CRISPR

Proactive or Sinister? Experts Divided on Govt’s Relaxation of Gene Editing Regulations

While plant scientists feel that the government’s move will help develop high-yield, disease-resistant crops, activists and policy experts have objected to the change being introduced through an office memorandum, which the public cannot raise objections against.

Kochi: Over two decades after they were first introduced, farmers now cultivate nearly 20 different genetically modified (GM) crops on around 192 million hectares worldwide.

India joined the GM bandwagon in 2002. We now grow ‘Bt Cotton’ on around 12 million hectares. Bt Cotton contains a ‘foreign’ gene – from a bacterium – that helps the plant produce toxins to ward off pests.

But debates have raged over the disadvantages of GM organisms, such as the health risks they could pose to people. India has not approved any other GM crop for use since Bt Cotton.

However, in a move that might open up India to more GM crops, the Union Environment Ministry on March 30 permitted the development of plants whose genes have been edited using specific methods that do not involve inserting foreign DNA.

According to plant scientists, this “proactive” step by the government will help develop higher yielding crop varieties or those resistant to diseases. However, activists and policy experts are crying foul over the introduction of this change through an office memorandum (which the public cannot register objections against).

Moreover, the permitted methods of gene editing could still cause unintended changes in the plants’ genomes, even if it does not involve inserting foreign DNA, they said. However, others argue that as India stares at low yields due to several factors including heatwaves caused by climate change, genetically edited crops may be the best way out.

Also read: With New MoEFCC Memo, Are Indian Policy Makers Supporting ‘Big Biotech’?

It’s all about genes

After scientists developed the first GM organism in the early 70s, there’s been no looking back. In 1987, American scientists developed Bt Cotton by inserting specific bacterial genes (from the bacterium Bacillus thuringiensis, hence ‘Bt’) into the genome of the cotton plant. These genes from the ‘foreign’ bacterium help the plant produce a specific toxin which wards off bollworms, a kind of moth larvae that feed on cotton fruit and drastically affect crop yields.

According to government data, adopting Bt Cotton in India has increased yields from around 8 million bales in 2002 to around 34 million in 2017, reported Down to Earth. The Indian government and plant breeding scientists, therefore, call Bt Cotton a runaway success.

However, activists and scientists have been vocal about its cons. For example, scientists found in 2018 that the cotton bollworm is fast building a resistance to Bt Cotton in Telangana and Andhra Pradesh. Bt Cotton yields have also stagnated, according to another study. Moreover, economic factors, such as high input costs and low farmer incomes, have linked Bt Cotton to farmer suicides in India.

Tampering with genes, clearly, is tricky business. So India’s ‘Rules 1989’ (Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells Rules, 1989) lays down regulations to govern GM organisms in light of biosafety. Such organisms have to meet several criteria – such as being approved by the Genetic Engineering Approval Committee (GEAC) under the Environment Ministry – before experimental field trials can be conducted and the organisms can be released into natural systems.

Today, however, scientists can alter plant genomes without introducing another organism’s gene into them. With latest ‘gene-editing’ methods, for instance, scientists can target a specific gene – already existing within the genome of a plant – and alter or ‘edit’ it to bring about a desired quality, such as pest or heat resistance.

These are called ‘Site-Directed Nuclease’ (SDN) techniques. In gene edits that involve SDN1 and SND2 techniques, scientists edit a specific gene without inserting foreign DNA (they cleave the genome, tweak a gene and repair it using the same plant’s DNA). In the SDN3 technique, however, repairs are made using foreign DNA. This technically makes plants developed using SDN3 genetically modified.

Also read: For Genetically Engineered Crops, India Is No Country for Regulation

New rules

The Environment Ministry has used this difference in methodology to exclude some gene-edited plants from the country’s existing biosafety rules. As per an office memorandum (OM) dated March 30, gene-edited plants developed using SDN1 and SDN2 techniques – which do not introduce foreign DNA into the plants – will be exempted from Rules 1989.

“It’s a very important and proactive decision by the government,” said A.K. Singh, director of the ICAR-Indian Agricultural Research Institute, New Delhi. “Genome editing is a powerful tool which helps alter the gene in a very targeted manner without making changes to the [rest of the] genome.”

This ability to target only a specific gene – through modern technologies such as CRISPR – has been a “dream” for plant scientists. Since there are no biosafety concerns, this does not require regulation, he said.

According to him, the move to exempt such gene-edited plants from regulations will address problems of nutrition (such as fortifying crops with vitamins), crop resistance to abiotic and biotic stresses, and crop quality.

Scientists had already expressed their disappointment over the government dragging its feet on approving norms related to gene-editing over the past two years. The GEAC had sent draft guidelines in this regard to states last year, but scientists had felt that this could delay the process drastically.

In October last year for instance, agricultural experts under the banner of the India Agriculture Advancement Group International (IAAG) wrote to Prime Minister Narendra Modi urging him to hasten the process.

Era of OMs

Activists, on the other hand, are crying foul over two aspects of the move. Firstly, this change in regulation has been introduced through an OM, which people cannot voice objections against. Public policy expert Narasimha Reddy Donthi called it a “sinister attempt” to dilute India’s GM regulations and a “circumvention of the processes enshrined in [the] Indian constitution, which has defined democratic participation in matters of critical importance”.

“Through a mere Office Memorandum, [the] government has initiated a major shift in regulatory action,” he wrote in his letter addressed to officials at the Environment Ministry. “This is, in fact, a shift in policy. Policy change cannot be brought in through [an] OM.”

This, incidentally, is not the first time that the Environment Ministry is introducing changes to regulations through OMs. It made changes to the Environment Impact Assessment (EIA) Notification 2006 through an OM in April and in early May, it used another OM to permit some coal mines to increase production by up to 50%, without a fresh EIA or public consultation.

Another major cause for concern is that the specific methods of gene-editing that are being permitted could still cause unintended changes in the plants’ genomes, even if it does not involve inserting foreign DNA, Reddy told The Wire. Indeed, numerous studies including this one point to this drawback of gene-editing techniques, including CRISPR.

Such off-target genetic changes could occur, but that happens in natural plant breeding processes as well, commented Singh. In such cases, scientists discard the plants after observing them for two-three generations. Gene-edited plants, too, can be screened at this level, he added.

According to Singh, such gene-edited crop varieties will improve crop quality, production as well as the crops’ adaptation to both abiotic stressors (such as droughts and floods) and biotic ones. Such crop characteristics are crucial to cope with extreme events triggered by climate change, such as the recent heatwave that affected wheat production in northwest India. Studies show that emerging gene editing applications aimed at crop improvement could help adapt to the impacts of climate change.

With New MoEFCC Memo, Are Indian Policy Makers Supporting ‘Big Biotech’?

The MoEFCC’s recent decision to exclude new-gen GM plants from the ambit of existing biosafety rules endangers our food system, food exports, farmers’ rights over their crops and the country’s biological heritage for the sake of corporate profits.

Christmas came early for Big Biotech companies and their allied seeds multipliers as the Ministry of Environment, Forest and Climate Change (MoEFCC) has recently, through an office memorandum, excluded the new generation genetically modified (GM) plants – also known as genetically edited (GE) plants – from the ambit of India’s biosafety rules.

This means that Big Biotech companies will be able to by-pass India’s stringent genetic approval framework for their new generation of genetically modified organisms (GMOs). The end result will be a small step for agri-innovation, but a giant leap for corporate control over seeds and plants through patents. But how will this happen?

Before looking at the patent question, let’s look at the law.

All GMOs in India, as per the Environmental Protection Act, 1986, and the subsequent Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms/Genetically Engineered Organisms or Cells, 1989 (‘Rules, 1989’ for short), must be approved by the Genetic Engineering Appraisal Committee (GEAC), which has very unique set of approval mechanisms. Yet, somehow, two classes of gene edited plants – SDN 1 and SDN 2 – have been relegated to a less stringent regulatory process, perhaps to speed up approvals for the new GE product.

We must keep in mind that these are a newer generation of GMOs. The question which therefore arises is, why are their approvals being subjected to a lower standard?

India’s Rules, 1989 were drafted with the aim of protecting the environment, nature and the health of the people from the harmful affects of gene technology and micro-organisms. At that time, genetic engineering technologies were in their early stages; that is, gene-modification with one gene from another organism, and so on.

But our world has transformed over the past 40 years. Now, GE crops derived by using tools like CRISPR and the like are the latest generation of GMOs that are created by modification (that is, gene splicing/editing) of the genomic structure. Often, plant genomes are edited using artificial means and fused with foreign genomes too. Of course, this is not possible naturally and while it could potentially help accelerate plant breeding, it is generally consider a con.

This tool has the power to make a rose lose its redness forever; or our mustard its pungency, with one wrong edit.

Also read: For Genetically Engineered Crops, India Is No Country for Regulation

In the post-Wuhan leak investigation and ‘gain-of-function’ world, we are well aware that things could go wrong. We need to be more caution on genetic tech regulation. Furthermore, should we allow these technologies to enter our food system based on a corporation’s own biosafety data? Nope. Without third party data and audits, rely on corporations’ biosafety data poses a big risk.

Barring the US, these technologies are regulated as ‘GM technology’ in the European Union (EU) and other parts of the world. The EU-led regulatory mechanism treats the new generation of GMOs, produced through CRISPR and other gene-editing technologies, as GM food.

The Court of Justice of the European Union (CJEU) ruled in 2018 that crops produced from by using genetic material editing techniques ought to be regulated in the same way as GMOs. That means all regulatory process, as well as labelling, are the same. Of course, lobby groups are actively trying to reverse this decision. But the EU is holding out strong against pressure from Big agriculture (Ag) and Biotech companies.

The Indian market, however, is very lucrative for them.

With the current memorandum, India is clearing opening the castle gates for deregulation. Keep in mind that the Food Safety and Standards Association of India (FSSAI) has already brought out a notification to not label GMO products having less than 1% GM content as GM foods.

We are blindly trying to emulate the US’s policies and are helping foreign companies bypass the regulatory process. Various experts have raised biosafety concerns as GE crops can disrupt evolution in nature and lead to genetic contamination; the fact that they have not been proven to increase productivity or yield notwithstanding.

Farmers across the world have also resisted GE crops as they will lead to further consolidation by corporate giants, especially in the Global South. Mexico is a good example. But seeds companies maintain that this technology is good for industry and farmers.

A corn farmer places corn cobs on the ground during a protest against the growing of transgenic or genetically modified corn in Mexico City, January 23, 2013. Photo: Reuters/Bernardo Montoya.

Also read: Mexico Farm Lobby Blasts Ban on GMO Corn, Organic Growers Welcome It

Coming back to the question of Intellectual Property Rights (IPR) and patents; firstly, these are patented technologies which profit a handful of corporations. There are also concerns about ‘seed sovereignty’ as corporations can now, by editing one gene within the genome, claim a patent on entire species. India could be thrown into serious IPR turmoil once some of these varieties are let out in the open. This would undermine millions of years of evolution and the collective efforts of our ancestors to co-evolve a species.

But how does this nexus work? This questions is dealt with in Bertram Verhaag’s documentary film, Percy Schmeiser – David Versus Monsanto. There are many examples of how, in the past, Big Ag and Big Biotech companies have claimed entire harvests of farmers because their seeds randomly pollinated said farmers’ fields. What prevents these companies from extracting these illegal royalties? Given that India is a biodiversity hotspot, are we willing to risk our biological heritage for potential corporate profits?

Next, we come to public health. There are studies on both sides of the fence; some claiming the dangers and some, the benefits of eating GM foods. But one thing is for certain; that the world’s wealthiest people eat organic and not GM food.

Almost all of Europe has banned GM foods. Then why the urgency to have them in India? When life term studies are not conducted for GM crops, how can we conclude they are safe? This issue was also raised by the parliamentary standing committee on GM crops, headed by Renuka Chowdhary.

Taking cognisance of the aforementioned problems, what Indian policy makers should do is stop passing the buck and take responsibility. We need to conduct independent studies to verify the efficiency of this technology, which would include third-party-led long-term studies on biosafety and environmental and health affects.

Moreover, a special committee needs to be formed to deliberate on the IPRs of GE crops; how they impact farmers and how the issue would play out with the existing Protection of Plant Varieties and Farmers’ Rights Authority (PPVFR) patent laws.

There are also trade issues, as many countries don’t except GM or GE foods. If pollination and unintended gene transferring takes place in the open environment, India could be looking at losing its agriculture exports too. India is a major source of non-GM food exports. If GE crops spread, we could soon lose that tag and risk losing a major chunk of our agri-exports forever. And because there genes would be in the open environment, the spread can never be curtailed. It’s an irreversible process.

Given India’s murky genetic contamination history with Herbicide Tolerant (HT) Bacillus Thuringiensis (BT) cotton, India should carefully conduct trials for gene-edited crops. Gene-editing is a new technology; we aren’t certain of its long-term affects on human and environmental health.

India should aim to create new, progressive laws at are aligned with Indian patent laws and take into account independent science, rather than be influenced by lobbying or propaganda.

China Jails Scientists for CRISPR Gene-Edited Babies

A court has found Chinese scientist He Jiankui guilty of illegal medical practice. He had claimed credit for genetically engineering twins resistant to HIV in a controversial procedure.

A Chinese court on Monday sentenced biophysics researcher He Jiankui to three years in prison for creating the world’s first “gene-edited” babies.

Two other scientists who assisted He were also handed lesser sentences.

“The three accused did not have the proper certification to practice medicine, and in seeking fame and wealth, deliberately violated national regulations in scientific research and medical treatment,” said the court, according to China’s Xinhua news agency.

“They’ve crossed the bottom line of ethics in scientific research and medical ethics.”

He used a procedure known as CRISPR which allows one to edit snip and replace gene

‘My work will be controversial’

In 2018, He released a YouTube video announcing the results of his medical intervention and the birth of gene-edited twins. He said the genes were edited using CRISPR to prevent embryos from contracting HIV, noting that the twins’ father had the virus.

“Their parents don’t want a designer baby,” He said. “Just a child who won’t suffer from a disease which medicine can prevent. I understand my work will be controversial, but I believe families need this technology and I’m willing to take the criticism for them.”

Ethical issues

His actions were widely condemned by the scientific community for failing to adhere to research guidelines that forbid such practices, especially without oversight.

In the US, the medical procedure is strictly limited to laboratory research. In China, while human cloning is outlawed, gene editing is not.

The MIT Technology Review warned that “the technology is ethically charged because changes to an embryo would be inherited by future generations and could eventually affect the entire gene pool.”

A study published afterward found that the people who have comparable natural genetic modification are likely to die earlier .

This article was originally published on DW.

Here’s Why Many CRISPR/Cas9 Experiments Could Be Wrong – and How to Fix Them

Researchers assumed that CRISPR was turning off genes. They shouldn’t have.

Every living cell on Earth has proteins. Typically thousands of them, that serve as molecular machines to digest food, sense the environment, or anything else a cell must do. However, many genes, and the proteins they code for, have unknown functions. In humans, the function of about 1 out of 5 of genes is unknown. To explore these dark corners of the genome, scientists can break up DNA to disable a gene, making their encoded proteins nonfunctional, and watch what happens to cells as a result, inferring the lost function from what goes wrong.

When CRISPR/Cas9 came online in 2012, it offered scientists a tool to do exactly this – cut genes. The Cas9 enzyme searches through DNA, using a “guide RNA” to look for a specific sequence, and makes a cut when it finds a match. The gene, split in two, is repaired by the cell, but often with a large chunk missing. Many scientists assume that if a chunk of a gene is missing then the protein that it encodes will not function, or even be produced.

Researchers at the European Molecular Biology Laboratory in Heidelberg, Germany used CRISPR to make cuts in 136 different genes. In about a third of cases, proteins were still produced from these “damaged” genes and, furthermore, many of the proteins remained partially functional. This strange phenomenon, of damaged DNA producing functional protein, does more than punctuate life’s remarkable adaptability and resilience.

It means that dozens, or hundreds, of studies that used CRISPR/Cas9 to knock out genes, but failed to validate that the encoded protein was fully removed, could be incorrect or misleading.

Also read: How Gene Editing Is Changing the World

While many labs that use CRISPR to knock out genes do validate that the encoded protein is no longer produced, other labs fail to check. Searching for one protein in a cell is time-consuming and technically challenging; testing for protein function takes even longer. There are some methods available to look for specific proteins, but many CRISPR/Cas9 studies fail to run these experiments – or scientific journals don’t ask for the data.

While many labs that use CRISPR to knock out genes do validate that the encoded protein is no longer produced, other labs fail to check.

Nature Methods, the same journal that published the paper from the Heidelberg laboratory, recognised shortcomings in CRISPR validation early on. In 2017, they highlighted a genome-editing consortium, in collaboration with the US National Institute of Standards and Technology, that aims to develop standardized procedures for CRISPR research, including publishing guidelines that include which guide RNAs were tested, how they were designed, and which controls were used in experiments.

The problem with major scientific developments, especially CRISPR/Cas9, is that experimental tools often explode in popularity before scientists and editors can implement standard procedures. When DNA sequencing was developed in the 1970s, for instance, there was little need for standards because it was so challenging to decipher the sequence of even a short piece of DNA. A decade later, however, GenBank, a DNA sequence repository, came online and journals began to mandate that researchers deposit their sequences. This requirement, together with reporting standards issued by journals like Nature, have ensured that a rapidly growing collection of DNA sequences can be vetted and independently analysed by the scientific community. The same is true for methods like x-ray crystallography, with journals requiring that protein structures be independently validated and uploaded to publicly-accessible databases.

But while some scientists were shocked by the new study, others took a laissez-faire approach to the findings. On Twitter, many vented their rage at what they felt was a lack of careful controls by the scientific community. Raphael Ferreira, a postdoctoral fellow at Harvard Medical School, was inspired, perceiving this study as a game changer for the CRISPR community.

“I was as surprised by the results in a really positive way, as this paper rings the wake-up call for every scientist using CRISPR/Cas9,” Ferreira said.

Despite the enthusiasm, however, Ferreira will not change how he performs his own experiments. “The few times I have [used CRISPR/Cas9] in mammalian cells, I have always confirmed them with a Western blot,” referring to an experimental method to detect specific proteins.

Victor de Lorenzo, a research professor at the National Center for Biotechnology in Madrid, agreed, claiming that, “…the only way to ensure that a protein is altogether removed is by making a Western blot.”

Down the hall or across the street from my office, dozens of scientists use CRISPR/Cas9 to uncover protein functions. One of these researchers is Shashank Gandhi, a PhD student at the California Institute of Technology (CalTech) that has published CRISPR/Cas9 methods to delete genes in chicken embryos. Though he agrees with Ferreira and de Lorenzo, Gandhi asserts that validations could be taken a step further, and believes that journal editors should take action.

Also read: Is There More to Gene Editing Than Creating ‘Designer’ Humans?

“I think that journal editors should encourage authors to present supplemental data on how the knockouts were validated,” insists Gandhi. “I know that Nature requires that information as part of a “research summary” document that is submitted to the journal with each paper submission.”

If Nature, which is widely considered the premier academic research journal, takes action to ensure that CRISPR knockouts are validated, then perhaps other publishers will take notice. In the meantime, Gandhi and others are not taking any chances.

“I use several approaches to validate my CRISPR knockouts. For starters, I design and test multiple [guide RNAs] targeting the same gene for all my knockout experiments. Secondly, wherever applicable, I try to perform rescue experiments to establish loss of function phenotypes,” says Gandhi, referring to an experiment in which a deleted gene is restored to test whether that protein’s phenotype returns, confirming a link between a gene and the function that was lost when the gene was broken.

While all of the scientists that I spoke with agreed that researchers could do more to double check their experiments, it is unclear what actionable steps could be taken. Perhaps a combination of scientific, academic, and institutional changes could alleviate the potential for misleading studies. Faster experimental methods to detect proteins, standardised publishing procedures, and an academic database that describes which guide RNAs have been tested in each organism, would all serve to enhance the rigour of current studies.

Unfortunately, academic institutions and scientific publishers are hulking bureaucracies with slow-moving policy changes. Ensuring that CRISPR/Cas9 produces repeatable experiments – rather than blemishes on the scientific record – will require the collective action of scientists. It will demand self-governance.

Nicholas McCarty, Bioengineering, California Institute of Technology

This article was published in MassiveScience. Read the original here.

How Gene Editing Is Changing the World

In ‘Hacking the Code of Life’, Nessa Carey explores advances that are giving us new powers to alter the genome.

Across the US, more than 100,000 people are awaiting organ transplants. But there simply aren’t enough hearts, lungs, livers, and kidneys to meet demand, and 20 people die every day without the organs they need. For decades, scientists have dreamed of using animals to help fill the gap. They’ve been particularly interested in harvesting organs from pigs, whose physiology is similar to our own. Unfortunately, pigs also present some big biological challenges, including the fact that their genomes are chock full of genes that code for what are known as retroviruses, which could pose a serious threat to patients who receive porcine organs.

In 2015, George Church, a geneticist at Harvard University, announced a stunning breakthrough: Working with pig cells, he and his colleagues had managed to disable 62 copies of a retrovirus gene in one fell swoop. “This would have been virtually impossible and a logistical nightmare with older forms of genetic modification,” writes Nessa Carey in her new book, Hacking the Code of Life: How Gene Editing Will Rewrite Our Futures. But by using the new gene editing technology known as Crispr, the task was a relative cinch.

Nessa Carey
Hacking the Code of Life
Icon Books

It’s just one example of how gene editing is giving us the power to alter the genome with unprecedented speed and precision. Carey, a biologist with a background in the biotech and pharmaceutical industry, offers a brisk, accessible primer on the fast-moving field, a clear-eyed look at a technology that is already driving major scientific advances – and raising complex ethical questions

“It’s giving every biologist in the world the tools to answer in a few months questions that some scientists have spent half their careers trying to address,” Carey writes. “It’s fueling new ways to tackle problems in fields as diverse as agriculture and cancer treatments. It’s a story that began with curiosity, accelerated with ambition, will make some individuals and institutions extraordinarily wealthy, and will touch all our lives.”

Though there are several different approaches to gene editing, the most prominent – and the one that really supercharged the field – is Crispr. The technique, based on an anti-viral defence system that’s naturally present in bacteria, requires two pieces of biological material: an enzyme that acts as a pair of minuscule scissors, slicing strands of DNA in two; and a guide molecule that tells the enzyme where to cut.

In bacteria, these guide molecules direct the enzyme to chop up the genomes of invading viruses, preventing them from replicating.

But in 2012 and 2013, two teams of scientists reported that it was possible to hack this system to slice into any strand of DNA, at any complementary location they chose. Researchers could, for instance, create a guide molecule that steered the enzyme to one specific gene in the mouse genome and insert the editing machinery into a mouse cell; the enzyme would then make its cut at that exact spot.

Also Read: Is There More to Gene Editing Than Creating ‘Designer’ Humans?

The cell would repair the severed DNA, but it would do so imperfectly, disabling the gene in question. In the years that followed, scientists refined the technique, learning to use it not only to inactivate genes but also to insert new genetic material at specific locations along the genome.

The approach is cheaper, easier, and faster than older methods of genetic engineering, which were first developed in the 1970s. In addition, as Carey explains, “it can be used to create smaller modifications to the genome, and leaves fewer extraneous genetic elements. In its most technically exquisite form, gene editing leaves no molecular trace at all. It may just change, in a precisely controlled manner, one letter of the genetic alphabet.”

missing heritability problem, gene variants, rare diseases, genome wide association studies, whole genome sequencing, DNA sequencing, body mass index, human body height, polygenic risk score, preprint paper, peer review, genetic variation, heritability,

But in 2012 and 2013, two teams of scientists reported that it was possible to slice into any strand of DNA. Photo: qimono/pixabay

The applications are almost endless. Gene editing has immense potential for basic research; scientists can learn a lot about what genes do by selectively disabling them. In addition, researchers have used the technology to create a wide variety of organisms that could become valuable agricultural commodities, including mushrooms that don’t brown; wheat that produces fewer gluten proteins; drought tolerant, high-yield rice and corn; disease-resistant pigs; and super muscular goats.

How these products will do on the market – if they ever reach it – remains uncertain. Globally, gene-edited organisms are regulated by a patchwork of conflicting rules. For instance, in 2018, the US Department of Agriculture announced that it would not regulate gene-edited crops that “could otherwise have been developed through traditional breeding techniques.” A few months later, however, the European Union said that it would subject gene-edited plants to stringent restrictions.

Beyond agriculture, gene editing has enormous potential for medicine. It might, for instance, become a much-needed treatment for sickle cell disease. That painful, debilitating disease results from a genetic mutation that causes patients to produce a deformed version of haemoglobin, a protein that helps red blood cells transport oxygen. In a clinical trial currently underway, scientists are removing stem cells from the bone marrow of sickle cell patients, using Crispr to edit them, and then infusing the edited cells back into patients.

Also Read: Explainer: What Is CRISPR and How Does It Work?

Even if this trial succeeds, however, gene editing will not be a cure-all. It doesn’t always work perfectly and can be challenging to administer directly to living humans (which is why some scientists are instead editing patients’ cells outside the body). Moreover, many diseases are caused by complex interactions between multiple genes, or genes and the environment. “In fact, many of the most common and debilitating conditions aren’t likely to be good candidates for gene editing any time soon,” Carey writes.

And, of course, the ethics of human gene editing can be enormously fraught. That’s especially true when scientists modify sperm cells, egg cells, or early embryos, making tweaks that could be passed down to subsequent generations. This kind of gene editing could theoretically cure some absolutely devastating genetic conditions, but we still have a lot to learn about its safety and effectiveness. It also raises a host of difficult questions about consent (an embryo obviously cannot give it), inequality (who will have access to the technology?), and discrimination (what will the ability to edit a gene related to deafness mean for deaf people, deaf culture, and the disability rights movement more broadly?).

Even in the face of these questions, at least one scientist has already forged ahead. In November 2018, He Jiankui, a researcher then at the Southern University of Science and Technology in China, shocked the world by announcing that the world’s first gene-edited babies – twin girls, who He called Nana and Lulu – had already been born. Months earlier, when Nana and Lulu were just embryos, He had edited their CCR5 genes, which code for a protein that allows HIV to infect human cells. By disabling the gene, He hoped to engineer humans who would be protected from HIV infection.

Also Read: How a Rogue Chinese Experiment Might Affect Gene-Based Therapies in India

The outcry was swift and harsh. Scientists alleged that He’s science was sloppy and unethical, putting two human beings at unnecessary risk. After all, there are already plenty of ways to prevent HIV transmission, and the CCR5 protein is known to have some benefits, including protecting against the flu. And He had raced ahead of the experts who were still trying to work out careful ethical guidelines for editing human embryos. “He Jiankui has shot this measured approach to pieces with his announcement, and now the rest of the scientific community is on the back foot, trying to reassure the public and to create consensus rapidly,” Carey writes.

Scientist He Jiankui attends the International Summit on Human Genome Editing at the University of Hong Kong in Hong Kong, China November 28, 2018. Credit: REUTERS/Stringer/File Photo

Scientist He Jiankui attends the International Summit on Human Genome Editing at the University of Hong Kong on November 28, 2018. Photo: REUTERS/Stringer/File Photo

Hacking the Code of Life doesn’t break much new ground, and for readers who have been paying attention to Crispr over the past few years, little in the book will come as a surprise. But it does provide a broad, even-handed overview of how much has already happened in a field that is less than ten years old.

Carey swats down the most dystopian dreams about Crispr, like the prospect that criminals might edit their own DNA to evade justice. She’s similarly skeptical that we’ll end up using the technology to create “super-beings with enhanced genomes that will make them taller, faster, more attractive.”

“We actually understand very little about the genetic basis of these traits and what we do know suggests that it will be very difficult to enhance humans in this way,” she writes.

But she also acknowledges real risks, including the possibility that the technique could be used to create dangerous bioweapons, that gene-edited organisms could destabilise natural ecosystems, and that our new, hardy crops could prompt us to convert even more of the Earth’s undeveloped places into farmland.

None of this means that the technology should be abandoned; it has immense potential to improve our lives, as the book makes clear. But it does mean we need to proceed with caution. As Carey writes, “Ideally, ethics should not be dragged along in the wake of scientific advances; the two should progress together, informing one another.”

Emily Anthes, who has written for Undark, The New York Times, The New Yorker, Wired, and Scientific American, among other publications, is the author of the forthcoming book The Great Indoors.

This article was originally published on Undark. Read the original article.

University of California’s Fresh CRISPR Patent Could Revive Gene-Editing Row

The bitter dispute between the university and the Broad Institute over patent rights for the valuable CRISPR technology was settled recently in court.

New Delhi: The University of California (UC) will soon gain its third patent on the gene-editing technology knows as CRISPR, four years after it entered into a legal battle with the Broad Institute due to a crossover between patents filed by the two parties.

UC has obtained a notice of allowance from the US Patent and Trademark Office, meaning the patent will likely be received in eight weeks.

CRISPR is a natural mechanism that prokaryotes use to defend themselves against viruses. Prokaryotes are unicellular organisms whose cells lack membranes. Eukaryotes are multicellular and their cells have membranes.

The CRISPR-Cas9 system, developed first by the University of California, combines CRISPR with Cas9 – a protein – to create a molecular tool. This tool can pick out and cut specific sections of a gene, removing it from the genetic sequence. It can be used to remove faulty genes that result in undesirable mutations.

Because of this, patent rights to the technology are likely worth millions of dollars as it can revolutionise the treatment of diseases and assist with genetically modifying crops. CRISPR-Cas9 has proved to be more efficient that other gene-editing technologies.

The new patent was awarded to UC in collaboration with Emmanuelle Charpentier of Umeå University and Krzysztof Chylinski of the University of Vienna. According to the university’s CRISPR lead patent strategist Eldora Ellison, the newer version of CRISPR is more careful about where the genetic sequence needs to be cut.

Also Read: Is There More to Gene Editing Than Creating ‘Designer’ Humans?

According to Reuters, the fresh patent stems from an application filed in 2012 by microbiologists Jennifer Doudna of the University of California at Berkeley and Charpentier.

This application was the first ever for a CRISPR-related patent. The scientists discovered that CRISPR-Cas9 could be used to edit the DNA of prokaryotic cells.

The Broad Institute, a research centre affiliated to the Massachusetts Institute of Technology (MIT) and Harvard University, also applied for their own patent that could edit the DNA of eukaryotic cells.

The team, led by bioengineer Feng Zhang, opted for a fast-track review process, which meant they landed the first CRISPR patent in 2014. The UC’s first patent was only granted in early 2018.

Because the University of California felt there was a crossover between the two patent applications, it filed a petition with the Patent and Trademark Office in 2015. It said the Broad Institute’s work was not patentably different from that of Doudna and Charpentier.

However, in late 2017, the USPTO’s Patent Trial and Appeal Board rejected the claim. The board’s decision was upheld by a federal court in September 2018. The Wire has previously reported the consequences of the court’s decision.

The fresh patent is likely to revive the rivalry between the university and the Broad Institute. UC reported that other systems and CRISPR-related patents are already under development.

However, David Cameron, spokesman for the Broad Institute, said the fresh patent “does not affect the CRISPR patent estate held by Broad, MIT and Harvard in any way”.

To exploit the lucrative nature of the technology, both institutions have licensed their intellectual property to biotech companies. Some companies are using the technology to develop treatments for sickle cells (inherited conditions that affect red blood cells), the rare blood disease beta thalassemia and other ailments.

Where do UC’s three patents differ?

Ellison, the university’s lead strategist, said the three patents are not limited to use in eukaryotes. They allow CRISPR to be used in both cellular and noncellular environments, such as laboratories.

The three patents differ in the specific guide RNAs. Guide RNAs direct the Cas9 protein in the CRISPR technology to a specific genome location to accurately edit the DNA.

While older patents were limited to research, the new one will have implications for commercial use as well.

“Together, this patent application and prior U.S. Patent Numbers 10,000,772 and 10,113,167, cover CRISPR-Cas9 methods and compositions useful as gene-editing scissors in any setting, including in vitro, as well as within live plant, animal and human cells,” the university said in a statement.

The new patent will encompass the use of CRISPR-Cas9 technology in “any cellular or non-cellular environment,” Ellison stated.

How a Rogue Chinese Experiment Might Affect Gene-Based Therapies in India

Many Indian scientists edit the human genome in cells obtained from their patients.

The gene-editing tool CRISPR Cas9 became a talking point among biologists after He Jiankui, a Chinese researcher, announced he had edited the genomes of two babies in November. In a YouTube video, Jiankui explained he had cut the CCR5 gene out to make them resistant to HIV. The episode set off a furore in the international biologists community.

The genetic editing of human embryos is banned in most of the world. This is partly because scientists are still learning how to use CRISPR to do this.

“CRISPR has certainly made gene-editing easier, but the strategy is not entirely foolproof and may sometimes introduce mistakes at unintended positions” of the genome, Debojyoti Chakraborty, a scientist at the Institute of Genomics and Integrative Biology, New Delhi, told The Wire. What these off-target changes could cause remains uncharted territory.

Sonam Mehrotra, a scientist at the Advanced Centre for Treatment, Research and Education in Cancer, Mumbai, said, “From practical experience, I can tell you that the outcome of CRISPR varies between cases.” Mehrotra uses CRISPR to deliberately introduce mutations in fruit flies (Drosophila melanogaster). Given the vagaries of working with flies, whose genomes are much smaller, she thinks it’s way too early to edit human embryos.

However, both Mehrotra and Chakraborty agree CRISPR has a lot of potential to treat genetic disorders.

Also read: Editing Embryos – Six Steps to an Informed Opinion

The human genome is a long sentence composed of four alphabets: A, T, G and C. Sometimes, when a wrong alphabet appears in a given position in the sentence, it could cause a genetic disease. Armed with CRISPR, scientists are learning how they can correct these mistakes by editing the faulty part.

This is the opposite of what Jiankui did. The embryos he edited didn’t have any genetic errors that made them susceptible to HIV. Instead, Jiankui modified the sequence of letters such that the newborn twins were “ resistant to HIV,” Chakraborty explained. ‘This kind of preventive medicine is not what scientists are aiming for, especially now, while we are still trying to understand CRISPR biology.”

This rather questionable use of CRISPR has since sparked a dialogue on human gene-editing regulations.

Tinkering with genetic material is a sensitive issue because it impinges on one’s identity. At present, there is an international moratorium on the genetic editing of human embryos for reproductive purposes. The practice has even denounced by China’s medical board; it only permits the editing of human embryos less than 14 days old.

In India, the ethical guidelines of the Indian Council of Medical Research (ICMR) disallow any research related to germline genetic engineering or reproductive cloning. But editing the genomes of adult human cells is permissible subject to approval by an ethics committee.

In administrative terms, “we have three levels of regulation,” S.R Rao, senior advisor to the Department of Biotechnology, said at a talk at the second International Summit on Human Genome Editing. It was held in Hong Kong in the last week of November 2018, and counted Jiankui among its participants.

At the first level, an institutional ethical committee screens all proposed projects. The approved ones are then assessed by a risk evaluation body of the Department of Biotechnology. In cases where there could be risks to the environment, the project may require an ‘okay’ from the environment ministry as well.

All clinical trials involving genetic engineering products come under the Drugs and Cosmetics Act, 1940.

Thus far, this labyrinthine process has not deterred scientists from exploring CRISPR as a treatment option for genetic disorders. Many Indian scientists edit the human genome in cells obtained from their patients. Their biggest focus area is developing a therapy for blood disorders due to defects in single genes.

This form of genetic editing is distinct from embryonic editing because it involves adult patient cells, not germ cells. The problem with editing the DNA of embryos is that both somatic and germ cells will carry the mutation, and the edited DNA will be passed on hereditarily.

But when working with adult cells – such as blood cells from patients – CRISPR can be used to correct mutations in the lab. And since the technique is patient-specific, any alterations made in the genome remain confined to one individual and won’t affect the next generation.

In that sense, CRISPR presents a lot of opportunities. China realised this early and eased regulations. And so far, Chinese scientists have used CRISPR to edit the genes of monkeys, human embryos less than 14 days old and are currently testing CRISPR-based therapies in cancer patients.

Things are moving in the US as well. American scientists having embarked on CRISPR-related clinical trials, with the country’s Food and Drug Administration keeping a close watch.

India is yet to start.

At the moment, scientists like Chakraborty are testing proof-of-concept studies in the lab, where he and his colleagues attempt to correct mutations in human blood cells. The next step is to test the technique in animal models, and then begin human trials. The timeline hasn’t been finalised, however.

“Technically, genome editing is not a challenge,” Chakraborty said. But one of CRISPR’s bigger caveats is that one size doesn’t fit all. “The outcome of CRISPR-based therapies will differ from one cell to another, from one gene to another and even from one delivery agent to another,” Chakraborty said. So each clinical trial will have to seek approval on a case-by-case basis. This does suggest officials will pay each proposal the attention it deserves – but it still also falls short.

Also read: Is There More to Gene Editing Than Creating ‘Designer’ Humans?

What India really needs, and lacks at the moment, is a proper framework to regulate CRISPR-based clinical trials. There has been a lot of talk about the need for new policies “but India is unlikely to go the China way in hurrying things up,” Deepti Trivedi, a scientific officer at the National Centre for Biological Sciences, Bengaluru, told The Wire.

Mehrotra is particularly worried about how Jiankui’s brazen foot forward may affect the future of CRISPR Cas9. “If a handful of researchers continue these reckless acts, governments may impose stringent regulations on the use of CRISPR.” This has already happened with stem cells: fearing rampant malpractice, the ICMR banned the use of stem cell technology in 2017 and limited access to them.

Jiankui’s actions prompted a sharp response from the Chinese government. It launched an investigation into his work, his university suspended him and he might be under house arrest. At the same time, scientists rallied to plan a gene-editing meeting in Massachusetts this year, where social scientists and geneticists will discuss the technology’s central issues.

Notwithstanding whether Indian scientists are going to be part of this conversation, Chakraborty believes something similar – “a dialogue between scientists and policymakers” – needs to happen in India. If it doesn’t, this path-breaking tech might never leave the pharmaceutical fringes it currently occupies.

Sarah Iqbal is a freelance science writer.

Should GM Crops Feature in the ‘Evergreen Revolution’ India Dearly Needs?

K. VijayRaghavan, principal scientific adviser to the Government of India, and M.S. Swaminathan discuss an article the latter recently penned arguing that GM crops are unsustainable in the prevailing regulatory regime.

In November, M.S. Swaminathan and P.C. Kesavan penned an article in the journal Current Science criticising genetically modified organisms (GMOs). The text polarised readers, drawing widespread support as well as criticism.

Kesavan and Swaminathan began by asserting the need for an ‘Evergreen Revolution’ to improve agricultural productivity and sustainability without the “adverse environmental and social impacts” of the Green Revolution.

They then argue that Bt crops and herbicide-tolerant crops cannot be part of this regime because they are “highly unsustainable”. They conclude asking for more basic research to “understand the causes of ‘unintended effects’” and that it would be “prudent to adhere to the recommendations of the Task Force on Agricultural Biotechnology … (2004)” when developing GM crops.

In a recent email exchange, K. VijayRaghavan, principal scientific adviser to the Government of India, debated the article’s points with Swaminathan. The emails were placed in the public domain (available to read here). The following excerpt reproduces the last emails from each scientist, with their consent. They are presented in full, lightly edited for style.

Dear Prof VijayRaghavan,

An article by Prof Kesavan and me in Current Science seems to have caused considerable concern and confusion. The last para of the article reads as follows:

Genetic engineering technology has opened up new avenues of molecular breeding. However, their potential undesirable impacts will have to be kept in view. What is important is not to condemn or praise any technology, but choose the one which can take us to the desired goal sustainably, safely and economically.

As far as I am concerned, the following has been my view throughout.

It is unfortunate if the article has created the impression that I am opposed to GM as a technology. Technology always creates divergent viewpoints. For example, the gene-editing technology CRISPR is now undergoing divergent views. This is why it is important to have a transparent regulatory mechanism which is supported by professionals, government departments and the private sector. I shall be grateful for your views on how to clarify our views on biotechnology. After all we started genetic engineering research in 1990 for transferring genes from mangroves to rice for salt tolerance.

Genetic modification is the technology of choice for solving abiotic problems like drought flood, salinity, etc. It may not be equally effective in the case of biotic stresses since new strains of pests and diseases arise all the time. This is why the [M.S. Swaminathan Research Foundation] choose mangroves for providing genes for tolerance to salinity.

I have always said that the green revolution should not become a ‘greed revolution’ and therefore we should ensure that the long-term productivity of the soil and water also becomes a part of the technology. I also believe that GMO is the best pathway for breeding crop varieties with resistance to abiotic stress and will hence become more important in an era of climate change.

I thought I should let you know that there has been some misunderstanding about my views to ensure sustainable productivity by avoiding the spread of greed revolution resulting in the undermining of the long term production potential. In this context, Norman Borlaug and I shared the same concern for ensuring sustainable food and nutrition security.

I hope you are all well. I send you and your family my good wishes for your health and happiness during the Christmas and New Year.

With warm personal regards,

Yours sincerely,

M.S. Swaminathan

Also read: Why Genetic Engineering is Stranger Than You Think it is

K. VijayRaghavan responds

Dear Professor Swaminathan

Many thanks for your e-mail. I am very glad that you took the time to reach out and explain the recent Kesavan and Swaminathan ‘review’ in Current Science. I am also pleased to hear your clarifications and views on new technologies in agriculture. As requested by you in your mail, may I respectfully submit my very serious concerns about the review?

In your e-mail, you highlight the last paragraph of the review:

Genetic engineering technology has opened up new avenues of molecular breeding. However, their potential undesirable impacts will have to be kept in view. What is important is not to condemn or praise any technology, but choose the one which can take us to the desired goal sustainably, safely and economically.

Yet, as scientists, we must read and understand the article as a whole and not look at it selectively. We then distill its key messages. A review article in science usually analyses the literature, presenting multiple examples in an area. It then summarises the state of the field. Next, it summarises the consensus in the field and then gives the view of the authors, stating why they agree or disagree. The Kesavan and Swaminathan piece is more of an opinion piece than such a review. But that is a quibble.

Whatever the nature of the piece, there is a requirement that that any article:

a. Not selectively omit inconvenient results

b. Not selectively represent work that suits one’s hypotheses as valid without referring to the other work that discredits it and explaining the rationale for the choice made

c. Not misrepresent referenced work. That is, if the work says one thing but the article (the review in this case) refers to it as saying the opposite or something very different.

The Kesavan and Swaminathan review starts by pointing out how fertilisers, pesticides, high-yielding varieties of crops, etc. ushered major changes in agriculture but also raised major concerns for sustainability and ecology. One cannot but agree with such a generalisation. (Similarly, it can be argued that extensive mining, the steam locomotive, the internal combustion engine, an addictive use of fossil fuels, greenhouse gas emissions, a huge livestock population, air-travel, shipping, the chain-saw, ocean trawlers, etc. have contributed to pushing our planet to the edge. One cannot but agree with such generalisations, too).

Thus, in this part of the article, while pointing out important concerns of intensive agriculture, the review neglects to put this in the context of broader issues of human intervention. In that – in this part – it can charitably be said to have merely missed an opportunity.

But the review uses the above to make a case for how the unintended consequences of technologies per se can have a negative impact. Here, it omits … the distinction between the technologies and the nature and extent of their use by human agencies. These consequences of technologies are then used to segue into views on GM crops, the main thrust of the review: arguing that one must be wary of technologies in general.

In this section on GM, sadly, the review is even more severely flawed. The specific instances where results are selectively omitted, selectively represented or misrepresented are rife. Each of these egregious [instances], I am sure, will be addressed in response to your review by scientists soon. Indeed, the bulk of the scientific points made in this part of the review have been raised previously and have been scientifically discredited widely and one has to only study the literature to see this.

The review puts in one bin the four components of efficacy, safety, commercial interests and regulation. And, above this, the review seamlessly flows from one type of genetic modification to another, clubbing them all together. This is not only flawed scientifically [but] has the implication that those who defend the science or the regulatory system are defending specific commercial interests or loss of biodiversity.

Finally, the review makes extraordinary generalisations about the Indian regulatory system. It alleges both incompetence and collusion. These are very, very serious allegations against entire committees and the Government of India. (It is this same structure, incidentally, which has put in place and monitors the regulation of GM research at the MSSRF, which your letter refers to.) In a complex area that involves many fields, India’s regulatory system has steadily ratcheted its quality over the years. It acts in accordance with national law, international protocols and best-in-class procedures.

Critical analysis and criticism are always welcome. But gratuitous generalisations undermine years of work and, more importantly, cause deep and lasting damage to entire areas of research and consequently to our people at large.

The use of GM technology and its release in agriculture is and must be regulated and done well. Experts, as also the authors, know that there are many kinds of such GM technologies. Some involve loss-of-function, others involve gain-of -function, yet others involve new function. There is research and development in the publicly funded sector and in the private sector the world over. There are commercial interests and public interest, which may overlap in one case and not in another.

There are vested interests in all parts of the spectrum and there are also very genuine people across the spectrum. There are environmental and biodiversity issues which may be very critical in some cases and less so in another. There are new technologies, which may require new regulatory steps.

In these and in all matters, we as scientists are obliged to take a careful and rational view. Evidence must always be critically examined and expressed with neither fear nor favour in our research work and in the opinions and advice we publicly, privately and officially give. We must have the courage to change our views when presented with new contrary evidence.

What needs to be done with the evidence, in terms of process, policy or action, is another complex area that involves interacting with society, and dealing with reality and perceptions, with real and imagined concerns, economics, etc. This is also a difficult task and scientists have a critical role here, too.

Also read: Why Transgenic Mustard is Unlikely to Hurt You or Your Environment

Today’s world is at a tipping point. In the Anthropocene epoch, humans are the stewards of the planet’s future. Difficult local and global decisions have to be taken by the peoples of the world. For this, the public must have access to the complexities of every debate, conveyed by scientists in their writings and talks. Neither the hubris of technologies nor the blanket denial of their roles makes sense.

Eminent scientists and global leaders, such as you, have participated and coordinated discussions on these issues. Their voice [has] a special impact in society. Their missteps also have consequences that are immense, sometimes very damaging and lasting. In a large country like ours, the damage can be vast and deep.

I have been frank and critical because, quite simply, I would be negligent if I were otherwise. We stand by the entirety, not selective parts, of our publications and are free to revise our views or not. Your mail points out some aspects that you particularly stress. I must presume that you nevertheless continue to stand by the entirety of the publication. In any event, with the Kesavan and Swaminathan opinions in public, I am sure that various protagonists will publicly respond and discuss, which is what should be done in science.

I deeply admire and applaud your many contributions to science, your wisdom and your courage and your national and international contributions. We all look forward to your continued role in science and in policy.

With warmest personal regards,

K. VijayRaghavan, Principal Scientific Adviser, Govt. of India
MSS/DB/7 December 2018

Chinese Geneticist Says Another ‘Potential’ Gene-Edited Pregnancy

He Jiankui, who has been challenged by several peers, says he is proud of his work.

Hong Kong: A Chinese scientist at the centre of an ethical storm over what he claims are the world’s first genetically edited babies said on Wednesday he is proud of his work and revealed that another there was a second “potential” pregnancy as part of the research.

He Jiankui, an associate professor at Southern University of Science and Technology in Shenzhen, China, addressed a packed hall of around 700 people attending the Human Genome Editing Summit at the University of Hong Kong.

“For this case, I feel proud. I feel proudest,” He said, when challenged by several peers at the conference.

“This study has been submitted to a scientific journal for review,” He said. He did not name the journal and said his university was unaware of his study.

He, who said his work was self-funded, shrugged off concerns that the research was conducted in secrecy, explaining that he had engaged the scientific community over the past three years.

In videos posted online this week, He said he used a gene-editing technology known as CRISPR-Cas9 to alter the embryonic genes of twin girls born this month.

He said gene editing would help protect the girls from infection with HIV, the virus that causes AIDS.

But scientists and the Chinese government have denounced the work that He said he carried out, and a hospital linked to his research suggested its ethical approval had been forged.

The conference moderator, Robin Lovell-Badge, said the summit organisers were unaware of the story until it broke this week.

Also read: The Exhilarating World of Neurogenetics

CRISPR-Cas9 is a technology that allows scientists to essentially cut and paste DNA, raising hope of genetic fixes for disease. However, there are concerns about safety and ethics.

The Chinese Society for Cell Biology in a statement on Tuesday strongly condemned any application of gene editing on human embryos for reproductive purposes and said that it was against the law and medical ethics of China.

More than 100 scientists, most in China, said in an open letter on Tuesday the use of CRISPR-Cas9 technology to edit the genes of human embryos was dangerous and unjustified. “Pandora’s box has been opened,” they said.

He’s research focuses on genome sequencing technology, bioinformatics and genome editing, according to his biography on the summit’s website.

He received his PhD at Rice University in Houston, Texas, and worked as a postdoctoral research fellow in Stephen Quake lab at Stanford University according to the site.

Continued study

He, who said he was against gene enhancement, said eight couples were initially enrolled for his study while one dropped out. The criteria required the father to be HIV positive and the mother to be HIV negative.

David Baltimore, president emeritus, Robert Andrews Millikan Professor of Biology, spoke after He’s speech, saying it was irresponsible to have proceeded until safety issues were in order.

“I don’t think it has been a transparent process. Only found out about it after it happened and the children were born,” he said.

He Jiankui said his results could be used for millions with inherent diseases. He said he would monitor the two newborns for the next 18 years and hoped they would support continued monitoring thereafter.

Shenzhen Harmonicare Medical Holdings Limited, reported by media as being involved in He’s project, sought to distance itself by stating the hospital never participated in any operations relating to the gene-edited babies and no related delivery had taken place.

In a statement published to the Hong Kong stock exchange on Tuesday, the group said preliminary investigations indicated the signatures on the application form circulated on the internet are “suspected to have been forged, and no relevant meeting of the Medical Ethics Committee of the hospital in fact took place”.

Chinese Scientist Apologises for Leak of Baby Gene-Editing Results

He Jiankui, who has claimed to have helped make the world’s first gene-edited babies, said that his study has been submitted to a journal for review.

Hong Kong: A Chinese scientist at the centre of a controversy over what he claims are the world’s first genetically edited children apologised on Wednesday for the result being leaked unexpectedly as he detailed his findings at a conference in Hong Kong.

“First, I must apologise that this result was leaked unexpectedly. This study has been submitted to a scientific journal for review,” He said. He did not name the journal and said his university was unaware of his study.

Also read: CRISPR Gene Editing and How It Works