Italy investigates Bayer drug scandal

המידע באדיבות medicontext.co.il
Last Updated: 2001-08-20 17:24:20 EDT (Reuters Health)

MILAN, Italy (Reuters Health) – An Italian public prosecutor leading an inquiry into Bayer AG's recalled cholesterol-lowering drug Baycol (called Lipobay in Italy) on Monday began questioning executives from the German company.

Tomorrow the prosecutor, Raffaele Guariniello, will call officials of the Health Ministry to testify as to why the drug was allowed to stay on the market after the side effects were known, and whether the Italian "active surveillance" program, designed to identify adverse reactions to medicines, is working properly.

Bayer, Germany's largest drugs group, withdrew Lipobay on August 8 because of potentially fatal side effects including rhabdomyolysis.

"It is not a problem for the Health Ministry," Carlo Tomino, director of clinical experimentation at the Italian Health Ministry, told Reuters Health. "In Italy, cases of rhabdomyolysis caused by cholesterol-lowering drugs are at the expected rates."

The drug has been linked to 52 deaths worldwide. "In Italy, no deaths linked to Lipobay have been recorded, as doctors have prescribed much lower doses of the drug," Tomino noted. "In fact, when in the United States the dose was fixed to 0.8 mg, in Italy the maximum dose was set to half that."

Separately, another public prosecutor in northern Italy on Monday began investigating claims that a 70-year-old woman needed hospitalization due to muscle weakness caused by Lipobay. Bruno Giardina told Reuters Health that he had set up an inquiry on the case of Gabriella Bridi, from the northern city of Trento.

"Mrs. Bridi has spent 1 week in hospital suffering muscular pain. At the end, the diagnosis by the doctors was clear: it was caused by Lipobay," Giardina said. "Today we have already received five calls, all from Trento, asking for legal advice from patients worried about adverse effects of the drug," he added.

"The worst-case scenario? If more people sue and if their suspicions about Lipobay are confirmed by medical analysis, than Bayer risks being found guilty of causing an unpremeditated epidemic. According to Italian law, those found guilty of such a crime can be jailed for up to 5 years," he said.

Referring to the worldwide class action suit filed last week by Chicago law firm Kenneth B. Moll & Associates, Giardina said: "If more cases like Mrs. Bridi come out, it would be convenient to join legal forces internationally."

An Italian consumers association, Adusbef, said that it is backed by a pool of 200 lawyers ready to defend Italian patients affected by Lipobay or other drugs that could have caused dangerous adverse reactions.

The prospect of more legal action in Italy was heightened by the numbers of Italians who have sought advice from a free phone number introduced last Friday by the Italian Health Ministry.

About 1500 calls have been received in the last 4 days, Carlo Tomino, the coordinator of the infoline, told Reuters Health. "Most of the callers are scared and ask for medical advice. Some, though, have also asked how they can find legal help," he told Reuters Health.

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