New technologies in biology offer a brave new world of possibilities. Promising solutions to some of the most urgent challenges faced by humanity: climate change, environmental protection, growing population, renewable energy and improved health care. Scientific and technological progress has been remarkable. Simultaneously, emerging life science technologies raise outstanding ethical, legal and social questions.
In this research seminar, Prof. Esther Van Zimmeren from the University of Antwerp joins Prof. Timo Minssen, Postdoc Ana Nordberg and Ph.D. Student Jakob Wested from the Centre for Information and Innovation Law, debating bold new policies for intellectual property law and incentive to life science innovation.
15:00 – 15:10
Welcome Prof. Timo Minssen, CIIR, Faculty of Law, University of Copenhagen.
15:10 – 15:30
Waiting for the Rumble in the Jungle: – An overview of current CRISPR/CAs9 patent disputes, central legal issues and some thoughts on conditioning the innovation system. PhD Student Jakob Wested, CIIR, Faculty of Law, University of Copenhagen.
15:30 – 15:50
From FRAND to FAIR for Synthetic and Systems Biology? The Implications of Openness, IP Strategies, Standardization and the Huawei-case. Prof. Esther van Zimmeren, Faculty of Law, University of Antwerp.
15:50 – 16:10
Keeping up with the technologies: IP Law and Regulation in the age of gene editing. Postdoc Ana Nordberg, CIIR, Faculty of Law, University of Copenhagen.
In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.
The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:
“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”
I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Continue reading →
The underlying policy is made explicit in the first paragraph of the Strategy’s Executive Summary (p4):
The policy of the United States Government is to seek regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers
Apart from clarifying the current roles of the FDA, EPA and USDA and setting out the path for future developments, both documents make it clear that they aim
to help the public understand how the safety of biotechnology products is evaluated and
to help businesses navigate the current regulatory structure.
This is the first time this particular technique has been used to produce a live, but I am not sure from an ethical standpoint the arguments are all that different. That said, for those deeply interested in the more philosophical question of harm to children and the propriety of best interests argument in light of Parfit’s Non-Identity Problem (my take here and here) it may matter whether mitochondrial replacement is done through Pronuclear Transfer or Maternal Spindle Transfer as argued quite well here.
The fact that the doctors are from New York, the Patients are from Jordan, and the procedure took place in Mexico is not insignificant. This is a form of medical tourism, a topic I wrote a book on, most similar to cases of fertility and stem cell therapy tourism I cover in the latter half of the book. Absent making domestic prohibitions extraterritorial, something that I argue is permitted by international law and justified in some instances, there is very little that a home country can do about this. The going abroad is likely in part at least a function of some U.S. laws on the subject Eli Adashi and I wrote about for JAMA prohibiting FDA from considering approval of the technology.
As I wrote on this blog in February in relation to the IOM report “whatever the US policy in a world where medical tourism is possible and other countries adopt their own systems, so long as not everyone adopts the approach of the US some of these problems will manifest no matter what. So this is about harm reduction not harm avoidance.” This was a bit quicker than even I thought, but is not surprising. More generally if your concern about MRT is harm to offspring and transmission to future generations, people born elsewhere through the technology will inevitably enter the United States and/or marry, and procreate with U.S. citizens who themselves become U.S. citizens. To sound a bit X-Files about it “THEY WILL BE AMONG US!” This is a great example of the limits of unilateral regulation in a world of globalized health care.
Interesting that it was a male birth. This may be coincidence or in keeping with the IOM recommendation that only male embryos be transferred (to get rid of germ line transmission). Eli Adashi and I raised some ethical questions in Nature about whether that was an ethically problematic form of sex selection or not but in the reporting I have seen so far it has not been clear that they used only male embryos on purpose.
I wish we could stop calling it in the media “Three Parent IVF” or “Three Parent Reproduction.” That assumes the answer to what I think of as a subtle and interesting set of questions — is the mitochondrial donor a “parent” and what sense of the word do we mean.
The public health crisis in Flint, MI is a long way from resolved. The short-term public health effects have been staggering, a state of emergency has been declared in the city, uncertainty looms in the long-term, and the city, state, and federal government have a serious trust issue on their hands.
Last April, the city of Flint changed its water source from Lake Huron to the Flint River in an effort to reduce mounting financial pressure on the city. However, the new water source corroded the city’s old pipes, leaching lead into the water. Adding insult to injury,
when residents complained about the taste, smell, and appearance, or attributed rashes and other medical conditions to the water source, city officials told residents that they were continually monitoring the levels to ensure that they were safe (a claim which has been called into question). Despite concern over the quality of the water dating back almost immediately after the switch, a state of emergency was declared when parents started bringing children in to the pediatrician for concerns about delayed development. When researchers at Hurley Medical Center looked into the issue, they found that the proportion of infants and children with above-average lead levels close to doubled after the switch. Residents filed a class-action lawsuit against the Governor, the state, the city, and 13 public officials in November for damages from the high levels of lead in the water, claiming that their 14th amendment right was violated when the city took away their safe drinking water and replaced it with a cheaper, more dangerous alternative.
Do not miss this splendid opportunity to get support for organizing symposia at on of the most beautiful spots in Europe:
The Brocher Foundation is inviting junior and senior researchers to submit proposals for a 1.5 day multidisciplinary symposium project on the Ethical, Legal and Social Implications of new medical developments.
The Brocher Foundation will host and support the costs of the event between February and April or between July and October 2016.
The fully equipped Brocher Center Conference room – situated in Hermance, 15 kilometers from Geneva downtown, can welcome up to 60 participants in its exceptional location on the shores of Lake Geneva.
Excepted the travel reimbursements which will be directly arranged by the organizers, the Brocher Foundation will be responsible for all the logistics, according to its standard.
The call will end on the 17 May 2015 at midnight GMT.
It probably depends on who you ask. Proponents of fracking laud the energy independence, creation of jobs, environmentally friendly nature of natural gas, national security and economic benefits. Opponents to fracking have concerns about the impact to the environment, public health issues, and water use. Each side dismisses the other side’s arguments.
Perhaps a primer on hydraulic fracturing, known as fracking, is helpful. Fracking is the process of creating long vertical wells below the earth’s surface and then horizontal wells that break open the shale and allow the natural gas to be released and captured. Fracking uses millions of gallons of water to create these wells. A proprietary mix of chemicals in the water is used to create the fissures in the shale. Since the shale is far below the surface, proponents of fracking were able to convince Congress to exempt the industry from the Safe Water Drinking Act, which is now affectionately called the Halliburton Loophole.
The problem with assessing proponents and opponents positions on fracking is the lack of scientific data. While it may be true that the fracking wells are far below the surface, leaks in the fracking wells could impact the aquifers. The EPA is conducting a large scale drinking water impact study, with results that are eagerly anticipated to be released later this year. It could be that, for example, drinking water is/has been contaminated, but that with new regulations and novel innovations, these wells could be made safe such that drinking water is not contaminated. But, we don’t know if there is a problem without the scientific studies and if there is a problem, we need to determine if science/innovation can address the problem.
The proponents of the Affordable Care Act (ACA) tax subsidies law suits (currently pending in both the D.C. and Fourth Circuits and which I have discussed here, here, here, and here) have seized on the Court’s recent decision in Utility Air Regulatory Group v. EPA—going so far as to file letters of supplemental authority with both courts highlighting the case as additional relevant authority for the subsidies suits. We should hope that the courts understand the ACA—and the specifics of the subsidies challenge—well enough to understand how different these cases are. There is also much in Utility Air, not mentioned by the challengers, that supports the Government’s position in the ACA case, and that should resonate with even the most textualist of judges.
The ACA challengers’ filings and blog posts highlight the part of Utility Air in which the Court refused to let EPA “tailor” the Clean Air Act’s explicit pollution thresholds (raising them higher than the statutory allowance because greenhouse gas emissions are much greater than conventional pollutants). They also highlight the Court’s invocation of the so-called “major questions” rule—the presumption that Congress does not delegate decisions to agencies of vast economic and political significance without making that delegation clear.
The subsidies challenges present completely different facts. The issue in those cases is whether a line in the ACA that provides that the subsidies shall be available to individuals enrolled in insurance “through an Exchange established by the State under section 1311,” clearly also excludes individuals enrolled through federally-operated exchanges. The challengers have made this argument because more than half of the states are using federal exchanges and denying the subsidies on those exchanges would be lethal to the ACA’s operation. Both HHS and the IRS have interpreted the statute as providing the subsidies on the insurance exchanges operated by both the state and the federal governments. Their interpretation is based on the fact that numerous other provisions of the statute, as elaborated in the government’s briefings, would be nonsense and superfluous under the challengers’ reading. One of many possible examples is ACA §36B(f), which provides that: Continue reading →
Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard. The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.
I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.
Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.
The third conference session, “Regulating Farm Production: From 0 to 60,” was moderated by Robert Greenwald, Director of the Center for Health Law Policy and Innovation at Harvard Law School. To make the presentations more cohesive, the presenters divided each of their fifteen-minute presentations into two seven-minute presentations. The panel discussed the FDA’s proposed Produce Safety rule under the Food Safety and Modernization Act (FSMA), the rule’s focus on produce and growing of food, and the large question of whether FSMA makes our food safer.
During the government shutdown in October 2013, a battle in part over the future of healthcare reform, a non-negligible amount of media attention focused on the shutdown of public parks. Perhaps because the parks were the least expected casualty of the shutdown, or the most ludicrous – many are, after all, large outdoor spaces that functioned for millions of years before there were federal funds for them – Americans were frustrated or amused that they could not walk around outside some places because politicians in D.C. could not agree on a budget.
The healthcare reform debate pitted those who believed that everyone should have health insurance or that access to healthcare was a right against those who believed that health spending was already too high or that everyone does not have a right to access to healthcare. In a world of infinite resources, where everyone could have complete access to healthcare without anyone having to give up anything of their own, it is difficult to imagine that anyone would say that there should not be universal access to healthcare, that some are not deserving of the service. It would be strange to require a threshold public showing of effort to obtain health insurance through employment if there was no cost to giving the healthcare – if fairness is an issue, as it appears to be a concern for some, there are certainly other services that could be denied. It is likely that for most the fairness concern only becomes salient in the face of resource constraints where these same funds could fund other programs or allow others to pursue their interests.
The USDA’s Animal and Plant Health Inspection Service (APHIS) has released a Draft Environmental Impact Statement associated with its deregulation of a new generation of genetically modified herbicide-resistant crops. While many in the agricultural industry hail this as a much-needed step in the development of new weed-control technologies, critics worry that it will accelerate an “herbicide treadmill” at the cost of more sustainable management strategies.
As a bit of background, the development of the first generation of genetically modified (GM) herbicide-resistant crops revolutionized agricultural weed management in the mid 1990s. Prior to this development, weed management required significant skill and knowledge. Farmers had to not only carefully manage the timing of various herbicide applications, but also integrate other nonchemical control practices. Herbicide-resistant crops, by contrast, were effective and easy to use.
During the initial phase of development, a variety of GM options came to market, but Monsanto’s “RoundupReady” varieties (which are resistant to a broad-spectrum herbicide known as “glyphosate”) quickly became dominant. By 2008, 63% of corn fields and 92% of soybean fields in the US were being planted with RoundupReady seeds. The outcome of this single-track approach to weed management has been a dramatic increase in the number of weed species that are resistant to the herbicide glyphosate.
In response to the evolution of these “super weeds,” Congress has held hearings to assess whether additional government oversight is needed to address the problem. The response of the seed and agrichemical industries, by contrast, has been to develop new GM seeds that are resistant to other broad-spectrum herbicides for which weeds have not yet developed resistance. Continue reading →
This conference will bring together scholars to discuss a range of issues related to the Food Safety and Modernization Act, including FSMA and risk regulation strategy; regulating farm production; benefits, challenges, and gaps in FSMA’s approach; and international issues and trade implications.
KEYNOTE: Peter Barton Hutt, Harvard Law School/Covington & Burling – The Food Safety Modernization Act in Historical Perspective
At last year’s Petrie-Flom conference on the FDA in the 21st Century, I had an experience that I’ve never really had before in my academic career. I gave a paper (co-authored, actually) that was met with genuine ire. The paper dealt with labeling GMO foods. Several in the audience—including friends—heard me as going over to the dark side of anti-science, irrational skepticism, and downright immoral ignorance of important nutritional and commercial advantages. I wasn’t buying into such bad science, however. The written paper (concededly it’s always possible that a lengthy legal argument doesn’t come across in a nuanced way in a short presentation) argued three points: (1) the FDA has not acted to the full extent of its statutory labeling authority; (2) the present processes for granting market clearance for particular GMO products is highly deferential to industry submissions with respect to safety (the safety of a particular GMO product is a different question from the general question of GMO safety—the FDA’s own example is the unknown allergenic effects of adding peanut genes to other agricultural products); and (3) in a context in which scrutiny of safety is so industry-dependent, there is a case to be made for labeling so that consumers can make their own choices.
In a nutshell, the current FDA process for allowing a particular GMO product to be marketed is a variant of the process for allowing marketing of additives Generally Recognized as Safe (GRAS). Under the GRAS process, anyone can petition for a determination that an additive is GRAS; industry can also make its own GRAS determinations. The procedure for clearing GMO foods is a consultative process that is also voluntary and entirely reliant on information from industry. Unlike the GRAS process, however, it does not even require publication of the information relied on for consultations.
In an article published this week in JAMA Internal Medicine, Neitner et al. demonstrate the extent to which GRAS determinations are riddled with conflicts of interest. The authors conclude, “The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.” Given the parallels between the GRAS process and the process applied to GMO foods, one might hypothesize that conflicts of interest are similarly present in the latter. The FDA should address these concerns, too. This is not anti-science; it is respect for good science.
Last Friday, Princeton ethicist Peter Singer joined Petrie-Flom for a lecture on “Ethics and Animals: Where are we now?” Singer began his talk with a historical look back at various religious and philosophical views of the relationship between humans and animals. He traced the lineage of thought from the view of dominion, which entails the idea that man has been granted free reign over animals by God (first found in Genesis, and also espoused by Aristotle); to the notions developed by Thomas Aquinas and Immanuel Kant, who believed that abuse of animals was not itself morally problematic except to the extent that it may inculcate bad habits in those who practice it; to the early English Utilitarians, who recognized the capacity of animals to suffer; to Charles Darwin, whose groundbreaking theory of evolution muddied previous distinctions between human and non-human animals.
Singer went on to discuss modern views of proper animal treatment. He articulated the prevailing view that humans have some obligations to treat animals well and without cruelty, but that human interests exceed those of animals. Singer then laid out his main principle regarding the treatment of animals—that of equal consideration of interests. In other words, the interests of non-human animals should be considered equally with human interests. To favor human interests over animal interests is a speciesist stance, similar in nature to other –isms, like racism and sexism, and equally morally indefensible, in Singer’s view. Singer carefully noted that while equal consideration of interests would mandate better treatment of many animals, such as those raised as livestock, his principle does not imply that humans and animals should receive the same treatment.
[…] commercial farming of oranges and grapefruit is in dire peril from an insect-borne bacteria that causes a disease known as “citrus greening.” An uncontrollable fungal blight is destroying the banana crop around the world. Coffee rust is knocking out plants in Central and South America. Diseases like rice blast, soybean rust, stem rust in wheat, corn smut in maize, and late blight in potatoes destroy at least 125 million tons each year of the world’s top five foods. The damage done to rice, wheat, and maize alone costs global agriculture $60-billion per year. The effects are especially catastrophic in the developing world, where 1.4 billion people rely on these foods.
There is a way to get rid of such otherwise unstoppable plant diseases, which waste scarce resources, bring about malnutrition and starvation for hundreds of millions, and cost the world economy billions of dollars. Genetically modified organisms.
Specifically, engineering plants to resist the diseases. So why don’t the folks bearing the bad news about GMOs make a connection to the huge problems that could be fixed by genetic engineering? The answer is the bungling mismanagement of a potentially useful breakthrough technology by the GMO industry, alongside market forces that produce GMOs friendly to pesticides rather than hostile to fungi. [….]
Bad management thus turned a technology that should have been greeted as a way out of chemically based farming into a public-relations nightmare.
If you were watching television this week you may have seen this clip of a taste test for hamburger meat grown in a “test tube” in London discussed here. The meat was grown from stem cells from existing cows used to grow 20,000 strands of tissue. Costing more than $330,000 to make, with funding by google Co-Founder Sergey Brin, the day where this will be available at your grocery store or served at your fast food franchise is far away. But it may come sooner if we conclude that there may be a moral duty to develop and eat this kind of meat rather than animal-grown meat and press our governments to start funding this work. What is the morality of test tube meat consumption?
Sometimes narrative can be a way into ethics so consider this bit from one of my favorite novelists (and Canadian public intellectuals) Margaret Atwood from her novel Oryx and Crake. She imagines a dystopian future that includes the the consumption of “Chickie Knobs” in one scene:
“This is the latest,” said Crake.
What they were looking at was a large bulblike object that seemed to be covered with stippled whitish-yellow skin. Out of it came twenty thick fleshy tubes, and at the end of each tube another bulb was growing.
“What the hell is it?” said Jimmy.
“Those are chickens,” said Crake. “Chicken parts. Just the breasts, on this one. They’ve got ones that specialize in drumsticks too, twelve to a growth unit.
“But there aren’t any heads…”
“That’s the head in the middle,” said the woman. “There’s a mouth opening at the top, they dump nutrients in there. No eyes or beak or anything, they don’t need those.”
To be clear the test tube meat unveiled earlier this week is not a Chickie Nob, it is grown from stem cells rather than being a cow with extra parts and brains missing (Atwood is silent on some characteristics of the Chickie Nob that may matter ethically such as whether it feels pain or is sentient), but I think many will react to the test tube meat the same way: disgust. Some in bioethics, like Leon Kass, think there can be a “Wisdom of Repugnance.” In my own work I have been a persistent skeptic on this theme. For me repugnance and disgust are good and should be cultivated as reactions for that which we deem immoral, but should be broken down and overcome for those things which we conclude are morally worth pursuing. Thus repugnance is a tool whose proper deployment depends on prior moral conclusions. In the case of test tube meat, whatever repugnance we feel is one we should get over and media, government, etc, should help us do so.