According to their own description, the U.S. Pharmacopeia (USP) "is a nonprofit scientific organization that has set standards for the quality of medicines and their ingredients since 1820. These standards help ensure the medicines that patients take are of high quality, are pure, are of the appropriate and expected strength, and are consistent from one pill, bottle, shelf, and pharmacy to the next. Once USP develops a drug standard and it becomes 'official' (after an extensive process of public review, as described below), it is enforceable by the U.S. Food and Drug Administration (FDA). USP does not approve a drug for sale in the U.S. market, determine a drug's safety or efficacy, or enforce the standards it creates--these are all responsibilities of FDA."USP contacted me recently to let me know that they have issued a statement at their website, titled Q&A on USP's Levothyroxine Sodium Standard, to help clarify their position regarding levothyroxine.
This new statement addresses the continued misinformation coming out of Forest Laboratories, which has claimed that the unavailability of their medication Thyrolar (generic name is liotrix, and it's a synthetic T4/T3 combination drug) is due to "new specifications" from USP.
Specifically, earlier this fall, Forest had posted at the Thyrolar website that USP "has mandated new specifications for the manufacturing of Thyrolar. As a result, all strengths of Thyrolar are currently on long-term back order while Forest makes the modifications necessary to meet these new specifications." The problem with that statement was that there wasn't any mandate from U.S. Pharmacopeia for new specifications for the manufacturing of Thyrolar, and Karen A. Russo, Ph.D., Vice President at USP, confirmed that in an interview with me.
Now, Forest has changed its message at Thyrolar.comto read: "U.S. Pharmacopeia...has mandated new specifications for a component used in the manufacturing of Thyrolar." (italics are mine.)
The component used in the manufacturing of Thyrolar that Forest is referring to is levothyroxine (the generic name for synthetic T4 medications like Synthroid, Levoxyl, Levothroid, Unithroid, etc.) Back in 2005, USP started the process of updating the standard for levothyroxine.
So what is the problem?
Specifically, as per USP's normal procedure, all manufacturers -- including Forest -- were invited to participate in the revision, and the revised standard was issued in May 2007. The final standard was published on February 1, 2008 and became official on August 1, 2008.
According to USP: "No reports of any problems regarding compliance with this revised standard were communicated to USP by any pharmaceutical manufacturers. USP was made aware of the apparent shortage of Thyrolar when contacted by patients beginning in mid-August 2009-more than one year after the standard became official, more than two years after the revision was proposed, and roughly four years after initiating outreach on its intent to revise."
They also state: "Since learning of this situation, USP has reached out both to the affected manufacturer and to FDA. To date, USP has not received a request to revise the standard, which would need to be submitted along with an explanation of the reason for the requested revision. USP is able to revise a standard under an accelerated process when there is an urgent public health concern, and could do so in this case if a change were proposed and justified. It is also important to note that FDA can intervene and suspend its enforcement of a USP standard if public health dictates."
Finally, USP asks the question "What can patients do in the interim?"
Patients who have had trouble obtaining their medication can contact the FDA and report a drug shortage at this link: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm. USP will consider changes to its standard in the interest of patient need on an accelerated timeline if a proposal is made by a manufacturer, FDA, or other credible party and sufficient justification is provided.
Some Thoughts
First, I'd like to thank USP. Every time I've contacted them, they have been forthcoming, professional, well-informed, and seem focused on patient interests.
This is in sharp contrast to Forest Labs, whose only response to several years of availability problems for Thyrolar and Armour Thyroid is "see our website." (That's when they even bother to respond -- frequently, they just ignore phone calls or emails entirely).
So let's read between the lines and take a look at what sort of game Forest has been playing.
Forest knew as far back as 2005 that the standards for levothyroxine -- an ingredient in their drug Thyrolar -- were going to be changed.
The standards were changed, and yet Forest apparently did nothing to address the issue. Instead, they let their supply of Thyrolar run out.
They then released a statement, claiming that USP "has mandated new specifications for the manufacturing of Thyrolar. As a result, all strengths of Thyrolar are currently on long-term back order while Forest makes the modifications necessary to meet these new specifications" -- even though the "new" specifications were already several years old, and were for levothyroxine, NOT Thyrolar.
When their information was exposed as misleading, and USP stated that there were no new guidelines for Thyrolar (liotrix), Forest then rephrased their website statement.
In the meantime, according to USP, Forest could submit a request to revise the standard, which could take place under an accelerated process. Forest could also request that the FDA intervene and suspend its enforcement of the USP standard as applies to Thyrolar. Either option could be a temporary solution to the total lack of availability of Thyrolar.
But Forest has, apparently, done neither.
Forest had several years to plan for the impact of the USP levothyroxine specification on their Thyrolar supply, but they didn't, and now thyroid patients taking Thyrolar have been left high and dry.
Forest has the opportunity to attempt to submit a request to revise the standard, or have the FDA intervene, but they haven't, and thyroid patients taking Thyrolar are being left high and dry.
Of course, this abandonment of their Thyrolar customers is not occurring in a vacuum. Forest has also shown a serious lack of judgment when it comes to their product Armour Thyroid, the natural desiccated thyroid drug that used to be the market leader.
Earlier in 2009, Forest took Armour off the market -- with no advance notice to patients, leaving many patients unable to fill prescription. They then reformulated Armour Thyroid, reportedly adding more cellulose, and reducing the dextrose content. The change was not announced, nor was it communicated to doctors, pharmacists or patients. The result was that a substantial percentage of patients taking Armour Thyroid -- who are seemingly unable to successfully absorb or utilize the reformulated version -- saw the return of hypothyroid symptoms, elevation of TSH levels, and a host of other health concerns. The company refused to comment on the reasons for the reformulation, or the concerns of practitioners and patients regarding the lack of effectiveness of the "new" Armour.
Since Spring of 2009, the reformulated Armour has been on backorder, and except for sporadic shipments of reformulated 1 grain Armour, Armour Thyroid is no longer available. Forest has refused to offer any information regarding Armour, and whether they intend to return to production.
Is Thyrolar ever coming back? Is Armour ever coming back? At this point, any sensible thyroid patient or practitioner has to ask that question, given Forest's total unwillingness to cooperate or communicate with thyroid patients and practitioners in any way, their mismanagement, their disregard for patient health, and their clear lack of interest in these two medications.
Given the obvious mismanagement of their thyroid drugs, the Thyrolar and Armour debacles this past year and the severe impact they have had on the health of hundreds of thousands of patients, coupled by the misinformation coming from Forest, the only conclusion I can come to is this: Forest Laboratories is a company that has no interest in or concern for thyroid patients, and does not want the business of thyroid patients going forward.
You know that book and movie that came out a while back, called: "He's Just Not That Into You." Well, thyroid patients, it's sad to say, but I think it's time to face the truth. "Forest Labs is Just Not That Into You.."
MORE INFORMATION:
- The Armour Thyroid and Nature-Throid Shortage Information Center
- Save Natural Thyroid Coalition Website
- Save Natural Thyroid Coalition Yahoo Listserv
Image: istockphoto.com
Hooray!!!!!! Mary!!!!!! – Finally – the truth be told… –
Forest has been running poor thyroid patients around for months with their fibs and ignorance and put many people is such a quandry for way too long. That new formula is trash – we know it – they know it -and they could care less.
As I say on SNT all the time… “Shame on you Forest Pharmacuticals!” “Shame on you for changing the best thing that kept us well and now you proving you do not care one bit.” Shame, shame, shame on you!.
Sounds like Forest is now holding hands with the big boys now Mary, and also on the “Big Pharma Wagon Cash Train” I would never give them my business ever again after the choices and arrogance they did. See ya Forest Phamacuticals! – Your new formula is junk as I said months ago! I pray you don’t make the T4 only patients suffer as you have done to us! (OK vent over
thanks Mary for the information – Take care and best health and happiness to you.
Yea this is insane. There needs to be a lawsuit brought or hopefully criminal charges. Peoples’ lives are at stake. Has anyone had serious injuries from not being able to take their dessicated thyroid medication?
I consider having my Armour “messed with” to be life threatening. In May 09 my Armour was working great, but I had other problems which led me to discover a gluten/wheat allergy (also: Sulfa & Delayed Release allergy). That resolved, I had about two months of feeling ABSOLUTELY FANTASTIC (lost a great deal of weight– was dancing!!!) before I ran out of the Armour, was put on Levoxyl (which I’d left behind years before– it made me ill) and quickly lost all benefits gained. Then, I snagged some Armour (or what I was told was Armour) from Canada– only to discover it was apparently NEW Armour. Instead of making me feel better again– I now had migraines, swollen-angry feet, bags under my eyes– much more– but the worst– my Metformin quit working. Just. Simply. Quit. Working. THIS is what was life-threatening. I nearly went to the hospital.
They’ve put something in it that wasn’t there before (wheat binding???). After many days of agony, I’m now trying “raw” thyroid from a health food store. Already I’m feeling relief. Due to see my doctor next week…. Am I angry? Whaddaya think? You bettcha. I’d sue if I could.
Sorry to hear that Ginny. We need to start a non profit organization and/or start organizing testimonials for a class action lawsuit
Right, Jon. Alas. *I* don’t know how. But if someone starts the ball rolling– I’m there. Those two months were the first time in YEARS I’ve felt human. I’m filled with rage over this (one of the lingering symptoms– really).
Thanks for asking, BTW! If you’ve not had your thyroid medication “messed with”, you really don’t know what it’s like to feel “not human”. My husband can only guess, and I don’t like to discuss it with my friends. It sounds like so much wine with cheese.
Ginny, can you elaborate on the “raw thyroid” you are taking from the health food store? I am not familiar with what that would be? I am very interested to get information on this if it is helping you! Can you share a brand name or elaborate? Thank you very much!
Any help would help as far as what and where you are getting your natural thyroid and the name of it. Please share. I was on Armour and slowly but surely gained weight, and had muscle and joint aches. This is a pain. I agree – there should be a class action law suit. Messing with peoples lives is criminal and it is one big experiment I don’t want to be in. What other meds are in line next for tampering with. I do not like being a guinea pig! I wonder if Codex Alimentarius has anything to do with this. Look it up folks , educate yourself. Codex is very scary, kind of a global control of supplements.
Mary- Have you approached “60 Minutes” or one of the major networks in doing an expose’ of this issue. I’m sure they’d be quite interested.
During this period of limbo, I hope many individuals are considering a compound T-4 & T-3. Many of my patients are on compounds at my recommendation, including myself. Johnson Compounding & Wellness Center in Waltham, Ma. is excellent pharmacy.
Great job Mary….I am now manufacturing my own dessicated thyroid at this point. I have lost faith completely in medicine’s ability to be scientific. It is a challenge to be sure you have the consistent dosage, but this can be done. My next project is to clone healthy human thyroid tissue from me. When I and others get these processes down entirely, we will put these on website somewhere for all humanity for free. It has come to the point that people may have to literally take pharmaceuticals and medicine into their own hands.
Hey Kathy, How do you manufacture your own dessicated thyroid? Thanks
Kudos to Mary for exposing the jackasses at Forest.
Speaking as a former Thyrolar user: I’m not sure why we should even be concerned about the availability of Thyrolar, since taking T3 and T4 in the proper ratio is the same thing. Thyrolar users could probably reduce their costs significantly by getting T3 and T4 from the right places and rolling their own.
I’m very happy to have gone on T3-only (to fix a reverse T3 dominance problem) earlier this year … I feel well and I haven’t had to worry about the hijinx in the natural thyroid market.
I spent years and $$$ on specialists suffering on Synthroid and finally convinced my pcp to prescribe Armour. I never even got the dose tritated correctly when the reformulated product screwed up my symptoms and my lab results. I lost my health, and my pcp of 24 years (who finally told me I was out of his league). Now I’m waiting for compounded thryoid and looking for a second job to pay for holistic doctors and care not covered by my insurance. I will NEVER take another product produced by Forest Laboratories, and I’m already making sure everybody that ever even mentions healthcare (a hot topic right now!) knows to avoide Forest Laboratories products. I may have a little voice, but I’m going to use it!
Forest can kiss my bootie–I will never give them another dime of my money for anything. Been sick since last July–worked up until a month ago while being totally sick and started passing out; water retention, weight gain,heart problems, breathing problems, emotional problems, etc. Finially was on sick leave until I could get the compounded….I sware I will be one of the first to jump on a lawsuit bandwagon. I have had a great job for 18 years and that is threatened by these people screwing around with our lives/health. I am beginning to feel better–about 90%–but I feel so bad for the people who are still where I was for the last 4 months. Good luck to all; and thank you, EVERYONE for the communications on here and all the help.
Diane says:
Ginny, can you elaborate on the “raw thyroid” you are taking from the health food store? I am not familiar with what that would be? I am very interested to get information on this if it is helping you! Can you share a brand name or elaborate? Thank you very much!
Diane: I didn’t name the raw thyroid because I only wanted to take responsibility for experimenting on *me*. But– if I make it **absolutely clear** I’m *NOT* recommending it– it’s “Thyroid Caps” by Solaray. “Thyroxin-Free, Freeze-Dried– Raw Gland Concentrate with support nutrients. Thyroxin-Free Bovine 150mg” (I’m not happy with some of the “support nutrients”– Copper for one and I’m not completely sure of the dosage). I *should* be on 2GR of Armour– was– when I had the “Golden Two Months” (after being stable on it for over 2 years). I’ll remember every day of those two months for the rest of my life.
The best result I’ve had is the “mosquito buzzing” headache is mostly gone– but a lot of the bad ju-ju is still there. I’m wondering if I’ve had a small stroke from all this crap. Left cheek is a tad numb. I’d go to the ER, but there’s a Killer-Clown Doctor there who’s got my number. So, I’m steering clear of him for my safety.
I’ve got an appointment tomorrow to find out (hopefully) the “better path” for ME. I’m VERY interested in reading more about these bio-thyroid medications.
You know? If we were these jerks’ “beloved pets”, perhaps they wouldn’t be so quick to kill us off. Sheesh.
Yep. I agree. Forest can bite me. Run, Forest, run. Jackasses.
As I’m researching this, I’m running into more and more pages like this one and would like to pass along some information I just learned regarding the Armour Thyroid mess.
I’ve been taking thyroid in some form or another for almost 20 years since mine failed. I’ve been through this garbage with Thyrolar and was lucky enough to find Armour Thyroid. Now that’s in jeopardy.
Call these people. Now.
International Academy of Compounding Pharmacists
800-927-4227
http://www.iacprx.org
Give them your zip code so you can find some compounding pharmacies in your area. Call one of the pharmacies and tell them what you’re looking for (an Armor Thyroid replacement) and confirm that they can produce the “compounded equivalent” (this phrase is important, especially for your doctor to use when putting the prescription together for you).
You may be very pleased at what you hear.
It’s so comforting to read that I am not the only one that has had strange symptoms while taking the “new” Armour. I became suspicious the moment my pharmacy told me that it was on backorder. A medication on backorder is never a good sign. My father is an endocrinologist so I was able to get more medication from his vendor. I felt lucky that I was able to get my meds…. until the strange symptoms started popping up. Heart palpitations, swollen eyelids, weight gain, and depression. I then turned to the web to research and found literally thousands of posts from patients who are suffering like I am. I am waiting for my order of Thyroid from ERFA. Thryroid is produced in Canada and is similar to the original formula of Armour. I’ve heard that patients have done well switching to Thyroid. I hope so! It’s such a awful feeling when you are not in control of how your body functions.
Has anyone changed rx and their doctor should know what to change to.. What happens to the patient ?