A new opioid overdose antidote to enter the market

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Today’s edition: More women denied abortions have joined a lawsuit against Texas’s restrictive law. Seniors are flooding homeless shelters that can’t care for them. But first … 

Some have concerns over the potential cost and side effects of the new opioid reversal drug

The Food and Drug Administration approved a new medication to reverse overdoses from opioids and the powerful synthetic opioid fentanyl, a major driver of the nation’s drug crisis. 

The drugmaker, Indivior, is touting the potent nasal spray as a way to save lives more quickly while protecting against more overdoses for hours. 

But not everyone is thrilled. As our colleague David Ovalle reports, there’s been some pushback to the drug from public health experts, physicians and community groups. They’ve expressed concerns over the potential cost of the new medication — especially with likely cheaper opioid antidote drugs already on the market — and the potential for some users to experience long-lasting withdrawal symptoms.

This comes as federal and state health officials grapple with a staggering number of drug overdoses per year, which has continued to top 100,000 deaths. The crisis has spurred debate in Congress and within the public health community over what policies are effective tools to stem the scourge of deaths — with House Republicans putting a fentanyl bill up for a vote this week. (More on that below.)

The new drug from Indivior is called Opvee, which is a spray version of the drug nalmefene and will be available in the fall.

But how much will the drug cost? Per David: The company hasn’t detailed the price of the medication. Indivior has projected $150 million to $250 million in sales per year and is aiming the medication at health departments, fire and law enforcement agencies and school districts.

In a statement, Mark Crossley, the CEO of the drug company, called the FDA’s approval “a significant achievement in the development of new treatment options” to address opioid overdoses. 

Yet, there’s some skepticism that the more powerful reversal drugs, like nalmefene, are more effective than naloxone — a medication commonly used to reverse opioid overdoses — as well as concerns its potency could lead to longer periods of withdrawal symptoms. One population that could be a key market for the drug is younger people who don’t have a tolerance to opioids. 

• Utah state Sen. Jen Plumb (D), who founded the organization Utah Naloxone, told David she believes the company is trying to “capitalize on fear … marketing to the places with the pots of money.” 
• Meanwhile, Crossley counters that “it’s about having the right options out there, for first responders, for patients, and I think we’ll let the market choose.”

The divisions over the benefit of the new medication yesterday came as lawmakers in the House were debating legislation to permanently place fentanyl-like substances in a category reserved for the most dangerous drugs.

The White House said it “has long supported” two key provisions of the bill, though it didn’t actually specify whether the president would sign or veto the measure — a question lawmakers sparred over during a House Rules Committee meeting yesterday afternoon.

The Biden administration pointed to provisions in the legislation to permanently classify all fentanyl-related substances as Schedule I drugs and expedite research into such substances. 

“These two provisions are critical components of the Biden-Harris Administration’s 2021 recommendations to Congress to combat the supply of illicit FRS and save lives,” the White House wrote in a statement of administration policy on the HALT Fentanyl Act, which the House is slated to vote on Thursday.

The statement also included this line: “The Administration’s 2021 recommendations to Congress included additional provisions to improve public safety. The Administration calls on Congress to pass all of these critical measures to improve public safety and save lives.”

In September 2021, the White House issued recommendations to Congress on fentanyl-related substances, which among other items, said to exclude such substances from mandatory minimum penalties except in cases of death or serious bodily harm. Some top Democrats have concerns the legislation doesn’t include these policies.

Bloomberg News’s Alex Ruoff:

At the Rules hearing there’s some debate over whether or not this is a veto threat or a statement of support.

Rep. Michael Burgess suggests they should just pass the bill and see what happens.

— Alex Ruoff (@Alexruoff) May 22, 2023

More women join lawsuit against Texas in post-Roe case

Eight more women are joining a lawsuit against the state of Texas over its abortion ban, saying that the law prevented them from getting the procedure despite the complicated — and sometimes life-threatening — circumstances of their pregnancies. 

The new plaintiffs have added their names to a lawsuit originally filed in March by five women and two doctors over the state’s abortion restrictions, which makes performing an abortion a felony unless a pregnant patient’s life or serious health is at risk.

The Center for Reproductive Rights, which is representing the plaintiffs, is now seeking a temporary injunction to block the state’s abortion ban in cases of pregnancy complications while a legal challenge against it plays out, according to an amended complaint in the case filed yesterday in a district court in Travis County.

The lawsuit also asks the court to affirm that physicians can make exceptions to the state’s ban and clarify under what conditions. The plaintiffs allege that vague language around the scope of the exception has stoked fears among physicians of losing their licenses, being fined, and possibly facing civil and criminal charges for performing lifesaving obstetrics care.

CBS Austin’s Melanie Torre: 

TODAY: Eight more women have joined a lawsuit against the State of Texas over the abortion ban. They are not trying to overturn the law but are instead seeking clarification about when doctors can end a pregnancy due to health complications. Here’s Jessica Bernardo’s story: pic.twitter.com/UwIKjfxzWo

— MelanieTorre (@melanietorre) May 22, 2023

Seniors are flooding homeless shelters that can’t care for them

Shelters across the country are struggling to accommodate a surge in elderly Americans experiencing homelessness, many of whom require a higher level of care than the nation’s social safety net can provide, The Post’s Christopher Rowland reports.

Communities are racing to come up with novel solutions for the crisis, including establishing senior shelters that provide medical and social services tailored to the elderly and hiring specially trained staff to help unhoused seniors manage their daily needs.

A closer look: Doctors and advocates describe a cycle that they say leaves seniors particularly vulnerable to life on the streets. Homeless people contract chronic diseases and other geriatric problems much earlier than average, and elderly patients usually take longer to recover. However, Medicaid will only pay for a long-term nursing home or assisted living bed if someone is unable to care for themselves — a threshold many elderly homeless people aren’t debilitated enough to meet.

As a result, after treatment for an acute illness, hospitals often discharge homeless patients, who wind up back in shelters or even back into their sidewalk tents and makeshift lean-tos, in what health practitioners in Phoenix ruefully call “treat-and-street,” Christopher writes.

Why it matters: The federal government estimates that nearly a quarter of a million individuals 55 or older were homeless in the United States during at least part of 2019.

Care at U.S. border facilities under review after latest child’s death

The deaths of three migrant minors in U.S. government custody this year has prompted a review of the health-care practices of facilities run by Customs and Border Protection, our colleague Nick Miroff reports.

The agency will also assess all of the “medically fragile” individuals under its care, Troy Miller, CBP acting commissioner, said in a statement.

The details: An 8-year-old migrant girl who was taken into U.S. custody after crossing the border in South Texas died last Wednesday after falling ill with the flu. Federal authorities at the processing facility where she was being held didn’t send her to a hospital when her symptoms worsened despite her medical history, which included sickle cell anemia and heart disease, according to a government timeline of the incident.

Just days before on May 10, a 17-year-old Honduran boy died while staying at a shelter in Florida for teens and children who cross the border without parents. The federal health department has also confirmed that a 4-year-old girl from Honduras who had been in the agency’s care since 2019 died on March 17 after going into cardiac arrest. She was also considered “medically fragile.”

The bigger picture: The recent deaths have refocused attention on U.S. medical care and treatment for migrant teens and children detained by the government, while underscoring the risks at border facilities where U.S. agents and staff are strained by record numbers of illegal crossings. CBP officials say they have significantly improved medical care and screening procedures in recent years, Nick writes.

Rep. Raúl M. Grijalva (D-Ariz.): 

The death of an eight-year-old girl in CBP custody is distressing and tragic. This is the third death of a migrant child in federal custody under the Biden administration. I give my sincerest condolences to the families for their heartbreaking loss. https://t.co/Wnta51zArf

— Raul M. Grijalva (@RepRaulGrijalva) May 18, 2023

• New this a.m.: Surgeon General Vivek Murthy has issued a new advisory about the effects social media use has on youth mental health. 
• Abortions at 12 weeks of pregnancy are now prohibited in Nebraska after Republican Gov. Jim Pillen signed a new ban into law yesterday that went into effect immediately. The legislation also restricts gender-affirming care for people younger than 19 in the state, which takes effect Oct. 1, Omaha World-Herald’s Erin Bamer reports.
• Some patient advocates are criticizing a proposed trial funded by the National Institutes of Health that plans to study exercise as a potential treatment for long covid. They argue that such a trial could be potentially dangerous for long-covid patients with chronic fatigue syndrome, since physical excursion has been shown to worsen symptoms of the disease, The Post’s Amanda Morris reports.

Funders Thought Watching Bats Wasn’t Important. Then She Helped Solve the Mystery of a Deadly Virus. (By Caroline Chen | ProPublica)

Covid Loan Fraud Probes Turn to the Bankers Who Approved Them (By Ben Penn | Bloomberg Law)

How Tuberville’s blockade of Pentagon nominees could end (By Joe Gould and Connor O’Brien | Politico)

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