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2013年2月16日 (土)

iPS研究 実用化を進める法制度が要る

The Yomiuri Shimbun (Feb. 16, 2013)
Legal system needed to spur treatment with iPS cells
iPS研究 実用化を進める法制度が要る(2月15日付・読売社説)

What could be a significant first step has been made toward practical medical treatment using induced pluripotent stem cells.

Clinical research by the Riken Kobe Institute on the treatment of age-related macular degeneration (AMD), an intractable eye disease, has been approved by the Institute of Biomedical Research and Innovation Hospital, where the research will be conducted.

A Riken team will file an application with the Health, Labor and Welfare Ministry for the implementation of its clinical research. If approved, clinical research will start in fiscal 2013 at the earliest to confirm the efficacy and safety by conducting iPS cell treatment on patients.

AMD is a disease that advances with age and leads to reduced vision or blindness due to a disorder in some retinal cells. No fundamental clinical treatment has been established. There are reportedly about 700,000 patients in Japan.

The planned treatment calls for applying a cell sheet generated from a patient's stem cells to the damaged retina, thereby restoring the patient's vision.

As for iPS cells, the risk of them becoming cancerous has been pointed out. But eye tissue, including the retina, has little possibility of doing so. It also shows almost no cellular rejection. For these reasons, the treatment of AMD was chosen for the first clinical application of iPS cell treatment.


Approval system defective

A matter of concern is that even if sufficient results are obtained through clinical research, it may take some time before approval is obtained from the health ministry for practical application.

First of all, there is no legal system in place for that type of procedure.

In order for drugs to be approved for use, procedures must be taken in line with the Pharmaceutical Affairs Law. Clinical treatment using iPS cells--generated from patients' own cells--will require screening criteria different from that applied to manufactured drugs, which are foreign to humans.

So the approval system must be revised.

Even in cases of regenerative medicine not using iPS cells, it takes time to obtain approval. Regenerative medicines, such as those using skin and cartilage, have been put into commercial use one after another in South Korea and the United States. In Japan, there are only two such products.

In South Korea, provisional approval is given on regenerative medicines after their safety is confirmed to a certain degree, thereby encouraging the development of such products.

Japan must study a plan to establish a system under which regenerative medical products can be swiftly put into practical use by adopting a temporary approval system similar to South Korea's and giving full endorsement by accumulating safety data after sales begin.


Fiscal assistance vital

It is essential to provide funds to help expand this planned clinical research to the treatment of other diseases, such as heart disease and diseases of the blood. The government will provide 110 billion yen over 10 years to help finance regenerative medicine using iPS cells and the development of new drugs. Research centers must be continuously expanded.

It must be noted, however, that hopes regarding regenerative medicine have led to the emergence of treatment methods whose safety is questionable. The health ministry plans to regulate such practices with a new law. Safety is important but legitimate research should not be constrained.

As symbolized by the fact that Prof. Shinya Yamanaka of Kyoto University received a Nobel Prize for production of iPS cells, Japan's basic research on regenerative medicine is among the world's best. The country should not fall behind in practical applications, either.

(From The Yomiuri Shimbun, Feb. 15, 2013)
(2013年2月15日01時20分  読売新聞)


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