In 1995, 12-year-old Eddie Bisch was on a family fishing trip in the Florida Keys when his father, Ed Bisch, splurged and rented a boat on Islamorada. The mahi-mahi were everywhere; when Eddie snagged one it jumped so crazily on his line he screamed. That memorable Florida fishing trip would be their last.
Earlier that year, Purdue Pharma had begun a major public relations effort to blanket regulators and prescribing doctors alike with information about OxyContin — much of which came with obfuscation about how addictive the drug, a version of oxycodone with a time-release mechanism, actually was. The F.D.A.-approved language on the initial label, stating that delayed absorption was “believed to reduce” abuse of the drug, was so valuable that, as Purdue executives gushed in one internal report, it could have easily served as OxyContin’s “principal selling tool.”
A recently discovered 2006 Department of Justice memorandum described the approval process for OxyContin as having been “tainted” by Purdue’s efforts to position the drug as less addictive and prone to abuse than other opioids.
During a year in which half a million Americans have died of Covid-19, it’s easy to overlook a much longer epidemic — the worst drug crisis in American history, a crisis fueled in part by the unholy alliance between F.D.A. officials and pharmaceutical companies. Since Eddie Bisch’s Florida fishing trip, at least 500,000 Americans have died of an opioid-related overdose. Millions now have what’s called opioid use disorder. Drug overdose deaths in the year ending May 2020 reached a record high.
Meanwhile, the interim F.D.A. commissioner, Dr. Janet Woodcock, long known as the nation’s top drug cop, is reported to be under consideration by the Biden administration to permanently lead the agency.
She became director of the F.D.A.’s Center for Drug Evaluation and Research in 1994, the year before the agency approved OxyContin. In her more than two decades in this role, Dr. Woodcock helped preside over what Dr. Andrew Kolodny, co-founder of Physicians for Responsible Opioid Prescribing, has called “the worst regulatory agency failure in American history.”
While President Biden attempts to overturn so much of what went wrong during his predecessor’s tenure, 28 groups fighting the opioid crisis sent a letter to the new administration urging it to appoint someone other than Dr. Woodcock to lead the F.D.A. permanently because of her role in the approval of OxyContin and other opioids that came to market in its wake.
It’s not just physicians and public-health groups that have taken issue with Dr. Woodcock’s possible nomination. It’s the families of opioid victims themselves.
She is not, of course the only former F.D.A. official of that era to come under question. That same 2006 memo touched on the regulator-to-industry revolving door. In 1998, the medical review officer who evaluated OxyContin went to work for Purdue, earning at least $379,000 his first year. But he is not up for F.D.A. commissioner.
When Eddie turned 16 in 1998, just four years after Dr. Woodcock became director of the Center for Drug Evaluation and Research, Ed Bisch bought his only son a used Mercury Sable. The family had just moved from Fishtown, their longtime Philadelphia neighborhood, to a New Jersey suburb 10 miles away. Eddie didn’t love the Sable — it had a “little old man” look, he complained — but he was glad to have it to get him to his after-school job.
Eddie often drove the car to Fishtown to see old friends. When he found a culinary school nearby he liked, father and son celebrated his admission by booking a return fishing trip to Islamorada in 2001.
Six days before the vacation, Eddie’s younger sister found him in his bedroom — unresponsive, his skin bluish.
The night before, Eddie had gone to a party in Fishtown. He’d chewed and swallowed OxyContin, a method that circumvented the drug’s time-release mechanism. That night in his sleep, the drug mixed with alcohol and illicit benzodiazepines to repress his respiratory system.
Soon after the drug’s introduction in 1996, this became the common hack for getting a high from a drug marketed as not providing one: crushing leftover OxyContin pills swiped from a family medicine cabinet or, more likely in Eddie’s case, purchased from drug dealers who frequented the office of a known pill-mill doctor just outside of Philadelphia, Richard Paolino. (Dr. Paolino was later arrested and sentenced to 30 to 120 years in prison.)
In July 2001, five months after Eddie’s death, the F.D.A. finally required Purdue to add a “black box” warning about the potential for abuse and misuse to OxyContin labels. Paradoxically, the new label, while seeming like a rebuke, actually helped Purdue market the pills even more broadly for long-term treatment by allowing Purdue to write that OxyContin would be beneficial in instances where “a continuous, around-the-clock opioid analgesic is needed for an extended period of time.” Purdue shrugged the changes off as “more of an exercise in graphic design.”
“The action by the F.D.A. to clarify the OxyContin tablets labeling has created enormous opportunities,” the company wrote in a 2002 budget plan. “This is a positive action which helps to combat the negative reports perpetuated by the media.”
A week after his son’s death, Ed Bisch created a message board to connect similarly grieving families across the nation. He used vacation time to lead them in rallies outside conferences in which Purdue participated.
In 2002, when OxyContin began making headlines across the country, the F.D.A. convened an advisory panel to help the agency re-evaluate its policy on opioids and discuss the safety of prescribing opioids to patients with chronic non-cancer related pain. Eight of the 10 panelists had been paid speakers or consultants for Purdue or other opioid makers; the panelists did not recommend any changes to OxyContin’s label.
In a recent letter to Senator Maggie Hassan of New Hampshire, Dr. Woodcock wrote that the 2001 label change narrowed the use indication and that “it does not appear that there was any notable increase in the overall number of oxycodone E.R. prescriptions dispensed as a result of the 2001 change.” (Purdue has also denied that the 2001 label broadened the drug’s use indication.)
Around that time, pharmaceutical makers like Purdue began paying entrance fees as high as $35,000 to attend invitation-only conferences, organized by a drug company-funded group called IMMPACT, with F.D.A. and National Institutes of Health representatives, elbow-rubbing affairs held at posh hotels that raised concerns about a possible “pay for play” arrangement. (IMMPACT and the F.D.A. have said that there were no improprieties.)
One idea discussed in the meetings was “enriched enrollment randomized withdrawal,” a drug trial design that has been accused of tilting the process in favor of F.D.A. approval. Enriched enrollment meant that people who didn’t respond well to the drugs were excluded from clinical trials — an omission, many experts believe, that makes it far more likely for a drug to appear to be effective while simultaneously concealing, obscuring or overlooking what might happen once the drug reaches the general population.
Prescription opioid deaths had already more than doubled between 1999 and 2006 when the F.D.A. approved a painkiller manufactured by Endo, Opana ER, using the questionable enriched enrollment testing methods. More than a decade later, and only after IV use of Opana was linked to to an H.I.V. outbreak in rural Indiana and a hepatitis C surge across Appalachia, did the F.D.A request a halt to sales of Endo’s reformulated Opana ER.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Dr. Woodcock said in 2017. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.” She claimed the action would protect the public from further misuse and abuse, but the action was beyond belated: 11 years had passed since that drug’s approval, with an estimated 1.7 million Americans already suffering from substance use disorders related to prescription opioids.
In 2007, Purdue and three executives admitted to misleading regulators, doctors and patients about OxyContin’s risk of addiction, and agreed to pay $634.5 million in fines. Outside the federal courthouse in Virginia where they pleaded guilty to “misbranding,” Ed Bisch led relatives of the dead in a protest.
One of several parents who spoke at the court hearing, Mr. Bisch argued that the executives should face jail time. “The lies and deceits started at the top and caused to ruin countless lives,” he said. But to date no one from Purdue has ever gone to prison for the role that OxyContin has played in the opioid crisis.
And still the agency’s greenlighting of opioids continued. In 2013, the F.D.A. approved an opioid called Zohydro even though its own scientific advisers voted 11-2 against it. Critics were worried that the painkiller would be as easy to abuse as OxyContin initially was. But when they approved the drug, Dr. Woodcock and the F.D.A. did not demand the manufacturer at the time, Zogenix, add features that would have made it more difficult for users to crush the pill.
In 2015, the agency and Dr. Woodcock gave the nod to OxyContin for use in patients as young as 11 years old. In 2018, the F.D.A. approved Dsuvia, a fentanyl analogue that’s 1,000 times more potent than morphine. Even though one of the F.D.A.’s own advisory chairs predicted that the Dsuvia’s approval would lead to more abuse and death — nearly 47,000 Americans died of opioid-related overdoses in 2018 — this super-potent drug came to market anyway.
In the letter to Senator Hassan, Dr. Woodcock wrote that “our goal has been to ensure that our approval and other regulatory actions regarding opioids are science-based and that the agency’s benefit-risk framework considers not only the outcomes of prescription opioid analgesics when used as prescribed but also the public health effects of inappropriate use.”
But the pattern is clear. As drug overdoses fueled a decline in American life expectancy, drug makers kept bringing new opioids to market. Even when evidence suggested the risks outweighed the benefits, the F.D.A. was in the pocket of the pharmaceutical industry, which funds 75 percent of its opioid-approval budget via user fees. The agency has denied that this funding buys influence, and Dr. Woodcock has claimed that user fees accelerate innovation, but to many families, that drive for innovation actually resulted in a dereliction of duty, willful blindness and a generation lost.
The responsibility to prevent the nation’s most preventable epidemic was not that of one person, of course. And the failure is broad. But activists see Dr. Woodcock’s possible nomination as a referendum on that failure.
Last month, Mr. Bisch helped convene more than two dozen activist groups in an attempt to block Dr. Woodcock’s promotion, including the artist Nan Goldin’s P.A.I.N. and the Fed Up! Coalition. Meanwhile, as Purdue and its Sackler family owners try to keep their freedom and wealth intact, survivors of the scourge have marched and testified till their voices are hoarse.
As of Feb. 19, Eddie Bisch has been dead 20 years — longer than he lived.
Just because regulation of painkillers has been lax during four presidential administrations does not mean the threat Dr. Woodcock poses isn’t real. If industry insiders want Dr. Woodcock elevated to the permanent position of F.D.A. commissioner, it’s because they can count on her to serve them rather than the public.
Beth Macy is the author of “Dopesick: Dealers, Doctors, and the Drug Company That Addicted America.”
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