Friday, February 10, 2012
One of the peculiarities of our current approach to regulating innovative medical activities is the importance placed on determining whether a novel approach to a problem constitutes “research with human subjects.” If an activity is characterized as research, it is typically subject to an extensive system of prospective ethical oversight, designed to ensure that the rights and well-being of the participants will be adequately protected. By contrast, innovative medical activities that do not meet the definition of research can often be conducted without any prior review or approval, regardless of the risks or uncertainties involved.
Recent proposals to roll out a cholera vaccination campaign in Haiti, a country that has been devastated by a deadly cholera epidemic for the past 15 months, have led me to wonder about the sharp line we draw between research and non-research in determining the necessity of prior ethical oversight.
Given that the primary intent of such a campaign would be to benefit the Haitian people currently at risk of developing cholera, rather than to develop “generalizable knowledge” for the benefit of future populations, it is unlikely that such a campaign would be considered “research” as that term is typically defined. Yet, even if it does not technically constitute research, a campaign to distribute cholera vaccines in Haiti clearly raises significant ethical issues for which prospective oversight seems warranted.
For example, while a vaccine campaign would undoubtedly provide real health benefits to some individuals, it also involves risks, including the potential diversion of resources from interventions that offer greater long-term health benefits (particularly the improvement of water and sanitation systems) and the possibility of creating a false sense of security that reduces individuals’ willingness to engage in behavioral change. In addition to risks, vaccine campaigns can have significant implications for social justice and equity, particularly when there are insufficient vaccines for the entire population and decisions must be made about how scarce resources will be prioritized.
As NPR reports, the Swiss arm of Doctors without Borders has cited some of these concerns in its decision not to participate in the Haitian vaccination campaign, calling the campaign a “distraction” from more pressing issues of water and sanitation control.
Considerations related to risk-benefit assessment, social justice, and other ethical matters are precisely the kind of issues that must be formally assessed by interdisciplinary committees before a proposal to conduct research with human participants is allowed to proceed. Yet, for activities that do not meet the definition of research, there is no agreed-upon mechanism for prior ethical oversight, even when the ethical issues are substantial and the evidence basis is scant.
In a 2009 report that I helped draft, the World Health Organization called on policy-makers to ensure that “most, if not all, emergency public health activities are subject to some form of ethical oversight, whether or not those activities are formally characterized as research.” Those responsible for the decision to launch a cholera vaccine in Haiti would be well advised to take these recommendations to heart.
A big welcome to our guest blogger for the month of February, Carl H. Coleman, who is a Professor of Law at Seton Hall Law School where he serves as Director of Global Initiates for Seton Hall’s Center for Health Pharmaceutical Law & Policy and Gibbons Institute for Law, Science & Technology. He is the lead author of The Ethics and Regulation of Research with Human Subjects (Lexis, 2005, with Menikoff, Goldner, and Dubler), as well as numerous articles on health law and policy in leading legal and heath policy journals. During the 2006-07 academic year, he served as Bioethics and Law Advisor at the World Health Organization (WHO), and he continues to work closely with WHO on various projects related to ethics and public health. In addition, he is a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which is charged with providing expert advice to the Office for Human Research Protections of the U.S. Department of Health and Human Services.
Before coming to Seton Hall, he was Executive Director of the New York State Task Force on Life and the Law, where he worked on projects on assisted reproductive technologies, genetic testing and screening, physician-assisted suicide, and surrogate healthcare decision-making. He received his J.D., magna cum laude, from Harvard Law School, where he was Supervising Editor of the Harvard Law Review. Following law school, he served as law clerk to the Hon. James L. Oakes, Chief Judge of the U.S. Court of Appeals for the Second Circuit.
Thursday, February 9, 2012
Earlier this year, I reported on the murder prosecution of Bei Bei Shuai, a woman who swallowed rat poison in a suicide attempt while pregnant. While Ms. Shuai survived and doctors delivered her fetus by C-section, the baby died a few days later.
Yesterday, the Indiana Court of Appeals paved the way for Ms. Shuai to be released on bail nearly 11 months after she was jailed. However, the court declined to dismiss the murder charge against her.
Wednesday, February 8, 2012
For those who have been following disputes over drug shortages: late last year there was an interesting intervention from the American Antitrust Institute (AAI). As the AAI notes, "shortages ... illustrate the relationship between competition and public policy in healthcare." The AAI worries that certain business practices may be exacerbating drug shortages:
We set forth the basis for the concern that certain bundled discounting practices in the market for important pediatric and teenage (henceforth “pediatric”) vaccines may be anticompetitive. A number of recent cases (e.g., LePage’s Inc., v. 3M and FTC v. Intel) have given antitrust authorities the opportunity to reflect on the correct analytical frameworks for evaluating the competitive effects of bundled discounts and market-share or volume discounts. Because vaccination has positive spillover effects on those that are not immunized, the harms resulting from exclusionary bundled discounts also extend to the general population. This highlights the integral role that competition policy plays in achieving broader public policy goals in healthcare. As the lead antitrust agency in this area, the FTC is ideally positioned to probe bundled discounts involving vaccines to determine if further action is necessary.
Given extant antitrust concerns about GPO's, this is an area that bears further attention.
Compiled by Thomas L. Hafemeister, J.D., Ph.D., Assoc. Prof., Univ. of Virginia School of Law
Emily P. Walker, Memo Reveals Obama Thinking on Malpractice, MedPage Today, Feb. 3, 2012.
A memo from two White House aides to President Obama reveals the administration's thinking on medical malpractice reform and its role in passage of the Affordable Care Act.
The memo—and Obama's response to it—made clear that, in July of 2009, the president was most interested in an approach that included early disclosure of an error, an apology, and mediation, in hopes that it would secure buy-in on healthcare reform from the American Medical Association (AMA), which supported that approach.
Ultimately he didn't want to do anything on malpractice reform that would upset the chances that healthcare reform would pass.
The memo and the President’s hand-written response can be found in a Jan. 27 posting by The New Yorker. They are part of a lengthier article containing various memos from the President that explores “the making” of his Presidency published in The New Yorker. The Southern Methodist University Law Review has also published an article that similarly explores the approach taken to medical malpractice reform in the Affordable Care Act, what influenced the approach taken, and the likely consequences of that approach.
Mark Oppenheimer, A Counselor’s Convictions Put Her Profession on Trial, N.Y. Times, Feb. 3, 2012.