Thousands of lawsuits across the US have accused a drug company owned by the billionaire Sackler family of using false claims to push highly addictive opioids on an unsuspecting nation, fueling the deadliest drug epidemic in US history.
Yet, even as its US 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.
The documents and interviews indicate that representatives from the Sacklers’ Chinese affiliate, Mundipharma, tell doctors that time-release painkillers such as OxyContin are less addictive than other opioids — the same pitch that Purdue Pharma, the US company owned by the family, admitted was false in court more than a decade ago.
Illustration: June Hsu
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, the interviews and documents showed.
These tactics mirror those employed by Purdue Pharma in the US, 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 US.
In China, Mundipharma managers have required sales representatives to copy patients’ private medical records without consent, in apparent breach of Chinese law, current and former employees said.
Former representatives also said that 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 US, marketing material in China made claims about OxyContin’s safety and effectiveness based on company-funded studies and outdated data that has been debunked.
More than 3,300 pages of training and marketing materials used by Mundipharma staff, as well as internal company documents and videos, were examined. These files came from three independent sources and were verified by cross-checking. One current and three former OxyContin sales representatives who worked at the company last year were interviewed.
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 that it wants sales to surpass those in the US by 2025.
Although 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 US 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 US.
Mundipharma said that it was taking immediate action to investigate the allegations uncovered. Representatives of the Sackler family did not respond to detailed requests for comment.
In the US, Purdue stopped promoting OxyContin to doctors last year and got rid of its entire opioid sales staff.
Meanwhile, Mundipharma is hiring in China.
CELESTIAL CHALLANGE
China is a tantalizing market for the Sacklers. The country’s per capita consumption of opioids is low and it has millions of new cancer cases every year.
However, if convincing doctors in the US that opioids are safe was a hard sell, in China, it would be even more difficult.
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 that addicts can be forced into police-run treatment centers. The country does not appear to have an opioid crisis anything like in the US.
Two decades ago, as stories of OxyContin abuse began to circulate in the US, 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.
Yu Buwei (于布為), director of anesthesiology at Shanghai’s prestigious Ruijin Hospital, was skeptical. Philosophical and soft-spoken, Yu is 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. However, raising it to a human right and the fifth vital sign — we think this is controversial.”
However, many of his younger colleagues appeared under the thrall of these foreign ideas. They believed that the best medical practices came from the US. Few understood how deeply the Western consensus about pain had been shaped by the financial self-interest of pharmaceutical companies.
“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.”
SEEKING SALES
In 2007, Purdue and three executives pleaded guilty in US court to misrepresenting OxyContin as less addictive than other opioid painkillers and paid US$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 US 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.
The GPM campaign was started in 2009 and launched two years later as a nationwide campaign by the Chinese government. In February 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.
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’s initial contract gave it a seat on the GPM leadership team, but barred it from using the program to market its products, according to sections of the contract obtained.
However, in internal company documents, Mundipharma treated the program as part of its marketing strategy and used it to tout the superiority of its own products.
“We were definitely talking about OxyContin 90 percent of the time,” said a former sales representative who spoke on condition of anonymity for fear of retribution.
The oncology society declined to answer questions. The Chinese Ministry of Health, which was reorganized as the Chinese National Health Commission, said that it had not designated a company to provide assistance for the program.
One GPM presentation that Mundipharma employees said was still being used last year suggested that OxyContin is the preferred option for cancer pain treatment under WHO and other guidelines, before detailing why competing painkillers such as acetaminophen, fentanyl patches and immediate release morphine are not recommended.
However, the WHO does not recommend OxyContin as superior to other drugs for cancer pain care.
In the years after GPM was launched, from 2012 through last year, sales of Mundipharma’s oxycodone, the active ingredient in OxyContin, at nearly 700 of China’s major hospitals rose fivefold, 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 about 60 percent of the cancer pain market in China, up from just more than 40 percent in 2014, company documents show.
Tony Chen, a former OxyContin sales representative who spoke on condition that he only be identified by his English name, said that 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.”
The pressure to perform was intense.
Chen and other representatives said that 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 did not, he could lose his job.
He said that he was prepared to “get fired up” about driving growth, but he was not prepared to break the law.
China has some of the strictest regulation in the world on the use of opioids. Opioid painkillers such as 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.
However, as pain treatment expanded in China, with the establishment of pain clinics beginning in 2007 and the launch of GPM, more doctors became certified to prescribe opioids. Pain management 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 US 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 were not 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 representatives from his department.
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.’”
FAMILIAR PLAYBOOK
When Chen started work at Mundipharma, he was taught that OxyContin was a good drug and widely used in the US.
The company gave him hundreds of pages of documents to study. Chen read that the risk of getting addicted to opioid painkillers was virtually nonexistent and that OxyContin’s slow-release formulation made it even safer.
Chen did not bother to check the references that Mundipharma cited as proof. Neither did most doctors at China’s notoriously overburdened hospitals and the legal sanctions that Purdue faced in the US did not apply in China, where some people had never heard of the company or its troubles.
“I considered this a problem in terms of humanistic care for patients,” Chen said. “This is a really good product.”
In the 2007 lawsuit filed by US prosecutors, Purdue conceded that some of its employees had falsely claimed that long-acting opioids are less addictive, because they have fewer “peak and trough” effects and cause less euphoria. Purdue entered into a legally binding agreement with the US government to ensure that their staff never made such claims again.
“Purdue in 2007 accepted responsibility for the misconduct and has since then strived never to repeat it,” the company said again in a legal filing in September.
Yet, three current and former employees of Purdue’s international affiliate in China made the same claim: OxyContin reduces the risk of addiction, because it is released slowly into the bloodstream, causing fewer “peaks and troughs” than immediate-release drugs.
This argument has no scientific basis, according to a 2016 US Centers for Disease Control report.
Sustained-release technology “further reduces the incidence of addiction,” reads a Mundipharma PowerPoint slide that staff said was still in use last year. It referenced a study in the scientific journal Cancer from 1989 funded by Purdue and co-authored by a Purdue employee, and a brief 2004 Chinese study.
Neither paper actually examined addiction risk.
Some influential doctors in China also continue to make Mundipharma’s argument.
“The prolonged release formulation doesn’t easily give rise to drug dependence,” Fan Bifa (樊碧發), the director of the pain clinic at the China-Japan Friendship Hospital in Beijing, said in May.
Fan has spoken at Mundipharma-funded conferences and appeared in a pain awareness video alongside Mundipharma China’s general manager, other prominent doctors and celebrities. The China-Japan Friendship Hospital was among the first to obtain certification under the GPM program in Beijing.
Fan said that he has never taken money directly from Mundipharma.
When told about Purdue’s 2007 guilty plea, Fan seemed shocked, saying that he had never looked for scientific evidence to prove that sustained release opioids are less likely to cause addiction.
The US Centers for Disease Control has said that as many as 1 in 4 people prescribed opioids for long-term use struggles with addiction.
The Mundipharma sales representatives said that they had a pitch for doctors worried about addiction: If used properly, the risks of addiction to opioid painkillers are virtually nonexistent.
Patients who seem addicted might just need more drugs to control pain, staff PowerPoints say.
“Based on my experience, that’s like a joke,” Yu said, adding that patients could slip into addiction within a few days. “They came to you and started talking repeatedly about pain and asked you to prescribe medicine. We call this drug-seeking behavior.”
Mundipharma called it “pseudoaddiction,” a notion coined and popularized by J. David Haddox, who went on to spend nearly two decades as an executive at Purdue Pharma.
OxyContin’s label approved by the US Food and Drug Administration warns that even if taken as prescribed, OxyContin carries potentially lethal risks of addiction and abuse.
Purdue now faces multiple US lawsuits for spreading ideas about pseudoaddiction, as well as claiming that the risk of opioid addiction is low and that doses can be increased without risk.
The idea that patients can safely take as much OxyContin as they want was great for Chen’s bottom line.
Mundipharma sometimes offered special bonuses for selling the 40mg pills of OxyContin, the largest, most expensive dose sold in China, internal documents and interviews show.
However, Chen said that cramming people full of pills “would lay heavy on my conscience.”
Chen flipped through a PowerPoint presentation on high-dose opioids that he said he got from his boss at Mundipharma and pointed to an example of a patient taking 1,500mg twice a day.
“It’s terrifying,” he said.
A year after the US Centers for Disease Control said that taking more than 33mg of OxyContin a day at least doubles the risk of overdose, Mundipharma came out with a marketing plan pushing its 40mg pill.
Mundipharma said its training covers “appropriate dosage levels for cancer patients” and provides information “in accordance with current best practice.”
As Chen looked back over his training documents, he found presentations touting opioid painkillers as a safe and effective treatment for chronic pain, citing outdated studies with authors linked to Mundipharma and other companies.
The US Centers for Disease Control has said that there are risks of “serious harms” from taking opioids long-term for chronic pain, but evidence for the potential benefits is lacking.
Mundipharma said in a statement that OxyContin “is used in practice only for the treatment of cancer pain in China.”
However, under Chinese regulations, OxyContin can be used to treat moderate to severe pain, whether it is caused by cancer or not.
Chinese government guidelines published in 2002 specify that strong opioids such as OxyContin can be used after other methods have failed for non-cancer patients aged 40 or older who suffer from a handful of painful conditions.
However, the guidelines are not rigorously followed.
Three doctors were spoken to who said that they prescribed OxyContin for a range of chronic pain conditions, although all said that the numbers of non-cancer pain patients on OxyContin in China are small.
In China, the National Health Commission, the National Medical Products Administration, the State Administration for Market Regulation and the National Development and Reform Commission all declined to comment.
UNCERTAIN LEGACY
If the US has entered an endgame in its battle with prescription painkillers, China is somewhere near the beginning. While some people believe that China’s painful history with opium and strict regulations will protect it against a US-style outbreak, others fear for the future.
“Why am I afraid of a drug epidemic?” Yu said. “If our doctors can’t stand temptation and want to make tens or hundreds of thousands of yuan a month, it is easy to be manipulated by other people.”
Sitting in a large, Spartan office at Ruijin’s campus in suburban Shanghai, Yu had an air of resignation. His beliefs about how to shepherd people through suffering have fallen out of fashion in China, but Yu seemed at peace with his lost prestige.
“In the end, it relies on the doctor’s conscience,” Yu said.
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