Watching the oral arguments at the U.S. Supreme Court on March 25 about the U.S. Food and Drug Administration removing patient safeguards for abortion-inducing drugs in 2021 and allowing them to be dispensed through the mail, I doubt I was alone in wondering:

Who speaks for the public, people of faith, the young mothers, the 90% of medical professionals who do not want any part of abortions, the taxpayers and healthcare providers paying for abortion-related care, and … who speaks for the innocent unborn babies?

Something at the very heart of this case was missing in the courtroom discussions: the “professional” part of what it is to be a medical or nursing professional.

Doctors and nurses are much more than 9-5 workers. Medical vocations come with a deeply held moral commitment and responsibility on the practitioners’ part for the patients in their immediate care, but also a duty to speak out for sound, ethical medical care for all patients.

Money for Big Pharma

Danco Pharmaceuticals (which was given the exclusive right to manufacture, market, and distribute mifepristone in 1994) said in court the company was primarily concerned with the fact that it might make less money if patient safeguards are reinstated (51:17-25, 52:1-2). But this case wasn’t about money, power, or politics for the plaintiffs. It was about caring for lives and the sanctity of life. It was about trying to do the right thing, medically, scientifically and ethically. The plaintiffs had petitioned the FDA several times for violating its statutory obligations, as that is the only way anyone can raise a concern to the FDA. (97:12-19)

As Justice Samuel Alito asked, when the FDA flagrantly violates the law and endangers women’s health, do the American people have no remedy? The FDA’s attorney argued just that, saying, “It’s just too bad, nobody can challenge that in court” (13:20-25, 14:1-4).

Alito then asked if anyone “could challenge in court the lawfulness of what the FDA did here?” (in removing the safeguards).

“No,” the attorney replied (10:13-17).

But doctors and other medical professionals have been trying to do exactly that since 2000.

No Tests, No Studies, No Science

This author independently analyzed the publicly recorded evidence the FDA cited in its actions surrounding mifepristone-misoprostol. This comprehensive investigation documented that none of the FDA’s actions were supported by “substantial evidence.” In fact, despite the standards set forth in Federal Regulations 21CFR314.126, the FDA has failed to cite a single randomized, controlled, blinded clinical trial to support any of its actions on the abortion pills for the past quarter century.

In other words, the FDA has not acted “within the bounds of reasoned decision making.” To most medical professionals and the public, the FDA has indeed acted in an “arbitrary, capricious [manner or] an abuse of discretion.”

Who Speaks for Patients? Nobody

The FDA’s Solicitor General asserted that the FDA had approved mifepristone based on the agency’s scientific judgment that the drug is safe and effective (4:12-14), and that “only an exceptionally small number of women suffer the kind of serious complications that could trigger any need for emergency treatment” (5:4-6). She went on to assert that the FDA’s actions “were lawful” and that the agency had “relied on dozens of studies involving tens of thousands of women.”

Neither the FDA’s nor Danco’s lawyers offered any evidence to support these assertions — because there is no evidence.

As this health professional uncovered, even the most basic look at the FDA medical reviews of mifepristone-misoprostol easily demonstrates that the FDA had no sound science to support any of its actions. The Supreme Court can clearly recognize that, too.

Fake Science, Real Money

Yet, the lawyers for Danco/Population Council and FDA seemed incredibly disrespectful and condescending to the Supreme Court justices. Danco’s lawyer told Justice Ketanji Jackson the company was concerned that courts don’t have specialized scientific knowledge about pharmaceuticals, and further concerns about judges secondguessing the FDA. Danco said these sorts of errors “can infect judicial analyses precisely because judges are not … experts in statistics, they are not experts in … the methodology used for scientific studies, for clinical trials” (58-59).

That’s why, according to Danco, the “FDA has many hundreds of pages of analysis in the record of what the scientific data showed” and the pharmaceutical company relied on “FDA’s gold standard review process” (58).

The FDA’s counsel even stated that the agency had done “an exhaustive examination” and [incorrectly] stated that “up to ten weeks of gestation, there is no observable increase in serious adverse events” (25:12-20) to pregnant women taking the drugs. She later backtracked and admitted that by eliminating in-person prescribing by doctors, “there was some evidence that there were increased ER visits,” but those didn’t correlate “with an increase in serious adverse events” (39:16-21). She claimed that misopristol could be “safely dispensed without in-person visits” and that the FDA “had voluminous evidence” to support its 2021 conclusion (40:1-3).

The FDA Is Lying to SCOTUS

A comprehensive look at all the research the FDA relied upon, however, contradicts these statements. Calling something “science” does not make it science or scientific evidence.

During its review of the 1996 application for its 2000 approval of the drugs, the FDA had no randomized, controlled, blinded clinical trials; instead, it relied on one U.S. non-controlled trial. That study found effectiveness dramatically dropped after 49 days gestation, while adverse events rapidly increased. FDA’s approval acknowledged that 7.9% of women (<49 days gestation) required surgical interventions due to complications and failed abortions; 80-90% of women would experience heavy bleeding, averaging 9-16 days, with up to 8% bleeding 30 or more days, and 4.8% requiring medical intervention for bleeding.

Yet, in its 2000 regulations, the FDA removed the safety protections that had been submitted with the drug application, eliminating:

• the requirement for ultrasound,
• qualified prescribing physician,
• proximity to hospital care, and
• follow-up exams.

According to every professional association, an ultrasound is the only way to determine gestational age and diagnose ectopic pregnancies — which account for 10-15% of all deaths in pregnancy.

Burying the Evidence

FDA’s post-marketing surveillance similarly has proven to be a total failure. It has buried and failed to respond to serious adverse events and recorded deaths from the drugs.

• The Federal Adverse Events Reporting System (FAERS) failures were well documented by the Patient Safety & Quality Healthcare and detailed in U.S. Government Accountability Office testimony by an associate director of the U.s. Health and Human Services Department. Every outside review has found the FDA’s system to grossly underestimate actual adverse events.
• For years, the FDA failed to improve safety measures and ignored post-marketing information of women dying from undiagnosed ectopic pregnancies and sepsis, instead relying on letters to healthcare professionals from 2002-2004.
• Even though FAERS was reporting significant preventable adverse events through 2011 (58 ectopic pregnancies, 339 hemorrhages requiring transfusions, 256 infections, 612 hospitalizations and 14 deaths), the FDA continued to make no effort to improve safety measures.
• Subsequently, two studies using FOIA data from the FDA found the FDA’s FAERS data 2009- 2019 was even worse than the government was admitting (over 5,100 infections and 9 deaths from sepsis; 91 ectopic pregnancies with 26 ruptured, 56 emergency surgeries and two deaths; over 1,600 cases of severe hemorrhaging with 595 transfusions; over 1,600 failed abortions; and 23 deaths).
• On top of that, the FDA has continued to fail to fully report deaths. CDC data, which only reports on 80% of abortions in the U.S., reported more than four times as many abortion-related maternal deaths between 2000-2019 than the FDA was admitting to in FAERS; even attempts to parse out chemical abortions leaves significant disparities. During those years, the CDC had reported 133 deaths.

Hide the Risks

The FDA has also been promoting the unapproved, “off-label” use of misoprostol for abortions: a drug that the manufacturer had specifically contraindicated in pregnant women at any stage because of significant risks for fatal uterine ruptures and perforations. Searle Pharmaceutical reported 19 cases of uterine ruptures and perforations to the FDA in 1999. The FDA deputy director specifically called for a search of all post-marketing data and by 2000, the FDA had identified 32 reports of uterine ruptures. The FDA continues to make no mention of these risks in its patient agreement or medication guides.

Still without a single randomized controlled clinical trial to support the safety of its actions, in 2016, the FDA:

• extended the gestational age for taking the drugs to 70 days;
• allowed self-administering misoprostol at home;
• allowed “certified prescribers” at pharmaceutical companies to dispense the drugs instead of licensed medical professionals;
• eliminated requirements for follow-up clinical exams or dosage changes.

Instead, the FDA used a hodgepodge of surveys, opinions, and anecdotal reports, feasibility tests, self reports of clinician perceptions, case control and retrospective cohort studies, data dredges, and systematic reviews. None of these complied with its statutory requirements for “substantial evidence” for safety.

Worse, every study the FDA used was from abortion activists or the drug company. There were zero objective sources or studies that had been independently replicated or confirmed.

Additionally, the papers the FDA cited even contradicted its conclusions and reported significant serious adverse events in the use of mifepristone and misoprostol.. For example, the only U.S. study it cited for extending use through 70 days gestation reported on only 729 women − half the number registered with ClinicalTrials.gov − and even then “lost to follow-up” another 98 women.

Despite these irregularities, that study still reported 7% of women overall required surgical interventions (persistent nonviable sacs, uterus debris), 4.6% in 49-70 days gestation (3.7% in <49 days gestation) experiencing major adverse events and going to the ER; and pain and nausea were so severe that 84% of the women required opiates for pain and 46% required anti-emetics to help control vomiting.

No Safety Studies. None.

In fact, the FDA admitted that no abortion studies had been done to evaluate the drugs’ safety for women. The agency said that serious adverse events, including deaths, hospitalizations, serious infections, bleeding requiring transfusions, and ectopic pregnancy complications, were rarely reported in any of the literature it reviewed.

How are these not “substantial risks?”

Using the FDA’s own acknowledgement that ER visits and surgical interventions were sometimes needed: they equal an additional 25,700 ER visits and 43,877 surgical interventions each year.

During the Supreme Court hearing, Danco’s lawyer argued that only the FDA can determine whether increases in emergency room visits rise enough to be considered “sufficient” (30). He also argued that increased risks for emergency care with mifepristone-misoprostol were not a “substantial risk” (49:25, 50:1-2).

When Chief Justice John Roberts asked what percentage of adverse consequences and emergency room visits would be enough to qualify as “substantial,” Danco only said that “substantial risk” wasn’t present in this case (50:1-20).

Using the FDA’s own data, however, the risks clearly are substantial. Even by its own admissions, FDA stated up to 4.6% of women end up in the ER, and 7% (in 2016) and 7.9% (in 2000) of women taking mifepristone required surgical interventions for complications, hemorrhaging, or incomplete abortions.

Bending the Rules, Since Women Apparently Don’t Matter

For any other elective drug being given to healthy young women, these would be unacceptable risks. For instance, both the National Institutes of Health and the World Health Organization define “substantial” risks for HIV drugs at 3 deaths per 100 users

The risks of mifepristone are well beyond any credible definition of substantial risks. There is no way the FDA can sincerely claim mifepristone-misoprostol is safe.

By allowing telemed prescribing and mailed abortion pills, the FDA eliminated oversight from any state medical board, usurping prescriptive authority from the states. In a letter to abortion activists dated April 12, 2021, the FDA admitted to using:

• an abortion group study of self-reported results of mailed abortion pills and satisfaction surveys;
• a small abortion group retrospective cohort report of telemed abortions with phone and text self-reported follow-ups, with no clinical exams to confirm outcomes and which didn’t record or report side effects or complications other than admit that 4% of the women required surgical interventions and 3.8% required ER visits;
• a small abortion group study from the United Kingdom of telemed questionnaires assessing only “acceptability” of procedures, and which followed an incomplete and highly unusual reporting technique of recording complications only if the women called the clinic for help with adverse events;
• a marketing paper that was a data-dredge, “non-inferiority study” – a highly problematic, biased technique that tries to describe whether a new treatment is “acceptably worse” than the standard care. This paper hadn’t even used the FDA-approved drug regimen, nor did the researchers follow up with any patients to confirm their reports.

Clearly, none of these studies meet the FDA’s own requirements for “substantial evidence.”

All Safety Measures Gone for Good

Yet, with no further clinical trial evidence, the FDA went on to permanently and completely repeal all safety measures for the abortion drugs. In its 2023 review of evidence for this, the FDA simply responded to each request from the drug company with “we agree” or “we agree with the Sponsor’s proposal.”

The FDA’s drug approval and regulatory process is broken and has become completely corrupted. It is now a political entity, answering to massively funded special interests focused on population control and abortion.

Removing patient safeguards was done only to help abortionists end more lives and to continue to sell the lie that the abortion pills are “safe” and that having an abortion is as easy as popping a pill. The FDA long ago abandoned its role of using science to protect public health and safety.

We can only pray now that the Court will be guided by what is true and good.

 

Sandy Szwarc, BSN, RN, is a retired nurse with decades of experience serving patients.

 A longer version of this article previously ran in The Remnant. Reprinted with permission.