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)
http://www.mext.go.jp/b_menu/houdou/19/10/07101715.htm
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 |
535 |
In research facilities, testing | 86 |
Stillborn | 77 |
Post-natal death | 90 |
Death from sickness, etc | 128 |
Death from accidents | 8 |
Redundant | 11 |
Experimental slaughter | 135 |
In uterus | 22 |
- | - |
Total Number of Somatic Cell Clone Pig Births | 256 |
Total Number of Somatic Cell Clone Sheep Births | 9 |
GM crop approvals for October 2007
Table 2. GM crops approved for open field cultivation (Type 1 usage) (Biodiversity Impact Assessment Investigative Commission) |
Crop | Trait | Application (Developer) | Name | Approval Date* |
Rose | Alteration of flavonoid biosynthetic pathway |
Suntory | WKS82/130-4-1, OECD UI: IFD-52401-4 | 04 October 2007 |
Rose | Alteration of flavonoid biosynthetic pathway |
Suntory | WKS82/130-9-1, OECD UI: IFD-52901-9 | 04 October 2007 |
Maize | Insect resistance + herbicide tolerance |
Dow Chemicals Japan | TC6275, OECD UI: DAS-06275-8 | 04 October 2007 |
Maize | Insect resistance |
Monsanto Japan | MON89034, OECD UI: MON-89034-3 | 04 October 2007 |
Soy Bean | Herbicide tolerance |
Monsanto Japan | MON89788, OECD UI: MON-897881-1 | 04 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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