How can societies encourage innovation in the life sciences, and still protect the public from unreasonable risks? Those who design or modify living organisms have long claimed there is little or no risk to what they do. As a result, billions (at least) of genetically engineered plants, animals and bacteria have been released into the wild. But terms like “bioengineering” and “biotechnology” imply a knowledge of the mechanics of living things that is simply untrue by any reasonable standard. Scientific discoveries are constantly changing our fundamental understanding of biology. Whatever declarations of safety were made based in the past, no one actually knows what the wild and the engineered are eventually going to make of each other – or maybe, eventually, of us. Watch the video: http://vimeo.com/15766379

1. THINKING ABOUT RISK
DENISE CARUSO
Senior Research Scholar, Department of Engineering and Public
Policy, Carnegie Mellon University
Author, Intervention: Confronting the Real Risks of Genetic
Engineering and Life on a Biotech Planet
Executive Director, The Hybrid Vigor Institute
Former Technology columnist, The New York Times ...
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2. OPTIMIST, PESSIMIST, REALIST
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3. MORALIST
We have a moral
imperative to
save the planet!
It is wrong to
play God!
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4. REALISTS HAVE ISSUES ...
With assumptions
about the science
With the dismissal of
precedent
With the outdated
Industrial Age
methods used to
make risk decisions
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5. THREE KINDS OF RISK
Unprecedented
events, scientific
innovations —
scientists don’t
know or can’t
agree
Infectious disease,
toxins — need
instruments and
scientific training
Biking, driving,
operating heavy
machinery
(Source: John Adams)

6. THERE IS A BETTER WAY
But you will have to wait until the end
of my talk to find out what it is.
It’s very
exciting!
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7. ISSUE 1. IS ‘BIO-ENGINEERING’
AN OXYMORON?
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8. My view of biology is, ‘We don’t
know shit.’ - Craig Venter, 2000
This from the guy who is trying to patent the first artificial life form.
Thank you
for sharing!
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9. Human genome
~25,000 genes
WHY DO I HAVE MY MOTHER’S
NOSE ... BUT NOT A TAIL ?
Mouse genome
~25,000 genes

10. WHY IS AN EAR NOT A HEART?
(Differentiation)

11. HOW — AND WHY?? — DOES
PUBERTY START?
(It’s called time-based signaling)

12. DNA EXPLAINS SIMILARITIES,
NOT DIFFERENCES
Human genome, ~25,000 genes *
Mouse genome, ~25,000 genes **
Arabidopsis (plant), 25,000 genes
* Before the human genome was sequenced, estimate was 100,000
** 99 percent are the same as humans
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13. ‘We don’t know [even
more] shit’ now.
Seriously.
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14. ENCODE Study, 2003-2007
Goal was a ‘parts list of all biologically
functional elements’ in 1% of the human
genome — they couldn’t do it
Genes operate in ‘complex, interwoven
networks’
‘Reshaped our understanding of how the
human genome functions’ and ‘poses
some interesting mechanistic questions’

15. ‘INTERESTING QUESTIONS’ INDEED
Billions of
transgenic
organisms have
already been
released,
based on the
‘parts list’
assumption

16. AND THEN THERE IS THE MEDIA.

17. STORY ON GM TREES IN
THE NEW YORK TIMES:
‘Genetically engineered trees [may] arouse even
more controversy than GM crops ... That is partly
because [1] many people have an emotional
attachment to forests that they do not have to
cornfields.
Moreover, because[2] trees live longer than
annual crops and generally can spread their
pollen farther, there are concerns that unintended
environmental effects may spread and persist
longer ... than in crop fields.
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18. WHAT KINDS OF EFFECTS?
Deep interdependence
between trees, plants,
animals, insects,
bacteria, water, soil,
sunlight ...
So complex that
scientists cannot
predict effects
‘Emotional attachment’?

19. BIOLOGY IS NOT PHYSICS
Prediction is the
foundation of
engineering —
AND OF SAFETY.
If you cannot
predict its behavior
over time, you
cannot declare a
product is safe.

20. WHAT IF YOU BUILT A BRIDGE ...
... and one day,
it just started to
reproduce?
What kind of
engineer would
you be, if you
couldn’t predict
that?

21. PERSISTENCE AND RESISTANCE
Antibiotics – overprescribed as ‘miracle drugs’
resistance is persistent, i.e., ABR cannot be reversed
DDT – overused as a ‘miracle pesticide’ -- bugs
became resistant, remains in ecosystem for 10-15 years
after application
Transgenic crops globally – 77% of soybeans, 49% of
cotton (90% in U.S., Australia and South Africa), 26% of
corn, 21% canola
80-fold increase from 1996 to 2009
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22. ISSUE 2. IGNORING PRECEDENT
AMNESIA +
DÉJÀ VU =
We have
forgotten this
before.

23. KUDZU (amnesia)
That big lump in the middle is a house.

24. GM SUPERWEED (déjà vu)
Herbicide-resistant soy and cotton crops transferred their
HR genes to the giant pigweed. Infestations abound.
Howard F. Schwartz, Colorado State University

25. GM COTTON (DÉJÀ VU)
Pink bollworm
has
developed
resistance to
the pesticide
protein
produced by
Monsanto’s
GM cotton.

26. GM MAIZE
International Journal of
Biological Sciences:
New health effects linked
with eating 3 strains of GM
maize.
‘Mostly associated with the
kidney and liver, the dietary
detoxifying organs ....’

27. NILE PERCH v. GM SALMON
(Amnesia)
(Déjà vu in waiting?)

28. WHAT IS HAPPENING?
WHAT HAPPENED?
SHIFT HAPPENED.

29. ISSUE 3. OLD METHODS DO NOT
WORK FOR NEW TECHNOLOGIES
INDUSTRIAL AGE
 Little uncertainty –
systems well described,
risk can be calculated
 Change relatively
predictable in terms of
cause and effect
 Unintended
consequences minimal,
largely controllable
 BAN or APPROVE,
assuming reliable data
INFORMATION AGE
 Radical scientific
uncertainty – no reliable
data to calculate risk
 Change unpredictable,
cause and effect often
unknown or misattributed
 Unintended consequences
cannot be controlled
 NEED DIFFERENT RULES

30. ...
OLD-SCHOOL RISK IS EASY — BIO-
NANO IS OUT THERE IN THE DARK

31. NO TRACKING OR MONITORING

32. NEW TECHNOLOGY REQUIRES A
DIFFERENT APPROACH ...
What do the risk experts say?

33. THEY SAY, ‘COLLABORATE’
‘ANALYTIC-DELIBERATIVE PROCESS’
Abandons the single-analyst,
Industrial Age model
All the relevant experts and
stakeholders are at the table
Combines analysis where data is
available, and deliberation about
uncertainty when it is not

34. FOR A SPECIAL KIND OF PROBLEM
1. When lots of different dimensions can be affected by
the outcome
2. Where there’s scientific uncertainty — where there’s
not enough science to know how things will turn out
3. When people disagree about benefits or outcomes,
and they may change if they’re given new information.
4. No single authority can be trusted to know all the
answers.
5. Where a decision must be made before “getting
certain”

35. BIOENGINEERING CERTAINLY
MEETS THOSE CRITERIA

36. IN GENERAL,
SCIENTISTS HATE THIS IDEA
They think that laypeople are ignorant,
and have zero tolerance for risk.

37. BUT IF THAT WERE TRUE ...
The pharmaceutical industry would
have gone bust long ago.

38. ANALYSIS + DELIBERATION CAN
ELIMINATE BIAS AND INFLUENCE ...
... both of which I have left out of this talk,
for the sake of brevity and sanity

39. AND OUTCOMES IMPROVE
 By questioning scientific judgments and
assumptions with fresh eyes.
 By challenging each other’s biases.
 By calling out critical uncertainties that are invisible
to or ignored by experts.
 By helping scientists come up with new research
agendas to answer specific risk questions.
 Collaborating on risk decisions uses the variety of
human experience as a positive force —for society
and for science.

40. NO CLEVER ENDING
I JUST DON’T KNOW
WHAT WE’RE
WAITING FOR
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41. IF YOU WANT
TO KNOW
MORE ...Denise Caruso is the founder and
executive director of the nonprofit
Hybrid Vigor Institute. Her most recent
work aims to augment traditional risk
analysis with new methods that are
better suited to innovations in science
and technology. She is presently
working on projects in the area of
emerging infectious diseases.
Also a veteran technology analyst and
journalist, Caruso has more than 20
years experience assessing the
converging industries of digital
technology, telecommunications and
interactive media. Her perspectives
have been featured in The New York
Times, where she served for five years
as Technology columnist, as well as
in the Wall Street Journal, Columbia
Journalism Review, WIRED, MSNBC,
and her own newsletters, Digital Media
and Technology & Media.
Intervention: Confronting the Real Risks of Genetic Engineering
and Life on a Biotech Planet challenges two of the most sacred tenets
of modern society, innovation and technology, from the perspective of the
unique risks they present. Using genetic engineering as its model, it paints
a vivid picture of the scientific uncertainties that biotech risk evaluations
dismiss or ignore, and lays bare the power and money conflicts between
academia, industry and regulators that have sped these risky innovations
to the market. Intervention champions an alternative method for assessing
the risks of technology, developed by the world's top risk experts, that can
eliminate such conflicts, help regain public trust in science and government,
and drive research and development toward more useful, safer products.
The nonprofit Hybrid Vigor Institute was founded in 2000 to stimulate more and
better collaboration between experts. Its work has been supported by the U.S.
government, public and private foundations, and individuals. More information on
the Institute and its work is available online, at www.hybridvigor.org
Confronting the Real Risks of Genetic
Engineering and Life on a Biotech Planet
INTERVENTION
DENISE CARUSO
INTERVENTIONDENISECARUSO(hv)i