Mundipharma allegedly using fake doctors, misleading claims to drive OxyContin sales in China

Boxes of OxyContin tablets sold in China sit on a table in southern China's Hunan province on Sept. 24, 2019. Representatives from the Sacklers' Chinese affiliate, Mundipharma, tell doctors that OxyContin is less addictive than other opioids — the same pitch that their U.S. company, Purdue Pharma, admitted was false in court more than a decade ago. (AP Photo/Mark Schiefelbein)

SHANGHAI — Thousands of lawsuits across the United States have accused a drug company owned by the billionaire Sackler family of using false claims to push highly addictive opioids on an unsuspecting nation, fuelling the deadliest drug epidemic in U.S. history.

Yet, even as its U.S. drugmaker collapses under the charges, another company owned by the family has used the same tactics to peddle its signature painkiller, OxyContin, in China, according to interviews with current and former employees and documents obtained by the Associated Press.

WATCH: Family behind OxyContin secretly wired $1 billion to themselves, New York finds

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The documents and interviews indicate that representatives from the Sacklers’ Chinese affiliate, Mundipharma, tell doctors that time-release painkillers like OxyContin are less addictive than other opioids—the same pitch that Purdue Pharma, the U.S. company owned by the family, admitted was false in court more than a decade ago.

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Mundipharma has pushed ever larger doses of the drug, even as it became clear that higher doses present higher risks, and represented the drug as safe for chronic pain, according the interviews and documents.

These tactics mirror those employed by Purdue Pharma in the U.S., where more than 400,000 people have died of opioid overdoses and millions more became addicted. An avalanche of litigation over the company’s marketing has driven Purdue Pharma into bankruptcy in the U.S.

WATCH: Big pharma paid $151M to doctors, hospitals in 2017-18, but we don’t know who got paid or why

In China, Mundipharma managers have required sales representatives to copy patients’ private medical records without consent, in apparent violation of Chinese law, current and former employees told AP. Former reps also said they sometimes disguised themselves as medical staff, putting on white doctor’s coats and lying about their identity to visit patients in the hospital. As in the U.S., marketing material in China made claims about OxyContin’s safety and effectiveness based on company-funded studies and outdated data that has been debunked.

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The AP examined more than 3,300 pages of training and marketing materials used by Mundipharma staff, as well as internal company documents and videos. These files came from three independent sources and were verified by cross-checking. AP also spoke with one current and three former OxyContin sales representatives who worked at the company last year.

Mundipharma has promoted its blockbuster product, OxyContin, in questionable ways in other countries, including Italy and Australia. But the company has particularly high hopes for China — the world’s most populous nation and second largest economy— where it has said it wants sales to surpass those in the U.S. by 2025.

Though Mundipharma and Purdue are separate legal entities, both are owned by the Sackler family. Today, Mundipharma is a bargaining chip in negotiations to settle sweeping U.S. litigation. The Sackler family agreed to cede ownership of Purdue, but wants to keep Mundipharma for now to sell OxyContin abroad. They have discussed eventually selling Mundipharma to fund the family’s contribution to a nationwide settlement in the U.S.

Mundipharma said it was taking immediate action to investigate the allegations uncovered by AP. In a statement, the company did not respond to specific allegations but said it has rigorous policies in place “to ensure that our medicines are marketed responsibly and in accordance with China’s strict regulatory framework governing analgesics.”

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In response to detailed questions, Purdue said Mundipharma is an independent entity, operating in a different country, under different laws and regulations. Representatives of the Sackler family did not respond to detailed requests for comment.

In the United States, Purdue stopped promoting OxyContin to doctors in 2018 and got rid of its entire opioid sales staff.

Meanwhile, Mundipharma is hiring in China.

A celestial challenge

Mundipharma China was born in 1993 in a signing ceremony at the Great Hall of the People on Tiananmen Square. Just as in the U.S., the Sackler family’s business interests in China coincided with their philanthropy.

The month after Mundipharma’s creation, the Arthur M. Sackler Museum of Art and Archeology opened its doors at Peking University in Beijing. Outside the museum is a statue dedicated to Arthur Sackler and his wife by the China Medical Tribune, a journal he helped found that now claims a readership of more than a million Chinese doctors.

These seeds of philanthropy and political alliances would bear fruit for the Sacklers just as opioid prescriptions began to fall in the U.S.

China was a tantalizing market for the Sacklers. The country’s per capita consumption of opioids was low and it had millions of new cancer cases every year.

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But if convincing U.S. doctors in America that opioids are safe was a hard sell, in China, it would be even more difficult.

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China fought two wars in the 19th century to beat back British ships dumping opium that fueled widespread addiction. Today, the cultural aversion to taking drugs — in Chinese, literally “sucking poison” — is so strong addicts can be forced into police-run treatment centers. The country does not appear to have an opioid crisis anything like in the U.S.

Two decades ago, as stories of OxyContin abuse began to circulate in the United States, foreign pharmaceutical companies helped spread a new gospel of pain treatment across China, recasting pain as the fifth vital sign—alongside blood pressure, heart rate, respiratory rate, and temperature—and pain treatment as a human right.

Dr. Yu Buwei, director of anesthesiology at Shanghai’s prestigious Ruijin Hospital, was skeptical. Philosophical and soft-spoken, Yu was deeply grounded in traditional Chinese medicine. During China’s Cultural Revolution he used acupuncture as anesthesia on patients undergoing major surgery.

“It is necessary to treat pain,” Yu said. “We agree with this. But raising it to a human right and the fifth vital sign, we think is controversial.”

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Many of his younger colleagues, however, appeared in thrall of these foreign ideas. They believed the best medical practices came from the United States. Few understood how deeply the Western consensus about pain had been shaped by the financial self-interest of pharmaceutical companies..

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“In China, doctor’s groups, especially the young doctors, show their respect to American doctors or the European doctors,” Yu said. “What they say, that’s truth. What you say, that’s interfering.”

Desperately seeking sales

In 2007, Purdue and three executives pleaded guilty in U.S. court to misrepresenting OxyContin as less addictive than other opioid painkillers, and paid $635 million in penalties, one of the largest settlements in pharmaceutical company history.

Sackler family members began to worry about a “dangerous concentration of risk” in their U.S. business, and trained their sights on the global market. Not long after, Mundipharma helped launch a campaign to improve cancer pain care in China called Good Pain Management, or GPM, according to interviews and company documents.

Today, the program is portrayed as a government public health initiative. But Zhang Li, director of internal medicine at Sun Yat-sen University Cancer Center in Guangzhou, said GPM “got the energetic support of Mundipharma during the launch process.”

According to Zhang, the GPM campaign was started in 2009 under his leadership, by a group within the Guangdong Provincial Anti-Cancer Association, a non-profit that accepts corporate funding. Pharmaceutical companies helped by covering the cost of training and educational materials, he said.

Two years later, the Chinese government launched the campaign nationwide. On February 22, 2011, Mundipharma won a contract to implement the program with an initial target of establishing model GPM wards in 150 key hospitals within three years.

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It was a watershed moment for the company.

Mundipharma was responsible for helping train doctors and educate patients, as well as distributing pamphlets and placards to raise awareness about pain. “Mundipharma will eventually become your best supporter and partner in creating a demonstration ward,” proclaimed a PowerPoint assembled in 2009.

The program was a three-way alliance among the then-Ministry of Health, the Chinese Society of Clinical Oncology and Mundipharma, according to Zhang and presentations used by Mundipharma sales staff.

Mundipharma’s initial contract with the oncology society gave it a seat on the GPM leadership team and barred the company from using the program to market its products, according to sections of the contract obtained by AP. In internal company documents, however, Mundipharma treated the program as part of its marketing strategy and used it to tout the superiority of its own products.

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“We were definitely talking about OxyContin ninety percent of the time,” said a former sales rep who spoke on condition of anonymity for fear of retribution.

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The oncology society declined to answer questions. China’s Ministry of Health, which was reorganized as the National Health Commission, said it hadn’t designated a company to provide assistance for the program.

One GPM presentation that Mundipharma employees said was still being used last year suggested OxyContin is the preferred option for cancer pain treatment under World Health Organization and other guidelines, before detailing why competing painkillers such as acetaminophen, fentanyl patches and immediate release morphine aren’t recommended.

The WHO does not recommend OxyContin as superior to other drugs for cancer pain care.

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In a statement to AP, the company said its role in GPM is only to assist with implementation. “The Program is independently initiated and managed with the goal of improving the medical community’s understanding of cancer pain management treatments,” the company said.

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Mundipharma told AP that all marketing materials undergo multi-level approval. But current and former employees acknowledged that they sometimes altered the officially-vetted presentations. The messages contained in all three sets of documents were consistent and contained information that Purdue Pharma has used in the United States.

In the years after GPM rolled out, from 2012 through 2018, sales of Mundipharma’s oxycodone, the active ingredient in OxyContin, at nearly 700 of China’s major hospitals rose five-fold, according to previously unreported data from the government-linked China National Pharmaceutical Industry Information Center.

During that same period, sales of morphine, widely considered an affordable “gold standard” for pain treatment, remained flat at those same hospitals. By early 2017, OxyContin had captured roughly 60 percent of the cancer pain market in China, up from just over 40 percent in 2014, company documents show.

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Tony Chen, a former OxyContin sales rep who spoke on condition that he be identified by his English name, for fear of retribution, said he loved GPM because the government backing got him high-level access at hospitals and helped drive sales.

“We didn’t need to bribe,” he said. “That’s why I liked it.”

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The pressure to perform was intense. Chen and other reps said quarterly sales targets rose by as much as 30 percent. If he surpassed them, he could more than double his take home pay. If he didn’t, he could lose his job.

He said he was prepared to “get fired up” about driving growth. He wasn’t prepared to break the law.

One current and three former sales reps who worked in different parts of China told the AP that managers required them to upload patients’ medical records, obtained without consent, to a company chat group each day.

READ MORE: U.S. settlement won’t end B.C. lawsuit against Purdue Pharma, says province’s attorney general

AP was shown snapshots of prescription records staff said were sent to managers. Handwritten on pink slips of paper, they included the patient’s full name, age, phone number, ID number, diagnosis and prescription.

The more precise the information, the better Mundipharma could plan sales targets, as well as guide doctors to increase dosages and switch to OxyContin from rival drugs, former sales reps explained.

Chen knew he had no legal right to copy personal information, and at first scribbled over patients’ names before uploading the documents. He and his colleagues said they used to discreetly snap photos of patient records during the night shift, or during lunch breaks.

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Ultimately, Chen said, he decided his effort to protect privacy was a waste of time because other people in his group were uploading full patient records. He told himself it was OK because the information wouldn’t circulate outside Mundipharma.

When it was time for hospital rounds, Chen sometimes slipped on a white doctor’s coat and mingled with medical staff. If anyone asked who he was, he lied and told them he was a doctor or an intern. He said he sometimes asked patients directly if they felt sore, swollen or numb and how they were sleeping.

Two other former OxyContin sales reps said they also disguised themselves in doctor’s coats and sat in on patient meetings.

READ MORE: Makers of OxyContin, accused of fueling opioid crisis, to pay $270 million in U.S. settlement

The key to this access was good relationships with doctors. Just as Purdue was accused of doing in the U.S., Mundipharma cultivated doctors with paid speaking gigs, dinners, event sponsorships and expense-paid trips to meetings, sometimes routing payments through third parties, sales reps said. Speakers, who sometimes delivered presentations created by or with Mundipharma sales staff, could earn 500 yuan ($70) to several thousand yuan per speech, current and former employees said.

Two of Chen’s former colleagues said they also used gift cards to encourage doctors to prescribe more. It was easy to fake receipts for company expense reports and get cash to fund under-the-table payments, they claimed.

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Mundipharma told AP it promotes ethical behavior and compliance with Chinese law through internal monitoring as well as external audits. “We have detailed policies covering interactions with healthcare professionals, grants and donations, and sponsorships and incentives,” the company said, adding that a compliance team monitors expense claims and meetings.

China has some of the strictest regulation in the world on the use of opioids. Opioid painkillers like OxyContin are not available at pharmacies. They are stored under double-lock at hospitals and governed by so-called “red prescriptions,” which only specially certified doctors can write.

But as pain treatment expanded in China, with the establishment of pain clinics beginning in 2007 and the rollout of GPM, more doctors became certified to prescribe opioids. Pain management ceased to be the purview of anesthesiologists like Ruijin Hospital’s Dr. Yu. It became a matter for surgeons, pain clinicians and cancer doctors.

“Patients, or drug abusers, can get these kinds of drugs much more easily compared with 10 years ago,” Yu said. “That’s a problem.”

Yu read about what was happening in the U.S. and worried for China. “There is already a quite enormous group of drug users in this society,” he said.

Yu resisted the notion that opioid painkillers weren’t addictive and could be safely used, at any dose, for all kinds of pain. He checked the scientific references on clinical presentations and often found them unconvincing. He barred sales reps from his department.

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Yu said he tried to persuade colleagues that some of the new notions about pain were silly, even risky. “I remember I argued with them, muscle pain or joint pain is not a good indication for opioid drugs,” he said. “But they said, it’s a human right. You have to relieve the pain.”

A familiar playbook

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