Greedy drug maker purposefully flooded black market with opioids

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After spending millions to combat the opioid epidemic ravaging its citizens, the working-class city of Everett, Washington, is taking the maker of opioid painkiller OxyContin to federal court. The city claims that the drug maker, Purdue Pharma, knowingly sold to black markets out of pure greed, enabling the devastating epidemic hitting Everett and the rest of the country.

According to the lawsuit (PDF) filed in federal court in Seattle, Everett accuses Purdue Pharma of “knowingly, recklessly, and/or negligently supplying OxyContin to obviously suspicious physicians and pharmacies and enabling the illegal diversion of OxyContin into the black market, including to drug rings, pill mills, and other dealers for dispersal of the highly addictive pills in Everett.” Purdue’s goal, Everett alleges, was to “generate enormous profits” at the expense of the people of Everett.

Purdue isn’t new to court battles. In 2007, the infamous drug maker and three of its executives pled guilty in federal court and paid out $634.5 million in fines for purposefully misleading regulators, doctors, and patients about the addictiveness of their opioid painkiller. Around the same time, Purdue was also sued by several states, including Washington, over similar allegations. Purdue agreed to a $19.5 million multi-state settlement. And in 2015, Purdue settled a case with Kentucky, agreeing to pay $24 million.

As part of the state settlements, Purdue was supposed to set up monitoring programs to make sure that its opioid drug didn’t wind up in the wrong hands. It was supposed to watch out for shady pharmacies, unusually large orders, or suspiciously frequent orders. But on this front, Everett alleges that Purdue once again put profits over people.

"Our community has been significantly damaged, and we need to be made whole," Everett’s mayor, Ray Stephanson, told ABC News.

In the lawsuit, Everett lays out internal Purdue e-mails that indicate that the drug maker was aware in 2009 that it was selling large quantities of OxyContin to an illegal drug ring based in Los Angeles. Yet, Everett claims, Purdue kept selling to the ring and didn’t notify the Drug Enforcement Administration, as it is legally required to do. The lawsuit also alleges that a Purdue executive referred to the company’s internal list of shady buyers as a “gold mine.”

The lawsuit notes that one of the drug dealers involved with the LA-based drug ring moved to Everett, which is north of Seattle, and began trafficking OxyContin there. In 2010, he was arrested, charged, and pled guilty to trafficking in Everett. The ring was also shut down. All in all, the scheme is thought to have diverted more than a million OxyContin pills onto the black market—and netted Purdue more than $15 million.

In a statement, Purdue disputed Everett’s claims, saying that it did notify the DEA and acted responsibly. "We look forward to presenting the facts in court," the company said. Purdue also said that its opioids now account for less than two percent of US opioid prescriptions.

In 2008, Everett experienced a spike of overdose deaths from OxyContin and other opioids, ABC notes. The city experienced another spike in 2010 of deaths from heroin, which is stronger and cheaper. Between 2011 and 2013, nearly one in five heroin-related deaths in the state of Washington occurred around Everett, a trend the city will argue was spurred by Purdue.

https://arstechnica.com/science/2017...-with-opioids/

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After pushing addictive OxyContin, Purdue now pursuing overdose antidote

Notorious OxyContin-maker Purdue Pharma—which has been widely criticized for deceptively marketing its highly addictive painkiller and for its role in spurring the current nationwide epidemic of opioid abuse and overdose deaths—is moving ahead with a new, potent drug, one said to be an antidote to opioid overdoses.

The company announced this week that the US Food and Drug Administration has granted fast-track status to its investigational drug nalmefene hydrochloride (HCl), an injectable, emergency treatment intended to rescue people suspected of having an opioid overdose. Purdue suggests that nalmefene HCl’s effects last longer than the similar emergency opioid antagonist naloxone. As such, the company hopes nalmefene HCl will out-compete naloxone at reversing overdoses from the most highly potent opioid, namely fentanyl, which is currently driving the alarming numbers of opioid overdose deaths. The FDA’s fast-track status will speed the development and regulatory review of the drug.

“Opioid antagonists like naloxone have played an important role in the emergency treatment of opioid overdose,” John Renger, Purdue’s head of Research & Development and Regulatory Affairs, said in a statement. “However, because of the increasing number of deaths due to fentanyl and its even more potent analogues, we are focusing on a potentially more potent and longer-lasting rescue option specifically intended to work in those overdose situations.”

Deaths from the extremely potent fentanyl began spiking nationwide in 2013. In 2017, synthetic narcotics (mainly fentanyl) were behind roughly 40 percent of the more than 70,200 overdose deaths in the country. The abrupt rise of fentanyl use and overdoses followed a quadrupling of use and overdoses from prescription opioids, such as OxyContin. As the crisis came to light, opioid prescribing leveled off and began declining in 2012, leading to the rise of illicit fentanyl and heroin use.

Amid the crisis, Purdue has been fiercely condemned for initially downplaying the addictiveness of OxyContin, which it began aggressively marketing in the mid-1990s, earning the company billions of dollars in sales. In 2007, the company and three executives pleaded guilty in federal court to criminal charges that they deceived doctors, patients, and regulators over the addictiveness of the drug. Since then, Purdue has been pummeled by lawsuits blaming the company for helping to spur the rise in opioid abuse and overdoses. The company has vigorously defended itself against the claims but is now considering filing for bankruptcy, which would soften the blow of litigation and judgments.

“What’s right”
In the statement this week, Purdue once again side-stepped any involvement in initiating the epidemic, focusing solely on illicit drug use. Purdue’s president and CEO, Craig Landau was quoted as describing the problem simply as “Fentanyl and illicit opioid deaths continue to increase in the United States, fueled increasingly by overdoses of this class of compounds.”

In a recent interview with the Washington Post, Landau said he expected Purdue’s efforts to treat opioid overdoses would be criticized, saying:

I recognize everything we do will be criticized in this regard, but in the end we’re going to do what’s right. These are good things that could and should have a positive impact on public health and on patients.

In line with that sentiment, Purdue announced that it doesn’t intend to make money on the new drug. “As part of Purdue’s commitment to advance meaningful solutions to address the opioid crisis, the company will work to bring forward this option with the commitment not to profit from any future sales of this drug.”
Still, according to internal discussions at Purdue that were made public in a lawsuit brought by the Commonwealth of Massachusetts, Purdue and members of the wealthy Sackler family that owns the company had carefully researched the money-making potential of treatments aimed at reversing the epidemic.

An un-redacted section of the lawsuit describes a secret plan called Project Tango, which explored Purdue’s expansion into selling treatment options. The lawsuit states that Purdue and a member of the Sackler family determined that the millions of people who had become addicted to opioids were a prime business opportunity. Purdue staff wrote in internal documents quoted in the lawsuit that “It is an attractive market. Large unmet need for vulnerable, underserved and stigmatized patient population suffering from substance abuse, dependence and addiction.”

https://arstechnica.com/science/2019...dose-antidote/