ARI SHAPIRO, HOST:
The small town of Austin, Ind., is still coping with an HIV outbreak that began more than a year ago. A-hundred-ninety people have tested positive for HIV in a town of about 4,500. As we heard yesterday, the outbreak is tied to IV drug use and people sharing needles.
AUDIE CORNISH, HOST:
The drug of choice in Austin is a prescription painkiller called Opana, specifically a version of Opana that was supposed to be abuse-deterrent. Our colleague, Tom Dreisbach, has been looking into this drug and the company that makes it, Endo Pharmaceuticals. Our co-host, Kelly McEvers, spoke to him about his reporting.
KELLY MCEVERS, HOST:
Tom, what did you find out about this drug, Opana?
TOM DREISBACH, BYLINE: So Opana came out in 2006. It's about twice as powerful as OxyContin, and it's indicated for moderate-to-severe chronic pain. And like a lot of opioids these days, it's been abused. Many people were crushing and snorting the pills. And what I found is that, in 2012, Endo Pharmaceuticals reformulated this drug. They added a coating that they said would make it crush-resistant. Now, that change seems to have had an unintended consequence. We talked to people in Austin who had been snorting this drug. They told us, after the reformulation, that's when they starting using needles to inject it. And I found evidence that this has been happening in other parts of the country, too..
MCEVERS: What has the company said about this?
DREISBACH: Well, Endo declined to talk on tape. In a statement, they told us, quote, "were dedicated to providing quality medications to treat the millions of patients diagnosed with chronic pain and to addressing opioid abuse." What I found is that they had both public health motivations, and interviews with experts, court filings and documents suggest they also had real business motivations for reformulating this drug.
MCEVERS: We're going to talk about that more in a minute, but first let's talk about some of the stories we heard while we reporting on this in Indiana.
DREISBACH: Right, well, there was this one woman named Joy. We're only using her first name to protect her privacy. She's a former registered nurse. She had a back injury, got prescribed painkillers, got addicted to those painkillers. And at some point, she started snorting Opana. Now, when the company reformulated the drug in 2012, she could not snort the drug anymore, but then she told us...
JOY: Some genius figured out, hey, we can cook this down and turn it into a liquid and shoot it up. And then it took off like wildfire after that. Everywhere you look in town was just sharing needles, and you saw where that led, you know - the HIV outbreak.
DREISBACH: Now, Joy says she's lucky. She didn't share needles, and she has tested negative for HIV. But we heard the same story again and again from people in Austin, Ind.
MCEVERS: We did. And while we were there, I watched, actually, how people cook Opana in the bottom of a soda can. All it took was a cigarette lighter and some tap water, and the coating on this pill just floated away. So the question is, why did the drug company change the drug?
DREISBACH: Well, Endo has maintained that the decision was about public health. They told the Food and Drug Administration that they wanted to make a drug that was just as effective and harder to abuse, but I found documents that suggest a strong financial motivation for this change. At the time, Endo was facing the threat of generic competition. And so when they reformulated the drug in 2012, they filed a petition with the FDA. They asked that their new drug get official labeling calling the drug abuse-deterrent. And they also asked the FDA to block all of their generic competitors. In a signed declaration, an Endo executive said that if generic competition came on the market, that would reduce sales of Opana by up to $135 million every year.
MCEVERS: Did Endo get what it wanted?
DREISBACH: No. The FDA rejected Endo's petition. They said they do not consider the drug abuse-deterrent. At the time, they wrote, quote, "reformulated Opana can be readily prepared for injection." They also said preliminary data suggests, quote, "the troubling possibility that a higher percentage of reformulated Opana abuse is via injection than was the case with the original formulation." That was the FDA. And I found two separate studies that seem to confirm the FDA's fears. The studies found, overall, Opana abuse had dropped after the reformulation, especially among people who snorted the drug. But according to one study co-authored by a medical director from Endo, most of the abuse of Opana is now by injection.
MCEVERS: So what does this mean for the bigger picture - I mean, the overall opioid crisis in this country?
DREISBACH: Depends on your perspective. I mean, people who support the development of abuse-deterrent drugs say they're not perfect, but stopping some forms of abuse, like snorting, is worthwhile. On the other hand, public-health experts worry that these drugs give a false sense of security. They say the abuse-deterrent versions do not stop people from abusing them orally. And there's this real worry that preventing one type of abuse for one drug without also increasing access for drug treatment just shifts people to using other painkillers or illegal drugs, like heroin. You know, the FDA has encouraged these reformulations because they think they can at least help with the country's opioid problems. And they've actually approved abuse-deterrent labeling for five opioid painkillers so far. An agency spokesperson told me they are monitoring all of those drugs very closely and that they are, quote, very concerned about potential unintended consequences.
MCEVERS: That NPR's Tom Dreisbach. Thanks for your reporting, Tom.
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