Fake doctors, misleading claims drive OxyContin China sales
This Feb. 19, 2013 file photo shows OxyContin pills arranged for a photo at a pharmacy in Montpelier, Vt. (AP Photo/Toby Talbot, File)
SHANGHAI -- OxyContin is a dying business in the United States. Purdue Pharma, owned by the billionaire Sackler family, is collapsing under an avalanche of lawsuits that accuse the company of using false claims to push its blockbuster painkiller in the U.S., profiting as an unsuspecting nation slipped into a devastating drug crisis.
Meanwhile, another company owned by the family in China has been promoting OxyContin with the same tactics Purdue was forced to abandon in the U.S. as opioid overdose deaths soared, according to interviews with four current and former employees and more than 3,300 pages of training and marketing material obtained by the Associated Press.
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 Purdue admitted was false in U.S. court more than a decade ago. Mundipharma has pushed ever larger doses of opioids, 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.
Thousands of lawsuits in the United States against Purdue say claims like these wrongly convinced a generation of doctors that opioids were safer and less addictive than everyone had long thought, contributing to the deaths of more than 400,000 Americans to opioid overdoses and helping drive millions more into addiction. Purdue, which declared bankruptcy in September, has denied those allegations.
As the backlash against opioids in the U.S. grew, sales fell and the Sacklers trained their sights on the global market. In China, Mundipharma managers tried to boost profits by requiring 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marketing materials in China made claims about OxyContin's safety and effectiveness based on company-funded studies and outdated data that has been debunked.
Mundipharma said it was taking immediate action to investigate the allegations uncovered by AP. In a statement, the company 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."
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.
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 settlement in the U.S.
Mundipharma has promoted OxyContin in questionable ways in other countries, including Italy and Australia. But the company has particularly high hopes for China, where it has said it wants sales to surpass those in the U.S. by 2025.
China today does not suffer from widespread abuse of opioid painkillers. Strict rules mean OxyContin is not available at pharmacies and can only be prescribed by specially certified doctors. Some believe those regulations, along with China's painful history with opium, have inoculated it against a U.S.-style outbreak. But others worry that China will also see rising abuse as the same questionable messages that were spread in the U.S. about the safety of opioid painkillers take root.
"Why am I afraid of a drug epidemic?" said Dr. Yu Buwei, director of anesthesiology at Shanghai's Ruijin Hospital. "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."
Despite their separate legal structures, Purdue and Mundipharma shared a similar marketing playbook.
In a 2007 lawsuit filed by U.S. prosecutors, Purdue conceded its employees had falsely claimed long-acting opioids are less addictive because they have fewer "peak and trough" effects and cause less euphoria. Purdue and its executives paid $635 million in penalties and entered into a legally binding agreement with the U.S. government to ensure staff never made such claims again.
In conversations with the AP more than a decade later, three current and former sales reps in China made the same misleading pitch, which was repeated in training and marketing materials used by Mundipharma staff.
"Immediate-release morphine and Dolantin are more addictive," a current employee recently told AP on condition of anonymity for fear of losing her job. OxyContin, which enters the blood slowly, she explained, "doesn't resemble immediate-release morphine, rising and falling with these frequent peaks and troughs that cause a euphoric feeling."
"I'm shocked," she said, after AP showed her documents from the U.S. legal case and 2016 guidelines from the U.S. Centers for Disease Control that say there is no evidence long-acting opioids reduce risks of abuse.
"Why after more than ten years would they still do the same thing and go against the laws and regulations of society?" she said.
Mundipharma said it "mandates warnings of addiction risk" in material used by sales representatives and trains staff about "addiction risk and appropriate dosage levels for cancer patients," but did not provide further detail.
To better target sales, Mundipharma managers required reps to copy patients' private medical records without consent and upload them to a company chat group, in apparent violation of Chinese law, according to interviews with four current and former employees and photographs seen by AP.
The three former sales reps, who worked in different parts of China last year, told AP they also sometimes wore white doctor's coats and lied about their identity to visit patients in the hospital.
"If other people asked, I would just say I am the director's graduate student, but most people didn't ask," said one on condition of anonymity for fear of retribution.
Current and former employees told AP they used paid speaking gigs to deepen relationships with key physicians. Two said they also gave under-the-table gifts.
Mundipharma said it promotes ethical behaviour and legal compliance. It added: "We have detailed policies covering interactions with healthcare professionals, grants and donations, and sponsorships and incentives."
Publicly, Mundipharma has kept a tight focus on cancer pain in China, just as Purdue did in the early years as it was trying to change the culture of pain management in the U.S.
But training materials and interviews show Mundipharma staff also presented OxyContin as safe and effective for chronic pain, citing outdated and company-linked scientific studies.
Mundipharma told AP OxyContin "is used in practice only for the treatment of cancer pain in China."
In fact, Chinese regulations also allow OxyContin to be used for non-cancer pain, and AP spoke with three doctors who prescribe it for chronic pain. All said the number of chronic pain patients on OxyContin is low.
China's National Health Commission, National Medical Products Administration, State Administration for Market Regulation and National Development and Reform Commission declined to comment. Sackler family representatives did not respond to detailed questions.
In the U.S., Purdue stopped marketing OxyContin to doctors last year and got rid of its opioid sales staff.
Meanwhile, Mundipharma is hiring in China.
Associated Press researcher Chen Si in Shanghai contributed to this report.