Mannkind on "worst" list for handling of suspect data

Mannkind takes the number seven spot on Jim Edwards's list of the worst drug companies of 2010 based in part on a lawsuit filed by John Arditi, former senior director/GCP/regulatory affairs. Arditi says Mannkind fired him in retaliation for reporting suspect clinical trial data for Afrezza, the company's high-stakes inhaled insulin product that's about to be reviewed by the FDA.

Arditi found that that data from a site in Russia indicated unusually consistent blood pressure readings for trial volunteers over several months. He suspected protocol violations and fraudulent data. Arditi found also that a site in Bulgaria had submitted suspect data, and that Mannkind therefore had submitted potentially fraudulent and misleading data to the FDA in its Afrezza NDA.

According to the lawsuit, Arditi advocated immediate disclosure to the agency. He charges that the company resisted; his relationship with management became strained and he was fired.

Edwards, in detailing Mannkind's presence on his list, says the drugmaker had been sued previously by a former VP on similar allegations.

- see the list

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