Ruminations

Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Sunday, April 16, 2023

Mifepristone, an Essential Medicine

"Because mifepristone alone will not always complete the abortion, FDA mandates a two-step regimen; mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother's womb."
Judge Matthew Kacsmaryk, Texas-based district court judge, April ruling
 
"Note that nowhere in the medical literature does it say that mifepristone 'halts nutrition, and ultimately starves the unborn human until death'."
Dr. Daniel Grossman, professor of obstetrics, gynecology and reproductive sciences, University of California, San Francisco
 
Several packages of a medication are shown next to cups.
Reuters
"Any way that you can get mifepristone to a pregnant person who does not want to be pregnant is safe."
"The thing that I most fear is that people might read about what's happening in the U.S. and believe they don't have options here [in Canada]."
"We know, historically, that people sometimes take desperate measures or even feel that they can't continue their own life if they wouldn't have access to [abortion] care."
"We don't want people believing that what they're hearing in the United States is the case here."
"Canada is working with the science behind this. What's happening in the States is not reflecting scientific evidence."
Dr. Wendy Norman, researcher in sexual and reproductive medicine, University of
British Columbia

"We should also be concerned about the expansiveness of tactics that people are using to rationalize their anti-abortion stance, so, discrediting the FDA."
"[Any argument that the drug shouldn't have been approved 20 years ago is] very limp."
"Over 202 studies have been done that say this is a safe and effective abortion pill."
Farrah Khan, executive director, Action Canada for Sexual Health and Rights
A woman protests in support of access to abortion medication on March 15, 2023 in Amarillo, Texas.
Protests in support of access to abortion medication.  David Erickson / AP
There is concern among Canadian doctors that the uncertainties about abortion procedures as a necessary health alternative for women unwilling to carry a pregnancy to birth may cause problems in Canada, as a spillover from the situation now prevailing in the United States. Canada's largest, most active 'pro-life' group has expressed satisfaction that the furore over abortion rights in the United States may lead Canadian women to engage in 'kitchen table' discussions brings to mind the horrors of botched abortions when women died during primitive abortions on kitchen tables when medical abortions were closed to them.

Last June abortion rights in the United States was sent into a tailspin when the Supreme Court ruled on a challenge overturning Roe v.Wade and in the process the assurance of the federal constitutional right to abortion in the United States came to a thudding halt. Since then, a number of American states have banned abortions while others have instituted time limits during pregnancy. More latterly an appeals court ruled that mifepristone can remain on the market while imposing restrictions; halting the pill by mail order and its availability only through seven weeks of pregnancy as opposed to the Food and Drug Administration-approved ten weeks.

The drug has been on the market since it was approved by the FDA 23 years ago as a safe, reliable abortion pill. Health Canada authorized use of the drug in 2014 following one of the lengthiest drug approval processes on record, for the drug once known as RU-486. Some 87,495 abortions wee tallied in 2021 in Canada, according to the Canadian Institute for Health Information. Of those abortions, 40 percent were medical abortions with the use of mifepristone, the two-drug regimen sold under the brand name Mifegymiso.

A large study of abortions performed in Ontario found no surge of abortions followed, once restrictions on the use of Mifepristone were lifted as well as "no material changes" in the incidence of serious outcomes. The study concluded that serious adverse events occurred at 0.04 percent following mifepristone use. The abortion drugs are free of charge in every Canadian province and "primary care practitioners of all stripes" are able to prescribe it for use within the first nine weeks of pregnancy.

Mifepristone has been approved for use in abortions by every drug regulator in high-resources countries. It is listed as an essential medicine by the World Health Organization, which names it as a non-invasive and highly acceptable option to pregnant persons. "In order for anything to get on the [essential medicines] list", points out Dr Norman, "a high standard of safety must be proven". There are, however, side-effects and risks with the use of the abortion pills.

Painful cramps can ensue with their use and heavy bleeding, along with nausea, vomiting, diarrhea or dizziness. There is a warning on the product monograph that Mifegymiso can lead to serious bacterial infection, inclusive of rare cases of fatal septic shock. Over 5.6 million American women have made use of mifepristone in a pregnancy termination since its approval in 2000. There were 28 deaths attributed to the drug and reported to the FDA up to June of 2022; nine deaths associated with sepsis.

Canada saw 41 serious adverse reactions reported to Health Canada, one death of a 19-year-old included, from septic shock. There are understandable concerns from advocates for abortion choice that the American court rulings will result in misinformation and disinformation clouding the issues involved. That abortion is not safe, and that women regret their decisions will now be trumpeted by 'pro-life' groups is viewed as an inevitability.

"We don't expect them to heed our pleas, because our government bureaucracies are so ideological that they're willing to sacrifice the health of mothers and their pre-born children in the name of expanding abortion access."
"I think more realistically what we're hoping for is kitchen-table conversations about the harm of chemical abortion."
"I can't tell you how many stories I've read of women who've fainted, who've been vomiting, who've lost so much blood ... there are so many women out there who have had these experiences who probably haven't talked about them because they recognize this is something that is controversial, perhaps they feel ashamed."
"Our hope is that the news from the United States prompts these women to start talking to their family members, their friends, about their own experiences, so we can talk about how crazy it is that not only does the pill present these risks, but Canada has got rid of some of the few safeguards they had in place."
Jose Luetke, director of education and advocacy, Campaign for Life
Protesters stand outside the Mary Lou Robinson United States Courthouse ahead of a public hearing in a lawsuit against the abortion medication mifepristone on March 15, 2023.
Protesters stand outside the U.S. courthouse ahead of a lawsuit over the abortion medication mifepristone in March. Photograph: Michael Cuviello, Amarillo  Globe-News

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