Study Guide on the Guatemala STD Inoculation Studies

Talk about perfect timing.  Just on the heels of Tuesday’s fantastic event at HLS on the Guatemala STD Inoculation studies (video to come soon), the Presidential Commission for the Study of Bioethical Issues has released A Study Guide for “Ethically Impossible” STD Research in Guatemala from 1946 to 1948.  This is the Commission’s first foray into pedagogy, and an absolutely fantastic way to keep the discussion going.  Be sure to check it out, and to share widely.

Training Doctors, The Importance of Tx Intensity and Patient Preferences?

The Dartmouth Atlas of Health Care recently published a report entitled, “What Kind of Physician Will You Be?: Variation in Health Care and Its Importance for Residency Training.” (2012; https://www.dartmouthatlas.org/pages/residency).  Briefly, this report analyzes Medicare data to create indexes and variables used to describe varying levels of treatment intensity, particularly at the end of life, for 23 top U.S. medical centers. This report is targeted to medical students who are choosing their residency programs, hoping that prospective residents look at a wider-array of factors, including: how well these hospitals utilize effective, proven health care interventions; to what extent the care they provide is dependent on supply-induced demand; and how well the hospitals allow for patient preferences in treatment plans.

This report grabbed my attention given that I conduct research in end-of-life (EOL) care, and I am sympathetic to efforts to improve the quality of care provided to people with advanced and terminal diseases. I am also quite interested in how our medical system can change the culture of medical care to provide higher-quality EOL, and to reduce the use of often ineffective and invasive medical interventions, particularly through hospitalization and ICU admissions. The education of residents seems like a good place to start in changing the current intensity and specialty-driven culture.

However, the gaps in this report compromise its arguments and potentially reduce its effectiveness. I will only highlight two here.

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Architecture for those with Disabilities

My colleague Jonathan Lazar who studies the way in which the web creates barriers to people with disabilities mentioned to me a neat program/event that may be of interest to some BOH readers in the Boston area: As part of the Architecture Boston Expo currently going on there is a Universal Design: Accessibility Exhibit, which features two spaces for attendees to navigate. One is made up using universal design features, the other features “common” design errors (sometimes quite subtle) making it difficult or impossible to use.

Architects and other attendees are put in a wheelchair and asked to try to make use of both spaces. The idea is that by experiencing the space as would someone with a disability, architects will be better able to understand the ways in which their small decisions have big impacts on people’s lives.

I thought this was a really interesting and novel approach to the problem, and one wonders whether architecture schools should make these kinds of experiences part of the curriculum?

The Prescription Drug Abuse and Overdose Crisis: Focus on the Supply Chain

By Scott Burris

There’s so much we still don’t know about the prescription opioid problem. The partial remedies advanced so far reflect this:

  • Prescription Drug Monitoring Programs, which in essence define the problem as doctor-shopping patients;
  • treatment guidelines, which define the problem as doctors without expertise; and
  • crackdowns on “pill-mills,” which see the issue as physician corruption. Each of these diagnoses has an element of truth, but not necessarily enough to make the treatments effective.

One huge part of the problem has gotten far too little attention: the pharmaceutical supply chain where all these drugs start and along which they are distributed. Now, John Coleman, a former DEA officer, has given us a thorough and compelling primer on the supply chain, describing it and showing where the pressure points are for action. He is not happy about what he sees: DEA is overwhelmed, and too secretive with its data;  and the distributors are too interested in profits and far too unwilling to police paying customers. But he also sees room for action and even hope. This article is well worth a read if you are interested in the overdose problem and how to solve it:

Coleman, John J. “The Supply Chain of Medicinal Controlled Substances: Addressing the Achilles Heel of Drug Diversion.” Journal of Pain and Palliative Care Pharmacotherapy 26, no. 3 (2012): 233-50.

P.S. — One of the hopeful signs he sees was Florida’s legislation beefing up state-level monitoring and controls. This takes me back to the successful Wisconsin Cancer Pain Initiative in the 70s and 80s, which articulated the Principle of Balance in drug control and demonstrated that it was possible to have good access to pain medicine and effective control. In those days, David Joranson, the state drug controller, worked closely with DEA, using state regulatory authority to shut down docs and pharmacies who were acting outside the law. The possibility of history repeating itself is a ray of sunlight in the cloudy skies of this issue. (If you are interested in the story, here’s one place to start: Joranson, D., and J. L. Dahl. “Achieving Balance in Drug Policy: The Wisconsin Model.” In Advances in Pain Research and Therapy, edited by CS Hill Jr. and WS Fields. 197-204. New York: Raven Press, 1989.)

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”)

Drug Law Factoids for Your Consideration

By Scott Burris

This is a succinct paragraph from the weekly newsletter of U. Maryland’s Center for Substance Abuse Research. Seems relevant both to the conference on law  enforcement and public health I reported on earlier this week, and the election results on marijuana:

There were an estimated 12,408,899 arrests in the United States in 2011, according to data from the national Uniform Crime Reporting (UCR) Program. The highest number of arrests were for drug abuse violations—selling, manufacturing, or possessing drugs, followed by larceny-theft and driving under the influence. The majority (82%) of these arrests were for possession and one-half of these drug abuse violations involved marijuana. A poll conducted in 2011 found that one-half of U.S. residents think that marijuana should be legalized (see CESAR FAX, Volume 21, Issue 19).

Open Access to Health Research: Highlights from the NIH Public Access Policy panel

By Adriana Benedict

As of 2008, the NIH Public Access Policy requires “that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication.”  Four years later, approximately 80% of NIH-funded research articles make their way into PubMed Central.  Institutional Open Access resolutions such as Harvard’s Open Access Policy have helped accommodate the NIH Public Access Policy requirements, but Harvard Medical School and Harvard School of Public Health have yet to adopt it.

In May, the Harvard Library Faculty Advisory Council issued a public letter calling on faculty to promote open access scholarly publishing, noting that “Many large journal publishers have made the scholarly communication environment fiscally unsustainable and academically restrictive”.  In a Petrie-Flom Center-sponsored Open Access Week panel (moderated by Open Access Liaisons Scott Lapinski and June Casey), Peter Suber, Amy Brand, Winston Hide and Patrick Taylor discussed the challenges and opportunities for progress towards achieving open access to health research.  Highlights from the panel are presented below, and the video should be available on the Petrie-Flom website shortly.

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Gowder on Death and Taxes in the individual mandate: The Finger-Wagging Lopsided Giant?

By Christopher Robertson

Paul Gowder (Iowa Law) has shared a draft of his new article, Death and Taxes in NFIB v Sebelius.  Gowder thoughtfully develops some of the themes that I gestured towards in my “Lopsided Giant” post last week, trying to figure out how the Roberts opinion could uphold the constitutionality of the individual mandate as a regulatory tax but not as a regulation of commerce.  Drawing on a range of philosophical sources, Gowder tries “to aggressively apply the principle of charity to understand what the opinion actually means by making sense of it.”  (I love the ambiguity with the word, ‘making.’)

Gowder is smart in his use of philosophers (from Hayek to Raz, and others) to try to shed some light on Roberts’ ideas about coercion and regulation.  Gowder’s analysis makes me think that the Roberts’ opinion might deserve an even broader examination of whether there is a coherent theory of coercion between the individual mandate section and state mandate to expand Medicare section.  On the other hand, Gowder reaffirms my sense that the individual mandate’s Commerce Clause problem was not that it was too coercive.

The most provocative question is why the mandate was upheld as a tax.  On Gowder’s charitable reading, Roberts’ opinion does not provide Congress with unlimited power to mandate behavior using the tax power.  It is strictly limited.  But the limitation is merely one of “expressiveness”, depending on whether a mandate “labels those who break it as lawbreakers.”  (p16)  As I discuss below the fold, this creates a novel rule of Constitutional law — we might call it the finger-wagging-rule.    Read More

Reminder, TODAY – The Guatemala STD Inoculation Studies: What Should We Do Now?

TODAY
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School

In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to, and infecting them with a number of STDs without their consent.  The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby.  The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming.   Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective.  Panelists will include:

  • Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
  • I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
  • Wendy Parmet,  George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
  • Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School

This event is free and open to the public.  Lunch and refreshments will be served.