Elisabeth Rosenthal
Tue, 02 Jul 2024 09:00:00 +0000

Over the past two years, a simple but baffling request has preceded most of my encounters with medical professionals: “Rate your pain on a scale of zero to 10.”

I trained as a physician and have asked patients the very same question thousands of times, so I think hard about how to quantify the sum of the sore hips, the prickly thighs, and the numbing, itchy pain near my left shoulder blade. I pause and then, mostly arbitrarily, choose a number. “Three or four?” I venture, knowing the real answer is long, complicated, and not measurable in this one-dimensional way.

Pain is a squirrely thing. It's sometimes burning, sometimes drilling, sometimes a deep-in-the-muscles clenching ache. Mine can depend on my mood or how much attention I afford it and can recede nearly entirely if I'm engrossed in a film or a task. Pain can also be disabling enough to cancel vacations, or so overwhelming that it leads people to opioid addiction. Even 10+ pain can be bearable when it's endured for good reason, like giving birth to a child. But what's the purpose of the pains I have now, the lingering effects of a head injury?

The concept of reducing these shades of pain to a single number dates to the 1970s. But the zero-to-10 scale is ubiquitous today because of what was called a “pain revolution” in the '90s, when intense new attention to addressing pain — primarily with opioids — was framed as progress. Doctors today have a fuller understanding of treating pain, as well as the terrible consequences of prescribing opioids so readily. What they are learning only now is how to better measure pain and treat its many forms.

About 30 years ago, physicians who championed the use of opioids gave robust new life to what had been a niche specialty: pain management. They started pushing the idea that pain should be measured at every appointment as a “fifth vital sign.” The American Pain Society went as far as copyrighting the phrase. But unlike the other vital signs — blood pressure, temperature, heart rate, and breathing rate — pain had no objective scale. How to measure the unmeasurable? The society encouraged doctors and nurses to use the zero-to-10 rating system. Around that time, the FDA approved OxyContin, a slow-release opioid painkiller made by Purdue Pharma. The drugmaker itself encouraged doctors to routinely record and treat pain, and aggressively marketed opioids as an obvious solution.

To be fair, in an era when pain was too often ignored or undertreated, the zero-to-10 rating system could be regarded as an advance. Morphine pumps were not available for those cancer patients I saw in the '80s, even those in agonizing pain from cancer in their bones; doctors regarded pain as an inevitable part of disease. In the emergency room where I practiced in the early '90s, prescribing even a few opioid pills was a hassle: It required asking the head nurse to unlock a special prescription pad and making a copy for the state agency that tracked prescribing patterns. Regulators (rightly) worried that handing out narcotics would lead to addiction. As a result, some patients in need of relief likely went without.

After pain doctors and opioid manufacturers campaigned for broader use of opioids — claiming that newer forms were not addictive, or much less so than previous incarnations — prescribing the drugs became far easier and were promoted for all kinds of pain, whether from knee arthritis or back problems. As a young doctor joining the “pain revolution,” I probably asked patients thousands of times to rate their pain on a scale of zero to 10 and wrote many scripts each week for pain medication, as monitoring “the fifth vital sign” quickly became routine in the medical system. In time, a zero-to-10 pain measurement became a necessary box to fill in electronic medical records. The Joint Commission on the Accreditation of Healthcare Organizations made regularly assessing pain a prerequisite for medical centers receiving federal health care dollars. Medical groups added treatment of pain to their list of patient rights, and satisfaction with pain treatment became a component of post-visit patient surveys. (A poor showing could mean lower reimbursement from some insurers.)

But this approach to pain management had clear drawbacks. Studies accumulated showing that measuring patients' pain didn't result in better pain control. Doctors showed little interest in or didn't know how to respond to the recorded answer. And patients' satisfaction with their doctors' discussion of pain didn't necessarily mean they got adequate treatment. At the same time, the drugs were fueling the growing opioid epidemic. Research showed that an estimated 3% to 19% of people who received a prescription for pain medication from a doctor developed an addiction.

Doctors who wanted to treat pain had few other options, though. “We had a good sense that these drugs weren't the only way to manage pain,” Linda Porter, director of the National Institutes of Health's Office of Pain Policy and Planning, told me. “But we didn't have a good understanding of the complexity or alternatives.” The enthusiasm for narcotics left many varietals of pain underexplored and undertreated for years. Only in 2018, a year when nearly 50,000 Americans died of an overdose, did Congress start funding a program — the Early Phase Pain Investigation Clinical Network, or EPPIC-Net — designed to explore types of pain and find better solutions. The network connects specialists at 12 academic specialized clinical centers and is meant to jump-start new research in the field and find bespoke solutions for different kinds of pain.

A zero-to-10 scale may make sense in certain situations, such as when a nurse uses it to adjust a medication dose for a patient hospitalized after surgery or an accident. And researchers and pain specialists have tried to create better rating tools — dozens, in fact, none of which was adequate to capture pain's complexity, a European panel of experts concluded. The Veterans Health Administration, for instance, created one that had supplemental questions and visual prompts: A rating of 5 correlated with a frown and a pain level that “interrupts some activities.” The survey took much longer to administer and produced results that were no better than the zero-to-10 system. By the 2010s, many medical organizations, including the American Medical Association and the American Academy of Family Physicians, were rejecting not just the zero-to-10 scale but the entire notion that pain could be meaningfully self-reported numerically by a patient.

In the years that opioids had dominated pain remedies, a few drugs — such as gabapentin and pregabalin for neuropathy, and lidocaine patches and creams for musculoskeletal aches — had become available. “There was a growing awareness of the incredible complexity of pain — that you would have to find the right drugs for the right patients,” Rebecca Hommer, EPPIC-Net's interim director, told me. Researchers are now looking for biomarkers associated with different kinds of pain so that drug studies can use more objective measures to assess the medications' effect. A better understanding of the neural pathways and neurotransmitters that create different types of pain could also help researchers design drugs to interrupt and tame them.

Any treatments that come out of this research are unlikely to be blockbusters like opioids; by design, they will be useful to fewer people. That also makes them less appealing prospects to drug companies. So EPPIC-Net is helping small drug companies, academics, and even individual doctors design and conduct early-stage trials to test the safety and efficacy of promising pain-taming molecules. That information will be handed over to drug manufacturers for late-stage trials, all with the aim of getting new drugs approved by the FDA more quickly.

The first EPPIC-Net trials are just getting underway. Finding better treatments will be no easy task, because the nervous system is a largely unexplored universe of molecules, cells, and electronic connections that interact in countless ways. The 2021 Nobel Prize in Physiology or Medicine went to scientists who discovered the mechanisms that allow us to feel the most basic sensations: cold and hot. In comparison, pain is a hydra. A simple number might feel definitive. But it's not helping anyone make the pain go away.

——————————
By: Elisabeth Rosenthal
Title: Pain Doesn't Belong on a Scale of Zero to 10
Sourced From: kffhealthnews.org/news/article/pain-scale-zero-to-10-no-better-alternative/
Published Date: Tue, 02 Jul 2024 09:00:00 +0000

Lauren Sausser
Tue, 02 Jul 2024 09:00:00 +0000

JACKSON, Miss. — Jerrian Reedy was 9 when his father was admitted to the hospital in Hattiesburg, about two hours northeast of New Orleans, after sustaining three gunshot wounds. Reedy recalled visiting his dad in the intensive care unit that summer in 2009, even though children weren't typically permitted in that part of the hospital.

“Just seeing him laid up in bed, in a hospital bed, it was traumatizing, to say the least,” Reedy said.

His father died within a week of being admitted, in the middle of a nine-month span when Reedy also lost an aunt and a grandmother. “They say death comes in threes,” he said.

That chain of events prompted him to pursue a career in medicine, one that might help him spare other children from losing loved ones too soon.

Fifteen years later, Reedy has completed his first year at the University of Mississippi School of Medicine — a remarkable feat, and not only because his career path was born of grief and trauma. Reedy is among a small share of Black medical school students in a state where nearly 4 in 10 people — but only 1 in 10 doctors — identify as Black or African American. Of the 660 medical school students enrolled in the same four-year program as Reedy, 82 students, or about 12%, are Black.

Medical schools around the country are trying to recruit Black, Hispanic, and Native American students, all of whom remain disproportionately underrepresented in the field of medicine. Research has shown that patients of color prefer seeing doctors of their own race – and some studies have shown health outcomes are better for Black patients seeing Black doctors.

But a recent swell of Republican opposition threatens to upend those efforts, school administrators say, and could exacerbate deep health disparities already experienced by people of color.

Since 2023 — the year the Supreme Court voted to outlaw affirmative action in higher education — more than two dozen states, including Alabama, Florida, Mississippi, North Carolina, and Texas, have introduced or passed laws to restrict or ban diversity, equity, and inclusion, or DEI, programs.

“I don't expect this movement of anti-DEI legislation to slow down or stop at all,” said Anton Gunn, a health care consultant and former head of the Office of External Affairs at the U.S. Department of Health and Human Services. “And it likely will exacerbate if Donald Trump gets the opportunity to be president of the United States again.”

Diversity Programs Face Pushback

In 2023, Florida and Texas became the first states to pass laws that banned DEI efforts in higher education. Several other states, including Idaho, North Carolina, and Wyoming, passed laws targeting such programs this year.

In Mississippi, state Rep. Becky Currie and state Sen. Angela Burks Hill, both Republicans, introduced separate bills that would have restricted how colleges and universities could spend money on DEI initiatives. Both bills died in legislative committees and were not brought before the 2024 legislature for a vote.

In a statement, Hill said that Mississippi needs more doctors of all kinds, not just more Black doctors, and that she thinks money spent on DEI salaries and programs should be reallocated to initiatives benefiting all students.

“Qualifications should determine who gets into medical school not color or socioeconomic status,” she said. “Can't we just be happy with more highly qualified doctors no matter their skin color? I thought a color blind society was the goal.”

Nationally, the movement to ban DEI programs has broad conservative support.

Jay Greene, a senior research fellow at the Heritage Foundation, a conservative think tank, said he believes diversity programs “fail for a hundred reasons.” He cited research he conducted with a conservative medical advocacy group called Do No Harm refuting the premise that access to Black doctors improves health outcomes among Black patients.

“That doesn't mean there's no potential benefits for having greater diversity in the doctor workforce,” Greene said. Having more Black doctors, for example, might encourage more Black children to consider a career in health care, he said. “But that benefit is not health outcomes.”

Meanwhile, school administrators are closely watching the progress of such laws.

In March, the University of Florida eliminated all DEI programs and terminated jobs related to those efforts. In Alabama, lawyers and school leaders are grappling with a bill signed the same month by Republican Gov. Kay Ivey that bans DEI programs in public schools, state agencies, and universities starting Oct. 1.

“We have to be very, very careful,” said Richard deShazo, who teaches at the University of Alabama's Marnix E. Heersink School of Medicine in Birmingham and used to chair a committee that raised money for Black medical school students.

“You cannot raise money for Black kids. You have to raise money for medical students,” he said.

A Bitter History

A shortage of Black doctors isn't unique to Mississippi. The same story could be told in many other places, especially across the South, where more than half of all Black Americans live and where health outcomes regularly rank among the worst in the United States.

But a look at Mississippi, one of the unhealthiest states in the country, shows how the roots of systemic racism continue to shape the nation's health care workforce.

“A lot of the Black physicians in the state have a bitter taste in their mouth about our medical school,” said Demondes Haynes, associate dean of medical school admissions at the University of Mississippi Medical Center, where he graduated in 1999 as one of four Black students in his class.

An estimated 1.1 million Black people live in Mississippi, where there are fewer than 600 Black doctors. Research suggests health outcomes would improve if there were more. One study published last year in the medical journal JAMA Network Open found that life expectancy was longer among Black patients in counties with higher ratios of Black primary care physicians.

In a study based in Oakland, California, that involved more than 1,300 Black men, those who were assigned a Black doctor were more likely to agree to screening tests for diabetes, cholesterol, and other health concerns, according to the findings published in 2018 by the National Bureau of Economic Research.

“We absolutely are not saying every Black patient has to have a Black doctor,” Haynes said. But because the patient population in Mississippi is diverse, “they should at least have the right to say, ‘This is what I want,'” he added.

However, most Black patients aren't afforded that choice. Nearly two dozen of Mississippi's 82 counties have no Black doctors, while four counties claim no doctors at all, according to a physician workforce report published by the state in 2019.

For more than a century, dating to its founding in the mid-1800s, the University of Mississippi didn't admit Black students — and that policy applied to its medical school. In 1972, nearly 10 years after the Civil Rights Act of 1964 banned racial segregation in higher education, the first Black physician graduated from the medical school in Jackson. Even then, very few Black students were admitted to study medicine there each year.

Before the federal government banned the school from rejecting Black applicants because of their race, aspiring Black doctors who applied were diverted to one of the historically Black colleges and universities, or HBCUs, such as Meharry Medical College in Nashville, Haynes said.

Many older Black physicians in Mississippi still remember getting those rejection letters, he said, pointing out composite photographs of physician graduates that line the walls of the medical school building in Jackson. Many of the earliest composites, dating to the 1950s, showcase classes of all-white, and almost all-male, students.

“Mississippi history — everybody remembers it,” Haynes said. “And those people who experienced it, it's hard for them.”

‘Shaping the Possibilities'

On a damp Saturday morning in mid-April, 17-year-old Dorothy Gray, a high school junior, stepped up to a hospital bed at the medical school in Jackson to intubate a mock patient in a simulation lab.

Gray was one of more than 100 high school and college students who attended the University of Mississippi School of Medicine's annual African American Visit Day, established more than 10 years ago to foster interest among prospective Black students. The administrators, who also host special visiting days for Hispanic and Native American students, said anyone, regardless of race or ethnicity, may attend. They acknowledge that most attendees won't become doctors, and their purpose isn't to extend preferential treatment to minority applicants.

“This is about shaping the possibilities of what could be,” said Loretta Jackson-Williams, the school's vice dean for medical education. “These kids are at that precipice where they can choose to do something that's really hard for their future or they can choose an easier pathway. That choice doesn't come about overnight.”

Besides African American Visit Day, medical school leaders in Mississippi also offer a test prep program for applicants from underrepresented backgrounds who have been rejected from medical school.

The school recently identified 16 applicants, 12 of whom are Black, who were not accepted to the medical school during the last admissions cycle because their MCAT scores were too low. This year, those applicants will receive a test prep course designed by The Princeton Review — free of charge — and will have a chance to meet with administrators to learn how their medical school applications might be strengthened.

“So many students have never had someone tell them, ‘You can do this. I believe you can do this,'” said Dan Coleman, the medical school's outreach director.

For Jerrian Reedy, who wants to become an orthopedic surgeon, the path to medical school was years in the making. He took advantage of the University of Mississippi Medical Center's PROMISE program — short for Promoting Recruitment Opportunities in Medicine with Individual Study Experiences — which assures acceptance to students from disadvantaged backgrounds who meet certain eligibility requirements, including a 3.0 GPA in their undergraduate science classes.

During his sophomore year as an undergraduate, Reedy saw an opportunity to learn more about medical school when Haynes, the assistant dean, visited the Ole Miss campus in Oxford to interview students.

“I saw some open slots, put my name down,” he said. “The rest is history.”

——————————
By: Lauren Sausser
Title: Mississippi Lacks Black Doctors, Even as Lawmakers Increasingly Target Diversity Programs
Sourced From: kffhealthnews.org/news/article/black-doctor-shortage-mississippi-diversity-dei-programs/
Published Date: Tue, 02 Jul 2024 09:00:00 +0000

Stephanie Armour
Mon, 01 Jul 2024 15:30:00 +0000

A landmark Supreme Court decision that reins in federal agencies' authority is expected to hold dramatic consequences for the nation's health care system, calling into question government rules on anything from consumer protections for patients to drug safety to nursing home care.

The June 28 decision overturns a 1984 precedent that said courts should give deference to federal agencies in legal challenges over their regulatory or scientific decisions. Instead of giving priority to agencies, courts will now exercise their own independent judgment about what Congress intended when drafting a particular law.

The ruling will likely have seismic ramifications for health policy. A flood of litigation — with plaintiffs like small businesses, drugmakers, and hospitals challenging regulations they say aren't specified in the law — could leave the country with a patchwork of disparate health regulations varying by location.

Agencies such as the FDA are likely to be far more cautious in drafting regulations, Congress is expected to take more time fleshing out legislation to avoid legal challenges, and judges will be more apt to overrule current and future regulations.

Health policy leaders say patients, providers, and health systems should brace for more uncertainty and less stability in the health care system. Even routine government functions such as deciding the rate to pay doctors for treating Medicare beneficiaries could become embroiled in long legal battles that disrupt patient care or strain providers to adapt.

Groups that oppose a regulation could search for and secure partisan judges to roll back agency decision-making, said Andrew Twinamatsiko, director of the Health Policy and the Law Initiative at Georgetown University's O'Neill Institute. One example could be challenges to the FDA's approval of a medication used in abortions, which survived a Supreme Court challenge this term on a technicality.

“Judges will be more emboldened to second-guess agencies,” he said. “It's going to open agencies up to attacks.”

Regulations are effectively the technical instructions for laws written by Congress. Federal agency staffers with knowledge related to a law — say, in drugs that treat rare diseases or health care for seniors — decide how to translate Congress' words into action with input from industry, advocates, and the public.

Up until now, when agencies issued a regulation, a single rule typically applied nationwide. Following the high court ruling, however, lawsuits filed in more than one jurisdiction could result in contradictory rulings and regulatory requirements — meaning health care policies for patients, providers, or insurers could differ greatly from one area to another.

One circuit may uphold a regulation from the Centers for Disease Control and Prevention, for example, while other circuits may take different views.

“You could have eight or nine of 11 different views of the courts,” said William Buzbee, a professor at Georgetown Law.

A court in one circuit could issue a nationwide injunction to enforce its interpretation while another circuit disagrees, said Maura Monaghan, a partner at Debevoise & Plimpton. Few cases are taken up by the U.S. Supreme Court, which could leave clashing directives in place for many years.

In the immediate future, health policy leaders say agencies should brace for more litigation over controversial initiatives. A requirement that most Affordable Care Act health plans cover preventive services, for example, is already being litigated. Multiple challenges to the mandate could mean different coverage requirements for preventive care depending on where a consumer lives.

Drugmakers have sued to try to stop the Biden administration from implementing a federal law that forces makers of the most expensive drugs to negotiate prices with Medicare — a key cog in President Joe Biden's effort to lower drug prices and control health care costs.

Parts of the health care industry may take on reimbursement rates for doctors that are set by the Centers for Medicare & Medicaid Services because those specific rates aren't written into law. The agency issues rules updating payment rates in Medicare, a health insurance program for people 65 or older and younger people with disabilities. Groups representing doctors and hospitals regularly flock to Washington, D.C., to lobby against trims to their payment rates.

And providers, including those backed by deep-pocketed investors, have sued to block federal surprise-billing legislation. The No Surprises Act, which passed in 2020 and took effect for most people in 2022, aims to protect patients from unexpected, out-of-network medical bills, especially in emergencies. The high court's ruling is expected to spur more litigation over its implementation.

“This really is going to create a tectonic change in the administrative regulatory landscape,” Twinamatsiko said. “The approach since 1984 has created stability. When the FDA or CDC adopt regulations, they know those regulations will be respected. That has been taken back.”

Industry groups, including the American Hospital Association and AHIP, an insurers' trade group, declined to comment.

Agencies such as the FDA that take advantage of their regulatory authority to make specific decisions, such as the granting of exclusive marketing rights upon approval of a drug, will be vulnerable. The reason: Many of their decisions require discretion as opposed to being explicitly defined by federal law, said Joseph Ross, a professor of medicine and public health at Yale School of Medicine.

“The legislation that guides much of the work in the health space, such as FDA and CMS, is not prescriptive,” he said.

In fact, FDA Commissioner Robert Califf said in an episode of the “Healthcare Unfiltered” podcast last year that he was “very worried” about the disruption from judges overruling his agency's scientific decisions.

The high court's ruling will be especially significant for the nation's federal health agencies because their regulations are often complex, creating the opportunity for more pitched legal battles.

Challenges that may not have succeeded in courts because of the deference to agencies could now find more favorable outcomes.

“A whole host of existing regulations could be vulnerable,” said Larry Levitt, executive vice president for health policy at KFF.

Other consequences are possible. Congress may attempt to flesh out more details when drafting legislation to avoid challenges — an approach that may increase partisan standoffs and slow down an already glacial pace in passing legislation, Levitt said.

Agencies are expected to be far more cautious in writing regulations to be sure they don't go beyond the contours of the law.

The Supreme Court's 6-3 decision overturned Chevron U.S.A. v. Natural Resources Defense Council, which held that courts should generally back a federal agency's statutory interpretation as long as it was reasonable. Republicans have largely praised the new ruling as necessary for ensuring agencies don't overstep their authority, while Democrats said in the aftermath of the decision that it amounts to a judicial power grab.

——————————
By: Stephanie Armour
Title: The Supreme Court Just Limited Federal Power. Health Care Is Feeling the Shockwaves.
Sourced From: kffhealthnews.org/news/article/supreme-court-chevron-deference-doctrine-health-care-policy-shockwaves/
Published Date: Mon, 01 Jul 2024 15:30:00 +0000