Good morning GFPs and welcome to this, the last Wednesday missive for a while, because today marks the release of the FINAL episode of Visible Women Season 2. We’ve covered sexist pianos, murderous menstrual blood, concussions, default male economics and TOILETs, oh my! And today, we’re finishing up with a deep dive on contraception: why has there been so little progress since the pill was first approved over SIXTY YEARS AGO; is the lack of genuine innovation leaving the field open for unscrupulous actors to prey on desperate women; and what can we do to move things on a little (or, ideally, a lot)?

We speak to Chelsea Polis, a reproductive expert who was sued by a tech company after she raised concerns about the efficacy claims they made on social media about their contraceptive device; Donna Drucker, a historian of contraception; Sarah Cairns-Smith, a consultant who explains what the regulatory blocks to progress are; and Lisa Haddad, who takes us behind the scenes on the latest research, and fills us in on some truly amazing-sounding contraceptive options that are currently in the works — let me tell you, I am jealous as hell of the women who are going to get to use them.

I hope you’ve enjoyed these episodes as much as we’ve enjoyed making them. I’d love to hear your thoughts on this episode but also on the series in general — what did you like? What didn’t you like? What would you like to hear more of? What would you like us to investigate next? Hit reply and let us know!

Gender data gap of the week

Sticking with the contraception theme, this week we’re diving back into history. I want to tell you about a contraceptive scandal that Sarah Cairns-Smith mentioned in our interview, but which didn’t make it into the final cut of the episode.

One of the things we touch on in the episode is the number of women who just sort of…put up with whichever method of contraception they ultimately land on. They don’t like it. It may cause unpleasant side effects. But…it’s the best of a bad bunch. For me, that was the copper IUD, which I had fitted after trying various formulations of the pill back in the early 2000s; it was (and to date, remains) the only non-hormonal method available other than using condoms or, you know, the rhythm method.

I remember when I had it put in, there was this sense that I was doing something kind of dangerous and a bit mad. This was partly because there was still an idea at the time that IUDs were suitable only for women who had given birth (this is a misconception, but apparently it lingers). I went ahead anyway since, you know, there was literally no other reasonable option for me, (thanks science!) And endured well over a decade of heavy and painful periods as a result. But still, best of a bad bunch!

Since interviewing Sarah, though, I wondered if the whole not having given birth thing wasn’t the only issue making doctors reluctant to fit me with an IUD…

Let’s rewind to the 1970s. By all accounts, 2022 era Brits will feel right at home there hahaha.

As well as being an era of rolling blackouts and rampant inflation, the 1970s saw the introduction of a new IUD onto the market. The Dalkon Shield, which I’m going to call the DS for short.

Doesn’t it look lovely? And in fact, this crab-like product was marketed as a girl’s best friend. The Dalkon Shield was for everyone, no matter how troublesome!

One of the major advantages the company touted was its benefit for women who struggled with the side effects of the contraceptive pill (which at the time contained “nearly 100 times more progestin and 3 to 5 times as much estrogen as the pills we take today”, so if you think the side effects are bad now…).

In fact, the inventor of the DS, a gynaecologist called Hugh J. Davis, testified to Congress in 1970 about the dangers of the pill. Davis argued that birth control pills were so hazardous that physicians prescribing them were behaving irresponsibly. Women deserved a a safer alternative, he declared — and, handily, he happened to know of just such a device. He lied under oath about his financial interest in said solution.

During the four years the DS was on the market, millions of women had one fitted in the US alone, with an additional 1.7 million sold in other countries. It quickly became the most popular IUD available in the US, capturing 60% of the IUD market.

Hang on though…four years? That doesn’t seem like a very long time for a contraceptive device so magical that even disorganised women could use it to be on the market? You’re right, GFPs, you’re right. But the trouble was, you see, that the DS turned out to be…just not that effective.

An early study of the Dalkon Shield claimed a low 1.1 percent pregnancy rate, comparable to the birth control pill and superior to the 2 to 3 percent pregnancy rate of other IUDs. But that study was severely flawed, and apparently Robins knew it. It was conducted by Dr. Hugh Davis, the inventor of the Dalkon Shield, who received consulting fees and royalties from Shield sales and therefore was not an impartial judge. The study followed patients for an average of only 5.5 months after insertion, during the first three months of which the women were told to use an additional form of contraception [a minor detail that Davis failed to mention in his report]. (Source)

Women who dropped out of the study, “an important subgroup worth noting because of likely problems,” were also not included in the results. Likely problems like….getting pregnant?

When more carefully designed studies finally were done, the Dalkon Shield had a pregnancy rate of between 5 and 10 percent, far higher than other, safer, IUDs. But Robins [A.H. Robins, the company that sold the Dalkon Shield] never publicized this information, and held on until the end touting Davis's biased study and 1.1 percent pregnancy rate claims. (Source)

Imagine a company using flawed science to push products!

It also turned out that in any case, the product which had been used in the “trial,” such as it was, was in fact not the same product as the one was ultimately released onto the market. The study had identified problems which were corrected prior to marketing the new and improved DS — which itself had never been tested. Oh and they also lied to the FDA about it:

Copper sulphate was added to the plastic because new studies indicated that copper increased the effectiveness of IUDs. In 1971, a new IUD, the Copper 7, was ruled by the FDA to be a drug and not a device because copper ions were released that contributed to the device’s effectiveness. In an effort to evade oversight by the FDA and the labeling of the Dalkon Shield as a medication [which would result in regulation that at the time didn’t exist for medical devices], Robins lied to the FDA and claimed that the copper sulphate added, did not have any contraceptive benefit but only helped with imaging.

Perhaps even worse, however, although it’s a close call tbf, was the fact that the product was actually dangerous - that’s if we ignore pregnancy itself being dangerous.

A year after the DS’s introduction to the market, case reports of medical problems began to surface. These were dismissed by A. H. Robins, the company that sold the DS, as simply the result of poor insertion technique by doctors…and poor hygiene by women. When in doubt, blame the women, that’s what I always say.

It ultimately transpired that women who used the device were twice as likely as users of other IUDs to develop pelvic inflammatory disease, “a severe infection that can lead to damage to the reproductive organs, sepsis (blood poisoning), infertility or sterility, miscarriage (especially the potentially lethal mid-pregnancy septic abortion), even death within 48 hours of the first flu-like symptoms.”

This increased risk of infections was apparently all to do with the string which trailed down from the device. This string, which was there to make it easier to remove the DS, was made up of lots of thin filaments wrapped up together “like a cable consisting of several smaller wires wrapped together” and encased in a nylon sheath. The trouble was, the sheath was open at either end, meaning bacteria could travel up into the little gaps between the filaments, and then the tail acted as a “wick,” bypassing the antibacterial properties of the cervical mucus, and transporting the bacteria into the uterus.

This resulted in sceptic pregnancies and other severe infections, bacterial infections of the placenta and foetus, infertility and death. According to a Washington Post article from 1985, one year after the Dalkon Shield was finally officially recalled in 1984, 90,000 US women suffered from major complications from which many of them would never recover. 13,000 women were rendered infertile. And at least 21 women were dead.

The worst part? According to the same Washington Post article, court testimony (inevitably, there were thousands of lawsuits, with 200,000 women testifying that they had been injured by the Dalkon Shield) “shows that Robins officials knew about the wicking problem as early as June 1970, six months before the Shield went on the market. They refused to do anything about it because it would add to manufacturing costs and, later, because it would look like an admission that something had been wrong with the original design.”

The company also doubled down on their earlier technique, beloved by misogynists everywhere, of blaming the women:

As part of their legal defense of the higher than expected infection rate, these lawyers attempted to place the blame on poor technique by the physician and the woman’s high risk sexual behaviors by attacking the moral character of the women who used the Shield hoping to stem more lawsuits. Plaintiff women were asked intimate questions about their sexual practices, their hygiene, and their personal relationships. Such personal scrutiny ruined some of these women’s family lives, their reputations, and their careers

Slut-shaming the women they maimed. Stay classy, lads.

This was all able to happen thanks to a lack of regulation, which led to a major data gap. At the time the Dalkon Shield was manufactured, medical devices did not have to undergo the same stringent testing as medical drugs. In 1976, two years after the Dalkon Shield was removed from the market, a new law was passed, mandating the testing and FDA approval of all medical devices, including IUDs.

Studies conducted in the years following, led to recommendations that IUDs should be avoided in “nulliparous women [women who haven’t given birth], teenagers, and populations at increased risk for PID.” Thanks Dakon!

Meanwhile in the 21st century, class action lawsuits are underway in several countries around the world over another medical device we put up women’s vaginas that has been causing long-term and serious complications, infections, injury and death.

Default male of the week

This week’s default male of the week ALSO comes courtesy of podcast material that ended up on the cutting room floor.

When I interviewed Dr Donna Drucker, our contraceptive historian, I asked her how she got interested in contraception. She told me that her interest was first sparked by her PhD on the work of Alfred Kinsey. And then she said this:

And as you may know […] Kinsey wrote two large books, one called Sexual Behavior in the Human Male, which came out in 1948 and another that's called Sexual Behavior in the Human Female, which came out in 1953.

Of course he did. Still, at least he sex disaggregated his data, eh?

Job Opp of the Week

The excellent Women’s Budget Group, whose work readers of Invisible Women will know I cite heavily in my book, are looking for a new Comms Officer and a new Head of Global Partnerships. The work that this group does is indispensable - these are amazing opportunities for anyone who cares about women, data, and evidence-based policy.

Poppy pic of the week

That’s it! Until next time, my dear GFPs….xoxoxo