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From Bio Journal - January 2006


Somatic cell cloned cattle continue to show large number of abnormalities

MAFF announced on 28 November 2005 the current state of cloned animals up to the end of September 2005. According to the released data, of 474 somatic cell cloned cattle born, 72 were stillbirths, 80 died immediately following birth, 102 died from illness and so on, and only 104 have survived, showing that abnormality has now become the norm.

So far 700 embryonic cell cloned cattle have been born, and it has been confirmed that 295 of these have been shipped as meat for human consumption. Since 63 head are listed as "unknown" it is thought that over 300 head have ended up on dinner tables. (See BJ February 2004)

In addition, 152 somatic cell cloned pigs have also been born, but details were not given in the announcement.

Table 1: Current Situation with Cloned Livestock (Unit: head)
Embryonic cell cloned cattleTotal births

700

Stillborn

73

Death immediately after birth

31

Death from illness and so on

100

Death from accidents and so on

90

Cattle sold

364

Confirmed to have become meat

(295)

Being raised by farmers

(6)

Unknown

(63)

In research facilities

42

Impregnated

7

Somatic cell cloned cattleTotal births

474

Stillborn

72

Death immediately after birth

80

Death from illness and so on

102

Death from accidents and so on

116

In research facilities

104

Impregnated

29

Somatic cell cloned swineTotal births

152

Somatic cell cloned goatTotal births

9






Cloned mini-pig at Kagoshima University

A research team under Professor Mitsutoshi Yoshida at the Faculty of Agriculture of Kagoshima University (in southern Kyushu) announced the birth of a cloned mini-pig on 24 November 2005. The pig, born at 5 kg at the end of October, was being developed for organ transplants for humans. In order to use pigs for organ transplant use it is necessary to overcome rejection symptoms, and it is thought that attention will now turn to the development of a GM mini-pig. (Western Japan Newspaper 2005/11/25)

However, due to the possibility of infection of humans by viruses peculiar to and hidden within the pig genome, clinical tests on the use of animal organs are being frozen and the general world direction is that of withdrawal from this field.



Niigata begins to formulate standards for GM crop cultivation regulation by-law

Niigata Prefecture has set up an investigative commission (Chairperson, Toshinori Fukuyama, Professor of the Faculty of Agriculture, Niigata University) in order to set inter-crossing distance (buffer zones) as preventive measures, following the approval of its draft GM crop cultivation regulation by-law. Unlike a similar commission in Hokkaido, this commission was formed only from 'experts', and does not include any consumers or producers,. The first meeting was held on 22 November 2005, and the commission members confirmed the adoption of buffer zones according to MAFF guidelines. Again, this is unlike the Hokkaido case where stricter rules than the Japanese government's were applied (See BJ September 2005). Additionally, the varieties of crops subject to the by-law are likely to be limited, making the effectiveness of the Niigata regulations look rather thin on the ground. (Mainichi Shimbun 2005/11/23)



MAFF to initiate discussions for review of Type I usage rule

The Type I usage rule, which became an obligation under the domestic Cartagena Law, starting in February 2004, has come under review after only one year and 10 months of operation. The most controversial part of the review regards the buffer zone for GM rice cultivation. Under the current guideline, it is set as 20m. However, according to the results of field tests conducted at the National Agricultural Research Center for the Tohoku Region, which showed crossing occurred at distances up to 25.5 meters downwind, a interim measure of 26m took effect in May 2004 (See BJ June 2005). Among those municipalities that have set up their own guidelines is Hokkaido, where the buffer zone has been set at 300m for GM rice cultivation in its detailed regulations. Moreover, the MAFF will also review the current rules for disseminating public information before GM crop outdoor experiments, at present the publication of plans and a public briefing.

On 2 December 2005, the first meeting of the investigative commission to review the current guidelines was held, and many of the commission members looked puzzled. Concerning the review of the buffer zones for GM rice cultivation, Yasuhiko Nakamura (a guest professor from Tokyo University of Agriculture) said, "when the guideline was established, MAFF explained that the government set what was a very strict rule by international standards and that researchers must compromise for the sake of consumer safety and security. Despite what MAFF said then, why is this being overturned just one year and a half later?" In response to Nakamura's remarks, the chief of the Technology and Safety Division at the MAFF, Mr Tojo, commented that the data from the Tohoku research results may have been affected by some specific weather condition such as a typhoon, and therefore the data was currently being further analysed to look into the wind direction and the wind speed.
Table 2) GM crops approved for open field cultivation (Type 1 usage)
(Biodiversity Impact Assessment Investigative Commission)
CropTraitApplication (Developer)NameApproval Date*
MaizeGlufosinate tolerantMonsanto JapanDLL25Nov 25
CottonGlufosinate-tolerant + Insect resistantDow Chemical Japan281/3006Nov 25
* Technically, approval is granted after public comments have been accepted.



MEXT considers reproductive cell production from human ES cells

The question of whether human ova and sperm should be produced from human ES cells is to be considered by a MEXT specialist committee. This is currently banned since it could be disrupting for social order if such reproductive cells were used to give birth to an individual. In the background to this move towards having the ban lifted is the research into human clone embryos. At present, the production and use of human clone embryos is under discussion, the core of the argument concerning the method of obtaining the basic research material; unfertilised ova. Sampling of ova from ovaries removed during operations, unused ova remaining from fertility treatments, provision by volunteers and so on have been mentioned as possible sources, but these methods are considered to be unrealistic from the points of view of both difficulty of obtaining the ova and the small number of ova that these methods would provide. Thus the notion of producing reproductive cells from the totipotent ES cell has arisen. A meeting of the specialist committee now discussing the possibility of a review of the ES cell research guidelines was held on 30 November 2005, where it was agreed to add to the current agenda the new question of whether human reproductive cells should be produced from human ES cells.



Closeup: Background to the new influenza strain pandemic hullabaloo

A "kamikaze" - a divine wind that brings salvation - is blowing through the pharmaceutical and biotech industry; the spread of avian flu, the possibility of human infection, and the fear of the appearance of a new strain of virus. In the background are the governments and pharmaceutical manufacturers who have urged on the vaccine production, and the medical practitioners and researchers who have strong links to the pharmaceutical companies.

The trigger to the new virus strain hullabaloo was the vaccine that was being mass inoculated to school children in 1994, but was suspended due to suspicions of ineffectuality and strong side effects. As a result, one of the six companies that was producing the vaccine suspended production and the other five companies drastically reduced production of the vaccine. Those who felt that the shrinking of the market was a crisis forced the Ministry of Health and Welfare (as it was called at the time) to set up an "investigative commission into countermeasures for a new influenza strain" in May 1997. The reason for establishing the commission was that there was a possibility of a new strain of influenza appearing and that it was necessary to ensure that suffering was kept to a minimum. The amazingly overstated conclusion was that if there was a pandemic of a new strain of virus, approximately 32 million people would be affected and that at least 30,000 to 40,000 deaths should be expected, and that therefore it was necessary to introduce large increases in the production of the vaccine.

In that same year, 1997, the Hong Kong avian influenza occurred and vaccine manufacturing was given a boost. Preventive inoculation was reviewed in November 2001 and preventive vaccine inoculation for over-65s was reintroduced. The demand for vaccine that had dropped to 300,000 doses in 1994 bloated to 10,400,000 in 2002. In the expectation that demand would rise again in 2005, MHLW instructed the manufacture of a planned 21,500,000 doses.

The oral anti-viral drug Tamiflu (common name: oseltamivir phosphate) is also selling like hotcakes. The effectiveness of Tamiflu is also unknown and side effects are reportedly severe. According to experiments carried out by the Swiss pharmaceutical manufacturer Roche, when the drug was given in large amounts to one-week-old rats, it became clear that some constituents of the drug entered the brain, causing severe side effects and death in some cases. The Japanese distributor, Chugai Pharmaceuticals Co., Ltd., has therefore advised the public that the drug not be given to infants under one year of age. There are also side effects including stomach pains, diarrhoea, acute renal failure, drop in white blood cell count, drop in blood platelet count, and there have been cases of death from trauma suspected to be secondary to unusual behavior brought on by use of the medicine and liver dysfunction.

These problems, however, are but a few autumn leaves in the wind. Sales of the vaccine are booming, and now that it has been decided to stockpile 25 million doses of Tamiflu, the manufacture of that drug can no longer keep up with demand. New drug development has also been stimulated. Innovations receiving special attention are DNA vaccines that can act against various types of viruses, and a vaccine that uses a human culture cell and can be inoculated just after a pandemic begins, and so on. The current new influenza panic is having a beneficial effect on the pharmaceutical and biotech industries, but there is also a strong possibility of the increase in drug-related health disasters.




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