On the eve of the U.S. National Academies of Sciences and MedicineInternational Summit on Human Gene Editing, theCenter for Genetics and Societyand Friends of the Earth released a new report Extreme Genetic Engineering and the Human Future: Reclaiming Emerging Biotechnologies for the Common Good.

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Summary: Recent research in genetic engineering and synthetic biology has enabled scientists to artificially redesign life everything from microbes to people. Amid the breakneck speed of recent developments in genetic engineering and synthetic biology that could be used to alter human DNA, this report examines health, regulatory, social and ethical questions about proposals ranging from genetically altering human gut bacteria to implementing germline editing altering human embryos and reproductive cells to produce permanent, hereditary genetic modification of future children and generations. It also examines the systemic and commercial incentives to rush newly discovered biotechnologies to market, regardless of their social utility and ahead of appropriate, transparent assessment and oversight.

The report calls for:

BackgroundEmerging biotechnologies are enabling researchers and corporations to control and manipulate the basic building blocks of life. The impacts of these technologies are already rippling through society, as corporations patent our genes and those of other organisms.

Researchershail synthetic biologya new set of extreme genetic engineering techniques as the future of manufacturing, engineering and medicine. Some of these techniques have also brought the prospect of genetically engineered humans closer to reality.

In April 2015, researchers from Sun Yat-sen University reported that they had used gene editing techniques toalter human embryos, thefirst time in historythis is known to have occurred. In September 2015, a group of six major UK research funders and theHinxton Group, an international consortium on stem cells and ethics, both released statements advocating for gene editing research in human embryos.

Recent genetic engineering discussions have focused onCRISPR/Cas9, a molecular complex intended to edit a genome by cutting out and/or splicing in parts of DNA sequences. This technique (which is not yet perfected, but is rapidly being refined) has been promoted as a promising tool to prevent genetic diseases. But, if used to modify embryos, it could result in permanent, heritable changes to future generations.

Risks and concernsThere are significant scientific, environmental, health and ethical challenges to the human applications of synthetic biology, which currently include reengineering the human microbiome, gene drives, xenotransplantation and gene editing.

Prominent individuals and organizations, including some scientists working in the field, haveexpressed deep concernsabout the unforeseen consequences that human applications of genetic engineering could have. Some believe there are lines that should not be crossed, especially attempts to create genetically modified human beings (sometimes called designer babies), and suggest that the risks to individuals and to society will never be worth any supposed benefit. Others argue that if its safe, anything goes. A few even hypothesize that humanity will have a moral duty to genetically enhance our children if the technology and underpinning genetics progress.

Using gene editing at the request of health-impacted patients with specific diseases, often referred to as somatic gene therapy, may be acceptable, if it is feasible, proven safe and the patient understands implications of such procedures. But using the same techniques to modify embryos in order to make permanent changes to future generations and to our common genetic heritage thehuman germlineas it is known is far more problematic. It is exceedingly difficult to justify on medical grounds, and carries enormous risks, both for individuals and society. The advent of human germline genetic engineering could lead to the development of new forms of social inequality, discrimination and conflict. Among the risks of heritable genetic modification is the possibility of a modern version of eugenics, with human society being divided into genetic haves and have-nots.

Lack of regulationFriends of the Earth believes that everyone needs to be aware of these new society-changing technologies and be able to engage in decisions about what is safe, ethical and beneficial.

Despite the outstanding environmental, safety and ethical concerns,the synthetic biology marketis expected to reach close to $39 billion by 2020. Already products of synthetic biology, such as synthetic biology-derived vanillin, stevia and oils, are entering food and consumer products ahead of independent environmental and safety assessments, oversight and labeling a worrying precedent for human applications.

Dozens of countries, including those with the most highly developed biotechnology sectors, have explicitly banned heritable human genetic modification, as has the Council of Europes binding 1997 Convention on Human Rights and Biomedicine. However, many countries, including the U.S., have not already enacted such a prohibition.

Friends of the Earth reiterates the call in Principles for the Oversight of Synthetic Biology, signed by 116 civil society groups from around the world, for a prohibition on the use of gene editing and synthetic biology to manipulate the human germline; for safeguards to be implemented to protect public health and the environment from the novel risks of synthetic biology; and open, meaningful and full public participation in decisions regarding its uses. Countries that have not already adopted laws prohibiting the creation of genetically modified human beings, especially including the United States, should do so as soon as possible.

Further information on this topic and recommendations are outlined in the new report Extreme Genetic Engineering and the Human Future.

Gene patentsSynthetic biology techniques and applications for human engineering raise significant questions about intellectual property rights and the ownership of DNA.

About 20 percent of the human genome has already been patented by corporations and scientists, granting companies ownership and sole access to these fundamental building blocks of life. Gene patents are dangerous and unfair: They give corporations monopolies over potentially live-saving research and treatments that are based on pieces of genetic code that have evolved naturally over millenia and are part of our common human heritage.

Scientists are only beginning to understand the complexity of the human genome. Research to date indicates that many common diseases, including cancer, heart disease and Alzheimers, correlate with a combination of environmental and genetic factors.

Patents on genes limit the ability of scientists and health researchers to learn more about gene-to-disease correlations and limit progress in fields that could benefit the health of all people, resulting in increasing prices for tests, impediments to alternative research and barriers to patients access to potentially life-saving technology. As weve seen in the case of patents on two genes that correlate to increased risk for breast cancer and ovarian cancer, gene patents can also prevent patients from receiving second opinions on genetic diagnostic tests.

Friends of the Earth is working to ban the patenting of human genes and all genes that occur naturally on our planet. Our current focus is passing a bill in Congress that would end this practices in the U.S. by reinforcing a fundamental principle of patent law that patents only apply to new, non-obvious products that do not already occur in nature. Decoding genetic material is akin to figuring out the composition of water. Both water and genetic material are common goods that occur naturally. Neither should be patentable.

In a June 2013 decision, the Supreme C
ourt ruled that human genes are may no longer be patented, invalidating the existing patents for over 20 percent of the human genome. Friends of the Earth, represented by the Center for Food Safety, had submitted an amici brief arguing that naturally occurring genes, DNA and cDNA must not be patentable. This marked a huge victory on the issue only apply to new, non-obvious products that do not already occurring in nature.

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Extreme genetic engineering and the human future - Friends ...