Rather than defend a law that the president loves, the VA will reinstate a hospital director whom it twice tried to fire.

This article was first published on Wednesday, May 15 in ProPublica.

By Isaac Arnsdorf

President Donald Trump often touts a law he signed to speed up firings at the Department of Veterans Affairs. He and other Republicans see the law as a model for weakening civil service protections across the federal government.

The administration's case for the new law centered on Brian Hawkins. Hawkins was the director of the VA hospital in Washington when an internal investigation discovered safety risks for patients. The VA tried to fire Hawkins but got held up on appeal. Then-Secretary David Shulkin said Hawkins showed why "we need new accountability legislation and we need that now." Once Congress passed the legislation, the VA used it to go after Hawkins a second time.

Now, almost two years later, the VA's case against Hawkins has fallen apart. On Tuesday, the government said it would give Hawkins his job back rather than defend the statute in court.

While the administration tried to make Hawkins into a symbol of why it needed the legislation, court records tell a different story: of Trump appointees so eager to score political points that they ran roughshod over legal protections for civil servants.

"They couldn't defend their actions in court," Hawkins said in an interview. "The VA took away my rights, I had no say, my 25-year career was gone. It violated everything I tried to teach my family and tried to believe in myself: this country was founded on a Constitution, the Bill of Rights, equal opportunity for all."

Hawkins argued that his firing was unconstitutional because the VA used a standard of proof that was too low. Since the government opted not to contest that claim, it could have repercussions for thousands of other VA employees who were fired under the accountability law, according to Jason Briefel, the executive director of the Senior Executives Association, which lobbies for high-ranking career officials.

"The passage of this law was a signature achievement for the president and many members of Congress," said Briefel, who also works for the law firm that represented Hawkins. "If they were wrong and this was indeed unconstitutional, now they're going to have to go figure out what to do with thousands of folks fired under this authority."

VA spokesman Curt Cashour said the agency "has complete confidence" in the law but declined to comment on the Hawkins case. A White House spokesman didn't respond to a request for comment.

House veterans committee chairman Mark Takano, a California Democrat, said he would hold hearings this summer to examine the VA's implementation of the accountability law.

"This is another example of how VA has misconstrued and unfairly applied legislation once lauded as the Administration's preferred method to root out corruption," Takano said in a statement. "Instead of weeding out troubled leadership and incompetent supervisors, this law has been exploited and misused to target whistleblowers and employees."

According to the government's court filing, Hawkins will get back pay, but the VA could try to fire him again. The government now wants the judge to throw out Hawkins' case as moot.

Many of the details in the litigation have been sealed for more than a year because the government considers the information protected by attorney-client privilege. But ProPublica uncovered the information from other documents and people involved.

Hawkins, 50, started working at the VA in 1992 cutting grass. He worked his way up through the ranks and in 2011 became director of the Washington hospital, overseeing a staff of 2,000 at the 200-bed facility three miles north of the Capitol. Under Hawkins' charge, the hospital struggled with stocking medical supplies and filling leadership positions. In early 2017, Hawkins found out about problems in the logistics department and reported his concerns to the VA's inspector general.

The inspector general's office found dirty storage areas and supply shortages that were endangering patients. The inspector general's report didn't name Hawkins but suggested that even higher-ranking officials in the VA health system were aware the problems and had failed to fix them.

Shulkin was under pressure from Trump. As a candidate, Trump had campaigned on cracking down on errant VA employees, a rallying cry for conservative critics of the government-run health system. "You just need to start firing people," Trump told Shulkin at a spring 2017 meeting with veterans groups, as reported in The Wall Street Journal. "Let them sue us. I don't care if they sue us."

The VA could have taken action against Hawkins based on the problems at the hospital he ran, but that would have required an investigation — and time. The Trump administration didn't want to wait. Political appointees said they wanted to fire Hawkins "for any reason we can find," according to a June 2017 email sent by Scott Foster, a senior official overseeing the staff responsible for investigating VA executives. According to the email, the staff investigators responded that there was "insufficient evidence." (Foster declined to discuss personnel matters, citing privacy rules, but he agreed to tell his story.)

"We are setting ourselves up for slam-dunk due process fouls," Foster said in the email, sent to his boss and the VA's top lawyer. "We will lose this case on appeal, and in a very embarrassing way."

The VA fired Hawkins anyway.

That same day, Foster was on a conference call where his boss, a political appointee named Peter O'Rourke, said he wanted 10 to 15 people who could be fired as soon as Trump signed the new accountability law, according to notes that Foster recorded later that month. Foster cautioned that the VA would still need to follow the legal process and act on evidence.

O'Rourke responded by moving to fire Foster. The stated reason, according to the written notice that O'Rourke gave to Foster, was that Foster had voiced concerns about the legality of how the agency was firing civil servants.

Foster knew that the law protected him from such explicit retaliation, but he wasn't sure if that would matter.

"I was wondering if I was going to be caught up in a time in our country's history when the people who ran the government did not necessarily feel compelled to follow the law," Foster said.

O'Rourke, who later served as acting secretary and left the agency late last year, didn't respond to phone messages.

Foster filed a complaint with the Office of Special Counsel, or OSC, an independent federal agency that investigates retaliation against whistleblowers. OSC blocked the VA from firing Foster.

OSC also received a complaint from Michael Culpepper, another senior official overseeing investigations of VA executives. Culpepper "witnessed VA leadership violate norms in seeking to terminate several senior level employees," according to his lawyer, Mark Zaid. Culpepper became a whistleblower and suffered retaliation, Zaid said. Culpepper resigned in May 2017.

Based on the complaints from Foster and Culpepper, OSC moved to halt Hawkins' removal. An administrative judge agreed to pause the firing for 45 days so that OSC could investigate further.

Shulkin seethed at the intervention. "No judge who has never run a hospital and never cared for our nation's veterans will force me to put an employee back in a position when he allowed the facility to pose potential safety risks to our veterans," he said in a press release.

Shulkin, who was forced out in March 2018, didn't respond to a request for comment.

Rather than honor the 45-day pause, the VA said it would deploy the new accountability law that Trump had just signed. A Wall Street Journal editorial headlined "Can the VA Fire Anyone?" called the Hawkins case a critical test for the law's powers. The order firing Hawkins was signed by Assistant Secretary for Congressional and Legislative Affairs Brooks Tucker, a political appointee who is outside the hospital system's chain of command.

"The media circus that the secretary went on really made me feel less than human," Hawkins said. "My children were laughed at and questioned by their friends. My neighbors stopped speaking to my family. It was a struggle to leave my home. I gained 30 pounds. I developed hypertension. I've been in counseling for stress and depression. I was unsure of how was going to provide for my family."

Hawkins maintains that the Washington hospital had been on the upswing during his six-year tenure. When the inspector general's office completed its review, it said Hawkins provided "ineffective leadership" but also faulted others above and below him. (A separate investigation found that Hawkins broke agency policy by sending sensitive information to a personal email account.)

Conditions at the hospital got worse after Hawkins left. The facility was designated "critical" last year and now ranks among the worst-performing hospitals in the entire VA system. The inventory problems still weren't fixed — inspections found that some procedures had to be canceled because the hospital ran out of needed equipment.

"You're using civil servants as political pawns to say, 'OK, I fired them, therefore the problem is better,' but a year or two years later, the logistics problem is still an issue," Hawkins said. "It kills the efficiency of the organization, and then the 'big bad VA doing bad things for veterans' becomes a self-fulfilling prophecy."

Cashour, the VA spokesman, said the Washington hospital is making "significant improvements" such as reducing wait times, hiring nurses and referring more patients to private providers. The latter was another Trump campaign promise.

Do you have access to information about the VA that should be public? Email Isaac at isaac@propublica.org. Here's how to send tips and documents to ProPublica securely.

UIC has played down its shortcomings in overseeing the work of a prominent child psychiatrist, but documents show that the school acknowledged its lapses to federal officials.

This story was co-published with The Chronicle of Higher Education and the Chicago Sun-Times.

By Jodi S. Cohen

For a year, the University of Illinois at Chicago has downplayed its shortcomings in overseeing the work of a prominent child psychiatrist who violated research protocols and put vulnerable children with bipolar disorder at risk.

But documents newly obtained by ProPublica Illinois show that UIC acknowledged to federal officials that it had missed several warning signs that Dr. Mani Pavuluri's clinical trial on lithium had gone off track, eventually requiring the university to pay an unprecedented $3.1 million penalty to the federal government.

UIC's Institutional Review Board, the committee responsible for protecting research subjects, improperly fast-tracked approval of Pavuluri's clinical trial, didn't catch serious omissions from the consent forms parents had to sign and allowed children to enroll in the study even though they weren't eligible, the documents show.

The IRB's shortcomings violated federal regulations meant to protect human subjects, putting it in "serious non-compliance," according to one of five letters from UIC officials to the federal government the university turned over to ProPublica Illinois after a nearly yearlong appeal for the documents under open records laws.

Still, UIC officials have continued to blame only Pavuluri. In written statements, the university told ProPublica Illinois last year — and again this week — that "internal safeguards did not fail" and that researchers are "responsible for the ethical and professional conduct" of their projects.

A ProPublica Illinois investigation published last year, "The $3 Million Research Breakdown," revealed Pavuluri's research misconduct and the university's oversight failures. The stories revealed that, in a rare rebuke, the National Institute of Mental Health in November 2017 ordered UIC to repay millions in grant money it had received for one of Pavuluri's lithium studies.

But information was limited — particularly relating to the university's response to federal officials about its own role — because the University of Illinois system withheld or redacted some documents, citing federal and state privacy laws.

ProPublica Illinois had requested the records under the Freedom of Information Act in early 2018, and, after the university declined to turn them over, appealed to the Illinois attorney general's public access counselor. The agency decided last month that the school had "improperly denied" ProPublica Illinois all or parts of five letters sent from UIC to officials at the National Institute of Mental Health and the U.S. Department of Health and Human Services' Office for Human Research Protections. Other requested records remain under review by the public access counselor.

In one of those letters, dated March 22, 2013, James Fischer, then UIC's director of the Office for the Protection of Research Subjects, told OHRP that an initial internal audit determined that the IRB shortcomings had "the potential to compromise the integrity of the human subjects protections program."

Another letter Fischer sent OHRP in October 2015 explains why a university investigative panel concluded children likely were harmed by Pavuluri's studies, despite her claim otherwise. The university has refused to release the panel's report, but an executive summary — referenced in the October letter — found that children were harmed based on reports from parents and "a preponderance of evidence."

"It is clear that it is not because of [Pavuluri's] actions that harms may have been avoided," the panel concluded, according to a quote from the report that Fischer included in his letter. "It is despite her actions that no subject came to worse harm."

The study, "Affective Neuroscience of Pediatric Bipolar Disorder," began in 2009 and aimed to use imaging to examine how the brains of adolescents with bipolar disorder functioned before and after taking lithium. The scans were compared with brain images of healthy, unmedicated children.

The study was almost complete, and the money spent, when it was shut down in 2013, when one of the young subjects became ill after she withdrew from other medication to begin receiving lithium for the study.

According to the protocol NIMH had approved, subjects should not have been able to participate if they had previously used psychotropic medication. The IRB did not approve medication withdrawal, records show.

The child's hospitalization was reported to the IRB and then to federal officials, who requested more information. UIC conducted the initial audit and then an investigation, keeping federal officials informed of the findings over the next two years.

NIMH officials eventually determined both Pavuluri and the IRB had failed in numerous ways and demanded the $3.1 million be refunded. The study, NIMH officials concluded, had been compromised and the results had no scientific merit. The university had previously returned about $800,000 for two of Pavuluri's other federally funded projects that also shut down prematurely when similar problems were discovered.

The newly obtained documents describe disorganization in Pavuluri's work, with poor record keeping that included missing dates and identification numbers for the research subjects, among other problems. That made it difficult for UIC officials who later reviewed the research to understand who took part in the trial and the details of their participation.

Still, the records contain details that explain why 89 of the 103 children who participated should have been ineligible, including because they had histories of substance abuse, seizures or suicidal tendencies.

Although the federal grant limited the study to teenagers between 13 and 17, the IRB approved Pavuluri's request to expand the age of participants to include 10- to 12-year-olds despite a specific prohibition by NIMH against doing this and a lack of proper documentation by Pavuluri about the reasons for the expansion.

Pavuluri went even further from the protocol and enrolled 8- and 9-year-olds, records show.

In another significant violation, the IRB approved the inclusion of research subjects as long as they hadn't taken lithium, even though the NIMH grant originally prohibited the participation of anyone who had previously taken any psychotropic medication. Nearly 25 percent of the children enrolled in the study withdrew from or tapered other medication before participating, including the girl whose illness ultimately prompted the study's shutdown.

NIMH has said it was not informed about the eligibility changes allowing younger participants and those with a history of taking other medications. It said "the changes were significant, because they increased risk to the study subjects."

In written responses to recent questions from ProPublica Illinois, a UIC spokeswoman said no employees were disciplined for the IRB noncompliance and the university did not fail in its oversight role.

UIC officials have said they took appropriate steps once they realized problems with Pavuluri's research, including reporting the concerns to the federal agencies, suspending her research and eventually ordering that she retract journal articles. They have said her case was an anomaly, that UIC "does not allow non-compliance," and that research on human subjects "was performed upholding the highest standards in ethical and responsible research conduct."

In its only universitywide communication to employees about Pavuluri's research, sent last spring days after the initial ProPublica Illinois story about the problems, school officials discussed Pavuluri's missteps but did not mention the IRB's compliance failings. The letter noted that UIC "did not have any systemic issues of lax research oversight."

Some "corrective actions" were taken, however, including changes to the IRB review process, records show. IRB panels were instructed to emphasize the research protocol as the preeminent document when reviewing researchers' requests to make changes to ensure compliance with the approved criteria.

UIC also conducted an audit to determine if consent documents provided to research subjects in other studies followed the rules. A UIC spokeswoman declined to tell ProPublica Illinois the results of that audit, though a document indicates the audit found deficiencies in consent forms for 11 of the 28 protocols examined.

UIC provided hundreds of pages of documents in response to ProPublica Illinois records requests last year, but withheld or heavily redacted others. Last May, ProPublica Illinois asked the attorney general's office, which is tasked with interpreting and enforcing the state Freedom of Information Act, to review whether the documents should be public, including the letters between UIC and federal officials.

Last month, the office of newly elected Attorney General Kwame Raoul issued an opinion on five of the letters, finding that all or parts of each were "not confidential" and should be public because they include the findings and corrective actions of the review process.

The university argued that the Illinois Medical Studies Act, which says medical-related peer reviews can be confidential, prohibited the documents' disclosure. The public access counselor agreed that limited parts of the letters that described internal quality control could be withheld.

Raoul's office has not yet ruled on ProPublica Illinois' appeals for other Pavuluri research records the university has refused to provide, including research protocols, documents submitted to the IRB and records created as part of investigating and correcting issues related to Pavuluri's work and university responses.

Pavuluri, who founded UIC's Pediatric Mood Disorders Clinic when she joined the university in 2000, retired in June and has opened a private practice, the Brain and Wellness Institute, in Lincoln Park. In an interview with ProPublica Illinois last year, she called her mistakes oversights and said she made decisions in the best interests of her patients. She said she received minimal research guidance and training from the university, though she received $7.5 million in National Institutes of Health grants during her tenure at UIC.

Pavuluri has said she expanded the criteria for who could enroll in the study because it was difficult to find enough subjects within the narrow age range, and who were not already taking other medication.

But she said university officials placed too much blame on her instead of recognizing that those responsible for oversight also were responsible.

"It was in their interest to kind of maybe see this as one person's mistake [rather] than the responsibility of the IRB as well," Pavuluri said in an interview last year. She has declined to speak again with ProPublica Illinois and did not respond to a recent request for comment.

UIC officials have said that while there were problems with Pavuluri's research, a review of her medical practice determined she provided "high quality patient care."

But following ProPublica Illinois' reporting, state regulators, who review complaints about Illinois doctors and decide if discipline is warranted, launched an investigation into Pavuluri. The state Department of Financial and Professional Regulation issued three subpoenas to UIC in August and September seeking records related to Pavuluri and her research.

State investigations of doctors are not made public unless the department imposes discipline.

Pavuluri's research also has been under investigation by two divisions of the U.S. Department of Health and Human Services, according to subpoenas, emails and other documents: the inspector general's office, which examines waste, fraud and abuse in government programs, and the Office of Research Integrity, which reviews claims of scientific misconduct.

As OxyContin addiction spurred a national nightmare, a member of the family that has reaped billions of dollars from the painkiller boasted that sales exceeded his 'fondest dreams,' according to a secret court document obtained by ProPublica.

By David Armstrong, ProPublica

This article is a collaboration between ProPublica and STAT. It was published Thursday, February 21, 2019, by ProPublica.

In May 1997, the year after Purdue Pharma launched OxyContin, its head of sales and marketing sought input on a key decision from Dr. Richard Sackler, a member of the billionaire family that founded and controls the company. Michael Friedman told Sackler that he didn't want to correct the false impression among doctors that OxyContin was weaker than morphine, because the myth was boosting prescriptions — and sales.

"It would be extremely dangerous at this early stage in the life of the product," Friedman wrote to Sackler, "to make physicians think the drug is stronger or equal to morphine….We are well aware of the view held by many physicians that oxycodone [the active ingredient in OxyContin] is weaker than morphine. I do not plan to do anything about that."

"I agree with you," Sackler responded. "Is there a general agreement, or are there some holdouts?"

Ten years later, Purdue pleaded guilty in federal court to understating the risk of addiction to OxyContin, including failing to alert doctors that it was a stronger painkiller than morphine, and agreed to pay $600 million in fines and penalties. But Sackler's support of the decision to conceal OxyContin's strength from doctors — in email exchanges both with Friedman and another company executive — was not made public.

The email threads were divulged in a sealed court document that ProPublica has obtained: an Aug. 28, 2015, deposition of Richard Sackler. Taken as part of a lawsuit by the state of Kentucky against Purdue, the deposition is believed to be the only time a member of the Sackler family has been questioned under oath about the illegal marketing of OxyContin and what family members knew about it. Purdue has fought a three-year legal battle to keep the deposition and hundreds of other documents secret, in a case brought by STAT, a Boston-based health and medicine news organization; the matter is currently before the Kentucky Supreme Court.

Meanwhile, interest in the deposition's contents has intensified, as hundreds of cities, counties, states and tribes have sued Purdue and other opioid manufacturers and distributors. A House committee requested the document from Purdue last summer as part of an investigation of drug company marketing practices.

Related: What You Should Know About Richard Sackler's Long-Sought Deposition

In a statement, Purdue stood behind Sackler's testimony in the deposition. Sackler, it said, "supports that the company accurately disclosed the potency of OxyContin to healthcare providers." He "takes great care to explain" that the drug's label "made clear that OxyContin is twice as potent as morphine," Purdue said.

Still, Purdue acknowledged, it had made a "determination to avoid emphasizing OxyContin as a powerful cancer pain drug," out of "a concern that non-cancer patients would be reluctant to take a cancer drug."

The company, which said it was also speaking on behalf of Sackler, deplored what it called the "intentional leak of the deposition" to ProPublica, calling it "a clear violation of the court's order" and "regrettable."

Much of the questioning of Sackler in the 337-page deposition focused on Purdue's marketing of OxyContin, especially in the first five years after the drug's 1996 launch. Aggressive marketing of OxyContin is blamed by some analysts for fostering a national crisis that has resulted in 200,000 overdose deaths related to prescription opioids since 1999.

Taken together with a Massachusetts complaint made public last month against Purdue and eight Sacklers, including Richard, the deposition underscores the family's pivotal role in developing the business strategy for OxyContin and directing the hiring of an expanded sales force to implement a plan to sell the drug at ever-higher doses. Documents show that Richard Sackler was especially involved in the company's efforts to market the drug, and that he pushed staff to pursue OxyContin's deregulation in Germany. The son of a Purdue co-founder, he began working at Purdue in 1971 and has been at various times the company's president and co-chairman of its board.

In a 1996 email introduced during the deposition, Sackler expressed delight at the early success of OxyContin. "Clearly this strategy has outperformed our expectations, market research and fondest dreams," he wrote. Three years later, he wrote to a Purdue executive, "You won't believe how committed I am to make OxyContin a huge success. It is almost that I dedicated my life to it. After the initial launch phase, I will have to catch up with my private life again."

"Clearly this strategy has outperformed our expectations, market research and fondest dreams."

—Richard Sackler, in 1996 email

 

During his deposition, Sackler defended the company's marketing strategies — including some Purdue had previously acknowledged were improper — and offered benign interpretations of emails that appeared to show Purdue executives or sales representatives minimizing the risks of OxyContin and its euphoric effects. He denied that there was any effort to deceive doctors about the potency of OxyContin and argued that lawyers for Kentucky were misconstruing words such as "stronger" and "weaker" used in email threads.

The term "stronger" in Friedman's email, Sackler said, "meant more threatening, more frightening. There is no way that this intended or had the effect of causing physicians to overlook the fact that it was twice as potent."

Emails introduced in the deposition show Sackler's hidden role in key aspects of the 2007 federal case in which Purdue pleaded guilty. A 19-page statement of facts that Purdue admitted to as part of the plea deal, and which prosecutors said contained the "main violations of law revealed by the government's criminal investigation," referred to Friedman's May 1997 email to Sackler about letting the doctors' misimpression stand. It did not identify either man by name, attributing the statements to "certain Purdue supervisors and employees."

Friedman, who by then had risen to chief executive officer, was one of three Purdue executives who pleaded guilty to a misdemeanor of "misbranding" OxyContin. No members of the Sackler family were charged or named as part of the plea agreement. The Massachusetts lawsuit alleges that the Sackler-controlled Purdue board voted that the three executives, but no family members, should plead guilty as individuals. After the case concluded, the Sacklers were concerned about maintaining the allegiance of Friedman and another of the executives, according to the Massachusetts lawsuit. To protect the family, Purdue paid the two executives at least $8 million, that lawsuit alleges.

"The Sacklers spent millions to keep the loyalty of people who knew the truth," the complaint filed by the Massachusetts attorney general alleges.

Related: Mass. AG Will 'Fight Like Hell' in Purdue Lawsuit

The Kentucky deposition's contents will likely fuel the growing protests against the Sacklers, including pressure to strip the family's name from cultural and educational institutions to which it has donated. The family has been active in philanthropy for decades, giving away hundreds of millions of dollars. But the source of its wealth received little attention until recent years, in part due to a lack of public information about what the family knew about Purdue's improper marketing of OxyContin and false claims about the drug's addictive nature.

Although Purdue has been sued hundreds of times over OxyContin's marketing, the company has settled many of these cases, and almost never gone to trial. As a condition of settlement, Purdue has often required a confidentiality agreement, shielding millions of records from public view.

That is what happened in Kentucky. In December 2015, the state settled its lawsuit against Purdue, alleging that the company created a "public nuisance" by improperly marketing OxyContin, for $24 million. The settlement required the state attorney general to "completely destroy" documents in its possession from Purdue. But that condition did not apply to records sealed in the circuit court where the case was filed. In March 2016, STAT filed a motion to make those documents public, including Sackler's deposition. The Kentucky Court of Appeals last year upheld a lower court ruling ordering the deposition and other sealed documents be made public. Purdue asked the state Supreme Court to review the decision, and both sides recently filed briefs. Protesters outside Kentucky's Capitol last week waved placards urging the court to release the deposition.

Sackler family members have long constituted the majority of Purdue's board, and company profits flow to trusts that benefit the extended family. During his deposition, which took place over 11 hours in a law office in Louisville, Kentucky, Richard Sackler said "I don't know" more than 100 times, including when he was asked how much his family had made from OxyContin sales. He acknowledged it was more than $1 billion, but when asked if they had made more than $5 billion, he said, "I don't know." Asked if it was more than $10 billion, he replied, "I don't think so."

By 2006, OxyContin's "profit contribution" to Purdue was $4.7 billion, according to a document read at the deposition. From 2007 to 2018, the Sackler family received more than $4 billion in payouts from Purdue, according to the Massachusetts lawsuit.

During the deposition, Sackler was confronted with his email exchanges with company executives about Purdue's decision not to correct the misperception among many doctors that OxyContin was weaker than morphine. The company viewed this as good news because the softer image of the drug was helping drive sales in the lucrative market for treating conditions like back pain and arthritis, records produced at the deposition show.

Designed to gradually release medicine into the bloodstream, OxyContin allows patients to take fewer pills than they would with other, quicker-acting pain medicines, and its effect lasts longer. But to accomplish these goals, more narcotic is packed into an OxyContin pill than competing products. Abusers quickly figured out how to crush the pills and extract the large amount of narcotic. They would typically snort it or dissolve it into liquid form to inject.

"Since oxycodone is perceived as being a weaker opioid than morphine, it has resulted in OxyContin being used much earlier for non-cancer pain. ... It is important that we be careful not to change the perception of physicians toward oxycodone when developing promotional pieces, symposia, review articles, studies, et cetera."

—Michael Cullen, in 1997 email

 

The pending Massachusetts lawsuit against Purdue accuses Sackler and other company executives of determining that "doctors had the crucial misconception that OxyContin was weaker than morphine, which led them to prescribe OxyContin much more often." It also says that Sackler "directed Purdue staff not to tell doctors the truth," for fear of reducing sales. But it doesn't reveal the contents of the email exchange with Friedman, the link between that conversation and the 2007 plea agreement, and the back-and-forth in the deposition.

A few days after the email exchange with Friedman in 1997, Sackler had an email conversation with another company official, Michael Cullen, according to the deposition. "Since oxycodone is perceived as being a weaker opioid than morphine, it has resulted in OxyContin being used much earlier for non-cancer pain," Cullen wrote to Sackler. "Physicians are positioning this product where Percocet, hydrocodone and Tylenol with codeine have been traditionally used." Cullen then added, "It is important that we be careful not to change the perception of physicians toward oxycodone when developing promotional pieces, symposia, review articles, studies, et cetera."

"I think that you have this issue well in hand," Sackler responded.

Friedman and Cullen could not be reached for comment.

Asked at his deposition about the exchanges with Friedman and Cullen, Sackler didn't dispute the authenticity of the emails. He said the company was concerned that OxyContin would be stigmatized like morphine, which he said was viewed only as an "end of life" drug that was frightening to people.

"Within this time it appears that people had fallen into a habit of signifying less frightening, less threatening, more patient acceptable as under the rubric of weaker or more frightening, more — less acceptable and less desirable under the rubric or word 'stronger,'" Sackler said at his deposition. "But we knew that the word 'weaker' did not mean less potent. We knew that the word 'stronger' did not mean more potent." He called the use of those words "very unfortunate."

He said Purdue didn't want OxyContin "to be polluted by all of the bad associations that patients and healthcare givers had with morphine."

In his deposition, Sackler also defended sales representatives who, according to the statement of facts in the 2007 plea agreement, falsely told doctors during the 1996-2001 period that OxyContin did not cause euphoria or that it was less likely to do so than other opioids. This euphoric effect experienced by some patients is part of what can make OxyContin addictive. Yet, asked about a 1998 note written by a Purdue salesman, who indicated that he "talked of less euphoria" when promoting OxyContin to a doctor, Sackler argued it wasn't necessarily improper.

"This was 1998, long before there was an Agreed Statement of Facts," he said.

The lawyer for the state asked Sackler: "What difference does that make? If it's improper in 2007, wouldn't it be improper in 1998?"

"Not necessarily," Sackler replied.

Shown another sales memo, in which a Purdue representative reported telling a doctor that "there may be less euphoria" with OxyContin, Sackler responded, "We really don't know what was said." After further questioning, Sackler said the claim that there may be less euphoria "could be true, and I don't see the harm."

The same issue came up regarding a note written by a Purdue sales representative about one doctor: "Got to convince him to counsel patients that they won't get buzzed as they will with short-acting" opioid painkillers. Sackler defended these comments as well. "Well, what it says here is that they won't get a buzz. And I don't think that telling a patient 'I don't think you'll get a buzz' is harmful," he said.

Sackler added that the comments from the representative to the doctor "actually could be helpful, because many patients won't get a buzz, and if he would like to know if they do, he might have had a good medical reason for wanting to know that."

Sackler said he didn't believe any of the company sales people working in Kentucky engaged in the improper conduct described in the federal plea deal. "I don't have any facts to inform me otherwise," he said.

Purdue said that Sackler's statements in his deposition "fully acknowledge the wrongful actions taken by some of Purdue's employees prior to 2002," as laid out in the 2007 plea agreement. Both the company and Sackler "fully agree" with the facts laid out in that case, Purdue said.

The deposition also reveals that Sackler pushed company officials to find out if German officials could be persuaded to loosen restrictions on the selling of OxyContin. In most countries, narcotic pain relievers are regulated as "controlled" substances because of the potential for abuse. Sackler and other Purdue executives discussed the possibility of persuading German officials to classify OxyContin as an uncontrolled drug, which would likely allow doctors to prescribe the drug more readily — for instance, without seeing a patient. Fewer rules were expected to translate into more sales, according to company documents disclosed at the deposition.

One Purdue official warned Sackler and others that it was a bad idea. Robert Kaiko, who developed OxyContin for Purdue, wrote to Sackler, "If OxyContin is uncontrolled in Germany, it is highly likely that it will eventually be abused there and then controlled."

Nevertheless, Sackler asked a Purdue executive in Germany for projections of sales with and without controls. He also wondered whether, if one country in the European Union relaxed controls on the drug, others might do the same. When finally informed that German officials had decided the drug would be controlled like other narcotics, Sackler asked in an email if the company could appeal. Told that wasn't possible, he wrote back to an executive in Germany, "When we are next together we should talk about how this idea was raised and why it failed to be realized. I thought that it was a good idea if it could be done."

Asked at the deposition about that comment, Sackler responded, "That's what I said, but I didn't mean it. I just wanted to be encouraging." He said he really "was not in favor of" loosening OxyContin regulation and was simply being "polite" and "solicitous" of his own employee.

Near the end of the deposition — after showing Sackler dozens of emails, memos and other records regarding the marketing of OxyContin — a lawyer for Kentucky posed a fundamental question.

"Sitting here today, after all you've come to learn as a witness, do you believe Purdue's conduct in marketing and promoting OxyContin in Kentucky caused any of the prescription drug addiction problems now plaguing the Commonwealth?" he asked.

Sackler replied, "I don't believe so."

The administration proposed new rules on paying for more veterans to see private doctors, but the lack of details makes the fiscal impact unclear.

This article first appeared January 31, 2019 on ProPublica

By Isaac Arnsdorf

When Congress passed a bill last year to transform the Department of Veterans Affairs, lawmakers said they were getting rid of arbitrary rules for when the government would pay for veterans to see private doctors.

Under the old program, veterans could go to the private sector if they would have to wait 30 days or travel 40 miles for care in the VA. Lawmakers and veterans groups, including conservatives, criticized those rules as arbitrary. The new law, known as the Mission Act, was supposed to let doctors and patients decide whether to use private sector based on individualized health needs.

On Wednesday, the Trump administration proposed new rules, known as access standards, to automatically make veterans eligible for private care. Instead of 30 days, it's 20 days for primary care or 28 days for specialty care. Instead of 40 miles, it's a 30-minute drive for primary care or a 60-minute drive for specialty care.

The announcement appeared to do little to settle the debate over whether the VA's rules are arbitrary.

"Twenty days is just as arbitrary as 30 days," Bob Wallace, the executive director of Veterans of Foreign Wars, one of the largest veterans service organizations, said in a statement.

What is clear about the new rules is that they are dramatically more permissive. The new drive-time standard alone will make 20% of veterans eligible for private primary care and 31% eligible for private specialty care, up from 8% for both kinds of care under the old program, according to a briefing document circulated on Capitol Hill.

"This is doubling down on the administrative rules such as drive times and wait times," said David Shulkin, the former VA secretary who was fired last year by President Donald Trump, in part over disagreements about this bill. "I was in favor of a system that was clinically based, that put veterans' needs first and allowed the right match of services. This is just changing and loosening the administrative rules."

VA spokeswoman Susan Carter declined to comment.

Last month, a ProPublica investigation of the private-care program that the administration is now expanding found overhead costs that were much higher than industry standards and comparable government programs. In response to the article, VA Secretary Robert Wilkie acknowledged that the agency was "taken advantage of" with these overhead costs and vowed to improve.

On the campaign trail, Trump presented himself as a champion for veterans, and as president he frequently boasts about what his administration has done for former service members. But at the same time, he has enthusiastically supported shifting more veterans to private medical care, over the objection of major veterans groups that want to preserve the VA's health system. He has also plunged the VA into chaos by upending his own leadership team at the agency and handing vast influence to three men nicknamed the "Mar-a-Lago Crowd" because they meet at the president's resort in Florida.

The new access standards are the most important step toward reshaping the VA in line with Trump's vision of enlarging the private sector’s role.

"None of this should be a surprise to anybody: President Trump has made it clear from pretty much the moment he started running he wanted full choice," said Dan Caldwell, the executive director of Concerned Veterans for America, a political group that advocates for more private care and that is backed by the Koch brothers, the industrialists who have donated hundreds of millions of dollars to conservative causes. "This does get us closer to full choice. That's the model we want to get to."

The VA is planning to continue widening the access standards, dropping the wait time for primary care to 14 days in 2020, according the agency’s briefing materials.

Already, according to the document, almost half of the VA's primary care sites (69 out of 141) have wait times longer than 20 days, meaning their patients could get private care. In gastroenterology, 81 out of 128 sites have waits longer than 28 days. But, the document cautioned, "This data is not reliable."

According to people present for briefings on Wednesday, congressional staff and veterans groups had a long list of questions that largely went unanswered by VA officials. Among them:

• How many more veterans will become eligible for private care based on the wait times standards?

• How does the software that the VA bought from Microsoft calculate drive times?

• How many more patients does the VA expect to choose private care?

• How many more private-sector appointments does the VA expect to pay for?

• How many more veterans will sign up for VA benefits, or use the VA instead of their other insurance coverage, now that they could see private doctors at no cost to them?

• How will the VA ensure, as required by the Mission Act, that veterans referred to the private sector can get appointments there sooner than they could in the VA? (The VA's briefing materials said average national wait times are higher than in the VA.)

"They just didn't provide a whole lot of answers to questions about the impact," said Carl Blake, Paralyzed Veterans of America's executive director. "The fact is it's going to open up eligibility. It's debatable whether there are adequate resources to do so. What won't be acceptable is for them to take money from other programs in the VA to pay for it."

The unanswered questions could dramatically change the program's cost. The official notice for the new rules on the website for the Office of Information and Regulatory Affairs says the "Anticipated Costs and Benefits" are "TBD." In Wednesday's briefings, officials said the new access standards will increase the agency's expenses by $2.7 billion to $3.1 billion next year and by $19 billion to $20 billion over five years, the people present said.

Lawmakers have cast doubt on the VA's cost projections. In a letter to Wilkie on Monday, 28 Democratic senators noted that officials had provided "widely varying and potentially contradictory" figures depending on the day.

"I don’t know why they’re not using the resources we used to model this," said Nancy Schlichting, the former CEO of the Henry Ford Health System who led a congressionally chartered commission that in 2016 issued a report on the VA's future. The commission estimated that paying for veterans to see private doctors without a referral from the VA could increase costs by $96 billion to $179 billion a year.

"It's very, very unsophisticated, frankly," Schlichting said of the administration's proposal.

When debating the Mission Act, lawmakers relied on a projection by the nonpartisan Congressional Budget Office that assumed the rate of veterans using the private sector would stay about the same. That assumption has now been blown up by the way the administration is implementing the law.

"Today's announcement hastily rolling out new access standards places core VA services and vital research programs at risk by shifting money towards care outside VA," House veterans committee chairman Mark Takano said in a statement on Wednesday, vowing to hold a hearing. "Today's announcement places VA on a pathway to privatization and leads Congress to assume the worst."

Wilkie had moved to pre-empt such criticism. "Some will claim falsely and predictably that they represent a first step toward privatizing the department," he said in a lengthy statement on Monday, two days before the news access standards were announced.

As evidence, Wilkie said appointments in the VA's health system have increased by 3.4 million since 2014 to more than 58 million in 2018. But his statement did not mention how much the VA's private-sector appointments have grown: more than four times as much. According to agency data provided to ProPublica, the VA’s private-care appointments increased by 14.9 million since 2014 to 33.2 million in 2017. Private care accounted for 58% of the VA's total outpatient appointments in 2017, up from 33% in 2014, the data shows.

In developing these access standards, Wilkie relied extensively on Darin Selnick, who previously worked for Concerned Veterans for America, the organization supported by the Koch brothers. Selnick signed onto an infamous 2016 proposal to dismantle the VA’s government-run health system. Selnick also worked closely with the trio of unofficial advisers known as the "Mar-a-Lago Crowd."

Selnick sat on the "executive steering committee" in charge of implementing the Mission Act and reported directly to Wilkie as a senior adviser, according to an organization chart obtained by ProPublica. However, when the VA presented a version of the same chart to Congress at a December hearing, Selnick's name was not there.

Lawmakers voted for the Mission Act with the understanding that access standards would automatically trigger private care for only a few kinds of services, such as lab tests, X-rays and urgent care, the 28 Senate Democrats said. But now the administration is making the access standards apply to everything, a plan that ProPublica first revealed in November.

"This proposal risks needlessly siphoning away VA resources to private providers, which could irresponsibly starve excellent existing VA clinics and hospitals," Senate veterans committee member Richard Blumenthal, D-Conn., said in a statement on Wednesday.

Lawmakers and the public may not get more information about the how the program will be funded until the White House releases its budget for 2020. But officials have indicated they won't submit the president's budget to Congress on time, blaming the 35-day partial government shutdown. The shutdown did not affect the VA, but it did furlough staff in the Office of Management and Budget, putting the VA at risk of being late on the Mission Act regulations that are due in June, according to an agency report obtained by ProPublica.

The VA recently chose Optum, a division of UnitedHealth Group, to take over administering the new private-care program in most of the country. However, because the agency was late in awarding the contracts, Optum won't be ready to start when the new program is supposed to take effect in June.

In the interim, program will be run by TriWest Healthcare Alliance, the old vendor that charged unusually high fees. TriWest has also filed a formal protest challenging the VA’s decision to hire Optum. The dispute will be adjudicated by the Government Accountability Office.