A major new technology known as Gene Editing has gained significant attention in recent months. Its advocates claim it will revolutionize everything from agriculture production to disease treatment. None other than Bill Gates has just come out in an article in the US foreign policy magazine Foreign Affairs in praise of the promise of gene editing. Yet a closer investigation suggests that all is not so ideal with Gene Editing. New peer reviewed studies suggest it could cause cancer. The question is whether this technology, which is highly controversial, is little more than a stealth way to introduce GMO genetic manipulation by way of another technique.
The scientific magazine, Nature Studies, has published two studies that suggest that gene-editing techniques may weaken a person’s ability to fight off tumors, and “could give rise to cancer, raising concerns about for the safety of CRISPR-based gene therapies.” The studies were done by Sweden’s Karolinska Institute and by the pharmaceutical firm, Novartis. Cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient the studies found. That could make some CRISPR’d cells ticking time bombs, according to researchers from Karolinska Institute and, in a separate study, by Novartis.
The CEO of CRISPR Therapeutics, Sam Kulkarni, admitted that the results are “plausible.” He added, “it’s something we need to pay attention to, especially as CRISPR expands to more diseases.” Given the stakes that is a notably nonchalant response.
Genes out of the bottle
The issue of gene editing to cut or modify DNA of a plant, animal or potentially human beings is by no means mature let alone fully tested or proven safe as the two new studies suggest. CRISPR, far the most cited gene editing technology, was developed only in 2013. In 2015 at a London TED conference geneticist Jennifer Doudna presented what is known as CRISPR-Cas9, an acronym for “Clustered regularly-interspaced short palindromic repeats.” It’s a gene-editing platform using a bacterially-derived protein, Cas9 that supposedly allows genetic engineers to target and break the DNA double strand at a precise location within a given genome for the first time.
The technique also has significant problems. It has been shown repeatedly that only a small minority of cells into which CRISPR is introduced, usually by a virus, actually have their genomes edited as intended.
In China scientists used human embryos given by donors of embryos that could not have resulted in a live birth, to edit a specific gene. The results were a bad failure as the tested cells failed to contain the intended genetic material. Lead researcher Jungiu Huang told Nature. “That’s why we stopped. We still think it’s too immature.”
A newer form of gene editing known as gene drive, as I noted in an earlier article, has an alarming potential to become a Frankenstein monster. Gene Drive gene editing, which is being heavily funded by the Pentagon’s DARPA, aims to force a genetic modification to spread through an entire population, whether of mosquitoes or potentially humans, in just a few generations.
The scientist who first suggested developing gene drives in gene editing, Harvard biologist Kevin Esvelt has publicly warned that development of gene editing in conjunction with gene drive technologies have alarming potential to go awry. He notes how often CRISPR messes up and the likelihood of protective mutations arising, making even benign gene drives aggressive. He stresses, “Just a few engineered organisms could irrevocably alter an ecosystem.” Esvelt’s computer gene drive simulations calculated that a resulting edited gene “can spread to 99 percent of a population in as few as 10 generations, and persist for more than 200 generations.”
Despite such warnings and problems, the US Department of Agriculture has endorsed gene editing, without any special testing, for use in agriculture crops. The Department of Agriculture has decided that genetically edited plants are like plants with naturally occurring mutations and thus require no special regulations and raise no special safety concerns, despite all contrary indications. And the Pentagon’s DARPA is spending millions of dollars to research it.
Enter Bill Gates
Most recently the Microsoft founder Bill Gates, a long-time advocate of eugenics, population control and of GMO, has come out in a strong endorsement of Gene Editing. In an article in the May/June 2018 magazine of the New York Council on Foreign Relations, Foreign Affairs, Gates hails gene editing technologies, explicitly CRISPR. In the article Gates argues that CRISPR and other gene-editing techniques should be used globally to meet growing demand for food and to improve disease prevention, particularly for malaria. “It would be a tragedy to pass up the opportunity,” he wrote. In point of fact, the Bill and Melinda Gates Foundation, which among other projects is working to spread GMO plants into African agriculture and which is a major shareholder of Monsanto, now Bayer AG, has financed gene editing projects for a decade.
Gates and his foundation are not at all neutral in the area of Gene Editing and definitely not in the related highly controversial Gene Drive applications. In December 2916 in Cancun Mexico at the UN Biodiversity Conference, more than 170 NGOs from around the world including the German Heinrich-Böll Stiftung, Friends of the Earth, La Via Campesina and others called for a moratorium on gene drive research.
However, inside the UN at their dedicated website the online discussion is dominated by something called the Ad Hoc Technical Expert Group on Synthetic Biology (AHTEG), a UN-approved “expert group” on synthetic biology. AHTEG is indirectly funded by the Bill & Melinda Gates Foundation through the PR company, Emerging Ag which wages an intense pro-Gene Drive lobby campaign within the UN. Emerging Ag has recruited some 60 biology researchers including from Bayer Crop Sciences to promote the high-risk gene drive technology. They advocate US-level non-regulation of gene editing and gene drive as does Gates, and they vigorously oppose any moratorium.
In his Foreign Affairs article Gates argues, “Gene editing to make crops more abundant and resilient could be a lifesaver on a massive scale…For a decade, the Bill & Melinda Gates Foundation has been backing research into the use of gene editing in agriculture.” He adds, without proof, “there is reason to be optimistic that creating gene drives in malaria-spreading mosquitoes will not do much, if any, harm to the environment.”
With the Bill & Melinda Gates Foundation, the USDA and the Pentagon DARPA all involved energetically advancing gene editing and especially the highly-risky Gene Drive applications in species such as mosquitoes, one has to ask is gene editing becoming the new name for eugenics in light of the fact that GMO technologies have been so vigorously opposed by citizen groups around the world. Honest scientific research is of course legitimate and necessary. But unregulated experimentation with technologies that could wipe out entire species is definitely not the same as planting a variety of hybrid corn. The CEO of CRISPR Therapeutics, Sam Kulkarni, admitted that the results are “plausible.” He added, “it’s something we need to pay attention to, especially as CRISPR expands to more diseases.” Given the stakes that is a notably nonchalant response.
Are Gene Edited Cows or Humans What We Really Need?
Scientists using the “second generation” of genetic manipulation technology have used gene-editing to alter the DNA of breed of cattle so that they supposedly do not grow horns. At around the same time another group of scientists claim to have injected human cells into monkeys to create chimeras, as in the ancient Greek myths of beings part lion, part snake. Earlier this year a group of Chinese researchers claimed to have deliberately gene-edited monkey clones with a mental disturbance. What few realize is that all this is taking place almost entirely without any serious health and safety regulation. Is this what mankind really needs at this juncture?
Gene-edited hornless cows
Scientists at the biotech company Recombinetics have filed a patent on cattle it has genetically engineered to not grow horns using gene-editing methods. They claimed the process to be safe and effective. However tests by scientists at the US Food and Drug Administration revealed that the CRISPR gene-editing process resulted in “unexpected alterations” of the genome, including “complex genomic rearrangements at or near the target site in 34 mammalian genome editing experiments.”
The FDA researchers found gene-editing errors in the genome of the animals that were being overlooked. They identified major unintended effects. The gene scissors used, known as TALENs, are often described as highly precise. However, the FDA research showed that apart from the desired gene sequences being inserted into the genome, DNA originating from genetically engineered bacteria used in the process was also inserted. Specifically, they found presence of unintended antibiotic resistance genes in the gene-edited cattle. Recombinetics reports that it is also developing a precision gene-editing breeding method to eliminate the need to castrate pigs. Unintended effects?
Human Monkey Brain?
In another recent application of the gene-editing technology, an international group of scientists working in China have used gene-editing to produce human-monkey chimeras. According to the Spanish paper, El Pais, a team of researchers led by Prof Juan Carlos Izpisúa Belmonte from the Salk Institute in the USA have produced monkey-human chimeras. The report says that the research was conducted in China “to avoid legal issues.” That should give pause.
Belmonte’s team states that the research is aimed at solving the problem of lack of organ donors as well as organ transplant rejection. Belmonte apparently has managed to produce both pig embryos and sheep embryos which contain human cells. They took cells from an adult human and reprogrammed them to become stem cells, which can give rise to any type of cell in the body. They are then introduced into the embryo of another species, such as the monkey or sheep or pigs.
Commenting on the implications of using gene-editing to produce human-animal chimeras, Prof Robin Lovell-Badge, a biologist from London’s Francis Crick Institute admits potential problems: “How do you restrict the contribution of the human cells just to the organ that you want to make?” he said. “If that is a pancreas or a heart or something, or kidney, then that is fine, if you manage to do that. [But] if you allow these animals to go all the way through and be born, if you have a big contribution to the central nervous system from the human cells, then that obviously becomes a concern.”
Other controversial China CRISPR gene-editing experiments have involved adding human brain genes, MCPH1, or microcephalin to monkeys. The gene-editing scientist, Bing Su, claimed, based on very small test results, that the monkeys seemed to be “smarter.” Bing Su and collaborators at the Yunnan Key Laboratory of Primate Biomedical Research exposed monkey embryos to a virus carrying the human version of microcephalin. They generated 11 monkeys, five of which survived to take part in a battery of brain measurements. The monkeys each have between two and nine copies of the human gene in their bodies. University of Colorado geneticist, James Sikela is critical: “The use of transgenic monkeys to study human genes linked to brain evolution is a very risky road to take.”
These are only several of the more alarming recent experiments using gene-editing CRISPR. The significant problem is that there is no scientific neutral oversight as to what experiments are being done. Because CRISPR requires very little relative investment in technology, it can be widely used even by irresponsible experimenters.
CRISPR is defined as a “RNA-guided gene-editing platform that makes use of a bacterially-derived protein (Cas9) and a synthetic guide RNA to introduce a double strand break at a specific location within the genome.” The widespread experimenting with CRISPR-CAS9, the currently most widely used, has only been around since about 2015. Geneticists back in the 1970’s were restricted to costly labs using highly trained scientists and strict controls. With CRISPR gene editing, the process is extraordinarily cheap and seemingly easy to use. As one critic described it, “anyone can buy some CAS9 for a few hundred bucks, any halfway decent lab can use it to alter the DNA of anything…We might be able to wipe out entire species on a whim…”
Potentially CRISPR gene-editing technology might enable positive change as well, such as treatments for genetic diseases; altering the germline of humans, animals, and other organisms; and modifying the genes of food crops for positive traits. We don’t know at this point. Yet the degree of unbiased scientific and government oversight over use of CRISPR is appalling.
Lack of Regulatory Oversight
In 2018 European Court of Justice ruled that organisms that arise from a new technique called directed mutagenesis (gene-editing) are GMOs as defined by the EU GMO Directive. As such they should be regulated in the same strict way as GMOs produced in the EU using older techniques. The ruling was greeted as a sane, rational step to ensure the health and safety of people and the planet is priority.
The interests backing CRISPR and other gene-editing, were not pleased. However, immediately the ECJ ruling was attacked as a departure from “science-based decision making” and “backward looking and hostile to progress,” even though the judges carefully consulted a variety of expert scientists. The powerful GMO industry lobby has organized an effort to have the new EU Commission create “a new legal regulatory framework for these new techniques,” one that is far less restrictive we can be sure.
In the US where Monsanto and the GMO industry has succeeded in creating effectively no government regulation of GMO plants such as corn or soybeans or cotton, the biotech industry has been more successful. The USDA recently proposed excluding the new gene-editing technologies such as CRISPR from in effect any regulation. This ignores the purpose of such regulation which is to hold the health and safety of the individual and of the environment paramount to any potential marketing gains from easy regulation. It is the well-established Precautionary Principle. That principle holds that government has a social responsibility to protect the public from exposure to harm, when scientific investigation has found a plausible risk. The onus of proof is on the GMO industry not the public. Just because they call their work “biotech” does not axiomatically mean that it is good for us. That we must carefully evaluate, most especially in a field such as gene-editing with the potential to “wipe out entire species on a whim …”