In a shocker, Japan’s 2nd largest newspaper, Asahi Shimbun, published an editorial yesterday saying that iPS cells are being pushed too fast to the clinic for economic reasons.
The piece was bluntly entitled “Too much of a rush for clinical trials with iPS cells”.
Asahi Shimbun, with a circulation of 10 million, is taking a bold step in questioning whether the iPS cell field in Japan might be moving too fast and the non-medical reasons behind that.
They start off their piece with a bang in the third short paragraph:
What we find worrisome is the somewhat over-eager attitude of the Abe administration, which wants to make iPS technology one of the pillars of its economic growth strategy. But the safety of the technology, much less its effectiveness, has yet to be confirmed.
I too am concerned about the speed with which things are moving overall on clinical translation of iPS cells.
Why the concern?
I have raised issues about pre-clinical data being minimal supporting using iPS cell-based therapies in humans at this time. I also published an opinion piece that the iPS cell research team should publish their data first before human patients are treated.
Yet the governmental regulators in Japan seem, based on their actions so far, inclined to let the first clinical study begin as early as this year.
We have to keep in mind that the regulators presumably get to see all the data, published and unpublished. Maybe there is a lot of compelling data. Maybe not. We just don’t know.
The team, led by Masayo Takahashi, just cleared another hurdle and the final regulatory approval by another governmental body could come as soon as next month. I think the clinical study will be approved and most likely without anybody but regulators and the team itself knowing how convincing the pre-clinical data is in reality.
Asahi Shimbun said in part:
There must be no laxity in the screening for approval of drugs just because they come under the heading of regenerative medicine. Even if the creation of new drugs using iPS cells is accelerated, they cannot be put to good use if inadequate systems are in place for clinical trials and screening.
It sure sounds like the newspaper editorial board is worried that things are moving too fast, leading to a risky situation.
They also argue quite logically for a balance between realistic (not too high) expectations of the government in terms of data from iPS cell studies and appropriate regulatory oversight:
The government must not push researchers for results. Nor should it lose interest if they suffer minor setbacks. For that matter, it must not give undue favor and spoil a “big-name rookie.” If the government engages in such behavior, it would likely do no good and much harm.
It is rare to see anyone, whether scientist or newspaper arguing for such a level-headed balance in the stem cell field.
I’m not sure what is meant by “big-name rookie” in this case though. Anyone know?
They conclude the piece with the following strong statement:
It is the role of the government to provide the right environment for research with a strong emphasis on safety and effectiveness. What it must not do is to be guided by economic motives.
I think it will be difficult for the Japanese government not to be guided at least in part by economic motives when it comes to rapid clinical commercialization of iPS cells, but let’s see how the next 12 months go. That should tell us a lot.
I commend Asahi Shimbun for this frank, assertive, and refreshingly balanced view of iPS cell clinical translation and commercialization.