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Friday, May 23, 2008

Bayer & Glaxo Linked To Bribes In Italy

Source: Ed Silverman's Pharmalot

...and the wheel of corruption keeps on turning!

A drug licences-for-cash scandal has engulfed Italy’s medicines regulatory agency with leading officials arrested along with people linked to major drugmakers, PharmaTimes writes. The most senior figure to have been held is Pasqualino Rossi, vice-president of Aifa, the Italian Agency for Pharmaceuticals), and one of Italy’s most senior representatives at the European Medicines Agency.

Five lobbyists have also been arrested, and an eighth person is being sought. Arrest warrants were issued after an investigating judge saw a 400-word police report suggesting money had changed hands in return for falsifying clinical data required for drug licences, according to PharmaTimes. At issue are licenses awarded to around 30 meds, mostly generics. The two-year investigation used wiretaps and covert cameras.

The scandal came to light following a routine comparison of a branded med and its generic equivalent, which turned out to have undergone fewer tests than were officially claimed and that data endorsing the product had been falsified. The discovery sparked a major investigation by the Turin’s prosecutor, Raffaele Guariniello.

“In this case the corruption and risks to people’s health were bound-up together, ” he was quoted as saying, according to Pharmatimes. “And the web and the magnitude of events that we’re shedding light on have unthinkable and very grave consequences.”

Italy’s La Repubblica newspaper named Bayer and GlaxoSmithKline as having links to some of those 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 Escani, a spokesman for Glaxo in Italy, denied that any associates of the company were involved in the scandal. “The claims are completely untrue. We deny any involvement whatsoever. These reports are groundless,” he told the Italian newspaper, according to PharmaTimes.

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

According to PharmaTimes, Martin Jarvis, a spokesman for the 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.”

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