From Bio Journal - December 2007

Chiba University and Hyogo College of Medicine violate Cartagena law

On 18 October 2007, MEXT handed out strict reprimands to Chiba University and to the Hyogo College of Medicine pointing out that they had violated the Cartagena law. The former did not seek confirmation from the Minister of State for Science and Technology when they used GM vaccinia virus in a genetic engineering experiment. The latter did not take necessary measures when they used a GM mouse in an experiment.
(Ministry of Education, Culture, Sports, Science and Technology 2007/10/18) Original article in Japanese.

AIST violates rules on handling of dangerous microorganisms

The International Patent Organism Depository (IPOD) of The National Institute of Advanced Industrial Science and Technology (AIST - located in Tsukuba City, Ibaraki Prefecture), under the administration of METI, knowing full well that it was in violation of regulations, accepted pathogenic microorganisms dangerous to human health, and had part-time staff culture these microorganisms without taking sufficient infection-preventing measures. Further, it has become known that a senior staff member who realized that there was a problem was told to keep quiet about it. METI also took no countermeasures despite the fact that it was aware of the situation in 2003. Facilities at the Depository are capable of accepting only level 1 of the WHO 1 to 4 danger levels stipulated for dangerous microorganisms. The Depository has, however, accepted 296 cases of level 2 and above pathogens, including 3 strains at level three, 2 strains of brucella bacteria and 1 strain of Burkholderia mallei.
(Asahi Newspaper 2007/10/18, and others)

Science Council of Japan report on assisted repromed focuses on surrogacy

The Science Council of Japan's Committee on the State of Assisted Reproduction Medicine has agreed on its report of about 20 pages, which focuses on surrogate motherhood. At the tenth meeting of the committee, held on 6 November 2007, the vice-chair, Professor MACHINO Saku of the law school of Sophia University, Tokyo, announced the framework of the report by stating, "It is impossible to mention all aspects of assisted reproduction medicine, and that would not have been possible in one year anyway. We were obliged to focus on the issue of highest priority, surrogate motherhood." The other committee members concurred with that opinion, but the conclusion on whether or not to approve surrogate motherhood has not yet been reached. A further report is to be published after another five committee meetings. The final meeting, planned for 30 January 2008, is to be a public symposium to explain the background and contents of the report to the general public.

Fertilized ovum cloned cattle become meat for human consumption

On 31 October 2007, MAFF announced its "Current State of Livestock Research" covering the period up to the end of September 2007. (2006 Report, BJ March 2007) According to the report, of the 716 head of cattle so far born through fertilized ovum cloning, 314 have been used as meat for human consumption, and 63 are unaccounted for. It is thought likely that these 63 head have also been distributed as meat for human food. The large number of cloned cattle that have become meat for human consumption is one of the features of the report.

Although somatic cell cloned cattle have not yet reached the market as meat for human consumption in Japan, it is now thought a strong possibility that the marketing of such meat will be approved in the USA. Thus far, 535 head have been born, and the number currently being raised or involved in research at research centers is only 86 head. More than half of the somatic cell cloned cattle, 295 head, were stillborn, died immediately after birth, or died later from sickness. If a further number of cattle involved in experimental slaughter, the details of which are unknown, are added to this we get, as ever, an extremely high figure for the number of abnormal fatalities. Further, it is stated that 256 somatic cell cloned pigs have been born, but the details are not given.

Table 1: Current State of Cloned Livestock Research in Japan (Somatic Cell Cloned Cattle, Pig and Sheep) Unit: head, (as of September 2007)
Total Number of Somatic Cell Clone Cattle Births


In research facilities, testing




Post-natal death


Death from sickness, etc


Death from accidents




Experimental slaughter


In uterus




Total Number of Somatic Cell Clone Pig Births


Total Number of Somatic Cell Clone Sheep Births


GM crop approvals for October 2007

Table 2. GM crops approved for open field cultivation (Type 1 usage)
(Biodiversity Impact Assessment Investigative Commission)
NameApproval Date*
RoseAlteration of flavonoid biosynthetic pathway SuntoryWKS82/130-4-1, OECD UI: IFD-52401-404 October 2007
RoseAlteration of flavonoid biosynthetic pathway SuntoryWKS82/130-9-1, OECD UI: IFD-52901-904 October 2007
MaizeInsect resistance + herbicide tolerance Dow Chemicals JapanTC6275, OECD UI: DAS-06275-804 October 2007
MaizeInsect resistance Monsanto JapanMON89034, OECD UI: MON-89034-304 October 2007
Soy BeanHerbicide tolerance Monsanto JapanMON89788, OECD UI: MON-897881-104 October 2007
* Technically, approval is granted after public comments have been accepted.

Closeup: Side effects in gene therapy for Parkinson's disease

On 11 October 2007, the MHLW Health Sciences Council published the "Report on the Serious State of Treatment", submitted by Jichi Medical University Professor NAKANO Imaharu and his group, who are carrying out gene therapy for Parkinson's disease. (Related articles: BJ September 2007, BJ October 2007.

Parkinson's disease occurs due to a reduction in the amount of dopamine, a substance involved in the transmission of nervous information in the brain (i.e. it is a neurotransmitter), and is a degenerative nervous disease resulting in a shaking of the hands and feet, walking disorder, and so on. Conventionally, the precursor of dopamine, L-DOPA, has been administered to relieve the symptoms of the disease. As it enters the body, L-DOPA is transformed into dopamine by the action of AADC, L-amino acid decarboxylase. The Jichi Medical University plan is to incorporate the AADC gene into a vector (a gene carrier) using genetic engineering techniques and then administer this to the patient in order to alleviate the symptoms of the disease and reduce the amount of drugs used. The vector used is the AAV (the adeno-associated virus).

According to the Report, the vector containing the AADC gene was administered to the patient, the second case in this study, on 23 July 2007. On 26 July, linguistic and other disorders appeared and a checkup on 27 July showed that venous brain hemorrhaging had taken place. The patient subsequently recovered, but the cause of the hemorrhaging was not clear. Although Jichi Medical University denies any cause and effect due to the gene therapy, they have decided to postpone the selection of the third case, effectively a temporary suspension of the program.

This temporary suspension has not been put into effect simply on the basis of the situation in Japan. Although the Jichi Medical University Parkinson's disease gene therapy takes the form of intramural clinical research, the manufacture and screening of the vector is carried out by the US biotechnology companies Genzyme Corporation and Avigen Inc. Jichi Medical University receives the vector and simply carries out the program. In the USA, under the leadership of Genzyme Corp., the Medical Center of the University of California at San Francisco is also carrying out gene therapy for Parkinson's disease using a similar vector. However, of nine patients there has been one case of venous brain hemorrhaging and one case of arterial brain hemorrhaging. On 5 September 2007, the Federal Drug Administration (FDA) issued a notification to Genzyme Corp. to suspend its clinical research. Adding to this the case at Jichi Medical University, three cases out of eleven have resulted in brain hemorrhaging. The FDA is currently investigating the situation.

The AAV is considered to be relatively more safe than retroviruses and so on, but now we see that side-effects occur with considerable frequency. On 26 July 2007, a patient died after taking the experimental drug being used in the genetic therapy for arthritis being carried out by the US Targeted Genetics Corporation. This was just after the FDA had issued its notification to suspend clinical trials. It is inevitable that gene therapy as a whole will be seriously affected by these events. It may also be that the reality behind gene therapy will become clearer. Currently, it seems that what are effectively experiments on human guinea pigs, using vectors whose safety has not been confirmed, is being carried out simply for the sake of the development of these vectors.

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