Testimony Before the New Jersey State Assembly by Don Brancato

Date: 11/04/2002

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:

  1. Cellular reproduction and apoptosis (death)
  2. Inter-cellular signaling (communication) and control
  3. Cellular metabolism, intra-cellular signaling, and control; and,
  4. 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.