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.

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

Earlier:

Monday, August 12, 2024

Kidney exchange in Brazil: prelude

IV fluid shortages in the U.S.--perhaps we should allow international imports?

There's a hurricane-induced shortage of intravenous (IV) fluid.  Maybe we should import some? (But...international borders...)

An obstacle is that FDA approval of the factories is usually needed, but can be (and in the past has been) suspended, to allow imports from places that do their own high quality inspection (like Australia and Ireland in 2017--I guess it's good that the labels are in English) .  

More generally, after the Covid pandemic we learned of the fragility of supply chains that have concentrated overseas sources (like surgical masks from Wuhan).  The reaction has been to onshore more production. But concentrated domestic production also makes for fragile supply chains, and being able to diversify to overseas producers could strengthen them.

Statnews has the story:

White House should declare national emergency over IV fluid shortages caused by Helene, says hospital group. Hurricane Helene shuttered a Baxter plant that manufactures 60% of IV solutions for the U.S.  By Brittany Trang 

"Amid Hurricane Helene shuttering a major IV solution manufacturing plant and Hurricane Milton now barreling toward other IV manufacturing facilities in central Florida, the American Hospital Association on Monday asked the Biden administration to declare a shortage of IV solutions and invoke national emergency powers to ease the crisis. 

'In late September, Hurricane Helene shut down a Baxter plant in Marion, N. C., which manufactures approximately 60% of the IV solutions for the U.S. Both Baxter and “all other suppliers” of IV solutions have restricted how much their customers can order and have stopped taking new customers, AHA president Rick Pollack wrote in the organization’s letter to Biden. As a result, hospitals have declared internal shortages and restricted IV use. 

...

"In addition, the letter asked for the government to declare a national emergency and public health emergency so that Medicare and Medicaid rules around IV infusions can become more flexible, and to invoke the Defense Production Act to expand the production of IV solutions and bags. The AHA also suggested the government put the Federal Trade Commission and Department of Justice on alert for price gouging during the shortage.

Another step the FDA could take is to allow the importation of IV bags from other countries,* as it did when Hurricane Maria shut down Baxter’s Puerto Rico-based IV saline plants in 2017. That shortage mostly affected small IV bags. According to Vizient, a health care performance improvement company, the North Carolina Baxter plant is largely a producer of large IV bags, including saline, dextrose, and Ringer’s lactate solutions.

#####

*In 2017: "To address a shortage of intravenous solution bags exacerbated by Hurricane Maria, the Food and Drug Administration has granted permission for a health supply company to import certain products to the United States from Australia and Ireland."

#########

Related:

Wednesday, August 28, 2024

WHO Says Countries Should Be Self-Sufficient In (Unremunerated) Organs And Blood, by Krawiec and Roth

The NAS proposes that bans on studying marijuana and its effects should be relaxed

 The National Academy of Sciences has just issued a new report on marijuana and public health.  Among their recommendations is that bans on research should be rescinded. (Because marijuana is currently a Schedule I drug in the Controlled Substances Act, it's hard to get permission to study it and its effects...)

Cannabis Policy Impacts Public Health and Health Equity (2024)

The first four patients who received transplants of organs from genetically modified pigs

 NBC reports on the four patients who have so far received organ transplants from genetically modified pigs.

Their loved ones died after receiving pig organ transplants. The families have no regrets. Four people have received hearts or kidneys from pigs. Some of their relatives recount a roller coaster of hope and uncertainty. By Aria Bendix

"David Bennett Sr., had severe congestive heart failure and wasn’t a candidate for a human transplant. He knew he would likely die soon. There was nothing more to do — other than take a chance on a novel, cutting-edge surgery. Bennett Sr. and his son agreed it was worth the risk.  

"The achievement made headlines around the world after the transplant surgery in January 2022.

...

"But two months later, Bennett Sr.’s body rejected the heart and he died at age 57. In a paper, his doctors at the University of Maryland Medical Center explained that his body had likely produced too many antibodies that fought off the new organ.

...

Three other patients have followed in Bennett Sr.’s footsteps and received pig organs, most recently a pig kidney transplant in April. Together, they represent the pioneer patients of the burgeoning field of xenotransplantation. For their families, three of which spoke to NBC News about the experience, the journey came with a roller coaster of emotions, from uncertainty to blind hope — and, ultimately, admiration for their loved one’s decision. 

...

"None of the patients survived more than three months. To the public, that might seem like failure. But to the families, the transplants accomplished their goals: to buy their loved ones more time and advance research that could potentially save lives one day."

Optimism and pessimism on psychedelic drugs as medicine

 "Psychedelics" may prove to be a broad church, with psilocybin and LSD quite different from MDMA, etc., but here are two articles that express very different views about the progress towards making them part of standard medical practice.

Here's some optimism in Columbia Magazine:

The Magic and Mystery of Psychedelic Therapies.  As new trials show that psilocybin and LSD may help treat depression and anxiety, mental-health providers get ready for a revolution.  By Paul Hond |

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And here's some pessimism, in the NYT:

How Psychedelic Research Got High on Its Own Supply, By Caty Enders

"The drug company Lykos Therapeutics had spent much of this year expecting to vault to meteoric heights. It had sent an application to the Food and Drug Administration seeking approval to use MDMA to treat post-traumatic stress disorder. Lykos expected F.D.A. approval; it was banking on it.

"And then on Aug. 9, the F.D.A.’s decision came through: rejection. It was the capstone to months of increasingly loud concerns being voiced over the quality of Lykos’s clinical trials. And in the wake of the F.D.A. decision, the journal Psychopharmacology retracted three papers related to research on MDMA, citing “unethical conduct,” an apparent reference to allegations of sexual abuse on the part of an unlicensed therapist at one of the trial sites. Several of the authors of the retracted papers were affiliated with Lykos.

"It is a shocking decrescendo for a drug that had been promoted for years as best positioned to lead a psychedelic mental health revolution. The F.D.A.’s rejection signals greater uncertainty for the future of psychedelic medicine."

Travel for medical aid in dying

 CBS has the story:

Why Americans are traveling to Vermont and Oregon to die

""Dying with medical assistance wasn't an option when Milano learned in early 2023 that her disease was incurable. At that point, she would have had to travel to Switzerland — or live in the District of Columbia or one of the 10 states where medical aid in dying was legal.

"But Vermont lifted its residency requirement in May 2023, followed by Oregon two months later. (Montana effectively allows aid in dying through a 2009 court decision, but that ruling doesn't spell out rules around residency. And though New York and California recently considered legislation that would allow out-of-staters to secure aid in dying, neither provision passed.)

...

"At least 26 people have traveled to Vermont to die, representing nearly 25% of the reported assisted deaths in the state from May 2023 through this June, according to the Vermont Department of Health. In Oregon, 23 out-of-state residents died using medical assistance in 2023, just over 6% of the state total, according to the Oregon Health Authority."

Medical aid in dying debated in NY, extended in the Netherlands

 Here are two related stories, one from the NYT about a debate on whether to allow medical aid in dying in New York State. The other is from Fox News, about the medically assisted death of a physically healthy young woman afflicted with a frightful psychiatric disorder.

In New York, there's a debate about whether to become the 11th state to legalize medical aid in dying.  Some of the opponents worry about a slippery slope, leading to the Netherlands, where mental illnesses can qualify candidates for such aid.

Here's the NYT on the debate in NY:

Doctor-Assisted Death Is Legal in 10 States. Could New York Be No. 11? Activists have renewed attention on legislation related to the emotional issue of so-called medical aid in dying that has long languished in Albany.

"New York is one of 19 states where lawmakers are considering bills that would legalize medical aid in dying, a practice that is legal in 10 states and Washington, D.C.

"The bill in New York would allow mentally competent, terminally ill adults with no more than six months to live to request prescriptions from their doctors for life-ending medication. The patients would have to be able to ingest the medication on their own, and only the person seeking to die could request the prescription.

...

"Opponents worry that some patients might choose to end their lives based on an inaccurate prognosis or after being pressured to do so. And while the current bill is restricted to terminally ill people, they worry that lawmakers could expand eligibility for medical aid in dying after any initial legislation is passed."

*************

Here's Fox News on the Netherlands:

Physically healthy Dutch woman dies by assisted suicide at age 29. Zoraya ter Beek died by assisted suicide in the Netherlands last week.  By Kendall Tietz Fox News,  June 1, 2024

"29-year-old Zoraya ter Beek's life was terminated last week after waiting three years for final approval for her euthanasia, which is legal in the Netherlands if the patient is deemed to be experiencing "unbearable suffering with no prospect of improvement."

...

"she tried various things to treat her mental illness, including 33 rounds of electroconvulsive therapy, in which electric currents jolt the brain. But, after her last treatment in August 2020, her psychiatrist told her, "There’s nothing more we can do for you. It’s never going to get any better."

...

"My whole friends and my support system, we really did it together," she had told The Free Press. Ter Beek reportedly saw herself as an ambassador for the Dutch euthanasia program and believed there is proper protocol in place to prevent abuse of the system. 

"We’ve had this law for more than 20 years," she had told the outlet. "There are really strict rules, and it’s really safe."

Organs, tissues, and medical devices are regulated very differently

 Here's an article in JAMA by a Michigan doctor and his Congresswoman, on the lack of regulation for some substances of human origin.

Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue–Based Products, by Robert P. Dickson, MD; Deborah A. Dingell, MS, JAMA. 2024;331(20):1703-1704. doi:10.1001/jama.2024.6834

" In 2021, an outbreak of M tuberculosis occurred in the US when contaminated bone graft material was implanted into 113 patients, 77% of whom developed clinically apparent tuberculosis.

...

[Again in 2023] "the Centers for Disease Control and Prevention (CDC) had identified additional tuberculosis-infected patients who had received implants of the same product, harvested from the same donor. At final count, 36 patients in 7 states had undergone implantation of bone graft tissue contaminated with M tuberculosis.

...

"Given the rigorous safety testing required of most medical therapies, how could 2 lethal outbreaks of tuberculosis occur in as many years, arising from the same product, distributed by the same company?

"The answer lies in the FDA’s designation of this product as a human cells, tissues, and cellular and tissue–based product (HCT/P) (Table). This class of therapies, which includes bone grafts, skin grafts, and stem cells, is not subject to the same regulatory standards as pharmaceuticals, biological products (such as blood products and monoclonal antibodies), or organ transplants. This designation has profound regulatory and clinical consequences

Main causes of death around the world, 1990-2021

 Here's a recent article from the Lancet that traces leading causes of death around the world, in more than a thousand countries and subnational locations.  Kidney disease went from #18 in 1990 to #9 in 2019, to #11 in 2021 (when Covid entered the list at #2)  So it looks like the rest of the world is catching up to the developed world in chronic disease as compared to infectious disease.

Naghavi, Mohsen, Kanyin Liane Ong, Amirali Aali, Hazim S. Ababneh, Yohannes Habtegiorgis Abate, Cristiana Abbafati, Rouzbeh Abbasgholizadeh et al. "Global burden of 288 causes of death and life expectancy decomposition in 204 countries and territories and 811 subnational locations, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021." The Lancet (2024).

Most diseases are causing less premature death, but Diabetes and Chronic Kidney Disease (CKD) are among the few that are causing more premature death, along with Malaria, AIDS, Covid and Other Pandemic Related Mortality (OPRM). (War is not included in the study.)

Signaling in medical residency applications

 We're starting to see descriptive studies of how signals are being used in the labor market for new doctors.  Each medical specialty has chosen to adapt the kinds of signals used in Economics in its own way, with some specialties using only a handful of signals and others eliciting as many as 30.

Here are two papers from a recent issue of Academic Medicine.

Impact of Applicants’ Characteristics and Geographic Connections to Residency Programs on Preference Signaling Outcomes in the Match, by Benjamin, William J. MPH; Lenze, Nicholas R. MD, MPH; Bohm, Lauren A. MD; Thorne, Marc C. MD, MPH; Abraham, Reeni MD; Sepdham, Dan MD; Mihalic, Angela P. MD; Kupfer, Robbi A. MD,  Academic Medicine 99(4):p 437-444, April 2024. | DOI: 10.1097/ACM.0000000000005551

"Abstract

Purpose : To assess the impact of applicant and residency program characteristics on preference signaling outcomes in the Match during the first 2 years of implementation across 6 specialties.

Method : Data were obtained from the Texas Seeking Transparency in Application to Residency survey for applicants applying into otolaryngology during the 2020–2021 and 2021–2022 application cycles and into dermatology, internal medicine (categorical and preliminary year), general surgery, and urology during the 2021–2022 application cycle. The primary outcome was signal yield, defined as the number of interviews at signaled programs divided by the total number of signals sent. Associations with applicant-reported characteristics and geographic connections to residency programs were assessed using Wilcoxon rank sum testing, Spearman’s rank correlation testing, and ordinary least squares regression.

Results : 1,749 applicants with preference signaling data were included from internal medicine (n = 884), general surgery (n = 291), otolaryngology (n = 217), dermatology (n = 147), urology (n = 124), and internal medicine preliminary year (n = 86). On average 60.9% (standard deviation 32.3%) of signals resulted in an interview (signal yield). There was a stepwise increase in signal yield with the percentage of signals sent to programs with a geographic connection (57.3% for no signals vs. 68.9% for 5 signals, P < .01). Signal yield was positively associated with applicant characteristics, such as United States Medical Licensing Exam Step 1 and 2 scores, honors society membership, and number of publications (P < .01). Applicants reporting a lower class rank quartile were significantly more likely to have a higher percentage of their interviews come from signaled programs (P < .01).

Conclusions: Signal yield is significantly associated with geographic connections to residency programs and applicant competitiveness based on traditional metrics. These findings can inform applicants, programs, and specialties as preference signaling grows."

And here are the introductory paragraphs:

"The rising number of residency applications submitted per applicant has led to concerns that programs will not be able to adequately perform a holistic review of all applications and will instead rely on easily reviewed metrics, such as United States Medical Licensing Exam (USMLE) scores, class rank, and medical school reputation.1,2 In addition, COVID-19–related changes to the residency application process, such as the introduction of virtual interviewing and a cap on the number of away rotations medical students can complete, have limited applicants’ ability to informally express their interest in programs.3 Further, there is evidence that, while applying to the maximum number of programs is advantageous at the individual level, it leads to poorer overall results when all applicants follow this practice.2 To address this issue, new systems have been proposed, including personalized application paragraphs,4 program-specific messages,5 and preference signals.4,6,7

"Otolaryngology implemented a preference signaling system in 2021, which was based on theory developed by the American Economic Association (AEA) in 2006. The AEA used a preference signaling system for job market applicants, whereby applicants were allowed to express special interest in particular employers in their applications.8 Results from the AEA program highlighted that preference signals were beneficial to both candidates and employers in a labor market where employers are unable to provide full attention to every application they receive.9 Building off previous economic work, a computer simulation study run on 2014 otolaryngology Match data found that the number of interview invitations improved when applicants provided preferences on their Electronic Residency Application Service application; this result would have benefitted both programs and applicants.2

"Based on this research, the Otolaryngology Program Directors Association formally implemented a preference signaling system during the 2020–2021 application cycle in which applicants were granted 5 “signals” to send to residency programs prior to interviews indicating their strong interest in that program. Each program then received a list of the applicants who had sent them a signal.6,10,11 Data from the 2021 otolaryngology Match were notable for significantly increased interview rates at signaled programs across all levels of applicant competitiveness.10,12 Furthermore, the majority of program directors and applicants strongly supported the continuation of preference signaling.10,11 During the 2021–2022 application cycle, preference signaling pilot programs were implemented in 5 additional specialties: dermatology, internal medicine (categorical), internal medicine preliminary year, surgery (categorical), and urology, with each specialty using 5 signals per applicant, except dermatology, which used 3 signals"

#########

The Relationship Between Program and Applicant Characteristics With Applicant Program Signals in the 2022 Residency Recruitment Cycle: Findings From 3 Specialties, by LaFemina, Jennifer MD; Rosman, Ilana S. MD; Wallach, Sara L. MD; Wise, Paul E. MD; Smink, Douglas S. MD, MPH; Fletcher, Laura PhD, Academic Medicine 99(4):p 430-436, April 2024. | DOI: 10.1097/ACM.0000000000005586

"Abstract

Purpose: Continuing increases in application volume have driven a national dialogue to reform the residency recruitment process. Program signaling allows applicants to express interest in a program at the preinterview stage with the goal of helping programs identify applicants with more genuine interest in their programs. This study explored the relationship between program signals and program and applicant characteristics.

Method: Participating dermatology, general surgery, and categorical internal medicine (IM) programs and applicants of the 2022 supplemental ERAS application (SuppApp) were included. Data from the SuppApp, the MyERAS Application for Residency Applicants (MyERAS), and the 2020 GME Track Survey were used. Cohen’s h was used to determine effect size, and chi-squared was used to determine statistical significance.

Results:There was an uneven distribution of signals to programs, with 25% of programs receiving about half of the signals across all 3 specialties. Programs with larger numbers of both residents and applicants received greater numbers of program signals relative to their program density, although this effect was small (h < 0.50, P < .001). No meaningful differences were seen across genders for any specialty. Only Hispanic applicants in IM sent a higher proportion of signals to programs with more underrepresented in medicine residents than White only applicants (40% vs 26%, h = 0.30, P < .001). Across all specialties, there was a small-to-moderate effect for international medical graduate (IMG) applicants sending a larger proportion of signals to programs with more IMG residents (h < 0.80, P < .001).

Conclusions: This first-year pilot study (i.e., SuppApp) provided initial evidence that supports the feasibility and fairness of program signals in residency selection. As program signals become more common across specialties, future research should continue to evaluate trends in where applicants send signals, and possible relationships between program and application characteristics."

"IMG applicants were more likely to signal programs with a greater proportion of IMG residents. The effect was small in dermatology and increased to moderate in GS and large in IM. In the NRMP’s 2022 Main Residency Match, 11 IMGs (U.S. and non-U.S.) matched into postgraduate year 2 dermatology, representing 2% of positions. This compares to the 10% and 38% IMG Match rate into GS and IM, respectively.21 While at this time, correlation of signal distribution and the likelihood of successfully matching is not available, these findings suggest that in general, IMG applicants sent more signals to programs they knew to be “IMG friendly” (i.e., more likely to accept IMGs), which they could easily identify with tools such as the Residency Explorer Tool22 and the Residency Programs List.23 However, if IMGs continue to send more signals to programs with already higher proportions of IMG residents, this may maintain the status quo or even further restrict the IMG applicant pool all programs are willing to consider during their resident selection process because programs with fewer IMGs will continue to receive a lower proportion of signals from IMG applicants. This could ultimately negatively affect diversity across programs"

Vatican statement on gender-affirming surgery and human dignity

 A new statement from the Vatican has been widely covered in the press.

Here's the story from the National Catholic Reporter:

Vatican condemns surrogacy, gender-affirming surgery, gender theory in new doctrinal note. Vatican doctrinal chief calls it 'painful' that some Catholics support gay criminalization  BY CHRISTOPHER WHITE, April 8, 2024

"Sex change operations, gender theory and surrogate motherhood pose grave threats to human dignity, according to a major new Vatican document released on April 8. 

While the highly anticipated treatise, "Dignitas Infinita: on Human Dignity," which has been the source of much speculation for months, offers a broadside against the creation of new rights motivated by sex and gender, it is largely a reiteration of long-held Catholic teaching on a number of social and moral concerns. 

The new document, however, seeks to elevate a number of social themes emphasized by Pope Francis during his decadelong papacy — such as poverty, migration and human trafficking — as being equally a part of the full panoply of potential threats to human dignity as bioethical concerns, such as abortion and euthanasia.   

...

"Among the newly identified threats to human dignity are poverty; war; the travail of migrants; human trafficking; sexual abuse; violence against women; abortion; child surrogacy; euthanasia and assisted suicide; the marginalization of people with disabilities; gender theory; sex change; and digital violence.

Gender theory, according to the document, is a subject of considerable debate among scientific experts, and risks denying "the greatest possible difference that exists between living beings: sexual difference."  

The document repeats a frequent warning of Francis against "ideological colonization," where the pope has sharply criticized western governments for allegedly imposing their sexual values on the developing world. All efforts to eliminate sexual differences between men and women must be rejected, says the document. 

At the same time, the document also begins with a caveat that all persons, regardless of their sexual orientation, must be respected, and "every sign of unjust discrimination is to be carefully avoided, particularly any form of aggression and violence."

"For this reason," the document continues, "it should be denounced as contrary to human dignity the fact that, in some places, not a few people are imprisoned, tortured, and even deprived of the good of life solely because of their sexual orientation."  

Last year, Francis became the first pope to specifically condemn the criminalization of homosexuality and said that the Catholic Church must work towards an end to what he described as "unjust" laws that criminalize being gay. At present, at least 67 countries have laws criminalizing same-sex relations. 

In its brief section on gender-affirming surgeries, the document avoids using the term "transgender" and instead offers a muted prohibition against medical interventions for such purposes.

...

"Catholic LGBTQ groups criticized the new Vatican document within hours of its publication, saying it failed to acknowledge the concrete experience of transgender and nonbinary individuals.

New Ways Ministry, an advocacy group that had an historic meeting with Francis at the Vatican last October, said in a statement that the text "fails terribly" and shows the limits of the church's understand of human dignity.

...

"The new document also goes on to repeat the pope's recent call for an international ban on the rising practice of surrogate motherhood, declaring that the "legitimate desire to have a child cannot be transformed into a 'right to a child' that fails to respect the dignity of that child as the recipient of the gift of life."  

In January, Francis used his annual "State of the World" address to ambassadors accredited to the Holy See to push for a global ban on surrogacy. 

While the pope had previously condemned the practice, the pope's sweeping remarks on the topic — where he called it a "grave violation of the dignity of the woman and the child" — marked the first time he had made such a specific policy proposal. Last month, the Vatican's ambassador to the United Nations, Archbishop Gabriele Caccia, also pressed for an international prohibition against the practice. "

Interviews by lottery at Queens University School of Medicine

 Overwhelmed by large numbers of applications, and concerned about fairness, Queens University will set admissions thresholds (on grades and exam scores) and then determine by lottery which applicants move to the interview stage.

New admissions process improves equitable access to the Queen’s MD Program

"Queen’s Health Sciences (QHS) is adapting its MD Program admissions process to create a more inclusive entry point for all applicants, minimize systemic barriers to becoming a doctor, and increase student diversity.

"The renewed medical student admissions process will launch this fall, for 2025 admissions, and includes a pathway for lower socioeconomic status (SES) applicants and adjustments to the current Indigenous pathway. A new comprehensive approach to support the recruitment of Black students will launch in a second phase of this admissions change.  

...

"The MD Program will set admissions thresholds for grade point average (GPA), Medical College Admission Test (MCAT), and Casper (a situational judgment test) at levels that align with the potential for predicting success in medical school, without concern for the number of applicants who meet these thresholds. While the MD Program already posts GPA thresholds, as part of this change, MCAT thresholds will be posted as well. All applicants who meet these thresholds will be entered into a lottery to determine who will be invited to interviews. "

HT: Jonah Peranson (of National Matching Services)