It’s time for Big Pharma companies that were caught lying to the public to pay up. 

A new report compiled by ConsumerShield suggests the past decade was defined by record-high settlements and penalties in the pharmaceuticals sector, totalling over $80 billion in fines and penalties.

ConsumerShield’s report, “The Pharmaceutical Industry: Balancing Profits, Penalties, and Public Safety,” was published on Oct. 17, and it shows that the lion’s share of violations involve synthetic opioids that clearly cause dependence and are powerful enough to stop breathing.

London Loves Business reports that the study shows that since 2010, the pharmaceutical industry has incurred $82.8 billion in penalties during over 500 instances of recorded violations due to drug and medical device safety non-observance, unapproved promotion of medical products, breaches of the False Claims Act, and other violations.

The biggest culprit—Johnson & Johnson—clocked in with over 45 violation records during the study period, leading to a total of  $24.5 billion in penalties. Johnson & Johnson paid $18 billion USD in penalties over the past five years in opioid and talc cases alone. Next is Teva Pharmaceuticals with penalties of $8.5 billion, AbbVie with penalties of $7.1 billion, GSK plc with penalties of $5.6 billion, and Pfizer with penalties of $3.2 billion.

The report also lists significant settlements, with one case standing out: the Purdue Pharma case, resulting in an order to pay $8.3 billion. On Oct. 21, 2020, the Department of Justice announced a massive fine culminating its criminal and civil investigations into the opioid manufacturer Purdue Pharma, and a civil resolution of its civil investigation into individual shareholders from the Sackler family.  

Purdue and the Sacklers continued to market OxyContin and opioid products to over 100 health care providers despite the company knowing there was good reason to believe they were diverting opioids and reporting misleading information to the DEA to boost Purdue’s manufacturing quotas. 

Hundreds of thousands of people overdosed and died in the process. Nearly 88% of opioid-involved overdose deaths involved synthetic opioids, and opioids were the cause of 80,411 overdose deaths in 2021—75.4% of all drug overdose deaths, the CDC reported in 2021 when overdoses peaked. Compare that to heroin overdoses, which caused just 9,000 overdoses in 2021 unless they were mixed with opioids. Almost ten times more OD’d on synthetic opioids.

“The abuse and diversion of prescription opioids has contributed to a national tragedy of addiction and deaths, in addition to those caused by illicit street opioids,” said Deputy Attorney General Jeffrey A. Rosen.  “With criminal guilty pleas, a federal settlement of more than $8 billion, and the dissolution of a company and repurposing its assets entirely for the public’s benefit, the resolution in today’s announcement re-affirms that the Department of Justice will not relent in its multi-pronged efforts to combat the opioids crisis.”

Most of us know about the ravages of the opioid epidemic, but what’s the deal with talc? Pharmaceuticals can kill you in other ways. Talcum powder lawsuits claim consumers were diagnosed with cancer after using talc-based Johnson & Johnson baby powder.

A Solemn Warning

The ConsumerShield report kicks off with a solemn warning:

“It is with a sense of urgency and responsibility that we delve deep into the prevailing paradigms of the pharma industry,” the report reads. “Our investigation is geared towards understanding whether the soaring profits are inadvertently overshadowing the paramount need for consumer safety, ethical promotions, and pioneering research initiatives.

“The stark discrepancy between R&D investments and marketing expenditures, coupled with the persistence of unethical practices despite soaring penalties, necessitates a comprehensive examination of the industry’s commitment to ethical practices and consumer well-being.”

ConsumerShield representatives say that what the data shows is disturbing.

“The juxtaposition of soaring revenues and escalating penalties is alarming,” ConsumerShield Senior Analyst Jane Doe told London Loves Business. “But what’s even more disturbing is the obvious disparity between companies’ spending on research and development (R&D) and their enormous marketing budgets.”

The False Claims Act is the federal government’s primary litigation tool in combating fraud against the government, and part of that includes consumer protections.

“Pharmaceutical companies that have engaged in illegal off-label marketing or promotion of their drugs have paid the Government hundreds of millions of dollars as a result of Federal False Claims Act cases, often times brought by pharmaceutical sales representatives, sales managers, compliance officers, other pharmaceutical company employees, physicians, nurses and/or employees of hospitals or physician practices,” the False Claims Act Pharmaceutical Fraud summary reads.

The report shows the repercussions of marketing opioids despite receiving warnings about its enormous deadly impact, notwithstanding the people who actually need opioids to deal with high levels of pain.

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Members of the Sackler family–the wealthy owners behind Purdue Pharma and OxyContin—paid upwards of $19 million in donations to The National Academies of Sciences, Engineering and Medicine, a powerful institution that advises U.S. opioid policy, according to a bombshell report by The New York Times.

The Times outlined a series of events that pose a possible conflict of interest. Dr. Raymond Sackler, his wife, Beverly, and the couple’s foundation started donating large sums of money to the Academies in 2008, according to treasurer reports. They died in 2017 and 2019, respectively. Dame Jillian Sackler also made millions of dollars’ worth of donations to the Academies beginning in 2000. The Academies invested the funds, growing to over $31 million by the end of 2021.

The allegations continue: The Pain Care Forum, a group co-founded by Burt Rosen, the Purdue lobbyist at the time, pushed for legislation introduced in 2007 and 2009 that included plans calling for an Academies report to “increase the recognition of pain as a significant public health problem.”

If the allegations are true, they present a serious conflict of interest. So the Times called upon Michael Rehn Von Korff—a medical researcher who studies the treatment of chronic pain, among other fields, for insight on the matter.

“I didn’t know they were taking private money,” Von Korff told The New York Times. “It sounds like insanity to take money from principals of drug companies and then do reports related to opioids. I am really shocked.”

Last Prisoner Project founder Steve DeAngelo posted the report on Instagram and called the revelations “disgusting.” Medical cannabis is frequently used as an alternative to opioids for some situations.

The Role of OxyContin in the Opioid Crisis

OxyContin was developed and patented in 1996 by Purdue Pharma L.P. and was originally available in multiple doses, the U.S. Department of Justice notes. At first, it appeared that OxyContin revolutionized medicine, but then the opioid epidemic unfolded. 

According to the U.S. Department of Health & Human Services, (HHS) over 760,000 people have died since 1999 from a drug overdose, with nearly 75% of drug overdose deaths in 2020 involving an opioid. The Centers for Disease Control and Prevention reports that the number of drug overdose deaths “quintupled since 1999.”

A 2011 The National Academies of Sciences, Engineering and Medicine report claims that 100 million Americans suffered from chronic pain—one-third of the entire U.S. population—and while that’s often cited by government organizations, now that number is being challenged as preposterous. That report influenced the U.S. Food and Drug Administration to approve at least one powerful opioid, Zohydro, which is a slow release hydrocodone.

In 2016, just months after the National Academies scooped up a $10 million Sackler family donation, the F.D.A. asked the institution to form a committee to create new recommendations on opioids. But the Academies were blamed for having sketchy ties to opioid makers, including Purdue Pharma. Four people were removed from the panel after that incident.

The National Academies of Sciences, Engineering and Medicine was created by Abraham Lincoln, and U.S. laws are shaped by the data it releases. For the past few decades though, the academy was utilized to combat the American opioid crisis.

The opioid crisis is complex and it’s difficult to distinguish between people who are addicted and people who genuinely have high levels of pain. But the overdose death toll is impossible to ignore as it surpasses death toll numbers from war and sickness. In 2017, the HHS declared the opioid crisis a public health emergency.

There is also another side to the story. Megan Lowry from the National Academies told The New York Times that the Sackler donations “were never used to support any advisory activities on the use of opioids or on efforts to counter the opioid crisis,” and that they are prevented from returning the Sackler donations because of legal restrictions.

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Big pharma’s moment of reckoning for roles in the opioid crisis began to unravel recently. On November 24, 2020, opioid maker Purdue Pharma LP pleaded guilty to fraud and kickback conspiracies amid a flurry of litigation over its role in the opioid epidemic. Purdue Pharma pitched a massive bankruptcy settlement to essentially make the bulk of litigation go away.

But a federal judge tossed out OxyContin maker Purdue Pharma’s bankruptcy settlement on December 16—including thousands of individual lawsuits—because of one particular, pricey provision that would have shielded members of the Sackler family from facing lawsuits of their own.

The Rise of Opioid Drugs

The Sackler family’s company Purdue Pharma unveiled OxyContin® 25 years ago, before more powerful opioids started popping up everywhere, including on the street. Documents made public in 2020 show how Purdue Pharma actively pushed to get higher numbers of prescriptions for painkillers. This happened before America hit a “record high” of drug overdoses during the pandemic last year, crowning decades of addiction, caused largely by people who are introduced to drugs through opioids.

While a New York bankruptcy court initially approved the bankruptcy settlement, it was quickly struck down. U.S. District Judge Colleen McMahon said in a written opinion on Thursday the New York bankruptcy court that approved the settlement did not have authority to grant the Sacklers immunity from future opioid litigation.

The Sackler Family—accused of fueling the opioid epidemic through doctor perks and more—insisted on installing legal shields, or nondebtor releases, in exchange for a $4.5 billion cash payout to resolve opioid litigation. Nondebtor releases protect parties that have not filed for bankruptcy themselves.

Under the scrapped deal, members of the Sackler family would give up ownership of the company—which would continue to sell opioids—but redirect profits to “fight the opioid crisis.” Under the deal, Purdue Pharma would also develop more novel anti-addiction and anti-overdose drugs and provide them at “little or no cost.”

Per the deal, the Sackler family members would fork up $4.5 billion in cash, USA Today reports, and charitable assets as part of larger deal that could hit $10 billion, which includes the future value of the new anti-addiction drugs, if they pan out. In other words, Purdue Pharma would continue to cash out on both ends of opioid addiction. Even WebMD saw an ethical problem with Purdue making buprenorphine wafers to solve addiction caused by the same company, in a 2018 analysis.

An Appeal is in Order

Purdue said it would appeal the decision in a statement published Friday.

“While the district court decision does not affect Purdue’s rock-solid operational stability or its ability to produce its many medications safely and effectively, it will delay, and perhaps end, the ability of creditors, communities, and individuals to receive billions in value to abate the opioid crisis,” said Steve Miller, Chairman of the Purdue Pharma LP Board of Directors. “These funds are needed now more than ever as overdose rates hit record-highs, and we are confident that we can successfully appeal this decision and deliver desperately needed funds to the communities and individuals suffering in the midst of this crisis.”

The Sackler saga was even turned into a live action series, Hulu’s Dopesick—which asks hard-hitting questions such as whether or not Purdue Pharma and the Sackler family are truly responsible for their roles in the opioid crisis.

The Associated Press reports that Connecticut Attorney General William Tong, who slammed the $4.5 billion deal, called the ruling “a seismic victory for justice and accountability.” He also said the judgement will “re-open the deeply flawed Purdue bankruptcy and force the Sackler family to confront the pain and devastation they have caused.”

In 2021, the opioid crisis is worse than ever before. It’s important to keep in mind that people living in high pain still need access to opioids, and often get confused with addicts.

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Last week, NPR TV critic and adjunct professor at Duke University Eric Deggans hosted a Twitter Spaces discussion on Hulu’s Dopesick—asking hard questions such as whether or not Purdue Pharma and the Sackler family are responsible for their roles in the opioid crisis.

The Sackler family’s private company Purdue Pharma introduced OxyContin® in 1996—ushering a new era of powerful painkillers. Documents made public last year show how Purdue Pharma actively pushed for more prescriptions of painkillers.

Has the opioid crisis improved? Absolutely not. The U.S. Centers for Disease Control and Prevention reported a “record high” of drug overdoses in the 12-month period ending in March 2021—overwhelmingly led by opioids. It’s a complex problem, as opioid restrictions due to the crisis also prevent people with actual pain from receiving their meds.

The limited series on Hulu was created by Danny Strong and stars Michael Keaton, Rosario Dawson, Peter Sarsgaard and William Jack Poulter. Keaton stars as Dr. Samuel Finnix, who caught in the middle of a crisis between drug manufacturers and patients. The limited series is inspired by the New York Times bestseller Dopesick: Dealers, Doctors and the Drug Company that Addicted America, written by author Beth Macy.

Macy’s book and the corresponding Hulu series tackle the opioid crisis with a specific focus on Purdue Pharma. The first three episodes of the eight-episode series were released on October 13, 2021, and the latest episode aired Wednesday.

Who’s to Blame for the Opioid Crisis?

The New Yorker tore into the Sackler family’s reputation in 2017—calling the Sacklers “the family that built an empire of pain,” adding that through their “ruthless” marketing of painkillers, millions have died.

In recent years, there has been a massive reckoning. Last year, the Department of Justice announced that Purdue Pharma agreed to plead guilty in federal court in New Jersey to a three-count felony, reaching a whopping $8 billion settlement. 

“The abuse and diversion of prescription opioids has contributed to a national tragedy of addiction and deaths, in addition to those caused by illicit street opioids,” said Deputy Attorney General Jeffrey A. Rosen. “With criminal guilty pleas, a federal settlement of more than $8 billion, and the dissolution of a company and repurposing its assets entirely for the public’s benefit, the resolution in today’s announcement re-affirms that the Department of Justice will not relent in its multi-pronged efforts to combat the opioids crisis.”

The Sacklers themselves were ordered to pay $4.5 billion, but were able to absolve themselves from some of the allegations. Judge Robert Drain, of the U.S. Bankruptcy Court in White Plains, New York called the results bittersweet, because so much of the Sackler’s fortune was diverted to offshore banking accounts.

Then earlier this year, Johnson & Johnson and the “big three” distributors—McKesson, AmerisourceBergen and Cardinal Health—agreed to pay a total sum of $26 billion for their roles in the opioid crisis.

The flux of opioids, eventually leading to fentanyl and other painkillers can be traced to Purdue Pharma’s brand of oxycodone. 

Cast as the Villain

At first glance, there doesn’t seem to be much accountability on the end of Big Pharma juggernauts like the Sacklers. “Abusers [of OxyContin] aren’t victims,” Richard Sackler wrote in a 2001 email. “They are the victimizers.”

But Deggans’ discussion asked whether or not the Sacklers should be cast as villains, given the complexity of the situation. He was joined in the Twitter Spaces discussion with NPR addiction correspondent Brian Mann, Dopesick author Beth Macy, Dopesick series creator Danny Strong and others.

“There’s so much we need to do, and a lot of it falls right under the umbrella… of unraveling the War on Drugs,” Macy said. “We [should] start treating people less like criminals, stop hammering abusers like Richard Sackler told us to do, and start treating these folks as people with a genuine medical condition, which is what they are.”

In Hulu’s series, Richard Sackler and his family are portrayed as the main villains, however the series does mix up some fact with fiction. Deggans contends that reality is a bit more complex, and that the opioid crisis cannot be analyzed in black and white.

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