The study, published in Health Services Research and Managerial Epidemiology, claims there is a “significant” gap in U.S. Food and Drug Administration (FDA) reporting of chemical abortions due to pill complications, raising questions about whether officials were informed when they deregulated its use in December.
This month, the Food and Drud Administration (FDA) cited data from adverse event (AE) reporting to justify its decision to remove the in-person requirement for the drug.
But a group of doctors from the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) declare that the available data shows a “significant discrepancy” between the FDA data and reports from sources reporting those numbers.
Determining the FDA’s accuracy is relatively difficult, since it requires comparing the agency’s own data with that of private entities. The FDA relies on AE reports from Danco Laboratories, which makes the abortion pill, and uses Planned Parenthood’s information.
The researchers, who were able to compare 2009-2010 data from the FDA’s online reporting system, actual reports of AE obtained through the Freedom of Information Act, those uncovered by a study by Kelly Cleland and others, who used data from Planned Parenthood, found that there were significant differences in the number of total AEs and reported for the 2009 and 2010 mifepristone abortions identified by Planned Parenthood and those from the FAERS [FDA Adverse Events Reporting System]. In this regard, the reliability of FAERS in evaluating the safety or efficacy of mifepristone abortions is questioned.
The American College of Obstetricians and Gynecologists (ACOG) has endorsed the deregulation of mifepristone use and has criticized the study on the grounds that medical abortion was safe and effective and that it poses risks similar to other common medical procedures. ACOG supports the FDA’s recent removal of specific restrictions on mifepristone, claiming that the new study is flawed, but without specifying what they are.
This is not the first time that FDA data has come under scrutiny for lack of scientific rigor, as the FDA’s adverse event reporting only covers deaths and is based on manufacturers’ reports.
A study by the Charlotte Lozier Institute, that is against abortion, has analyzed Medicaid data, concluding that ER admissions increased for the chemical version of abortion at a faster rate than for surgical procedures. In the case of chemicals, the rates increased by 507% (8.5 to 51.7 per 1,000) between 2002 and 2015, those of surgical abortions increased by 315%.
There are three issues that must be analyzed in the bioethical assessment of this fact.
First, the liberalizing trend in the administration of an abortion medication, intended to cause the death of human embryos in the early stages of pregnancy, means that the possibilities of clinical and pharmacotherapeutic control are difficult, promoting, through the ease of obtaining it and the absence of controls situations of risk to women’s health.
Second, the alleged deregulation promoted by ACOG reduces the chances that a woman who is considering having an abortion receives information about its risks, possible sequelae, and alternatives.
And third, the biases detected in the handling of information by organizations of the prestige of the FDA, which seem to exclusively collect data from sources favorable to the extension of abortion practices, represent an attack against the exercise of the autonomy of the patient, which requires that the information provided be rigorous, truthful, complete and up-to-date, without which free decision-making would not be possible.