Posts Tagged ‘book review of American Overdose’

Book Review: “American Overdose: The Opioid Tragedy in Three Acts”

 

 

 

 

This last year, publishers churned out books about the U.S. opioid use disorder epidemic with some regularity. I’ve already reviewed some of the more well-known, such as “Fentanyl, Inc.;” “American Pain;” Dopesick;” and “Dreamland.” Published in 2010 and far ahead of its time, “Painkiller,” by Barry Meier, had an updated second edition released in 2018. All these books are worth reading.

“American Overdose,” written by Chris McGreal, is a little different. Instead of long stories about particular people who became addicted to opioids, this author dug into the history of factors that set up this tragedy and how it evolved. He describes how prominent people and agencies that should have protected us either ignored the problem or had weak and inadequate responses.

He divided his book into three parts: “Dealing” was about the factors that contributed to the opioid epidemic and the people who tried to warn of impending problems; “Hooked” was about the failures to act after the epidemic was well underway; “Withdrawal” describes how changes finally were made to the opioid prescribing landscape, and the heroin epidemic that followed as an unintended consequence of tighter controls on prescription opioids. This section also talks about our task of trying to repair the damage done by a few decades of opioid epidemic.

The author gives the names of individual people who left their mark, for good and for bad, on the opioid epidemic. He also names specific organizations that lit the match and fanned the flames of the opioid disaster. Other people who have written or talked about the opioid epidemic have refrained from blame, saying that though people were wrong, they had good intentions and it isn’t helpful to blame. If that’s your outlook… this book probably isn’t for you. He names and blames people, often individuals who are leaders of organizations.

He specifically focused on Purdue Pharma’s drug OxyContin as the “most powerful narcotic painkiller ever released for routine prescribing.” He’s right about his claims, and prescribing data tells the story. OxyContin was heavily promoted to rural areas, and specifically to rural Appalachian areas. These places have the highest prescribing rates, the highest opioid use disorder rates, and the highest opioid overdose death rates.

I remember attending ASAM’s (American Society of Addiction Medicine) “Pain and Addiction: Common Threads” course in 2004 or 2005.  Purdue Pharma was still a major sponsor of that conference. (Later, due to the objections of ASAM’s members, drug companies were no longer allowed to sponsor whole conferences, but were allowed to have small informational booths at the conference, should attendees wish to talk to them). I remember how a physician was chided for mentioning OxyContin by name as a factor in our region’s burgeoning opioid addiction problem. He was told that people weren’t misusing only OxyContin, and that other brands like Percocet and Lortab were also involved, so we shouldn’t point the finger at one drug company.

Those of us working in the field knew bullshit when we smelled it. Maybe there were more combination oxycodone/acetaminophen pills sold, but they didn’t have the opioid firepower of an OxyContin 40mg, let alone an Oxy 80, and – for a brief time – an Oxy 160mg. From 2001 when I started at an OTP until around 2010, the drug my patients mentioned, nearly without fail, was OxyContin. I was working in rural and small-town Western North Carolina at that time: Hickory, Concord, Statesville, Gastonia, and Marion. What I saw every day did NOT match what the drug company shills were saying.

Books like McGreal’s and earlier sources have since examined the facts behind how Purdue Pharma operated, how they made misleading statements about the addiction potential for patients prescribed their drug, and how they blamed people who got addicted as causing their own troubles.

In 2007, relatively early in the epidemic, a U.S. attorney in Virginia, John Brownlee, was able with much difficulty and resistance to get Purdue to admit to felony misbranding of OxyContin. The three top executives pled guilty to misdemeanors and the company paid $600 million in a settlement.

If you think this slowed Purdue and caused them to re-think what they were doing…nope. There’s a great deal of evidence to show you would be wrong. In 2003, representatives of Purdue told Congress that they were working on an abuse-deterrent formulation of their OxyContin, but they didn’t re-formulate until 2010. The patent on OxyContin was due to expire in 2013, so re-formulating meant the new patent would last until 2030.

The Sackler family, owners of Purdue Pharma, is mentioned only briefly near the end of the book.

The book took great pains to point out how Big Pharma paid to influence decisions made by the government at all levels, and how Big Pharma sought to silence well-intentioned people who worked a government regulatory bodies about what was happening in the beginning of the epidemic.

The book spends much ink dwelling on the failings of the FDA (Food and Drug Administration). The author traces the FDAs weakening status from the days of HIV. After the FDA was criticized for its slow pace for approval of new medications, the FDA created pathways for drugs to get approved more quickly. Big Pharma took notice and took advantage. In 1992, a deal was struck between pharmaceutical companies and the FDA that said the drug companies would pay fees to fund the approval of their drugs. As time passed, the FDA became more dependent on these fees. However, the FDA continues to insist that the fees did not buy influence.

The author says that this money, combined with the money pharmaceutical companies spent lobbying members of Congress, changed the atmosphere at the FDA from that of a watch dog to that of a business partner, eager to please the drug company partners. This attitude weakened their response to the opioid epidemic.

The FDA’s response to the approval of two new opioids, Opana and Zohydro, underlined this new attitude. For Opana, the FDA agreed to let the pharmaceutical company do drug safety trials with “enriched enrollment,” which means the drug company had permission to exclude any trial subjects that appeared to develop signs of addiction or misuse from the final data presented to the FDA. This meant that the very people who might overdose and die from the drug were excluded from studies, which will skew safety data, making a drug look safer than it is. After Opana was approved by the FDA in 2006, it became popular with people who sought to crush and inject or snort the drug. More than a million prescriptions per year were written for this drug before it was ultimately taken off the market in its easily abusable form.

Injected Opana was associated with an outbreak of patients in Eastern Tennessee with a specific blood disorder called thrombotic thrombocytopenic purpura (TTP), and an outbreak of HIV infections in a small town in Indiana.

Zohydro ER sought FDA approval in 2012. This medication contained hydrocodone at up to ten times the dose found in hydrocodone pills already being sold. Like OxyContin and Opana, it could be crushed to be snorted or injected. But the drug company making Zohydro, Zogenix, promised it would watch for any sign their medication was being abused, and wouldn’t allow it to be abused like OxyContin had been. The FDA’s advisory committee wasn’t convinced and voted against approval of Zohydro. However, the FDA unexpectedly went against the recommendations of its own advisory committee and approved the drug.

The book gives a quote from a physician who was on the FDA’s advisory committee, and who was in a position to know: “…The FDA puts pharma’s interests first.”

The deeds of Doctors Acting Badly are described in detail in the book. Prescribers of pain pills, claiming they are trying to alleviate pain while “seeing” and prescribing to more than a hundred people per day, acted as essential links in the chain. Without them, the streets couldn’t have been flooded with prescription opioids. I feel the most disappointment and distain towards these providers.  I think they knew they were doing wrong but didn’t care.

Don’t get me wrong. Plenty of good doctors work at pain clinics. But those are not the ones described in this book.

The doctors in McGreal’s book did things like prescribe “more than 2 million pills to 4,000 patients in over 101 days…” (p 102). It’s impossible to give good care seeing that many patients per day. In fact, in some cases the prescriptions were pre-signed and other staff members filled them out, so patients weren’t even seen by the physician.

Many of these physicians went to jail and/or lost their medical licenses.

But these weren’t the only doctors who contributed to the opioid epidemic. There were others, experts in pain management, who fueled the opioid prescribing frenzy by touting benefits of opioids for chronic pain, though safety data was lacking at that time. Some of these physicians also had financial connections with the drug companies manufacturing prescription opioids.

These experts talked at medical conferences sponsored by drug companies. With the mantle of authority that the podium gives, they taught other medical professionals that the risk of developing opioid use disorder was negligible for patients prescribed opioids for chronic pain. Even after it was apparent these patients often did develop addiction, these experts claimed prescribers needed to maintain a balanced approach and chose patients more wisely. The “bad” patients who were prone to misuse the opioids should be separated from the “good” patients who could take them as prescribed.

I think the doctors who jumped on the crowded bandwagon to prescribe opioids for chronic pain did what they thought was right, but their thinking was clouded by the benefits they gained personally. The science wasn’t strong enough to support the claims made by the pain medicine experts and the drug companies who sometimes funded them.

The role of the Centers for Disease Control and Prevention’s (CDC) is mentioned briefly. While individual physicians collected data about opioid overdose deaths and tried to sound an alarm, weak leadership at the CDC did not encourage the FDA to act upon the science the CDC had collected. It wasn’t until 2009, when Dr. Tom Frieden took over as CDC director, that he focused national attention on our escalating opioid situation. He was perhaps the first head of a governmental agency to take the opioid epidemic seriously, and to call it an epidemic. Even though the CDC joined the fight against opioid epidemic late, at least they did begin to participate.

The book helped me understand the role of the major drug distributors in our nation’s opioid epidemic. I the past, I thought the big companies like McKesson, AmerisourceBergen, and Cardinal were merely supplying pills to pharmacies who asked for them. I wasn’t sure why they were wrong to merely supply pills where there’s a demand. But the author says the law requires that drug distributors of controlled substances must report suspicious orders of controlled substances and cease deliveries until the DEA investigates. It’s part of the job if you want to distribute potentially addicting medications.

In chapter 15, titled “A Free Pass,” I read how distributors blatantly disregarded their legal obligations to report unusual orders of opioids. As early as 2008, the big three distributors were warned they must comply with the law and were fined millions of dollars. And even after that, some of the companies continued to provide large shipments of opioids to suspicious customers with little legal repercussions.

In fact, in West Virginia, these drug distributors delivered 780 million doses of prescription opioids over a six-year period. That was enough for 433 pills for every person living in the state. And during those six years, overdose deaths rose dramatically. In the small town of Kermit, West Virginia, population of 406 in 2010, 9 million pain pills were delivered and sold over two years. That area had several well-known pill mills, shuttered long ago, and an unethical pharmacy that would fill any prescription for the right price. Looking at those kinds of numbers, the distributors had to be willfully blind instead of purely unaware.

If you want recommendations about treatment, don’t look in this book. Treatment isn’t covered in the book.

Compared to our present COVID19 pandemic, one might be tempted to dismiss the problem of the opioid use disorder epidemic. But remember this: the U.S. saw 350,000 overdose deaths from 1999 to 2016 from opioids and opioids in combination with other drugs. By 2018, around 200 people per day were dying from drug overdoses, and overdoses were the most frequent cause of death for Americans under fifty.

This is the best book around if you want to understand factors that caused the opioid epidemic and factors that allowed it to continue for so long. It’s far more comprehensive that I can describe in a review, so get a copy and read for yourself.