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From Bio Journal - March 2004


Ibaraki Prefecture announces GM crop cultivation restriction guidelines

On 4 March 2004, Ibaraki Prefecture announced its own GM crop cultivation guidelines, which include seeking consent by neighbouring farming household as well as demanding measures to prevent cross-contamination by GM crops to other conventional crops. As Ibaraki is famous for "Mito natto" (fermented soybean food product produced around Mito, Ibaraki), its main ingredient, soybeans, is very important. However, since the "Informal Council on Bio-crops" began planting GM soy a few years ago (see BJ October 2003), and since there are also Monsanto field trial sites, MAFF research facilities, and Tsukuba University situated in Ibaraki, there has been rising concern over GM contamination spread to the conventional soybeans varieties by pollen. The aim of the guideline is to prevent GM pollution on general farm land. This will be the first prefectural government level initiative for GM crop cultivation restriction in Japan.



MHLW reports on serious situation in gene therapy

The Science and Technology Panel (a consultative body under the MHLW Health Sciences Council) held a meeting on 14 January 2004 at which a "Serious Situation Report" concerning unpredicted consequences of gene therapy which have occurred at the three medical institutes currently carrying out gene therapy was made public. At the university hospital of Osaka University, a 66-year-old man suffering from chronic arteriosclerosis obliterans, the tenth case study of gene therapy for this disease, was operated on for cataracts. At the university hospital of Nagoya University, a 54-year-old man suffering from malignant glioma, the third case study of gene therapy for this disease, died 2 years and 2 months after the start of gene therapy. At the Tokyo University Hospital, a 61-year-old woman suffering from cancer of the liver, the third case study of gene therapy for this disease, died 2 years and 8 months after the start of gene therapy. The report states that the patient at Osaka University Hospital suffered from cataracts before the gene therapy began and that there is no causal relationship between the gene therapy and the cataracts. As for the other two cases, at Nagoya University and Tokyo University, the disease which was supposed to be relieved by the gene therapy deteriorated, resulting in the death of the patients. This indicates that the gene therapy was not effective.



New GM food safety evaluation standards approved

On 21 January, 2004, the specialist panel on GM foods of the Food Safety Committee approved its new GM food safety evaluation drafts. Previously, safety assessment was being carried out under standards set by MHLW. On 29 January, the Food Safety Committee approved 2 new standards, and therefore GM food approval procedures will be re-opened according to the new standards. The new standards are "Safety Assessment Standards for GM Foods (Seed Plants)" and "Policy on Safety Assessment of GM-GM Plant Second Generation Hybrids". Even though the authority has received many critical opinions and comments from the public regarding the draft standards, indicating several basic problems which were pointed out in the February issue of Bio Journal, the authority has basically approved the standards without any changes.



Two further GMO-GMO varieties approved

On 6 February, 2004, the specialist panel on GM foods of the Food Safety Committee approved two varieties of second generation GM hybrid (GMO-GMO hybrid) for the first time after the new GM food safety standards took effect, without any particular review. One of the varieties is a DuPont GM maize - a hybrid of Dow AgroScience's insect (lepidoptera) resistant / herbicide (glufosinate) tolerant Line 1507 and Monsanto's herbicide (glyphosate) tolerant NK603. The other is a Monsanto GM maize - a hybrid of insect (lepidoptera) resistant MON810 and insect (coleoptera) resistant MON863. Only in Japan have GM hybrid varieties been approved, demonstrating clearly the lax nature of Japan's safety evaluation system.



Gene inserted into fish sperm

A research group led by Asst. Prof. Noriyoshi Sakai at Fukui Prefectural University has inserted an experimental gene into the sperm of zebra fish, inseminated ova with the sperm, and has bred GM fish. It has previously been thought that inserting genes into sperm is extremely difficult, but Asst. Prof. Sakai and his group succeeded in inserting the gene into immature sperm cells. 90 adult fish were obtained from about 100 ova inseminated, of which the inserted gene was detected in about 5 fish.
(Kyodo Tsushin 27 January 2004)




Resumption of gene therapy using retrovirus

The MHLW Science and Technology Panel has approved changes in the program of use of gene therapy involving retrovirus for breast cancer at the hospital of the Japanese Foundation for Cancer Research. The gene therapy began in February 2000, but was later suspended (See BJ March 2003) when gene therapy carried out in France for X-linked severe combined immunodeficiency (XSCID or X-SCID), which uses a retrovirus vector, resulted in the development of leukemia as a side-effect of the therapy. The gene therapy is now to be allowed to resume, based on the program changes. The same changes have already been approved, in October 2003, for Hokkaido University Hospital and Tsukuba University Hospital. The changes include regular testing for leukemia after the start of the gene therapy. A statement concerning the possibility of side-effects has also been added to the explanation for soliciting informed consent. It appears that gene therapy involving retrovirus has been allowed to resume without a through investigation into the cause of the side-effects.




Tokyo University Professor Yusuke Nakamura refuses debate with citizens

The MEXT "Project to Actualize Order-made Medical Treatment", into which an enormous 20 trillion yen is being poured, began in April 2003. The main pillar of this project is the 300,000 person gene bank. The DNA Issue Research Association and other citizens' groups have planned a public citizens' symposium to consider and discuss from the point of view of the citizenry the social impact of the establishment of such a huge gene bank within Japan. The organizers had originally obtained the agreement of the project leader Professor Yusuke Nakamura to attend the symposium, but he suddenly expressed a wish not to attend about a month before the symposium and the awaited debate between the project leader and citizens' groups did not take place. The reason for the cancellation was apparently that when Prof. Nakamura read the report of the symposium sponsored by the project secretariat published in the newsletter of the co-sponsor organizations, he thought that, "These are people who do not listen to the opinions of others." (!)




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