Any history of the pharmaceutical industry in America is going to be in part a history of corporate crime.
And any history of corporate crime in the pharmaceutical industry won’t take long before it gets to the Sackler family, their company Purdue Pharma and the opioid crisis that has claimed hundreds of thousands of American lives.
And so it is with Gerald Posner’s new book Pharma: Greed Lies and the Poisoning of America (Simon & Schuster 2020).
“The first drug the Sacklers had was a time-released morphine product for end of life cancer patients,” Posner told Corporate Crime Reporter in an interview last week. “It was developed for their British pharmaceutical arm – Napp. Cicely Saunders opened the first hospice care facility there. And she was using heroin to keep patients free from pain. But they had to dose it every three to six hours. They knew they needed a longer acting pain reliever so they could send people home. They needed it so it was easy to give so they wouldn’t have to give it through an IV.”
“The Sacklers came up with a twelve hour oral dosing morphine end of life pill. It became the pill used by hospices in the UK and then eventually over here. This was in the mid-1980s.”
“That pill was used here also, and dispensed almost always by oncologists. The Sackler family said – we would like to come up with a new opioid based painkiller, different than that morphine one. And we don’t want to use morphine because when people hear the word morphine they think – end of life.”
“They focused on oxycodone. Same type of action as morphine and heroin. They used the same twelve hour invisible polymer coating that allowed the drug to dissolve slowly. And they went to the FDA for approval. And were able to get the FDA to put an extraordinary line on the label. And it said – this drug is likely to be less subject to abuse and to addiction.”
Was that true?
“No. It turns out that was not true. But it made sense. Monday morning we know all the right answers. The FDA should have erred for the worst possible situation. Instead, they bought the argument from Purdue, which they presented very well. They said – the abuse on the instant release opioids went like this – people bite them, and that releases all of the amount. You get the full dose of the opioid right away. Ours releases it over twelve hours. It was more like eight or nine. But they had enough evidence to make the case for twelve hours. As a result, you don’t get the rush all at once. You will be fine. You won’t get addicted because you are not chasing that high. And won’t get the high from it.”
“The FDA said – that makes sense. People aren’t going to abuse these. And that made doctors feel safer about prescribing it. It also coincided with a movement among some doctors who said pain was being underdiagnosed. That’s how we end up with – pain is one of the five vital signs. You go to a doctor and they check your heart rate and blood pressure and ask you if you are feeling any pain. That came from the 1980s.”
“And these doctors argued that opioids had been tarnished for too long as too addictive. And they really were not as addictive as we thought. That was an independent movement that the Sacklers took and took advantage of by putting some of those doctors on speakers bureaus and having them go around and lecture.”
“The Purdue board was dominated by the Sackler family. It was a family run operation. The company was privately held. And the Sacklers and Purdue underplayed the risk of addiction as those reports started to come in. They did not report the instances of abuse. They pushed their sales team to go right to the line and sometimes over it, I believe, in terms of saying – this pill is useful for osteoarthritis. It failed to show that it was.”
“Back pain. They targeted veterans. They targeted the old. They targeted opioids virgins – people who had never had opioids. They went to the highest prescribing doctors. And when those doctors prescribed more pills for that particular town than people who existed in five surrounding counties, they never raised it with the Drug Enforcement Administration or anybody else. They fought every effort to show that the drug was addictive even when their own information was showing that it was.”
“And in 2007, they ended up in a federal court in Virginia. Three top executives plead guilty to having misrepresented the drug. They plead guilty. They paid $30 million in personal fines. And the company pays over $600 million and signs a compliance agreement with the federal government saying they will not do any of those things again.”
“Stop right there. We are in 2007 or 2008. And if you were interviewing me, I would say – this company Purdue got way ahead of the drug. They pushed it. They caused all types of problems. There were about 10,000 people dead at that point from prescription opioids. And they just paid a price in court.”
“There were hearings into whether somebody should have been sent to jail. And the Senate concludes – no it was a fair outcome. This is what happens in the pharmaceutical world by the way. The Sacklers are not alone. Nor is Purdue. What is the result time and time again almost always? Crimes are committed and pleaded to. And it’s a fine. It’s a big, big fine. They figure that as part of their costs. And it cuts into their profits. But they keep going ahead doing the same thing.”
“In 2007 or 2008, I would have said to you – that’s the end of the story. Oxycontin is finished as a problem drug because this firm just got run into federal court. They pleaded guilty. It’s over. And guess what? I would have been completely wrong. Because at that point on, oxycontin became the biggest seller ever in the painkiller market. It went from 2008 and on that they repeat not only the same activity, but it becomes even more aggressive. The drug makes $35 billion in sales from 1996 to 2019. But over $20 billion came from 2012 to 2019.”
“The remarkable story here is not – misdeed, charges, crime found, and justice served.”
“Instead it was misdeed, crime found, justice apparently served and then not served at all, but allowed to grow into this lethal epidemic that has claimed more lives than the Civil War. That is just astonishing.”
“And the U.S. Attorney at the time – John Leslie Brownlee – has not spoken publicly about this since he testified before the Senate years ago. He clearly wanted to bring the toughest possible charges he could. The case was dialed back a little bit by DC headquarters. They said – let’s not make this into the greatest case ever brought. Let’s make it into a case you can win. And they went for the lower hanging fruit, which was the misbranding and misrepresentation.”
Purdue hired the former U.S. Attorney Rudolph Giuliani. What role did he play?
“When Giuliani formed Giuliani Partners in 2002, Purdue was his first big client. Giuliani knew Asa Hutchinson, who headed the DEA at the time. He was friends with Hutchinson. They were worried about what the DEA was looking at. He knew all of the players. He came in with a lot of credentials. Purdue hired him for having that influence. There is no doubt about that.”
“I looked hard to see if in fact he pressed the scales in a way that could be proven in terms of documents, phone calls or anything else. I can’t find it.”
Could the pharmacists have stopped this?
“The pharmacists could have stopped it on their own. But there is plenty of blame to go around on this. I talk about what Purdue and the Sacklers are responsible for. But they don’t stand alone. They have become the poster child for the opioid crisis. But you could not have had this crisis if you did not have doctors who were reevaluating opioids, who then sold their souls to Purdue and other manufacturers to go out on the lecture circuit to make money as consultants. There were other pharmaceutical companies that had their opioid products on the market. Johnson & Johnson just lost a judgment in Oklahoma – it was a $500 million judgement down now to $350 million. They control much of the poppy production from Tasmania. And that supplies two-thirds of all of the opioid production for manufacture of drugs in the United States.”
“The companies have dirty hands. But so do the distributors – McKesson, Cardinal Health, AmerisourceBergen. These multi billion dollar companies. They were the distributors. They knew exactly where every pill was going. Purdue would know they were selling 100 million pills to AmerisourceBergen. But in the end, the distributors know which little pharmacy in West Virginia is ordering 9 million pills for a town of 1800 people. And that’s impossible.”
“The doctors who became pill mills. They happened to have a medical degree, but they were no different than the heroin dealer on the street, except they are writing prescriptions.”
“The pharmacists who were diverting some of the supply to the side – not all of them, but some were. They are responsible. Responsibility is far and wide. But Purdue is taking the brunt of the hit because their drug is the most successful. But I believe there are a lot of entities who are breathing a sigh of relief that all of the focus is on Purdue because if it wasn’t, it would be widespread and on them as well.”
[For the complete q/a format Interview with Gerald Posner, see 34 Corporate Crime Reporter 22(9), Monday June 1, 2020, print edition only.]