Interview in the Brazil Journal

 I was interviewed for the Brazil Journal by Giuliano Guandalini. The interview was conducted in English, but appears in Portuguese. We discussed controversial markets generally, including kidney exchange, which is not legal yet in Brazil.

Troca de rins. Drogas. Barriga de aluguel. Este Nobel sugere liberar tudo  (Kidney exchange. Drugs. Surrogacy...)

 Here's a snippet that comes through pretty clearly in retranslation back into English by Google Translate:

"In the US and many other countries, his work and that of other researchers has contributed to improving the waiting list for kidney transplants. In Brazil, we continue with the traditional system, with a long wait for donors. Why is it so difficult to make reforms of this kind in public services based on the teachings of modern economics?  

"A transplant always depends on an organ donation, whether from a dead person or a living individual. It is natural that family members and society in general are concerned about how this will be done in an ethical and careful manner. 

"Brazil does a lot of transplants. So there is no restriction on the medical capacity side so that more transplants can be done. But when we look at total kidney transplants in relation to population size, the number is not that big. 

"Meanwhile, there are thousands of people on dialysis because transplants have not been enough. The issue, therefore, is to allow more donations to occur in life, and changing kidneys is a way for people to help save someone they love. 

"Brazil may be one of the next countries to carry out the exchange of kidneys. Some experimental surgeries have already been performed, with legal authorization. Researchers will be able to gain support to perform more operations of this type and then, perhaps, society will be able to convince itself of the importance of changing kidneys. 

"What are the obstacles that prevent the adoption of organ exchange? Are they ethical, moral, religious issues? 

"A little bit of all those things. There are those concerned that poor and vulnerable people may have their organs stolen. Evidently, there must be complete assurance that this will not happen. But of course the poor would also like to save the lives of loved ones by giving them a kidney. "

Drug Overdose Deaths Topped 100,000 Again in 2022

 

The WSJ has the story: the headline speaks for itself  

Drug Overdose Deaths Topped 100,000 Again in 2022 https://www.wsj.com/articles/drug-overdose-deaths-topped-100-000-again-in-2022-37cd1709

Supervised drug use sites to be banned in Pennsylvania

 Statnews has the story:

Pennsylvania set to ban supervised drug use sites, in setback for harm reduction  By Lev Facher

"Pennsylvania lawmakers are set to pass a new ban on supervised drug consumption, effectively ending a Philadelphia nonprofit’s long-running effort to offer a sanctioned substance-use site meant to prevent overdose and death.

"A bill outlawing sites that “knowingly” provide a space for drug consumption passed a committee vote by a wide margin on Tuesday. It now advances to the full state senate, where it is also expected to pass. Gov. Josh Shapiro, a Democrat, has expressed strong opposition to supervised injection sites in the past, and is expected to sign the legislation.

...

"While the Biden administration has expressed unprecedented support for harm reduction, many Americans remain hostile to the approach.

"Some harm-reduction tools, like syringe exchanges and fentanyl test strips, have gained a degree of acceptance, but supervised consumption is still largely taboo. Pennsylvania advocates had high hopes for a planned site in Philadelphia, however, and say the legislation would deal a demoralizing blow to local efforts to avert overdoses and save lives.

...

"Offering medical supervision as people consume drugs that can cause overdose, like heroin and fentanyl, is among the most controversial tactics employed to prevent overdoses. But in recent years, as U.S. drug deaths have surpassed 100,000 annually, the strategy has gained support among some public health advocates. While critics argue that supervised injection condones drug use, studies from cities including Vancouver and Barcelona show that offering the service can lead to a marked reduction in overdose deaths.

...

"Currently, only a few supervised consumption sites are in operation around the U.S. — and none have formally received the federal government’s blessing. Most notably, the nonprofit OnPoint NYC opened two supervised consumption sites in Manhattan late last year. Rhode Island has legalized supervised consumption sites as well, though it’s unclear when a planned site in Providence will open. "

New York doesn't ban Menthol cigarettes, amid controversy

 The NYT has the stories, first about the proposed ban, and then about the budget compromise that defeated it:

Black Smokers at Center of New York Fight to Ban Menthol Cigarettes. A proposal to make New York the third state to ban menthol cigarettes has created a furious and expensive lobbying war, and has divided Black leaders. By Luis Ferré-Sadurní

"A push by Gov. Kathy Hochul to ban menthol-flavored cigarettes in New York has become the focal point of a fierce and expensive lobbying fight, pitting Big Tobacco against the medical community.

"Caught in the middle are Black smokers, who smoke menthol cigarettes at higher rates than white smokers, and are the main group the ban is meant to help. Decades of aggressive marketing by tobacco companies have caused Black smokers to consume menthol cigarettes, whose cooling sensation on the throat makes them more appealing and addictive.

...

 "Well intentioned as the ban may be, it has angered some Black leaders, including a group of ministers who have rallied against Ms. Hochul’s proposal because they worry it could increase encounters between Black people and the police if menthol cigarettes were to go underground and authorities crack down on sellers.

"Other Black opponents of the ban suggest it may be discriminatory, a heavy-handed crackdown on the preferred nicotine fix of Black smokers, even if African American men have the highest rates of lung cancer, according to the Centers for Disease Control and Prevention. 

...

"Although lawmakers have signaled their support for the tax increase, the menthol ban’s prospects are far less certain, according to four officials familiar with the negotiations.

The issue has divided Black lawmakers, leaving the measure hanging by a thread in the State Capitol "and potentially forcing Ms. Hochul to weigh how much political capital she should expend on the ban, as opposed to other policy priorities."

********

And here's a story saying that the governor abandoned the proposed ban in a set of budget compromises:

New York Would Change Minimum Wage and Bail in $229 Billion Budget Deal. After weeks of dissension, leaders in Albany reached a handshake agreement on a budget that saw Gov. Kathy Hochul fall short on some of her key objectives. By Luis Ferré-Sadurní and Grace Ashford

"Lawmakers managed to knock down other divisive ideas, including ... a ban on the sale of menthol cigarettes that was opposed by Big Tobacco and had divided Black leaders. Lawmakers did agree, however, to raise taxes on cigarettes to $5.35 a pack, up from $4.35."

**********

All posts so far on menthol

Kidney transplants from donors who died from illegal drug use

 There was a time when the modal deceased kidney donor had suffered a head injury in an auto accident, but that time is long gone, due to increased auto safety and to the rise in drug overdose deaths.  Those latter deaths now constitute a large proportion of deceased donors, and here's a report from Canada confirming that those kidneys work well in their new owners.

Xie, Max Wenheng, Sean Patrick Kennan, Amanda Slaunwhite, and Caren Rose. "Observational Study Examining Kidney Transplantation Outcomes Following Donation From Individuals That Died of Drug Toxicity in British Columbia, Canada." Canadian Journal of Kidney Health and Disease 10 (2023): 20543581231156853.

"Abstract:

"Background: The illicit drug toxicity (overdose) crisis has worsened across Canada, between 2016 and 2021 more than 28 000 individuals have died of drug toxicity. Organ donation from persons who experience drug toxicity death has increased in recent years. 

"Objective: This study examines whether graft loss after kidney transplantation differed by donor cause of death. 

Design: Retrospective cohort. 

"Setting: Provincial transplant program of British Columbia, Canada. 

"Patients: Transplant recipients who received kidney transplantation from deceased donors aged 12 to 70 years between 2013 and 2019 (N = 1012). 

"Measurements: Transplant recipient all cause graft loss (graft loss due to any cause including death) was compared by donor cause of death from drug toxicity or other. 

"Methods: Five-year Kaplan-Meier estimates of all-cause graft survival, and 3-year complete as well as stratified inverse probability of treatment weighted Cox proportional hazards models were conducted. 

"Results: Drug toxicity death donors donated to 25% (252/1012) of kidney transplantations. Drug toxicity death donors were more likely to be young, white, males, with fewer comorbidities such as diabetes or hypertension but were more likely to have a terminal serum creatinine ≥1.5 mg/dL or be hepatitis C virus (HCV) positive. Unadjusted 5-year estimate of all cause graft survival was 97% for recipients of drug toxicity donor kidneys and 83% for recipients of non-drug toxicity donor kidneys (P < .001). Recipients of drug toxicity death donor kidneys had decreased risk of all cause graft loss compared to recipients of non-drug toxicity death donor kidneys (hazard ratio [HR]: 0.30, 95% confidence interval [CI]: 0.12-0.77, P = .012). This is primarily due to the reduced risk of all-cause graft loss for recipients of younger (≤35 years) drug toxicity death donor kidneys (HR: 0.05, 95% CI: 0.00-0.55, P = .015). 

"Limitations: Potential selection bias, potential unmeasured confounding. 

"Conclusions: Donation after drug toxicity death is safe and should be considered more broadly to increase deceased donor kidney donation."

...

"illicit drug toxicity remains the leading unnatural cause of death in BC accounting for more deaths than homicides, suicides, and motor vehicle incidents combined.

...

"The United States is also undergoing an opioid epidemic which began earlier than Canada and has recorded similar increases in organ donation from individuals that died of illicit drug toxicity.9-11 Studies in the United States have found that recipient survival after kidney transplantation from individuals who died from drug toxicity was similar for recipients of kidneys from donors that died of any other cause of death."

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."

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

Colorado legalizes magic mushroom/psilocybin therapies

Harm reduction at work in NYC's opioid crisis

 The NY Times follows some harm reduction workers through their work in New York City, including a city-sponsored safe injection facility.  Not so easy to do, and not so easy to read.

One Year Inside a Radical New Approach to America’s Overdose Crisis. By Jeneen Interlandi

"Since its official opening on Nov. 30, 2021, OnPoint has met with both praise and protest. Shopkeepers and school principals routinely thank Mr. Jones and his colleagues for their daily rounds of needle collection. But local civic groups have been furious about yet another substance abuse program in a neighborhood dense with them and have argued that, however well intentioned, the organization’s approach will only make a bad problem worse. People who are addicted to drugs need tough love and harsh consequences, they insist, not coddling. Community outreach’s mission was therefore twofold: Convince skeptics that programs like these can be a net positive for the community and persuade those with substance use disorders to accept the lifeline that OnPoint was offering."

Incarceration isn't always the best treatment for drug addiction

 Here's a NY Times editorial:

America Has Lost the War on Drugs. Here’s What Needs to Happen Next.  Feb. 22, 2023

It begins with this bit of history, and ends with a call for evidence-based solutions:

"For a forgotten moment, at the very start of the United States’ half-century long war on drugs, public health was the weapon of choice. In the 1970s, when soldiers returning from Vietnam were grappling with heroin addiction, the nation’s first drug czar — appointed by President Richard Nixon — developed a national system of clinics that offered not only methadone but also counseling, 12-step programs and social services. Roughly 70 percent of the nation’s drug control budget was devoted to this initiative; only the remaining 30 percent went to law enforcement.

"The moment was short-lived, of course. Mired in controversy and wanting to appear tough on crime, Nixon tacked right just months before resigning from office, and nearly every president after him — from Reagan to Clinton to Bush — followed the course he set. Before long, the funding ratio between public health and criminal justice measures flipped. Police and prison budgets soared, and anything related to health, medicine or social services was left to dangle by its own shoestring.

...

"Study the solutions. Leading public health agencies, including the Food and Drug Administration and the Centers for Disease Control and Prevention, failed to prevent or even adequately respond to the opioid epidemic that has engulfed the nation. But health officials can still step up. As opioid settlement funds are deployed (along with federal dollars) and harm reduction programs are begun, the C.D.C. especially should impartially study what is working and what is not. The response to this crisis should finally be based on evidence.

"The nation’s leaders are not the only ones with work to do. To fully replace the war on drugs with something more humane or more effective, the public will have to come to terms with the prejudices that war helped instill. That means accepting that people who use drugs are still members of our communities and are still worthy of compassion and care. It also means acknowledging the needs and wishes of people who don’t use drugs, including streets free of syringe litter and neighborhoods free of drug-related crime. These goals are not mutually exclusive. In fact, they go hand in hand. But to make them a reality, lawmakers and other officials will have to lead the way."

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:

Monday, February 22, 2021

Ethical Payment in Human Infection Challenge Studies in the American Journal of Bioethics

Monday, March 1, 2021

Compensating challenge vaccine trial participants: further discussion in the American Journal of Bioethics

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, November 1, 2020

What do we know about the effects of payments to participants in challenge trials for vaccines, and other public spirited activities?

Canada experiments with decriminalization of opioids and other drugs in British Columbia

 From the CBC:

What you need to know about the decriminalization of possessing illicit drugs in B.C.  B.C. granted exemption by federal government in November 2022; pilot will run until 2026  by Akshay Kulkarni ·

"it is no longer a criminal offence to possess small amounts of certain illicit drugs in B.C. for people aged 18 or above.

"It's part of a three-year pilot by the federal government, which granted B.C. an exemption from the Controlled Drugs and Substances Act (CDSA) on May 31, 2022. 

...

"Under the exemption, up to 2.5 grams of the following four drug types can be legally possessed:

"Cocaine (crack and powder). Methamphetamine. MDMA. Opioids (including heroin, fentanyl and morphine).

"Fentanyl and its analogues were detected in nearly 86 per cent of drug toxicity deaths from 2019 until 2022, according to the latest report from the B.C. Coroners Service."

The trade in guns and drugs on the Mexico-US border

 It's well known that a lot of illegal drugs enter the U.S. over the border with Mexico.  Less well known in the U.S. is that a lot of guns cross illegally into Mexico over that border, destined for Mexican drug cartels.  

Here's a story from the Guardian:
How Texas’s gun laws allow Mexican cartels to arm themselves to the teeth by Sam Garcia.

"Despite Mexico’s well-documented high levels of violence, legally purchasing guns there is actually quite difficult. The nation of nearly 130 million people has a single store that can legally sell guns.

...

"Mexican foreign affairs ministry legal adviser Alejandro Celorio Alcántara estimates that half a million guns annually are purchased legally in the US and then brought into Mexico illegally. About 70% of guns seized in Mexico from 2014 to 2018 and submitted for tracing had originally come from the US, according to officials with the American bureau of alcohol, tobacco, firearms and explosives (ATF).

*******

Here's another report:

Dribs and Drabs: The Mechanics of Small Arms Trafficking from the United States

"Robust arms export licensing regimes are necessary but not sufficient for stopping small arms trafficking. Many of the traffickers studied did not apply for arms export licences or attempt to exploit licensing exemptions; they simply bypassed the licensing system entirely. At the same time, recent examples of attempted and successful diversion of authorized small arms exports highlight the continued need for rigorous licensing and post-shipment end-use monitoring.

"Arms trafficking from the United States goes well beyond gun-running to Mexico. Traffickers in the 159 cases studied shipped weapons, parts, ammunition, and accessories to at least 46 countries and foreign territories on six continents. Intended recipients of these items range from Honduran farm workers to a Finnish motorcycle gang 

"The illicit trade in parts and accessories for small arms is more significant than commonly assumed. Networks that traffic in firearms parts are among the most prolific and geographically expansive of the smuggling operations studied"

HT: Sarah Hirsch

Post Roe (post Dobbs) legal efforts to secure rights established in previous Court decisions

 Since the Supreme Court ruling in Dobbs that overturned Roe and said that abortion was subject to regulation by each State, and not an individual right, there have been attempts in Washington to moderate some of its potential effects, particularly in light of Justice Thomas' opinion that the ruling could lead the way to rolling back other rights established by previous court rulings.

There have been some successes and some failures.

Here's a story from the Guardian about some new regulations and interpretations.

The US government just took two big steps on abortion. Will they matter? While the decisions cannot undo abortion bans in the 13 states they exist, it could make a huge difference where the right is protected  by Poppy Noor

"This week, the federal government announced two decisions designed to improve abortion access in the US. The first, a rule change made by the Food and Drug Administration, allows pharmacies to dispense mifepristone, one of the two drugs needed for a medication abortion. The second, an opinion drafted by the justice department, gives the US Postal Service the all clear to continue mailing abortion pills, even to states where abortion is severely restricted.

South Carolina supreme court rules six-week abortion ban unconstitutional

Read more

...

These decisions cannot undo abortion bans in the 13 states where they exist. While major pharmacies such as Walgreens and CVS have announced they will seek certification to dispense mifepristone, a prescription for it still will not be legal in states with a ban. Anyone distributing or taking abortion pills in banned states could still face severe consequences. And the justice department opinion will not protect anyone sending pills to a banned state from being prosecuted in that state, or anyone who takes the pills knowingly to induce an abortion from being investigated.

But in states where abortion is protected, both moves could make a big difference, advocates say.

Take California as an example, which recently expanded access for abortion care in its state constitution. Until now, abortion pills had to be dispensed by a doctor, an abortion clinic, or a mail order pharmacy. But even in California, many people live hundreds of miles away from an abortion clinic.

...

"It is unclear whether the FDA ruling will see pharmacies dispensing mifepristone in states with limits on abortion that fall short of total bans."

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

One of the concerns is that some states may declare fetuses to be persons, in a way that would extend their abortion bans to also include forms of assisted reproductive technology such as IVF, which create embryos to allow infertile couples start families.  An effort to protect IVF was introduced just before the close of the previous Congress, but it wasn't made into law, and the new Congress is likely to be less sympathetic.

Right to Build Families Act of 2022 (proposed by Senator Tammy Duckworth, but not enacted)

"A BILL To prohibit the limitation of access to assisted reproductive technology, and all medically necessary care surrounding such technology."

*********

Earlier:

Wednesday, December 14, 2022

Biden Signs Bill to Protect Same-Sex Marriage Rights

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

Opioid prescription reductions and suicides

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.”

California referendum bans flavored tobacco

More midterm election news on controversial markets and repugnant transactions:

California bans flavored tobacco products, including vapes, by Nicholas Florko at Statnews

 "On Tuesday, Californians overwhelmingly voted to ban all flavored tobacco products in the state.

"The move makes California by far the largest state to ban such products, which are already illegal in a smattering of smaller states, including Rhode Island, New Jersey, and Massachusetts.

"Regulators have targeted flavored products in particular because they are overwhelmingly preferred by young people. More than 84% of young people who vape reported using flavored products, according to recently released survey data by the Centers for Disease Control and Prevention.

"California’s ban would also outlaw menthol cigarettes, which federal regulators have proposed banning nationwide because they argue such products are easier to start and harder to quit. Survey data also show that menthol cigarettes are overwhelmingly preferred by Black smokers."

***********

Here's a recent (massive) report on the marketing efforts that went into making menthol flavoring popular (suggesting that we can soon expect to see menthol substitutes):

Advertising Created & Continues to Drive the Menthol Tobacco Market: Methods Used by the Industry to Target Youth, Women, & Black Americans. Jackler RK, Ramamurthi D, Willett J, Chau C, Muoneke M, Zeng A, Chang M, Chang E, Bahk JR, Ramakrishnan A. SRITA Research Paper 

Full Report: high-resolution PDF link (1.62Gb) / low-resolution PDF link (46.4Mb)
Executive Summary: high-resolution PDF link (6.2Mb)

Colorado legalizes magic mushroom/psilocybin therapies

 Denver is the mile high city, and the 2022 midterm elections have now legalized therapy with magic mushrooms/psilocybin, which has medical uses in treating post-traumatic stress disorder, among other things.

Colorado becomes second state with legalized ‘medicinal psychedelics’ by Olivia Goldhill in Statnews

"Colorado is the second state to legalize psychedelics, following Oregon’s 2020 passage of a similar ballot question. Like Oregon, Colorado plans to create licensed “healing centers” where people can take magic mushrooms under supervision.

“This is a truly historic moment. Colorado voters saw the benefit of regulated access to natural medicines, including psilocybin, so people with PTSD, terminal illness, depression, anxiety and other mental health issues can heal,” Kevin Matthews and Veronica Lightning Horse Perez, leaders of Natural Medicine Colorado, which campaigned for the measure, wrote in a statement emailed to STAT.

...

"The most advanced study for psilocybin, a Phase 2b trial on the drug for treatment-resistant depression published earlier this month, found the drug was effective at inducing remission in many patients, but the results were less striking than in earlier studies."

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And from Time Magazine:

Colorado Voted to Decriminalize Psilocybin and Other Psychedelics,  by Tara Law

"Colorado voters have approved the broadest psychedelic legalization in the U.S., which would decriminalize five psychedelic substances and enable adults to receive psychedelics at licensed centers.

...

"The ballot measure decriminalizes the possession of certain psychedelic drugs for personal use in the state and specifically legalize psilocybin, the psychedelic component of magic mushrooms, for use at licensed facilities starting in 2024. (In those ways, it’s similar to 2020 measures approved in Oregon, which decriminalized possession of small amounts of drugs in 2021 and is launching a psilocybin access program in 2023.)

"However, Colorado’s Proposition 122 goes further in several ways. In addition to decriminalizing possession, it decriminalizes the growing and sharing of five psychedelics for personal use: psilocybin, psilocyn (a psychedelic also found in magic mushrooms), dimethyltryptamine (commonly known as DMT, which is found in plants and animals, including certain tree frogs), ibogaine (derived from the bark of an African shrub), and mescaline (which is primarily found in cacti; however, Prop 122 excludes peyote). It also clears a pathway for the use of all these psychedelics at “healing centers”—facilities licensed by the state’s Department of Regulatory Agencies where the public can buy, consume, and take psychedelics under supervision. The regulated access program would initially be limited to psilocybin, which would launch in late 2024, but if recommended by a Natural Medicine Advisory Board appointed by the governor, it could be expanded to include DMT, ibogaine, and mescaline in 2026."

Marijuana legalization advances in the 2022 elections

Time Magazine published this map under the headline "Why Marijuana Had a Terrible Night in the 2022 Midterm Elections"

It doesn't look so terrible to me, so much as increasingly inevitable. The grey states on the map (where marijuana remains entirely illegal) are shrinking steadily: it doesn't appear that opponents will succeed in making America grey again.

 "Nineteen states and the District of Columbia allow recreational use of marijuana; 13 states outlaw it entirely. The rest of the states—including Arkansas, South Dakota and North Dakota—allow its use for medicinal purposes. It remains illegal under federal law."

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It's going to become increasingly hard for States to enforce draconian laws against something that is legal in neighboring states.  That doesn't mean that legalization is always going to go smoothly--the end of Prohibition didn't end alcoholism, and the end of marijuana prohibition won't make marijuana chemically safer (in fact competition will develop strains that are chemically more potent).  But removing legal risks from what would otherwise be uncontrolled black markets, and taking them out of the hands of criminals, still seems to have momentum.

Decriminalizing drugs at the head of the supply chain--Colombia

 The criminalization of drugs has different consequences on different parts of the supply chain. Here's a harm reduction proposal from Columbia--the Washington Post has the story.

Colombia, largest cocaine supplier to U.S., considers decriminalizing. By Samantha Schmidt and Diana Durán 

"It’s the largest producer of cocaine in the world, the source of more than 90 percent of the drug seized in the United States. It’s home to the largest Drug Enforcement Administration office overseas. And for decades, it’s been a key partner in Washington’s never-ending “war on drugs.”

"Now, Colombia is calling for an end to that war. It wants instead to lead a global experiment: decriminalizing cocaine.

"Two weeks after taking office, the country’s first leftist government is proposing an end to “prohibition” and the start of a government-regulated cocaine market. Through legislation and alliances with other leftist governments in the region, officials in this South American nation hope to turn their country into a laboratory for drug decriminalization.

“It is time for a new international convention that accepts that the war on drugs has failed,” President Gustavo Petro said in his inaugural address this month."

Pharmacy Benefit Managers--Alex Chan on NPR's Planet Money podcast

 Alex Chan is interviewed on the role of pharmacy benefit managers, their role in drug pricing, and some problems with the market design.