Nello Martini, director of Italy's scandal-hit medicines agency, Aifa (the Italian Agency for Pharmaceuticals), has been sacked, following a six-week suspension.
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.
Prosecutors in Turin charged Martini with disastro colposo, or "causing unintentional disaster", for bureaucratic delays in updating the packaging information on the side effects of a few drugs.
However, Martini's removal only appears to have fuelled the row engulfing Aifa, with claims that it was his tough line on drugs spending and the pharmaceutical industry that cost him his job.
Martini's supporters note that his involvement in the recent scandal was relatively minor. And they insist his replacement by microbiologist Guido Rasi, a supporter of the Berlusconi government, was politically motivated.
It has emerged this week that nine experts in clinical pharmacology, including, Dr Gianni Tognoni, director of the Mario Negri Sud Consortium, have given testimony saying that Martini's sacking was unwarranted, since the delayed intervention only involved some rewording of sentences on drug packets.
Another senior figure, Professor Silvio Garattini of Milan's Mario Negri Institute, has also defended Martini. He noted that the accusations of the Turin prosecutor Raffaele Guariniello, related to illegal activity; Martin, though was accused of administrative incompetence. "This doesn't seem so serious to me," he has said.
Prof Garattini, a frequent critic of the pharmaceutical industry, also praised Martini for having reduced Italy's drug spending.
Accusations of corruption and political manipulation are nothing new for Italian drugs regulation. Aifa was set up in 2004 to ensure that the registration of drugs was independent of government, following the monumental "Clean Hands" corruption trials that shook in nation in the 1990s.
In 1993, the police broke into the house of the head of the national committee for drug registration only to find gold bullion under the floor boards. In his role as head of the new agency, Martini won plaudits for successfully limiting Italy's spiralling drug expenditure to 13% of the total health budget. But in the process he incurred the wrath of the drugs industry, say some observers.
According to an editorial in the latest issue of Nature magazine, "even more worryingly", the government planned to "reduce Aifa's power by separating the pricing of drugs from technical considerations of their efficacy, bringing pricing back into the health and welfare ministry".
It said the agency needed to retain its autonomy and wide remit to keep down drug costs in Italy. It said, too, that the health and welfare ministry's connections with industry were "uncomfortably close", noting that the wife of the minister Maurizio Sacconi was the director-general of Farmindustria, the association that promoted the interests of the pharmaceutical industry.
Meanwhile, the investigation into the drug licences for cash scandal, which has seen the arrest of senior Aifa official Pasqualino Rossi, continues.
By Michael Day
PharmaTimes
1 comment:
There is a large Swiss company whose name does not start with'R' that has had its sales representatives utilize Italian studies regarding thier promoted products.
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