Use of Estimated Data Should Require Informed Consent

Guest post by Donna M. Gitter, Zichlin School of Business, Baruch College, based on Professor Gitter’s presentation at the Petrie-Flom Center’s 2016 Annual Conference, “Big Data, Health Law, and Bioethics,” held May 6, 2016, at Harvard Law School.

Cross-posted from the Hastings Center’s Bioethics Forum.

The Icelandic biotech firm deCODE Genetics has pioneered a means of determining an individual’s susceptibility to various medical conditions with 99 percent accuracy by gathering information about that person’s relatives, including their medical and genealogical records. Of course, inferences have long been made about a person’s health by observing and gathering information about her relatives. What is unique about deCODE’s approach in Iceland is that the company uses the detailed genealogical records available in that country in order to estimate genotypes of close relatives of individuals who volunteered to participate in research, and extrapolates this information in order to make inferences about hundreds of thousands of living and deceased Icelanders who have not consented to participate in deCODE’s studies. DeCODE’s technique is particularly effective in Iceland, a small island nation that, due to its largely consanguineous population and detailed genealogical records, lends itself particularly well to genetic research.

While Iceland’s detailed genealogical records enable the widespread use of estimated data in Iceland, a large enough U.S. database could be used to make similar inferences about individuals here. While the U.S. lacks a national database similar to Iceland’s, private companies such as 23andme and Ancestry.com have created rough gene maps of several million people, and the National Institutes of Health plans to spend millions of dollars in the coming years sequencing full genome data on tens of thousands of people. These databases could allow the development of estimated data on countless U.S. citizens.

DeCODE plans to use its estimated data for an even bolder new study in Iceland. Having imputed the genotypes of close relatives of volunteers whose DNA had been fully catalogued, deCODE intends to collaborate with Iceland’s National Hospital to link these relatives, without their informed consent, to some of their hospital records, such a surgery codes and prescriptions. When the Icelandic Data Protection Authority (DPA) nixed deCODE’s initial plan, deCODE agreed that it will generate for only a brief period a genetic imputation for those who have not consented, and then delete that imputation from the database. The only accessible data would be statistical results, which would not be traceable to individuals.

Are the individuals from whom estimated data is gathered entitled to informed consent, given that their data will be used for research, even if the data is putatively unidentifiable? In the U.S., consideration of this question must take into account not only the need for privacy enshrined in the federal law of informed consent, but also the right of autonomy, which empowers individuals to decline to participate in research. Although estimated DNA sequences, unlike directly measured sequences, are not very accurate at the individual level, but rather at the group level, individuals may nevertheless object to research participation for moral, ethical, and other reasons. A competing principle, however, is beneficence, and any impediment to deCODE using its estimated data can represent a lost opportunity for the complex disease genetics community.

Continue reading

BioData World Congress USA, Sept 14-15 in Boston

BioData Congress Americas 2016

BioData World Congress USA 2016
September 14-15, 2016

Hyatt Regency, Boston, MA

BioData World Congress USA is the world’s leading event for individuals working with Big Data in precision medicine.

The two day conference will feature case study applications of Big Data and Genomics to drive precision medicine into the clinic through the assembly of the multidisciplinary cohort involved in the delivery of the Precision Medicine

The event will cover a range of different topics including:

  • How to manage data generated in bioinformatics
  • How to utilise NGS to develop more targeted therapeutics
  • How to practically apply genomic data in precision medicine
  • Utilizing the Cloud for collaborative research
  • Developing secure information systems
  • Ethical considerations in the sharing of genomic data
  • How to transition big data into the clinic
  • How to access open source technologies in LS research
  • How to apply big data analytics to mine information

Click here for more information, including how to register.

NPRM Symposium: Privacy and Promises, Promises, Promises

Part Two of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The first blog post in this series probably provided a few surprises, but the surprises are just beginning. Can the NPRM to amend the Common Rule keep its promises?

The NPRM promises that patients will be able to consent to use of their clinical data in research, which is actually two promises, not one. The first is that the consent will be given effect. The second is that the refusal will be given effect.  As to refusal, the NPRM absolutely does not keep its promise.

The NPRM is filled with page after page of exceptions where your consent is not required. These include examples like trailing you and spying on you in public, some tests done on how to affect children’s behavior, and more. Continue reading

Call for Proposals: Innovations in Life Sciences and Stakeholder and Agency Responses

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions on innovations in life sciences and stakeholder and agency responses for presentation at our Tenth Annual Health Law Symposium. The Symposium will take place at Loyola University Chicago School of Law on Friday, October 28, 2016 at 9:30am.

The Symposium will explore recent innovations in life sciences and responses by regulatory agencies including FDA, FTC, and DOJ as well as stakeholder responses and recommended next steps for policy and regulatory reforms.

A range of topics will be considered, including but not limited to gene editing, mobile health,
cybersecurity, personalized/precision medicine, 3-D printing technologies, Cancer Moonshot 2020, biosimilars and interchangeable biologics, and vaccine development and incentives (e.g., Zika).

Submission Information: Those interested in participating, please send a 1000-word abstract to  health-law at luc.edu by May 31, 2016. Authors will be notified of decisions no later than June 15, 2016. If your abstract is selected, a full paper will be due by January 6, 2017.

Covered expenses: Hotel, travel, ground transportation, three provided meals.

Questions: E-mail questions to health-law@luc.edu Continue reading

Looking Towards 2030 in Patient Safety

There is a clear need for those charged with patient safety policy making to prepare for the future and to take account of emerging trends. This would be so in any commercial or professional organisation. These issues were addressed in the context of patient safety at the recent,Patient Safety Global Action Summit held in March 2016 in London. The conference was designed to mirror the discussions contained in the report  by NIHR (National Institute for Health Research), Patient Safety Translational Research Centre at Imperial College London and The Imperial College NHS Trust on the priorities and direction that the patient safety movement should follow going towards 2030.

There is a lot that is excellent in this report  which is very rich in analysis and detail. Lots of deep thinking about patient safety issues with interesting and novel ideas expressed on nearly every page.

Emerging threats to patient safety

In the report, in chapter one, it is acknowledged that there are many existing issues at the root of patient harm that have yet to be solved. Also that unfortunately trends in healthcare are likely to increase the risks to safety. The report focuses on four emerging trends: Continue reading

Amicus brief in Sequenom v. Ariosa: Why the U.S. Supreme Court should grant the petition for a writ of certiorari

I am happy to announce that on April 20th the New York attorney Robert M. Schwartz and I have filed an amicus brief at the US Supreme Court with Berkeley-based Andrew J. Dhuey as Counsel of Record. The brief, which was signed by 10 prominent  European and Australian Law Professors as amici curiae, adds a European perspective to the many amicus briefs that have been submitted in support of Sequenom’s petition for certiorari to the United States Supreme Court. Sequenom’s petition in Case No. 15-1182 was filed on March 21, 2016 and seeks review of the Federal Circuit’s controversial decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, reh’g denied, 809 F.3d 1282 (Fed. Cir. 2015). The case concerns the revocation of Sequenom’s patent claims directed to inventive methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this highly beneficial, non-invasive prenatal diagnostic test, patients were placed at higher risk and maternal plasma was routinely discarded as waste. Distinguishing this case from previous Supreme Court decisions and highlighting the mitigating effects of other patentability requirements, we are concerned that the Federal Circuit’s overly rigid approach to claims eligibility decision might jeopardize the development of new therapies in an increasingly important area of modern medicine.

As most Bill of Health readers know, the US Supreme Court has in a recent series of cases (i.e. the combined effect of Bilski, Prometheus, Myriad and Alice) barred the patent eligibility for many genetic inventions as “products and processes of nature”. In Sequenom the CAFC interpreted these to mean – in essence- that “laws of nature” had to be entirely eliminated from the test of patent eligibility under §101 of the Patent laws. Should this interpretation be institutionalized it will contravene the tests for exclusions and exceptions under the EPC, arguably contradict longstanding US treaty policy and disrupt international patent harmonization. More importantly, we fear that the broader impact of such an restrictive interpretation may have grave consequences for a sustainable global drug delivery system, which should involve both public and private actors.

Although we believe that patents will remain the backbone of the industry, we acknowledge in our brief that  there are certain areas of biomedical innovations, such as antibiotics and orphan drugs, where the patent system does not work particularly well. We further recognize that both in Europe and in the US concerns have been raised about overly pre-emptive patents scope, but these are addressed at different levels. In contrast to Europe, the CAFC has interpreted the uncodified exception as part of a “threshold test” for patent-eligibility applied before other patentability requirements can be assessed. A strict and coherent application of these requirements, however, would invalidate overly-broad patent claims (including some of Sequenom’s arguably too broad and badly drafted claims), while also permitting, well-defined, narrower claims on diagnostic technology. In our view, the current approach conflates the patent eligibility test with issues that can be more sensibly addressed within a strict and coherent assessment of novelty, non-obviousness and sufficient disclosure criteria or at the post-grant level. We believe that, the Federal Circuit’s threshold test has not sufficiently considered the manner in which today’s statutory requirements have developed in both the U.S. and Europe to address policy rationales for patentability exceptions. To entirely transplant those issues into the patent eligibility assessment would categorically close the patentability door on many well-defined and beneficial inventions that deserve patent protection. In absence of sufficient public involvement and appropriate alternative incentives we risk that the wells driving technological progress run dry and that companies engage in business strategies, such as increased reliance on trade secrecy, that are not necessarily beneficial for our innovation system.

Accordingly, we urge the Supreme Court to clarify a patent eligibility test in line with its longstanding jurisprudence and in harmony with international and European law.

If the CAFC’s restrictive interpretation should prevail, however, I believe that it will be crucial to swiftly optimize the framework for PPPs and alternative innovation incentives, such as prizes and regulatory exclusivities. This would have to be done on an international level to allow for greater flexibilities and encompass further technological areas, such as biomedical diagnostics. Regarding regulatory exclusivities, Article 39 of the TRIPS agreement should provide sufficient leeway for such changes. The pros and cons of the different alternative approaches would of course have to be carefully considered.

The Amici curiae have no stake in the parties or in the outcome of the case. A full list of the Amici is appended at the end of the brief.

 

REGISTER NOW! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

2016 Annual Conference:
Big Data, Health Law, and Bioethics
May 6, 2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data).

Defined as such, health care has become one of the key emerging use cases for big data. For example, Fitbit and Apple’s ResearchKit can provide researchers access to vast stores of biometric data on users from which to test hypotheses on nutrition, fitness, disease progression, treatment success, and the like. The Centers for Medicare & Medicaid Services (CMS) have vast stores of billing data that can be mined to promote high value care and prevent fraud; the same is true of private health insurers.  And hospitals have attempted to reduce re-admission rates by targeting patients that predictive algorithms indicate are at highest risk based on analysis of available data collected from existing patient records. Continue reading

From Chance to Choice to Court

[Cross-posted from the Huffington Post Blog]

By Dov Fox

It used to be that whether you got the child you wanted — or one you hadn’t planned on — was left to cosmic fate or the randomness of reproductive biology. Now, new powers of reproductive medicine and technology promise to deliver us from the vagaries of the natural lottery.

The likes of voluntary sterilization and embryo screening give people who can afford them greater measures of control over procreation. Except, that is, when reproductive professionals make mistakes that frustrate efforts to pursue or avoid pregnancy or parenthood.

When, for example — just a few recent cases — a pharmacist fills a woman’s birth control prescription with prenatal vitamins. Or when a fertility clinic implants embryos carrying the hereditary disease that a couple underwent in vitro fertilization (IVF) to screen out. Just this week comes another report of losing IVF embryos.

Continue reading

The Petrie-Flom Center & Coalition to Transform Advanced Care Launch “The Project on Advanced Care and Health Policy”

The Project on Advanced Care and Health Policy will foster development of improved models of care for individuals with serious advanced illness nearing end-of-life, through interdisciplinary analysis of important health law and policy issues.

March 28, 2016 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Coalition to Transform Advanced Care (C-TAC) today announced a new collaboration, The Project on Advanced Care and Health Policy.

This initiative is prompted by the fact that current health law policy and regulation, developed largely in a fee-for service environment with siloed providers, creates barriers that may impede widespread adoption of improved models of care for those with advanced illness. The Project will seek to address this problem through policy and research projects that will identify and analyze these barriers, and propose policy solutions that promote development and growth of successful programs. This may entail developing proposed regulatory approaches for the advanced care delivery model that could be adopted by policymakers at the state and federal levels, as well as exploration of potential payment methodologies for this model of care.  Continue reading

TOMORROW, 3/25 in NYC! Book Talk & Panel: FDA in the 21st Century – The Challenges of Regulating Drugs and New Technologies

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FDA in the 21st Century:
The Challenges of Regulating Drugs and New Technologies

March 25, 2016 12:00 PM

92nd Street Y
1395 Lexington Ave. (at 92nd St.), New York, NY

Join co-editors Holly Fernandez Lynch (Petrie-Flom Executive Director) and I. Glenn Cohen (Petrie-Flom Faculty Director) and contributor Lewis Grossman (American University) for a discussion of FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015). This volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This is a ticketed event. To learn more, visit the 92nd Street Y’s website!

Sponsored by the 92nd Street Young Men’s and Young Women’s Hebrew Association (New York, New York) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

PANEL (4/5): The National Security Implications of the Genetics Revolution

 

Technology Concept

The National Security Implications of the Genetics Revolution
April 5, 2016 12:00 PM
Pound Hall, Room 101
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA

 

Panelists:

  • Jamie Metzl, JD ’97, Senior Fellow for Technology and National Security of the Atlantic Council. He has served on the U.S. National Security Council, State Department, and Senate Foreign Relations Committee, as Executive Vice President of the Asia Society and with the United Nations in Cambodia. A globally syndicated columnist and regular guest on national and international media, he is the author of a history of the Cambodian genocide and the novels The Depths of the Sea and Genesis Code.

Topic: The National Security Implications of the Genetics Revolution

  • George J. Annas, JD, MPH, William Fairfield Warren Distinguished Professor and Chair of the Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health; Professor in the Boston University School of Medicine, and School of Law

Topic: Post-9/11 Uses of Public Health and Medicine by National Security Agencies 

  • Jonathan D. Moreno, PhD, David and Lyn Silfen University Professor of Ethics, Perelman School of Medicine, University of Pennsylvania

Topic: National Security and Biology

This event is free and open to the public. Lunch will be provided.

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the Harvard National Security & Law Association, the Harvard National Security Journal, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Uterus Transplants: Challenges and Potential

[Cross posted at the OUPBlog]

By John A. Robertson

The birth of a healthy child in Sweden in October, 2014 after a uterus transplant from a living donor marked the advent of a new technique to help women with absent or non-functional uteruses to bear genetic offspring. The Cleveland Clinic has now led American doctors into this space, performing the first US uterine transplant in February, 2016 as part of an Institutional Review Board (IRB)-approved series of ten transplants using cadaveric donors. Dallas and Boston medical centers have also been approved for this program, as will other programs as progress continues. An estimate of 50,000 American women are potential clients.

The path to womb transplants, however, will not be easy. On 7 March, the Cleveland Clinic celebrated its transplant with a media announcement full of joy and celebration. Two days later in a decidedly different key, the Clinic informed the world that the organ was surgically removed because the recipient had “suddenly developed a serious complication.” One can only imagine the disappointment of the patient and medical team, who had smiled so happily in media coverage. Of course, early failure is not surprising with innovative surgery, and no doubt the Cleveland clinic will proceed with other patients. The case is a reminder that the road to success is long, and initial steps should be closely monitored by IRBs, as is occurring in Cleveland, Sweden, and elsewhere. Continue reading

One Patent Law, Two Economic Sectors: Is The One-Size-Fits-All Patent Law Still Workable?

This new post by Claire Laporte appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Ever since the first patent was issued in 1790, the United States has had a single patent law to protect inventions in all fields. Over the past three decades, that law has been strained to the breaking point in covering both the life sciences and other technologies.

On the life sciences side, patents protect platform technologies as well as specific products and are important at every stage of a product’s life cycle. Many scientific breakthroughs arise from federally funded research in universities and other institutions. Under the Bayh-Dole Act, these institutions license the resulting patents to companies, often start-ups, which develop the technology until it is ready to be marketed.

During the many years of the development process, companies need to attract investment, and investors often assess the merits of the patent portfolio as an indicator of the ultimate strength of the company. Once a product is released to the market, patents still matter; each day of patent protection for a blockbuster drug is worth millions. Patent litigation in the life sciences is typically between competitors and reflects an effort by one of those competitors to maintain its exclusivity. […]

Read the full post here.

Bioethicist Arthur Caplan: Using Genetically Modified Mosquitoes To Fight Zika Is The Right Thing To Do

A new piece by Bill of Health contributor Art Caplan on Forbes:

When most of us think of mosquito control, we think of repellent, sprays and DEET. You might think long sleeves, window screens or mosquito control trucks, too. We’ve gotten pretty used to the idea that mosquitoes live around and among us–even when those mosquitoes carry diseases like West Nile, dengue, malaria and Zika. The best we can do to avoid their pesky, and sometimes lethal, bites is make our bodies unreachable or unappetizing.

The Zika outbreak sweeping through South America, Central America, Mexico and the Caribbean–and steadily moving north–has made mosquito control a top priority for national and international leaders, including the CDC and WHO. Transmitted primarily by the bite of the female Aedes aegypti mosquito, Zika has been linked to microcephaly in babies born to mothers infected during their pregnancies, as well as Guillain-Barré syndrome, which causes paralysis and even respiratory failure. Zika can get into the blood supply. A few cases of Zika appear to have been sexually transmitted. […]

Read the full article here.

Sequenom vs. Ariosa and international approaches to the patent eligibility of biomedical innovation

With a potential petition for writ of certiorari in the Sequenom v. Ariosa case approaching, it appears as if the US Supreme Court  will once again have to consider crucial patent eligibility questions with a great significance for biomedical innovation and diagnostic methods.

The claims at issue (see U.S. Patent No. 6,258,540 ) are directed to methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this non-invasive prenatal diagnostic test, patients were placed at much higher risk and maternal plasma was routinely discarded as waste.

In an earlier decision the district court ruled that the method claims were patent ineligible and an – apparently reluctant  – Federal Circuit agreed in Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F.3d 1377 (Fed Cir. 2015). Judge Linn, for example, wrote that the innovation deserves patent protection, but also that the “sweeping language of the test” established in Mayo v. Prometheus requires a determination that the claims are patent ineligible. Continue reading

Stem cell patenting on the other side of the pond

We are pleased to announce a new publication in the International Review of Intellectual Property and Competition Law (IIC). Our paper analyzes new case law in European stem cell patenting and compares these developments with the US situation and International treaties. Further information and an abstract is available below:

Authors: Ana Nordberg & Timo Minssen, University of Copenhagen, Centre for Information and Innovation Law (CIIR)

Title: A “Ray of Hope” for European Stem Cell Patents or “Out of the Smog into the Fog”? An Analysis of Recent European Case Law and How it Compares to the US
Journal: IIC – International Review of Intellectual Property and Competition Law, 47(2), 138-177
DOI: 10.1007/s40319-016-0449-x

ABSTRACT:  Continue reading

NHPC 2016: Growing National Debt Requires Strategic Changes in Health Care Spending

By Cornelia Hall, Master of Public Policy Candidate, Harvard Kennedy School, Class of 2017

This is the third entry in a three-part series on the AcademyHealth National Health Policy Conference, held in Washington, DC, on February 1-2.  Read the first entry here and the second entry here.

The national debt as a percentage of GDP has spiked in the last several years, rising from approximately 35% in 2007 to nearly 74% in 2015.  Federal budget projections suggest that this trend will continue, with the debt nearly exceeding the size of the economy by 2040.  Discussion about these predictions frequently returns to the topic of health care.  Indeed, as the “baby boomer” generation retires and enrolls in Medicare, federal health care spending is expected to rise dramatically.  In an NHPC plenary session, federal budget experts explored this topic and discussed possible methods of controlling the growth of health care spending in years to come. Continue reading

TOMORROW (2/18)! Assessing the Viability of FDA’s Biosimilar Pathway

16.02.18, FDA Biosimilars Pathway posterAssessing the Viability of FDA’s Biosimilar Pathway
February 18, 2016 12:00 PM
Pound Hall, Room 100
Harvard Law School
1536 Massachusetts Ave., Cambridge, MA

Description

The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.  Continue reading

REGISTER NOW! (3/29) The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration

PFC 10th Logo-Horizontal-Otlns-FnlThe Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration
March 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center is celebrating its first decade and kicking off the next by looking at the future of health law and policy!

Please join us as we bring together Petrie-Flom and other prominent Harvard Law School alumni to discuss major trends, developments, and open questions in the fields of health law policy, biotechnology, and bioethics. We’ll hear about the founder’s vision for the Center and the Dean’s perspective on the Center’s influence within the Harvard Law School community and beyond. Center Leadership will discuss what we have accomplished in the first ten years, and more important, our plans for the future. Alan Weil JD ’89, Editor-in-Chief of Health Affairs, will deliver the keynote address.

Agenda

Continue reading