I just had the chance to speak at length with Dai Jinn, Chief Pharmacist and Chief Science Officer at RLC Laboratories, the manufacturer of the natural desiccated thyroid drugs Nature-Throid and Westhroid.I'd had a conversation with Dai back on November 23, and at that point, Dai had said that RLC would begin shipping 1 grain Nature-Throid that week. That didn't happen, and on December 2, I checked back in with Dai to get an update. At that time, Dai said that erratic quality and availability of raw materials were making it difficult to meet their manufacturing goals, but that they expected to begin shipping 1 grain (65 mg) Nature-Throid later that week -- but more likely the following week (which would have been last week). Unfortunately, as of today, RLC is still not shipping product, as they'd hoped.
Patients and some practitioners have become increasingly concerned, to the extent that some have suggested that perhaps RLC is under some sort of gag order from the FDA, or that RLC has been forced to shut down production by the FDA, or some other action has taken place that has prevented RLC from moving forward.
I wanted to reassure thyroid patients that, according to Dai, there is no gag order, RLC has not been told to stop production by the FDA, and the issue remains, as before, the acquisition of a sufficient quantity of decent quality raw material -- the concentrated form of Thyroid USP (desiccated thyroid powder) that RLC uses to manufacture its pills.
As Dai told me, "There are many intricacies involved in producing a good quality, natural thyroid that meets the proper specifications of T4/T3 content, and the proper T4/T3 ratio. I can't just take the raw material, stick it in a blender and turn it into a pill." According to Dai, the raw materials go through various assays and quality control steps along the way, and that culling process has rendered a percentage of all his raw material stock unusable.
The good news is that according to Dai, he now feels that just in the past few days, RLC has obtained a sufficient quantity of good quality raw material, production has started and is in progress, and he feels confident that RLC will begin shipping 1 grain Nature-Throid by the end of the month of December.
Keep in mind that it can take several weeks after a drug ships for pharmacies to actually start to receive shipments, as they make their way from manufacturer, to distributors, to pharmacies, so the earliest patients are likely to start seeing Nature-Throid 1 grain in pharmacies is mid to late January.
Do I believe RLC? Yes. I do believe they are being honest with patients. I do not believe they are trying to keep information from us. In fact, they seem truly perplexed at the problems they are having with the inadequate supply of raw materials, and the quality issues of the raw material they are getting -- as perplexed as patients are about the lack of available medication.
What Does This Mean For You As a Patient?
If you rely on a natural desiccated thyroid drug, what does this continuing delay mean for you?
My advice is, continue to get your alterate form of thyroid medication until you actually have Nature-Throid in hand. Don't base any of your decisions on the promise of shipment. You must have your medication, and at this point, with Nature-Throid's availability still so up in the air, the most responsible thing to do is to make arrangements to have enough supply of your alternative medication to get you through until you actually have Nature-Throid pills in hand.
That means you should be planning ahead to have alternative medication that will carry you through February, and actually I recommend March to be safe. (RLC has, after all, pushed back the shipping date a number of times, and while they are doing their best, it's still very possible that their shipping date may yet change again.)
If you are taking compounded natural desiccated thyroid, or Erfa Thyroid from Canada, or another option, make sure you have enough prescriptions from your physician, and if you need an appointment with the doctor to get a prescription for refills, then make your appointment now. And if you need to order from Canada or elsewhere and wait for long-distance delivery, place your orders accordingly so you are not left without medication. Be sure you have enough actual medication to last until you have a supply of Nature-Throid actually in hand.
I also think that efforts of patients and practitioners who rely on natural desiccated thyroid drugs -- including the efforts of the Save Natural Thyroid Coalition should focus on trying to learn more about why there is still a mysterious and unexplained shortage of natural desiccated thyroid that is of sufficient quality for drug manufacturing.
MORE INFORMATION:
- The Armour Thyroid and Nature-Throid Shortage Information Center
- Save Natural Thyroid Coalition Website
- Save Natural Thyroid Coalition Yahoo Listserv
Image: istockphoto
Mary wrote,
“Do I believe RLC? Yes. I do believe they are being honest with patients. I do not believe they are trying to keep information from us. In fact, they seem truly perplexed at the problems they are having with the inadequate supply of raw materials, and the quality issues of the raw material they are getting — as perplexed as patients are about the lack of available medication.”
Thank you Mary! I appreciate all your hard work and I’m thankful that you’re looking out for us, as ever, and working so hard at it. You’re a good egg.
Toward the end of your article, you said that we need to know why there is a shortage of dessicated. Yes–we must know why.
Is this profits over patients? What’s going on? Why all these problems and all at once? Somethings wrong …
I think that throwing money at the healthcare crisis is not the answer–although I do believe everyone must have access to healthcare.
It’s like giving gobs of government money to those financial firms on Wall Street that are crooked! More wasted money …
I think our President and Congress need to see the medical field as being high finance and a great part of it dirty finance–and when they finally see the light on this, it’s then that We The People will get real healthcare from doctors and can better afford it and the attendant other medical needs. It’d be far cheaper for our government.
But until they realize this … it’s about screw the patient in much of the medical field.
Thank you again, Mary
Hi Mary
Thanks for the update. My concern here is – I can buy the fact Dai is giving these reasons on “quality” with desiccated thyroid, and if this is really the case then their efforts to produce the right medications is honorable.
But, how are others manufacturers like compound pharmacies, ERFA and the little guys – like Nuti-meds (etc) getting the materials? Erfa has no shortage of this substance and are producing decissated thyroid medications like mad…. from the same porcine suppliers in New Zealand as does RLC. I have checked this out with both RLC ( back when I went to Naturethroid in May after the Amour havoc) – and I also talked to ERFA recently. The suppliers of the porcine desiccated thyroid are the same suppliers in New Zealand. Now with ERFA, they do also have connections with Thailand where I can’t comment on if RLC also uses them.
That fact does scare me and makes me think RLC may have other issues going on and not just their “quality” and inconsistant statements. What leads me into more fear is we heard the same things from Forest months ago when they had “issues” with supplying these meds….and when we called them… Their answers then, seemed to be very similiar as what we are hearing now from RLC. My dark -side of thinking feels like this may be some side-stepping on the real answers of what our future is with getting our medications.
Another odd thing happening right now that fits right into this whole thing, is that health care bill and those provisions they are suggesting. Its clear in there – they are looking to modify our ways of getting medications from overseas and Canada which right now, getting ERFA thyroid is the only way we can get desiccated thyroid if you chose not to use compound pharmacies.
I respect all that you do and I certainly am not challenging the conversation you had with Dai. You have a strong connection with RLC. I feel Dai though is not being completely upfront with everything said to you – he is expecting us to “ride this out” until???. Dais comments back in December seem identical as they do now and I can’t believe a manufacture that produces life saving thyroid medications can have quality issues and production delays this long. I fear his arms are tied behind his back, and his mouth is taped shut – but he seems to respect you and appeases your efforts for answers.
I hope I am wrong though.
I joined Save Natural Thyroid, and I visit here as often as I can, but I have a wee little hypothyroid problem that limits the energy I can spend online. If I had more energy, I’d be organizing a Class Action suit, naming the FDA and the manufacturers as defendants. IS ANYONE ORGANZING TO SUE? If cigarette smokers can win, just think how much more easily we would prevail. Don’t you think?
Well good news for the New Year after their comments on the shipments definately going to happen next week. Yesterday’s RLC comments finally let me “breathe” a sigh of relief that things are going to be OK. Thanks Mary for keeping the facts and finding out their release dates. Sounds like RLC is back on track with production now and we should see this medication back on shelves in plentiful supply very soon. Merry Christmas to you and your family. You do a spectacular job for all thyroid patients Mary and I appreciate all you have done for me personally.
Somewhere in the pipeline someone is stopping the free flow of product at any level they can. Follow the money and see where it starts – the drug cartels. They are behind this and they are American not Mexican.
Why is everyone not getting Armour thyroid? I’ve just had a script filled. If one needs 60 mg. it is available.
Thanks Mary for all your efforts.
Pat
I had taken Armour for years and loved it. Then a year ago I began to not feel well. Even my doctor did not know what was happening with Armour. My tests came back low thyroid. Long story short, when Armour had to change their formula I was not responding to their change. I was allergic to the fillers.
I got a compounded dessicated thyroid and matters got much, much worse. I became so sick I could hardly drive. I was severely allergic to filler.
I switched to Naturethroid which was still available and did fine. My labs were perfect. Three days ago I went to my doctor to get more and found out no one could get any. Two days before Christmas I had no thyroid meds.
My doctor quickly prescribed Synthyroid and a Cytomel (generic Liothyronine) for T3 and T4. I started taking the Synthyroid this morning and will add on the Liothyronine in a week.
My fear is that when Naturethroid comes back it will be like the new Armour and I won’t be able to take it. The FDA has forced them to completely change their formulas which aren’t any good.
If the my new prescription works I will stick with it. I’ve had an awful year and don’t want to switch back if this works.
What I haven’t seen explained anywhere is “Why?” WHY is there this shortage? What country does the raw material come from? What’s happened in the past year to interrupt the supply chain? Anyone know???
As a pharmacist, I unfortunately see drugs go off the market and then come back later at a greatly inflated price. If compounding pharmacies are not having difficulty getting raw materials, then that is not the problem. I cannot help wondering if some of the large pharmaceutical houses who make synthetic thyroid meds are “gumming up the works” so to speak. Either they are buying the materials up and hoarding them to prevent Forest and RLC from getting them to reduce competition, or they plan to introduce their own “natural dessicated” thyroid later when patients are desperate and charge very much greater prices for them. The other alternative is that there is a disease or disorder in pigs that no one wants to admit to for fear of large-scale panic. However, there is no evidence for that at the present time. I suspect if someone follows the money, we would find the answer. I hate to be a cynic, but as a long-time pharmacist, I see some things done just for the money without care for the patient. Wouldn’t be the first time.
But what if Armour, when their product(s) return, is using the same over-abundance of the particular filler that kept
so many people from being able to absorb it??
You have written at length about this problem and yet YOU DON’T MENTION IT AT ALL while rejoycing that they will be back in January.
Will they be making me very, very sick again??
Donald, I understand your concern, but this update is about Nature-Throid, not Armour. It is a different drug made by a different company. From what I understand the fillers in Nature-Throid are hypoallergenic.
Thanks for the great information and hopeful news, Mary!
As a former lab tech who has run similar assays for other incoming raw materials screening, I know that Dai’s explanation is very plausible. RLC’s raw material testing specification ranges may also differ from the specification ranges used by Forest, so RLC or Forest may have a harder time finding material which falls within their own predetermined specification ranges.
NDT raw material variability at RLC may not be a recent event. The current raw material failure rate may have been the same all along. If so, it might simply be that RLC had to order and test more NDT raw material in order to step up their production and meet increased demands. Demands on RLC’s supply chain must be higher now due to the unavailability of Armour and generic brands, as well as a backorder flood of people trying to stock up on several months or a year’s worth of NDT all at once. Hypothetically, if demand for RLC’s Nature-Throid has doubled in the past year, the amount of NDT raw material screened would also have to double in order to meet new demands, even if raw material failure rate has stayed relatively constant. However, if NDT raw material failure rate has also increased, that would cause further delays in production like we are seeing now.
So this leads to my questions 1) how much did RLC have to increase their production in order to meet current demands, and 2) is the raw material failing at a higher rate now than before? I think these are some key questions to help us determine why RLC has been unable to produce NDT. If the NDT raw material is failing at a higher rate, it leads me to wonder whether the increasing percent of the human population effected by hypothyroid disorders is being mirrored in the animal world, due perhaps to envirnmental influences. If pig thyroids are being affected, and their T4 and T3 ratios are shifting, it might be hard to find suitable porcine thyroid material.
If however, RLC’s raw material screening failure rate is consistent with failure rates prior to the NDT availability crisis, then it may be 1) the raw material vendor from New Zealand just can’t supply enough raw material to meet both RLC’s and Forest’s demand, or 2) RLC is working around the clock doing raw material assays and doesn’t have sufficient resources to meet increased testing and production demands or 3) some other hidden agenda. It would be nice to have more information so we can be certain that they are doing whatever they can to make NDT widely available. We’ve heard too many promises in the past, and they have yet to deliver.
Another question from other posts is in regards to NDT raw material demand for compounding pharmacies. Several months ago, I obtained Major’s generic NDT 120mg tablets from a compounding pharmacy. When I asked the pharmacy about compounding, they told me that they order 2 & 4 grain tablets, and then crush them to make compouded tablets. They told me that they don’t add fillers, and they didn’t make them from NDT raw material powder. So for my final question, do compounders use NDT raw material powder, or do they crush 2-4 grain tablets to make compounded NDT? My compounding pharmacy charged $22 for 90×120mg (180 grains total) generic tablets, while they now charge $160 for 120×90mg (180 grains total) compounded tablets. That is 7 times more expensive for compounded NDT than for generic and Armour NDT. Talk about healthcare profits, just for crushing some tablets!
I’m currently underdosing my 3-grain prescription for Armour down to 2-grain just to get me through Feb 2010. I’ve been considering trying the levoxyl/cytomel 4:1 ratio combo, but I’m trying to avoid paying for additional doctor’s office visits and lab tests just to confirm proper dosing of the synthetics, if they would even work for me. I spent 10 years on Levoxyl and T4 alone left me in constant pain. My doctor is also getting tired of rewriting new prescriptions for a different pharmacy and different brand of NDT every other month, and I’m getting tired of calling around to pharmacies looking for any NDT stock every month. I’m hoping that Mary is correct, and by February 2010, we’ll have availability of Nature-Throid. That will make 2010 a happy new year!
Dear Mary,
To found Dai’s statement: “…..I can’t just take the raw material, stick it in a blender and turn it into a pill.” to be rude and condescending.
I think this guy is playing games for whatever reason.
As for the supply of porcine product – I know alot of pigs were killed in the panic about swine flu and can’t help but wonder if that combined with Forrest’s abandonment has caused this bottle neck.
Hi Mary,
Can you tell me why RLC can ship to Canada but US patients do not get these shipments? I am in Canada and I have no problem receiving what I need from my Naturopath. Just curious why you can’t get it in the states. THanks
Judy
Hi Marry,
Why isn’t RLC able to get the raw materials necessary? Armour (Forest Labs) played right into the hands of the FDC by changing its formula which would require a new drug application. They did this after receiving a warning from the FDA. They knew what the outcome would be. They were warned. Something must have been going on behind the scenes.
There is no reason for the FDA to take RLC’s Nature-throid/Westhroid off the market. If they can’t get the required raw materials, they are out of business. If it is found that there is something going on behind the scenes that is causing this, they would probably have a lawsuit in antitrust for being put out of business.
It just dawned on me that if they ship and they use raw material that isn’t up to standard, the FDA would be within their rights to shut them down.
I think RLC needs expert legal advice and NOW.
I just order natural dessicated porcine thyroid from Nutri-Meds and they actually called me and were going to try to ship Express before the holiday but the girl wasn’t sure she could get it thru shipping. Anyway, there is no shortage with them, I actually ordered double just in case everyone starts going thru Nutri=Meds and they get short. I pay direct and I haven’t felt this good on ANY thyroid med EVER. I just pray I and MY THYROID have met their match and I will pay forever if I can actually feel so terrific. It is the best and yes their supply comes from New Zealand the girl told me on the phone. They also sell a ‘beef’ version but have never tried that. Good luck to all with their THYROID dilemma’s, and I know there are many. I feel in the end it all boils down to money in some big wigs pocket as opposed to good health for us unfortunate consumers.
To the last poster who started taking the nutri-meds please report back on how many you started with and if you increased dosage. It seems many of us are interested in nutri-meds but there is very little response as to how people feel on it and how much they are taking. I actually have it in my kitchen and I’m unsure as to how much I should start with. I’m a low dose of compounded material and while the first batch was just ok the second batch has definitely made me sick. The levo I was on really made me ill. If possible please report back how you started the nutri-meds and your impressions now. thanks
I just orderd the nutri-meds porcine, should have it in by March 15. Had a thyroidectomy a couple months ago, tried synthroid + armour combo, but had cramps + diarreah with the synthroid, went on 3×30mg armour but still felt hypo, then doc changed script to 1×90mg armour, got headaches, heart palpitations and dizzy, didn’t realize until today that it’s been bad since I started on the 1×90mg, so it SEEMS as though the 90 mg does NOT equal 3×30mg. Trying all day to get a script for Naturethroid from the covering doc, but according to her receptionist, the covering doc is trying to get me to take synthroid. (???!!)