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Women in News

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It recently went public that a study on injectable hormone contraceptives for men was terminated early due to adverse side effects reported by a significant number of men participating in the study. These side effects included acne, injection site pain, increased libido, headaches, weight gain, and mood disorders.

The premature discontinuation of this study has stirred up a considerable amount of upset and has been receiving a great deal of critical press coverage the past few weeks. Women are infuriated by the fact that this study was halted, seemingly as a result of risk factors that women taking oral contraceptives are expected to tolerate as part of the cost of using this form of contraception.

After looking into the most recent study on male contraceptives and the history of the female birth control pill, I soon discovered statistics that are upsetting, unsettling, and highlight blatant misogyny and the clear double standard that exists when it comes to hormonal contraceptive options.

Women’s health has been an important issue this past election season, and the results of the election have made many concerned that many women will no longer be able to afford birth control. Under President Barack Obama’s Affordable Care Act, female oral contraceptives dropped significantly in cost, and, with some insurance coverage, have become free of cost. Donald Trump has promised to repeal the Affordable Care Act (ACA) during his first one hundred days in office, and with ACA will go inexpensive birth control options for women. So isn’t this all the more reason to look into new, alternative contraception methods?

The results of this most recent study, along with an explanation as to why the the study was terminated, were published in the Journal of Clinical Endocrinology and Metabolism (JCEM) this past month. If you have the time, I do highly encourage you read the article, as it illustrates in greater depth many of the statistics I highlight here. This publication indicates that although the drugs had a 95 percent efficacy rate, 65 of the 913 participants (around 7 percent) reported the development of mood disorders soon after beginning the study.

However, none of these mood disorders were described as “severe.” In fact, only two of these cases were considered “moderate,” and the other 63 were categorized as “mild.” It is also interesting to note that 62 of these 65 cases were all reported at the same center in Indonesia. During the course of this study there was a death by suicide of a single participant; however, his family stated that he had been diagnosed with depression prior to beginning the study and “he could not cope with his academic pressure,” essentially ruling out the conclusion that his death was in any way caused by the drugs he was being administered.

So why was the study canceled?

Well, two private safety committees deemed the study unsafe to continue because of the rate at which mood disorders were being reported.

I do not see a problem with the fact that the study was terminated due to the adverse side effects the participants were facing; however, I do have problem with the double standard this creates by default. A woman taking oral contraceptives faces the same risks these men faced in this study, yet it is commonplace for a woman to take a birth control pill in spite of these side effects.

It is interesting to look into the history of the birth control pill, particularly looking at preliminary studies in the 1950s with Enovid, the first hormonal birth control pill. Trials were conducted in Puerto Rico in order to avoid American anti-birth control laws, and, within the first few months, the study appeared to prove that the pill was 100 percent effective. However, there were so many adverse side effects that Dr. Rice-Wray, a female doctor working on the trails, wanted to discontinue the study.

Early on in the study two women, who appeared entirely healthy prior to taking Enovid, died of unknown causes, yet no autopsies were conducted to determine the cause of death and the study was continued without hesitation.

This is what absolutely infuriates me: to say that the study on male birth control should not have been stopped because ones on female birth control were not is not the correct answer. Two wrongs do not make a right, but in the case of this most recent male hormonal contraceptive study, it was stopped abruptly after the death of a single participant whose death was entirely unrelated to the use of the drug.

People make the argument that the additional side effects of the drug are what caused the committees to halt the study, but, as already discussed, these side effects are the same ones that women who take birth control as part of their daily routine face. In fact, the “high rates of depression” which were reported during this study are markedly lower than the rate of depression reported by women on birth control.

While 30 percent of women taking oral contraceptives report depression, only 3 percent of men from this study reported depression.
In surveys conducted during and following the study on male hormonal contraceptive injections, nearly 90 percent of couples involved in the study responded by saying that they would use the injections as a primary form of birth control should it become available on the market.

So the problem is not with the participants as much as it is with the sponsors and donors for this research. When a sponsor pulls out funding halfway through a study there is no way a drug can be approved and marketed. The study is terminated, and it goes back to square one.

As it is with most things, money is the issue, and people are not willing to put the necessary money into research to improve contraceptive options for men.

Women’s health issues and contraception are a branch of health care that is expected to change tremendously in the upcoming months, first and foremost from a financial perspective. It will be interesting to see if these changes further inhibit research on male contraceptive methods or if they encourage such research.
I certainly hope the latter.