Friday, April 21, 2023

The Supreme Court Stay On Mifepristone Ban Should Be Permanent


The following is a letter to the Houston Chronicle by Houston medical students Rebecca Chen and Michelle Dad.

Earlier this month, a Texas judge issued a ruling to invalidate the two-decades long U.S. Food and Drug Administration approval of mifepristone, one of two medications that are used in combination for abortions. Now the Supreme Court says that it will decide whether to uphold that ruling on Friday.

We very much hope that mifepristone remains available. The Texas ruling not only jeopardizes nationwide access to safe abortion, but it also puts our health care infrastructure as a whole at risk.

As medical students, we are often the hospital worker caregivers with the most time to sit down and talk with patients. We have heard them express misgivings about their health care options, from questions about effects of long-term contraception to rumors they have heard about the COVID-19 vaccine. The mifepristone ruling will increase distrust about medications that we know are safe and effective

The FDA approved mifepristone in 2000, and since then it has been used in around 5 million cases with only 13 pregnancy-associated deaths as of 2021. Mifepristone is safer than other commonly used drugs such as Viagra, which was linked with 522 deaths its first year on the market. It is also 14 times saferto use mifepristone for a termination than to carry through with a pregnancy. Yet a Texas judge has partnered with anti-abortion groups to attempt to disavow the FDA approval of mifepristone.

The FDA has the important job of “protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs.” . In that role, the FDA oversees clinical trials and regulates which drugs are allowed to enter the market and thereby be used by patients. Thousands of clinical trials are conducted each year, and the FDA only approves 50 or fewer novel productsper year. Drugs that are improperly tested or fail to meet patient safety standards will not be approved.

The FDA has to be trusted in hand with the physicians and researchers who conduct extensive safety and efficacy trials. An open letter, now signed by over 200 pharmaceutical executives, warns that “if courts can overturn without drug approvals without regard for science or evidence…any medicine is at risk.”

Mifepristone has been approved for more than 20  years. It has been on the market for the same amount of time as the Prevnar vaccine (a flu vaccine we give to infants), two forms of insulin, and a popular gastric reflux remedy. Nobody has raised doubts about the FDA approval of these other medications; we can only assume that the association of mifepristone with abortion care is the reason it is being singled out. Yet that action opens the door to a true public health hazard — one of our own making — if federal regulations cease to be followed.

Strong partisan perspectives on abortion often miss what physicians witness on a daily basis — that all women, regardless of party allegiance, socioeconomic status or place of residence, may be harmed if they don’t have options to terminate their pregnancies.

One patient we remember came to our Houston clinic alone and distraught. Her first pregnancy had ended in preterm labor and massive blood loss, leading to a months-long hospitalization for her and her newborn. Since then, she had been too afraid to have intercourse with her husband, as she knew she was at higher risk for similar experiences in her future pregnancies. When she found out she was just past six weeks pregnant, she broke down crying.

She said, “I kept hoping that I was just imagining my symptoms, as I couldn’t bear to think about being pregnant again. I can’t put another baby through what my baby girl went through, and I can’t die and leave my kids without their mama.”

Quietly, she said that she and her husband had always been vehemently pro-life, but that her life also mattered. If she were to continue this pregnancy, she would have to relocate to live closer to our hospital for months, as only a handful of hospitals have the appropriate resources to treat her condition in case of emergencies. She asked about her options for an abortion. Her only choice was to drive to another state, but under Texas law, we were not allowed to counsel her on her next steps.

The patients that we see are your neighbors, your family members. They are Democrats and Republicans, pro-life and pro-choice. They come to us because they are scared for their lives and their potential babies’ lives. When there is a medically safe option that has been the standard of care in the United States and other countries such as the United Kingdom, Sweden, France and China, it directly contradicts our Hippocratic oath to withhold these treatments to women in need.

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