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  • SEVERING OF THE SPECIES

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    Severing of the Species

    Implications of Genetic Editing and Artificial Intelligence on the human substrate[1]

     

    Joseph R. Carvalko, Jr.

    Interdisciplinary Center for Bioethics, Yale University

    New Haven, Connecticut, USA

    carvalko@sbcglobal.net

     

     

     

     

    Abstract—This paper reports on the confluence of current data gathering such as genomic-wide association studies,  related to the heritability and manipulation of traits, and bioengineered processors, which combined have the potential to influence the further development of our species. Specifically addressed are: genetic editing for enhanced cognition; the technology of implantable bioengineered devices (e.g. synthetic DNA digital constructs); regulatory considerations; and ethical implications. In the near term implantable devices will couple biotechnology platforms and 5-G telemetry within an anatomically interior intranet communicating with the Internet. It reasonably can be presumed that combined, these developments will lead to a distinct techno/bio human demographic, which collectively are intrusive, threaten autonomy, and may change “what it means to be human,” raising questions as to the appropriate level of government regulation and the extent to which society permits commercial interests to control the operation, distribution and use of technology that alters the human construct.

    Keywords- Genetic editing, technology law,  patent law, science policy,  transhuman, telemetry, molecular computer, IQ, unawareable, in-the-body technology, human enhancement,  synthetic DNA, artificial intelligence, evolution, technology ethics.

    I.          Introduction

    This paper discusses the technical, legal and ethical implications of the confluence of genetic editing and implantable in-the-body technologies.[2] In November 2018, we reached a milestone between two different evolutionary states, when geneticist He Jiankui edited the germline of the genome of twins. His ostensible objective was to modify the CCR5 gene, which encodes a protein that affects HIV entry into human cells.[3] In one form, this gene exists in about 10% of Europeans protecting them from HIV infection. However, the gene also has been implicated in enhanced ability to learn and form memories, which might influence IQ.[4] With the availability of  gene editing technology, such as Clustered Regularly Interspaced Short Palindromic Repeats, referred to as CRISPR/cas9 technology, hundreds of researchers across the world are searching for genes specific to inheritable diseases, including those that express for intelligence. These efforts capitalize on genomic wide association studies (GWAS), which produce data on thousands of subjects whose DNA has been sampled for genes that express heritable disease and above-average intelligence.

    Below is discussed current developments in (a) germline and somatic genetic editing and (b) implantable bio-computer processors. The technology of in-the-body electronics for  ameliorating health issues came into prominence  with the pacemaker in 1960. It’s subsequent development has served as a model for the use of microprocessors and telemetry in maintaining wellness at the embedded level.[5] On the biological side, the first direct insertion of human DNA into the genome was performed in September 1990, when Ashi DeSilva was treated successfully for  adenosine deaminase deficiency ADA-SCID, an autosomal recessive metabolic disorder that causes immunodeficiency.[6]

     

    Populations in developed nations will increasingly resort to genetic editing and implantable technologies, not only for critical life saving therapies, such as the pacemaker performs in dozens of medically therapeutic interventions,[7] but to enhance the quality of lives intellectually and socially.[8] Genetic editing, together with digital silicon and synthetic biology based processors represent a convergence of technologies, referred to as nano-bio-information-cogno (NBIC).[9]

    New computer technology mileposts are being achieved at an exponential rate.[10] For example, Intel claims its Intel Stratix 10 FPGAs is capable of 10 teraflops (1013). It contains about 30 billion transistors. Semiconductor technology soon will commonly use 11 nanometers technology incorporating fifty-cores allowing 100 simultaneous hyper- threads. On the near horizon, substrates that are a material part of the computer, now measured in micrometers (μm) or the size of blood cells, will dive deeply into the realm of wafer-thin graphene (carbon) and MoS2 (molybdenum disulfide) measured in nanometers, a few atoms thick. Processors will continue to shrink to the size of a bacterium, 2 μm in length and 0.5 μm in diameter, with a cell volume between 0.6 – 0.7 μm3. Transistors, but a few atoms wide, will populate state-of-the art processors housing upwards of 13 billion transistors.

    A strong prospect exists that genetic and digital technologies will imbue psychological and anatomical enhancements in Homo sapiens of tomorrow, referred to as Homo futuro, creating a departure from humans-as-we-exist, today.[11] What follows considers current biogenetic and bioengineering developments as they involve: A. genetic editing for enhanced human cognition; B. implantable bioengineering technology; C. regulatory considerations; and D. ethical implications.

     

        II. GENETIC EDITING FOR ENHANCED COGNITION

     

    The genotype is the genetic composition of an organism, essentially its DNA, which accounts for the structure of the anatomy as well as particular traits. A phenotype expresses itself in the physical appearance and function of an organism.  DNA comprises strings of single nucleotide polymorphisms (SNPs) that in sum represent our biological diversity.  A difference in a single DNA base pair, consisting of one of four molecules, adenine (A), thymine (T), guanine (G) or cytosine (C) may change a physical trait or cause the occurrence of a debilitating or lethal disease. A heritability of 40% or 50% for any trait means that percentage difference, between individuals, which can be attributed to an inherited trait, such as height, weight or intelligence.

    Using the latest high-density SNP microarrays, scientists search for genomic variations across populations in large numbers. Genotyping on a grand scale coupled with “Big Data” analytics add to the power of GWAS initiatives, allowing scientists to compare DNA gene sequences and their associations with disease and other traits.  These studies are being combined with brain imaging, which together reveal gene complexes associated with brain related diseases such as schizophrenia, bipolar disorders, dementia and Alzheimer’s, as well as the heritable genes implicated in albinism, cystic fibrosis, and muscular dystrophy. The aim of course is to modify gene sequences using technologies, such as CRISPR to target candidates SNP for genetic code alteration to eliminate disease and disability.[12] The first U.S. human trials that will test CRISPR are beginning in 2019, the first which plans to treat a form of Leber congenital amaurosis, a common cause of inherited childhood blindness that occurs in 2 to 3 of every 100,000 births.[13]

    Intelligence or IQ has been shown to have a high degree of heritability. Thus in the way scientists look for aberrant gene sequences that may cause the occurrence of a disease, the same process may be used to explore the genetic roots of intelligence itself. In children, the heritability of intelligence is 0.45, and rises to 0.75 for late adolescents and adults.  IQ is related to the g-factor, which includes subsets of mental abilities: fluid intelligence, crystallized intelligence, visuospatial processing, working memory and quantitative reasoning. A detailed meta-analysis of intelligence involving 78,308 individuals looked for associations between intelligence and specific genes.[14] It identified 336 associated SNPs in 18 genomic loci, of which 15 had not previously been discovered. It confirmed 40 novel genes for intelligence. The identified genes were predominantly found in brain tissue. Overall the SNPs accounted for a non-negligible 5% difference in intelligence.

    Biological mechanisms that also account for variations in individual g-factors range from brain size and density to the synchrony of neural activity and overall connectivity within the cortex. Researchers have uncovered evidence for the molecular genetic background of music, such as composing, improvising and/or arranging music. Creativity in music was found to co-segregate with a duplication covering the glucose mutarotase gene at chromosome band 2p22, which influences serotonin released in the brain and the  membrane trafficking of the human serotonin transporter.[15]

    These populations are made available through GWAS referred to earlier, and are proving invaluable for uncovering the genetic roots for differences associated with a variety of traits having to do with working memory capacity or one’s risk of developing Alzheimer’s disease. But, these root differences are complicated by the fact that traits, many which underlie most birth defects and common diseases (e.g., coronary heart disease, diabetes mellitus and obesity), combine into what is referred to as multifactorial and polygenic inheritance. GWAS data and multifactorial polygenic scoring is used to assess this type of inheritance, traits which depend on multiple genes, each having only small effects.[16]

    By looking through GWAS at factors contributed by multiple individual genes, investigators surprisingly have seen a correlation between gene sets and academic achievement levels.[17],[18] Gene associations with normally varying intelligence differences in adults show weak effects for academic achievement levels in any one gene.[19] However, it would seem feasible that where an the overall polygenic score is determined, it could then be used to genetically engineer the more significant markers. If a gene were expressed for even a small increase in IQ, it could be significant. That having been said, polygenic scoring puts the matter of improving IQ through gene manipulation into what may be a longer term realizable objective. If an SNP association is found, say for IQ on the order of 0.01 % (i.e., a .01 change in the average IQ of 100), it means that to account for heritability in the 50% range, theoretically requires at least 5,000 SNPs be found to show the sought after trait.[20] Some traits are well below 0.01 %, by orders of magnitude, and therefore require enormous numbers of associations be found using existing databases. However, and importantly, the eventual discovery of genes that can make a difference, may simply be a matter of time.

    As with discovering genes operative in cognition, neuroscientists have discovered neural correlates of subjective phenomena by manipulating neurons, via molecular biology. These findings are then employed with the latest magnetic imaging technology to actually observe areas of the brain, where emotion and cognition play a role in behavior. For example, we know that genetics plays a role in our  temperament, or emotional response, as well as our personality, which is characteristic of behavior, feelings, and thoughts. Personality traits, which have a heritable basis, are referred to as the Big Five: Openness to Experience, Conscientiousness, Extraversion, Agreeableness, and Neuroticism. Social potency, a trait associated with forceful leadership and extroversion, was estimated to be roughly 61%  inherited.  Social closeness, a trait associated with a preference for emotional intimacy, is contributed 33% by genetics and 67% by environment. Again, what specific genes may be involved is yet to be well-defined, but one would anticipate their discovery is time dependent.

    Bottom line is that currently we do not know with any degree of certainty, if and when we will be at a point where we can, beyond what has been located, alter genes that importantly express for intelligence or personality factors associated with higher degrees of apparent cognitive or emotional intelligence, and thereafter use this information to create templates to genetically edit these traits. Note that BGI, a company based in China possesses the largest gene-sequencing facility in the world. In 2012, it launched a project to study the basis of intelligence.[21] Whether BGI will succeed in its endeavor to find a spectrum of genes related to intelligence is an open question. Some geneticists have expressed doubt and others optimism. Nevertheless, if a gene complex, and there are more than a few as mentioned, could be expressed through editing, even a small increase in IQ, could be significant, if deployed within a non-trivially sized population. This is made clear in an article that considered iterative embryo selection.

    Carl Shulman and Nick Bostrom, from the Future of Humanity Institute, Oxford University, proposed using iterative embryo selection (IES) in vitro, through the compression of multiple generational selections, to increase IQ.[22] They hypothesize that IQ gain will depend on the number of embryos used in selection, where a 1 in 2 embryo selection would produce a gain of 4.2 points. Along the same lines, a 1 in 10 embryo selection would result in an IQ gain of 11.5 points.   Over five generations, a 1 in 10 embryo selection protocol would max out at a 65 point gain due to diminishing returns; and a 10 generation protocol would likewise max out at a 130 point gain. Shulman and Bostrom focus on a biological solution for increasing IQ, however, other non-biological technologies such as AI computational devices may  provide enhanced memory, and thus result in an apparent IQ increase.[23]

     

      III. IMPLANTABLE BIOENGINEERING TECHNOLOGY

     

    Discrete forms of engineering exist that do not implicate the human genome and yet are at the forefront of enhancing the human anatomy. For well over twenty years researchers have been implanting biomimetic electronic devices in human brains. These generally consist of a computer processors, programs and an interfaces installed to allow individuals with severe brainstem injuries to move prosthetic limbs through the shear force of their cognition. Duke University, Carnegie Mellon, Brown, and others have led the way assisting human subjects in utilizing their electrical brain activity to directly control neuroprosthetic devices via brain-machine interfaces (BMI). [24]

    Much of the technology relating to brain interface employs conventional electronics as applied to computation (mathematical, logical), control and interface. But a more elegant technology developed from synthetic forms of DNA will eventually produce a variety of products, even new life forms and relevant to this discussion, bio-computers for prosthetic control.  As discussed below, researchers are experimenting with synthetic biological circuits that mimic computer logical switches, and which in a few short years will construct devices that operate at a complexity level rivaling microcomputer processors. Along these lines scientists are developing synthetic genes to interface with the brain, and thus alter the functionality of perception, cognition, processing speed, memory and self-consciousness.

    In 2003, Nobel Laureate, Hamilton Smith was part of a group that synthetically assembled the genome of the virus, Phi X 174 bacteriophage.  His efforts, at the J. Craig Venter Institute (JCVI), were to partially synthesize a species of bacterium derived from the genome of Mycoplasma genitalium.[25] Then in 2008, synthetic biology was brought into prominence when Venter impressed a TED forum on his work in creating living bacteria from synthesized molecules.[26] Two years later, JCVI announced the creation of the world’s first self-replicating synthetic genome in a bacterial cell of a different species.[27],[28] In 2010, Venter’s team had assembled a complete genome of millions of base pairs, which inserted it into a cell caused the cell to start replicating.[29]

    JCVI’s success in self-replicating synthetic genomes, led President Obama to convene the President’s Commission for the Study of Bioethical Issues, in 2010, to identify the risks and ethical concerns. The Commission held a series of public meetings to assess the science, ethics, and public policy and then issued a report entitled New Directions: The Ethics of Synthetic Biology and Emerging Technologies. While recognizing that synthetic biology could likely lead to cures for diseases, such as muscular dystrophy, Parkinson’s disease, cystic fibrosis and cancer, the commission concluded that it would be “imprudent either to declare a moratorium on synthetic biology until all risks can be determined and mitigated, or to simply ‘let science rip,’ regardless of the likely risks.”[30], [31] Successful synthetic biological systems now include multicellular applications, e.g. bacteria that sense and destroy tumors and organisms that produce drug precursors.

    For purposes of this discussion, let’s return to 2000, when scientists reported the construction of two devices that worked inside E. coli cells, by altering its DNA sequence, causing the cells to blink predictably—that is, turn on and turn off. [32] These and other similar acting modules have the potential for regulating gene expression,  protein development, and cell-to-cell communication. Six years ago scientists at Stanford University constructed a bio-transistor from genetic material that worked inside of living bacteria.[33] These products use genetically encoded logic, data storage, and cell-cell communication to reprogram living systems and improve cellular therapeutics.

    In 2007, researchers demonstrated a universal logic evaluator that operates in mammalian cells, which, in 2011, was proof-of-concept for therapy that used biological digital computation to detect and kill human cancer cells.[34]

    Enzyme logic gates provide Boolean operations such as combining the presence of two inputs into one output. These are referred to as “AND” and “NOT AND” or “NAND” functions. This type logic of course underpins the digital computer. Another similar device contained a feedback loop allowing it to flip-flop, emulating the electronic circuits used in computer memory, pulse generators, time-delay circuits, oscillators, and logic-computational formulation.[35]

    Chris Voigt, a synthetic biologist at the University of California—San Francisco and his team engineered a bacterial system to regulate gene expression in response to a red light and another to sense its environment and conditionally invade cancer cells. As reported in Nature: “[T]he system consists of a synthetic sensor kinase that allows . . . bacteria to function as a biological film, such that the projection of a pattern of light on to the bacteria produces a high-definition two-dimensional chemical image (about 100 megapixels per square inch). The spatial control of bacterial gene expression could be used to ‘print’ complex biological materials and to investigate signaling pathways.”[36]

    Voigt and his colleagues also successfully demonstrated a logical AND gate inside bacteria. This latter achievement ranks on a par with the electronic AND gate invention, used by electrical engineers in developing control circuits, which eventually led to the creation of the modern computer. [37]

    With advances spurred on by CRISPR-type developments, Voigt and his colleagues reported that they are employing new forms of Cas9, RNA-guided DNA endonuclease enzyme, such as dCas9, which uses small guide RNAs or sgRNAs, to repress genetic loci via the programmability of RNA:DNA base pairs for building transcriptional logic gates to perform computation in living cells. [38] In 2017, other researchers similarly demonstrated a Boolean logic and arithmetic system to engineer digital computation processes in human cells.[39]

    To fully develop computer systems on biological platforms, engineers will need computational components, as well as circuits that transform the real world of continuous variables, such as temperature, motion, pressure, and electronic analog signals.[40] One such example of this technology resulted in U.S. Patent 9,697,460 (‘460), entitled “Biological analog-to-digital and digital-to-analog converters,” issued (2017) to J. Collins and T. Kuan-Ta Lu.

    Whereas the ‘460 patent relates to discrete bio-computational devices, the concept of adding electronic devices themselves to artificial cells has been around since about 2004 when the  European Commission sponsored a project to develop the Programmable Artificial Cell Evolution, with a specific aim of developing embedded IT using programmable chemical systems that approach artificial cells having properties of self-repair, self-assembly, self-reproduction, and the capability to evolve.[41]  In 2008, the project reported that it had achieved three core functions of artificial cells (a genetic subsystem, a containment system and a metabolic system), and generated novel spatially resolved programmable microfluidic environments for the integration of containment and genetic amplification. As part of the mission the team studied vesicles as a container for one family of artificial cells, which would self-assemble into higher order building blocks using processes similar to computer aided manufacturing systems.

     

                                                                                      IV.           REGULATORY CONSIDERATIONS

     

    In the U.S. and countries that have a system of common law, the foundational legal corpus originates in legislation and judicial decisions. On the civil side, a body of law also exists in the governmental agencies and departments that administrate, regulate and adjudicate the broader legislative and case-based mandates. Patents, drugs, medical research, and medical devices are examples of technology that is in one or another way regulated by agencies.

    Much international regulation is not driven by country-specific statute, but via treaties. Enforcement as to subjects such as intellectual property protection and standards  are thereby addressed.[42] Medical research is addressed in a similar manner.[43] On a U.S. domestic level, Congress may establish agencies, such as the Food and Drug Administration (FDA) to administer, legislate regulation and enforce its policies, viz., implantable/telemetry, medical enhancements. On the other hand, non medical uses could be exempted from regulation, as for example implantable RFID for identification or even genetic editing to improve lifespan, cognitive performance, or even change the color of one’s eyes.

    As genetic editing and implantable technology becomes commonplace, the law needs to establish clarity on ownership and institutional control of the particular technology. This is necessary to: (a) apportion responsibility, performance and warranty issues; (b) to determine rights to access for purposes of upgrading or repair; and (c) intellectual property ownership issues.  As we witness now with drug availability, patents play a major role in distributive justice, i.e., price and availability. In 2018, patent filings around the world reached 3.17 million, representing a 5.8% growth over 2016 figures.[44] This can partially be explained by the fact that patents increasingly represent the currency of competition.

    No U.S. law makes patenting transhuman innovation categorically impermissible, but the Supreme Court has weighed in on patentability when natural phenomena, laws of nature or the basic tools of scientific and technological work lie beyond the domain of patent protection.[45] Along these lines, the U.S. position, since 2004, has been framed by the Weldon Amendment, which makes it illegal to grant patents on human organisms, including fetuses and embryos.[46]

    In the future, any sovereignty might consider legislation banning patents that seek to create monopolies on gene alterations directed at humans. But there will continue to be differences around the world. For example, the European Court of Justice may circumscribe some types of patents and the U.S. other types. In 2011, the European Court of Justice, in Oliver Brüstle vs Greenpeace, opined on whether a patent should be granted for the neural precursor, i.e., stem cells and the processes for their production from embryonic stem cells, and their use for therapy in diseases such as Parkinson’s, Huntington’s, and Alzheimer’s. The decision effectively banned patenting stem cell processes that involved destroying a human embryo.

    Europe Union, Article 6(2)(c) of Directive 98/44/CE specifically deals with the legal notion of “human embryo” in patent law. This article is known as the ethical clause of the Directive, establishing that “Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality.” It proceeds to enumerate inventions that cannot be patented, e.g., “human embryos for industrial or commercial purposes.”

    Yet, as among scientists, no consensus exists regarding prohibitions to germ line editing. In March 2019, eighteen scientists and ethicists from seven countries called for an international governance, including a global moratorium on changing heritable DNA (in sperm, eggs or embryos) to make genetically modified children. They propose the “establishment of an international framework in which nations, while retaining the right to make their own decisions, voluntarily commit to not approve any use of clinical germline editing unless certain conditions are met.” Others have chimed in, such as The New England Journal of Medicine, which published two articles, each in favor of germ line editing.

    In 2017, the U.S. National Academy of Medicine and the National Academy of Sciences published an exhaustive report on human genome editing. [47] The report addressed questions about the human application of genome editing, such as germline editing. It considered balancing potential benefits with unintended risks, governing the use of genome editing, and “incorporating societal values into clinical applications and policy decisions.” But in light of He Jiankui’s germline editing in 2018, it then called for an international commission on the most controversial use of that technology.

    As with any drug or complicated medical intervention, safety is a prime consideration. Manipulating genes in most cases is not straight forward. Unfortunately scientists often have little information about the full effect that any one gene has on the entirety of other potential bodily processes. So, without considerable scientific investigation, altering even one gene may result in deleterious unintended consequences. An added concern has to do with the accuracy of a gene alteration, where a gene engineering tool, such as CRISPR, may not guarantee that one is able to accurately target the gene of interest. Off target genetic interventions can therefor cause  unintended consequences.

    In November, 2018, international academies of science convened the Second International Summit on Human Genome Editing at the University of Hong Kong.[48]  Following the summit, the International Commission on the Clinical Use of Human Germline Genome Editing was convened by the U.S. National Academy of Medicine, the U.S. National Academy of Sciences and the Royal Society of the U.K., with the participation of science and medical academies around the world. The aim of the ICC is, via a society of scientists, clinicians, and regulatory authorities, to develop a framework to consider when assessing potential clinical applications of human germline genome editing. The framework will identify a number of scientific, medical, and ethical requirements that should be deliberated, and could inform the development of a potential pathway from research to clinical use, and whether the society concludes that a particular heritable human genome editing application is acceptable, according to their standards and practices. The first meeting of the commission was held at the National Academy of Sciences in Washington, D.C., August 13, 2019. A second meeting of the commission will take place in London, November 14-15, 2019. [49]

     

                           V.          ETHICAL IMPLICATIONS

     

    For children being born today, the quality and extent of their lives will be driven, not as it has been by genes cast over 3.5 billion years, but in a significant way by genetic editing and the circuitry of new technology.[50]  Thus, beyond policy questions about safety and efficacy, we must face the difficult ethical questions concerning human essence—, that which makes us who we are as a species.

    Consider that as we transition from a humans-as-we-exist today to a Homo futuro form, we risk losing the “I” that makes each of us an individual and at the same time, a part of the whole of humanity, that spirit which sits at our common core. Given that Homo futuro will have potentialities markedly different from those extant in the current version of the species, it might be that a new and different set of Universal values emerge, those which encompass morality, aesthetic preference, human traits, aspirations, struggles, and social order. Issues of individual essence and values are at the surface of the deeper philosophical question about one’s place in the Universe. That said, we must appreciate the inevitability of our evolutionary trajectory, one not based on Nature alone. Thus we need cautiously move forward with so-called progress, i.e., genetic alteration coupled with instantiated AI. This importantly calls for consideration of paradigms that avoid a demise of the human form or its essence, as we know it.

    When any germline edit is made it affects the human gene pool. All humanity is at stake, every one of us. As such germline edits must be scrutinized by some acknowledged agency that considers the extraordinary ramifications. Said in another way, germline editing affects the inalienable rights of all members of the human family. However, even somatic genetic editing, except those which eradicates heritable disease and disability, that reach into the realm of IQ enhancement or other modes of physical superiority, should be allowed only where there is a wide-spread near universal consensus.

    The 1948 Universal Declaration on Human Rights, acknowledged the “inherent dignity” and “equal and inalienable rights of all members of the human family.”  Dignity implies autonomy and the right to self-determination. But, because patents grant monopolies, personhood itself is put at risk as we entangle germline editing and to a lesser degree monopolistic ownership, such as afforded through patenting which implicates elements of the human genome in any significant way. Perversely, because novel synthetic genes may be patentable, there does not appear any logical reason why, when engineered into the human anatomy, that portion of technology also cannot be patented.

    As technology is applied to improve aptitudes, skills and life spans, we risk creating a world of “haves” who can afford and “have nots,” who cannot afford the latest innovations.  As such the situation likely would follow conventional prescription drug patterns, where some “treatments” would be available to most, then a smaller number of “treatments” available to only those who can nominally afford them and finally a select few “treatments” that are cost prohibitive to the vast majority of the population (other analogies might be drawn from disparate and unequal educational opportunities).[51]

    Some computational processing therapies might not have a health-related purpose, but rather will aim to provide a greater level of intellectual quickness or greater access to commercial opportunities.  Part of what will distinguish Homo futuro having implanted computational devices from a population that does not, will be features and enhancements that can connect to the Internet, opening vast opportunities, clinical monitoring, and consequential risk, namely hacking or direct mind control.

    As mentioned, undoubtedly there will be a substantial number of individuals or entire populations, who will not have access to a world of bioengineered implants/telemetry for medical necessity, let alone enhancements to one’s intellect, longer and healthier lives and improved skills.  As such we need to begin a conversation that reevaluates the implications for a society that espouses principles for distributive justice. The inequitable distribution of implants and genetic modification will affect each of us and certainly our progeny—just as the inequitable distribution of health care, education, clean air, water, water rights, or land affects those that live among us presently.[52]

     

    VI.          CONCLUSION

     

     

    As present-day prosthetics or gene therapies apparently serve to remediate anatomical dysfunction, few would argue their importance in society. However, technology to improve one’s natural intellect or attained skill through genetic editing or even a built-in prosthetic, (e.g., leading to mathematical quickness, business acumen, musical virtuosity, or superior athleticism), raises concerns having to do with an individual’s persona, his or her essence—, that which sits at the core of one’s being.

    As society transitions to dependence on in-the-body technology, perhaps at the top of anyone’s list of concerns would be: at what point will attitudes begin to change about what the conventional notion of being ‘human’ means? We must commence a dialogue to explore whether it’s possible as we move headlong into the future to conserve our current blueprint, and especially before we entrust our destiny to the intelligent designers of tomorrow. As scientists, programmers and engineers, we need to understand the moral implications of where we are headed.

     

     

     

     

    REFERENCES

    [1] This manuscript contains commentary, data and conclusions, some of which is original and others of which has been disseminated in the author’s recent publications, among which are: Conserving Humanity at the Dawn of Posthuman Technology, (Palgrave Macmillan, 2019) and The Techno-Human Shell-A Jump in the Evolutionary Gap (Sunbury Press, 2012).

    [2] A neologism “unawareable” has  recent emerged  and may be in the process of entering common use, and throughout this paper, it should be considered a subset of the in-the-body, as “unawareable,” relates to devices that one is not aware of its physical presence, where as in-the-body devices may, and does in many instances, present a frequent awareness of it being a foreign object present within the body.

    [3] Human germline editing produces change that is heritable, whereas somatic editing involves change that only affects the individual, but not the next generation.

    [4] Ueland, J.,  China’s CRISPR twins might have had their brains inadvertently enhanced, MIT Technology Review, See, https://www.technologyreview.com/s/612997/the-crispr-twins-had-their-brains-altered/ (last visited 08/22/2-019);  Miou Zhou, et al.,  CCR5 is a suppressor for cortical plasticity and hippocampal learning and memory, eLife 2016;5:e20985 doi: 10.7554/eLife.20985.

    [5] Today’s pacemaker comprises a telemetry system, an analog sensing amplifier, an analog output circuit, and a microprocessor controller. See, R. S. Sanders and M. T. Lee, Implantable pacemakers, Proceedings of the IEEE, vol. 84, no. 3, pp. 480-486, 1996. The leading pacemaker manufacturer Medtronic designs its microprocessors to operate on a few microamperes between 1 or 2 V. The company patterned its early microprocessors after the 16-bit RCA 1802 and Motorola 6805 microprocessors.

    [6] Sheridan, C. (February 2011). “Gene therapy finds its niche”. Nature Biotechnology. 29 (2): 121–8. doi:10.1038/nbt.1769. PMID 21301435.

    [7] Pacing devices, similar to the pacemaker, are used to reduce the effects of Parkinson’s disease, to correct obsessive compulsive disorders, to stop tremors, reduce depression, dystonia, epilepsy, gastroparesis, obesity, bowel disorders, interstitial cystitis, urinary incontinence, and chronic back pain. Arnold J. Greenspon, et al., Trends in Permanent Pacemaker Implantation in the United States From 1993 to 2009: Increasing Complexity of Patients and Procedure writes, “Between 1993 and 2009, 2.9 million patients received a permanent pacemaker in the United States. During this time, overall use increased by 55.6%, from 121,300 in 1993 to 188,700 in 2009. This represents 46.7 implantations per 100,000 persons in 1993, which increased to 61.6 implantations per 100,000 persons in 2009.” J Am Coll Cardiol. 2012; 60(16):1540-1545 doi:10.1016/ j.jacc. 2012.07.017.

    [8] Fukuyama argues in Our Posthuman Future (Fukuyama, 2002), for restrictions on the use of biotechnology for “enhancement.” President George W. Bush convened the U.S. President’s Council on Bioethics, under the leadership of Chairman Leon Kass, to study and critique of human enhancement medicine leading the authorship of Beyond Therapy, taking essentially the same position as Fukuyama, who incidentally was a member of the same commission. (President’s Council on Bioethics, 2003).

    [9] Dr. M.C. Roco, Chair of the U.S. National Science and Technology Council Subcommittee on Nanoscale Science, Engineering, and Technology writes: “Converging, emerging technologies refers to the synergistic combination of nanotechnology, biotechnology, information technology and cognitive sciences (NBIC), each of which is currently progressing at a rapid rate, experiencing qualitative advancements, and interacting with more established fields such as mathematics and environmental technologies.” J Nanopart Res DOI 10.1007/s11051-007-9269-8 “Information Technology and Cognitive Science,” Mihail C. Roco, citing  Roco and Bainbridge, eds. (Arlington, VA: National Science Foundation, 2002).

    [10] I refer to Kurzweil’s Law of Accelerated Return, see, http://www.kurzweilai.net/the-law-of-accelerating-returns.

    [11] I coined the word Homo futuro, a technological offshoot of Homo sapiens, modified via genetic enhancement or computationally-based implantable in-the-body processors exhibiting greater intellect and creative capacities, who will have longer, healthier lives, and who will off-load much of the world’s mundane, arduous and dangerous work to subservient successors and ever improving humanoid robots.

    [12] Scientists Attempt Controversial Experiment To Edit DNA In Human Sperm Using CRISPR, August 22, 2019, Stein, R., NPR, Morning Edition, https://www.npr.org/sections/health-shots/2019/08/22/746321083/scientists-attempt-controversial-experiment-to-edit-dna-in-human-sperm-using-cri?utm_source=npr_newsletter&utm_medium=email&utm_content=20190822&utm_campaign=&utm_term=&utm_id=46555144, (Last visited, 08/22/2019).

    [13] M.L. Maeder et al. Development of a gene-editing approach to restore vision loss in Leber congenital amaurosis type 10. Nature Medicine. Vol. 25, February 2019, p. 229. doi:10.1038/s41591-018-0327-9.

    [14] Sniekers, S. et al. Genome-wide association meta-analysis of 78,308 individuals identifies new loci and genes influencing human intelligence. Nat. Genet 49,1107–1112 (2017).

    [15] Ukkola-Vuoti L1, et al., (2013) Genome-wide copy number variation analysis in extended families and unrelated individuals characterized for musical aptitude and creativity in music. PLoS One. 2013;8(2):e56356. doi: 10.1371/journal.pone.0056356.

    [16] Dudbridge, Frank (2013-03-21). “Power and Predictive Accuracy of Polygenic Risk Scores”. PLOS Genet. 9 (3): e1003348. doi:10.1371/journal.pgen.1003348. ISSN 1553-7404. PMC 3605113. PMID 23555274.

    [17] Lee, J. J., et al  (Aug. 2018). Gene discovery and polygenic prediction from a genome-wide association study of educational attainment in 1.1 million individuals, Nature Genetics. Vol. 50, Issue 8.

    [18] Lee, J. J.; et al (July 2016). “Predicting educational achievement from DNA.” Molecular Psychiatry. doi:10.1038/mp.2016.107. ISSN 1476-5578. PMID 27431296.

    [19] Davies, G, et al. (2011). “Genome-wide association studies establish that human intelligence is highly heritable and polygenic”. Mol Psychiatry. 16 (10): 996–1005. doi:10.1038/mp.2011.85. PMC 3182557. PMID 21826061.

    [20] Plomin, R. Blueprint, (2018) How DNA Makes Us Who We Are, MIT Press, Cambridge, MA.

    [21] Yong, E. (2013). “Chinese project probes the genetics of genius”. Nature. 497 (7449): 297–299. doi:10.1038/497297a.

    [22] Shulman, C., et al., (2014). “Embryo Selection for Cognitive Enhancement: Curiosity or Game-changer?”. Global Policy. 5 (1): 85–92. doi:10.1111/1758-5899.12123. ISSN 1758-5899.

    [23] Ensembles of CA3 and CA1 hippocampal neurons, recorded from rats performing a delayed-nonmatch-to-sample (DNMS) memory task, exhibited successful encoding of trial-specific sample lever information in the form of different spatiotemporal firing patterns. See, Berger, T. W., et al., (2011). A cortical neural prosthesis for restoring and enhancing memory. Journal of neural engineering, 8(4), 046017.

    [24] In well-publicized example of using computers interfaced to the brain, individuals, previously unable to move their limbs, as a result of damaged brain stems, have had electrodes implanted in their motor cortex to guide a robotic arm through neuronal signals associated with the intention to move. See, “People with paralysis control robotic arms using brain-computer interface,” May 16, 2012, https://news.brown.edu/articles/2012/05/braingate2.

    [25] The J. Craig Venter Institute is a non-profit genomics research institute founded by J. Craig Venter, in October 2006. The Institute consolidated four organizations: the Center for the Advancement of Genomics, The Institute for Genomic Research, the Institute for Biological Energy Alternatives, and the J. Craig Venter Science Foundation Joint Technology Center.

    [26] JCVI had created the largest man-made DNA structure by synthesizing and assembling the 582,970 base pair genome of a bacterium, Mycoplasma genitalium JCVI-1.0.

    [27] J. Craig Venter et al., (2010) “Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome,” Science.

    [28] For a full discussion of synthetic biology read: New Directions: The Ethics of Synthetic Biology and Emerging Technologies, Presidential Commission for the Study of Bioethical Issues, 2010.

    [29] Cheng, A.; Lu, T. K. (2012). “Synthetic Biology: An Emerging Engineering Discipline.” Annual Review of Biomedical Engineering. 14 (1): 155–178. doi:10.1146/annurev-bioeng-071811-150118. PMID 22577777.

    [30] Purnick, P. E.M., and Weiss, R. “The second wave of synthetic biology: from modules to systems.” Nature Reviews Molecular Cell Biology, vol. 10, no. 6, 2009, p. 410+. Health Reference Center Academic, http://link.galegroup.com/apps/doc/A201086861/HRCA?u=a13qu&sid=HRCA&xid=cabdf1d3.

    [31] Kaebnick, G. E.,. Gusmano, M. K. and Murray, T. H., “The Ethics of Synthetic Biology: Next Steps and Prior Questions,” Synthetic Future: Can We Create What We Want Out of Synthetic Biology?, special report, Hastings Center Report 44, no. 6 (2014): S4‐S26. DOI: 10.1002/hast.392

    [32] T.S. Gardner, et al., “Construction of a genetic toggle switch in Escherichia coli,” Nature 403 (6767) (January 2000).

    [33] Jerome Bonnet, et al., “Amplifying Genetic Logic Gates” Science:  Vol. 340  no. 6132, May 3, 2013, 599-603.  http://www.sciencemag.org/content/early/2013/03/27/science.1232758.abstract?sid=27de36f9-9333-4a17-b891-cdb5c2567577, (Last visited 01/02/2014).

    [34] Rinaudo K, Bleris L, Maddamsetti R, Subramanian S, Weiss R, Benenson Y (July 2007). “A universal RNAi-based logic evaluator that operates in mammalian cells”. Nature Biotechnology. 25 (7): 795–801. doi:10.1038/nbt1307. PMID 17515909.

    [35] Singh, V. (December 2014). “Recent advances and opportunities in synthetic logic gates engineering in living cells”. Systems and Synthetic Biology. 8 (4): 271–82. doi:10.1007/s11693-014-9154-6. PMC 4571725. PMID 26396651.

    [36] A. Levskaya, “Synthetic biology: engineering Escherichia coli to see light,” Nature 438 (7067) (2005).

    [37] Walther Bothe, inventor of the coincidence circuit, got part of the 1954 Nobel Prize in physics, for the first modern electronic AND gate in 1924. Konrad Zuse designed and built electromechanical logic gates for his computer Z1 (from 1935–38).

    [38] Nielsen, A.A.K. and Voigt, C.A. (2014) Multi-input CRISPR/Cas genetic circuits that interface host regulatory networks Molecular Systems Biology 10(11): 763

    [39]  Weinberg, B.H., et al; (May 2017). “Large-scale design of robust genetic circuits with multiple inputs and outputs for mammalian cells”. Nature Biotechnology. 35 (5): 453–462. doi:10.1038/nbt.3805. PMC 5423837. PMID 28346402.

    [40] According to one developer of these devices, “The ability of DNA-based tracers to store information makes them attractive for performing distributed measurements and delivering localized information upon recollection. . .  We have demonstrated that smart DNA-based tracers can measure temperature, oxidative stress, and light intensity or duration.” See, http://www.fml.ethz.ch/research/fosslab.html#CED4.

    [41] Programmable Artificial Cell Evolution (PACE); See, https://cordis.europa.eu/project/rcn/74624/factsheet/en, (Last visited 08/22/2019).

    [42] The World Intellectual Property Organization (WIPO) with 184 member states is the United Nations agency that coordinates international treaties regarding intellectual property rights. See,http://www.giswatch.org/institutional-overview/civil-society-participation/world-intellectual-property-organisation-wipo.

    [43] The Helsinki Declaration (Ethical Principles for Medical Research Involving Human Subjects) was amended by the World Medical Association’s General Assembly in 2008. This document provides principles physicians and researchers must consider when involving humans as research subjects. The Statement on Gene Therapy Research initiated by the Human Genome Organization in 2001 provides a legal baseline for all countries. Human Genome Organization’s document emphasizes offers recommendations for somatic gene therapy.

    [44] WIPO (2018). World Intellectual Property

    Indicators 2018. Geneva: World Intellectual Property

    Organization.

    [45] The U.S. patent office publishes the Manual of Patent Examining Procedure (MPEP), which encapsulates its position on patenting various subject matter. MPEP 2106.04 deals with whether a subject is patent eligible under the U.S. statute 35 USC 101 (i.e., process, machine, manufacture, or composition of matter). The eligibility analysis expands on these terms, and limits claims directed to nothing more than abstract ideas, such as mathematical algorithms, or natural phenomena, laws of nature and basic tools of scientific and technological work lie beyond the domain of patent protection. Diamond v. Diehr, 450 U.S. 175, 185, 209 USPQ 1, 7 (1981). Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, 1979 (2013)); Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978). Myriad, 133 S. Ct. at 2112, 2116, 106 USPQ2d at 1976, 1978 (noting that Myriad discovered the BRCA1 and BRCA1 genes, which discovery was not patentable).

    [46] Weldon Amendment, Consolidated Appropriations Act,. 2009, Pub. L. No. 111-117, 123 Stat 3034.

    [47] Human Genome Editing: Science, Ethics, and Governance (2017), available at http://dels.nas.edu/Report/Human-Genome-Editing-Science-Ethics/24623.

    [48] https://www.nap.edu/catalog/25343/second-international-summit-on-human-genome-editing-continuing-the-global-discussion.

    [49] At present, financial support for the Commission is being provided by the U.S. National Institutes of Health, The Rockefeller Foundation, the Royal Society of the U.K., the Cicerone Endowment Fund of the U.S. National Academy of Sciences, and the NAM Initiatives Fund of the U.S. National Academy of Medicine.

    [50] “. . .most scientists hold that the first organisms on Earth were much like bacteria of today…” http://www.actionbioscience.org/newfrontiers/jeffares_poole.html (Last visited, 8/7/2012).

    [51] In certain instances, governments operating under international agreements and treaties, such as the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights Agreement (“TRIPS Agreement”), and the Doha Declaration on TRIPS and Public Health permit the issuance of compulsory licenses in order to enhance social and public welfare, while protecting the interests of a patent owner. See, http://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm (Last visited 12/17/2012).

    [52] By 2012 estimates, 61 million children around the world do not attend school.

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