State Hopes Pharma Settlement Will Stop False Marketing of Opioid Painkillers

Jan 20, 2017

For over a year, the New Hampshire Attorney General’s office has been trying to determine whether drug makers break the law in how they marketed opioid painkillers in the state. It’s a slow legal battle that could determine that pharmaceutical companies knew they were putting people at risk by overselling highly addictive painkillers. Many of those painkillers were abused – leading to an addiction and overdose epidemic.

There’s been a new development in that story, and NHPR’s Jack Rodolico sat down with Morning Edition to talk about it.

This week the Attorney General’s office announced it had reached an agreement with a company most people have probably never heard of: Insys Therapeutics. The state alleged Insys engaged in an illegal kickback scheme with prescribers.

Right, so the drug of choice here was called Subsys, and that’s just a brand name for fentanyl. Fentanyl is a very powerful opioid. It’s also – people should understand – the number one cause of drug overdose deaths in the state right now.

This is a type of fentanyl is delivered in a spray under the tongue. And when it was approved by the federal government, by the FDA, it was approved for breakthrough cancer pain – one very specific purpose. But what the AG alleged is that it was marketed for chronic pain, things like back pain, headaches.

It was clearly not indicated for that?

Clearly not indicated for that. Yet that’s what it was mostly advertised for to prescribers and then sold to consumers with pain.

This sounds like a conspiracy. In New Hampshire all we’re focused on is one prescriber?

Yeah, there’s a national conspiracy element to this, but in New Hampshire it focuses on one physician’s assistant named Christopher Clough. This is a guy who’s since lost his license. He’s been in the news a lot. He worked for Pain Care, a well-known pain management clinic in the state.

What happened with Clough is that he was given these “speaker fees” - $44,000 worth of “speaker fees” – but what these speaking fees really were was he would sit down at a fancy restaurant with friends and coworkers. And he was given, like, $4,000 a pop to do this.

In the meantime there were over 100,000 doses of this drug prescribed in this state over two years. Eighty four percent were prescribed by Christopher Clough - the vast majority. So this problem was really focused on this one individual in New Hampshire.

The state feels they took care of this because Clough no longer has his license. And the settlement, the company agreed to pay $3.4 million dollars to the state. They admitted no wrongdoing, but they signed an agreement saying we will not break the law in the future. That’s a legally binding agreement.

But this case in N.H. is sort of the least of this company’s problems right now.

Yeah, you do not want to work for Insys Therapeutics today. Last month six of their top executives were arrested and indicted on federal conspiracy charges. The FBI is looking for victims of this mass conspiracy of people who were prescribed this drug in error.

And what was really interesting to me was many of the top prescribers of the drug have all gotten in trouble with the law all around the country: one in Alaska, a couple in Alabama, one in Connecticut, one here in New Hampshire, another in Michigan. Even the investors in this company are doing their own investigation.

But there’s a bigger legal question still playing out here. Insys is one of six drug manufacturers the state has subpoenaed, asking them to turn over documents that show how they marketed opioids in the state. And this is the only company that cooperated. Where do the other cases stand?

This company Insys is one of six companies the state has subpoenaed and the other five have not complied with the subpoenas. Purdue Pharmaceutical, for example, they manufacture OxyContin. There’s way more OxyContin in the state [than Subsys].

So those companies have refused to hand over marketing material to the state that would indicate to the state whether they broke the law when they marketed these drugs to prescribers. I talked to the lead investigator for this case, Jim Boffetti. He is the head of the Consumer Protection Division at the Department of Justuce. Let’s hear what what he has to say.

What all these cases involve, which is the marketing of brand name opioids, this will send a message hopefully that you have to market them in a way that is not unfair and not deceptive. And then prescribers can do what they do best, which is look at their patients and make the best decisions for those patients.

What happens now is these five pharmaceutical companies have been appealing the state’s request to give documents. And next month they go to the Supreme Court. That’s pretty much the end of the story. If the Supreme Court says hand over the documents, they will – well, we’ll see if they will. Or perhaps the Supreme Court will rule in their favor and that will be the end of it.