Facing scrutiny in the US, Purdue Pharma markets OxyContin overseas

Purdue Pharma, which has gained notoriety in the US for its role in creating the opioid epidemic by aggressively marketing its addictive painkiller OxyContin, is continuing to employ the same misleading tactics used in the US to push the drug overseas in China and other countries through its foreign affiliate, Mundipharma.

“It’s right out of the playbook of Big Tobacco. The United States takes steps to limit sales here, the company goes abroad,” David A. Kessler, a physician and former head of the Food and Drug Administration (FDA), told the Los Angeles Times in a December 2016 article that investigated Mundipharma’s sales tactics.

Last month, the Associated Press published its investigation of Mundipharma’s marketing practices, based on some 3,300 pages of training and marketing materials and interviews with four current or former employees.

The Sackler family, which owns Purdue Pharma, enriched itself by aggressively marketing OxyContin to US doctors. Since the drug was first approved by the FDA at the end of 1995, the company has pulled in some $35 billion in sales, while the Sackler family accumulated an estimated family fortune of $13 billion.

Purdue Pharma’s push to get doctors to prescribe opioids for everyday chronic pain conditions is largely responsible for the opioid epidemic that is devastating communities across the country. According to the Centers for Disease Control and Prevention (CDC), more than 700,000 people died from a drug overdose between 1999 and 2017. In 2017, 70,200 individuals died from drug overdoses, which is 6 times higher than the 1999 figure.

As a result of heightened scrutiny of the company and its marketing practices, sales of OxyContin in the US have collapsed, while Purdue Pharma faces more than 2,500 lawsuits from individuals, municipalities and states. Previously, in 2007, Purdue Pharma and three of its executives pled guilty to misbranding its product and were fined $635 million.

In response to this pressure, the Sackler family has moved its marketing strategy overseas, repeating the same lies it used in the United States. Thus, while Purdue Pharma discontinued marketing OxyContin in the US and disbanded its sales force last year, Mundipharma is busily hiring sales reps in China and other countries.

According to the AP, OxyContin sales in China have surged fivefold since its introduction across 700 major hospitals, while sales of the much cheaper morphine has flattened.

Like they did in the United States, sales representatives for Mundipharma are aggressively marketing OxyContin to Chinese physicians for everyday aches and pains, downplaying its addictive properties and giving misleading claims about how long it is effective.

In China, sales reps for Mundipharma pushed for higher doses when patients complained the painkiller didn’t work long enough. Sales reps also accessed and copied patient records without consent to be used to target sales and develop marketing strategies. According to the AP, sales reps would even don doctors’ clinical coats when visiting hospital patients and lie about their identity.

Chinese state health officials and Purdue Pharma both declined to comment on the AP story.

Mundipharma, Purdue Pharma’s foreign affiliate, is headquartered in Cambridge, England and Singapore. It has a sales presence in 122 countries, including those in Europe, Australia, Latin America, the Middle East, Africa, and areas of Asia. The company has reportedly set a goal of surpassing US OxyContin sales in China by 2025.

A recent company-produced promotional video, apparently referring to the success of OxyContin in the US, proclaims, “We’re only just getting started.”

Mundipharma recognized that countries outside of the US were large untapped markets. If OxyContin was prescribed for everyday chronic pain, the company estimated that the number of customers in Mexico would increase by 28 million, 80 million in Brazil and 11 million in Colombia.

According to the December 2016 investigation by the LA Times, Mundipharma hired Joseph Pergolizzi, Jr., a doctor who ran a Florida pain management clinic, to “talk up” opioids to Latin American and Asian physicians. His task was to overcome doctors’ aversion to prescribing opioids—a position Mundipharma management referred to as “opiophobia”—because of their addictive properties.

For example, Pergolizzi lectured to doctors at a Rio de Janeiro cancer pain meeting sponsored by the company. Mundipharma exaggerated Pergolizzi’s credentials, claiming he was a visiting faculty member at both Johns Hopkins and Temple University medical schools. While the LA Times confirmed that Pergolizzi had a temporary adjunct faculty position at Johns Hopkins, it failed to find evidence of his association with Temple.

At the meeting, Pergolizzi dwelt on what he called “the death sentence of chronic pain” and the relief provided by opioids. He noted that the use of pain medicines in Brazil was “still low” compared to the US, Canada and Europe. He added, “unfortunately, you may not have all the tools you need to properly address the pain.”

By sponsoring such international meetings, Mundipharma was simply following the playbook used by Purdue Pharma in the United States, where the company identified “key opinion leaders” in the field of pain management and invited them to all-expenses-paid weekend conferences at resorts in Boca Raton, Florida and Scottsdale, Arizona. Data collected by the company showed that physicians who attended such meetings were twice as likely to write prescriptions for opioids.

Company marketing similarly downplayed the drug’s risks. A South Korean company representative complained to the Korean Herald that “doctors worry too much about addiction.” In Spain, TV advertisements by Mundipharma featured nude celebrities exhorting viewers “not to resign yourself [to chronic pain],” claiming that “chronic pain is an illness in and of itself.”

By contrast, government agencies have warned physicians about the addictive qualities of opioid painkillers.

For example, in 2017 the CDC notified physicians of the findings of a study conducted at the University of Arkansas Department of Medical Science, which looked at the medical histories of 1.3 million cancer-free Americans over the age of 18 who had received one or more prescriptions for an opioid between June 2006 and September 2015.

Although none of the individuals had a history of opioid abuse, the study found that even with only a one-day supply of an opioid, 6 percent of those prescribed were still taking an opioid one year later. The percentage of those still taking an opioid a year later increased to 10 percent if provided a five-day supply, 20 percent for a 10-day supply, and 45 percent for a 30-day supply. These figures were even worse if higher doses were given at the outset.

The Sackler family has sought to protect their fortune by filing for bankruptcy protection for Purdue in September, which would likely freeze the current lawsuits, while moving funds around to minimize their liability.

For example, the New York Attorney General’s office reported a wire movement of at least $1 billion from one of 33 financial institutions linked to the family that answered a subpoena for records. Oregon’s attorney general says the funds moved offshore are much, much greater.

As part of the proposed settlement for bankruptcy protection, the company’s drug inventory, including OxyContin, an overdose rescue medicine and other pharmaceuticals will be handed over to the states. It is estimated that sales of these drugs by the states could generate $3 billion to $4 billion. The Sackler family would also contribute $3 billion. The total settlement could be as high as $10 billion to $12 billion, although critics of the deal are skeptical of this figure.

The Sacklers, however, have made it clear that they will only agree to the deal if the lawsuits against family members are dropped.

On November 6, federal bankruptcy Judge Robert Drain halted all lawsuits against Purdue Pharma and members of the Sackler family until April 8, 2020. The extension of protection to the Sackler family was highly unusual because the Sacklers themselves have not yet filed for bankruptcy. Even Judge Drain conceded that the order was “extraordinary.”

An audit released earlier this week found that the Sackler family began withdrawing huge sums of money after the company reached its 2007 criminal settlements. The family withdrew over $10 billion from the company between 2008 and 2018, eight times as much withdrawn in the previous 13 years.

“The Sackler’s pocketed billions of dollars from Purdue while thousands of people died from their addictive drugs,” Massachusetts Attorney General Maura Healey said in a statement after the release of the audit. “This is the very definition of ill-gotten gains.”

Discovery court documents released in 2018 and earlier this year reveal the cynical approach company executives took as they began marketing OxyContin.

For example, Richard Sackler was disappointed when he was informed that Germany had designated OxyContin a controlled substance in 1997.

In company emails from that time, Robert Kaiko, charged with the drug’s development at Purdue, wrote Sackler that if the drug were uncontrolled, “it is highly likely that it will eventually be abused there and then controlled. This may be more damaging to OxyContin internationally than any temporarily higher sales that could be gleaned from an uncontrolled status.”

In reply, Sackler callously inquired, “How substantially would it improve your sales?”

To add insult to injury, Mundipharma is also promoting a naloxone nasal spray, Nyxoid, to treat individuals who overdose on OxyContin and other opioids.

According to an article published last week by the AP, lawsuits filed by the attorneys general of Massachusetts and New York allege that Purdue Pharma discussed a secret proposal, known as Project Tango, during a 2014 conference call. Sackler family member Kathe Sackler was reportedly on the call.

According to an internal slideshow, Purdue Pharma could become an “end-to-end provider,” that is, provide “pain treatment” at the front end and “opioid addiction treatment” at the back end.

“It is an attractive market,” the staff wrote in the slideshow, according to the Massachusetts lawsuit.

Lawyers for the Sackler family claim that the proposal was put forward by a third-party private equity fund as a potential joint venture that never went anywhere.

According to the New York lawsuit, Purdue first looked into selling suboxone in 2015, but switched to naloxone the following year.

The Massachusetts attorney general claims that internal company communications stated that naloxone was a “complementary” product to its OxyContin. Purdue staff even suggested marketing its naloxone product to the same doctors to whom it was marketing its addictive painkillers.

Although Project Tango was apparently abandoned in the United States, Mundipharma soon began promoting its pricey naloxone nasal spray in Australia.

In response to a 2018 Australian coroners’ investigation into six fatal opioid overdoses in New South Wales, Mundipharma submitted a 15-page document highlighting the life-saving benefits of naloxone and encouraging government officials to make it more accessible.

The Australian government used the findings of a Mundipharma-funded study as a blueprint for a pilot program to distribute naloxone that included Nyxoid. The government even subsidized the price of Nyxoid, bringing the cost for Australians down from the US-equivalent of $50 to around $4.50 per pack.

“The way that they’ve pushed their opioids initially and now coming up with the expensive kind of antidote—it’s something that just strikes me as deeply, deeply, cynical,” Ross Bell, executive director of the New Zealand Drug Foundation told the AP.

“You’ve got families devastated by this, and a company who sees dollar signs flashing,” he said.