Novartis has acknowledged that employees of the company participated in five “independent” investigator-initiated post-registration trials without disclosing their relationship to the company. The company said that a broader “comprehensive investigation with independent third party experts is ongoing” but that it has “provided an update” to Japanese medical societies and to the principal investigators of the five trials.
The
Novartis statement is the latest development in a growing scandal involving clinical trials in Japan with Novartis’s former blockbuster drug Diovan (valsartan).
As previously reported here, one trial, the Kyoto Heart Study, has been
retracted by the European Heart Journal. Several other papers by the trial’s principal investigator,
the once-prominent cardiologist Hiroaki Matsubara, have also been retracted. Matsubara subsequently resigned from his post at Kyoto Prefectural University, as reported by
Retraction Watch. A second large trial,
the Jikei Heart Trial, came under scrutiny when it was revealed that a Novartis employee, Nobuo Shirahashi, was involved with both studies. In both cases his only listed affiliation was Osaka City University.
The new statement from Novartis admits that “one of our former employees [presumably Shirahashi] had varying levels of involvement in five investigator initiated valsartan trials in Japan.” The statement also disclosed that “a second former employee (who reported to the first former employee) had involvement which was limited to one of these trials.” Novartis said that independent investigation is continuing but that so far there has been no indication of a “specific company strategy to integrate the first former employee into the five valsartan investigator initiated trials.” However, the investigation has revealed
that some of this former employee’s superiors in Japan knew of his participation in these trials and were supportive of him in these activities. They believed that employees of a business that had academic titles could perform clinical research support as academics, without any conflict of interest issues arising. In addition, there is no indication that any of his supervisors knew or approved of the incomplete disclosure of his affiliation in the published papers for these studies.
Novartis also stated that “some, if not all, of the physicians involved in conducting the studies were aware of his employment by Novartis.” Further:
Our current understanding is that the former employee believed he was allowed to engage in research if this was done in his capacity as a part-time lecturer of Osaka City University and took steps to separate his involvement in the studies from his work for the company. This employee, some of his supervisors, and the trial investigators believed that employees of a business that had academic titles could perform clinical research support as academics, without any conflict of interest issues arising.
Finally, Novartis acknowledges that its previous defense of the Kyoto Heart Study was mistaken:
When previous statements were made about the involvement of Novartis Pharma K.K. (NPKK), Japan in the Kyoto Heart study, they were provided based on the information which was available at the time and were believed to be accurate. We are correcting those statements by issuing this update based on the latest information which was obtained from the ongoing independent investigation and we apologize for the statements made without verification.
Here are links to the complete Novartis statement in English and in Japanese.
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