Chicago Tribune (Sunday)

Fake doctors, misleading claims drive sales of highly addictive opioids

- By Erika Kinetz

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, fueling 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.

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.

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 to 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.

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 the 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marketing material in China made claims about OxyContin’s safety and effectiven­ess based on company-funded studies and outdated and debunked data.

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. The 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 Australia and Italy. 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.

In a statement, Mundipharm­a 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.”

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.

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 Archaeolog­y 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 1 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.

But convincing Chinese doctors opioids are safe wouldn’t be easy. 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.

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.

“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.”

Many of his younger colleagues, however, appeared in thrall of these foreign ideas. 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.”

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 nonprofit that accepts corporate funding. Pharmaceut­ical companies helped by covering the cost of training and educationa­l materials, he said.

Two years later, the government took 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.

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 the 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.

“We were definitely talking about OxyContin 90% of the time,” said a former sales rep who spoke on condition of anonymity.

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.

In a statement to the 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.

Mundipharm­a told the 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% of the cancer pain market in China, up from just over 40% in 2014, company documents show.

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.

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

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.

The AP was shown snapshots of prescripti­on records staff said were sent to managers. Handwritte­n on pink slips of paper, they included the patient’s 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.

When it was time for hospital rounds, Chen sometimes slipped on a doctor’s coat and mingled with medical staff. If anyone asked who he was, he said he was a doctor or intern. He said he sometimes asked patients 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.

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.

Mundipharm­a told the 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 “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.”

 ?? MARK SCHIEFELBE­IN/AP ?? Documents and interviews indicate that representa­tives from the Sackler family’s Chinese affiliate, Mundipharm­a, tell doctors that OxyContin is less addictive than other opioids.
MARK SCHIEFELBE­IN/AP Documents and interviews indicate that representa­tives from the Sackler family’s Chinese affiliate, Mundipharm­a, tell doctors that OxyContin is less addictive than other opioids.

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