12/26/23

The Sackler Cartel Goes Before the Supreme Court

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 4^th 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?

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 17^th 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

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 10^th 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.”

02/1/22

Carrot-and-Stick Tactics of Purdue and the Sacklers

In the aftermath of frustration with the bankruptcy settlement with Purdue Pharma that shielded the Sackler family from any future legal action, the Metropolitan Museum of Art and the Sackler family announced the Sackler name would be removed from seven exhibit spaces. The New York Times said this was a significant break between the world’s largest museum and one of the world’s biggest benefactors. The Sackler family said they thought it was in the best interest of the museum and the mission it serves. “The museum had already severed ties to the family’s funding, announcing in 2019 that it would no longer accept gifts from the Sacklers, given their links to the maker of OxyContin.” Then a week later, a federal judge overturned the settlement that legally shielded members of the Sackler family from future litigation.

Reuters reported that U.S. District Judge Colleen McMahon said the New York bankruptcy court did not have the authority to grant the Sacklers legal protection from future opioid litigation. Attorney General Merrick Garland agreed, and was pleased by the ruling. He said: “The bankruptcy court did not have the authority to deprive victims of the opioid crisis of their right to sue the Sackler family.”

McMahon raised questions about more than $10 billion that Purdue distributed to the members of the Sackler family over a ten-year period of time preceding the company’s filing for bankruptcy. A statement from the family about the transfer of funds 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 bankruptcy settlement was said to be worth $8 billion, a record payout by a pharmaceutical company. However, the Sackler family threatened to walk away and scuttle the settlement unless the legal protections were included. The family was to contribute over $4 billion of their personal funds to charitable assets over nine years as part of the settlement.

The Hill reported that in September 2021, U.S. Bankruptcy Judge Robert Drain approved the initial settlement plan. It would have led to the dissolution of Purdue Pharma and the transfer of its assets to a nonprofit company whose mission would be to fight the opioid crisis.

Representative Carolyn Maloney (D-N.Y.), Chair of the Committee on Oversight and Reform, said: “Today’s ruling striking down Purdue Pharma’s bankruptcy plan and its illegal releases for the Sacklers is a monumental step toward justice for the victims of the Sacklers’ cruel, deliberate plan to flood our communities with the highly addictive opioid, OxyContin.” She added,

The Sacklers must not be permitted to evade accountability by abusing our bankruptcy system, and I applaud the District Court for recognizing what I’ve long believed — that nonconsensual third-party releases are not only immoral and unjust, but also illegal.

Of course, Purdue will appeal the district court’s decision. Steve Miller, Purdue’s chairman, said:

While the district court decision does not affect Purdue’s rock-solid operational stability or its ability to produce its many medications safely and effectively, it will delay, and perhaps end, the ability of creditors, communities, and individuals to receive billions in value to abate the opioid crisis.

This sounds suspiciously like Purdue and the Sacklers are using a “carrot-and-stick” approach to their negotiations—the billions in settlement money as the carrot and the threat of rejecting the settlement without legal protection of the Sacklers from future opioid litigation as the stick.

Paul Pelletier, a former Department of Justice fraud chief and Beth Macy, a journalist and the author of Dopesick, wrote an opinion piece for STAT News. They noted that in late 2020, Purdue pled guilty to defrauding federal health agencies and violating anti-kickback laws. Although the Department of Justice won a $225 million civil settlement, it won’t collect on the $8.3 billion fine, as the company was already in bankruptcy. It failed to bring charges against any individuals for their roles in the company’s crimes. But the 2020 settlement did not close the door on criminal prosecution of Sackler family members.

Sacklers Avoiding Justice?

Fifteen years ago, prosecutors in western Virginia uncovered evidence of fraud and recommended multiple felony charges against the three top executives at Purdue. These charges included money laundering, conspiracy, misbranding, interstate wire and mail fraud. Pelletier and Macy said “the evidence of callous greed was chilling.” But political appointees at the DOJ, swayed by Purdue’s lawyers, refused to approve felony charges for the executives.

Purdue received a $600 million fine and pleaded guilty to “misbranding” OxyContin while marketing. The three executives pleaded to a misdemeanor “misbranding” charge, but did not admit any wrongdoing. The case was settled through a plea bargain and the evidence within the case forgotten until a copy of the Justice Department memo was leaked. For more information on this, see “Giving an Opioid Devil Its Due.”

The company had fired employees who tried to blow the whistle on its crimes and maneuvered to have reporters who were onto the story fired or removed from their beats. Sales reps were encouraged to allow doctors to believe — falsely — that morphine was stronger than OxyContin when executives knew the opposite was true. The company’s medical director, Dr. Paul Goldenheim, lied to Congress when he testified that executives hadn’t known until 2000 that OxyContin was being widely abused: in fact, they’d become aware of addiction-related abuse shortly after the drug’s introduction in 1996.

“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.”

Pelletier and Macy said after avoiding a legal trial related to the above investigation, they know the Sacklers and Purdue intensified their marketing of OxyContin. Purdue hired consultants to advise them how to “turbocharge” sales. They concentrated on well-known pill mills, and pushed the highest-dose pills. They also joined with other opioid makers to get around FDA regulators.

Beth Macy’s book, Dopesick was made into a television series. The show’s creator said it was “the trial that Purdue Pharma and the Sackler family never had.” As Pelletier and Macy pointed out, America is not supposed to rely on books and a movie for justice. “We pay taxes and give the Department of justice legal authority to enforce the law.” They said that Judge McMahon’s ruling was a win for accountability, “but it may not endure.”

So far, no criminal charges have been filed against any member of the Sackler family. But a new U.S. attorney for the federal district responsible for investigating the Sacklers has been sworn in. And Pelletier and Macy think he could be the perfect Special Prosecutor. We’ll have to wait and see if this makes a difference. Meanwhile, the Metropolitan Museum of Art continues to distance itself from the Sacklers and Purdue.

While the billionaire Sacklers may spend this holiday season ruminating on the ignominy of having their name removed from New York’s Metropolitan Museum of Art and other museums they showered with blood money, a million families across America will have to endure it without their children, spouses, parents, and friends whose lives were either eviscerated or cut short by opioids. It is shameful that, at least for now, they must live without justice, too.

For more information on the initial settlement, see: “It Doesn’t Seem Right.”

09/7/21

It Doesn’t Seem Right

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 12^th 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 1^st, 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

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.

03/26/19

Runaway Pharma Gravy Train

The Pharmaceutical Research and Manufacturers of America (PhRMA) spent $27.5 million on lobbying in Washington last year. This was a new record, surpassing the previous high set in 2009, when PhRMA spent over $27 million. “The new record also topped 2017’s lobbying spend—$25.43 million, at a time when Trump was taking office and pricing was often on the airwaves—by about 8%.” The increases parallel steadily increasing prices for several years. For example, Medicaid drug costs nearly doubled to $31 billion.

Rep. Elijah Cummings initiated an investigation of 12 pharmaceutical companies in an effort to uncover pharma pricing practices. Cummings sent letters seeking information and documents about the companies’ pricing practices. This is the first step of the Committee on Oversight and Reform’s review of pricing practices. The Committee will also hold hearings in order to hear from experts and patients affected by rising drug prices.

The Centers for Medicare and Medicaid Services projects that spending on prescription drugs will increase more rapidly than spending on any other health care sector over the next ten years. The federal government bears much of the financial burden of escalating drug prices through Medicare Part D, which provides drug coverage to approximately 43 million people. The government is projected to spend $99 billion on Medicare Part D in 2019. In 2016, the 20 most expensive drugs to Medicare Part D accounted for roughly $37.7 billion in spending.

The hearing was held on Tuesday, January 29, 2019, just two weeks after Rep. Cummings sent out his letters. There also seems to be bipartisan support to rein in drug prices. FiercePharma wondered whether this was real bipartisan unity or just talk. Rep. Mark Meadows, A Republican from North Carolina, said President Trump asked him to make sure the House knew on this issue, “He’s serious about working in a bipartisan way to lower prescription drug prices.” At the hearing Cummings acknowledged Trumps support, but said: “But tweets are not enough—we need real action and meaningful reforms.”

STAT News reported that Cummings is asking for “10 years worth of sales, revenue, pricing, rebate, discount, and commercialization data.” Additionally he’s asked for information detailing research and development expenses; information on patents and indications; employee compensation and bonus details; each company’s interaction with federal agencies; and details of company’s contracts with PBMs (pharmacy benefit mangers). Although his probe already includes most of the country’s largest pharmaceutical companies, he’s not finished. “There’ll be more.” Other congressional committees, such as Energy and Commerce and the Senate Finance Committee, are planning to do their own investigations.

The ten most expensive brand-name drugs accounted for $15.6 billion of spending in the catastrophic coverage phase of the Medicare Part D benefit in 2015. While the number of prescriptions fell by 17%, the Part D payments for brand-name drugs increased by 62% from 2011 to 2015. The payments for about 94% of commonly used medications more than doubled. The percentage of Medicare Part D beneficiaries who paid at least $2,000 out-of-pocket for their drugs almost doubled from 2011 to 2015. Cummings is focusing his inquiries on drugs that are among the costliest to Medicare Part D. If you’re curious, there is a link in the article to a list of the companies and drugs for conditions ranging from arthritis, cancer and cholesterol to diabetes.

An NPR and Center for Public Integrity investigation found drug companies have penetrated almost all aspects of the process that determines how their drugs are covered by taxpayers. Doctors on obscure committees advising state Medicaid programs receive free dinners and consulting contracts with the pharmaceutical companies. Speakers who don’t disclose their financial ties to the pharmaceutical companies are asked to testify about the companies’ drugs. State Medicaid officials are invited to attend all-inclusive conferences for free where they mingle with drug representatives.

Beyond that, drugmakers use other tactics to get their products paid for by the Medicaid programs: lobbying state lawmakers to achieve their goals or helping doctors fill out extra paperwork to get Medicaid to pay for the costlier drugs as Warner Chilcott did. The result is that Medicaid sometimes spends more than necessary and may pay for medicines inappropriate for patients.

The drug companies say they are not responsible for the problems. A spokesperson for PhRMA said: “As an industry, our priority is ensuring that patients have access to the medicines they need . . . . States should consider changes to Medicaid that are in line with the intended goal of ensuring robust access to medically necessary drugs.” Pharmaceutical companies have strong incentives to be included on states’ lists of approved drugs. Doctors are far more likely to prescribe an approved drug to Medicaid patients and may encourage other insurers to do the same. To gain a spot on the coveted lists, drug makers offer the states “supplemental rebates,” which are on top of other price concessions required by federal law. “The drug committee meetings where those list decisions are made are a frequent destination for drug company representatives — and those who benefit from their largesse.”

Across the country, drugmaker representatives and pharma-friendly clinicians with industry ties swarm these low-profile drug committees, a review of meeting minutes shows. Center for Public Integrity and NPR reporters saw similar dynamics play out this spring in meetings in Arizona, Washington, D.C., and Louisiana. The committees, usually known as pharmacy and therapeutics committees or drug utilization review boards, are typically made up of volunteer pharmacists and doctors.

Critics of the practice say when pharma companies target these committees, the states don’t get good deals. They also can make bad decisions for their patients. Three out of five doctors voting on state Medicaid decisions received perks from pharmaceutical companies. There are at least 38 states with doctors serving on their Medicaid drug committees who collected more than $1,000 from pharmaceutical companies while they served on the committees. Consider that while this amount may point to how money influences Medicaid decisions, a study in JAMA Internal Medicine, “Pharmaceutical Industry-Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries” found that when doctors get as little as a $20 lunch, they are more likely to prescribe the company’s drugs.

As compared with the receipt of no industry-sponsored meals, we found that receipt of a single industry-sponsored meal, with a mean value of less than $20, was associated with prescription of the promoted brand-name drug at significantly higher rates to Medicare beneficiaries. The differences persisted after controlling for prescribing volume and potential confounders such as physician specialty, practice setting, and demographic characteristics. Furthermore, the relationship was dose dependent, with additional meals and costlier meals associated with greater increases in prescribing of the promoted drug.

The NPR article told of a nonprofit organization, the American Drug Utilization Review Society (ADURS), whose mission is to provide a forum of leadership and support for its members. It hosted a free conference for Arizona state Medicaid officials in Scottsdale, where Michael Magnotti, an endocrinologist, gave a talk on diabetes. He was paid $1,545 for the talk by Sanofi-Aventis; and he received more than $108,000 in consulting fees from pharmaceutical companies for that year. Sanofi S.A. is the world’s fifth-largest multinational pharmaceutical company. And it was one of the companies to receive a letter from Rep. Cummings.

A more disturbing ADURS conference took place in 2003 when Purdue Pharma helped to fund it. A speaker told his audience that addiction from the medical use of opioids was rare, and he then described a phenomenon called “pseudoaddiction.” A slideshow of the presentation (linked in the STAT article) said pseudoaddiction included “appropriate drug seeking behavior” such as demanding doses before they are scheduled. In support of his claims, he referenced a letter published in the New England Medical Journal back in 1980: “Addiction Rare in Patients Treated with Narcotics.”

This article has been repeatedly misused by pharmaceutical companies (like Purdue) as they assert that the risk of addiction from the medical use of opioids is almost nil. The potential influence of pharmaceutical companies like Purdue on opioid prescribing and the opioid epidemic has received significant attention in the media. Currently 24 states and Puerto Rico have sued Purdue for downplaying or concealing the risks of its painkillers. See the book by Barry Meier, Pain Killer for more on this issue. Also see “Doublespeak in the Opioid Crisis,” Part 1 and Part 2 for more about the misuse of the 1980 article. See “Giving an Opioid Devil Its Due” for more on Purdue Pharma. This concern is now being looked at in the research literature.

A new study released on January 18, 2019 in JAMA Network Open suggested there may be a link between aggressive marketing, drug company money and overdose death rates. The researchers found that counties receiving pharmaceutical marketing of opioids to physicians subsequently experienced increased mortality rates. Commenting on the study, Science Alert said while the study did not demonstrate a cause-and-effect relationship, it did suggest that frequent trust-building visits, like lunches sponsored by drug sales reps, did more to promote prescribing the company’s drugs than high-dollar payments to physicians. One of the researchers said: “What seems to matter most wasn’t the amount of money doctors were paid, it was the number of times they were paid.”

Our findings suggest that direct-to-physician opioid marketing may counter current national efforts to reduce the number of opioids prescribedand that policymakers might consider limits on these activities as part of a robust, evidence-based response to the opioid overdose epidemic in the United States.

While Pharma’s spending on lobbying and advertising to doctors (and consumers) continues to rise, so do the negative consequences. Pharma knows marketing has a tremendous potential to grow its profits. So spending on lobbying has increased alongside that of marketing to doctors and consumers. The public pays a price by permitting these activities to continue unhindered. Unchecked greed seems to have helped facilitate the opioid crisis. Hopefully the efforts of legislators like Elijah Cummings will make it out of their respective committees and into law. We need to stop the runaway Pharma gravy train.

12/4/18

The Bondage of Buprenorphine

It’s not often that a patent award creates a media storm, but it happened recently when a patent was awarded for a novel oral formula of buprenorphine, the opioid in Suboxone and its generic cousins. The new formula is a buprenorphine-wafer that is proposed for MAT (medication assisted therapy) with opioid addicts as well as for treating chronic pain. The wafer formula is said to be more “diversion and/or abuse-resistant” than the existing ones, which are tablets (ie., Subutex and Zubsolv) and sublingual film (i.e., Suboxone). It just so happens that one of the six listed inventors of the buprenorphine wafer is Richard Sackler; and Purdue Pharma LP was the original assignee for the patent. Members of the Sackler family and Purdue Pharma are currently facing hundreds of lawsuits that claim they played a role in the birth and growth of the opioid crisis.

The connection of the Sackler family and Purdue Pharma to the opioid crisis is tellingly documented by Barry Meier in his book, Pain Killer, which was recently released in a second, updated edition. Read: “Giving an Opioid Devil Its Due” for an overview of Meier’s book, with links to two NYT articles he wrote as Pain Killer was published in May of 2018. Also see “The Tale of the OxyContin Lie,” “Greed with OxyContin is NOT Good,” and “Doublespeak in the Opioid Crisis, Part 2” for more on the connection of Purdue Pharma and the Sackler family to the opioid crisis.

Among the media outlets describing the Sackler and Purdue connection to the buprenorphine-wafer patent was STAT News and The Washington Post. Both news outlets noted how several critics are outraged that the Sacklers and Purdue are positioning themselves to benefit financially from the opioid epidemic they are seen as having facilitated in the first place. Luke Nasta, the director of a New York-based drug and alcohol addiction treatment center said the Sackler family “shouldn’t be allowed to peddle any more synthetic opiates—and that includes opioid substitutes.” He added: “It’s reprehensible what Purdue Pharma has done to our public health.”

The patent application for the buprenorphine-wafer said there is a need for “other diversion and/or abuse-resistant dosage forms of buprenorphine, which can be used in drug substitution therapy.” Additionally, the preparation would also provide “efficient analgesia” when used for pain relief.

It is an object of the present invention to provide an oral pharmaceutical dosage form of the active agent buprenorphine that is less prone to diversion and/or abuse in drug substitution therapy. It is another object of the present invention to provide an oral dosage form of the active agent buprenorphine that can be used for drug substitution therapy and/or pain treatment.

The patent does not seem to only envision using the wafer technology with buprenorphine. It points out how “the invention and its various embodiments which are set out below, can be extended to any opioid or analgesic whose preferred route of administration is oral, preferably sublingual, as is the case for buprenorphine.” One embodiment of the wafer is also said to release buprenorphine or other “pharmaceutically acceptable salt” in less than three minutes, and perhaps as quickly as one or two minutes.

Even more preferably, substantially all of the buprenorphine or said pharmaceutically acceptable salt thereof will be released within less than thirty seconds, twenty seconds, ten seconds or even within less than five seconds after oral, preferably sublingual, application of the dosage form.

Reflect for a moment on how rapid, “instant” absorption of a drug intravenously or nasally is often the preferred method of drug ingestion by an addict because the euphoria is more immediate. The good news here is the wafer technology will seemingly restrict diversion, but the bad news is it may initiate another rapid ingestion method for individuals looking for an opioid high. The biochemical nature of buprenorphine is said to have a “euphoric ceiling” that limits its long-term abuse potential, but the same is not true for other addictive “pharmaceutically acceptable salts.”

Another red herring in the patent application is describing how drug addicts take prescription drugs for replacement therapy “under the close supervision of medical parishioners.” This means that the slower absorption of buprenorphine in the other formulas, taking five to ten minutes to dissolve, could result in drug addicts trying “to divert these sublingual buprenorphine tablets by removing them from the mouth when the supervising healthcare professional’s attention is directed to other activities.” Methadone, which is only used within a medical setting in the U.S., did have these kinds of problems years ago so the formula was changed from a tablet to a liquid form. Ingesting buprenorphine in MAT is NOT supervised in a medical setting in the U.S. The patient gets a prescription and takes the medication without any medical supervision, so the supposed advantage of the rapidly absorbed buprenorphine wafer in limiting diversion is nonexistent.

Also in the news about the Purdue Pharma debacle is the role of Rudy Giuliani, who acted as legal counsel for Purdue in the mid-2000s. FiercePharma, The Hill and others reported that two Democratic Senators are requesting documents detailing information about Purdue Pharma’s interactions with the Department of Justice and the Drug Enforcement Agency when Purdue was under investigation for its OxyContin promotions. They are trying to determine whether or not Giuliani “secured leniency for opioid maker Purdue Pharma through conflicts of interest.” At the same time he was representing Purdue Pharma in its dealings with the Department of Justice over a probe of Purdue’s marketing of OxyContin, Giuliani’s firm worked for the DOJ under a $1 million contract to provide advice on reorganizing its major drug investigations. FiercePharma said:

According to the letters, Giuliani convinced political appointees at the Department of Justice to reject career prosecutors’ recommendations in the opioid marketing case. As a result, the company entered a guilty plea to “misbranding” OxyContin, its powerful painkiller. Under the deal, the senators also said Giuliani convinced DOJ to assign fault to Purdue Frederick, a holding company, to allow Purdue Pharma to continue to do business with the federal government. Purdue paid $640 million under the agreement in 2007.

The bottom line is it seems Giuliani helped Purdue keep OxyContin on the market after 2007. Top Justice Department officials in 2006 failed to follow their Virginia prosecutors’ recommendations to indict Purdue Pharma executives on felony charges instead of the lesser misdemeanor charges and no jail time they ultimately received. Even with this sweet plea deal in hand, the night before the plea agreement was set to expire—meaning the company would face charges—a senior Justice Department official (“at a Purdue lawyer’s request”) phoned John Brownlee, the U.S. Attorney pursuing the indictment, at his home in an attempt to convince him to extend the deadline and give Purdue more time. It didn’t work.

By the time the negotiations were complete, Purdue’s holding company, Purdue Frederick, would plead guilty to a single misbranding felony and the company’s executives to misdemeanor charges of misbranding the drug. Ultimately, though, it was the holding company, not Purdue Pharma, that was banned from doing business with public health programs, a Giuliani-arranged deal that allowed OxyContin sales to continue growing—and the epidemic to continue festering, largely unchecked.

Another factor to remember in the pursuit of Sackler and others to bring their buprenorphine wafer to market is the anecdotal reports of individuals withdrawing from buprenorphine. Regularly in my years of experience working with opioid addicts, those who used and/or abused buprenorphine reported how buprenorphine was harder for them to “kick” than heroin, methadone or any other opioid. Could we be looking at the creation of an entire population of individuals who are physically dependent on buprenorphine without the ability to discontinue the drug once they use it for an extended time period? See Pain Killers or the Politico article, “They Were All Lawyered Up and Rudy Giuliani’d Up” for more on how Giuliani fought for Purdue. Politico also unpacks some of the back-story to the 2007 plea agreement reached with Purdue by the DOJ.

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 20^th], 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 5^th 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.

Faith Seeking Understanding

Charles Sigler, D.Phil.

Tag Archives: Purdue Pharma