U.S, drug overdose deaths at 93,000 in 2020

Fentanyl infused opioids are epidemic on the street. Here's the story from the Washington Post:

Drug overdose deaths soared to a record 93,000 last year By Lenny Bernstein  and Joel Achenbach

 The death toll jumped by more than 21,000, or nearly 30 percent, from 2019, according to provisional data released by the National Center for Health Statistics, eclipsing the record set that year.

...

"The estimated number of overdose deaths reached 93,331 in 2020, according to the new data. Annual final numbers usually differ little from the provisional figures released Wednesday. More than 900,000 people have died of overdoses since the U.S. drug epidemic began about 1999, according to the Centers for Disease Control and Prevention. The National Center for Health Statistics is part of the CDC.

"Opioids, primarily illegal fentanyl, continued to drive the death toll, as they have for years. Overdose deaths involving opioids reached 69,710 in 2020, up from 50,963 in 2019, according to the data. Deaths from methamphetamine and cocaine also rose.Nora Volkow, head of the National Institute on Drug Abuse, said in an interview that fentanyl has so thoroughly infiltrated the illegal drug supply that 70 percent of cocaine overdose deaths and 50 percent of methamphetamine overdose deaths also involved fentanyl."

The art of money laundering through the art market

 What looks like privacy to some looks like secrecy to others.

The NY Times has the story:

As Money Launderers Buy Dalís, U.S. Looks at Lifting the Veil on Art Sales. Secrecy has long been part of the art market’s mystique, but now lawmakers say they fear it fosters abuses and should be addressed.  By Graham Bowley

"Billions of dollars of art changes hands every year with little or no public scrutiny. Buyers typically have no idea where the work they are purchasing is coming from. Sellers are similarly in the dark about where a work is going. And none of the purchasing requires the filing of paperwork that would allow regulators to easily track art sales or profits, a distinct difference from the way the government can review the transfer of other substantial assets, like stocks or real estate.

...

"In January, Congress extended federal anti-money laundering regulations, designed to govern the banking industry, to antiquities dealers. The legislation required the Department of the Treasury to join with other agencies to study whether the stricter regulations should be imposed on the wider art market as well. The U.S. effort follows laws recently adopted in Europe, where dealers and auction houses must now determine the identity of their clients and check the source of their wealth.

“Secrecy, anonymity and a lack of regulation create an environment ripe for laundering money and evading sanctions,” the U.S. Senate’s Permanent Subcommittee on Investigations said in a report last July in support of increased scrutiny.

"To art world veterans, who associate anonymity with discretion, tradition and class, not duplicity, this siege on secrecy is an overreaction that will damage the market. They worry about alienating customers with probing questions when they say there is scant evidence of abuse.

...

"What is the origin of such secrecy? Experts say it likely dates to the earliest days of the art market in the 15th and 16th centuries when the Guilds of St. Luke, professional trade organizations, began to regulate the production and sale of art in Europe. Until then, art was not so much sold as commissioned by aristocratic or clerical patrons. But as a merchant class expanded, so did an art market, operating from workshops and public stalls in cities like Antwerp. To thwart competitors, it made sense to conceal the identity of one’s clients so they could not be stolen, or to keep secret what they charged one customer so they could charge another client a different price, incentives to guard information that persist today.

...

"Auction catalogs say works are from “a private collection,” often nothing more. Paintings are at times brought to market by representatives of owners whose identities are unknown, even to the galleries arranging the sale, experts and officials say. Purchasers use surrogates, too. 

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Here's a related State Department report on how art sales have been used to circumvent U.S. sanctions on Russian oligarchs:

THE ART INDUSTRY AND U.S. POLICIES THAT UNDERMINE SANCTIONS.  STAFF REPORT, PERMANENT SUBCOMMITTEE ON INVESTIGATIONS, UNITED STATES SENATE

‘Harm Reduction’ Gains Federal Support.

 Another shot has been fired in the American war against drugs, this time in the battle between those who insist that drug abuse is everywhere and always a criminal problem, and those who think that even drug abusers might be entitled so some support in their personal fight against fatal overdosing.

The NY Times has the story.

Helping Drug Users Survive, Not Abstain: ‘Harm Reduction’ Gains Federal Support. By Abby Goodnough.

"Overdoses have surged during the pandemic. Now, for the first time, Congress has appropriated funds specifically for programs that distribute clean syringes and other supplies meant to protect users."

...

"Overdose deaths rose by nearly 30 percent over the 12-month period that ended in November, to more than 90,000, according to preliminary federal data released this month — suggesting 2020 blew past recent records for such deaths. The staggering increase during the pandemic has many contributing factors, including widespread job loss and eviction; diminished access to addiction treatment and medical care; and an illegal drug supply that became even more dangerous after the country essentially shut down.

...

"Now, with the nation reopening, the Biden administration is throwing support behind the contentious approach ... known as harm reduction. Instead of helping drug users achieve abstinence, the chief goal is to reduce their risk of dying or acquiring infectious diseases like H.I.V. by giving them sterile equipment, tools to check their drugs for fentanyl and other lethal substances, or even just a safe space to nap.

"Such programs have long come under attack for enabling drug use, but President Biden has made expanding harm-reduction efforts one of his drug policy priorities — the first president to do so. The American Rescue Act includes $30 million specifically for evidence-based harm reduction services, the first time Congress has appropriated funds specifically for that purpose. The funding, while modest, is a victory for the programs, both symbolically and practically, as they often run on shoestring budgets.

...

"Still, many elected officials and communities continue to resist equipping people with supplies for drug use, including the recent addition of test strips to check drugs for the presence of illicitly manufactured fentanyl, which shows up in most overdose deaths. Some also say that syringes from harm reduction programs end up littering neighborhoods or that the programs cause an increase in crime. Researchers dispute both claims.

"West Virginia just passed a law making it far more difficult for syringe service programs to operate, even though it is seeing a surge in H.I.V. cases driven by intravenous drug use. North Carolina’s legislature weighed a similar proposal this spring, and elected officials in Scott County, Ind., whose syringe exchange helped curb a major H.I.V. outbreak six years ago, voted this month to shut it down. Mike Jones, a commissioner there who voted to end the program, said at the time that he feared the syringes it distributed could be contributing to overdose deaths."

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Earlier post: 

Friday, May 14, 2021

Clean needle exchange faces renewed opposition in Indiana and elsewhere

Clean needle exchange faces renewed opposition in Indiana and elsewhere

Harm reduction measures in connection with intravenous drug abuse can remain repugnant even where they were successful.

Statnews has the story:

Years ago, a syringe exchange helped end a devastating HIV outbreak. Now it might be forced to close  By Lev Facher

"The Indiana county at the center of a devastating HIV crisis in 2015 may soon close the syringe exchange program widely credited with helping to end its outbreak.

"For public health advocates in Scott County, home to 24,000, the controversy is all too familiar. Six years ago, the county drew national attention for recording roughly 200 HIV cases in a single year, largely driven by injection drug use. Critics have charged that the state government’s slow response and monthslong refusal to permit needle exchanges only made the crisis worse.

"Closing the exchange now, they warn, could lead to a new wave of HIV and hepatitis C cases and increased drug overdoses. Nationally, too, many are worried it could trigger a broader wave of closures. Scott County’s syringe exchange was hailed as a success in 2015 and paved the way for other programs to open across the country. Many fear that shuttering the program, similarly, could inspire activists from coast to coast seeking to close syringe exchanges in their communities.

...

"The new debate in Indiana comes amid a wave of anti-syringe-exchange activism across the country, including a controversial new law in West Virginia that critics say could force many local programs there to close. West Virginia is experiencing a worst-in-the-nation HIV outbreak not unlike Indiana’s six years ago.

...

"Despite the reduced rates of transmission, Scott County is still among those most vulnerable to HIV outbreaks, according to the Centers for Disease Control and Prevention. It sits at the western edge of the country’s largest HIV hotspot: An area spanning several hundred miles that includes parts of Indiana, Kentucky, Ohio, West Virginia, Virginia, and Tennessee, where much of the HIV transmission is thought to be driven by injection drug use.

"Still, neighbors and local lawmakers there have sought to close the exchange, citing fears it encourages or facilitates drug use and crime (data shows that such programs do not). They have also charged that syringe exchanges lead to hazardous litter, like stray needles — a problem that, in some cases, harm reduction advocates have acknowledged and pledged to help address."

Can heroin be used responsibly? Is the war on drugs worse than the crime?

 The psychologist Carl Hart, who studies drug addiction, has a book in which he describes his own careful use of heroin, and suggests that pharmacology isn't fate:

Drug Use for Grown-Ups. Chasing Liberty in the Land of Fear.

The New Yorker has an article about him and the book in its latest issue.

Is There a Case for Legalizing Heroin? The addiction researcher Carl Hart argues against the distinction between hard and soft drugs.   By Benjamin Wallace-Wells

Here's a description of a drug injection clinic in Switzerland that caught my eye:

"In Geneva, he met a physician who invited him to visit a heroin-maintenance clinic with which she was affiliated. Hart spent several months there in 2015, watching heroin users behave as efficiently and functionally as the weighted gears in a watch. Patients checked in twice a day for injections, during one period that began at seven in the morning and another at five in the afternoon. In between, many of them went to work. The patients were each assigned a cubby to stash their respective belongings, and often one would leave a beer there, to drink after injection. Hart noticed that though American doctors worried endlessly over the harms of mixing booze and opioids, it didn’t seem a very big deal to the Swiss users, maybe because they knew the exact dose of heroin they were getting and could trust its purity. When one patient had to attend a wedding in less enlightened England, utterly lacking in injection clinics, she carefully planned out her doses and travel arrangements so she could make the trip. When Hart told me about the Geneva injection clinic, he spoke about it in the way that liberal parents speak about Montessori schools—as a fanatically engineered expression of trust. Of the users, Hart said, “They were always on time.”

"Shortly after visiting the clinic, Hart began regularly snorting heroin, as he recounts in a new book, “Drug Use for Grown-Ups.” 

Repugnance as paternalism: bans on flavored tobacco products

 The NY Times has the story on the recent FDA policy:

Biden Administration Plans to Propose Banning Menthol Cigarettes. The move has been long sought by public health and civil rights groups, after decades of marketing aimed at Black smokers.  By Sheila Kaplan

"The Biden administration is planning to propose a ban on menthol cigarettes, a long-sought public health goal of civil rights and anti-tobacco groups that has been beaten back by the tobacco industry for years, according to a federal health official.

"For decades, menthol cigarettes have been marketed aggressively to Black people in the United States. About 85 percent of Black smokers use menthol brands, including Newport and Kool, according to the Food and Drug Administration. Research shows menthol cigarettes are easier to become addicted to and harder to quit than plain tobacco products.

"The F.D.A. is being forced to act by a court deadline — a federal district judge in Northern California had ordered the agency to respond by April 29 to a citizens’ petition to ban menthol. But the odds are unlikely that a ban would take effect anytime soon, because any proposal is likely to wind up in a protracted court battle. The proposal would also include a ban on all mass-produced flavored cigars, including cigarillos, which have become popular with teenagers.

...

"Delmonte Jefferson, executive director of the Center for Black Health and Equity, one of the organizations behind the petition, called the decision a victory for African Americans and all people of color.

“This has been a long time coming,” said Mr. Jefferson. “We’ve been fighting this fight, since back in the 1980s. We told the industry then, we didn’t want those cigarettes in our communities.”

...

"Menthol is a substance found in mint plants, and it can also be synthesized in a lab. It creates a cooling sensation in tobacco products and masks the harshness of the smoke, making it more tolerable." 

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Here's the announcement from the Food and Drug Administration:

FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers  Efforts to ban menthol cigarettes, ban flavored cigars build on previous flavor ban and mark significant steps to reduce addiction and youth experimentation, improve quitting, and address health disparities

"April 29, 2021: Today, the U.S. Food and Drug Administration announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the leading cause of preventable death in the U.S. The FDA is working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars; the authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave the agency. This decision is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009.

“Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products. With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products,” said Acting FDA Commissioner Janet Woodcock, M.D. “Together, these actions represent powerful, science-based approaches that will have an extraordinary public health impact. Armed with strong scientific evidence, and with full support from the Administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.

...

"If implemented, the FDA’s enforcement of any ban on menthol cigarettes and all flavored cigars will only address manufacturers, distributors, wholesalers, importers and retailers. The FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product. The FDA will work to make sure that any unlawful tobacco products do not make their way onto the market.

"These actions are an important opportunity to achieve significant, meaningful public health gains and advance health equity. The FDA is working expeditiously on the two issues, and the next step will be for the agency to publish proposed rules in the Federal Register allowing an opportunity for public comment. "

Not all excess mortality during the pandemic comes from infection: overdose deaths in Cook County

 A recent paper in JAMA reminds us that not all excess mortality during the pandemic is due to infection with Covid-19:

Mason M, Arukumar P, Feinglass J. The Pandemic Stay-at-Home Order and Opioid-Involved Overdose Fatalities. JAMA. Published online April 23, 2021. doi:10.1001/jama.2021.6700

"A total of 4283 opioid overdose fatalities occurred in Cook County from January 2018-December 2020, ranging from 12 to 53 weekly (eFigure in the Supplement). There was a mean of 23.0 deaths per week during the initial 100-week period (2018-2019), with little apparent seasonal variation. During the subsequent 15 weeks beginning in December 2019, deaths increased to a mean of 35.1 per week, followed by an even more pronounced increase during the 11-week stay-at-home order: 44.1 mean weekly deaths. In the 29 weeks after the stay-at-home order was lifted mean weekly deaths sharply declined and then began to increase toward the end of the period, at 32.7 deaths. Although deaths have declined below the peak weekly numbers seen during the stay-at-home period, opioid overdose deaths following the stay-at-home period remain elevated above pre-2020 levels."

Financing drug discovery

 Bloomberg has a nice story about financial innovation in funding drug discovery startups:

Out of Grief, MIT’s Andrew Lo Invented a Better Way to Finance Biomedical Innovation.  A company he inspired, BridgeBio Pharma, is worth $9 billion and is creating cures for orphan diseases   by Peter Coy

"The main factor in the dearth of financing, Lo realized, was the lack of diversification. Let’s say a drug costs $200 million to develop and has only a 5% chance of success. If it does succeed after 10 years of development, it could earn $2 billion a year annually for 10 years. Intriguing, but too much of a lottery ticket for most investors. 

"But what if you could raise $30 billion to fund 150 startups at once? If the success of each was independent—that is, uncorrelated with the success of any other drug in the portfolio—then the chance of at least three becoming blockbusters was 98% and the chance of at least five becoming blockbusters was 87%. Those odds were so attractive, Lo realized, that even conservative fixed-income investors who like single-A-rated bonds would be willing to finance such a fund.

"Lo had been lecturing and publishing papers along these lines for several years when a former student, Neil Kumar, told him he wanted to put Lo’s ideas into practice in a company that would focus on treatments for orphan diseases caused by single-gene defects and cancers with clear genetic drivers. It was a perfect test of the concept because each rare disease was unique; their causes were uncorrelated, as in Lo’s thought experiment.

"Lo made a small investment and was listed as a co-founder of what became BridgeBio Pharma Inc. in Palo Alto, Calif. According to Bloomberg data, the company had a market value of $9.3 billion as of Feb. 4, making Kumar’s 5.6% stake worth more than $500 million. In the webinar, Lo said, “I’m most proud of the fact that they have 20 projects of which four are in Phase 3 trials.” The company anticipates approval of one by the end of 2021 and another by the end of 2022, he said, adding, “These are therapies that would not have been developed” if not for BridgeBio."

Marijuana in the House (but not yet in the Senate)

 The NY Times has the story:

House Passes Landmark Bill Decriminalizing Marijuana  By Catie Edmondson, Dec. 4, 2020

"The House passed sweeping legislation that would decriminalize marijuana and expunge nonviolent marijuana-related convictions. The measure is all but doomed in the Republican-led Senate.

"The 228-164 vote to approve the measure was bipartisan, and it was the first time either chamber of Congress had ever endorsed the legalization of cannabis. The bill would remove the drug from the Controlled Substances Act and authorize a 5 percent tax on marijuana that would fund community and small business grant programs to help those most impacted by the criminalization of marijuana.

...

"The legislation intends to give states power and incentives to enact their own reforms, and its passage came as states around the county, including some conservative-leaning ones, have become increasingly open to decriminalizing marijuana amid a growing consensus that the war on drugs has been destructive. Fifteen states have legalized recreational cannabis, and voters in five states last month voted on legalization issues, bringing the number of states where medical marijuana is legal to 35."

America's "war on drugs" appears to be winding down after this election

 Vox has the story:

Election Day was a major rejection of the war on drugs--In every state where marijuana legalization or another drug policy reform was on the ballot, it won.  By German Lopez

"In every state where a ballot measure asked Americans to reconsider the drug war, voters sided with reformers. In Arizona, Montana, New Jersey, and South Dakota, voters legalized marijuana for recreational purposes. In Mississippi and South Dakota (separate from the full legalization measure), voters legalized medical marijuana.

"In Oregon, voters decriminalized — but not legalized — all drugs, including cocaine and heroin. Also in Oregon, voters legalized the use of psilocybin, a psychedelic drug found in magic mushrooms, for supervised therapeutic uses.

"In Washington, DC, voters in effect decriminalized psychedelic plants, following the lead of several other cities.

"With its vote, Oregon became the first state in the US to decriminalize all drugs in modern times. And marijuana is now legalized in 15 states and DC, although DC still doesn’t allow sales."

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Update: and here's Kristof in the NYT:

Republicans and Democrats Agree: End the War on Drugs--Voters in red and blue states may be in accord on nothing else, but they passed measures to liberalize drug laws.  By Nicholas Kristof

"In Arizona, Mississippi, Montana, New Jersey and South Dakota, voters decisively passed measures liberalizing marijuana laws. Marijuana will now be legal for medical use in about 35 states and for recreational use in 15 states.

...

"Under the new Oregon measure, manufacturing or selling drugs will still be crimes, but possession of small amounts of heroin, cocaine or methamphetamine would be equivalent to a traffic ticket. The aim is to steer people into treatment so that they can get help with their addictions."

Drug delivery: antibiotics and vaccines

 Two recent papers discuss different issues concerning drug delivery to those in need, where the obstacles may be individual reluctance to take the drug (antibiotics) or lack of social support for the drug program (for vaccines):

Predicting and improving patient-level antibiotic adherence

Isabelle Rao, Adir Shaham, Amir Yavneh, Dor Kahana, Itai Ashlagi, Margaret L. Brandeau & Dan Yamin, Health Care Management Science (2020), 05 October 2020

Abstract: Low adherence to prescribed medications causes substantial health and economic burden. We analyzed primary data from electronic medical records of 250,000 random patients from Israel’s Maccabi Healthcare services from 2007 to 2017 to predict whether a patient will purchase a prescribed antibiotic. We developed a decision model to evaluate whether an intervention to improve purchasing adherence is warranted for the patient, considering the cost of the intervention and the cost of non-adherence. The best performing prediction model achieved an average area under the receiver operating characteristic curve (AUC) of 0.684, with 82% accuracy in detecting individuals who had less than 50% chance of purchasing a prescribed drug. Using the decision model, an adherence intervention targeted to patients whose predicted purchasing probability is below a specified threshold can increase the number of prescriptions filled while generating significant savings compared to no intervention – on the order of 6.4% savings and 4.0% more prescriptions filled for our dataset. We conclude that analysis of large-scale patient data from electronic medical records can help predict the probability that a patient will purchase a prescribed antibiotic and can provide real-time predictions to physicians, who can then counsel the patient about medication importance. More broadly, in-depth analysis of patient-level data can help shape the next generation of personalized interventions.

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Covid-19: how to prioritize worse-off populations in allocating safe and effective vaccines

Harald Schmidt, Parag Pathak, Tayfun Sönmez, and M Utku Ünver, BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m3795 (Published 05 October 2020)

"When compared with previous pandemics covid-19 is unique, not only in its substantial economic impact but in exposing the consequences of historical and ongoing structural disadvantages among minority groups,123 particularly in the US. Minorities have experienced far higher rates of unemployment, infections, hospital admissions, and deaths.23456 So, as safe and effective vaccines become likely but in limited supply, should policy makers prioritize worse-off minorities in their allocation of stocks?

"Traditional allocation focuses on maximizing overall benefits, with less regard to how these benefits are distributed among different population groups. Giving more vaccines to disadvantaged groups who are expected to live less long would generally be deemed undesirable. However, the current debate around covid-19 vaccines indicates a profound reorientation in what worse-off population groups are owed."

Opioid deaths in Canada during the pandemic, and what to do about it.

 Canada has a different political culture than the U.S., and attitudes towards drug abuse are one place in which that shows through clearly.

The Washington Post has the story--drug overdoses have risen during the pandemic:

Canada’s other health crisis: As overdoses surge, officials call on government to decriminalize illicit drugs

By Amanda Coletta

"a growing chorus, including top public health officials, the premier of British Columbia and the nation’s police chiefs, is calling on Prime Minister Justin Trudeau to decriminalize the possession of illicit drugs for personal use.

...

"British Columbia, the epicenter of the crisis, recorded its deadliest month in May — and then surpassed it in June. Nearly four times as many people in the province have died of a suspected overdose this year as have died of the coronavirus.

...

"Border closures have disrupted drug markets, making the street supply more unpredictable and toxic. Authorities have urged people to stay at home, pushing some to use drugs alone, without anyone nearby to help when dosages go wrong. Some supervised consumption sites and treatment centers have reduced operations, cutting people off from support networks.

...

"For the pandemic, officials have marshaled extraordinary financial resources and provided daily updates. Lawmakers have stood side-by-side with public health officials, largely deferring to their advice.

"But they’ve not always backed the remedies those same officials have offered to fight overdoses.

...

"“The most important thing we can do is make it okay for people to talk about their drug use and to seek assistance for it,” Henry said. “Labeling somebody a criminal is one of those major barriers that keeps people hiding and afraid and ashamed.”

... 

"That followed an extraordinary endorsement from the Canadian Association of Chiefs of Police, which said police resources would be better spent on cracking down on drug trafficking, illegal production and importation than on pursuing users.

"The chiefs said that arresting people for simple possession has been “ineffective” and that police should instead direct users to ­social services and health care, which could reduce recidivism and ancillary crimes."

The economics of antibiotics

Penicillin changed the world, it gave us a weapon against disease causing bacteria. Other antibiotics followed. But then evolution changed bacteria--natural selection in an antibiotic rich environment helped them become drug resistant.  Today, the bacteria are sometimes winning--there are some drug resistant bacteria that seem able to resist all available antibiotics. But drug discovery of antibiotics is slowing. What's going on?

Drugs (including antibiotics) are expensive to develop, test for safety and effectiveness, and bring to market.  Part of the problem is that there isn't likely to be a big market for a new super antibiotic. The reason is that, if it is oversubscribed, it will stop being super--bacteria will become resistant.  So a new super antibiotic would be used sparingly, as a drug of last resort.  That's another way of saying that it wouldn't have big sales.

The NY Times has a story:

Drug Giants Create Fund to Bolster Struggling Antibiotic Start-Ups
"New medicines are desperately needed to treat a growing number of drug-resistant infections, but many companies developing the drugs are short on cash and investments."
By Andrew Jacobs, July 9, 2020

"Twenty of the world’s largest pharmaceutical companies on Thursday announced the creation of a $1 billion fund to buoy financially strapped biotech start-ups that are developing new antibiotics to treat the mounting number of drug-resistant infections responsible for hundreds of thousands of deaths each year.

"The fund, created in partnership with the World Health Organization and financed by drug behemoths that include Roche, Merck, and Johnson & Johnson, will offer a short-term but desperately needed lifeline for some of the three dozen small antibiotic companies, many of them based in the United States, that have been struggling to draw investment amid a collapsing antibiotics industry.
...
"“Antibiotics are the mortar that holds the entire health care system together,” said David A. Ricks, the chief executive of Eli Lilly, who helped spearhead the effort. “We make drugs for diabetes, cancer and immunological conditions, but you couldn’t treat any of them without effective antibiotics.”

"In an interview, Mr. Ricks said he was well aware of the irony that Eli Lilly and many of the other companies contributing to the fund were once the giants of antibiotic development but have long since abandoned the field because of their inability to earn money on the drugs. “We know firsthand how broken the system is,” he said.

"The crisis stems from the peculiar economics and biochemical quirks of drugs that kill bacteria and fungi. The more often antimicrobial drugs are used, the more likely they are to lose their efficacy as pathogens survive and mutate. Efforts to promote antibiotic stewardship mean that new drugs are used as a last resort, limiting the ability of companies to earn back the billions of dollars it can take to create a new product.
...
"Between 1980 and 2009, the Food and Drug Administration approved 61 new antibiotics for systemic use; over the past decade that number has shrunk to 15, and a third of the companies behind those medicines have since gone belly up.  Those backing the fund acknowledge that the effort is largely a stopgap measure. Industry executives and public health experts say that fixing the broken marketplace for antibiotics would require sweeping government intervention to create financial incentives for drug companies, including policy changes that would increase reimbursements for lifesaving drugs kept under lock and key and used only when existing therapies fail."

Safe injection sites: surreptitious harm reduction, in the NEJM

When healthcare interventions must be conducted secretly, it's likely that something is very wrong with the law.

A letter in the New England Journal of Medicine brings us up to date on safe injection sites, to combat deaths from drug overdoses.

Evaluation of an Unsanctioned Safe Consumption Site in the United States

by Alex H. Kral, Ph.D., Barrot H. Lambdin, Ph.D., Lynn D. Wenger, M.S.W., M.P.H., and 

Pete J. Davidson, Ph.D.    July 8, 2020

"Nearly 70,000 people in the United States die each year from a drug overdose.1 Opioid-involved overdose deaths may be preventable by the timely administration of naloxone. Eleven countries have responded to health concerns regarding people who use drugs by opening sanctioned safe consumption sites; however, no such sites exist yet in the United States. Safe consumption sites provide a space for people to bring preobtained drugs and use them with sterile supplies under clean conditions and with safe disposal of used drug equipment. These sites provide monitoring by staff equipped and trained in the use of naloxone to reverse overdose. Most sanctioned sites can also provide related services, including voluntary screening for infectious diseases, peer counseling, wound care, and referral to other social and medical services, such as substance use treatment. 

...

"In September 2014, in response to a local opioid overdose crisis, an organization in an undisclosed U.S. city opened an unsanctioned safe consumption site. 

"Although this evaluation was limited to one city and one site that is unsanctioned, and therefore the findings cannot be generalized, our results suggest that implementing sanctioned safe consumption sites in the United States could reduce mortality from opioid-involved overdose. Sanctioning sites could allow persons to link to other medical and social services, including treatment for substance use, and facilitate rigorous evaluation of their implementation and effect on reducing problems such as public injection of drugs and improperly discarded syringes."

Intermediation in the wholesale pharmaceutical market, by Alex Chan and Kevin Schulman

Intermediaries called Pharmacy benefit managers (PBMs) play an important, but complicated role in the market for pharmaceutical drugs. Here's an article by Chan and Schulman, explaining why the role of PBM's is so opaque (quick summary: the industry is very concentrated, and is paid by both sides of the transactions that are being intermediated...)

Examining Pharmaceutical Benefits in the United States
Alex Chan,  Kevin Schulman

"...consolidation has resulted in a situation in which the 3 largest PBMs have approximately 80% market share.
...
"One of the largest criticisms of PBMs is the lack of transparency surrounding the structure and scale of payments from manufacturers to the PBM. The current PBM business model is shrouded in secrecy. Descriptions of PBM audits by payers and employers entail visits to PBM sites and examination of paper records under conditions of confidentiality, usually performed by a set of consultants that specialize in this role.5 Only the PBM knows the actual scope of payments from drug manufacturers to the PBM (for example, rebates and other payments, such as service fees). In 2016, for 13 pharmaceutical companies, payments to PBMs and other intermediaries were $100 billion, or 50% of gross sales.2 Without transparency, a PBM might develop formularies that maximize payments to the PBM rather than maximize value to patients. Anthem sued its PBM for $15 billion in 2016 for overpayments on drug pricing.6

"Finally, the issue of who is negotiating on whose behalf in drug markets remains contentious. In other words, the agency of PBMs is not clear. When PBMs depended on service fees from health plans and employers as their main source of revenue, it was clear that they served the payer (ie, the employer or the health plan). Under the rebate model, the role of the PBM has evolved to serving as an agent of both the payer and the manufacturer. In fact, as the prescription drug market has evolved, PBM profits appear to have grown with the growth of rebate dollars and manufacturer payments rather than with the growth of payer fees. It is increasingly hard to disentangle the multiple roles of the PBM and to clarify who PBMs serve as intermediaries."

Caught between a block and a high place: legal cannabis firms struggling to compete with the still thriving black market

Blocked from using federal bankruptcy protections, cannabis businesses that are legal under state laws but illegal under federal laws are facing financial difficulties.
Bloomberg has the story:

Pot Firms’ Grim Reality: Cash Crunch, No U.S. Bankruptcy Access

"It was only a year ago that exuberance enveloped the marijuana industry. Legalization was spreading and the growth potential seemed boundless.

"But that bubble has burst as the reality of a difficult regulatory landscape sunk in. Since March, stocks are down by about two-thirds. Capital markets have largely frozen for all but the strongest companies. And now a cash crunch is leaving some on the verge of going bust. Only, thanks to the illegal status of cannabis under U.S. federal laws, firms there are blocked from seeking protection in bankruptcy court."
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And this from the LA Times:
Two years in, California’s legal marijuana industry is stuck. Should voters step in?
 PATRICK MCGREEVY DEC. 24, 2019
" Two years after California began licensing pot shops, the industry remains so outmatched by the black market that a state panel recently joined some legalization supporters in calling for significant change
...
"In its annual draft report, the Cannabis Advisory Committee warned Gov. Gavin Newsom and California legislators that high taxes, overly burdensome regulations and local control issues posed debilitating obstacles to the legal marijuana market.
...
“as much as 80% of the cannabis market in California remains illicit.”
...
"The 22-member advisory panel — made up of industry leaders, civil rights activists, local officials, law enforcement and health experts — noted that California is expected to generate $3.1 billion in licensed pot sales in 2019, making it the largest market for legal cannabis in the world. But nearly three times as much — $8.7 billion — is expected to be spent on unlicensed sales."

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And in Canada (from the NYT):
From Canada’s Legal High, a Business Letdown
Investors poured money into Canada’s marijuana market, but one year after legalization, the euphoria has evaporated.

"...provincial governments in Ontario and Quebec, whose residents account for about two-thirds of Canada’s population, have opened or licensed legal pot shops at a glacial pace — despite a clear demand. Potential customers are still underserved with just 24 legal marijuana shops for Ontario’s 17.5 million residents. So many are still buying on the black market.

"And freed from taxation, the black market is generally cheaper across the country.
...
"Despite the crushing business disappointments, there has been a bright spot: Prime Minister Justin Trudeau’s experiment in legalizing cannabis has not turned Canada into a stoner nation, as was widely feared.

"Marijuana-impaired motorists are not menacing the nation’s highways, and workers are not getting high on the job. There has not even been much change in marijuana use, except for a small rise among people over 65, according to Statistics Canada, the government census agency.
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And, from the Washington Post, internationally:
America’s marijuana growers are the best in the world, but federal laws are keeping them out of global markets
Federal prohibitions are getting in the way of efforts to grow the U.S. marijuana business into a global industry. That’s allowed Canadian cannabis growers to dominate the export market.
Markian Hawryluk, Dec. 27, 2019

"Because marijuana is legal in many states but still illegal federally, marijuana growers are unable to ship their products to other countries or even other American states that have legalized the drug. So while U.S. cannabis firms have driven product innovation and mastered large-scale grow operations, they restlessly wait for the export curtain to lift.
...
"With 11 states plus Washington, D.C., approving recreational use and 33 states legalizing medical marijuana, industry insiders believe marijuana may be legalized nationally in the near future, greatly expanding their market.

"In November, the House Judiciary Committee passed a bill with more than 50 co-sponsors that would effectively make marijuana legal in the U.S. Though unlikely to pass Congress immediately, it is seen as a sign of hope for the future."

100 years since Prohibition

An op-ed in the NY Times points out that Prohibition didn't start suddenly when the 18th Amendment went into effect in January 1920--it was a popular movement that had started with ordinary legislation.

Why Americans Supported Prohibition 100 Years Ago
Temperance crusaders weren’t crackpots. They were fighting the business of making money off addiction.  By Mark Lawrence Schrad

"The United States had already been “dry” for the previous half-year thanks to the Wartime Prohibition Act. And even before that, 32 of the 48 states had already enacted their own statewide prohibitions.

“With little that differed from normal wartime prohibition drinking habits, New York City entered at 12:01 o’clock this morning into the long dry spell,” this newspaper solemnly noted.

...

"Temperance was the longest-running, most widely supported social movement in both American and global history. Its foe wasn’t the drink in the bottle or the drunk who drank it, but the drink traffic: powerful business interests — protected by a government reliant on liquor taxes — getting men addicted to booze, and then profiting handsomely by bleeding them and their families dry.

...

"For a better understanding of temperance and prohibition, forget Bible-thumping “thou shalt nots.” Think instead about a major industry making outlandish profits by getting people hooked on an addictive substance that could kill them. Maybe that industry uses some of those profits to buy corrupt political cover by currying favor with government and oversight bodies. Let’s call this substance “opioids,” and the industry, “Big Pharma.”

"This is the same type of predatory capitalism that the temperance-cum-prohibition movement fought 100 years ago. Should big businesses be able to use addiction to reap tremendous profits from the poor? If your answer is no, and you were around 100 years ago, you likely would have joined the vast majority of Americans calling for the prohibition of liquor traffic."

Black markets for drugs in Europe: report of the European Monitoring Centre for Drugs and Drug Addiction

Here is the 2019 report from the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and Europol, the EU's police organization:

EU Drug Markets Report 2019
EMCDDA, Europol, Lisbon, November 2019

Summary: The EU Drug Markets Report 2019 is the third comprehensive overview of illicit drug markets in the European Union by the EMCDDA and Europol. The analysis presented in this report spans numerous topics such as the links between drugs and other crimes, the licit economy and society more generally as well as the processes and players involved in the trade, from production and trafficking to distribution. Taking an evidence-based approach, the report reviews the markets for heroin, cocaine, cannabis, amphetamine, methamphetamine, MDMA and new psychoactive substances. It also provides action points to inform policy development at EU and national level. This publication is an essential reference for law enforcement professionals, policymakers, the academic community and indeed for anyone seeking up-to-date information and analysis on drug markets in Europe.

Here is the full report.

From the Executive Summary:

"The drug market is a major source of income for organised crime groups (OCGs) in the EU, with minimum estimated retail value of EUR 30 billion per year. In addition to the economic impact, drug-related deaths and other harms to public health, there are broader consequences of drug markets, such as links with wider criminal activities and terrorism; the negative impact on the legal economy; violence in communities; damage to the environment; and the increasingly important issue of how the drug market can fuel corruption and undermine governance.
...
" All data indicate that overall drug availability within Europe, for both natural and synthetic drugs,
remains very high. The European drug market is increasingly characterised by consumers having access to a wide variety of high-purity and high-potency products that, in real terms, are usually equivalent in price or cheaper than they have been over the past decade.
...
"Cannabis
Europe’s biggest drug market is for cannabis and significant production of the drug takes place within the EU. With around 25 million annual users, the retail market for cannabis was estimated to be worth at least EUR 11.6 billion in 2017. Around one in seven young adults in the EU reports having used cannabis in the past year, with prevalence rates generally stable but with early signs of possible  increases in some countries.
...
"Herbal cannabis is extensively produced within the EU, with estimates indicating that at least 20 000 cultivation sites are dismantled each year, and is a major source of income for the criminal economy. Despite efforts to counter production, the Western Balkans, and Albania in particular, appear to remain an important source of origin for seized herbal cannabis
...
"Heroin and other opioids
The use of heroin and other opioids still accounts for the largest share of drug-related harms. The retail value of the heroin market in 2017 was estimated to be at least EUR 7.4 billion. There are indications that heroin availability in the EU may increase: recent opium production estimates from Afghanistan, levels of seizures in Turkey and intelligence assessments of activity along the main trafficking routes to Europe are all high, and large consignments of heroin have been detected within the EU.
...
"Cocaine
The cocaine market is the second largest illicit drug market in the EU, with an estimated minimum retail value in 2017 of EUR 9.1 billion. Surveys estimate that about 4 million people in the EU will have used cocaine in the past year. Use is still concentrated in the west and south of Europe but appears to be becoming more common elsewhere.
...
"While Colombian and Italian OCGs have historically played a central role in the trafficking
and distribution of cocaine, increasingly other groups are becoming more significant, including Albanian-speaking, British, Dutch, French, Irish, Moroccan, Serbian, Spanish and Turkish OCGs. At the same time some European OCGs have established a presence in Latin American countries, developing a new ‘end-to-end’ business model for managing the supply chain, with large quantities of cocaine purchased near production areas at lower costs. This may be driving competition and conflict within the cocaine market and leading to increasing cocaine market-related violence and corruption within the EU.
...
" The global market for cocaine appears to be growing and a knock-on effect of this is that the EU appears to be increasingly used as a transit area for cocaine destined for other markets such as Australia, New Zealand, Russia, Turkey and countries in the Middle East and Asia. The cocaine market is increasingly enabled by digital technology, including darknet markets and the use of the surface web, social media and mobile phone apps to advertise and facilitate the delivery of cocaine to consumers. Innovation seen in the supply chain at the consumer level is suggestive of both high
availability and attempts by OCGs to increase market share.
...
"Synthetic drugs: amphetamine, MDMA and methamphetamine
Europe’s synthetic drugs market, particularly in respect to stimulants like amphetamine, MDMA and methamphetamine, is evolving rapidly. Within the stimulant market, these drugs compete for market share alongside cocaine and a number of new psychoactive substances. Of the two closely related stimulants, amphetamine continues to be more commonly used than methamphetamine in most EU countries, though there are growing signs of a gradual diffusion of methamphetamine use. The value of the EU retail market for amphetamines (amphetamine and methamphetamine combined) in 2017 is estimated to be at least EUR 1 billion, and for MDMA EUR 0.5 billion.
...
"New psychoactive substances
Policies relating to new psychoactive substances (NPS) appear to be having some impact, especially those aimed at reducing open trade in the EU as well as measures taken in source countries, such as China. There has been a slow-down in the number of first detections of NPS in Europe. Currently around 50 new substances are reported annually, giving a total of over 730 that have been reported to the EU Early Warning System."

Drug wars and drug addiction, black markets and homelessness, in Seattle and elsewhere

This is the third of three posts on the twin problems of trying to reduce drug addiction and to reduce large-scale incarceration as the primary response to addiction.  

In my post yesterday, among the sentences I excerpted from Nicholas Kristof's NY Times column entitled Seattle Has Figured Out How to End the War on Drugs were these: "As I see it, the problem is that while Seattle has done an outstanding job halting the war on drugs, it hasn’t done well in financing the war on addiction. It closed the law enforcement toolbox without fully opening the public health toolbox."

Following his article, lots of the online comments pointed out that drug addiction, related crime, and homelessness has remained very visible in Seattle.  Some of the letters point to a video called “Seattle is Dying”.

Which brings me back to my post on Friday, which I titled

Clean needle exchange programs may be both helpful and harmful, which briefly reported on a recent NBER paper by Analisa Packham. on the effect of syringe exchange programs (SEPs). 

She concludes "I find that SEP openings decrease HIV diagnoses by up to 18.2 percent. However, I present new evidence that SEPs increase rates of opioid-related mortality and hospitalizations"

So... the headline to Kristof's piece is overly optimistic.  Drug addiction and its collateral damage are a giant problem, that we don't now how to solve.  It seems to me (in cases like this more generally) that experimentation is in order. We have a pretty good idea about some things that haven't worked very well, and we need to find policies that work better  Persistent black markets (which have survived decades of war on drugs) make clear that criminalizing markets needn't succeed in making them go away.  Nor does simply de-criminalizing them.

I anticipate that dealing with addictive drugs will be one of the important market design issues of the next decades.

Fighting addiction in Seattle, where incarceration isn't the treatment of choice

Here's Kristof in yesterday's NY Times:

Seattle Has Figured Out How to End the War on Drugs
While other cities are jailing drug users, Seattle has found another way.

"SEATTLE — On gritty streets where heroin, fentanyl and meth stride like Death Eaters, where for decades both drugs and the war on drugs have wrecked lives, the city of Seattle is pioneering a bold approach to narcotics that should be a model for America.

"Anyone caught here with a small amount of drugs — even heroin — isn’t typically prosecuted. Instead, that person is steered toward social services to get help.

"This model is becoming the consensus preference among public health experts in the U.S. and abroad. Still, it shocks many Americans to see no criminal penalty for using drugs illegally, so it takes courage and vision to adopt this approach: a partial retreat in the war on drugs coupled with a stepped-up campaign against addiction.

"The war on drugs has been one of America’s most grievous mistakes, resulting in as many citizens with arrest records as with college diplomas. At last count, an American was arrested for drug possession every 25 seconds, yet the mass incarceration this leads to has not turned the tide on narcotics.
...
"In effect, Seattle is decriminalizing the use of hard drugs. It is relying less on the criminal justice toolbox to deal with hard drugs and more on the public health toolbox.
...
"As I see it, the problem is that while Seattle has done an outstanding job halting the war on drugs, it hasn’t done well in financing the war on addiction. It closed the law enforcement toolbox without fully opening the public health toolbox.

"Local officials found that in a world of competing budget silos, money saved from jails can’t easily be reallocated to treatment. This is so even though researchers repeatedly find that drug treatment pays for itself by saving huge amounts of taxpayer money, not to mention lives. One study found that substance abuse treatment in California paid for itself seven times over in reduced crime and other savings.