Category Archives: Events

Online Symposium on the Law, Ethics & Science of Re-identification Demonstrations

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Over the course of the last fifteen or so years, the belief that “de-identification” of personally identifiable information preserves the anonymity of those individuals has been repeatedly called up short by scholars and journalists. It would be difficult to overstate the importance, for privacy law and policy, of the early work of “re-identification scholars,” as I’ll call them. In the mid-1990s, the Massachusetts Group Insurance Commission (GIC) released data on individual hospital visits by state employees in order to aid important research. As Massachusetts Governor Bill Weld assured employees, their data had been “anonymized,” with all obvious identifiers, such as name, address, and Social Security number, removed. But Latanya Sweeney, then an MIT graduate student, wasn’t buying it. When, in 1996, Weld collapsed at a local event and was admitted to the hospital, she set out to show that she could re-identify his GIC entry. For twenty dollars, she purchased the full roll of Cambridge voter-registration records, and by linking the two data sets, which individually were innocuous enough, she was able to re-identify his GIC entry. As privacy law scholar Paul Ohm put it, “In a theatrical flourish, Dr. Sweeney sent the Governor’s health records (which included diagnoses and prescriptions) to his office.”

Sweeney’s demonstration led to important changes in privacy law, especially under HIPAA. But that demonstration was just the beginning. In 2006, the New York Times was able to re-identify one individual (and only one individual)  in a publicly available research dataset of the three-month AOL search history of over 600,000 users. The Times demonstration led to a class-action lawsuit (which settled out of court), an FTC complaint, and soul-searching in Congress. That same year, Netflix began a three-year contest, offering a $1 million prize to whomever could most improve the algorithm by which the company predicts how much a particular user will enjoy a particular movie. To enable the contest, Netflix made publicly available a dataset of the movie ratings of 500,000 of its customers, whose names it replaced with numerical identifiers. In a 2008 paper, Arvind Narayanan, then a graduate student at UT-Austin, along with his advisor, showed that by linking the “anonymized” Netflix prize dataset to the Internet Movie Database (IMDb), in which viewers review movies, often under their own names, many Netflix users could be re-identified, revealing information that was suggestive of their political preferences and other potentially sensitive information. (Remarkably, notwithstanding the re-identification demonstration, after awarding the prize in 2009 to a team from AT&T, in 2010, Netflix announced plans for a second contest, which it cancelled only after tussling with a class-action lawsuit (again, settled out of court) and the FTC.) Earlier this year, Yaniv Erlich and colleagues, using a novel technique involving surnames and the Y chromosome, re-identified five men who had participated in the 1000 Genomes Project — an international consortium to place, in an open online database, the sequenced genomes of (as it turns out, 2500) “unidentified” people — who had also participated in a study of Mormon families in Utah.

Most recently, Sweeney and colleagues re-identified participants in Harvard’s Personal Genome Project (PGP), who are warned of this risk, using the same technique she used to re-identify Weld in 1997. As a scholar of research ethics and regulation — and also a PGP participant — this latest demonstration piqued my interest. Although much has been said about the appropriate legal and policy responses to these demonstrations (my own thoughts are here), there has been very little discussion about the legal and ethical aspects of the demonstrations themselves. As a modest step in filling that gap, I’m pleased to announce an online symposium, to take place here at the Bill of Health the week of May 20th, that will address both the scientific and policy value of these demonstrations and the legal and ethical issues they raise. Participants fill diverse stakeholder roles (data holder, data provider — i.e., research participant, re-identification researcher, privacy scholar, research ethicist) and will, I expect, have a range of perspectives on these questions:

Misha Angrist
Madeleine Ball
Daniel Barth-Jones
Yaniv Erlich
Beau Gunderson
Stephen Wilson
Michelle Meyer
Arvind Narayanan
Paul Ohm
Latanya Sweeney
Jennifer Wagner

I hope readers will join us on May 20.

Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation

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[Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc]

Moderated by Emily Broad Leib, Harvard Law School

Robin Craig, Leslie Francis, and Erika George, University of Utah The FDA’s Authority Over Labeling: Current Ironies and Future Improvements:

Goal is to look at FDA authority over safety and labeling of Genetically Modified (GM) foods argue that FDA should do more, and argue for human right to food approach.

By GM we mean rDNA modification not husbandry and not careful selection.

FDA has moved to use guidance and policy. In particular two are relevant here. First, in food additives there is GRAS – Generally Recognized as Safe. E.g., Cinnamon was treated as GRAS. Manufacturers can self-determine a product is GRAS without notifying FDA, or, if in doubt, request a GRAS notice letter from FDA. This was proposed in 1997 and final review never issued, but this is how they do it. Has increased frequency of GRAS review request from FDA. But the process is voluntary and relies entirely on info from producer not scientific separate work by FDA.

In 1992, FDA issued a policy document related to GM foods. Stated no scientific evidence that GM foods have more safety concerns than existing husbandry techniques, so GM technology is NOT material information. This was NOT a conclusion that GM foods were GRAS.

In 1996, FDA issued a guidance for GM foods. Consultation process to determine whether there are material differences between GM version and non, voluntary process, encouraged to get consumer trust. Like GRAS totally voluntary, totally reliant on FDA data. 95 reported consultations between 1996 and 2012.

Alliance for Biointegrity v. Shalala, challenged in 2000 in D.D.C., court deferred to agency on safety questions and whether the info on GM was “material” and therefore needs to be disclosed.

Where would FDA get authority to regulate GM foods? May pose allergy risks? May be relevant to nutrition or quality. Maybe an additive not GRAS. But each of these arguments apply to specific GM food not GM foods as a whole.

Their argument: Consumers have a right to know so they can make their own consumption risks, and consumer or religious views are not merely preferences but a ground for the information that is material to consumers.

On why this is best understood as Human Right to Food. Adequate right to food is an HR right framed after WWII about enough food that is not adulterated and not against your faith or ethics (kosher, halal, vegan) and respectful of environment. U.S. is not part to Socioeconomic rights convention, which is most explicit protection of this right, but are signatories to other treaties that protect the right more indirectly.

Whole Foods has moved ahead on this as have others. Even if not a worry as GRAS, consumption may be inappropriate. We need a national strategy. More of a precautionary take that understands material to matter to consumers.

Jennifer Pomeranz, Yale, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels:

Obesity and diabetes is the big problem in public health. And also people showing nutritional deficiencies because too much processed food. Current labeling is misleading makes people think food is healthier than they are. This is a unique public health problem. FDA has very weak authority and power here.

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Live Blogging from FDA in the 21st Century Conference, Panel 5: Major Issues in Drug Regulation

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 [Live-blogging off-the-cuff, all errors, typos, etc, are my fault]

Geoffrey Levitt, Pfizer, Drug Safety Communication: The Evolving Environment

A drug by itself is just an object. Because of that fact it creates turf, governance. You must have effective processes for communicating accurate info.

Pharmacovigilance is the accuracy part. Spontaneous adverse event reports are flooding to companies. 600,000 of such reports go to Pfizer a year, with 2000 a day on avg. Each has to be classified, reported, and followed-up. If you mess up you get a warning letter. But it has limits: passive, haphazard, poor signal to noise value. Main value is generating safety signals to follow up on. But studies of that kind for follow-up are very expensive and competing with other possible safety studies and new drug development for funding.

For this reason there has been interest in active real-time drug safety monitoring, like Sentinel.

Once you have accurate and up to date info, how do you communicate it to the audiences that need it. It is not static info, dynamic and constantly changing, and often not fully baked. Timing is everything. That leads to governance. Who owns it? Which stakeholders get to drive it. In Wyeth v. Levine, S. Ct says drug sponsor owns the label, and is responsible at all times for content of the label, including safety info. In reality not that simple. Today there is a number of players outside health authority and drug sponsor who have emerged as powerful forces. Academic researchers, drug payers, detailers, and many others.  This is not by accident. One reason is emergence of vocal critics who have critiqued the sponsors ability to directly communicate. Claim that this is a form of collusion  of which Levitt does not agree.

Vioxx sparked a few important developments. IOM produced one of the most important recommendations that led to FDAAA especially as to post-market surveillance and power over the safety label. Balance of authority shifted from that authority towards FDA. FDA also began to be more proactive about communicating, even before fully confirmed and without participation of sponsor. Also put into place obligations to post clinical trial results on public website, so clinicaltrials.gov is born. In retrospect, that was the opening shot in a full barrage of FDA on clinical trial transparency. In Europe this had led to a drastic new policy of affirmatively publishing clinical study reports full-scale not just trial results.

Critics of the current model want to tear down the gate, and reinterpret data themselves by own standards. That may lead to different results and different conclusions. Will the erosion of the primacy of the sponsor and FDA lead to more truth or more confusion?

W. Nicholson Price II, Petrie-Flom Center, The Role of Innovation Policy in Pharmaceutical Manufacturing

M & M manufacturing is more precise than drug manufacturing. Poor innovation in drugs. 200 to 300 billion dollars a year are spent on drug manufacturing. This is very expensive and inefficient, contrary to the typical story that drug manufacturing is cheap. Drugs are way behind computers and electronics. Uses same processes as decades ago. A 20% reduction in manufacturing costs would lead to a gain annually 50 billion for consumers if paid back directly, or even more if invested in R & D. Connected also to drug shortages.

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May 22 (note new date): Dan Brock delivering the Gay Lecture on “The Future of Bioethics”

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Please join the Division of Medical Ethics for:

The 2013 George W. Gay Lecture in Medical Ethics

Dan W. Brock, PhD
Frances Glessner Lee Professor of Medical Ethics, Department of Global Health and Social Medicine, HMS

“The Future of Bioethics”
Wednesday, May 22, 2013 (note new date)
4:00 PM

Harvard Medical School, Tosteson Medical Education Center

Carl W. Walter Amphitheater
260 Longwood Avenue, Boston

Please pass this invitation along to other interested friends and colleagues.
RSVP to  DME@hms.harvard.edu.

The George W. Gay Lecture is the oldest endowed lectureship at Harvard Medical School, and quite possibly the oldest medical ethics lectureship in the United States. The lectureship was established in 1917 by a $1,000 gift from Dr. George Washington Gay, an 1868 graduate of HMS. Since its inception, many of the nation’s most influential physicians, scientists, researchers and social observers, including Erich Fromm, Felix Frankfurter, Margaret Mead, Elizabeth Kübler Ross, E.O. Wilson, and Joshua Lederberg have given the Gay Lecture. Elie Wiesel, Marian Wright Edelman, Paul Krugman, Nicholas Kristof and Donald Berwick have given recent Gay Lectures.

 

A Tale of Two Polities

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By Scott Burris

Last week, Northeastern University’s effort to convene a much-needed conference on the future of health policy was a casualty of the successful manhunt for the Boston Marathon bombers.  One hardly wants to make too much of a stymied conference given all the human damage of the bombing and its aftermath, but all of us who had gathered for the meeting regretted that we would not hear from the panelists, and sympathized with organizers who had put so much into planning it.  In recognition of that, I am summarizing here what I planned to say there.  It is a tale of two polities that seem to compete for existence in our perceptions of the politics of public health.

One public health is incredibly popular with citizens and lawmakers alike – demonstrated by polling and passage of legislation.  I’ve recently blogged on this here.  The other public health is the despised nanny state, big government, the sequestered and slashed-to-the bone struggling provider of essential services that don’t get no respect and don’t deserve the meager tax dollars we still pay in. We see this in budget cuts, in hyperbolic allegations of “corruption,” and in disingenuous advocacy for a radical caveat emptor regime for all legal products.

What do we make of these two radically different views of where public health now stands in the public’s regard? My claim is that the former is largely the truth – public health is popular, not despised – but the latter view is what is driving budgets and a lot of policy. The action points follow: a sustained fight to mobilize public support and win more battles over budgets and laws. I see three main strands of work:

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4/25: Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies

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by Adriana Benedict

Universities Allied for Essential Medicines (UAEM)
Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies

Thursday, April 25th, 3-5pm
Coffee and refreshments at 2:45pm; reception following the event
Harvard Medical School New Research Building – 77 Avenue Louis Pasteur
Seminar Room 1031

How do innovative medical technologies make their way to a global population, including patients in resource-limited settings? As centers of medical innovation, universities are well-placed to influence the global dissemination of the fruits of biomedical research and enhance access to advances in drug, vaccine, diagnostic and device technologies. In the past five years, several institutions in Boston and beyond have acknowledged this fact and taken bold steps to encourage the transfer of medical technologies to the developing world. Licensing provisions such as tiered, reduced and zero royalties for products sold in developing countries; march-in rights; agreements to agree; agreements not to patent or not to enforce patents in developing countries; and humanitarian licensing exceptions are just some of the strategies used to implement global access licensing of medical technologies.  Others can be found in UAEM’s Global Access Licensing Framework, as well as the multi-institution Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies.

In this Forum, technology transfer officials and academic research leaders from Harvard, MIT, Tufts, BU, Northeastern, Children’s Hospital and Partners Healthcare (MGH/BWH) will speak to their institutions’ philosophy and experience with global access licensing strategies. In an hour-long Q&A, the audience – including invited experts with significant experience in medical technology development – will contribute to the discussion. The Forum is open to the public; and researchers, entrepreneurs, university leaders and students are highly encouraged to attend.

UAEM is an international interdisciplinary student organization that works with universities to leverage academic research for global health. Since our founding in 2001, we have worked towards illuminating the poorly understood process that brings discoveries from the laboratory to widely accessible products and services meant to improve human health.

Registration through this link is appreciated, but not required.

This event is co-sponsored by grants from the Harvard Global Health Institute (HGHI), the HMS Division of Medical Sciences, and Harvard Law School Advocates for Human Rights.

Harvard Clinical Bioethics Course

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Harvard Clinical Bioethics Course

June 12–14, 2013 • Wednesday–Friday
Harvard Medical School, 260 Longwood Avenue, Boston, MA

Earn up to 21.75 AMA PRA Category 1 Credits

This intensive course is designed for members of ethics committees and others interested in ethical aspects of clinical practice.

The target audiences are physicians, ethics consultants, nurses, chaplains, social workers, health care administrators, respiratory and other therapists, human rights officers, patient representatives, psychologists, risk managers, moral philosophers, hospital attorneys and trustees. Any or all of these health professionals may be members of hospital ethics committees. Members of clinical ethics committees, organizational ethics task forces and ethics support services identified the need to learn theories of ethics and ethical analysis of clinical cases to prepare staff to serve on clinical ethics committees and perform clinical ethics consultations. Knowledge of common ethical problems and dilemmas in medicine, and strategies to address them will help participants increase their competence in addressing ethical questions in medical care.

The combination of lectures, case discussions and seminars cover core information about ethical theories, principles, and methods, key bioethics cases from US courts, evolving standards for ethics consultation, and areas of clinical ethical controversy and consensus.

Faculty for the course are drawn from the Division of Medical Ethics at Harvard Medical School and from the Harvard-affiliated hospitals and institutions who are experts published in the specialty areas in which they teach, including bioethics, moral philosophy, medicine and health care.

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Event – NY SAFE Act: What Does It Mean for Mental Health Providers and Their Patients?

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New York State’s SAFE Act: 

“What Does It Mean for Mental Health Providers and Their Patients?”

Wednesday, May 1, 2013; 5:00pm-8:00 pm 

ALUMNI HALL B, NYU School of Medicine

Sponsored by the NYU Division of Medical Ethics and the Department of Psychiatry
Co-Chairs: Arthur L. Caplan, PhD and Elizabeth Ford, MD

Please RSVP to  jessica.oyola at nyumc.org

Click through to see the working agenda.

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Health Law and Policy Workshop: Petrie-Flom Fellow Nicholson Price on Making Due in Making Drugs

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The Petrie-Flom Center at Harvard Law School is happy to announce the penultimate session of this year’s Health Law Policy, Biotechnology and Bioethics Workshop in the Spring 2013 semester. We’re delighted to welcome a stellar lineup of leading researchers and opinion-makers in the fields at the intersection of health and law.  Professors Elhauge and Cohen lead the 2012-13 workshop series.

This spring’s next presenter is Petrie-Flom Academic Fellow Nicholson Price. He will be presenting his paper “Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing” on Monday, April 8th  at 5pm in Hauser 105. The full text of the paper is available here, and the abstract is copied below the “read more”

The workshop will conclude on Monday, April 15th with a lecture from WilmerHale Professor of Intellectual Property Law at HLS and Faculty Director of the Berkman Center, Terry Fisher. Workshops are open to the public and copies of papers will generally be posted a week in advance on the Petrie-Flom Website: http://www.law.harvard.edu/programs/petrie-flom/workshop/index.html.

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14th Annual Hospital & Health Law Conference 2013

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Implementation of Federal and State Health Reform:

PPACA + Chapter 224 = opportunities, dynamism, and risk

12:00 Noon – 5:00 P.M.
Thursday, May 9, 2013
MCLE Conference Center,
10 Winter Place, via Winter Street

Addressing the growing cost of health care, desire to leave no person uninsured, and expectation that care should be delivered at the highest levels of quality have caused major changes to the health care landscape in the Commonwealth over the past several years. In 2012 there were two significant developments propelling these changes. First, Federal Health Reform, through the Patient P—assured by the Supreme Courts ruling and the reelection of President Obama. Second, Massachusetts has embarked on Health Reform II through the passage of Chapter 224 of the Acts of 2012. These two forces combine to make 2013 a busy year for lawmakers, regulators, payors, providers, drug and device manufacturers, patients, and the lawyers who serve these diverse groups.

This cutting-edge Conference is designed to address these dramatic changes in the Massachusetts health care marketplace and beyond from a sophisticated legal perspective. What do lawyers need to anticipate in order to advise clients? What new business opportunities await the industry and their legal counsel? What should organizations be doing now to prepare for change in the near term?

With many important perspectives to be heard about these developments, the Conference seeks to bring together diverse viewpoints and experiences to give attendees both breadth and depth on these important subjects. Hear from health lawyers as well as health care industry insiders living with a dynamic market. Lawyers that help their clients respond to a market in flux, exposing both risks and opportunities, are providing a critical service at this time. This Conference distills and addresses key issues and provides essential insight on the skills of lawyering in this evolving practice area.

Registration information and agenda available at the conference website.

Harvard HIP (High Impact Philanthropy): Toby Ord speaking tonight

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Are you interested in foreign aid, global development, medicine? Want to know how philanthropy and charitable giving can do the most good?

Aid Works (On Average) - By Toby Ord

Tuesday, March 26th; Emerson Hall 108; 8 PM

There is considerable controversy about whether foreign aid helps poor countries, with several prominent critics arguing that it doesn’t. Dr. Ord shows that these critics have only reached this conclusion because they have failed to count the biggest successes of aid, such as the eradication of smallpox, which have been in the sphere of global health rather than economic growth. These health successes have often been neglected in analysis of aid because they have only made up a small proportion of aid spending. When we look at the impact of this spending, though, we see that it the big wins have been so utterly vast that they more than justify all aid spending to date.

Dr. Toby Ord is a philosopher at the University of Oxford and a research associate at the Uehiro Center for Practical Ethics and the Future of Humanity Institute. He is also the founder and director of Giving What We Can, an international society dedicated to eliminating poverty in the developing world.

Join Dr. Ord tonight, March 26, at 8 PM for a talk and discussion of the effectiveness of foreign aid. Refreshments will be provided, and a reception will follow.

Planning to come? Please RSVP on Facebook to help us plan refreshments.

Times Report Models Worst Practices for Policy Research Reporting

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By Scott Burris

I read the Times daily, and so naturally would like to be able to think it deserves to be regarded as a credible “newspaper of record.”  Today the paper outdid itself to disappoint, in a story by Sam Dolnick headlined “Pennsylvania Study Finds Halfway Houses Don’t Reduce Recidivism.” In the cause of making lemons from lemonade, I am drawing a list of “worst practices” from this little journalistic fender-bender:

Worst Practices Reporting Policy Evaluation Research (Provisional – come on readers, add your own.)

1. Don’t provide a title or author of the study or publication information on the study being described.

The story says only that it was conducted by the PA Department of Corrections and overseen by the state corrections department. There is a link later in the story to what turns out to be the Department’s annual report on recidivism. Not quite a “study” of halfway houses.

2. Don’t clearly describe the study.

The story does describe the study adjectivally – as “groundbreaking.”  It is, first of all, a bit of a stretch to call it a “study” at all. This is not the result of a systematic effort to explore the specific question of whether halfway houses work better than direct release to the street; it certainly was not a peer-reviewed or published study. Rather, the Times story is drawing on one section of an annual report produced by the state on recidivism among all prisoners released through all release mechanisms. The term “study” and the consistent suggestion that the study is important (“groundbreaking” results “so conclusive” that have “startled” leaders and experts) might lull the reader into believing that the “study” was well and deliberately designed to answer the question it supposedly posed – for example, a randomized, controlled and blinded trial of releasing prisoners directly to the street compared to halfway houses. Nope. This report is just a summary of outcome statistics, with a couple of paragraphs reporting in general terms on some statistical analysis meant to control for differences in the prisoners sent to halfway houses compared to those released to the street.

3. Just ignore the obvious problems for causal inference.

The plain and fundamental problem with pumping this study as powerful support for the claim that halfway houses don’t work is that we have no reason to be confident that the prisoners put into halfway houses are, as a group, the same as prisoners released directly to the street. It is elementary that statistical controls for observed differences cannot make up for a non-random, retrospective design that cannot also control for unobserved or unknown differences. Saying that this study “is casting serious doubt on the halfway-house model” is perhaps an attempt at caution, but way too weak a one. This study cannot cast serious doubt on anything, though it certainly points, as the report itself says, to worrisome outcomes in the halfway house system.

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