The secret history of birth control pills
by Sarah Kliff
The History of the Birth Control is barely believable and ethically questionable
It's hard to decide which is the crazier part of birth control pills
[http://www.vox.com/2014/9/19/6418767/birth-control-pills-effectiveness-how-to-use-common-questions] journey from experimental contraception to a federally approved drug. Was it when they were tested on non-consenting, male patients at mental hospitals or when some women were given the pill as a treatment for infertility?
Development on the birth control pill began in 1950, when Planned Parenthood founder Margaret Sanger approached a scientist named Gregory Pincus to begin work on a reliable, easy-to-use contraceptive. Pincus was working at an independent lab in Massachusetts, the Worcester Foundation for Experimental Biology.
What happens next is, honestly, a bit unbelievable. The pill ultimately became an integral and important resource for millions of women, allowing them to take control of their fertility, their families, and their lives. But the path to building this-now ubiquitous drug was paved with questionable ethics and dodgy research methods that would never pass muster today. The creators of birth control are responsible for developing a revolutionary contraceptive but they misled their test subjects, many of whom were not equipped to give consent, along the way.
All of this is recounted in a new book [The Birth of the Pill [http://www.amazon.com/The-Birth-Pill-Reinvented-Revolution/dp/0393073726]. I recently spoke with its author, Jonathan Eig, about the surprising and unsettling history behind oral contraceptives.
1) Women were tricked into being birth control pill test subjects
In the middle of the 20th century, it was still illegal to distribute contraceptives in some states. This presented a challenge for researchers who were developing them: it was illegal to distribute their product to the women they would need for trials.
"The first crazy thing is that [researchers] have to prove that progesterone and estrogen [two hormones] can stop ovulation," Eig said. "How are they going to get over that hurdle, if you can't test that on women? They don't go over the hurdle; they go under it. They begin to pass it off to women who are seeking fertility treatments. And they basically told them, 'It will make you really infertile, but then you might get pregnant after that."
2) 130 women tried the pill before it went to market
When the Food and Drug Administration approves a drug these days, it has usually been tested on thousands of patients during three specific testing phases that can take more than a decade to complete.
This is essentially the opposite of how the birth control pill came to be. When the FDA approved the drug in 1960, it had been tested on exactly 130 women. Even back then, Pincus and his team of researchers knew the FDA would find this tiny cohort suspect. So they fudged the numbers a bit.
"To make his studies sound more impressive, [Pincus] stopped talking about the number of women participating in trials," Eig wrote in his book. "In fact, he stopped talking about women altogether. Instead, he talked about the number of menstrual cycles observed in the experiments. 'In the 1,279 cycles during which the regime of treatment was meticulously followed,' he wrote in one study, 'there was not a single pregnancy.'"
The study "sounded way bigger than it actually was," Eig said. "They gave out 40,000 pills but only about 100 women were taking those pills. It could have never been approved if they handed in that research today. This is a drug that they're proposing for healthy people to take every day. It's not like popping an aspirin every once in a while."
3) Birth control was mostly tested in the slums of Puerto Rico and sanitariums
"The part that struck me as most fascinating was when they have to go to Puerto Rico, where some women are willing to try it," Eig said. Working in Puerto Rico was easier because the territory did not bar the distribution of birth control. Still, there were hurdles to convincing women to take a largely untested medication. The researchers' solution ultimately boiled down to manipulating women, recruiting college students and threatening them with bad grades if they didn't participate in trials.
"That they thought they could operate like this is mind-boggling," Eig said.
Then, there were the tests in mental hospitals. Eig interviewed Enoch Calloway, who worked at Massachusetts' Worcester State Hospital when Pincus tested the pill there. "You could do experiments there you would never think of doing these days," Calloway told him. "You never asked the patients for permissions. Nobody supervised. I'd say, 'John, would you mind if I gave you a shot to see what it does to you?' And he'd say, 'Oh, sure doc.'"
Testing in the state hospital did not turn out to be especially helpful for reasons that, in hindsight, were completely predictable. "The women were not having sexual intercourse, which made it difficult to be certain they weren't ovulating," Eig wrote. "It was similarly difficult to tell whether the compounds affected ovulation because psychiatric problems disrupted the menstrual cycles of many women."
4) Researchers tested birth control on mentally-ill men for no clear reason
Patients at an Italian mental hospital in the 1920s
"Pincus believed that progesterone might lower their sperm counts and reduce their sexual desire," Eig wrote. "It's not clear if he was interested in this for purposes of birth control or merely for curiosity. [Margaret Sanger and Katherine McCormick, the two main funders of the research] had made it clear they weren't interested in a birth-control pill for men."
The experiments on men did not go especially well: "One psychotic male subject appeared to have shrunken testicles after taking progesterone for five months â€¦ the investigation went no further in part because the researchers couldn't persuade the male asylum patients to produce semen samples."
In the end, researchers concluded that the asylum patients were "just as psychotic as they were when we began to give them the drug."
5) The doctor running many of the trials was a devout Catholic
John Rock is a pivotal character in Eig's book and in the development of the birth control pill. He was an obstetrician and gynecologist based in Marlborough, Massachusetts, who recruited the first women for Pincus' birth control trials. He also happened to be a devout Catholic.
"He didn't have to be sold on this," Eig said. "He believed the Catholic Church was wrong, and that sex was a very important part of marriage. It wasn't just for procreation. He saw the challenges his patients faced with unplanned pregnancies, and he was able to reconcile his faith and his personal beliefs.
"He was very brave to make this stand on the pill. And it really lent a lot of credibility to the pill. Instead of having this one scientist [Pincus], you had this very handsome, very conservative-looking doctor who was Catholic saying Catholics should be fine using it."
[Note: An article that belongs in the Tangled Web collection -- that includes Planned Parenthood and John Rock! There is also a long history of the U.S. being involved in similar highly unethical medical research (often touted for national security reasons) -- even since post-WWII to the present. References on request. Given that IVF was mis-sanctioned by the FDA, what about the dozens of ARTs (Artificial Reproductive Technologies) that have already been graciously offered to the public for 'infertility' purposes for the last decades? ARTs do not need to use fertilization to produce a new human embryo. And some ARTS involve genetically engineering sperm and oocytes before fertilization with genes that researchers don't really know much about, or genetically engineering embryos after fertilization. Where are those 3 phases of clinical trials? Neither IVF nor ARTs are even regulated here. And given the recent efforts of NIH and others with invested interests to do away with the requirement of "informed consent" from those participating in clinical trials, this should give the public pause. The original publication has been deleted or moved.-- DNI]