Japan officials allege data cooking in Alzheimer’s drug study

j-adniJapanese health officials are reportedly investigating whether researchers fabricated data in a 2.8 billion yen ($21.12 million) Alzheimer’s drug trial.

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

5 thoughts on “Japan officials allege data cooking in Alzheimer’s drug study”

  1. Or translated, roughly 300,000 million JPN Yen (roughly 3 million US$; http://www.xe.com) PER paper. Wow, real, great profitable productivity.

    Unknown to many in the West, Japan has a rish history of fraud and corruption.

    May heads roll, may fraudulent scientists be sacked and may the English and Japanese newspapers and blogs have a real field day. This may be an excellent opportunity to deepen our understanding of the misty relationship between government and big pharma. I hope that the Japanese tax-payer is furious. We don’t want to see deep head-bowing in front of flashing cameras and fake, pseudo-apologietic words. We want to see real justice: loss of jobs, refunded abused salaries and funding, withdrawn PhDs, and more. How about some prison time, too? I hope some big-shot lawyers try and grill these guys until they are burnt.

    The Abe Government throws away tax-payer’s money for one simple reason; it isn’t their money to spend. Just yesterday appeared the news that Japan donated hundreds of millions to the “poor” countries of Africa. Unlike China – who is now laughing at their neighbour in an escalating feud for implementing neo-bubble policies – that invests its millions or billions in Africa, in a fair and profitable investriment to explore resources, Japan still thinks that throwing money at Governments, many of which are corrupt like crazy, will somehow win them favour over China. This story just forms part of a puppet Government in place by the big banks. The whole system is cockeyed, and fraut with errors.

    MEXT is going to start feeling the heat I hope, very soon. There is no way to stem this tide, or is there? New laws outlawing anti-government dissent is also aimed at science-related issues. In this case, it was too high profile to hide, or mask. I strongly encourage pro-active, peaceful whistle-blowing of fraudulent Japanese professors, money squandering (and/or laundering), abuses of power, disrimination and general unethical or non-academic behaviour.

    These academics are paid fortunes, get massive grants at times, spend a sickening amount of money on travel and travel-related luxuries, in some cases only to present one poster, and they are allowed to conduct, in some cases, incomprehensibly unacceptable academic transgressions. Time to rile the Japanese public and tax-payer who is suffering miserably, and who will suffer even more come April, when the Japanese Government hikes consumption tax rates from 5% to 8% (in a bid to reach 10%. Bankers, Big Pharma, Governments… and now corrupt scientists. Same nonsense everywhere.

    The positive image of an honest Japan is fading rapidly, sorry to say. The 3-point reform plan implemented by Abe benefits the rich and powerful almost exclusively. It pads the pockets of the banks and the corporations, and leaves the rest of the population in misery and increased poverty. And much more to be said, completely unaware of Western societies that overly praise Japan. Folks, Japan is not only about Mt. Fuji, the bullet train, ninjas and sushi.Deep corruption, an increasingly powerful yakuza (Japanese mafia), a sex industry that acounts for 1% of GDP and that incorporates as many as 1 in 5 females in the population, a banking sector being run over by international banks, and the continued neo-colonial subservient attitude towards the US following their attrocities in pre-WWII are just some of the issues that you should keep in mind as you follow this story about J-ADNI and mega-frauds like Shigeaki Kato (http://retractionwatch.com/category/by-author/shigeaki-kato/). 2014 may be an important year of revelations about fraud in Japanese science…

    My opinions are based on 15 years of (extremely happy and often bitter) experience and on, among others, the following sources (more limited in English):

    On fraud and corruption in politics, in the nuclear industry, in sumo wrestling, in the police force, in the building and concrete industry, etc., etc.
    http://www.heritage.org/index/country/japan (2014 score is likely to crash in 2015: my hypothesis)

    On the Yakuza (http://en.wikipedia.org/wiki/Yakuza):

    On education, sex and human trafficking:

    Okinawa (now this is a story to follow, with military links and all)

    Older background:

    and so much more…

    At the end of the day, you have to ask yourself, who is in who’s pocket? Keywords: Government (including MEXT), Yakuza, Big Banks, Big Pharma, The Education system and Higher Institutes of Learning, The building and nuclear industries, the home and building + green technology sectors, science.

    1. Thanks Sugoi..you gave us a lot of material to think on..I was not aware that the situation in Japan was so bad.. I’ll try to read all the material…thanks again….

  2. This is peculiar to me because it is not an efficacy study for any drug. At least, it is described as an effort to validate clinical measures of progression that can be used to evaluate drugs in subsequent studies. If that is the case, I don’t understand what is to be gained by manipulating the results.

    1. What if they had manipulated the pilot data to obtain the grant in the same direction to begin with? They must have had some convincing pilot data to get the grant, right?

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