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Owners of OxyContin Maker Gave $19 Million to Institute That Shaped Federal Opioid Policy

By Michael Nevradakis, Ph.D. | The Defender | April 25, 2023

As the opioid crisis in the U.S. grew, the National Academies of Sciences, Engineering, and Medicine, an advisory group that helped shape the federal government’s response to the crisis, accepted millions of dollars in donations from the Sackler family — owners of Purdue Pharma, the producers of OxyContin.

The donations occurred despite ongoing legal battles — and a number of settlements — involving Purdue Pharma in recent years, and as other public health entities, including the World Health Organization (WHO), severed ties to the drugmaker, The New York Times reported.

The new revelations come as questions emerge about the lack of transparency regarding how money from several opioid-related settlements has been used by state governments, and the federal government’s lack of oversight in connection to this issue.

According to data from the Centers for Disease Control and Prevention (CDC), more than 564,000 Americans died as a result of opioid overdoses between 1999 and 2020. The opioid epidemic costs the U.S. economy approximately $78.5 billion each year, according to the CDC.

Strong ties between the National Academies and the Sacklers

Several members of the Sackler family, including Dr. Raymond Sackler and his wife, Beverly Sackler, the couple’s foundation, and Dame Jillian Sackler and her husband Arthur, contributed about $19 million to the National Academies since 2000, according to the Times.

The National Academies’ treasurer report for 2021 stated that these funds were invested and had grown to more than $31 million.

The donations, however, appeared to remain under the radar for members of the National Academies — and the general public — until recently.

According to the Times, the Sackler donations emerged as “an internal issue for the advisory group in 2019, when members of the governing council were briefed about the money” and were reportedly “outraged.”

After internal meetings, the National Academies “quietly removed the Sackler name” from conferences and awards the family had sponsored.

Also in 2019, an article in The BMJ stated that the National Academies had “not disclosed that one of its presidents, and members of a panel it convened to advise on prescribing opioids, had recent links to the drug industry.”

Potential conflicts of interest between Purdue Pharma and public health organizations are not limited to the National Academies. The WHO, for instance, was accused of such a conflict of interest and as a result, in 2019, retracted two opioid policy reports.

However, the Times reported that, unlike the WHO, “the National Academies has not conducted a public review to determine if the Sackler donations influenced its policymaking, despite issuing two major reports that influenced national opioid policy.”

One of those reports, issued in 2011, continues to be used by federal public health agencies as the basis for opioid policy decisions — even though, according to the Times, the report is “now largely discredited.”

According to the Times, the report “described chronic pain that limited function and cost the nation billions of dollars in lost salary and wages.” Later estimates from the CDC, “defined chronic pain by different categories of severity, saying the condition affects 7% to 21% of Americans.”

“Regulatory, legal, educational and cultural barriers inhibit the medically appropriate use of opioid analgesics,” the report argued.

The report claimed that approximately 100 million Americans suffered from chronic pain, “an estimate that proved to be highly inflated,” the Times stated.

However, this report helped influence aggressive opioid sales campaigns on the part of drugmakers and influenced the approval of “at least one highly potent opioid” by the U.S. Food and Drug Administration (FDA).

The 2011 report was issued even as the White House stated that the U.S. was facing an opioid addiction crisis.

In the years preceding the publication of the report, Purdue Pharma lobbied for legislation — which passed in 2010 — that would recognize pain as a significant public health problem. Purdue also called for the National Academies to issue similar recognition. Meetings between Purdue Pharma lobbyists and members of the academies followed.

A 2014 investigation by the Milwaukee Journal Sentinel and MedPage Today found that within three years of working on the report, nine of the 19 people on the panel that produced it had financial connections to makers of narcotic painkillers.

According to the Times, the report did not disclose any conflicts of interest involving its author — nor did a 2014 article published by the National Academies in the JAMA journal, explaining how the committee arrived at the “100 million Americans” figure.

Several members of the committee that produced the 2011 report directly or indirectly received money from Purdue Pharma — including Dr. Richard Payne, then-president of the American Pain Society, who received more than $900,000, and Myra Christopher, whose nonprofit received $934,770.

Separately, in 2016 — months after the National Academies received a $10 million donation from members of the Sackler family and with opioid-related deaths on the rise — the FDA, under pressure from Congress, called on the Academies to “form a committee to issue new recommendations on opioids,” according to the Times.

Dr. Robert Califf, FDA deputy commissioner for Medical Products and Tobacco in 2016 (now FDA commissioner), turned to the National Academies for guidance. Notably, Califf was elected to the National Academy of Medicine later that year.

According to the Times, Califf cited the “100 million” figure in an article he and other FDA officials published in the New England Journal of Medicine, which stated that the National Academies bring “an unbiased and highly respected perspective on these issues that can help us revise our framework.”

Members of the committee subsequently formed had multiple conflicts of interest, which were first identified by Sen. Ron Wyden (D-Ore.) in a 2016 letter to Dr. Victor Dzau, president of the National Academy of Medicine. The BMJ also examined those conflicts of interest, in a 2018 article.

One member of the committee, for instance, who had received funding from Purdue, characterized opioid addiction using the term “pseudoaddiction.”

Ultimately, four members of the committee were replaced, but the final document produced by the committee remains a cornerstone of the opioid policy currently pursued by the FDA and Califf.

The “100 million” figure was previously invoked by then-FDA commissioner Dr. Margaret Hamburg in 2014, upon the agency’s approval of a “controversial and potent opioid called Zohydro,” according to the Times. Zohydro was later pulled from the market.

And in 2012, Purdue’s lawyers used the “100 million” figure as part of a Senate inquiry, citing it as evidence that pain was “untreated or under-treated,” the Times reported.

According to the Times, this is not the only instance in which the National Academies have “come under criticism for lapses over disclosing conflicts of interest,” citing similar instances involving reports on biotechnology, genetically engineered crops and pharmaceutical pricing.

Similarly, donations that were provided by the Sacklers to other institutions drew scrutiny — and in several instances, action on the part of those entities.

For instance, Tufts University released a review of possible conflicts of interest pertaining to pain research funded by Purdue Pharma, as part of a broader relationship with the institution which included Purdue executives delivering lectures to Tufts students.

According to the Times, Tufts and other academic institutions, such as Brown University, have redirected financial donations received from the Sacklers, now using them “to address the prevention or treatment of addiction.”

Billions of dollars in settlements from opioid producers

Multiple pharmaceutical companies and drug store chains have reached settlements stemming from their production and marketing of opioids and painkillers — and their subsequent contribution to the opioid addiction crisis.

Information provided by OpioidSettlementTracker.com reveals that these settlements involve companies such as Johnson & Johnson ($26 billion), the “big three” drugstore chains — CVS, Walgreens and Walmart ($13.8 billion), Teva ($4.25 billion), Allergan, now part of AbbVie ($2.37 billion), Mallinckrodt ($1.7 billion) and Endo ($450 million).

According to the Times, the National Academies of Sciences, Engineering, and Medicine “continued to accept funds from some members of the Sackler family, including those involved with Purdue Pharma,” even as the opioid crisis raged on and its impacts on American society became increasingly apparent.

The donations totaled approximately $19 million — but the National Academies “have kept quiet” about their decision to accept these funds, the Times reported, adding that they have “largely avoided such scrutiny” and continue to advise the federal government on opioids and painkillers.

This is despite the fact that Purdue Pharma has twice pled guilty to federal criminal charges connected to its marketing of OxyContin, in 2007 and 2020, and has faced a spate of lawsuits. While none of those lawsuits has gone to trial, many of those cases have been settled out of court.

Purdue Pharma continued to promote OxyContin to doctors as recently as 2018. By then, the Sackler family had amassed an estimated $10.7 billion from sales of the drug. However, the family has repeatedly denied any responsibility for the nation’s opioid crisis.

The National Academy of Medicine — formerly known as the Institute of Medicine — is a nongovernmental institution chartered by President Abraham Lincoln in 1863 to independently advise the nation on issues related to science and medicine, according to the Times. New members are elected each year.

Despite the nongovernmental status of the National Academies, the White House and Congress rely on its advice to help shape the federal response to the opioid crisis. This advice is delivered via policy recommendations, the drafting of reports and the organizing of expert panels, the Times reports.

Moreover, according to the Times, the National Academies “receives 70 percent of its budget from federal funding.” Some of the remaining 30%, however, comes from prescription drug makers like Purdue Pharma.

In October 2020, the U.S. Department of Justice (DOJ) announced a $225 million settlement with Purdue Pharma regarding a program through which Purdue representatives “intensified their marketing of OxyContin to extreme, high-volume prescribers … causing healthcare providers to prescribe opioids for uses that were unsafe, ineffective, and medically unnecessary, and that often led to abuse and diversion.”

However, other lawsuits against Purdue Pharma regarding OxyContin have taken a circuitous route through the courts. The same October 2020 DOJ statement also announced an $8.3 billion settlement with Purdue Pharma for its role in perpetuating the opioid epidemic.

At the time, the Times noted “it is unlikely the company will end up paying anything close to the $8 billion negotiated in the settlement deal” because “it is in bankruptcy court and the federal government will have to take its place in a long line of creditors.”

This prediction appears to have been confirmed by later developments in the case.

A Sept. 1, 2021, settlement would have required members of the Sackler family to pay $4.5 billion over nine years to resolve civil lawsuits related to the opioid crisis, but did not require the family to admit any responsibility for the crisis. It also included a compensation fund that would pay victims of the opioid epidemic between $3,500 and $48,000.

Immunity would extend to members of the family and to hundreds of foundations, trusts, business partners, attorneys, lobbyists, Purdue subsidiaries and other entities. Purdue would be dissolved and re-established as a public benefit corporation, with profits from sales of OxyContin and other products used to fund addiction treatment and prevention programs.

As part of that settlement, Dr. Richard Sackler, the longtime president and board member of Purdue Pharma, was deposed — in what may be the only instance where he or other family members have testified under oath in relation to the opioid crisis.

Throughout the eight-hour deposition, Sackler denied any wrongdoing on the part of his company or his family.

In December 2021, a federal court threw out this settlement on the basis that the bankruptcy court hearing the case lacked the authority to grant the Sacklers future legal immunity.

In March 2022, the Purdue settlement amount increased to $6 billion after nine state attorneys general agreed to drop their objection to an immunity deal, with the additional funds to be directed to programs designed to tackle the opioid crisis. However, the immunity provided to the Sacklers would remain in place for civil cases.

The federal government would still be able to pursue criminal charges against members of the Sackler family if it wished, NPR reported.

However, some plaintiffs challenged his settlement. They included Canadian local governments and First Nations; two mothers of sons who died of opioid overdoses; and the U.S. Trustee Program, an arm of the DOJ responsible for overseeing the administration of bankruptcy cases and private trustees.

In April 2022, the 2nd Circuit U.S. Court of Appeals held a hearing connected to these appeals. Few developments have followed since. The case is still pending and may ultimately end up before the Supreme Court.

The $225 million settlement reached in 2020 with the DOJ remains in place. Separately, the Sackler family contributed $75 million to Oklahoma in 2019 as part of a settlement, and reached a $24 million settlement with Kentucky in 2015.

Questions over how opioid settlement funds are being allocated

Despite settlements totaling many billions of dollars, questions remain over how these funds are actually being allocated — and about the federal government’s lack of oversight on this matter.

According to the Kaiser Family Foundation (KFF), the Biden administration “promised to play a key role in ensuring opioid settlement funds went toward tackling the nation’s addiction crisis,” including a plan to appoint an “opioid crisis accountability coordinator.”

However, according to the KFF, “as billions of dollars actually start to flow and state and local leaders make crucial decisions on how to spend the more than $50 billion windfall to tackle this entrenched public health crisis, the federal government has gone mostly quiet.”

For instance, no opioid crisis accountability coordinator has been hired. KFF also notes that “The Office of National Drug Control Policy has not released public statements about the settlements in over a year” and “the settlement funds are mentioned just twice in a 150-page national strategy to reduce drug trafficking and overdose deaths.”

Even though, according to KFF, “the federal government is not legally obligated to engage in the discussion,” as lawsuits against opioid makers have been filed by states, “there is an expectation that the federal government, including the nation’s leading agencies on mental health and addiction, should play a role.”

Parallels are drawn with previous settlements with Big Tobacco. According to KFF, tobacco companies agreed in 1998 “to pay states billions annually for as long as they continued selling cigarettes.”

However, no restrictions were placed on how the funds would be used, “and much of it went to plugging state budget gaps, filling potholes, and even subsidizing tobacco farmers.” KFF notes: “Today, less than 3% of the annual payouts support anti-smoking programs.”

Questions about transparency at the state level are also raised by KFF, which states that “governments are required to report only on the 15% of the money that can be used for things unrelated to the epidemic, like offsetting budget shortfalls or fixing old roads,” and noting that as of March 28, “only three states and counties had filed such reports.”

The same KFF report, citing OpioidSettlementTracker.com, notes that “only 12 states have committed to detailed public reporting of all their spending.”

Even though the opioid settlements, unlike previous settlements with tobacco companies, contain a provision that at least 85% of the money states will receive must be spent on “opioid-related expenses,” defining such expenses has proven to be vague and confusing.

For example, KFF states, citing real-world examples, that “defining those concepts depends on stakeholders’ views — and state politics. To some, it might mean opening more treatment sites. To others, buying police cruisers.”

Moreover, “enforcement of the 85% standard is, oddly, left to the companies that paid out the money,” KFF stated, adding that “They are unlikely to be vigilant,” according to legal experts.

It also remains unclear whether the federal government will still attempt to claim repayment for Medicaid expenses that have been linked to opioid addiction, according to KFF. In 2019, these expenses were estimated to total $23 billion.

That same year, the Centers for Medicare & Medicaid Services attempted to recoup part of Oklahoma’s $270 million settlement with Purdue Pharma. However, it remains unclear if there will be a broader push on the part of the federal government for such repayments.

Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

April 27, 2023 Posted by aletho | Corruption, Deception | United States | Leave a comment