FDA notified of scientist at US pharma company
(ANSA) - Rome, June 27 - Italian pharmaceutical watchdog AIFA has alerted the US Food and Drug Administration (FDA) that an Italian scientist at an American drug company was presumed to be involved in the "bogus" Stamina stem-cell treatment it banned in 2012, according to a letter seen by ANSA on Friday. Dated January 2014, the letter says Camillo Ricordi, a member of the scientific board of Bioheart and a University of Miami professor, was involved in supporting Stamina. "It's an example of how individuals and organizations in the US are supporting (Stamina) dealers offshore," said AIFA chief Luca Pani. Stamina's credibility has long been suspect, and last fall the health ministry ruled that the Stamina Foundation would no longer be allowed to test the treatment on humans. The foundation was also stripped of its non-profit status after a study found its treatment was "ignorant of stem-cell biology". Recent investigations have shown risks of the treatment range from nausea to cancer, and as many as one-quarter of all patients treated have experienced "adverse effects". The head of the foundation, Davide Vannoni, may face indictment. In April, after study results became known, hospitals in Italy announced they had suspended the stem-cell treatment program. However some local judges have ruled in favor of its application, despite the bans, amid heavy pressure from advocates and the families of patients.
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Stamina getting 'offshore' help says drugs watchdog update