Comments on the International
Regulation of Biotechnologies:
Preserving hope and value
By
Paul R. Billings MD, PhD,
FACP, FACMG
President and Chief Executive
Officer
Cellpoint Diagnostics, Inc.
Testimony before the House
Committee on Foreign Affairs’ Subcommittee on Terrorism, Nonproliferation, and
Trade at a hearing entitled “Genetics and other Human Modification
Technologies: Sensible International
Regulation or a New Kind of Arms Race” to be delivered on June 19, 2008 at the
Chairman Sherman, Ranking Member
Royce, and other distinguished Subcommittee Members, I am Dr. Paul R. Billings,
President and Chief Executive Officer of Cellpoint Diagnostics, Inc. a biotechnology
company seeking to develop tests that will revolutionize the management of
cancer worldwide. Among other
professional activities, I am also awaiting final appointment as a member of
the HHS Secretary’s Committee on Genomics, Health and Society and am past Chair
and President, now Director, of the Council for Responsible Genetics, the
oldest biotechnology “watchdog” organization in the
Science is a hopeful and creative
human activity. Scientific discovery
while mostly incremental--building on previous work that is known and shared--is
also serendipitous. No one who knows the
history of the discovery of penicillin can not take away two points: luck is a great thing in science and success
comes to those who are prepared. It is
crucial that scientific freedom, the ability to inquire broadly about the
natural world and to create understanding about our vast experience in this
amazingly varied universe, not be fettered unreasonably or unnecessarily. In fact, we should cherish scientific freedom
and look for ways to unleash science and scientists more. Insights and advancements should be nurtured
for a whole range of demanding human concerns.
Even reforms of our policy and law generating practices, to accommodate
more easily and quickly proven
scientific facts, should occur; they are likely to yield a system that produces
more rational and appropriate tenets and legislation than other historical
systems we have applied over the course of human culture and history. A good example of this is the evolving role
of DNA identification methods in our system of investigation and criminal
justice. This method, a result of basic
study of human DNA variation, is fostering revolutionary changes in how we
conduct criminal investigations, allowing criminals who might have escaped
prosecution to be brought to trial, and also revealing injustices committed by
our less scientifically informed justice system in the past. We are still learning how to balance these
powerful methods and facts with other cherished principles of individuality,
privacy, and freedom from unwarranted governmental suspicion or coercion. We need to generate more examples of
improvements in our varied lives through good science.
What is good
science? Even more important the
uniqueness of its discovery component is the rigor applied to the design of
experiments, the critical view of the purported facts generated by applied
methods, and the absolute necessity for independent and multiple verification
of results by unconflicted researchers.
Openness, publication, sharing in professional settings, verification
across labs, geographies and other sources of variability are all essential to
good science and for the production of true and applicable scientific
fact. Any consideration of international
scientific policy must first enforce values and principles that will enhance
the production of good and reliable science; where the applications and limitations of scientific facts are
sought and made known.
What is
possible, particularly in the biotechnologies?
As Niels Bohr, the famous physicist is said to have noted, “Forecasting,
particularly about the future, is difficult”.
What can be said reliably is that the conduct of basic research in the
human biotechnologies is now more common than ever before, is produced by more
skilled and motivated scientists, and that its pace and accomplishments are
dizzying. The speed that we have
accumulated basic knowledge about the components of our genes, cells and bodies,
and then the creativity demonstrated in taking that core information and
manipulating it (or the methods used to derive it) to produce more hypotheses,
studies and hopefully insight and progress, are breathtaking. Take for instance my current field of
interest, circulating tumor cells (CTC).
We have known for centuries that cancer often killed people by spreading
to distant sites in our bodies. Even
after the invention of anesthesia and aseptic surgical methods, with some
people being cured by simple removal of their tumors and surgical recovery,
many others succumbed eventually to distant recurrences. We hypothesized, long ago, that the initial
tumor spread via the blood stream and lymphatic system (and possibly by other
yet to be discovered routes), seeding distant sites in the body. But no methods for studying this imaginary
phase in cancer human biology existed. We
now have such tools and these are beginning to reveal new facts in oncology. In addition, the methods are being translated
in to clinical tests that may disrupt current assessment paradigms and
revolutionize cancer management. We have
discovered for instance that there is heterogeneity in the characteristics of
CTC. Some of the cells we can now
identify may be cancer stem cells. An
ability to access those cells and deliver them for assessment may yield very
significant advances in management and treatment. The rapidity by which new methods are
changing our views of cancer, and the speed that basic work is being verified
and then translated in to clinical effort, would have been unimaginable even 10
years ago.
Mass DNA
sequencing of human genes and genomes; isolating
and studying stem cells; imaging, measuring and modifying aspects of human
brain activity; accurately measuring and predicting complexity using the
approaches of systems biology; and creating new solutions to biological or
other problems with synthetic biology programs; these are all now possible projects
of biotechnology inquiry and are underway.
As scientific methods for these and other programs are created, and
mixed with rapidly evolving protocols in engineering (for instance,
nanotechnologies), the potential to translate some of this basic science
work in to attempts by scientists, physicians or other components of society (for
instance the Raelians), to alter the human germline, engage in reproductive
cloning, create animal/human chimeras or human/machine hybrids, or attempts to
create new human subspecies with enhanced or curtailed traits for some
instrumental purpose, may occur. One of
the byproducts of greater understanding and developments in engineering is that
some approaches are very simple and thus might disseminate in society in
unpredictable ways. Eugenics in varying
new guises, for instance, to protect national interests might be
attempted. Techniques that may provide
benefit like those employed in prenatal and preimplantation clinical settings
could be perverted towards some eugenic or instrumental aim. For instance, the use of ultrasound during
pregnancy has improved the health of many fetuses and mothers, while also
resulting in the abortion of millions of female conceptions worldwide. Despite this fact, success or even
effectiveness of such programs on a significant scale is generally unlikely, but
attempts may be made and intermediate but unfortunate outcomes could
occur. Even endorsement by powerful
governmental elements of such programs is conceivable. We must consider carefully how to lessen the
probability of these occurrences and the resulting harms.
How should
we proceed to enhance scientific efforts that can benefit people around the
world even in the face of risks for abuse and harms? First, we must all agree that the
biotechnologies have great value particularly as they produce insight in to
individuals and illnesses. For societies
with a variable history of respect for individuals, and that includes our own,
this will likely generate new power and respect for ALL individuals. A good example of that result is the Genetic
Information Non-Discrimination Act of 2008 recently signed by President
Bush. Along with federal Civil Rights
legislation, and protections for the disabled, that law continues to modernize
and broaden our traditions of inclusion and acceptance of individuality and
human difference. Other societies, cultures
and nations should take note as international bodies have.
Scientists
and scientific communities should be more transparent about how projects are
created, funded and how individual scientific careers are motivated and
incented. Conflicts of interest,
political coercion and other differences in international scientific cultures
should be well known. Harmonization with
internationally accepted values ought to be attempted.
When
scientific facts and methods are translated in human societies, particularly
powerful basic biotechnologies, multidisciplinary assessments and approaches to
studies should occur. It is a very
interesting development that research groups comprised of basic and applied
scientists, engineers, social scientists with historians and others are now
common in many biotechnology investigational settings in the developed world. This development may help curtail premature
applications and point out more limitations of knowledge or potential for misuse.
In balancing
other human values with the goal of fostering scientific insight and progress,
international policy and laws may be necessary to generate some uniformity (a
baseline) and prohibit rogue behavior.
This should only be pursued after significant study by multiple broadly
constituted bodies and determination of need (including that based on real risk
not just precaution). Then recommended policies should seek narrow applications
and provide flexibility in crafting (“sunsetting” of provisions) so as to
accommodate new facts as they develop.
It should be clear that while prohibiting methods and applications may
be necessary, individuals who are suffering may find relief delayed by these
actions. This is a harm too and should
be minimized.
Finally, as
biotechnologies gain more momentum in discovery, development and delivery in
our societies, and as we consider policies to control the inevitable ways these
powerful insights will alter how we consider human life--the individual and our
experiences, we should reemphasize in international policy two traditions that
are already codified in the UN Charter and other global documents. First, that citizen safety, whether
those individuals are patients or research participants or in other ways
engaged in applications of science is paramount. Their knowledge and consent are
required. Our abilities to alter aspects
of human life with biotechnologies need to be matched by powerful new ways to
assess safety and optimize this crucial value.
Then after we assure our neighbors that scientific facts and
applications are safe, we must then strive to deliver them with equity
to ALL those who need or desire them.
Mr. Chairman
and members, only when science is allowed to be fully creative in an international
environment of optimal individual safety and equitable delivery of needed
progress, will the great potential of advances in biotechnology be realized. With
broad and careful study, novel policy crafting, and a healthy sense of how
limited scientific knowledge is, how unlikely bad translations are, along with a
recommitment to all those in need and to better monitoring of harms--good
international science policy and good
science will arise.
Thank you for the opportunity to
testify today and I would be delighted to answer any questions I can.