fda tags

There’s an over-the-counter weight loss drug called Alli made by the huge pharmaceutical GlaxoSmithKline. You can see it on the shelves of most any Wal Mart or local drug store.  It’s also called Orlistat which is marketed under the trade name of Xenical by the pharmaceutical Roche.

It’s promoted as safe, and it works by limiting the absorption of fats from what you eat, which in turn reduces your intake of calories.  (What has always turned me off about Alli or Orlistat is that is creates oily and loose stools. Bleck. )

Medscape just today reported about an FDA warning: the Use of orlistat may decrease L-thyroxine (T4) absorption and lead to hypothyroidism. Clinicians are advised to administer levothyroxine and orlistat at least 4 hours apart…

Oh jolly. So now we have the FDA giving a warning about Alli causing problems with “thyroxine” use,  yet it’s the VERY “thyroxine” use that causes a certain large percentage of those using Alli to need to use it in the first place. You can see that reality in the questions about the hypo problem on the Alli forum.  i.e They are all on thyroxine!

Hitting my head against the wall.

P.S. Reported in Endocrine Today and from just a month ago, and article titled Hypothyroid patients required increased levothyroxine during pregnancy.  Zombie Endocrinologists. Zombies. That’s like having an article titled Sick patients need more blood-letting. i.e LEVOTHYROXINE SUCKS AND SHOULD BE IN THE PAST just as much as blood-letting.  WAKE UP ENDOCRINOLOGISTS!! WAKE UP!!

*Check out patient response to the newly formulated Armour below, and add your own comments.

I can remember a few people the past year who proclaimed fervently that Armour was being discontinued because of the shortage.  And I chuckle about it.  Hopefully, my previous posts helped calm that fear.

But in case you haven’t heard, those larger sizes are back!  And you can keep track of what’s going via the Forest Pharmaceuticals customer product availability hotline: 1-866-927-3260  As of today, April 19, they state that the one grain tabs (60 mg) and 1 1/2 grains tabs (90 mg) are on backorder, and will catch up with production on April 20th, tomorrow as I am writing this.  We’ll see.

Unfortunately, the new formulation has made Armour lacking in sweetness, and it’s almost impossible to do it sublingually.  Sad. Maybe another pharmaceutical will get the hint. In the meantime, if you swallow your desiccated thyroid, make sure to avoid calcium, iron and estrogen at the same time. And if you’ve been doing it sublingually, and have to switch to swallowing, you may need a tad more.

Remember: if you have any issues with natural Armour desiccated thyroid in the treatment of your hypothyroidism, you can always ask your doctor for a prescription switch to Naturethroid or Westthroid, both fine FDA-approved, US Pharmacopeia standard prescription desiccated thyroid.

Janie

Want to be informed of my posts? Curious what I am raving about as a Thyroid Patient Activist? You can sign up for a Notification at the bottom of the links to your left.

P.S. If you haven’t bought the Stop the Thyroid Madness book yet, wanted to tell you that numerous patients are emailing me, stating they find the book even easier to refer to than this vast website (plus it has more details and information).  So if you want the ease of referral, the book may be the way to go.

With the recent blog post by health writer Mary Shomon concerning Dr. Sidney Wolfe’s new 4-year term with the FDA’s Drug Safety and Risk Management Advisory Committee, there has been much brooha and fear-mongering on thyroid patient groups.

Why? Well look at it this way. This is a man of stature. He is an MD, an Adjunct Professor of Medicine, the director of Public Citizen’s health research group which promotes drug safety and public health, and editor of the newsletter Worst Pills, Best Pills, and since August of  ‘08, a member of the Drug Safety Committee.  He also has a resume a mile long.

Yet in spite of his seemingly caring activism for our health and well-being, and his immense experience and education, he is clearly and completely off-base about Armour and other desiccated thyroid prescription drugs.

For example, as as editor of the Worst Pills, Best Pills newsletter,  Wolfe declared Armour desiccated thyroid as a “Do Not Use” product because it is not adequately guaranteed to provide appropriate blood levels of thyroid hormone and reliable alternatives are available”. (Gee, funny how our experiences are completely otherwise….)

Then in the May 2003 issue (of which you have to have a paid prescription to read), he wrote an article titled  “Do Not Use! Natural or Desiccated Thyroid (ARMOUR THYROID) For Thyroid Hormone Replacement Therapy.”   In that article, the clueless Wolfe stated that he supported The American Thyroid Association’s statement “There is no evidence that desiccated thyroid, a biological preparation, has any advantage over synthetic thyroxine.” (I guess millions of us and our improved heartrate, stamina, cholesterol, depression and more…aren’t evidence?)

He then proposes that Armour is mostly prescribed for weight loss, is a niche market for the unscrupulous, and concludes with “if you are offered natural thyroid hormone replacement treatment for any reason, this is a red flag and you should get a second opinion.”   In a letter to consumers, Wolfe and Public Citizen state that that T3 is only needed from conversion and is predictably found from conversion, that the T2 and T1 also found in desiccated thyroid has essentially no activity, that desiccated thyroid is an unpredictable mixture, that is has no predictable biological activity…plus so many more complete and total inaccuracies based on “intellectual head chatter” not on observation and experience.

Thud.

Mary Shomon, in 2003, did a bang-up job trying to communicate with Wolfe, Worst Pills, Best Pills, and Public Citizen about the inaccuracies of their beliefs and statements…basically to no avail. The TRUTH is here, and in more detail in Chapters 1 and 2 in the STTM book which are enlightening those reading it all!

So we are left wondering, six years later, what his four-year appointment to this committee will mean. But let’s make a few things quite clear to contrast some of the fears going on and expressed on thyroid groups:

1) Armour is not being banned.
2) Wolfe is one of a current 9 members of this committee. Wolfe is not “the committee”.
3) Wolfe and seven others currently have voting rights. He is the only “Consumer Representative”.
4) There are still six more vacancies.
5) The committee is NOT the power. They simply make recommendations. And historically, the FDA can be slow to act on their recommendations, or doesn’t follow them at all (which is a GOOD thing when it comes to a SAFE and EFFECTIVE medication like desiccated thyroid).

So what can you do? I challenge you to follow and act on the below, which puts our energies into communication, not feeding the ego and power of a misguided man with our overtly expressed fears as if they have actually come to pass :

1) Remember 1-5 above. Armour is fully available. Keep the facts straight, and fear-mongering down.

2) STTM has a powerful and growing page of testimonies of those who switched to desiccated thyroid.  Are you in there? If not, you need to be. This website currently has a huge audience. It’s noticed by doctors all over the world, as is the STTM book, which is YOUR book of YOUR experiences,  which is also being ordered by doctors. Use the Contact Me form at the bottom of that page.

3) Tell your experience with Synthroid or other thyroxine medications at the following websites:  www.rateadrug.com,  www.drugs.com,  www.askapatient.com They don’t include any of the desiccated thyroid meds yet, but you can tell of the negative experiences with all the T4-only drugs, including adrenal fatigue if you fell into that, and all your lingering thyroid symptoms.  The above links will take you to their Synthroid page–you can search for the other T4 meds.  Remember to mention Armour or other desiccated thyroid meds and how they have helped you!! Update: thyroid patient Gina found the drugs.com Armour page: http://www.drugs.com/comments/thyroid-desiccated/armour-thyroid.html

4) Report your T4-only experience to MedWatch, the FDA’s  program for reporting problems.  You will see an Online Reporting Form to download. Don’t fail to mention which problems were removed or greatly improved when you switched to Armour, or the fact that you now have to deal with adrenal fatigue thanks to the inadequacy of T4-only treatment. You can also call 1-800-FDA-1088, but remember: your call is not to draw attention to Wolfe’s opinions! It’s to draw attention to how lousy a treatment T4 is as compared to how much better Armour has been.

5) Go to my article titled Synthroid Sucks: the Rallying Cry of Thyroid Patients vs. Clueless Doctors and comment on this article, including mentioning what Armour, Naturethroid or other desiccated thyroid did for you. Rate it as well. Both keep this article in the media and in the eyes of others.

6) Go to www.medications.com where patients ask questions and YOU can answer, mentioning YOUR experience and how much better desiccated thyroid has been. Clicking on that will take you to the Synthroid patient questions. Answer them. Be careful with links–they may not catch them at first, but will remove them if they do.  You can mention website names, tho, like Stop the Thyroid Madness.

7) Send people here to follow all these steps. Power is in numbers!

8 ) Use the following website to email or write your senators and representatives: http://www.visi.com/juan/congress/ THEY DO READ THEM. And they will remember this!  Here’s a template letter you can use:  www.stopthethyroidmadness.com/template-letter-to-your-senator-or-representive/

If you have other ideas and places to write or call, add your comment to this post. Remember,  put your power in communication! LOTS of communication.

P.S. Did you know that the American Thyroid Association, in cooperation with the American Association of Endocrinologists, together support January as “Thyroid Awareness Month”…which is supported through an unrestricted grant from Abbott Laboratories, the makers of Synthroid?? Major UGH.

Oh jolly.

Diane, a thyroid and adrenal patient, informed me of a recent visit to a local Endocrinologist.  The doc stated that she was on a committee that is working with the FDA to do away with saliva testing, strongly proposing that it’s not accurate testing and is “harming” people.

Well, let’s see. For a couple of years now, thyroid patients who strongly suspect they have adrenal fatigue by the reactions they have to desiccated thyroid have been using saliva testing…and lo and behold,  the results they receive nearly completely conform with how they feel! i.e. saliva testing, which tests one’s cortisol levels at four key times during a 24 hour period,  has worked beautifully in helping thyroid patients with adrenal fatigue identify their problem, in helping these patients doctors have a better understanding of their problem, and knowing better what might be their best treatment, which can range from using licorice root, to over-the-counter adrenal support, to hydrocortisone (HC).

Harmful?? Give me a break. (And why are we not surprised this is coming out of the mouth of an Endocrinologist.)

Could it be that medical school trained doctors just hate and despise any method which a patient might benefit from WITHOUT going to the doctor and paying big bucks??  hmmmm.  And once again, could it be that a method NOT taught in medical school just MIGHT be a good one (just as desiccated thyroid like Armour, Naturethroid, etc. is far, far better than Synthroid or Levoxyl, which ARE taught in medical school)?

The FDA approved saliva testing for AIDS in 2005. They approved saliva testing for ovulation in 2003. They approved saliva testing to detect if a woman is going into premature labor in 1998. And there’s many more they have approved.  So…perhaps this is all a gasp of a committee who hates to see patients have some control over their health (terrible, awful thing, isn’t it?) or the cry of a committee that only reveals its ignorance.

p.s. Dr. Best of San Antonio recently posted the following excellent article on saliva testing: http://besthealthandwellnessinfo.com/hormone-testing-i-spit-on-your-blood-test/

HO! HO! HO! Laughing Grape Publishing will send the STTM book for you to a loved one or friend for the holidays!

A very overreactive rumor is being started as I type this about the FDA and Armour, and I think this whole topic needs to be leveled out. The rumor is as follows:

1) The FDA has stopped manufacture of all grandfathered drugs like Armour.
2) Armour will no longer be available at your local pharmacy

i.e. it’s being banned, discontinued, taken off the market, gotten rid off…you name it.

Now first let me clarify that all are totally and completely false. Forest Labs is still making Armour, and you can also find Armour at your local pharmacy, even if certain strengths are easier found than others.

Here is what is going on: In the January-February issue of the 2007 (i.e. a YEAR AGO) FDA Consumer Magazine, an article came out by Michelle Meadows titled The FDA Takes Action Against Unapproved Drugs. But this is NOT new news. This is based on the June 2006 release guidance by the FDA, called Marketed Unapproved Drugs—Compliance Policy Guide. What the FDA is doing is working to get unapproved drugs meet their approval guidelines.

What is an unapproved drug? For one, they are those drugs which were around before the FDA (Federal Drug Administration) came into existence in 1938, and these drugs were ‘grandfathered’ in with the subsequent FDA-approved drugs thereafter. (Armour is an example. Synthroid was too until it did what it took to be approved in 2002) Other examples, as explained in the January/February 2007 article, are when only one company may have approval to market a drug, but other companies are illegally marketing their versions of the drug without having gone through the FDA’s approval process. Another scenario is that a combination of ingredients is approved by the FDA, but a company is marketing a single ingredient without approval.

The article also clearly states: Before pursuing regulatory action against unapproved drugs, the FDA plans to consider the effects on the public health, including whether the product is medically necessary. The agency recognizes that some unapproved therapies offer benefits. An example is Phenobarbital, a drug used to control seizures. In some cases, FDA action requiring drug approvals will be gradual to avoid shortages of medically necessary products. In other words, whenever the day may come that Forest Labs is asked that Armour meet the regulations of the FDA, the process will be gradual and Forest will be given a fair deadline to do what it takes.

Kathy, a pharmacist with Forest Labs, reminds us that Armour has never been asked to go through that process (or they may not be admitting it yet so they can go through it in peace.). And if the day comes, they will do what it takes. Armour is a safe and life-giving product. And you bet your booties that even if it looked threatened some day, there would be a huge uprising from patients to stop it. But that’s not going to happen, just as it was for Synthroid where Abbott labs did what it took to be approved, and succeeded.

So, take heart: everything is fine. Armour is still being made. Your pharmacies still have it, even when some strengths are easier to come by than others. And I’ll keep you informed. And remember: I’ve always told you to stock up on your desiccated thyroid products anyway.

p.s. The root of the rumor comes from a recent recall by Forest Labs concerning its 3, 4 and 5 grain tablets, which had a 6-month potency problem, and a misunderstanding about it’s implications by individuals. Those tablets are currently scheduled to be out again by the end of January.

http://www.fda.gov/fdac/features/2007/107_drug.html
http://www.fda.gov/cder/guidance/6911fnl.pdf

***Want to spread the word and be your own thyroid patient advocate? Get your t-shirt here.

Is this akin to “improving” cardboard?

The FDA announced today that they are tightening the potency specifications for levothyroxine sodium (aka Synthroid, Levoxyl, etc) “to ensure the drug retains its potency over its entire shelf life” rather than what often occurs with any T4 med: the deterioration of T4 before it’s expiration date. They state that this tightening will improve the quality of the product.

Cough.

Let me give you some history. After it was isolated, T4 was first produced as a treatment substance over 80 years ago. The T4 did result in some improvement in patients they tried it on at the time. But guess why they never gave it to patients beyond the early experiments? BECAUSE THEY KNEW IT WASN’T STABLE. They knew that fact 40+ years before it came back on the market in the 60’s due to the heavy and moronic pharmaceutical promotion.

And the irony of this so-called improvement is that it’s NOT going to stop the deterioration of T4. They are only attempting to stop it before “the expiration date”.

Sorry FDA. You can improve the tensile strength of cardboard, but you can’t improve the FACT that T4-only meds are about as effective as giving a hypothyroid patient CARDBOARD…whether it’s stable or not.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01717.html

(Thanks Stephanie)