Glenn Cohen

Drugs that failed to make it to the market in the U.S. and elsewhere are finding new life in China...But the new trend also raises the question of whether China has become a dumping ground for inferior drugs. I. Glenn Cohen, a Harvard Law School professor who studies medical ethics, said that because of differences in regulatory standards it isn’t unusual or unlawful for a company to get a drug approved in one jurisdiction and not another. For one thing, in China a drug doesn’t have to prove superiority over existing drugs—a major hurdle in the U.S., where 90% of candidates get dropped in the clinical-trial process.

A week after Harvard Law School’s seal change became final, a group of faculty members are publicly speaking out in support of Law School Dean Martha L. Minow, charging that student activists at the school have not given her due credit for her efforts to address racial issues on campus. Seven Law School faculty members—Glenn Cohen, Randall L. Kennedy, Richard J. Lazarus, Todd D. Rakoff, Carol S. Steiker, Kristen A. Stilt, and David B. Wilkins—published an open letter in the Harvard Law Record Monday defending Minow. They wrote, “Our goal here is… to express our support and deep appreciation for Dean Minow and all that she has done during this difficult and important process, and to advance the cause of justice throughout her long and distinguished career.”

An article by I. Glenn Cohen and Eli Y. Adashi...Mitochondrial replacement therapies (MRTs) constitute a family of technologies that seek to prevent the transmission of mutant mitochondrial DNA (mtDNA) from carrier mothers to their children. The embryos so created comprise nuclear DNA from the intended mother and nonpathogenic mtDNA from another woman (the 'mitochondrial donor')2. As such, MRTs allow a woman at risk to be the 'genetic mother' of the resulting child (at least in terms of her nuclear DNA) without passing on the pathogenic mtDNA.

So-called “three parent babies” may be returning to labs in the United States. But it won’t happen this year and the experiments will probably be limited to male embryos only. A recent advisory report concludes that clinical research into mitochondrial therapy procedures on human embryos is “ethically permissible” as long as it meets several conditions. ... I. Glenn Cohen, JD, the faculty director at Harvard Law School’s Petrie-Flom Center, published a blog post about the report. He described the recommendations that MRT be limited to the transfer of male embryos as “clever and interesting.” He said it could have some negative ramifications, such as requiring that female embryos be discarded or frozen. That move could anger some religious conservatives.

While the US Food and Drug Administration (FDA) sits on the fence over whether to approve preclinical or clinical trials using mitochondrial replacement techniques (MRT) to help prevent the transmission of certain diseases passed from mother to child, the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine came out with a new report on Wednesday detailing how it believes FDA should allow such trials and regulate them. ...Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, wrote on the center’s blog Wednesday: “The big headline is they have recommended FDA largely move toward allowing [MRT] to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues)."

Glenn Cohen liked The Martian, which this morning earned itself seven nominations in the Academy Awards, including a slot in the coveted Best Picture category. The Martian, Cohen says, was one of his top 15 movies of the year, “maybe top 10.” But Cohen isn’t a film critic. He’s a Harvard Law School professor who specializes in bioethics. And the narrative thrust of The Martian—a Herculean effort to save a stranded Matt Damon—tickled Cohen’s inner ethicist. Not long after seeing the film in theaters, Cohen wrote a short blog post titled “Identified versus Statistical Lives at the Movies.” In the post, Cohen argues that we latch onto individuals in peril when they have a name and face and become a sort of cause célèbre in the media. We will go to great lengths to save the identified individuals, financially and logistically. But when populations are in peril, when we’re presented with statistics rather than individuals, we’re less likely to take meaningful action.

The FDA is easing its restrictions on gay and bisexual men who want to make a blood donation. But there's a catch -- the lifetime ban is being replaced with a new policy that requires gay and bisexual men to abstain from sex for a year before being able to donate. Harvard Law professor Glenn Cohen joins CBSN with more on the legal issues that could result.

Medical tourism is not only bringing ethical questions home with returning patients, but also higher costs to fix botched procedures or antibiotic resistant infections, says an international expert in the field. Glenn Cohen, a Harvard law professor and author of Patients with Passports: Medical Tourism, Law and Ethics, says North Americans need to take a hard look at the consequences of millions of trips taken outside their countries each year for medical or dental treatment...Most medical tourists seek procedures that are legal in both the patient’s home country and the clinic location — dental treatment, joint replacements or cosmetic surgery — and the decision to travel is based on getting quicker, cheaper services. Even so, there are documented cases of residents in the U.K. and Sweden bringing back bacterial infections that are resistant to medication and can be traced to medical treatment in India, Pakistan and the Balkan states, he notes. Even more troubling for Cohen are people who seek treatments that are illegal or unethical at home such as buying a kidney for transplant or going to a fertility clinic that will implant multiple embryos in an older woman.

More than two years after Texas's controversial abortion law was approved over a widely-watched filibuster, the U.S. Supreme Court could decide Friday whether to give the legislation a place in national history. The court has scheduled a private session to discuss whether to hear arguments about several cases, including a lawsuit filed by abortion providers challenging the law known as House Bill 2...Glenn Cohen, a former U.S. Department of Justice lawyer and current law professor at Harvard University, said the cases satisfy the two most important criteria: they are important, and they have produced different decisions from different federal appeals courts. "The petition in this case makes a good showing on both fronts," Cohen said. "It's been quite a number of years since the Supreme Court decided an undue burden case, and this would seem to be a perfect opportunity."

When Harvard Law School publicly launches its capital campaign on Friday, kicking off an effort that aims to raise several hundred million dollars, it will continue a years-long attempt to rebrand itself. Instead of evoking the halcyon days of the donors’ student experiences as a way to entice them to open their wallets, according to Steven Oliveira, dean of development and alumni relations, the Law School will share another message: The school is very different now...The launch will also showcase the work of professors in new disciplines of law that may not have even existed when some of the donors were students. At a 90-minute panel discussion titled “HLS Thinks Big,” Law School Dean Martha L. Minow will moderate a panel of experts from fields like bioethics and internet law. I. Glenn Cohen, one of the professors who will speak on Friday, wrote in an email that he will discuss bioethics and health law. “As part of the campaign I do whatever I can to connect with alumni interested in these areas (health law, bioethics, food and drug law, biotechnology) and explain why this is such an exciting time for our students and our law school to be involved in these issues,” Cohen wrote.

The state of Florida has declined to investigate a complaint from a mother whose baby died after heart surgery at St. Mary's Medical Center in West Palm Beach, which CNN found had a high mortality rate for pediatric open-heart surgeries from 2011 to 2013....I. Glenn Cohen, a bioethicist at Harvard Law School, said inspections like these are not meant to directly assess whether patients received the appropriate care, or try to find the cause of bad outcomes. He said site visits evaluate the systems around the care, such as whether doctors and nurses are licensed and whether operating rooms are cleaned properly. "The analogy would be to driving a car. Let's say you get into a lot of accidents, they would come and certify that the signals work and you've taken your driver's license test, but they don't actually look at your driving record," he said.

California's health insurance exchange wants to know why you got sick this summer. With 1.4 million people enrolled, the state-run marketplace is embarking on an ambitious effort to collect insurance company data on prescriptions, doctor visits and hospital stays for every Obamacare patient...Glenn Cohen, a professor at Harvard Law School and expert on the ethics of using healthcare data, said the lack of an opt-out was troubling because many exchange customers don't have the option to shop elsewhere. Nearly 90% of Covered California customers receive a federal premium subsidy, and they can access those tax dollars only through the exchange. "I worry about these people being a captive audience," Cohen said. "The more voice you give to patients in this process, the more ethically justified you are doing this with big data."

An op-ed by I. Glenn Cohen and Eli Y. Adashi. Last week, the Food and Drug Administration released highly anticipated draft recommendations that would allow gay men to donate blood after one year of celibacy. While an improvement from the current, highly criticized lifetime ban, the new policy, which was announced in December, still caters to fear and stigma rather than science. It should be reconsidered.

...John Iovine, his health still a work in progress, was finally sent home in April of last year, after several months in a rehab facility. And this moment in a patient's recovery--when they seemingly have to sink or swim on their own--is the one that everyone in the health system is paying attention to right now. For too long, too many Johns sunk, ending up right back in the hospital. The industry calls these preventable readmissions, and they are a huge drain, costing Medicare alone $15 billion annually..."I think there is a lot of interest in the area right now, and it is a great coming together of the healthcare world and the computer science world, as well as the patient experience world," says I. Glenn Cohen, a professor at Harvard Law School, who has written about the legal and ethical concerns raised by the collision of health care and big data. He believes there are still gray areas, though, about ownership and control of the information. "Here there are questions of whether people whose data is going to be used to build the engine have the right to opt out, do they have to affirmatively opt in? Do they have to even be notified it's being used?"

When the United Kingdom resoundingly approved mitochondrial replacement therapy in February, it became the first country to give people this new medical option. In parallel it gave the United States serious cause to reflect on how it handles matters of reproductive innovation, argues a trio of experts in the journal Science. "We have fundamentally different regulatory cultures," said co-author Dr. Eli Adashi, former dean of medicine and biological sciences at Brown University. The essay's other authors are I. Glenn Cohen of Harvard Law and ethicist Julian Savulescu of the University of Oxford.