Wednesday, January 05, 2011

Come on, BBC

UPDATE 9/01/11: Thank you, Ben Goldacre, for your ability to talk to the right people and find the right numbers. The real story: 584 failures out of 1.355 Million users.

Almost exactly TRIPLE the number in 2005, which I cited as a conservative estimate in any case.

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I just read THIS shock-and-alarm article.

Part 1. Understanding Statistics.

Yeah, did you read the whole thing? 584 unintended pregnancies...out of the entire user base...in 11 years.

Eleven years.

Implanon contraceptive devices have demonstrated a failure rate of .05% in clinical trials. 1 in 2000 users may become pregnant. 14 women involved in a lawsuit cited in the above article hadn't even been wearing one--their doctors missed, and nobody noticed. Human error happens--when I got an IUD it took 3 tries--3 IUDs--to get one to fit because I stupidly consented to letting a supervised trainee insert it. (Oh the unimaginable agony. Seriously. Still makes me flinch, and that was three years ago. I don't know how any woman would consent to giving birth, let alone more than once.) So of the 584 failures, probably about 5% had nothing to do with the device at all. It was human error compounded with negligence, exhaustion, or poor eyesight.

The article does not mention the whole number of implant users over the past 11 years, just mentions that it is popular. So I've been looking it up. The NHS National Institute for Health and Clinical Excellence (NICE) reported that, as of 2005, 3% of women age 16-49 were using an implant, and the only one licensed for use in the UK is Implanon. (helpful) So. I asked the department of statistics what those deets were--14 million women were aged between 16 and 49 as of the 2001 census. I'd imagine that number has grown considerably, but that's the most recent official data. The CIA world factbook bets the UK has 20 million women between 15 and 64, or probably closer to 17 million women of childbearing age.

So. As of 2005, 3% of, let's be reasonable and say 15 million used an implant. 450,000 women that year.

This is not the same as the number of implantations, as the implant is intended to be replaced every 3 years.

This is also not the total number of women who have used it since it was introduced in 1999, which IS the non-existent data set the "oh the humanity!" articles are citing.

I am certain hundreds of thousands more users have existed or currently exist. Merck does not seem to have any sales figures or total-usage-per-country statistics available, and NICE suggests that they don't really know how many women have gotten them, how many times.

The usage rate cited was accurate for the device being available for 5 years. It has now been available--and gaining in popularity--for over 10. Usage may have doubled. Anyone with better data please let me know.

But this is the data I have. okay. .05% failure rate. 250 pregnancies allowable per 450,000 users. we're out by 350. This is clearly an epidemic and the drug should be taken off the shelves.

Except.

The failure rate is for perfect use, when neither doctor nor patient is a moron. If you read the relevant trial data you'll find that about half the failures associated with the implant were in fact pregnancies that were already under way. Implanon is not a day-after pill and is not marketed as such. Patient didn't know she was pregnant, urine test came up with a false negative, implant went ahead, statistical fail. Okay, do blood and urine tests before implantation. Zing. Other failures were pregnancies that appeared to have started within a week of insertion. Apparently the patient was so excited to go try it out she didn't hear when the doctor said "give it two weeks to get into your system. If you've already ovulated, this will not retroactively prevent egg release. Hold your horses until you've had your next period." Not an indication of the drug failing to work as it says on the tin.

Still others cited well-known drug interactions (many of which were not mentioned until after the discovery of a pregnancy), poorly-inserted implants, and morbid obesity as reasons for failure (and undetected pregnancy, both for visual and chemical reasons). The device is intended as a one-size-fits-most, and if your body needs more, your doctor should notice that when you show up. These are still not faults of the drug or even its distribution method, but failures in staff training.

It is a common medicine, but that doesn't mean it shouldn't be taken seriously--it should only be administered by trained, informed medical practitioners who understand how it will work for each individual patient. I'm sorry, but "the doctor prescribed it to me even though I'm too fat for it to work" is not a fault of the product, it is a fault of the doctor. There are other things that will work for the obese, such as IUDs and local-absorption products such as the Ring.

Most of the complaints, of the 584 cited by the BBC, were apparently device-expulsion related. Yes, bodies do that. They don't like foreign objects embedded in them. It's why piercings sometimes disappear (my sister had an eyebrow piercing suddenly and painlessly vanish. The ring just fell off in her hand. True!) and how splinters quietly slip away. If the device is properly implanted subcutaneously this is less likely to happen. Again, Human Error. If the damn thing falls out, and you run off and get knocked up anyway, don't blame the device. Blame your stupid self for not calling your doctor immediately and saying "look bitch, the damn thing fell out" and using condoms until you can get it re-inserted properly.

There may have been a few people for whom the drug just didn't work. I'm sure there are. And people have gone off it for reasons such as weight gain, headache, mood changes, and desire to have children. Some people have expressed anger about scars the IMPLANTED BIG PIECE OF PLASTIC GOD DAMN DO YOU LISTEN TO YOURSELF WHEN YOU SPEAK? left after removal. These are all well-documented risks that you should discuss with your doctor in a pre-insert session so you can determine if this is the right birth prevention method for you.

The 584 pregnancies are not statistically relevant. They should not deter women who wish to prevent pregnancy from using this product.



Part 2. Why I'm Angry.

I'm not surprised to see the BBC's health team cite piss-poor statistics again. Every time an issue regarding medicine or public health comes up they manage to completely blow it out of proportion, be completely wrong, or simply not understand the scientific relevance of the data they're citing, pro or con. Their statistical analysis team is pathetic, probably because it's one high school-aged intern in a windowless room with an unrestricted internet connection (for medical research, after all) and an HD monitor for better porn viewing. They're usually wrong, and if they're not wrong, they're exaggerating, and if they're not exaggerating, it's not relevant.

Nevertheless, they have a responsibility to uphold when it comes to issues of public health, particularly family planning issues. (don't you hate that term? 'family planning--of course everyone plans to have a family someday, just not right now!' what about 'family prevention' issues? That's my kind of term.) The BBC is the most respected news provider in the world. What they write gets read and trusted.

Most people do not read news articles' statistics with an air of complete unbelief. Most people do not have the time or patience to check their facts and figure out where their numbers are coming from, or are composed of. Most people just read "600 pregnancies! This stuff is useless! I'll never waste my money on it, no way. I'll trust my good sense." Not realizing that it's 600 out of hundreds and hundreds of thousands, not realizing that most of the failures are in fact unrelated to the medicine entirely, not realizing that this news is not newsworthy. It's the 5th most popular story on their site today. The BBC is affecting people's judgement with their pure, unadulterated idiocy. Some dumb teenage girls who were considering an implant may now decide to try their luck without, ('cos hey, you know what's smart? teenagers.) because Doofus in the office wanted to make a sensational headline. Or they'll go with the Estrogen/Progesterone combi pill, which has over 60 years worth of reported side effects and time-sensitive dosage related failures to its name.

This insert is one of dozens of medicines which have emerged in response to the regular failures of the original pill. We know it sucks. It works, but at such a cost as to make it not worthwhile to many people. The daily pills at exactly the same time; the weight-gain, the bloating, the depression, the nausea, the acne, the drug interactions, the fibroids, the migraines...it's all well-reported. Is Implanon the be-all fix? Of course not. We can always strive to improve it, and there's plenty of other options that work well for plenty of women. I'm happy with a non-hormonal IUD. In 10 years I'll have to get another one, but hopefully by then the fear will have passed. But the point is, it is hugely irresponsible for the BBC to wag its ass around bad-mouthing what are, even where they aren't perfect, clear improvements on the old medicine. It is stupid to try and shock the public into mistrusting a drug which is far more trustworthy than most alternatives, including Old Reliable.

The new drugs have developed because people figured out how to do things better, even if the primary improvement needed was in the patient herself. Implants and IUDs don't have different numbers in the 'perfect use' and 'typical use' columns. Because they don't rely on a normal human brain with a normal memory and normal habits to keep them working. If you miss one Pill, even by a few hours, your entire month is wasted. That's not reliable, even if the chemical in them technically is.

Implanted hormonal birth control is the best option for teenagers--it's low-dose so it doesn't screw with their brains or bodies too much, it steadily delivers, they don't have to think about it, it may slightly lower libido which could help them focus in school, and as IUDs may slightly increase your likelihood of contracting an STI if you sleep around they're a better bet for kids with poor impulse control or who get pressured by stupid boys out of using condoms.

Throwing teen girls directly into daily pill regimens does not teach responsibility. It relies on a responsibility that is usually absent--a dearth which is likely to have devastating consequences. Our state and culture should encourage usage of thought-free birth control for girls. The Pill has gone the way of the Studebaker--the clunky, awkward old technology without anti-lock brakes, crumple zones, or airbags. Birth control needs to keep you safe from yourself as well as others, which pills cannot be relied upon to do--particularly when you're in situations (lake house weekends) where sexual activity is likely (the whole reason you're there.)

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I also believe our state and culture should encourage teenage through college-age boys and girls to think that buying condoms is coooool. It's just not right that it's so awkward to go to the student health centre and see the big fishbowl full of brightly-coloured prophylactics on the desk next to the kind-eyed elderly receptionist. "I..I want them, I know they're there for us, there's even a heart-shaped sign on the front that says 'Take what you need!' but...but...what if she's a widow? What if she hasn't had any in like, half a century? What if she's judging me, or jealous? How am I going to get any good use out of these if all I can think about is the old condom lady?" I remember gingerly taking a couple on my way out one day after having my arse x-rayed, just because I can't resist free stuff, and she looked at me, smiled, and said "Always the girls taking those. I don't think the boys can face me for them, but I've always insisted on having them out for you kids. Be safe!" I smiled as I left the building--my bruised but not broken coccyx still aching--then shuddered at the idea of ever using Sweet Old Lady Condoms.

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