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

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.

EPA Seeks Comments on Monsanto’s Request for Experimental Use of Genetically-Modified BT Corn

Efthimios Parasidis

The Environmental Protection Agency has determined that Monsanto’s request to plant a new strain of genetically-modified corn “may be of regional and national significance.”  As a result, the agency is seeking public comment on Monsanto’s application.

Monsanto seeks permission to test the new corn in Puerto Rico and 22 states over the next two years.  The corn is bioengineered to produce Bacillus thuringiensis (BT)a bacteria that is known to kill rootworm.  The risks of BT-engineered crops are not fully known.  In addition to impacting the biodiversity of the soil and environment, BT toxin is known to kill other insects such as moths and butterflies, and some have argued that crops genetically-engineered to produce BT toxin have led to colony collapse disorder which has devastated beehives all over America for a number of years.

To be sure, naturally-occurring BT-products are allowed for USDA certified-organic production, and genetically modified BT-corn may be more environmentally friendly that other strains of genetically-modified corn since the corn itself produces the toxin, and thus theoretically would require less spraying of pesticides.  However, rootworm is known to adapt quickly and become resistant to bioengineered BT toxin.  In fact, farmers have had to spray their corn with chemical pesticides that the bioengineered BT corn was supposed to avoid. Notably, studies have found that genetically-modified BT crops adversely impact the health of humans and livestock, while BT toxin has been discovered in the blood of pregnant women and fetuses.  Given the widespread health and environmental concerns, to the extent the EPA is inclined to grant Monsanto’s request, the agency should condition the experimental use on funding for independent research that evaluates the long-term effects of bioengineered BT crops on humans, livestock, and the environment.

Upcoming Event – Stem Cell Therapy and Medical Tourism: Of Promise and Peril? 11/28/12

Wednesday, September 28, 2012
3-4:30 pm (reception to follow)
Austin 111, Harvard Law School

Experimental breakthroughs within the field of regenerative medicine are reported in the media on a daily basis worldwide.  Despite this progress, the overwhelming majority of clinical problems for which stem cell-based intervention offers hope remain therapeutically unproven, and a major gap exists between current public understanding and the availability of innovative therapies.

This event will feature a distinguished panel of speakers addressing various aspects of medical tourism for stem cell therapy.  Presentations will cover the state of stem cell science, historical context and comparisons related to earlier instances of medical utopianism, empirical data on the nature of stem cell tourism, how to address patient hopes in the realm of unproven therapies, and special issues related to stem cell tourism by parents for their children.

The event will be moderated by M. William Lensch, Harvard Stem Cell Institute.  Speakers and topics include:

  • Brock Reeve, Harvard Stem Cell Institute
    Welcome and Introductions 
  • George Q. Daley, Harvard Stem Cell Institute
    Stem Cells: The Gap Between Current Science and Clinical Implementation 
  • Jill Lepore, Harvard University
    Resurrection, Past and Present 
  • Tim Caulfield, University of Alberta
    Stem Cell Tourism: Is the Problem Getting Worse? 
  • Insoo Hyun, Case Western Reserve University School of Medicine
    Therapeutic Hope and Its Challenges for Rational Ethical Discourse 
  • I. Glenn Cohen, Petrie-Flom Center, Harvard Law School
    Stem Cell Tourism, Children, Abuse, and Reporting

There will be substantial time set aside for audience Q&A, and the conversation will continue after the event at an open reception.

This event is free and open to the public.  Co-sponsored by the Harvard Stem Cell Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Third World Reproductive Health Outcomes

By Michele Goodwin

The most sophisticated medical technologies are available in the United States.  The luxury afforded elite health care consumers is best captured by “executive health care” and “personalized” medicines.  Given the tailored health care afforded top-tier health care consumers, consciously or unconsciously those at the other end of the spectrum might be overlooked.

For example, the Centers for Disease Control and Prevention issued a report this year that places some US states in the range of Third World countries for health outcomes with mothers and babies.   The report,  Infant Mortality Statistics From the 2008 Period Linked Birth/Infant Death Data Set, exposes a sad reality; race disparities persist in medicine.   The neonatal mortality rate of African Americans is about 2.5 times that of whites.  What’s more—class matters.  But here’s the interesting part.  Class matters at both ends of the scale.

The report exposes how Mississippi, the nation’s poorest state, leads the nation in babies that will die before reaching their first birthday.   According data collected by CNN, “for every 1,000 Mississippi babies born in 2011, 9.4 died before their first birthday.”  One reporter found that such data “makes Mississippi’s infant mortality rate more comparable to countries such as Costa Rica (9.2), Sri Lanka (9.5) and Botswana (10.5) than the United States (6.0).”  The common answer to the challenges of infant mortality looks toward poverty—and in part such analysis is right.  However, wealth matters too and sophisticated reproductive choices can lead to dangerous outcomes.  One of the leading causes of infant mortality is womb-crowding caused by multiple gestations, which has dramatically increased as a byproduct of assisted reproductive technologies.  Those who can afford these sophisticated technologies are usually upper-income individuals, who can afford the multiple rounds of treatments, which are usually required before a pregnancy results.  In fact, ART related births are associated with the 100-fold increase in higher order births in the United States.  Low birth-weight, one of the leading causes of infant distress, is a common feature of multiple births—as are pre-term deliveries.  As we think about solutions to these challenge public health concerns, it will be important to look at both ends of the socio-economic scale.

Twitter Round-Up (11/11-11/17)

By Casey Thomson

Don’t just read the summaries – check out the tweets themselves! From now on, links to the original tweets will be included in our round-up. Additionally, 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. With that, read on for this week’s round-up…

  • Arthur Caplan (@ArthurCaplan) posted an article about the growing trend of paying for convenience in healthcare with privacy, sometimes without formal consent. The latest example (and the subject of this article) is palm-scanning at New York University Langone Medical Center. (11/11) [Note: Dan Vorhaus also tweeted this the next day.]
  • Frank Pasquale (@FrankPasquale) linked to a post on the potential valuables (medicines, solvents, chemical treatments) hidden amongst newly-discovered marine micro-organisms. With regulations hefty on land but largely non-existent for water, there are concerns that damage from harvesting could result in ecosystem damage or exploitation of water resource-rich developing nations. (11/11)
  • Dan Vorhaus (@genomics lawyer) brought up a link describing the “particularized consent approach” of the website my46, meant to facilitate the process of helping people decide what results of genetic testing to see and when to see such results. Combining this with his post about the direct-to-consumer genomics of 23andMe, it is clear that this is an area to watch. (11/12)
  • Daniel Goldberg (@prof_goldberg) exclaims his love for the term “empathotoxin” in conjunction with the link for this blog post. The post talks about the declining sense of empathy correlated with medical training as according to a research review by American Medicine, with results based on self-reporting. (11/12)
  • Kevin Outterson (@koutterson) tweeted an article about the oncoming scrutiny likely to hit Congress in the throngs of the current meningitis outbreak. While state boards and the F.D.A. are receiving much of the onslaught as a result of their lax oversight, Congress has hindered stronger regulation for drug compounders particularly in regards to defining the F.D.A.’s policing authority – and thus, say some, is partly deserving of blame. (11/14)
  • Daniel Goldberg (@prof_goldberg) also linked to an article that talked of lessening the gaps between the mainstream views concerning disability (the “outside” view) and those within the disability community (the “inside” view) when considering law. By proposing a certain set of “framing rules” facilitated by input from the inside view, nondisabled people can make more informed decisions regarding the relationship to disability. (11/14)
  • Dan Vorhaus (@genomicslawyer) posted an article that followed up on an earlier tweet from our weekly round-ups detailing China’s new draft regulation for human genetic materials, including but not limited to organs. (11/15)
  • Frank Pasquale (@FrankPasquale) included a link to the The New York Times piece on the massive drug shortages plaguing the nation’s healthcare system.  Pasquale noted in his tweet that organizations which purchase on behalf of groups, often for hospitals, may be contributing to this shortage. (11/17)

Roundup of State Ballot Initiatives on Health Issues

By Katie Booth

This November, voters weighed in on an array of state ballot initiatives on health issues from medical marijuana to health care reform. Ballot outcomes by state are listed below (more after the jump).

Voters in Alabama, Montana, and Wyoming passed initiatives expressing disapproval of the Affordable Care Act, while a similar initiative in Florida garnered a majority of the vote but failed to pass under the state’s supermajority voting requirement. Missouri voters passed a ballot initiative prohibiting the state executive branch from establishing a health insurance exchange, leaving this task to the federal government or state legislature. Florida voters defeated a measure that would have prohibited the use of state funds for abortions, while Montana voters passed a parental notification requirement for minors seeking abortions (with a judicial waiver provision). Perhaps surprisingly, California voters failed to pass a law requiring mandatory labeling of genetically engineered food. Several states legalized medical marijuana, while Arkansas voters struck down a medical marijuana initiative and Montana voters made existing medical marijuana laws more restrictive. Colorado and Washington legalized all marijuana use, while a similar measure failed in Oregon. Physician-assisted suicide was barely defeated in Massachusetts (51% to 49%), while North Dakotans banned smoking in indoor workplaces. Michigan voters failed to pass an initiative increasing the regulation of home health workers, while Louisiana voters prohibited the appropriation of state Medicaid trust funds for other purposes.

Affordable Care Act:

  • Alabama Health Care Amendment, Amendment 6: Approved 59.52% to 40.48% (prohibits mandatory participation in any health care system)
  • Florida Health Care Amendment, Amendment 1: Defeated 51.46% to 48.54% (required 60% support to pass) (would have prohibited passing laws compelling the purchase of health insurance)
  • Missouri Health Care Exchange Question, Proposition E: Approved 61.8% to 38.2% (“prohibit[s] the Governor or any state agency, from establishing or operating state-based health insurance exchanges unless authorized by a vote of the people or the legislature”)
  • Montana Health Care Measure, LR-122: Approved 66.83% to 33.17% (prohibits “the state or federal government from mandating the purchase of health insurance coverage or imposing penalties for decisions related to the purchase of health insurance coverage”)
  • Wyoming Health Care Amendment, Amendment A: Approved 76.98% to 23.02% (stating that “the right to make health care decisions is reserved to the citizens of the state of Wyoming”)

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

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)

Using Tissue Samples to Make Genetic Offspring after Death

By Yu-Chi Lyra Kuo

Last month, John Gurdon and Shinya Yamanaka were jointly awarded the 2012 Nobel Prize for Medicine for their research on induced pluripotent stem cells (iPSCs).  iPSCs are capturing the public imagination as embryonic stem cells did fifteen years ago, but without the controversy surrounding the destruction of embryos: iPSCs can be garnered instead from living somatic tissue of an organism at any point in its lifespan–even late adulthood.  Yamanaka’s research has shown that somatic cells can be “reprogrammed” to develop into any kind of cell–including an embryo–speaking to the vast research potential of iPSCs.

In light of the research potential of iPSCs, I wanted to highlight the results of a remarkable study (published last month) where scientists induced iPSCs from mice into primordial germ cell-like cells, and aggregated them with female somatic cells to create mature, germinal oocytes. The team was then able to show that these oocytes, after in vitro fertilization, yield fertile offspring. Essentially, the research team created viable mouse embryos from skin cells, and fertilized them using IVF to produce healthy mice, some of which have already produced offspring of their own.

Read More

Reminder, TODAY – Advances in HIV Prevention: Legal, Clinical, and Public Health Issues

TODAY!
12-1:30pm
Austin Hall, Room 111
Harvard Law School

On July 3, 2012, FDA approved OraQuick, the first at-home HIV test available for sale directly to consumers, allowing individuals to self-test and receive confidential results in about 20 minutes. Then on July 16, FDA approved once-daily Truvada, an already-approved HIV therapy, as the first agent approved for pre-exposure prophylaxis in uninfected, at-risk adults. These developments represent dramatic changes in the fight against HIV, and raise a host of legal, clinical, and public health issues. Please join us for a panel discussion of these issues with some of the preeminent leaders in the field, moderated by Robert Greenwald, Director of the Center for Health Law and Policy Innovation at Harvard Law School:

  • Douglas A. Michels, President and CEO, OraSure Technologies, Inc.
  • David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc.
  • Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute
  • Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health
  • Mark Barnes, Senior Associate Provost, University Chief Research Compliance Officer, Harvard University

This event is free and open to the public. Lunch and refreshments will be served. Co-sponsored by the Petrie-Flom Center, the Center for Health Law and Policy Innovation, and the Fenway Institute.

Reminder: Tomorrow, Institutional Financial Conflicts of Interest in Research Universities

Friday, November 2, 2012
8:30am – 6:30pm (reception to follow)
Milstein Conference Rooms, 2nd Floor
Wasserstein Hall
1585 Massachusetts Avenue
Cambridge, MA

The Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Derek Bok and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!