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The Tufts Daily
Where you read it first | Thursday, June 13, 2024

Report reveals loose conflict-of-interest policies, deference to donors benefitted Purdue Pharma

Ballou Hall is pictured on Apr. 20, 2018.

An independent report released Thursday indicates that a systemic lack of oversight at the Tufts University School of Medicine (TUSM) and a culture of appeasing donors allowed the Sackler family and its controversial pharmaceutical company, Purdue Pharma, to buy influence and bolster their reputation long after their central role in the opioid crisis came to light.

The report, written by former U.S. Attorney for Massachusetts Donald K. Stern and Attorney Sanford F. Remz of Yurko, Salvesen & Remz, P.C., found no clear violations of Tufts’ conflict-of-interest policies nor evidence that Purdue or the Sacklers had a significant impact on the university’s academic program. Nonetheless, Stern and Remz identified several ways in which the Sackler family and Purdue were able to exercise influence on the university, including the appointment of a Purdue official to a faculty position and an aversion to criticism of the company’s role in the opioid crisis.

Purdue has been implicated in the opioid crisis for manufacturing and distributing the drug OxyContin, one of the major drugs responsible for the crisis. In January, Massachusetts Attorney General Maura Healey presented evidence from the Commonwealth’s lawsuit against Purdue alleging the company deceived medical professionals into overprescribing opioid painkillers and exploited the resulting addiction epidemic for its own corporate gain.

University President Anthony Monaco tapped Stern in February to review the university’s relationship with the Sackler family and Purdue amid growing pressure from the Tufts community.

Tufts’ financial ties to Purdue and the Sackler family

That relationship began in 1980, when Arthur, Mortimer and Raymond Sackler made a significant contribution to Tufts in exchange for the university attaching the Sackler name to its new School of Graduate Biomedical Sciences. Three years later, Arthur Sackler entered a similar agreement to secure naming rights for the TUSM building.

The Sackler-owned pharmaceutical company, Purdue Pharma, established a financial relationship with Tufts in the following decades. In 1999, Purdue funded the new Pain Research, Education and Policy (PREP) program at TUSM, contributing over $2 million to the program over the next 10 years. The company also donated approximately $380,000 to TUSM’s Center for the Study of Drug Development (CSDD) — which conducts research for pharmaceutical companies, regulators and policymakers — between 1997 and 2010.

In all, Stern and Remz found that Tufts has received approximately $15 million from the Sackler family and Purdue since 1980. Their report illustrates how Tufts enabled Sackler family members and Purdue Pharma officials to exploit this relationship and wield undue influence on the university.

Little consideration for conflicts of interest

The inaugural funding agreement for the PREP program, executed in 1999, gave Purdue the capacity to modify curricula and encourage preferred research at TUSM. Purdue was granted a representative on the steering committee that oversees and evaluates the PREP program and was also given the opportunity to help develop curricula. In addition, Purdue agreed to fund the Comprehensive Educational Program (CEP) as a host for specific projects that benefit both Tufts and Purdue. The funding agreement also included provisions that encouraged cooperation between Tufts and Purdue in their respective marketing strategies and established an annual lecture formerly known as the ‘Sackler Lecture.’

This arrangement offered the Sackler family and Purdue Pharma a myriad of opportunities to advance their individual and corporate interests through their relationship with Tufts. Stern and Remz concluded that the 1999 funding agreement “gave Purdue far too much potential influence over the PREP program” and clarified that it would violate the current University Gifts Policy Statement, which preserves Tufts’ complete autonomy over non-sponsored research as well as all academic programs.

One such avenue of influence came through the promotion of David Haddox, a senior executive at Purdue, to adjunct positions in the PREP program. Haddox, who advocated for opioid painkillers as Purdue’s vice president of health policy from 1999 to 2018, was “positioned to further Purdue’s interests” as a regular lecturer in two of the PREP program’s required courses until 2018, according to the investigation.

Haddox was appointed to adjunct assistant clinical professor in 2006 and promoted to another adjunct role in 2011. Stern and Remz concluded that it is unlikely Haddox would have been appointed without Purdue funding the PREP program. Haddox was given further opportunity to advance Purdue’s interests through his designation as the company’s representative on the PREP steering committee, though it is unclear whether he ultimately filled that role.

Professor of Public Health and Community Medicine Daniel Carr’s role as director of the PREP program also raises concerns about Tufts’ conflict-of-interest considerations. Carr’s advocacy for chronic pain treatment — views which he held before PREP’s creation — aligned with Purdue’s corporate interests. Sackler and Remz found that while Carr never violated university policy, he forged an inappropriately close relationship with Purdue on multiple occasions, including his appearance in a Purdue print advertisement and Purdue’s request that he testify in front of a 2002 Food and Drug Administration committee as the company’s consultant. Their report suggested that Tufts either encouraged these incidents or failed to consider the conflict-of-interest implications in these actions.

It also found that existing conflict-of-interest training for TUSM students and faculty is “minimal” and not subject to annual review.

Sackler and Remz documented how Sackler family members have also accrued influence and legitimacy at Tufts through their philanthropic efforts, consistent with the tactics described in Healey’s memorandum.

Richard Sackler, who served as president of Purdue from 1999 to 2003 and continues to sit on the company’s board of directors, was a member of the TUSM Board of Advisors for nearly 20 years until his resignation in 2017. Stern and Remz found no evidence that Richard Sackler advanced Purdue’s business interests as a board member, despite taking an active role on the board at times.

However, Stern and Remz identified several concerns with the honorary degree Tufts gave to former Purdue Chairman Raymond Sackler in 2013. They concluded the history of donations to the university by Raymond Sackler and his family “undoubtedly affected the amount of scrutiny given to his background [vetting]” and that in honoring Raymond Sackler, Tufts hoped he would make another significant donation to the university. Four months after the degree was conferred, the Raymond and Beverly Sackler Foundation pledged a contribution to Tufts.

The vetting process for Raymond Sackler’s honorary degree was further complicated by the review committee’s neglect for concerns surrounding Purdue’s 2007 criminal conviction as well as its role in the opioid crisis. That conviction was the result of Purdue’s misleading marketing tactics, for which the company paid over $600 million in fines and other forms of compensation.

The honorary degree review committee — a group selected from Tufts’ Board of Trustees — was aware of Purdue’s conviction and its role in distributing opioids but did not address either issue comprehensively, according to Stern and Remz. In reference to Raymond Sackler’s honorary degree, Stern and Remz concluded “the University should have been more intentional and cautious in its relationships with the Sackler family.”

Monaco expressed in an interview with the Daily that he was aware of Purdue’s 2007 criminal conviction when the university gave Raymond Sackler an honorary degree but regrets not giving it greater consideration at the time.

“I would say that we, on reflection, did not do as much due diligence on that issue as we might have wanted to,” Monaco said.

Soliciting donations in the midst of a crisis

Even after Purdue’s 2007 conviction, and as the dangers of opioid medications like OxyContin slowly came to light, university administrators continued to ignore these concerns. Instead, Stern and Remz found that efforts by University Advancement to solicit donations from the Sacklers continued into early 2018.

Peter Dolan, chairman of Tufts’ Board of Trustees, explained that while the university last received a donation from the Sackler family in 2013, it engaged with family members in subsequent years due to their long philanthropic history.

“The university, through its Advancement division, would have kept relationships with donors — especially donors that we’ve known for decades,” Dolan said. “So although the last funding was in 2013, there would have been communications with the family up to 2017–18.”

Tufts began to reconsider its relationship in fall 2017 after pieces in Esquire and The New Yorker lambasted Purdue Pharma for perpetrating the opioid crisis. At that point, the university quietly retreated from its contacts with the Sackler family and Purdue and stopped seeking donations, according to Dolan.

The Sackler and Purdue influence in Tufts curricula

Stern and Remz found “no evidence of any quid pro quo arrangement whereby Purdue or any of the Sacklers agreed to fund PREP, CSDD or any other program or research in TUSM conditioned on certain outcomes.” Nonetheless, their investigation revealed that the Sackler family and Purdue Pharma exhibited a clear and, at times, successful effort to influence Tufts’ academic programs.

The Commonwealth’s lawsuit against the company cited the PREP program as a prime example of Purdue’s influence. 

“The MSPREP Program was such a success for Purdue’s business that the company considered it a model for influencing teaching hospitals and medical schools,” according to the complaint.

Stern and Remz acknowledge the potential for Purdue to influence in the PREP program but assert no such influence occurred. The report does, however, show how Purdue attempted to leverage its relationship with the university through the program.

Of Purdue’s annual $330,000 payments to the PREP program from 1999 to 2004, $200,000 supported the program specifically, $100,000 went to CEP and $30,000 was reserved for PREP scholarships. That funding came with numerous strings attached, as laid out in the 1999 contract, which Purdue attempted to exploit.

Stern and Remz documented that Purdue tried to obtain information about medical education programs related to OxyContin’s impact and the opioid crisis on at least one occasion. Those programs were sponsored by Tufts Health Plan, which is independent of and unaffiliated with the university.

The report does not examine several other signs of Purdue influence on the PREP program identified in Healey’s memorandum. Those incidents include a 2009 meeting at Purdue headquarters in which the PREP’s steering committee sought input from Purdue about the program.

Stern and Remz identify Haddox’s involvement in the PREP program as the primary way in which Purdue influenced Tufts’ academic impact.

“Dr. Haddox, as a relatively senior member of Purdue’s management team that promoted the use of OxyContin as being safe to prescribe for various types of pain, including chronic moderate to severe non-cancer pain, was positioned to further Purdue’s interests by lecturing in the PREP program,” the report reads.

While the report stops short of characterizing Haddox’s lectures in the PREP program as biased, it outlines several incidents that point to corporate influence in his classes.

Haddox failed to address opioid addiction in a lecture on opioids, nor did he address the side effects of drugs in the oxycodone class, to which OxyContin belongs, despite presenting the side effects of other drugs. Haddox also advised a PREP student’s capstone project, which examined medical students’ attitudes toward opioids and addiction, but had limited interaction with the project’s author, according to Stern and Remz.

The report characterizes the effect of these incidents as relatively small, however, in showing that very few graduates of the PREP program are now licensed prescribers. It also outlines several other events that indicate bias, including Haddox’s “analogizing regulation of opioids to Prohibition” and a 2017 lecture in which several students felt he downplayed the opioid crisis and rejected the pharmaceutical industry’s role in it. Haddox consistently disclosed his position at Purdue in those guest lectures.

“[Haddox] was in the position to influence students through his classroom lectures, one or two of which in part may have reflected a point of view aligned with his employer, which was disclosed,” Stern and Remz said.

Carr also contributed to creating “the appearance of an alignment between Purdue and the PREP program,” which Purdue hoped would lend academic legitimacy to its operations — a motivation that was featured heavily in Healey’s memorandum.

Most prominent among Carr’s actions was his presence in a 2002 Purdue advertisement in The Boston Globe. The advertisement featured his image, affiliation with Tufts and his endorsement of Purdue’s efforts to fight prescription drug abuse.

“While the ad did not promote a product, it reflects an uncomfortable, inappropriate association with a commercial financial supporter. It also gave some credibility to Purdue’s claim to be fighting opioid abuse,” Stern and Remz said. “Although no then-existing Tufts policies were violated, better judgment should have prevailed.”

The report found that Carr defended Purdue from criticism over its role in the opioid crisis at times and “sought opportunities to collaborate in fighting ‘Opioidphobia,’ which he viewed as an irrational fear of prescribing opioids for chronic pain under any circumstances.” The term “opioidphobia” was integrated into certain PREP academic materials, which Stern and Remz noted could stigmatize prescribers for exercising caution.

The report also outlines several incidents in which Tufts officials exhibited inappropriate deference to Purdue due to their status as a large donor.

The committee tasked with selecting a common book for all incoming TUSM students in the 2015–16 academic year considered “Dreamland” (2015), which examines Purdue’s role in creating the opioid crisis. Stern and Remz conclude that “Dreamland” was ultimately rejected due “in significant part” to the university’s “desire to avoid controversy regarding [its] relationship” with Purdue and the Sackler family.

TUSM Dean Harris Berman told the Daily that the report overstated the discussion around “Dreamland” and clarified that “Dreamland” and the Sacklers did not factor prominently in the decision.

“During the course of a short discussion in [the TUSM] leadership team, somebody mentioned the book ‘Dreamland’ might also be an appropriate one,” Berman said. “They did mention that it was not kind to the Sackler family. But we weren’t really [considering] ‘Dreamland.’”

Recommendations and decisions

Stern presented the findings of his investigation to the university’s Board of Trustees on the weekend of Nov. 2. The investigators declined to recommend whether Tufts should remove the Sackler name, claiming it was not within the scope of their investigation.

Dolan explained that the Board of Trustees has been discussing this particular issue for about 18 months.

“We had an opportunity to see the written report, but we wanted to give the Trustees the opportunity … to hear from Don Stern, himself, to add any color to what he had written and then to directly ask him questions,” Dolan said. “All of that was context and background as we began to think through the process of answering the question: What do we do with the Sackler name on this campus?”

The university announced Thursday that it will remove the Sackler name from all buildings on its Boston Health Sciences Campus and establish a $3 million endowment to prevent and treat substance abuse and addiction.

Stern and Remz did, however, propose a number of recommendations, primarily aimed at strengthening Tufts’ various conflict-of-interest prevention policies. In order to prevent conflicts of interest created by donations, Stern and Remz suggested creating a gifts policy committee to evaluate certain high-level donations and review all anonymous contributions, as well as a formal vetting process for all major contributors.

The report recommends that a gifts policy committee should review donations over $250,000 and comprise Tufts administrators, university counsel, members of the Board of Trustees, an ethics expert, members of the Advancement office and faculty representatives.

Their report also recommended that the university provide greater transparency in disclosing who funds its academic programs and research.

Monaco and Dolan said the university would implement these policies but did not provide further details.

“As we looked at the body of what he was suggesting, we thought many of those … had good intent, and we are looking at how to implement them,” Dolan said.

However, Monaco added that a set of guiding principles in receiving gifts and donations would be established separate from the full gifts policy that Tufts follows, in line with the report’s recommendation that the university clarify and publish its gift-acceptance standards. 

Stern and Remz also recommended that Tufts establish institution-wide conflict-of-interest policies in order to protect academic programs and curricula as well as research. They also proposed that the university review its existing conflict-of-interest training policies and make them more accessible to students and faculty.

Finally, Stern and Remz encouraged Tufts to give “rigorous due diligence” to all honorary degree candidates, regardless of whether they have an existing relationship with the university.

Alexander Thompson contributed reporting to this article.