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Monday, April 1, 2024

Open Letter to the Supreme Court (…If concerned citizens were actually able to talk to the Court)

By:   Sandy Szwarc
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Open Letter to the Supreme Court (…If concerned citizens were actually able to talk to the Court)

Open Letter to the Supreme Court

(What I wish I could share with the Justices, if concerned citizens were actually able to talk to the Court.)

Watching the oral arguments in the FDA/Danco Laboratories vs Alliance for Hippocratic Medicine on March 25, 2024, 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 court room discussions. It felt very troubling.

The "professional" part of what it is to be a medical or nursing professional was forgotten. Doctors and nurses are much more than 9-5 workers. Medicine and nursing are vocations that come with a deeply-held moral commitment and responsibility for the patient in their immediate care, but also a duty to speak out for sound and ethical medical care for all patients.

The lawyer for Danco Pharmaceutical's (which had been given the exclusive right to manufacture, market and distribute mifepristone from the Population Council in 1994) told Justice Alito that the company was primarily concerned that they might make less money if patient safeguards were reinstated (51:17-25, 52:1-2), and Justice Kagan repeatedly tried to connect the doctors' organizations to specific members' concerns of harm or to claim a doctor who objected to abortions could simply walk away from a woman suffering an emergent life-threatening complication.

Even the most basic look at the FDA medical reviews of mifepristone-misoprostol easily demonstrated that the FDA had NO sound science – not one randomized, controlled, blinded clinical trial − to support any of its actions.

But this case wasn't about money, power, politics for the doctors. It was about caring… caring for lives and the sanctity of life. It was about trying to do the right thing, medically, scientifically and ethically. The doctors had petitioned the FDA (with Citizen Petitions) several times for violating its statutory obligations, as it is the only way anyone can raise a concern to the FDA. (97:12-19)

As Justice Alito said, when the FDA flagrantly violates the law and endangers the health of women, do the American people have no remedy?

The FDA's attorney argued just that, he said, "it's just too bad, nobody can challenge that in court." (13:20-25, 14:1-4)

Justice Alito then asked if there was "anybody who could challenge in court the lawfulness of what the FDA did here?"

The FDA's lawyer replied "no." (10:13-17)

But that is exactly what doctors and other medical professionals have attempted to do since 2000.

This author independently analyzed the publicly recorded evidence cited by the FDA in its actions surrounding mifepristone-misoprostol. This comprehensive investigation documented that none of the FDA's actions were supported by "substantial evidence." In fact, the FDA had not used a single study that met its statutory requirements (under Federal Regulations 21CFR314.126) to evaluate drugs using adequate, well-controlled, randomized, blinded clinical trials to support claims of safety and effectiveness for its intended use. 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 [or] an abuse of discretion."

The APA is the only remedy for medical professionals and the public to seek a judicial review when a federal agency, like the FDA, fails so intently and blatantly to do its job and has put the lives of millions of women and babies at risk… patients that have no one to speak for them against the government. (This ignores, of course, the entire issue of whether a drug designed to kill innocent life can even be considered a healing "medicine," let alone mandated in communities that do not want it.)

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 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 or 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 demonstrated that the FDA had NO sound science – not one randomized, controlled, blinded clinical trial − to support any of its actions. Any citizen who's taken the time to look at the FDA reviews can also easily see that. The Supreme Court Justices can clearly recognize that, too.

Calling something "science" does not make it science or scientific evidence.

Yet, the lawyers for Danco/Population Council and FDA seemed incredibly disrespectful and condescending to the Supreme Court Justices. Danco's lawyer admitted to Justice Jackson it had significant concerns that courts don't have specialized scientific knowledge with respect to pharmaceuticals and about judges parsing medical and scientific studies and second guessing 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 FDA had done "an exhaustive examination" and [incorrectly] that "up to ten weeks of gestation, there is no observable increase in serious adverse events." (25:12-20) She later backtracked and admitted that by eliminating in-person prescribing by doctors, "there was some evidence that there were increased ER visits," but that they weren't "actually correlated with an increase in serious adverse events," (39:16-21) that misopristone could be "safely dispensed without in-person visits" and that the FDA "had voluminous evidence" to support its 2021 conclusion. (40:1-3).

A comprehensive look at all of the researchrelied upon by the FDA, however, contradicts these statements. Calling something "science" does not make it science or scientific evidence.

1. During its review of the 1996 application for its 2000 approval, the FDA had no randomized controlled blinded clinical trial; instead, it relied on one U.S. non-controlled That study found effectiveness dramatically dropped after 49 days gestation, while adverse events rapidly increased. FDA's approval acknowledged 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. An ultrasound is the only way to determine gestational age and diagnose ectopic pregnancies – according to every professional association − which account for 10-15% of all deaths in pregnancy.

2. FDA's post-marketing surveillance has proven to be a total failure. The FDA has buried and failed to respond to serious adverse events and deaths that were reported.

  • FDA's Federal Adverse Events Reporting System (FAERS) failures were well documented by the Patient Safety & Quality Healthcare and detailed in U.S. GAO testimony by an HHS Associate Director. 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 2 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 over 4 times more 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.

3. The FDA has also been promoting the unapproved, "off-label" use of misoprostol for abortions: a drug that the manufacturer had specifically contraindicated in women who are pregnant at any gestational age because of significant risks for fatal uterine ruptures and perforations. Post-marketing surveillance data of misoprostol being used off-label for abortions was increasingly reporting to the FDA cases of uterine ruptures and perforations. Searle Pharmaceutical reported 19 cases 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 to patients in its patient agreement or patient medication guides.

4. The FDA didn't have a single randomized controlled clinical trial to support the safety of its 2016 actions: extending the gestational age to 70 days; allowing self-administering misoprostol at home; allowing drug-company "certified prescribers" instead of licensed medical professionals; eliminating follow-up clinical exams; or the 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."

Not only did the FDA have no credible science, but the papers it cited even contradicted its conclusions and reported significant serious adverse events.

Worse, every study used by the FDA was from abortion activists or the drug company. The FDA did not have a single objective source and not one study had been independently replicated or confirmed.

Not only did the FDA have no credible science, but the papers it cited even contradicted its conclusions and reported significant serious adverse events. For example, the only U.S. study cited by the FDA for extending use through 70 days gestation reported on only 729 women − half of the number registered with ClinicalTrials.gov − and even then "lost to follow-up" another 98 women.

Despite these irregularities, it still reported 7% of women overall required surgical interventions (persistent nonviable sacs, uterus debris), 4.6% in the 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.

Yet, the FDA admitted that even this study had not been powered to evaluate safety.

In fact, the FDA admitted that NO abortion studies had been done to evaluate safety. The FDA reviewers 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 of rates of ER visits and surgical interventions: they equal an additional 25,700 ER visits and 43,877 surgical interventions each year.

(According to Guttmacher Institute, 626,815 chemical abortions were performed in the U.S. in 2023.)

During the Supreme Court hearing, the Danco/Population Council lawyer argued that whether increases in emergency room visits rise sufficiently to be considered "sufficient" is up to the FDA. (30) It also argued that increased risks for emergency care with mifepristone-misoprostol were not a "substantial risk." (49:25, 50:1-2)

When asked by Justice Roberts what percentage of adverse consequences would be enough, and what percentage of emergency room visits would be enough to be considered substantial, Danco only argued 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 intervention for complications, hemorrhaging or incomplete abortions.

If this were any other elective drug being given to healthy young women, these would be unacceptable risks. But how is "substantial risk" defined elsewhere in Federal drug regulations? The most cited definition of "substantial risk" by the National Institutes of Health and echoed by the World Health Organization evolved from HIV risks, which were defined as "substantial" at rates of 3 per 100.

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

5. Incredibly, the FDA did not use a single randomized, controlled, blinded clinical trial throughout 2020- 2021 to support its removal of all of the remaining patient protective measures for these abortifacients: eliminating in-person prescribing by a medical prescriber and allowing the drugs to be prescribed over the internet by a telehealth certified prescriber and dispensed through the mail to the women's homes.

Removing patient safeguards is only to help abortionists end more lives and to continue to sell the falsehood that the abortion pills are "safe" and abortions are as easy as popping a pill.

By allowing telemed prescribing and mailed abortion pills, the FDA eliminated any State Medical Board's oversite of the qualifications of medical providers or patient safety, and the FDA presumed to take prescriptive authority from the States. The FDA hadn't conducted a formal review of evidence for these latest changes, referring to a nonpublic review in a letter on April 12, 2021 to abortion activists. In that letter, the FDA admitted to using:

  1. an abortion group study of self-reported results of mailed abortion pills and satisfaction surveys;
  2. 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 that didn't record or report side effects or complications other than admit 4% required surgical interventions and 3.8% required ER visits;
  3. a small abortion group study from UK of telemed questionnaires assessing only "acceptability" of procedures and that followed an incomplete and highly unusual reporting technique of recording complications only if the women called the clinic for help and the adverse events;
  4. a marketing paper that was a data dredge "non-inferiority study" – a highly problematic biased technique that tries to describe if a new treatment is "acceptably worse" than the standard care; this paper hadn't even used the drug regimen approved by the FDA, nor did it do clinical follow-up of any patients to confirm anything.

Clearly, none of these studies complied with the FDA's requirements to use "substantial evidence."

6. Yet, with no further clinical trial evidence, the FDA went on to completely repeal all safety measures permanently. In its 2023 review of evidence for this last modified REMS, 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 and a political entity, answering to massively-funded special interests focused on population control and abortion.

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

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

Sandy Szwarc, BSN, RN, retired emeritus

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Last modified on Wednesday, April 3, 2024