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Sunday, April 14, 2024

The Mom Who Took on Purdue Pharma for Its OxyContin Marketing

Twenty-nine-year-old Jill Carol Skolek was a single mom in Phillipsburg, New Jersey. April 29, 2002, was the first time her 6-year-old son, Brian, had come back from school and didn't her waiting for him at the bus stop near their house. When Brian got home he discovered his mother in bed, in what he thought was a deep sleep. He fixed a snack, spent a few hours watching cartoons and playing with toys, and then crawled beside her and fell asleep. The next morning, when she still seemed asleep, he shook her and kept yelling “Mommy.” Finally, Brian called 911. “I need your help. I think my mommy’s heart stopped.” Only when the emergency medical personnel arrived did they realize that Jill had been dead since the previous day.

Jill’s mother, Marianne Skolek Perez, a part-time nurse, lived 30 minutes away in Whitehouse Station, New Jersey. The unexpected death of her daughter left her to care for her grandson. Marianne could not understand why her daughter died. Her only physical problem was a recent back injury. Friends and family packed her funeral three days later. The obituary in the Courier-News, which serves the center of the state, read in part: “Jill, I love you with all my heart and am truly proud of the way you raised your son. Rest in peace precious daughter until we can be together again. Love Mommy.”

One morning, a week after Jill’s funeral, Brian startled his grandmother: "Mommy changed when she started taking OxyContin."

He had gone with his mother on visits to a family doctor and remembered how her back felt much better after she got something the doctor called “Oxy.”

Perez, who worked weekend shifts at the oncology unit at Somerset Medical Center, was familiar with OxyContin. She dispensed it herself to end-of-life cancer patients. “I turned to my grandson and said, ‘Mommy didn’t take OxyContin, honey.’” Marianne was stunned when the medical examiner’s toxicology report confirmed that Jill had died of respiratory arrest. The cause? Heart failure due to OxyContin.

The death was ruled accidental. “Anyone who is responsible for this is going to be held accountable,” she vowed.

It was time to start digging into what happened to her daughter. She wanted answers as to why the drug she administered to terminally ill cancer patients was prescribed to Jill for back pain. Marianne was no stranger to research. She recalls being the top student and president of her graduating nurse class in 1991. She had a paralegal certification and had served on the local community editorial board for Gannett’s Courier-News. Her volunteer service at an AIDS support group earned her a community service award in 1992 from a local HIV/AIDS task force, and she later wrote several editorials on the subject.

She tracked down a friend of her daughter's, who told her that after Jill’s first appointment with her physician, subsequent ones were with the receptionist, who handled the Oxy refills. That prompted Marianne to contact the New Jersey and Pennsylvania medical boards where the physician was licensed. She says that state investigators interviewed her and opened a case.

Meanwhile, she met with lawyers at a Philadelphia-area firm. According to Marianne, they seemed confident there was a wrongful death action for what had happened to Jill. Marianne says they worked for weeks with her on preparing a complaint.

They told her they were about to serve the doctor with their complaint, she says, but a few days later, one of the attorneys called her. They could not proceed. She says he claimed they did “not have the resources for it,” and that Jill’s doctor had followed the standard of care in place at the time.

It made no sense to her that lawyers who had been so hot to take the case suddenly dropped out. At home that evening, she sat at her dining room table. It doubled as a work desk, half of it filled with a computer, printer, and fax. What could they have meant by “we don’t have the resources”? Then it dawned on her.“I said aloud, ‘It’s not the doctor—it’s the pharmaceutical company!’ ”

Her first online search was to learn more about the company that made OxyContin—Purdue Pharma. Every night she explored the web for information about the executives who ran Purdue and the history of OxyContin. “It was becoming more and more evident to me as I dug that it was a web of deceitful marketing.”

Promising herself that her daughter’s death would not be in vain, Marianne Skolek Perez became a one-person advocate on behalf of Jill and other OxyContin victims. She delved into how the drug was being dispensed nationwide. Her grandson, Brian, sometimes asked, “Did you get the bad guys yet?”

For six months she says she peppered the FDA with letters providing examples in which she thought Purdue was mass-merchandising its powerful painkiller. She also called local reporters in New Jersey and Pennsylvania and encouraged them to look into the company and its best-selling medication. A few small-town newspapers in areas hard hit by OxyContin reported that “Marianne has launched her own investigation into her daughter’s death.”

She did not then know it, but her letters helped move the FDA to issue a January 2003 “warning letter” to Purdue. It read in part, “Your journal advertisements omit and minimize the serious safety risks associated with OxyContin, and promote it for uses beyond which have been proven safe and effective.” In particular, the FDA highlighted osteoarthritis, which Purdue’s detail team pushed as a treatable condition at the same time downplaying the drug’s potential addictiveness. Purdue supervisors had also drafted an article published in a medical journal without any disclosure of the company’s role. It claimed that patients taking less than 60 milligrams per day can stop the drug “abruptly without withdrawal symptoms.” The detail team cited that extensively in sales pitches.

A few years later, federal attorneys had enough evidence of misconduct to commence an investigation into Purdue Pharma’s advertising strategy, including print ads that overstated the benefits of treating arthritis with OxyContin and failed to list that it was potentially deadly in large doses. Purdue had hired Rudy Giuliani in 2002, after he opened his own consulting and legal firm after two terms as “America’s mayor” in New York City. According to several news reports at the time, people involved with the case said Giuliani met a half-dozen times with government attorneys during the proceedings.

The month after the FDA letter to Purdue, Perez drove to New York for a conference at Columbia University’s National Center on Addiction and Substance Abuse. She had decided to attend after seeing a notice that Purdue was sending its vice president of health policy, J. David Haddox. “I wanted to see what made this company tick,” she later wrote. Perez read about Haddox before the conference, and learned he was the dentist turned doctor who had helped invent the now-debunked theory of pseudoaddiction. Haddox and his coauthor relied on a study with a single cancer patient to theorize that addictive behavior was often simply evidence of undertreated pain, and it could be resolved with larger or more frequent opioid dosages. Besides Haddox, Perez got a chance to see the DEA’s Laura Nagel, who warned about the abuse potential for “hillbilly heroin.” Richard Blumenthal, Connecticut’s attorney general (and now US senator), was also a panelist that day. Purdue’s Stamford headquarters were in Blumenthal’s jurisdiction.

Perez sat in the front row. She had bought off eBay an OxyContin “window shade” pen that had been one of the many small gifts the detail team distributed to doctors by the tens of thousands. She had wanted that pen because it was an example of Purdue’s aggressive marketing tactics. The pen’s pullout tab contained a simplified reference chart that made it easy for physicians to switch their patients using painkillers to OxyContin, without weighing the risks of OxyContin’s higher abuse potential. (Purdue says it stopped distributing the pens after the FDA began requiring stronger warning labels on OxyContin.)

In Haddox’s presentation, he extolled Oxy’s pain relief benefits and glossed over its potential for addiction, according to attendees. Perez stared at him and played with the pull-out shade. She was incensed by his unorthodox attitude about the risks of addiction.

When the conference ended, Haddox walked through a makeshift aisle between dozens of rows of folding chairs. As they passed one another, Perez says she “did not hear the word ‘now’ but felt the word ‘now.’ ” The 100-pound Perez rammed Haddox with her shoulder and sent him crashing into the folding chairs.

“Now you know how the victims of OxyContin feel when they hit the depths of addiction and are on their knees fighting the horrific effects of the withdrawing from the drug,” she remembers saying as she walked past. (Haddox did not reply to a request for comment.)

Also in attendance was Robin Hogen, Purdue’s soft-spoken press spokesman. (His official title was vice president of public affairs.) At one point during the conference, some reporters gathered around Hogen. He was easy to spot with his trademark bow tie.

The Purdue press office was familiar with Perez. Initially they had avoided saying anything publicly about her. It was a no-win, they likely concluded, to get into a public fray with a grieving mother. A few months before the Columbia conference, however, Hogen’s senior press director, James Heins, told reporters that Perez had “raised a lot of fear and concern based on misinformation. … The death of her daughter is tragic, but I don’t know the real circumstances behind it and I haven’t seen the autopsy report. … She [Marianne] might be a well-meaning person, but I don’t believe she is an expert in pain management.”

As the Columbia conference broke up, Hogen indicated that he had additional information about Perez’s daughter. “We think she [Jill] abused drugs.” Though Hogen reportedly admitted that he didn’t really know for sure. Bob Braun, a New Jersey Star-Ledger reporter, later noted the medical examiner’s report had not mentioned that. “That’s a pretty heavy charge to make against a young woman who died, leaving behind a 6-year-old son … because Jill can’t defend herself.”

But Hogen had done what he apparently wanted to do—plant a seed of doubt. Maybe Jill Skolek was not, as often described, an adoring and innocent mother. One of Purdue's successful defense strategies, in early lawsuits filed against it, was to portray the plaintiffs as addicts who should be held responsible for their own actions. Purdue had gotten a number of suits dismissed with its aggressive defense that put the victims on trial. It often claimed—or strongly suggested—that the plaintiffs were addicts who had latched on to the painkiller to satisfy their drug habits.

Braun wrote about Hogen’s “disclosure” in his Star-Ledger column a few days later. What Hogen said was important “because it might lead journalists—like me—to avoid writing about her mother’s efforts to hold a big pharmaceutical house accountable. No one wants to create sympathy for a junkie. But Jill was no junkie.”

Hogen and others at Purdue misjudged Marianne Skolek Perez if they thought she would abandon her search for answers if they tarred her daughter’s reputation: “I told Hogen that you messed with the wrong mother.” She redoubled her commitment to expose Purdue as “an out-of-control, greedy pharmaceutical company.” The same day as Braun’s column appeared, Hogen sent a letter to Perez in which he offered a “full and sincere apology” and that “I have regretted my remarks ever since I made them.” Two weeks after that, the newspaper published a response from Purdue’s chief operating officer, Michael Friedman. His statement read, in part: “I write on behalf of Purdue Pharma LP to repudiate the comment about Jill Skolek made by our employee, Robin Hogen, as reported in Bob Braun’s March 5 column. … Hogen’s inappropriate remark is inconsistent with our values and our commitment, and we regret that it was made.” (When reached for comment, Hogen acknowledged his statement was insensitive, adding that “We have learned a lot about the disease of addiction in the 15 years since I left Purdue Pharma.”)

The diminutive grandmother attended local hearings and she refined her investigation and writing skills. At one point, when she learned of an academic study coauthored by a Purdue employee, concluding that opioids are “an effective and safe pharmacological option” for the treatment of pregnancy pain, she quickly alerted the FDA, attorneys general, and public health advocates. (Purdue maintains that it never marketed OxyContin for pregnancy pain.)

At the end of 2002, investigators working for US Attorney John Brownlee got in touch with Perez. She had written to all 50 state attorneys general and dozens of federal prosecutors, beseeching them to investigate Purdue and offering whatever help she could provide. The timing was ideal for Brownlee, who had just started one of the first criminal investigations into Purdue. By fax and email, she remained in weekly or even daily contact, and she says she gave his investigators some early leads. For example, she had found an employee in Purdue’s legal department when buying some OxyContin promotional items on eBay. Perez traveled to Stamford to meet with her at a Starbucks, where they discovered that the Purdue employee had become “addicted to OxyContin and was fired. … She had worked for Purdue for close to 25 years.” The ex-employee “was petrified of Purdue Pharma and their power, but what a story she had to tell.” Perez says she put her in touch with “Delta Force,” her nickname for one of the investigators working on the Brownlee task force. (Brownlee declined to comment on Perez’s contributions to the investigation or the employee in Purdue’s legal department, but stated that Perez was “a powerful force for the case against Purdue.”)

Perez seemed to be everywhere. She set up a website, oxydeaths.com, as a resource for those who wanted to share stories about the drug’s dangers. She teamed up with Chelly Griffith, an outspoken mother who had become an addict after being prescribed OxyContin for a back injury. She was furious that even when the FDA strengthened OxyContin’s warning label in 2001, the agency failed to require Purdue to include the word “addictive” on Oxy’s label instead of the more obtuse notice that it has “an abuse liability similar to morphine.” (Today, the label warns consumers that “OxyContin exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.”) And Perez says she got Purdue to remove from its website a press release titled “65–0: OxyContin Cases Against Purdue Pharma LP Dismissed at Record Rate.” She recalls telling the company that “it was very bad taste to call them an OxyContin victory and to gloat over it.” Purdue says it removed the post after the company began settling legal claims against it, not as a result of Perez’s objections.

Perez was featured in reporter Doris Bloodsworth’s seminal front-page, five-part Orlando Sentinel series titled “OxyContin Under Fire.” The first installment, “Pain Pill Leaves Death Trail,” appeared on October 19, 2003. The Columbia Journalism Review, in a later analysis of early media coverage about OxyContin, noted that “The Sentinel’s coverage was more ambitious [than earlier reporting]. At its core was a claim that posed a serious threat to Purdue’s business: taking OxyContin as prescribed could lead to dependence, addiction, and death.”

Instead of tackling the larger claims at the heart of the story, Purdue looked for mistakes in the series. “In retrospect, despite the Sentinel's prescience, journalistic carelessness caused the project to backfire, and thus miss its target. Within days, serious reporting errors in the series emerged.” Two innocent victims appeared to have a history of drug problems. Bloodsworth’s conclusions from her analysis of the autopsy reports were overstated; instead of 573 fatal overdoses “caused by oxycodone” in Florida during 2001 and 2002, only about 25 percent of those were from oxycodone alone. As the Sentinel made a series of corrections, the Columbia Journalism Review noted that Purdue used the “unforced errors” to “attack the Sentinel in a PR campaign ultimately aimed at avoiding a regulatory crackdown and ensuring a bonanza of profits." (Purdue disagreed with this characterization of its motives. The Sentinel never retracted the story, but “launched an investigation into how the reporting, editing, and communication failures occurred.” It took nearly three months before the paper printed a 2,000-plus word report by two staff reporters about what had gone wrong.)

In May 2007, Purdue and three of its top executives pleaded guilty to misbranding OxyContin. The company admitted that it had illegally promoted misleading claims that its product was not as addictive and had less potential to be abused than rival narcotic pain medications. Purdue was fined $600 million and the three executives another $34.5 million. US Attorney Brownlee asked Perez to make an impact statement at the sentencing. It was so moving that when the Senate Judiciary Committee held hearings two months later into whether Purdue’s punishment was sufficient, Perez was asked to make her statement again. This time, she brought along Brian, Jill’s 11-year-old son.

She wanted him to see where the fight to get justice for his mother had brought them. The Senate chamber fell hushed when Marianne settled at the large oak table and pulled out a few sheets of paper with handwritten notes. Before she began, she noticed that only two seats away was Jay McCloskey, who had been the US Attorney for the District of Maine from 1993 to 2001. He had been one of the first federal prosecutors to take notice of problems with OxyContin abuse. She had considered him one of the good guys, “relentless in exposing Purdue Pharma.” However, since leaving the government, McCloskey had gone on to work as a hired consultant for Purdue Pharma. McCloskey says his role was to help Purdue “stem the diversion and abuse of OxyContin.”


Perez told the senators that “pain patients from various pain societies will speak of the merits of OxyContin and their quality of life being restored because of the drug. [Many of] these pain societies throughout the country, are funded [in part] by Purdue Pharma.”

Her voice picked up tempo. “Anything that is imposed against these convicted criminals will not give us back Jill, but I will guarantee that Purdue Pharma will never forget the name Jill Skolek. … I want to know why … letters were sent by the FDA to Purdue Pharma about their marketing of OxyContin, and to this day, they are not required to put ‘highly addictive’ or ‘addictive’ on the label of the drug. I want to know why Curtis Wright, while employed by the FDA, played an intricate part … in the approval of OxyContin and then was hired by Purdue Pharma. I want to know how Rudy Giuliani could be the ‘big star’ hired by Purdue Pharma to play down the abuse and diversion of OxyContin and then get paid by the [Justice Department] for work performed for them. I want to know why the Sackler family has not been held accountable for their involvement. Eventually Purdue Pharma will introduce another blockbuster drug similar to OxyContin. … My advice to Purdue Pharma is when you are ready to introduce another drug such as OxyContin … look behind you, because I will be right there. I will be working at having Howard Udell disbarred for his criminal activities and Paul Goldenheim’s medical license revoked. I will accomplish this … do not doubt me at not being successful at achieving this. Her name was Jill Carol Skolek. She did not deserve to be prescribed OxyContin and die because of the criminal activities of individuals of Purdue Pharma. Please give my family justice and investigate the criminal activity of Purdue Pharma.”

Perez used her investigative talents to become a writer. Her tagline on her emails is “Investigative Reporter exposing the manufactured opioid epidemic and Purdue Pharma.” She writes for Salem-News.com. She also regularly blasts out to her enormous email list all developments in the massive opioid litigation. In interviews on podcasts, she hammers away at Purdue and keeps the pressure on both the attorneys general and the private attorneys to not settle for anything but total victory. And, for Perez, justice is nothing less than jail time for some Sackler family members.

From PHARMA by Gerald Posner. Reprinted by permission of Avid Reader Press, an Imprint of Simon & Schuster, Inc.

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