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

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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

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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

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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

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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?

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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?

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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.

New Data Reports on Learning “Research Integrity”

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When it comes to research with human subjects, about 60 percent of faculty members and 50 percent of graduate students learned about ethics through online or print resources according to a recent survey. These data could be seen as good or bad news—depending on how you feel about getting your ethics through online training modules, such as CITI. These stats—and many more measures of ethics—are included in a remarkable new data set collected and made publicly available by the Council on Graduate Schools.

The data set is a great resource. Anyone with a browser can build custom tables that include different variables and topics related to “research integrity.” Users can slice data by fields of training (life sciences, social sciences, etc.) and by rank of researcher (faculty members, postdocs and graduate students).

Here is the punch line on human-subjects training—and a few questions about the data (the CGS has covered questions about methodology covered):

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An International Meeting of Public Health and Law Enforcement

Temple University Center for Public Health Law Research 1 Comment

By Scott Burris

We know, and now most people acknowledge, that police activity has some clear, and in some instances intentional, effects on health.  To start with the obvious, police are instrumental in reducing the number of people who are murdered, assaulted, raped, or otherwise terrorized. Policing – like any form of social intervention – can also have unintended consequences. There is, for example, considerable evidence that criminal law and legal practices can increase risks of HIV and other harms among drug users.

These facts are well-established and pretty well recognized. So now the question is not whether policing has health consequences, but rather whether social and health work is to be seen as an integral element of law enforcement in the 21st century.  In much of their day to day work, police are engaged in far more than the prevention of crime or the maintenance of social order.  This is something we all know, something that has probably always been true of police work, something that is shaping a lot of programs around the world, and yet something we need to talk more openly about.

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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)

Reminder: Abstracts for Petrie-Flom Annual Conference Due 12/10/12

The Petrie-Flom Center Staff Leave a comment

Just a reminder, abstracts for the Petrie-Flom Center’s annual conference – this year entitled “The Food and Drug Administration in the 21st Century” – are due no later than December 10, 2012.  This one and a half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts.

For further details, see the Call for Papers/Presentations.