Concerns over designer babies rose to the public consciousness decades ago when recombinant DNA technology and in vitro fertilization IVF were being developed, and again when Dolly the sheep was cloned [].
In the years since, many countries have passed laws or embraced guidelines that regulate the scientific use of human embryos. A majority of countries with advanced research programs have laws or guidelines in place that either ban or restrict genetic modification of human embryos for reproductive purposes [4]. In the US, the regulatory landscape is unique.
Rather than ban any practices outright, Congress has instead tied the federal purse strings. In , Congress passed an appropriations bill with a rider attached known as the Dickey-Wicker Amendment, which effectively prevents the use of federal funds to conduct research on human embryos [5,6]. This work received private funding and was performed for research purposes, aimed at curing a genetic disease, not at creating a super baby [8]. If similar work was to be brought to the clinic, it would need approval by the FDA, regardless of the source of funding.
To prevent any such application from coming to market, Congress added a stipulation to appropriated funds that prevents the FDA from considering any applications that involve editing human embryos [9]. So, for now at least, genetically engineered babies will not be made in the US any time soon, no matter the motivation.
Even among scientists and policy groups, genetic germline enhancements are strongly cautioned against. None of the statements or guidelines published in the last few years by major ethics groups or important research and medical academies recommend any forays into germline enhancements [14]. Not only is the regulatory landscape unfavorable for creating a super baby, the biology makes it difficult.
The characteristics people tend to associate with designer babies — intelligence, height, and athletic ability — are not controlled by one or even a few genes. Take the seemingly simple trait, height. For example, the hormone EPO is considered a performance-enhancing drug and is produced by a single gene. But the World Anti-Doping Agency already tests for performancen-enhancing gene therapies in athletes, and recently updated its ban to include all forms of gene editing [17], as hard as that may be to enforce.
Recent publication covers spotlight genetic enhancements. Despite the concerns over designer babies, many scientists and doctors are calling for a regulatory path forward to allow gene editing in human embryos for research []. The goal would be to understand basic human biology, and potentially, to prevent extreme cases of genetic disease.
The World Health Organization estimates there are about 10, diseases known to be caused by a mutation in a single gene [21]. Many of these are extremely debilitating. It does not store any personal data. Functional Functional. Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. Performance Performance.
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In , when the U. Last month , when Genomic Prediction, a New Jersey company, announced its DNA screening panel for embryos would also assess the risk for complex diseases such as Type 2 diabetes and heart disease that are caused by multiple genes, fears of engineering babies with high IQ or athletic prowess emerged.
The same issues arose on Nov. The designer baby doom scenarios have not evolved with the technology. But no one seems to be questioning whether these traits are solely a product of our genes such that they can be selected or edited in embryos. Wondering about designer babies was understandable in the early days, but repetition of these supposed fears now suggests lack of understanding of how DNA, and the genes they encode, work. Mutations in the BRCA genes substantially increase the risk of breast and ovarian cancer.
Variations are changes in the genetic code that are more common than mutations and associated with common traits and diseases.
DNA variants increase the likelihood that you may have a trait or develop a disease but do not determine or cause it. The genetic editing of a speck-size human embryo carries significant risks, including the risks of introducing unwanted mutations or yielding a baby whose body is composed of some edited and some unedited cells.
In a scientific presentation in at Cold Spring Harbor Laboratory, which is posted to YouTube , He described a very large series of preliminary experiments on mice, monkeys, and more than human embryos.
But He claimed he found few or no unwanted changes in the test embryos. A new breed of biotech companies could ultimately reap a windfall should the new methods of conferring health benefits on children be widely employed.
According to the clinical trial plan, genetic measurements would be carried out on embryos and would continue during pregnancy to check on the status of the fetuses. A listing describing the study was posted in November, but other trial documents are dated as early as March of That was only a month after the National Academy of Sciences in the US gave guarded support for gene-edited babies, although only if they could be created safely and under strict oversight.
Currently, using a genetically engineered embryo to establish a pregnancy would be illegal in much of Europe and prohibited in the United States. It is also prohibited in China under a ministerial guidance to IVF clinics. It is not clear if He got special permission or disregarded the guidance, which may not have the force of law.
In recent weeks, He has begun an active outreach campaign, speaking to ethics advisors, commissioning an opinion poll in China, and hiring an American public-relations professional, Ryan Ferrell. The new opinion poll , which was carried out by Sun Yat-Sen University, found wide support for gene editing among the sampled 4, Chinese, including a group of respondents who were HIV positive. People without working copies of the gene are believed to be immune or highly resistant to infection by HIV.
The attempt to create children protected from HIV also falls into an ethical gray zone between treatment and enhancement.
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