EDITORIAL: Japan’s clinical research need serious reforms to clear international standards

January 11, 2014

A data falsification scandal has raised serious doubts about the wisdom of pouring taxpayer money into clinical research under the government’s strategy for stroking economic growth.

The scandal has struck a government-financed project to establish an effective method for early diagnosis and treatment of Alzheimer’s disease.

It is suspected that researchers involved in the Japanese Alzheimer’s Disease Neuroimaging Initiative (J-ADNI) have altered and even falsified clinical study data. The revelations, which emerged on the heels of allegations of exaggerated advertising for the high blood pressure drug Diovan, have called into question the ethical standards within Japan’s medical research community.

The Ministry of Health, Labor and Welfare needs to carry out a swift and rigorous investigation into the allegations and start taking steps to create a system to improve the quality of clinical research.

The project, modeled after the Alzheimer’s Disease Neuroimaging Initiative set up by the U.S. National Institutes of Health (NIH), was launched in 2007. Financed by the government and pharmaceutical companies, the project involves 38 medical institutions across the nation.

Under the project, a series of medical tests and procedures are conducted on 600 elderly subjects over two to three years, including diagnostic imaging of the brain, blood tests and neuropsychological tests, in order to develop new effective drugs as well as a system to detect and treat the disease at an early stage. But the latest revelations have seriously undermined the credibility of the costly project.

J-ADNI tests were supposed to be conducted according to the procedures adopted in the United States so that the research results can be easily and effectively shared internationally. But it has been alleged that some data was not collected appropriately and subsequently altered. It is also suspected that some of the subjects were not qualified for the research.

If the allegations are true, the mammoth research project has, ironically, revealed that clinical studies in Japan don’t measure up to the international standards at the most basic level.

Clinical studies are mainly conducted by professors at the medical departments of universities. In Japan, many professors seek to add to their achievements and develop their research careers through basic research using animals and cells.

Researchers in Japan tend to complain that clinical studies involving human subjects don’t produce enough rewards to justify the hard work required. As a result, experts point out that Japanese researchers are constantly tempted to focus on the kind of research that offers an opportunity to make achievements quickly.

The Abe administration has mapped out a strategy for promoting medical research that envisions the Japanese version of the NIH, which serves as the nerve center for medical research in the United States. Prime Minister Shinzo Abe’s strategy is aimed at capitalizing on Japan’s relative strength in basic medical research to promote promising clinical study and industrial application projects. The administration has earmarked 120 billion yen ($1.15 billion) for policy efforts under this strategy for the fiscal year that starts in April.

Even if this policy is aimed in the right direction, it is still premature to pour huge amounts of taxpayer money into clinical study projects, if the scandals are any indication of the state of things in the field.

The number of joint international clinical research projects involving several countries is on the rise. But Japan has been left out of the trend. Experts say that’s because there are international doubts about the credibility of data collected in Japan and concerns about some problems with the way clinical trials are conducted in this country.

The policy priority should be placed on fixing such basic problems with clinical research in Japan. If misconduct like falsifying data to ensure quick results is not uncommon, it cannot be expected that research in Japan will lead to effective new treatment methods or drugs. Investment in such research is simply money ill-spent.

All the parties involved, including the government, drug makers and researchers, should take the situation seriously and set out on radical reform to remedy the problems.

--The Asahi Shimbun, Jan. 11

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The internal document on the left asks a medical institution to change the test time, while the document on the right shows the revision to the test data. (The Asahi Shimbun)

The internal document on the left asks a medical institution to change the test time, while the document on the right shows the revision to the test data. (The Asahi Shimbun)

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  • The internal document on the left asks a medical institution to change the test time, while the document on the right shows the revision to the test data. (The Asahi Shimbun)

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