Risk & Benefit of Biomedical Innovation

Yesterday, I attended a symposium ‘Think about Regenerative Medicine and Gene Therapy – Understanding Risk and Benefit of Biomedical Innovation’, organized by the Japan Society for Regenerative Medicine. Regenerative medicine is a topic that I studied previously and am likely to come back in the future. I was particularly keen to learn what changed since I moved on.

So what’s changed? Two things has changed significantly. First, the field has certainly advanced. As we know, Dr. Masayo Takahashi’s group at RIKEN CDB did the first case of autologous iPS cell therapy a few years back, and is now doing allogeneic one. There are a few more promising lines of regenerative medicine research that are pretty close to move into clinical studies. Prof. Yasufumi Kanada also explained that the same applies to gene therapy, while it had challenging time in the 1990s. Advancement of these fields should not be limited in their technical refinements: Dr. Yoji Sato told us that regulatory science is now trying to catch up with it also. This relates to the second change, and it is that now Japan has a law that regulates regenerative medicine specifically.

But what has not changed? The experts still follows the ‘deficit model’ to some extent. They believe members of the public cannot distinguish the right technology from wrong ones because they do not understand properly the nature of biomedical innovation, which necessarily involves a time- and resource-consuming process of measuring risk and benefit. And mass media, by emphasizing the hope of the innovation, are partly responsible for their misunderstanding. Considering both regenerative medicine and gene therapy as the public good, the experts stress the importance of supporting the fields as society.

In the discussion session, Prof. Kaori Muto, who spoke about the value of patient participation and engagement in biomedical innovation, then raised an interesting question: what happens if society decides not to? Yes, there is a good chance that informed patients would say “we do not want this” to their researchers. If this happens, are the researchers willing to accept it? Or see it as a problem that is due to the public’s ‘not understanding properly’? As Prof. Atsuo Kishimoto said in his talk, acceptable level of risk cannot be determined by science alone. And that is why risk communication has to be mutual.


– 日本語(Japanese ver.)-







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