Healthy Skepticism Library item: 13874

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Day M.
Drug licences for cash scandal unfolds in Italy
PharmaTimes 2008 Jun 27
http://www.pharmatimes.com/WorldNews/article.aspx?id=13792&src=EWorldNews

Full text:

The director of Italy’s medicines regulatory agency has been suspended along with another top official, as the drug licences-for-cash scandal surrounding the organisation continues to unfold.

Nello Martini, director of Aifa (the Italian Agency for Pharmaceuticals), has been suspended along with Caterina Gualano, head of medicines registration for the agency. The development follows a two-year investigation in which police found evidence that money had changed hands in return for the falsification of clinical data required for drug licences.

Earlier this month PharmaTimes World News reported how Pasqualino Rossi, one of Aifa’s most senior representatives at the European Medicines Agency (EMEA), had been arrested along with another Aifa official and five drugs company lobbyists in connection with the scandal.

The second Aifa official has since been released. However, investigating judge Sandra Recchione has now ordered the two-month suspension of Martini and Gualano, saying the evidence suggested both as a result of their actions “have caused the situation”.

One senior figure, Professor Silvio Garattini of Milan’s Mario Negri Institute, came to the defence of Martini, however. He noted that the accusations of the Turin prosecutor Raffaele Guariniello, related to illegal activity; Martin, though appeared to be accused of administrative incompetence. “This doesn’t seem so serious to me,” he told the Italian press.

Prof Garattini, a frequent critic of the pharmaceutical industry, also praised Martini for having reduced Italy’s drug spending. The scandal came to light in Turin following the routine comparison of a branded medicine and its generic equivalent. It emerged that the generic drug had undergone fewer tests than were officially claimed and that data endorsing the product had been falsified.

The discovery sparked a major investigation by Guariniello. As a result, licences awarded to around 30 medications, mostly thought to be generic products, are now under suspicion. Some reports suggest that Guariniello is investigating 12 deaths that might be linked to the products.

No evidence of public harm
A preliminary report by a Government-appointed panel has suggested there is no evidence that any harm has been done to the public, however. The names of the drugs have not been revealed, despite demands from consumer groups for the government to do so.

Carlo Rienzi, president of Codacons, the umbrella organisation of Italian consumer protection groups said: “The public has a right to know which medicines were marketed without the proper controls or as a result of pay-offs.” No press statements were posted on the Aifa website. And telephone requests for statements were not returned.

Italy’s La Repubblica newspaper earlier this month named the drug giants Bayer and GlaxoSmithKline, as two companies with links to some of the arrestees. Daniele Rosa, a spokesman for Bayer’s Italian division said: “The investigation does not concern the behaviour of the company, but alleged behaviour that could be traced back to some collaborators whose behaviour the company has no knowledge of.” Massimo Escani, a spokesman for GlaxoSmithKline in Italy, denied that any associates of the company were involved in the scandal. “The claims are completely untrue,” he said.