Japan vows action over claims of fabricated drug data


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Translation: Leave the fraudulent medicine in Japan to J-pharma.

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Just say NO to drugs.

The Mayo Clinic: Lifestyle plays an important role in treating your high blood pressure. If you successfully control your blood pressure with a healthy lifestyle, you may avoid, delay or reduce the need for medication.

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One major problem now is that the conduct of clinical trials, and subsequent data management, is so complicated that drug company staff, and their clinical trial organization counterparts have to be an integrated part of the study team. Physicians forget to fill out forms correctly, nurses do blood tests the wrong way, staff mislabel a urine sample; every deviation has to be accounted for, corrected where possible, and recorded. Even training the staff to conduct the trial and monitor the patient correctly is a major undertaking. Too many of these mistakes can render the whole study programme invalid.

However outright falsification of data is rare, and Japan seems to have an above average incidence of this, such as the 172 clinical trial papers by the anesthetist Yoshitaka Fujii, which had to be withdrawn after the data was found to be fabricated, and the 5 papers by virologist Naoki Mori which were also withdrawn. Workers have postulated that that dominant position of university physicians as trial leaders and subordinates inability to question their behaviour are contributing factors.

20~30 years ago, an independent, motivated, interested physician could conduct a study with an off-the-shelf statistics package and no company support; but now, the analyses and evaluations are so complicated that professional support is required. Companies conduct multiple analyses to try to obtain a statistically significant difference that can translate to an advantage over a competitor or standard therapy.

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Very interesting Wanderlust. Have you read Bad Pharma by Ben Goldacre? I read his Bad Science and am thinking of getting it.

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@scotchcegg - yes. There are many other books exposing the controversial activities of Big Pharma; however, few pay more than lip service to the greedy physicians and researchers who are also complicit in their activities, and sell their reputation. You can read the criticism of the DSM by Frances Allen, conflicts of interest with advisory members; or about Medical Ghostwriting, but the falsification of scientific data is something else.

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Fabricated drug data and fabricated financial report (Olympus). Unlike China, Japan needs to restore integrity in both public and private data.

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Concerning the falsification of data, don't forget Moriguchi Hisashi, an erstwhile Tokyo University researcher, with no medical degree and merely a nursing license to his name, who published papers and claimed to have succeeded in clinical trials with iPS cells.

“Scientists, journalists and regulators here need to be especially careful not to let their pride in Yamanaka’s achievement affect their critical faculties, or overwhelm them in national fervour," says Douglas Sipp, who researches stem-cell ethics and regulation at the RIKEN Center for Developmental Biology in Kobe, Japan.

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Where Big Food goes, Big Pharma ain't far behind.

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What kind of action will be taken? The same kind that was given to Olympus! Just as they destroyed the credibility of Japanese financial reporting and the consequences of defrauding the public confidence with no real action taken i suspect the same will occur here in this case.

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