 60mg pills

Cross Border Pharmacy:

• Excellent customer service, great prices, two week arrival from date of order, wish pharmacies here were this good.

Canada Drugs Online:

• Good experience, prompt (7-10) days service getting my Erfa thyroid

See more recommendations in the Comments section for this post. And I’m going to hope that no pharmacy “uses” this to advertise their pharmacy. This is FOR PATIENT COMMENTS ONLY.

What has been your experience with online Canadian Pharmacies? Do I need to remove any from the Options for Thyroid Treatment for any reason? Do I need to add any?

ARE YOU A CANADIAN PATIENT ON DESICCATED THYROID? Use the Contact Me form if you’d like to be interviewed by a well-known Canadian reporter about desiccated thyroid in Canada. I’ll need your name and email address. You need to contact me before Monday, January 25.

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Recent blog posts worth reading:

Read a guy’s email to me about his experience with doctors being afraid of HC, which patients know is safe and WORKS!

Will the FDA be more transparent for thyroid patients on desiccated thyroid with their new initiative?

Listen to the second interview, Episode 9, I had with Dr. John C. Lowe. What a brilliant man!

A press release just came out stating that the U.S. Food and Drug Administration (FDA) has “unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval process.”

Of course, this doesn’t mean thyroid patients can stop what seems like an inane decision to require makers of desiccated thyroid to “prove” , via expensive clinical trials, that it’s a safe and effective medication. RLC Labs, for example, the makers of Naturethroid and Westhroid, will be affected.  Over 110 years of patient use, with 70 years by RLC, certainly reveal it’s a safe and effective treatment. But at least this transparency initiative will “potentially”  give us better information about the process. We’ll see.

About the upcoming Part 2 with Dr. Lowe (see the blog post right below this): Some folks were booted off last Thursday and had to quickly get back on. The problem is when you get back on, you may lose your ability to chat.  i.e. the system stops the chat ability once there are 300 individuals already on the chat.  You can listen, but you can’t chat after 300 are on.

So there are three things you can do to prevent being booted off and having to get back on:  first, make sure you have closed anything else on your computer–i.e only Talkshoe should be up. Second, make sure no other programs are running in the background, or will come on, like your anti-virus, and 3) ahead of time, download Live Pro from Talkshoe and use that. It’s more stable.

I, in turn, will be doing a strategy to strengthen this call from boots.  Additionally, if necessary, some who aren’t chatting out of the first 300 will have their option changed to no-chat to allow those who came in latter to do it.  It’s not personal because I don’t know who a lot of you are. It’s just spreading the ability into the call.

Do you take regular aspirin? Just as we warn about swallowing your meds when you have just eaten anything with calcium, iron or estrogen (they bind the thyroid hormones), you need to be aware that aspirin can have a negative affect on your thyroid levels, as well.  i.e. though it may help lower high thyroid levels, it’s not good for your thyroid treatment if you regularly take it.

How did we get to where we are with the FDA’s actions towards desiccated thyroid today? Go here.

Please note: Dr. Lowe is NOT an MD or DO who see’s patients and can prescribe. He’s a thyroid and fibro “researcher” with good knowledge about T3,  fibro, metabolism, supplements etc. Many questions have been coming in which are already answered on STTM, or are more targeted to a practicing physician, not a researcher. FYI.

On the heels of an informative and wonderful THYROID PATIENT COMMUNITY CALL on Talkshoe last week with Dr. John C. Lowe (see posts below), we’re going to do it again this coming Thursday, January 14th.  Join us for Part 2!

Dr. Lowe is a fibromyalgia, thyroid, and metabolism researcher who has always been such a champion for better diagnosis and treatment in thyroid patients. He is Editor-in-Chief of the open access journal www.thyroidscience.com as well as his own www.drlowe.com

And this time, Dr. Lowe is going to spend more time answering  your specific questions. Check out his websites above to get an idea what his expertise is, which includes the use of T3,  Hashimotos autoimmune thyroid disease, iodine, fibromyalgia, the tyranny of the TSH lab test, good supplements, the FDA, and more.

So here’s your chance: think of one or two questions you’d like to hear him answer. Please, if you have more more than two,  narrow them down to the two most important, and keep them brief.  No exceptions. Two max only, and brief.  Then use the Comments below to post them.  Be sure and check out if your questions have already been asked in other comments.

I’ll be collecting the questions ahead of time and will let him preview them. He wants to give you his best.

TIPS ABOUT TALKSHOE: Some reported being booted off and having to quickly rejoin. One step that may help is to download the Talk Shoe Live Pro ahead of time (takes 25 minutes for some) and use that software during the call, since it gives you far more stability.  Also, make SURE you have everything else closed and/or not running on your computer at the same time you are in the Talkshoe call. I will also be chatting with Talkshoe support and will get more ideas.

Also, don’t wait until the call occurs to mention your question. We found it difficult to try collecting them on the Chat. Ask now!!

Yes, you can also call in live during the Call, but it’s good to first let me know your question here.

And finally, at a certain point of those who join (after 300 on chat), Talkshoe participants are automatically unable to post on the chat. You can listen, but no chatting. So if you want to chat, join as soon as the Call opens up, which is 15 minutes before the actual audio begins. Times for the audio are 9 pm Eastern, 8 pm Central, 7 Mountain, and 6 pm Pacific.

The Stop the Thyroid Madness Talkshoe page: http://www.talkshoe.com/talkshoe/web/talkCast.jsp?masterId=62603&cmd=tc

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See the blog post below those about Lowe for a very insightful Guest Blog Post by Amy about her role as an Undercover Thyroid Advocate. Below that, you can read how I was wrong about what it was like to be thyroidless, and several great comments.