Closing Comment Topic 2
This is my first contribution to this AHTEG. I was a member of the 2015 AHTEG, a representative, then and now, of the Canadian Friends (Quakers), who have had a sustained interest in biotechnology, particularly in its social justice, ecological and spiritual dimensions.
I am a retired physician, trained in epidemiology, whose career focused on tobacco addiction at clinical and population levels. Decision-making under uncertainty has interested me for a long time.
Thank you to Ms. María Andrea Orjuela Restrepo, for taking on the daunting task of moderating this discussion. And my appreciation to the contributors for the many articulate, informing, and passionate contributions they have made.
I had not expected to write anything for Topic 2, since my framing of risk strays beyond published evidence. However, the broad discussion leads me to agree with Deborah Scott (#8698) and to also recommend to Ms Orjuela Restrepo that she include in her summary the substance and flavour of the contributions that addressed risks and benefits of LMOs without offering published evidence.
I agree with Ms. Scott (#8698) about the value of the 2012 Nuffield report Emerging Biotechnologies.
In medicine, the testing of new pharmaceuticals, even in large, well-done, randomized trials, sometimes does not have the statistical power to detect rare but serious adverse effects. In changing a species’ genetics, the potential for very rare but very serious adverse effects may have consequences much greater than those even rarely seen in drug trials. So, given the dynamic, changing nature of living organisms, the varying environments they might encounter and the length of time that might precede the appearance of adverse effects, I would think published evidence would not account for all their potential risk. Joyce Tait (#8700) has recognized this type of uncertainty and provided an approach.
I look forward to the continuing discussion.
posted on 2017-07-31 08:15 UTC by Dr Frederic Bass, self-employed
I support the views posted by Dr. Bass.
Other than human trials, for experiments in other sections of biology/ life sciences the level of significance tested is 95%. That means in every trial 5% damage is allowed. In this condition how it can be considered safe ? if any of the published “evidence” says any trial as 100% fit and safe, then it may be considered.
Here the question is how a published research is being considered as “evidence” for biodiversity level damages?
posted on 2017-07-31 09:03 UTC by Ms. Jeshima k Yasin, India
Although it was not my intention to post again in this forum without offering the kind of supporting references that have been requested by the chair, I would like to take a moment to respond to some things which have been posted. First, I am obligated to point out that Ms. Jeshima Yasin in Post #8716 has grossly mis-stated the concept of statistical tests of significance. The "standard" 95% confidence interval used in determining significance in statistical analysis does not, in any way, indicate that 5% damage is accepted. That's just a misunderstanding of statistics. The confidence is a measure of any particular tests ability to distinguish between possible outcomes or groups in a comparison. None of the tests done are measuring damage directly and instead they are contributing to a weight of evidence assessment. The confidence interval used in statistical analyses should be carefully considered for the task. But again, in no way does that indicate a tolerance for 5% damage.
I'd also like to point out that, while the contribution of Dr. Bass in regard to medical testing is fascinating, people should consider carefully what this means in terms of conservation and sustainable use of biodiversity. In medicine, the protection goal is the health and safety of every individual. So rare events matter quite a bit - especially if they are highly adverse. In the conservation and sustainable use of biodiversity, what constitutes a rare event? And if it is rare in that context does it really matter?
The suggestion behind this and several other posts is less about evidence of adverse effects from synthetic biology applications as about how much evidence is required to reasonably conclude that adverse effects are unlikely. Reasonable people may have reasonable disagreements about this topic. However, the possibility of "unknown unknowns" - harms that may not manifest immediately or frequently and that might be seen in the future - is in no way unique to synthetic biology or to biotechnology in general. This is a theoretical possibility for every decision we make.
(edited on 2017-07-31 09:43 UTC by Mr. Andrew Roberts)
posted on 2017-07-31 09:42 UTC by Mr. Andrew Roberts, International Life Sciences Institute Research Foundation
I am Naoto Koyama, working for Japan Bioindustry Association (JBA), a non-profit organization dedicated to the promotion of bioscience, biotechnology and Bioindustry in Japan. As I’m new to this online forum, firstly, I’d like to thank Maria Andrea for moderating this discussion.
Just wanted to make a short comment on the previous post made by Ms. Jeshima Yasin [#8716];
I don’t think we are talking about whether products of synthetic biology are 100% safe or not. There are no 100% safe things at all. Whether potential adverse effect(s) found in the product are intrinsic to the technology from which the product derived is what we should focus on.
posted on 2017-07-31 10:22 UTC by Mr. NAOTO KOYAMA, Japan Bioindustry Association
I support Mr. Koyma's statement.
Joaquim A. Machado
posted on 2017-07-31 11:49 UTC by Mr. Joaquim A. Machado, Brazil