Novartis Japan staffers shredded and deleted to cover trial misconduct, panel finds

Novartis' ($NVS) Japanese unit didn't fake clinical data in a head-to-head leukemia drug study, an investigatory panel found. But that doesn't mean the Swiss drugmaker's staff is off the hook in its latest Japanese scandal. According to the panel's report, employees not only broke the rules repeatedly--they also engaged in a cover-up.

A panel of third-party investigators, all attorneys, flagged more than 20 instances of improper behavior among Novartis' local sales staff, The Wall Street Journal reports. After misconduct allegations surfaced, the employees tried to hide their missteps by shredding documents and deleting online files, the investigators said.

"I didn't expect to come across this many [problems]," Kunio Harada, who headed up the three-member panel, told reporters in Tokyo.

For instance, at least 9 Novartis reps collected patient questionnaires in a study comparing the side effects of leukemia treatments, including the company's own next-gen drug Tasigna (nilotinib), the panel said. The Novartis staffers faxed the questionnaires to researchers at University of Tokyo Hospital, despite the fact that trial protocol required doctors to turn in the questionnaires themselves. And the employees often held onto the questionnaires, which included personal patient data, another no-no, the panel found.

When allegations of misconduct hit last year, many Novartis sales staff participated in the cover-up, the panel said in its report. "We can't rule out that these activities have been carried out at an organizational level," Harada said (as quoted by the WSJ). "Even more surprisingly, these things have become an everyday occurrence for them, without any notion that this was inappropriate."

Novartis said it will study the report and take necessary action against any employees who behaved unethically. "[W]e seriously take the possibilities that our Japanese staff obtained personal information and engaged in destruction of evidence," the company said in a statement obtained by the Journal. "These are activities that go against Novartis' code of conduct."

The Swiss drugmaker has been in hot water in Japan for some time. A separate probe of potential data-tampering has resulted in criminal charges against the company for false advertising. The company's top pharma executive has cut local managers' pay until the investigations are resolved and apologized for any employee misbehavior.

- read the WSJ piece (sub. req.)

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