Tag: opioid marketing

02/1/22

Carrot-and-Stick Tactics of Purdue and the Sacklers

© kmiragaya |123rf.com The Metropolitan Museum of Art in Manhattan

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.”

 

08/21/18

A Time of Reckoning is Coming

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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