Imagine a completely new method of contraception. Instead of taking it every day at the same time, you only take it once a week. If you don't have regular sex, you can stop taking this pill and just take it after you've had sex, it works great as a "morning after" pill. Many of the side effects associated with current birth control pills, such as weight gain, mood swings, and decreased libido, aren't an issue because it doesn't contain hormones. If you take it for a long time, it will thin your uterus and eliminate your period. It has the ability to treat and even prevent breast cancer.
It sounds too good to be true. This hypothetical birth control pill already exists, has been extensively researched for both safety and efficacy, and is an FDA approved medication. What's the catch? Republicans around the country are attempting to ban the abortion pill, known as the "abortion pill". At a time when abortion access feels precarious, abortion advocates are hoping that a focus on the contraceptive properties of Mifepristone will help tear down the artificial wall between abortion and contraception.
The same mechanism that makes mifepristone work for abortions could prevent ovulation altogether
It isn't news that Mifepristone's contraceptive properties are news. The compound's efficacy as both emergency contraception and a birth control pill was examined by researchers throughout the 90s and 2000s. The general consensus was that it showed great promise as a non-hormonal contraceptive, despite some debate over whether it worked best as a weekly or monthly contraceptive. The same mechanism that it uses to stop fetal development can also be used to stop ovulation and thin the uterus.
Gemzell Danielsson thinks that research interest in the drug waned because of abortion stigma. ulipristal acetate had the same promise as an emergency contraceptive and fibroid treatment. According to Gemzell Danielsson, the decision was made that ulipristal acetate should be developed more for contraceptives than for abortion.
ulipristal is riskier than Mifepristone. There have been rare instances of serious damage to the bile duct when taking regularly to treat fibroids. Mifepristone has been found to be safe even when taken in large amounts on a daily basis, even for patients withCushing's Syndrome. Gemzell Danielsson has been involved in studies that show promise for using the drug for breast cancer prevention.
Gemzell Danielsson is working with Dr. Rebecca Gomperts, best known as the founder of abortion access organizations Women On Waves and Women on Web.
Seven hospitals are on board to participate in a study on the pill’s reliability
Women on Web has convened a team of medical, scientific, and ethics experts from around the globe to conduct a year-long clinical trial involving nearly 1000 women in the Netherlands. The study was designed to follow FDA and European Medical Agency protocols and has already recruited seven hospitals as participants. Women on Web wants to find out where Gemzell Danielsson's research left off, determining the most effective dosage for contraceptive use, as well as any unforeseen side effects that might arise from weekly use of low-dose mifepristone.
Women on Web will register the medication as a contraceptive if the study shows that it is safe and effective. The medication will be distributed by a number of organizations. There is a chance that the FDA will approve a low-dose contraceptive pill along with the abortion pill.
Mifepristone could be distributed more widely and cost less. Insurance companies are required to cover contraception, but abortion is not. Regulations that aren't applied to the Cushing's formula are binding providers who wish to distribute the abortion formula.
“It’s a very steep mountain to climb”
It isn't guaranteed. Beverly Winikoff, president of Gynuity Health Projects, is not sure if the end results of this study will be the same as previous ones. She says that the mountain is very steep. Even if the compound has already been approved for other uses, it can be difficult to meet the FDA's requirements. There are several hurdles to overcome in the best-case scenario for a contraceptive version of Mifepristone.
Funding is one of the obstacles. There is no major profit incentive behind this study because contraceptives are generally cheap and out of patent.
Grants have proved difficult to get. Women on Web applied for funding through a ZonMw program. The application committee responded in a very telling way. Repeated prescriptions run the risk of saving up and illegal resale to induce an abortion. You are asked to explain how the drug is used in legal abortion practice.
She found it odd that abortion is legal in the Netherlands and accessible to everyone. She says that the argument isn't about the medication but about the distrust of women. There are a lot of easy to use items that can be harmful if used wrong. Mifepristone is viewed in a different way. The European Medicines Agency and Dutch Pharmaceutical Agency were the only funders who had this concern. Giving money to things is more political according to Dr. Gomperts.
Mifepristone offers new options that other birth control methods don’t
Women on Web is trying to raise money for a scientific study. The amount needed to begin the initial phase of research is $500,000. It is not known how successful the strategy will be, but Dr. Gomperts is still excited by the idea of putting her study's funding directly in the hands of the people who could benefit from its findings the most.
This isn't the first time medical research has turned to the people. Project violet was launched about a decade ago by the oncologist and cancer researcher Jim Olson. The ethics of using crowd funding for medical research was discussed, but it was not the same as what Women on Web is doing. Dr. Gomperts and her team are researching a well-studied, out-of-patent medication that anyone can manufacture and profit from, so there isn't much concern about Women on Web enriching itself through research. Donations used to fund a number of research organizations are not different from their use of GoFundMe.
If the study goes well, it will hopefully break down some of the stigma around the drug and allow it to be seen as more than just an abortifacient. Gemzell Danielsson says there's a lot of potential. The connection to abortion was the reason for the delay.