From Bio Journal - August 2009

Blood abnormalities in gene therapy at Kyushu University

A meeting of the Science and Technology Panel of the Health Sciences Council of MLHW was held on 30 June 2009 at which one new application for a gene therapy program was approved (see BJ June 2009). This is a program by Mie University Hospital for cancer of the esophagus and the vector (carrier) used for the introduction of the gene will be a retrovirus. This brings the number of approved gene therapies to 25.

At the meeting, a 'serious situation report' submitted by Kyushu University Hospital was also made public. From January 2006 this hospital has been implementing gene therapy to create new blood vessels by treating obstructive arteriosclerosis and other illnesses using fibroblast growth factor 2 (FGF-2) inserted into a Sendai virus (SeV) vector and administered by intramuscular injection. A 68-year-old male patient treated in this way in May 2007 developed the blood abnormality myelodysplastic syndrome (MDS) in January 2009. Since there is no cure for MDS, the patient is under observation. It seems that gene therapy is being carried out using terminal patients as guinea pigs primarily in order to assess the safety of vectors despite the fact that the treatment has resulted in no clear benefits. The SeV is receiving particular attention as a domestically produced vector. While the report states that 'it is not necessarily possible to deny the causality' between the gene therapy and the blood abnormality, it concludes that 'this is a disease that may occur incidentally in such cases' and finds that there is no problem in allowing the program to continue.

Closeup: Food Safety Commission re-assesses cloned livestock food products as safe

Rush to submit report just before end of commission members' term

A meeting was held at the Food Safety Commission between consumers groups and the commission secretariat on 2 July 2009. The original intent of the consumers groups was to negotiate with the commission members, asking them "not to submit a report to the MHLW assessing somatic cell cloned livestock food products as safe since it was not possible to guarantee the safety of such foods with any confidence at all." However, since the commission had rushed to approve the safety re-assessment and had submitted the report to the MHLW on 25 June, just before the termination of the term of the current commission members on 1 July, the negotiation turned into a protest.

After assessing cloned livestock food products as safe, more than 80% of the people who submitted public comments were opposed to the assessment and the commission decided on 12 March that the deliberations would have to begin again from the specialist investigating committee on newly developed foods, which had come up with the original assessment (see BJ July 2009). However, the specialist committee decided that further deliberations were unnecessary and notified the commission of this on 8 June, resulting in the commission's decision of 25 June. It is thus now highly possible that somatic cell cloned livestock food products will appear on the market.

So will cloned livestock food products now be appearing in the shops soon? It appears not. This is because in 1999 MAFF issued a request to research institutes not to ship somatic cell cloned livestock for consumption and this request is still valid. However, if you look at the document carefully, it only covers Japanese research institutes, not private companies. Especially problematical is beef imported from the US, where cloned livestock food products are already being distributed, and there is a possibility that there will now be a push to have these products distributed to the Japanese market.

Unscientific assessment

In the negotiations with the Food Safety Commission secretariat on 2 July, two things became clear. One was that although the Food Safety Commission is a body that carries out scientific assessment of foodstuffs, the recent assessment of somatic cell cloned livestock food products was extremely unscientific. There are many abnormalities associated with cloned cattle and pigs, but nothing is known about the causes of these abnormalities. The animal experimentation that forms the basis for the assessment has so far been carried out only once in Japan, and at that time only one cloned cattle was used. Animal experiments carried out overseas have used only mice, and even this has been carried out on only very small numbers.

The second thing that became clear was that young cattle and pigs were not considered to be a problem. The Food Safety Commission stated in its assessment that, "There are numerous abnormalities in somatic cell cloned livestock, but those that survive more than 200 days are considered to be equivalent in healthfulness to livestock born through conventional reproduction techniques." Everyone thought that because of this livestock under 200 days after birth would not be shipped for consumption, but not so; young cattle and pigs are also to be judged "healthy."

The offspring and further descendants of cloned cattle are already on sale as food in the US. These may have already entered Japan, and with no labeling it is impossible to distinguish these foods from any other kind of livestock food product. Furthermore, with the recent assessment from the Food Safety Commission, even if these food products are distributed, nobody is going to consider it a problem.

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