A Premature Finish
Have you heard the joke about the male contraception trial? It finished prematurely.
Recently there have been a lot of articles posted around the internet about the male birth control shot and the recent decision to prematurely stop human trials. The decision was made after the side effects experienced by some men in the trial were considered too severe. The shot is now set to undergo further development until researchers can find a way to reduce those side effects. An important byproduct of this recent turn of events is the discussion on female hormonal contraceptives. Some have shamed the men of the trial and the decision to end it early because many of the symptoms considered too severe are commonly experienced by a large number of women currently using FDA-approved contraceptives. Among these symptoms, those that were most important to shutting down the trials were depression and mood swings. Both symptoms, some would argue, are felt by women monthly, whether using contraceptives or not.
According to a CNN report on the trial, the male contraceptive method was 96% effective for those participating–compared to 99% effectiveness of the birth control pill if taken correctly. 20 out of 11,491 of participants who reported unpleasant side effects dropped out of the trial early. Also, despite the number of participants who experienced those side effects, 75% of them said they would be willing to use it again as contraception, though part of that has been attributed to the positive effects of the testosterone in the drug. Basically, it would seem that the 25% who would not retake the drug was enough evidence that the symptoms were too severe. Many believe that this is a little ridiculous. However, there are other, more serious underlying reasons the study was shut down. One article from the Popular Science Magazine stated that when the drug entered the second phase of its trial and moved to testing larger sample groups the side effects increased in frequency and severity. Also it seemed that this new development was skewed toward certain testing areas. These discontinuities were ultimately what halted the trial.
The outrage surrounding what seems to be the coddling of the male participants was definitely misinformed. Most of it is seemed to be trying to make the point that women are stronger and are more willing to handle almost identical side effects and how the trial was unreasonably cut short. Instead of comparing the strength of women to that of men and the perceived sexism within this particular trial, it’s more important to use the trial as a way to recognize how women should have been treated during the clinical trials for the female contraceptive. Those trials and the women who experienced them were crucial to gaining the rights we have come to expect today during all experimental drug testing. In an article published by PBS, one of the earliest birth control pill trials was conducted in Rio Piedras, Puerto Rico. The women in this trial were exploited because of their race, poverty status, and lack of education. It was believed that if those women could follow the instructions for the drug, then it would prove that any women could. They also weren’t informed that they were taking part in a clinical trial or that what they were taking was experimental and could have numerous health risks. When women ultimately began dropping out of the trails in Puerto Rico, subjects were recruited from different areas and in some instances forced to take the drug without their consent. In one case, women who were confined in a mental asylum were used as test subjects. In addition to these unethical methods, many of the side effects the women experienced were completely disregarded, which if taken seriously, were severe enough to consider the drugs unacceptable for the general population. Despite all of this obviously appalling evidence, technically these studies were conducted within the grey area of legality at the time. There was a severe lack of informed consent policies in the 1950s the time period in which the research took place. It was studies like these that made birth control one of the leading reasons we have strict informed consent guidelines, as well as other ethical guidelines for human trials, today.
So instead of berating those for quitting the male contraception clinical trial, we should take this as an opportunity to appreciate the women who suffered so that a clinical trial is conducted in such a way that the complaints of its subjects are heard. Without them we wouldn’t have the kind of contraception we have today, and clinical trials would not have to meet as high standards. The fact is the perception of the weak-minded male participant is the wrong way to approach the news of this trial. It’s possible that the lower standards of the FDA during the years that the female contraceptive was developed could have meant different things for the male trial conducted today. If anything the recent news should spark a debate on whether women should demand a better quality for their own contraception and serve as a reminder of how we got the standards we have today.
Marilu DeSimone is a third year who finishes all of her essays…prematurely.