Comparing Birth Control Trials Today to Those in the 60s Ignores a Sea Change in Research Ethics

Vox has a wonderful article on the recently published male birth control study that is a useful corrective to the narrative that falsely equates it to the original studies of The Pill. Though I say ignore their title, too, because it’s also not that helpful of a narrative either. But the content is useful in arguing against what seems like a terrible and callous framing of the study in most commentary. The key line: “And, yes, the rate of side effects in this study was higher than what women typically experience using hormonal birth control.” Also, can we point out if something like 10 women a year at a school like UVA were committing suicide and it might be linked to a medication they were taking, people would probably be concerned? There’s something disturbing about well-off American women mocking these effects that seemed to disproportionately affect men of color (the most side effects were reported from the Indonesian center, followed by the Chilean center).

My bigger concern here, though, is that most people seem to not understand (or are basically ignoring) how modern research ethics works. For instance, the notion of benefits being weighed in the evaluation of continuing the study aren’t merely the potential benefits of the treatment, but the added benefit of acquiring more data. This was an efficacy study (so I think Phase II, or maybe it was combined Phase I/II, although it might be a really small Phase III trial). It seems like the institutional review board felt enough data had been collected to reach conclusions on efficacy that more data didn’t justify the potential high rate of adverse effects. Which also DOES NOT mean that this treatment has been ruled out forever. The authors themselves recommend further development based on the 75% of participants claiming they would use this birth control method if it were available. I imagine they will tweak the formulation a bit before moving on to further trials. Also, it’s sort of amusing that complaints on this come from people who typically think moves toward regulatory approval are controlled by Big Pharma at the expense of patient health.

Yes, this is different than the initial birth control trials. Yes, the women of Puerto Rico were chosen as human guinea pigs. Though it’s worth pointing out another major factor in choosing Puerto Rico was that it actually had a pretty well organized family planning infrastructure in the 50s and 60s. Admittedly, there’s more racism almost certainly coming into play there, because the politics of family planning were super complicated through the early and mid 20th century and there were definitely overlaps between eugenics and family planning. It’s also worth pointing out the study was encouraged by Margaret Sanger (and earlier studies by Planned Parenthood). Also, the FDA didn’t even initially approve Enovid for contraception because the atmosphere was so repressive back then on reproductive health; it was for menstrual disorders but prescribed off-label for contraception, which is why we know so many women desperately wanted the pill. Heck, even the Puerto Rico study was nominally about seeing if the pill helped with breast cancer. It took another year of discussion by the researchers and companies to get the FDA to finally approve contraception as an on-label use. The company making the pill was actually so concerned about the dosage causing side effects they begged for FDA approval for a lower dose just for contraception (see page 27-28 there) but were rebuffed for another year or two and they refused to market the initial dose for solely for contraception. (Also, to clarify, no one is taking these medications anymore. These versions of the pill were phased out in the 80s.)

Was there sexism at play? Absolutely, and I totally get that. But that doesn’t mean the narrative from 2016 neatly maps onto the narrative of the 1950s and 1960s. Which brings me to my last point. If your view of research ethics is primarily colored by the 1960s, that’s terrifying. You know what else happened at the same time as the initial contraception pill studies? The US government was still letting black men die of syphilis in the name of research. The tissue of Henrietta Lacks was still being cultured without the knowledge or consent of anyone in her family. (And the way they were informed was heartbreaking.) People were unknowingly treated or injected with radioactive material (one of many instances is described here in the segment of testimony by Cliff Honicker). One study involved secretly injecting healthy people with cancer cells, and to prove a theme, those cells were descendants of the ones originally cultured from Henrietta Lacks. Heck, there’s the Milgram experiment and then the Stanford Prison Study was in the 70s. The ethics of human experimentation were a mess for most of the 20th century, and really, most of the history of science. Similarly, medical ethics were very different at the time. Which isn’t to justify those things. But don’t ignore that we’ve been working to make science and research more open, collaborative, and just over the last few decades, and people seem caught up in making humorous or spiteful points than continuing that work right now.

(Other aside, it’s worth pointing out that the comparison here probably does have to be to condoms, which you know, skip the side effects though their typical effectiveness rate is worse. Most of the methods don’t obviously change ejaculate, so unless measuring sperm concentration and motility is a couple’s idea of foreplay, sexual partners who don’t know each other well will still probably want a condom [or unfortunately another method, because yes, the system is sexist and women are expected to do more] as assurance. It’s worth pointing out the study design only worked with “stable” couples who were mutually monogamous and planned on staying together for at least a year during the duration of the study, so there presumably was a high degree of trust in these relationships.)

Red Eye Take Warning – Our Strange, Cyclical Awareness of Pee in Pools

The news has been abuzz lately with a terrifying revelation: if you get red eye at the the pool, it’s not from the chlorine, it’s from urine. Or to put it more accurately, from the product of chlorine reacting with a chemical in the urine. In the water, chlorine easily reacts with uric acid, a chemical found in urine, and also in sweat, to form chloramines. It’s not surprising that this caught a lot of peoples’ eyes, especially since those product chemicals are linked to more than just eye irritation. But what’s really weird is what spurred this all on. It’s not a new study that finally proved this. It’s just the release of the CDC’s annual safe swimming guide and a survey from the National Swimming Pool Foundation. But this isn’t the first year the CDC mentioned this fact: an infographic from 2014’s Recreational Water Illness and Injury Prevention Week does and two different posters from 2013 do (the posters have had some slight tweaks, but the Internet Archive confirms they were there in 2013 and even 2012), and on a slightly related note, a poster from 2010 says that urine in the pool uses up the chlorine.

A young smiling boy is at the edge of a swimming pool, with goggles on his forehead.

My neighborhood swim coach probably could have convinced me to wear goggles a lot earlier if she told me it would have kept pee out of my eyes.

Here’s what I find even stranger. Last year there was a lot of publicity about a study suggesting the products of the chlorine-uric acid reaction might be linked to more severe harm than just red eye. But neither Bletchley, the leader of study, and none of the articles about it link the chemicals to red eye at all, or even mention urine’s role in red eye in the pool. Also, if you’re curious about the harm, but don’t want to read the articles, the conclusion is that it doesn’t even reach the dangerous limits for drinking water. According to The Atlantic, Bletchley is worried more that it might be easier for an event like a swimming competition to easily deplete the chlorine available for disinfecting a pool in only a short amount of time. This seems strange because it seems like a great time to bring up that eye irritation can be a decent personal marker for the quality of the pool as a way to empower people. If you’re at a pool and your eyes feel like they’re on fire or you’re hacking a lot without swallowing water, maybe that’s a good sign to tell the lifeguard they need to add more chlorine because most of it has probably formed chloramines by then.

Discussion of urine and red eye seems to phase in and out over time, and actually even the focus of whether its sweat or urine does too. In 2013, the same person from the CDC spoke with LiveScience and they mention that the pool smell and red eye is mainly caused by chloramines (and therefore urine and sweat), not chlorine. A piece from 2012 reacting to a radio host goes into detail on chloramines. During the 2012 Olympics, Huffington Post discussed the irritating effects of chloramines on your body, including red eye, and the depletion of chlorine for sterilization after many Olympic swimmers admitted to peeing in the pool. (Other pieces seem to ignore that this reaction happens and assume it’s fine since urine itself doesn’t have any compounds or microbes that would cause disease.) In 2009, CNN mentions that the chloramines cause both red eye and some respiratory irritation. The article is from around Memorial Day, suggesting it was just a typical awareness piece. Oh, and they also refer to a 2008 interview with Michael Phelps admitting that Olympians pee in the pool. The CDC also mentions chloramines as potential asthma triggers in poorly maintained and ventilated pools and as eye irritants in a web page and review study that year. In 2008, the same Purdue group published what seems like the first study to analyze these byproducts, because others had only looked at inorganic molecules. There the health concern is mainly about respiratory problems caused by poor indoor pool maintenance because these chemicals can start to build up. Nothing about red eye is mentioned there. In 2006, someone on the Straight Dope discussion boards refers to a recent local news article attributing red eye in the pool to chlorine bonding with pee or sweat. They ask whether or not that’s true. Someone on the board claims it’s actually because chlorine in the pool forms a small amount of hydrochloric acid that will always irritate your eyes. A later commenter links to a piece by Water Quality and Health Council pinning chloramine as the culprit. An article from the Australian Broadcasting Corporation talks about how nitrogen from urine and sweat is responsible for that “chlorine smell” at pools, but doesn’t mention it causing irritation or just using up chlorine that could go to sterilizing the pool.

Finally, I just decided to look up the earliest mention possible by restricting Google searches to earlier dates. Here is an article from the Chicago Tribune in 1996.

There is no smell when chlorine is added to a clean pool. The smell comes as the chlorine attacks all the waste in the pool. (That garbage is known as “organic load” to pool experts.) So some chlorine is in the water just waiting for dirt to come by. Other chlorine is busy attaching to that dirt, making something called combined chlorine. “It’s the combined chlorine that burns a kid’s eyes and all that fun stuff,” says chemist Dave Kierzkowski of Laporte Water Technology and Biochem, a Milwaukee company that makes pool chemicals.

We’ve known about this for nearly 20 years! We just seem to forget. Often. I realize part of this is the seasonal nature of swimming, and so most news outlets will do a piece on being safe at pools every year. But even then, it seems like every few years people are surprised that it is not chlorine that stings your eyes, but the product of its reaction with waste in the water. I’m curious if I can find older things from LexisNexis or journal searches I can do at school. (Google results for sites older than 1996 don’t make much sense, because it seems like the crawler is picking up more recent related stories that happen to show up as suggestions on older pages.) Also, I’m just curious about the distinction between Bletchley’s tests and pool supplies that measure “combined chlorine” and chloramine, which is discussed in this 2001 article as causing red eye. I imagine his is more precise, but Bletchley also says people don’t measure it, and I wonder why.

Public Health Involves Science Communication, Too

This tweet has been making the rounds on social media lately.

I actually think the tweet is funny, but I’m really tired with the way media seems to be considering actual policy concerns with it. Cutting off flights would have seriously hampered the Ebola response. But there is in fact a different policy used for traveling to/from regions with vaccine-preventable outbreaks: it is often recommended that you go and get the vaccine before travelling there or if you are from a region with an outbreak, you may be asked to prove you have been immunized. It would be perfectly reasonable for Nigeria and other countries to demand American travellers prove that they are vaccinated against measles as part of obtaining a visa. That policy isn’t possible with diseases without vaccines that we don’t have effective, standard treatments for.

And this has become an increasing concern of mine with so much of the coverage about the measles outbreak. There is actually a well-documented literature about effective science communication, but based on news articles, you wouldn’t know it exists. The idea that science communication is only about filling people’s head with scientific knowledge (the “bucket model”) has been discredited for over 20 years. Treating your audience snarkily like they know nothing (or really, treating your actual, narrow audience like they’re geniuses and everyone in the outgroup like they’re insane) has never really been shown to be effective in technical matters despite half the business model of Mic and Gawker.

What do Einstein and Elvis Have In Common?

  Aside from fantastic hair and piercing eyes?

They can both help diagnose dementia.

Recognizing famous pop culture figures can be used as a measure of several mental tasks, like the ability to recognize faces (which can be a really complicated process, resulting in the common phenomenon of seeing faces in random objects called pareidolia) and how easily a person can name things. One problem that the researchers came across when evaluating people was how old the original face test was. A person in their 70s or 60s may know what Emperor Hirohito looked like, but could you expect that of a 40-year-old coming in to see if they had early-onset dementia? So the team at Northwestern decided to modernize the sample. Einstein made the cut to stay, since his mug can still be found everywhere in our culture. But now we have Oprah instead of Martha Mitchell (the wife of Nixon’s attorney general, evidently).

Weird Science News – December 2012 Edition

While I try to be diverse in sources, I have to link to The Atlantic again.  The November/December had a great article/short fiction piece about recent advances in biotechnology.  While I think it borders a bit on the paranoid at times (anyone can get genes!!11!), it also paints a pretty accurate picture of the convergence of molecular biology and computer science that is rapidly defining synthetic biology.  I just think the one thing the author forgets to emphasize is that while we can combine lots of genes, we still don’t understand what many do or the reverse problem, which genes control functions we want to have in synthetic organisms.  And as we learn more about epigenetics, factors that influence development beyond the genome, I wouldn’t be surprised if we learn that many things we want to splice into organisms require more complicated interactions than just inserting gene A into target B.

Our second, more whimsical bit of news for the day is also courtesy of The Atlantic.  Boeing wanted to test how well its in-flight WiFi systems work.  The challenge is that you also need something to account for the presence of passengers if you want to make sure the signal reaches everywhere in a crowded plane.  But it’d probably be hard (and expensive) to recruit a plane’s worth of volunteers to just sit around while you check signal strength.

Forgive the pun!

Not a couch potato

So what makes a suitable replacement? Potatoes. Lots and lots of potatoes, arranged in vaguely humanlike shapes.  How does that work?  When dealing with electromagnetism, one of the most important traits of the human body is that we’re mostly water.  And water is dielectric, which basically means the electrons in water atoms align to reduce the electric field in water when it is exposed to an external field, like say the wave from a WiFi router.  So if you want a quick and dirty approximation to people, you can basically model a person as an equivalent volume of water.  This would be difficult to make as a physical experiment.  That’s where spuds save the day.  Potatoes, it turns out, are also mostly water (this is also why you avoid cutting them to make mashed potatoes – it’d be a soupy mess) .  And they’re a lot easier to buy and move around than giant jugs of Aquafina.

I’m Calling a Slight Win for Myself

So you may recall my previous post looking at anti-science trends in the left.  One of the points I made was that the anti-vaccine movement is not limited just to progressives, although I admit I’m not sure where it started.  Almost as if to prove the point, the Congressman for Indiana’s 5th district, Dan Burton, recently held a House committee investigation on “autism-related issues”, which seemed to include a lot of questions about whether vaccines contribute to autism.  Important for my argument, Congressman Burton and his colleague Bob Posey (of Florida) are both Republicans.  And the article shows that their statements don’t just seem like basic questioning of the issue.  Instead, both Congressmen seem openly hostile to the scientists they brought in to testify, and these scientists are directors of institutes in the CDC and NIH (which are pretty big deals in medical research). I can be fine with some vaccine skepticism, but you need to show you’re operating in good faith.  And not recommending random medical treatments that can potentially kill people with the wrong condition.