Harsh side effects
From Stat News in February 2017:
Sharissa Derricott, 30, had no idea why her body seemed to be failing. At 21, a surgeon replaced her deteriorated jaw joint. She’s been diagnosed with degenerative disc disease and fibromyalgia, a chronic pain condition. Her teeth are shedding enamel and cracking.
None of it made sense to her until she discovered a community of women online who describe similar symptoms and have one thing in common: All had taken a drug called Lupron.
Thousands of parents chose to inject their daughters with the drug, which was approved to shut down puberty in young girls but also is commonly used off-label to help short kids grow taller.
I guess this is like the “safe, properly regulated access to puberty blockers” that Jolyon Maugham is talking about with such affection?
There have been more than 10,000 adverse event reports filed with the FDA.
In interviews and in online forums, women who took the drug as young girls or initiated a daughter’s treatment described harsh side effects that have been well-documented in adults.
Women who used Lupron a decade or more ago to delay puberty or grow taller described the short-term side effects listed on the pediatric label: pain at the injection site, mood swings, and headaches. Yet they also described conditions that usually affect people much later in life. A 20-year-old from South Carolina was diagnosed with osteopenia, a thinning of the bones, while a 25-year-old from Pennsylvania has osteoporosis and a cracked spine. A 26-year-old in Massachusetts needed a total hip replacement. A 25-year-old in Wisconsin, like Derricott, has chronic pain and degenerative disc disease.
So what I’m wondering is…why do activists for trans ideology see it as such a slam-dunk that none of that matters compared to the joy of blocking puberty? And how, how, how are they so confident that none of this is to do with social contagion? How are they so confident that they’re not cheering on and spreading the very delusion that encourages teenagers to take this drastic step? How do they even sleep at night?
The FDA is also reviewing deadly seizures stemming from the pediatric use of Lupron and other drugs in its class. While there are other drugs similar to Lupron, it is a market leader and thousands of women have joined Facebook groups or internet forums in recent years claiming that Lupron ruined their lives or left them crippled.
But the FDA has yet to issue additional warnings about pediatric use, and unapproved uses of the drugs persist.
H/t Papito
Back when I still commented at Pharyngula I made the point that the long-term effects of using blockers was largely unknown, and that using it ‘off-label’ as a means of delaying the normal onset of puberty was a potentially dangerous experiment on children not old enough to fully understand the risks, and because the people giving them blockers either didn’t themselves know the risks or skirted around any side-effects that were suspected.
I compared what was happening to Thalidomide, a seemingly harmless drug that was so successful in initial trials that it was released before anybody suspected the damage it caused during foetal development (and took far too long for the authorities to take action, even when the link between Thalidomide and the damage it caused was proven), which could have been prevented had proper long-term trials been undertaken.
The response? I didn’t know what I was talking about, and anyway they’re different drugs for different problems, and there is no proof that blockers are dangerous (fucking genius, that last one!). It would be nice to be able to think that reports such as the above would cast serious doubts in the minds of the TRAs, but I’m not nearly naive enough to believe in fairy tales. I’m sure they’d write the cases off as individual one-offs, or caused by something else, or…well, anything they could come up with as long as it doesn’t involve having to admit they were wrong.
AoS, that’s one of the things that galls me. Oh, sure, nothing bad could happen from chemically delaying a normal human developmental stage. Nothing at all.
Right. And nothing bad could happen from taking hydroxychloroquine off label for COVID, either, right?
Well they could say correlation is not causation. Nothing in the article said anyone knows for sure that all these symptoms are caused by puberty blockers. But would you think caution is warranted? Yes I think you would.
Yeah, I’ve heard them say things like that. Correlation is not causation is the big buzz word for anyone who wants to ignore science. The global warming deniers use it a lot. So if they want to throw the religious right at us, we should just throw the global warming deniers at them…except I don’t think things work that way. Believing one right-headed thing that I agree with (and if I agree with it, it’s right-headed, right? ;-) does not mean I agree with everything they say. But no, only a TERF would say that, a truly TERF-y TERF. The TERFiest of TERFs.
Well it may be a buzzword but it’s still true. The article really is all correlation, and it doesn’t provide any “while the numbers you’d expect to see would be more like ___” or similar. It’s best to be careful about these things.
Oh, I know it’s true. It’s just…even when you have numbers and evidence (again, global warming, and all that…) it gets thrown out like TWAW as a conversation stopper. When you get a correlation, it could mean causation, and might be worth studying further. But the TRAs don’t want us to study this further.
Ophelia, #3:
Quite. Nobody knew for sure that there was a causative link between the babies born with severe deformities and the Thalidomide that the mothers had been given to treat morning sickeness during pregnancy, despite the drug being the one common factor in the tragedy.
Not all women who had taken Thalidomide gave birth to deformed children, not by a long way, but the fact that all of those women whose babies were harmed during development had been given Thalidomide should have set alarm bells ringing long before any official action was taken.
The Thalidomide story alone should stand as a permanent reminder that caution is always warranted, and that if a widespread number of people reporting unusual symptoms and illnesses are or have taken the same drug or type of drug then investigations independent of the manufacturer or developer must be carried out urgently and thoroughly to either prove or disprove causation.
The attitude that correlation is not necessarily causation so shut the fuck up and let us get on with it is simply abhorrent, and the idea that it passed on a biology professor’s blog without any mention from said professor beggars belief. I’m sure that once-upon-a-time there was a ‘scientific method’ thing that he was so passionate about. I wonder what happened to that?
Another issue with using drugs off label (or as planned, either) is that doctors are supposed to report unusual side effects, especially with a new drug, or a new use, but often don’t. If it isn’t listed as a side effect, they often dismiss it, or if they accept it, just don’t take the trouble.
As an example, when I was on Prozac, my blood pressure shot up. I never had high blood pressure in my life, but about a week after going on it, my blood pressure was up. It remained high until about a week or 2 weeks after going off. Now, this could be coincidence, except I went on and off Prozac three times, and it happened every time. That sounds like something at least worth looking into, especially since HBP can lead to serious consequences. My doctor said “that isn’t a known side effect of Prozac, so it wasn’t the medicine”. At this time, Prozac was still a relatively new drug, and they were giving it to nearly everyone for nearly everything. What else might it have been doing that was dismissed because it didn’t show up in clinical trials, or wasn’t reported if it did?
Drug testing has a lot of good things going for it, but when a drug goes on the market, there is still so much not known about it. We should always be cautious, even with a drug that has been out a long time, because our bodies do not all respond the same way. I often have effects that are the opposite of what you’re supposed to have; for instance, caffeine keeps me awake.
The comparison with Thalidomide is reasonable. When drugs are tested, the tests are rarely of sufficient duration to determine long-term effects (in this case, Lupron use on children would require a study at least fifteen years long), and they focus on the intended effect of the drug. So Thalidomide might be great for relieving nausea during pregnancy. And Lupron might be great for stopping puberty in children, or for reducing endometriosis or uterine fibroids in women. But look down the road a little? Out of scope, apparently.
It took sixty years to figure out how and why Thalidomide caused such severe birth defects. In 2018, scientists at Dana Farber figured out it had to do with removal of the SALL4 transcription factor from fetal cells. This is a bit too late to help the cohort affected by it.
In the case of Lupron, controlled clinical studies demonstrated loss in bone density of around three percent. The key statement here is:
It’s not may result. Use of Lupron will result in irreversible bone loss, and it will do so in a period of use of three months. The recommendation for adults is to use hormonal therapy with Norethindrone to mitigate the bone loss, and never to use Lupron for more than six months. In children? Norethindrone is not recommended and is not used. There is no mitigation of bone loss in children, who use it for much longer than adults do.
Let’s compare the labels. Here’s the label for adult use of Lupron:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020011s040lbl.pdf
Bone density loss is addressed on page 12. Now, for the pediatric use of Lupron:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s036lbl.pdf
Where is bone density loss addressed? Nowhere. And the duration of use in children? Years, not months.
What might a reasonably insightful person suspect would happen here? Perhaps that
https://www.nejm.org/doi/full/10.1056/NEJMoa013555#t=articleTop
The conclusion was that, given that Lupron in children will cause life-long bone density problems, use of Lupron to delay puberty for the purposes of addressing short stature is not justified. That NEJM article is from 2003. Seventeen years ago. We should know better by now. But what does the FDA have to say about it?
https://khn.org/news/women-fear-drug-they-used-to-halt-puberty-led-to-health-problems/
It’s going to take a while to turn the ship around on this. One of the big problems is that by the time it’s clear these young women have serious problems, they’re not being treated by pediatricians anymore, and the prescribing pediatricians never hear about it. But small studies keep happening, and they keep finding the same things, the predictable things.
Will someone ever do a study on the effects on bone density of Lupron use for the purpose of arresting puberty in “trans children?” No. It would find the same thing as the other studies – lifelong bone density loss – but it would be transphobic to even mention it.