I’ve recently been forwarded a document that the Victoria University of Wellington’s Mauri Ora Student Health clinic has been using to blanket deny their patients progesterone, even going as far as to forcibly discontinue the prescription from people already prescribed it.
I normally avoid doing a critique of a specific practice because there are many factors that go in to the decision to prescribe, but I was shocked that this practice would just invalidate a standing prescription without any evidence of harm. Not prescribing because of a lack of knowledge of the correct process or side effects is one thing - a doctor cannot provide informed consent if they themselves are not informed - but to remove an existing medication because they don’t like it is quite another. Imagine if a doctor refused to continue a contraceptive prescription because they had a personal belief against it? In certain circumstances doctors can refuse to prescribe due to personal beliefs, in which case they are required to refer you to someone who will.
So lets pick apart their reasoning to see if there’s anything behind it, because if progesterone is dangerous despite multiplesources saying it should be up to the patient I’d like to know, and I’m sure a lot of others would as well.
Firstly, a question to those against this. Why do people feel the need to self-request medical tests?
Tests requested by a medical practitioner are free, when you self-request they are not, often costing more than a GP appointment. Clearly people feel they are not getting the care they need - I have had my health concerns completely dismissed by GPs with no follow-up so understand why someone would get tests done by themselves.
I’m sure there’s a lot of misinformation out there are people getting unnecessary tests, but we should not remove a service just because some people use it - at their own cost - when they don’t need to.
So, back to why people self-request tests, and I’m going to start with a transgender perspective.
Progesterone is by far the most controversial hormone in transgender HRT. Almost bizarrely so, the amount of clinical misinformation, dis-information, gaslighting, and just straight ignorance is astounding. So let’s look in to it!
Misinformation?
I’ve been told that progesterone has “no benefits”, which from personal experience is not true (“no proven benefits” is technically correct, but we’ll get in to that later), and others I know have been told that it’s “risky” - though without specifying the risks - and even that it’s a carcinogen, which would be pretty astonishing if true given that progesterone is part of every healthy human’s system!
Every so often articles pop up claiming that transgender hormone therapy is “experimental” or “unapproved”. HRT has been used by transgender people since the 1950s, so it definitely isn’t experimental though like all medicine it’s always improving. However it is “unapproved”, or, as it’s more commonly known, off-label.
This isn’t strange though, many medicines are used off-label. One that I’ve had before is bupropion which comes in multiple brands with different approvals. The only approved brand of bupropion in New Zealand is Zyban, and its approval is only for an aid to quit smoking in 150mg doses. Overseas the Wellbutrin XL brand, which has the same active ingredient and same doses as Zyban, is approved as an anti-depressant. Because Wellbutrin isn’t approved in NZ doctors just prescribe Zyban, this is off-label but backed by overseas approvals.
Bupropion is also used for ADHD. While this is backed by emerging research it isn’t approved for ADHD treatment anywhere, so all ADHD treatment with Zyban is off-label.
Using approved medicines for off-label uses is permitted under NZ law at the discretion of doctors, the safe treatment levels and side effects are established so the risk is minimal. Unlike completely unapproved medicines there’s no special requirement to record these prescriptions.
So why don’t manufacturers apply for these uses? Because it costs money. To get approval in NZ you need a sponsor in the country - normally the importer - and have to submit all the documentation to Medsafe, pay them, and wait. While overseas approvals do help the process they aren’t automatically recognised. So if you make Wellbutrin are you going to go through this, knowing that Pharmac won’t fund it because they already fund one sort of bupropion? Nope. If you make Zyban are you going to pay for the update to the approved indications and submit all the documentation given that doctors can already prescribe? Unlikely.
The only time the Medsafe fee is worth paying is for medicines advertised direct to consumer, as only approved indications can be advertised. This also applies for advertisements sent to clinicians, but there are ways to avoid that and clinicians do read published studies so are likely to be aware of changes.
So where does this leave HRT? The market is small, so the expensive studies required are both hard to justify and hard to find participants for, the medicines are already approved and available, and safe levels are established in literature (and given the hormones are bio-identical easy to validate). This means no manufacturer is going to go to the effort of getting their medicine approved for transgender HRT - menopausal HRT is the vast majority of its use.
I’ve now heard from multiple people that their doctors or endocrinologists have told them laboratory tests for oestrogen levels are either inaccurate or cannot detect exogenous oestrogen, so there’s either no reason to test or no reason to take action based on test results. This always seems to be used to deny increase in hormone doses, but for decreases the blood levels are always trusted. Interesting that…
Medsafe is New Zealand’s medication regulatory authority. Except in a few cases all the medications on sale in New Zealand, and certainly any you see on shelves or advertised, have Medsafe approval.
This is a very important role - Medsafe ensures medicines meet the quality and efficacy the manufacturers claim, is safe to use in the way the manufacturer has specified, has appropriate guidance for patients and prescribers, and has a secure distribution network.
With the shortage of Estradot I’ve seen quite a few people wondering what all the different ways medication is described in New Zealand actually mean. What is an unapproved medication? What is a special authority? Hopefully I’ll answer that!
This isn’t an exhaustive list, just the ones you’re likely to see.