Sackler-owned opioid maker pushes overdose treatment abroad

New Delhi: The gleaming booth towered over the medical conference in Italy in October, advertising a new brand of antidote for opioid overdoses. "Be prepared. Get naloxone. Save a life," the slogan on its walls said.

Some conference attendees were stunned when they saw the booth's company logo: Mundipharma, the international affiliate of Purdue Pharma - the maker of the opioid, OxyContin, widely blamed for unleashing the American overdose epidemic.

Here they were cashing in on a cure.

"You're in the business of selling medicine that causes addiction and overdoses, and now you're in the business of selling medicine that treats addiction and overdoses?" asked Dr Andrew Kolodny, an outspoken critic of Purdue who has testified against the company in court. "That's pretty clever, isn't it?"

As Purdue Pharma buckles under a mountain of litigation and public protest in the United States, its foreign affiliate, Mundipharma, has expanded abroad, using some of the same tactics to sell the addictive opioids that made its owners, the Sackler family, among the richest in the world. Mundipharma is also pushing another strategy globally: From Europe to Australia, it is working to dominate the market for opioid overdose treatment.

"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," said Ross Bell, executive director of the New Zealand Drug Foundation and a longtime advocate of greater naloxone availability.

This story was produced with support from the Pulitzer Center on Crisis Reporting.

Mundipharma's antidote, a naloxone nasal spray called Nyxoid, was recently approved in New Zealand, Europe and Australia. Mundipharma defended it as a tool to help those whose lives are at risk, and even experts who criticize the company say that antidotes to opioid overdoses are badly needed. Patrice Grand, a spokesman for Mundipharma Europe, said in a statement that heroin is the leading cause of overdose death in European countries and nasal naloxone is an important treatment option.

Injectable naloxone has long been available; it is generic and cheap. But Nyxoid is the first in many countries that comes pre-packaged as a nasal spray - an easier way for those who witness an overdose to intervene. Nyxoid is more expensive than injectable naloxone, running more than $50 a dose in some European nations. And in some countries, Nyxoid is the only nasal naloxone product approved.

Some critics say Nyxoid's price is excessive. Grand said the price reflects the company's investment, manufacturing cost and the value of the technology while recognizing the "prevailing financial pressures that exist within care sectors."

The Sackler family's pharmaceutical empire has long considered whether it might make money treating addiction, according to lawsuits filed against Purdue and the family. In the U.S., Purdue Pharma called its secret proposal Project Tango, the attorneys general of Massachusetts and New York have alleged and discussed it in a September 2014 conference call that included family member Kathe Sackler.

In internal documents, the lawsuits allege, Purdue illustrated the connection they had publicly denied between opioids and addiction with a graphic of a blue funnel. The top end was labelled "Pain treatment." The bottom: "opioid addiction treatment." The slideshow said they had an opportunity to become an "end-to-end provider" - opioids on the front end, and addiction treatment on the back end.

In its response to the court, the family's lawyers wrote that the plan was proposed by a third-party private equity fund as a potential joint venture and "at the very most, Project Tango was mentioned in passing on a few occasions and the proposal was subsequently abandoned." A press release issued by the Sacklers said no member of the family or board had an active role in the presentations or supported the proposal. It called the lawsuits "sensationalized" and "misleading." Purdue declined to comment.

New York's lawsuit alleges that in 2015, Project Tango was presented to Purdue's board as a joint venture to sell the addiction medication suboxone that could become the "market leads in the addiction medicine space."

Project Tango stalled. It was revised the next year with a new plan to sell naloxone, the lawsuits allege. The family's press release said Purdue's board rejected the plan.

But in Australia, Mundipharma embarked on a sweeping effort to promote naloxone.

As part of an Australian coroner's investigation last year into six fatal opioid overdoses in New South Wales state, Mundipharma submitted a document touting the benefits of naloxone. If people around the overdose victims had had access to naloxone, the company wrote, many of those deaths may have been avoided. At the same time, Mundipharma was registering Nyxoid in Australia, a fact it acknowledged within its submission.

In the document, the company suggested officials change Australia's laws to allow for easier access to naloxone and establish a national, free take-home naloxone program.

Health experts also praised the drug. The coroner ultimately recommended that Nyxoid be given to the state's emergency responders.

Mundipharma also paid for a drug policy institute's study on naloxone that the federal government used as a blueprint for a 10 million Australian dollar ($6.8 million) pilot program to distribute naloxone, including Nyxoid. And in October, Australian Health Minister Greg Hunt announced the government would subsidize Nyxoid prescriptions.

Asked in an interview whether the government had any concerns about following the recommendations of a Mundipharma-funded report that could benefit the company financially, Hunt replied: "All of the advice is that this is a product that will save lives and protect lives and our approach is to be fearless of the source of the product."

In a statement, Mundipharma Australia denied its Nyxoid strategy had any connection to or was influenced in any way, by Purdue's Project Tango. Grand, the spokesman for Mundipharma Europe, also rejected any link.

"Mundipharma Australia and Purdue Pharma are independent companies," the Australian company wrote. "Mundipharma Australia introduced Nyxoid to help meet a clear clinical need."

Thomas Clausen, a professor at the University of Oslo in Norway who runs the nation's naloxone program, said in its basic, generic form, the drug is so cheap that the United Nations launched a pilot program in central Asian countries that is providing injectable naloxone at a cost of around $1 per kit.

Stephen Wood, a fellow at the Harvard Medical School Center for Bioethics who studied how pharmaceutical companies in the U.S. raised prices on naloxone products as the addiction epidemic intensified, says that Sackler-owned companies manufacturing naloxone have an ethical duty to make it widely available.

"If they were trying to find a solution, they would just distribute naloxone for free," Wood said. "They could use all that money they made off opioids to help support a program where they are giving away this life-saving medication."

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