The AMA’s Disregard for the Nation’s Basic Foundational Precepts In Its Opposition to the Mifepristone Ruling Is Stunning.

by

Julio Gonzalez, M.D., J.D.

The latest disastrous display of ignorance by the AMA came through President Jack Resneck’s predictable and unimaginative response to the Fifth Circuit Court of Appeals’ ruling regarding the FDA’s approval of the abortion inducing medication, mifepristone or R-486.  In short, the senselessness of the objection raised by Dr. Resneck is so immense as to make it difficult to condense it into one article, but we will try. 

First, let’s share Dr. Resneck’s statement in toto.  On April 13, 2023, the AMA published the following press release regarding the Fifth Circuit’s opinion and ruling: 

Last night's decision from the Fifth Circuit Court of Appeals is a profoundly dangerous step backwards on access to mifepristone. The appeals court elevated speculative pseudoscience over data and evidence, arbitrarily rolling back access to a safe and effective drug and leaving millions of women without a critical medication for reproductive health care. The AMA fully supports the Department of Justice’s request for emergency relief from the U.S. Supreme Court and will continue fighting to prioritize evidence-based decisions that maintain access to mifepristone.

Judges and lawmakers should not be substituting their own opinion for the experience, expertise, and authority of the U.S. Food and Drug Administration. Nor should they ignore the substantial weight of scientific evidence from hundreds of studies and millions of patients confirming the safety and effectiveness of mifepristone, which has been used for decades in both medication abortion and miscarriage management. The appellate court order, if allowed to stand, creates more barriers to care, harms patients and physicians, and exacerbates the maternal mortality crisis, especially for historically marginalized communities. It also opens a pandora’s box for similar politically motivated, unscientific attacks by judges with no medical or scientific training against the FDA’s scientific, evidence-based approvals of countless other medications.

 As expressed in the press release, Dr. Resneck brings up a number of objections to the court’s decision.  Here, we will address some of them. 

“The Appeals Court Elevated Speculative Pseudoscience Over Data and Evidence.”

According to Dr Resneck, the court, through its decision, “elevated speculative pseudoscience over data and evidence.”  This is a fascinating statement for the leader of what is ostensibly the largest medical organization in the United States to make since it blatantly ignores the questions the court actually addressed. 

Despite Dr. Resneck’s claim, neither the appellate court nor the trial court use arguments regarding the science, pseudoscience, data, or evidence regarding the safety and efficacy of mifepristone as bedrocks for their actions.  Rather, what was under review was the legality of the process the FDA employed in granting the mifepristone its approval.  For Dr. Resneck to claim otherwise demonstrates either a fundamental lack of understanding regarding the issues being considered by the court or a profound and purposeful disingenuousness designed to misinform the public and his colleagues.  Either way, the blunder is inexcusable for an organization of this size and self-proclaimed importance.

“Judges and lawmakers should not be substituting their own opinion for the experience, expertise, and authority of the U.S. Food and Drug Administration.”

This statement is particularly incongruous because it purposefully dismisses the fact that the plaintiffs in this case—the Alliance of Hippocratic Medicine (AHM) and the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), the American College of Pediatricians, the Christian Medical & Dental Associations, Shaun Jester, D.O., Regina Frost-Clark, M.D., Tyler Johnson, D.O., and George Delgado, M.D— are physician organizations representing the very doctors whose expertise Dr. Resneck claims the court is ignoring!  Indeed, Judge Matthew J. Kacsmaryk of the United States District Court for the Northern District of Texas, Amarillo Division, is not substituting any opinion of his for those of the physicians.  Quite the contrary, he is acknowledging the appropriateness and weight of the opinions of the very doctors that would have largely been members of the AMA if the latter weren’t such a divisive and fringe organization. 

If Dr. Resneck or his supporting staff at the AMA had read Judge Kacsmaryk’s order, they would recognize that the question before the court was whether the process the FDA undertook in granting the medication its approval was compliant with federal law.  In reviewing the new drug application (NDA) for mifepristone, the FDA employed Subpart H, a provision in federal law implemented to expedite the approval of investigational HIV medications.  According to Judge Kacsmaryk, using Subpart H, the most that could have been allowed by the FDA was to permit the use of mifepristone “where a pregnant woman’s life or health is in danger.”  More appropriately, according to Judge Kacsmaryk’s, Subpart H should not have even been employed by the FDA in this case since the provision was to be used in cases where approval of treatment for “serious or life-threatening illnesses,” was being sought.  As Judge Kacsmaryk correctly points out, no one has ever categorized pregnancy as an “illness” thus invalidating the use of Subpart H when evaluating mifepristone’s NDA.

Additionally, the AHM and AAPLOG were able to successfully argue that the authorization for the drug to be delivered by mail was also invalid since it violated the 150-year-old Comstock Act, prohibiting the mailing of any “article, instrument, substance, drug, medicine, or thing” designed to result in an abortion.  Thus, Judge Kacsmaryk never opined on anything dealing with the “evidence-based” nature of mifepristone’s approval nor of its scientific foundation.  Rather, his concern was the utter disregard for the law displayed by the FDA in considering mifepristone’s NDA.

“The appellate court order . . . exacerbates the maternal mortality crisis, especially for historically marginalized communities.”

This is another policy-based argument made by Dr. Resneck that is immaterial to the case at hand as we have previously pointed out.  However, we bring attention to this portion of Dr. Resneck’s statement because it is illustrative of the oft-employed, neo-liberal progressive technique of invoking racism when it finds itself losing an argument. 

Dr. Resneck’s comment regarding marginalized communities is not only unsubstantiated it is completely inapplicable to these proceedings since the deliberation deals with governmental abuse of authority.  In fact, one can only imagine the harm that could befall the various races and marginalized communities if the court adhered to Dr. Resneck’s call of ignoring the law for the benefit of a particular special interest. 

“[The Fifth Circuit’s ruling] also opens a pandora’s box for similar politically motivated, unscientific attacks by judges with no medical or scientific training against the FDA’s scientific, evidence-based approvals of countless other medications.”

This last comment is perhaps the most revolting, as it subscribes to an elemental pillar of American Progressivism: the concept of letting the experts devise the rules absent input or objection from the rest of us.  If we have learned anything during the calamitous and overtly oppressive handling of the COVID-19 pandemic it is that the last group we should be entrusting with our rights and liberties is the one to which government-entrenched “experts” belong.  Our very system of government was created to prevent one class of individuals from running ram shod over the rights of others absent checks or balances.  Dr. Resneck is telling the court that it should ignore the actions of our nation’s unelected “experts” regardless of their illegality for the sake of providing greater access to an abortion inducing medication!  That Dr. Resneck and the AMA would ignore the invaluable role the court is undertaking in in checking the actions of an out-of-control bureaucracy is, frankly, stunning. 

Clearly, the AMA has become a fringe organization that encourages the disregard of process and rule of law simply to promote its selfish agenda.  We at the USMA favor a different approach regarding the mifepristone controversy: 

 The USMA is closely following the legal proceedings regarding the FDA’s approval of mifepristone.  We thank the Alliance for Hippocratic Medicine and the American Association of Pro-Life Obstetricians and Gynecology, the American College of Pediatricians, the Christian Medical & Dental Associations, Shaun Jester, D.O., Regina Frost-Clark, M.D., Tyler Johnson, D.O., and George Delgado, M.D. for their efforts at bringing the question regarding the appropriateness of the FDA’s approval process as applied to mifepristone to light.  Obviously, the United States Medical Association desires the broadest access to medications and remedies for the treatment of diseases afflicting Americans.  However, if the FDA, or any other government agency bypasses the restrictions placed upon it by Congress for the purposes of promoting an agenda, the USMA will not cooperate with such an effort and altogether condemns it. 

Our nation is a wonderful, miraculous place instituted under the premise of the equal application of the law, a premise that especially applies to government bureaucrats, regardless of their level of expertise.  The USMA looks forward to evaluating the results of this legal process and advising its members accordingly.  However, above all the USMA hopes that judges and physicians alike will uphold the just laws governing our fragile republic. 

Dr. Julio Gonzalez is an orthopaedic surgeon practicing in Venice, Florida, and a former Florida State Representative.  He is President of the United States Medical Association.