TOPICS > Health

OxyContin Maker Guilty of Misleading Public

May 11, 2007 at 6:15 PM EDT

JIM LEHRER: And now, punishing the makers of the drug OxyContin. Ray Suarez begins with some background.

RAY SUAREZ: OxyContin, the powerful narcotic pain relief medication, has generated billions of dollars in sales since it was introduced to the market in 1996. Doctors prescribed the drug to millions suffering chronic pain.

Yesterday, the government announced both fines and a plea agreement against the drug’s manufacturer, Purdue Pharma. Under the plea deal, Purdue will pay $634 million in fines and other payments for misbranding their product. Prosecutors say the company described OxyContin as less addictive, thus less likely to be abused.

JOHN BROWNLEE, U.S. Attorney, Virginia: Despite knowing that OxyContin contained high concentrations of oxycodone, had an abuse potential similar to that of morphine, and was at least as addictive as other pain medications on the market, Purdue, beginning in January of 1996, with the intent to defraud and mislead, marketed and promoted OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.

RAY SUAREZ: Three current and former Purdue execs pleaded guilty to misdemeanors. Together they will pay almost $35 million of their own money in fines. Of the $600 million Purdue will pay, $130 million will be used to resolve civil suits brought by patients who say they became addicted to the drug.

Over the years, OxyContin has legitimately helped many patients cope with pain, but its criminal abuse has been widespread. The drug has been connected with hundreds of deaths and arrests.

Holding the company accountable

RAY SUAREZ: Now, two views of the penalties and plea deal in this case. John Brownlee is the U.S. attorney for the western district of Virginia. He was the government's lead prosecutor. And Dr. Sidney Wolfe is the director of Public Citizen's Health Research Group, an advocacy group concerned with oversight and the labeling of drugs. We invited Purdue Pharma to participate, and they declined.

Mr. Brownlee, let's start with you. In your announcement yesterday, you discussed the crime rates, the teenage drug addiction and deaths, and said the results of Purdue's crimes were staggering.

JOHN BROWNLEE, U.S. Attorney, Virginia: Yes, sir.

RAY SUAREZ: Does the penalty meted out for three misdemeanor pleas match what you saw as a staggering toll?

JOHN BROWNLEE: Well, I believe that it does. And I think we need to look at the agreement in whole.

First of all, the most significant thing in my opinion that this plea does is it holds the company accountable for its criminal acts. This plea agreement covers a time period between 1996 and 2001, so we go back over 10 years where they began the criminal activity. And we are able to build a case to hold them accountable for conduct, again, a long time ago.

We have found the truth in bringing this case and demanding that this company plead guilty to the felony misbranding of OxyContin. So I think getting to the truth, finding the truth is significant.

I think there was a perception, a wrong perception, that somehow the OxyContin epidemic was our fault, that people who lived in southwest Virginia or other rural communities, that we were to blame for this OxyContin epidemic. And with this plea agreement, with this conviction, the truth has been told.

And it was, in fact, the company's fault, the company's responsibility. By misbranding this drug, with the intent to defraud and mislead, they are responsible.

We've also extracted $600 million from them. In addition, we've also demanded that the top three executives, the CEO, the general counsel, and the former chief medical officer plead guilty to misbranding OxyContin.

I think, if you look even in the New York Times today, Barry Meier's article, he talks about the fact that that's a rare move on behalf of these kinds of cases. And I think that's true.

Typically, in a corporate kind of plea, the corporation does the plea, and the executives don't have to go to court. But in our case, they had to come to court in Abingdon, Virginia, yesterday, stand before a federal judge, and say that they are guilty. And we think that that, plus the fines, is significant.

Why not criminally prosecuted?

RAY SUAREZ: Well, Dr. Wolfe, you just heard John Brownlee describe Purdue Pharma as suitably held accountable. Do you think so?

DR. SIDNEY WOLFE, Public Citizen's Health Research Group: Well, if you believe that corporations are faceless, I think that's right. And I have no dispute with the investigation that was done.

The question is, the definition of a felony, which would be subject to jail, as opposed to just fines, as occurred in this case, is, did they intend to defraud or mislead? And I think that the papers that were produced yesterday clearly show that somebody in the company intended to defraud and mislead.

The fact is -- and I have no reason to doubt U.S. Attorney Brownlee -- that, for those three people, they did not come up with that evidence. But someone in the company, it wasn't robots, designed this program to mislead doctors into thinking that this drug was much safer than it was and get them to prescribe it preferentially over other drugs.

So I guess one of my questions is, why wasn't anyone criminally prosecuted under a felony charge wherein they could go to jail? We have all sorts of people in this country languishing in jail, including people that sold OxyContin. So much of it was prescribed, thanks to the criminal activities of the company, that it's all around, so there are people in jail for a 100, 200, 300 pills.

We estimate that this company sold hundreds of millions of dollars of pills, according to one of the last pages in this document that was released yesterday. They made over $2.5 billion in profit.

So two questions: Why hasn't anyone gone to jail? Even if those three didn't have evidence for going to jail, who are the other people in the company that actually intended to do this? And, secondly, why wasn't the fine much higher? Why was it just a fraction of the profits they made just off of this drug?

Setting up the case

RAY SUAREZ: Well, let's take that first question. John Brownlee, why were there no felony charges? Why did no one go to jail?

JOHN BROWNLEE: Right, I think you have to -- I think that Dr. Wolfe and I may be kind of like ships passing in the night. He looks at -- and if you listen to his statement carefully -- he poses rhetorical questions, but he also says he believes, he thinks.

As a prosecutor, as the United States attorney, my obligations are much higher. When I look at a case, I have to ask myself, do I have evidence that's admissible in a court of law that I can prove, beyond a reasonable doubt to a unanimous verdict, that, in fact, a particular individual, not just someone, but a particular individual, violated the law?

We spent five years looking through millions of documents. And these people who did this case, the professional prosecutors, Assistant United States Attorney Randy Ramseyer, Rick Mountcastle, Barbara Wells, Sharon Burnham, investigators from the IRS, like Phil Barnett and others, they spent years culling through millions of documents, looking for the evidence.

And what they did is they were able to piece together a corporate culture that allowed this product to be misbranded with the intent to defraud and mislead.

So I certainly hear the doctor's comments and, in many ways, agree with him. But, of course, as a prosecutor, as a United States attorney, I am bound by the evidence that we have. I think this case was thoroughly investigated.

But I just -- I think it's important to look at the positive things that come from a case like this. The fact that we are able to convict the company, tell the truth, take $600 million from them, in addition convict the executives, and take almost $35 million from them is, in my opinion, significant.

RAY SUAREZ: Just to be sure I understand you, sir, are you saying that, given the evidence you had, you were not sure that you could have made felony charges stick in this case?

JOHN BROWNLEE: Well, we look at this evidence carefully and only proceed forward when we believe we have enough evidence to prove beyond a reasonable doubt to a unanimous verdict.

And so all things, once we looked at this case and the professional prosecutors who did it, as well, we believe that, by convicting the company and convicting the individuals, and taking almost $635 million, plus instituting an independent monitor inside the company that will make sure this doesn't happen again, is significant. And certainly, in our district, and I think the response we've received just in the last day has been pretty remarkable.

Changing the literature

RAY SUAREZ: Now, Dr. Wolfe, that independent monitor appointment, the promise to change the literature that accompanies the drug, are these positive steps, in your view, in trying to prevent the abuse, the future abuse of OxyContin?

DR. SIDNEY WOLFE: Those are clearly positive steps. I mean, it's though the company itself, if you look at it as a company, has been addicted to making money off of this drug. And they are now in some remedial treatment for their addiction to selling this drug. And so having them fund an outside independent group to come in there I think is a great idea.

But just going back to this other point, which is, the papers that were released yesterday state explicitly that the company intended to defraud and mislead people. And it even describes the categories of employees who did this.

And so the question I'm raising, let's assume that U.S. Attorney Brownlee is right about the top three people, but they actually identified categories of people who were involved in this intending to defraud and mislead. Some of them were salespeople; some of them were sales managers. I believe that going after those people might have also pointed the way more to the top.

I don't know that at all, but what I do know is that their admission is that somebody in this company -- it was not -- I mean, for sure, the corporate culture is horrible, a company that is willing to essentially act as a white-collar drug trafficker, and have hundreds of millions of pills going out there under false pretenses, no doubt it's a bad corporate culture.

But they had people in there, and there's no evidence here -- let's say you tried to convict the top people of felonies. But I believe that there must be people in here, you identify by category, who perpetrated these felonies and should go to jail.

RAY SUAREZ: Gentlemen, thank you very much.