Atul Gawande on the destruction of USAID

 Here's an interview with Atul Gawande, about the destruction of USAID.  The latter part of the url says it succinctly: https://www.newyorker.com/podcast/the-new-yorker-radio-hour/atul-gawande-on-elon-musks-surgery-with-a-chainsaw

Hundreds of Thousands Will Die
The writer, surgeon, and former U.S.A.I.D. senior official Atul Gawande on the Trump Administration’s decimation of foreign aid and the consequences around the world.
By David Remnick 

"A lot of people are going to die as a result of this. Am I wrong?

"The internal estimates are that more than a hundred and sixty thousand people will die from malaria per year, from the abandonment of these programs, if they’re not restored. We’re talking about twenty million people dependent on H.I.V. medicines—and you have to calculate how many you think will get back on, and how many will die in a year. But you’re talking hundreds of thousands in Year One at a minimum. But then on immunization side, you’re talking about more than a million estimated deaths."

Low back pain: meta-analysis

 The NYT has the story:

What Works for Low Back Pain? Not Much, a New Study Says
Researchers looked at 56 treatments for acute and chronic pain. Few of them were effective. By Nina Agrawal

"Acetaminophen. Acupuncture. Massage. Muscle relaxants. Cannabinoids. Opioids. The list of available treatments for low back pain goes on and on. But there’s not good evidence that these treatments actually reduce the pain, according to a new study that summarized the results of hundreds of randomized trials.

Low back pain affects an estimated one in four American adults and is the leading contributor to disability globally. In most diagnosed cases, the pain is considered “nonspecific,” meaning it doesn’t have a clear cause. That’s also partly what makes it so hard to treat.

In the study, published on Tuesday in the journal BMJ Evidence-Based Medicine, researchers reviewed 301 randomized trials that compared 56 noninvasive treatments for low back pain, like medications and exercise, with placebos. 

...

The researchers found that only one treatment — the use of nonsteroidal anti-inflammatory drugs, or NSAIDs, like ibuprofen and aspirin — was effective at reducing short-term, or acute, low back pain. Five other treatments had good enough evidence to be considered effective at reducing chronic low back pain. These were exercise; spinal manipulation, like you might receive from a chiropractor; taping the lower back; antidepressants; and the application of a cream that creates a warming sensation. Even so, the benefit was small.


“The big takeaways from this paper are that low back pain is exceptionally difficult to treat,” said Steve Davidson, the associate director of the N.Y.U. Pain Research Center, who was not involved in the study. “There are a few treatments that they found that were effective, but those that were effective are marginally clinically effective.”

Lawfare and market design: New legal standard for medical malpractice

 In the U.S. at least, a not insignificant part of medical practice (sometimes called "defensive medicine") is shaped and enforced by medical malpractice suits. The American Law Institute has formulated new guidelines for such suits.

Aaron DG, Robertson CT, King LP, Sage WM. A New Legal Standard for Medical Malpractice. JAMA. Published online February 26, 2025. doi:10.1001/jama.2025.0097 

"Abstract
Importance  Patients in the US have persistent needs for safe, evidence-based care. Physicians in the US report fear of liability risk and the need to practice “defensive medicine.” In 2024, the American Law Institute revised the legal standard for assessing medical negligence. Understanding the implications of this change is crucial for balancing patient safety, physician autonomy, and the legal system’s role in health care.

Observations  The updated standard from the American Law Institute shifts away from the traditional reliance on customary practice toward a more patient-centered concept of reasonable medical care. Although this revised standard still includes elements of prevailing medical practice, it defines reasonable care as the skill and knowledge regarded as competent among similar medical clinicians under comparable circumstances and acknowledges that, in some cases, juries can override customary practices if they fall short of contemporary standards. The restatement also embraces evidence-based practice guidelines, while leaving questions open about the variations in the quality of those guidelines. The restatement makes additional recommendations regarding informed consent and other aspects of physician-patient communication.

Conclusions and Relevance  The new standard of care from the American Law Institute represents a shift away from strict reliance on medical custom and invites courts to incorporate evidence-based medicine into malpractice law. Although states may adopt the recommendations from the American Law Institute at different times and to varying degrees, the restatement offers health professionals and the organizations in which they practice an opportunity to reconsider how medical negligence will be assessed, and to focus more directly on promoting patient safety and improving care delivery. Nonetheless, physicians should recognize that, at least for now, many courts will continue to rely significantly on prevailing practice in assessing medical liability."

 ...

"The restatement from the ALI centers medical negligence on reasonable care rather than on customary care. It reads: “The standard of reasonable medical care is the care, skill, and knowledge regarded as competent among similar medical providers in the same or similar circumstances.”27 The restatement reassures physicians that its competency-based standard of reasonableness does not require above average or even average care. The comments accompanying the restatement observe that “those who have less than median or average skill may still be competent and qualified.”28 In other words, medical care need only be acceptable (above a minimum floor) to meet the standard.

"The restatement lists circumstances that may be relevant in determining reasonable medical care, including “the state of medical knowledge and the treatment options available at the time,” with the commentary acknowledging the importance of “prevailing professional practices” (ie, custom).29 The restatement takes account of the “resources available to the provider in the particular location or practice setting” in assessing the reasonableness of care, but it no longer factors in deference to the practice habits of physicians within any given locality or community.27

"Physicians have, at times, been slow to adapt to changes in medical science, relying instead on habits from their own, possibly decades-old training, which may reproduce structural inequities.30,31 Much of what is learned in medical school and training will change during practice.32 Examples include (1) cardiac stenting may be no better than medical management for stable coronary artery disease,33 (2) use of low-dose aspirin to prevent cardiac arrest may be harmful for many patients,34 (3) many older adults are prescribed medications on the Beers list that may harm their health,35 (4) many cancer treatments do not serve patient interests,36,37 and (5) opioids are far riskier than commonly believed 20 years ago.38,39 Although the restatement from the ALI will allow physicians to point to “prevailing professional practices,”29 it will also allow injured plaintiffs to point to the best scientific evidence and argue that a reasonable physician would have practiced accordingly. "

 

Abortion bans have increased both births and infant mortality (JAMA)

 Not unexpectedly:

US Abortion Bans and Infant Mortality, by Alison Gemmill, PhD1; Alexander M. Franks, PhD2; Selena Anjur-Dietrich, PhD1; et alAmy Ozinsky, BS1; David Arbou r, PhD3; Elizabeth A. Stuart, PhD4; Eli Ben-Michael, PhD5; Avi Feller, PhD6; Suzanne O. Bell, PhD1  JAMA. Published online February 13, 2025. doi:10.1001/jama.2024.28517

"Findings  This analysis of US national vital statistics data from 2012 through 2023 found higher than expected infant mortality in states after adoption of abortion bans (observed vs expected, 6.26 vs 5.93 per 1000 live births; relative increase, 5.60%). Estimated increases were relatively larger among infants who were Black, had congenital anomalies, or were born in southern states.

Meaning  Abortion bans were associated with increases in infant mortality. These increases were larger for populations that already experienced higher than average rates of infant mortality." 

########

There's also an accompanying editorial:

Abortion May Be Controversial—Supporting Children and Families Need Not Be  by Alyssa Bilinski  JAMA. Published online February 13, 2025. doi:10.1001/jama.2025.0854
 

"In this issue of JAMA, 2 articles characterize the impact of recent state abortion restrictions.1,2 Applying observational causal inference methods, the authors estimate a 1.7% increase in birth rates from abortion restrictions in affected states (corresponding to about 22 000 excess births) and a 6% increase in infant mortality (about 500 excess deaths) from 2021 to 2023.1,2 Excess births occurred disproportionately among racially and ethnically minoritized, low-income, and unmarried individuals.1 Among births linked to abortion bans, infant mortality rates were about 4 times higher than rates in the general population.2 The authors note that this likely resulted both as a consequence of abortion bans requiring pregnant individuals to carry fetuses with lethal abnormalities to term and from excess births occurring disproportionately among individuals at high risk for complications. "

Politics, Physician Senators, and the Hippocratic Oath (regarding the confirmation of RFK Jr. as HHS secretary)

 Here's an opinion piece from MedpageToday

Physician Senators, What Have You Done?— They have betrayed the Hippocratic Oath in voting to confirm RFK Jr.   by Joseph V. Sakran, MD, MPH, MPA, and Samuel Okum, February 14, 2025 

"When Senator Bill Cassidy, MD (R-La.) -- a physician, longtime advocate for healthcare policy, and potential swing vote on the Finance Committee -- voted to advance Robert F. Kennedy Jr. as secretary of HHS, he didn't just make a political choice. He made a choice that undermines science, public health, and the very Hippocratic Oath he once swore to uphold.

"While Cassidy claims to have taken this decision "very seriously," he must know it is wrong. As a legislator, he understands that the HHS secretary oversees critical health institutions like the CDC, FDA, and CMS. As a doctor, he has firsthand knowledge of how these agencies impact patient care, from ensuring access to safe medications to shaping life-saving public health policies. Entrusting this role to Kennedy -- a man with no qualifications beyond his fame as a purveyor of medical disinformation -- isn't just reckless. It endangers us all. 

...

"Through his organization, Children's Health Defense, Kennedy has falsely linked vaccines to autismopens in a new tab or window, opposed COVID-19 safety measuresopens in a new tab or window, and promoted debunked medical treatmentsopens in a new tab or window. In 2021, the Center for Countering Digital Hate identified him as one of the "Disinformation Dozenopens in a new tab or window" -- a small group responsible for nearly two-thirds of anti-vaccine content circulating online. All of this suggests this promotion of falsehoods has eroded public trust in vaccines, contributing to preventable disease outbreaks and declining immunization ratesopens in a new tab or window.

"The consequences of his rhetoric have been deadly. In 2019, Kennedy traveled to Samoa to support an investigationopens in a new tab or window into routine childhood vaccinations. His visit coincided with a devastating measles outbreak that infected thousands and killed dozens of unvaccinated children. When confronted by the country's prime minister, Kennedy expressed no remorse. Instead, he baselessly suggested that the measles, mumps, and rubella (MMR) vaccineopens in a new tab or window itself may have been responsible for the deaths.

...

"

We believe Cassidy prioritized political expediency over medical integrity. He arguably chose to align himself with President Donald Trump and conspiracy rather than the national interest and public health.

Meanwhile, Cassidy set the stage for his physician colleagues -- Republican senators Roger Marshall, MD (Kan.), John Barrasso, MD (Wyo.), and Rand Paul, MD (Ky.) -- to follow suit. They have all betrayed their oath as doctors."

Altruism and financial incentives in medicine (less altruistic physicians more readily respond to payments by drug companies)

 Physicians have professional obligations to care for their patients, and also deal with financial incentives that may not perfectly align with patient care.  The paper below experimentally examines a sample of physicians for altruism, by observing their behavior in a dictator game over different budget constraints, and compares their measured altruism with the  payments they recieve from pharma companies and the extent to which they respond to those payoffs by prescribing the brand name drugs those payments promote. Lower measures on altruism correspond to more prescription of promoted drugs.

The Role of Physician Altruism in the Physician-Industry Relationship: Evidence from Linking Experimental and Observational Data  by Shan Huang, Jing Li & Anirban Basu. NBER Working Paper 33439, DOI 10.3386/w33439, January 2025

Abstract: Altruism is a key component of medical professionalism that underlies the physician's role as a representative agent for patients. However, physician behavior can be influenced when private gains enter the objective function. We study the relationship between altruism and physicians' receipt of financial benefits from pharmaceutical manufacturers, as well as the extent to which altruism mitigates physicians' responsiveness to these industry payments. We link data on altruistic preferences for 280 physicians, identified using a revealed preference economic experiment, with administrative information on their receipt of financial transfers from pharmaceutical firms along with drug prescription claims data. Non-altruistic physicians receive industry transfers that are on average 2,184 USD or 254% higher than altruistic physicians. While industry transfers lead to higher drug spending and prescribing on paid drugs, these relationships are entirely driven by non-altruistic physicians. Our results indicate that altruism is an important determinant of physicians’ relationships with and responses to industry benefits.

Why is achieving financial neutrality in organ donation so hard?

For some years now, many opponents of compensation for kidney donors have come to agree that at least donors should not have to bear large expenses to donate.  But it has been hard to operationalize this apparent agreement.

Here's a paper that (somewhat inadvertently) explains why.  They take the position that it is ethically allowable to compensate donors for out of pocket financial expenses, but ethically forbidden to do so in a way that might  sometime pay some donor for an expense  they might have incurred even if they hadn't donated. (So, for example, they forbid paying anything towards funeral expenses for deceased donors.)

This was a point of view that I encountered when I was on the advisory board of NLDAC, the federally funded U.S. agency that can pay some expenses for poor donors. Originally NLDAC issued special credit cards to donors who qualified, that could only be used for airfare, hotels, and restaurants, i.e. for travel and meals.  But some donors indicated that they preferred not to eat in restaurants, but to go to a supermarket and bring food back to eat in their hotel room.  NALDAC eventually decided that the special credit card could also be used for grocery stores, even though this meant that some donor might sometime buy a dozen apples, and bring the uneaten ones with them when they returned home, and thus have received some compensation in addition their travel expenses. (When I write it like that it seems that I must be exaggerating, but here's an article that argues that any inadvertent generosity to donors would cross a red line, and must therefore be avoided.)

Supporting Financial Neutrality in Donation of Organs, Cells, and Tissues, by Martin, Dominique E. PhD1; Capron, Alexander M. LLB2; Fadhil, Riadh A. S. MD3; Forsythe, John L. R. MD4; Padilla, Benita MD5; Pérez-Blanco, Alicia PhD6; Van Assche, Kristof PhD7; Bengochea, Milka MD8; Cervantes, Lilia MD9; Forsberg, Anna PhD10; Gracious, Noble MD11; Herson, Marisa R. PhD1; Kazancioğlu, Rümeyza MD12; Müller, Thomas PhD13; Noël, Luc MD14; Trias, Esteve MD15; López-Fraga, Marta PhD16,
Transplantation 109(1):p 48-59, January 2025. | DOI: 10.1097/TP.0000000000005197 

Abstract: "The avoidance of financial gain in the human body is an international ethical standard that underpins efforts to promote equity in donation and transplantation and to avoid the exploitation of vulnerable populations. The avoidance of financial loss due to donation of organs, tissues, and cells is also now recognized as an ethical imperative that fosters equity in donation and transplantation and supports the well-being of donors and their families. Nevertheless, there has been little progress in achieving financial neutrality in donations in most countries. We present here the findings of an international ethics working group convened in preparation for the 2023 Global Summit on Convergence in Transplantation, held in Santander, Spain, which was tasked with formulating recommendations for action to promote financial neutrality in donation. In particular, we discuss the potential difficulty of distinguishing interventions that address donation-related costs from those that may act as a financial incentive for donation, which may inhibit efforts to cover costs. We also outline some practical strategies to assist governments in designing, implementing, and evaluating policies and programs to support progress toward financial neutrality in donation."

" The principle of financial neutrality in donation states that donors of organs, cells, and tissues, or donor families, should neither lose nor gain financially as a result of donation.

...

"we explore concerns regarding the use of financial incentives for donation (see Box 1) and discuss potential difficulties in distinguishing legitimate coverage of costs from practices and policies that may provide financial incentives for donation and thus violate the prohibition of trade in SoHOs. We argue that anxiety regarding the use of financial incentives may, in some countries, deter or undermine efforts to remove financial disincentives from donations. 

...

"Efforts to address the costs of living kidney donation notably became a focus in North America in the wake of a decline in living donor rates in the mid-2000s, disproportionately impacting poorer populations.

...

" Like the removal of financial disincentives to donation, avoidance of financial incentives for donation is essential for achieving financial neutrality ... "Sustained efforts are thus needed to deter use of financial incentives and ensure that efforts to promote financial neutrality in donation do not create actual or perceived incentives

...

"Some proposals intended only to cover donation-related costs may inadvertently incentivize donations or result in inappropriate financial gains.

...

"After more than a decade of expressed support for the principle of financial neutrality in donation, it is time for policymakers in all countries to act in pursuit of the goal of financial neutrality."

#############

Earlier: Thursday, March 31, 2022  National Living Donor Assistance Center (NLDAC) support for lost wages and dependent care

2024 Shkreli Awards, for profiteering and dysfunction in healthcare

 Here are the 2024 Shkreli Awards, the Lown Institute’s top ten list of the worst examples of profiteering and dysfunction in healthcare, named for the infamous “pharma bro” Martin Shkreli.

"Nominees for the Shkreli Awards are compiled by Lown Institute staff with input from readers of Lown Weekly. An esteemed panel of patient activists, clinicians, health policy experts, and journalists help determine the winners. (press release | previous winners)"

##########

At least some of the 'prizes' they award are subject to dispute, including their choice for #1"

Diane Coleman, Fierce Foe of the Right-to-Die Movement, (1953-2024)

 A courageous, long-lived disability-rights activist who made an eloquent case against medical aid in dying has died.

Diane Coleman, Fierce Foe of the Right-to-Die Movement, Dies at 71
Her fight for disability rights included founding a group called Not Dead Yet, which protested the work of Dr. Jack Kevorkian and others.   By Clay Risen

"At the core of her critique was the argument that the idea of a “right to die” was evidence of how little society valued people like her and a warning that the health care system was broken.

“It is already possible in some states for impoverished disabled, elderly and chronically ill people to get assistance to die,” she told the House Judiciary Committee in 1996, “but impossible for them to get shoes, eyeglasses and tooth repair.”

"Not Dead Yet showed up at Princeton University in 1999 after the university announced the hiring of Peter Singer, an Australian philosopher who had argued for voluntary euthanasia for people with disabilities.

...

“It’s the ultimate form of discrimination to offer people with disabilities help to die,” she told The New York Times in 2011, “without having offered real options to live.”

Should big Tobacco fund (and program) continuing medical education?

 Should physicians learn about tobacco from the source?

The Tobacco Industry Has No Business Funding Continuing Medical Education, by Robert K. Jackler, MD1,2; Pamela M. Ling, MD, MPH3,4, JAMA. 2024; doi:10.1001/jama.2024.9241 

"Recently, the for-profit medical media company Medscape promoted a series of continuing medical education (CME) courses (see the Supplement) funded by a grant from tobacco company Philip Morris International (PMI).1 These activities were certified (see the Supplement) by the Accreditation Council for Continuing Medical Education (ACCME) along with other health care professional education organizations (American Nurses Credentialing Center, Interprofessional Continuing Education, Accreditation Council for Pharmacy Education, American Board of Internal Medicine). As cigarette sales decline, PMI is promoting “harm reduction” nicotine products. This superficially appealing slogan thinly disguises PMI’s campaign to promote company brands designed to sustain nicotine addiction among people who smoke and entice youth who do not smoke to adopt new nicotine products.

...

"The tobacco industry has a long history of undermining science to promote its products, the leading cause of preventable disease and premature death in the US, indicating inherently unresolvable conflicts incompatible with education of clinicians or sponsorship of certified CME. PMI’s hypocrisy in promoting a harm reduction agenda is highlighted by its aggressive marketing of Marlboro, the world’s leading cigarette brand, including campaigns manifestly targeting youth."

...

Regulating emerging technologies

 Here's a recent RAND report, on the current diverse attempts to regulate emerging biotechnologies, focusing on organoids,* embryos, genes, and neurotechnology:

State-of-play and future trends on the development of oversight frameworks for emerging technologies
Part 2: Technology oversight report, by Sana Zakaria, Ioli Howard, Eva Coringrato, Anna Louise Todsen, Imogen Wade, Devika Kapoor, Alec Ross, Katarina Pisani, Chryssa Politi, Martin Szomszor, Salil Gunashekar, Dec 16, 2024 

"This RAND Europe study commissioned by Wellcome explores the current and future oversight frameworks for emerging technologies, focusing on organoids, human embryology, engineering biology and neurotechnology. 

...

"Key Findings:

Lack of specific frameworks for organoids

• There is an absence of specific regulatory frameworks for organoids, with current oversight relying on broader stem cell and biomedical regulations. Emerging mechanisms, such as Japan's consent-to-govern approach, are gaining traction to address ethical challenges, particularly around donor consent and privacy concerns.

Challenges in human embryology oversight

• Existing frameworks, like the UK's Human Fertilisation and Embryology Act, are outdated and not designed for new technologies such as AI in embryo selection. Disparate national regulations complicate international collaboration, and there is a need for frameworks to adapt to scientific advancements and public interest.

Fragmented oversight in engineering biology

• The global landscape features disparate oversight mechanisms, creating obstacles for international collaboration. There is a need for alignment across diverse applications and jurisdictions, with potential solutions including cross-sector collaboration and international biosecurity measures.

Neurotechnology oversight gaps

• Current regulations do not address the unique challenges posed by neurotechnologies, such as data privacy and dual-use concerns. Ethical guidelines, like Chile's neurorights, offer proactive models, but there is a need for stronger post-market surveillance and international guidelines to prevent misuse.

Priority considerations for future oversight

• The report outlines eight priority considerations, including developing interconnected oversight networks, ensuring equity, harmonizing international governance, fostering public involvement, and integrating adaptive and anticipatory strategies into oversight frameworks."
  

#########

* "Organoids are three-dimensional structures that are derived from stem cells and are capable of self-organising into structures that mimic the key functional, structural and biological complexity of an organ."

MAID in Canada,

 Medical Aid in Dying (MAID) in Canada is regulated more liberally than in many places, since it doesn't require the recipients to be terminally ill, but can be accessed by people whose diseases are incurable and intolerable.  Nevertheless, most patients who access it are terminally ill.

The Guardian has the story:

Canada’s rate of medically assisted deaths rises to record high. Roughly 96% of deaths by euthanasia in 2023 were for those with a terminal condition, as growth in overall cases slows 

"A growing share of deaths in Canada are from euthanasia, but the vast majority are for terminal illnesses, according to new government figures.

"More than 15,000 people received medical assistance in dying in Canada in 2023, the highest figure on record. But federal statistics show the growth in cases has slowed significantly, with assisted death making up 4.7% of deaths, compared to 4.1% the previous year.

"In both 2023 and 2022, roughly 96% of cases were those with a terminal condition, with cancer cited as the most common reason for accessing assisted death. The median age of someone requesting euthanasia is 78.

"Canada is among a few countries that have introduced assisted dying laws in recent years, alongside Austria, Australia and Spain. The United Kingdom recently passed legislation on the issue."

###########

Fifth Annual Report on Medical Assistance in Dying in Canada, 2023
 

Medical Treatments for Transgender Minors--Oral argument in Supreme Court

 Yesterday the Supreme Court heard oral arguments about the Tennessee ban on transgender treatment for minors.

Supreme Ct. Hears Case on Medical Treatments for Transgender Minors
"The Supreme Court heard oral argument in United States v. Skrmetti, a case on whether Tennessee’s ban on transgender medical treatments for minors violated the Equal Protection Clause of the 14th Amendment. Tennessee enacted its law in March of 2023, which stated that there was a “compelling interest” to protect minors from physical and emotional harm by banning health care providers from administering hormone/puberty blockers and surgery to minors for transgender purposes. Transgender minors and their families sued the state, and the Justice Department intervened on their behalf, arguing the law discriminated on the basis of sex. A district court then stopped the ban on hormone and puberty blockers, but the Sixth Circuit Court of Appeals reversed that decision. The Justice Department then appealed to the Supreme Court. Chase Strangio, who argued on behalf of trans minors and their parents, was the first openly transgender lawyer to argue before the Court. 

Opening statement (text compiled from uncorrected Closed Captioning):

"MR. CHIEF JUSTICE, AND MAY IT PLEASE THE COURT, THIS CASE IS ABOUT ACCESS TO MEDICATIONS THAT HAVE BEEN SAFELY PRESCRIBED FOR DECADES TO TREAT MANY CONDITIONS INCLUDING GENDER DYSPHORIA. BUT SB-1 SINGLES OUT AND BANS ONE PARTICULAR USE. IN TENNESSEE THESE MEDICATIONS CAN'T BE PRESCRIBED TO ALLOW A MINOR TO IDENTIFY WITH OR LIVE AS A GENDER INCONSISTENT WITH THE MINOR SEX. IT DOESN'T MATTER WHAT PARENTS DECIDE IS BEST FOR THEIR CHILDREN. IT DOESN'T MATTER WHAT PATIENTS WOULD CHOOSE FOR THEMSELVES, AND IT DOESN'T MATTER IF DOCTORS BELIEVE THIS TREATMENT IS ESSENTIAL FOR INDIVIDUAL PATIENTS. SB 1 CATEGORICALLY BANS TREATMENT WHEN AND ONLY WHEN IT'S INCONSISTENT WITH THE PATIENT'S BIRTH SEX. TENNESSEE SAYS THAT SWEEPING BAN IS JUSTIFIED TO PROTECT ADOLESCENT HEALTH, BUT THE STATE MAINLY ARGUES THAT IT HAD NO OBLIGATION TO JUSTIFY THE LAW AND THAT SB 1 SHOULD BE UPHELD SO LONG AS IT'S NOT WHOLLY IRRATIONAL. THAT'S WRONG. SB 1 REGULATES BY DRAWING SEX-BASED LINES AND DECLARES THAT THOSE LINES ARE DESIGNED TO ENCOURAGE MINORS TO APPRECIATE THEIR SEX. THE LAW RESTRICTS MEDICAL CARE ONLY WHEN PROVIDED TO INDUCE PHYSICAL EFFECTS INCONSISTENT WITH BIRTH SEX. SOMEONE ASSIGNED FEMALE AT BIRTH CAN'T RECEIVE MEDICATION TO LIVE AS A MALE, BUT SOMEONE ASSIGNED MALE CAN. IF YOU CHANGE THE INDIVIDUAL SEX, IT CHANGES THE RESULT. THAT'S A SEX CLASSIFICATION FULL STOP, AND A LAW LIKE THAT CAN'T STAND ON BARE RATIONALITY. HERE TENNESSEE MADE NO ATTEMPT TO TAILOR ITS LAW TO ITS STATED HEALTH CONCERNS. RATHER THAN IMPOSE MEASURED GUARDRAILS SB 1 BANS THE CARE OUTRIGHT NO MATTER HOW CRITICAL IT IS FOR AN INDIVIDUAL PATIENT. THAT IS A STARK DEPARTURE OF PEDIATRIC CARE IN ALL OTHER CONTEXT. SB 1 LEAVES THE SAME MEDICATIONS AND MANY OTHERS ENTIRELY UNRESTRICTED WHEN USED FOR ANY OTHER PURPOSE EVEN WHEN THOSE USES PREVENT SIMILAR RISKS. THE SIXTH CIRCUIT NEVER CONSIDERED WHETHER TENNESSEE COULD JUSTIFY THAT SEX-BASED LINE BECAUSE THE EQUAL PROTECTION CLAUSE REQUIRES MORE, THIS COURT SHOULD REMAND SO THAT SB 1 CAN BE UNDER THE CORRECT STANDARD. I WELCOME THE COURT'S QUESTIONS. 

########

HT: Kim Krawiec

 

Medpage Today summarized the hearings under this headline:

Supreme Court Appears Likely to Uphold Bans on Transgender Care for Minors
— Justices' decision is not expected for several months

Britain moves towards legalizing medical aid in dying

 The Guardian has the story:

MPs vote for bill to legalise assisted dying in England and Wales
Terminally ill adults with less than six months to live will be given right to die under proposed legislation, by Jessica Elgot, Eleni Courea and Rowena Mason 

"MPs have taken a historic step toward legalising assisted dying in England and Wales after backing a bill that would give some terminally ill people the right to end their lives.

"The Commons backed the bill by 330 votes in favour to 275 against, a majority of 55. Keir Starmer and Rachel Reeves both voted in favour, Labour MPs told the Guardian.

"The private member’s bill, brought by the Labour MP Kim Leadbeater, gives terminally ill adults with less than six months to live the right to die once the request has been signed off by two doctors and a high court judge.

"The change is unlikely to occur for three years as the bill must pass several more hurdles in parliament and will not be brought before MPs again until April. The government is likely to assign a minister to help work on the bill, without formally giving its support.

...

" Peter Prinsley, a Labour MP and surgeon, said he had changed his mind over his years in medicine after witnessing the “terrifying loss of dignity and control in the last days of life”.

“When I was a young doctor I thought it unconscionable. But now I’m an old doctor and I feel sure it’s the right change. I have seen uncontrollable pain, choking, and I’m sorry to say the frightful sight of a man bleeding to death whilst conscious as a cancer has eaten away at a carotid artery.”

"Opponents of the bill said it would fundamentally change the relationship between the state and its citizens, and between doctors and patients. They argued the bill was rushed and the safeguards for vulnerable people were insufficient."

##########

Earlier:

October 15, 2024 Medical aid in dying comes up for a vote in England

The labor market for Ob-Gyn docs, in states that criminalize abortion

 States that criminalize abortion (and hence also care for miscarriages) are losing obstetricians...

The New Yorker has the story:

The Texas Ob-Gyn Exodus. Amid increasingly stringent abortion laws, doctors who provide maternal care have been fleeing the state.  By Stephania Taladrid 

"Across Texas, reports were surfacing of women being sent home to manage miscarriages on their own. In 2021, the state had passed a law known as S.B. 8, banning nearly all abortions after electrical activity is detected in fetal cells, which typically happens around the sixth week of gestation. The law encouraged civilians to sue violators, in exchange for the possibility of a ten-thousand-dollar reward.

From a medical standpoint, the treatment for abortion and miscarriage was the same—and so, even though miscarriage care remained legal, physicians began putting it off, or denying it outright. After Roe was overturned, the laws in Texas tightened further, so that abortion was banned at any phase of pregnancy, unless the woman was threatened with death or “substantial impairment of a major bodily function.” Violations could send practitioners to prison for life.

...

"the new laws were already having an effect on the health-care system. Across Texas, residency applications in ob-gyn dropped significantly. Data from the Gender Equity Policy Institute revealed a fifty-six-per-cent spike in maternal deaths in the state between 2019 and 2022. When the Supreme Court overturned Roe v. Wade, Texas was no longer an outlier; in the weeks after the ruling, thirteen states moved to ban abortion. By then, Serapio and Salcedo had already left Texas. Another ob-gyn at the practice, Pam Parker, would follow soon.

...

"Kornberg was moving to Los Angeles to finish her residency. Like the doctors who had left before her, Kornberg had come to see herself as “part of the problem,” she said. “I have the knowledge, all the support staff, everything to be able to help this person avoid one of these horrible outcomes—and they’re begging me to do it, but I’m not allowed to.” The bans felt like a personal attack, she said: “The state sees you as a felon.” When the act of caring for pregnant women in Texas could carry the same penalty as murder, the inevitable conclusion for Kornberg was “You don’t want me here? Fine, I’ll leave.”

...

"A report released last month by Manatt Health, a health-care consultancy based in Los Angeles, confirmed Brown’s fears. Manatt surveyed hundreds of ob-gyns in Texas to examine the impact of abortion bans. Seventy-six per cent of respondents said that they could no longer treat patients in accordance with evidence-based medicine. Twenty-one per cent said that they were either considering leaving the state or already planning to do so; thirteen per cent had decided to retire early. The report found “historic and worsening shortages” of ob-gyns, which “disproportionately impact rural and economically disadvantaged communities.” As in the Rio Grande Valley, the bans were shrinking the field’s future workforce: residency programs across Texas have seen a sixteen-per-cent drop in applications.

"Texas is among the twenty-one states where abortion is banned or severely restricted. In Idaho, nearly a quarter of the state’s ob-gyns have left since the ban went into effect, and rural hospitals have stopped providing labor and delivery services. In Louisiana, three-quarters of rural hospitals no longer offer maternity care. "

Payments to physicians from medical vendors

 A useful rule of thumb when studying the design of markets is that when you see many related rules against something, that something may still be happening.  In yesterday's post I described the code of conduct that speakers at a medical conference are asked to subscribe to, mostly concerning payments received from medical vendors.  Below is a contemporary article about the incidence of such payments, to cardiologists (interventional cardiologists in particular), starting when they are still trainees.

Dhruva SS, Han M, Jing Y, Trock BJ, Hogan SO, Redberg RF. Industry Payments to Cardiology Fellows and Early-Career Cardiologists. JAMA Intern Med. 2024;184(9):1123–1125. doi:10.1001/jamainternmed.2024.3130 

Here's the introduction to the paper:

"Industry marketing payments to physicians may compromise the objectivity and integrity of clinical decision-making, playing a role in nonrecommended care, higher health care costs, and reduced patient trust. Payments to trainees merit scrutiny because these payments may be formative on future practice. The Association of American Medical Colleges (AAMC) recommends policies “that prohibit the acceptance of any gifts from industry by physicians…and trainees.”1 The Accreditation Council for Graduate Medical Education (ACGME) states “promotional activities by industry can seriously compromise the professional relationships that form the substance of medicine.”2 The National Academy of Medicine (NAM) also argues financial relationships do not benefit the educational mission in ways that offset the risks created.3 We quantified industry payments to cardiology fellows and the association of these payments with payments received after training."

And here is a summary of the results:

"During the year before fellowship graduation, 1993 fellows (80%) in procedural intensive subspecialties and 2057 of 3055 (67%) in nonprocedural intensive subspecialties received industry payments. Median (IQR) payment amount per physician in procedural intensive subspecialties was $1801 ($282-$4445; median [IQR] payments, 17 [4-38]). In nonprocedural intensive subspecialties, median (IQR) payment amount received per physician was $198 ($0-$893; median [IQR] payments, 3 [0-13]).

"A median (IQR) of 3 (2-5) years after fellowship, 2385 physicians (96%) in procedural intensive subspecialties and 2483 (81%) in nonprocedural intensive subspecialties received industry payments. Median (IQR) payment amount per physician per year was $1112 ($372-$2870) and $277 ($95-$838), respectively."

Medical conference code of conduct

  Different fields have different conference cultures, and these change over time.  I've agreed to give a talk at a conference that physicians may attend for Continuing Medical Education (CME) credit, and it came with the following list of things for me to attest. Most of them seem to be assurances that my discussion will not be influenced by companies that have paid me in some way.

Attestations

• The content and/or presentation of the information with which I am involved will promote quality or improvements in health care and will not promote a specific proprietary business interest of an ineligible company.
• Content for this activity, including any presentation of therapeutic options, will be well-balanced, unbiased, and evidence-based. Opinions that are not supported by evidence or are supported by limited or preliminary evidence will be so identified. Recommendations involving clinical medicine will be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to will conform to the generally accepted standard of experimental design, data collection, and analysis.
• I have not and will not accept any honoraria, additional payments, or reimbursements directly for this CE activity from an ineligible company.
• I understand that my presentation and/or content may need to be peer-reviewed prior to the activity, and will provide educational content and resources in advance as requested.
• If I am discussing specific healthcare products or services, I will use generic names to the extent possible. If I need to use trade names, I will use trade names from several companies when available, and not just trade names from any single company.
• If I am discussing any product use that is off-label, I will disclose that the use or indication in question is not currently approved by the FDA.
• If I have been trained or utilized by a commercial interest or its agent as a speaker (e.g., speaker's bureau) for any ineligible company, the promotional aspects of that presentation will not be included in any way with this activity.
• If I am presenting research funded by a commercial interest, the information presented will be based on generally accepted scientific principles and methods and will not promote the ineligible company or the funding company

 

A medically aided death in New Jersey: Pat Koch Thaler

 Following a full life, a peaceful end.

Pat Koch Thaler, Sister to a Famed Mayor, Chose to Die on a Saturday
Ms. Thaler, a former dean at N.Y.U., used her last interview to reminisce about her brother, Ed, and to publicize the alternatives to prolonging pain and suffering. By Sam Roberts

"After 22 years of fending off cancer, Ms. Thaler had run out of miracles. Twice the disease had gone into remission, only to return. One kidney had been removed. She had been bombarded by radiation, chemotherapy and ablation. Finally, the tumors had been declared inoperable.

“My mother died in agony,” Ms. Thaler recalled. Her mother was 62, misdiagnosed and undergoing an operation to remove her gall bladder when surgeons found her body was riddled with cancer.

"Of her own experience, Ms. Thaler said she had been offered a drug that “would slow things down, but would have some serious side effects.”

“And I decided, I’m 92 and a half years old, I have lived a very, very rich life, a very happy life, and I didn’t want to torture myself anymore,” she said. “I did what I could, and knowing that the law is on my side, I decided to take advantage.”

"A New Jersey law that took effect in 2019 allows a mentally alert adult — whose prognosis of having less than six months to live has been certified by two doctors — to self-administer a lethal prescription. The powdery medication is mixed with three ounces of juice, must be consumed within two minutes, immediately induces sleep and, within hours, causes death.

...

"Ms. Thaler spent her last few days paying bills, disposing of her furniture, distributing her artwork to her children and grandchildren, and confirming the funeral arrangements

...

"She chose Saturday, she said, because her children worked, and she wanted a time that would be most convenient. Wearing a white long-sleeved shirt and loose black pants in her apartment, surrounded by her family, she took the powdered medication mixed in apple juice under a doctor’s supervision at 11 a.m.

"At 4:58 p.m., she was pronounced dead."

Medical Aid in Dying Laws in the U.S.

 JAMA has a review of the current state of medical aid in dying in the 12 U.S. jurisdictions (if Delaware proceeds) that now allow it.

Medical Aid in Dying Laws: More Accessible in More States by Thaddeus Mason Pope, JD, PhD, JAMA. 2024;332(14):1139-1140. doi:10.1001/jama.2024.15925

"Delaware may soon become the 12th US jurisdiction to authorize medical aid in dying. The Ron Silverio/Heather Block End-of-Life Options Law1 becomes a statute as soon as the governor acts and takes effect once the Delaware Department of Health and Social Services promulgates regulations to implement the statute. Delaware could follow 11 other US jurisdictions that have authorized medical aid in dying; more than 15 000 patients have received prescriptions for medical aid in dying since 1998 in California, Colorado, Hawaiʻi, Maine, Montana, New Jersey, New Mexico, Oregon, Vermont, Washington, and Washington, DC.

...

"Medical aid in dying has become an increasingly prominent end-of-life option. More than 20 states considered new medical aid in dying legislation in 2024, and most of the 11 jurisdictions that previously authorized medical aid in dying have amended their original statutes during the past 5 years (eTable in the Supplement).2-6 When enacting or amending medical aid in dying statutes, state policymakers have been carefully recalibrating the balance between safety and access

...

"Medical aid in dying is only available to terminally ill adults with decision-making capacity. They must have an “incurable and irreversible illness” with a prognosis of 6 months or less. If patients can navigate the other eligibility requirements and safeguards, they can get a prescription for lethal medications that they might later self-ingest to hasten their death.6

"Hospice and palliative care are often sufficient to address the suffering of patients, and one-third of those who receive medical aid in dying prescriptions never obtain them from the pharmacy or ingest them.3,4 Most of the remaining patients administer the prescriptions by mixing the powdered drugs with 2 oz to 3 oz of apple juice or push a plunger on a feeding or rectal tube. The patients fall asleep within minutes and usually die within an hour. There is never intravenous administration of the prescriptions or clinician- or third-party administration of the prescriptions.

...

"The Delaware end-of-life options law would require the patient to make 3 requests, 2 of which must be separated by at least 15 days.1 A waiting period has been a requirement in all jurisdictions that have authorized medical aid in dying. However, significant evidence showed that many patients either died or lost decision-making capacity before expiration of the waiting period.4 Many states (California, Colorado, Hawaiʻi, New Mexico, Oregon, and Washington) have either shortened their waiting periods or permit the waiting period to be waived when the patient is likely to die or lose decision-making capacity.

"The Delaware end-of-life options law would be limited to residents of Delaware1; however, for nonresidents, Delaware residency can be established by renting an apartment in Delaware.4 Residency requirements remain an additional hurdle in a long list of obstacles that terminally ill patients must navigate to become eligible. Within the past 2 years, both Oregon and Vermont removed their residency requirements.2,4,6 And the constitutionality of New Jersey’s residency requirement is being challenged in federal court.6 Nationwide, many bills proposed in 2024 omitted residency preconditions.

...

"Commentators regularly express concerns about the use of medical aid in dying in Canada7 and in Europe. It is important to protect vulnerable populations from coercion, duress, and inadequately considered choices; patients should not be steered toward choosing to request medical aid in dying. In addition, the adverse effects of orally ingested medications must be mitigated.4 In California, SB 1196 would have probably solved that problem by permitting (self-administered) intravenous administration of the end-of-life prescriptions. However, any change that would allow intravenous administration and other new and imminent expansions for medical aid in dying raise their own set of novel challenges for US clinicians.

"Given the number of bills and other indicators of interest, medical aid in dying is likely to be authorized in more states over the next few years, and the use medical aid in dying is likely to increase with more accessible terms and conditions. Although medical aid in dying continues to be used by less than 1% of dying patients,2 it is becoming a more integral part of end-of-life care."

Kidney exchange in Brazil, continued (with pictures)

 In August I posted about a trip to Brazil with Mike Rees where we traveled with Dr. Gustavo Ferreira, the director of transplantation at the hospital Santa Casa de Misericórdia de Juiz de Fora

Part of our trip was spent in the capital, Brasilia, talking to the government about extending Brazilian transplant law to allow kidney exchange, after which we went to Juiz de Fora.  Here's my blog post about that trip:  Kidney exchange in Brazil: prelude. 

That post concluded by saying "On Saturday we had an exciting finish to the trip, but it's not my story to tell yet, so I'll blog again after there is an official announcement."

Now Brazil's first three-way kidney exchange has been announced, as part of a clinical trial that I hope will help change Brazilian law to allow kidney exchange as a regular medical procedure.  The three donors and three recipients all did well, and left the hospital very shortly after the actual surgeries, but came back to tell their stories to the Brazilian news show Profissão Repórter (Professional Reporter). You can see the video here  https://globoplay.globo.com/v/12997336/

It's in Portuguese but you will quickly get the idea, presented even more briefly on Instagram by the transplant nephrologist Dr. Juliana Bastos here: https://www.instagram.com/reel/DA4JBVIsFta/?igsh=d2hnb3hoNjJxN2I4     where you can see the three incompatible patient-donor pairs rearrange themselves for the camera into the three-way exchange in which each patient received an organ from a compatible donor. (Dr. Bastos recently added a PhD to her MD, with a dissertation on kidney exchange.)

Here's another Instagram link to the video.

I had the privilege of observing parts of five of the six surgeries (three nephrectomies and three transplants), and some pictures are below.  

If someone directs a movie about this kind of transplant surgery, there will be two dramatic scenes, one in which the donated kidney is carried across the hall to the transplant operating room, and the second showing the moment the clamps are removed from the blood vessels of the transplanted kidney, so that it turns from grey to pink as blood returns to it. 

But here's a photo I took at  the start of what I think is the most dramatic moment of the surgery, as the artery from the kidney is just about to be connected to the artery of the recipient.

The artery from the donated kidney is the small white tube being pointed to by the instrument held in the fingers at the top right of the picture. Immediately in front of it--the long red tube--is the artery of the recipient, to which it must be connected so that blood can again flow to the kidney.  Notice that a small incision has already been made in the recipient's artery--this is where the two will be attached. The connection has to be perfect, so that the blood can flow without obstruction that could cause a clot.

The surgeon who first figured out how to do this kind of vascular surgery, Dr. Alexis Carrel, won the 1912 The Nobel Prize in Physiology or Medicine

I was able to follow the proceedings thanks to the running commentary offered to me by the Brazilian surgeons and by Mike Rees (who wasn't busy doing surgery). That wasn't the only kind of support Mike offered me in the OR (as I balanced on a pair of stools to better appreciate the commentary):

And here's a post-op picture of most of the big team that made it happen:

##########

Parabéns ao Gustavo e à Juliana! Congratulations. Your work and leadership can make a big difference not just to your patients, but to people all over Brazil.

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Earlier:

Monday, August 12, 2024

Kidney exchange in Brazil: prelude