Tokyo hospital exec says Novartis employees deeply involved in leukemia-drug trial

Novartis employees were more involved in a Japanese drug study than previously suspected, a Tokyo hospital official said. In an investigative report released last week, the University of Tokyo Hospital said doctors not only let Novartis ($NVS) employees collect patient data from various trial sites but also allowed the Swiss drugmaker into its records on all 255 trial participants, Japanese media reports.

Plus, at least one Novartis employee was involved in planning the trial, designed to compare side effects of multiple leukemia treatments, the hospital found, according to Japan's Mainichi news. Those treatments included Tasigna, the company's follow-up to the hugely successful Gleevec (imatinib).

In fact, according to NHK World, hospital director Takashi Kadowaki said Friday that Novartis employees were "virtually managing the study." The hospital says it's now investigating four other leukemia research programs in which Novartis employees were allegedly involved.

The Tokyo hospital has been probing Novartis' involvement in the leukemia research since January, and officials reported their findings at a news conference last week. Now, officials in the Ministry of Health, Labor and Welfare want the hospital to turn over details of its investigation. Both the hospital and the ministry are weighing "punitive measures," Mainichi reports.

The health ministry and several leading hospitals had already been probing Novartis' involvement in clinical research on its blood pressure treatment Diovan (valsartan). Researchers have retracted one key Diovan study, and at least one hospital said it found evidence of data-tampering. Japanese prosecutors have since brought a complaint against Novartis under the country's false-advertising law, because the flawed Diovan data was used in promotional materials for the drug.

Till the Diovan data was discredited, Novartis used it to give the drug an edge on its competitors. The leukemia study offered a similar opportunity. Gleevec's patent is running out, and Novartis aims to build up Tasigna to take its place once biosimilar rivals appear.

The company used mid-term data from the side-effects study in advertisements for the newer drug, Mainichi says. "The researchers were aware of the possibility (the trial data) would be used for advertisement purposes," Kadowaki said at the news conference (as quoted by Mainichi).

"We want to apologize to patients and doctors," a Novartis spokesperson told Mainichi. "We must refrain from comment on the investigation, which is being handled outside our company." Novartis is also looking into the matter, with the help of outside investigators. 

Novartis executives have already apologized repeatedly for the Diovan missteps. The company has said its own investigation found no data-tampering in the Diovan studies, though at least one employee was involved in 5 of them. Pharma chief David Epstein not only promised that new controls would prevent similar mistakes in the future but also docked Japanese executives' pay until the data probe is resolved.

- read the Mainichi story
- get more from NHK World
- see the Japan News article

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