The Iraq War and Health Worker Brain Drain

I am writing my student fellowship paper under the broad topic of health worker “brain drain,” so I have been keeping an eye out for related news stories.  Two stories that caught my eye in the past few weeks were about the health worker migration from civil war torn Syria and economic-crisis ridden Sudan.   In Syria for example, half the doctors in Homs and all of the country’s nine psychiatrists have recently migrated.   In Sudan, 1620 doctors left the country last year compared to 338 in 2008.  In countries like these, especially Syria where medical personnel have been targets of violence, solutions to stem the migration or replenish the ranks seem particularly futile.  Additionally, these countries’ self-inflicted wounds, including civil wars and poor administration, complicate matters.  Not only do these internal struggles diminish the probable efficacy of potential solutions to the brain drain, but they also negate the perceived responsibility of the countries receiving these migrants, diminishing their will to help counteract the deleterious effects of the brain drain.

Civil war stricken countries like Syria present especially difficult cases for developed nation responsibility and intervention.  But these news stories led me to think about brain drain and responsibility that results from war, specifically wars waged by developed nations in developing ones.  A prime example is the recent war in Iraq.  The Brookings Institute estimates that 20,000 of the 34,000 Iraqi doctors in the country in 2003 have migrated, and only 1525 had returned as of 2009.  They also cite that 2000 Iraqi physicians have been murdered and 250 have been kidnapped over the same period.  50% of surveyed Iraqi doctors living both in Iraq and abroad said they had been threatened.[1]  A recent article in Lancet describes that before 2003 the major problems facing the Iraqi healthcare system stemmed from drug shortages and poverty.  These problems have been superseded by violence and failing infrastructure in the intervening years.  The brain drain has likely been exacerbated by these new threats.

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Disseminating Where It Matters

By Scott Burris
Public Health Law Research funded Dr. Caleb Banta-Green to evaluate the implementation and initial effects of a Washington State “Good Samaritan 911” law meant to encourage people witnessing a drug overdose to call for help. The research results are getting out in the usual way, but it was great to see Dr. Banta-Green talking about his findings and what the might mean on the blog of the Office of National Drug Control Policy. Overdose is a huge health issue in the US, but solving it will require the buy in of law enforcement and legislators who defer to law enforcement on drug issues.  It’s great to see research producing the right conversation in the right place.

Cyborg Bugs and Glow-in-the-Dark Cats

That’s what CNN called yesterday’s report with science writer Emily Anthes about her new book, Frankenstein’s Cat, which examines “genetically modified this, or cloned that,” as she put it, or “creatures that combine electronic bits and biological ones.” Wrestling with the ethics of such cases, Anthes explains, “reveals that we’re deeply conflicted about the role that animals play in our lives.” Yet she laments that this tension supplies no satisfying answers to underlying questions like “Is this unnatural?” and would “that make it wrong?”

Our confusion lies, I’ve suggested, in the failure of animal welfare discourse to capture the sense many of us share that animal “nature” has value apart from its happiness or well-being. If its welfare were all that mattered, then we shouldn’t be troubled by animals designed to experience less frustration living in the conditions for which they’re destined. Consider three examples of designer animals that are currently being developed: cows with stunted sentience, less apprehensive of going off to slaughter; chickens that lack nesting instincts, more satisfied to a life confined to laying eggs in a battery cage; and pigs without legs, better suited for a sedentary existence as ham and bacon in potentia.

The dominance of the animal welfare view obscures a reason to resist such creations: to preserve animal integrity. Cows should be able to fear danger, pigs to play in the mud, and chickens to peck about in the sand, according to this view, less because those capacities make the animals happy than because they are integral to an intrinsically valuable way of being. To deprive a cow of its responsiveness, or a pig of its limbs, or a chicken of its proclivity for pecking would, on this account, violate its essential “cowness” or “pigness” or “chickenness,” even if those animals were perfectly content in their designated roles.

For thoughts on why animal nature may indeed be worth preserving, and implications for conventional breeding (e.g., dogs for companionship, or horses for racing), and what all of this  means for designer children and embryonic stem cell research, check out the article.

Petrie-Flom Interns’ Weekly Round-Up: 3/23-3/29

By Hyeongsu Park and Kathy Wang

Henrietta Lacks, Publishing Genomes, and Family Vetos

Rebecca Skloot, author of the very interesting and well-written bestseller The Immortal Life of Henrietta Lacks — a book about the poor and badly treated black woman whose cells became the famous (and very heavily used) HeLa cells, medicine and the treatment of African-Americans, and who owns products derived from one’s genes — had an interesting op-ed in the New York Times on March 23, with the clever title The Immortal Life of Henrietta Lacks, the Sequel. As Skloot writes:

“On its own, the HeLa genome doesn’t say anything specific about Lacks: it’s a string of billions of letters that detail the genetic information that makes up a HeLa cell, which is useful for science. A news release from the European Molecular Biology Laboratory, where the HeLa genome was sequenced, said, “We cannot infer anything about Henrietta Lacks’s genome, or of her descendants, from the data generated in this study.”

But that’s not true. And a few scientists decided to prove it. One uploaded HeLa’s genome to a public Web site called SNPedia, a Wikipedia-like site for translating genetic information. Minutes later, it produced a report full of personal information about Henrietta Lacks, and her family. (The scientist kept that report confidential, sharing it only with me.) Until recently, few people had the ability to process raw genome data like this. Now anyone who can send an e-mail can do it. No one knows what we may someday learn about Lacks’s great-grandchildren from her genome, but we know this: the view we have today of genomes is like a world map, but Google Street View is coming very soon. . . .

After hearing from the Lacks family, the European team apologized, revised the news release and quietly took the data off-line. (At least 15 people had already downloaded it.) They also pointed to other databases that had published portions of Henrietta Lacks’s genetic data (also without consent). They hope to talk with the Lacks family to determine how to handle the HeLa genome while working toward creating international standards for handling these issues.

The publication of the HeLa genome without consent isn’t an example of a few researchers making a mistake. The whole system allowed it. Everyone involved followed standard practices. They presented their research at conferences and in a peer-reviewed journal. No one raised questions about consent.”

Skloot then quotes a number of scientists and bioethicists decrying the practice. I actually think things are not quite as Skloot sees them. Let me explain why:

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Oral Arguments in FTC v. Actavis (SC pay for delay case)

By Adriana Benedict

As Jonathan Darrow notes below, on Monday, the Supreme Court heard oral arguments in Federal Trade Commission (FTC) v. Actavis, the “pay for delay” case questioning whether or not reverse payment settlements in Hatch-Waxman litigation should be presumptively anticompetitive, a question on which the Circuit Courts are divided.  This particular case involves Solvay Chemicals Inc., whose patent on AndroGel cream, a synthetic testosterone formulation (set to expire in 2020) was challenged by three generic pharmaceutical companies that filed ANDA applications in 2003 for generic version of AndroGel (which is 1/6 the cost of the branded version).  Following a 30-month stay triggered by Solvay’s subsequent infringement lawsuit, the FDA approved the generic version of Androgel in 2006, at which point the generic companies’ motion for summary judgment on the validity of Solvay’s patent was ready for decision.  Instead of risking the judgment, the parties settled, with the generic companies agreeing to stay out of the market until 2015 in return for an estimated $186 – 252 million from Solvay over the course of six years.  The FTC, expressing concern that consumers would ultimately bear the costs of delayed generic entry, unsuccessfully challenged this settlement as presumptively unlawful restraints of trade.  The Eleventh Circuit affirmed the District Court’s decision in 2012, which rejected the FTC’s approach in favor of a “scope of the patent” test.  Several months later, though, the Third Circuit reached the opposite verdict in a similar case, accepting the FTC’s position that reverse payment settlements are presumptively unlawful agreements not to compete. The Supreme Court granted cert to resolve this conflict.

I found a couple features of yesterday’s oral arguments particularly striking.  First was Justice Breyer’s statement that he thought one of the four briefed scenarios in which a reverse payment settlement may rebut an anticompetitive presumption was “neutral”:

JUSTIC BREYER: [B]the person’s already in the market thinks that the next year or two or three years is worth $100 million a year, and the person who’s suing thinks it’s worth 30 million a year. And so he says, hey, I have a great idea, I’ll give him the 30 million and keep the 70. And — and that, I don’t see why that’s anticompetitive if that’s what’s going on.

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Branded Drugs and Generics: Reverse Payment Settlement Agreements

By Jonathan J. Darrow

Earlier this week the Supreme Court heard oral arguments in FTC v. Actavis, in which the Federal Trade Commission is asserting that it is impermissible for a brand name drug company to pay a generic drug company to stay out of the market. Normally, such collusive behavior would constitute a clear violation of antitrust laws, because it reduces competition and thereby has the potential to raise prices to the detriment of consumers. But a complication arises in the case of branded and generic drugs because a patent is involved, giving the patent holder the lawful right to exclude competitors from the marketplace.

In a typical “reverse payment” case, the scenario unfolds as follows: First, the branded company enters the market with a new drug product that is covered by a patent. Some time later, but before the expiration of the patent, a generic drug company seeks to market a generic version of a drug, asserting that the patent is either invalid or not infringed (the assertion takes the form of a Paragraph IV certification, named for the section of the U.S. statute under which the certification arises, see 21 U.S.C. 355(j)(2)(A)(vii)(IV)).  Rather than litigate the case to completion, however, the two firms settle, with the patent holder agreeing to pay the generic company to stay off the market until some future date, such as the date that the patent is set to expire. The “monopoly” profits are thus shared between the two companies, to the detriment of consumers.

Defenders of reverse payment settlements argue that such agreements should be legal so long as they are “within the scope of the patent,” that is, so long as the restrictive agreement does not extend beyond the patent expiration date (see, e.g., Edward Stewart, Skepticism from the Court in Drug Case, N.Y. Times, Mar. 25, 2013).  The fundamental weakness of this argument—and what the N.Y. Times article does not mention—is that many drug patents (73% according to a 2002 government report (see page vi)) turn out to be invalid, not infringed, or otherwise insufficient when litigated in court. If many drug patents would be invalid or not infringed if litigated to conclusion, then the actual “scope of the patent” would be less than its nominal term would suggest, and the high cost borne by consumers would be greater than the patent law contemplates. Continue reading

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

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

Aid Works (On Average) – By Toby Ord

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

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

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

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

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

Common Rule Wrap-Up at National Academies

Working in private, the National Academy of Sciences’ panel on human-subjects regulations in social-behavioral sciences met this weekend to draft a final report.  On Friday, the panel had wrapped up its public “Workshop on Proposed Revisions to the Common Rule in Relation to Behavioral and Social Sciences.” The workshop aimed to critique OHRP’s proposed revisions to federal human-subjects regulations (known as the Common Rule), rather to critique the regulations directly.

Here is what the National Academy panel members said they took to be a few take-points from the public workshop, which I attended:

  • LOW-RISK: It’s essential to change regulations for lower-risk research, but the ANPRM does not currently set out a good way to do this. Few participants seemed keen on the new category of “excused,” nor did they like the current use of “exempt.” The key question to my mind is, How much autonomy, do the panelists think, should be handed over to scholar-investigators and taken away from IRBs? Speaker Lois Brako advocated requiring everyone to register their studies with their institutions. Other speakers (Brian Muskanski, Rena Lederman) suggested researchers should be given leeway to interpret abstract terms like “risk” and key moments such as when a study begins. Do panelists agree that scholar-investigators are trustworthy and knowledgeable enough to interpret regulations?
  • INTERNATIONAL: The Common Rule gives little attention to research outside the USA, and OHRP’s proposed revisions do not address this dangerous and retrograde gap. Pearl O’Rouke of Partners Healthcare and Thomas Coates of UCLA usefully emphasized this important point and showed the stakes. To my mind, the question for many researchers will be, How should cross-national differences—in institutions’ resources, in study populations—be taken into account in the regulations? Medical anthropologists, for example, are in the midst of a raging debate over this issue. The traditional view has been that we should respect local differences, and this was the original point of requiring IRBs to account for “community attitudes,” which has morphed into a big problem for multisite studies in the present day. The avant garde in medical anthropology suggests that such “ethical variability” is not just inhumane, but it indulges a western insistence on treating some people as “others” rather than as us—whether in the USA or abroad—which happens to be very convenient for drug developers. In my own research, IRB members also faced the more routine question of whether “community” meant a study population, local residents of a region, or something else altogether. The panel may not have time to consider whether it makes sense to clarify what “community” means and, more broadly, who gets to speak on behalf of a “community” regarding its attitudes.
  • PRIVACY: We have to come up with a system for reviewing social-behavioral research that is either more flexible or more refined. There is a wide range of appropriate protections, but they can quickly seem inappropriate if applied to some studies. Comparing a few of the presentations makes this point. George Alter explained the rigorous and necessary privacy protection plan for the big data sets and collaborative networks involved in University of Michigan’s ICPSR. On the flip side, Brian Mustanski and Rena Lederman explained the overweening attention to the so-called risks in their studies that involve first-hand interviews and observations.
  • EVIDENCE: We need more data on IRB outcomes. It is apparent that the data exist—as talks such as Lois Brako’s showed, in which she documented her team’s impressive overhaul of the IRB at University of Michigan, dysfunctional only a few years ago. The data need to be expanded, analyzed and shared—and supported for the long term. Who will have the money or time for that? That remains to be seen, but either way I will be curious to see the effects of the workshop buzz word: “evidence-based” decision-making. Although panelists saw value in case studies, it would be easiest for them and for policymakers to prioritize problems that can be documented with statistics rather than stories. I wonder, How might this skew the problems that are identified the people included in discussions?

Worth Reading This Week

By Nicolas Terry

Times Report Models Worst Practices for Policy Research Reporting

By Scott Burris

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

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

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

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

2. Don’t clearly describe the study.

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

3. Just ignore the obvious problems for causal inference.

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

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Academic Freedom and Responsibility

by Suzanne M. Rivera, Ph.D.

Earlier this month, the American Association of University Professors (AAUP) recommended that researchers should be trusted with the ability to decide whether individual studies involving human subjects should be exempt from regulation.  The AAUP’s report, which was prepared by a subcommittee of the Association’s Committee on Academic Freedom and Tenure, proposes that minimal risk research should be exempt from the human research protection regulations and that faculty ought to be given the ability to determine when such an exemption may apply to their own projects.

Specifically, the report states, “Research on autonomous adults should be exempt from IRB approval straightforwardly exempt, with no provisos and no requirement of IRB approval of the exemption) if its methodology either (a) imposes no more than minimal risk of harm on its subjects, or (b) consists entirely in speech or writing, freely engaged in, between subject and researcher.”

These recommendations, designed to address long-standing concerns by social scientists about bureaucratic intrusions into their work, are misguided and could result in real harm to research subjects. Continue reading

Fox on Prenatal Genetic Testing

front-page story in today’s Sunday Boston Globe quotes Bill of Health blogger Dov Fox on whether the routine use of new prenatal blood testing could “‘bring a tendency to exclude rather than accommodate people whose abilities fail to meet [certain] demands'” of modern society or “‘exert[] social pressure on parents to terminate pregnancy for fear of criticism or reproach from people who regard the[ir] choice [to have a] child with a disability [] as negligent, or irresponsible.'”
If these non-invasive tests (which look at potentially unlimited amounts of fetal DNA) were able to provide genetic information for conditions beyond just sex and health, might we come to think in similar ways about children of “merely” average looks or normal height or ordinary intelligence? Dov explored this question and others in a talk that he gave as a 2006 summer fellow at the Petrie-Flom Center. His article is called Silver Spoons and Golden Genes.

House Holds mHealth Hearings, FDA Promises Final Guidance Forthcoming

by Dan Vorhaus

[Cross-posted from Genomics Law Report]

Digital Hospital - 262 wideThree days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th).

The hearings, convened jointly by several subcommittees of the House Energy and Commerce Committee, were announced last week following a pointed letter to the FDA (pdf) from seven committee members on March 1st. In the letter, the Congressmen pressed the FDA for information on the agency’s mHealth regulatory timeline and the implications for innovation and industry of the proposed regulations.

A Preview of Guidance to Come. As covered previously here at the Genomics Law Report, in July 2011 the FDA released draft guidance (pdf) outlining its intent to regulate a limited subset of mobile medical applications based on their perceived risk to patients and consumers.

In testimony before Congress, which was supported by a formal written response to the House subcommittee’s inquiry (pdf) as well as a recent FDA blog post, the FDA provided substantial additional clarity regarding its regulatory intent and the timeline for finalized mHealth regulatory guidance. Here are the highlights:

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Petrie-Flom Interns’ Weekly Round-Up: 3/16-3/22

By Hyeongsu Park and Kathy Wang