5/20 conference: “Biostatistics & FDA Regulation: The Convergence of Science & Law”

Biostatistics and FDA Regulation: The Convergence of Science and Law

Tuesday, May 20, 2014, 8:00am – 5:00pm

Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation. The full conference agenda is available on the website.

Registration is required in order to attend this event. Please register here.

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Whose Business Is It If You Want To Induce a Bee To Sting Your Penis?

Photo source: WikiMedia Commons

You might think that the answer to this question is obvious. Clearly, it’s your business, and yours alone, right? I mean, sure, maybe it would be considerate to discuss the potential ramifications of this activity with your partner. And you might want to consider the welfare of the bee. But other than that, whose business could it possibly be?

Well, as academic empiricists know, what others can do freely, they often require permission to do. Journalists, for instance, can ask potentially traumatizing questions to children without having to ask whether the risk to these children of interviewing them is justified by the expected knowledge to be gained; academics, by contrast, have to get permission from their institution’s IRB first (and often that permission never comes).

So, too, with potentially traumatizing yourself — at least if you’re an academic who’s trying to induce a bee to sting your penis in order to produce generalizable knowledge, rather than for some, um, other purpose.

Yesterday, science writer Ed Yong reported a fascinating self-experiment conducted by Michael Smith, a Cornell graduate student in the Department of Neurobiology and Behavior who studies the behavior and evolution of honeybees. As Ed explains, when, while doing his other research, a honeybee flew up Smith’s shorts and stung his testicles, Smith was surprised to find that it didn’t hurt as much as he expected. He began to wonder which body parts would really smart if they were stung by a bee and was again surprised to learn that there was a gap in the literature on this point. So he decided to conduct an experiment on himself. (In addition to writing about the science of bee stings to the human penis, Ed is also your go-to guy for bat fellatio and cunnilingus, the spiky penises of beetles and spiders, and coral orgies.)

As Ed notes, Smith explains in his recently published paper reporting the results of his experiment, Honey bee sting pain index by body location, that

Cornell University’s Human Research Protection Program does not have a policy regarding researcher self-experimentation, so this research was not subject to review from their offices. The methods do not conflict with the Helsinki Declaration of 1975, revised in 1983. The author was the only person stung, was aware of all associated risks therein, gave his consent, and is aware that these results will be made public.

As Ed says, Smith’s paper is “deadpan gold.” But on this point, it’s also wrong. Continue reading

Expedited FDA Approval for Breakthrough Therapies: Promises and Pitfalls

By Michael Young

In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”  This pathway added to a variety of other accelerated FDA approval programs aimed at improving access to innovative, safer, or more effective therapies for serious medical conditions.

In a recent New England Journal of Medicine article, Jonathan Darrow, Jerry Avorn and Aaron Kesselheim examine the clinical consequences and ethical dimensions of the breakthrough-drug category, and raise a variety of vital questions about its implications for patients.

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Saturday, April 5th: Aid Grade! (from Harvard Effective Altruism)

A communication from Harvard Effective Altruism:

 

Hi altruists,

Saturday, April 5th is a big day for EA at Harvard: we have three different awesome events for you! Our guest for the day, flying up from DC for the occasion, will be Dr. Eva Vivalt, the founder of AidGrade. AidGrade helps figure out what works in international development by doing rigorous and engaging analyses of different interventions to find out their effects. They’re also looking for interns and full-time hires for this work, so please visit if you’re interested!

We’ll be having a talk on AidGrade’s research from 1-2pm, followed by a research-a-thon from 2-6 where we help AidGrade do some meta-analysis. The day will be topped off by a Boston-area effective altruism meetup at Clover–with another special guest, Jacob Trefethen of 80,000 Hours Cambridge UK, and many awesome local effective altruists.

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Evidence in Policy Innovation

In the last few decades, there has been a broad effort to strengthen the use of evidence-based law as a tool for the promotion of population health. There are two major fronts in the campaign, each essential, and both largely successful, though much work also remains. One aims to increase the quantity and quality of empirical research on the health effects of existing policy choices. The other focuses on how best to get such knowledge into action in the form of policy and practice. In a new PHLR Theory Practice and Evidence paper, Evan Anderson and I draw attention to a third front: the formulation of new legal interventions. Though policy experimentation is inevitable, it has been the subject of relatively little systematic study. For proponents of evidence-based public health law, policy experimentation presents a paradox: if a legal intervention is truly innovative, there will not yet be direct evidence of its impact. Yet direct evidence from policy evaluations is never the only source of research knowledge relevant to a policy decision, even under conditions of novelty and uncertainty. And few interventions are truly new in a broad sense; in most instances, similarly designed laws have been deployed before, just not for the same specific purpose.

We use the case of youth sports concussion and Washington’s Lystedt Law as a case study of how even new legal strategies dealing with new problems can be built on evidence. We show  how evidence about the problem lawmakers are addressing, combined with widely-used analytic tools like the Haddon Matrix and an understanding of the generic mechanisms through which law influences behavior and outcomes, can bring existing research knowledge into the crafting of even very innovative legal interventions for newly perceived problems.  While we don’t expect the policy sausage factory to suddenly start looking like a research lab, there’s no question that legislators typically care about getting policy right and want evidence.  The point of our paper is to get the research world to think about ways we can help even when no one has yet studied the specific law at issue.

Call for applications: Brocher Summer Academy 2014: Ethical Choices for DALYs and the Measurement of the Global Burden of Disease

Confirmed speakers: Christopher Murray (IHME)—Keynote, Matt Adler (Duke), Greg Bognar (La Trobe U), John Broome (Oxford), Dan Brock (Harvard), Richard Cookson (York U), Owen Cotton-Barratt (Oxford), David Evans (WHO), Marc Fleurbaey (Princeton U), Ned Hall (Harvard), Dan Hausman (U of Wisconsin, Madison), Elselijn Kingma (U of Eindhoven), Jeremy Lauer (WHO), Colin Mathers (WHO), Erik Nord (Norwegian Institute of Public Health, Oslo), Ole Norheim (U of Bergen), Andreas Reis (WHO), Joshua Salomon (Harvard and IHME), Abha Saxena (WHO), Erik Schokkaert (KU Leuven), Drew Schroeder (Claremont McKenna), Alex Voorhoeve (LSE), James Woodward (U of Pittsburgh).

Organizers: Daniel Wikler (Harvard), Nir Eyal (Harvard), Samia Hurst (U of Geneva)

The biennial Summer Academy in the Ethics of Global Population Health is hosted by the Brocher Foundation on the shores of Lake Geneva June 9-13 2014, introducing faculty and advanced graduate students to population‐level bioethics. This fast‐developing academic field addresses ethical questions in population‐ and global health rather than ones in individual patient care.

The Global Burden of Disease (GBD) project is a systematic, scientific effort to quantify the comparative magnitude of health loss due to diseases, injuries, and risk factors. From its inception in the early 1990s, scientists and philosophers recognized that ethical and philosophical questions arise at every turn. For example, it must be decided whether each year in the lifespan is to count alike, and whether future deaths and disabilities should be given the same weight as those in the present. These choices and decisions matter: the share of disease burden due to myocardial infarction could vary as much as 400% depending on what position is adopted on two of the ethical choices described in the GBD 2010 report.  Continue reading

Harvard Effective Altruism: Josh Greene this Tuesday

Emotion, Reason and Altruism
with Professor Joshua Greene

Tuesday, March 11th, 7 PM,
Fong Auditorium, Boylston Hall
Why do people have radically different opinions as to who to help and how? How can we get along with people who seem to fundamentally disagree with us about what to want? Professor Josh Greene addresses this and more in Emotion, Reason, and Altruism.
Joshua Greene direct Harvard’s Moral Cognition Lab, which uses cutting edge cognitive neuroscience techniques to study how people actually make moral decisions, integrating thinking from philosophy, social science, and social psychology to address questions of why people disagree as much as they do, and what we can do about it.

Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading

Capturing Value in Advanced Medical Imaging

On December 12, a bipartisan bill entitled the Excellence in Diagnostic Imaging Utilization Act of 2013 (HR 3705) was introduced in the House of Representatives which would require clinicians to use electronic clinical decision support tools (CDS) before ordering advanced diagnostic imaging tests for Medicare patients.  Structured around appropriate use criteria  developed by professional medical societies, the tools would aim to increase the value of advanced imaging studies by informing and guiding practitioners’ decisions across a variety of clinical settings.

Such tools would provide active feedback on the appropriateness and evidence base of various imaging modalities, and would require physicians to furnish rationales for ordering tests that are inconsistent with appropriate use criteria.  The bill also envisions the creation of registries that document how diagnostic tests are used in order to facilitate research and to enable feedback to clinicians on metrics related to appropriate use criteria.  In a press release, the American College of Radiology lauded the proposed legislation, stating that it would “revolutionize the specialty of radiology.”

Mandating the use of electronic clinical decision support tools portends at least three key improvements in clinical workflows and healthcare quality more broadly.

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Sleep versus Training: The NY Times on Surgical Work Hours

Pauline Chen at the NY Times Blog has an article on cut backs on the number of hours of training for young surgeons.

According to her story:

“For the past decade, in response to increasing pressure from politicians, unions and sleep experts, the Accreditation Council for Graduate Medical Education, the organization responsible for accrediting American medical and surgical training programs, has been working to cap the hours that residents work. In 2011 the council passed the strictest limits yet. To maintain their accreditation, residency training programs had to abide by a 22-page set of scheduling rules that limited all in-hospital work including any elective “moonlighting” jobs to 80 hours per week, mandated the number of hours “free of duty” after different “duty periods” (eight hours off after 16-hour duty periods and 14 hours off after 24-hour duty periods) and even specified the timing of “strategic napping” in no uncertain terms (after 16 hours of continuous duty and between the hours of 10 p.m. and 8 a.m.).

While most residency programs chafed under the exhaustively detailed regulations, surgical training programs had particular difficulty adopting the new mandates. For nearly a century, surgical residency had been a period of both intensive experience and increasing responsibility under the guidance of more experienced surgeons. More recent research has affirmed that approach, demonstrating the strong link between a surgeon’s operative skill, the number of operations performed and patient outcomes. With limits set on their time at the hospital, young surgeons-in-training had fewer opportunities to care for patients or scrub in on operations. While previous generations of trainees had the luxury of participating in at least one operation a day, new trainees had only enough time to be involved in two or maybe three operations each week.

Calculating the number of hours “lost” by cutting back on in-hospital time, surgical leaders estimated that young surgeons-to-be were now missing out on as much as a year’s worth of experience”

She relies heavily on an new Annals of Surgery Article, wherein, as Chen reports,

“Researchers sent questionnaires to the directors of subspecialty fellowship training programs and asked them to comment on the bedside and operating skills of the young surgeons enrolling in their programs. These fellowships are a kind of high-level and often prestigious surgical “gap year” where young surgeons who have completed the basic five-year surgery residency can delay independent practice to pursue an additional year or two of training.

The results were abysmal. Fewer than half of the young surgeons could operate or make clinical decisions on their own. Nearly a third of them were incapable of performing even the most basic operations like a gallbladder removal on their own. And a quarter were unable to recognize the early signs of complications.

Even in areas of surgery where the young surgeons had had supplementary online learning modules during their residency, they performed poorly, with more than half unable to perform basic maneuvers.”

While acknowledging that “some observers have criticized the study for being self-serving – most respondents also noted that the young surgeons’ deficiencies resolved after additional training under their auspices —” Chen’s article reads largely as an attack on these new residency work hour rules.

Since I have written on the subject of these residency work hour rules with sleep specialists earlier this year in the Journal of Law, Medicine, and Ethics, it may be unsurprising that I take a somewhat different view.

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Ethics and Oversight in Recombinant Genetic Research

By Michael Young

In 1972, biochemist Paul Berg and his student Janet Mertz published groundbreaking details of their first successful attempt at devising a procedure to cleave separate pieces of DNA and recombine them into a single novel molecule.  These innovations, dubbed recombinant DNA (rDNA) technology, spurred a flurry of concerns from members of the scientific community who worried about the safety, risks and potential drawbacks of creating recombinant DNA molecules.  Motivated by these concerns, the NIH established the Recombinant DNA Molecule Program Advisory Committee (RAC) in 1974.  The RAC was charged with the mission of overseeing research and implementation of rDNA technologies, with a particular focus on proposals involving the transfer of recombinant or synthetic DNA into humans (i.e., human gene transfer).

Last week, after nearly 40 years of providing an additional layer of oversight to this class of research, the RAC received recommendations from an independent Institute of Medicine (IOM) committee that was convened to assess “whether the current oversight of individual gene transfer protocols by the Recombinant DNA Advisory Committee (RAC) continues to be necessary.”

The committee’s report calls for significant changes to the prevailing structures of rDNA research regulation and oversight, and represents a victory for many gene transfer researchers who have challenged RAC regulations. Continue reading

New Data on Drug Overdose Law

Image

By Scott Burris

Working with Corey Davis of the Network for Public Health Law, PHLR has completed and posted updated longitudinal datasets of state laws authorizing naloxone distribution and creating “Good Samaritan” immunity for callers reporting a drug overdose to 911. Take a look at www.lawatlas.org.

On the theory that an image beats a few hundred words, here’s a report on the state of the law:

HHIP: Evaluating Effective Charities – GiveWell cofounder Elie Hassenfeld: Tuesday, 8 PM

Harvard High Impact Philanthropy presents:

Evaluating Effective Charities with Elie Hassenfeld of GiveWell

How can you maximize the impact of your charitable giving?  What distinguishes the most effective causes and organizations? Elie Hassenfeld, co-founder and co-Executive Director of GiveWell, will describe how his organization is revolutionizing charity evaluation with completely transparent, rigorous analysis. Q&A to follow.

8 pm, Tuesday, Nov. 12; Sever 102

RSVP here

Elie Hassenfeld graduated from Columbia in 2004 and co-founded GiveWell in mid-2007 where he currently serves as co-Executive Director. GiveWell finds outstanding charity and publishes the full details of its analysis to help donors decide where to give. The Boston Globe has called GiveWell “The gold standard for giving” and its research has attracted attention from Peter Singer and other media. GiveWell has tracked over $10 million in donations to its recommendations as a direct result of its research.

Disruptive Innovation and the Rise of the Retail Clinic

By Michael Young

The Association of American Medical Colleges (AAMC) projects that by 2025 the United States will face a shortage of 130,600 physicians, representing a near 18-fold increase from the deficit of 7,400 physicians in 2008.  The widening gap between physician supply and demand has grown out of a complex interplay of legal, political, and social factors, including a progressively aging population, Congressionally mandated caps on the number of Medicare-funded residency slots and funding for graduate medical education, and waning interest among medical school graduates in pursuing careers in primary care.

These issues generate unprecedented opportunities for healthcare innovators and entrepreneurs to design solutions that can effectively address widening disparities between healthcare supply and demand, particularly within vulnerable and underserved areas.

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Avoiding the Crash: New research on fatality rates for cyclists and pedestrians in distracted driving crashes

By Jacqueline Jefferson, BS (’14), Temple University Department of Public Health

Today it seems impossible for drivers to keep both hands on the steering wheel and eyes on the road, with all the technology that is available to us, temptation is at its best. Somewhere along the road our eyes look down at a text message or our hands wander to program the GPS — both distract us from the task at hand: driving. There are laws being enacted all over the country to curb distracted driving (such as the one just recently passed in Maryland) but, there are other factors in this issue. The question also becomes about whether our roads and communities are protecting pedestrians and bicyclists — in other words, how are we protecting the people who do not have four sides of steel protecting them from injury?

Let’s take a closer look at the problem. A study published this week in Public Health Reports by PHLR grantee Fernando Wilson, PhD, examines victims of fatal distracted driving crashes and shows that fatality rates of motorist victims of distracted driving crashes are falling while fatalities of pedestrian and bicyclist distracted driving crashes substantially increased from 2005 to 2010. Continue reading

Unreliable Biomedical Science, and a Solution?

The Economist has a long, detailed, and readable piece about the difficulties of inferring anything from the published findings of biomedical science.  There are all sorts of problems that fall short of scientific fraud, including the the biases caused by industry-funding of biomedical science, the biases of unblinded raters who see what they want to see, and the biases of journal editors towards only publishing “positive” findings.  (I am particularly enamored with this graphic, which shows the fundamental problem of inference.)  It is rare for researchers to even bother to attempt to replicate prior findings, but when replications are attempted, they often fail.  

The Economist piece can be read as something close to an outright assault on empiricism, at least as we now know it.  In practical terms, it is prudent for physicians, patients, and payors to be wary of the findings presented in even the top journals.

One of the beauties of our scientific system is that it is wildly decentralized.  Scientists (and their funders) can test any hypothesis that they find interesting, and they can use whatever methods they prefer.  Likewise, journal editors can publish whatever they want.  While such academic and market freedom is attractive, it results in quite a hodgepodge of science, with replication studies and publication of null results being afterthoughts.  The NIH and NSF have in the past functioned to set an agenda and demand rigor, but as their funding wanes, the chaos waxes.

The problems are scientific, but any solution will be institutional (and thus legal).  I have argued for a partial solution to industry bias in my short article, called “The Money Blind:  How to Stop Industry Influence in Biomedical Science Without Violating the First Amendment.”  Independent scientific testing could be conducted by a neutral intermediary, which would pool funds.  In a similar vein, there is also a new project of the Science Exchange, called “The Reproducibility Initiative.”  This program offers to be the independent scientific agency, which attempts to validate known results.   But there is not yet a large-scale funding model in place.  If biomedical journal editors would at least put disclosures in their structured abstracts (an intervention we have tested), over the long run that may also nudge industry to use such gold-standard independent testing, when they have something that is truly provable.  And, at least in the domain of the products regulated by the FDA, the agency should consider using its current statutory authority to push companies towards independent, robust, and replicated science.

Another Legislative Win for Opioid Death Prevention

By Scott Burris

The rising public and legislative awareness of opioid overdose has been a case study in the twists and turns of culture, risk perception and the role of evidence in policy making. An interesting case study, which does not mean I understand what happened or why.

I first got involved in overdose through Dan Abrahamson, the Legal Director at the Drug Policy Alliance. This was back in 1999 or 2000, and a group of drug researchers and drug policy people convened a meeting in Seattle to discuss the chronic, neglected problem of overdose among heroin users.  There were a few health people who were highly aware of the human and economic costs, and the scale of the problem. Karl Sporer, a San Francisco ER doc, was one of the few publishing on the problem. One of the interesting ideas discussed at the meeting was distributing naloxone, the standard antidote for opioid overdose, directly to heroin users. New Mexico, which had the nation’s highest OD death rates, was trying it as a way to deal with the great distances that divided rural heroin users from EMS assistance. With Joanna Norland and Brian Edlin, I ended up writing an analysis of the legality of distributing this prescription drug to drug users.

In the next few years, led by people like Dan Bigg of the Chicago Recovery Alliance, needle exchange programs in urban areas began naloxone programs. They were spurred in 2006 when several US cities experienced an epidemic of overdose tied to the adulteration of the heroin supply with a synthetic opioid, fentanyl. By May, 2009, 57 naloxone programs were operating in 17 U.S. states.  That year, DPA funded a group of scientists and practitioners to brainstorm on how to increase drug users’ access to this life-saving intervention.  Continue reading

The Troubled Peer Review System, the Open Access Wars, & the Blurry Line Between Human Subjects Research & Investigative Journalism

Legal academics who work across disciplines sometimes find themselves in the uncomfortable position of explaining to their stunned colleagues the process by which second- and third-year law students, armed with author c.v.s, decide what gets published and where.

Well, get ready to get your schadenfreude on. For the past 10 months, John Bohannon, a contributing correspondent for Science magazine, has been conducting a sting of (other) science journals and their peer review processes. Much like the famed Sokal hoax, Science submitted to 304 journals a bogus paper written by a fictitious researcher from a nonexistent institution. The paper described “the anticancer properties of a chemical that [the fictitious researcher] had extracted from a lichen,” and according to Bohannon, “[a]ny reviewer with more than a high-school knowledge of chemistry and the ability to understand a basic data plot should have spotted the paper’s short-comings immediately” and rejected it promptly. And yet, over half of the journals accepted the paper. Recall that the bogus paper purports to report on the discovery of the anticancer properties of lichen. Let the prospect of bogus cancer research published in peer reviewed medical journals sink in.  Continue reading

(Taboo) Science, Policy & the Importance of Good Science Communication: Redux

In late May, I wrote the following:

Yesterday, the Social Science Genetic Association Consortium, an international consortium that pools and conducts social science research on existing genome-wide association study (GWAS) data, and on whose Advisory Board I sit, published (online ahead of print) the results of its first study in Science. That paper — “GWAS of 126,559 Individuals Identifies Genetic Variants Associated with Educational Attainment” — like much human genetics research, has the potential to be misinterpreted in the lay, policy, and even science worlds. That’s why, in addition to taking care to accurately describe the results in the paper itself, including announcing the small effect sizes of the replicated SNPs in the abstract, being willing to talk to the media (many scientists are not), and engaging in increasingly important “post-publication peer review” conversations on Twitter (yes, really) and elsewhere — we put together this FAQ of what the study does — and, just as important, does not — show. So far, our efforts have been rewarded with responsible journalism that helps keep the study’s limits in the foreground.

I had no role in the GWAS itself; that credit goes to SSGAC’s extraordinarily meticulous scientists. I did, however, have a strong hand in the FAQs. And so I am really pleased that in a new editorial, the editors of Nature (not for nothing, Science’s main competitor) highlighted our FAQ as an example of best practices in behavioral genetics research and science communication. They write:

For clarity, scientists would do well to follow the example of the Social Science Genetic Association Consortium. In June, this group published a paper on genetic variants associated with educational attainment (C. A. Rietveld et al. Science 340, 1467–1471; 2013). Accompanying this was a nine-page Frequently Asked Questions document that, in plain, easy-to-understand language, addressed such questions as why the researchers did the study, what they found and what the implications of the work are — and are not (see go.nature.com/7mov2j). The document spelled out that the consortium had not found ‘the gene’ for educational attainment, that each genetic marker found has only a very small effect on length of schooling, and that any policy response based on that single study would be premature.

Scientists cannot be held responsible every time someone misinterprets their work. But simple steps such as these could help to prevent and address some of the potential distortions of behavioural genetics — and could help to ensure that society continues to support the work.

For more on taboo science—including IQ, race, violence, and sexuality—see Erika Check Hayden’s accompanying article, which discusses our Science GWAS in the IQ category and (elsewhere in the article) quotes Duke lawprof (and new Conspirator!) Nita Farahany and Bill of Health guest contributor Yaniv Erlich. Now if we could only get popularizers of science to understand that their lay audience will rarely know that they are “oversimplifying” that science.

[Cross-posted at The Faculty Lounge]

Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3 (Re-Identification Symposium)

This post is part of Bill of Health‘s symposium on the Law, Ethics, and Science of Re-Identification Demonstrations. Background on the symposium is here. You can call up all of the symposium contributions by clicking here. —MM

By Daniel C. Barth-Jones

In Part 1, and Part 2 of this symposium contribution I wrote about a number of re-identification demonstrations and their reporting, both by the popular press and in scientific communications. However, even beyond the ethical considerations that I’ve raised about the accuracy of some of these communications, there are additional ethical, “scientific ethos”, and pragmatic public policy considerations involved in the conduct of re-identification research and de-identification practice that warrant some more thorough discussion and debate.

First Do No Harm

Unless we believe that the ends always justify the means, even obtaining useful results for guiding public policy (as was the case with the PGP demonstration attack’s validation of “perfect population register” issues) doesn’t necessarily mean that the conduct of re-identification research is on solid ethical footing. Yaniv Erlich’s admonition in his “A Short Ethical Manifesto for the Privacy Researcher blog post contributed as part of this symposium provides this wise advice: “Do no harm to the individuals in your study. If you can prove your point by a simulation on artificial data – do it.” This is very sound ethical advice in my opinion. I would argue that the re-identification risks for those individuals in the PGP study who had supplied 5-digit Zip Code and full date of birth were already understood to be unacceptably high (if these persons were concerned about being identified) and that no additional research whatsoever was needed to demonstrate this point. However, if additional arguments needed to be made about the precise levels of the risks, this could have been adequately addressed through the use of probability models. I’d also argue that “data intrusion scenario” uncertainty analyses which I discussed in Part 1 of this symposium contribution already accurately predicted the very small re-identification risks found for the sort of journalist and “nosy neighbor” attacks directed at the Washington hospital data. When strong probabilistic arguments can be made regarding potential re-identification risks, there is little possible purpose for undertaking actual re-identifications that can impact specific persons.

Looking more broadly, it seems more reasonably debatable whether the earlier January re-identification attacks by the Erlich lab on the CEPH – Utah Residents with Northern and Western European Ancestry (CEU) participants could have been warranted by virtue of the attack having exposed a previously underappreciated risk. However, I think an argument could likely be made that, given the prior work by Gitschier which had already revealed the re-identification vulnerabilities of CEU participants, the CEU portion of the Science paper also might not have served any additional purpose in directly advancing the science needed for development of good public policy. Without the CEU re-identifications though, it is unclear whether the surname inference paper would have been published (at least by a prominent journal like Science) and it also seems quite unlikely that it would have sustained nearly the level of media attention.

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