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Friday, June 29, 2007

Session 6: Public Comments

J.D. Hanson of the International Center for Technology Assessment

MR. HANSON: Thank you. Is this on? Thank you very much. I work on human genetics and nanotechnology at the International Center for Technology Assessment. I want to commend the Council for its opening entry into the discussion of nanotechnology. I think the principles of bioethics would be well applied to nanotechnology. We are working with a group of about 30 other non-governmental organizations, trying to look at what kinds of questions need to be asked about nanotechnology. We think some of our concerns actually amplify the traditional applications of bioethics. 

We do think that there are at least eight things that need to be carefully looked at and one is that there needs to be a precautionary foundation. We don't see this as a no but we think the precautionary principle needs to be applied to nanotechnologies largely because the existing science so far suggests that the release of nanomaterials, nanodevices or products of nano biotechnology may result in serious harm to human health and the environment. 

We think the second principle ought to be mandatory nanoregulations. The current legislation doesn't provide adequate oversight. And we don't think voluntary initiatives have been shown to be a good way to control technologies. The third point is we think that health and safety of the public and workers needs to be a paramount concern and that we need adequate information on this. I would say I think what we're learning in the medical applications of nanotechnology can be readily applied to some of the environmental and other human health aspects and I hope there will be ways found to do that. 

A fourth principle we see is environmental sustainability. Even in the area of medical applications, things get into the environment rather quickly. We have Prozac in fish that we didn't think were going to go there. So we need to look at how we monitor environmental aspects. A fifth point is transparency. We think the public's right to know includes labeling of all uses of nanotechnology. 

Interesting side note, Consumer Reports did their first review of nanotechnology looking at some sunscreens and they found of the eight sunscreens they looked at, all eight had engineered nanoparticles in them. Only one labeled it as having that, so how would a person be able later on to follow up what caused what? Fifth, public participation, we'd underscore Dr. Ferrari's comments about public participation and how much that can add to it.

The seventh point, we do need to look at the broader impacts. I think the example of taxol, nanotaxol, is a wonderful example of how the broader impacts need to be looked at. This medication has, basically just gone — taxol has just gone generic. It costs about $150.00 a dose for the generic. The nano version which in my opinion basically allows the extension of a patent, the nano version goes for $4,000.00. And it's not just rich people that are paying for this. 

It's all of us in this society because it's Medicare approved. So we do need to look at the broader impacts of all of this. And an eighth point, we believe liability should follow all the way to the end of the product, all the way through the life cycle. The insurance industry has concerns about this and we do, too. I'll finish up by saying that as the Council looks at all of these issues, I know all of you pay attention to this in other fields, but continue to pay attention to rhetorical contradiction. You have an interesting situation in the field where very often the same people call this revolution technology in one context and then they turn around and say it's ordinary, it doesn't need to be regulated. 

So you go to the Patent Trade Office, and say, "This is so revolutionary I need to get a patent on it, because it's never been done before." Then you go to the FDA and say it's so ordinary since we already approved taxol, you don't need to look at the separate aspects of nanotaxol. You've had a day and a half this long. I have copies of a paper that's nine pages long that summarizes papers that are longer that I'll leave with the committee and thank you for your work.

CHAIRMAN PELLEGRINO:  Thank you very much. As we close, your usually silent chairman would simply indicate that the ethical examination of these issues will go beyond the four principled approach. That heretical statement to be made by someone from Georgetown and I hope I'll not be ex communicated before I get back from lunch. But thank you very much.


(Whereupon, at 11:56 a.m. the above-entitled matter concluded.)

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