National

Data: CDC; Chart: Erin Davis/Axios Visuals 

Drugs for treating opioid abuse aren’t reaching most high-risk patients, potentially widening gaps in care as overdose deaths hit record highs.

The big picture: New provisional data show a 15% surge in overdose deaths during the pandemic, rekindling a debate over whether enough Americans in the throes of the addiction crisis have access to potentially life-saving treatments.

Driving the news: Nearly 53% of patients with opioid use disorder were not prescribed buprenorphine, which reduces the risk of future overdoses, according to a new analysis of insurance claims from about 180,000 people.

More than 70% of opioid users who also misuse other substances, such as alcohol or methamphetamine, weren’t prescribed the drug, per the analysis in JAMA Network Open, which was based on data that predated the pandemic.

The analysis also found buprenorphine was better at helping prevent future overdoses than another commonly used addiction treatment, naltrexone.

What they’re saying: “This is equivalent to giving those with advanced cancer a less aggressive treatment,” said co-author Laura Bierut, a professor of psychiatry at Washington University. 

“It seems obvious to many of us that we should be giving the most aggressive and effective treatments to those who are most seriously ill.”

Many doctors remain reluctant to prescribe buprenorphine for use at home without supervision. Some experts say there’s also a lack of data about the drug’s effectiveness in those who misuse multiple substances.

A 2020 VA study of veterans found a lower likelihood of buprenorphine treatment for patients with multiple substance use disorders.

The American Medical Association recommends other strategies, such as making the easy-to-use opioid overdose antidote naloxone available over-the-counter and legalizing the use of strips that test drugs for the synthetic opioid fentanyl, which remain illegal in about half the states.

Where it stands: The National Center for Health Statistics said at least 107,622 people died from overdoses in 2021 -- more than in any other year on record and a major increase from the estimated 93,655 deaths in 2020.

A growing number of deaths involve fentanyl, which is often mixed with other drugs, and the stimulant methamphetamine.

The Biden administration last month sent Congress its first national drug control strategy, which emphasizes addressing untreated addiction through harm reduction strategies and evidence-based treatments and clamping down on drug trafficking.

Harm reduction, which includes steps like expanded access to needle exchanges, has drawn controversy, as well as skepticism from health experts who say it won't make a major dent in overdose deaths. 

The big question: It remains to be seen if the worsening addiction crisis leads to more prescribing of buprenorphine -- or a broader reevaluation of treatment strategies. 

Opioid abuse treatments don't reach those most at risk

Opioid addiction

Opioids

<div><figure><iframe frameborder="0" height="400" id="datawrapper-chart-Kfl0i" scrolling="no" src="https://datawrapper.dwcdn.net/Kfl0i/1/" title="Estimated number of U.S. drug overdose deaths"></iframe><figcaption>Data: <a class="gtmContentClick" data-vars-link-text="CDC" data-vars-click-url="https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm" data-vars-content-id="074c75a9-6cd4-4cc3-9c16-895c93efac29" data-vars-headline="Opioid abuse treatments don&#x27;t reach those most at risk" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm" target="_blank">CDC</a>; Chart: Erin Davis/Axios Visuals </figcaption></figure></div>Drugs for treating opioid abuse aren’t reaching most high-risk patients, potentially widening gaps in care as overdose deaths hit record highs.The big picture: New provisional data show a <a class="gtmContentClick" data-vars-link-text="15% surge in overdose deaths" data-vars-click-url="https://www.axios.com/2022/05/11/us-100000-overdose-deaths-2021" data-vars-content-id="074c75a9-6cd4-4cc3-9c16-895c93efac29" data-vars-headline="Opioid abuse treatments don&#x27;t reach those most at risk" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2022/05/11/us-100000-overdose-deaths-2021" target="_self">15% surge in overdose deaths</a> during the pandemic, rekindling a debate over whether enough Americans in the throes of the addiction crisis have access to potentially life-saving treatments.

The U.S. faces a range of health care flashpoints — unaffordable drugs, opioids, vaping — as we debate whether to adopt universal care. For now, the Affordable Care Act is the law of the land, but Republicans want to issue it a final death blow.

Health

A week after the maker of a controversial Alzheimer's drug announced it would largely stop marketing it, Congress is readying legislation that tinkers with the pathway used by the FDA to approve the drug, but avoids making large-scale changes.

Why it matters: Aduhelm's approval created heightened scrutiny around whether the FDA's "accelerated approval" process is being used appropriately. But as the drug fades largely into the background, so are the calls for stringent reforms.

Be smart: Accelerated approval lets drugmakers sell their products based on preliminary evidence and finish clinical trials once they're already on the market. 

14 of the 50 new drugs the FDA approved last year went through the accelerated pathway, including Takeda Pharmaceuticals' Livtencity for post-transplant infections. 

But the process has drawn concern because of the way it could put big-ticket drugs in the public's hands that may wind up being ineffective or unsafe. 

The Aduhelm approval came amid doubts that the criteria used for its approval proved the drug was effective, and the FDA's own advisory board had recommended against its approval. Manufacturer Biogen said last week it's cutting back on marketing the drug as part of efforts to refocus its business.

Driving the news: House Energy and Commerce leaders are proposing fixes as part of a broader legislative package to renew FDA programs that will be marked up today.

They would strengthen the FDA's power to ensure there are clear conditions for completing confirmatory trials and gives regulators the authority to require studies to be underway before approval is granted.

The bipartisan legislation also clarifies conditions under which the FDA could withdraw an accelerated approval and adds labeling requirements for drugs that go through the process.

Between the lines: Democrats and Republicans were divided over how far to go, with Democrats in favor of putting more of the onus on manufacturers to justify keeping the approvals and Republicans wanting to expand the use of the pathway, per Cowen analysts Eric Assaraf and Rick Weissenstein.

The House package focuses on areas where there's consensus and approaches that have been endorsed by the Biden administration, the analysts said.

The big drug industry lobby PhRMA says the process should be left as is, adding just six of 165 products that received accelerated approval in the last decade have been withdrawn, and that another nine sponsors pulled their applications.

The big picture: While experts and policymakers say the pathway can deliver breakthrough therapies faster, there are lingering questions about whether the program could be misused.

As with drug pricing, lawmakers appear set on making changes the pharmaceutical industry can tolerate.

Editor's note: This story has been corrected to reflect that Regeneron's Evkeeza was granted FDA's priority review but not accelerated approval.

Fast-track drug approval process marked for limited changes

Illustration of a stopwatch made from a large round prescription pill

Food and Drug Administration (FDA)

A week after the maker of a controversial Alzheimer&#x27;s drug announced it would largely stop marketing it, Congress is readying legislation that tinkers with the pathway used by the FDA to approve the drug, but avoids making large-scale changes.Why it matters: Aduhelm&#x27;s approval created heightened scrutiny around whether the FDA&#x27;s &quot;accelerated approval&quot; process is being used appropriately. But as the drug fades largely into the background, so are the calls for stringent reforms.

Data: Our World In Data, Johns Hopkins University; Chart: Thomas Oide/Axios

Long COVID is emerging as the next phase of the global health crisis, afflicting millions of people with neurological issues, cognitive difficulties, breathing problems and organ damage months after they fell ill.

It's also testing already overtaxed health systems with waves of chronic illness and patients who may never truly get better.

Why it matters: Our understanding of long COVID is so new that many patients can't get a clear medical explanation, and they face frustrating struggles to get diagnosed and find treatment.

The big picture: Increasingly, "long-haulers" find themselves falling through gaps in the social safety net, especially when they're too sick to work but not ready or able to be designated disabled.

There's growing evidence the condition also increases the risk of serious non-COVID health outcomes like heart attacks, strokes, diabetes and brain shrinkage.

Worse yet, long COVID is still so new and mysterious that many physicians and researchers are trying to figure out how to treat it — leaving frustrated patients without the medical help they desperately need.

"There's not a definite plan to actually help this pain go away," Julie McGehee, a tech worker in Austin, Texas, who contracted the virus while in Mexico in January, tells Axios.

"It is a waiting game, and I have no idea what that means, and my life is kind of on hold because of it."

By the numbers: The impact of long COVID is growing.

As many as 24 million Americans may have experienced long COVID symptoms.

10% to 30% of those who had COVID reported at least one symptom up to six months after the virus left their bodies.

1 in 20 fully vaccinated people infected with the Omicron strain could become long-haulers, according to some experts — and experts say the prevalence could be as high as 20% in unvaccinated people.

A U.K. study of 2,320 COVID patients discharged from the hospital in the first 13 months of the pandemic found fewer than half had fully recovered a year after contracting the disease.

Women were 33% likelier to have lingering symptoms.

What it's like: Cara — a 39-year-old Baltimore accountant who would have described herself as "Type A" just a few months ago — tells Axios she now struggles to make it through her workday or even walk up a flight of stairs without gripping the railing.

Her brain fog is one of the symptoms that bothers her the most. "I have to use my brain. ... I'm scared s--tless. I don't know when it'll come back," she says. 

"I don't know how long it's going to be, and it's frightening as hell."

What we're hearing: The condition is forcing a reckoning throughout medicine and testing a social safety net ill-equipped to deal with such a crisis.

It has kicked off a polarizing debate about how to best treat and rehabilitate people with complex post-viral conditions, including chronic fatigue syndrome.

Many of those who develop symptoms wind up paying out of pocket for care, thanks to gaps in unemployment and disability coverage that have surfaced since federal unemployment benefits expired in September 2021.

Applying for disability benefits is fraught with complications due to questions about whether some symptoms are real or if there's enough evidence to show an inability to work.

What they're saying: "I'm really worried that we're going to have patients that aren't going to get better," says Benjamin Natelson, a neurologist who heads the Pain and Fatigue Study Center at the Icahn School of Medicine at Mount Sinai. "We'll have an avalanche of continued illness."

"It's not the disease itself but the symptoms," says Glenn Kantor, founding partner at Kantor & Kantor, a Los Angeles law firm that represents long-haulers who believe they've been improperly denied benefits.

"Carriers weren't prepared for a significant number of people who have lingering symptoms that leave them unable to work."

The federal response: The National Institutes of Health has launched a $1.15 billion effort called the RECOVER Initiative to find new ways to predict and treat the condition, including repurposing already approved drugs.

Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, tells Axios the effort aims to enroll 40,000 adults and kids with existing and old infections, as well as study tissue samples from autopsies and electronic health records.

The Biden administration recently took other steps, including affirming that some long-haulers may have a disability under civil rights laws like the Americans with Disabilities Act.

How health care is changing: The U.S. medical system is beginning to reconfigure itself in anticipation of years of additional demands for care. 

Some large hospitals and health systems have opened long-COVID clinics where physicians can assess whether long-haulers have organ damage, do imaging studies and see how hard patients can be pushed in rehab.

Experts also see an uptick in demand for physical medicine and rehabilitation practices and for integrated medicine, which incorporates alternative treatments like acupuncture with conventional medicine and is already used for chronic fatigue, fibromyalgia and other conditions.

And the pandemic has instilled a growing recognition that long-haulers have a chronic, complex disease whose symptoms shouldn't be dismissed, even when they can't be ideally documented.

"The single best predictor of a doctor who can act is someone who had an ill person in their family," says Nancy Klimas, director of the Institute for Neuro-Immune Medicine at Nova Southeastern University.

The bottom line, according to Klimas: "I think everyone is going to know a family member or friend with long COVID."

The next COVID crisis

It's leaving millions wondering if they'll ever truly get better.

Deep Dive - Long COVID

Coronavirus

Long COVID is emerging as the next phase of the global health crisis, afflicting millions of people with neurological issues, cognitive difficulties, breathing problems and organ damage months after they fell ill.<ul><li>It&#x27;s also testing already overtaxed health systems with waves of chronic illness and patients who may never truly get better.</li></ul>

Axios Vitals

The Biden administration is expected to signal this week whether it's ready to end the COVID-19 public health emergency — which would affect a host of health care policies, including vaccines for kids.

Why it matters: Ending the emergency would allow a president who campaigned on ending the pandemic to declare victory over the virus. But the complex series of policy changes — and the continued threat of more COVID waves — could leave the government ill-prepared for whatever comes next.

Driving the news: The Department of Health and Human Services in April extended the emergency declaration through July 15, and has said it would give states and health providers 60 days' notice before it ends. 

That makes Tuesday the decision deadline.

What they're saying: The public is eager to put COVID in the rearview and generally unwilling to give Biden much credit for the recovery. Extending a state of emergency in that kind of climate could almost be seen as an admission of failure.

But hospitals, physician groups and advocacy organizations like AARP say keeping the emergency status is essential to maintain flexibility in the health care system as new variants emerge and the effectiveness of currently available vaccines wanes. 

A decision to end the emergency "will be based on political considerations and not likely the consensus of the scientific community inside and outside of the administration," Raymond James analyst Chris Meekins wrote in a recent report. 

Between the lines: Congress stalling on emergency COVID funds to secure additional boosters for the fall only adds further complication.

Yes, but: The administration still could go halfway and undo selected policies it thinks aren't necessary while keeping others. 

Where officials draw the line will determine questions like whether vaccines for children 6 months to 5 years old go through an expedited process or will need full FDA approval, which would take longer.

What’s at stake: Lifting the emergency would bring major policy shifts to insurance markets, drug approvals and telehealth. 

Medicaid coverage: Temporary pandemic-era reforms to Medicaid and the Affordable Care Act marketplaces caused enrollment in each to swell. Millions of people could lose their health coverage if the public health emergency expires.

Emergency approvals: Emergency use of COVID-19 diagnostics, vaccines and therapies is also tied to any declaration. HHS could pull products off the market, rewrite the authorizations or reclassify products if the emergency ends.

Free shots: The emergency declaration helps ensure that COVID-19 tests, vaccines and therapies are free or available at a reduced cost.

Relaxed telehealth boundaries: Virtual doctor's visits and health tools boomed during the pandemic, thanks to emergency flexibilities. Providers can more easily prescribe controlled substances using telemedicine as part of those rules.

Liability protections: The declaration provides liability protections to businesses and individuals who make, distribute or administer COVID-19 countermeasures. 

The bottom line: Many states have already let their public health emergencies expire by now, and it'll hardly be surprising if HHS does. But ending the federal public health emergency is much more complex than flipping a switch — and could be hard to unwind if COVID-19 decides to surprise us again.

What the end of America's public health emergency could mean

The decision will have far-reaching impacts.

Illustration of a covid particle reflected in a rearview mirror

The Biden administration is expected to signal this week whether it&#x27;s ready to end the COVID-19 public health emergency — which would affect a host of health care policies, including vaccines for kids.Why it matters: Ending the emergency would allow a president who campaigned on ending the pandemic to declare victory over the virus. But the complex series of policy changes — and the continued threat of more COVID waves — could leave the government ill-prepared for whatever comes next.

Between 5.3 million and 14.2 million people could lose their health coverage when temporary pandemic-inspired reforms to Medicaid expire at the end of the public health emergency, according to a new Kaiser Family Foundation analysis.

The big picture: Democrats who hoped they'd enact transformational health legislation with control of the White House and Congress could instead face a historic jump in the U.S. uninsured rate.

Background: Congress in 2020 included measures in pandemic relief legislation that increased the share of federal Medicaid spending if states offered continuous coverage to enrollees, suspending the program's usual churn.

The extra allowances sunset with the end of the public health emergency, which is due to expire July 15 unless the Biden administration extends it again.

Go deeper: Kaiser examined scenarios for how states can determine whether their Medicaid enrollees are still eligible for coverage when policy changes hit the safety net program.

The biggest losses are expected to be among adults who gained coverage through the Affordable Care Act's Medicaid expansion, other adults eligible for reasons other than a disability, as well as children.

Medicaid enrollment is expected to grow 25%, or by 22.2 million people, from fiscal 2019 through 2022, mostly because of the pandemic-driven allowances, the researchers project.

Millions could lose coverage when COVID public health emergency ends

Democrats who hoped to enact transformational health legislation could instead face a historic jump in the U.S. uninsured rate.

Illustration of a person looking over the edge of a large cliff chasm shaped like a medical cross

Health care

Between 5.3 million and 14.2 million people could lose their health coverage when temporary pandemic-inspired reforms to Medicaid expire at the end of the public health emergency, according to a new <a class="gtmContentClick" data-vars-link-text="Kaiser Family Foundation analysis" data-vars-click-url="https://www.kff.org/medicaid/issue-brief/fiscal-and-enrollment-implications-of-medicaid-continuous-coverage-requirement-during-and-after-the-phe-ends" data-vars-content-id="fb7dfaeb-e81d-4bcb-a755-3635b21518bd" data-vars-headline="Millions could lose coverage when COVID public health emergency ends" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.kff.org/medicaid/issue-brief/fiscal-and-enrollment-implications-of-medicaid-continuous-coverage-requirement-during-and-after-the-phe-ends" target="_blank">Kaiser Family Foundation analysis</a>.The big picture: Democrats who hoped they&#x27;d enact transformational health legislation with control of the White House and Congress could instead face a historic jump in the U.S. uninsured rate.

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Adriel Bettelheim

Stories

What the end of America's public health emergency could mean

Opioid abuse treatments don't reach those most at risk

Fast-track drug approval process marked for limited changes

Millions could lose coverage when COVID public health emergency ends

The next COVID crisis