Chronicle Book Review: American Cartel

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

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Pulitzer Prize-winning Washington Post investigative reporters Scott Higham and Sari Horwitz have been on the opioid beat for years, teaming up (with others) on the Post's "The Opioid Files" series, which was nominated for a Pulitzer in 2020. Now, with American Cartel, the pair provide a deeply-sourced account of how opioid manufacturers, distributors, and pharmacies waged an all-out campaign to fend off DEA efforts to stanch the flow of billions of opioid pain pills, and to evade any culpability, even as the overdose death toll mounted year by year.

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.

Permission to Reprint: This article is licensed under a modified Creative Commons Attribution license.
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Second half is more like a legal thriller, covering the massive wave of civil lawsuits against pharmaceutical companies that is impressive to read.

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