While Americans may be well acquainted with China’s quest for influence through the projection of power in the diplomatic, economic, and military spheres, they are less aware of the various ways in which Beijing has more recently been exerting cultural and informational influence. According to a new report, some of these ways challenge and even undermine our democratic processes, norms, and institutions.

With a growing realization that the ambition of Chinese influence operations requires far greater scrutiny than it has been getting, a group of American scholars and policy practitioners set out to document the extent of China’s influence-seeking activities in American society. The working group, co-chaired by Larry Diamond, senior fellow at the Freeman Spogli Institute for International Studies and at the Hoover Institution, and Orville Schell, Arthur Ross director of the Asia Society’s Center on U.S.-China Relations, just released its findings and recommendations in a report that has drawn much attention, “Chinese Influence and American Interests: Promoting Constructive Vigilance.” On December 4, Diamond and Schell discussed the report’s findings and implications at a special roundtable organized by Shorenstein APARC’s U.S.-Asia Security Initiative (USASI).

Diamond and Schell described the report’s detailing of a range of assertive and opaque “sharp power” activities that China has stepped up within the United States in multiple sectors, including Congress, state and local government, universities, think tanks, media, corporations, technology and research, and the Chinese American community. These activities, they argue, penetrate deeply the social and political fabric of our democratic society and exploit its openness. Unlike legitimate “soft power” efforts within the realm of normal public diplomacy, they constitute improper interference that demands greater awareness and a calibrated response.

“The report was born out of a recognition that things have changed,” said Schell. “Our engagement with China has either failed or is teetering on the brink of failure. The report aims to put the question of our interaction and exchange with China within the context of policy.”

Diamond noted that “The question at least has to be asked whether there is a threat to U.S. national interests.” He emphasized that the members of the working group that produced the report seek a productive relationship between China and the United States. The report therefore advocates for perspective and framework that are built on three principles regarding U.S.-China relations: transparency, institutional integrity, and reciprocity.

Diamond and Schell were joined at the panel by Hwang Ji-Jen, a Taiwanese scholar in the Institute for East Asian Studies at the University of California - Berkeley, who helped situate the forms and effects of Chinese “sharp power” in the United States in comparison to its practice in and toward Taiwan. Karl Eikenberry, director of USASI, chaired the discussion.

The event was co-sponsored by the US-Asia Security Initiative in the Asia-Pacific Research Center, and FSI’s Center on Democracy, Development, and the Rule of Law.

Audio from the event is available for download or streaming:

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.

___

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.

The Trump administration has proposed a new rule that would require direct-to-consumer TV advertisements for prescription drugs to disclose the price of their products.

The Centers for Medicare & Medicaid Services (CMS) said the disclosures would help consumers “make informed decisions that minimize not only their out-of-pocket costs, but also expenditures borne by Medicare and Medicaid, both of which are significant problems.”

The idea enjoys broad public support, since medical care and drug costs continue to skyrocket.  A U.S. Senate report earlier this year revealed that the cost of the 20 most commonly prescribed brand-name drugs have risen tenfold in the past five years.

In a June 2018 poll, 76 percent of Americans favored required drug advertisements to include a statement about how much the drugs cost.

But Michelle Mello, a Stanford Law School professor and Stanford Medicine professor of health research and policy, writes in this New England Journal of Medicine perspective that the proposed rule raises substantial public health and legal concerns.

A potential unintended consequence of price disclosure may be to dissuade patients from seeking care, writes Mello and her co-author, Stacie B. Dusetzina of Vanderbilt University School of Medicine, because of the perception that they cannot afford treatment. For example, Trulicity, a widely advertised drug for type 2 diabetes has a list price of $730 a month.

“Patients who could benefit from diabetes treatment may assume that they cannot afford it, when in fact insured patients’ costs for Trulicity may be much lower, and cheaper treatment options available,” they write. Metformin, for instance, costs $4 per month for patients who pay cash.

CMS would demand drug makers use the list prices from the Wholesale Acquisition Cost (WAC) in their television ads, including that costs “may be different” for those who are insured.

“This wording doesn’t communicate that costs to patients are probably much lower than the WAC,” writes Mello, a core faculty member at Stanford Health Policy.

This could have important legal implications as well, as compelled disclosures in advertising impinge on commercial speech protected by the First Amendment. Furthermore, they write, “disagreement about whether the WAC accurately represents a drug’s price could affect how courts assess the rule when constitutional challenges are inevitably filed.”

The researchers say three aspects of the proposed rule undercut the government’s ability to argue that it would improve patient decision-making and reduce drug spending: 

1. Price information does little to inform consumer decisions if it inaccurately represents actual cost.
2. Consumers can already obtain information on cash prices online and their own cost from their insurer.
3. The rule contains no meaningful enforcement mechanism; CMS plans only to list violators on its website, calling into question whether companies will comply.

“We think that a better alternative would be making patient-specific cost information accessible at the point of prescribing, “ the authors write. 

The cost of prescription drugs should become a routine part of clinician-patient discussions, although they acknowledge that this would put more time constraints on medical practices.

“Providing salient cost information at the right time could help reduce drug spending while preserving patient choice, but we believe that direct-to-consumer advertising is the wrong vehicle,” they write.

A national panel of medical experts is recommending for the first time that clinicians offer daily preventive medication to patients who are at high risk of acquiring HIV/AIDS.

The U.S. Preventive Services Task Force estimates that 1.1 million Americans are currently living with HIV. More than 700,000 people have died from AIDS in the United States since the first cases were reported in 1981 and some 40,000 Americans are diagnosed with the virus each year.

Though HIV is treatable, there is still no vaccine and it has significant health consequences.

But the Task Force said in a published draft recommendation on Tuesday that it found “convincing evidence” that taking a daily pre-exposure prophylaxis, known as PrEP, provides a substantial benefit in decreasing the risk of HIV infection in people at high risk. 

PrEP is a combination of two drugs, tenofovir disoproxil fumarate and emtricitabine, taken in one daily pill. The Centers for Disease Control and Prevention says that PrEP reduces the risk of getting HIV from sex by more than 90 percent and by 70 percent for intravenous drug users.

“Unfortunately, HIV is still a major problem in the United States,” said Stanford Health Policy’s Douglas K. Owens, vice-chairman of the Task Force, an independent, voluntary panel of experts in prevention and evidence-based medicine. “But the evidence on this daily treatment is that, if you take it properly, it’s very effective.”

The Task Force, whose recommendations are followed by primary care physicians and clinical practices across the country, gave the recommendation its highest grade, an A. But it noted that PrEP currently is not being used in many persons at high risk of HIV infection. 

“We hope our recommendation will bring attention to a very effective preventative service,” Owens said. “We want clinicians to be aware that for patients at high risk of HIV, PrEP is an important preventive strategy to discuss.”

The global AIDS epidemic has slowed in recent year. AIDS-related deaths have been reduced by more than 50 percent since the peak of the AIDS crisis in 2004. In 2017, 940,000 people died from AIDS-related illnesses worldwide, compared to 1.4 million in 2010 and 1.9 million in 2004.

But many people remain at risk, including sex workers and people who have been trafficked.

The Task Force recommendation is only for those Americans who remain at high risk for contracting the virus, including:

1. Sexually active men whose male partners are already living with HIV, or have a recent sexually transmitted infection (STI) such as syphilis, gonorrhea, or chlamydia;
2. Heterosexual women and men who are sexually active and have an STI or partner living with HIV or who are inconsistent in their use of condoms with a partner at high risk of HIV;
3. People who inject drugs and either share drug injection equipment.

The Task Force reaffirmed its 2013 recommendation that people ages 15 to 65 and all pregnant women also be screened for HIV in an additional draft recommendation. Both recommendations are open for public comment until December 26.

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