Showing posts with label medicine. Show all posts
Showing posts with label medicine. Show all posts

Friday, March 31, 2023

Opioids and Appalachia by Sally Satel

 Sally Satel, who has treated patients in Appalachia, writes movingly of the drug addiction problem there. Here's a paragraph that sets the stage.

"The history of opioid pain relievers in Appalachia is a prime illustration of the fact that drug epidemics rarely burst onto the scene out of nowhere. Instead, they find their place in regions that are already home to an established base of individuals who abuse similar drugs. Thus illicit OxyContin, a more potent opioid, efficiently gained popularity over Percocet and Vicodin in the same way heroin would substitute for prescription opioids as the latter grew scarce after 2010."

That's from Opioids and Appalachia by Sally Satel, in the current issue of National Affairs.

The whole thing is well worth reading; here are a few more paragraphs that caught my eye.

"The churn of pills — diverting, using, and selling them — soon had eastern Kentucky, southeastern Ohio, and West Virginia pulsing with crime. Realtors routinely told home sellers not to leave pills in their medicine chests during open houses. Funeral directors and hospice nurses cautioned the bereaved not to mention in obituaries that their loved ones had succumbed to cancer — a red flag signaling that huge bottles of pills were likely on the premises. In eastern Kentucky, local law enforcement was often stymied by close ties between people within communities. Loyalty within large families and fear of retaliation by neighbors made it hard to cultivate informants and to impanel neutral juries that would convict when prosecutors proved their case.

...

"Appalachians seemed to take the corruption in grudging stride. In one survey, 90% of over 100 Kentuckians working in law enforcement, health, and community governance said the rural OxyContin problem in the early 2000s was "fueled by a cultural acceptance of drug misuse." Indeed, many residents tolerated unlawful activity, since it generated revenue for the community from sales of pills to outsiders. This happened in places like Williamson, West Virginia — dubbed "Pilliamson" — where the local Wellness Center was a hub of reckless prescribing. Cash-laden out-of-staters flocked there to buy painkillers and, in a small area near the center, trade and sell those pills.

"Pablo Escobar and El Chapo couldn't have set things up any better," wrote Eyre. "The coal barons no longer ruled Appalachia. Now it was the painkiller profiteers."

...

"Today, opioid pills are no longer pouring into Appalachia as they once did; highly lethal products like fentanyl-laced heroin, methamphetamine, and counterfeit fentanyl pills are what people are selling."

Monday, March 6, 2023

Reconsideration of covid convalescent plasma

Recently Statnews reported that Covid convalescent plasma (CCP) may in fact be useful in preventing severe illness, despite the fact that earlier clinical trials did not show success in reversing severe illness:

Covid convalescent plasma: the ‘little engine that could’  By Michael J. Joyner, Nigel Paneth and Arturo Casadevall

"Unlike monoclonal antibodies, which can be defeated by new SARS-CoV-2 variants, CCP collected from vaccinated donors after recent breakthrough infections (VaxCCP) evolves with the variants and retains the ability to neutralize them. What makes CCP an even more promising therapy is that there are now many potential donors available in the U.S. who have been vaccinated and had recent breakthrough infections.

...

"An array of data, including randomized controlled trials and careful retrospective studies, show a clear survival benefit when CCP is given to immunocompromised individuals who test positive for SARS-CoV-2. There are also impressive case reports and case series showing that Covid convalescent plasma, especially VaxCCP, is effective in patients with smoldering Covid-19.

...

"the early “major” RCTs that tested the efficacy of CCP on survival in hospitalized patients tested the wrong use case. These studies treated patients who were too sick for too long to benefit from antibody therapy. But the major “negative” trials all showed evidence of effectiveness among people who received CCP earlier, who were not already desperately ill, who were immunocompromised, or who received the most antibodies. Unfortunately, these positive signals, which were consistent with impressive real-world data on Covid-19 and CCP, were buried under the top-line results."

*********

Earlier posts on convalescent plasma

Sunday, March 5, 2023

Australia legalizes medical use of psychedelics

 Scott Cunningham points out that Australia has become the first country to legalize the medical use of certain psychedelics. 

Here's the announcement from the Australian Government's Therapeutic Goods Administration (TGA)

Change to classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists

"From 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.

The Therapeutic Goods Administration (TGA) will permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression. These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients.

Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established. To prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee. The Authorised Prescriber Scheme allows prescribing permissions to be granted under strict controls that ensure the safety of patients.

The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.

For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard. For all other uses, they will remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials."

*********

Scott shares a post by Shane Pennington on drugs that contrasts the Australian (medical) decision with the U.S. Drug Enforcement Agency's (legal) decision to maintain the ban on these drugs, despite the growing medical evidence (from U.S. studies, on which the Australian government relied) that psychedelics have some important medical uses.

"To support its decision, the TGA relied heavily on studies conducted in the U.S. and recent U.S. Food and Drug Administration (FDA) decisions recognizing psilocybin and MDMA’s extraordinary therapeutic potential. Around the same time, DEA shot down a petition—based on those same arguments and evidence—that Matt and I submitted on behalf of a palliative-care doctor, requesting rescheduling of psilocybin under U.S. law. The DEA’s four-sentence analysis completely ignored the same studies and FDA decisions that persuaded the Australian regulator to reschedule.  

"The dramatically different fates of these similar petitions reveal a troubling reality about U.S. drug law: Under DEA’s watch, the scientific and medical determinations of the nation’s leading public health agency carry considerable weight around the world but are often ignored at home. That revelation should terrify anyone interested in rational, evidence-driven drug policy. "

******

But the States are the laboratory of democracy: here's an earlier related post.

Sunday, November 13, 2022


Wednesday, March 1, 2023

Evaluating kidney patients and donors without consideration of race

 Somewhere in the history of nephrology, a patient's race was included as a factor in estimating their kidney function.  This has at various times been important for various kinds of treatment, including of course preventive treatment, as well as starting dialysis, and entry and perhaps priority on kidney transplant waitlists. And it has also been important for evaluating the quality of deceased donor kidneys that can be offered for transplantation. There have been important recent changes in this, and more may be on the way. The current issue of JAMA devotes a number of articles to that, linked below.


Viewpoint

Redressing the Harms of Race-Based Kidney Function Estimation

Dinushika Mohottige, MD, MPH; Tanjala S. Purnell, PhD, MPH; L. Ebony Boulware, MD, MPH

Audio: Race-Neutral Estimates of Kidney Function: Enhancing Equity

Video: Race-Neutral Estimates of Kidney Function: Enhancing Equity

Time to Abolish Metrics That Sustain Systemic Racism in Kidney Allocation

John S. Gill, MD, MS; Burnett Kelly, MD, MBA; Marcello Tonelli, MD, SM

Medical News & Perspectives

Race-Based Equations Delayed Black Patients From Getting Onto Kidney Transplant Lists—An Unprecedented New Policy Seeks to Undo the Damage

Jennifer Abbasi

PREVIOUSLY PUBLISHED

JAMA | Research

Association of Estimated GFR Calculated Using Race-Free Equations With Kidney Failure and Mortality by Black vs Non-Black Race

Orlando M. GutiĆ©rrez, MD, MMSc; Yingying Sang, MS; Morgan E. Grams, MD, MHS, PhD; et al

JAMA | Opinion

Race-Free Estimation of Kidney Function: Clearing the Path Toward Kidney Health Equity

L. Ebony Boulware, MD, MPH; Dinushika Mohottige, MD, MPH; Matthew L. Maciejewski, PhD

JAMA Network Open | Research

Association of the Estimated Glomerular Filtration Rate With vs Without a Coefficient for Race With Time to Eligibility for Kidney Transplant

Leila R. Zelnick, PhD; Nicolae Leca, MD; Bessie Young, MD, MPH; et al

Audio

Race-Neutral Estimates of Kidney Function: Enhancing Equity

Video


Join the conversation. Follow JAMA on Twitter.


Monday, February 27, 2023

Judge shopping for abortion rulings

 Justice (like politics, sausage and econometrics) is constructed in complex ways. The Washington Post has a story on the case against an anti-abortion drug, now being heard by federal judge Matthew Kacsmaryk in Amarillo Texas, which could result in a nationwide ban on that drug.  The case concerns medical issues about drug regulation, and isn't directly concerned with the legal controversy about abortion rights.

The Texas judge who could take down the abortion pill. A devout Christian, Matthew Kacsmaryk has been shaped by his deep antiabortion beliefs. By Caroline Kitchener and  Ann E. Marimow  February 25, 2023 

"The abortion pills lawsuit, which Kacsmaryk could rule on any day, is the latest in a long line of politically explosive cases to appear on the judge’s docket. In a practice known as “forum shopping,” conservative groups have zeroed in on the Amarillo division of the Northern District of Texas as a go-to place to challenge a wide range of Biden administration policies. Because Amarillo is a federal district with a single judge, plaintiffs know their arguments will be heard by Kacsmaryk — who, like any federal judge, is positioned to issue rulings with nationwide implications.

"Appeals from Kacsmaryk’s district follow a path that has regularly yielded favorable outcomes for conservatives — reviewed first by the U.S. Court of Appeals for the 5th Circuit, which upheld a strict Texas abortion ban long before Roe v. Wade was overturned, then ultimately by the conservative-controlled Supreme Court."

********

Here's a related story from Medpage Today:

A Ban on the Abortion Drug Mifepristone Is Looming— A Texas lawsuit may be disastrous for effective abortion access and FDA's authority by Lawrence O. Gostin, JD, LLD, and Sarah Wetter, JD, MPH, February 23, 2023

"In the most consequential and controversial attack on reproductive rights since the overturning of Roe v. Wadea Texas judge could ban the safest, most effective, and most common method for abortion in all 50 states. The hyper-conservative anti-abortion group Alliance Defending Freedom  (ADF) is seeking to overturn the FDA's approval of mifepristone (Mifeprex), a medication in a two-pill regimen used to terminate pregnancies through the first 10 weeks gestation. The lawsuit does not target the other medication, misoprostol (Cytotec)which FDA approved to treat stomach ulcers, and can be prescribed off-label for abortion.

...

"Given the FDA's rigorous risk evaluation and mitigation strategy (REMS) for mifepristone and its safe use for 23 years, the case is utterly frivolous and political, but due to "judge shopping" the repercussions for reproductive health and equity are real. Perversely, a single federal trial judge has the power to block a federal law, rule, or action on a national scale. The case could make its way to the Supreme Court, with potentially disastrous consequences for safe, effective abortion access and the authority of the FDA."

opens in a new tab or windowfor mifepristone and its safe use for 23 years, the case is utterly frivolous and political, but due to "judge shopping" the repercussions for reproductive health and equity are real. Perversely, a single federal trial judge has the power to block a federal law, rule, or action on a national scale. The case could make its way to the Supreme Court, with potentially disastrous consequences for safe, effective abortion access and the authority of the FDA.

Saturday, February 18, 2023

Compensation for participating in clinical trials

 Here's an opinion piece from Medpage Today:

It's Time to Pay Clinical Trial Participants More — Accelerating trial enrollment can catalyze access to much-needed medications  by Gunnar Esiason 

He writes:

"Most people I know with cystic fibrosis have participated in at least one, if not several clinical trials. 

...

"Participating in a trial can be like working for a company that hasn't invested in its employees in a long time. In this case, the employees are clinical trial participants. The pay is low despite the time required to participate in research and the growing number of trials that need participants.

"From 2019-2022, the number of registered clinical trials grew by 25%opens in a new tab or window globally -- yet participant pay remains arbitrary and inconsistentopens in a new tab or window between studies. It's almost like mismatched supply and demand curves, where participants are in high demand but unwilling to participate.

"Increasing trial participant pay might be a path toward alleviating the participant supply crunch in trials hungry for patients. One key benefit of increasing pay for patients could be substantial: namely, speeding up clinical trials through a more competitive enrollment process.

...

"More than 80% of clinical trials fail to enroll on time, leading to costs of anywhere from $600,000 to $8 million per dayopens in a new tab or window and making trials take up to twice as longopens in a new tab or window.

"And yet it has been shownopens in a new tab or window that moderately increasing pay can motivate participation without being an "unjust inducement." In other words, patients are encouraged to participate -- but not coerced to do so.

"If increasing participant pay can accelerate trial enrollment, then a safe and effective drug can reach the market faster and therefore reduce the amount of time products remain in the pre-revenue stage. The return on investment for study sponsors who increase participant pay should be clear from a business perspective.

"From a patient perspective, even a marginal improvement in time to accessing new drugs is something worth celebrating. For patients, we pay the cost of delays with our health."

*********

Some earlier related posts:

Thursday, October 29, 2020

Paying participants in challenge trials of Covid-19 vaccines, by Ambuehl, Ockenfels, and Roth

"we note that increasing hourly pay by a risk-compensation percentage as proposed in the target article provides compensation proportional to risk only if the risk increases proportionally with the number of hours worked. (Some risky tasks take little time; imagine challenge trials to test bulletproof vests.) "

Sunday, December 11, 2022

Euthanasia in Canada

 The NYT columnist Ross Douthat considers the medical aid in dying policies in Canada, and warns us that conservative politics is what protects us against the slippery slope that might lead us down the Canadian path.

 What Euthanasia Has Done to Canada

"In recent years, Canada has established some of the world’s most permissive euthanasia laws, allowing adults to seek either physician-assisted suicide or direct euthanasia for many different forms of serious suffering, not just terminal disease. In 2021, over 10,000 people ended their lives this way, just over 3 percent of all deaths in Canada. A further expansion, allowing euthanasia for mental-health conditions, will go into effect in March 2023; permitting euthanasia for “mature” minors is also being considered.

...

"The rules of civilization necessarily include gray areas. It is not barbaric for the law to acknowledge hard choices in end-of-life care, about when to withdraw life support or how aggressively to manage agonizing pain.

"It is barbaric, however, to establish a bureaucratic system that offers death as a reliable treatment for suffering and enlists the healing profession in delivering this “cure.” And while there may be worse evils ahead, this isn’t a slippery slope argument: When 10,000 people are availing themselves of your euthanasia system every year, you have already entered the dystopia.

"Indeed, according to a lengthy report by Maria Cheng of The Associated Press, the Canadian system shows exactly the corrosive features that critics of assisted suicide anticipated, from health care workers allegedly suggesting euthanasia to their patients to sick people seeking a quietus for reasons linked to financial stress.

...

"in the Canadian experience you can see what America might look like with real right-wing power broken and a tamed conservatism offering minimal resistance to social liberalism. And the dystopian danger there seems not just more immediate than any right-authoritarian scenario, but also harder to resist — because its features are congruent with so many other trends, its path smoothed by so many powerful institutions.

...

"without a potent conservatism, the cultural balance tilts too much against these doubts. And the further de-Christianization proceeds, the stronger the impulse to ... rationalize the new order with implicit reassurances that it’s what some higher power wants.

"It’s often treated as a defense of euthanasia that the most intense objections come from biblical religion. But spiritual arguments never really disappear, and the liberal order in a dystopian twilight will still be infused by some kind of religious faith.

"So I remain a conservative, unhappily but determinedly, because only conservatism seems to offer a stubborn obstacle to that dystopia"

*********

Update, January 14: in a followup column, Douthat responds to supporters of Canada's euthanasia policies,* and summarizes his position with this concluding sentence: 

"And if euthanasia is kept within limits or rolled back from its advances, I suspect it will be the old taboos and Christian prohibitions that make the difference, not a libertarianism that so quickly and easily yields to pagan destinations."

*See in particular

Canadian Euthanasia as Moral ProgressIndividual liberty, the common good, and human dignity. by Richard Hanania

Here's a summary paragraph:

"First, I will show that the MAID program is currently small, and likely represents cases of the most extreme suffering given the data that we have. I then go on to refute arguments against MAID that have appeared in the popular press. Sometimes, these arguments are simply false, as when it is claimed that it will eventually lead to large numbers of healthy young adults killing themselves with state sanction. Other times, the arguments may be correct but actually make the case for euthanasia. It is true, for example, that some people might feel “pressured” to commit suicide because they don’t want to be burdens on their families or the government. I don’t think there’s anything wrong with this — in practically every other kind of situation, it is usually considered pro-social to care about the impact your life has on others. This gets to the point that my support for euthanasia does not simply rest on libertarian and utilitarian grounds, but also on the idea that people should behave in ways that consider the common good and that, yes, preserve human dignity. The state’s interest in saving costs, as long as it’s going to pay for healthcare, is also legitimate, although I won’t dwell on that here."

Wednesday, November 30, 2022

Opioids and pain management: revised CDC guidelines

 Concerned over the opioid addiction epidemic in the U.S., and the increasing number of overdose related deaths, the CDC issued the 2016 CDC Opioid Prescribing Guideline, which led to reduced opioid prescriptions by doctors. Sometimes this led to the undertreatment of pain, which in turn may have led to patients accessing opioids on the black market, where they are less safe. It may also have led to suicides of patients with unbearable pain.

The CDC has now issued some updated guidelines that appear aimed at balancing concerns with over-prescription against concerns with under-treatment.

Here are the updated guidelines:

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022

"This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years. It updates the CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 (MMWR Recomm Rep 2016;65[No. RR-1]:1–49) and includes recommendations for managing acute (duration of <1 month), subacute (duration of 1–3 months), and chronic (duration of >3 months) pain.

...

"CDC recommends that persons with pain receive appropriate pain treatment, with careful consideration of the benefits and risks of all treatment options in the context of the patient’s circumstances. Recommendations should not be applied as inflexible standards of care across patient populations. This clinical practice guideline is intended to improve communication between clinicians and patients about the benefits and risks of pain treatments, including opioid therapy; improve the effectiveness and safety of pain treatment; mitigate pain; improve function and quality of life for patients with pain; and reduce risks associated with opioid pain therapy, including opioid use disorder, overdose, and death.


A central tenet of this clinical practice guideline is that acute, subacute, and chronic pain needs to be appropriately and effectively treated regardless of whether opioids are part of a treatment regimen. 

...

"To avoid unintended consequences for patients, this clinical practice guideline should not be misapplied, or policies derived from it, beyond its intended use (67). Examples of misapplication or inappropriate policies include being inflexible on opioid dosage and duration, discontinuing or dismissing patients from a practice, rapidly and noncollaboratively tapering patients who might be stable on a higher dosage, and applying recommendations to populations that are not a focus of the clinical practice guideline (e.g., patients with cancer-related pain, patients with sickle cell disease, or patients during end-of-life care)

*********

Earlier post:

Tuesday, March 15, 2022

Saturday, November 19, 2022

Why is it so easy to get drugs, and so hard to get drug abuse treatment? Overdose deaths continue to climb.

 Here's an update on drug abuse in the U.S., from the WSJ. One quote particularly struck me, from a mom whose child died: "it’s so easy to get drugs,”  “It’s so much more available than treatment.”

How Meth Worsened the Fentanyl Crisis. ‘We Are in a Different World.’ Methamphetamine fatalities are rising, increasingly in combination with opioids  By Jon Kamp and Arian Campo-Flores.

"One in five of the total fatal overdoses last year involved an opioid and a psychostimulant, a drug class dominated by meth, preliminary federal data show. A decade earlier, about 2% of drug deaths involved such combinations.

...

"The rise in fatalities involving stimulants, often combined with opioids, has created a fourth wave of the decadeslong U.S. overdose-death crisis, according to Dr. Daniel Ciccarone, a professor of addiction medicine at the University of California, San Francisco. Deaths from combinations of opioids and cocaine, another stimulant, are also climbing.

...

"Fentanyl drove U.S. overdose deaths to a record-breaking tally of more than 108,000 last year, according to the federal data.

"Now, the combination of meth and opioids—especially fentanyl—is supercharging those numbers. Meth-related deaths, though smaller in number, are increasing at a faster rate than opioid and overall drug fatalities.

"About 33,400 deaths last year involved psychostimulants such as meth, up more than 340% from roughly 7,500 five years earlier, the federal data show. In the same time span, deaths involving synthetic opioids like fentanyl rose about 270% to around 72,000, and overall drug fatalities rose about 71%.

...

"it’s so easy to get drugs,” said Mr. Ryan’s mother, Alicia Vigil-Ryan. “It’s so much more available than treatment.”

Saturday, October 8, 2022

Black markets in abortion pills

 Americans differ in their opinions about whether American women have a right to end a pregnancy, or whether state legislators have the right to decide the issue for residents of their state.  Six American Supreme Court justices hold the latter opinion, and so overturned the constitutional right defined 50 years ago by the same court in Roe v. Wade.

This means that different states are going to have different laws about abortion. But medical technology is such that abortion pills exist, and can arrive in the mail. So even State laws criminalizing that may not stop it, when abortion and abortion pills remain legal in other states. That is, we're about to see a situation ripe for black markets. We may also see a legal conflict among the states.

The NY Times has a story on that:

Risking Everything to Offer Abortions Across State Lines. Doctors and midwives in blue states are working to get abortion pills into red states — setting the stage for a historic legal clash.  By Emily Bazelon

"When the landscape settles, abortion is likely to be illegal or severely restricted in at least 20 states — where just two years ago, in 2020, about 250,000 people had abortions. It is clear that clinicians in those states will face imminent prosecution if they continue to provide abortions. What is much less clear is what happens if providers in blue states offer telemedicine abortions to women in states where that’s against the law. These clinicians, too, could be arrested or sued or lose their medical licenses. To protect themselves, they may have to give up traveling to certain parts of the country — and it’s still no guarantee.

"In the face of so much uncertainty and an invigorated anti-abortion movement, large organizations and most clinicians are loath to gamble. But Aid Access providers think that the end of Roe calls for doctors to take bold action. Their answer is to mail many more pills to women who otherwise may be forced to carry pregnancies they don’t want.

"The court’s decision overturning Roe last June, Dobbs v. Jackson Women’s Health Organization, polarized the public while opening the door to a new threat — a direct clash among the states over abortion law. In jettisoning the single national standard Roe established, the court invited states to pass or enforce their own laws, which could be diametrically opposed to those of neighboring states."

"Sitting in her office in New York, hundreds of miles from states that could go after her, Prine, at 71, was close to retirement and willing to take chances. “I don’t want younger physicians to be embroiled in lawsuits or criminally charged,” she said. “I’m the one that should happen to. Doctors like me who are at the end of our careers, we should be the ones to step up.”


"Article IV of the Constitution, which addresses the relationships among states, says that if a person charged with a crime in one state flees to another, she must be “delivered up,” or extradited, to the first state. If a doctor from Connecticut, for example, went to Texas, performed an illegal abortion there and then went home, Connecticut would have to send that doctor to Texas for prosecution. But courts have held in the past that if the person never set foot in the state that is prosecuting her, then she didn’t flee, and her state of residence has no constitutional obligation to extradite her. 

...

"But there’s a catch. If a provider travels outside her home state while Texas has a warrant for her arrest, another state without a shield law could follow the customary practice of interstate cooperation — and extradite her to Texas. In addition, if an abortion provider in a pro-access state like Connecticut is sued in Texas rather than prosecuted, Article IV requires the states to help enforce a civil judgment. Connecticut would probably be obligated to comply in collecting damages, for example, if a family member of a woman who had an abortion won a lawsuit for the wrongful death of a fetus. To deter these sorts of suits, Cohen, Donley and RebouchĆ© suggest that states that want to shield their abortion providers could authorize them to countersue for interfering with legally protected health care. “If you’re hoping for a $1 million judgment in Alabama, but you know New York will let someone try to get it back from you, maybe you don’t sue in the first place,” Cohen says.

"The closest historical analogy, however imperfect, for the coming clash may be the conflict between Southern and Northern states over fugitive slave laws in the 19th century. “There are genuinely significant differences between slavery and abortion, morally and legally,” says Jamal Greene, a law professor at Columbia University. “But it’s a reasonable starting point for understanding why it’s a problem, in a nation that wants to hold itself together, when individual states are allowed to make policy about basic rights that people feel extremely strongly about, on both sides.”

"Tensions among the states can become corrosive. The framers of the Constitution gave enslavers the power to recapture enslaved people who escaped to free states. As the cause of abolition gained support, some free states passed personal liberty laws that protected Black people from kidnapping. In 1842, in Prigg v. Pennsylvania, the Supreme Court weighed in on the side of the South, striking down the conviction in Pennsylvania of a slave catcher for kidnapping a mother and her children."

Tuesday, August 30, 2022

Kidney news from Cambridge on possibility of removing blood type barriers

 Here's some very preliminary kidney news (a press release) in The Guardian and at Cambridge, that could have the potential to have an impact sooner rather than later in helping potential transplant recipients with blood type O, who can only receive blood type O kidneys (which can be received by patients of any blood type)...  

Researchers change blood type of kidney in transplant breakthrough University of Cambridge team’s work could significantly increase supply of organs for people with rarer blood types

"University of Cambridge researchers used a normothermic perfusion machine – a device that connects with a human kidney to pass oxygenated blood through the organ to better preserve it for future use – to flush blood infused with an enzyme through the deceased donor’s kidney.

"The enzyme removed the blood type markers that line the blood vessels of the kidney, which led to the organ being converted to type O."

*******

https://www.cam.ac.uk/stories/kidneybloodtype

The scientists mentioned are Professor Michael  Nicholson and PhD student Serena MacMillan .

Monday, July 11, 2022

Medical assistance in dying: palliative care

A lot of the discussion of medical assistance in dying has focused on assisted suicide, but there is also the question of trying to die well by avoiding doomed heroic medical procedures at the end. Deborah James, an Englishwoman who chronicled how she dealt with her grim diagnosis, died recently, and is remembered in the British Press.

Here's a story, by a palliative care doc, from the London Sunday Times: 

How to have a ‘good death’ like Deborah James  by Dr Rachel Clarke

"As a palliative care doctor, I’m endlessly astounded by my patients’ capacity to savour their final days with a passion and intensity that can put the rest of us to shame. As time slips through their fingers, people find ways to be incandescent with life.

...

"I often ask patients: “What is the one thing you are most afraid of?” Invariably, the answer isn’t being dead per se, but the imagined horrors of the dying process. A conversation unfolds in which they learn that there are no upper limits on the doses of drugs we can give and that dying is rarely as dreadful as people fear. For the first time, they may start to feel a sense of control over their future.

"Practically speaking, planning ahead gives you the best chance of authoring how your life ends. Deborah, for example, died last week, aged 40, precisely on her terms — at her parents’ house, in the heart of her family, with domestic life quietly unspooling around her — by laying out her wishes clearly.

"Where would you like to be at the end — home, hospital or hospice? Who would you like to be with you when it happens? Sometimes patients regret being swept along by an impersonal medical machine that pushes endless rounds of gruelling treatment. Writing an advance care plan is the best way to ensure that what matters to you is placed centre stage. Appointing a legal power of attorney means that if you lose the capacity to make decisions for yourself, someone else can do so on your behalf.

"Consider asking to be referred to a palliative care team as early as possible. We can help with logistics such as finding carers, equipment, financial advice, “just in case” medications to store at home, and psychological support for adults and children."

Wednesday, June 29, 2022

Medical aid in dying in Italy--a first

 The NYT has the story:

Man Paralyzed 12 Years Ago Becomes Italy’s First Assisted Suicide  By Elisabetta Povoledo

"Paralyzed 12 years ago in a traffic accident, “Mario” faced a series of legal, bureaucratic and financial hurdles in his pursuit of death

"On Thursday, “Mario,” identified for the first time by his real name, Federico Carboni, ended his life, becoming Italy’s first legal assisted suicide, in his home in the central Italian port town of Senigallia.

"Mr. Carboni, an unmarried truck driver, was surrounded by his family, friends, and people who had helped him to achieve his goal, including officials with the Luca Coscioni Association, a right-to-die advocacy group that assisted Mr. Carboni during the past 18 months and announced his death.

...

"An Italian court ruling has declared assisted suicide permissible in Italy under certain limited circumstances, but there is no legislation enshrining the practice, which for Mr. Carboni, led to delays.

...

"In a landmark ruling in 2019, Italy’s Constitutional Court said that assisted suicide could not be considered a crime as long as certain conditions were met.

...

"The Constitutional Court ruled that in some cases assisting someone could not be considered a crime as long as the person requesting aid met certain conditions: they had to have full mental capacity and suffer from an incurable disease that caused severe and intolerable physical or psychological distress. They also had to be kept alive by life-sustaining treatments.

...

"The Roman Catholic Church is firmly opposed to assisted suicide and euthanasia, which it has called “intrinsically evil” acts “in every situation or circumstance.” 

Tuesday, June 7, 2022

What might the abortion gray market look like, post Roe?

 My favorite psychiatrist points out that, before abortions became generally legal except when the woman's life was at risk, psychiatrists were often called upon to make a decision.

The ‘Open Secret’ on Getting a Safe Abortion Before Roe v. Wade  By Sally L. Satel

"Dr. Satel is a visiting professor of psychiatry at Columbia and a senior fellow at the American Enterprise Institute."


"If the Supreme Court overturns Roe v. Wade, will psychiatrists resume their pre-Roe role as arbiters of abortion access? The law once compelled psychiatrists and pregnant women to perform dishonest rituals to get abortions. Will psychiatrists once again need to be complicit post-Roe?

"Before Roe v. Wade, a number of states allowed abortions if doctors could certify that the mother’s health, not solely her life, was at serious risk. A great number of those certifications were granted by psychiatrists, some of them by the professors who taught me as a resident in the mid-1980s in Connecticut.

"Through the 1940s and 1950s, medicine advanced to the point where health problems like heart disease and tuberculosis were generally no longer considered to be indications for therapeutic abortion. As a result, psychiatric justification became the primary rationale for therapeutic abortion before Roe.

...

"It was an “‘open secret,’” Dr. Richard A. Schwartz of the Cleveland Clinic observed in 1972, the year before Roe was decided, “that a woman can obtain a safe abortion in a licensed hospital if she can find a psychiatrist who will say she might commit suicide.

"To accommodate such women, psychiatrists used a combination of empathy and civil disobedience to declare them at risk unless they were allowed to terminate their pregnancies."

***

If the Supreme Court overturns Roe, laws about abortion will go back to the individual States. One difference from the pre-Roe environment is that there will now be probably around half of the states that will continue to allow legal (and hence safe) abortions.  So the gray market in states with abortion bans will also involve travel, for those who can afford it (and perhaps mail order pills for those well organized enough and for whom travel isn't a good option).


Monday, June 6, 2022

The return of convalescent plasma as a treatment for Covid

 As evidence accumulates, it appears that convalescent plasma helps some patients with Covid.  Here's an article from Medpage

COVID Convalescent Plasma Finds a Therapeutic Role. — Growing evidence shows benefits in the immunocompromised

by Arturo Casadevall, MD, PhD, Jeffrey P. Henderson MD, PhD, Brenda J. Grossman, MD, MPH, Michael J. Joyner, MD, Shmuel Shoham, MD, Nigel Paneth, MD, MPH, and Liise-anne Pirofski, MD June 19, 2022

"In the dark days of the early COVID-19 pandemic, when there was no known therapy, COVID-19 convalescent plasma (CCP) brought a ray of hope. COVID-19 survivors, community organizers, clinicians, regulators, and blood bankers collaborated to quickly bring CCP to patients. First used at the end of March 2020 in the U.S., 40% of all hospitalized patients were being treated with CCP by October 2020, considerable progress for a treatment without pharmaceutical industry support.

"Since those early days, CCP use has largely fallen off based on insufficient evidence of efficacy in hospitalized patients and the availability of other therapies. But growing evidence has shown benefits of CCP in a population with diminished treatment options and vaccine responses: the immunocompromised. This population encompasses about 3% of the population and their needs have been relatively neglected in treatment guidelines during the COVID-19 pandemic.

...

"As the pandemic progressed, further evidence showing that CCP was effective when used early and with high antibody content emerged, strengthening support for the FDA EUA in specific groups. However, with evidence of widespread benefit being considered insufficient in the broader patient population, CCP was largely branded as ineffective, collections dropped, and little or no CCP was available when Omicron surged in early 2022.

...

"The continued needs of immunocompromised patients and the discovery that CCP obtained from vaccinated convalescent donors possess extremely high levels of antibodies that neutralize all known variants to date, including Omicron, have promoted a CCP comeback. CCP use is now recommended for immunocompromised patients by multiple major professional organizations, including the Infectious Diseases Society of America (IDSA) and the Association for the Advancement of Blood and Biotherapies (AABB).

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Earlier:

Sunday, April 25, 2021

Wednesday, June 1, 2022

Health data and privacy, in a world of overlapping data

 Re-identifying de-identified data, by combining it with other data sets, sometimes provides a way of legally circumventing medical privacy laws such as HIPAA.  Data re-identification isn't illegal.

Here's a story from Stat:

 Top privacy researchers urge the health care industry to safeguard patient data. By Megan Molteni 

"As a STAT investigation published Monday revealed, data brokers are quietly trafficking in Americans’ health information — often without their knowledge or consent, and beyond the reach of federal health privacy laws. This market in medical records has become highly lucrative  — $13.5 billion annually —  thanks to advances in artificial intelligence that enable the slicing, dicing, and cross-referencing of that data in powerful new ways.

"But the building of these algorithms often sidelines patient privacy. And researchers who’ve been tracking these erosive effects say it’s time to reform how health data is governed and give patients back control of their information.

...

"One of the most frequent harms he and other researchers have chronicled: Patients being denied care or insurance coverage based on information payers drew from their social media activities after combining datasets to re-identify them. 

Friday, April 15, 2022

Future treatments for kidney failure

 The future treatments of kidney failure are just around the corner, where it seems they have been for a long time. So it's perhaps appropriate that this optimistic look at emerging technologies was published on April 1, but I think that's just an accident.

Beyond kidney dialysis and transplantation: what’s on the horizon? by Hamid Rabb, Kyungho Lee, and Chirag R. Parikh, J Clin Invest. 2022 Apr 1; 132(7): e159308., Published online 2022 Apr 1. doi: 10.1172/JCI159308

"There are currently over 750,000 patients with end-stage renal disease (ESRD) in the United States. Globally, 2.6 million patients receive renal replacement therapy with either dialysis or a kidney transplant, which is estimated to double in number by 2030 (1). Kidney care was revolutionized by the invention of the dialysis machine in 1943 by Willem Kolff and the subsequent development of the arteriovenous fistula in 1960 by Belding Scribner. The first successful human kidney transplantation was performed in 1954 by Joseph Murray, teaming with John Merrill, and has since become the treatment of choice for patients with ESRD. Although there have been only incremental innovations since that time, recent exciting developments in kidney research have the potential to transform treatment beyond dialysis and transplantation. Here, we highlight five emerging approaches for ESRD."

They go on to briefly discuss:

  • Wearable and bioartificial kidneys
  • Kidney-on-a-chip
  • Growing a new kidney from stem cell–derived organoids
  • Immune tolerance protocols for kidney transplants
  • Xenotransplantation

Monday, February 14, 2022

Building capacity in science

 Here's a post from Nature about some of the projects highlighted by the recent Einstein Foundation awards for promoting quality in research


Science Should Value Building Research Capacity

T
The Source
Written by Patrick S. Forscher and Moreen Terer

Science values outstanding, already-completed scientific achievements and the people who make them. This priority is illustrated in the profusion of scientific awards, such the Nobel Prize, Fields Medal, and Breakthrough Prize, that reward these accomplishments. However, science places less emphasis on efforts to promote quality within the research ecosystem itself. Nor does science typically recognize the critical capacity-building activities that are necessary to create the robust scientific ecosystems necessary to produce high quality research in the first place.


On November 21, 2021, the Einstein Foundation broke with this trend by issuing a series of awards for efforts to promote quality within the research ecosystem itself. Even more unusually, one of its award categories, the Early Career category, recognized not past achievements but rather outstanding proposed projects that showed special promise in promoting future quality. Four projects were shortlisted for this €100,000 award.

The projects that were shortlisted for the Early Career award shared something in common that may be unexpected: they are unusually focused on building a strong scientific community, especially in groups and settings that science has neglected. Take the first author’s (Patrick Forscher’s) project, for example. This project aimed to grow behavioral science in Africa by building a website, called “Lab in a Box”, to make it easy to set up a new behavioral lab in Africa, enhancing an existing database of measures with existing measures that are adapted to African languages and contexts, and stocking that database with newly translated and adapted measures. These activities are feasible due to Patrick’s position at a research center, the Busara Center for Behavioral Economics, that is both headquartered in Africa and dedicated to advancing behavioral science in the Global South. As Africa currently produces 2% of all research output (Kasprowicz et al., 2020), capacity-building activities such as the ones proposed are critical if behavioral science is to establish a robust presence in Africa.

***********

Capacity building is important in medicine as well as in science.  Here's a paper on global chains of kidney exchange, that would contribute to building surgical capacity around the world.

Global kidney chains, by Afshin Nikzad, Mohammad Akbarpour, Michael A. Rees, Alvin E. Roth, Proceedings of the National Academy of Sciences Sep 2021, 118 (36) e2106652118; DOI: 10.1073/pnas.2106652118