PARMA, Italy -- 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 of intentionally deceiving doctors and misleading the American public about the addictiveness of OxyContin.
Investigative files obtained by The Associated Press detail the case in which Dr. Guido Fanelli was accused of being paid to 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, D-Mass., 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.
GLOBAL PROBLEM
As the U.S. market contracts, opioid consumption is climbing overseas. Canada and Australia are already following America's course, with rising rates of addiction and death. And 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% in six years.
Italian opioid consumption has increased, though authorities say widespread addiction has not taken root because of 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, about $500,000 from Mundipharma and $700,000 from Grunenthal flowed into businesses Fanelli 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 who prosecutors allege were involved, including Marco Filippini, general manager for southern Europe.
FAMILY-OWNED COMPANY
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, he began meeting with executives from the Italian branches of Mundipharma and Grunenthal and Italian companies including Molteni and Angelini, prosecutors say. 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 said they heard Fanelli say. "That is the business of pain."
Additionally, prosecutors say, 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."
Business on 05/30/2019