Japan officials allege data cooking in Alzheimer’s drug study
According to Japan Today:
Health officials said they were questioning researchers after being told false data was used in clinical testing for the 2.8 billion yen government-backed Alzheimer’s study, aimed at improving diagnosis of the disease.
The research involved 11 drugs firms, including Pfizer and Bristol-Myers Squibb and Japanese giants Takeda Pharmaceutical and Astellas Pharma, medical imaging companies and nearly 40 hospitals and medical organizations. The public and privately-financed study, dubbed J-ADNI [the Japanese Alzheimer’s Disease Neuroimaging Initiative], began in 2007.
The whistleblower was an unidentified ex-professor at Tokyo University who was involved in J-ADNI, the news outlet said.
Citing the Asahi Shimbum, Japan Today reported that:
the newspaper had obtained internal documents highlighting at least four instances where researchers linked to the drugs makers and medical institutions tried to falsify data.
Obviously, the prospect of retractions in this case looks likely, but the J-ADNI doesn’t seem to have many papers. We found only a handful on PubMed, none of which have been cited more than nine times, according to Thomson Scientific’s Web of Knowledge.
Here’s how the project is described:
Background: In view of the upcoming clinical trials of disease-modifying drugs for Alzheimer’s disease (AD), there is a compelling need for the establishment of a complete set of surrogate biomarkers that reflect and predict the progression of AD, especially conversion from mild cognitive impairment (MCI) to AD. For this purpose, AD neuroimaging initiative (ADNI) is currently being conducted in US, collecting MRI and PET images as well as biological fluids, together with psychometric measures. In concert with this trend, Japanese clinicians and researchers on AD started Japanese ADNI (J-ADNI), which is sponsored by governmental funding bodies (NEDO and MHLW) as well as pharmas, from April 2007.
Research plan: Thirty-eight clinical sites in Japan will conduct a longitudinal study enrolling 300 amnestic MCI individuals, 150 cognitively normal aged controls and 150 early AD patients for 3 (AD: 2) yrs using neuropsychological batteries (100%), 1.5T MRI (100%), FDG-PET (~70%), amyloid imaging (~45%); will also collect biological fluids (blood 100%, CSF ~40%, DNA samples 100%). All the protocols are designed to gain as much compatibility to that of US-ADNI. Takeshi Iwatsubo heads the group as PI with the assistance of core PIs (Clinical: Takashi Asada and Hiroyuki Arai, Neuropsychology: Morihiro Sugishita, MRI: Hiroshi Matsuda, PET: Kengo Ito and Michio Senda, Amyloid PET: Kenji Ishii, Biomarker: Ryozo Kuwano and Hiroyuki Arai, IT: Noriko Sato and Fumio Yamashita).
Timeline and funding: A 5-year research program is being conducted. Participant enrollment: July 2008-March 2011. Study: July 2008-March 2014. Initial analysis: January 2010. Final analysis and report: April 2014. Public funding: grants from NEDO (a foundation of ministry of economy, trade and industry), from ministry of health, labor and welfare (2007-2009, 2010-2012). Funding from pharmas (11 companies as J-ISAB: Astellas, Bristol-Myers Squibb, Daiichi-Sankyo, Dainippon-Sumitomo, Eisai, Eli-Lilly, Merck-Banyu, Pfizer, Shionogi, Takeda, Tanabe-Mitsubishi), 2007-2012.
Hat tip: Daron Standley