SBPWG:Meetings/Oct 26 2011

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Meeting Notes: October 26 2011

October 26th 6:30-8:30pm @ Stanford Y2E2 Building Room 300

• Nita Farahany, visiting associate professor at Stanford Law School and member of the Presidential Commission for the Study of Bioethical Issues (PCSBI), will discuss the Commission's report on Syn Bio and potential mechanisms of 'prudent vigilance'.
• Background reading: Executive Summary (18 pg) and Press Release from the PCSBI report
• Dinner provided by SynBERC

Attendees

• Megan Palmer (Stanford)
• Josh Wolf (Stanford)
• Andy Chang (Stanford)
• Jay Vowles (Stanford)
• Sara Aguiton (Stanford)
• Derek Greenfield (LS9)
• Eli Groban (LS9)
• Stephanie Galanie (Stanford)
• Monica Ortiz (Stanford)
• Peter Tosikurik (Stanford)
• Steve Laderman (Agilent)
• Erica Lieberman (Stanford)
• Nita Farahany (Stanford)

Notes

Updates

• Next meeting: Nov 15th @ UCSF with Chris Anderson, discussing biosafety : good design for a safer chassis, new educational project, and new software tools for assessing risk levels
• OSTP RFI on Building the Bioeconomy due December 6th
• LiP Bootcamp : 6 people are working on organizing the workshops ~ summer 2012. Opportunities for others to participate ,
• Dec 13th Siebel-SynBERC event: details TBA
• Nov 6th is Bay Area Science Festival Discovery Days - SynBERC coordinating with EBI tent
• Potential Future meetings : EPA / Risk Assessment

Talk: Nita Farahany – The Presidential Commission for the Study of Bioethical Issues

Important Note: Rough notes here taken by Sara Aguiton. These are rough, imperfect notes, and should not be used as direct quotations.

Nita is here on behalf of the Commission.

Some Background : Every President had some version of the Commission, with a different name each time. The creation of the commission was quite different than the last. The last Commission was writing very long, philosophical reports that were often not useful for policy. So, we decided to make the report more pragmatic and policy – oriented. We can choose any issues we want, but that hasn't yet happened because the President has requested certain cases.

This commission includes 2 people from the government, which is great to get feedback from Washington

The first topic picked was SB because of Venter's announcement in May 2010. Before it was announced, Venter went to the White House to say that it was about to be announced, and so the President set up an emergency conference call to be able to react straightforwardly after Venter's announcement. The unusual thing : we had to assess the whole field, and not only a specific area / technology (like “dolly the sheep”) as with previous commissions.

We had 3 public meetings, but also private meetings with experts and workshop, even if we never had a private meeting, because everything have to be public.

We started by looking at the benefits and risks of SynBio. Benefits : 1) vaccines 2)Biofuels 3)improved by synthetic pharmaceuticals. Also, feedback from other on potential ethical issues and risks : 1) Playing God 2) Threat to biodiversity 3) ...

Some important reassurances:

• There's a lot of regulations that already imply Synthetic biology application, there were no regulatory gap.
• We discussed a lot about the governance, but we didn't come to any specific conclusions.
• We did really try to get the time line, that has a lot to do with prudence vigilence. Because SB is really at its infant stage, and the main threats are not there yet. We also concluded that the Venter Institute didn't create life, because the "playing god" issues was one of the biggest ethical (per se) issues.

Principles to assess the emerging technologies :

• We wanted to provide a framework to engage emerging technologies in general, not only synthetic biology.
• Question : how did you approach this ?
• Answer : we went back to the case of recombinant DNA, we were asking the question “what's unique in SB”. There are some difference, and we try to focus this. But, our focus was about getting tool to understand and policy building for emerging tech.

5 main principles

1. Public beneficent

• Review of public founding and looking at the funding for technics to assess risks and the study of ethical issues. That was quite controversial, because there's a lot of private funding and it's a tricky subject, because of transparency issues.
• Ensure that the promising research are made on behalf of the publication determing if the licensing and sharing is sufficient to ensure public beneficient

2. Responsible stewardship

• We should act in a way that we could be responsible for everybody else, including the next generation.
• Big divide between the two radical position of the spectrum : proactive approach (step out of the way and wait for industry and people to regulate themselves) and precautionary principles (wait until certainty to be sure that there will be no risks and no bad effects) that is achieved often through bans (stem cells, cloning humans). PP is a pretty radical approach, if you believe in scientific progress.
• The question was: where / how the government should enter or stop ? Our answer: you should check out along the way, and reassess along the way about the technology. It's a cautionary approach that allows the development of the technology. The idea was to say: Don't over regulate too early
• Many of our points address the scientific community: to stop and ask the right question : are we doing the right work ? Are the right safety protection in place ? If the research community is able to build a strong ethos of safety and security, then the government won't have to regulate too much.
• Question: What about the risks taken by the army? Answer: The “man in black” was in charge of that – we had a look on that with the help of the department in charge in the government. Is there some historical example of the government had to regulate an industry because the self governance didn't work ? Pharmaceuticals – FDA look at that at Walgreens on genetic tests for example.
• Question: What is the sense of of the mechanism already in place for self policing ? Answer: it's a field with a very engage community, the Do it yourself are doing together. We realized that the community, in its diversity, is already working a lot on its practices.
• Risk in being prescriptive ? The government moves slowly, both in making law and in removing it. And, if there's hysteria, like after Venter's announcement, we could have a huge block on the research because of a political panic. Venter was risking something, even if they had some policy works done in house, but Venter made a big thing with that announcement, a lot of press coverage, a lot of funding. The media attention is not bad for the field, nor the Presidential Commission, so I think it's good that Venter did that.
• They were a lot of people reacting to the report, to push for the precautionary principles, but they were very nice, saying that the process was really open and transparent. So, we cannot satisfy all the radicals, but we're happy that these letters acknowledge the process of the Commission. We didn't wanted to be seen too close to such position, because if not, your polarize position. We even had some pro-choice people, and they didn't care about bacteria. So, at least for now, they're not much polarization.
• The main critics are about environmental release, because they don't believe safe practices are in place.
• Prudent vigilance doesn't say “zero risk” (precautionary principles). Rather, maximize public benefit, minimize harm => utilitarian perspective.
• Question : did you try to diagnose previous policy making, where the government had regulated too much or too less ? Answer : in fact, prudent vigilance already existed, we only put a word on it in order to update the bioethical debate. It's a concept the people can think about it, as a way to consider emerging technologies.

Responsible Stewardship :

• No additional agency for Synthetic Biology
• Urge the Ex Office of the President to work on several point in 18 months : coordinating regulations, discuss risks assessment and a “reasonable risk assessment”. We didn't want to say “make sure they're suicide gene”, because if we had done that, it's the only thing they would have done.
• The question for example is to look at the EPA, knowing if they have enough founding, enough means to make such analysis.
• Specific recommendation on educational ethics: Ethics is perceived too much as a check box. So, we wanted to integrated ethic in practices.

3. Intellectual freedom and responsibility

• We wanted people to be totally free. So, we said “don't over regulate”. Scientists were happy, though some people, like ETC, said we should have done it differently.
• Question : what would it have been to do it (over regulate)?A: you would have to register to do anything that you want to do. We really think that personal “responsibility” is the right thing. Q: And the critics? A:

Some people would forbid recombinant DNA, they would forbid Artemisinin, go back to the middle ages.

• Compliance and oversight by the government. It's very easy from a policy perspective to regulate something that you found, because you put it as a mandatory thing for the founding, but it's very difficult to regulate the private industry

4. Democratic Deliberation

• Trying to make possible more feedback from the public, to raise awareness to combat blind fear.
• Mention of fact checking for educating the public. If this would have been done for stem cells, people may have been much more open to it.

5. Justice and fairness Justice in the distribution of benefit and risk. We didn't take any position on what is is “to be fair” “to distribute risk and benefit” because we didn't know/agree, and we weren't able to take any position on it. So, except the idea of “targeting” a population that is quite obvious, we didn't have any position.

Questions

• Q: If the President hadn't called for you to work on SB, would you have looked at it?
• A: no

• Q: What was the most beneficial outcome of the commission's investigation :
• A: having such attention on a field, and also preparing the framework and the reflexions like the ones we are having now. Also, raising awareness could help funding.

• Q: how would the last Commission have handle such a topic ?
• A: The report would have been huge, not accessible. Our report was re-written to be more readable, more pragmatic. I think that they would have spent much more time on the 'playing god aspects', on the more essential issues. It would have been a nice "philosophical text” to make you think about SB, but they wouldn't have any specific recommendations.

• Q: How did the community members get chosen?
• A: Muhamad Ali's wif :a big donor for the Obama candidacy, quite involved as “someone in a Community”

• Q to the group: How can we support individual effort to exert “prudent vigilance” ? How can the Practice thrust could help you to do that ? What would you ask for ?
• A from one: very concerned by environmental release, and don't know about the way to really assess the environmental safety of the project we are doing, would request help exploring.

• Q: How do you differentiate SB from what is already in the environment with GMOs etc?
• A: the difference is self replicating organism – and gene transfer. Monsanto's organism don't self replicate.

• Comment: I try to put myself into that position, asking myself about risk. But, there are just no metrics to analyze what we are doing, there are no standards, no way to ask the good questions to even wonder about what we are doing.
• Response: the EPA is working on such tools, the existing regulatory framework does not already exist – but the fact is that we don't even know what is really adequate in terms of regulation – and in the risk analysis process. Risk to the environment and to the people. Containment is not the good thing to bet on, because it's a short time strategy, so you should rather think about surveillance, because there will be some escape anyway. That's why we didn't enter into prescriptive practices yet. So, containment alone is not going to be sufficient : they grow, evolve and evolute. Containment is a short term strategy.

• Q: Has the report had any impact on the funding of synthetic biology ?
• A: Not yet, because it's a bad time for funding, but it really help for funding and it's becoming a high priority item

• Q: This community is struggling is confronting a nascent technology platform : do we need to detail the potential benefits of the research ?
• A: yes, clearly we need to have much more engagement of the community in articulating the diversity of benefits