February 25, 2012
ACA and Disparities
I was recently speaking at the Conference on Race, Class, Gender and Ethnicity (CRCGE) at UNC-Chapel Hill. I heard a terrific talk by Ronny A. Bell on health disparities, which mentioned many initiatives in the ACA that aim to narrow the health disparities gap. Here is a bit on Bell's background:
Dr. Bell is Professor in the Division of Public Health Sciences, Department of Epidemiology and Prevention, Wake Forest University School of Medicine, with training in nutrition and epidemiology. Dr. Bell’s primary interests are chronic disease prevalence and risk factors, with particular emphasis on ethnic minority populations. He is Director of the Maya Angelou Research Center on Minority Health. Dr. Bell served as the Principal Investigator of the HEARTQUEST project, an NHLBI-funded contract serving as one of six vanguard Enhanced Dissemination and Utilization Centers (EDUCs) nationwide. The project targeted African Americans, Native Americans and whites in Robeson and Columbus counties, North Carolina, to address the tremendous cardiovascular disease burden in these communities.
While on my way to the conference, I read John McDonough's post on the need for critics of the ACA to propose their own methods of improving health care in the US. I am particularly interested in whether critics of the Act have proposals to address disparities, or prefer to redefine or deny the problem.
Imagining The Next Quarter Century of Health Care Law
On the occasion of the twenty-fifth anniversary of the Hall Center for Law and Health, we are pleased to announce this year's Indiana Health Law Review Symposium. A stellar group of health law scholars will celebrate this important milestone by looking ahead to the next quarter century of health care law and policy, casting their critical predictive analyses on the major themes of the field. Topics range from finance and access through quality and ethics to emerging scientific and technological challenges.
Making the event even more special will be this year's McDonald-Merrill-Ketcham Lectureship and Award for Excellence in Law and Medicine, jointly sponsored by the Indiana University School of Medicine and the Indiana University Robert H. McKinney School of Law. We are proud to announce that the 2012 awardee is Wendy Mariner, the Edward R. Utley Professor of Health Law, Bioethics & Human Rights at Boston University.
February 24, 2012
Worth Reading This Week
Susan Appleton, Reproduction and Regret, SSRN/Yale Journal of Law & Feminism
Alan Rubel, Justifying Public Health Surveillance: Basic Interests, Unreasonable Exercise, and Privacy, SSRN/Kennedy Institute of Ethics Journal
Robert G. Hauser, Here We Go Again — Another Failure of Postmarketing Device Surveillance, NEJM
Steven J. Willis & Nakku Chung, No Health Care Penalty? No Problem: No Due Process, SSRN/AJLM
Marsha Gold, Medicare Advantage — Lessons for Medicare's Future, NEJM
February 21, 2012
Guest Blogger James T. O'Reilly: Changing The Culture of Those Who Market Probotic Cultures
Fecal transplants, anyone? Yes, if you have a clostridium difficile infection, the best medicine may be to have a gastroenterologist implant a piece of non-infected fecal matter into your rectum and allow it to dissolve. No, please, no rush of donors to volunteer. Before health law profs choke, gag, or put this into an exam question, the science of the lower bowels is becoming a major area for study. You’ll have a gut feeling that there will be a lot coming out on this topic, most of it banned from polite tableside conversation….
The National Institutes of Health study of probiotics regulatory options has wrapped up its third and final two-day session on Feb. 17 at the University of Maryland, with a report to follow this spring. Probiotics, including pills, yogurts, and liquids, are a potential billion-dollar market opportunity for bowel problems. If you’re just a regular guy like me, you can leave the marketing to Jamie Lee Curtis and other Activia activists. But for many, the bloating and gas and sometimes serious infections pose an opportunity for the preventive consumption of millions of special bacilli which re-populate the intestinal flora and are hoped to reduce the problems in the humane microbiome.
As a member of the study dialogue, I recommended that the probiotics marketers who now have an “anything goes” approach should be constrained to tell the whole relevant truth. If they label their product with probiotic claims, there must (at the end of the marked shelf life) be enough active biologic entity in the consumer’s dose of that product, such that the probiotic will actually deliver the promised benefit. A yogurt whose Cosmo ad promised faster “transit time” in the gut (and we’re not talking speedier subway cars) must actually deliver. To get to the enforcement of this ideal state the FDA and FTC must have clear guidance, hence the NIH’s efforts.
I recommended to NIH and FDA the use of the OTC Monographs (21 CFR Parts 330 et seq.) as the readily available, Supreme Court-blessed, no statute needed, mechanism for the characterization of biologic contents, effectiveness studies, supporting documentation and actually defensible marketing claims. To say that industry threw a lot of anal output my way is to say it mildly. The probiotic toothbrush makers, the probiotic lipstick makers and the goddess of yogurt-borne regularity will not embrace FDA review and FTC norms. They prefer to be vendors of pricier versions of old, normal, little-regulated foods or cosmetics or within that magical, regulation-eluding mélange cloaked as “dietary supplements”. We’ll watch for the final report and will cover it in this blog, but for now, probiotic fans must caveat their emptor, each time they empty their wallets. Wishing you all faster transit time and fewer consumer frauds…..
Guest Blogger Carl H. Coleman: What to Look for at This May's World Health Assembly: An International Convention on R&D for the Developing World?
I spent most of last week participating in the second annual Executive Course on Intellectual Property, Diplomacy, and Global Public Health, co-sponsored by Seton Hall Law School and the Graduate Institute of International and Development Studies in Geneva. One of the key issues discussed in the course was a World Health Organization (WHO) working group’s recent recommendation for the adoption of a binding international convention to promote research and development related to diseases predominantly affecting developing countries. The proposal is expected to be on the agenda for the May 2012 meeting of the World Health Assembly (WHO’s governing body), where it is likely to generate significant discussion.
The recommendation is grounded in a recognition that our existing intellectual property system—under which companies recoup their R&D costs by patenting their products and selling them to end users at high monopoly prices—provides no incentive to develop products that will be used primarily by individuals who have no money to spend.
Creating an alternative financing system for medical products predominantly used in developing countries raises several challenging issues. First, funding for R&D has to come from somewhere; companies cannot be expected to invest the resources necessary to invent medical products for developing countries if they have no reasonable expectation of recovering their costs. While voluntary donations can help in the short term, a stable and sustainable system will depend on binding financial commitments by WHO members. In a time of global financial insecurity, convincing governments to make these commitments may be a hard sell.
Even if governments can be convinced to make the necessary financial commitments, a second challenge remains: determining where the funds are best directed. Ideally, funding should go to developing products that actually result in significant health improvements for the world’s population, but it is impossible to know in advance whether a particular line of research will end up producing public health gains. One possible solution to this problem is awarding prizes to researchers who achieve pre-defined objectives. Unlike traditional research grants, which are awarded prospectively based on judgments about a project’s potential, a prize system does not pay anything unless the research actually succeeds.
The trick with a prize system is determining the circumstances under which prizes should be granted. At one extreme, prizes could be offered for fully achieving public health outcomes that are undeniably important—for example, a prize for creating a safe, effective, and inexpensive vaccine for HIV, tuberculosis, or malaria. The problem is that, from the perspective of a particular research team, the likelihood of achieving such a broad objective in a reasonable period of time is likely to be too low to warrant a significant investment of resources up front. An alternative approach is to award “milestone” prizes for achieving smaller steps along the product development pathway. This approach provides more realistic incentives, but achieving a milestone is no guarantee that a successful product will result. As such, a milestone system is likely to result in some prize money going to research that ultimately produces no public health benefits at all.
An intriguing approach that has received a great deal of attention in the academic literature is the Health Impact Fund, championed by philosophy Professor Thomas Pogge of Yale University. Under that approach, funds would be awarded based on the demonstrated health impact of new medical products, as measured by the extent to which using the product causes individuals to experience additional quality-adjusted life years. Because Health Impact Fund payments would depend on a product’s demonstrated impact on the health status of the intended beneficiaries, companies would have an incentive not only to create the product and put it on the market, but also to engage in activities that promote the product’s accessibility and correct use. Unfortunately, the latest report from the WHO working group suggests that the members were not enthusiastic about adopting the Health Impact Fund model, perhaps based on concerns about the complexity of administering it.
However the details of the system are ultimately worked out, the fact that serious attention is being given to incentivizing the development of medical products for developing countries is an encouraging development. Let’s hope that this May the process of creating a binding international agreement will finally begin in earnest.