Roe v Wade

Why anti-abortion laws are putting autoimmune patients at risk

Methotrexate treats rheumatoid arthritis, lupus and certain cancers. It can also be used to end pregnancies. After the collapse of Roe v Wade, patients tell Alex Woodward that they fear losing access to a critical drug

Friday 15 July 2022 15:42 BST
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One month after receiving a two-month prescription for methotrexate, Jennifer Crow received a call from her pharmacist declining a refill until she talked to her physician.

Ms Crow has taken a weekly methotrexate pill since April to treat inflammatory arthritis. She also has myasthenia gravis, a chronic autoimmune disorder causing weakness and fatigue. Adding methotrexate to her regimen “was that missing piece to give me that extra bit of independence and to cure the pain and inflammation,” she tells The Independent. “It helped me get strong again.”

The call came on a Friday, hours after the US Supreme Court struck down the constitutional right to abortion. Her health provider was closed for the weekend.

Methotrexate is considered a first-line treatment for people living with autoimmune conditions, including rheumatoid arthritis, lupus and psoriasis, among other chronic conditions, as well as some forms of cancer.

The drug can also end pregnancies. Six states specifically mention methotrexate in their laws barring medication abortion, and more than 30 states have restricted access to abortion drugs. States that have outlawed abortion extend those restrictions to medication abortion.

A two-drug regimen of mifepristone and misoprostol, approved for use up to 10 weeks of pregnancy in most cases by the US Food and Drug Administration, is the most common form of abortion care, and can often be taken in the comfort of the patient’s home and prescribed online.

Doctors use methotrexate to end some ectopic pregnancies, in which a fertilized egg grows outside the uterus and presents a life-threatening risk to the patient.

Ms Crow lives in Tennessee, which has outlawed most abortions after roughly six weeks of pregnancy. A state law that bans nearly all abortions is expected to go into effect later this month.

She typically takes methotrexate on Sunday nights, and she eventually was able to get her medication the following week. But the delay in her routine can mean “the difference between participating in daily life and being too tired and fatigued and worn out and in pain to do anything,” she says.

She is not alone. Patients across the US shared their stories about their delayed or denied medications across social media, in Facebook groups for people living with autoimmune diseases, and with health organisations and medical groups collecting reports that pharmacies and physicians were beginning to reject prescriptions in the wake of the Supreme Court’s decision in Dobbs v Jackson Women’s Health Organization on 24 June.

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Women in Alabama, South Carolina, Tennessee and Texas, among other states with restrictive anti-abortion laws, have reported delays or obstacles to getting critical methotrexate prescriptions filled.

“This is a terrible situation since so many patients depend on methotrexate,” Donald Miller, chair of the pharmacy practice department at North Dakota State University, said in a statement from the Arthritis Foundation. “It’s very sad that pharmacists must protect themselves from going to jail for filling a prescription.”

For patients with chronic illness, losing access to medication can be ‘catastrophic’

Methotrexate is among a class of drugs considered “disease modifying anti-rheumatic drugs,” or DMARDS. Millions of Americans rely on it. It also is relatively cheap. A typical monthly prescription from a retail pharmacy is priced at roughly $10.

The American College of Rheumatology says it is “aware of the emerging concerns surrounding access to needed treatments” including methotrexate.

The organisation is determining whether rheumatoid providers and patients are experiencing any widespread difficulty “or if any initial disruptions are potentially temporary [and] due to the independent actions of pharmacists trying to figure out what is [and] isn’t allowed where they practice,” according to a statement.

The Lupus Foundation of America also is working with the Medical-Scientific Advisory Council “to guide our efforts going forward so we can help ensure that people with lupus have access to the treatments they need,” according to a statement.

Patient advocates told The Independent that pharmacists appear to be pre-emptively denying prescriptions based on state-level abortion restrictions to avoid potential legal liability in states where abortion care is now criminalised, or could soon be outlawed.

Patients with chronic conditions losing access to medications can be “catastrophic,” says Steven Newmark, chief legal officer and director of policy with the Global Healthy Living Foundation, which has received similar complaints from across the US in the wake of the Supreme Court decision.

“It can take years of trial and error on all different kinds of medication before finally finding a treatment that works for you,” he tells The Independent. “So not being able to have access to the treatment [can] literally be the difference between spending a day or days – depending how long you get the medication – in bed, writhing in pain, or going about your day.”

“Overzealous” readings of recently enacted laws that restrict access to drugs affiliated with abortion care, or pharmacists exercising extreme caution to avoid legal liablity, like requiring patients to return to their physicians to get their medication, are putting up barriers to care “that these chronically ill individuals shouldn’t have to put up with,” Mr Newmark says.

Major pharmacies tell The Independent they are complying with new state laws. The Biden administration warns them not to withhold medication

This week, President Joe Biden’s administration issued a warning to the nation’s 60,000 retail pharmacies that they risk violating federal civil rights law if they refuse to fill prescriptions for certain medications.

Guidance from the US Department of Health and Human Services on 13 July warns that failing to prescribe medications could constitute discrimination on the basis of sex or disability.

The guidance clarifies that providers must adhere to federal antidiscrimination protections in their activities, including prescribing medications as well as “making determinations regarding the suitability of prescribed medications for a patient” and “advising a patient about prescribed medications and how to take them”.

If a pharmacy refuses to fill prescriptions for arthritis patients “or does not stock methotrexate because of its alternate uses, it may be discriminating on the basis of disability,” according to the guidance.

US President Joe Biden signs order on abortion access

Two of the nation’s largest retail pharmacy chains, CVS and Walgreens, told The Independent that the companies intend to comply with new state laws on medication restrictions following the Dobbs decision.

A spokesperson for CVS told The Independent that doctors who prescribe medications to pharmacists in states that outlaw medication abortion are required to “validate that the intended indication” for misoprostol or methotrexate prescriptions is “not to terminate a pregnancy”.

“We encourage providers to include their diagnosis on the prescriptions they write to help ensure patients have quick and easy access to medications,” according to spokesperson Amy Thibault.

Asked whether patients are likely to face delays or be denied their medications if a physician is refilling an existing prescription or a new one, without explicitly indicating that it is not pregnancy-related, Ms Thibault said the company’s goal “is to minimize any potential delays by encouraging providers at the outset to include the diagnosis on the prescriptions they write for these medications”.

A spokesperson for Walgreens told The Independent that its pharmacies are “prepared to adhere to new federal and state laws and regulations and will update any protocols as a result of the Supreme Court decision”.

“Our pharmacy team members work with prescribers to ensure that any prescription medications, including pregnancy-ending medications, are dispensed in compliance with applicable laws,” said Fraser Engerman, senior director for external relations at Walgreens.

Walmart, the nation’s third-largest retail pharmacist, did not respond to The Independent’s requests for comment.

A spokesperson for the American Pharmacists Association told The Independent that the organisation is “closely monitoring the issue”.

“We are concerned about potential patients jeopardized access to medications that are being used for another indication but may also be used for an abortion,” said E Michael Murphy, adviser for state government affairs.

He said the association also is “looking into issues related to access” to misoprostol, ulcer prevention medicine and other medications that may be included in the definition of “abortion-inducing drug” definition under state laws.

‘It took 144 hours for me to have less safe healthcare because Roe was overturned’

Michigan’s Department of Health and Human Services has clarified that emergency contraception as well as medication abortion remains legal and acessible in the state, where officials are battling a nearly 100-year-old anti-abortion law pre-empting Roe v Wade. A state judge blocked enforcement in the law in May.

But one lupus patient in Michigan told The Independent that her pharmacist said her methotrexate prescription “could not be filled unless they know what it was being filled for”.

The pharmacist also told the patient that methotrexate is only approved by the US Food and Drug Administration for breast cancer and that her doctor would need to confirm its use, and then asked for the results from a pregnancy test “as I was presumably fertile and this was just a precaution,” the patient said.

“I’ve gotten the same exact prescription from the same pharmacy in 2020/2021 for a duration of [seven] months, no questions asked,” she tells The Independent.

She called her rheumatologist’s office, where the receptionist told her to try another pharmacy, according to the patient. A prescription was faxed to another pharmacy, which left a voicemail saying the prescription would not be filled, she says.

A message from their physician shared with The Independent noted that the office “will not be processing any prescriptions or refills for methotrexate after [4 August]”.

Becky Schwarz, who has lupus, said she received an email from her rheumatologist on 30 June telling her that the healthcare system will no longer fulfill any refills of methotrexate because it is considered an abortion-inducing drug.

The health organisation paused prescriptions of the drug pending reviews of state law that would not expose providers to any legal consequences, according to the message.

“In less than one week I lost access to healthcare that I need because the drug could be used to induce abortions,” she shared in a viral Twitter thread. “It took 144 hours for me to have less safe healthcare because Roe was overturned.”

Her home state of Virginia currently permits legal abortion care through the second trimester. The state’s Republican Governor Glenn Youngkin supports legislation that would outlaw abortions at 15 weeks of pregnancy.

“If this is happening in a blue state with no trigger law, think of those in red states where abortion isn’t even legal,” she wrote. “And those states that have trigger laws causing extreme and immediate loss of access.”

Another patient in Virginia who has Crohn’s disease told The Los Angeles Times that she is waiting for her methotrexate prescription to be refilled.

“I’ve tried all the options,” she told the newspaper. “Anything weaker, I’ll go out of remission. And anything stronger, I’ll get these infections.”

Ms Crow says she has access to resources and a team of providers to help her navigate her healthcare, but she tells The Independent that she fears for the future of others who are “fighting autoimmune diseases and fighting for medicines that literally make the difference between … being able to participate in life and not.”

Anti-abortion laws could impact miscarriage treatment and create obstacles across state lines

Some states have explicitly named methotrexate in their laws banning abortion care. Senate Bill 4 in Texas outlaws “abortion-inducing drugs” including the use of “off-label use of drugs, medicines, or other substances known to have abortion-inducing properties that are prescribed, dispensed, or administered with the intent of causing an abortion, including the mifeprex regimen, misoprostol … and methotrexate.”

The law notes that “abortion-inducing dugs” does not include “a drug, medicine or other substance that may be known to cause an abortion but is prescribed, dispensed, or administered for other medical reasons”.

Misoprostol and mifepristone are also the only drugs recommended by the American College of Obstetricians and Gynecologists for treating an early pregnancy loss. Miscarriages occur in roughly one out of every 10 pregnancies. Some patients in Texas have reported that their pharmacies refused to fill their prescriptions.

Miscarriages also can be treated through dilation and curettage, vacuum aspiration, and dilation and evacuation procedures – effectively the same used in procedural abortion care.

Nineteen states require a clinician providing medication abortion to be physically present when the drugs are administered, effectively banning telemedicine appointments to prescribe the medication.

Patients in those states must still go through the same obstacles – in-person appointments, waiting periods, long-distance travel – as they would for procedural abortions, and many states are also making it illegal to obtain the medication by mail.

Abortion remains legal in Montana. But four of the state’s five clinics, including three operated by Planned Parenthood, are preemptively restricting access to medication aborton to out-of-state patients while providers navigate potential civil and criminal actions from surrounding states preparing to enact anti-abortion laws that criminalise care.

Abortion is illegal in neighbouring South Dakota, with no exceptions for rape or incest. But similar “trigger” bans in neighboring states Idaho, North Dakota and Wyoming are not yet in effect.

In New Orleans, Louisiana, a doctor said she prescribed misoprostol to make it easier to insert a patient’s intrauterine device, or IUD. The pharmacy called her to ask whether it was for an abortion, then refused to dispense the drug.

After Missouri outlawed abortion care in the hours after the Supreme Court’s decision striking down Roe v Wade, Saint Luke’s Health Center – which operates 16 facilities across Missouri and Kansas – announced that it would no longer provide pregnant victims of rape and incest with emergency contraception over legal concerns that doing so would violate the state’s newly enacted law.

“As a system that deeply cares about its team, we simply cannot put our clinicians in a position that might result in criminal prosecution,” the centre said in a statement.

The following day, the healthcare network reversed its decision.

The Supreme Court opened the door for challenges to reproductive healthcare

Legal analysts and providers are bracing for other potential restrictions on reproductive health medication following the Supreme Court’s landmark ruling, which Justice Clarence Thomas suggests should open the door to revisiting 14th Amendment protections for contraception, among other decisions.

At least one right-wing legal challenge is already taking aim at Descovy and Truvada, two medications that are used to prevent HIV transmission when taken as pre-exposure prophylaxis, also known as Prep.

Jonathan Mitchell, the former solicitor general of Texas who helped draft Senate Bill 8, the state’s anti-abortion law, is representing several clients in a lawsuit against the the Affordable Care Act’s mandate that insurance providers support Prep coverage.

“The Prep mandate forces religious employers to provide coverage for drugs that facilitate and encourage homosexual behavior, prostitution, sexual promiscuity, and intravenous drug use,” the lawsuit states. “It also compels religious employers and religious individuals who purchase health insurance to subsidize these behaviors as a condition of purchasing health insurance.”

Following the court’s decision in Dobbs, scores of Democratic members of Congress have also urged the FDA to promptly review any applications for over-the-counter birth control medication. More than 100 Democrats have also signed a bill that would require insurance companies to cover the cost of over-the-counter birth control. Paris-based drug manufacturer HRA Pharma has asked the FDA to authorize its pill for over-the-counter sales in the US.

Melissa Murray, law professor at New York University School of Law, told the House Judiciary Committee on 14 July that “it would be a mistake to dismiss” the opinion from Justice Thomas.

She said his writing has signalled that “the goalpost has moved”.

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