Category Archives: Michelle Meyer

Kudos to This American Life

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A few weeks ago, I blogged about a recent episode of This American Life, “Dr. Gilmer and Mr. Hyde,” about the quest of one Dr. Gilmer (Benjamin) to understand why another, beloved Dr. Gilmer (Vince), had brutally murdered his own father after hearing voices that compelled him to do so. The episode ends (spoiler alert) with the revelation that Vince suffers from Huntington’s, a rare, neurodegenerative disease that causes progressive physicial, cognitive, and psychological deterioration.

Listeners, it seemed to me, could naturally conclude from the episode that it was Vince’s Huntington’s that had caused him to murder his father. That might or might not be true in this particular case. Huntington’s can cause behavioral and mood changes, including irritability, aggression and belligerence. It can also cause (less often) psychosis. But even if Huntington’s caused Vince to murder his father, or somehow contributed to the murder, the extreme violence that Vince displayed — strangling his father, then sawing off his father’s fingertips to preclude identification — is in no way typical of the Huntington’s population as a whole. And so what most troubled me about the episode was its failure to note just how rare this kind of extreme violence is among those with Huntington’s, just as it is very rare among human beings generally. And so I wrote to TAL, requesting a clarification.

I’m happy to report that the TAL producer for the episode, Sarah Koenig — who had not intended to suggest any causal link between Vince’s murder of his father and his Huntington’s, much less between murder and Huntington’s more generally — has issued a clarification on the show’s blog, and promises to make a similar clarification in the episode itself, should they ever re-air it. Kudos to TAL, and many thanks to Sarah for being incredibly gracious in our exchanges.

One clarification deserves another. In my earlier blog post, I also worried that some listeners might  conclude that Vince’s father was similarly driven to commit horrific acts of sexual abuse on Vince and his sister because he, too, was (presumably) suffering from Huntington’s (an autosomal dominant genetic disease). Although I think that a listener who didn’t know better could reasonably conclude that Huntington’s causes people to become sexual predators almost as easily as they could conclude from the episode that Huntington’s causes people to become murderers, nothing in the episode suggests that Sarah, Benjamin Gilmer, or anyone else at TAL believe that Huntington’s causes sexual abuse, or that they intended for listeners to reach that conclusion. I regret anything in my earlier post that suggested otherwise.

Again, I’m very grateful to Sarah and everyone else at TAL for hearing me (and other listeners) out and for agreeing to make the clarification — and just in time for HD Awareness Month!

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, Plenary 2: Alta Charo on Integrating Speed and Safety

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[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

Day two of PFC’s FDA in the 21st Century conference begins with a morning plenary by the very fabulous Alta Charo, of the University of Wisconsin Law School, who is speaking on “Integrating Speed and Safety.”

Today Alta is presenting what she calls “more of an initial idea than an actual proposal,” and she notes that she’s very interested to hear responses to it, so comment away or contact her offline. She wants to integrate into the usual and longstanding “FDA speed versus safety” debate some concerns that should be of interest to industry. “In other words,” she said, “I’d like to be nice to the drug people.”

Alta begins with a brief history of the speed versus safety debate, which turns out to be quite cyclical. Before 1906, she asks us to recall, we had true snake oil: products with high toxicity and little or no efficacy. Often these products were nevertheless perceived as effective because they contained alcohol or other drugs, so made you feel better at least, but of course that’s part of what made these products so dangerous, especially for children.

And so with the Federal Food and Drugs Act of 1906, we get post-market remedies for misbranding, although they require proof of intent. And then in 1937 over 100 children die from elixir of sulfanilamide. And the following year we get the Food, Drug, and Cosmetic Act. But the FDCA targets only safety. (Although rightly Alta notes that it’s hard to see how regulators were truly only looking at safety and not also at some form of efficacy, since there is no such thing as safety in the abstract, only safety relative to purpose for which someone is taking the drug.) Continue reading →

Live Blogging from FDA in the 21st Century Conference, Panel 2: Preserving Public Trust and Demanding Accountability

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[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

First up is Mark Lange from Eli Lilly (who notes that he is here in his personal capacity only!), speaking about “Data Transparency and the Role of the FDA.”

He prefaces his talk by noting that when he refers to “data,” he means raw, patient-level data from clinical trials. Most calls for the transparency of such data, he says, reflect a common theme about lack of trust in the pharmaceutical industry. So we might wonder: why doesn’t the pharmaceutical industry simply accede to that request and make their data available?

Mark notes that industry has several concerns. One important one pertains to data exclusivity. In several (if not all) markets, data exclusivity rights are premised on keeping the relevant data confidential, and posting it publicly would be deemed a waiver of those rights. In addition, data exclusivity prevents generic competitors from free riding, and publishing data could allow them to circumvent the very point of data exclusivity.

Moving to privacy concerns, Mark notes that research subjects’ understanding is that their data will be used for particular purposes and shared with regulators, but not be publicly posted on the Internet for anyone to do with whatever they want. Relatedly, there is the potential for interpretation of public data to be biased; research results may be over-interpreted and analyses may be flawed or even erroneous. Competitors might look for fairly trivial flaws the the data and try to use them to their advantage rather than sincerely trying to advance scientific progress and transparency.

Mark suggests, however, the choice between privacy and transparency is a false one. A better alternative is available — namely, for objective, expert regulators such as the FDA to receive and vet data in ways that address both audiences and both sets of concerns. The FDA is in fact already experienced in doing this. For example, it determines whether research demonstrates that a drug is safe and effective for a particular use through its marketing application approval mechanism, and it determines the accuracy and adequacy of the portrayal of research results in product labeling and product advertisements. And late last year, it was given responsibility for overseeing clinicaltrials.gov, which includes results from all pre-specified primary and secondary outcomes measures from nearly all clinical trials either conducted in the U.S. or intended to be used in support of an application for marketing approval in the U.S. This new responsibility, Mark suggests, could be a powerful tool, depending on how the FDA uses it. For instance, the FDA could exercise authority to monitor and enforce the absence of required results and the inclusion of false or misleading results data.

In concluding, Mark stresses that, when faced with requests for public access to patient-level trial data, we should consider the important role of regulators as trusted intermediaries who can balance competing concerns. Continue reading →

This American Life and Stigma

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Update: TAL has made a clarification. Please see this post for more.

Let me begin by saying how much I absolutely adore This American Life. I listen to it religiously. I particularly had been looking forward to the most recent pocast episode of TAL: Dr. Gilmer and Mr. Hyde. As the episode’s blurb teases, “Dr. Gilmer and Mr. Hyde” concerns a doctor — Benjamin Gilmer — who takes over the rural South Carolina practice of Vince Gilmer (no relation). Vince is no longer available to see patients because he is serving a prison sentence for killing his father. As Benjamin gets to know Vince’s — and now his — patients, he forms a picture of Vince that’s at odds with his status as a convicted father murderer. How could this doctor who was so devoted to his patients have so brutally murdered his own father?

This episode is right up my alley. True crime? Check. Forensic psychology? Check. The intersection of law and medicine? Yes, please. So when I awoke yesterday morning at 5 am and couldn’t go back to sleep, I eagerly cued up the podcast. The episode recounts, in TAL’s  typically-riveting fashion, the story of Benjamin’s search for the truth behind Vince’s murder of his father. I enjoyed every minute of the episode until the last five minutes or so, when I became troubled by one critical omission.

Spoilers  follow after the jump; listen to the episode first. Continue reading →

Twitter Round-Up (2/16-2/23)

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By Casey Thomson

This week’s round-up discusses the upcoming cases relevant to bioethics in the Supreme Court, the benefits of the Physician Payment Sunshine Act, the surprisingly low effectiveness rate of this year’s flu vaccine, and the problems with ACA’s Accountable Care Organizations. See below for details and more summaries:

  • Frank Pasquale (@FrankPasquale) shared a post on what’s being called the “alcoholism vaccine” being developed at the Institute for Cell Dynamics and Biotechnology at Universidad de Chile. The vaccine, which would have to be administered every 6 months or year, would mimic the alcohol intolerance mutation that prevents the breaking down of acetaldehyde and produces an instant “hangover-type” state. (2/16)
  • Dan Vorhaus (@genomicslawyer) retweeted a timeline from the Center for Law and Bioscience at Stanford Law’s blog giving dates for the upcoming Supreme Court cases relating to biosciences. (2/17)
  • Frank Pasquale (@FrankPasquale) additionally included a piece on the Physician Payment Sunshine Act, a provision of the Affordable Care Act that would “[require] manufacturers of drugs, medical devices and biologics to report the monetary value of gifts and payments to doctors and teaching hospitals on a publicly accessible website.” The author of the piece, a family physician with 15 years of experience, discussed his support for the plan. (2/17)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link explaining the scientific foundations of the Brain Activity Map Project, namely how it aims at “reconstructing the full record of neural activity across complete neural circuits” to better understand “fundamental and pathological brain processes.” (2/18)
  • Arthur Caplan (@ArthurCaplan) posted a news story on police arresting those involved in the illegal harvesting of eggs from women in Bucharest, Romania. The police reports claim that 11 suspects have been implicated in the trafficking, which would harvest the eggs to be sold to Israeli couples with fertility problems. (2/19)
  • Alex Smith (@AlexSmithMD) retweeted a link to his post on asking about a patient’s PPD (preferred place of death), noting that this is not one of the concerns often cited as part of advanced planning procedures. Such a practice was considered “vital” in the UK, in contrast. (2/20)
  • Alex Smith (@AlexSmithMD) shared a link to a post on the blog he co-runs, GeriPal, on “Five Things Patients and Physicians Should Question in Palliative Care and Geriatrics.” The post shares the two lists posted by the American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS), which Smith claims “provide targeted, evidence-based recommendations to help physicians and patients have conversations about making wise choices about their care in order to avoid interventions that provide little to no benefit.” (2/21)
  • Arthur Caplan (@ArthurCaplan) also included a link reviewing the low effectiveness of this year’s flu vaccine: there was evidence that it was only effective in 56% of the cases, on the low end of the usual 50-70% effectiveness rate. His tweet noted that this was strong evidence in favor of mandating the vaccine for healthcare workers. (2/21)
  • Michelle Meyer (@MichelleNMeyer) posted an op-ed piece by The Wall Street Journal about the problems with Affordable Care Act’s Accountable Care Organizations (ACOs), namely their false assumptions: that success can come without changing doctor behavior, and without changing patient behavior, in a way that will save money. (2/23)

R.I.P. Ronald Dworkin (Dec. 11, 1931–Feb. 14, 2013)

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I woke this morning to the very sad news that legal philosopher and NYU law professor Ronald Dworkin died in London early this morning of leukemia, at the age of 81.

I’m not sure whether his illness was well known to those within the legal academy, but it came as news to me, so I confess I’m slightly shocked by news of his death. Others, of course, are much better positioned to give thoughts about his life and career, and no doubt will, here and elsewhere. I’ll share just one brief remembrance. I was the founding co-editor of the Harvard Law Review Forum, and for our very first issue, I solicited a response from Professor Dworkin to Fred Schauer’s (Re)Taking Hart. These were the days when online supplements to law reviews were new, and we didn’t really know how scholars would view these opportunities. When he readily agreed to provide a response, I recall emailing the news around Gannett, to much rejoicing. This was an especially meaningful “get” for me, as in addition to his work in legal philosophy, I had read and appreciated Life’s Dominion as an undergraduate studying bioethics. I was terribly nervous about interacting with him, but he was incredibly kind and gracious and unassuming throughout the process.

Professor Dworkin leaves behind his wife, two children, and two grandchildren. They and his friends and colleagues are in my thoughts.

Update: Brian Leiter is aggregating memorial notices here.

Twitter Round-Up (1/27-2/7)

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By Casey Thomson

Even the surprisingly resurrected Richard III (on the Twitter-sphere, anyway) appreciates bioethics concerns. Read on to find out more about Richard III’s eagerness for patient confidentiality and other updates in this week’s (extended) Twitter round-up:

  • Stephen Latham (@StephenLatham) included a link to his blog post challenging Andrew Francis’ recent claim that penicillin was the central drug spawning the sexual revolution of the 1960s. While penicillin may have facilitated the widespread acceptance of pre-marital relations, it was The Pill that “translat[ed] that newfound sexual freedom into sexual equality.” (1/28)
  • Dan Vorhaus (@genomicslawyer) posted a summary video regarding the Neanderthal baby story that rocked the internet in the past few weeks, as reported by Taiwan’s Next Media animation. (1/28)
  • Michelle Meyer (@MichelleNMeyer) shared a news report on Israel’s recent admittance to giving birth control to Ethiopian Jewish immigrants, frequently without either consent or knowledge. Concerns first arose after an investigative journalist began to explore why birth rates in the community had fallen so drastically and seemingly inexplicably. (1/28)
  • Arthur Caplan (@ArthurCaplan) linked to a piece explaining the future implications and consequences of the guidance requiring schools to make “reasonable modifications” in order to include students with disabilities in either general athletic programs or provide them with parallel opportunities. The guidance, while a potential huge move forward for individuals with disabilities, nonetheless will be nothing without “tough and honest conversation about financing and revenue – and soon.” (1/28)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article showing the return of the “invisible gorilla” from the 2010 book, but this time in the fake CT scans shown to both expert radiologists and volunteers alike. The gorilla was large in size compared to the typically indicative nodules, and was unmistakably a gorilla, but yet 20 out of the 24 radiologists failed to see the gorilla. It’s a frightening real-life example of what the original study’s jargon terms as “inattentional blindness.” (1/29)
  • Kevin Outterson (@koutterson) live tweeted the Pew meeting concerning new antibiotic development pathways for limited populations. See the string of tweets on his Twitter page for further details of how the meeting proceeded. (1/31)
  • Daniel Goldberg (@prof_goldberg) shared a link describing the first scientific evidence suggesting that doctors can “truly feel” their patients’ pain. The study, done by Harvard researchers, used brain scans to indicate activated regions of physicians’ brains during a simulated interaction with patients. (2/1)
  • Frank Pasquale (@FrankPasquale) linked to a story on the problems associated with over-prescribing amphetamine-based medications, particularly to teenagers and young adults. While focusing on the individual story of an aspiring medical student named Richard Fee, the author delves into the underexposed side effects of often overzealous prescribing and the surprisingly casual attitude that most Americans hold towards this medication. (2/3)
  • Frank Pasquale (@FrankPasquale) also posted a piece inspired by the talk surrounding World Cancer Day on the problems related to cancer treatment in developing countries. Contrary to being solely a problem of so-called developed nations, cancer remains an issue globally – including such cancers that are caused by an infectious agent. Fighting the false notions – that cancer in developing nations is minimal, that it is always not “catchable,” and that enough care (particularly vaccines) is being delivered – is essential to reducing the global inequity in cancer treatment. (2/4)
  • Michelle Meyer (@MichelleNMeyer) retweeted the (supposedly resurrected and technologically adept) Richard III’s tweet regarding publication of details surrounding his newly-identified bones: “Hmmm not so happy about my physical attributes being discussed in public. What happened to patient confidentiality ???” (2/4)
  • Daniel Goldberg (@prof_goldberg) shared a report on a new study that found a correlation between low self-esteem and female body representation and obsession in “chick lit.” The report noted that the results suggested a possible “intervention tool” by having characters seek support from friends and family for such body concerns. (2/5)
  • Michelle Meyer (@MichelleNMeyer) retweeted a graphic eloquently summarizing one of the simplest and most potent arguments in favor of vaccination, and arguably the greater biopharmaceutical industry. (2/6)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Are You Ready for Some . . . Research? Uncertain Diagnoses, Research Data Privacy, & Preference Heterogeneity

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As most readers are probably aware, the past few years have seen considerable media and clinical interest in chronic traumatic encephalopathy (CTE), a progressive, neurodegenerative condition linked to, and thought to result from, concussions, blasts, and other forms of brain injury (including, importantly, repeated but milder sub-concussion-level injuries) that can lead to a variety of mood and cognitive disorders, including depression, suicidality, memory loss, dementia, confusion, and aggression. Once thought mostly to afflict only boxers, CTE has more recently been acknowledged to affect a potentially much larger population, including professional and amateur contact sports players and military personnel.

CTE is diagnosed by the deterioration of brain tissue and tell-tale patterns of accumulation of the protein tau inside the brain. Currently, CTE can be diagnosed only posthumously, by staining the brain tissue to reveal its concentrations and distributions of tau.[1] According to Wikipedia, as of December of 2012, some thirty-three former NFL players have been found, posthumously, to have suffered from CTE. Non-professional football players are also at risk; in 2010, 17-year-old high school football player Nathan Styles became the youngest person to be posthumously diagnosed with CTE, followed closely by 21-year-old University of Pennsylvania junior lineman Owen Thomas. Hundreds of active and retired professional athletes have directed that their brains be donated to CTE research upon their deaths. More than one of these players died by their own hands, including Thomas, Atlanta Falcons safety Ray Easterling, Chicago Bears defensive back Dave Duerson, and, most recently, retired NFL linebacker Junior Seau. In February 2011, Duerson shot himself in the chest, shortly after he texted loved ones that he wanted his brain donated to CTE research. In May 2012, Seau, too, shot himself in the chest, but left no note. His family decided to donate his brain to CTE research in order “to help other individuals down the road.” Earlier this month, the pathology report revealed that Seau had indeed suffered from CTE. Many other athletes, both retired and active, have prospectively directed that their brains be donated to CTE research upon their death.[2] Some 4,000 former NFL players have reportedly joined numerous lawsuits against the NFL for failure to protect players from concussions. Seau’s family, following similar action by Duerson’s estate, recently filed a wrongful death suit against both the NFL and the maker of Seau’s helmet.

The fact that CTE cannot currently be diagnosed until after death makes predicting and managing symptoms and, hence, studying treatments for and preventions of CTE, extremely difficult. Earlier this month, retired NFL quarterback Bernie Kosar, who sustained numerous concussions during his twelve-year professional career — and was friends with both Duerson and Seau — revealed both that he, too, has suffered from various debilitating symptoms consistent with CTE (but also, importantly, with any number of other conditions) and also that he believes that many of these symptoms have been alleviated by experimental (and proprietary) treatment provided by a Florida physician involving IV therapies and supplements designed to improve blood flow to the brain. If we could diagnose CTE in living individuals, then they could use that information to make decisions about how to live their lives going forward (e.g., early retirement from contact sports to prevent further damage), and researchers could learn more about who is most at risk for CTE and whether there are treatments, such as the one Kosar attests to, that might (or might not) prevent or ameliorate it.

Last week, UCLA researchers reported that they may have discovered just such a method of in vivo diagnosis of CTE. In their very small study, five research participants — all retired NFL players — were recruited “through organizational contacts” “because of a history of cognitive or mood symptoms” consistent with mild cognitive impairment (MCI).[3] Participants were injected with a novel positron emission tomography (PET) imaging agent that, the investigators believe, uniquely binds to tau. All five participants revealed “significantly higher” concentrations of the agent compared to controls in several brain regions. If the agent really does bind to tau, and if the distributions of tau observed in these participants’ PET scans really are consistent with the distributions of tau seen in the brains of those who have been posthumously-diagnosed CTE, then these participants may also have CTE.[4]

That is, of course, a lot of “ifs.” The well-known pseudomymous neuroscience blogger Neurocritic[5] recently asked me about the ethics of this study. He then followed up with his own posts laying out his concerns about both the ethics and the science of the study. Neurocritic has two primary concerns about the ethics. First, what are the ethics of telling a research participant that they may be showing signs of CTE based on preliminary findings that have not been replicated by other researchers, much less endorsed by any regulatory or professional bodies? Second, what are the ethics of publishing research results that very likely make participants identifiable? I’ll take these questions in order. Continue reading →

Twitter Round-Up (1/20-1/26)

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By Casey Thomson

Though simply the consequence of bad translation, the story of the Harvard geneticist George Church looking for a woman to act as surrogate for a Neanderthal clone shocked the internet bioethics world. A look at the problems with this hypothetical situation is just one of the components of this week’s Twitter Round-Up.

  • Frank Pasquale (@FrankPasquale) linked to an opinion piece discussing the reasoning behind the United States’ place in the world rankings of life expectancy at different stages of life. The news is a big hit to ideas of American exceptionalism: according to a report by the National Research Council and the Institute of Medicine, Americans have a substantially higher death rate for those younger than 50 as compared to Western Europeans, Canadians, Japanese, and Australians, but once they reach the age of 80, they have some of the longest life expectancies globally. (1/20)
  • Arthur Caplan (@ArthurCaplan) shared his article on why Neanderthal cloning is a bad idea, both in terms of safety and in terms of avoiding cruelty. (1/22)
  • Arthur Caplan (@ArthurCaplan) posted a news story on the reopening of bird flu experimental procedures for vaccine creation. Caplan was quoted in the article as stating: “I have no issue with restarting the research but some issue with where they are going to publish it and where they present it because bad guys can use it too.” (1/23)
  • Daniel Goldberg (@prof_goldberg) included an evaluation as to the medical disparities occurring in Colorado, particularly between races. The article emphasized in its conclusion that the existence of the disparities themselves is quite clear, but discussion on how to erase such differences is noticeably absent. (1/23)
  • Michelle Meyer (@MichelleNMeyer) retweeted a post that attempted to quantifiably compare the quality of care in Medicare options, namely whether Medicare Advantage plans 1) will eventually shortchange patients by skipping out on care quality because of profit motive or 2) have incentives to improve care quality because of the newly implemented systematic quality monitoring, where poor ratings impact them financially. The author found that most existing data makes the second theory more compelling, though the amount of data regarding the subject in general is largely lacking. (1/24)
  • Michelle Meyer (@MichelleNMeyer) also shared a link to an explanation of the intricacies of “personalized regulation” in medicine, which aims to preserve patient choice in an era leaning more and more towards paternalistic medical oversight. Understanding that patients may choose to make rational decisions that diverge from the community or committee consensus is key towards improving medical care to better reflect patient wants, and rights. (1/24)
  • Arthur Caplan (@ArthurCaplan) included a story on the large imbalance in misconduct reports in research between the genders. Men overwhelmingly led the charge, with only nine women out of the 72 faculty members who committed research misconduct. (1/24)
  • Michelle Meyer (@MichelleNMeyer) additionally shared a letter written by the Editor of The Hastings Center’s Bioethics Forum on the reasoning behind publication of a controversial article on the social pressures leading to obesity. The letter calls for the importance of recognizing that publication means that an article contributes to the larger debate on an issue, though does not affirm that the publication medium agrees with the views espoused within; it also encouraged responses to the ideas of the article. (1/25)
  • Stephen Latham (@StephenLatham) posted a video link from Comedy Central on the perils of WebMD and vegetarianism. (1/25)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Outsourcing the Up Goering of My Job Talk Paper to Forbes: Personalized Medicine, Personalized Regulation

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So, one thing they say about being on the law teaching market is that you likely will never before have enjoyed — and, less happily, will likely never again enjoy — so much attention to your work and so many opportunities to discuss it. That’s totally true, and it’s totally fabulous. But there’s a flip side of that that they don’t tell you: after a while, you get burned out on talking about the same paper over and over again. You’ve likely moved on to other projects and are more excited about them, even if (or because) those projects build on your job talk paper. At this point in the process, your recitation of your job talk paper may have become rote and uninspired. You may, like me, have come to dread the act of rattling off your job talk paper’s thesis and why it matters.

And so it is that, having promised some months ago to blog my job talk paper on what I call the “heterogeneity problem” in research regulation, I have yet really to do so. I’ve blogged around the edges, to be sure (see, e.g., here, here, here, and here), but I can’t bring myself to explain the central thesis one more time. I also owe book editors (holla, Glenn and Holly!) a chapter on the challenges of heterogeneity for the growing global trend in “risk-based regulation” across many industries, and I’ve been procrastinating that, too, I think, largely because it requires me first to provide the reader with a précis of the heterogeneity problem. All of this is annoying, because there are lots of things that build on that central thesis that I’d like to write about, if only I could get over this strange aversion.

Enter physician-scientist David Shaywitz, whose overly kind piece yesterday in the Pharma & Healthcare section of Forbes.com, Personalized Regulation: More Than Just Personalized Medicine — And Urgently Required, highlights my work and, essentially, Up Goers it for me. It of course doesn’t cover all of the points I make in the paper, and in other ways it extends my thesis beyond what I defend in the paper, but it gives readers the gist. Thank you, David! (Let this also serve as supplemental answers to hiring committee questions about “What does your work have to do with the law?” and “Aren’t you ‘just’ a bioethicist whose work has no relevance for health or administrative law?”)

And now, with that out of the way, in my next post I’ll feel free to apply the heterogeneity problem to this question I was asked on Twitter. I can almost guarantee you that it will be my first and last post about football.

[Cross-posted at The Faculty Lounge]

Twitter Round-Up (1/13-1/19)

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By Casey Thomson
The flu, gun control, and legal action against the FDA – all amongst our Twitter feeds this past week. Read on for more:
  • Frank Pasquale (@FrankPasquale) retweeted a link to the FDA’s current legal trouble concerning their failure to disclose antibiotic resistance data. The Government Accountability Project (GAP) is accusing the FDA of violating the freedom of information law, failing to release data on antibiotic drug usage within the meat industry in order to, as they claim, protect industry secrets. This failure takes special significance when considering that, according to GAP, “80% of all antibiotics sold in the US are utilized by the meat industry.” (1/14)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article in the Health Affairs Blog concerning how to improve the Learning Healthcare System (LHS), which adapts data into knowledge that directs evidence-based practice and health system change. Specifically, the U.S. Department of Veterans Affairs is developing two approaches, namely Point-of-Care Research (“a method of performing clinical trials within the daily practicalities of the [health-care system] (with the intent of advancing these systems to LHS)”), and the Collaborative Research to Enhance and Advance Transformation and Excellence (strengthening health services research, which analyzes the factors regarding the obtainment of care). (1/14)
  • Arthur Caplan (@ArthurCaplan) reported on the American College of Physicians’ new recommendation that all healthcare providers receive the influenza vaccine for this particularly harsh flu season, in addition to other listed immunizations. (1/15)
  • Frank Pasquale (@FrankPasquale) additionally added a post on the inequality of the 2012-2013 flu outbreak – namely, the disproportionate number of lower-income individuals who are contracting the illness. The article noted the results of a study which found that while the majority of efforts for vaccinations occur in more wealthy neighborhoods, covering poorer neighborhoods with vaccine care early benefits the wealthier neighborhoods more so than if such vaccinations were delayed. (1/16)
  • Arthur Caplan (@ArthurCaplan) also shared a link to an examination into New York’s newly passed major gun control law, which addressed gun control ownership of those with mental illness. Caplan dissolved claims that the new measures were “draconian,” noting that such practices of reporting individuals that may pose concern for the safety of others have already been in practice but that these new policies make the process of reporting a legal imperative, and simpler.
  • Daniel Goldberg (@prof_goldberg) shared an article on SAGE Journals about the experience of gender within the healthcare science environment, specifically looking at the subtle practices of masculinist actions taking place that may remain unnoticed or unchallenged. The report is based on the discussed experiences of healthcare scientists with men in healthcare science laboratories. (1/16)
  • Alex Smith (@AlexSmithMD) linked to an article on an intervention for “post-hospital syndrome”, commonly known as the Acute Care for Elders (ACE) Unit. The intervention, while evidence-based and already in place in many hospital locations, may be overlooked by practitioners or healthcare authors. This unit works to reduce the effects that often derive largely from the “allostatic and psychological stress” accumulated during a hospital stay. (1/18)
  • Frank Pasquale (@FrankPasquale) posted a report on bias in reporting on breast cancer clinical trials. The study found that “nearly one-third of reports on large, randomized studies over-emphasize some benefits of therapy,” in addition to providing “insufficient attention or discussion of treatment side effects.” Considering that such reports factor prominently in how doctors decide to pursue treatment and therapy for patients, this misreporting leaves many doctors unaware of the true consequences of tested treatments – and may cause them to decide plans for treatment that they would not otherwise pursue. (1/19)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Twitter Round-Up 1/1-1/13

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By Casey Thomson

Due to the string of December holidays and some traveling by the round-up author, this post belatedly summarizes tweets from the end of 2012 to the beginning days of the new year. The round-up will resume a regular schedule following the conclusion of this week. Read below for this (extended) round-up:

  • Frank Pasquale (@FrankPasquale) posted an article about China’s growing obesity problem, one that shocks those who remember the Great Famine of 1958-61 and which is still largely minimized by government officials. The total number of obese individuals in China has risen from 25% in 2002 to 38.5% in 2010, according to the World Health Organization. (1/1)
  • Frank Pasquale (@FrankPasquale) also tweeted this blog post on the possibilities of cyborgs, a potential reality that a recent BBC article notes may not be too distant. Such an invention could potentially result in direct mental control of machines, augmented intelligence, augmented learning, and mood modification, among other benefits, postulates the article author. (1/1)
  • Frank Pasquale (@FrankPasquale) additionally posted a piece addressing the idea of love between humans and robots. (1/3)
  • Alex Smith (@AlexSmithMD) announced the release of PREPARE, an online advanced care planning tool meant for individuals to foster communication skills and prepare for decision-making rather than make premature plans. The project in part is meant to help empower individuals rather than have them tied to the medical establishment. (1/4)
  • Dan Vorhaus (@genomicslawyer) included a blog post on crowd-funding personalized bioscience, particularly summarizing companies aiming to contribute outside the genetics realm. This includes sequencing the gut microbiome and noting biomarker concentrations through the blood. (1/7)
  • Michelle Meyer (@MichelleNMeyer) posted an article decrying the paternalistic attitudes surrounding the release of genetic information to patients. Not only does this article claim that “People are smarter & more resilient [re #genetic info] than ethic debates give them credit for”, as Meyer references from the article, but it also recognizes that the complexities of the genome do not make it less necessary for doctors to figure out how to discuss it with the public. (1/7)
  • Michelle Meyer (@MichelleNMeyer) also posted about the Supreme Court’s decision regarding a case on government funding of embryonic stem cell research. SCOTUS declined to hear an appeal to stop the research, which opponents claimed was in violation of the 1996 Dickey-Wicker law. (1/7)
  • Daniel Goldberg (@prof_goldberg) posted about a recent study on the influence of body weight and gender on courtroom judgments. The Yale Rudd Center for Food Policy and Obesity found that only an obese female was punished when in consideration along with a lean male, an obese male, and a lean female. Goldberg notes in his tweet that the results are “unreal but sadly [unsurprising]“. (1/8)
  • Alex Smith (@AlexSmithMD) retweeted an article lamenting the continued fall of fellowship trained geriatricians, which noted that the decrease in numbers is surprising considering that a boost from the Affordable Care Act raises a geriatrician’s annual salary by 12 percent through 2015. (1/9)
  • Arthur Caplan (@ArthurCaplan) shared a link on a sperm donor custody case in Kansas where the sperm provider thought he had absolved any connection to the child that his sperm would create, but is now being called upon to pay child support. While similar cases have not received as much media attention, the concept – being responsible financially as a result of having genetic ties to a child – has come up in cases involving fathers who were deceased yet were called to pay through their estate, and even in a similar sperm donor case in Pennsylvania in 2011. (1/10)
  • Frank Pasquale (@FrankPasquale) posted an article discussing the recent move by  various healthcare centers requiring their health practitioners (doctors and nurses alike) to get a flu vaccine – possibly at the risk of their job. Should this be grounds for termination, or should the healthcare providers have the same choice to abstain from vaccination as does a patient? (1/13)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Twitter Round-Up (12/9-12/15)

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By Casey Thomson
This week’s round-up looks at the problems of substandard drug prevalence abroad, NIH’s possible push for an anonymous grant-awarding process, and the Liverpool Care Pathway investigation. Check it out below!
  • Dan Vorhaus (@genomicslawyer) included a link to a report on the recent launch of Personal Genome Launch Canada. The post includes links to help navigate the content and learn more about the intricacies of this project. (12/9)
  • Frank Pasquale (@FrankPasquale) shared a post on the benefits and detriments of raising the age of Medicare eligibility from age 65 to 67 – an idea that has recently gained sway in the political arena. The author ultimately concludes that the move would only be a matter of cost shifting rather than cost saving, and thus harm the disenfranchised 65-66 year-olds that would front the cost. (12/10)
  • Frank Pasquale (@FrankPasquale) also included this article on Dr. Oz’s wrongful diagnosis on organics. While concerns about finances must indeed be taken into consideration when families decide what foods to purchase, families must also be concerned about the presence of pesticides in their food. Organic food, while more expensive, avoids this health hazard. (12/10)
  • Frank Pasquale (@FrankPasquale) additionally linked to this report on the preponderance of substandard (and oftentimes, consequentially lethal) drugs particularly in emerging markets. Efforts to crackdown on substandard drugs have thus far focused largely on counterfeit drugs, rather than those that are the result of “shoddy manufacturing and handling…or deliberate corner cutting,” which constitute an arguably much greater public health threat. (12/10)
  • Daniel Goldberg (@prof_goldberg) shared this post on the prevalence of worthless clinical practice guidelines. The article notes the need to distinguish the guidelines that meet much of the Institute of Medicine (IOM) quality criteria from the rest. (12/10)
  • Alex Smith (@AlexSmithMD) linked to a blog post on advance care planning and the gap between the needs of the healthcare system and those of patients. Currently, much of the paperwork required for advance directives is given without providing families and patients concrete skills needed for both identifying their desires and communicating such desires to direct their own medical care. This article calls for refocusing on providing direct patient empowerment in addition to the existing efforts to improve clinician communication in order to facilitate the ability of advance care planning to reflect the patient’s wishes. (12/11)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article about the NIH’s consideration of introducing anonymity into the grant-awarding process in order to alleviate some of the concerns with bias that have long-plagued the agency. (12/12)
  • Dan Vorhaus (@genomicslawyer) also posted a report on BGI, a world-leading DNA sequencing organization based in China, and their commercial expansion efforts into the healthcare, agriculture, and aquaculture sectors. The question of whether BGI is more a research institute or commercial enterprise comes into question in the article. (12/12)
  • Stephen Latham (@StephenLatham) included a link to his own blog post on the recently renewed controversy concerning the Liverpool Care Pathway for the Dying Patient (LCP), particularly as to whether patients put on the LCP had a discussion with their care providers prior to the decision and whether hospitals were wrongly putting patients on the pathway. The talk of scandal sparked an independent investigation into the LCP; Latham’s article expressed his hope for thoroughness in the investigation and for serious consideration on how to renew the LCP effectively. (12/12)
  • Arthur Caplan (@ArthurCaplan) posted a link concerning the implications of 23andMe, a personalized genomics company, and their launch of the $99 genetic test in the hopes of inspiring greater numbers to get tested. The article’s author reflects on how the real benefit will likely not be immediate for individuals, but will rather depend on the chance that greater data will lead to more breakthroughs in understanding the human genome. (12/14)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

The Risk of Revictimization and the Ethics of Covering School Shootings: What Journalists Can Learn from IRBs

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Updated below

Like most parents, after learning about the latest mass school shooting this morning, my thoughts immediately went to my own kindergartener. And of course, like most reading this blog, I thought about how poorly we handle guns and mental illness. Before too long, though, I couldn’t help but make a less direct connection between today’s events and my scholarly interests. I’m thinking of the way journalists cover school shootings as compared to how we regulate human subjects research.

As I write in The Heterogeneity Problem, 65 Admin. L. Rev. __ at 14-16 (forth. June 2013):

Studies on sexual abuse and assault, grief, war, terrorism, natural disasters and various other traumatic experiences are critical to better understanding and addressing these phenomena. But exposure to trauma — whether as a survivor or as a first rescuer or other third party — often causes substantial psychological morbidity. . . . Given their potentially fragile state, IRBs understandably worry that “questioning [or otherwise studying] individuals who have experienced distressing events or who have been victimized in any number of ways . . . . might rekindle disturbing memories, producing a form of re-victimization.”

IRBs — local licensing committees who operate according to federal statute and regulation and must approve most studies involving humans before researchers can even approach anyone about possibly participating — sometimes impose burdensome requirements on the way trauma research is conducted in order to protect adult subjects from the risk of revictimization. And they do so in addition to applying regulations that require that researchers disclose that risk (and others) to subjects.

Contrast this with the way journalists cover trauma. Continue reading →

Twitter Round-Up (12/2-12/8)

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By Casey Thomson
This week’s Twitter Round-Up features an “American Idol-style” selection of research grant winners, the problems facing children in Syria attempting to be vaccinated, and a review of where we stand with current patient health information privacy and security.
  • Michelle Meyer (@MichelleNMeyer) retweeted an article about a newly emerging landmark case in the United Kingdom. In the suit, a childless couple denied IVF funding due to the woman’s age is suing Health Secretary Jeremy Hunt (because he is “ultimately accountable for healthcare in England”) on the basis of age discrimination. Thought to be the first venture to sue the Health Secretary concerning decisions about this NHS fund rationing, this case also will be the first instance where age discrimination laws have been employed to try for fertility treatment. (12/3)
  • Alex Smith (@AlexSmithMD) shared an article about a problem patients must deal with when approaching post-hospitalization care: Medicare’s offer to pay for hospice care or for a Skilled Nursing Facility (S.N.F.), but only rarely at the same time. Not only does the choice create a financial predicament, but it also has extensive repercussions for the patient’s health. Calls for a combined benefit process between hospice/palliative care and S.N.F. have been made, including a proposed “concurrent care” demonstration project in the Affordable Care Act. (12/6)
  • Dan Vorhaus (@genomicslawyer) linked to a summary of the Ponemon Institute’s Third Annual Benchmark Study on Patient Privacy & Data Security, reporting on the challenges still being faced to safeguard protected health information (“PHI”). (12/6)
  • Michelle Meyer (@MichelleNMeyer) additionally retweeted a link explaining Brigham and Women’s Hospital’s attempt to deal with the rising difficulty of choosing which research grants to support: an “American Idol-style” public online voting. With almost 6,500 votes cast, the public engagement experiment picked a project hoping to research methods for integrating genomic sequencing into newborns’ routine medical care. When future grant holders are struggling to award between a set of equally deserving project proposals, this push for public involvement (after having confirmed scientific rigor) may have intriguing implications. (12/6)
  • Daniel Goldberg (@prof_goldberg) also linked to a study in Denmark testing the relationship between socio-economic status (SES) and blood pressure levels. Despite having a healthcare system that is free and equal-access regardless of factors like SES, the study found that SES had a “significant effect on BP [blood pressure] control” in this survey. (12/7)
  • Arthur Caplan (@ArthurCaplan) posted a report by UNICEF on the efforts by parents in the Syrian Arab Republic to get their children vaccinated. With many medical centers destroyed by the conflict, and with health practitioners having to operate and transport supplies in the dangerous environment, children have been unable to receive routine vaccinations for several months. This campaign aims to provide such vaccinations (specifically for measles and polio) to children, having advertised via churches, mosques, schools, television, and even by SMS to get greater coverage. (12/7)
  • Frank Pasquale (@FrankPasquale) included a book review of Pharmageddon by David Healy, a look at how pharmaceutical companies are excessively influencing the medical industry particularly with “diagnostic categories and clinical guidelines.” The result, according to Healy: a society where people “think about their bodies as a bundle of risks to be managed by drugs,” with a workforce that is “getting ‘sicker,’” and with “major pharmaceutical companies…banking on further overdiagnosis and overtreatment,” all “undermining universal health care.” (12/8)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Twitter Round-Up (11/18-11/24)

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By Casey Thomson

After what we hope was a hearty meal (or at least a restful, happy holiday) this past Thanksgiving for all of our readers, we are back with this week’s Twitter round-up – just a few days behind schedule.

  • Daniel Goldberg (@prof_goldberg) tweeted an article by Stefan Fatsis on the different perspectives regarding child participation in tackle football. As Goldberg noted in his tweet, from the perspective of neuroethics, the choice is clear: tackle football (or American football) is harmful for kids. (11/19)
  • Frank Pasquale (@FrankPasquale) included a link to a piece describing why data from all clinical trials should be readily accessible to doctors, or the origins of the BMJ Open Data Campaign. The article used the case of the Tamiflu anti-flu drug as an example, where the article authors described their hurdles in communicating with the drug’s producers concerning drug test results while trying to review the efficacy of the drug through Cochrane Collaboration. (11/21)
  • Kevin Outterson (@koutterson) posted his article, published in the New England Journal of Medicine, concerning the path for new federal regulations for compounding pharmacies in the wake of the meningitis outbreak and the New England Compounding Center (NECC). (11/23)
  • Arthur Caplan (@ArthurCaplan) brought up a recent post concerning the American College of Obstetricians and Gynecologists (ACOG) and their declaration that making birth control pills over-the-counter (OTC), rather than prescription, could reduce the rate of unplanned pregnancies in the United States (which has not changed in 20 years). While the change would not occur overnight, there are many consequences that remain unclear – including changes in price and insurance coverage. (11/23)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link to David Shaywitz’s article, which noted the increased criticism and distrust facing industry studies as compared to those of university scientists. Shaywitz encouraged contextualization of industry criticism to recognize that such critiques often plague medical science in general, not just industry. (11/24)

Note: As a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet.

Twitter Round-Up (11/4-11/10)

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By Casey Thomson

[Ed. Note. 11/12/12: Just to be clear, retweeting should not be read as an endorsement of or agreement with the content of the original tweet.]

With Election Day now come and gone, our bloggers were tweeting this week about the results, in addition to the greater happenings in health law and ethics. Read below for this week’s round-up:

  • Arthur Caplan (@ArthurCaplan) retweeted a post about the recent clinical trial done on chelation, a “fringe” heart disease treatment whose popularity often hinges on a patient’s distrust of conventional medicine. Evidence of the treatment’s effectiveness looks to be marginal, at best. (11/4)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article that explained the problems in the intersection between neuroscience and law, namely how emerging technologies in neuroscience are not being used appropriately to understand criminal behavior. The author advocates for a renewed look at how neuroscience and law can work together, not only to evaluate defendants effectively, but also to customize plans that can serve the interests of both the defendant and the public. (11/5)
  • Dan Vorhaus (@genomicslawyer) linked to a new piece he co-authored on clinical data and genetics, entitled “The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets?” (11/6)
  • Michelle Meyer (@MichelleNMeyer) aptly summarized the results of Massachusetts’ ballot questions with her tweet: “Sick folk in MA can now smoke pot but, it seems likely, not have the aid of their doc in controlling the timing & nature of their death.” (11/6)
  • Daniel Goldberg (@prof_goldberg) linked to a study done on children with epilepsy  and their families. Goldberg noted that the study’s results indicate a serious “ethically pernicious” problem that in fact worsens the condition of those afflicted with epilepsy more so than may be originally perceived: stigmatization. (11/7)
  • Frank Pasquale (@FrankPasquale) tweeted a blog post that talked of the need to increase the FDA’s power in order to curb the fungal meningitis outbreak now affecting individuals nationwide. Lamentations of the state-based system’s inability to handle the problem had undertones of concern for future situations similar to this one sprouting up again. (11/8)
  • Frank Pasquale (@FrankPasquale) also published a news update from Georgia, where legislators are ending the discount on license renewal prices that had previously been given to motorists who signed up to be organ donors. While many expressed fear that the policy would decrease the number of donors, others in the medical community admitted that there had been no demonstrated link between the policy and increases in donor sign-ups. (11/10)

Twitter Round-Up: What Our Bloggers Are Tweeting About (10/28-11/3)

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By Casey Thomson
[Ed. Note: Several of our bloggers are active on Twitter.  In a new feature, we'll be posting some highlights of their tweets each week so you can stay in the know - or think about following them directly!]
  • Dan Vorhaus (@genomicslawyer) linked to Bloomberg’s article on the current underutilization of genetic tests for Lynch Syndrome, responsible for potentially 3% of all cases of colon cancer. Authors Langreth and Lauerman note that the lack of testing is but one example of the tendency to avoid such tests due to “doctors’ ignorance and financial disincentives.” (10/29)
  • Daniel Goldberg (@prof_goldberg) shared Iona Heath’s article on the problematic nature of current breast cancer screening awareness programs, discussing how women are not given enough information to decide if the potential treatments that follow are indeed worth the psychological devastation often invoked. (10/30)
  • Michelle Meyer (@MichelleNMeyer) retweeted an editorial on medical genetic paternalism. The post by Razib Khan discussed how physicians deciding whether to tell parents about unforeseen genetic test results of their children can be considered not only an act of malpractice, but also morally wrong. (10/30)
  • Einer Elhauge (@elhauge) linked to a new review of his acclaimed book, Obamacare On Trial by the National Law Review. (10/31)
  • Daniel Goldberg also tweeted a review by Boddice of Javier Moscoso’s new book, Pain: A Cultural History. (10/31)
  • Arthur Caplan (@ArthurCaplan) linked to news about China’s promised initiative to reduce the dependence on death row inmates for organs. A new national organ donation system, based on a system previously piloted by the Red Cross Society of China, could take effect as soon as early 2013. (11/2)
  • Arthur Caplan also posted on the Vatican’s announcement to hold its second “International Adult Stem Cell Conference,” revisiting this complicated issue. (11/2)
  • Arthur Caplan additionally linked to a report on the debate and complications regarding feeding tube use, as published by Krieger of Mercury News. (11/2)

Bleg: IRBs & Health Disparities Research

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As most readers of this blog well know, health disparities of various kinds are rampant in the U.S. — in obesity, infant mortality and morbidity, cardiovascular health, and many other areas. In most cases, however, we seem to know more about the extent of health disparities than we do about what causes and what is most likely to ameliorate them.

To rectify this situation, we need to conduct research — and lots of it. Typically, however, health disparities research will have to occur with the same populations who are most likely to be considered vulnerable and in need of extra protections from research. Often, moreover, health disparities research will need to occur in the clinical setting (as opposed to the lab), where patients normally rightly expect that everything done there is designed to serve their individual best interests, rather than to produce generalizable knowledge. Health disparities research might involve research methodologies that are relatively unfamiliar to IRBs, such as community-based participatory research (CBPR), which blurs the traditional distinction between investigator and subject on which the regulations are built. To the extent that disparities are thought to derive from provider discrimination or bias, researchers may face difficulties from a research review system that is designed to protect all “subjects,” including professionals who are incompetent or worse. Eventually, health disparities research scales up to multiple research sites, which usually requires approval from multiple, often conflicting, IRBs. Many interventions to address health disparities, finally, will take the form of public policy rather than clinical treatment. If we want such policies to be evidence-based (and we should), they will have to be tested, perhaps in ways that raise legal or ethical issues (say, randomizing a state’s Medicaid recipients to receive or not receive particular benefits, or randomizing the businesses in a jurisdiction to be required to display nutrition information on the food they sell — or not).

I’m delighted to have received so many comments, both on- and offline, on my last IRB post from those with experience in the research trenches. As I begin a new project along these lines, I would be very interested in hearing again from both researchers and research reviewers with experience in health disparities research, whether you have struggled with these or similar issues (or have abandoned research plans at least partly out of fear of such problems), or have experienced smooth sailing. Feel free to leave comments here, anonymously if you wish, or contact me directly at mmeyer at law dot harvard dot edu. Many thanks in advance.