‘Off label’ abortion-reversal drug has precedent | OPINION

Recently U.S. District Court Judge Daniel D. Domenico of Colorado heard legal arguments in a case in which the Medical Board was attempting to defend a new law, Senate Bill (SB)190, which refers to the use of progesterone in “medical abortion reversal” as unprofessional conduct. I commend Judge Domenico for his preliminary injunction, for doing due diligence in approaching this case with a view of “strict scrutiny” and for recognizing the hypocrisy of abortion-rights advocates in their selective concern about “off-label” medication uses. This is a very grave issue, one that could result in loss of one’s professional license and practice.
I also commend Bella Health and Wellness. It takes courage to go up against our legislators and professional boards. To me this is not just a religious-discrimination matter. This represents obstruction, coercion and intimidation of health-care professionals by our legislators and professional boards, which could have far-reaching, unintended consequences.
In this case, the legislators and boards are wrong and need to be challenged.
The argument against use of progesterone is essentially that it is not approved by the U.S. Food and Drug Administration for this purpose and attempts to call into question its efficacy.
I am a retired acute care nurse practitioner. My specialty was hematology and oncology. In over 40 years as a health-care provider, I have never seen a law that singles out a drug in this manner. Had it not been for the use of many chemotherapy drugs “off-label,” we would not have witnessed the progress in cancer treatment.
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Drugs are usually approved by the FDA based on their safe and effective use. Once approved, uses are often expanded beyond the initial indication over time. Taxol®, (paclitaxel) for example, was initially approved by the FDA for the treatment of metastatic breast cancer. Since the initial FDA approval, paclitaxel has been administered to millions of patients and its use has expanded into the treatment of other cancers, such as certain lung cancers and ovarian cancer. It is also used in “off label” treatment of advanced bladder, cervical, gastric and esophageal cancers to name a few.
Even drugs as common as aspirin have “off-label” uses. Approved by the FDA for the treatment of mild to moderate pain, aspirin is used by millions following the placement of coronary stent placements to prevent blood clots. Metformin, which has FDA approval for type 2 diabetes, has recently been recommended by both the American Medical Association and the Endocrine Society for use in people with pre-diabetes, which is “off label” usage. A current fad is to prescribe Ozempic®, which is a prescription medication used for the treatment of diabetes, for weight loss, clearly “off label” and not without serious effects. No one is pushing for laws to single out the use of Ozempic ® “off label” as unprofessional or deceptive practice, or grounds for “discipline.” Thousands of drugs have “off-label” usages.
Progesterone has been approved and prescribed for over five decades in the treatment of multiple medical issues: to prevent miscarriage, to prevent endometrial hyperplasia, to treat endometriosis and dysfunctional uterine bleeding are a few examples in the OB/GYN sphere. Progesterone has been used in an effort to treat a variety of cancers such as endometrial cancer.
It is curious that progesterone in the setting of abortion reversal is singled out in SB 190 by Colorado’s legislators.
It is important to note even those who oppose the use of progesterone to override the effect of mifepristone in an effort to reverse the chemical abortion, have no problem prescribing, and promoting, the use of estrogen or testosterone for gender transitioning, which is “off label” prescribing, without adequate data regarding the long term effects in minors. The same applies to the use of estradiol in “chest feeding” in the transgender population, which requires much higher doses of estradiol than the FDA approved for menopausal women, and poses the risk of blood clots and/or stroke. This year the international journal Contraception published its support of using misoprostol-only abortion, eliminating the second drug (mifepristone) in chemical abortions, and this without FDA approval. Therefore, one can only reach the conclusion that this law is blatantly biased against the use of progesterone to reverse chemical abortions.
Wendy Smith, RN, MSN, ACNP, is a retired acute-care nurse practitioner in Colorado Springs. Her practice was in hematology/oncology. She serves as a volunteer for four anti-human trafficking organizations, and has 18 years experience volunteering in prisons providing life-skills counseling. She is a fellow with the Colson Center for Christian Worldview.

