The opioid epidemic: Is it only about the USA? (Part III)

The "Pasimafi" investigation brought over fifty people and ten companies to justice. At the center of this was Dr. Guido Fanelli, a medical icon of pain therapy. The scandal extended to Mundipharma, the international arm of Purdue Pharma.

Guido Fanelli, the doctor who exchanged opiate prescriptions for bribes

The "Pasimafi" investigation brought over fifty people and ten companies to justice. At the center of this was Dr. Guido Fanelli, a medical icon of pain therapy. The scandal extended to Mundipharma, the international arm of Purdue Pharma. Purdue Pharma itself is facing about 2,000 lawsuits in the US alone for its role in the so-called opioid epidemic.

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For a long time, the Police and the Carabinieri worked in the shadows, intercepting Dr. Fanelli's conversations on his mobile phone, in his office, and even at the trattoria that he visited frequently. This investigative activity is compiled in hundreds of pages of reports that describe to great detail how Dr. Fanelli helped the managers of the Italian branch of Mundipharma and other companies to promote the use of opioid analgesics in Italy. The strategy included writing articles, organizing conferences and working to minimize government warnings about increasing opiate consumption. Dr. Fanelli contributed to the increase in the prescription of opiates, pointing out frequently the benefits of these drugs and minimizing any fears over the risks of addiction. 

The police operation took the name of "Pasimafi", the yacht purchased by a company that Dr. Fanelli created to manage money from pharmaceutical companies. This is the first known case in which the pharmaceutical empire owned by the Sackler family has been criminally involved outside the United States. According to the investigators, the same practices that the pharmaceutical industry used in the United States since the 1990s and that led to the opioid epidemic were used in Italy. The investigation suggests that, therefore, with the contraction and drop in sales within the US market, the Sacklers' objective was to increase the consumption of opiate drugs abroad.

In Italy, investigative interceptions for operation “Pasimafi” began in 2015. At the time, Dr. Fanelli was a star in the Italian medical world. He was responsible for the Department of Anaesthesiology and Pain Therapy of the Ospedale Maggiore of Parma, and, with his credentials as a university professor, he often appeared in newspapers and television. Dr. Fanelli even provided an important contribution to the drafting of Law 38 from March 15th, 2010, titled "Provisions to ensure access to palliative care and pain therapy", (Italy Official Gazette No. 65, March 19th, 2010) which facilitated the prescription of opiates. It was a legal tool intended to alleviate the suffering of patients with chronic pain.

It seems, however, that already by 2009, while helping to draft the law, Dr. Fanelli had begun to meet with the managers of Mundipharma, and several other Italian pharmaceutical companies managers, and the Italian branch of the German Grunenthal. Pharmaceutical companies saw him as the most effective influencer and vehicle to promote their drugs in the market. According to investigators, since 2009 Dr. Fanelli had collected hundreds of thousands of euros from several pharmaceutical companies with the aim of promoting the prescription of opiates. In the case of most pharmaceutical companies, the money was channeled for legitimate services, such as consulting and event organization.

According to the investigators, however, the same strategies were used in Italy to push the opiate drugs that in the United States, and in a similar vein, the result was catastrophic. For example, already in 2015 Luca Pani, then Director-General of AIFA (the Italian medical regulating agency, short for the Italian: Agenzia Italiana del Farmaco), expressed at a press conference that the 30% increase in the prescription of opiates following the introduction of law 38 deserved reflection, and he urged doctors to be more cautious. At the time, Dr. Fanelli took immediate action, implementing a countermeasure that was discussed with the leaders of Mundipharma and Grunenthal, along with the Italian pharmaceutical companies Molteni and Angelini. According to the accusations that took place after the events, the countermeasure against Luca Pani’s cautions was an article published in the journal Minerva Anestesiologica called "Opioids and chronic pain: Data from the other side of the pond". In the article, Dr. Fanelli claimed that alarm bells ringing in the United States was no cause for alarm in other countries and that doctors should continue to prescribe opioids for chronic pain. 

In Italy, the same system of factual manipulation over the true hazardous nature of the opiates was used in the United States. And this strategy has now evolved into hundreds of thousands of dollars at stake in lawsuits underway against Purdue in the US. Purdue and other companies, as it would happen eventually in Italy, would pay "opinion leaders" (often important doctors involved in pain therapy), to write documents assuring the safety of opioids and thus adding a veneer of science to commercial claims.

On May 8th, 2017, at 4 am, two hundred Carabinieri from the “Counter Adulterations and Health Unit” (the food and medication investigation branch of the Italian police know was NAS, or “Nuclei Antisofisticazioni e Sanità”) moved from Parma to different parts of Italy, ringing bells, questioning doctors and managers, and withdrawing documents from the offices. Dr. Fanelli was taken into custody with many others. The prosecutor's office requested indictments against fifty-five people and ten companies. Mundipharma and Grunenthal Italia were not among them, because they immediately accepted settlements. Dr. Fanelli spent four months under house arrest in his penthouse in Parma. He was professionally suspended without pay and prevented from medical practice until the end of the criminal case.

Source: 
Galofaro C, D'Emilio F. Purdue foreign arm caught up in opioid probe in Europe. AP News. May 29, 2019

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