From Bio Journal - January 2016

Trend: Gene Commercialization "Genome Cohort Studies" Begin in Earnest

In 2016, million-participant genome cohort studies are to get underway in earnest. In these studies, biological cell samples are taken from a large number of people, searches are conducted for genes related to health aspects such as diseases and obesity, leading on to the development of novel medicines and treatment methods and health foods in order to gain some economic effect. While consent is obtained from sample donors, no profits are returned to the donors and the corporations monopolize the rights.

In 2013, this research began with a recommendation by the Science Council of Japan's Subcommittee on Investigation of the Framework for Genome Cohort Studies. The preparatory period was three years, the period of implementation 13 years and the size of the budget 100 billion yen (private companies providing 30 billion of this sum). In the year before, 2012, MEXT appropriated budget to have Tohoku University (Sendai City) and Iwate Medical University launch a Tohoku Medical Megabank Organization, which is effectively pioneering million-participant genome cohort studies.

Tohoku Medical Megabank is targeting people affected by the 2011 disaster in Miyagi and Iwate Prefectures, Tohoku University taking charge of those in Miyagi Prefecture and Iwate Medical University taking charge of those in Iwate Prefecture. Biological cells are sampled from the subjects, 80,000 regional residents of age 20 and over and 70,000 people of three generations, in the search for genes related to health and diseases with the aim of pushing forward toward the commercialization of genes. The whole of the funds for this study are provided from the earthquake disaster recovery budget.

Under the My Number system, recently introduced in Japan, the personal number will be linked with medical data. It seems that there is an emergent fear that before long this will lead on to the genetic management of human beings.

Genome editing

On 15 December 2015, the government bioethics specialist panel discussed the conclusion of the International Summit on Human Gene Editing that was held in Washington D.C. on 1-2 December with the participation of researchers from 20 countries, that "the application of gene editing to humans will be recognized provided that the basic research which is carried out does not involve an embryo being returned to the uterus." Statements for the panel participants urged the necessity for measures including the upgrading of legislation.

The trigger for the convening of the International Summit was the genetic treatment using genome editing carried out by a research team under Huang Junjiu at Zhongshan University in China. Genome editing technology that uses restriction enzymes that can pinpoint genes and prevent them from functioning. There are several types of editing technology, which are known according to their restriction enzyme names as "ZFN", "TALEN", "CRISPR/Cas9" and so on. These are able to pinpoint DNA in a specific location on the DNA strand and break it at that point. Currently, CRISPR/Cas9 is in general use. Preventing a gene from functioning is known as "knockout", which up to now required complex gene engineering, but has now become very simple to perform. Restriction enzymes have parts that split DNA and parts that repair DNA. Thus, after splitting the DNA strand, it is then repaired, but the function of a certain proportion of the DNA is prevented. Since it is also possible to insert a gene at the location of the split at the time of repair, it is possible to stop the function of genes at a specific location and insert a new gene there. This has literally made possible gene substitution, which could not be performed using previous methods of genetic engineering.

Using genome editing technology, the research team under Huang Junjiu at Zhongshan University has manipulated the genes in 86 fertilized ova sampled from women with hereditary blood disorders who are undergoing fertility treatments. It is reported that genes were successfully inserted as planned in four cases. However, the paper by Huang et al. Was rejected by the journals Nature and Science due to ethical issues.

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