Three Thyroxine Monkeys
No Bananas!
A while back I blogged about Pharmac’s cost-cutting efforts with the drug thyroxine. Today the Herald on Sunday says that there have been over 750 complaints since June about side effects of the drug. In my original post, I was just talking in general about the problems of generic substitution – same drug but a different brand. However, the thyroxine story is slightly different because the brand has not changed; the drug manufacturer Glaxo Smith Kline (GSK) have simply moved their manufacturing process to a cheaper venue in Germany. Theoretically, the drug should be identical – so why all the reports of side effects?
There are a number of dangerous things happening in this scenario. Firstly, it is possible that GSK have changed the formulation of their drug (the stuff they put in to make a pill, not the active substance). If so, they have done this without conducting fresh bioavailability studies (studies that check how the body absorbs it). To illustrate: I could make a very nice thyroxine pill out of plastic or concrete. You wouldn’t get a single molecule of the active drug when you swallowed it, but there would be the right amount in the pill – and Pharmac would be happy.
There is another possibility, and it is that we may be getting loads of fake thyroxine substituted for the real thing, probably while it is being imported from Germany. Last year there was a large haul of fake Eltroxin discovered in Mumbai by the Indian FDA. It is certainly possible that these fake drugs have found a new home in New Zealand.
Whatever the cause, 750 complaints in three months tells me that there is a serious problem with the absorption of this drug. Which brings me to problem two.
The three parties involved – GSK, the manufacturer; Pharmac, the purchaser; and Medsafe, the drug oversight people – are playing a game of responsibility ping-pong (no, it’s your problem…). Nobody wishes to take any responsibility of what is promising to be a multi-million dollar stuff-up with potential legal action from effected patients. While this unlovely game of pass the parcel is being played, people are getting hurt.
Considering the potential for serious harm here, one wonders why nothing is apparently being done? This brings me to problem three – the system in New Zealand is not designed for this. Let me explain:
If Pharmac had changed to a new brand of drug, they would have had to notify both doctors and Medsafe. Medsafe would have monitored the new drug and doctors would have been on the look-out for changes in side effects. But this is not a new drug, this is the same drug, by the same company. GSK says it is identical. Pharmac takes their word for it, Medsafe is not looking for new problems.
The result is that the system is now responding in true government style – slowly and with much denial. Pharmac refuses to fund the alternative drugs, Goldshield and Synthroid, saying that they are still paying for the same drug – it was working up ’till now, wasn’t it? Medsafe is running the line that these are all “media” side effects – generated by the publicity of a few people with genuine problems. After all, its the same drug, isn’t it? What else can it be? So Medsafe are officially “collecting more information”. And GSK are just scratching their heads – New Zealand is apparently the only country having these problems.
So what needs to happen?
GSK – Check your new German facility. Do a small bioavailability study, just to be sure (They are cheap to do). Thoroughly investigate your shipping route to New Zealand.
Pharmac – Temporarily fund the alternatives until the matter has been properly investigated.
Medsafe – Check the formulation of Eltroxin in a lab right away. Do your own small bioavailability study.
Take responsibility. That’s what we pay you for.
Additional:
Good to hear today on 3 News that Pharmac has decided to find an additional source of thyroxine. About time, guys, about time.
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- Pill Thrills | MacDoctor Moments — [...] of staying on the old drug, but must switch to the new formulation, with unpredictable results (the thyroxine saga ...
Sep 8 08 2:00 pm
about half of my patients taking the new formulation of thyroxine have been shown to be hypothyroid on blood testing.
pharmac are certainly taking a head in the sand approach.
Yes, I’ve noticed an increase in older folk coming into the emergency department with symptoms of hypothyroidism. Had my first myxoedema coma in years, just a few weeks ago. All were taking Eltroxin
Sep 8 08 11:18 pm
Yes I am one of those on the “poison” formulation of GSK’s levothyroxine/eltroxin. Hypothyrodism people have been labelled as a bunch of “nutters” dreaming up symptoms, but I can tell you now they are real. There are a lot of Drs and Pharmacists who are NOT acknowledging there is a problem with this drug and are treating people on their symptoms and not the underlying problem – the meds. Even with media exposure Drs are not willing to accept that there is a problem with this medication. It has also been noted that Drs are not doing the most basic of tests. Some only test TSH and not the free T3 and T4 as well. If there Drs out there who believe there is a problem with GSK’s drug, please air your views to Pharmac and Medsafe. This issue has certainly opened by eyes and I now probably know more than my GP
You might well know more than your GP, neither Pharmac nor Medsafe have been particularly forthcoming about this. Your GP should test T4 and free T3 regularly while you are on Eltroxin. TSH alone is fine as a screening test, to make the initial diagnosis, but not to monitor treatment.
Sep 9 08 4:46 am
as one of the 750 who have complained to CARM about GSK Eltroxin since June, I am glad to read the challenge to GSK, Pharmac and Medsafe.
IT is unbelievable to me that I had to ask my pharmacist WHY my prescription had been filled with a tablet different in size and colour than previous. Was not given any instructions as to HOW to take it, although their are CLEAR INSTRUCTIONS provided, whihc do eleviate some symptoms.
DOctors know far too little about Thyroid treatment and government departments like ledsafe and pharmac only appear to care about cost cutting
shame on them all
Sep 9 08 10:35 am
I’m a sufferer too. Oh and it’s not imaginary by the way, my Mum has similar symptoms. Now, why would a mother and daughter have the exact same problem and the exact same time? It’s the drug. There is proof for you.
I’m only 18 and should not be having all this trouble. It is affecting my whole way of life. Not only that but I am waiting for the other pill to arrive at our pharmacy. It costs the earth and I have to take them for the rest of my life. I seriously hope Pharmac and Medsafe work together on this one, for the good of the 70,000 people in NZ taking Eltroxin. We have to swallow the little pills just to stay alive, however it has turned from medicine into being poison as well. What a paradox.
Sep 9 08 7:05 pm
I was so ill while taking this poison ,i was also living on panadol which could not even stop my pain. I was a fit 41 year old up until october 2007, It affected my whole life I could not function in the work place and had to take time away from my job, I never new what the cause was until i read about other people experencing the same side affects. I had been going to the doctor non stop with aching bones she told me it was poly myalga. Im now taking the Goldshield brand and within 2 days my symptoms were gone and I can now function again without brain fog and headaches. My husband thought i was going mad, so i decided to have a CT scan which came back clear however it has cost me alot of money with different tests I have had to have. I guess Pharmac are laughing as they are saving alot of money and making it while we all have to buy pain killers for our aching bones. Shame on them.
Sep 10 08 8:11 pm
Well it looks as though Pharmac and Medsafe are finally coming to the party after pressure from Government and all our complaining. Announcement will be made tomorrow (Thursday) regarding two alternatives that will be available. By the way I loved your Three Monkeys Article – very well written!
Sep 12 08 12:06 pm
Having read the many articles surrounding Eltroxin at the moment, I am wondering if there are other issues that need to be addressed as well. Are the blood tests for Throidism adequate? Do our GPs get enough training regarding the role of the Thyroid and the symptoms of Hypo/Hyperthyroidism? I ask this because at 42 I was told by a Dr that I didn’t have a thyroid problem, that I wasn’t getting any younger and couldn’t expect to climb mountains any more!!
I am presently taking GSK Eltroxin while waiting for an alternative. Within hours of the first reformulated dose, I had incredibly itchy skin on back and legs. Although that subsided, I have since had many of the symptoms of hypothyroidism return. My blood tests remain within the “normal” range. Believe me it is hard enough feeling this unwell, without having to fight the medical profession as well as the govt depts involved, in an attempt to regain health.
Gayle: Hypothyroidism is a tricky diagnosis, as it resembles a number of other, more common problems. It is also rare in middle age (Usually, the young, with genetic problems, have long been diagnosed and the only other common groups are the obese and the elderly).