Thread by @to_discussion

It is repeatedly claimed that abortion pills via telemedicine are "safe and effective" in support of the FDA's decision to remove an in-person appointment requirement.

What evidence did the FDA use to make that decision?

#abortionishealthcare ?

In an April 12, 2021 letter to Drs. Phipps and Grobman, the FDA pointed to four studies to support their change in policy allowing abortion pills to be prescribed without an in-person visit.

aclu.org/sites/default/…

Kerestes et al. (2021) studied medical abortions in Hawaii. Of 327 patients, 110 were seen in person, with two requiring an ER visit and one requiring additional misoprostol (Kerestes et al., 2021).

doi.org/10.1016/j.cont…

The remaining 217 patients were telemedicine patients (Kerestes et al., 2021). Of those, nine required ER visits, two required blood transfusions, and three required additional misoprostol (Kerestes et al., 2021).

doi.org/10.1016/j.cont…

The study by Chong et al. was prior to FDA approval for telemedicine distribution of misoprostol. In this study, "individuals were required to obtain a pre-abortion ultrasound or pelvic exam" to be eligible for the program (an in-person appointment).

doi.org/10.1016/j.cont…

Reynolds-Wright (2021, Scotland): Of the 663 women who had a medical abortion at home, 2.4% "made unscheduled attendances to the hospital” and 18.5% contacted the abortion service for "clinical advice".

doi.org/10.1136/bmjsrh…

In 8.4% of cases, a clinical follow-up was required due to a continued positive pregnancy test, invalid pregnancy test results, or persistent pain (Reynolds-Wright, 2021).

doi.org/10.1136/bmjsrh…

Aiken et al. (2021) studied the 2 months prior to the availability of telemedicine abortions ("traditional model") and the 2 months following availability of telemedicine abortions in the UK ("telemedicine-hybrid model"). Neither group is exclusively telemedicine.

They found that telemedicine abortions resulted in 4.2 days less time "from referral to treatment" (p. 1464).

They only monitored for complications (defined as hemorrhaging requiring a transfusion, infections requiring hospital admission, major surgery or death) for 6 weeks.

The traditional model (22, 158 patients): 0.04% required a transfusion.

The telemedicine-hybrid group (29, 984 patients): 0.02% required a transfusion.

Both groups include in person visits.

doi.org/10.1111/1471-0…

On their website, the FDA points to a review of the "single, shared system Risk Evaluation and Mitigation Strategy (REMS) for mifepristone" to support the December 16, 2021 change removing the in-person requirement for abortion pill prescriptions.

fda.gov/drugs/postmark…

They state that the data supports "modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks" (Question 5).

BUT...

A REMS change on March 29, 2016 limits reporting requirements for complications to ONLY patient DEATHS (Question 4).

fda.gov/drugs/postmark…

In the same document, the FDA notes concerns that include the possibility of an undiagnosed ectopic pregnancy, inaccurate dating of gestational age, and the inability to access emergency care, but supported removing safeguarding anyway.

The FDA guidelines conflict with DANCO laboratory's [Mifeprex manufacturer] directives for safe use. Their label includes three office visits on day 1, day 3, and day 14 with specific tests and clinic capability requirements.

accessdata.fda.gov/drugsatfda_doc…

Even the FDA requirement for healthcare providers doesn't seem to align with eliminating in-person appointments.

fda.gov/drugs/postmark…

https://twitter.com/to_discussion/status/1602381911921500165?t=QwLlpEucWOY53ig3QhhNsQ&s=19