Italian police arrest drug agency officials over alleged falsification of data

A scandal involving drug licences for cash has engulfed Italy’s drug regulatory agency, and leading officials have been arrested, along with people linked to major drug companies.

The most senior figure to have been arrested and held by the police in his own home (“arresto al domiciliaro”) is Pasqualino Rossi, vice president of the Agenzia Italiana del Farmaco (AIFA), the Italian Agency for Pharmaceuticals. Dr Rossi is also one of Italy’s most senior representatives at the European Medicines Agency (EMEA).

Six drug company lobbyists have also been held. As the BMJ went to press, four people were in custody and three were under house arrest. Another individual wanted by the police was not in Italy.

Arrest warrants were issued after a Turin investigating judge, Sandra Recchione, saw a 700 page police report concerning alleged falsification, in return for cash payments, of clinical data needed for drug licences.

At the centre of the investigation are licences awarded for around 30 drugs, mostly thought to be generic products.

The two year investigation, centred on Turin, Rome (where the AIFA headquarters is based), Padua, and Alessandria, has involved the use of wire tapping and covert cameras.

The allegations originally arose in Turin after the routine comparison of a branded drug and its generic equivalent. It emerged that the generic drug had undergone fewer tests than were officially claimed and that data endorsing the product may have been falsified.

The discovery sparked a major investigation by the city’s prosecutor, Raffaele Guariniello. After the arrests he said, “In this case corruption and risks to people’s health were bound up together. And the web and magnitude of events that we’re shedding light on have unthinkable and very grave consequences.”

He claimed that serious side effects, some potentially life threatening, had been concealed.

Italy’s La Repubblica newspaper named the drug giants Bayer and GlaxoSmithKline as two companies with links to some of the people arrested.

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. We will cooperate, as always, with the investigating authorities for everything that will be requested.”

Massimo Ascani, 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. “We deny any involvement whatsoever. These reports are groundless.”

Initially AIFA issued a brief statement denying that its employees were among those under investigation. When the Italian press named the senior officials arrested, however, the statement was removed from the website, and the spokesman told the BMJ that a new one was being prepared.

Martin Jarvis, a spokesman for the London based EMEA, said, “We are aware of the reports, and we have written to the Italian authorities in order to clarify Dr Rossi’s status. Our concern is that he is in a position to perform his duties at the EMEA.”

Meanwhile the Italian health ministry has announced that it is setting up an expert commission to investigate the scandal. And Carlo Rienzi, president of Codacons, the umbrella group of Italian consumer protection groups, has called on the health ministry to release the names of the drugs under investigation.

“The public has a right to know which medicines were marketed without the proper controls,” he said.