Aaron E. Carroll's Blog, page 30

Wards close but the babies keep coming

In early December, Vice President Harris marked the first ever Maternal Health Day of Action, emphasizing the work still left to do to keep both mothers and babies healthy in this country. The United States has long struggled with abysmal maternal morbidity and mortality and the all too frequent closure of hospital maternity wards isn’t helping.

Babies will always be born. So, timely access to high quality obstetric care is a must. How do we make that a reality for all?

Access to obstetric care

A 2020 report by March of Dimes shows that ten percent of births occur in counties with inadequate maternity care. Over two million women of childbearing age live in counties with no obstetric care — maternity care deserts — and another 4.8 million live in counties with minimal care available.

And access keeps dwindling. For example, the Windham Hospital in Connecticut is in the process of closing its maternity ward. A 2016 study surveyed over 260 rural hospitals and found that about seven percent closed their wards between 2010 and 2014. Another study found that, from 2014 to 2018, there was a net loss in obstetric services in rural counties nationwide (though a net gain in urban counties).

Hospitals often argue they are forced to close their maternity wards because of low birth volumes and financial challenges. This is what Windham Hospital has said as well as the hospitals interviewed in the 2016 study. They noted physicians retiring and an unavailability of anesthesia services, low birth volumes leading to undertrained staff, and budget cuts and hospital system consolidations.

Mothers and advocates maintain that ward closures lead to increased health risks. For one, travel times during labor automatically increase. One woman impacted by the Windham Hospital closure delivered on the side of the road on the way to a different hospital. Additionally, a recent study found that living in a maternity care desert is linked to higher risk of death during pregnancy and up to one year postpartum.

Both sides have fair points. Maintaining “under-performing” maternity wards may not be possible — or, more importantly, safe — but closing them does reduce access for expectant mothers. So, how do hospitals stay in the black while still providing critical obstetric care?

Keep the wards open

Some argue that hospitals should just keep their maternity wards open. Policymakers should financially safeguard maternity care through increased reimbursement rates — especially for Medicaid, the number one payer — or value-based payment models, such as bundled payments.

While understandable, this likely isn’t a long-term solution. (Childbirth is already extremely expensive in the United States.) Being open is one factor, but maternity wards must also be safe. They must be adequately staffed, and the staff must be adequately trained. Anything less is dangerous and retaining high quality staff in low volume wards will remain challenging, even if reimbursements go up.

Precarious wards could also increase staffing of non-physician providers. The National Advisory Committee on Rural Health and Human Services contends that certified nurse midwives can provide a critical access boost in rural areas if allowed to practice at the top of their licenses. March of Dimes agrees in their 2020 report, including access to doulas in their list of recommendations.

Close the wards

Closing a maternity ward may end up being the only option because of financial and/or staffing concerns. Hospitals can prepare for the inevitable by training other staff in obstetrics and maintaining emergency supplies, such as blood for transfusions. John Cullen, a family physician in Valdez, Alaska, said in an interview that “even if a community is not planning on providing maternity care, they still are going to be providing maternity care.” Cullen’s hospital trains its nurses in labor and delivery and regularly conducts simulations to keep skills sharp. They have to; the next maternity ward is six to seven hours away.

Another approach when closure is unavoidable is to partner with neighboring hospitals, as the American College of Obstetricians and Gynecologists encourages. This leads to important care continuity. For example, in New Mexico, five sparsely populated, poor, rural counties formed a maternity care consortium, with telehealth as the cornerstone. Non-physician staff run satellite obstetric clinics at community health centers and physicians from the nearest hospital videoconference in. Mothers also receive “telehealth kits” so they can check their blood pressure and glucose levels at home and report back to their care team in real time.

The bottom line is that, while closing maternity wards may be inevitable, it will not stop babies from being born. Somehow, hospitals must utilize limited resources effectively and efficiently to continue to care for women in labor. The lives of mothers and babies cannot wait.

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Pregnancy and The Covid Vaccine

Pregnancy can be a scary time for many reasons, one of which is having so many things feel off-limits for the safety of the fetus. But what about vaccines? Especially the Covid-19 vaccine? To understand the answer to this question you need data about the vaccine in pregnancy, but you also need data about lacking protection from Covid-19 in pregnancy. Fortunately, we discuss both in this episode!

 



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Suggestions for Navigating Towards More Open Access

Academic research is often taxpayer funded—yet kept behind expensive paywalls. Those affiliated with large universities or institutions have access to libraries with wide-ranging subscriptions to scientific journals but not all journals are included and not all individuals have institutional access, further gatekeeping the information.

Open access publishing turns this on its head, granting free access to research for readers but requiring the researcher to pay a substantial upfront cost. However, it still contributes to the significant profit that academic publishing draws in, and it might cause greater disparity in whose voices are heard, centering those who can afford to pay. Open access fees can range up to five thousand dollars, effectively knocking out those in the Global South or anyone anywhere without generous funding.

While more open access could help make the academic research space more equitable, it cannot fix all the problems and it must be carefully done.

Open access and equity

At its core, access to scholarly work highlights long-term equity issues in research. Some are trying to address this.

As a public institution, the University of California (UC) system has made a significant push towards open access for all their work. More funders, including the Robert Wood Johnson Foundation, require any research funded by their grants be available open access. Articles published with funding from the National Institute of Health or Centers for Disease Control and Prevention must be made accessible on PubMed, a biomedical research database, within a year of publication.

But—if only researchers from elite institutions can afford to publish and cover the open access or are even getting research grants, whose voices are being crowded out? What about smaller institutions that cannot afford to do what UC is doing? If every step in the process—admissions, mentorship, job placement, research funding, publishing, and even audience—is stacked against underrepresented scholars, is there really any hope in reshaping science?

Right now, science is facing a credibility crisis on one side, due to the politicization of the COVID-19 pandemic, and an equity crisis on the other, due to financial pressures on higher education and structural racism. The long-term goal is making the scientific funding model more sustainable and equitable so all voices can be heard. But doubling down on open access publishing and new models of access is a start.

How can we make it better?

While there is no simple solution to opening things up in a way that benefits everyone, small steps are possible.

Completely changing things up is not unheard of: PeerJ is a natural sciences publication platform that has a disruptive membership model. It allows authors to publish a certain number of open access articles per year for a set fee. But this model has not been widely embraced across other disciplines, especially those that may attract non-researchers, such as economics or health and social policy.

The newspaper paywall model could be another useful, gradual way to start. It could allow individuals free access to a certain number of articles in a given time period. The New England Journal of Medicine already does this. Plus, most abstracts are available for free, so people can carefully choose their free articles.

Academic publishing is an extremely profitable (and problematic) industry and likely one that cannot be disrupted overnight. For example, the publishing giant Elsevier reported nearly a billion British pounds adjusted operating profit in 2019. Plus, the industry is heavily reliant on free labor. Both the authors are unpaid to provide their manuscript, and their peer reviewers are unpaid. A new study estimated the value of this free labor in 2020 exceeded $2 billion just for United States, United Kingdom, and Chinese researchers alone.

But to navigate towards long-term solutions in both open access and true equity, the financial burden must shift to the haves from the have nots. Funders could both require and provide funding for open access – which, depending on the discipline, might lead to more citations.

Increasing pressure for open access

The open access debate is a longstanding one but rapidly becoming hard to ignore as institutions either push for it in the name of equity or deal with budgetary pressures.

In 2019, the UC system dropped their subscription with Elsevier, which has actively lobbied against open access policies for government-funded research in the United States. Then, in 2021, UC announced a novel four-year agreement with the publisher, allowing for all UC-led work to be made available to anyone, including research published in some of the most prestigious scientific and medical journals.

On the other hand, the University of North Carolina (UNC) announced a $5 million cut in library funding to address a budget shortfall. It saves UNC money, but it also shifts the cost of accessing research to individuals in an environment where equity in grant funding has a long way to go.

There is a quiet current workaround to all this, if individuals feel emboldened enough to e-mail an article’s corresponding author and ask for a copy. This almost always works and is generally allowed under most journals’ copyright agreements.

But what’s more likely? If an individual does not have access to an article, they give up and move on. Unfortunately, this helps no one and is especially harmful from an equity lens. Yet, individuals can only do so much; the system needs to be willing to give up some power to make research more equitable for all.

The post Suggestions for Navigating Towards More Open Access first appeared on The Incidental Economist.

A Vaccine for Malaria!

Malaria kills a lot of people every year, and many of those people are young children. Developing a vaccine against this deadly disease has been a long and difficult journey, but there’s been a breakthrough! While we are still working toward a vaccine with higher efficacy, we’ve dedicated this episode to the major public health win of the first approved vaccine against a human parasite.

 



The post A Vaccine for Malaria! first appeared on The Incidental Economist.

Risk Behaviors Among Men and Women Who Inject Drugs

Men and women who inject drugs live with different risks of acquiring infections such as HIV, yet research that assesses gender-specific risks has historically been scarce. Understanding these differences is key to reducing the harms of injection drug use and facilitating effective interventions.

For example, compared to men, women are more likely to share needles and injection equipment. Reasons for this include more women than men begin injecting drugs in social settings like in romantic relationships or friend groups. Women also have higher rates of some underlying mental health conditions, such as depression, anxiety, and post-traumatic stress disorder (PTSD), that are linked to increased needle sharing. This makes women who use drugs particularly vulnerable to infection and disease.

Meanwhile, men have higher overall rates of substance use disorders and are more likely to overdose or need emergency care.

Understanding gender-based differences in injection drug behavior is critical. Especially now during the COVID-19 pandemic, overdose deaths in the United States increased to 100,000 people between April 2020 to April 2021 — a 30 percent increase from the twelve months prior. Studying the differences in injection drug risk behaviors between men and women can guide targeted public health responses.

New Research

A new study in the Journal of Addiction Medicine used data collected from an urban safety net hospital on injection drug behaviors among men and women to assess associated risks.

The study’s authors are Breanne Bondi, MPH, a researcher at Boston University School of Public Health (BUSPH) Department of Health Law, Policy, and Management (HLPM), Brad Anderson, PhD, from Butler Hospital, Kristina Philips, PhD, from Kaiser Permanente Center for Integrated Health Care Research, and Michael Stein, MD, from BUSPH HLPM.

Participants (n = 252) were recruited from 2014 to 2018 for a randomized trial aimed at reducing infections for people who inject drugs. Patients self-identified their gender, and all data were collected via interview. The study assessed behaviors such as sharing needles or injection equipment, employment and caregiver status, substance use disorder severity, opioid use disorder treatment, mental health history, and engagement in transactional sex.

Analysis

The main analyses of the study used the Risk Assessment Battery (RAB) drug score, which quantifies drug-related HIV risk behaviors and the number of times in the past three months that participants injected with a previously used needle. The RAB is an eight-question assessment with a total score of 0 to 22, with higher scores indicating greater occurrence of the behaviors. Additionally, researchers asked participants to specify how often they used needles previously used by someone else to confirm directionality.

These variables were measured against independent variables such as age, race, homelessness, caregiver status, and injection partners. (“Injection partners” was categorized as the number of times the participant injected alone, with romantic partners, or with non-romantic partners.)

Multiple linear regression models were used to analyze the RAB score against injection partners and other covariates. A negative binomial regression (a generalization of the Poisson regression) measured the association between the number of times the participant injected with a used needle, injection partners, and other covariates. Separate models were run for men and women to observe gender-based differences.

Women had significantly higher RAB drug risk scores than men and were more likely to inject with a previously used needle. Compared to men, women were less likely to inject alone and more likely to inject with a sexual partner. Both men and women who reported injecting with a sexual partner were more likely to report injecting with used needles compared to participants who injected alone.

Women in this study also had higher rates of PTSD (which aligns with previous research), depression, opioid dependence, and were more likely to report transactional sex than men. Men were more likely to experience homelessness. Employment impacted drug injection behaviors slightly differently among men and women. Women who were employed were less likely to inject with a previously used needle. Men who were employed shared fewer needles and equipment with others; thus, employment among men who inject drugs may be protective to other people in their network.

Discussion

The study has some limitations. Participants were recruited from an urban safety-net hospital, and the results may not be generalizable to other populations. Additionally, the sample size and self-reported nature of the study may impact reliability. Notwithstanding these limitations, this study supports previous evidence that men and women exhibit different risks behaviors related to injection drug use.

These findings upheld that injecting drugs in a relationship setting is especially concerning for women. Women who inject in the context of a relationship are especially likely to share needles, and thus are more prone to injection-related infections. This implies that targeting dyads who inject drugs is important for reducing needle sharing behavior, particularly for women. Needle exchanges and other harm-reduction services should prioritize these dyads for additional education and support.

People who inject drugs face many barriers to obtaining and maintaining employment such as stigma, decreased productivity, and institutionalized abstinence-only policies (“drug-free workplaces”). This study highlights how increasing stable employment for men and women who inject drugs is linked to fewer risk behaviors. Specifically, employment was associated with women using fewer previously used needles and with reductions in men sharing needles or equipment with others. These findings demonstrate how stable employment can be a powerful protective and mitigating factor, suggesting policymakers should lean into employment as a harm reduction strategy.

Fleshing out gender-based risk behaviors among people who inject drugs can inform tailored harm-reduction interventions. This may lead to better engagement with services, which is critical to addressing the current overdose and addiction crisis.

The post Risk Behaviors Among Men and Women Who Inject Drugs first appeared on The Incidental Economist.

Justices mull Chevron and voice skepticism of Medicare’s rate cut for hospital drugs

Over at Scotusblog, I’ve posted a recap of yesterday’s oral argument on American Hospital Association v. Becerra.

The Supreme Court appeared receptive to the claim that Medicare overstepped its authority when it cut the amount that it paid certain hospitals for drugs they dispensed in their outpatient departments. None of the justices voiced sympathy with the government’s argument that Congress had precluded judicial review of the question. And while oral argument mainly involved a technical discussion about statutory meaning, several of the conservative justices toyed with the possibility of abandoning Chevron deference — the principle that the courts will defer to an agency’s reasonable interpretation of the statute that it administers.

It is always treacherous to try to anticipate what the justices will decide from the questions they ask at oral argument. Still, it’s safe to say that the hospitals challenging Medicare’s rate change had a good day in court. If they prevail, 340B hospitals will recoup billions in withheld payments and will continue to have an enormous incentive to dispense expensive drugs in their outpatient centers, even when cheaper and equally effective alternatives exist.

That’s a bad policy outcome, whatever the Supreme Court thinks the law requires. If Medicare lacks the legal power to fix it, however, it will be up to Congress to narrow the gap between 340B drug costs and Medicare payments. We could be waiting a very long time for a solution.

@nicholas_bagley

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Healthcare Triage Podcast: Studying Pesticides and Other Risks to Expecting Moms & Babies

David Haas, MD, returns to the Healthcare Triage podcast to share his research about expecting moms and their babies, including a new study about how pesticides and herbicides can impact their health called, “The Heartland Study.” He also talks about how the ongoing COVID-19 pandemic has affected his research, and how his team has adapted to be more flexible because of it.

 

 

This episode of the Healthcare Triage podcast is sponsored by Indiana University School of Medicine whose mission is to advance health in the state of Indiana and beyond by promoting innovation and excellence in education, research and patient care.

IU School of Medicine is leading Indiana University’s first grand challenge, the Precision Health Initiative, with bold goals to cure multiple myeloma, triple negative breast cancer and childhood sarcoma and prevent type 2 diabetes and Alzheimer’s disease.

The post Healthcare Triage Podcast: Studying Pesticides and Other Risks to Expecting Moms & Babies first appeared on The Incidental Economist.

Covid Natural Immunity vs Vaccine Immunity

There’s a lot of talk about “natural immunity” to Covid-19, and some people are refusing vaccination on the grounds that they’ve got this natural immunity thanks to a previous Covid-19 infection. In this episode we take a look at how infection and vaccination compare in terms of immunity, reinfection, and overall health risks and benefits.

 



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Chevron deference at stake in fight over payments for hospital drugs

Over at SCOTUSblog, I’ve written a case preview for American Hospital Association v. Becerra, which is being argued tomorrow. The case is not only important for what it could mean for administrative law. It’s important in its own right because billions of dollars in hospital payments are at stake.

The case centers on part of a 2003 law that gives Medicare two options for how to pay for [certain expensive outpatient] drugs. Under the first option, Medicare would survey hospitals about what it cost them to acquire the drugs. Medicare would then draw on the survey data and reimburse hospitals for their “average acquisition costs,” subject to variations for different types of hospitals. It’s a rough-cut way to make hospitals whole without requiring them to submit receipts for every drug purchase.

But Medicare immediately encountered a problem: It just wasn’t practical to survey hospitals about their acquisition costs. Fortunately, the law anticipated that possibility and gave Medicare a second option. In the absence of survey data, Medicare could pay the “average price” for the drug, “as calculated and adjusted by the Secretary [of Health and Human Services] as necessary for purposes of this [option].”

This approach turned out to be costly. A drug’s “average price” is fixed elsewhere in the Medicare statute, typically at 106% of the drug’s sale price. As a policy matter, this “average sales price plus 6%” approach is hard to defend. Because 6% of a large number is bigger than 6% of a small number, hospitals have an incentive to dispense more expensive drugs, even when there are cheaper and equally effective therapies.

Other developments soon made the payment policy look even more dubious. Back in 1992, Congress created something called the 340B program to support health-care providers that serve poor and disadvantaged communities. Eligible providers get steep discounts on the drugs that they purchase — anywhere between 20% and 50% of the normal price.

Initially, few hospitals qualified for the 340B program. Today, more than two-thirds of nonprofit hospitals participate. (For-profits are excluded from the program.) For years, Medicare kept paying those 340B hospitals 106% of the average sales price of their outpatient drugs. The upshot was that hospitals were buying highly discounted drugs and then charging the federal government full price. That heightened the incentive to prescribe very expensive medications — which is partly why Medicare spending on outpatient drugs has ballooned, growing an average of 8.1% per year from 2006 through 2017.

I’ll also be recapping the oral argument and discussing the outcome when the case is resolved. Read the whole thing here!

@nicholas_bagley

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Cancer Journal: To Hope or Not to Hope

Evelyn de Morgan, The Angel of Death, 1855.

I am a patient with recurrent throat cancer and an end-stage diagnosis, although I’m currently in remission. This means that I live in a liminal world, a thin place where both life and death are vividly present. In trying to learn to live there, I have been thinking about hope.

What is hope? Hope is more than just wanting a future uncertain outcome, hope cherishes that outcome. Hope is a principal theme in palliative care, the branch of medicine most applicable to the end of life. It is one of the three theological virtues of Christianity. I am studying hope to get leverage on this question: What should I hope for?

To recap my story: I was initially treated with 35 sessions of radiation. My redoubtable tumour battered through that and surged back last fall. Its location made the tumour inoperable. ‘Inoperable’ sounds like a technicality, as in, “the pass was ruled incomplete because an ineligible receiver was downfield.” Inoperable meant: “the tumour is growing into the root of your tongue and, yeah, we can cut, but you will lose your ability to speak, take food by mouth, or keep infections out of your lungs.” My surgeon gave me a “months, not years” prognosis, with no treatment options.

My wife, dog, and I left home in our car, cancer refugees wandering in search of care. We were searching for information about treatment options and places that would supply treatment, given my insurance. The result was that we learned about pembrolizumab and found an oncologist who helped me get access to it. Against the odds, it’s reducing the tumour.

But does this mean I will be cured? I doubt it, and my doctors are not telling me that. That is a statement of hope, not despair.

Dr. Isaac Kohane has written a beautiful essay on the illness of his wife, Heidi Kohane. Isaac wrote that at some point in her treatment,

My colleagues at the Dana Farber Cancer Institute [Kohane is a professor at the Harvard Medical School] told us grimly that the prognosis was so poor, standard chemotherapy could not help us.

Undaunted, Heidi pressed for an alternative, and she joined a clinical trial of pembrolizumab.

Two months after Heidi entered the… trial, her tumours started to melt away. The doctors were beside themselves with joy… Heidi’s scans remained, tumour-free, and within a few months it felt as if the cancer had just been a bad dream… But more than three years after her diagnosis we learned that the cancer had recurred. This time, nothing worked. As the Sabbath left us one beautiful fall evening [Isaac is an observant Jew], so did Heidi.

Heidi’s journey was so close to mine. My view is that, contrary to my surgeon’s prognosis, like her, I may have a few years. What should I do with such a miraculous gift? This depends on what I can hope for. That must sound odd. I imagine you telling me, “You have cancer: you are entitled to hope for whatever you want.” I don’t see it that way for two reasons.

First, I should not hope for anything that requires magical thinking. For example, I want to be cured, but I won’t indulge the magical belief that visualizing the destruction of the tumour may help destroy it. What’s wrong with a bit of magical thinking? I’ve tried to live as a scientist, and I don’t want to betray that here at the end. A cardinal scientific virtue is “no bullshit.” Good writing is the practice of that virtue. Of course, even though I strive to write what I sincerely believe, much of it is bullshit. Writing is an interminable cycle of winnowing out bullshit. Trying to write something I don’t believe in is self-induced writer’s block.

Nietzsche, by Edvard Munch

The second reason to worry is that to hope is to cherish, that is, to deepen your attachment to an outcome. Cherishing the hope of a miracle can weaken you and exposes you to pain. This, I take it, is why Nietzsche was so hostile about hope.

Hope. Pandora brought the jar with the evils and opened it. It was the gods’ gift to man, on the outside a beautiful, enticing gift, called the “lucky jar.” Then all the evils, those lively, winged beings, flew out of it. Since that time, they roam around and do harm to men by day and night. One single evil had not yet slipped out of the jar. As Zeus had wished, Pandora slammed the top down and it remained inside. So now man has the lucky jar in his house forever and thinks the world of the treasure. It is at his service; he reaches for it when he fancies it. For he does not know that that jar which Pandora brought was the jar of evils, and he takes the remaining evil for the greatest worldly good–it is hope, for Zeus did not want man to throw his life away, no matter how much the other evils might torment him, but rather to go on letting himself be tormented anew. To that end, he gives man hope. In truth, it is the most evil of evils because it prolongs man’s torment.

Nietzsche is wrong, but not obviously so. Some people press hope on cancer patients. They say, “You can’t go on without hope,” in urgent, earnest tones. Oh, really? Nietzsche persevered, and so can I. That said, I’ll never tell a friend that I don’t need hope, because I don’t want to hurt them. Their words are meant kindly; they fear that I’m in despair. They fear losing me, and their urgency is a measure of their love.

If you are tempted to urge someone to hope, it might be the right thing to do. Consider, though, that the patient may be trying to steel herself to accept what will come and finish her life with dignity based in fortitude. She may believe that cherishing the possibility of a cure would sap energy from her commitment to struggle. Listen carefully to the patient, and give her space to find her best path.

God willing, my future will be similar to Heidi Kohane’s. I’ve outlived my surgeon’s prognosis, and I am playing with house money: each additional month of life is an unexpected gift. I am with Nietzsche and the commitment to struggle, with this dissent. I have hope, because unlike Nietzsche, I do not just live for myself. And you don’t either. I’ll discuss this in future posts.

If you know someone who has cancer, consider sending them a link to this post.To read the Cancer Journal from the start, please begin here.A table of contents for the Cancer Journal is here.To get the Cancer Journal in email, subscribe here.

@Bill_Gardner

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