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by Markus PohlmannGattaca is a 1997 Hollywood film which features the distinctions between genetically improved humans and the naturally conceived ones, known as "in-valids" or "God-children". The title "Gattaca" is composed of the abbreviations of the four nucleobases of DNA: A for adenine, C for cytosine, G for guanine and T for thymine. The sequence of these bases as GATTACA can surprisingly often be found in human DNA. Now in China, for the first time ever, the path seems to have been opened for genetically engineered humans, as the twins "Nana" and "Lulu", were born into the world. Another genetically edited baby is to follow. This has not yet been confirmed by appropriate publications. But the Chinese authorities have not contradicted that and Dr. He Jiankui, the scientist in question, has already been kept under guard on the basis of preliminary investigations. The Chinese Ministry of Health responded to this issue in a prompt manner not typical of the unwieldy bureaucracy in Beijing and ordered any research projects of similar nature to be immediately halted.[caption id="attachment_10887" align="alignnone" width="3840"] Dr. He, source: Wikipedia[/caption]What is otherwise written in science-fiction movies for mad scientists and all too often ends in monster horror, was apparently secretly and quietly practiced in China and then advertised with YouTube videos. And these genetic modifications are no longer easy to get rid of, but are likely to be inherited. With CRISPR / Cas9 (clustered regularly interspaced short palindromic repeats / CRISPR associated protein 9), all the requirements were met for genetically engineered humans and it was only a matter of time before anyone would break the rules and introduce genetically modified babies into the world. The door was broken with a breach of the rules of the international academic community and the rather unclear regulations in China, and we will most likely be unable to close them.Everything starts with loose national regulations. In China, the relevant regulations date back to 2003 and have not yet been updated since. Otherwise, there are only ethical guidelines from the Ministry of Health. Wang Yue, a professor of Peking University specializing in health law opinionated that “even though the Ministry of Health has issued ethical rules, the legal responsibility is unclear and the penalties are very light”. Nevertheless, Dr. He, the scientist responsible for the genetically modified babies is now put under house arrest and the activities of the Chinese authorities suggest a criminal prosecution against genetic manipulation, even though it remains unclear in what form this should take place. Xinhua, the official news agency, reported on a first investigation report that “This behaviour seriously violated ethics, scientific research integrity and relevant state regulations causing adverse effects at home and abroad.”[caption id="attachment_10884" align="alignnone" width="2147"] Source: Wikipedia[/caption]Dr. He is in a pioneering field of science in which many have already experimented with genetically engineered modifications, but without bringing embryos to fruition. Genetic manipulations of human embryos have been carried out for research purposes in the United Kingdom, the United States, Sweden and China. In 2015, a team led by Huang Junjiu of Sun Yat-sen University in Guangzhou had genetically engineered 86 human embryos for research purposes, but then stopped the trials because of the low success rate. Although there are restrictions on stem cell research in many countries and genetic manipulation for reproduction purposes is completely prohibited, just as many countries still have ambivalent, ambiguous or loose regulations. This has created a competitive situation in the field of human gene technology, which has obviously now increased the readiness for rule breaks.The 35-year-old Dr. He Jiankui was born to a peasant family in China’s Hunan Province. He studied contemporary physics at University of Science and Technology of China and earned his doctoral degree in biophysics at Rice University in Houston, Texas. After that he spent one year at Stephen Quake Laboratory of Stanford University as a post-doctoral research associate. Prof. Quake was not only a leading scientist in gene sequencing, but also a multi-millionaire who founded or helped found more than a dozen tech companies, including three listed ones. In the US, Dr. He learned not only about the world of genetic engineering research, but also about the parallel world of the billion-dollar business of genetic engineering. CRISPR alone has multiplied the investments made by bio-science companies and the global market for gene manipulation continues to grow. Upon returning to China in 2012 to join the Department of Biology of Southern University of Science and Technology (SUST) in Shenzhen, Dr. He founded his first company: Direct Genomics Co., Ltd., a company valued in 2017 at RMB 1.5 billion (€200 million) in which he controlled, directly and indirectly, over 1/3 of the shares. Later, he also became the largest shareholder in Nanke Life-Sciences Co., Ltd., a company in which SUST also participated. The main product of these two companies was the 3rd-generation genomic sequencing system, which went on market in China on 31 July, 2017. By the end of 2018, he has been shareholder at seven companies, six of which he was the legal representative and over five of which he had effective control. Since his return from the US, Dr. He has managed to collect some $ 35 million for his start-ups. He personally benefited from the genetic manipulation that took place during a leave of absence from the SUST since February 2018. The combination of personal enrichment with a start-up corporate culture, in which the business orientation clearly overlaid the research orientation, is typical of this case of rule breakage by genetically engineered manipulations of humans. Again, academic socialization is in the background in a field in which the rapid commercialization of the results of basic research has become the dominant standard.[caption id="attachment_10893" align="alignnone" width="1240"] CCR5 gene, source: Wikipedia[/caption]Dr. He has plenty justifications to offer for his human experiments in his YouTube videos. He is always concerned with the safety, health and life chances of his patients. It should, as he writes with colleagues in November 2018, be about the social idea of helping couples who otherwise would not have a chance to have a healthy child. And the technique should only be used for serious illnesses, neither for vanity nor for the optimization of humans. Dr. He modified  the gene for the cell receptor CCR5, that allows the HI virus to enter a cell.His own use of gene technology in HIV-endangered babies, however, does not seem to fit the formulated ethics. There are other methods that prevent infection. How often does the demonstrated ethics of success, which does not reflect consequences and side effects, serve as a justification that neither discloses the underlying business model nor include it in the reflection.[caption id="attachment_10885" align="alignnone" width="960"] Source: Pixabay[/caption]In these – in the opinion of many colleagues of Dr. He rather dilettantishly and irresponsibly carried out – human experiments, obviously not enough light was shed for the participants on the risks. According to what has been known so far, participants agreed on a study aimed at the development of an AIDS vaccine but were not adequately informed about the risks involved. What could happen in the polygenetic gene concert with other genes if one gene was modified and how this manipulation can change the susceptibility to other diseases, did not become an issue. Nor did the problems that could arise when creating a mosaic, i.e. the genetic manipulation was only half successful.Once again, we stumble into a new epoch of history, moderated by the amalgamation of scientific and commercial interests, where political controls get dumped, and ethics prove to be what they often are: as a symbolic record of supposedly good intentions. We are still a long way from designer babies in the sense of Gattaca. In addition, the polygenetic concert of the genes is much too complex and too under-researched and our ways of thinking are still - like those of Dr. He - far too simplistic to do justice to our organism. This applies in particular to the realm of ideas behind the Nobel laureate seed banks. Nevertheless, Dr. He has opened a door which, in all probability, will not close. For some people with hereditary diseases or genetically-caused, serious illnesses that may be good news. For others, skepticism may prevail because we can neither know nor estimate where the new era of human genetic manipulation will take us.Sources:Brinegar, K, AK Yetisen, S Choi, E Vallillo, GU Ruiz-Esparza, AM Prabhakar, A Khademhosseini, und SH Yun (2017), The commercialization of genome-editing technologies. Critical Reviews Iin Biotechnology 37 (7). Abingdon: Taylor &#38; Francis Ltd: 924–32.He Jiankui, Ryan Ferrell, Chen Yuanlin, Qin Jinzhou, and Chen Yangran (2018), Draft Ethical Principles for Therapeutic Assisted Reproductive Technologies, The CRISPR Journal.Lanphier, E, F Urnov, SE Haecker, M Werner, und J Smolenski (2015), Don’t edit the human germ line. Nature 519 (7544). London: Nature Publishing Group: 410–11.Puping Liang Yanwen Xu Xiya Zhang Chenhui Ding Rui Huang Zhen Zhang Jie Lv Xiaowei Xie Yuxi Chen Yujing Li Ying Sun Yaofu Bai Zhou Songyang Wenbin Ma Canquan Zhou Junjiu Huang (2015), CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes. 蛋白质与细胞：英文版 6 (5). Beijing: Higher Education Press: 363–72.Ramzy, Austin, Sui-Lee Wee (2019), Scientist Who Edited Babies' Genes Is Likely to Face Charges in China, The New York Times.Sample, Ian (2015), Scientists genetically modify human embryos in controversional world first, The Guardian.von Schaper, Eva (2018), Preprint wipes millions off CRISPR companies’ stocks. Nature Biotechnology 36 (3). New York: Nature Publishing Group: 211–211.Schmitt, Uwe (2005), Die Kinder der Genie Fabrik, Die Welt.Spiegel TV,  Samenbank der Genies.Stallmach, Lena (2018), Der Erschaffer der genveränderten Babys hat sein eigenes Wertesystem, Neue Zürcher Zeitung.Dr. He's YouTube channel