HealthLawProf Blog

Guest Blogger Carl Coleman: Ethical Questions Over Vaccination Campaign in Haitii

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.

- Carl H. Coleman

Introducing Guest Blogger Professor Carl H. Coleman

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.

Prosecutors and Pregnancy Update

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. 

[DO]

Potentially Exclusionary Bundled Discounts for Pediatric Vaccines

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. 

[FP]

Health Law Headlines of the Week (Week of Jan. 29, 2012)

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.

In 2009, Julea Ward, a teacher and an evangelical Christian, was studying for a master’s degree in counseling at Eastern Michigan University in Ypsilanti. As part of her training, she was required to treat clients, and she expressed her reluctance to work with any who were in same-sex relationships. A professor, heeding Ms. Ward’s wishes, referred a gay client to another counselor.

That seemingly simple request became a problem for Ms. Ward when the university expelled her for having made it. Ms. Ward sued, and her case raises the question of whether a counselor’s religious convictions can disqualify her from the profession.

A federal court dismissed Ms. Ward’s claim of religious discrimination. But on Jan. 27, the United States Court of Appeals for the Sixth Circuit ordered the lower court to rehear the case, finding that Eastern Michigan “cannot point to any written policy that barred Ward from requesting this referral.”

The Sixth Circuit ruling can be found here. The article notes that the Sixth Circuit distinguished “another recent case, Keeton v. Anderson-Wiley, in which Jennifer Keeton, a counseling student at Augusta State University, in Georgia, was required to enter a remediation program because she said she planned to tell gay clients that homosexuality was wrong,” with the Eleventh Circuit ultimately ruling “Augusta State had done nothing wrong in removing Ms. Keeton, who had refused to enter remediation, from its program.” The Eleventh Circuit ruling can be found here, while a Dec. 11 article discussing the Eleventh Circuit's ruling can be found in The Chronicle of Higher Education.

Michael Smith, Child Abuse in One Year Costs Billions in Long Run, MedPage Today, Feb. 3, 2012.

The lifetime costs—including healthcare, lost productivity, and criminal justice costs—of all the children abused in the U.S. over a single year total up to $124 billion, researchers reported.

The figure . . . is based on an estimated lifetime cost of $210,012 for each nonfatal case and nearly $1.3 million for each fatal case. . . . The estimated burden of child abuse on an individual basis is comparable to such public health problems as stroke and type 2 diabetes. . . .

Maltreatment of children—including physical, sexual, and psychological abuse, as well as simple neglect—has been shown to have lifelong health, social, and economic consequences, the researchers noted. . . . The consequences include increased medical needs, a higher risk of becoming involved in crime, and a greater need for special education . . . .

The report itself was published this week in Child Abuse & Neglect (accompanied by another article that addresses the consequences of children being exposed to Intimate Partner Violence, which can be found here). The Centers for Disease Control and Prevention issued a related press release, as well as examples of “demonstrated” “effective” programs for responding to child abuse and additional related data. A Ohio Northern University Law Review article identifies and describes the various governmental responses to child abuse (as well as their history) and explores their respective effectiveness.

Denise Lavoie, Bone Marrow Donor Recruiting Cases Settled, CBS Boston, Feb. 2, 2012.

A bone marrow registry and medical laboratory company that used fashion models wearing high heels and short skirts to recruit potential donors will pay the states of Massachusetts and New Hampshire $770,000 for engaging in an improper marketing practice, officials in both states said Thursday. . . .

According to a final judgment filed Thursday in Suffolk Superior Court, the registry and lab company — both subsidiaries of UMass Memorial Health Care — will pay restitution to Massachusetts consumers for any out-of-pocket payments they previously made for donor testing.

They will also pay the state $500,000 for initiatives to improve health care services and to combat unlawful marketing practices . . . . They also agreed to not charge health plans more than $175 over the next five years for donor testing.

New Hampshire Attorney General Michael Delaney Thursday announced a separate consent judgment in which UMass Memorial will pay the state of New Hampshire $200,000 in civil penalties for unfair and deceptive practices . . . and donate $100,000 to the National Bone Marrow Registry.

Delaney said UMass Memorial violated the public’s trust by overcharging for testing done by its lab and paying commissions to employees who lured donors who had private insurance.

An article appeared in The Denver Post last summer, which reported that the long waits of the tens of thousands of “transplant hopefuls in medical purgatory, already at five years' wait and moving toward 10 in some states, is pushing more and more donation advocates into previously taboo territory: removing longtime prohibitions on paying donors for their healthy organs.” A recent article in The Washington Post addresses the additional barriers that individuals with mental disabilities may face in obtaining an organ transplant. An article published by the University of Kansas Law Review addresses possible fiduciary duties associated with the marketing of medical products and services.

Dina ElBoghdady, Some Doctors Try to Squelch Online Reviews, Wash. Post, Jan. 28, 2012.

Fuming about a billing dispute with his dentist, Robert Allen Lee posted his complaints on two consumer review Web sites, triggering a legal battle over a technique designed to snuff out negative online commentary.

In late August, a day after Lee posted his comments on Yelp and DoctorBase, he received a letter from the dental practice threatening to sue him for at least $100,000 for “defamation, slander and libel.” The letter reminded him that he’d signed an agreement with his dentist that barred him from publishing a critique of her or her office.

While extreme, such do-not-talk contracts underscore the struggle between consumers that are eager to share their thoughts online and companies that are looking for ways to protect their reputations in an environment in which social media helps shape opinions on just about everything.

A recent article published by Kaiser Health News discusses the patient safety ratings of thousands of the nation’s hospitals reported at the website of the Centers for Medicare and Medicaid Services, with a parallel article on hospital errors published by the Washingtonian.

An interesting related article appears in The New York Times, describing a web site with social network features where users can post medical questions and doctors can provide brief replies, with fellow physicians able to show if they concur with the advice given and the users able to show their appreciation with a “thank you.” A doctor who receives twenty-five thanks is given a “Doogie Howser Award” and a physician who receives fifty thanks receives a “Dr. Heathcliff Huxtable Award.” It is suggested that “[b]y participating, doctors who want to attract new patients have a chance to gain visibility.” The article also reports that the owner of the website, which was started last May, “says that it has signed up more than 9,000 physicians and that it is adding 100 a day.”