Glenn Cohen

What if we could instantly double COVID-19 vaccine availability in America? This is the tantalizing prospect raised by data collected while testing the double-dose regimen for the Moderna and Pfizer vaccines. As two Canadian researchers highlighted in a letter to the New England Journal of Medicine this month, both vaccines have been found to achieve 92 percent efficacy 14 days after a recipient has been given just one dose. The second dose, administered three to four weeks after the first, offers comparatively small gains by this measure: It boosts the Pfizer vaccine's efficacy to 95 percent, and the Moderna vaccine's to 94 percent, differences of just three and two points, respectively...I reached out to I. Glenn Cohen, a professor of health law and bioethics at Harvard University, and Holly Fernandez Lynch, an assistant professor of medical ethics at the University of Pennsylvania. Together they edited FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, which explores the FDA's function, successes, and failures...If the companies do apply for a change, Cohen said he would expect the FDA to move quickly enough to give an answer within the critical period of vaccine shortages this spring. "As agencies go, FDA is appropriately careful in their review of these matters," he said, "but given the amount of data experience they have with Pfizer and Moderna thus far, if provided appropriate data, I think they could probably make a determination of whether such a change was warranted fairly quickly."

As recently as 10 years ago, Jeannie Suk Gersen was still telling people that the area of law she specialized in—sexual assault and domestic violence—didn’t hold much interest for the general public. A quiet corner of the profession, she thought. Remembering that now, she laughs. “But, you know,” she adds, “every area of law does end up moving into focus. Because, in the end, law is really about every aspect of our lives.” Which is partly why Gersen, J.D. ’02, has always taken it so seriously. “Words don’t just describe things,” she explains. In the law, “words actually do things.” ... “Jeannie is intellectually fearless,” says Bemis professor of international law Jonathan Zittrain. That’s a common sentiment among her colleagues... “There are a lot of people who are afraid to say things in our business,” says Learned Hand professor of law Jack Goldsmith, “and she’s not afraid to say what she thinks.” ... “Her whole response to Title IX has been very, very striking—and I think completely correct,” says Beneficial professor of law Charles Fried, who was Gersen’s teacher before he was her colleague ... Says her former teacher, Loeb University Professor emeritus Laurence Tribe, “I was always impressed by how both meticulous and yet unconventional her insights were. She would often come at issues in a kind of perpendicular way. Rather than finding a point between A and B, she would say that maybe that axis is the wrong axis.” ... “She has one of those amazing brains,” says Williams professor of law I. Glenn Cohen, who worked on the Harvard Law Review with Gersen. “She was a year ahead of me in law school, and we all regarded her more like a faculty member, even back then. She just seemed to know everything.”

As Florida residents struggle to get appointments for COVID-19 vaccines, some are worried the already limited supply may be going to people who don't even live in the state...Under Florida's vaccine plan healthcare workers, long-term care workers and those 65 years and older who are at least part-time residents are eligible to get the vaccine. Data from the Florida Department of Health revealed more than 1.1 million people have been vaccinated in the state. Out of those 1.1 million people, 39,000 reside outside of Florida. It's a new trend being called "vaccine tourism," in which people from outside the state travel to Florida to get vaccinated...Harvard law professor Glenn Cohen, a medical tourism expert, said he wasn't shocked when he heard of vaccine tourism and he sees it growing. "Yeah, I think the best thing we could do would be assisting other countries to meet their rollout and to supply them with vaccines to meet the needs of their population so that we don't create this market where the wealthy and able-bodied can travel," said Cohen. "Unfortunately, we've ended up in a place where every country has its purchase order and every country is doing its own distribution. And that setup is part of what has set the preconditions for this instance of vaccine tourism."

With Pfizer and its partner BioNTech on the cusp of an authorized COVID-19 vaccine in the United States, a major ethical dilemma now stands in front of the companies and regulators: If the vaccine is authorized, what will happen to the thousands of people who volunteered to participate in Pfizer’s trial? That question was put forth before an independent committee of FDA advisors meeting Thursday to discuss the Pfizer vaccine...From the start, all the people who volunteered for the study knew there would be a 50-50 chance they might get a placebo shot. “You disclose to them at the outset that it’s possible they’re going to receive a placebo,” Harvard Law professor Glenn Cohen said. “It’s not considered unethical,” he added, because researchers don't yet know whether the experimental vaccine is effective...Having two groups of participants allows researchers to “hold everything equal, such that we are confident that any differences we see in the result are from the vaccine itself,” Cohen said. Big experiments are designed this way so scientists can know for sure if a vaccine is working significantly better than placebo. In the final analysis, Pfizer’s vaccine was 95% effective at preventing COVID-19 disease, and it has been shown to be safe over more than two months, the threshold for emergency authorization.

Infectious disease epidemiologist Dr. Monica Gandhi and Harvard Law professor and bioethics expert Glenn Cohen join Dr. Ian Smith to discuss taking thymosin alpha-1, a treatment that might show promise but is not FDA approved. Dr. Gandhi shares that she’s really concerned about people taking thymosin alpha-1 because it could lead to something far worse than COVID-19. Plus, Glenn shares that it’s actually unlawful for companies to promote this treatment.

As Election 2020 looms, the next Congress will have another important decision to make - what is permitted, and what is not, when it comes to human genetic editing of the gamete (sperm and eggs). Currently, a ban on federal funding of genetic editing of the human embryo is in place. This rider, dating from 2015 and renewed annually, prohibits approval or funding to go to any research project that intentionally creates or destroys a genetically modified human embryo. This ban disallows the FDA approving any drug or other biological products created from such an experiment. However, the rider is unclear if this ban on funding and research applies to genetically modifying sperm and eggs. In a recent article in The Journal of Law, Medicine, and Ethics, Professor I. Glenn Cohen of Harvard Law School, Professor Jacob Sherkow of the University of Illinois Urbana-Champaign, and Professor Eli Y. Adashi of Brown University state that the next Congress will need to address the question and ethics of gamete editing - that is - editing of the sperm and egg...There are many ethical issues when it comes to editing the embryo, yet some of these do not necessarily apply to the editing of the gamete. This is where Cohen, Sherkow, and Adashi step in. They argue that the ethical issues of editing an embryo are quite different from editing gametes. The coming Congress will need to decide if the current ban should include - or exclude - the editing of sperms and eggs... “Sperm and egg editing occurs before that moment [the moment that the sperm and egg meet and the genetic code is set], upending the claim that editing alters ‘a person.’ The activity is more like selecting a sperm or an egg donor,” say the authors.

Since February of last year, tens of thousands of patients hospitalized at one of Minnesota’s largest health systems have had their discharge planning decisions informed with help from an artificial intelligence model. But few if any of those patients has any idea about the AI involved in their care. That’s because frontline clinicians at M Health Fairview generally don’t mention the AI whirring behind the scenes in their conversations with patients. At a growing number of prominent hospitals and clinics around the country, clinicians are turning to AI-powered decision support tools...Hospitals and clinicians “are operating under the assumption that you do not disclose, and that’s not really something that has been defended or really thought about,” Harvard Law School professor Glenn Cohen said. Cohen is the author of one of only a few articles examining the issue, which has received surprisingly scant attention in the medical literature even as research about AI and machine learning proliferates...Harvard’s Cohen said he wants to see hospital systems, clinicians, and AI manufacturers come together for a thoughtful discussion around whether they should be disclosing the use of these tools to patients — “and if we’re not doing that, then the question is why aren’t we telling them about this when we tell them about a lot of other things,” he said. Cohen said he worries that uptake and trust in AI and machine learning could plummet if patients “were to find out, after the fact, that there’s a rash of this being used without anyone ever telling them.” “That’s a scary thing,” he said, “if you think this is the way the future is going to go.”

In the special wards of Shanghai’s Public Health Clinical Center, nurses use smart thermometers to check the temperatures of COVID-19 patients. Each person’s temperature is recorded with a sensor, reducing the risk of infection through contact, and the data is sent to an observation dashboard. An abnormal result triggers an alert to medical staff, who can then intervene promptly. The gathered data also allows medics to analyze trends over time. The smart thermometers are designed by VivaLNK, a Silicon-Valley based startup, and are a powerful example of the many digital products and services that are revolutionizing healthcare. After the Internet of Things, which transformed the way we live, travel and work by connecting everyday objects to the Internet, it’s now time for the Internet of Bodies. This means collecting our physical data via devices that can be implanted, swallowed or simply worn, generating huge amounts of health-related information...But today, all sorts of seemingly non-sensitive data can also be used to draw inferences about your health, through data analytics. Glenn Cohen, a professor at Harvard Law school, told me in an interview that even data that is not about health at all, such as grocery shopping lists, can be used for such inferences. As a result, conventional regulations may fail to cover data that is sensitive and private, simply because it did not look sensitive before it was processed.

Several years ago, Harvard Law School (HLS) administrators observed that the profile of incoming law school students was very different than it was even a decade ago. Students coming to HLS now reflected many different backgrounds and lived experiences, with many more having majored in a STEM field in college, spent four or more years in the workforce, or come to HLS from abroad. In response, in 2018 HLS worked with the Harvard University Office of the Vice Provost for Advances in Learning (VPAL) to launch a new online, pre-term course called Zero-L—meant to ensure that all incoming students, whatever their backgrounds and previous areas of study, start with the foundational knowledge that will enable them to thrive in law school...Professor I. Glenn Cohen ’03, part of the HLS committee responsible for developing Zero-L, notes, “The learning curve at law school can be steep.” Zero-L was designed as an “on-ramp to help ease this transition; we want to ensure all law students have access to that on-ramp.”

Amid wide concern driven by the COVID-19 pandemic (Is it safe to attend?) and recession (Can I afford it?), with many colleges and universities expecting enrollment to plummet this fall, Harvard Law School (HLS) has decided to offer Zero-L - its online, pre-matriculation orientation to legal education free to law schools nationwide, beginning July 1. This "on-ramp" to the unique features of legal reasoning, writing, and pedagogy (reported in detail here) was designed to introduce students from diverse backgrounds, with increasingly diverse academic preparation, to their first-year experience, so they can embark on their professional education more confidently and proficiently... "I know first-hand the devastation this pandemic is causing to our social structure," said Zero-L faculty director, Attwood and Williams professor of law I. Glenn Cohen, who specializes in health law and bioethics. "I know how many students are finding their time in college disrupted, and their plans to really 'hunker down' and get ready for law school disrupted by a sick family member or the need to help support their families." In light of those constraints, and the limitations on regular orientations this summer, he continued, "[K]nowing we had an excellent course with a demonstrated ability to help students start law school, making it freely available this year seemed like a small thing HLS could do for law students and law schools across the country to try to make the fall 2020 just a little bit easier."

Law schools across America will be facing difficult choices this summer, as orientation sessions for incoming students may be truncated, delayed, or moved online due to the global pandemic. And all must be prepared for the possibility that new law students, many of whom experienced significant disruption in recent months, may experience novel and unexpected challenges preparing for their first year in law school. To assist both law schools and their incoming students, Harvard Law School recently announced plans to offer its online pre-matriculation program, Zero-L, to law schools around the country for free this summer. The course was developed and launched in 2018 in collaboration with the Harvard University Office of the Vice Provost for Advances in Learning (VPAL) to ensure that all incoming Harvard Law students, whatever their backgrounds and previous areas of study, start with a shared base of knowledge. (The name Zero-L is a play on the traditional terms for first-, second-, and third-year law students—1Ls, 2Ls, and 3Ls). Harvard Law Today recently spoke by email with Zero-L’s faculty director, Professor I. Glenn Cohen ’03, about the program, the decision to make it available for free to interested American law schools this year, and how he expects it can help them and their students prepare for the fall semester.

Governments and health agencies around the world are considering issuing “immunity passports” to help restart their economies — documents certifying that the holders are immune to COVID-19 because they’ve already had it. But global health authorities warn that such documents would be unreliable and potentially dangerous...Meanwhile, the World Health Organization says there’s no proof that being infected once with the coronavirus makes a person immune. And critics warn that granting additional freedoms to people who are theoretically immune would risk creating a black market for certification – and even create an incentive for deliberate infection...Harvard University bioethicist Glenn Cohen said he worries that some people might be tempted to intentionally expose themselves to the virus in the hope they can battle through and then get back to work. And there is concern that some people could resort to illegal tactics to get an immunity badge, creating a black market. “I'm really worried about the diverting of resources which are finite to cracking down on the black market rather than have these resources aimed at the interventions that are most efficacious in curbing infection and helping people survive,” Cohen said.