Pharmaceutical crime, FDA: "The big names in the web are waging war on data"

Fedaisf editorial staff

November 7, 2017

Da un incontro a margine del G7 Salute è emerso che il contrasto alle attività illecite è limitato dall’ostruzionismo di colossi come Google e Amazon (parola di Robert Burke, della Food and drug administration) e dalla scarsità di risorse umane ad hoc. In Italia solo l’1% dei siti che vendono farmaci è legale

Of Stefano Di Marzio e Maurizio Di Lucchio – Aboutpharma – 6 novembre 2017

The pharmaceutical crime? “The worst is yet to come”. He said it Alain Lemangnen, responsible for the French Oclaesp (Central Office against environmental and health crime), during the meeting "Strategies to Fight Pharmaceutical Crime", organized alongside the G7 Health in progress in Milan. At the meeting - coordinated and introduced by the new director of the Carabinieri Nas, il major general Adelmo Lusi – attended by the main agencies fighting theft, counterfeiting and illegal trade of medicines worldwide. The challenges concerning health are global (the Minister of Health has emphasized this several times Beatrice Lorenzin in his inaugural speech) and global strategies for prevention and containment must be: not only of diseases but also of crimes.

Pharmaceutical crime in Italy

The director general of Aifa Mario Melazzini he recalled that “344,615 units of drugs were seized in 2016”. Since 2013, Melazzini specified, Italy has had "a database on drug theft, where all cases of drugs stolen or lost in the area and in the various stages of the process are recorded". However, according to the numbers provided and the counterfeit statistics, the tools for fighting crime are becoming more and more advanced but the danger is always high.

Reports of suspected pharmaceutical crimes in our country

What did the reports of suspicious cases taken care of by the Italian Medicines Agency concern? “For example – said the dg Aifa – falsified versions of original products that contain botulinum toxin marketed by subjects without authorization. Or illegal products to treat male dysfunction. Or drugs presented as food supplements. Or again, other types of product that actually contain active substances at a pharmacological level. In September of this year, more than 90 thousand units of illegal or counterfeit medicines and medical devices were seized with the Pangea X operation”.

As for the legal websites authorized to sell medicines online, Melazzini declared that they are fewer than the 1% compared to the entire offer on the web. “And today there are five hundred sites closed, with servers located in Italy”. Melazzini also said that 99 out of 100 drugs circulating online are of dubious quality. It goes without saying how high the risk is for those who buy drugs on the internet.

The dedicated taskforce and the two cases dealt with recently

“Pharmaceutical crime – said the general manager of Aifa – puts patient safety at risk, creating a public health problem. For this reason, Aifa, together with the Ministry of Health and the Carabinieri Nas, pays particular attention to the fight against pharmaceutical crime, focusing specifically on the production and distribution of illegal or falsified medicines, theft and recycling of medicines, the promotion and sale of medicines through unauthorized websites. Aifa's commitment is evidenced by a series of initiatives such as the drug traceability system or the establishment of a dedicated taskforce”.

The FDA: "Google, Microsoft and Amazon are at war with us"

The circumstances (and figures) reported to Milan by Daniel Burke, program director, are disturbing CyberPharm within the Food and Drug Administration. According to the official, the proliferation of electronic currencies (bitcoins and the like) which slow down the possibility of tracing economic transactions (a fundamental weapon for investigators) and the obstructionism of giants such as Microsoft, Google and Amazon complicate investigations into trafficking on the dark web as well as those that take place in the open. “They make war on us – said Burke – and deny the data that the domains lead back to people and organizations. It took a US Supreme Court ruling to allow us access to online pharmacy data." Among the case histories referred to in Milan, Burke spoke of a fake drug for atrial fibrillation (which contained only talc) which earned 12 million dollars thanks to fake information conveyed by the web.

France is in the front row

In anticipation of the international report on the actions undertaken by the EU states which will be presented in Paris on 13 December, among the various cases summarized in Milan, the one recounted by Alain Lemangnen. Recently, the French Gendarmerie managed to dismantle – collaborating with the customs of Sweden and Finland – a British organization that was placing huge quantities of Subutex (trade name of the synthetic opioid buprenophine) on the French market. The numbers: 28,000 tablets seized, which come from thefts; 150 thousand euros confiscated in addition to movable and immovable property; compliant prescriptions for 110,000 blister packs and 770,000 tablets; sales estimated at 77 million euros and a loss for the French health service of around 2 million euros.

An unequal fight?

The international law enforcement strategy - according to experts - suffers from the scarcity of competent human resources. In the opinion of Lusi, Burke and Lemangnen, cyber investigators are a rare commodity.