Tag: OxyContin

12/26/23

The Sackler Cartel Goes Before the Supreme Court

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The Sackler family’s legal maneuverings to avoid financial consequences from their privately-owned company, Purdue Pharma, just had another development. In August of 2023 the U.S. Supreme Court temporarily blocked the bankruptcy deal for Purdue Pharma that would have shielded members of the Sackler family from additional lawsuits and cap the Sacklers’ personal liability at $6 billion. This was in response to a Justice Department objection that said the settlement would allow the Sackler family to take advantage of legal protections meant for debtors in financial distress, while the Sackler family is reportedly worth $11 billion. The New York Times and SCOTUSblog reported on the Supreme Court arguments on Monday, December 4th over the bankruptcy deal.

The case could have far-reaching implications for similar lawsuits. If the court approves the deal, it would affirm a litigation tactic that has become popular in resolving lawsuits where people claim similar injuries from the same entity, whether that is a drug or a consumer product. “By turning to the bankruptcy courts as a tool to resolve those claims, businesses aim to free themselves from civil liability and prevent future lawsuits.” If the Supreme Court were to block the use of such a mechanism in this case, the Sackler family would no longer be shielded from civil lawsuits. Additionally, the Purdue Pharma bankruptcy settlement deal would be in jeopardy as the Sackler family previously threatened to walk away from the settlement if the bankruptcy protections were not included in the agreement. See “Carrot-and Stick Tactics of Purdue and the Sacklers” and “Supreme Court considers $6bn deal that shields Sacklers.”

The NYT said it was rare for the Supreme Court to hear a bankruptcy dispute, but this one was precipitated when a watchdog office of the Justice Department, the U.S. Trustee Program, petitioned the court to review the deal. Additionally, the opioid crisis is a nationally important issue. Allowing third parties to be shielded without declaring bankruptcy themselves has become an increasingly popular tactic for avoiding liability. And these rulings have divided lower courts.  The objection by the U.S. Trustee Program was, if approved, the Sacklers would get the benefits of bankruptcy without its costs.

Individuals who may want to sue individual Sackler family members—the ones actively involved in decisions made by Purdue Pharma—in civil court would be prevented from doing so. “The U.S. trustee argued that their constitutional due process rights would be summarily extinguished.” While the Justice Department and a few other plaintiffs are challenging the settlement, most others are concerned about the potential loss of funds to initiatives intended to address the opioid crisis.

Under the deal, Purdue would pay $1.2 billion toward the settlement immediately upon emerging from bankruptcy, with millions more expected in the years to come. The Sacklers would pay up to $6 billion over 18 years, with almost $4.5 billion due in the first nine years.

According to an agreement with tribal plaintiffs, all 574 federally recognized Native American tribes are eligible for payouts from a trust worth about $161 million.

Each state has devised a formula with its local governments for distributing the Purdue money. But all must follow the guidance for using it: that it be largely applied to initiatives intended to ease the opioid crisis, including addiction treatment and prevention.

If the agreement is upheld, about 138,000 plaintiffs, individuals and family members of victims who died from overdoses, would be able to file claims to a trust that would hold $700 to $750 million. Payments are expected to range from $3,500 to $48,000. “Though the payouts are small, the Purdue plan is one of only very few opioid settlements across the nation that set aside money for individuals.”

Purdue Pharma would cease to exist. A new company, Knoa Pharma, would receive the assets from Purdue. Knoa would be owned by creditors, and would manufacture addiction treatment and opioid reversal medicines at no profit. See “The Bondage of Buprenorphine” for a potential new product already developed by a Sackler. Knoa would continue to make opioids like OxyContin as well as nonopioid drugs, with the profits going towards the settlement funds. The Sacklers have been off the Purdue board since 2018, so why it there such resistance to members of the Sackler family avoiding further financial liability?

CNN reported members of the Sackler family withdrew more than $10 billion from Purdue Pharma and placed the money in family trusts and holding companies as pressure built over the nation’s opioid epidemic. An audit of Purdue related to its filing for bankruptcy in September 2020 showed that from 2008 to 2018 the family withdrew more than eight times as much money from the company as the previous 13 years. “From 1995 through 2007, the Sacklers received $1.3 billion from Purdue; but from 2008 through 2018, those payments amounted to $10.7 billion.” The larger withdrawals came after Purdue’s 2007 plea deal with the Justice Department to pay a $600 million penalty on a felony charge of misleading and defrauding physicians and consumers over OxyContin.

The withdrawals came during a time when Purdue Pharma was accused of fueling the nation’s opioid epidemic and amid growing concerns from many states that a significant amount of the family’s wealth may be held overseas; therefore unavailable to plaintiffs seeking relief through the courts.

According to StatNews, political appointees at the Justice Department refused to approve felony charges for Purdue executives, letting the company off with a $600 million fine. Richard Sackler admitted he never bothered to read the entire 2007 plea deal document where prosecutors gave guidelines for Purdue’s future behavior. Instead, they doubled down on marketing OxyContin. The important result of the ruling was there was no trial. “A trial would have exposed the company’s OxyContin profits to forfeiture or prompted one of the executives to expose the magnitude of OxyContin scion Richard Sackler’s participation in the admitted crimes.”

An attorney for the Raymond Sackler family said the amount the family withdrew was publicly known. ““These distribution numbers were known at the time the proposed settlement was agreed to by two dozen attorneys general and thousands of local governments.” But Letitia James, the New York Attorney General said the audit showed the need for even more information:

The fact that the Sackler family removed more than $10 billion when Purdue’s OxyContin was directly causing countless addictions, hundreds of thousands of deaths, and tearing apart millions of families is further reason that we must see detailed financial records showing how much the Sacklers profited from the nation’s deadly opioid epidemic.

CNN said a spokesperson for the Sackler family defended the withdrawals, saying: “Members of the Sackler family who served on Purdue’s board of directors acted ethically and lawfully, and the upcoming release of company documents will prove that fact in detail.” The statement of the Purdue audit said the family’s ownership interest of Purdue Pharma had been valued at between $10 billion to $12 billion.

In his testimony for federal bankruptcy court, Dr. Richard Sackler, a former president and co-chairman of the bord of directors of Purdue Pharma said he, the Sackler family and Purdue Pharma did not have any responsibility for the opioid crisis in the United States. Yet during his tenure, Purdue pleaded guilty twice to federal criminal charges related to marketing and sales of OxyContin. In an email he wrote in 2001, he said “We have to hammer on abusers in every way possible… They are the culprits and the problem. They are reckless criminals.”

A congressional committee investigating the Sacklers, released a statement saying the Sackler family, who owned a controlling interest in Purdue Pharma since 1952, were collectively worth $11 billion. See the statement for a listing of the Sackler family’s assets. The chairperson of the committee said the family built its enormous fortune in large part through sales of OxyContin:

Members of the Sackler family pushed Purdue to use deceptive marketing practices to flood communities with this dangerous painkiller, and now the Sackler family is attempting to use Purdue’s bankruptcy proceedings to evade individual responsibility for their role in fueling the opioid epidemic.

Untangling the contributions of the Sackler family from executives for Purdue Pharma in order to get a clear picture of exactly what individual family members were responsible for may be an impossible task. But looking at how family members contributed to the opioid epidemic and Purdue Pharma’s facilitation of the opioid epidemic is easily done.

Arthur Sackler’s marketing strategies were applied to OxyContin after his death, and Mortimer Sackler transferred millions of dollars from trust companies to himself as early as 2009. Records show approximately $1 billion in wire transfers between the Sacklers, entities they control, and different financial institutions—including funds placed in Swiss bank accounts.

According to StatNews, the evidence of callous greed by Purdue was chilling. The privately-held company fired employees who tried to blow the whistle on its activities and maneuvered to have reporters working on the story of fraud at Purdue fired or removed from their beats. Sales reps were encouraged to allow doctors to believe morphine was stronger than OxyContin; it wasn’t. Executives at Purdue knew the opposite was true.

The 2007 plea deal document discussed above didn’t slow them down. It allowed Purdue Pharma to continue marketing and selling OxyContin. Now with the assistance of consultants at McKinsey & Co., they “turbocharged” their sales, concentrating on known pill mill operators, pushing the highest-dosage pills, “and banning together with other opioid makers to pull end-runs around FDA regulators.”

For more information on the Sacklers and OxyContin, read Pain Killer, by Barry Meier, which “exposes the roots of the opioid epidemic at the hands of Purdue Pharma and Raymond and Mortimer Sackler.”  Also see: “What Purdue and the Sackler Family Treasure,” “It’s Strictly Business,” and “Giving an Opioid Devil Its Due.” Read “The Tale of the OxyContin Lie” and watch PainKiller on Netflix if you think the Sackler family should get a pass by the Supreme Court.

06/7/22

A Coming Opioid Storm?

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When Rahul Gupta was sworn in as the Director of the Office of National Drug Policy (ONDCP) on November 18, 2021, he said on Twitter that the overdose epidemic would be his top priority. He is the first physician to lead the ONDCP. President Biden made it clear to him that addressing the overdose epidemic was an urgent priority. “As director, I will diligently work to advance high-quality, data-driven strategies to make our communities healthier and safer.” Tellingly, the day before Gupta was sworn in, the CDC reported on November 17th that there were an estimated 100,306 drug overdose deaths in the U.S. during the 12-month period ending in April of 2021, an increase of 28.5% from the same time period the year before.

Overdose deaths from opioids increased to 75,673 in the year prior to April 2021, an increase of 35% from the same time period the year before. Nearly 500,000 people died from overdoses involving any opioid from 1999-2019. The CDC said this took place in three distinct waves, with commonly prescription opioids (1990s), heroin (2010) and synthetic opioids (2013). See the graph below, which shows the three categories as well as opioids overall.

The Stanford-Lancet Commission was formed in response to the rising opioid-related morbidity and mortality rates in the USA and Canada over the past 25 years. An article by Humphreys et al in The Lancet in February of 2022, “Responding to the opioid crisis in North America,” noted that in the past 25 years, more people died of overdoses in the USA and Canada than World War 1 and World War 2 combined. Following the above-noted waves, the article made the following observations.

Humphreys et al said the approval of Purdue Pharma’s opioid medication OxyContin in 1995 marked the beginning of the first wave. Purdue fraudulently marketed it as less addictive than other opioids and thus more acceptable for a broad range of indications at high doses. See “Giving an Opioid Devil Its Due,” “The Tale of the OxyContin Lie,” and “Doublespeak in the Opioid Crisis, Part 2” for more on Purdue Pharma and OxyContin.

Backed by the most aggressive marketing campaign in the history of the pharmaceutical industry, OxyContin became the best known of a number of opioid medications (both extended-release and immediate-release formulations) whose prescription rate exploded in the USA and Canada.

There was a departure from decades of medical practice where opioids were used mainly for cancer, surgery and palliative care (people living with a serious illness like cancer). US and Canadian medical practitioners expanded opioid prescribing to include a broad range of non-cancer pain conditions that included lower back pain, headaches and sprained ankles. Per-person opioid prescribing roughly quadrupled between 1999 and 2011. There were 275 million opioid prescriptions written—approximately equal to the population of the two nations. The following graph shows UN data on international per-person consumption of opioids in 2010-12.

The political and cultural environment at the time the crisis emerged was not conducive to an early response; indeed, complacency allowed it to worsen. To attain respectability, trust, and influence throughout the world, opioid manufacturers strategically donated a small share of their profits to prominent institutions, including hospitals, medical and dental schools, universities, museums, art galleries, and sporting events. These donations secured goodwill and increased the credibility of the industry’s message that it was a selfless healer, pushing back against cruel anti-opioid prejudices.

The second wave began around 2010, as drug traffickers realized individuals addicted to prescription opioids were an untapped potential market for heroin. People were drawn in by the comparatively lower price of heroin. Before controls on prescribing were introduced, an analysis of national data suggested that 79.5% of Americans using heroin started with prescription opioids. When efforts began to stop the increase in prescriptions and reduce diversion of prescription opioids, addicted people began turning to heroin more rapidly than they otherwise might have.

The third wave of the opioid crisis began around 2014, as illicit drug producers began adding extraordinarily powerful synthetic opioids, such as fentanyl, to counterfeit pharmaceutical pills, heroin, and stimulants. This wave brought unprecedented lethality in addition to—rather than instead of—the previous waves, both of which continue today. Large numbers of US and Canadian people are still becoming addicted to prescription opioids each year, and most of those who die from heroin and fentanyl overdoses are previous or current users of prescription opioids.

An anonymous editorial in The Lancet accompanied the report of the Stanford-Lancet Commission, Managing the opioid crisis in North America and beyond.” It said the COVID-19 pandemic may have contributed to the number of overdose deaths by disrupting treatment programs and access to medications like naloxone, as well as disrupting support networks. The Commission called for characterizing opioid use disorder (OUD) as a chronic condition, requiring “innovation in treatment of OUD and in the treatment of pain. However, this innovation “must be met with reinforced regulation.”

A Mental Elf article commenting on the Stanford-Lancet Report, said it was an important and authoritative summary of the development of the opioid crisis in North America. It was called an invaluable resource for anyone interested in the problems associated with opioids. But the author, Ron Poole, thought it has a number of weaknesses. He said in his opinion, “at the heart of the international opioid problem is a false belief that pain can be eliminated pharmaceutically.” If we are to move forward, we need to embrace a rehabilitation approach to chronic pain “where opioids play a small and specific role,” rather than continuing to search for an “analgesic magic bullet.”

The pain-elimination myth is not soley the creation of the pharmaceutical industry; it has deep-seated roots in medical socio-cultural beliefs.”In the UK, gabapentinoids are frequently used alongside heroin, and the combination is a potent cause of respiratory depression and death. Gabapentinoids have a limited role in pain management, but they are widely prescribed. They are dependency forming in much the same way as benzodiazepines. Gabapentinoids are not mentioned in the Report.

Poole is right to point to these weaknesses with the Stanford-Lancet Report, especially the failure to mention that gabapentin, which is the sixth-most prescribed medication in the U.S. It has an addictive potential, but is not yet a scheduled substance by the DEA. Other researchers have referred to concomitant use of gabapentinoids and heroin as an emerging public health problem. See “The Truth About Gabapentin.”

Hopefully, we will have time to implement the recommendations in the Stanford-Lancet Report. Humphreys et al said it took more than a generation of mistakes to create the opioid crisis in North America and might take a generation of wiser policies to resolve it. Let’s hope the three “waves” of the opioid crisis, illustrated in the above CDC graph, aren’t signaling a coming storm surge of the opioid epidemic before that time.

04/26/22

It’s Strictly Business

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While news on the fighting in Ukraine was dominating the headlines at the beginning of March in 2022, a struggle of a different kind came closer to an end. The legal battle between the Sackler family and Purdue Pharma on the one side, and a group of states who refused to sign off on the settlement last summer seems to have ended when both sides agreed to a mediated settlement. The New York Times reported it was the first time in three years of negotiations that all states accepted a settlement agreement with Purdue Pharma and the Sacklers. “While the deal is a breakthrough, it is likely to leave many people disappointed that members of the Sackler family did not acknowledge wrongdoing or any personal responsibility for the public health crisis.”

If the judge presiding over Purdue’s bankruptcy proceedings approves the agreement, the Sackler family would pay up to $6 billion to help communities provide assistance for the damage from the ongoing opioid crisis. This was an increase of more than $1 billion from an earlier offer. The Sacklers would have 18 years to make payments of the additional $1 billion. In return, Sackler family members would be protected from all current and future civil claims against them over their company’s prescription opioid business. However, the deal does not protect them from potential criminal cases, which are difficult to prove.

The Sacklers’ position on prohibiting future civil lawsuits was a major obstacle for states that opposed the plan. The latest deal included an agreement by the Sacklers to create a public repository of confidential documents that detail lobbying, public relations and marketing activities with OxyContin. The attorney general of Connecticut, one of the states that rejected the earlier offer, said the settlement was both significant and insufficient, “constrained by the inadequacies of our bankruptcy code.” This settlement resolves their claims against Purdue and the Sacklers, but the fight continues against the wider addiction industry.

The new mediated agreement has several additional terms. Family members from the Sackler family were to attend a hearing that would allow people who suffered from OxyContin addiction to describe what they endured. Any medical centers, art or educational institutions that bear the Sackler name can remove it without their action being contested by the family. Also, there was a statement attached to the settlement that was characterized as an “apology.” Widely described as an apology, this statement doesn’t seem to qualify as one. The Sackler family said:

The Sackler families are pleased to have reached a settlement with additional states that will allow very substantial additional resources to reach people and communities in need. The families have consistently affirmed that settlement is by far the best way to help solve a serious and complex public health crisis. While the families have acted lawfully in all respects, they sincerely regret that OxyContin, a prescription medicine that continues to help people suffering from chronic pain, unexpectedly became part of an opioid crisis that has brought grief and loss to far too many families and communities.

The new settlement still faces a difficulty. The U.S. Trustee program, which oversees the bankruptcy system within the Department of Justice, has argued vigorously against the proposed immunity shield for the Sacklers. Before the tentative agreement, there was a conflict building in the U.S. Court of Appeals for the Second Circuit. So far, the Justice Department has not commented on whether it would continue to challenge that condition of the tentative settlement.

The above-noted hearing was conducted on March 10th by the judge overseeing Purdue’s bankruptcy and featured 26 people from 19 states. The NYT said it was the first time individuals were able to directly address members of the Sackler family. The three members of the Sackler family who attended the hearing were: Dr. Richard Sackler, a former president and chairman of the board; David Sackler, a former board member; and Dame Theresa Sackler, a former board member and widow of Dr. Mortimer Sackler, one of the company’s founders.

Dame Theresa sat quietly; her expression unchanging. David Sackler sometimes shifted his position. Dr. Richard Sackler, who was the family member seen as most involved in the company’s aggressive marketing of OxyContin, remained off camera the whole session. This infuriated some of the participants. One of the individuals referred to the Sacklers as “killers,” saying that to this day, they deny any wrongdoing; that the family acted lawfully in all respects. “Richard, can you honestly say that with a straight face? If so, why don’t you turn on your camera and let’s see?”

Dr. Sackler was permitted to remain off camera by prior agreement. Also by prior arrangement, the Sacklers did not speak during the session and did not issue a statement afterwards. An individual testifying at the hearing, who was himself in recovery from an opioid addiction, quoted a statement made by Dr. Sackler in 2001, which said: “We have to hammer on the abusers in every way possible. They are the culprits and the problem. They are reckless criminals.” He then accused Richard Sackler, “You are the abuser. You are the criminal and you are the culprit . . . I hope that every single victim’s face haunts your every waking moment.”

A man from Indiana, who was a criminal court judge, lost his son to an overdose. The man and his wife began their testimony time by playing a recording of the 911 call made when they found their son dead from an overdose. He was “a straight-A student in college, studying law.” The judge said to Dr. Sackler, “I have put away drug dealers with a single rap of a gavel without blinking an eye. Oh, how I wish I could do the same to you, Richard Sackler.”

Foundations, art galleries and museums around the world have requested they become distanced from the Sackler name, including: The Metropolitan Museum of Art and the Dia Art Foundation in New York, the Serpentine Gallery and the four Tate galleries in the U.K., and the Louvre in Paris. Others, including the Guggenheim and the American Museum of Natural History in New York, and the British Museum in London have not announced plans to remove the Sackler name from their institutions.

Members of the Sackler family have persistently denied that the billions of dollars removed from Purdue Pharma over the course of a decade was done to shield assets from potential litigation over their role in the opioid crisis. But a review of emails, memos and other documents showed that Sackler family members discussed exposure to potential litigation as early as 2007, “a full decade before they faced a new wide-ranging legal attack and significant financial transfers stopped.”

Blomberg Businessweek published an article noting “How the Sacklers Shifted $10.8 Billion of Their Opioid Fortune.” Initially, Purdue and its subsidiaries moved billions to companies registered in Luxembourg, the British Virgin Islands and Delaware. “From 2008 through 2017, $10.8 billion flowed out of Purdue in hundreds of transactions through numerous subsidiaries.” The money eventually landed in two Delaware companies, Rosebay Medical Co. and Beason Co., which are trusts for the benefit of the Sackler family. See the Bloomberg article for particulars of the monetary shell game with Purdue funds.

Blomberg said a spokesperson for the family said in a statement: “All of the Sackler family members, including those who served on Purdue’s board, have always conducted themselves properly.” From 2007 to 2019, 10 Sacklers were Purdue directors. The following graphic appeared in the Blomberg article.

NPR reported last year that “Purdue Pharma conducted Massive Probe of the Sacklers, But The Findings Are Secret.” The company acknowledged hiring attorneys, forensic accountants and other financial experts to probe members of the Sackler family. The team searched for evidence of wrongdoing by the family and reported their findings to a special committee of Purdue’s board between April 2019 and March of 2021. But Purdue chose to reveal essentially nothing of what investigators uncovered. “Purdue’s disclosure filing says it paid its lawyers for a 22,000-hour investigation of the Sacklers, but it doesn’t disclose any of their findings.”

Writing for NPR, Brain Mann said the Purdue Pharma document suggests the primary goal of the investigation “was to inform and shape bankruptcy talks” that were underway at the time. Speaking on behalf of the Sacklers, spokespersons downplayed the significance of the investigation and maintained members of the family did nothing wrong. An attorney for the Raymond Sackler family said: “As we have said before, we support the release of documents and they will continue to show Sackler family members who served on Purdue’s board acted ethically and legally.”

A few clues about what investigators found were evident in the filing. The filing stated that “certain dealings between Purdue Pharma and the Sackler families and various Sackler entities were not conducted on arm’s-length terms.” There is a link to the “Alix Report on Distributions to Sacklers,” noting compensation, pension benefits, travel and expense reimbursements, legal expenses incurred on behalf of Sackler family members, and fringe benefits provided to members of the Sackler family such as cell phones, fleet vehicles and personal service employees up until April 30, 2019.

It seems the Sacklers were playing the long game from the time of Purdue’s first admission of illegal actions in “misbranding” OxyContin in 2007. See “Giving an Opioid Devil Its Due.” From 2008 until 2017 there was a transfer of over $10 billion out of the company. From 2007 to 2019, 10 different members of the Sackler family served on Purdue board. An extensive investigation by Purdue was done of members of the Sackler family looking for evidence of wrongdoing.

The investigative team reported to a special committee of the board between April of 2019 and March of 2021, but failed to publicly disclose any of its findings. The Sacklers consistently denied any wrong doing and repeatedly warned that a failure to protect family members from all current and future civil claims against them over their company’s prescription opioid business would scuttle the bankruptcy negotiations and perhaps end “The ability of creditors, communities, and individuals to receive billions in value to abate the opioid crisis,” according to Steve Miller, Purdue’s chairman.

The Sacklers will not face any civil charges; criminal filings are very difficult to prove and will likely not be filed. Despite the transfer of billions of dollars from Purdue, ultimately to family trusts, members of the family deny having done anything ethically or legally wrong. Their so-called apology was formed in non-apologetic rhetoric that took no responsibility for Purdue Pharma’s or the family’s role in birthing the opioid crisis. There is no apparent remorse by members of the Sackler family involved in the day-to-day operations and decisions of Purdue Pharma that led to the eventual addiction and deaths of hundreds, if not thousands of people. There seems to have been one unverbalized, but clearly communicated statement by the Sacklers in their so-called apology quoted above: “It’s not personal; it’s strictly business.”

For further information on the Sacklers and Purdue Pharma, see: “It Doesn’t Seem Right,” “Carrot-and-Stick Tactics of Purdue and the Sacklers” and “What Purdue and the Sackler Family Treasure.”

09/7/21

It Doesn’t Seem Right

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Back in October of 2020 Purdue Pharma signed an $8 billion-plus settlement with the U.S. Department of Justice. Purdue agreed to plead guilty to three federal criminal charges for its role in creating the nation’s opioid epidemic and shut down the company. The charges included conspiracy to defraud the U.S. government. The Daily Beast reported Purdue will admit it impeded the DEA by falsely representing it had maintained an adequate program to stop drug diversion while the company’s internal system was beginning to sound an alarm. Purdue will also admit to violating antikickback laws by inducing doctors to write more prescriptions for opioids through a paid speaker program.

Some states objected to the settlement. CNN Business reported that while the $8 billion plus agreement would be a record settlement paid by a pharmaceutical company, it is only a fraction of the cost to federal, state and local governments fighting the opioid crisis. State lawsuits throughout the country have filed claims for over $2 trillion. State attorneys general and members of Congress objected to the settlement, saying it does not hold the Sackler family and Purdue properly accountable. The Connecticut Attorney General said: “The federal government had the power here to put the Sacklers in jail, and they didn’t. Instead, they took fines and penalties that Purdue likely will never fully pay.”

If the only practical consequence of your Department’s investigation is that a handful of billionaires are made slightly less rich, we fear that the American people will lose faith in the ability of the Department to provide accountability and equal justice under the law.

Members of the Sackler family withdrew more than $10 billion from Purdue Pharma and placed it in family trusts, as the company faced growing scrutiny related to its role in the opioid epidemic. A statement from the family said, “Members of the Sackler family who served on Purdue’s board of directors acted ethically and lawfully, and the upcoming release of company documents will prove that fact in detail.”

The New York Times (NYT) reported a Purdue Pharma proposal to restructure itself as a nonprofit company was put to a vote and approved by huge majority of its creditors. The restructuring plan would protect the company from further legal action over opioids. It also includes a blanket release from civil lawsuits for the Sackler family, who argued if the plan is confirmed, they should be covered by the same release from all present and future lawsuits as their company would be. “Neither the company, nor the Sacklers, would admit to wrongdoing in connection with these lawsuits.”

Under the plan, the Sacklers would surrender control of Purdue. The company would receive a new name and be run by an independently appointed board. The Sackler family would also pay at least $4.5 billion of their personal funds over nine years. That is in addition to the $225 million from a separate civil settlement with the DOJ.

According to the plan, the reconstituted, as-yet unnamed company would fund about a half-dozen trusts, including separate ones for tribes, adults and children. Proceeds from the sales of the nonprofit’s overdose-reversing medications as well as from moderate quantities of OxyContin would continue to be pumped into these trusts.

In July 2021, NPR said fifteen states, including Massachusetts, New York, Pennsylvania, Colorado and Illinois dropped their opposition to the Purdue bankruptcy plan, according to documents filed by a court mediator. Federal bankruptcy judge Shelley Chapman said in the legal filing, “The negotiations were difficult and hard-fought, with the outcome uncertain.” Chapman was appointed to mediate a settlement the opposing states could accept. The settlement is all but certain to be finalized. In addition to members of the Sackler family, the settlement would shelter many of their associates from future opioid lawsuits.

Under the mediation agreement, Purdue agreed to release more than 30 million documents to a public repository, including private communications with lawyers. Although those documents are expected to expose the full story of the company’s and the Sackler family’s complicity in selling OxyContin, they will be shielded from any further legal action by the Purdue restructuring plan. Members of Congress have introduced legislation to close a loophole in the bankruptcy code that permitted Purdue Pharma to declare bankruptcy, while its owners—the Sacklers—did not. They will remain as one of the richest families in the U.S. Even if the legislation passes, the Purdue plan will have been long since resolved.

The hearing before the U.S. House of Representatives’ Judiciary’s Subcommittee on Antitrust, Commercial and Administrative Law took place as Democratic members of the House and Senate introduced legislation aimed at reforming areas of bankruptcy law relevant to the Sackler family and Purdue situation.

The Nondebtor Release Prohibition Act of 2021 would prohibit litigation shields for owners or insiders of bankrupt companies. Though not included in the legislation, Wednesday’s hearing also focused on potential reforms to limit the ability of bankrupt companies to select judges they think will be favorable to them.

According to Reuters, the trial over the Purdue Pharma settlement began on August 12th and was supposed to take two weeks. The settlement is supported by all but nine states, including Connecticut (where Purdue is headquartered), California, Maryland and Washington. Washington’s attorney general said he could not in good conscience accept the terms of Purdue’s deal. “The latest settlement plan ‘allows the Sacklers to walk away as billionaires with a legal shield for life.’” Adding insult to injury, he said “they don’t even have to apologize.”

Purdue says the deal is worth more than $10 billion. If the settlement is approved, Purdue assets will be transferred to the new company. The company will be governed by a new independent board, “who will operate in a responsible and sustainable manner taking into account long-term public health interests related to the opioid crisis.” The Sackler family will have no involvement in the new company, and will end their involvement in pharmaceutical companies worldwide.

Critics of the settlement oppose the “third-party releases” that would provide legal protections to the Sacklers. The company has said that without the releases, the entire settlement, including billions of dollars for state and local opioid abatement programs, would collapse.

On September 1st, The NYT reported the settlement agreement was provisionally approved and Purdue Pharma was dissolved. The presiding judge said the case was a B-I-T-T-E-R result, spelling out the word. He was incredibly frustrated that so much of the Sackler money was in offshore accounts. He had wished for and expected a higher settlement. The costs of further delay and the benefits of the agreement with its focus on lessening the impact of the opioid epidemic influenced his decision.

Just last month, Dr. Richard Sackler, a former president and cochairman of the board for Purdue, testified that neither the family, the company nor its products bore any responsibility for the opioid epidemic. Other Sacklers struck a more conciliatory note, saying they were horrified that a medication intended to alleviate pain had, in fact, caused pain to so many. But neither apologized nor took personal responsibility.

So, there it is. It appears that the full story of how OxyContin helped fuel the opioid epidemic will only become known when it is too late for any legal actions to be taken against individuals from Purdue Pharma or the Sackler family. The company, but no persons will be found guilty of federal crimes; no one will apologize or be held accountable for their actions. And that doesn’t seem right.

For other articles on this issue, see: “What Purdue and the Sackler Family Treasure,” “Giving an Opioid Devil Its Due,” The Tale of the OxyContin Lie,” and more.

09/24/19

What Purdue and the Sackler Family Treasure

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The New York Times and FiercePharma reported on September 11, 2019 that Purdue Pharma and the Sackler family have reached a tentative settlement with 23 states and nearly 2,300 other plaintiffs (cities, counties, tribes) in the first major opioid settlement. Although specifics of the deal have yet to be finalized, it would involve Purdue filing for Chapter 11 bankruptcy. “The company would be dissolved, and a new one would be formed to continue selling OxyContin and other medicines, with the profits used to pay the plaintiffs.” The settlement does not include an admission by Purdue or the Sackler family of wrongdoing. The agreement was approved by Purdue’s board on Sunday, September 15, 2019 approximately 48 hours after the New York State Attorney General charged members of the Sackler family with transferring $1 billion into Swiss bank accounts.

The tentative deal was reached just six weeks before the start of the first trial before a federal judge in which Purdue is a defendant. But it isn’t clear whether the settlement will absolve the company or family members from all existing and future claims. The NYT reported that because the deal falls short of what some state attorneys general were seeking, several states vowed to continue to pursue legal action. Maura Healey, the Massachusetts attorney general, said, “It’s critical that all the facts come out about what this company and its executives and directors did, that they apologize for the harm they caused, and that no one profits from breaking the law.” Under the deal the Sackler family will pay plaintiffs $3 billion over seven years. Some attorneys general wanted $4.5 billion up front, but the family refused.

A critical sticking point has been the timing of the family’s sale of its global pharmaceutical business, Mundipharma, and the contribution the family would make from the proceeds. Some attorneys general, including those from Massachusetts, New York, New Jersey, Pennsylvania and Connecticut, who have not signed on to the settlement, had been pressing the family to sell Mundipharma immediately and to discontinue manufacturing drugs for international markets.

Often in Chapter 11 bankruptcy, all litigation against a company is stayed. At this time, it is unclear if the Sackler payouts in the settlement would bind them into Purdue’s bankruptcy proceeding “and therefore halt the lawsuits against them as well as the company.” The NYT reported that many of the states have named individual members of the Sackler family as defendants.  The Times said the family members have been intentionally siphoning billions of dollars out of the company since 2007, when Purdue and three of its executives paid a $635 million fine to resolve federal charges related to their “misbranding” of OxyContin. See “Giving an Opioid Devil Its Due” for more on this ruling.

In court filings on Friday, September 13, 2019, New York state Attorney General Letitia James said members of the Sackler family used Swiss bank accounts to transfer $1 billion from the company to itself. She said, “Records from one financial institution alone have shown approximately $1 billion in wire transfers between the Sacklers, entities they control, and different financial institutions, including those that have funneled funds into Swiss bank accounts.” She referred to the proposed deal as “an insult.”

The court filing highlights the activities of Mortimer D.A. Sackler, a former Purdue board member. It alleges that Sackler transferred millions of dollars from trust companies, at least one of which was previously unknown, through Swiss bank accounts to himself as early as 2009. Some of the funds were directed to real estate companies that owned Sackler family homes in Manhattan and the Hamptons, the filings said.

A spokes person for Mortimer Sackler said the decade-old transfers were entirely legal. “This is a cynical attempt by a hostile AG’s office to generate defamatory headlines to try to torpedo a mutually beneficial settlement that is supported by so many other states and would result in billions of dollars going to communities and individuals across the country that need help.” A Purdue Pharma media representative said the company had no comment. The New York Attorney General’s office believes there is more to be learned about the family’s holdings, “and that information is central to arriving at a just settlement.”

FiercePharma noted how Massachusetts Attorney General Maura Healey filed a complaint that alleged members of the Sackler family played a major role in the marketing for OxyContin “and pocketed billions of dollars in profits over the years.” The company used “coffee, ice cream, catered lunches and cash” to tempt doctors to prescribe the drug. It also used face-to-face interactions to conceal a paper trail for its sales tactics and hide the identities of potential witnesses. According to Healey’s filing, when a sales rep emailed a sales pitch to a doctor, a Purdue VP said the company should “fire her now” since the company did not want a record of their communications.

At Purdue’s launch party for OxyContin, Richard Sackler, then the Senior Vice President of Sales, said the launch “will be followed by a blizzard of prescriptions that will bury the competition.” He was also said to support a blame shifting tactic for the deaths and opioid epidemic onto those who became addicted. According to the lawsuit, in a confidential email he was reported to have written that they are “the culprits and the problem.” And that “we have to hammer on the abusers in every way possible.” Healey’s lawsuit said: “By their misconduct, the Sacklers have hammered Massachusetts families in every way possible. And the stigma they used as a weapon made the crisis worse.”

The lawsuit alleges the company deceived doctors and patients to get more people on its opioid painkillers, including OxyContin, by downplaying the risks and overstating benefits. Members of the Sackler family directed the company’s marketing strategy for opioids and worked to cover their tracks, the lawsuit claims.Purdue argued that its marketing was consistent with the FDA’s official labeling on its drugs. And Massachusetts still covers Purdue’s drugs as “brand preferred” in state programs, the company’s new filing contended.

STAT News reported that Richard Sackler was especially involved in efforts to market OxyContin, saying that he pushed staff to pursue deregulation in Germany. He was also alleged to instruct Purdue staff not tell doctors the truth about OxyContin for fear of reducing sales. In 1997, the year after OxyContin was put on the market, Michael Freidman, at the time the head of sales and marketing at Purdue, told Richard Sackler he did not want to correct a false impression among doctors that OxyContin was weaker than morphine. Friedman’s reason was because the myth was driving prescriptions and sales. He said it would be extremely dangerous at this early stage “to make physicians think the drug is stronger or equal to morphine.” Sackler said he agreed.

Friedman was later one of three Purdue executives who pleaded guilty to a misdemeanor charge of “misbranding” OxyContin (See “Giving an Opioid Devil Its Due” linked above for more on this). “No members of the Sackler family were charged or named as part of the plea agreement.” The Massachusetts lawsuit also alleges the Sackler-controlled Purdue board voted that three executives, but no family members, should plead guilty as individuals. Amid concern by the family to maintain the allegiance of two executives, when the case concluded Purdue paid them millions for their silence.

“‘The Sacklers spent millions to keep the loyalty of people who knew the truth,’ the complaint filed by the Massachusetts attorney general alleges.” ProPublica reported the Massachusetts lawsuit claims Purdue paid $5 million to Howard Udell in November 2008, and up to $1 million in November 2009. “In February 2008, the company paid $3 million to Friedman.”

On July 31, 2019, Arizona Attorney General Mark Brnovich filed a complaint in the US Supreme Court charging that members of the Sackler family who owned and controlled Purdue companies, made “billions of dollars off the promotion and sale of opioids.” The lawsuit also claimed members of the Sackler family intentionally transferred billions of dollars from the company into family held bank accounts, “looting” Purdue in the process. “Sackler family members have long constituted the majority of Purdue’s board, and company profits flow to trusts that benefit the extended family.” From 2007 to 2018, the Sackler family received more than $4 billion in payouts from Purdue, according to the Massachusetts lawsuit.

The State brings this action because it has evidence that the Sacklers, Purdue, and the other Defendants were parties in recent years to massive cash transfers—totaling billions of dollars—at a time when Purdue faced enormous exposure for its role in fueling the opioids crisis. These transfers threaten the ability of Purdue to satisfy any relief the State may obtain in its pending proceeding against Purdue. The State therefore brings this action to hold the Defendants accountable for their attempts to loot Purdue, and to ensure that the people of Arizona can obtain adequate relief for the devastation that the Sacklers and Purdue have wrought in this state.

FiercePharma reported the suit named eight members of the Sackler family, including the former president and CEO Richard Sackler of Purdue, of ‘strip mining’ the company’s finances. The transfers are thought to have been done in order to set Purdue up for a bankruptcy filing and to avoid paying the potential multibillion-dollar settlements in state and federal courts. A Purdue spokesperson said the US Supreme Court was an improper forum to conduct a trial of the claims being made by Arizona. “This petition was filed solely for the purpose of leapfrogging other similar lawsuits, and we expect the Court will see it as such.”

This dismissal of the Sackler family’s influence over Purdue seems disingenuous. In late 2010, Purdue told the family that sales of the highest dose of OxyContin and the most profitable opioids were lower than expected. That meant an anticipated quarter-end payment to the family of $320 million was at risk of being reduced to $260 million. This prompted an email from Mortimer D.A. Sackler: “Why are you BOTH reducing the amount of the distribution and delaying it and splitting it in two? … Just a few weeks ago you agreed to distribute the full 320 [million dollars] in November.”

ProPublica reported that after the company pled guilty in 2008 to the federal charges of understating the risk of addiction to OxyContin, Richard Sackler advised other family members that it was important to select a new chief executive who was loyal to the family. He allegedly wrote that, “People who will shift their loyalties rapidly under stress and temptation can become a liability from the owners’ viewpoint.” The company installed five new, non-family board members. Yet in hundreds of board votes, the new directors didn’t once oppose the family.

In September of 2014 Purdue began a secret project, code-named Project Tango, to cash in on an industry growing as a result of the opioid epidemic—addiction treatment medication. Dr. Kathe Sackler, sister to Mortimer Sackler and a daughter of the company co-founder Mortimer Sackler, participated in phone calls and urged staff to give the project their “immediate attention.” So, while OxyContin sales were declining, there was an internal team at Purdue calculating how they could enter into the addiction treatment market, which was expanding. See “The Bondage of Buprenorphine” for more on this.

Company documents suggested Purdue wanted to become an “end-to-end pain provider.” They intended to sell buprenorphine (Suboxone). Then in 2015, Purdue became interested in Narcan, calling it a “strategic fit.” Executives even discussed how Purdue’s sales force could promote Narcan to the same doctors who prescribed the most opioids! Ultimately Purdue decided against acquiring the rights to Suboxone and Narcan.

The story of Purdue, the Sackler family and OxyContin, brings two sayings to mind, one biblical: the love of money is the root of all kinds of evil (1 Timothy 6:10a), and one from recovery: denial is not a river in Egypt. The biblical passage in First Timothy passes judgment on Purdue and the Sackler family from the beginning of their attempts to bring OxyContin to market: “But those who desire to be rich fall into temptation, into a snare, into many senseless and harmful desires that plunge people into ruin and destruction. For the love of money is a root of all kinds of evils” (1 Timothy 6:9-10a). The saying on denial highlights how Purdue and the Sacklers have used denial in its various forms from their original marketing of OxyContin, through their attempts to negotiate a way out of the multiplication of lawsuits that are now coming to light. And that leads to another biblical saying, “For where your treasure is, there your heart will be also” (Matthew 6:24).

In an interesting post script, the Wall Street Journal reported on October 4th that according to court records and testimony, Purdue Pharma transferred $12 billion or $13 billion in profits to members of the Sackler family. Neither the Sackler family nor Purdue disputed the reported amounts. They were revealed in bankruptcy court filings on 10/3 and 10/4. They could complicate efforts to settle the lawsuits against the company, by giving credibility to opponents of the tentative deal who think the Sackler family should contribute more than they have agreed. It is not clear when the distributions occurred.

08/21/18

A Time of Reckoning is Coming

in the public domain; etching by Arnold van Westerhout (1651-1725)

There was an interesting study published in JAMA Internal Medicine noting that doctors who received any opioid-related payments in 2014—even for a single meal—prescribed more opioids in 2015. “One company, INSYS Therapeutics, accounted for 50% of nonresearch payments.” A relatively small number of physicians given nonresearch opioid-related payments (perks), 436 of 25,767 (1.7%), received $1,000 or more in total. The researchers said their findings suggested manufacturers should consider either a voluntary decrease or complete cessation of marketing to physicians for opioids. Federal and state governments were urged to consider legal limits on the number and amount of payments that could be given to doctors.

The research letter by Hadland et al. can be found here. In “More evidence companies pay some doctors to prescribe opioids,” Maggie Fox noted the Hadland study found that one out of every 12 U.S. doctors received something of value (money, lunch, etc.) from companies making opioids. PhRMA (Pharmaceutical Research and Manufacturers of America), the lobby group for pharmaceutical companies, issued a voluntary code of conduct to curb the once-widespread practice of handing out free branded items (mugs, prescription pads and other “swag”).

The three opioid manufacturing companies with the highest payment totals were Insys Therapeutics, Teva Pharmaceuticals USA and Janssen Pharaceuticals. Insys makes Subsys, a spray formulation of fentanyl licensed for extreme pain in cancer patients. “Payments made by Insys topped $4.5 million. Teva and Janssen each spent more than $800,000.”

Former Insys executives were charged with conspiring to “mislead and defraud” health insurance companies. See “Fentanyl: Fraud and Fatality.” Two former Insys executives have pled guilty and are cooperating federal prosecutors. “The company’s billionaire founder, John Kapoor, and other Insys officials and employees are also under indictment.” Insys said a new management team is making efforts to build a company culture of “high ethical standards.”

A company spokesperson wrote: “The company no longer hosts speaker programs for Subsys.” Further, he said there was a decrease of Insys-hosted physician speaker programs by 87% and an 82% drop in the amount in honoraria paid to those physician speakers from 2015 to 2017.  “In reality, according to federal prosecutors, the ‘lectures’ were just booze-fueled social gatherings, and the fees were kickbacks paid to prescribe Subsys.”

In “Opioid-Makers Cut Back On Marketing Payments To Doctors,” Charles Ornstein and Ryann Grochowski Jones wrote how the past two years has been a “time of reckoning” for pharmaceutical manufacturers over their contribution to the opioid epidemic through how they promoted opioid drugs. State and local governments have sued Purdue Pharma, Insys Therapeutics and other drug makers for their allegedly deceptive marketing of opioids. See “Giving an Opioid Devil Its Due” for more on Purdue Pharma and its promotion of OxyContin.

In 2016, drugmakers spent $15.8 million to pay doctors for speaking, consulting, meals and travel related to opioid drugs. That was down 33 percent from $23.7 million in 2015 and is 21 percent less than the $19.9 million spent in 2014. Companies are required to report the payments publicly under the Physician Payment Sunshine Act, a part of the 2010 Affordable Care Act.

The ProPublica Dollars for Docs online tool showed there were $9 billion in promotional payments made to more than 900,000 doctors between 2013 and 2016. The biggest decreases among opioid payments were for Subsys (from more than $6 million in 2015 to less than $2.4 million in 2016); and Hysingla ER, an extended release formula of hydrocodone made by Purdue, which dropped from around $6.3 million in 2015 to $2.2 million in 2016.

Purdue ended its speaker program for OxyContin at the end of 2016 and for Hysingla ER in November 2017. Earlier this year, it ended all direct promotion of its opioids to prescribers and last week [June 20th], the company laid off its remaining sales representatives.

Michael Barnett, an assistant professor of public health and management at Harvard thought while the decline in opioid marketing is potentially good news, it isn’t clear exactly why it is happening. He said if it is because manufacturers were aware their advocacy and payments to physicians could be seen as pushing opioids in a way that was ethically dubious, that would be a beneficial development. “Given the deluge of media attention with the opioid epidemic, I think we’ve seen the pendulum swing in the opposite direction.” Instead of opioids being seen as a needed and compassionate way to treat pain, they are now “being viewed as pretty toxic and only to be used as a last resort.”

Unfortunately, there has been a slower decrease in the use of prescription opioids than the sharp drop in marketing them noted above. The number of opioid prescriptions in Medicare was 81.7 million in 2014, dropping to 80.2 million in 2015 and then 79.5 million in 2016. Yet the rate of opioid overdoses continues to grow. Of the 42,000 reported overdoses in 2016, 40% involved a prescription opioid.

In a blog post on May 14, 2018, the FDA Commissioner Scott Gottlieb referred to opioid addiction as the biggest public health crisis facing the FDA. He said he regularly hears stories about “the emotional, physical and financial toll this epidemic is taking on Americans.” The FDA is considering guidelines for doctors to encourage the “more rational prescribing” of opioids. One idea is to encourage medical societies to develop evidence-based guidelines on prescribing opioids for acute medical indications.

Having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.

While there are many individuals in need of opioids for short and long-term use, a time of reckoning still needs to take place with the opioid manufacturers who exploited this need for their own financial ends. In March of 2018 the CDC released an in-depth analysis of drug overdose data for 2016. From 1999 to 2015, 568,699 persons died from drug overdoses in the U.S. “There were 63,632 drug overdose deaths in 2016; 42,249 (66.4%) involved an opioid.” Increases were noted across demographics, urbanization levels and states. Overdose deaths from prescription opioids increased by 10.6%, from 2015 to 2016. Eight states had significant increases in death rates that included prescription opioids. West Virginia, Maryland and Maine and Utah had the highest rates.

07/10/18

Giving an Opioid Devil Its Due

thorny devil lizard; licensed under the Creative Commons Attribution-Share Alike 3.0 Unported license

In December of 2002, Purdue Pharmaceutical executives received a subpoena from the office of the United States Attorney for the Western District of Virginia. Federal prosecutors were notifying Purdue that the Department of Justice had formally opened an investigation into how the company marketed OxyContin. Two assistant U.S. Attorneys had become aware of the false marketing claims made by Purdue sales reps for OxyContin “and they began to wonder if high-ups in the company had orchestrated that campaign.” The two men noticed that since Purdue had begun marketing OxyContin the cases they were getting had changed drastically. “By 2001, virtually all of them—robberies, fraud, assaults, and pill-mill cases—had a connection to Purdue’s drug.”

Over the next four years a team of federal prosecutors and investigators worked through thousands of Purdue emails, records and other documents. “They called former Purdue sales reps, marketing executives, researchers medical officers, and chemists to testify under oath before a federal grand jury.” While going through the subpoenaed documents, they discovered how Purdue misrepresented data in order to minimize OxyContin’s addictive potential. “The FDA has told Purdue that data was bogus, but the company trained its reps to use it anyway.”

They also discovered Purdue had concealed information that contradicted a claim made when OxyContin was first marketed, namely that patients on low doses (less than 60 mg daily) “could stop it abruptly without going through the anxiety and discomfort associated with opioid withdrawal.” This claim had been based on a Purdue-funded study that low dose patients exhibited “no overt withdrawal syndrome.” A Purdue researcher re-examined the study’s underlying data in 2001 and found that 25% of patients showed symptoms consistent with withdrawal. “But prosecutors found emails showing the company allowed sales reps to give the questionable study to doctors, apparently with the blessing of senior executives.”

Some Purdue medical officers wanted the company to notify the FDA about the withdrawal issue; to admit that tapering a dose was a “more prudent medical recommendation than stopping low dose OxyContin abruptly. “In grand-jury testimony, FDA officials said the agency never got that report.”

Prosecutors discovered that by 2000 Purdue has begun receiving calls from patients on low doses, who were experiencing significant withdrawal symptoms. Soon, Purdue officials were sending one another emails about the “risk management” implications if the study’s findings were inaccurate.

To this day, Purdue insists it first became aware of abuse problems with OxyContin in early 2000, “as a result of articles in Maine newspapers and when the U.S. Attorney there sent out an alert to doctors in the state.” But during their investigation prosecutors came across emails indicating that senior executives at Purdue “learned about wider abuse of OxyContin well before they said they did.” Prosecutors believed they had more than enough evidence to show that three senior company executives had misrepresented when they first learned of OxyContin’s abuse. They recommended the men be indicted on charges that included conspiracy to defraud the United States. In late September 2006 they sent a 120-page memo to their boss, the U.S. Attorney for the Western District of Virginia, with the recommended indictments. It was then forwarded to officials at the Justice Department headquarters for review and approval. The following excerpt is from the memo:

Had the conspirators provided Congress and their sales representatives with the truth, that is that PURDUE had been aware, at least as early as 1997-1998, that both MS Contin and OxyContin were subject to widespread abuse and diversion but continued to market OxyContin as less addictive, abusable and subject to diversion in the face of this knowledge, the sales representatives would have lost all credibility with health care providers, and PURDUE’s conduct would likely have been subject to much greater regulatory and Congressional scrutiny.

The above was gleaned from the expanded and updated edition of Barry Meier’s book, Pain Killer. Coinciding with the publication of the expanded edition of Pain Killer, two articles by Meir appeared in The New York Times, where he has been a reporter since 1989. Those articles are: “Origins of an Epidemic: Purdue Pharma Knew Its Opioids Were Widely Abused” and “Every Time I Thought the Purdue Pharma OxyContin Story Was Over, I Was Wrong.” In “Origins of an Epidemic,” Meir gave further details of how Purdue Pharma knew about serious abuse in the first years after OxyContin was put on the market. Even members of the Sackler family had been alerted about abuse problems with OxyContin and MS Contin.

Company officials had received reports that the pills were being crushed and snorted; stolen from pharmacies; and that some doctors were being charged with selling prescriptions, according to dozens of previously undisclosed documents that offer a detailed look inside Purdue Pharma. But the drug maker continued “in the face of this knowledge” to market OxyContin as less prone to abuse and addiction than other prescription opioids, prosecutors wrote in 2006.

But top Justice Department officials did not believe the felony charges against Purdue executives were justified. Instead, the case was settled through a plea bargain. “When the case was settled, the memo and the evidence within it were sealed and forgotten.”

In 2007, Purdue Pharma pleaded guilty to a felony charge of “misbranding” OxyContin while marketing the drug by misrepresenting, among other things, its risk of addiction and potential to be abused. Three executives — the company’s chief executive, Michael Friedman; its top medical officer, Dr. Paul D. Goldenheim; and Mr. Udell, who died in 2013 — each pleaded guilty to a misdemeanor “misbranding” charge that solely held them liable as Purdue Pharma’s “responsible” executives and did not accuse them of wrongdoing. The company and the executives paid a combined $634.5 million in fines and the men were required to perform community service.

In “Every Time I Thought the Purdue Pharma OxyContin Story Was Over, I Was Wrong,” Meier described how the complete Purdue OxyContin story told in Pain Killer came to him in spurts. He became interested in the back-story to Purdue Pharma and OxyContin after a 2001 interview he had with the Purdue CEO, Michael Friedman. This led to his 2003 edition of Pain Killer. Meir heard rumors of the Justice Department investigation, but when nothing happened, he assumed it just ran out of steam. Then he heard of the plea bargain, where “Purdue Pharma and the three executives I had interviewed were about to plead guilty to charges connected to the company’s deceptive marketing of OxyContin.” He received a tip about the sentencing from the U.S. Attorney for the Western District of Virginia because his writing on the issue for The New Times and in Pain Killer helped inform the original investigation documented in the 2006 memo.

Once again, Meier thought the OxyContin story was over. That is until he was given a copy of the 2006 Justice Department memo. After reading it, he realized just how much he hadn’t known back then. He even discovered that he was mentioned in the memo. Prosecutors found a tape recording of his 2001 interview with the Purdue CEO and planned to use it as an example of how the Purdue executives publically misrepresented the company’s knowledge of early OxyContin abuse. “Now, with the report in hand, I finally had the chance to bring the story of Purdue Pharma and OxyContin full circle, both in The Times and in an expanded edition of Pain Killer.”

Then on May 15, 2018 Reuters noted that six states, Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee filed lawsuits against Purdue Pharma LP, accusing the company of “fueling a national opioid epidemic by deceptively marketing its prescription painkillers to generate billions of dollars in sales.” Sixteen other U.S. states and Puerto Rico have already filed lawsuits against Purdue, with New York and California preparing similar lawsuits. Fierce Pharma announced Massachusetts would be the first to not only file suit against Purdue, but also against its current and former executives and board members. This group includes members of the Sackler family that owns the stable of privately held Purdue Pharma companies.

On July 5th Purdue Pharma dropped its effort to keep the Tennessee lawsuit sealed. The Tennessee Coalition for Open Government and the Knoxville News Sentinel were successful in their efforts to make public the details of the 274-page lawsuit against Purdue Pharma. The Tennessee Attorney General told the News Sentinel: “The state’s complaint contains specific examples of defendant’s unlawful conduct, its scale and impact on the state, the company’s knowledge of activities and financial gain.” He said there is proof the firm lied about the addictive properties of the drug OxyContin and actively marketed it to addicts.

The New York Daily News reported the unsealed lawsuit said Purdue called on two providers 48 times after the company had been told by law enforcement they were responsible for “significant interstates OxyContin diversion.” The lawsuit further states:

Purdue continued to make sales calls in spite of credible reports of patient overdoses, indictments, adverse licensure actions, a provider admitting he was addicted to heroin, a knife fight outside a provider’s office, muggings over controlled substances outside of a pharmacy linked to a specific provider, a clinic that had no examination tables or equipment, an admission by a provider that he was running a pill mill, a provider changing the name of his practice shortly after he was notified of a state investigation into his practice, a patient being coached in the waiting room about how to fill out intake forms, armed guards in provider waiting rooms, high numbers of patients who purchased OxyContin in cash, high numbers of out-of-state or out-of-county tags in providers’ parking lots, accusations of insurance fraud, choreographed urine screenings and pill counts, standing-room-only waiting rooms, and additional signs of problematic high volume practices.

It sounds like one of the devils in the opioid epidemic may just get its due.

06/8/18

Doublespeak in the Opioid Crisis, Part 2

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Last year The New York Times reported drug overdoses were now the leading cause of death for Americans under the age of fifty. The nationwide total for drug-related deaths was around 64,000 in 2016. According to Vox, this is more than the number of soldiers killed during the entire Vietnam War (an estimated 55,000); more than the 43,000 Americans who died in car crashes at the peak of auto-related deaths in 1972; and more than the 43,000 who died of HIV/AIDS in 1995 at the height of that epidemic. A CDC infographic using data from the National Survey on Drug Use and Health (NSDUH) for 2011-2013 reported that individuals who are addicted to opioid painkillers are forty times more likely to be addicted to heroin. Let this last statistic sink in: Today’s heroin addict often begins as someone who first used opioids for pain relief.

In Part 1 of “Doublespeak in the Opioid Crisis” we saw how the misuse of a 1980 letter published in the New England Medical Journal helped to generate these statistics. Here we will look closer at how the accelerated rate in opioid prescribing and one of the players in that increase contributed to the current opioid crisis. Purdue Pharmaceuticals will be shown to have played a crucial role in the birth and growth of the opioid problem in the U.S.

In the Annual Review of Public Health, Kolodny et al. gave the following information in: “The Prescription Opioid and Heroin Crisis.” Since 2000, the consumption of hydrocodone more than doubled and the consumption of oxycodone increased by almost 500%. Parallel to this, the OPR-related overdose death rate increased almost fourfold. Between 1997 and 2011, emergency rooms saw a 900% increase of individuals seeking treatment for addiction to OPRs (opioid pain relievers). “The correlation between opioid sales, OPR-related overdose deaths, and treatment seeking for opioid addiction is striking.” See chart below taken from “The Prescription Opioid and Heroin Crisis.”

In 1986 a paper by Portenov and Foley, “Chronic Use of Opioid Analgesics in Non-Malignant Pain,” concluded that pain patients could be treated safely on a long-term basis with OPRs. “Despite its low-quality evidence, the paper was widely cited to support expanded use of opioids for chronic non-cancer pain.” Along with the misquoting and misuse of Hershel Jick’s 1980 letter in the NEMJ, the stage was being set for the coming increase in the prescription and consumption of opioids. The gradual upward trend of opioid use that began in the 1980s accelerated rapidly after the introduction of OxyContin to the OPR market in 1995.

Between 1996 and 2002, Purdue Pharma funded more than 20,000 pain-related educational programs through direct sponsorship or financial grants and launched a multifaceted campaign to encourage long-term use of OPRs for chronic non-cancer pain. As part of this campaign, Purdue provided financial support to the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the Joint Commission, pain patient groups, and other organizations. In turn, these groups all advocated for more aggressive identification and treatment of pain, especially use of OPRs.

In 1995 the American Pain Society introduced a campaign entitled: “Pain is the Fifth Vital Sign.” Health care professionals were encouraged to assess pain with the same zeal as they do with other “vital signs”; and become more willing to use opioids to treat non-cancer pain. Before the introduction of OxyContin, physicians were reluctant to prescribe OPRs on a long-term basis for common chronic pain conditions, as they were concerned with their patients developing tolerance, physiological dependence and addiction. Opioid manufacturers, including Purdue, had physician-spokespersons publish papers and give lectures on ‘opiophobia,’ claiming the medical community has been confusing addiction and ‘physical dependence,’ which they said was “clinically unimportant.”

In “The Promotion and Marketing of OxyContin,” Art Van Zee said from 1996 to 2001 Purdue conducted more than 40 national pain management and speaker-training conferences at resorts in Florida, Arizona and California. “More than 5,000 physicians, pharmacists, and nurses attended these all-expenses-paid symposia, where they were recruited and trained for Purdue’s national speaker bureau.” In 2001 alone Purdue spent $200 million in a variety of approaches to market and promote OxyContin. Using data on the prescribing patterns of physicians nationwide, Purdue targeted physicians who were the highest prescribers of opioids across the country.

They specifically went after primary care physicians, encouraging a more liberal use of opioids. By 2003, almost half the physicians prescribing OxyContin were primary care physicians. Some experts became concerned that primary care doctors were not sufficiently trained in pain management or addiction issues. Those who worked within a managed care environment of time constraints had the least amount of time to evaluate and follow up on patients with complicated chronic pain.

There was a bonus system in place to encourage sales representatives to increase the sales of OxyContin in their territories. Physicians with high rates of opioid prescriptions received a large number of visits. In 2001, Purdue paid out almost $240 million in sales incentive bonuses to its sales representatives. From 1996 to 2000 Purdue increased its sales force from 318 to 671 sales representatives. The company also had a starter coupon program that provided patients with a 7- to 30-day supply of OxyContin. “By 2001, when the program was ended, approximately 34,000 coupons had been redeemed nationally.”

Branded promotional items like OxyContin fishing hats and stuffed plush toys were distributed. There was even a compact music disc: “Get in the Swing With OxyContin.” The breadth and scope of such marketing was unprecedented for a Schedule II opioid.

Purdue “aggressively” promoted the use of opioids for use in the “non-malignant pain market.” A much larger market than that for cancer-related pain, the non–cancer-related pain market constituted 86% of the total opioid market in 1999.  Purdue’s promotion of OxyContin for the treatment of non–cancer-related pain contributed to a nearly tenfold increase in OxyContin prescriptions for this type of pain, from about 670,000 in 1997 to about 6.2 million in 2002, whereas prescriptions for cancer-related pain increased about fourfold during that same period.

Kolodny et al. indicated that in addition to minimizing the risks of OPRs, opioid manufacturers and pain organizations exaggerated the benefits of long-term OPR use. “In fact, high-quality, long-term clinical trials demonstrating the safety and efficacy of OPRs for chronic non-cancer pain have never been conducted.” Surveys of patients with chronic non-cancer pain receiving long-term OPR treatment suggested that most patients continued to experience significant chronic pain and dysfunction. “The CDC and some professional societies now warn clinicians to avoid prescribing OPRs for common chronic conditions.”

Although increased opioid consumption over the past two decades has been driven largely by greater ambulatory use for chronic non-cancer pain, opioid use for acute pain among hospitalized patients has also increased sharply. A recent study found that physicians prescribed opioids in more than 50% of 1.14 million nonsurgical hospital admissions from 2009 to 2010, often in high doses. The Joint Commission’s adoption of the Pain is the Fifth Vital Sign campaign and federally mandated patient satisfaction surveys asking patients to rate how often hospital staff did “everything they could to help you with your pain” are noteworthy, given the association with increased hospital use of OPRs.

Van Zee indicated in “The Promotion and Marketing of OxyContin” that a consistent feature in Purdue’s promotion and marketing of OxyContin was a systematic effort to minimize the risk of addiction when using opioids to treat chronic non-cancer-related pain. In the literature and audiotapes of their promotional campaign for physicians, and on its “Partners Against Pain” website, Purdue claimed the risk of addiction from OxyContin was extremely small. Purdue trained its sales force to affirm that the risk of addiction was “less than one percent.” They cited the 1980 NEMJ letter to the editor by Jick (see Part 1 of this article for more information on this) and other studies to minimize the risk of addition. “Misrepresenting the risk of addiction proved costly for Purdue,” to the tune of $634 million in fines:

On May 10, 2007, Purdue Frederick Company Inc, an affiliate of Purdue Pharma, along with 3 company executives, pled guilty to criminal charges of misbranding OxyContin by claiming that it was less addictive and less subject to abuse and diversion than other opioids.

While research showed OxyContin was simply comparable to other available opioids in safety and efficacy, Purdue’s marketing made it into a blockbuster product. Sales escalated from $44 million in 1996 to almost $3 billion over 2001 and 2002. Prescriptions increased from 316,000 to over 14 million.

The remarkable commercial success of OxyContin, however, was stained by increasing rates of abuse and addiction. Drug abusers learned how to simply crush the controlled-release tablet and swallow, inhale, or inject the high-potency opioid for an intense morphine-like high. There had been some precedence for the diversion and abuse of controlled-release opioid preparations. Purdue’s own MS Contin had been abused in the late 1980s in a fashion similar to how OxyContin was later to be; by 1990, MS Contin had become the most abused prescription opioid in one major metropolitan area. Purdue’s own testing in 1995 had demonstrated that 68% of the oxycodone could be extracted from an OxyContin tablet when crushed.

Purdue Pharmaceuticals and its subsidiary companies are privately owned by the Sackler family, named in 2016 by Fortune Magazine as the 19th richest family in the US. None of the Sackler family has even been charged in the past litigation against Purdue. Although family members are not involved in the day-to-day operations of Purdue Pharma companies today, several Sacklers are current board members of Purdue Pharma. In “Meet the Sacklers,” Joann Walters pointed out how the Sackler family has a reputation for its cultural and academic philanthropy to institutions such as Harvard, Yale, MIT, Columbia, Cornell, Stanford and other universities in the US; as well as the Guggenheim Museum, the Smithsonian, the Serpentine Sackler Gallery, the Royal Academy in Britain and others.

Allen Frances said in his article for The Guardian there is no Pablo Escobar Wing at New York’s Metropolitan Museum of Art (there is a Sackler Wing); and no El Chapo Guzman gallery at the Guggenheim (there is a Sackler Center for Art Education). Oxford would no longer be Oxford if it had one of its libraries named in honor of the Cali cartel (but there is a Sackler Library). “The Sackler name is emblazoned on, and disgraces, dozens of the world’s greatest museums, universities, and performing arts centers. So far, none has turned down their donations, none has returned their money already given.” He thought a solution was for institutions to elicit and receive permission from the family members to remove their name, “without any quid pro quo requirement for returned funding.”

I’m not sure about that idea, but I could definitely support two other ones he suggested. First, the family should use its fortune to provide “free treatment for the people they addicted.” Second, they should mount “a reverse marketing campaign to undo their previous brainwashing of doctors and patients.” But I don’t think those ideas will ever happen.

While Purdue announced it halved its sales force and will no longer send out field representatives to promote OxyContin to health professionals in the U.S., there is no indication that the same approach will be taken by its overseas subsidiaries, such as Mundipharma. In “OxyContin Goes Global,” the LA Times noted where a network of international companies owned by the Sackler family are expanding into Latin America, the Middle East, Africa and other regions. “In this global drive, the companies known as Mundipharma, are using some of the same controversial marketing practices that made OxyContin a pharmaceutical blockbuster in the U.S.”

If you’re interested in more information on Purdue Pharma, the Sacklers and OxyContin, also look at: “The Tale of the OxyContin Lie” and “Greed With OxyContin Is NOT Good.”

05/29/18

Doublespeak in the Opioid Crisis, Part 1

© Lightsource | stockfresh.com

How did we get to the place where overdose deaths from opioids were five times higher in 2016 than 1999? On average, 115 Americans die every day from an opioid overdose. An estimated 66% of all the drug overdose deaths in 2016 involved an opioid. From 1999 to 2016, more than 630,000 people died from a drug overdose. And there is evidence that a 1980 one-paragraph letter published in the New England Medical Journal was used to get us there.

The above statistics were from a CDC page on opioid overdose called, “Understanding the Epidemic.” The article showed a graphic representation of three waves in the rise in opioid overdose deaths. The first wave began in the 1990s with increase of overdose deaths from prescription opioids. “The second wave began in 2010, with rapid increases in overdose deaths involving heroin.” The third wave began in 2013 and is associated with illicitly manufactured fentanyl.

The letter was co-written by Dr. Hershel Jick, a drug specialist at Boston Medical Center. A Boston Globe article reported that Dr. Jick said his letter only referred to hospital patients getting opioids for a short period of time, not long-term outpatient use. He said: “I’m essentially mortified that that letter to the editor was used as an excuse to do what these drug companies did.” In his book, Pain Killer, Barry Meier noted years after the publication of his 1980 letter Dr. Jick said that he and his coauthor submitted their statistics about opioid use as a letter “because they were not robust enough to merit a study.” He added that nothing could be concluded about the long-term use of opioids from his study.

A team of Canadian researchers demonstrated the connection between Jick’s letter and the opioid epidemic. Their analysis of this connection was published in an editor’s note for the New England Medical Journal: “A 1980 Letter on the Risk of Opioid Addiction.” The original 1980 letter is in an appendix for the June 2017 editor’s note by Juurlink et al. in the NEMJ. It is quoted here in its entirety:

Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well-documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine [Demerol] in two patients, Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.

Dr. David Juurlink, who led the analysis, was quoted by the Boston Globe as saying: “It’s difficult to overstate the role of this letter. . . .  It was the key bit of literature that helped the opiate manufacturers convince front-line doctors that addiction is not a concern.” The NEMJ said its readers should be aware Jick’s letter was heavily and uncritically cited as evidence addiction was rare with opioid therapy. “People have used the letter to suggest that you’re not going to get addicted to opioids if you get them in a hospital setting. We know that not to be true.”

Here’s what Juurlink and his colleagues did. They identified 608 citations of the 1980 letter “and noted a sizable increase after the introduction of OxyContin (a long-acting formulation of oxycodone) in 1995.” Of the articles citing the 1980 letter, 80.8% (491) cited it as “evidence that addiction was rare in patients treated with opioids.” Additionally, 80.8% (491) of the 608 articles did not point out the patients who were described by Jick in his letter were hospitalized at the time they received the prescription. Affirmational citations of the article began to decrease after 2002. See the NEMJ article for a chart illustrating this.

Now let’s look at this trend from another perspective. The Joint Commission (formerly The Joint Commission on the Accreditation of Healthcare Organizations or JCAHO) published a document titled: “The Joint Commission’s Pain Standards: Origins and Evolution.” In 1990 the President of the American Pain Society wrote an editorial criticizing the lack of improvement in pain assessment and treatment since 1970. He said the failure was because patients didn’t tell their doctors and nurses about their pain, nurses weren’t able to adjust doses, and doctors were reluctant to use opioids. Pain, he said, was often invisible. “Pain relief has been nobody’s job.”

In addition to his recommendations to help “make pain visible,” he emphasized the received wisdom of the day that “therapeutic use of opiate analgesics rarely results in addiction.” This wisdom “was based on only a single publication that lacked detail on how the study was done.”  That “study” was the one done by Dr. Hershel Jick and the citation was his 1980 article in the NEMJ. The next year the American Pain Society released quality of assurance standards for the relief of both acute pain and cancer pain. The recommendations followed the previous recommendations of its President. The Joint Commission followed suit and announced new standards for health care organizations to improve pain management in 2000.

Recall that the CDC marked the beginning of the first wave of overdose deaths as beginning in 1999. In “Understanding the Epidemic” a CDC chart tracked the number of drug overdose deaths since 1999. It noted the initial wave of overdose deaths was due to increased prescribing of opioids (natural and semi-synthetic opioids) beginning in the 1990s; with the second wave of heroin beginning in 2010; and synthetic opioids coming as the third wave in 2016. Below is a CDC data brief apparently used to compile the CDC’s three-wave chart.

The Joint Commission standards were lauded by pain management specialists and called “A rare and important opportunity for widespread and sustainable improvement in how pain is managed in the United States.” However, some raised concerns that the new standards would encourage the inappropriate use of opioids. Total opioid prescriptions had been steadily increasing in the U.S. since 1991, which the Joint Commission attributed to the efforts of advocacy work by pain experts. From 1997 the acceleration for opioid prescribing seems to have become more rapid. “Some of this acceleration in the rate of increase in opioid prescribing may have been due to the 1995 approval of the new sustained-release opioid OxyContin.”

The FDA had approved labeling for OxyContin which said that iatrogenic addiction was “very rare” and that the delayed absorption from the sustained-release formulation in OxyContin “reduced the abuse liability of the drug.” These claims were used by Purdue Pharmaceuticals in marketing campaigns to physicians and in more than 40 national pain-management and speaker training conferences; all expense paid ones, that is. In 2001 the FDA required Purdue to remove these unsubstantiated claims form the OxyContin labeling. But the damage was done. “However, the concept that iatrogenic addiction was rare and that long-acting opioids were less addictive had been greatly reinforced and widely repeated, and studies refuting these claims were not publish until several years later.”

So a one-paragraph 1980 letter became a kind of doublespeak, misused by Purdue Pharmaceuticals and others to change popular and medical thinking about pain management. And the first wave of the opioid epidemic was the result.

Updated with additional information on Dr. Jick’s 1980 letter on 6/8/2018

12/12/17

Greed with OxyContin is NOT Good

© Linda Bucklin | 123rf.com

The health insurer Cigna announced that effective January 1, 2018, it will no longer cover OxyContin as a preferred medication. The company is in the process of notifying customers with current OxyContin prescriptions and their doctors of the upcoming change. Individuals who have begun using OxyContin for hospice care or cancer treatments will continue to be covered through 2018. If a doctor believes the use of OxyContin is medically necessary, Cigna will consider approving coverage. Needless to say, Purdue Pharmacy, the manufacturer of OxyContin, disagrees with the Cigna decision.

Cigna will offer an oxycodone equivalent medication with abuse deterrent properties, Xtampza ER with Collegium Pharmaceuticals. Collegium signed a “value-based contract” with Cigna, which will hold the company financially accountable if average daily dosage strengths of Xtampza ER prescribed for Cigna customers exceed a specific threshold. If the threshold is exceeded, Collegium will reduce the cost of the medication. “Linking financial terms to dosage metrics may encourage more education to prevent overprescribing.”

The Fix reported a Purdue spokesperson said there were few differences between OxyContin and Xtampza ER. “Unfortunately, Cigna’s decision limits the tools prescribers can use to help address the opioid crisis as both products are formulated with properties designed to deter abuse.” Cigna responded by saying the point is to change prescription practices. “The insurer hopes that doctors will begin to prescribe drugs like Xtampza ER ‘in lesser quantities and for lesser amounts of time.’”

Cigna’s decision comes in the midst of increasing pressure on Purdue Pharmacy for their aggressive, and at times illegal marketing practices of OxyContin. The pharmaceutical company came under scrutiny partly because of a series of investigative reports by the LA Times that noted a series of issues. The issues including how Purdue Pharma knew pain relief with OxyContin did not last the 12 hours as it claimed; but the company continued to insist the drug did last, in part, to protect its revenue. When doctors complained about the duration, Purdue instructed them to prescribe stronger, not more frequent doses. “OxyContin’s market dominance and premium price hinge on its 12-hour duration.” Purdue allegedly knew of this issue for more than twenty years.

For years, Purdue Pharma lied to federal regulators and the public about the addictiveness of OxyContin and countless patients got hooked on this deadly painkiller. We need to know if Purdue once again lied about the longevity of OxyContin’s pain-relieving properties and hold Purdue accountable.

Additionally, Purdue knew OxyContin was being overprescribed and illegally trafficked, but in many cases, did nothing about it. With one such operation, Lake Medical, Purdue did not stop supplying OxyContin and did not tell authorities what it knew for several years until the clinic was out of business and its leader indicted. By that time, 1.1 million pills has been put on the street.

A Los Angeles Times investigation found that, for more than a decade, Purdue collected extensive evidence suggesting illegal trafficking of OxyContin and, in many cases, did not share it with law enforcement or cut off the flow of pills. A former Purdue executive, who monitored pharmacies for criminal activity, acknowledged that even when the company had evidence pharmacies were colluding with drug dealers, it did not stop supplying distributors selling to those stores.

In 2015 Kentucky received $24 million from Purdue to settle the state’s 2007 against the company over their allegedly illegal promotion of OxyContin. As is usual in cases where pharmaceutical companies settle outside of court, they requested the records gathered in the court case be sealed and destroyed. In this case, there were 17 million pages of documents, including a deposition of Dr. Richard Sackler, the former president of Purdue Pharma and a member of the family who owns the privately held company. As part of the agreement, the Kentucky attorney general destroyed its copies of the documents provided by Purdue. However, copies of several key documents, including the Sackett deposition, filed under seal at the Pike County court, were not destroyed.

STAT News learned of the existence of these documents and filed a motion in March of 2016 to unseal the documents. In May of 2016 a Kentucky judge ordered that the documents be unsealed by June 12th. The judge said he would stay the release of the records if there was an appeal filed before then.  As of June of 2017, the documents were still not released. Purdue appealed the ruling to the Kentucky Court of appeals and although the appeals court said it expected to rule on the matter by the end of August, there was still no announcement by the middle of October.

The President of the Kentucky state Senate planned to file a motion to support the efforts by STAT to unseal the documents, saying that shielding the records from public view was “inappropriate.” He acknowledged his request to intervene could be unsuccessful, and it seems that it was. He thought the documents could help evaluate whether the $24 million payment from Purdue was a good settlement for Kentucky. “Two prior attorneys general valued the case at between $100 million and $1 billion.” Senate President Robert Stivers was concerned the state settled for “pennies on the dollar.”

Purdue was already pivoting to go overseas with its marketing strategy by 2011. With the growing concern over the opioid crisis in the U.S. and the awareness of the role OxyContin played in it, prescriptions fell by almost 40% since 2010, meaning billions in lost revenue for Purdue. Again, the LA Times documented this market expansion by Purdue in a December 2016 article, “OxyContin Goes Global.” Using a network of international companies owned by the Sackler family, Purdue Pharma is moving rapidly into Latin America, Asia, the Middle East, Africa and other regions. “In this global drive, the companies known as Mundipharma, are using some of the same controversial marketing practices that made OxyContin a pharmaceutical blockbuster in the U.S.”

In 2011, operations were started in China, Russia, Turkey, Hong Kong and South Africa. 2013 saw activity in Indonesia, Vietnam, Thailand and Taiwan. Dubai, Brazil, Columbia and Spain came on board in 2014. Lebanon and Portugal opened operations in 2015; Argentina in 2016. Chile, Ecuador, Peru, Uruguay and Venezuela plan to launch operations in the near future.  There is an interactive map on “OxyContin Goes Global” that graphically illustrates this expansion.

In Brazil, China and elsewhere, the companies are running training seminars where doctors are urged to overcome “opiophobia” and prescribe painkillers. They are sponsoring public awareness campaigns that encourage people to seek medical treatment for chronic pain. They are even offering patient discounts to make prescription opioids more affordable.

Like the initial marketing of OxyContin in the U. S., some Mundipharma representatives and promotional material minimize the risks that patients will become addicted to opioid medications. While U.S. public health officials were warning of the growing pain killer threat in 2015, a Mundipharma executive in Seoul South Korea was saying doctors there worry too much about addiction: “Many studies have shown that it’s almost impossible for those with chronic or severe pain to become addicted to narcotics, as long as the drug is used for pain relief.” The opioid problem in the U.S. is said to be largely due to recreational abuse of the drugs.

“That is exactly the same thing they were teaching U.S. physicians when they launched OxyContin in this country,” said Sharon Walsh, an addiction expert who advises the FDA on risks from pain medications.

Mundipharma uses consultants (referred to as thought leaders in the U.S.), as did Purdue and other pharma companies, to overcome this opiophobia among doctors reluctant to prescribe narcotics. Top company officials have said their success in new markets depends on defeating this mind-set.

In Spain, Mundipharma used a series of actors, musicians and models in a campaign against chronic pain. “Ebélate contra el dolor (Rebel against the pain).” The ads did not recommend a specific medication, but urged viewers to seek out a healthcare professional (call your doctor?).  “The campaign is part of a strategy to redefine back pain, joint aches and other common conditions as a distinct malady — chronic pain — that doctors and patients should take seriously.” Mundipharma sales were up seven-fold since 2007.

Around the world, Mundipharma companies cite statistics suggesting there is a great unmet need for their products. Opening an office in Mexico in 2014, Mundipharma officials declared that 28 million citizens were suffering from chronic pain. In Brazil, the company cited a figure of 80 million. In Colombia last year, a company news release said 47% of the population — about 22 million people — were afflicted by ‘this silent epidemic.’”

Meanwhile, back in the US, the lawsuits against Purdue Pharma just keep on coming. In May of 2017 the NYT reported Purdue and three current and former executives pleaded guilty in federal court to criminal charges “that they misled regulators, doctors and patients” about the drug’s addiction risk and potential for abuse. In order to resolve criminal and civil charges stemming from the drug’s “misbranding,” Purdue agreed to pay $600 million, one of the largest amount ever paid by a drug company in such cases. Three executives, including its president and its top lawyer pleaded guilty as individuals to misbranding, which is a criminal violation. “They agreed to pay a total of $34.5 million in fines.”

Purdue Pharma acknowledged in the court proceeding today that “with the intent to defraud or mislead,” it marketed and promoted OxyContin as a drug that was less addictive, less subject to abuse and less likely to cause other narcotic side effects than other pain medications.

Reuters reported that New Hampshire announced in the beginning of August of 2017 that it was suing Purdue for engaging in deceptive marketing practices. The lawsuit followed similar cases against Purdue and other pharmaceutical companies by Oklahoma, Mississippi, Ohio and Missouri and several cities and counties in California, Illinois, Ohio, Oregon, Tennessee and New York.

A week later, South Carolina filed suit against Purdue Pharma, according to Reuters. Again the company is accused of unfair and deceptive marketing of opioid painkillers. South Carolina had been part of a 2007 settlement when Purdue and three executives pleaded guilty to federal charges of misbranding OxyContin. In the August 2017 lawsuit, “South Carolina claimed that since the 2007 settlement, Purdue has continued to engage in misleading opioid marketing practices rather than reforming them to conform with the law.”

In the 1987 movie Wall Street, Michael Douglas as Gordon Gekko famously said, “Greed, for lack of a better word, is good.”  He went on to claim that greed captured the essence of the evolutionary spirit. “In all of its forms; greed for life, for money, for love, knowledge has marked the upward surge of mankind.” At the end of his speech, he was applauded. The greed of Purdue Pharma and the Sackett family, which privately owns Purdue Pharma and OxyContin, is not good. Their unrestrained greed has contributed to the current opioid epidemic in the U.S., despite the denials of the company. And now they want to export the same drug and marketing strategy to the world.