Thyrogen is a damn expensive shot (not always covered by insurance) that simulates the experience of being hypothyroid and allows thyroid cancer patients to undergo full body scans, and sometimes even treatment, while still on their hormones. I have used thyrogen and it is remarkable. While on thyrogen I was able to work and function as a normal human being. It was heaven compared to the other times I had gone hypo without thyrogen and was so fatigued I felt like my marrow hurt, my hands went in and out of paralysis, and I could not physically take care of myself.
So, you can imagine my concern when I learned the FDA announced this week that due to operational manufacturing problems, Genzyme will have to halt production of thyrogen. The injection will be limited to patients whose doctors deem it “medically necessary.” Here is what medical necessity is based on:
1. Patients undergoing initial radioiodine ablation of thyroid tissue remnants, post-thyroidectomy, deemed to be at significantly increased risk of side-effects/complications from undergoing thyroid hormone withdrawal.
2. Follow-up testing of patients considered high risk for thyroid cancer recurrence (those with 1. macroscopic tumor invasion, 2. incomplete tumor resection, 3. distant metastases, and possibly 4. thyroglobulinemia out of proportion to what is seen on the post‑treatment scan) and who have unmeasurable basal thyroglobulin (Tg) levels and are deemed to be at significantly increased risk of side-effects/complications from undergoing thyroid hormone withdrawal.
The FDA has complete information listed here about what qualifies as increased risk of side-effects and complications. If you are concerned about obtaining thyrogen, read the linked info, print it out, take notes, and discuss it with your doctor.
Have you ever gone hypo for full body scans or radioactive iodine treatment? Have you ever used thyrogen before?
To learn more about thyroid cancer, read Everything Changes: The Insider’s Guide to Cancer in Your 20s and 30s.
“Everything Changes is, without doubt, the most forthright, emotionally sophisticated, and plain-old valuable book of its kind I've seen.”
May 28th, 2010 at 11:30 AM
Thank you for this post. I had Thyrogen prior to my radioactive iodine treatment in September 2009. I am supposed to get the Thyrogen injections in September 2010 prior to my full body scan to see if there is any cancer and then possible re-treatment. I printed out the FDA article and will be contacting my doctors to make sure I don’t have problems. Another thing to have to worry about - just what I needed.
May 28th, 2010 at 12:17 PM
[...] This post was mentioned on Twitter by Kairol Rosenthal, Sarah Glenn and Sarah Glenn, Dear Thyroid. Dear Thyroid said: RT There is a shortage on Thyrogen and the FDA has placed restrictions on who can use it. Get Facts http://ow.ly/1QS7g #ThyCa via @kairol [...]
May 28th, 2010 at 4:56 PM
Thanks for the heads-up, Kairol. I haven’t had Thyrogen, but understand that it’s supposed to make going hypothyroid a lot more tolerable. That is awful to hear there is a shortage of it. I noticed on the link you provided to the FDA’s announcement, that it’s only supposed to be a temporary shortage. I wonder how long the shortage will last? Don’t you just love it how there is nothing stated about efforts to accelerate production of Thyrogen, and when the shortage is expected to end?! :P The restrictions on who would be eligible for Thyrogen based on ‘medical necessity’ are pretty ridiculous, too; it pretty much excludes all young adults with thyroid CA since generally young adults don’t have those comorbidities that were listed.
May 29th, 2010 at 1:13 AM
Kim,
It pains me just to think about going through a full body scan without the use of thyrogen. But, I don’t mind so much being a young adult who could be excluded from the list of patients who need thyrogen as a medical necessity. Lots of things suck about having cancer young, but I think one of the things that is to our advantage is that the majority of us do not have comorbities like renal failure, history of stroke and heart disease.
I too am curious about timeline and when they anticipate more thyrogen will become available. Were I currently in need of it, I would talk to my doctor about whether it was sensible to delay scanning/treatment until more thyrogen becomes available. Even though my thyroid cancer has been very persistent, it is luckily still slow growing. I have been fortunate to delay treatment in the past and get continued monitoring via ultrasound and thyroglobulin tests to make so nothing changed while I waited a year to have my treatment.
May 29th, 2010 at 3:29 AM
I am also in my twenties. I have never done the total hormone withdrawl, though I have heard the stories about going hypo. Even for RAI I used Thyrogen.
When, earlier this year, I had my initial 6-mo.-post-RAI Tg test to see if the initial treatment was successful, the Thyrogen only raised my TSH up to about 6. It is supposed to be >30. When I took it for RAI it got me to >150. Since it didn’t get me fully “stimulated” (really,a TSH of just under 6) the Tg numbers - while in range - didn’t provide me with any reassurance. Yet my doctor still wanted to use Thyrogen again for the next testing, a year from the first testing. It was not until the recall that he agreed to schedule me for the total hormone withdrawl. I am not looking forward to going hypo, but I will be relieved to have an accurate measure of surveillance… living with the unknown is anxiety provoking.
That said, it is unfortunate that there are so many people who will have to go hypo. I would love to hear if anyone knows when Thyrogen will be available for all again.
May 29th, 2010 at 9:35 AM
Hi Nora,
I remember the days when I had to fight with my docs to get thyrogen and they were so reluctant because my case is challenging, so few things light up on the screen. Interesting to hear that your experience sounds to be the opposite.
I’m usually the last person in the cancer world to pull a PollyAnna, but here goes. I just want to put out a reminder that some patients do go hypo with no problem at all, they continue to go to work and lead pretty normal lives. We don’t tend to hear about many of these stories online just because people who usually have an easy breezy time with a medical experience aren’t the ones going online to write about it. That’s not to downplay any of us who have had challenging times and want to write and talk about it, just know that what you read online and sometimes hear in support groups are a disproportionate representation of the thyroid/hypo experience.
I hope that going hypo is a smooth ride for you and that it brings you some piece of mind to have an accurate measure of surveillance. Your anxiety over the unknown sounds pretty warranted and challenging!
All my best!
Kairol
May 31st, 2010 at 1:19 AM
Oh wow. This explains a lot. I used thyrogen before my last scan and was surprised my endo didn’t suggest it for my upcoming RAI treatment.
I loved Thyrogen last time…it made my life so much easier before the scan. Now I’ll have to try and work and go to class while I’m super-hypo. Not fun.
Are there people we can raise money for to increase production of this drug?
May 31st, 2010 at 2:41 PM
Anna,
Sorry you are having to go through RAI treatment at all, and especially without thyrogen. I really feel for you trying to work and go to class in the midst of it all. I hope that if you need to, you can work with your employer and professors to cut you some slack. (I’m not a lawyer but my understanding is depending on the size company you work for the law might require they cut you some slack if you request it. By law educational institutions must make accommodations for you. Feel free to ask me more about this if you need any specifics.)
On to your fantastic question about raising money to increase production of the drug. I could and will write a whole post about this but for now:
This is a great example of where in the cancer community raising money is not always the answer. Genzyme had to halt manufacturing because their plant violated FDA safety standards and glass, metal, fibers, and rubber were found in their thyrogen. Excuse my french, but this company makes a shit ton of money ($4.6 billion in revenue in 2008). Us fundraising for Genzyme isn’t what is needed because they don’t lack money. What they lack is the will to make sure they are following safety standards. So what they need from us is pressure and incentives for them to not make these kinds of mistakes in the first place.
If Genzyme had to face significant fines for violating safety standards, they would have the incentive to do it right and thousands of us wouldn’t be worrying about how to swing work, school, and parenting without thyrogen. Instead, all that Genzyme is doing is giving back $175 million from unlawful sales they have made on contaminated products. (If someone sold me a product that was lethally contaminated, I’d want my money back too - but where is the motivation for them to do it right if they aren’t facing major fines on top of that? Here’s an example: A bakery makes a dozen cupcakes that sell for $24 dollars and are laced with salmonella because they don’t have a fridge for their milk and eggs. If we were applying the Genzyme situation to them, all the bakery would have to do is give me their profit back on $24, which might be something like $18. But in the world of food safety, they’d get a whopping huge fine by the health department for not having proper sanitation and equipment. The bakery would also get non-stop coverage on the local news that will likely make them go out of business. This kind of pressure is exactly what needs to happen with pharmaceutical companies. If we put enough legislative and social pressure for them to do things right, and make sure they are inspected regularly, perhaps we won’t face incidents like this.)
The very best thing we can do to change the situation of contaminated thyrogen is to become more active in petitioning the government to have more stringent regulations and penalties for drug manufacturers. No this does not help any thyroid cancer patient in the short term get more thyrogen. (Urgh!) It might be too late for that. It is kind of like the oil in the gulf - we are having a hell of a time controlling the damage that has already been done, but we are fools if we don’t use this as a wake up call to change enforcement of safety measures for the future.
Thanks for the question Anna! Hang in there with your RAI.
Kairol
June 10th, 2010 at 6:33 PM
After a whole year of not being able to get Amour thryoid (I cannot tolerate synthroid) I am completely bummed about this news.
Do you know where the factory was? In this country? In china? Somewhere else overseas?
The protocols have recently changed so that it looks like I no longer have to do the evil diet, but Thyrogen plus scan is due in the fall. Maybe by then it will be fine, or we can put things off a few months. My TG and TGAB have been undetectable since surgery and 2 scans have been clear. I will be 3 years out come the fall. The first scan we did withdrawl. I don’t think I could go through that again. It was quite simply tortue for me. Maybe I would qualify for one of the people who cannot tolerate withdrawl.
Looks like a call is in order to my doc.
Oooh I am soooo bummmed about this.
June 11th, 2010 at 1:22 AM
Alk,
While it seems perfectly reasonable to suspect the factory would be in a newly industrialized country with an unregulated system, the factory is actually in Massachusetts! (Time for the FDA to increase fines and penalties to drug companies for non-compliance with safety regulations.)
So people can do with drawl with minimal side effects. I was not one of them. So I can totally relate to your position of not wanting to be tortured. With your history of good scans, I would be curious what your doctor would say about monitoring you through TG and putting off the scan until you can get thyrogen? I’ve delayed scans and even surgery before by six months and a year. My cancer is very slow growing (papillary) so my doctors and I have made these choices with confidence. But I realize that for some people it might not be the right choice.
Hang in there and sorry to be the messenger of bad news!
Kairol
June 11th, 2010 at 8:47 PM
I am really glad you told me of the news. Better to be prepared. I called my dr this AM and emailed him the link. Thanks so much for the info. I have No Evidence of Cancer so my risk factor at year 3 is shifting. (papillary, no spread to nodules but 2.2 cm tumor with another 1.1 mm tumor) It’s N2. Bloodwork clear since the surgery and each scan clear….We’ll see what my dr says. I cannot tolerate withdrawl either physically, emotionally or financially so maybe we’ll qualify for the medical hardship factor. It was really, really, really terrible for me. In my kind of situation, it is easy to float along and then bammm get hit with it. Oh well. I feel traumatized by a year of having my thyroid levels off b/c of the stupid inavailabilty of armour, and now this. old formulation, new fofrmulation, old formulation, compounding. then old formulation. 8 weeks of misery for my body to get used to the dosage each time….OY OY OY. One big Oy vey. I don’t think I can emotionally deal with being super duper non functioning hypo due to withdrawl, so I am just going to hope my dr is open to either waiting (like you mentioned) or take the time to negotiate w/genzime to get me a dose.
After I posted that note, I saw that the factory is indeed in Boston. In fact, I pass it most days on my way to work. There was a $175 million dollar fine. That’s a serious infraction. (and a lot of clams) You don’t mess with the FDA.
PS the factories abroad are also regulated by the FDA and once they shut you down it’s very hard to get re-certified.
We’ll see what my DR says. I am compliant. Want to protect my health, but don’t want to suffer (terribly) for no reason. Even the diet I hate. Hopefully I won’t have to do that this round due to protocol change.
Thanks again for sharing the info. I am not into shooting the messenger. Rather, I thank her.
June 12th, 2010 at 1:12 AM
ALK,
Crazy that you drive past that plant everyday! The $175 million was not actually a fine, it was just profit they had made off of selling tainted doses of thyrogen, in other words just refunding the customer their $. I think they should pay a fine and it should be a lot heftier than $175 million considering their 2008 revenue was $4.6 billion.
Good luck moving ahead while navigating this. If your doc is one willing to prescribe Armour, I would think they would go to bat for you in other ways that are liberal with your care and deviating from the norm. Keep me posted.
After posting my response to you last night I had horrible nightmares that I was going through withdrawing all over again. So I will close this comment with something wonderful and happy so I have sweet dreams instead. There is a baby bunny living outside my apartment that could fit in the palm of my hand. Soft looking ears, little cotton tail.
Be well!
Kairol
June 13th, 2010 at 9:58 AM
I am sorry about the nightmares. Withdrawl for me IS a nightmare too.
Baby bunnies are good. Hope that helped.
No call from the dr but maybe Monday.
I cannot tolerate synthroid and due to the epilepsy nothing about my treatment is the norm…. :)
PS Just called my sister the litegator — says in a payment in a consent decree is an agreement to pay a settlement in somekind of legal prceeding to avoid goint to trial. She says it is a fine, more or less, but you are also right the amount negotiated relates to profits. Genzyme paid up b/c they wanted to avoid further costs and court time.
June 13th, 2010 at 12:14 PM
Hi Alk, I’ve talked about this a lot with my husband who is also a litigator. (He practices environmental law and is involved in suing, trials, and settlements with big corporations who violate EPA standards.) I’m curious what the base fine is in the FDA statute that they were able to negotiate with the government such a low fine. Also curious if the companies consider this a low fine and if not is the fine high enough to encourage them to comply with safety standards in the first place. And, wouldn’t it be interesting if the government bought and provided thyrogen (a necessary medication for some) as they do with things like vaccinations? Ooooh - socialism! I would love to be an investigative reporter covering the FDA, but don’t think I could… I’m way too biased!
June 23rd, 2010 at 10:08 PM
yeah, good questions. No idea what the statute is or what the base fine is or how they came up with that number. I just want the D&&*GW@!!!) shot available. I feel like writing a personal note to the president of Genzyme explainign how their lack of compliance affects their consumer, who is not really a consumer of a product like a lipstick or a pencil, but rather a person, who has suffered. Then they come up with a way to decrease suffering only to bring make it worse due to their neglegnece. Oh it makes me mad.. Guess the FDA is making it available to people who REALLY need it due to medical necessity…..just not people like me who also REALLY need it but don’t qualify for the list of people who REALLY need it. Oh well. I got my bloodwork back and everything looks good. TG undetectable and TSH OK. My dr says we can wait until it becomes avail again or skip a year. He’s a pretty conservative/old school guy but he’s a thinking Dr and an endo prof so I feel that he treats me and not the disease…he’ll tell me the stats if I ask but help me weigh out the options. I pretty much told him that whereas I wasn’t 100 percent willing to say I would not do withdrawl again, that I would only do it if he told me I must. So he said, let’s see what the blood work says. I am 3 years out with clean scans/clean ultrasounds. N2 but no spread. If he told me to do withdrawl I would. If he says we can wait. I am fine with that. I hate that damn diet anway, so I don’t mind putting it off a bit if it doesn’t put my health at risk. so that’s the plan for now. Thanks for listening….
June 24th, 2010 at 1:10 AM
Alk, It sounds like you made a very sensible decision. Congrats on an undetectable tg. If you and up sending a letter to Genzyme, I’d love for you to share it with us! Hope you are well, Kairol
July 16th, 2010 at 6:10 PM
I talked to my Endo about the Thyrogen shortage this past week, and he said there isn’t actually a true shortage, at least at my medical institution. I wonder if it’s only certain medical centers that are having difficulties obtaining enough Thyrogen? Hmmm.
July 19th, 2010 at 10:16 AM
Hi Kim, I have heard from patients whose hospitals have a limited supply and others that do not. I don’t know what accounts for the inconsistency in supply. Perhaps larger university hospitals can afford to purchase a larger supply and they might have a larger usable supply on hand when the supply became limited as compared to smaller community hospitals (just a guess, I don’t know if there is any accuracy to my theory.) There is no update on the FDA site since the May press release that describes the initial limited supply problem. There are three different drugs that the manufacturer makes and I read an article saying that the two others were still in short supply. I don’t know if omitting thyrogen from that list means that it is back into full production yet or not. Their consent decree with the FDA requires them to move thyrogen to a new production facility by November of 2010. They have big incentive to keep the supply flowing - due to increased use of RAI (I presume due to increased diagnosis of thyroid cancer) sales for thyrogen grew by 15% from 2008 - 2009.
August 15th, 2010 at 9:37 AM
I’m really hoping that this all gets resolved very soon. I’m past due for my scan but my endo is allowing me to slide till January in the hopes that the Thyrogen will become available. I went hypo 3 years ago for my first scan after a thyroidectomy after a diagnosis of thyroid cancer but have been getting the thyrogen injections since then. I simply cannot fathom going into a hypo state again. It was the most miserable, painful experience of my life. I do not have 6 weeks to check out of living. I’m praying that this gets resolved. Is there anything I can do? Can I write to someone? How can I help?
October 7th, 2010 at 8:08 AM
Thank you so much for your post and for all the comments by all. I just wanted to write in as someone who had papillary thryoid cancer at the age of 27. It was found by a wonderful doc feeling a lump on my neck. After a fine needle aspiration - it was determined I had the cancer. 2.7 cm nodule of it - and 4 lymph nodes. After the iodine treatment - I had a total withdrawl of the hormone about 8 months later - and I actually really well - I was able to work, live, sure I was a bit crabby at times, and a bit exhausted at times (but who isn’t) and the testing then showed I had more to remove. So they removed 22 lymph nodes and 14 were positive for the cancer! … 2 years later another total withdrawl … again I did fine - more crabbiness and exhaustion - but really it didn’t diminish my quality of life at all. I still did everything I wanted to - just had an excuse for my ‘wanting to sleep in’. It is always nice to have a medical professional tell you it is ok to be exhausted - but I really did still keep up my quality of life - I pushed through! 2 more lymph nodes were surgically removed and I have been cancer free for the last 5 years … I did undergo a thyrogen stimulated test last year - and YES IT WAS SUPER EASY. But I am ok having to go back to the old way too - such is life - sometimes we have to take the hard things that come. None of us wanted cancer or thyroid problems - if 6 weeks of ‘slowness’ is the worst we have to go through and still keep on living - well I am ok with that! Have a great day all - I am going to!
October 7th, 2010 at 11:29 PM
Celia, I really appreciate your comment. All too often online cancer communities are a forum for survivors’ worst experiences and worst case scenarios. It is great that people have a place to go to talk about the hard, hard times. But it makes it so very important when we can come across comments like yours where we can also learn that for some people RAI is manageable. Cancer is no picnic for anyone, but it sounds like you have tolerated your procedures very well. I wish you continued good health and thanks for inspiring us to remember that it isn’t all hell or gloom!
Best,
Kairol
May 20th, 2011 at 5:16 PM
I am new to all of this. I had a thyroidectomy last july then the radioactive iodine scan in Sept. A recent ultrasound revealed more cancer and possibly in the nodes. I want to change surgeons, I live at the jersey shore and do not know where to go. I thought Sloane Kettering or Beth Israel. Please if anyone has any suggestions please let me know. Thank you. Sarah
May 21st, 2011 at 2:21 AM
Sarah, I’m sorry that your case of thyroid cancer is turning out to be a bit more complicated. While I cannot advise where you should go for care, I’m happy to pass along the following information and conclusions I have come to while researching what institutions to go to for my own care:
I believe that the top institutions in the U.S. for thyroid cancer are MD Anderson, Memorial Sloan Kettering, Ohio State, and John Hopkins. Luckily for most thyroid cancer patients, their cases can be easily treated at other hospitals in their area. But when cases become more complex and you want a second opinion about how to proceed with surgery, treatment, or follow-up protocol, I do see tremendous value in seeking opinions from top notch docs in the field - if your time, money, and insurance allow.
I live in Chicago and am currently receiving care through Memorial Sloan Kettering. I could not be happier with my doctor. Because of his research and sole focus on thyroid cancer, his knowledge is so much more advanced than other docs I have seen.
I hope this helps some. Please feel free to contact me directly via email if I can be of further help to you.
Hang in there!
Kairol
May 23rd, 2011 at 12:09 PM
Hello! I was diagnosed with Hurthle Cell thyroid cancer in 2009. Last year was the first time my endo used Thyrogen injections. Really made everything easier. At my last appointment I was informed of the shortage. I have to call in the beginning of June to see if he was able to get Thyrogen. If not, I will be taken off my meds. Not good. Maybe the people at Genzyme should go hypo and then follow a crappy diet for two-weeks. I bet they will produce Thyrogen then. I suppose the alternative is worse. We get to wake up everyday.
July 14th, 2011 at 3:08 PM
Hello! I just got the call from my insurance company that Thyrogen will be delivered to my doctor on Tuesday. So I begin my round of treatment. If any of you haven’t heard from your doctor yet concerning the availability of Thyrogen I would advise you to call your doctor.
August 4th, 2011 at 12:45 PM
PLEASE tell me anywhere that you can get Thyrogen. I called Genzyme directly & was told they are waiting on the release of three lots that are already allocated for patients - shortage applies to US & Canada - expected to continue all the rest of this year & likely most of 2012. I am scared crapless! My Endo already called around for me to no avail. Any chance of help in Europe? I am serious. I cannot go off my med - but really need the scan - I can wait a couple+ months but not a year+. Any info, help is greatly appreciated!!!
August 4th, 2011 at 9:00 PM
did u read
http://ask.metafilter.com/191948/Help-finding-Thyrogen
emails went back and forth on July 28 2011
Good Luck!! Keep Smiling!
August 10th, 2011 at 7:18 PM
If any of you want to do what Robin did and call Genzyme to ask about the thyrogen shortage, you can do so by following these instructions I got from the Genzyme website: If you are a patient residing in the United States and would like to speak with a Case Manager in your area, call Genzyme Care Coordination
8am until 6pm EST, Monday through Friday
1-800-745-4447 (option 3) (toll free) or
1-617-768-9000 (option 3)
Robin, I wish I had an answer for you as to how to get your hands on some. It sounds like some doctors are beginning to get it while others are not. I do not know how it is determined who gets the shipments first. I am curious if the FDA has any updated information.
August 11th, 2011 at 6:22 AM
I am told that the “fill & finish” operation is to be transferred from Genzyme, MA to a company Hospira. I contacted them & they won’t tell me anything; they seem to have some affiliation w/ Abbott Labs.
I also received two calls from the pharmacy distributor of Thyrogen and now have a contact there. They literally do not have any right now but confirmed at least that I was a high priority case. All of my friends and family and my Endo are all looking for me. I know there is only one source. It took me two+ years to recover from the last treatment; I have never gone off the meds. I already know I need surgery since it has returned to my Lymph nodes. I really have to think about what I am going to do. Thanks for the info.
September 7th, 2011 at 11:54 AM
The shortage of thyrogen is such a frustration for the people that just cannot go “hypo” for what ever reason. It is a drug that has to be made more readily available. As a thyroid cancer patient, I went “hypo” four times for treatments and scans and the fifth time I used the injections. There is just no comparison as to how you feel and how you can function. So let’s hope with the change of companies the situation will improve.
September 7th, 2011 at 12:34 PM
I saw my Endo this week & her info says availability of Thyrogen in February.