Category: Scott Burris

Where Are We Now: Post 3, The Agony (and Potential Ecstasy) of Defeat

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By Scott Burris

Law has been an extremely effective mode of public health intervention in the last thirty years, which means that proponents of its use have won more than a few tough political battles.  Nonetheless, it is hard to escape the fact that, in recent years, the public health side has been getting killed wherever law is made. The First Amendment turns out to create a right to mine prescription records for data (Sorrell v. IMS Health), advertise liquor prices (44 Liquormart), keep warning labels off cigarette packs (RJ Reynolds v FDA)  – even operate a tattoo parlor in a city that lacks the resources to regulate its safety.  With the Heller case, the strictest forms of gun control were taken off the table, and there is a lot more litigation ahead to define what can be done. The ACA case raises the possibility of future limits on federal regulation via the spending clause. In the latest and most chilling development, the DC Circuit panel in the FDA label case laid the foundation for questioning whether there is even a rational basis for regulations aimed at discouraging people from using “lawful” but dangerous products:

We are skeptical that the government can assert a substantial interest in discouraging consumers from purchasing a lawful product, even one that has been conclusively linked to adverse health consequences.

Things aren’t a whole lot better over in the elected parts of government.  State and local health departments have been experiencing steady budget strangulation ever since (and even before) the Great Recession. The federal life-line, the Prevention and Public Health Fund, was raided once already by Congress, and remains a tempting target. Using the money we do get to promote legal interventions for health is under attack: with the help or acquiescence of Democrats, the long-standing restriction on lobbying in the HHS appropriations bill was changed. Despite legal analysis concluding that the old lines – educating public and policy makers is OK, just don’t push for specific legislation – are still in place, broad language about “future” legislation and threatening letters from an outfit called “Cause of Action” has reportedly chilled a lot of funding recipients.

For many of us, the succession of reverses and cuts looks like public health as usual: public health is usually the underdog whatever the topic. On the other hand, there are arguments that things are different now, ranging from the simple claim that the cuts have now reached bone to the belief that there is an active effort to put the “new public health” entirely out of business. So what is happening?

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Researchers to Lawmakers: Naloxone Distribution to Prevent Overdose Death is Cost-Effective

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By Scott Burris

Phil Coffin and Sean Sullivan have published a cost-effectiveness study of interventions that equip heroin users and others to administer naloxone in the event of a witnessed opioid overdose.  Naloxone is the standard antidote, and can easily be administered by lay people with a minimum amount of training.  Family members and friends of opioid users can quickly get the drug into an overdosing user via injection or a nasal spray. In an accompanying editorial, top brass at NIDA and FDA sum up the news like this: the study

“represents a significant step in the evolution of the science in this area: a detailed analysis of the cost-effectiveness of overdose intervention with naloxone administration for heroin abusers. The authors suggest that lay naloxone administration is likely to be highly cost-effective in this setting, a robust finding that holds up under various assumptions. Future analyses that extend their findings to the setting of prescription opioids would be welcome.”

The editorial flags one of the major legal issues that gets in the way of wider naloxone distribution – its status as a prescription drug approved for use by injection. Changing this is a torturous regulatory process. In the short term, though, lawmakers can do a lot to get distribution going where it is needed.  As of July of 2012, eight states had passed laws to clearly authorize or otherwise reduce legal barriers to the prescription of naloxone to drug users and other potential good Samaritans. That leaves 42 states where programs may have trouble operating out of concerns related to prescribing a drug for a lay person to administer. LawAtlas covers the law and has examples of the legislative approaches these states have taken.

One more thing: evidence that naloxone distribution looks to be cost-effective ought to motivate lawmakers to consider these programs.  Many places don’t have them at all: a study published last year in MMWR reported, among other things, that “Nineteen (76.0%) of the 25 states with 2008 drug overdose death rates higher than the median and nine (69.2%) of the 13 states in the highest quartile did not have a community-based opioid overdose prevention program that distributed naloxone.”  In others, programs are operating but with little or no public funding to purchase naloxone, whose price has been rising precipitously (that’s another story about our creaking system for producing essential medicines).

Where Are We Now: Post 2, The Thrill of Victory

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By Scott Burris

Between budget cuts and “nanny state” attacks, it’s easy to feel that public health is a perennial political loser.  As for the courts, the first two constitutional amendments alone are throwing up enough barriers to reasonable health regulation to keep us on the defensive for years. In this series of posts about how public health protagonists are faring in these politico-legal contests, I will criticize our side. There’s a great deal we do wrong, or at least fail to do well, and those failures are the first place to look if we want to stop being under-appreciated, underfunded and over-invalidated.  But before I put on the hair shirt, I will don satin with a post devoted to the very positive things there are to say about public health law and those who theorize and study it.

Make a list of the biggest health threats that have faced our people in the last fifty years. That list will certainly include lung cancer, cardiovascular disease, motor vehicle crashes, gun violence, communicable diseases, lead poisoning, mental illness and, more recently, drug overdose and obesity.  Now consider what law has done or is doing to address these threats.

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Not too late for that ethically inclined law and society loved one’s stocking

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Nicky Priaulx of Cardiff and Anthony Wrigley of Keele have edited the latest volume in the Ashgate book series, “Ethics, Law and Society.”  Matthew Weait and I have contributed a piece on the ethics of sex with HIV, but the book covers a wide range of contemporary health/ethics/legal questions, including cloning, organ procurement, surrogacy, confidentiality in family courts, informed consent, and the place of child-rearing men in a gendered world.  Robin West says it “provokes, intrigues, and enlightens, suggesting multiple paths for the futures of the related fields of bioethics, the study of care and caregiving, and the ethics and law of reproduction and reproductive technologies.”

Details on the paper and e-book are here.

The State of Public Health Law: Post I, “Who Am I? Why am I Here?”

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By Scott Burris

Early in January, Lindsay Wiley and the Network for Public Health Law will convene a group of health law professors and (and a few colleagues from public health law practice) in Washington.  They will be spending a couple of days advancing a conversation about how academic health lawyers can make a bigger contribution to the cause of improving the level and distribution of health in the United States.  The conversation will pick up where a smaller group, organized by Wendy Parmet and Leo Beletsky, left off last Summer. You can read more about that meeting here.

The impetus for these meetings has been a sense that there is a well-organized and well-funded legal effort to blunt key initiatives in public health – and that it seems to be winning.  And that “our side” is not putting up much of a fight. Whether it is the creeping First Amendment or the shrinking Commerce Clause – or just the battle for public hearts and minds – many of us law professors shared the feeling that we needed to rethink our game, not just in the short term, but for the long haul.

The discussion in January will be addressing three questions essential to that rethink: (1) where are we now? (2) where would we like to be in 20 or 30 years? and (3) what will we have to do to get there?  In advance of the meeting, we are thinking about these questions, and I have taken on the task of offering some thoughts on question 1, in the form of a series of blog posts over the next three weeks.  These will be personal essays, describing my own perhaps confused thoughts. I consign them to ablog as much for future deniablilty as present dissemination. I’ll be happy to have comments.

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Gun Violence: Lessons Learned from Car Crashes

Temple University Center for Public Health Law Research 1 Comment

By Scott Burris, JD

“I have an absolute right to drive any vehicle I want, on any road, at any time, at any speed, and under any conditions.”

That’s an argument few people would take seriously. And few people would take seriously the argument that we should ban or substantially limit automobile use, despite the fact that America suffers more than 30,000 motor vehicle deaths every year.

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You Have to Read This

Temple University Center for Public Health Law Research 7 Comments

By Scott Burris

Australian public health law savant Chris Reynolds recently stopped by Temple Law School to discuss the South Australia Public Health Act of 2011.  It is a fresh look at how to write a basic public health law statute, but one provision took my breath away.

62—Minister may issue code of practice

(1) The Minister may issue a code of practice in relation to preventing or reducing the incidence of a non-communicable condition.

(2) A code of practice may relate to—

(a) an industry or sector;
(b) a section or part of the community;
(c) an activity, undertaking or circumstance.

(3) Without limiting subsection (1) or (2), a code of practice may relate to the manner in which, for the purposes of public health—

(a) specified goods, substances or services are advertised, sponsored, promoted or marketed (including through the provision of certain information to consumers of certain goods, substances, or services);
(b) specified goods or substances are manufactured, distributed, supplied or sold (including the composition, contents, additives and design of specified goods or substances);
(c) buildings, infrastructure or other works are designed, constructed or maintained;
(d) the public, or certain sections of the public, are able to access specified goods, substances or services.

(4) The Minister must, before issuing or amending a code of practice, insofar as is reasonably practicable, consult with any person or organisation that the Minister considers to be representative of any industry or sector affected by the proposed code or amendment.

(5) The Minister may publish a report on the performance of an industry, sector or person in relation to a code.

(6) The Minister must, before publishing a report under subsection (5) that would reasonably be expected to have an adverse impact on a person specifically identified in the report, provide a copy of the report to the person and then allow the person at least 14 days to make written representations in relation to the contents of the report.

(7) No action lies against the Minister in respect of the contents of a report published under this section.

A code of practice is enforceable under a “general duty clause” that stipulates that  “a person must take all reasonable steps to prevent or minimise any harm to public health caused by, or likely to be caused by, anything done or omitted to be done by the person.”

Here’s a law, passed by actual legislators, that gives a health minister sweeping powers to directly, comprehensively, creatively and flexibly regulate products and activities that create both risks and benefits to the public.

We’ll wait with baited breath to see whether it works or not, but it’s already got me wondering whether they have any decent industry lobbyists in Australia.

Overdose Update: Celebrity Edition

Temple University Center for Public Health Law Research 1 Comment

By Scott Burris

You’ve probably heard about the good news/bad news experience of Stephanie Bongiovi, daughter of rocker Jon Bon Jovi. A college student, she ODed on heroin, but help was summoned and she’s going to be fine. The (temporary) bad news for her (and longer term for others in her plight) is that she and a companion were arrested IN SPITE of a recent New York Good Samaritan 911 law passed explicitly to encourage people to call for help.

There are some technicalities and prerequisites, so if you want to see the law it’s available on LawAtlas. But if she or her companion sought help, and absent a hyper-technical reading of the statute (it literally does not protect a victim unable to seek help), the charges should never have been filed and should be dropped. The problem for the rest of us is that these laws only work if people at an OD scene know about them and trust them. High profile arrests like this are — and for once I think there might be some truth to this claim — sending a message not to seek help.

Meanwhile, Leo Beletsky, Jody Rich and Alex Walley have a fine little piece in JAMA that thoroughly catalogues the removable barriers to OD prevention. The table alone is worth thousands of words, which is nice because JAMA’s editors were pretty tight on the word limit despite the importance of the topic.

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.)

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).