Managers with Mundipharma, the international arm of Purdue Pharma, have been swept up in a corruption case in Italy alleging they and other pharmaceutical executives paid a prominent pain doctor to help push more opioids in this country long leery of the powerful painkillers.
It is the first known case outside the U.S. where employees of the pharmaceutical empire owned by the billionaire Sackler family have been criminally implicated, more than a decade after Purdue executives were convicted over misleading the American public about the addictiveness of OxyContin.
Investigative files obtained by The Associated Press detail how Dr. Guido Fanelli was allegedly paid to help promote painkillers by an alliance of pharmaceutical managers he called "The Pain League." Prosecutors say Fanelli wrote articles, organized conferences and helped counter government warnings that opioid consumption was spiking and that physicians should be cautious. The message trumpeted, the AP found, was that there's an epidemic of chronic pain, opioids are the solution and addiction fears are exaggerated.
Those are the same practices, experts contend, the pharmaceutical industry employed in the U.S. that helped create an addiction crisis that has claimed 400,000 lives.
"It makes me feel sick more than anything else," said U.S. Rep. Katherine Clark , who sent a letter to the World Health Organization in 2017 warning that Mundipharma was repeating the "deceptive and dangerous practices" of Purdue, which faces some 2,000 lawsuits in the United States over its promotion of opioids. The letter implored the agency to act — before the American epidemic becomes a pandemic.
The case Italian prosecutors lay out offers a look at how Big Pharma executives still pushed opioids abroad even after the cause and consequences of the U.S. epidemic had become apparent.
As the U.S. market contracts, opioid consumption is climbing overseas. Canada and Australia are already following America's catastrophic course, with rising rates of addiction and death. Others may be on the cusp of crisis: Overdoses are increasing in Sweden, Norway, Ireland and England, fueled by prescription painkillers and the illicit drug trade. Researchers in Brazil report that prescription opioid sales have increased 465 percent in six years.
Italian opioid consumption has increased, though authorities say widespread addiction has not taken root due to strict regulations and a cultural skepticism of the drugs — both of which Fanelli apparently worked to reverse.
According to the investigative file, over a period of years, 464,000 euros from Mundipharma (about $500,000) and 640,855 euros from Grunenthal (about $700,000) flowed into businesses Fanelli allegedly set up to hide the payments. Spokesmen for Mundipharma Europe and Grunenthal, based in Germany, said the corporate offices were unaware of the alleged scheme and believed the payments went toward legitimate services.
Mundipharma's network of companies operates in more than 120 countries, and its emerging markets division has expanded into Asia, Africa and Latin America. Grunenthal, too, sells drugs in more than 100 markets.
Both companies said they have conducted extensive internal investigations and overhauled compliance and ethics policies. Mundipharma Europe spokesman Patrice Grand said the company "has transformed and redeemed itself" in the wake of the scandal. It fired two managers prosecutors allege were involved, including Marco Filippini, general manager for southern Europe.
Purdue and Mundipharma are both owned by the Sackler family, well-known philanthropists now facing lawsuits and public scrutiny for Purdue's promotion of OxyContin. Purdue agreed to pay a $270 million settlement this year in a case brought by the state of Oklahoma, but the company has vehemently defended itself. Spokesman Bob Josephson noted a judge this month dismissed a lawsuit in North Dakota after finding the company cannot control how doctors prescribe its drugs and how individuals use them.
Hundreds more lawsuits remain pending, many alleging that Purdue and other companies paid "key opinion leaders," often prominent pain doctors, to add a veneer of science to commercial claims about the safety of opioids for chronic pain. Prescriptions quadrupled between 1999 and 2010 in the U.S., and overdoses climbed.
In Italy, Fanelli was a chief of the anesthesiology and pain therapy department at Maggiore Hospital in Parma and called himself the father of a 2010 law that made opioids easier to prescribe, which he championed as necessary to ease suffering.
In 2009, as he was helping to draft the law, prosecutors allege he began meeting with executives from the Italian branches of Mundipharma and Grunenthal and Italian companies including Molteni and Angelini. Molteni did not respond to requests for comment. Dario Romano, a lawyer representing Angelini and one of its managers, said his clients did nothing wrong.
Carabinieri police stumbled onto the case during another investigation, then bugged Fanelli's cellphone and office.
"I created a system," police allegedly heard Fanelli brag. "That is the business of pain."
In addition to publishing pro-opioid position papers, he also planned a medical conference that prosecutors described as "upside down." The director is supposed to pick the speakers and subjects, but Fanelli, prosecutors say, turned that over to the companies.
Additionally, prosecutors allege, the doctor coordinated with a nonprofit hosting a 16-city roadshow professing about the plight of chronic pain and how opioids should be used for treatment. The president of the pain group's board was the marketing manager of the Italian branch of Mundipharma.
"They're using the same playbook that worked in the United States," said Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing, "despite knowing that it led to a public health catastrophe."
Grand, the Mundipharma spokesman, rejected that, saying: "There is no such playbook."
Mundipharma branches and Purdue have different managers and portfolios and do not share strategies, he said. The European operation has stopped promoting opioids, which now make up less than 40 percent of Mundipharma's European sales, he said.
Two Mundipharma executives — Filippini and Riccardo Cerbai, business and marketing director in Italy — accepted plea bargains in January, though a lawyer representing them said the pleas are not an admission of guilt. Grand said both were terminated in September. He said the company itself also did not acknowledge guilt in its agreement to accept a fine of 40,000 euros.
Grunenthal Italia was fined 50,000 euros. Grunenthal spokesman Stepan Kracala said the company, which operates mostly in Europe and Latin America, has implemented a new code of conduct, including an employee whistleblower hotline, and is committed to transparency about the addiction risk of its drugs.
Several Grunenthal executives are named in the investigation; their lawyers insist on their innocence. They are awaiting a series of hearings, after which a judge will decide whether they must stand trial.
Fanelli, through his attorney, declined to comment. He was suspended without pay and barred from practicing medicine pending resolution of the case.
Galofaro is an AP national writer. She reported in the U.S. and Italy. D'Emilio, based in Rome, reported from Italy. The AP's reporting is funded in part by a grant from the Pulitzer Center on Crisis Reporting.
If you are a doctor, law enforcement officer, pharmaceutical employee or resident living outside of the U.S. and have concerns about opioid availability or addiction in your country, please contact Galofaro at firstname.lastname@example.org or on Twitter at @clairegalofaro