Speak Out Rheum: To Prescribe Is Humane (Unless You’re In Texas)

You are a rheumatologist in Texas. You are very well trained. Your mentors included some of the leaders in rheumatology, and you are respected by your colleagues and your patients. You know the devastation of untreated rheumatoid arthritis and lupus.

A young woman with recent onset of systemic lupus erythematosus is your new patient. You discuss the indications and side effects with her, and you both agree that, in her case, methotrexate is the drug of choice. You are well aware of the ACR’s guidelines relating to the use of this drug when there are issues of reproductive health.¹ The risks of pregnancy with methotrexate are discussed as part of the informed consent process. The patient concurs and takes oral contraceptives for several months before initiating treatment with methotrexate.

After starting treatment, and despite using oral contraceptives, your patient becomes pregnant. (Author’s note: Oral contraceptives have a pregnancy prevention failure rate upward of 5%.²) The patient did not realize she was pregnant because her periods have been irregular since she became ill. However, she begins to have pain and severe bleeding, evidence of a spontaneous miscarriage.

A formerly friendly neighbor who is short of cash and is now a bounty hunter becomes aware of her plight and reports her to the authorities.³ The accusation is that she has induced an abortion.

The new pharmacist who refused to renew your methotrexate order for the patient justified that action based on suspicion that you are using it as a abortifacient because you did not indicate on the renewal prescription that it is being used to treat the patient’s lupus.^4-6 You note the drug is used for multiple ailments, and it is not the role of a pharmacist to determine the suitability of a medication for a patient.^7,8

Your happy days as a rheumatologist are over. The joyful days of being a dedicated physician who believed in the sanctity of the doctor–patient relationship is now a myth. The patient’s constitutionally protected rights and the right to privacy that existed prior to the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization are over in the state of Texas.

The Aftermath

You are accused of inducing an abortion and await your deposition. You ponder the questions: Did you induce the abortion deliberately? Of course not. Then why did you prescribe methotrexate knowing it can induce abortion? Did you conspire with the patient to end the pregnancy because you both feared the toxic effects on the fetus?

In its June 24 decision in Dobbs, the Supreme Court (SCOTUS) quoted a Mississippi law that states abortion is “demeaning to the medical profession.”⁹ But you wonder whether instead it is SCOTUS that is now demeaned. And with all your vaunted training and accolades, you have been thrust into the time warp of Texas’ inner sanctum horrors and its post-Dobbs antediluvian laws in which social media—but not a doctor—can be consulted for pregnancy care.

It was you who sent the patient to the emergency department because she was bleeding heavily. The obstetrician on call knew the rules of EMTALA [the Emergency Medical Treatment and Labor Act], requiring that one must treat an emergency, and determined the patient required an emergency abortion.^10-12 Your colleague has an outstanding reputation for providing pregnant patients with evidence-based, essential healthcare.

Although this patient needed, and met, medical criteria for emergency care, she did not meet political criteria allowing for an exception to prohibited abortions. That exception, found in Section 170A.002 of Texas’ law, mandates that an abortion could be performed to save a mother’s life when “the pregnant female … has a life-threatening physical condition … arising from a pregnancy that places the female at risk of death … .”¹³ Because the patient was not in shock, only had a rapid heartbeat and her hematocrit was only down to 30%, she was not yet at “death’s door.”

The obstetrician also knew of the September 2021 amicus brief, submitted in Dobbs by the American College of Obstetricians and Gynecologist, the American Medical Association and many other medical organizations, that stated “abortion is a safe and essential component of healthcare.”¹⁴

The obstetrician questions why risk of a patient’s death is to be ignored just because bureaucrats sitting safely in their offices have issued laws that go against sound medical science. They have no understanding of emergent obstetrical issues or reproductive health and have provided no directives on what a physician is to do when faced with a medical situation that requires immediate attention.

The state has created a classic catch-22 conundrum for physicians. It has barred physicians from relying on their professional judgment and traditional medical standards and procedures, and coerced compliance with the Texas law by threatening fines and imprisonment for its violation. But the state has not issued any alternative standards and procedures to be used in lieu of the best practices of medical treatment. This places you and the obstetrician in triple jeopardy: You may be sued for malpractice for failure to treat, lose your license, and be fined and go to jail.

You both are indicted and await trial. Are you now part of the new world of the criminalization of medical care?¹⁵ You reflect on how you have spent your entire career in medicine treating all those in need, regardless of their economic circumstances. This has been your calling. Your obstetrical colleague has been known to prescribe misoprostol and mifepristone for first trimester abortions, consistent with sound medical practice. But the state has taken steps to restrict access to these life-saving medications.

The pharmacist who refused to fill your order for methotrexate for your patient aided the state in its effort to restrict access to medication by demanding written details about the patient beyond that routinely and legally required to fill a prescription. Aside from violating a federal law (i.e., the Health Insurance Portability and Accountability Act of 1996 [HIPAA]), which protects a patient’s privacy, collection of protected medical information created a paper trail the state and others could follow, leading from you and your patient to the pharmacy, then to the healthcare insurer and even to the patient’s employer.¹⁶ This invasion of the patient’s privacy and coercion of the physician is justified in Texas because the state has determined it owns, and therefore can make decisions pertaining to, a woman’s body.

This invasion of the patient’s privacy & coercion of the physician is justified in Texas because the state has determined it owns, & therefore can make decisions pertaining to, a woman’s body.

On July 14, the Office for Civil Rights in the U.S. Dept. of Health & Human Services issued guidance that unequivocally stated that discrimination against a pregnant person, including denial of medication, is neither justified nor allowed under federal law: “Pharmacies … may not discriminate … with regard to supplying medications; making determinations regarding the suitability of a prescribed medication for a patient. … As recipients of federal financial assistance, … pharmacies are prohibited from discriminating on the basis of race, color, national origin, sex, age, and disability … under a range of federal civil rights laws. Under federal civil rights law, pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.”¹⁷

Personhood

You realize you now live in a new world in which a patient with diabetes, autoimmune disease, cancer, mobility problems or neuropsychiatric issues is of no concern to a state ranking 48 out of 51 on healthcare access and quality, service use and cost, health disparities, and health outcomes.¹⁸ And your obstetrical colleague reflects how this state has little interest in the pregnant woman’s suffering: potential pain, ectopic pregnancy, fetal chromosomal abnormalities, placenta previa and increased necessity for Caesarean deliveries. The state, which ranks as the fifth worst in the nation for children, is concerned about the concept of fetal personhood, overruling concern for the rights and needs of mothers and children.^19,20

You have heard the argument that a fetus is a person entitled to all protections accorded any living being. But is it?

Arguments and counter-arguments come from politicians, the courts, religious leaders, medical specialists and other groups with vested interests in the answer and actions that follow. The heart of the conflict is the tension between maternal and fetal rights and what takes priority: protecting the health and, possibly, the life of a pregnant woman or the desire to save a fetus. Who is to make the decision—the woman or some external party claiming authority to do so?

And what is a fetus, especially one that may not be viable? The argument is that it is a “baby” who should be given a chance to live, even at the literal expense of the mother’s life. But before the fetus is born is it—can it be—a living human being? If it first has to be born to live, then is a fetus a baby or only a possible baby?

You feel like you are back in your debate class in college, trying to convince your audience of the correctness of your position on the topic du jour: syllogisms.

Pushing the academic and intellectual questions aside, you recall the battle being fought today had its genesis in a 1987 court-ordered Caesarean section on a woman dying of cancer who was 26 weeks pregnant. The baby died two hours after the operation, and the mother died two days later. The family sued and, in a 7–1, precedent-setting decision, the D.C. Court of Appeals ruled that a woman has the right to decide about medical treatment for herself and her fetus. It said that only in “rare and exceptional” cases would it be possible to override the mother’s wishes and acknowledged that “some may doubt that there could ever be a situation extraordinary or compelling enough to justify a massive intrusion into a person’s body, such as a Caesarean section, against that person’s will.”²¹

What Next?

While you prepare for deposition, you are despondent. You are accused of prescribing methotrexate to induce an abortion and know that Texas law makes performing an abortion a felony, punishable by up to life in prison. You also know that you are facing a huge fine because the law mandates the attorney general seek a civil penalty of not less than $100,000, plus attorney’s fees.

The prosecution, citing the National Academy of Medicine’s controversial and flawed report To Err Is Human, proclaims that you are part of the problem with the medical establishment and that your treatment of the patient is a criminal offense in Texas.²²

As you await the court’s judgment and contemplate your future, you ask yourself why anyone would want to go to medical school or apply for residency in a state like this.

Residency review committees have already documented deficiencies in training in states with injunctions on providing training on such fundamental procedures as dilatation and curettage.

Why would any practitioner want to remain in a state with antediluvian laws that compel the practice of bad medicine at the patient’s expense over supporting best practices of the medical profession? If you want to practice good medicine, why not head to enlightened states and leave ones like Texas to become medical wastelands?

Finally, you ask when will your colleagues come together across the medical spectrum and exclaim, “We are mad as hell, and we aren’t going to take it anymore!” and then take action?²³

Wake Up!

Suddenly, you open your eyes. You’re in bed and in a cold sweat. You shudder, glance furtively around and whisper, “That sure was a scary nightmare!”

Or was it?²⁴

Raymond Scalettar, MD, DSc, MACR, is clinical professor of medicine emeritus, the George Washington University School of Medicine and Health Sciences, Washington, D.C.

References

1. Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases. Arthritis Rheumatol. 2020 Apr;72(4):529–556.
2. Teal S, Edelman A. Contraception selection, effectiveness, and adverse effects. JAMA. 2021 Dec 28;326(24):2507–2518.
3. Cahan E. Lawsuits, reimbursement, and liability insurance—Facing the realities of a post-Roe era. JAMA. 2022 Aug 9;328(6):515–517.
4. Creinen M, Vittinghoff E. Methotrexate and misoprostol vs misoprostol alone for early abortion. A randomized controlled trial. JAMA. 1994 Oct 19; 1994 Oct 19;272(15):1190–1195.
5. Cauterucci C. Abortion bans are already messing up access to other vital meds. Slate. 2022 May 24.
6. Burky A. Backlash against CVS, Walgreens raises questions about role of retail in post-Dobbs world. Fierce Healthcare. 2022 Sep 1.
7. Feibel C. Pharmacies may violate civil rights if they refuse meds linked to abortion, feds warn. NPR. 2022 Jul 13.
8. Shepherd K, Stead Sellers F. Abortion bans complicate access to drugs for cancer, arthritis, even ulcers. The Washington Post. 2022 Aug 8.
9. Supreme Court of the United States. Dobbs v. Jackson Women’s Health Organization. (597 U.S. __) (2022). https://www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf.
10. 42 U.S. Code § 1395dd (Examination and treatment for emergency medical conditions and women in labor). https://www.law.cornell.edu/uscode/text/42/1395dd.
11. Centers for Medicare & Medicaid Services. Emergency Medical Treatment & Labor Act (EMTALA). 2022 Aug 25. https://www.cms.gov/Regulations-and-Guidance/Legislation/EMTALA.
12. Whelan E. Federal court enjoins HHS EMTALA guidance on abortions in Texas. National Review. 2022 Aug 24.
13. Woman’s Right to Know Act, Texas Stat. § 170A.002 (2003 & rev. 2022). https://statutes.capitol.texas.gov/Docs/HS/htm/HS.170A.htm.
14. ACOG, AMA, et al. Brief of amici curiae in support of respondents (No. 19-1392; Dobbs et al. v Jackson Women’s Health Organization et al.). 2021 Sep 20.
15. Seo P. Set up to fail: The criminalization of clinical practice. The Rheumatologist. 2022 May 12.
16. 104th Congress Public Law 191. Health Insurance Portability and Accountability Act of 1996. https://www.govinfo.gov/content/pkg/PLAW-104publ191/html/PLAW-104publ191.htm.
17. U.S. Department of Health & Human Services. Guidance to nation’s retail pharmacies: Obligations under federal civil rights laws to ensure access to comprehensive reproductive health care services. Office for Civil Rights. 2022 Jul 14. https://www.hhs.gov/civil-rights/for-individuals/special-topics/reproductivehealthcare/pharmacies-guidance/index.html.
18. Radley DC, Baumgartner JC, Collins SR. 2022 scorecard on state health system performance. The Commonwealth Fund. 2022 Jun 16. https://www.commonwealthfund.org/publications/scorecard/2022/jun/2022-scorecard-state-health-system-performance.
19. Clarida K. 2021 kids count data book: Texas children deserve better. Every Texan. 2021 Jun 21. https://everytexan.org/2021/06/21/2021-kids-count-data-book-texas-children-deserve-better.
20. Ziegler M. The next step in the anti-abortion playbook is becoming clear. The New York Times. 2022 Aug 31. https://www.nytimes.com/2022/08/31/opinion/abortion-fetal-personhood.html.
21. Tillman J. A dying woman’s forced C-section launched a fight over fetal rights. The Washington Post. 2022 Aug 21. https://www.washingtonpost.com/history/2022/08/21/angela-carder-fetal-rights-cancer.
22. National Academy of Sciences. To err is human: Building a safer health system. Institute of Medicine (US) Committee on Quality of Health Care in America. 2000. https://pubmed.ncbi.nlm.nih.gov/25077248.
23. Wynia MK. Professional civil disobedience—medical-society responsibilities after Dobbs. N Engl J Med. 2022 Sep 15;387(11):959–961.
24. Arey W, Lerma K, Beasley A, et al. A preview of the dangerous future of abortion bans—Texas Senate Bill 8. N Engl J Med. 2022 Aug 4;387(5):388–390.