Last month, He Jiankui, a Chinese researcher, announced the birth of the world’s first gene-edited babies, whose DNA had been edited to reduce the risk of HIV infection. While the claim has not yet been verified, Chinese authorities have launched an investigation and ordered this researcher’s work to stop. In the discussion that follows, Stanford Law Professor Hank Greely, an expert in the ethical, legal, and social implications of new biomedical technologies, and a Stanford Health Policy Fellow, discusses the legal and ethical questions surrounding the new world of gene-editing.

First, can you explain what the Chinese researcher, He Jiankui, did?

I’ll try but, first, we don’t know whether He Jiankui** did anything except make YouTube videos and give a talk. There has been no independent verification that these babies exist, let alone that he edited their genes. It would be a very bold fraud, but bold frauds have been carried out before in bioscience, including, notably, Hwang Woo-Suk’s false claim in 2004-05 that he had successfully cloned human embryos.

Assuming He Jiankui did what he said he did, he used a fantastic new DNA editing tool called CRISPR (“Clustered Regularly Interspaced Short Palindromic Repeats”) in human embryos very shortly after the eggs were fertilized. His goal was to change a gene called CCR5. This gene makes a protein that sits on the outside of some our white blood cells, crucial to the immune system, called T cells. There is good evidence that T cells that lack CCR5 cannot be (or cannot easily be) infected with HIV; about 1% of Northern Europeans (and a smaller percentage of people elsewhere) have a particular change in their CCR5 gene that deleted 32 base pairs (“letters”) in the DNA sequence and they do not seem to get HIV infections. So, his stated goal was to provide these embryos (and the babies, teenagers, and adults they turn into) with immunity from HIV infection. The data he released, however, shows that one of the twins only had half of her cells modified. If half of her T cells have CCR5, she could still be HIV infected. The other twin had all of her cells changed but not in the way He Jiankui intended, and not in the way found in people. We have no idea whether she will be immune, wholly or partially, from HIV infection.

Is it legal in the U.S.—or anywhere? If not, why?

It is not legal in the U.S. The FDA takes the position, which I think courts would most likely uphold, that genetically altered human embryos are either drugs or biological products (or both) and so under its jurisdiction. It is illegal—a federal crime—to distribute a new drug without FDA approval. The FDA has not approved genome editing for embryos for clinical use. For research uses only, you can get FDA permission more easily. You need to submit an application to the FDA for what’s called an Investigation New Drug (IND) exemption. You need to show the FDA that there is good reason, based on non-human research, that this will not be too risky for the research participants and that there is a reasonable chance it will be effective. His work would not satisfy either side of this and so would not get an IND.

But that’s not relevant right now because since December 2015 Congress has regularly added an amendment to the FDA’s funding bill, prohibiting it from even considering any application, of any kind, for human germline editing. So, if you did this in the US now, you’d be doing it without FDA approval, which would make your use an illegal distribution of a new drug.

In many other countries, particularly in Europe, any germline human genome editing is illegal by specific statute (which it is not in the U.S.). In most countries there is no law on this—many poor countries have other things to worry about—so it is legal (at least, not specifically illegal) in most countries.

What are the dangers? What are the potential benefits?

One danger to the children is that CRISPR might have caused damage to other parts of their DNA. These so-called off-target effects are fairly common when CRISPR is used. In addition to changes in other parts of the genome, we know that He Jiankui did not accurately make the changes he aimed for in the CCR5 gene; it’s possible that the He Jiankui-modified gene would not only be ineffective at preventing HIV but affirmatively harmful.

A second danger is that life without a working CCR5 gene may have its own problems. The Northern Europeans without it include adults and appear healthy but they haven’t been closely followed to see if they are at higher risk for other problems. There is some early evidence, for example, that they might be more susceptible to West Nile Virus and influenza.

The potential benefit to the babies is HIV immunity but it is of very little weight. One twin cannot be immune because half of her cells have CCR5. The other may not be immune. And both are “saved” from the possibility, probably small, that they would become infected after being exposed to HIV (probably several decades in the future). HIV is already a manageable disease (though certainly not fun); we have no idea how easily preventable or treatable it may be in 20 years.

The potential benefit to science/medicine is showing that CRISPR’d babies can be born but if that is worth establishing, it could and should be done in a different setting, with an embryo with a very serious disease for which no good alternative exists.

When might it become legal? 

It could become legal any time Congress lets the appropriations rider lapse (next fall) and FDA decided there was enough safety information to allow it to proceed. I expect that neither of those will happen anytime soon.

When/if it does, would it be governed or overseen by an international organization? How might it be regulated? 

Highly unlikely. In the U.S. it will be overseen by FDA and local IRBs. Not perfect but not terrible.

What are the ethical challenges we’ll face when it does become legal?

For me, really not much. The safety issues for the kids are key. Apart from that, based on our current knowledge of human genetics, there are very few situations where gene editing in embryos will be better than embryo selection. We don’t know enough to make super babies and are unlikely to anytime soon. For some people doing any genetic editing that could pass down to future generations is itself a major ethical issue, a “line in the sand” we should not pass. As I have written elsewhere, I don’t think that’s right. See https://leapsmag.com/much-ado-about-nothing-much-crispr-for-human-embryo-editing/

What legal issues do you anticipate?

If this is tried before it is legal, I would expect federal criminal charges against the clinics/scientists. That might raise the question of whether a gene-modified human embryo really is a drug or biological device for purposes of FDA law. If this is tried after it is legal and it goes wrong, big malpractice suits. If it gets used under appropriate regulation, not much.

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Hank Greely is the Deane F. and Kate Edelman Johnson Professor of Law at Stanford Law School, Director of the Center for Law and the Biosciences, Professor (by courtesy) of Genetics, Stanford School of Medicine, Chair of the Steering Committee of the Center for Biomedical Ethics. And Director of the Stanford Program in Neuroscience and Society.

** He Jiankui was a postdoctoral scholar at Stanford in the laboratory of Prof. Stephen Quake from January 2011 to January 2012. His work in the Quake lab focused on computational analysis and was in no way related to gene-editing.

During the U.S.-Japan Council annual conference that was held in Tokyo on November 8 and 9, 2018, Rylan Sekiguchi was elected chair of the TOMODACHI Emerging Leaders Program (ELP). The ELP identifies, cultivates, and empowers a new generation of leaders in the U.S.–Japan relationship. Emerging Leaders participate in leadership education, design and implement original USJC programming, and develop powerful, lifelong personal and professional friendships. A new cohort of leaders aged 24–35 is selected annually through a highly competitive process. USJC Senior Vice President Kaz Maniwa, who oversees the ELP, commented, “We are delighted that Rylan Sekiguchi will lead the Emerging Leaders Program next year as the chair of the Steering Committee. Rylan has shown great passion, dedication, and commitment to the Emerging Leaders Program and we look forward to his leadership.”

Secretary Norman Mineta and Rylan Sekiguchi

During the conference, Sekiguchi gave an overview of the ELP and shared reflections of how his professional and personal lives have embraced the mission of the ELP. Sekiguchi spoke specifically about his current work at SPICE with USJC Vice Chair Norman Mineta, former Secretary of Commerce under President Bill Clinton and Secretary of Transportation under President George W. Bush. Mineta is the subject of a new documentary—An American Story: Norman Mineta and His Legacy—co-produced by Dianne Fukami and Debra Nakatomi, and Sekiguchi is finalizing web-based lesson plans that focus on the film’s key themes, including immigration, civil liberties, and leadership. The documentary was screened at the conference and is anticipated to air on PBS.

A short video that Sekiguchi shared during his speech brought applause from the audience. The video captured a snippet of a performance that he and other members of San Jose Taiko presented last year. The performance celebrated “swing music and the role it played in lifting people’s spirits amid the harsh reality of the Japanese-American internment,” shared Sekiguchi. “Through music and theater, we transported people back to a 1940s-era ‘camp dance’ to educate audiences about the painful, agonizing choices that incarcerees faced.” Mineta was a young boy when his family was uprooted from San Jose, California, and incarcerated in a camp for Japanese Americans in Heart Mountain, Wyoming. Mineta later became mayor of San Jose in 1971.

Through Sekiguchi’s reflections, audience members from both sides of the Pacific were prompted to reflect upon civil liberties during times of crisis—in this case, the incarceration of Japanese Americans following the Japanese attack on Pearl Harbor. My father was a high school student in a camp in Poston, Arizona, and the video prompted me to recall one of the few things that he shared with me about his life behind barbed wire—that camp dances and baseball brought some sense of normalcy to the lives of Japanese-American youth. By showing the video, Sekiguchi’s implicit message was clear: young Americans today—including of course, ELP members—must be aware of the sometimes fragile nature of civil liberties. I have the good fortune of working with another ELP member, Naomi Funahashi, and during the conference, it was rewarding for me to meet many ELP alumni and members of the newest cohort and to witness the beginnings of personal and professional friendships amongst them. Sekiguchi’s speech set the tone for the year ahead—like a “camp dance,” he wants the ELP members to have fun but to always remember the serious nature of what the ELP represents.

Shorenstein APARC's annual overview of the Center's 2017-18 activities  is now available to download. 

Feature sections look at the Center's seminars, conferences, and other activities in response to the North Korean crisis, research and events related to China's past, present, and future, and several Center research initiatives focused on technology and the changing workforce.

The overview highlights recent and ongoing Center research on Japan's economic policies, innovation in Asia, population aging and chronic disease in Asia, and talent flows in the knowledge economy, plus news about Shorenstein APARC's education and policy activities, publications, and more.

Suhani Jalota was only 20 years old when she established a foundation to help impoverished women in the slums of her native city, Mumbai. She was 23 when Forbes named her one of Asia’s 30-Under-30 Social Entrepreneurs as her foundation was taking off.

Now, at the ripe old age of 24, she is embarking on her pursuit of a PhD in health policy on the econ track at Stanford Medicine’s Department of Health Research and Policy.

As a social entrepreneur, she is hoping to create self-sustaining health organizations managed entirely by the people in the low-income communities they serve.

Last year, Jalota, who is also in the first cohort of Knight-Hennessy Scholars, received the Queen’s Young Leader award from Queen Elizabeth II and attended the royal wedding of Prince Harry and American actress Meghan Markle, who is now Duchess of Sussex.

The Myna Mahila Foundation— which provides affordable sanitary products and promotes employment and empowerment among women in Mumbai’s slums — was the only non-UK charity chosen to receive donations in lieu of gifts for the royal couple.

Stanford Health Policy caught up with Jalota to ask her a few questions about what inspires her and how she became so passionate about sanitary health and empowering women in India.

Who inspired you to become social-entrepreneur at such a young age?

I come from a government family and, growing up, our conversations at home were always about the development of India and the status of women. My father is an Indian civil servant who has worked on water sanitation for the city; my mom works with underprivileged girl children, and my brother creates water filters for the same slum community. My grandparents were in the police. It’s just what we do. It’s our family calling. 

As for entrepreneurship, it was Duke University, the Baldwin Scholars Program and the Melissa and Doug Entrepreneurship Fellowship that actually made me believe that all the dreams I had to change the pitiful state of things on the ground in Mumbai could actually be achievable. There I learned to translate the problems I saw to actionable items that the institution was willing to back and support endlessly.

Then in 2011, I met Dr. Jockin Arputham, who spent 40 years working in the slums of Mumbai as the founder of Slum Dwellers International. He became my inspiration, my idol and my mentor. He singlehandedly improved the lives of millions of women.

Dr. Arputham passed away in October. I am here to complete this mission.

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What inspired you to establish the Myna Mahila Foundation? 

When I started spending more time with women in the slum communities they told me horrific stories about living on the railway tracks, children dying in front of them, and not being able to walk the public toilets without being sexually harassed. Some were taking pills to constipate themselves just so they did not have to go to the public toilet. Others would tell me how they had been married off at 12 and were still living with drunk husbands who beat them every day. 

Women were ignoring their own health and it really struck me as how this would lead to such wasted potential for the women, and for India.

The slum community leaders and I began brainstorming — we became very chatty. That’s where the name comes from. Myna from the chatty South Asian bird and Mahila, which means women in Hindi. And we found that their menstrual cycles were physically and mentally exhausting. We found that sanitation and hygiene were clear signals of dignity for women, so we jumped on that.

You see, 320 million women in India do not have access to sanitary pads. And menstruation in India is a taboo health topic; there is a stigma to shopping for sanitary pads. Most women use rags on their periods and these often become dirty, leading to urinary and vaginal infections.

When you are trapped under an aluminum roof where your horizon is the lining of the slum settlement, and you only see limitations ahead of you, it is difficult to see another way of life. After more than six years of working on sanitation and health research with these women, I realized the problems lay deeply entrenched in a woman’s lack of agency, or ability to make decisions. You are brought up to think that what the generations ahead of you have been doing is the only way of life. Hiding your periods, not cooking food or sleeping with the family during your periods, not going to the temple or playing sports — you believe this is the only way to live.

So we came up with a scheme to sell sanitary pads door-to-door to women who would normally not leave their homes or go to a pharmacy to buy them from male clerks. And we get to know these women; they are opening up and exploring things outside the confines of their husbands’ world. I learned that if women were confident to talk about their periods and menstrual hygiene, it could break the silence surrounding domestic violence or sanitation.

Tell us about the women who work for you and the women you serve. 

We employ women from the slum communities we serve, including the accountants, production and sales managers, and the education trainers. We work mostly with Muslim women as that is a representation of the demographics of the communities we are in.

We currently meet about 10,000 women at their doorsteps every month in the 12 slums across Mumbai. It’s not about giving out free pads — a woman gets her period 450 times in her lifetime, so what we’re trying to do is make sure that she understands that it’s a normal health cycle that should not stop her from getting her education and jobs. We have more than 500 girls in our sponsor a girl program, with 100 more girls joining every month. We hold individual counseling and mentorship for these girls along with menstrual hygiene workshops at health camps. We employ 20 women and have partnerships with self-help groups across the city who work with us part-time.

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In the words of my mentor Dr. Arputham, it’s not our purpose to tell the women in the slums what to do; you must think about it from their perspective of what they need and help them create their own change. This has been my mission ever since.

We have millions of NGOs in India so you realize that if things are not really improving at a national level, then there’s something that we’re not doing right. We need the civic mindset to marry the efficiency of the business world. This makes people less dependent and more autonomous to be in control of their own situations. And that comes with a sense of pride.

Why focus on health and sanitation?

We are still struggling with the basics in India: basic health, which includes food, housing, potable water and improved sanitation. Numerous research studies have demonstrated that improvements in sanitation have led to dramatic improvements in health, such as life expectancy outcome measures. Unless we have basic health standards achieved, we will remain behind. To add to the problem, health-care is often deprioritized in India. While it accounts for nearly 18 percent of the GDP here in the United States, for example, it only accounts for 1 percent in India. Can you imagine that? With more than 1 billion people. The role of the public sector in India is to get people on the same level playing field with the basics: education, health care so you’re well enough to go to school or work, find food, shelter and water.

India is a true democracy — so if people start to recognize the importance of health and demand better health care, they can get it. 

What are your goals for the PhD?

To learn more research techniques to use for conducting experiments on the ground for a variety of topics, including women’s demand for health care, effects of positions of power in seeking health care, and the connection between environment and health. On the supply side, I am becoming increasingly interested in understanding pay-for-performance incentive structures in health institutions and for front-line health workers.

I will also be spending my December breaks and summers in India working at the foundation. After my second year, I hope to continue data collection for my dissertation topic: the effect of environmental changes on health outcomes, such as child stunting levels in the slums. As part of my undergrad thesis, I collected anthropometric data on 880 children to look at the effect of slum redevelopment (when the government forcibly relocates people from slums to government subsidized housing) on child stunting. I learned that when a child has one additional year in the buildings — instead of out in the slums with no toilets and clean water and proper ventilation — they were less likely to be stunted. The effect was even more pronounced (and significant) for children moving from slums without toilets than for children moving from slums with toilets.

Another area of research for me moving forward is how this plays out if a pregnant mother gives birth in the slums or the building. Is that affecting the child’s birth weight? Is water quality, sanitation, population density — have other health outcomes actually improved?

You could have gone anywhere for your PhD. Why Stanford?

The Knight Hennessy Scholars Program — that was a very compelling pull. Further, I think that being at Stanford gives you this additional advantage of having access to really positive technology like Virtual Reality — giving people exposure to a different world. We want people to demand better health care, so if they can experience what it feels like to walk into a hospital and a clean waiting room with a bench and a trash can, it can change their concept of what they deserve. I’m really excited to learn more about how new technologies can be applied in the slums to prompt people to stand up and demand better for themselves.

I took two women who work at Myna Mahila with me to the royal wedding. These are women who come from the slums — and what impressed them most was the cleanliness. They couldn’t believe how people could keep everything so clean. If more women see this through VR, they will start to think that this world should become theirs too. We have access to thousands of women and if we can teach menstrual hygiene education through this technology — well, as an entrepreneur, I get very excited about this. This is just one of the many technologies I want to learn more about and see if they can be applied in the slums.

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What did you make of Meghan Markle’s visit to the foundation in January 2017?

When she came to visit she told us she would support us in any way that she could. She kept her word. For us being chosen as one of seven charities for the royal wedding, I thought to myself, oh my God, she really thinks that we’re on to something that could actually change the world for many women. I feel like I have a huge responsibility to live up to their expectations. Now we have to keep our word to them and help women meet their true potential.

Donald Trump has stated his intention to ditch the Intermediate-range Nuclear Forces (INF) Treaty. He and National Security Advisor John Bolton also appear unhappy with the New Strategic Arms Reductions Treaty (New START).

Withdrawal from New START would leave Russian strategic forces wholly unconstrained and end the flow of valuable information from the treaty’s verification and on-site inspection provisions.

Having won a majority in the House, the Democrats can protect New START and, with it, nuclear stability with Russia. To do so, they should steal a page from the playbook of Sen. Jon Kyl (R-Ariz.).

Read the rest at The Hill