Contracting to counter gene patents – a 21st Century solution to access and innovation

By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GiM article Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of April. The selections feature topics ranging from the effect of a shortage of baclle Calmette-Guérin (BCG) on treatment costs for bladder cancer, to a comparison of regulatory review of new therapeutic agents by the FDA and the EMA, to the impact of CVS pharmacy’s discontinuance of tobacco sales on cigarette purchasing. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Davies BJ, Hwang TJ, Kesselheim AS. Ensuring Access to Injectable Generic Drugs – The Case of Intravesical BCG for Bladder Cancer. N Engl J Med. 2017;376(15):1401-3.
  2. Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents – FDA versus EMA, 2011-2015. N Engl J Med. 2017;376(14):1386-7.
  3. Fralick M, Kesselheim AS. FDA Approval of Desmopressin for Nocturia. JAMA. 2017 Apr 6. [Epub ahead of print]
  4. Gyawali B, Prasad V. Drugs that Lack Single-Agent Activity: Are They Worth Pursuing in Combination? Nat Rev Clin Oncol. 2017;14(4):193-4.
  5. Polinski JM, Howell B, Gagnon MA, Kymes SM, Brennan TA, Shrank WH. Impact of CVS Pharmacy’s Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014). Am J Public Health. 2017;107(4):556-62.
  6. Sharfstein J. Déjà Vu at the FDA. Milbank Q. 2017 Apr 4. [Epub ahead of print]

Is it legal for Trump to punish health insurers that do not support repeal of Obamacare?

By Christopher Robertson

In a recent story about how the health insurance marketplaces are being destabilized by the Trump administration’s vacillation, the LA Times reports:

At one recent meeting, Seema Verma, whom Trump picked to oversee the federal Medicare and Medicaid programs, stunned insurance industry officials by suggesting a bargain: The administration would fund the CSRs if insurers supported the House Republican bill to repeal the Affordable Care Act.

For what its worth, the Trump administration denied that she had done so.  But if she did, is that legal?  Can politicians actually offer to give money from the Federal Treasury to companies in exchange for their political support (or withhold it for lack of that support)?  If Ms. Verma was corruptly offering a “quid pro quo” exchange (as TalkingPointsMemo says), that would fit the statutory definition of the crime of bribery, as I discuss in a 2016 paper, The Appearance and Reality of Quid Pro Quo Corruption. However, this case also implicates the First Amendment rights of the insurance companies to support or oppose the Obamacare repeal. Continue reading

Nathan Cortez on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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With help from our good friend Nathan Cortez from SMU School of Law we discuss the American Health Care Act. Nathan is a thought leader in both health law and policy and administrative law and legislation–intersecting forms of expertise particularly valuable in these turbulent times.

In addition to coming to grips with some of its complex provisions, we speculated on how it will fare in the Senate, given emerging details about working groups and Democratic bridge-building by the Gang of Three (Joe Manchin, Heidi Heitkamp, and Tim “Copper Plan” Kaine). Here Professor Cortez’s expertise on Reconciliation and the Byrd Amendment proved essential. We also, let truth be told, took the opportunity to get a few things off our collective chests!

For background on AHCA: Andy Slavitt has been a diligent collector of summaries & critical commentary. In a media environment where the lies being told about AHCA’s effects on coverage are described as “flagrant,” “bald-faced,” and “gas-lighting,” expert voices are needed now more than ever. Some predict that the class warfare embodied in the bill’s distributional effects would cause a “humanitarian crisis” if it came to pass; others worry it would undo the pillars of not merely Obamacare and Medicaid, but also employer-sponsored plans. One thing appears certain: expect bankruptcy law to renew its advance onto health law syllabi. Continue reading

Genomes on-line and the Health of Privacy

By Effy Vayena and Alessandro Blasimme

Technology Concept

In January 1999, Scott McNealy, CEO of Sun Microsystems (now part of Oracle Corporation), announced that we should no longer be concerned with privacy, since consumers ‘have zero privacy anyway’ and should just ‘get over it.’ His argument, that in the era of information technology we have become unable to protect precisely what such technology relies on and delivers (information) has met the full spectrum of imaginable reactions – from outrage to enthusiastic endorsement. Many different cures have been proposed to treat at least the symptoms of the disease caused by the loss of privacy. Yet there is little disagreement concerning the diagnosis itself: privacy does not enjoy an enviable state of health. Recent emphasis on big data and their inescapable presence have only made the prognosis dimmer for the once cherished ‘right to be let alone’ – as Samuel D. Warren and justice Louis D. Brandeis famously defined privacy back in 1890.

Such a deteriorating outlook should sound especially alarming in the fields of healthcare and medical research. In such domains, professional norms of medical confidentiality have long ensured sufficient levels of privacy protection, accountability, and trust. Yet we are told that this may no longer be the case: sensitive, personal, health-related information – just like any other type of information – now comes in electronic formats, which makes it much more reachable than before, and increasingly difficult to protect. Imagine the consequences this may have in the case of genomic data – arguably one of the most sensitive forms of personal information. Should such information fall into the wrong hands, we may face harsh consequences ranging from discrimination to stigmatization, loss of insurance, and worse. To enjoy the right to genomic privacy, one has to be able to exercise some meaningful amount of control over who gets access to her genetic data, be adequately shielded from harms of the sort just mentioned, and yet retain the possibility of deciphering what’s written in her DNA for a variety of purposes – including, but not limited to, health-related ones. All this is undoubtedly demanding. All the more so now that we know how even apparently innocent and socially desirable uses, like genomic research employing anonymized DNA, are not immune from the threat of malicious re-identification.

In light of such considerations, one might be led to think that health privacy protection is a lost cause. In fact, one may go even further and argue that, all things considered, we shouldn’t worry too much about the decline of privacy. Having our sensitive data in a state of highly restricted accessibility, so the argument goes, prevents us from extracting medically valuable insight from those data and hinders medical discovery from which we may all benefit. Continue reading

Reflection and Review at The National Health Service Litigation Authority (NHS LA)

By John Tingle

The NHS LA is a pivotal organisations in the NHS whose work has a daily impact on the lives of patients and on all those who work in the health service. The NHS LA  have recently published its new five year strategy which reveals some very interesting and informative data, trends, insights into patient safety and regulation, governance and litigation.

NHS LA functions

If you work as a solicitor, lawyer handling  NHS clinical negligence claims, acting either for an injured patient or a hospital  then the NHS LA will be a daily feature of your professional life. They appoint solicitors to act for the hospital or other NHS organisation which is being sued from an approved panel of law firms and manage the claims process. Continue reading

Fetal Consequentialism and Maternal Mortality

By Nadia N. Sawicki

It is well known that maternal mortality rates in the United States are higher than in other countries in the developed world, and that many of these deaths are preventable. But a report published by NPR last week, just a few days before Mother’s Day, drew a direct link between these poor maternal outcomes and health care providers’ focus on fetal health. The report quotes Barbara Levy, vice president for health policy and advocacy at the American Congress of Obstetricians and Gynecologists, who said, “We worry a lot about vulnerable little babies, [but] we don’t pay enough attention to those things that can be catastrophic for women.” According to the authors of the NPR report, “newborns in the slightest danger are whisked off to neonatal intensive care units … staffed by highly trained specialists prepared for the worst,” while new mothers are instead monitored by nurses and physicians “who expect things to be fine and are often unprepared when they aren’t.”

These patterns are consistent with what Prof. Jamie Abrams calls “fetal consequentialism” – the premise that the birth of a healthy child outweighs any harm to the birthing mother. The increase in U.S. maternal mortality rates highlighted in the NPR report is certainly a product of such fetal consequentialism. So is the practice of obstetric violence, described in my previous posts, where health care providers dismiss birthing mothers’ informed requests for minimal intervention during labor and delivery in an effort to reduce the risk of fetal harm, even when that risk is minimal. Fetal consequentialism is likely driven not only by providers’ judgments of the relative liability risks for harms to fetuses versus harms to mothers, but also by conservative societal trends (evidenced by increasing anti-abortion legislation) that preference fetal interests over maternal interests. Continue reading

Quantified Self as Personal (Citizen) Science

This post is part of Bill of Health’s symposium on Critical Studies Citizen Science in Biomedical Research. Here, drawing upon interviews with self-trackers, Nils Heyen analyzes the different types of activities that self-trackers engage in and reflects on what kind of knowledge they produce. Background on the symposium is here. You can call up all of the symposium contributions published by clicking here.

By Nils B. Heyen

Quantified Self (QS) is the name of a growing international movement of people united by mainly one thing: an interest in collecting data about their own bodies and lives in order to obtain insights into their everyday health or performance. “Self knowledge through numbers” is the movement’s slogan, and indeed QS can be seen as an emerging field of knowledge production. Less obvious is, however, what type of knowledge is actually being produced here, how this knowledge production is to be characterized and how it relates to both science and citizen science. Based on interviews with self-trackers and participant observations of QS meetups and conferences in the context of an explorative empirical study, my post briefly deals with these questions (see this book chapter for more extensive considerations). Accordingly, my intention here is not to give a comprehensive classification or interpretation of the QS movement as a cultural phenomenon, but simply to shed some light on the aspect of knowledge production and on the relationship of self-tracking and citizen science. Continue reading

Petrie-Flom Center Welcomes New Executive Director!

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shachar_peopleWe are thrilled to announce that Carmel Shachar, JD, MPH (HLS ’10, HSPH ’10) will join the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School as our next Executive Director. In this role, Carmel will be responsible for oversight of the Center’s sponsored research portfolio, event programming, fellowships, student engagement, development, and a range of other projects and collaborations.

“We are delighted that Carmel will be joining the Center,” said I. Glenn Cohen, Professor of Law and Faculty Director of the Petrie-Flom Center. “Throughout her career, Carmel has focused on designing, developing, and executing large health law and policy projects. This expertise and leadership will be a strong resource for the Center as it implements the vision for its second decade.”  Continue reading

Citizen Science and Precision Medicine: a Route to Democracy in Health?

This post is part of Bill of Health’s symposium on Critical Studies Citizen Science in Biomedical Research. Here, Ilaria Galasso and Giuseppe Testa share their comparative case studies of the Precision Medicine Initiative and the 100K Genomes Project, examining the kinds of citizen science pursued in precision medicine projects. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Ilaria Galasso and Giuseppe Testa

Our post investigates the participatory dimensions in health and healthcare by analysing the cutting-edge approach of precision medicine, its societal impact, its discursive framings and its (potential) contribution to further public health and civic engagement.

Precision Medicine is defined by the NIH as “a groundbreaking approach to disease prevention and treatment based on people’s individual differences in environment, genes and lifestyle”(nih.gov), aimed at “delivering the right treatments, at the right time, to the right person”(whitehouse.gov).To pursue this aim, precision medicine efforts typically work on large cohorts of people to dissect individual differences in health and disease. Thence, massive large-scale involvement of “lay” participants is a key resource of precision medicine initiatives. Continue reading

Sentinel Policy Surveillance: A New Front in Legal Epidemiology?

Paul Erwin, Associate Editor of the American Journal of Public Health, recently wrote about the establishment of a  Sentinel Practitioner Surveillance System for Policy Change Impact,  or what might be called “sentinel policy surveillance.” The network of twelve diverse health officers will be trying to identify and share instances of harmful impact from Trump administration policies.

Erwin is suitably circumspect about what such a network can do. It is, he writes, no replacement of research, and, indeed, may be reporting perceived or feared effects as often as real ones.  I found the idea intriguing to ruminate on, though.  What follows are some scattered thoughts about the concept. I hope readers will add theirs.  Mostly I am interested in how the practice fits with general policy surveillance and public health law researchContinue reading

Robert Smoldt on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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We are joined by Robert K. Smoldt, Chief Administrative Officer emeritus of Mayo Clinic and Associate Director of the Arizona State University Healthcare Delivery and Policy Program. Robert has been involved in healthcare administration for over 30 years — both with the U.S. Air Force and Mayo. Mr. Smoldt joined Mayo in 1972, and he has worked in a variety of administrative positions in both medical and surgical departments. Prior to his CAO role, he served as chair of the Department of Planning and Public Affairs.

The topics discussed with Robert are alternate payment systems, including pay for value. We do a deep dive into P4P (pay for performance) and P4V (pay for value), elicit comparisons with healthcare in Japan, and ponder integrated care models and the future of health policy.

We also discussed “provider-specific benchmarks that reward improvement rather than the level of performance,” and several other unintended consequences of Advanced Payment Models (APMs). We’re sure you will find Robert’s edifying insights a vital part of top-level dialogue on the future of health care finance.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Citizen Science: Non-scientists enable sampling conditions in ocean sciences

This post is part of Bill of Health’s symposium on Critical Studies Citizen Science in Biomedical Research. In light of calls for stronger ‘crowdsourcing’ oceanic data production, Gregor Halfmann focuses in on the practices of non-professional seafarers who create scientific knowledge of the oceans as a means of shedding light on citizen science practices in medicine and science more broadly. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Gregor Halfmann

Outside of the medical sciences, the relationship between science and non-professionals has often developed in a more harmonious and less fraught manner. A consideration of ocean sciences, as an example of practices in the environmental sciences, may call attention to different conditions of and approaches to citizen science, and introduce new and potentially fruitful perspectives.

The size and adverse nature of the oceans, the variety of temporal and spatial scales relating to physical, biological, and chemical oceanic processes, and the high economic demands of operating research vessels impede the continuous production of important oceanographic data. As in other environmental sciences, oceanography has a long history of practices involving professional as well as non-professional seafarers, who create knowledge of the oceans. Yet, in light of today’s digital network technologies and the methodological simplicity of many fundamental oceanographic observations, ocean scientists have recently called for stronger “crowdsourcing” of oceanographic data production, in particular with citizen science projects (Lauro et al., 2014). A common way to characterize the involvement and contribution of people without scientific credentials in research processes is a view of participants being deployed as “collectors” of data or samples; volunteering citizens, who follow tight instructions provided by scientists, resulting in a contribution of materials and data (e.g. samples of water and organisms, reports of species sightings, water temperature data) for the scientists to interpret. Continue reading

Health in the Factory: The Historical Roots of Italian Citizen Science

This post is part of Bill of Health’s symposium on Critical Studies Citizen Science in Biomedical Research. In this post, Giulia Frezza and Mauro Capocci offer a historical look at how workers and scientists shaped a new approach to occupational and environmental health in Italy, asking if current practices of citizen science share the lineages of such radical movements. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Giulia Frezza and Mauro Capocci

The radical movement  critique of science in the turbulent decades of 1960s-70s in Italy, is a significant episode that can be useful for a critical reappraisal of contemporary definitions of the scope and the aims of Citizen Science (CS).

In those years, the deep social transformation of Italian society also involved a new perception of science and technology which emphasized that science was not neutral. Far from being a tool for workers’ empowerment, it became apparent that science and technology were ideologically determined. Trespassing the orthodox boundaries of Marxism, a group of scientists advocated a new relationship between science and society, while at the same time workers understood that they needed a new alliance with scientists in order to foster real social progress. An early result of this movement was the involvement of researchers and health professionals in the struggle for better working conditions within the factory. Through their personal experience and developing hegemonic power, workers criticized the traditional notions of risk management and health protection by actively collecting data and pointing to flaws in the existing industrial systems and the science behind them. Eventually, this activism resulted in a widespread science-based “Health in the Factory” movement. At the same time, a large number of sympathetic physicians and epidemiologists engaged in social efforts to create groups and associations that lent scientific support to activists. This proved to be of paramount importance when tragic accidents happened, such as the Seveso and Manfredonia chemical explosions that occurred within the span of a few months in 1976. Such tragedies proved instrumental for breaking “the illusory boundary” separating the factory and the outside world; the impact of what took place inside the production sites was far-reaching. Industrial accidents eventually connected local ecology, the city environment, families, citizens, scientists studying harmful substances in the lab, and society as a whole. These events were a turning point for spreading social awareness, allowing local struggles to turn into national developments, and resulting in the evolution of the public health system and regulations of risk prevention (exposure thresholds, health assessment of working conditions, prevention and management of industrial accidents). Continue reading

Citizen Science where there are no citizens: participation and exclusion in Antarctic science

This post is part of Bill of Health’s symposium on Critical Studies Citizen Science in Biomedical Research. Challenging the lay-professional divide in portrayals of citizen science, Vanessa Heggie examines a case study of an expedition to the Antarctic in the 1950s, where participants were at once researchers, research subjects, experts, and technicians. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Vanessa Heggie

The Antarctic environment poses plenty of challenges for scientists, but for those who need human participants there’s the additional problem of finding and recruiting ‘citizen scientists’.  With no indigenous residents, the residents of the Antarctic are a carefully selected population, most of whom are already doing some form of scientific work and juggling multiple identities and roles.  Radio operators take readings for meteorologists, geologists volunteer as guinea pigs for physiologists, and botanists collect rocks. There isn’t a clear divide between ‘scientist’ and ‘lay participant’; often human subjects, whether they’re collecting data or acting as human guinea-pigs, understand the principles of experimental design, and are able to give feedback about the experiment itself, not just the data generated.  At what point do citizen scientists become experimental collaborators? And who gets left out of these relationships? Continue reading

Do–It–Yourself Biology as Citizen Science: Taking Participation a Step Further

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Taking a closer look at the role of public participation in science, Rosen Bogdanov and Eduard Aibar argue that participation in DIY-biology is best understood as a collaborative experiment in technoscientific practices. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Rosen Bogdanov and Eduard Aibar

We begin our small blog contribution from the very proposition suggested by our subtitle – “taking participation a step further”. What do we mean by “a step further” and is participation inherently linear such that we can take it to another level?

Contrary to many accounts of public participation in science (especially those that aim to increase it), we don’t assume that scientific innovation will somehow speed up, or become more accountable, with more public input. Rather, recalling Michael Gibbons and Helga Nowotny’s work (2001), we argue that the production of scientific knowledge can be made more “socially robust” by including other perspectives. This, however, presents a dilemma when thinking about the case of “citizen science” as the current flagship field for public participation in science. Often, citizen science projects are presented as data-driven ventures whereby citizens are invited to participate in a specific stage, or stages, of this process, or they are framed from the start as the non-expert “public” that participates in collecting or analyzing data. Continue reading

More than Data Collectors: Valuing Data Expertise Beyond Professional Science

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Responding to controversies over the validity of patient and patient groups’ contributions to biomedical research, in this post, Sabina Leonelli turns to the environmental sciences in order to examine the construction of expertise in participatory research. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Sabina Leonelli

In the context of biomedical research, particularly following the emergence of evidence-based medicine, extensive debate surrounds the choice and evaluation of appropriate sources of evidence. Contributions from patients and patients’ groups generate substantial scientific, ethical and methodological controversies, and clinicians often regard with suspicion any dataset that is gathered by non-professionals outside controlled conditions. At the same time, the collection of health data through social media is becoming increasingly visible as a potential source of information, with defenders of precision medicine going as far as to value those strategies of data collection over traditional clinical trials. To shed some light on this situation and its potential pitfalls, it is useful to consider the experience of fields such as botany, ethology, oceanography, environmental science and ornithology, which have long relied extensively on contributions by non-professionals. With the recent emergence of “citizen science” projects, these contributions are often construed in the form of data offerings, with citizens volunteering to collect data that can be fed into scientific projects – as in the well-known cases of eBird and eOceans. Just as often, researchers conceptualise these offerings as an opportunity to get hold of data that would otherwise remain beyond their reach. Due to their location, occupation or hobbies, citizens may be able to document circumstances and events of interest to researchers, but which researchers themselves do not have the resources and personnel to identify and witness in person. Thus, citizens are positioned as precious data collectors, whose engagement with science consists in the provision of potential sources of evidence. At the same time, a line is drawn between such data collectors and professional scientists as the veritable data experts, who can direct and situate citizens’ efforts to procure the raw materials for scientific investigation. In this configuration, key questions such as what the evidence will be useful for, and whether the data will be of good enough quality to play that role, are left to the scientists in charge; and data collectors remain peripheral to the formulation and development of research projects and related knowledge claims. Continue reading

A Quarter of the Work Force: International Medical Graduates and the Lives They Save

By Wendy S. Salkin

On Monday, May 1, 2017, International Workers’ Day, thousands took to the streets across the United States to demonstrate in support of immigrants’ rights in the United States and against immigration policies recently rolled out by President Trump.

Among the Presidential Actions taken by President Trump during his first hundred days in office has been the issuance of his “Buy American and Hire American” Executive Order, issued just two weeks ago on April 18, 2017, in which the President states that “[i]t shall be the policy of the executive branch to buy American and hire American.” What is meant by “hire American” is detailed in section 2(b) of the Executive Order:

Hire American. In order to create higher wages and employment rates for workers in the United States, and to protect their economic interests, it shall be the policy of the executive branch to rigorously enforce and administer the laws governing entry into the United States of workers from abroad, including section 212(a)(5) of the Immigration and Nationality Act (8 U.S.C. 1182(a)(5)).

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Experiential Knowledge, Public Participation, and the Challenge to the Authority of Science in the 1970s

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Below, Bruno Strasser and Dana Mahr trace the rise of experiential knowledge in the 1970s, probing the historical origins of participatory research through the examples of urban planning, women’s health, civil rights, and toxic sites in the United States. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Bruno J. Strasser & Dana Mahr

In his Social History of Truth, Steven Shapin argued that, in the 17th century, the credibility of the natural philosopher’s testimony — but not that of the drunken sailor — derived from his social status as a gentleman (Shapin 1994). By the 19th century, with the professionalisation of science, the credibility of knowledge claims came to be tied to the professional expertise of the “scientist” and to the institutions where he, or more rarely she, worked. How then, in the 21st century, did a discourse emerge granting “lay people”, “amateurs”, or “citizen scientists” — which are neither gentlemen, nor scientists, and often work from home — credibility in the co-production of scientific knowledge? There is no simple answer to this question, yet we would like to offer one in this contribution.

Three narratives have tried to explain the historical origins of current participatory research. The first looks back at the contributions of amateur naturalists in the 19th century, the second at radical scientists’ movements in the 1960s, and the third at the personal computer revolution in the 1990s (Strasser et al. 2017 – forthcoming). Here, we suggest a different narrative, focussed on the rise of “experiential knowledge” in the 1970s. In current participatory research, the challenges to the monopoly of expert knowledge — experimental and clinical — rest in part on the claim that lay people’s experience of their own bodies and environments can be reliable sources of scientific knowledge. The ability of lay people to identify changes in their bodies (PatientsLikeMe), to notice disturbances in their environment (Community Based Environmental Monitoring Network), and even to recognise subtle patterns in images of galaxies (GalaxyZoo) or to fold proteins in three dimensions (Foldit), all rest on intimate bodily experiences. It is not reason at work, but bodily perception; not objective facts, but subjective sensations; not experiment, but experience. Then how can it be considered legitimate science, knowing that the very exclusion of experiential knowledge was part of the making of modern science? By the 1970s, we suggest, in the turmoil of the counterculture, activists challenging the authority of science attempted to reclaim experiential knowledge as a legitimate source of scientific knowledge, reopening the epistemological toolbox of science. The examples of urban planning, women’s health, civil rights, and toxic sites illustrate how such a transformation might have taken place.   Continue reading

Call for Abstracts: Wiet Life Sciences Law Scholars Conference

Loyola University Chicago’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for its inaugural Wiet Life Science Law Scholars Conference on Friday, October 13, 2017.

The conference is designed to provide a new intellectual venue for life science professors, scholars, and practitioners to convene and discuss current research and scholarship. The phrase “life science law” aims to capture research and disciplines spanning food and drug law, health law, intellectual property (IP), biotechnology, environmental, administrative, antitrust, and other realms that involve the life sciences in some meaningful respect. Our goal is to foster recognition of life science law as a cohesive, dynamic, area of legal study and strengthen connections among national life science law scholars.

Loyola is currently soliciting 750-1,000 word abstracts reflecting early or mid-stage ideas for the purpose of workshopping with other conference scholars. Modeled after successful events for law professors and scholars in other areas, participants will be organized in topical panels of three to five authors with approximately 15-20 minutes allotted to each abstract presentation, followed by discussions with scholar attendees. Abstracts from the authors will be distributed one week prior to the conference; authors may also submit draft articles for distribution to conference attendees.

SUBMISSION AND REVIEW TIMELINE: The deadline for 750-1,000 word abstracts, including author contact information is June 15. Submit via email to health-law@luc.edu with subject line Wiet Life Science Law.

Authors will be notified of speaker selections by email on or before July 15.

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