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ANSIRH Debunks Questionable Junk Analysis on Abortion Safety

Health and Human Services Sec. Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have expressed plans to conduct a new review of mifepristone’s safety based on an unverified and biased report from The Ethics and Public Policy Center (EPPC), sparking concern from reproductive health scientists over potential new restrictions on medication abortion access. 

In response, ANSIRH’s Ushma Upadhyay, PhD, MPH, a professor at UCSF and leading expert on abortion safety research, has conducted a nine-point review of major failings in the report. As a reminder, decades of scientific evidence amassed through more than 100 studiesbased on hundreds of thousands of patient outcomeshave established the safety record for mifepristone use in medication abortion.

Our Response to Unverified and Unreliable Claims About Medication Abortion Safety

In the report, an abortion-related emergency room visit was counted as a serious adverse event, but ER visits in and of themselves are not serious adverse events, as defined by FDA guidance.
Subsequent treatment to complete an abortion is not a serious adverse event. It is known and expected that about 3-5% of patients will need additional medications or a procedure to complete an abortion.
"Other abortion-specific complications" in the report are not clearly defined by the authors.
The authors conflate abortion with miscarriage and other uses of mifepristone.
The authors do not use a standardized definition of hemorrhage.
“Other life-threatening adverse events” are not clearly indicated as abortion-related.
The authors rely on diagnosis codes rather than treatment codes, which contradicts standard studies of medication abortion safety.
The report’s policy implications are not supported by their findings.
Analyses cannot be verified and the authors have refused subsequent requests to reveal the source of their data, precluding the ability to independently verify the results.

Implications: The FDA Must Ground Decisions on Peer-reviewed Research

Our research shows medication abortion has a long safety and efficacy record and is essential health care. This self-published report does not credibly cast doubt, nor outweigh the findings of a robust body of rigorous scientific studies that show that mifepristone is safe, including when provided through telehealth. 

Dr. Upadhyay states:

"This report, filled with methodological flaws, does not outweigh decades of safety research showing medication abortion is safe and can be prescribed via telehealth. We should all be alarmed if the people in charge of our public health are calling for a review of the science based on this analysis."

Download our full review of Hall and Anderson's report on abortion safety.

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