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My
name is Don Brancato. Thank you for the opportunity to speak here today.
I
am here representing all true scientists, who oppose the politicization of
the advancement of science diverting the funds for valid scientific
research to the special interests represented in this bill. Also, I am
here representing those unfortunate persons suffering from the various
ubiquitous diseases you mention in section 1 of your bill. It is those
people trusting, without recourse, Congress and the legislatures of
America to assist science
in seeking answers for their afflictions that are most harmed by this type
of interference. There is
absolutely no valid or credible scientific evidence that human embryonic
stem cell "research", or any human cell research for that matter, will
provide any useful information not more readily and economically available
from other mammalian cell research. Seeking knowledge of cell
differentiation and control, funds to that end must be directed to the
most cost effective and expeditious scientific efforts. Actions such as
this one, whether here in
New Jersey
, in Congress, or by any government, corporate or public, are explicitly
counter to that purpose. In this presentation, I hope to specifically and
objectively be able to make that clearly understood.
I
was asked to speak here by some who are aware of the fact that I, along
with others assisting me, have developed the only 100% successful human
clinical application of "stem cell" research that I know of. My
doctorate is from
Northwestern
University
, and my current teaching appointment is at the Washington University
School of Medicine.
In
the terms used currently in this particular area of scientific endeavor,
what we are about is called "tissue engineering". We try to achieve a
function or product that the immutable "Laws of Nature" have already
most efficiently and effectively provided to the more fortunate majority
who are unafflicted. We have never been, and probably never will be, able
to duplicate that overwhelmingly complex series of time dependent,
interactive chemical cascades of events that is also environmentally
critical and sensitive. It is that complexity that directly addresses how,
where, and to what end our miniscule efforts must be focused. Those who
invoke the unknowledgeable and unwitting to assist in their propaganda
efforts to deceive and defraud the public, the potential investors for
their nefarious schemes, and you, our representatives in this democratic
republic, can be stopped if the Truth is heard and heeded.
Succinctly,
that is my intention here today.
The
term, stem cells, though recently coming into vogue, has been around a
very long time. Very early on in my own research, we still primarily used
the term, precursor cells. Initially, in developing our synthetic cruciate
ligament, understanding that we were never going to be fully able to
replicate the intrauterine cellular growth and development, we sought to
isolate a cell, far enough along its differentiation pathway, that would
produce the desired chemical end-product(s). Then, that cell if able to
reproduce would provide other cells that would populate our synthetic
scaffold, and hopefully, the natural order assisting, in the right
chemical and mechanical environment, the host would grow a "new"
tissue. I have been involved in stem cell research since before it was
even called that.
Generically,
our research, described above, is relevant to your bill and other bills
now before the Congress, in that it exposes the lies and deceptions that
these special interest depend on. In attempting to specifically enumerate
those, I will also try to explain why based on fact, bills such as this
are not only impeding science and ignoring the scientific method, but are
additionally neither cost nor time effective.
(1.)
At present, with our current knowledge of
cellular differentiation and control, we are unable to detect any specific
differences in the chemical mediators or events, exclusive of time,
involved in cellular replication and growth between any species.
Relevance:
Cheap, readily commercially available cell sources of specific type
optimize research. Human cells, stem cells or otherwise, fit none of these
criteria.
(2.)
When our state of knowledge increases to
where we can discern cellular differences between species in laboratory
animals, we can easily look at other species such as humans.
Relevance:
Cellular and molecular biology has not progressed to the point that we
have any more than a rudimentary understanding of the, literally,
thousands of chemicals, usually extremely complex themselves, that must
interact in a time and concentration dependent manner to bring above even
the simplest cellular event. That information can best, and most
economically be gained from various hybrid cell lines specifically
engineered for that purpose.
(3.)
With our current knowledge, true scientists
are exploring cellular differentiation and control along four primary
paths. These are:
a.
Cellular reproduction and apoptosis (death)
b.
Inter-cellular signaling (communication) and
control
c.
Cellular metabolism, intra-cellular
signaling, and control; and,
d.
Genetic engineering
Relevance:
Currently available commercial cell lines more than adequately satisfy
research needs for the far foreseeable future in the most cost efficient
manner. Now, and into the distant future, unless some revelation of the
magnitude of Einstein's Theory of Relativity intervenes, human cells
afford no advantage to aid or advance scientific knowledge. These special
interests are trying to dupe our representatives in governments at all
levels, Federal, state, and corporate, in order to get funding under the
guise of "new" technology. The real tragedy is that they have stooped
to dangling false hope and totally unrealistic promises as bait.
(4.)
Apart from the true scientists, proceeding
meticulously, and painfully slowly, always limited by the immense
complexity and overlapping variables, according to and bound by the
scientific method; along those four paths, others are using lies and
deceptions to enlist public support.
Relevance:
Every attempt to short-circuit or by-pass the natural order, realizing
that we can never alter the natural laws themselves is always rewarded
with failures and inefficiency. Can getting one genetically defective
sheep out of something like 697 attempts stand any test for pragmatism and
economy? Even when so infrequently successful, the "cloned" embryo was
carried in a normal sheep uterus. It
is most efficient and conserving of time and money to build on established
and accepted facts, rather than to reinvent the wheel. The ability to
engineer a better wheel is certainly within the human domain, but to
create something to replace the wheel defies the laws of physics.
(5.)
To date, the real promise and achievements
with clinical application and relevance to the human condition have been
in genetic engineering. In that area, and in the area of tissue
engineering, there is real hope to address selected diseases. Genetic
engineering has given the diabetic an answer to the untoward immune
responses to bovine and porcine insulin. The synthetic ligament populated
by mesenchymal stem cells from bone offers an alternative to mutilating
and unsatisfactory surgery to over 100,000 people each year in the
United States
alone. Both of these, and the now several recombinant drug therapies, were
derived from combining current scientific information with known cellular
mechanisms.
Relevance:
Funding for research should support true scientists in the four study
areas listed above. There is absolutely nothing to be gained by any study
involving cloning until we have a much better and truer understanding of
the complexity of cellular reproduction and death. Studies to understand
and deal with cancer address the same questions in a meaningful and
relevant way. Efforts to improve genetic engineering to produce more and
more complex chemicals for recombinant drug therapy offer real and
attainable goals that truly deserve support. Synthetic scaffolds populated
by the appropriate stem cells, taking advantage of the irreproducible
complexity of the host environment, offer promise to a range of patients
suffering from arthritis, liver, kidney, and heart disease. When we can
treat cancer, then central nervous system disease solutions may not be too
far away.
(6.)
All cellular therapies require, at some
stage, the introduced cells to reproduce without activating an immune
response. Then those "new" cells must secrete and manufacture the same
chemicals in the same proportions, at the same time, in response to the
same signals as the cells they are meant to replace. Only adult stem cells
far enough along the differentiation pathway have that capacity. Embryonic
stem cells absolutely do not have that ability. Succinctly, we are only
scratching the surface of understanding the control of cellular
differentiation.
Relevance:
The current rudimentary information about the controls and signaling of
the tremendously complex and integrated sequences involved with cellular
reproduction and differentiation limit the clinical application of cell
therapies to situations where we can utilize natural mechanisms by placing
cells differentiated to a level like normal cells at the same stage in the
like environment. Examples of this, in current application, are in vitro
fertilization, the synthetic ligament, and some tissue culture derived
grafts. Except when utilizing natural hosts, we are only mechanics. We are
limited to placing the correct part in the right place, and, uniquely in
living things, we must also do it at precisely the right time. That even
now, as seen by the frequent and repetitive failures, is a formidable
task, which we are far from mastering.
For example,
(a.)
In the central nervous system, where in
contrast to the peripheral nervous, in the human species, after about the
age of two years, the cells of the brain and the spinal gradually lose
their reproductive / repair capacity.
(b.)
The change from fetal to "adult"
hemoglobin
(c.)
The onset of
Type II diabetes
(d.)
Organ differentiation and maturation from
conception to birth, and the list goes on and on
For
the most part, except for our minute awareness of some of the signals, we
are clueless. Funding to elucidate chemical mediators, concentrations,
time sequences, dependent interactions, and so forth; needs to be made
available to answer just some of the questions that need to be answered
before cell therapies, not relying on the host mechanism are even
practical. Science needs significant answers before the unfounded hopes,
falsely generated by those this bill represents, have any chance of being
fulfilled.
(7.)
Current methods to introduce the genetic
codes necessary for the production of recombinant therapies are often
inefficient and crude. Holding great and immediate promise for intrinsic
"cures" not requiring repetitive drug administration for a wide range
of genetic disorders from forms of diabetes and heritable heart diseases
to, perhaps, Altzheimer's; these efforts offer true hope.
Relevance:
Methods and tools to enhance and advance genetic engineering, lowering
costs to make recombinant therapies affordable have true and immediate
clinical applications. Now, many of the complex molecules only able to be
produced by these means are often only available for research, because of
their corporate developers' generosity in supporting scientific
research. When they are not donated, they consume disproportionate amounts
of the research budgets.
Producing Rh-insulin is an example. The viral transduction, or other means
of introducing the genetic codes to the cells cultured to make the insulin
using the natural cell machinery is inefficient and temporary. Succeeding
generations of the cells gradually lose their coding. Cells so genetically
programmed by currently available methods, implanted hoping to replace
deficient pancreatic beta cells would expect the same fate. That is
accelerated by the eventual immune response in animals to the foreign
antigens, viral or otherwise.
(8.)
Studies already completed, and currently
underway, on specific chemicals involved at various levels of cellular
activity have revealed cross species duplicity. Coupled with the cross
species redundancy of the basic DNA code, these facts suggest that, unless
modified by future research, species specific determinations and studies
may never be necessary until the final stages for clinical applications to
various species is reached.
Relevance:
In studying the cells of living organisms specific and unavoidable steps
and procedures must be followed and accomplished. First, some process,
mechanism, structure, or function of the cell must be determined. Then the
factors, chemicals, environment, etc., involved with, and possibly
affecting, the small segment focused on must be considered. Next, relative
to the controls and signals associated, the chemicals which mediate the
events must be identified, isolated, concentrated, and often frequently
reproduced. Literally thousands of enzymes, ligands, cytokines, and other
complex chemicals, along with simple chemicals, such as salts, oxygen,
carbon dioxide and sugars, all in specific and defined concentrations at
critical times; plus a myriad of environmental factors such as pressure,
tension, or flow can affect, what appears to be, even the simplest
cellular event. Interestingly, it is at the molecular level that the
differences between species often become obscured. This being the case,
until we are able to distinguish differences between laboratory animals,
there is no indication to imprudently and injudiciously expend our limited
resources outside the laboratory.
My
purpose here is not to condense years of graduate and post-graduate
education and research into a few minutes. From the above, which is just a
smattering - the tip of the iceberg so to speak, of what we do know;
hopefully, you can visualize the almost incomprehensible volume of
knowledge, we still lack. Clearly, what we don't need is the further
hindrance, impediment, and diversion of funds that would be accomplished
if the propaganda efforts of these unjust special interests were
successful in deceiving the public and this body, here assembled.
Constructively,
and specifically for
New Jersey
, I would suggest an opportunity for a more judicious stewardship of the
funds derived from the public than this bill affords. Enlisting resident
corporations, such as Johnson & Johnson, to make already applicable
technologies, such as the synthetic ligament or the alternative to
methymethacrylate "bone cement" for prosthetic fixation, available to
the public would benefit, not just the
New Jersey
economy, but a spectrum of humanity from professional athletes to the
elderly.
In
concluding, for your information and enlightenment, I am more than happy
to answer any questions you might have about the scientific material
presented here. Also, I would offer to stand here in public debate to
respond to any challenge from anyone relative to the scientific truth and
accuracy of these statements, if it is the desire of this committee.
Thank
you, for your time and indulgence in this matter affecting the health and
well being of people, not only here in
New Jersey
, but everywhere in our great Nation and around the world. |
