Post-Roe, autoimmune patients lose access to a crucial drug

Six days after the Supreme Court struck down abortion rights, lupus patient Becky Schwarz got an unexpected message from her rheumatologist.

“This is a notice to inform you that we are pausing all prescriptions and subsequent refills of methotrexate,” the message said. “This decision was made in response to the Roe vs. Wade reversal.”

Black was stunned. Methotrexate is a cheap, widely available drug prescribed to millions of Americans. Many have rheumatic diseases like her. Others take it to treat inflammatory bowel disease, psoriasis or cancer.

Yet few know that it’s used off-label to terminate ectopic pregnancies, or that it could be restricted by doctors or pharmacists even in states like Virginia that don’t ban abortion.

The grounds are numerous and muddy.

In Texas, supplying methotrexate to someone who uses it to induce a miscarriage after 49 days of pregnancy is a criminal offense; This makes pharmacists reluctant to fill out such prescriptions for almost anyone with a uterus. A new total abortion ban in Tennessee will effectively criminalize any drug that could interfere with pregnancy beyond the point of conception, with strict exceptions for a patient who would otherwise die. And in Virginia, confusion over who can prescribe drugs “qualified as an abortifacient” could block access to the drugs.

“That was shocking to me,” said Schwarz, a 27-year-old who lives in Tysons Corner, Virginia. “In a state where I thought I was relatively protected, regardless of what the Supreme Court ruled, I found I wasn’t.”

Methotrexate was originally developed as a chemotherapy drug more than 60 years ago. But in low doses, it has proven to be one of the safest, least expensive, and most effective treatments for about a dozen autoimmune diseases, from juvenile idiopathic arthritis to Crohn’s disease.

“It’s one of the drugs I prescribe the most,” he said dr Grant Schulert, a pediatric rheumatology specialist at Cincinnati Children’s Hospital. “It’s really a mainstay of our practice.”

In fact, methotrexate was first approved for the treatment of rheumatic diseases in 1959, before Schulert was born and nearly 15 years before Roe vs. Wade was decided.

A person throws a hanger onto red-painted steps.

A protester throws a hanger depicting unsafe abortions in front of Los Angeles City Hall.

(Wesley Lapointe/Los Angeles Times)

Since its reversal, many patients have been delayed or denied this “gold standard” treatment for conditions unrelated to pregnancy.

“I have had some reports of children being denied methotrexate for their juvenile arthritis until they have proven they are not pregnant,” said Dr. Cuoghi Edens, assistant professor of internal medicine and pediatrics at the University of Chicago for medicine and rheumatology expert who treats adults and children.

In one case, a pharmacist initially refused to give methotrexate to an 8-year-old girl in Texas. In a note the child’s doctor shared with Edens, the pharmacist wrote, “Women of possible childbearing potential must have a paper diagnosis with state abortion laws.”

Methotrexate is a folic acid antagonist that can cause miscarriage at high doses. Although not used in medical abortions, it is the treatment of choice for ectopic pregnancy, a rapidly fatal complication that affects approximately 100,000 patients annually in the United States

In the case of an ectopic pregnancy, the fertilized egg cell never reaches the uterus, but implants itself in the fallopian tube, for example. Such pregnancies are always fatal to the fetus and can also kill the mother.

These patients make up about 2% of the 5 million Americans who take methotrexate. However, this unusual off-label use is the basis for severe new restrictions on a drug that is disproportionately prescribed to women and girls of childbearing age.

“Most rheumatic diseases affect women much more frequently than men,” explained Edens. “The prevalence of rheumatoid arthritis in women to men is 3 to 1. In lupus it’s 10 to 1. As such, rheumatology is a very female-dominated patient population.”

These patients take methotrexate at a much lower dose than is used to treat ectopic pregnancy or breast cancer. Most are advised to use birth control and switch to alternative treatments if trying to conceive.

Still, some doctors have already stopped prescribing methotrexate to avoid risking violating abortion laws.

A portrait of Sarah Blahovec at home.

Sarah Blahovec, the Crohn’s patient awaiting her prescription, says, “When I’m weaker, I go out of remission. And anything stronger, I get these infections.”

(Kent Nishimura / Los Angeles Times)

Many pharmacists have also refused to fill out methotrexate prescriptions or have asked for additional proof before dispensing the drug to patients they believe may become pregnant.

Experts say it’s not yet clear how many patients will lose access to their drugs after the Supreme Court’s decision, or which states might try to limit it.

This has caused panic among many patients who depend on the drug.

“The biggest thing I’m hearing right now is just a lot of anxiety about what’s going to happen next,” Schulert said. “Even in patients who are doing well and who stop taking a drug, about half will have their disease flare up again in six to 12 months.”

Without methotrexate, many of Schulert’s juvenile idiopathic arthritis patients would no longer be able to hold a pencil or type on a computer. Others face irreversible damage to organs and joints.

“Patients say, ‘I’ve been on this drug for years, I finally feel like myself again, I don’t want to have to switch,'” said Zoe Rothblatt, community outreach manager at Global Healthy Living Foundation, a patient advocacy organization. “It’s the gold standard and we need to make it known so people don’t have fear and can get their medication.”

Methotrexate is in a class of drugs called “disease-modifying anti-inflammatory drugs,” or DMARDS, which also includes the antimalarial drug hydroxychloroquine, which former President Trump has touted as a treatment for COVID-19.

Some lupus patients switched from hydroxychloroquine to methotrexate in the early months of the pandemic when the federal government briefly stockpiled the drug. Now they fear having to search for a new alternative that their bodies will tolerate and that their insurance will cover.

That’s because methotrexate isn’t just effective. It’s also extremely cheap. Many chain pharmacies charge less than $10 to fill a typical monthly prescription of the round yellow or orange pills.

“Methotrexate is often a first drug that a person must take before they can proceed to the next step of medication, called biologics,” Edens said. “There’s a reason it’s recommended first, and that’s because it works.”

When DMARDs fail, biologics may be equally or even more effective in treating diseases like lupus, ulcerative colitis, and psoriasis. But most are new, patent-protected drugs that are given by IV infusion at a medical center. They cost a thousand times as much.

“We spend quite a bit of unpaid time battling insurance companies for those, even if they’re approved,” Schulert said. “Even if the financial cost to patients is not high, with good insurance coverage there is a lot of worry, ‘will it be approved?’ and they have to re-approve it every year.”

Two anti-abortion protesters yell at each other through megaphones.

An abortion protest before the Supreme Court last month. Experts say it’s not clear how many patients will lose access to drugs after Roe vs. Wade reverses.

(Kent Nishimura / Los Angeles Times)

Biologics also carry risks that DMARDs do not have, including a rare but serious risk of opportunistic infections.

That’s what happened to Sarah Blahovec of Alexandria, Virginia, a Crohn’s disease patient who is waiting to see if her methotrexate prescription gets refilled in the coming weeks.

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

That’s part of what makes the legal mess surrounding methotrexate so troubling, even for patients who still have access to the drug.

Not all medicines are the same,” explained Edens. “Some of our drugs don’t work as well as methotrexate. Other medications also have side effects that patients cannot tolerate, or they interact with other medications they have to take.”

With such complex patients, even delaying their medication can make them sicker.

“As a doctor, I took an oath not to do harm,” Edens said. “For me, that hurts.”

https://www.latimes.com/california/story/2022-07-11/post-roe-many-autoimmune-patients-lose-access-to-gold-standard-drug Post-Roe, autoimmune patients lose access to a crucial drug

Alley Einstein

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