American Cartel: Inside the Battle to Bring Down the Opioid Industry, by Scott Higham and Sari Horwitz (2022, Twelve Press, 400 pp., $30.00 HB)

Phillip S. Smith, with contributions from David Borden

The picture Higham and Horwitz paint of corporate and political malfeasance is damning. But the laser sharp focus with which they paint it, omits much of the context in which the opioid crisis has unfolded. And that context is also very important.

An article in yesterday's Guardian shows one of the reasons why. In much of the world, very few pain patients are able to access opioids at all. Much suffering results, sometimes leading to suicide attempts. Dr. MR Rajagopal, chair of Pallium India, told the Guardian, "Pain is not visible. It happens in hospital beds or patients' rooms and is not visible to the world. Addiction, on the other hand, is very visible in headlines which quote the US epidemic and overdose deaths. No one talks about the western European success over decades; all the news is about the opioid crisis in the USA. This means that when we try to have discussions, our work becomes harder because many minds are primed against opioids."

In other words, by speaking too solely to one side of an issue, one risks adversely impacting the other sides. Whether "opiophobia" is real or significant in the US is another question. Higham and Horwitz don't venture a view on this, at least not in American Cartel.

One entity that has warned about opiophobia (without using the term) is the US Centers for Disease Control. In a 2019 memo, CDC writes that a 2016 guidance the agency issued on prescribing opioids for chronic pain had seen "misapplication[s]" by some physicians that put patients at risk. The memo cites a New England Journal of Medicine commentary by the authors of the 2016 guidance. It warns against "hard limits" on opioid dosages or cutting patients off; abrupt tapering of prescriptions; applying the guidance to acute pain situations patients face in situations like active treatment for cancer or sickle cell anemia or post-operative care; and applying it to medication-assisted treatment prescriptions for addiction.

Technically the CDC memo addressed a period of a few years beginning in 2016. But the dynamics it describes are inherent risks in a situation where providers are charged with supplying a substance that's useful but also addictive and potentially deadly if misused, and for which they can be sanctioned professionally or even prosecuted and imprisoned if things go wrong or someone disagrees. Pharma-driven promotion of their new opioid products was a factor in driving up prescribing rates to where they reached. But a part of the increase was also the medical community reacting to a real problem of under-treatment or non-treatment of pain for some patients, a problem that coexists with over-prescribing to some other patients. That increase in turn came with a learning curve.

The authors also give short shrift to the impact of today's woes and inequalities in driving the so-called deaths of despair -- a concept coined by Princeton professors Anne Case and Angus Deaton -- alienation and anomie, helplessness and hopelessness afflicting many Americans who have been left behind in the modern economy, especially in the opioid use heartlands of the Midwest and Appalachia. The Midwest deindustrialized beginning in the 1970s, and both regions largely missed out on the tech boom of the '90s and '00s. Then came even more pain with the Great Recession, followed by COVID and more economic and social disruption. People there (and elsewhere) are dying not just of opioids, but of smoking, drinking, and suicide. Big Pharma is easily (and oh so deservingly) demonized, but the laser focus on the companies allows us not to have to look in the mirror about the pain our society produces.

That factors like these should play a role in the opioid crisis, though, doesn't exonerate Big Pharma. Rather, the misleading promotions of their products carried out by pharma, took an even greater toll due to the vulnerabilities those other factors had brought to the fore.

Meanwhile, the death toll continues to mount -- over 100,000 per year, and with a new record high every year. Prescription opioids still figure prominently in overdoses. But the greatest part of the problem by far is black-market fentanyl, used deliberately by some high tolerance heavy users of opioids, but primariy causing overdose as an adulterant in heroin, counterfeit prescription pills, and other street drugs, essentially a poisoning crisis. But as Higham and Horwitz note, that is part of a wave of opioid use that began with pharmaceutical companies such as Purdue Pharma taking Oxycontin onto the market in the late 1990s. The first decade of this century also saw other prescription opioids -- oxycodone, hydrocodone, Vicodin, Percocet, Opana, et al. -- hit the market.

Higham and Horwitz are fond of tossing around astounding numbers of pills produced by manufacturers or sold by certain pharmacies, such as Mallinckrodt producing 3.5 billion 30 milligram hydrocodone pills in one year, and critics could protest that those numbers need context, too. A prescription for a medication doesn't just have a number of pills to take. It specifies how large a dosage there is inside each pill. A smaller number of pills that each contain a higher dose might mean more than a larger number that each contain a smaller dose. And a higher dose prescription sometimes reflects a patient's tolerance to opioids built up through past medical (or non-medical) use. Maybe West Virginia didn't really need 81 million pain pills during a five-year span. But maybe it did. Without more information, it's just not clear what these numbers mean.

They do provide some context, though, for example by comparing pain pill sales across all drug stores in a region and pointing out anomalies not easily explainable by, say, differing rates of cancer or other serious illness. And they demonstrate that plenty of businesses -- from Big Pharma to the drug store chains and individual pharmacies -- were either in it for the money or at best screwed up, both through detailed analysis and telling anecdote. For example, there was the guileless Florida pharmacist who explains to investigators that she fills pain pill prescriptions all day long, but always keeps a certain number of pills on reserve "for my real pain patients."

When the DEA cracked down first on Wild West internet sales of opioids and then on the "pill mills," medical practices with perfunctory examinations and huge numbers of opioid prescriptions whose entire business model seemed to be writing opioid prescriptions, it succeeded in reducing access to those drugs. But the people using opioids didn't stop; they went to black market drugs, fueling first a resurgence in heroin use and now an opioid crisis driven by fentanyl.

A key figure in the tale is Joe Rannazzisi, who as head of DEA's Office of Diversion Control from 2006 to 2015 oversaw the agency's endless effort to ensure that prescribed opioids are only prescribed for legitimate medical purposes and not leaking into the black market. We are inclined to think of the DEA as a prohibitionist agency, but in this case, it is acting as a regulatory agency. And what Higham and Horwitz uncover is a case of regulatory capture -- when the industry being regulated manages to set the terms under which it is regulated, for its own benefit, not that of the public.

Rannazzisi and his team of DEA lawyers spent years going after opioid manufacturers, distributors, and pharmacy chains who were repeatedly (administratively) busted for failing to do due diligence about just who was buying their products. The companies would pay huge fines, promise not to do it again, and then continue to pump massive amounts of opioids through the supply chain.

The companies mobilized against Rannazzissi and his campaign, forming industry front groups, undertaking lobbying efforts, hiring legions of high-priced law firms, and crafting legislation that would rein in what they saw as an out-of-control agency. As Higham and Horwitz document in great detail, it worked.

Sponsored by Rep. Tom Marino (R-PA) and Sen. Marsha Blackburn (R-TN), both of whom received substantial contributions from the industry, but written by industry lobbyists, the nicely named Ensuring Patient Access and Effective Drug Enforcement Act removed from the DEA tools that Ranizzisi had been using to try to force drug distributors to monitor and report suspicious orders, such as the 1.2 million oxycodone tablets one distributor bought from Mallinckrodt in one day, only to order another 1.2 million the next day.

The bill passed, only to be drastically revised amidst scandal after an earlier Post report on the opioid bill derailed then-President Trump's effort to name Marino drug czar. But Higham and Horwitz also detail rot inside the DEA, where the industry managed to get to high-ranking officials who sidelined Rannazzisi, forcing him into retirement and forcing many of his team members into bureaucratic Siberia. It's an ugly little story of money and power, the sort that is all too common in Washington.

If the first part of American Cartel reads like a detective novel, the second part is more like a legal thriller, It covers the massive wave of civil lawsuits filed against the drug companies, and it is not particularly edifying reading. You see hundreds of high-powered attorneys from the country's top litigating firms -- including dozens of former DEA attorneys working now working for the industry they regulated -- facing off against armies of lawyers for the thousands of states, cities, and counties. You see massive settlements from the companies and massive damages wrested from companies that went to court and lost. While it is unclear just how the moneys won or negotiated by the various plaintiffs is actually being used to help people who suffered from the opioid crisis, what is clear is that it has been a bonanza for the legal profession, with winnings -- excuse me, earnings -- by attorneys reaching well over a billion dollars.

They weren't all in it for the money, though. Some, like West Virginia attorney Paul Farrell, whose state was one of the epicenters of the pain pill epidemic, were sickened by the toll of addiction they saw all around them. Not willing to settle for the pittance the town and county he represented would receive under a massive settlement agreed to by most of the suing entities, he gambled on going it alone against the drug distributors. As this book went to print in April, he was still waiting for a decision. Earlier this month, he lost, with a federal judge ruling that drug distributors were not responsible for the area's opioid crisis.

The litigation goes on, and the dying goes on. Sometimes the drug companies settle, sometimes they lose and have to pay even more. But sometimes they win.

The profit-driven wave of opioids that engulfed the country in the last couple of decades is not an anomaly. The pharmaceutical companies have a historical pattern of creating and marketing drugs that later wreak havoc. That's what they did with amphetamines, that's what they did with barbiturates, that's what they did with benzodiazepines. It's almost enough to make one wonder if profit-driven capitalist enterprises should be in charge of the nation's drug supply.

Read Higham and Horwitz's book. But read Case and Deaton's too. And when you see the next "pill mill" story, don't assume that it is, or isn't, what it seems.

Rhode Island is set to become the 19th legal marijuana state, West Virginia announces a big settlement with drug manufacturers over their role in the opioid crisis, and more.

After congressional inaction, President Biden issues an executive order on criminal justice reform. (whitehouse.gov)

Georgia Voters Approve Marijuana Legalization Ballot Question. State voters sent a strong signal to lawmakers Tuesday by overwhelmingly approving a non-binding ballot question on marijuana policy. Voters were asked: "Should marijuana be legalized, taxed and regulated in the same manner as alcohol for adults 21 years of age or older, with proceeds going towards education, infrastructure and health care programs?" A whopping 80 percent of them answered "yes."

Rhode Island Legislature Approves Marijuana Legalization. Both the House and the Senate voted Tuesday to approve a marijuana legalization bill, Senate Bill 2430. Gov. Dan McKee (D) is set to sign it into law today. The law will allow people 21 and over to possess, grow, and purchase limited amounts of marijuana. It also includes expungement and social equity provisions. Once the bill is signed into law, Rhode Island will become the 19th state to free the weed. Look for our feature story on this later today.

Opiates and Opioids

West Virginia Announces Settlement with Opioid Manufacturers. State Attorney General Patrick Morrisey announced Wednesday that the state had reached a $161.5 million settlement with two drug companies over their role in the opioid epidemic. The settlement came as the trial in the state's lawsuit against Allergan and Teva was nearing its end. Morrisey touted the settlement as "record-breaking," saying it was the highest per capita settlement in the country and blasted the two companies as "helping fuel the opioid epidemic in West Virginia by engaging in strategic campaigns to deceive prescribers and misrepresent the risks and benefits of opioid painkillers."

Criminal Justice

President Biden Signs Executive Order to Advance Accountable Policing, Strengthen Public Safety. Marking the second anniversary of the killing of George Floyd at the hands of Minneapolis police, President Biden on Wednesday issued a broad-ranging executive order to advance accountable policing and enhance public safety. The move comes after Congress largely failed to act on policing reform in the wake of the killing and the mass protests it generated. Among other provisions, the order creates a new national database of police misconduct, restricts the use of no-knock search warrants, bans the use of chokeholds and carotid restraints unless deadly force is authorized, requires new standards limiting the use of force for all federal agencies, restores the Obama administration's restrictions on the transfer of military equipment to law enforcement agencies, requires an updated approach to recruitment, hiring, promotion, and retention of law enforcement officers; requires all federal law enforcement agencies to track data on use of force; directs a government-wide strategic plan to propose interventions to reform the criminal justice system; and requires full implementation of the First Step Act.

The Biden White House sent its first National Drug Control Strategy to Congress on April 21. It breaks positive new ground by explicitly acknowledging harm reduction measures to prevent overdose and blood-borne diseases among drug users. At at the same time, though, it also relies heavily on the destructive and counterproductive pursuit of failed prohibitionist drug policies -- and funds more law enforcement much more heavily than harm reduction.

"The strategy focuses on two critical drivers of the epidemic: untreated addiction and drug trafficking," the White House said. "It instructs federal agencies to prioritize actions that will save lives, get people the care they need, go after drug traffickers' profits, and make better use of data to guide all these efforts. Saving lives is our North Star, and the 2022 National Drug Control Strategy calls for immediate actions that will save lives in the short term and outlines long-term solutions to reduce drug use and its associated harms, including overdose."

While the strategy includes long-familiar categories such as drug treatment, prevention, supply reduction, and criminal justice and public safety, it also emphasizes an evidence-based approach, "building a recovery-ready nation," and for the first time, harm reduction.

"The Biden-Harris Administration's efforts focus on meeting people where they are and building trust and engagement with them to provide care and services," the White House said. "Specifically, the strategy calls for greater access to harm reduction interventions including naloxone, drug test strips, and syringe services programs. It directs federal agencies to integrate harm reduction into the US system of care to save lives and increase access to treatment. It also calls for collaboration on harm reduction between public health and public safety officials, and changes in state laws and policies to support the expansion of harm reduction efforts across the country."

The strategy calls for "the coordinated use of federal grant funds for harm reduction," and the administration last year broke new ground with a $30 million grant program for harm reduction providers. But in a sign of continued reliance on traditional law enforcement priorities, the strategy also envisions a $300 million increase for Customs and Border Patrol and another $300 million increase for the DEA. Those figures were released as part of the White House's FY 2023 budget released last month.

"Responding effectively to the illicit production, trafficking, and distribution methods of domestic criminal organizations and Transnational Criminal Organizations (TCOs) is a significant challenge and remains a Biden-Harris Administration priority," the White House said.

That kind of talk suited mainstream Democrats just fine.

"Illicit drugs cause immeasurable pain and loss in our communities. As the Chairman of the Senate Caucus on International Narcotics Control, I've pressed for an updated federal plan to tackle them," said Sen. Sheldon Whitehouse (D-RI). I've been clear that the plan must include a more coordinated approach to cracking down on drug trafficking and transnational criminal organizations, especially the ways in which they launder and protect their ill-gotten gains using US rule of law and financial networks; and more and better cooperation with our international partners to reduce the supply of precursor chemicals used to manufacture illicit drugs and to levy tougher sanctions against transnational drug syndicates. I'm pleased to see my priorities reflected in this new strategy, and I look forward to working with the Biden administration to deliver on those priorities."

Whitehouse also lauded the strategy's "tearing down barriers to treatment, including expanding access to life-saving naloxone and medication-assisted treatment; improving our data collection systems to better understand the effects of our intervention efforts."

Reform advocates offered praise -- sometimes lukewarm -- for the administration's tentative embrace of harm reduction, but blasted its reliance on tired, failed drug war paradigms.

In its analysis of the strategy, the Washington Office on Latin America (WOLA) called it "a major step forward" and lauded the administration for "focusing on ensuring access to treatment for substance use disorders and highlighting the crucial role of harm reduction services." But WOLA also noted that, "when measured against the scale of the nation's overdose problems and the urgency of the needs, Biden's new plan appears quite timid."

WOLA also warned that the strategy's "positive innovations regarding investment in treatment and harm reduction strategies risk being undermined by a continued commitment to the kinds of policies that have exacerbated the present crisis and that continue to absorb the lion's share of resources, namely, drug criminalization at home and wildly exaggerated expectations for what can be achieved through supply control efforts abroad."

Similarly, the libertarian-leaning Cato Institute called the attention to harm reduction a "positive," but noted steps that it did not take, such as making the opioid overdose reversal drug naloxone available over-the-counter and repealing the so-called Crack House Statute that stands in the way of federal approval of safe injection sites.

"On a negative note," Cato observed, "the remainder of the new report calls for doubling down on interdiction, border control, and other law enforcement measures aimed at curtailing the supply of illicit drugs -- as if repeating the same failed strategies of the past half century, only with more gusto, will somehow work."

So there it is: The Biden administration's first crack at a national drug strategy deserves kudos for its embrace of harm reduction and evidence-based approaches, but beyond that, it is pretty much more of the same old same old.

Florida's Republican establishment may not be ready for marijuana legalization but the public is, the Justice Department drops an effort to send some First Step Act releasees back to prison, and more.

Drug distributors agree to pay out big-time for their role in the opioid crisis. (Pixabay)

Florida Poll Shows Strong Support for Marijuana Legalization. A new poll from Public Policy Polling has support for marijuana legalization at 59%. Two different efforts to get an initiative before the voters last year were quashed by the state Supreme Court, and the Republican-led state legislature this year passed a bill making it more difficult to finance initiatives, which Republican Gov. Ron DeSantis signed into law. Translating public support into marijuana reform is going to be more difficult than ever now.

Opioids

Major Drug Distributors Reach Agreement on $26 Billion Opioid Settlement. The three largest US pharmaceutical drug distributors -- McKesson, Cardinal Health, and AmerisourceBergen -- and drugmaker Johnson & Johnson have reached an agreement with a group of state attorneys general to pay out $26 billion to settle lawsuits related to their roles in the widespread prescribing of prescription opioids and the subsequent wave of addiction and overdose deaths. "The numerous companies that manufactured and distributed opioids across the nation did so without regard to life or even the national crisis they were helping to fuel," said New York Attorney General Letitia James, one of the attorneys general from 15 states involved in the deal. "Today, we are holding these companies accountable and infusing tens of billions of dollars into communities across the nation." Responding to that wave of addiction and overdoses, the states and the federal government have moved to restrict opioid prescribing, even though chronic pain patients have found their access to their medications more difficult.

Sentencing

US Correctional Population Drops for 12th Straight Year. The Bureau of Justice Statistics (BJS) reports that in 2019, the number of people in the US in jail or prison or on probation or parole was 6,344,000, down 65,200, or 1%, over the previous year and marking the 12th year in a row that that figure has declined. At the end of 2019, 4,357,700 people were under community supervision (probation or parole), while there were 2,086,000 people behind bars in jails or prisons. The BJS report did not discuss the types of offenses for which people were under correctional supervision, but a 2020 Prison Policy Initiative report found 190,000 doing time for drug offenses in state prisons, 157,000 in local jails, and 78,000 in the federal prison system, meaning drug prisoners account for about one-fifth of the US incarcerated population.

Justice Department Drops Appeal of First Step Act Releases. The Justice Department has dropped an effort to re-imprison four New Jersey men who were released from prison under the First Step Act's retroactive crack cocaine sentencing provision. The men had been released in November 2019 after serving more than 20 years on crack charges, but the Trump Justice Department then sought to send them back to prison. The Biden Justice Department had been under pressure from groups such as Families Against Mandatory Minimums (FAMM), which applauded the decision, saying: "We raised this case among others with the Biden transition team as an appeal that should be dropped right away. It would have been cruel and unjust it would be to send these guys back."