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.
As Persad sees it, dilemmas in medical ethics and health policy often involve two questions. One is a factual or descriptive question concerning “which benefits an intervention will have.” (183) The other is an ethical question concerning “how to distribute those benefits.” (183) Persad provides the following example to tease out the distinction:
determining who should receive priority for scarce vaccines in a pandemic involves answering two questions: the descriptive (factual) question of which benefits these vaccines are expected to have for their recipients and the normative (value) question of how those prospective benefits should be distributed. (183)
Persad is interested in considering how fair procedures can be used to address questions of the first sort—the “epistemological and factual questions in medicine.” (183) He sets for himself the following task: to “consider how fair procedures have been and can be used to develop and weigh factual evidence in medicine.” (184) Persad foresees an increase in both the significance and frequency of “debates over the validity and weight of medical evidence” as the amount of medical evidence that is both required and amassed increases. He foresees an acceleration in this trend, which he credits to
the expansion of clinical data collection and analysis; the growing relevance of scientific evidence to medical practice…; and the use of evidence to support payment and insurance coverage decisions that have financial implications for patients and providers. (184)
Peter Drahos and a roster of the minds that have made RegNet at the Australian National University the hub of regulatory research and theory have put (it seems) all they know into a new, FREE ebook, Regulatory Theory: Foundations and Applications. It is a comprehensive account of the field, written to serve both as a reference for the essentials and a text book for classes in regulation and governance. It even has a chapter on regulatory research methods in public health by this correspondent.
I am hoping to conduct a serial book review over the next couple of weeks. Here goes:
The first chapter is an introduction to the field by Drahos and Martin Krygier. It usefully orients the reader to the breadth of the field, a breadth that reflects the spread of regulatory activity beyond the state and across networks. Attention to those two phenomena, indeed, is properly presented as the foundation of the field. There is a bit of intellectual history, highlighting the sigificance of Ayres and Braithwaite’s Responsive Regulation, and the emergence of RegNet as an intellectual gathering place. (I saw that first hand, and had a little experience of RegNet collegiality, when I spent a semester there and ended up writing an article on Nodal Governance with Drahos and Clifford Shearing — still my most downloaded paper.) Continue reading →
When people fall acutely ill, they deserve a non-sleep deprived doctor—but they also deserve an adequately-trained doctor. There are only so many hours to the day, and so in medical education a resident’s need for self-care must be balanced against the need for maximum clinical exposure. Since 2003, when restrictions to resident duty hours were first enacted, there has been disagreement about how to best navigate the tension. Recently, the debate resurfaced when the Accreditation Council for Graduate Medical Education (ACGME) proposed a change to the policy governing resident duty hour limits. Perhaps the most surprising part of the announcement was that their proposal increased the time limit that interns (first year residents) can care for patients without sleep. The policy ACGME enacted in 2011 had capped interns at 16 hours on-call, and the proposal increases the limit to 28 hours.
In my prior post I raised arguments for and against the proposed changes to duty hour limits. Here I will unpack the conclusions and limitations of the best empirical evidence available to ACGME: the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial. Published in the New England Journal of Medicine (NEJM) in 2016, the FIRST Trial randomized 117 surgical residency programs nationwide to have either “standard” duty hour policies, which included the current 16-hour cap on interns, or “flexible” policies, which reflect the recent ACGME proposal. Data were collected from July 2014 to June 2105. The sister-study involving medical residencies nationwide has regrettably not yet published.
The FIRST Trial warrant close attention because, like a Rorschach test, different people see different things in the data. For instance, take the finding that neither group caused significantly more or less harm to patients, though shorter duty hours were associated with more handoffs of patient responsibility. Taken at face value, these results neither clearly bolster nor contradict the proposed duty hour changes; yet they are used to both support and undermine the tentative changes to ACGME policy. The study’s first author told NPR that, “We believe the trial results say it’s safe to provide some flexibility in duty hours.” On the other hand, an editorial published in NEJM alongside the study argues that, “The FIRST Trial effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in the continuity of care.” Is there a right conclusion to draw from the study? Continue reading →
I just watched the movie Concussion (2015) as an assignment for one of my bioethics courses. The movie is about a physician, Dr. Bennet Omalu, as he unravels the association between playing in NFL and an acquired neurodegenerative disease, a condition he calls, “chronic traumatic encephalopathy” (CTE). At one point Dr. Omalu tries to convince a prominent researcher that, despite suffering head traumas similar to those of football players, animals like the woodpecker have the means of avoiding CTE;
“The woodpecker’s tongue comes out the back of the mouth through the nostril and goes around the top of its head. Basically, it’s one big safety belt for the brain.” (source)
The tongue shoots out through the nostril? As a medical student, I found this trivial aside absolutely fascinating. But when I tried to learn more I quickly realized–to my dismay–that most experts would balk at this characterization. Woodpeckers don’t develop CTE for a variety of reasons, including; (1) smaller mass means less force from deceleration; (2) no head rotation during each peck as to decrease angular forces, and; (3) their skulls have a physiologic protective cushion. I won’t delve further into the weeds about where exactly the movie’s assertions depart from reality, but to put it generously, this crucial argument totally misrepresents the science.
The problem with all of this is that it’s tempting to watch Concussion and feel better informed about the controversies surrounding professional football and CTE. To be honest, I was mesmerized watching familiar events brought to life on screen, and it all seemed credible as it used the actual names of people involved. Movie reviews by Rolling Stone even suggest that it should be mandatory for football fans, and The New York Times remarks on how it, “sells a complex issue.” Sure, everyone knows Concussion is “for entertainment purposes only,” but can’t stories that are true also be entertaining? However, the seemingly-trivial inaccuracy about woodpeckers was a potent reminder that this film is not a documentary. Concussion should be viewed as it is–a major Hollywood blockbuster starring Will Smith and Alec Baldwin.
The symposium, which was inspired by the wonderful recent PFC & Berkman Center Big Data conference, featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.
Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.
“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”
According to the Centers for Disease Control and Prevention, more than 6.4 million US children 4-17 years old have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). The percentage of US children diagnosed with ADHD has increased by 3-5 percent per year since the 1990s. Relatedly, the percentage of children in this age group taking ADHD medication also has increased by about 7 percent per year from 2007-2008 to 2011-2012.
In response, some state Medicaid programs have implemented policies to manage the use of ADHD medications and guide physicians toward best practices for ADHD treatment in children. These policies include prescription medication prior authorization requirements that restrict approvals to patients above a certain age, or require additional provider involvement before approval for payment is granted.
In a new article published this afternoon in MMWR, CDC researchers compared Medicaid and employer-sponsored insurance (ESI) claims for “psychological services” (the procedure code category that includes behavior therapy) and ADHD medication among children aged 2–5 years receiving clinical care for ADHD.
The article references a newly released LawAtlas map that examines features of state Medicaid prior authorization policies that pertain to pediatric ADHD medication treatment, including applicable ages, medication types, and criteria for approval.
States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.
Addressing the high cost of drugs was at the top of President Obama’s list in his fiscal year 2017 budget, released last week. Many of his proposals were familiar. The President hoped to increase manufacturer contributions to prescription drug coverage under Medicare Part D and wanted to shorten the length of biologic market exclusivity from twelve to seven years. These proposals were also in the President’s fiscal year 2016 budget but were not put into place.
However, the budget also included a number of surprising, new proposals that underscore how post-market evidence might play an increasing role in controlling drug prices in coming years. Rachel Sachs has written about the role that the Centers for Medicare and Medicaid Services (CMS) can play in keeping down drug prices, and it seems like some of these ideas are gaining traction:
Modify reimbursement of Part B drugs. The White House estimates that changes to Medicare Part B payments could save the country $7.75 billion over ten years. Medicare Part B covers drugs and services dispensed in an outpatient setting. Many of the most expensive biologic drugs are currently covered under Medicare Part B. The budget proposal did not elaborate on how the White House hopes to change Part B payments, but the proposal likely refers to recommendations released by the Medicare Payment Advisory Commission (MedPAC) last June. MedPAC’s 2015 report recommended that Congress link Part B payments to clinical effectiveness evidence. For example, the government could group drugs with similar health effects and pay all drugs in each group the rate of least costly product in the group. This approach relies on having reliable clinical effectiveness data so that researchers can easily compare the relative effectiveness of two or more drugs. Continue reading →
Last week, Senator Edward Markey (D-MA) placed a hold on the Senate’s nomination of Robert Califf’s as head of the Food and Drug Administration (FDA). The move was less against Califf and more as political leverage against FDA’s approval of OxyContin. In August 2015, FDA approved OxyContin, a prescription painkiller, for pediatric patients ages 11 to 17. OxyContin is the painkiller most associated with United State’s prescription drug abuse epidemic, accounting for an increase in drug overdose and death over the last decade. FDA’s approval of OxyContin for children drew concern from Markey and others that the approval would lead to an increase in drug misuse for children and their family members. Markey, who has prioritized the fight against opioid addiction in his legislative agenda, hopes he can use the hold to convince FDA to reverse its August decision.
Senator Markey’s message is well intentioned, but may ultimately do more harm than good for children.
Before FDA approved OxyContin in August, children who suffered from severe, chronic pain due to cancer, extensive trauma, or serious surgeries had few drugs approved to treat their pain. Many physicians treating severe pain in children prescribed OxyContin off-label, without proof that OxyContin could safely and effectively treat children. These physicians often relied on their experience or intuition to not under or overprescribe the drug. FDA’s approval in August meant the pharmaceutical manufacturer finally provided physicians with instructions, backed by controlled studies, explaining how physicians could safely use OxyContin to treat children with severe pain. Continue reading →
Sen. Ted Cruz (R-Texas) not only wants to be your president; he wants to decide what medicines you can get. On Dec. 10, Cruz and Sen. Mike Lee (R-Utah) introduced legislation intended to speed up Food and Drug Administration review of drugs and devices that have been approved in certain foreign countries. The Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act would require FDA to approve or reject within 30 days of application any drug or device that has been approved in a “trusted” foreign country — specifically, Canada, Australia, Israel, Japan, and the European Union members. Should the FDA reject an application, Congress can override the agency. […]
On November 19, 2015, the FDA de-regulated the AquAdvantage Salmon. This salmon is genetically engineered to grow faster. This is the first time the FDA has de-regulated a genetically engineered animal.
Let me just say from the outset that the scientific consensus is clear that genetically engineered food is as safe as conventional food. Despite the onslaught of public outrage against GMO food, most of the main arguments against GMO food are just hype.
The genie came out of the bottle a long time ago and it’s not going back in. This happens time and again with scientific advances. Over the past few decades, our ability to understand, manipulate, edit, and otherwise employ the DNA of various organisms to facilitate human understanding has grown exponentially. Efforts to resist, combat, or villain-ize the application of biotechnology to impact society might delay, but will not ultimately succeed in keeping the application of scientific discoveries at bay.
This week, a JAMA Oncology article made a splash when it intensified discussion around what ductal carcinoma in situ (DCIS) should be considered – cancer, precursor, or risk factor – and whether current treatment approaches have been effective. The New York Times, The Guardian, and others have picked up the story, and readers have reacted extensively, only amplifying a demand for answers to questions raised.
Often called Stage 0 breast cancer, DCIS is considered to be abnormal cells that are confined inside the milk ducts and, as such, are not considered invasive. Because of the increased risk associated with DCIS, many women who are found to have DCIS (a growing number considering the frequency of and improvements in mammography) undergo lumpectomies or mastectomies often accompanied by radiation therapy. Continue reading →
I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.
What should the future look like for brain-based pain measurement in the law? This is the question tackled by our concluding three contributors: Diane Hoffmann, Henry (“Hank”) T. Greely, and Frank Pasquale. Professors Hoffmann and Greely are among the founders of the fields of health law and law & biosciences. Both discuss parallels to the development of DNA evidence in court and the need for similar standards, practices, and ethical frameworks in the brain imaging area. Professor Pasquale is an innovative younger scholar who brings great theoretical depth, as well as technological savvy, to these fields. Their perspectives on the use of brain imaging in legal settings, particularly for pain measurement, illuminate different facets of this issue.
This post describes their provocative contributions – which stake out different visions but also reinforce each other. The post also highlights the forthcoming conference-based book with Oxford University Press and introduces future directions for the use of the brain imaging of pain – in areas as diverse as the law of torture, the death penalty, drug policy, criminal law, and animal rights and suffering. Please read on!
The recent meeting at Harvard on neuroimaging, pain, and the law demonstrated powerfully that the offering of neuroimaging as evidence of pain, in court and in administrative hearings, is growing closer. The science for identifying a likely pattern of neuroimaging results strongly associated with the subjective sensation of pain keeps improving. Two companies (and here) recently were founded to provide electro-encephalography (EEG) evidence of the existence of pain. And at least one neuroscientist has been providing expert testimony that a particular neuroimaging signal detected using functional magnetic resonance imaging (fMRI) is useful evidence of the existence of pain, as discussed recently in Nature.
If nothing more is done, neuroimaging evidence of pain will be offered, accepted, rejected, relied upon, and discounted in the normal, chaotic course of the law’s evolution. A “good” result, permitting appropriate use of some valid neuroimaging evidence and rejecting inappropriate use of other such evidence, might come about. Or it might not.
We can do better than this existing non-system. And the time to start planning a better approach is now. (Read on for more on how)
I have an op-ed with Christopher Chabris that appeared in this past Sunday’s New York Times. It focuses on one theme in my recent law review article on corporate experimentation: the A/B illusion. Despite the rather provocative headline that the Times gave it, our basic argument, made as clearly as we could in 800 words, is this: sometimes, it is more ethical to conduct a nonconsensual A/B experiment than to simply go with one’s intuition and impose A on everyone. Our contrary tendency to see experiments—but not untested innovations foisted on us by powerful people—as involving risk, uncertainty, and power asymmetries is what I call the A/B illusion in my law review article. Here is how the op-ed begins:
Can it ever be ethical for companies or governments to experiment on their employees, customers or citizens without their consent? The conventional answer — of course not! — animated public outrage last year after Facebook published a study in which it manipulated how much emotional content more than half a million of its users saw. Similar indignation followed the revelation by the dating site OkCupid that, as an experiment, it briefly told some pairs of users that they were good matches when its algorithm had predicted otherwise. But this outrage is misguided. Indeed, we believe that it is based on a kind of moral illusion.
After the jump, some clarifications and further thoughts.
A remarkable new “sting” of the “diet research-media complex” was just revealed. It tells us little we didn’t already know and has potentially caused a fair amount of damage, spread across millions of people. It does, however, offer an opportunity to explore the importance of prospective group review of non-consensual human subjects research—and the limits of IRBs applying the Common Rule in serving that function in contexts like this.
Journalist John Bohannon, two German reporters, a doctor and a statistician recruited 16 German subjects through Facebook into a three-week randomized controlled trial of diet and weight loss. One-third were told to follow a low-carb diet, one-third were told to cut carbs but add 1.5 ounces of dark chocolate (about 230 calories) per day, and one-third served as control subjects and were told to make no changes to their current diet. They were all given questionnaires and blood tests in advance to ensure they didn’t have diabetes, eating disorders, or other conditions that would make the study dangerous for them, and these tests were repeated after the study. They were each paid 150 Euros (~$163) for their trouble.
But it turns out that Bohannon, the good doctor (who had written a book about dietary pseudoscience), and their colleagues were not at all interested in studying diet. Instead, they wanted to show how easy it is for bad science to be published and reported by the media. The design of the diet trial was deliberately poor. It involved only a handful of subjects, had a poor balance of age and of men and women, and so on. But, through the magic of p-hacking, they managed several statistically significant results: eating chocolate accelerates weight loss and leads to healthier cholesterol levels and increased well-being. Continue reading →
The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines?
Cross-disciplinary collaborations have become an increasingly important part of science. They are seen as a key factor for finding solutions to pressing societal challenges on a global scale including green technologies, sustainable food production and drug development. This has also been realized by regulators and policy-makers, as it is reflected in the 80 billion Euro “Horizon 2020” EU Framework Programme for Research and Innovation. This programme puts special emphasis at breaking down barriers between fields to create a path breaking environment for knowledge, research and innovation.
However, igniting and successfully maintaining cross-disciplinary collaborations can be a delicate task. In this article we focus on the specific challenges associated with cross-disciplinary research in particular from the perspective of the theoretician. As research fellows of the 2020 Science project and collaboration partners, we bring broad experience of developing interdisciplinary collaborations [2–12]. We intend this guide for early career computational researchers as well as more senior scientists who are entering a cross disciplinary setting for the first time. We describe the key benefits, as well as some possible pitfalls, arising from collaborations between scientists with backgrounds in very different fields.
Knapp B, Bardenet R, Bernabeu MO, Bordas R, Bruna M, Minssen T, et al. (2015) Ten Simple Rules for a Successful Cross-Disciplinary Collaboration. PLoS Comput Biol 11(4): e1004214. doi:10.1371/journal.pcbi.1004214
This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).
Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Continue reading →
Essentially what’s happened is that Florida has instituted a headgear rule ahead of the sport’s national governing body. Florida made this decision in advance of this season based on statistics that show that female lacrosse players experience the fifth-highest rate of concussions of any high school athlete. If you’ve ever held a lacrosse ball, this won’t surprise you.
Still, it is not immediately clear what the actual rate of concussions is in Florida. Identifying girls lacrosse as coming in 5th place doesn’t help the reader judge how pervasive the risk really is if we consider that there could be large gaps between the ordinal rankings. Florida officials have suggested that if even one injury is prevented by the introduction of headgear, the rule would be worth it. I’m not sure I’m so risk-averse. Continue reading →