American Scandal - Opioids in America | Cure for Pain | 1

Episode Date: June 13, 2023

Richard Sackler charts a new course for his family’s company, Purdue Pharma. At the center of the plan: a painkiller that could be the next blockbuster drug. Need more American Scandal...? With Wondery+, enjoy exclusive seasons, binge new seasons first, and listen completely ad-free. Start your free trial in the Wondery App, Apple Podcasts, Spotify or visit wondery.app.link/IM5aogASNNb now.  See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

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Starting point is 00:00:00 You're listening to the first episode of this American Scandal season. With Wondery+, you can binge the remaining episodes, listen to new episodes early, and explore more exclusive seasons completely ad-free. Start your free trial of Wondery Plus in the Wondery app, Apple Podcasts, or Spotify today. It's February 2001, and just outside Philadelphia, a car is barreling down the highway, weaving between lanes. The vehicle swerves, dodging a slow-moving sedan. And when it pulls off the highway, it begins racing through a suburban neighborhood where bare trees and colonial houses line the road.
Starting point is 00:00:47 Inside the car, Ed Bish is gripping the steering wheel with all his strength. He knows the other drivers probably think he's a madman, but he doesn't care. Right now, all that matters is getting home as fast as possible. About 20 minutes ago, Bish's daughter called him in a panic. She said she'd found her 18-year-old brother, Eddie Jr., unconscious in his bedroom. His skin was pale blue, and he looked like he was dying. Bish had been sitting at work about 10 miles away, so he told his daughter to call 911 and ran out and hopped in the car.
Starting point is 00:01:20 Bish is now only a few minutes from home, and he's trying to reassure himself that everything is going to be okay. Eddie Jr. is young and healthy. Whatever's happening, his son is going to get through this. But when Bish pulls up in front of the house, his body goes slack. There are policemen blocking off the sidewalk. EMTs are racing into the house, and an ambulance is parked out front,
Starting point is 00:01:42 lighting up the entire block with flashing lights. Bish throws the car in a park and leaps out, charging across the front yard, his feet crunching on old snow and breath coming out in quick bursts of steam. But as he heads to the front door, a paramedic blocks his path. Hey, I'm sorry, sir. Can't let you go any further. That's my house. My son is in there. But as he heads to the front door, no, that can't be right. I'm sorry. We did everything we could. Bish begins to stagger as the red and blue lights dissolve into a hazy blur. I...
Starting point is 00:02:35 No, no, what do you mean you couldn't resuscitate him? And he's a healthy kid. He's just started school and all. He plays soccer. The paramedic nods, but maintains a stoic look and pivots the conversation. Sir, I understand. This is not easy. But I need some information, perhaps, you can give me. Have you had any reason to suspect your son was using drugs? Drugs? No. I mean, maybe he smokes pot with his friends, but he's just a teenager.
Starting point is 00:03:03 Has he been sick at all recently? Maybe. Seemed like he was coming down with a cold the other day. Why are you asking me this? Well, your son Eddie probably didn't have a cold. He was probably in withdrawal. Withdrawal? From what?
Starting point is 00:03:19 We believe he overdosed on OxyContin. Overdosed? What the hell is OxyContin. Overdo- what the hell is OxyContin? Hours later, after the policemen and ambulances and EMTs have all left, hours after he finally stopped weeping, Ed Bish gets into bed and tries to fall asleep. But he can't. He's haunted by the image of his son, lying completely still, his eyes closed, and his body lifeless. And Bish can't stop replaying the conversation with EMT and his mention of that drug, OxyContin.
Starting point is 00:03:54 None of this makes sense. And finally, when he realizes he will not get any sleep, Bish kicks off the blanket and gets out of bed. He needs answers. So he sits down at his computer and begins searching online, trying to see what he can learn about OxyContin. And it doesn't take long to find stories of grief and loss. Clicking from webpage to webpage, Bish learns that OxyContin is a prescription painkiller
Starting point is 00:04:19 that's only been on the market a few years. But in the past three months alone, 13 people in the Philadelphia region have died from overdose, a number that now includes his son, Andy Jr. But the more Bish reads, the less everything seems to make sense. How could his son have gotten his hands on pills that Bish had never heard of? How could there be a prescription drug causing so much death? Why does it look like no one's doing anything to stop this? Get ready for Las Vegas style action at BetMGM, the king of online casinos.
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Starting point is 00:05:57 At the center of it all, the 737 MAX. The latest season of Business Wars explores how Boeing allowed things to turn deadly and what, if anything, can save the company's reputation. Make sure to season of Business Wars explores how Boeing allowed things to turn deadly and what, if anything, can save the company's reputation. Make sure to listen to Business Wars wherever you get your podcasts. From Wondery, I'm Lindsey Graham, and this is American Scandal. Over the course of more than two decades, opioid addiction has grown into a deadly epidemic across the United States. In 2021 alone, there were an estimated 80,000 overdose deaths involving opioids. While drugs like heroin have long been available on the black market, the surge of overdoses from similar opioids is relatively new in American history. Opioid prescriptions began
Starting point is 00:07:06 increasing in the late 1990s after the release of what became an enormously popular drug, OxyContin. Developed by a family-owned company called Purdue Pharma, OxyContin grew to be the best-selling painkiller in the United States just five years after its launch. By 2016, Purdue had made more than $30 billion in revenue off OxyContin alone. And that might be because from the very beginning, the leadership at Purdue Pharma was determined to make OxyContin a blockbuster drug. But before they could conquer the market, Purdue would have to face off against government regulators. And Purdue's small army of salesmen would need to convince doctors to adopt a new idea about chronic pain and the ability of pills like OxyContin to give patients a shot at a new life. This is Episode 1, Cure for Pain.
Starting point is 00:08:01 It's 1983 in Norwalk, Connecticut, about 18 years before the overdose of Eddie Bish Jr. Today, Richard Sackler is walking through the headquarters of Purdue Frederick, his family's company business. Sackler rounds a corner and passes a series of framed ads for the company's products. Medical goods like laxatives, antiseptics, and drops that help remove earwax. Sackler soon steps into a busier part of the office, where he's hit with a medley of voices, including members of the company's sales team, taking large-scale orders over the phone.
Starting point is 00:08:34 It's yet another bustling day at Purdue Frederick, and as Sackler stands staring out at the office, he feels a certain measure of pride. Sackler is 38 years old, with hooded blue eyes and a receding hairline. But he moves with a swagger like he owns the place, in large part because he does. Thirty years ago, Sackler's father and two uncles bought Purdue Frederick when he was a struggling medical company and only bringing in $22,000 a year. But Sackler's family was savvy enough to know that in the medical industry, a company like theirs
Starting point is 00:09:01 could only compete in niche markets, selling products like laxatives and earwax removers. And over the years, they used this strategy to build the company into a successful enterprise, with outsized profits coming in quarter after quarter. Sackler joined the company right after he finished medical school, and he's climbed his way up through various departments, all in preparation for the final step, taking over as president when his father, Raymond Sackler, retires. But even before that happens, there's a lot for Sackler to celebrate in Purdue Frederick, especially if you're only looking at the bottom line. But Sackler can't ignore some of the more foundational problems with the company. Because for a long time now,
Starting point is 00:09:40 Purdue Frederick has been coasting on the sales of lackluster products, like the flat brown cookie Sackler's holding right now. It's not a regular pastry. It doubles as a laxative, and it's been the bane of Sackler's existence. Purdue has been trying to get these laxative cookies to market, but so far, the scientists can't get them to work fast enough. It takes hours between when you eat one and when you feel the effects. But that's not Sackler's only frustration. There's a bigger issue at play, too.
Starting point is 00:10:10 He doesn't believe Purdue Frederick should be spending so much time on products like laxative cookies. Sackler went to medical school, and he wants to make real medicine. He wants Purdue Frederick to be mentioned in the same breath as Merck or Eli Lilly, companies known for groundbreaking medications. But making those changes isn't his call. Sackler is not yet in charge of Purdue Frederick. It looks like his uncle and father are more than happy selling simple products that bring in a simple, steady stream of revenue, or medications that piggyback off other people's breakthroughs. So for now, Richard Sackler has to tow the company line. If this is what his father and uncle want, then he's just going to have to make the best damn
Starting point is 00:10:49 laxative cookie the world has ever seen. Sackler soon enters the company's lab, where a group of scientists is sitting at a row of tables, hard at work. He marches over to one young man hunched over a microscope, and drops the cookie on the table. These things are still taking too long to work. By the time anyone feels the effects, they've forgotten they ate the damn thing in the first place. The young man looks at the cookie,
Starting point is 00:11:16 and then at Sackler. Yeah, yeah, it's an issue. But we've always been up against basic biology here. The laxative can't do its job until it gets to the colon. I know that. I have a medical degree. But I'm telling you, we have to get to work faster. But we're dealing with a digestive system. I mean, it takes time. We can't change that.
Starting point is 00:11:36 We can't change that? No, that is exactly what pharmaceuticals do. They change human biology. Richard, some things aren't possible. You know, you were hired because you were young, ambitious, and you wanted to make real breakthroughs. I do. Well, then let's break through. I don't care if it's the colon or the sphincter or the damn gastric epithelium. Enough complaining. Just make it happen. The scientist stares down at his lab bench, chastised. All right,
Starting point is 00:12:06 I'll see what I can do. Sackler grabs the cookie and throws it in the trash as he steps out of the lab. But when walking back to his office, a sense of gloom begins to settle over him. Sackler has ambitions. He wants to change medicine. Yet he can't even get his own people to make improvements to a simple laxative. It's demoralizing, to say the least. But he's not giving up. Somehow, Sackler is going to make his mark. It's the late 1980s, and Kathy Sackler is sitting in an upscale steakhouse in Norwalk, Connecticut. The restaurant is filled with a hum of happy conversation, people laughing, celebrating birthdays and anniversaries.
Starting point is 00:12:49 But all throughout dinner tonight with her cousin Richard Sackler, there's been nothing but awkward silence. Richard is three years older than Kathy, just enough to be a little stronger and a little better at just about everything. Growing up, Richard took advantage of his age, making it seem like a sign of his greater intelligence. Even now, in his 40s, he hasn't been humbled, and the two cousins still don't get along. Unlike Richard, Kathy doesn't work directly for Purdue Frederick. But her father
Starting point is 00:13:17 is one of the owners, and Kathy sits on the board, so it's her duty to make sure the company is on the right track. And that's especially important now. Purdue is facing a potentially serious problem, and Kathy has an idea about how to solve it. But it's probably up to Richard to make anything happen. Kathy takes a bite of mashed potato, and keeping the tone casual, she asks Richard how's it coming along finding a replacement for M.S. Cotton.
Starting point is 00:13:43 Richard grimaces. He's not fooled by her easy tone, because they both know the question is pointed. In the 1960s, Cathy's father oversaw the purchase of a British company called Knapp Pharmaceuticals. MS-Contin was a new drug the company was developing, made up of both morphine and a unique time-released coating, which slowed down the absorption of the potent painkiller. Up until then, the only way morphine could be delivered steadily and safely was through an intravenous drip,
Starting point is 00:14:11 and patients can only receive that in a hospital. But with MS-Contin, morphine could be taken as a pill from the comfort of their own home. Knapp launched the drug in the UK in 1980, and almost right away it was hailed as a breakthrough in treating pain. Almost four years later, as the owner of the British pharmaceutical company, Purdue introduced MS-Contin to the United States. And soon enough, the drug became the company's best-selling medication and a key contributor to Purdue's bottom line.
Starting point is 00:14:40 But there was always a problem looming on the horizon. Purdue's patent on MS-Contin has an expiration date. And at this point, they've only got a few years left. When that happens, other companies will be able to sell cheaper, generic versions of the drug. And Purdue could stand to lose $170 million in annual sales, devastating loss to the company and the Sackler's family wealth. Richard Sackler and the scientists at Purdue have been trying to come up with some sort of replacement, but they struggle
Starting point is 00:15:10 to figure out which drug should be at the core of their new medication. But the clock is ticking, and unless Richard and his team have a breakthrough, the company could be in dire straits, and Richard knows it. So having raised the issue, Kathy sits back and waits to see how her cousin is going to respond. At first, Richard remains silent, and the two cousins just sit, listening to the ambient chatter of a steakhouse. But finally, Richard admits that they have not made much progress, not since the last time she asked. Kathy nods, and then asks the next part of her query, what does the research team think about oxycodone? Richard has to admit that he's never heard of it.
Starting point is 00:15:48 So Kathy enjoys explaining to her older cousin Richard that oxycodone is a close relative of morphine, but twice as potent. It's commonly used in painkillers already on the market like Percocet and Percodan. And those drugs combine low doses of oxycodone with either aspirin or acetaminophen, but no one currently sells oxycodone straight in higher doses. Richard sits up, looking interested,
Starting point is 00:16:12 and asks if oxycodone works for severe pain. Now it's Kathy's turn to admit she doesn't know something, but she says it's worth looking into. Richard then affects an air of nonchalance, saying, yeah, we'll look at it. He'll mention it to Purdue's researchers, but they probably already rule it out. Kathy clenches her jaw. This is just like Richard. But really, Kathy doesn't mind. She's done her job, and as long as Richard doesn't completely disregard her suggestion, Purdue Frederick may have its next blockbuster drug. It's 1991 in Norwalk, Connecticut.
Starting point is 00:16:52 Richard Sackler is sitting at the head of a conference table surrounded by some of his top executives. They're a scrappy group, guys who grew up in Brooklyn and aren't afraid to throw a few elbows. And while the company's executives can be rough around the edges, they're exactly the kind of squad Sackler is depending on to make Purdue into one of the most important pharmaceutical companies in America and to help deal with a looming deadline. In four years, the patent is set to expire on Purdue's moneymaker, M.S. Cotton.
Starting point is 00:17:17 Once generics begin flooding the market, Purdue is going to need a new drug to make up for its lost revenue. And while four years might sound like a long time to an outsider, when it comes to launching a new drug, make up for its lost revenue. And while four years might sound like a long time to an outsider, when it comes to launching a new drug, it might as well be four seconds. The process requires research and development, government approval, manufacturing, sales, marketing. It's all a daunting challenge, but it's also an exciting time for the company, an opportunity to build Purdue into something bigger and more ambitious. Sackler even spun off a new separate company called Purdue Pharma, which is going to be
Starting point is 00:17:49 responsible for developing the new drug, and which Sackler is hoping will eventually become a titan among U.S. pharmaceuticals. But all that is getting ahead of himself. Today, Sackler is going to announce an important step, choosing the compound that's going to be at the core of their new painkiller. Sackler begins by telling the group that there's been a breakthrough in the research. For a while now, Purdue has been considering the semi-synthetic opioid oxycodone, but there have been a lot of questions, including whether they could pair the compound with Compton, their time-release coating. But another outstanding question was whether oxycodone was safe and effective on its own and when taken in high doses.
Starting point is 00:18:28 But Sackler tells her that he's just heard from Dr. Kathleen Foley, one of the country's leading pain specialists, and she reported she has good news. Foley has been doing tests on the effectiveness of oxycodone and at high doses. So far, the results show that oxycodone can relieve severe pain with no unusual side effects. Sackler brings home the point, saying he believes they've found the key ingredient for their replacement for MS-Contin.
Starting point is 00:18:54 Purdue can develop a new drug featuring pure oxycodone at its core and pair it with Contin, their time-release coating. Sackler pauses and then asks if anyone has questions. One of the other executives does, asking Sackler what he means when he says the researcher has been giving patients high doses. How high? Sackler says that Foley gave some patients up to a thousand milligrams of oxycodone every day. The executive raises his eyebrows. That seems like a shockingly high dose.
Starting point is 00:19:29 Drugs like Percocet, which contain oxycodone, only use 10 milligrams of the stuff. What, a thousand milligrams? Is Sackler sure the research is right, that it's safe to administer at those doses? Sackler nods, explaining that oxycodone is usually paired with painkillers like acetaminophen and aspirin, and too much of those can be toxic. But Dr. Foley's research shows that oxycodone by itself can be given at a very high dose, without issue. The key is the time-release coating that allows the drug to enter the bloodstream at a steady rate. There are murmurs around the table, and Sackler can see his executives are finally grasping the picture. This could be an enormously profitable
Starting point is 00:20:05 drug. But there's something else, too. It could change medicine in America. Sackler tells the executives that there are studies showing that one-third of Americans suffer from chronic pain. It's a crushing daily reality for too many people. But experts like Dr. Kathleen Foley are encouraging doctors to rethink their approach to pain, and they believe opioids should be prescribed more broadly to address the issue. And with this new drug, Purdue could be at the forefront of medicine. They could allow people sidelined with pain to finally regain control over their lives. Sackler tells The Room that this is the next step for the company and for pain management.
Starting point is 00:20:44 The only thing to do now, after making sure the R&D holds up, is to try and convince the American public. On January 5th, 2024, an Alaska Airlines door plug tore away mid-flight, leaving a gaping hole in the side of a plane that carried 171 passengers. This heart-stopping incident was just the latest in a string of crises surrounding the aviation manufacturing giant, Boeing. In the past decade, Boeing has been involved in a series of damning scandals and deadly crashes that have chipped away at its once sterling reputation. At the center of it all, the 737 MAX. The latest season of Business Wars explores how Boeing, once the gold standard of aviation engineering, descended into a nightmare of safety concerns and public mistrust.
Starting point is 00:21:33 The decisions, denials, and devastating consequences bringing the Titan to its knees. And what, if anything, can save the company's reputation. Now, follow Business Wars on the Wondery app or wherever you get your podcasts. You can binge Business Wars, the unraveling of Boeing, early and ad-free right now on Wondery Plus. I'm Jake Warren, and in our first season of Finding, I set out on a very personal quest to find the woman who saved my mom's life. You can listen to Finding Natasha right now, exclusively on Wondery Plus. In season two, I found myself caught up in a new journey to help someone I've never even met. But a couple of years ago, I came across
Starting point is 00:22:11 a social media post by a person named Loti. It read in part, three years ago today that I attempted to jump off this bridge, but this wasn't my time to go. A gentleman named Andy saved my life. I still haven't found him. This is a story that I came across purely by chance, but it instantly moved me, and it's taken me to a place where I've had to consider some deeper issues around mental health. This is season two of Finding,
Starting point is 00:22:37 and this time, if all goes to plan, we'll be finding Andy. You can listen to Finding Andy and Finding Natasha exclusively and ad-free on Wondery+. Join Wondery in the Wondery app, Apple Podcasts, or Spotify. It's the early 1990s in Norwalk, Connecticut. In the headquarters of Purdue Pharma,
Starting point is 00:23:04 Michael Friedman is staring at a whiteboard covered in notes, trying hopelessly to come up with a new idea. Friedman is Purdue's VP of Marketing, and Richard Sackler has given him the task of turning Purdue's newest drug into a blockbuster. The company is calling it OxyContin, a novel painkiller that combines the opioid oxycodone with contin, a time-release coating. Took years to develop the drug, and now that it's ready, Purdue wants it to take over the market. But they can't make a cent of profit unless doctors want to prescribe it. And that's where Friedman comes in. As the VP of marketing, it's his job to come up with a campaign that can win over patients and hesitant doctors. But Friedman keeps running up against a wall.
Starting point is 00:23:49 For decades, physicians have been cautious when prescribing opioids because of the possibility of addiction. In one study, only 12% of surveyed doctors thought it was even acceptable to prescribe strong opioids. So somehow Friedman is going to have to overcome these doctors' long-held beliefs and get them to start recommending OxyContin. Friedman gets up out of his chair and begins pacing in circles, trying to think. Across the room, sitting at a table, is Paul Goldenheim, Purdue's chief medical officer.
Starting point is 00:24:21 Goldenheim is here as a sounding board for marketing. And while the two men haven't made much headway, Friedman knows they can't call it quits yet. All right, Paul, let's give it another go. We gotta crack this thing. We've been at it all day. Why don't we just come back to it later? We don't have the time.
Starting point is 00:24:39 Let's just dig in one more time. So to restate, the core problem is doctors are scared of opioids, right? How do we get past that fear? Again, Michael, I don't know. Doctors are only willing to prescribe these kinds of drugs if someone is dying. And you know, they're not the only ones who are afraid. You tell someone getting knee surgery that they're going to need to get morphine and they'll get hysterical. Even a pharmacist wouldn't feel that prescription. Yeah, that's what's so frustrating because doctors want this thing. We know it from the research.
Starting point is 00:25:14 Physicians say they want a long-lasting drug for people dealing with pain after surgery, whether it's a knee or a skull or a back or anything else. And also people with chronic pain. Well, if only oxycodone wasn't an opioid. I can't think of a damn thing. And maybe you're right. Let's just, let's take a break and come back to it in a bit. Friedman begins making his way to the door when suddenly he's struck with a thought. Well, wait, wait, wait, wait. Hold on. Friedman rushes back to his desk and pulls open a drawer. He grabs a memo from a stack of documents and hands it over to Goldenheim. All right, take a look at this. This is from our market research. Okay, what am I looking at? There, the line about most doctors. All right, most doctors think oxycodone is less
Starting point is 00:25:58 powerful than morphine. Okay, how does that help us? The doctors are wrong, obviously. Oxycodone is twice as potent. Yeah, but for whatever reason, doctors think it's a weaker opioid, and we can use that. I don't see how. Look, doctors already prescribe Percocet and Percodan for short-term pain, and we both know those drugs contain oxycodone. Let's take advantage of that association. If doctors believe oxycodone is a weaker opioid, it's a friendlier drug. And we can make the pitch that thanks to our time-release coding,
Starting point is 00:26:30 this nice, friendly drug could be used for patients with chronic pain, even at higher doses. Well, I might not be wrong. I mean, if it's fear we're getting over and they're not afraid of oxycodone, yeah, then they're not afraid of OxyContin. All right, let's type this up for Richard. I think he might be happy. Well, I think he'd be happy with anything, anything that gets us moving. But you know, he's not the final word. We still need approval from the FDA. But that's a problem for another day, my friend. Soon enough, Friedman is typing up his thoughts, laying out a potentially broad marketing campaign for OxyContin, the friendlier opioid. And while
Starting point is 00:27:11 there's never any guarantee that a strong campaign will translate into sales, Friedman has a good feeling about this, a sense that their new drug is about to take off. It's the mid-1990s, and OxyContin is all but ready to go. The time-release coating has proven to work. Purdue Pharma has a finalized sales pitch. Now there's just one last step before the company can bring the drug to market. OxyContin needs FDA approval. Purdue leader Richard Sackler is well aware of the complexities. It can take years before the U.S. Food and Drug Administration gives approval for any new drug.
Starting point is 00:27:48 And Sackler knows it's also especially likely FDA regulators are going to take a narrow view of OxyContin. They'll probably hesitate to approve the drug for anyone other than patients suffering severe pain from cancer. But those patients don't represent the larger potential market for OxyContin. But those patients don't represent the larger potential market for OxyContin. There are more people to be helped and more money to be made off patients with moderate and chronic pain. So Sackler is going to have to convince the FDA to approve OxyContin for a wider use. And to accomplish that, he's going to need all hands on deck from the executives at Purdue Pharma. So today, Sackler has gathered company leaders in a conference room at Purdue's headquarters.
Starting point is 00:28:29 He needs to motivate them to make inroads at the FDA and to find some way to allay regulators' concerns. Once everyone has settled in, Sackler rises to address the room. He begins by reviewing the challenges ahead of them at the FDA. They are dealing with a fundamental issue. OxyContin is made with oxycodone, which is classified as a Schedule II narcotic, a drug with a high risk of addiction. Just by
Starting point is 00:28:51 that fact alone, the FDA's appetite for widespread use will be limited. But Sackler insists to the group that addiction isn't a problem with OxyContin. They solved that with their time-release coating. Addiction, as everyone knows, is driven by peaks and troughs, the high of the hit followed by the crash afterward. But the time-release coating means that with OxyContin, a steady dose of the drug is released over the course of 12 hours. There are no peaks and valleys, no chance to grow addicted. There's some chatter among the executives,
Starting point is 00:29:22 and someone points out that Purdue hasn't done any studies to prove that they've cracked the code of addiction. Without research, the FDA might not buy the argument. But at the same time, another executive says that he was recently at a conference and ran into an FDA regulator who oversees pain medication. After a brief conversation, the regulator seemed open to talking more about OxyContin. Richard Sackler says that's the idea. We need to cultivate a relationship with the FDA. We need to make them understand that OxyContin is safe, non-addictive, and should be available to anyone in pain. They need to work all the angles, because OxyContin has the potential to be a goldmine.
Starting point is 00:30:01 potential to be a gold mine. It's the mid-1990s in Silver Spring, Maryland. In the offices of the U.S. Food and Drug Administration, an executive from Purdue Pharma is watching intently as regulator Curtis Wright sits scrutinizing medical language that could be the key for the future of OxyContin. Wright is the FDA's regulator in charge of pain medication, and over the past few years, he and Perdue have developed a relationship. Wright has helped Perdue get extensively involved with its own application to the FDA, and there have been times when he seemed like an advocate for the pharmaceutical company, which has been a big help as Perdue looks to get
Starting point is 00:30:41 broad approval for OxyContin. But that approval is in doubt. For the last few days, Purdue and Wright have been going over the application for their drug. And according to Wright, the FDA is unlikely to approve OxyContin for anything other than severe pain. And approval for moderate or chronic pain appears to be off the table. And this news was a huge blow to Purdue. But there's still a path forward. When the FDA approves any medication, doctors still have the authority to prescribe it how they see fit. It's what's known as off-label use. And so the key is to make sure physicians see OxyContin as safe and effective for treating moderate pain. And the best way to win over individual doctors
Starting point is 00:31:24 is to get the right language on the package insert. The insert is a sheet of paper included with every medication dispensed. It describes the uses, side effects, and risks of a medication, helping doctors and patients who don't have the time to read journals or find the science behind new pharmaceuticals. And in that sense, the package insert serves as a kind of story. The story Purdue is trying to tell is that OxyContin is less addictive than other opioids. So now Purdue is working to craft the perfect language for OxyContin's insert. But FDA regulator Curtis Wright doesn't seem happy with the latest draft. Wright points to a sentence in the second paragraph and tells the Purdue executive meeting with him today
Starting point is 00:32:03 that they can't say OxyContin is safer than other opioids. You can't refer to competitors in the package insert. The executive stifles a groan. They've been going back and forth on the language, and he doesn't understand the quibbling. When Purdue says OxyContin is safer, they're not referring to other competitors. They don't even list other brand names. But Wright shakes his head, saying the other regulators will never go for this. But Purdue knows that time-release coating on OxyContin is what sets the drug apart. The delayed absorption makes the painkiller less addictive. It's an essential feature of the drug, and the kind of thing they should include in the
Starting point is 00:32:40 insert. Wright says he agrees, but the company can't definitively make that claim. It's not going to fly with his fellow regulators. It's obvious that Wright isn't going to budge on this. So the Purdue executive suggests that they come up with some alternative wording. And soon the two men begin tossing around other phrases. The idea is still to suggest OxyContin is less addictive, but without saying so directly. It takes a while, but finally, the two men settle on the language for the package insert. The sentence in question reads, delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of the drug. Wright tells the Purdue executive that he still thinks one or two of his fellow regulators might object, but enough of his
Starting point is 00:33:25 colleagues should be on board to push it through. The executive leans back in this chair, feeling a sense of satisfaction. They've done good work. And while it's not exactly the language Richard Sackler wanted, it does communicate the most critical point. OxyContin is less addictive than other opioids. He was hip-hop's biggest mogul, the man who redefined fame, fortune, and the music industry. The first male rapper to be honored on the Hollywood Walk of Fame, Sean Diddy Cone. Diddy built an empire and lived a life most people only dream about. Everybody know ain't no party like a Diddy party, so.
Starting point is 00:34:07 Yeah, that's what's up. But just as quickly as his empire rose, it came crashing down. Today I'm announcing the unsealing of a three-count indictment, charging Sean Combs with racketeering conspiracy, sex trafficking, interstate transportation for prostitution. I was f***ed up and I hit rock bottom, but I made no excuses. I'm disgusted. I'm so sorry. Until you're wearing an orange jumpsuit, it's not real. Now it's real. From his meteoric rise to his shocking fall from grace,
Starting point is 00:34:38 from law and crime, this is The Rise and Fall of Diddy. Listen to The Rise and Fall of Diddy exclusively with Wondery Plus. It's early January 1996, and the dining hall of the Wigwam Resort has grown raucous. The room is packed with sales staff from Purdue Pharma, men and women gabbing it up,
Starting point is 00:35:05 making their way through another round of overpriced food and cocktails after a long day out on the golf course. Richard Sackler is there too, trying to get through his own meal and remain present for all the socializing, when Sackler is feeling distracted. Sometime in the next hour, he's going to give a big speech honoring all the hard work, all the years of effort that went into their new drug, OxyContin.
Starting point is 00:35:32 In his speech, Sackler is going to try to strike a note of inspiration. But he has to remind his sales staff that in a lot of ways, the work is just getting started. It's now their task to get OxyContin into the homes of millions of Americans. Just a few weeks ago, the FDA finally gave its approval for Purdue's new painkiller. It was a relatively fast process, taking less than a year from start to finish. The agency approved OxyContin for patients with moderate to severe pain, and Purdue is banking on getting doctors to write prescriptions allowing patients to take OxyContin for chronic pain. Purdue's growing army of salesmen are going to be at the center of this work, because they're going to be the ones sitting
Starting point is 00:36:09 down with doctors, making the pitch that OxyContin isn't addictive. With all the work ahead of them, Purdue flew the sales team out to Arizona, both for a chance to bond and to get some training for the upcoming campaign. And now that tonight's dinner is coming to a close and the waiters are clearing away plates, it's time for Richard Sackler to address the room. He throws his napkin on the table and then rises. As he steps in front of a microphone, the room breaks into applause.
Starting point is 00:36:38 Sackler then thanks everyone for coming and he begins his speech by invoking a little history. He talks about how decades ago, his uncle Arthur turned Valium into a blockbuster drug and how today, Purdue is going to make history again by launching OxyContin. Sackler tells the sales team that they're part of a revolution
Starting point is 00:36:56 because for years, doctors were too scared to prescribe opioids and patients were left suffering needlessly from pain. But Purdue Pharma is going to change all that. They're going to blanket the country in OxyContin, and they're going to give people their lives back. The sales staff jump to their feet and give Sackler another boisterous round of applause. And for a moment, Sackler stands completely still, allowing him to soak it in. This is the dawn of a new era for Purdue. OxyContin has the power to transform
Starting point is 00:37:26 the company and America. It's the winter of 1998 in a former mining town in West Virginia. Mark Ross is sitting in the office of a family doctor, holding on to a bag of fast food. He checks his watch and hopes the doctor comes and joins him before the french fries turn cold and soggy. He's already been waiting a few minutes, but if there's one thing Ross has learned, it's that you've got to make sure the doctor is happy when you pitch them on a drug. Ross is a new sales rep for Purdue Pharma,
Starting point is 00:37:58 and he's about to have his first conversation with a physician about OxyContin. When Ross went through training, he learned that you should always come bearing food when you show up to a doctor's office. The people leading the training even had research showing that a cheap meal could change a doctor's prescribing habits. It makes sense. Ross is new to the company, but he already has experience in sales. He even worked as a rep for another pharmaceutical company when a friend reached out about working for Purdue. It was a good opportunity.
Starting point is 00:38:30 On top of a base salary, Purdue sales reps also make a commission based on the number of pills they sell. Most companies cap that number, but at Purdue, the more Oxy you sell, the more you make. Still for Ross, selling OxyContin wasn't only about the bonuses. His father worked in a coal mine in a town like this, and Ross saw how the job could take a toll on the body. He knows the country is full of people like his dad, people hobbled with pain, unable to pick up their kids or even get off the couch. So Ross was taken in by the company's message, promising a revolution in the way America deals
Starting point is 00:39:01 with pain. And now he's on the road, he's been eager to actually sit down with a doctor and make the pitch. And he gets his chance when the door opens and the white-haired doctor steps in. Sorry I'm late. It's one of those days. No apologies necessary. Patients come first, right?
Starting point is 00:39:18 But hey, busy day? I got something for you. Ross hands over the bag of fast food. Oh, thanks. I appreciate it. But listen, I'm going to be up front with you. I'm probably not going to start prescribing this drug. It's nothing personal, of course. I just don't like opioids. Oh, I can respect that. But I wonder if you're looking at some outdated information. I don't know. Well, let me ask
Starting point is 00:39:38 you this. Are any of your patients suffering from chronic pain? Yeah, that's pretty common around here. And the meds they're on, how much relief do they get? Four, six hours tops? That's about right. Will OxyContin last 12? Just think what that would mean for your patients. They could sleep the whole night, finally. They could leave the house without worrying if they have their pills. Yeah, sure, it sounds good until they get addicted. Then the drug's bigger problem than the pain. But that's what's so beautiful about OxyContin. It's time-release coating. Check this out.
Starting point is 00:40:08 Right here in the package insert, delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of the drug. The FDA approved that language. There's still the possibility of abuse. That's theoretically true, sure. But I'm not sure if you've seen, there's an article in the New England Journal of Medicine that says less than 1% of patients
Starting point is 00:40:29 on opioids actually get addicted. The doctor suddenly looks taken aback. You said the New England Journal of Medicine? Mm-hmm. Yeah. One of the most prestigious medical journals in the country. 1%. Huh. No, I missed that one. Could you send me a copy? Oh, of course. Yeah. And one last thing. Purdue is going to be hosting a seminar, not far from Miami. It's going to focus on pain management, and some of the country's leading experts are going to be there. They can surely answer all your questions.
Starting point is 00:40:58 So we'd love for you to come, and of course, it's all expenses paid. Well, free trip to Florida, huh? It would be nice to get out of the cold here in West Virginia. I wish I could go myself, but I'm not. But I'll leave you some info about the seminar. And here are some pamphlets about OxyContin. Well, okay, thanks. I got to get back to patients. But you've given me a lot to think about. My pleasure. Hope you get on a plane and head to Florida. Ross begins gathering his belongings. And as he steps out of the doctor's office, he grants himself a small moment of celebration. He said exactly what Purdue told him to say, and it seemed like it worked.
Starting point is 00:41:32 And although it may not happen today, sometime soon Ross can tell that this doctor is going to start prescribing OxyContin. It's 1999 in Norwalk, Connecticut. In the headquarters of Purdue Pharma, Howard Udell leans forward in his office chair, his long face hovering inches away from his computer monitor. Udell is reading a private memo sent by email, and as he takes in all the damning information one more time, his blood begins to run cold.
Starting point is 00:42:03 Udell is Purdue Pharma's general counsel. He's worked for Purdue for decades and loves his job, and the last thing he wants is trouble for Purdue or the Sackler family. But this memo could be revealing a serious and far-reaching issue. His legal secretary poked around online, found people discussing how to remove OxyContin's time-release coating so they could get high from the prescription drug. Udell can't say he's entirely shocked. In the three years since they launched OxyContin, the painkiller has become Purdue's bestseller.
Starting point is 00:42:35 All of the marketing efforts and sales blitzes have paid off, and this year OxyContin is on pace to bring in over $600 million. There's no doubt it will soon become the most prescribed painkiller on the market. But as OxyContin has grown more popular, sales reps have been sending in troubling reports that people were seeking out OxyContin for recreational use. That was never supposed to happen. The time-release coating was intended to prevent patients from getting high. At first, Udell dismissed the reports as outliers. The company had been hearing from patients all over the country,
Starting point is 00:43:09 thanking Purdue for producing the drug and allowing them to live their lives free of pain. But Udell couldn't ignore all the rumblings from the field. So he asked his legal secretary to research the issue. She began searching message boards online to see what people were saying. And now, reading the summary of her findings, Udell is feeling mortified. Not only are people sharing tips about how to remove OxyContin's coating and crush the pill, they're even debating whether you get a better high if you snort the drug or inject it.
Starting point is 00:43:39 Making the whole thing more troubling, the legal secretary included almost all of Perdue's top executives on her email when she sent the memo. If Perdue was ever sued over OxyContin, this memo could be damaging, showing that company executives knew the drug was being abused. Udell begins pacing his office, trying to figure out a plan. As Perdue's top lawyer, he needs to protect the company and minimize any potential legal harm. So he starts gaming out possible scenarios. If the company does one day get sued, the key is to limit the documents Purdue will have to turn over.
Starting point is 00:44:15 This means limiting what gets put into writing in the first place. So one idea is that sales reps should not write down any negative observations having to do with OxyContin. They should call in the problems over the phone, and their manager should keep notes to a minimum. Another idea is to establish a system to destroy internal documents. Technically, this is legal, so long as it's done before a company is sued. Perdue could even install a program that automatically destroys emails after a certain amount of time. Udell continues pacing the office, thinking through a range of scenarios. While he doesn't have all the answers, it's now clear that Purdue is going to have to move to protect itself, because there are threats looming on the horizon.
Starting point is 00:44:58 From Wondery, this is Episode 1 of Opioids in America for American Scandal. In our next episode, a small town doctor is shocked to discover the steep toll OxyContin is taking on his community. Facing pushback from the public, Perdue digs in, determined to defend their drug against damning accusations. If you'd like to learn more about the opioid epidemic, we recommend the books Empire of Pain by Patrick Radden Keefe, Dope Sick by Beth Macy, American Overdose by Chris McGreal, Painkiller by Barry Meyer,
Starting point is 00:45:34 Dreamland by Sam Canones, the documentary The Crime of the Century, directed by Alex Gibney, airing on HBO. This episode contains reenactments and dramatized details. And while in most cases we can't know exactly what was said, all our dramatizations are based on historical research. American Scandal is hosted, edited, and executive produced by me, Lindsey Graham for Airship. Audio editing by Christian Paraga. Sound design by Molly Bach. Music by Lindsey Graham. This episode is written by Austin Rackless. Ed edited by Christina Malsberger. Fact-checking by
Starting point is 00:46:05 Alyssa Jung Perry, produced by Andy Herman. Our senior producer is Gabe Riven. Executive producers are Stephanie Jens, Jenny Lauer-Beckman, and Marshall Louis
Starting point is 00:46:14 for Wondery.

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