Harvard Law School
Griswold Hall, Room 110
1525 Massachusetts Ave.
Cambridge, MA [Map]
Please join us for a lecture by Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussing the balance between speed and safety in FDA’s regulation of pharmaceutical products. Topics will include how FDA’s approach has ebbed and flowed over time, the various tools FDA has introduced to reach this balance, and the potential impact of FDA’s various approaches on products and companies, especially start-ups.
Neil Flanzraich graduated from Harvard Law School in 1968 and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012.
This event is free and open to the public. Lunch will be provided. Full event details are here.
Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus of this symposium is to explore this area from various perspectives – privacy and security, policy, open clinical trial data, systems and disease-oriented synthetic efforts and individually-provided, aggregated crowd-sourced data. The goal is to engage our biomedical and public health research community in a more nuanced appreciation of these and similar issues.
Topics include: data aggregation, access, annotation, refocusing on novel or unanticipated questions, and recombination with diverse demographic/epidemiologic data. Continue reading →
On 18th December 2014, the CJEU rendered its’ much-anticipated decision in C‑364/13 International Stem Cell Corporation v Comptroller General of Patents (ISCC). Qualifying its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ova stimulated by parthenogenesis, the Court held that in order to constitute a ‘human embryo’ – and thus to be unpatentable under the EU Biotechnology Directive – the stimulated ovum must have the “inherent capacity to develop into a human being”. This would allow patents on innovative parthenotes which had not been genetically modified to achieve totipotent capabilities. Hence the judgment establishes a crucial limitation of the broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo” since they are “capable of commencing the process of development of a human being”. The ISCC decision is to be welcomed since it provides an ethically justifiable leeway for patenting and offers reasonable support to the commercial viability of European cell therapy research. Yet, ISCC’s impact still depends on national implementations and only applies to certain hESC cells. Thus, further clarifications would be helpful concerning other non-totipotent hESCs.
Functional magnetic resonance imaging (fMRI) evidence of lie detection has, appropriately, faced difficulty gaining evidentiary acceptance in criminal courts. While a comprehensive discussion of the case law is beyond the scope of this post, it is important to note that courts have repeatedly refused to admit such evidence, both under a Daubert test, using Federal Rule of Evidence (FRE) 702, as well as under FRE 403.
Under Daubert, which governs the admissibility of expert testimony, courts have found that fMRI lie detection falls short in meeting the necessary standards, including the identification of error rates and maintenance of uniform testing standards. Courts have also pointed out that the motivation to lie may be different in research v. real-world settings. In a laboratory experiment, one can assume that the participant is complying with investigator directions. However, if the scan is to be used in the courtroom, the subject will have a personal interest in the outcome, and may try to employ counter measures, or disregard instructions, in order to “fool” the scanner. Recent research shows that this task may not be hard, at least not for those who know how to effectively “trick” the scanner.
Judges have highlighted that while there are peer-reviewed studies of fMRI lie detection, said studies have very small patient bases (all N<60), and included a range of participants who were not representative of the general population. Courts recognize that neuroimaging, for the purposes of lie detection, is still not generally accepted by the scientific community. Both of these factors limit the applicability of the results to the general population, and to any individual defendant in particular.
On 26th November 2013, the Danish Agency for Science, Technology and Innovation organized an expert meeting on “Synthetic Biology & Intellectual Property Rights” in Copenhagen sponsored by the European Research Area Network in Synthetic Biology (ERASynBio). The meeting brought together ten experts from different countries with a variety of professional backgrounds to discuss emerging challenges and opportunities at the interface of synthetic biology and intellectual property rights. The aim of this article is to provide a summary of the major issues and recommendations discussed during the meeting.
The ERASynBio consortium consists of 16 governmental funding bodies from 12 EU Member States (Austria, Denmark, Finland, France, Germany, Greece, Latvia, Netherlands, Portugal, Spain, Slovenia, and UK) and two Associated Countries (Norway and Switzerland)
The United States legal system places a great deal of importance on juries. With this faith comes a belief that juries are effective and reliable in determining the credibility of witnesses that testify in front of them. However, research has found that people, while generally good at lying, are terrible at detecting the lies of others. Scientific research has found that, in a face-to-face meeting, the average person is able to detect deception at only a slightly better than 50% rate, meaning that most people are no better at detecting deception than would be expected from pure guessing.
This tension has led courts to search for a technology-based method of lie detection, which could objectively improve on human’s natural inability to detect deception. While polygraphs have been around for a long time, there is tremendous (and well deserved) skepticism of this modality. In 2003, a National Academy of Sciences report found there was a startling lack of research in regards to the accuracy of polygraph machines under varying conditions. This study estimated that the accuracy of polygraphs was roughly 75%, but could be as high as 99% or as low as 55% depending on a variety of factors. These factors include the experience of the operator, the setting of the test (experimental vs. forensic), and what questioning format is employed.
The skepticism towards polygraphs partially explains the hope that one day, new and more accurate technology will replace them. Today, this enthusiasm is primarily aimed at the potential for functional neuroimaging to serve as an effective lie detector. Functional magnetic resonance imaging (fMRI) for lie detection is different from using a polygraph, in that neuroimaging measures the central (brain) rather than the peripheral (blood pressure, heart rate, respiration rate and galvanic skin response) correlates of nervous system activity. While, brain-based lie detection was pioneered in the late 1980s, using the method of EEG, fMRI is now touted as the preferred method, due to its superior ability to localize signals in the brain. Continue reading →
The House of Commons in the U.K. has now voted to permit mitochondrial DNA replacement, which enables babies to be born who have DNA from three people.
Mitochondria are the batteries of our cells that provide energy for cell division and growth. We get ours from our mother’s genes. If there is a defect in a mother’s mitochondria, it can have devastating consequences for her children, resulting in almost certain death. But, by extracting a mitochondrion from a healthy donor egg, scientists are now able to conduct a miniature organ transplant on the cellular level to create a healthy baby through in vitro fertilization. Such a baby has its parents’ genes, except for one small but crucial portion obtained from a donor.
If the House of Lords also approves, Britain will be the first nation to authorize the procedure. The United States is studying mitochondrial transplants. A series of meetings began last week at the Institute of Medicine at the request by the Food and Drug Administration.
Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during 2014 and what to watch out for in 2015. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.
The full agenda with speakers is available on ourwebsite.
Attendance is free and open to the public, but space is limited and registration is required. Please register here. Contact firstname.lastname@example.org with questions.
The growing accessibility of Electronic Health Records (EHRs) across hospitals and practitioners raises new concerns about patient privacy. Before EHRs, patients had control over how much information they shared with each healthcare provider. Receiving patient information from other practitioners has required a signed consent form specifying the information patients are comfortable sharing (e.g., radiological studies, mental health history, sexual history, etc.). And hospitalists have been expected to request the minimal necessary information to provide good care. With growing networks and increasing compatibility across EHRs, more providers now have access to information without the patients’ express permission or even awareness.
Recent works published in the Journal of General Internal Medicine reported the results of a study that designed and recorded patient and provider experiences with a patient-controlled EHR (in which patients chose which providers could access which data in their medical records). A preliminary survey showed that, before the study, only 10 percent of patients had access to their medical records. Half of surveyed patients did not know what information their EHR contained. However, all patients wanted access to their EHRs. Meanwhile, another study reported that only one-third of physicians thought patients should have EHR access. Continue reading →
I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2) “Synthetic Biology & Intellectual Property Rights”:
1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ , published in N I R (Nordic IP Review), vol 2014, nr. 4, s. 340-357.
Abstract: Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.
The FDA’s public workshop on their draft guidance framework for the regulation of laboratory-developed tests (LDTs) continued yesterday, featuring sessions on three additional issues: 1) notification and adverse event reporting, 2) public procedures for classification and prioritization, and 3) quality system regulation.
Many issues that had been raised during Thursday’s sessions reappeared in the context of these new subjects. Commenters considered whether and when laboratories should be able to submit one (rather than many) LDT notifications and/or registrations, the relationship between clinical use and risk classification, and the need to be sensitive to the diversity of LDTs and their providers in formulating the final guidelines. Other, more legal aspects were also raised again, including concerns about redundancy between FDA regulations and those already promulgated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments, whether the FDA possesses the legal authority to regulate most LDTs, and whether the FDA is required to proceed by notice-and-comment rulemaking rather than acting through the guidance process. (Litigation is almost certain to arise on these last two topics, about which I’ll have more to say in future posts.)
But I want to briefly highlight one theme that cropped up on both days more frequently than I had anticipated: the role of insurers and insurance reimbursement. Panelists considered whether insurers or other payers should have a seat at the table when advisory committees are convened to classify and prioritize LDTs for review. They discussed the effect of FDA approval on insurance coverage, debating whether the proposed regulations would increase or decrease access to FDA-approved LDTs. But most importantly (at least in my view), they explicitly considered the way in which increased FDA regulation would combine with decreasing insurance reimbursement to decrease incentives for innovation in diagnostic testing.
Over the past several months, I’ve been blogging (here, here, and here) about the FDA’s recent forays into regulating laboratory-developed tests (LDTs). Since the release of the draft guidance framework in October, serious arguments have been made on opposingsides of the issue, and industry groups have made additionalmoves in opposition to the proposed regulation. And now, today (and tomorrow), the FDA is holding a public workshop on their draft guidance framework, focusing on a wide range of issues.
Today’s workshop featured sessions on three main issues: 1) labeling considerations, 2) clinical validity and intended use, and 3) categories for continued enforcement discretion. Many commenters simply presented the unique concerns of their organization and urged the FDA to consider them in finalizing the guidelines, which was helpful when it did seem as if the draft guidance may have insufficiently considered the needs of a particular set of laboratories, such as public health laboratories that focus on testing for infectious diseases like Ebola and chikungunya (about which I’ve also blogged, here and here).
More helpful, though (at least in my view), were the comments of those who sought to provide concrete recommendations for the FDA on the basis of 1) the policy concerns they saw underlying the guidance and 2) the practical effects of implementation that they foresaw. I’ll illustrate with an example, which hopefully will display the complexity inherent in even the simplest questions that the FDA must answer here.
Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit.
The suit concerns Actavis’ attempt to extend monopoly protection for its drug Namenda. Namenda is one of only a few FDA approved drugs to treat Alzheimer’s disease, and the only approved drug in a class of medications that act on the glutamatergic system by blocking NMDA receptors. Namenda is also Actavis’ largest revenue generating drug; it brought in $1.5 billion in sales last year. Unfortunately for Actavis, Namenda’s patent protection is due to expire in 2015. Once the patent protection for Namenda has expired, Actavis should ordinarily expect to see a dramatic reduction in sales revenue, as much as 90% in the first year, as consumers switch to a lower-cost generic version.
The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.
While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.
In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.
Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’ ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.
In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval. Continue reading →
The following information has been extracted from the webpage of the BioBanking and Molecular Resource Infrastructure of Sweden on the course Biobanking as a Resource for Biomedical Research, February 9-13, 2015 at Karolinska Institutet (Stockholm).
Purpose and Goal
Biobanks constitute a powerful resource in medical research with access to millions of samples and associated data collected within health care and in specific research studies. New “omic-technologies” with high-throughput analytical platforms now permit large scale analyses without the need to wait for years while new samples are being collected.
However, successful research based on human biological samples and associated data requires applied knowledge about how the samples have been collected and processed. Standardized procedures, controlled pre-analytical variables and study documentation are key factors for the reliability and validity of the analytical findings.
This one week course addresses fundamental concepts in biobank infrastructures and biobank research, ethical and legal frameworks, technologies, sample analysis and practical considerations when new samples are to be collected. Continue reading →
I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics, or History of Medicine.
A grant by the Brocher Foundation enables international researchers to carry out their projects for a 1-4 month period at one of the most beautiful places in Europe. The Brocher Foundation’s seat is located in Switzerland at the shores of the beautiful Lake Geneva. The location is very close to the French border and to international organisations particularly relevant to the health sector, such as WHO, WTO, WIPO, UNHCR, ILO, WMA, ICRC, and others.
As NPR reported this morning, researchers in England may soon use genetic therapy to treat diseases that result from defects in mitochondrial DNA.
Mitochondria create energy for cells, and they have their own genes, distinct from the genes that help determine our looks, behavior, and other traits. Because mitochondrial activity is critical to normal cell functioning, abnormalities in mitochondrial DNA can be devastating. Some babies die in a matter of hours.
But because the therapy involves genetic manipulation, it is controversial. While critics are right to insist that we proceed carefully with genetic therapy, many of their arguments are misguided. Continue reading →