How A Painkiller Designed To Deter Abuse Helped Spark An HIV Outbreak

http://www.npr.org/sections/health-shots/2016/04/01/472538272/how-a-painkiller-designed-to-deter-abuse-helped-spark-an-hiv-outbreak

When Kevin Polly first started abusing Opana ER, a potent prescription opioid painkiller, he took pills — or fractions of pills — and crushed them into a fine powder, then snorted it.

When Opana pills are swallowed, they release their painkilling ingredient over 12 hours. If the pills were crushed and snorted, though, the drug was released in a single dose.

“Just think about it,” Polly says, “12 hours of medicine, and, ‘BAM!’ you’re getting it all at once.”

But the drug’s manufacturer, Endo Pharmaceuticals, reformulated Opana in 2012. The new pills featured a coating that was intended to make them more difficult to abuse by crushing them into powder or dissolving them.

Polly discovered he could no longer snort the medicine in the pill, to which he had become addicted. But he and other Opana users soon found a way to remove the drug’s hard coating and receive Opana’s powerful dose all at once: injection.

Polly says he used to inject Opana as many as five times a day. He often shared needles with other people.

He says he never anticipated what would happen next. In early 2015, Polly tested positive for HIV. “It was devastating news,” he says.

Kevin Polly is among the 190 people in Indiana’s Scott County who have tested positive for HIV since early 2015, in the largest HIV outbreak in Indiana history.

The Change To Opana That Was Intended To Prevent Abuse

For its part, Endo has said that its decision to reformulate Opana was a well-intended attempt to prevent abuse. As the company told the Food and Drug Administration in 2012, Endo reformulated the drug “to provide a crush-resistant product, equally as effective as Opana ER, which would discourage abuse, misuse and diversion.” Endo declined repeated requests from NPR for an interview.

According to study data, as well as interviews with Indiana residents addicted to Opana, the reformulation effectively deterred many people from snorting the drug. But the change also led a significant number of people to abuse the drug by injection. When needles are shared, the injection route can transmit HIV, hepatitis C or other infections.

And interviews with experts, court filings, documents from the FDA, as well as Endo’s own statements, suggest the company’s decision to reformulate Opana was also motivated in large part by financial interests.

Public health experts say “abuse deterrent” drugs may serve a role in reducing what the Centers for Disease Control and Prevention calls a national epidemic of prescription opioid abuse. The FDA and members of Congress have also supported their development. But the experience with Opana’s reformulation may serve as a cautionary tale for the potential effects of “abuse deterrent” drugs.

Experiences In Austin, Ind.

While NPR’s Kelly McEvers and I were reporting in Austin, Ind., people who abused Opana and were familiar with changes to the drug’s formula told us similar stories.

“The pharmaceutical company, they changed it so you can’t crush them and snort them,” said Devin, a 26-year old. “Whenever they done that, that’s when everybody started shooting them.”

Jeff, a veteran of the Army National Guard, said he became addicted to Opana after being prescribed opioid painkillers for a back injury he sustained in Iraq.

At some point, Jeff said, he began crushing and snorting pills. Then, he said, the company “reformulated them, and the only way you could do them is to inject them.”

Joy, a former registered nurse who got addicted to opioids after a back injury, said that she initially stopped using Opana after the reformulation. But that didn’t last long. “Some genius figured out, ‘Hey we can cook this down and turn [it] into a liquid and shoot it up,’ ” Joy said. “And then it took off like wildfire after that.”

(NPR is withholding Devin’s, Jeff’s and Joy’s last names to protect their privacy.)

Because of the coating added to Opana, the process of preparing it for injection does take a little work. But in the end, it’s not that difficult.

My colleague Kelly watched people prepare Opana for injection, using just the bottom of a soda can, a small lighter, a cigarette filter and tap water.

Behind The Reformulation, Public Health And Business Considerations

So why did Endo Pharmaceuticals reformulate the drug in the first place?

The answer involves both public health concerns and business considerations.

Endo Pharmaceuticals released Opana in 2006. Taken orally, Opana is about twice as powerful as OxyContin, and the company says it is “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.”

Soon afterward, though, communities around the country began reporting abuse of Opana and even overdose deaths.

Endo said those concerns over public health and abuse were key motivations to reformulate the drug. Opana also was a major moneymaker for the company.

In 2011, for example, Opana generated $384 million in net sales for Endo, accounting for 14 percent of the company’s total revenue that year.

But the company also faced the threat of generic competition.

So Endo developed a strategy that would block its competitors and maintain Opana’s share of the market.

The company reformulated the drug, this time with features designed to prevent abuse, a move that could potentially protect Endo at a time it faced the loss of patent protection.

The FDA approved Endo’s reformulated Opana, and in 2012 the company began replacing the old versions of Opana on pharmacy shelves.

In August of that year, Endo took another step. The company filed a petition with the FDA, arguing that it had removed the old, crushable version of Opana from the market “for reasons of safety or effectiveness.” It also asked the agency to “refuse to approve” and “suspend and withdraw the approval” of generic, noncrush-resistant versions of Opana.

If the FDA agreed with Endo, the agency would effectively eliminate the company’s generic competition.

“We see this again and again in the pharmaceutical industry,” says Dr. Anna Lembke, an assistant professor of psychiatry at Stanford University Medical Center. “They come up with some new fancy formulation of basically the same old drug … and then that way they have a new drug that they can charge a lot of money for.”

Filed under: General Problems