Thursday, August 28, 2014
Reversing its previous deference to corporate speech interests, the U.S. Court of Appeals for the D.C. Circuit came down in favor of consumer protection in a July 29 decision. In American Meat Institute v. U.S. Dept. of Agriculture, the court upheld a federal government regulation requiring meat companies to disclose the countries of origin for their products. If your beef comes from Argentina or Canada, you will know that from its label.
More importantly, the court gave the Food and Drug Administration greater freedom to reduce tobacco use in the United States. In explaining its reasoning, the court repudiated the logic of an earlier decision by the court that rejected the FDA’s graphic warnings for cigarette packs. According to the meat labeling opinion, the cigarette warning decision did not allow sufficient leeway for the government to mandate warnings or other informational disclosures to consumers.
Perhaps the U.S. Supreme Court will restore the D.C. Circuit’s previous balance, but for now, the tide has turned in favor of the public’s health.
Friday, April 25, 2014
It’s likely that most readers of this blog already know that the FDA just announced its intent to extend its regulatory powers to E-Cigarettes. E-Cigarettes have proven to be a "high interest" topic in both my "Constitutional Issues in Health Law" and "Legal Issues in Human Subject Research Classes." The struggle between the FDA and those it wishes to regulate raise questions about the powers of all three branches of Government. It can serve as a proxy for all administrative agencies in an Admin Class or as a direct source of study in a public health, environmental or (of course) food & drug law class.
But back to E-Cigarettes.
The FDA’s relationship with regulating tobacco products has been a complicated one. This book review by Margaret Gilhooley can bring you up to date on the history of FDA’s failed attempts to obtain jurisdiction. It was not until June 22, 2009 that the FDA finally did get regulatory power when President Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) that the FDA got any authority to regulate tobacco products—and that only through the filter (sorry) of protecting children. And that still remains the outer limit—protecting children.
So any regulation of E-Cigarettes has to be along the lines of making them less available to minors. That’s why what sounds like a relatively weak reason—“even if they are harmless, they are a gateway for children to real cigarettes” is important because that is the statutory basis of the FDA’s power. It’s not surprising that the FDA’s announcement has been met with immediate protest from Vapers. New York’s ban (and remember, all the FDA’s done is to announce it intends to assert its authority to look into the product’s safety) has sparked considerable push-back based on issues of “personal liberty.” Apparently this anti-regulation movement is not restricted to the U.S.
Vapers have had little success persuading cities to exempt e-cigarettes from public spaces, but they have been able to prevent outright bans and to allow the creation of “vaping lounges” –-the English majors among you know these better as modern day equivalent of a legal opium den—perhaps inhabited by today’s Keats, Shelleys and Coleridges. We even have them in Lubbock.
The FDA’s goal is to build on the actions of the cities that are equating e-cigarettes with “old style” tobacco to keep e-cigarettes as an “adults only” product.
April 25, 2014 in Constitutional, Drug and Device, Environmental Health, FDA, Food, Obama Administration, Policy, Proposed Legislation, Public Health, Public Opinion, State Initiatives | Permalink | Comments (0) | TrackBack (0)
Thursday, April 3, 2014
A Call out to the "Invicible" Young Adults--What You Don't Know About Childhood Diseases Could Prevent You From Having Any Children
One thing we’ve all heard during the discussion of the affordable care act is that young people don’t worry a lot about their health. It’s therefore likely that few young adults ever think about whether or not they received adequate vaccination.
Perhaps if they better understood the consequences, they would do so. What you've heard is true many childhood diseases are much more serious for adults than for children. For a general overview look here. Here’s some information about chickenpox.
Outbreaks of Mumps are being reported all over the country. This week there are 116 cases in and near Ohio State University in Columbus. Fordham University in New York reported 11 in late February. Just today, the NYC Board of Health reported 21 cases of Measels and Rubella (German Measels) isn't likely to be far behind. These numbers may seem small—until you appreciate that Mumps used to be a very common childhood disease in the United States but is now very rare because of a highly effective vaccine. Unfortunately, many parents have chosen not to vaccinate their child against Mumps because of concerns about the MMR vaccine—that now turn out to be the result of fraudulent scientific data. This piece put out by the Center for American Progress explains how states responding to political pressure from parents have been remarkably lax in enforcing mandatory vaccination laws for school children. At this point, almost anyone with a concern to claim an exemption.
So back to Mumps. Few had heard of it, and no one knew what should really be the main attention grabber. It can impair fertility—even to the extent of causing sterility. There hasn't been a lot of research done recently and permanent sterility is rare- probably no more than 10%. But why chance it when it can be prevented?
And that’s not the worst of it. Measels and Rubella carry even greater risks for young adults. A case of Rubella early in pregnancy caries with a 20% chance of serious birth defects. The risk of permanent hearing loss after measels is highest in children under 5 and adults over 20.
The good news on the public health front is that it’s never too late to be vaccinated. And preventive vaccination (even for childhood diseases) is covered under the Affordable Act. Young adults would be wise to look into their own vaccination status. If pediatric records aren’t available, a blood test can measure antibodies that show the presence (or absence) of vaccination against many serious childhood diseases that are coming back to infect young adults. But if vaccination laws continue to be lax, long after the reason for so many people's misgivings has turned out to be a fraud, we will not be able to get ahead of what should to everyone be a very frightening trend
Cigarette taxes have proved to be an effective strategy to reduce smoking, so one might think (as many experts do) that soda taxes would be an effective strategy to reduce obesity. Consumption of soft drinks seems to be an important risk factor for obesity, and people are sensitive to the price of their colas.
Moreover, soda taxes reflect the lessons of behavioral economics. People often over-indulge in activities that provide short-term gratification but impose significant harm in the long-term. Imposing a tax on unhealthy drinks supplies an immediate disincentive to the consumption of those drinks and can overcome the difficulty people have in postponing gratification.
However, two new articles in Health Economics question the effectiveness of soda taxes. One study based on UK data, the other on US data, come to the same conclusion--we should not expect much of an impact from taxes on sugary soft drinks. It seems that raising taxes on some beverages simply results in consumers switching to other beverages and replacing the forgone calories with other calories. And to make things worse, beverage taxes often are regressive.
The news is disappointing and adds to a growing list of disappointing policies for weight loss. Under the Affordable Care Act, for example, restaurants must disclose calorie information to customers. With better information, diners would know which salads really are healthy and which others are not. But researchers have not found mandates for calorie disclosure by restaurants (as in New York and Seattle) to be effective.
Legislative fixes for obesity are tempting and probably necessary. But lawmakers need to take better account of medical understanding before they act.
[cross-posted at PrawfsBlawg and orentlicher.tumblr.com]
Friday, March 14, 2014
Health Law Prof Extraordinaire Nina Kohn of Syracuse University, now visiting at Maine, shared this link with me http://www.cbc.ca/thecurrent/episode/2014/03/11/why-are-family-members-being-banned-from-visiting-their-relatives-in-nursing-homes/ because of an experience I had involving the ICU staff when my mother was hospitalized last year and I expressed concern about emerging pressure sores from compression socks that were not being monitored. I don't think this problem is unique to Canada.
I received wonderful help and advice from two very different groups--the National Center for Medicare Advocacy-a terrific resource for navigating a complex and often not very patient centered health care system--and Texas Right to Life which is promoting the Will to Live document as a counter to the assumption that the possession of an "advance directive" is the equivalent of a decision to forgo care in order to hasten death.
Friday, February 28, 2014
A big part of the job of being a Health Law Prof is to help students understand the intersection of the many legal specialties that comprise the big tent of "Health Law." Wellness Programs are a good way of doing that because one of the key features of the Affordable Care Act is the flexibility it provides employers to link the cost their employees pay for health insurance with the individual employee's participation in a company sponsored "welleness program." Here's an article I wrote explaining how PPACA went about doing that. Here's a link to the Department of Labor's summary of the current rules and a good overview by the law firm Nixon-Peabody. This report from Rand is an overview of what these programs are and how companies have increasingly fallen in love with them. At this point just about every insurance company is offering to create one--here's some information from Aetna.
The problem is, there's very little evidence that these programs do anything to demonstrably improve health (whatever that may mean). And quite a bit that they may promote many different kinds of social injustice.
This article in the Harvard Business Review does a great job describing the kinds of programs that are now descending on employees and how they are creating disatsifaction without any scientifically supportable improvement in "health."
There is also a growing literature suggesting that these programs may disproportionately discourage workers who employers aren't that unhappy to see go--but might not legally be able to actually fire. Here is some very interesting testimony by Jennifer Mathis Director of Programs, Bazelon Center for Mental Health Law
On Behalf of the Consortium of Citizens with Disabilities.
Michelle Mello at Harvard has coined the term "life-style discrimination" to describe the ways Wellness Programs may target individuals employers may perceive as undesirable because they are obese, smoke or have other non-job related characteristics.
Studying Wellness Programs--and the issues they raise--can be an accessible entry point for students who can easily be intimated by the regulatory complexity of health law and can also be a bridge to understanding how fundamentally the Affordable Care Act has affected the way health care will be paid for and delivered as our students begin their careers in advising those struggling to implement these new regulations.
February 28, 2014 in Access, Affordable Care Act, Consumers, Coverage, Disabilities, Effectiveness, Employer-Sponsored Insurance, Genetics, Health Care, Health Care Costs, Health Care Reform, Health Law, Health Reform, HHS, Insurance, Mental Health, Obesity, Policy, Politics, PPACA, Prevention, Public Health, Quality, Reform, Workforce | Permalink | Comments (0) | TrackBack (0)
Monday, January 20, 2014
What are We Learning About Brain Death from the McMath and Munoz cases?
By Jennifer S. Bard, J.D., M.P.H., Ph.D.
With the understanding that this is one of those topics that health law professors are supposed to know something about, here is a quick update of what’s going on. Along with my own views about the possible misuse by hospitals of declaring brain death in what are really medical futility cases.
Jahi McMath, age 12, in California who lost consciousness after a routine tonsillectomy and Marlize Munoz, age 32 in Texas who collapsed on her kitchen floor have both become involuntary public figures as their families struggle to make sense of both their medical conditions, which are complex, and of the laws which have declared them both legally dead based on a lack of brain activity. In legal terms, a person declared “brain dead” has the same status as any other dead person. Each state is entitled to make its own decision of whether or not to adopt a brain death statute. California’s and Texas’ are similar in that they require the “complete cessation” of all brain activity. The declaration of death is, in all states, a legal act. Most hospitals have a policy similar to this one which set criteria and require the participation of at least two doctors. A declaration of death cuts off any rights of the individual. The family of someone declared dead is no longer a surrogate decision maker. Rather, they have something like property rights to the disposal of the remains. More pointedly, a declaration of death ends all eligibility for medical insurance, including Medicaid and Medicare. If a family decides to release the organs for donation, their host becomes not a patient but rather a “heart beating organ donor.”
When a family wants to donate their loved one’s organs, a declaration of brain death is helpful mechanism for doing so. Indeed, a series of high profile cases involving anencephalic infants in the 1990s pointed out the frustrations of parents who wanted to donate their children’s organs but could not because they retained minimal brain function. However, there is never any legal need for a declaration of brain death in order for a family to withdraw life sustaining treatment. In 1993 bioethicist Robert Veatch wrote an important article in the Hastings Center Report in which he pointed out that “no one really believes that literally all functions of the entire brain must be lost for an individual to be dead.” And indeed, no one really believes that a piece of paper converts a warm, breathing body from alive to dead.
Many families in the McMath’s situation would have, even in their shock, heeded the doctors advice and stopped treatment. Although we do not, yet, know what actually happened, I suggest that it is possible that cases like the McMath’s can arise when hospitals and doctors seek to pressure families into withdrawing treatment by, essentially, taking away their right to receive care. This can be a lot more direct than the often times consuming and complex process of withdrawing "futile" care. Indeed, in the actual absence of all brain function there are no interventions that can replace the complex functions of the human brain and deterioration and decay are inevitable.
Although it is easy enough to say that Jahi’s family’s refusal to accept reality stems from ignorance or grief, it is not fair, as some have done, to call them crazy for mistrust of a diagnoses that is based in theory, not reality. Jahi may be irrevocably brain injured, but there are increasing signs that she may indeed have some brain function. Her thrashing movements may be reflex, not purposeful—but corpses do not have reflexes. This week, neonatologist Dr. Paul Burn notes, without citation so we do not know if it is true, that Jahi, has regained sufficient hypothalamus function to regulate her own body temperature. A corpse does not regulate its own body temperature.
This is not to suggest that the doctors are wrong about the amount of brain damage she has sustained or her chances of even retaining a sliver of consciousness—but that is not the same as “complete cessation” of all brain activity.
In contrast to the case in California, Marlize’s family, in Texas, want to let her go. The hospital is invoking a provision of the Texas Advanced Directives Act law which prohibits a hospital from withdrawing life sustaining treatment from a pregnant women. It may be, as bioethics experts law Tom Mayo at SMU explain, that this law does not apply after a declaration of death, but only when the mother is in a permanent coma. But, again, this points out the limits of using the legal concept of brain death to describe the medical condition of any particular person. Marlize may well be dead, but her fetus certainly is not. But until Marlize’s family gets clarification in the case it has filed in Tarrant County, or, ultimately, the Texas Supreme Court this distinction does not change their situation.
So where does that leave a health law professor? One of the reasons brain death is so hard to define is that we know relatively little about how the brain works. As the American Academy of Pediatrics Guidelines Determination Of Brain Death In Infants And Children,“ No randomized control trials examining different strategies regarding the diagnosis of brain death exist.” It even seems increasingly likely that we are not even sure where all of what we consider to be brain function happens—it turns out-—as folk wisdom has always believed—that a lot of it may happen in our guts. .
It may be that these two cases spur changes to the law—although other equally publicized situations have not-but for teaching purposes they both are helpful in exposing law students to how much we actually do not know about the human body and, especially, our brains.
Wired Magazine, in August 2011, ran a fascinating article called, “7 Creepy Experiments That Could Teach Us So Much (if they weren’t so wrong). These “7 Creepy Experiments” include some truly creepy things like using “a synthetic virus” to insert into an embryonic cell a “reporter” gene (green fluorescent protein, for example) in order to track embryonic development throughout the life cycle or deliberately separating twins at birth in order to study them.” I use it in my Human Subject Research Law class to get students thinking about the limits of consent, but more generally it and these cases tell us something about the reality that we need to make and enforce law in the face of limited information.
Tuesday, December 17, 2013
Stacey Tovino, a rock-star health law professor and Lincy Professor of Law at the UNLV William S. Boyd School of Law and I were nearly knocked off our chairs at a presentation by Wellesley College Professor Charlene Galarneau, PhD on The ACA Exemption of Health Care Sharing Ministries at the ASBH- American Association of Bioethics and the Humanity’s annual Meeting last month. If you are a health law professor (or hobbyist) and do not yet know what a Health Care Sharing Ministry is, prepare to be surprised. It is NOT insurance but rather a non-binding agreement among people of faith to share their health care costs. As the Alliance of Health Care Sharing Ministries explains, “A health care sharing ministry (HCSM) provides a health care cost sharing arrangement among persons of similar and sincerely held beliefs. HCSMs are not-for-profit religious organizations acting as a clearinghouse for those who have medical expenses and those who desire to share the burden of those medical expenses.” It specifically does not provide the essential services of an ACA qualified plan. Yet those without health insurance who are participating in one of these ministries are exempt from the obligation to purchase insurance or pay a penalty—even though it is highly likely that the cost of their care will fall on the community where they become sick and seek treatment. Read more about it here and here. Health Care Sharing Ministries are among the 9 exemptions in the Affordable Care Act, yet have not attracted significant attention. Given their important role in exempting large numbers of people from the obligation of obtaining health insurance, they deserve a place, or at least a shout-out, in all of our classes.
December 17, 2013 in Access, Affordable Care Act, Coverage, Health Care, Individual Mandate , Policy, Politics, PPACA, Private Insurance, Public Health, Uninsured | Permalink | Comments (0) | TrackBack (0)
Friday, October 18, 2013
Even health law professors who do not teach a class in research law may be asked to participate in their university's programs for training researchers. Now that the government is back in business, this seemed like a good time to feature some resources to help bring you up to speed. The information below focuses on some of the main Federal Government sources of not just information but very high quality educational material. All of this information is accurate as of today--but any web resource can suffer from link rot, and a direct Google search should lead you to all of these sources and more.
The most general place to start is actually not in the Federal Government, but rather CITI on-line training resources. Although today their website says that these materials are no longer available to the public for free, it is likely that anyone associated with an institution that conducts federally funded research is a subscriber. The unavailability of CITI to the public is unfortunate, but the amount of training provided for free by the federal government is beyond the scope of any individual human's ability to absorb information--everything from this point on is free!
The Federal Government's regulation of research misconduct, research integrity and protection of human and animal subjects of research (yes, all of these things are different) is scattered not just among the various entities sponsoring research, but also within agencies. While all have adopted "The Common Rule" when it comes to humans, in fact there can be significant differences in policies and regulations (especially in situations not involving humans). Here are some places to start looking.
The location of this information depends both on the kind of research and the source of funding. For research funded by the department of health and human services (biomedical research primarily) the relevant agency is the Office for Research Integrity (ORI) which " oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration" and this is the website that tracks cases they are and have investigated.
If the research safety violations involves people, you need to go to the entity within HHS currently known as the Office for Human Research Protections (OHRP)(remembering the "s" at the end of "Protections" shows you to be an insider). This is a vast repository of both reference material and current reports of active cases--you might want to look at this overview first.
If you are getting funding directly from the National Institutes of Health, you will want to check in with Human Subject Research Protections (HSRP) program (note the "s") and their rules and guidance. More information to be found here.
Research under the supervision, although not necessarily funding, of the FDA is monitored its Bioresearch Monitoring (BIMO) program is a comprehensive program of
on-site inspections and data audits designed to monitor all aspects of the
conduct and reporting of FDA regulated research. This is not to be confused with the FDA's Office of Criminal Investigations which has a broader scope and covers not just research but all FDA monitored activities.
Actually, "all" is an understatment because Recalls, Market Withdrawals and Safety Alerts are tracked elsewhere and there may be some spillover. Ditto MedWatch: The FDA Safety Information and Adverse Event Reporting Program. If the violations directly concern human safety you should check here and in general at the Center for Drug Evaluation and Research
The National Science Foundation (NSF) is another major source of information. The research it sponsors differs from that sponsored by NIH because it extends far beyond biomedical activities. Indeed, NSF is the place to look for information about social science or behavioral research.
The National Academy of Engineering has devoted considerable resources to issues of research ethics, misconduct and integrity which are available in its online Ethics Center. Texas Tech University also provides extensive resources in Engineering Ethics through the Murdough Center.
The Institute of Medicine is often asked by Congress to investigate issues in Biomedical and Health Research.
The Department of Energy is a major player in the field of research ethics/human subject protection (it does considerable nuclear and genetics research) and has many resources.
It's very hard to distinguish between "bioethical" issues and "legal" issues when it comes to research, so another very important source of information is the Presidenial Commission for the Study of Bioethics. which recently put out a remarkable report on Human Subject Research Violations which took place during the 1940's in Guatemala. (spoiler, the U.S. Public Health Service was giving people syphillis).
In future posts, I will dig deeper and provide more governmental and private sector resources.
Thursday, September 5, 2013
Don't miss a fascinating article in the August 30th issue of Science, "Poverty Impedes Cognitive Function." The article contends that there is a causal explanation for the correlation between poverty and disfunctional behavior, such as the failure to keep medical appointments or to employ healthy behaviors. Put crudely, the connection is that people in poverty have to think about so much just to keep going that they don't have the cognitive bandwidth to make carefully reasoned decisions.
The authors of the article, Anandi Mani, Sendhil Mullainanthan, Eldar Shafir, and Jiaying Zhao, present two studies in support of their claim. The first study involved four experiments in which shoppers at a New Jersey mall were paid participants. The income level of the shoppers varied, from the bottom quartile of US income to over $70,000. In the first experiment, participants were asked to think about a decision about how to pay for car repairs, and were randomized to inexpensive ($150) or expensive ($1500) costs of the repair. They were then asked to perform simple cognitive tests on a computer. Among those asked to think about the inexpensive repair, there were no significant differences by income level in performance of the cognitive task. By contrast, there were significant differences in performance by income among those confronted with the more expensive repair. Variations on this experiment involved problems where sums of money were not involved (to control for math anxiety), incentives in the form of getting paid for getting the right answers on the cognitive tests, and situations in which participants came to a decision about the financial problem, engaged in intervening activities, and then were asked to perform the cognitive tests. Each of these variations produced results similar to the initial experiment: the performance of people in poverty on the cognitive tests was significantly associated with the expensive repair, but the performance of those in higher income groups was not.
In the authors' second study, participants were a random sample of sugar cane farmers in Tamil Nadu in southern India. They were interviewed before and after the cane harvest. Pre-harvest the farmers faced more significant financial pressures (as measured by criteria such as numbers of pawned items, numbers of loans, and the like) than post-harvest. Performance on cognitive function tests was significantly higher post-harvest than pre-harvest. Because the cane harvest extends over a considerable time period, the authors were able to control for calendar effects; the difference was similar early or later in the 5 month period of the harvest. The authors conclude that poverty has about the same cognitive consequences as the loss of a night's sleep.
To be sure, other variables might explain the authors' findings. They are careful to discuss many of these such as physical exertion, stress, nutrition, or training effects. If the authors are right, however, their findings have some impressive implications for health policy. One, which they note, is that it may just be more difficult for people who are poor to perform complex tasks needed to apply for eligibility for programs such as Medicaid (why are we surprised that so many who are eligible don't sign up?). Another is that programs designed to incentivize healthy behaviors may just not work very well if they ignore cognitive loads.
September 5, 2013 in Access, Affordable Care Act, Consumers, Health Care Costs, Health Care Reform, Health Economics, Health Reform, Medicaid, Obesity, Prevention, Public Health, Uninsured | Permalink | Comments (0) | TrackBack (0)
Tuesday, September 3, 2013
Faculty Fellowships in Public Health Law - Call for Applications
Applications are invited for 10 faculty fellowships in public health law education.
Georgia State University College of Law and its Center for Law, Health & Society are leading an initiative funded by the Robert Wood Johnson Foundation for a faculty fellowship program to promote public health law education. Ten faculty members from law schools or schools/programs of public health will be selected to participate in a yearlong fellowship program designed to foster innovations in educational programming (including clinical, externship, and other experiential learning) and to build a strong learning community among faculty who teach in the public health law field.
All fellows, with their deans’ support, will design and implement a project for curricular change in public health law education at their home institutions. Each fellow will be paired with a faculty mentor in public health law. The fellows will begin their fellowship year by attending an intensive 10-day educational Summer Institute on July 16-26, 2014 in Park City, Utah. Over the course of the academic 2014-2015 fellowship year, the fellows and their mentors will regularly share ideas, experiences and models for public health law teaching, providing opportunities for professional growth and leadership development.
• Applicants must have a J.D. degree and be employed in a full-time faculty position at a law school or school/program of public health, or be a full-time faculty member affiliated with a law school or school/program of public health, with a tenure-track, tenured, clinical-track, joint, or comparable faculty appointment;
• Applicants must have at least three years of full-time teaching experience at a graduate- or professional-school level by July 2014; previous background in health care law, public health law, or related subjects is preferred;
• A dean’s transmittal letter of support for the proposal is required, as well as
two letters of reference.
For the complete list of eligibility and selection criteria and to review the full Call for Applications, visit www.law.gsu.edu/PHLFellowship.
HOW TO APPLY
• The application period opens Tuesday, Sept. 3, 2013. The deadline for applications is Friday, Dec. 13, 2013. Letters of reference are due Friday, Dec. 6, 2013.
• For instructions on how to apply and complete information about the program, download the full Call for Applications at www.law.gsu.edu/PHLFellowship.
Questions? Contact Stacie Kershner, associate director for the Center for Law, Health & Society, at firstname.lastname@example.org or 404-413-9088.
Friday, June 21, 2013
I am just back from Austin where I was privileged to attend the "launch" meeting of the Scholars in Residence Program, one of five fellowship programs funded by the Robert Wood Johnson Foundation in order to enhance and promote public health law. This press release put out by the Network for Public Health Law gives more detail on the scholars (I'm proud to say I'm one of them) and our projects. They are:
Jennifer S. Bard, Alvin R. Allison Professor of Law and Director of the Health Law Program and JD/MD program at Texas Tech University School of Law, will explore the interface between property rights and public health needs relating to nuisance and disease-spreading insects such as bed bugs and mosquitos. She will work with the City of Lubbock, Texas.
Alex Capron, University Professor at the University of Southern California and the Scott H. Bice Chair in Healthcare Law, Policy and Ethics at the Gould School of Law, will examine federal rules on human subjects research relating to the surveillance of pathogens and viruses. He will work with the Los Angeles County Department of Public Health.
Mary Crossley, Professor of Law and former Dean at the University of Pittsburgh School of Law, will identify innovative ways in which California health officials can use their legal authority to address the growing burden of chronic diseases through interventions targeting risk behaviors and social and economic factors that impact health. She will work with the San Francisco Department of Public Health.
Sharona Hoffman, Edgar A. Hahn Professor of Law and Professor of Bioethics at Case Western Reserve University, as well as Co-Director of the Law School’s Law-Medicine Center, will develop enforcement guidance for regulation of in-home care agencies in order to improve compliance and protect the well-being of the vulnerable individuals served by these agencies. She will work with the Oregon Health Authority in Portland.
Browne Lewis, Leon & Gloria Plevin Professor of Law and Director of the Center for Health Law & Policy at Cleveland-Marshall College of Law, will focus on current state and federal preemption issues regarding local government regulation of the labeling, marketing and sale of small cigars. She will work with both the Cleveland Department of Public Health and the Shaker Heights Department of Public Health.
Polly J. Price, Professor at Law at Emory University School of Law, will address the coordination of public health agencies in providing long-term tuberculosis therapy among migrants along the U.S. border with Mexico. She will work with public health agencies in El Paso, Texas and Las Cruces, New Mexico.
The meeting gave the six scholars, their supervisors from health departments all over the country, project leader Professor Fran Miller, RWJ liason and senior program officer Angela K. Mcgowan and consultant Nancy Kaufman and the team from the Network for Public Health Law, Judy Schector and Jackie Rose (Sara Rohde stayed behind to keep things running) a chance to meet and learn about the exciting projects and plans.
If anyone is not yet familiar with the Network for Public Health Law or their work, take a minute right now to join (its free). This is how it describes itself: "The Network for Public Health Law provides insightful legal assistance, helpful resources and opportunities to build connections for local, tribal, state and federal officials; public health practitioners; attorneys; policy-makers; and advocate." And indeed the assistance it provides is remarkable--it has put together a group of experts available to answer, free of charge, public health law questions.
The Network is linked with an impressive array of other RWJ funded public health law programs specifically:
- The National Policy & Legal Analysis Network to Prevent Childhood Obesity (NPLAN), a project of ChangeLab Solutions, provides leaders in the childhood obesity prevention field with educational resources and technical assistance on legal issues related to policies to improve nutrition and physical activity.
- The Northwest Center for Public Health Practice (NWCPHP) promotes excellence in public health by linking academia and the practice community, including developing training materials for public health law professionals.
- The Public Health Law Association (PHLA), a non-profit membership organization, serves as a vibrant and active community of public health law practitioners and stakeholders and provides opportunities for all members to learn and share ideas, best practices and research on public health law.
- Public Health Law Research (PHLR) builds the evidence for and increases the use of effective regulatory, legal and policy solutions to protect and improve population health and the public health system.
- Tobacco Control Legal Consortium, America’s tobacco control legal network, provides technical assistance to support public health professionals, attorneys and advocates as they develop, implement, interpret and defend tobacco control policies.
In addition to the Scholars in Residence, RWJ has already launched the the Visiting Attorney Fellows Program
There is also an active, and free of charge, students network designed to support law students interested in public health.
In the fall, a program directed by Charity Scott, Catherine C. Henson Professor of Law and center director, and
Stacie Kershner (J.D. ’08), associate director at The Georgia State College of Law's Center for Law, Health and Society will start accepting applications for "an intensive summer institute, work on course development, and create and direct
externships, clinics and other experiential-learning opportunities in public
health law. Experienced faculty mentors will guide these efforts, which will be
supplemented with connections to resources and organizations focused on public
health law in the practice setting."
Anyone with an interest in using the law to protect the public's health should be closely following the RWJ Foundation's innovative programing.
The Supreme Court decided Agency for International Development v. Alliance for Open Society International yesterday, a lower-profile case about unconstitutional conditions placed on federal funding. My initial reaction is that the opinion can be read in at least two ways. On the surface, this decision reads like the long line of First Amendment unconstitutional conditions cases such as Rust v. Sullivan and Legal Services Corp. v. Velazquez. Chief Justice Roberts' majority opinion held that the "Leadership Act" could offer federal funding to eradicate HIV/AIDS throughout the world, and that funding can express discouragement of prostitution by refusing to allow the funds to be used for the promotion of prostitution, but the Court held that the conditions on the funds cannot go so far as to require the organizations using the federal funds to explicitly oppose prostitution. (Fund recipients had expressed the fear that taking an overt stance against prostitution would harm their public health efforts by scaring those in the sex trade away from their doors.) The majority's opinion is a non-controversial read of that line of cases and even attempts to make sense of the somewhat inconsistent application of the doctrine by describing the difference between "conditions that define the limits of the government spending program" and "conditions that seek to leverage funding to regulate speech outside of the contours of the program itself." I don't necessarily buy this distinction. After all, conditions by necessity define the contours of a program - unless they are nongermane, which seems to underly the Chief Justice's leveraging concept but was never explicitly stated. But, it is one way to describe the differing outcomes in this line of cases that is worth considering.
But then I come to a second possible take: this case reiterates the Roberts Court's willingness to rein in congressional exercises of the spending power. On the heels of NFIB v. Sebelius, the spending aspect of this case is notable, given that this is the second case in two years to express disapproval of conditions on federal spending. Unlike NFIB, which created a novel coercion doctrine without contours, this decision tread familiar ground in its conclusion that conditions on spending cannot violate First Amendment rights. However, even during oral arguments, there were shadows of the ACA controversy from last term. And, although NFIB was not cited in the opinion, both the majority and the dissent (authored by Justice Scalia) contained familiar language about leveraging, coercion, and offers that can't be refused. It is unclear why Justices Scalia and Thomas would uphold this condition on federal funding when they so readily and forcefully rejected the Medicaid expansion last year. The simplest answer is probably that these justices have long rejected the unconstitutional conditions doctrine. (Another possibility is that the dissenting justices agree with the policy of rejecting prostitution (see Justice Scalia's bizarre "free love" comparison) but disagreed with the policy of universal health coverage.)
While the spending power is still robust, I am not sanguine about the conversation the Court is trying to have with Congress about the Spending Clause. It will be interesting to see how the Court furthers this project in the same-sex marriage cases that are sure to be handed down next week. If the cases turn on the doctrine of federalism, then read in combination, the Roberts Court may be continuing its adventures in the Federalism Revolution, once thought done and gone, and now revived through the spending power.
Saturday, May 25, 2013
It's no secret that the night staff of a hospital are both over-worked and over-tired. Nor is it any secret that many medical errors occur at night. But until we look at the totality of the human factors making up medical error, we are unlikely to make significant headway in addressing it. A review of the literature suggests that the reason isn't a lack of understanding about the factors which cause human errors, it's concern about the cost of addressing them.
The authors of a recent study in the Journal of the American Medical Association titled, Relationship Between Occurrence of Surgical Complications and Hospital Finances conclude that not only aren’t hospitals doing all they can to reduce medical errors, they actually have no financial incentives to do so.
I'd suggest that financial incentives are behind ineffective efforts to address the issues of staff over-work and the inherent dangers of intermittent shift work.
It's no surprise that another widely reported recent study has found that reductions in the hours medical residents work has not resulted in increased patient safety. The study authors conclude that this is because although residents worked less hours, they did not have a reduced work load. So, like Lucille Ball in the chocolate factory, the trying to cram more work in the same amount of time increased resident error.
The findings of that study need to be seen in combination with the vast amount of scientific research on the increase in errors caused during night shifts. A recent study of nurses working night shifts showed that “on average, the error rate increase 6% after the second night shift in a row, 17% after the third successive night shift and an astounding 35% higher on the fourth night shift.” See also this and this article by the Joint Commission. Although no one disputes the reality that human beings perform best in the day time, every hospital must be fully staffed 24 hours a day. The information is both anecdotal and research based. But no one seems to be listening.
An article in Nursing World does an excellent job of using available research to describe the scope of the problem, but implies that it can be effectively addressed by nurses proactively paying more attention to their sleep patterns. It advises nurses working the night shift to “take control of sleep.” In fact the NSF “recommends that nurses wear wrap around sunglasses when driving home so the body is less aware that it is daylight.” This advice ignores the scientific reality that humans are not as effective or alert at night as they are in the day time. Nor does it consider the human reality that medical shift workers do not have the luxury of using their days to sleep. Like everyone else living in a diurnal world, they must cope with the tasks of family and daily living.
Techniques like wearing dark glasses may work in making a shift to a new rhythm--like travelling to another time zone. But given the unlikeliness of medical staff to convert to a permanent change in their circadian rhthyms, as if they were working in a submarine (and that doesn’t work very well either) the answer is to address the reality that humans are less effective at recognizing problems and completing complex tasks at night. But that’s not where the problem solving is going.
May 25, 2013 in Cost, Effectiveness, Health Care, Health Care Costs, Health Care Reform, Health Economics, Health Law, Hospital Finances, Hospitals, Insurance, Medical Malpractice, Nurses, Patient Safety, Payment, Physicians, Policy, Public Health, Quality, Quality Improvement, Reform, Research, Science and Health, Substance Abuse | Permalink | Comments (0) | TrackBack (0)
Friday, May 17, 2013
Two widely reported studies this week about bed rest for women at risk of preterm delivery and reduction of salt consumption in order to promote heart health highlight two things we don’t think about enough—that a lot of standard medical practices are without any foundation in science and a lot of legal ones probably are too. However, medicine has more and more taken the public health approach of examining the practices of individual doctors to see how effective they actually are in the general population. For example, it is old news that prescribing bed rest to pregnant women at risk of preterm delivery is not effective. But what this Obstetrics & Gynecology study found that “activity restriction”, such as quitting work, is still prescribed to one at three women at risk for preterm delivery. The accompanying “Bed Rest in Pregnancy: Time to Put the Issue to Rest” makes an ethical argument that continuing to prescribe bed rest in the absence of evidence of its effectiveness violates the principles of autonomy and beneficence.
The Institute of Medicine just issued this report Sodium Intake in Populations: Assessment of Evidence “found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes other than some CVD outcomes (including stroke and CVD mortality) and all-cause mortality.”
We have similar research in law- a lot of it coming from the Empirical Legal Studies movement, including work done at the Center for Empirical Legal Research at Washington University Berkeley Emperical Legal Research , the Centre for Emprical Legal Studies at UCL (formerly known as University College London) among many others, but it is not as well funded or coming from as well established sources as the studies which attempt to find an evidence basis for medical practices. The salt reduction report was commissioned by the Institute of Medicine In contrast, the ACLU supports its empirical argument that the death penalty does not deter crime on an opinion survey of police chiefs. Translating information from research scientists to practicing physicians is still a slow process,—but no one questions the underlying principle that medical practice should be based on scientific evidence.
Part of the issue is funding. Medicine as a whole is in a constant quest to contain costs and stopping ineffective practices is an important component of that effort. But beyond a small number of progressive funders like the Robert Wood Johnson Foundation, there isn’t a lot of demonstrable interest, the kind supported by funding studies, in law making bodies in finding out what legal practices work and what do not.
This isn’t a new observation. Bryant Garth outlined the problem in 1997 when he explained the importance of more social science research into the foundational principles of practices civil procedure. But the steady flow of studies questioning conventional wisdom coming from the medical field has, as yet, no real counterpart in the world of law making.
Of course there will always be the problem of knowing the unknowable. But it would be interesting for law makers to consider taking a lesson from public health in challenging assumptions about the human body and mind or even more generally the physical world that underlie both common law and statutes.
May 17, 2013 in Bioethics, Comparative Effectiveness, Cost, Effectiveness, Health Care Costs, Health Law, Innovation, Policy, Public Health, Quality Improvement, Reform, Research | Permalink | Comments (0) | TrackBack (0)
Saturday, May 11, 2013
Remembering the Bad Old Days of HIV/AIDS Exceptionalism--and How News from Kansas, an HBO Documentary, and Dancing with the Stars Can Teach Students To See it When it Happens Again
The controversy in Kansas over Sub HB 2183, which was passed into law on April 17th, 2013, puts me in mind of how difficult it is to explain the period of time when "aids specific" laws emerged. My purpose in highlighting this situation is not to get deeply involved in Kansas law or politics. It is pull together some material that may be helpful for teaching public health law to students unaware of the lessons we have learned from the laws proposed, and passed, specifically in response to the emergence of HIV/AIDS during the 1980’s. Without an understanding of the fear and panic that accompanied a disease for which there was no test, no treatment, no vaccine and which quickly killed young, healthy people within months of starting symptoms, it is easy to minimize the risk of such a thing happening today.
What Happened in Kansas
As I understand it, Sub HB 2183 was presented as a statute similar to those in almost every state intended to protect first responders and others who face occupational exposure to infectious
diseases and pathogens. It gives the State’s Department of Health the authority to develop a mechanism for mandatory testing or even isolation of the person who is the possible source of infection
if he is unable to give consent or if no surrogate decision maker can be found. Time is of the essence in these situations and the goal is to provide prophylactic treatment as soon as possible—not to stigmatize the source of infection.
One of the effects of Sub HB 2183 was to eliminate a bill passed in 1986 which specifically prohibited the State from quarantining individuals based on a diagnosis of HIV/AIDS. This led to concerns that people living with HIV/AIDS in Kansas would no longer be protected. Ann Gotlib explains these concerns, and their historical context, clearly in IJFAB-the International Journal of Feminist Approaches to Bioethics.
In an open letter to concerned citizens, the Secretary of Kansas’ Department of Health & Environment explained that “This bill was never about isolation or quarantine related to persons with HIV infection.” Instead, the bill “provides the authority for the secretary…to adopt administrative regulations for prevention and control of HIV in addition to the other specified infectious diseases under current law.” He continues to explain that the Bill reflects an attempt to modernize an old statute from that era, KS 65001, that specifically prohibits the state from quarantining or isolating individuals diagnosed with HIV/AIDS.
Without getting in to Kansas politics and law any deeper, KS 65001 is indeed is a good example of an “AIDS specific” law of that era in that it prohibits the State from quarantining individuals based on a diagnosis of HIV/AIDS. Indeed, according to the Kansas Equality Coalition, the Bill passed based on a compromise that involved creating “a list of diseases ‘not’ subject to quarantine, and to include HIV/AIDS in that list.”
What Kansas Can Teach
Public Health Students Today
Whatever the motivation for the legislation or its effect on
the citizens of Kansas, the controversy deserves attention and study just as would thediscovery of a “living fossil.” It gives us direct access to studying the past.
For anyone else looking for ways to bring that time alive, here are a few words about my experience