Guest post: The CDC hepatitis B study is unethical and must never be published

The Committee on Publication Ethics (COPE), an international organization that establishes best practices for scholarly journals, has endorsed specific ethical standards for studies that involve vulnerable groups. Among these standards is this statement in the Declaration of Helsinki: “Reports of research not in accordance with this Declaration should not be accepted for publication.” The current controversy about the U.S. Centers for Disease Control and Prevention (CDC) funding for a proposed study of hepatitis B vaccines in Guinea-Bissau must serve as a reminder of this core requirement of publication ethics.

An unsolicited $1.6 million grant to the Bandim Health Project at the University of Southern Denmark (SDU) would randomly assign more than 14,000 newborns into two groups, those who would receive the vaccine at birth and those who would act as a control group with delayed vaccination. The purpose of the controversial study was to assess the “broader health effects” of the vaccine for the control group. 

But we already know the most critical health effect beyond the 48-months of the study: Withholding vaccination will predictably result in an increased incidence of liver disease later in life, including liver failure, cirrhosis and cancer. Therefore, the true scale of the tragedy brought on by this study would never be fully be known.

Already patently unethical, the study design would also exploit one of the world’s poorest countries, where more than 50 percent of its population live in poverty, according to the World Bank. The Center for Infectious Disease Research and Policy of the University of Minnesota reports that about 1 in 5 people born in Guinea-Bissau has chronic hepatitis B, that 9 in 10 babies who are exposed at birth develop a chronic infection and that 1 out of 4 of them will die of hepatitis B-related liver disease. 

There is a larger bizarre context surrounding this now paused study: The Trump administration’s Advisory Committee on Immunization Practices voted in December to abandon a 30-year recommendation that all babies born in the U.S. be vaccinated for hepatitis B at birth. This is a recommendation that flies in the face of the best available evidence about the dangers of failing to vaccinate. The World Health Organization and pediatric and infectious disease groups uniformly recommend hepatitis B vaccination at birth. It is only Kennedy and his cadre of anti-vaccination zealots who see harm from a beneficial vaccine where none has been shown and sought to initiate a study to vindicate their dangerous view.

How, then, should science journals respond to efforts by the SDU investigators to publish results if the study goes forward? Following the COPE guidance, none of that data should be published. Unlike flawed analysis or intentional fraud, unethical research is a moral failure at the outset, one that is evident not only to the scientific community but to the world at large. Journal editors therefore have a special responsibility to ensure that studies that violate consensus moral standards do not find their way into their pages. In the last two decades there has been an uptick in retractions for ethical violations and lack of ethics approval — retractions that could be prevented by abiding by COPE guidelines and not publishing the research in the first place.   

This is not a matter of censorship or “cancellation” of results that do not square with biases. It is a question of ensuring that there are no incentives for unethical research. The responsibility of journal editors is clear: No “data” from any discriminatory and life-threatening study including this one should be published.

The Guinea-Bissau Hepatitis B study is not a hard case. No study that is sure to expose newborns to a life-threatening involvement with a well-understood fatal disease that can easily be prevented is justifiable. Responsibility for even proposing manifestly unethical research falls on many parties, in this case not only the CDC funding agency which, before pushback, had contracted for the investigation but also the study group involved and Danish health and science authorities who approved it. The leadership of the University of Southern Denmark itself must also be called to account. 

To be sure, there are other ways to publish data these days, and there are plenty of disreputable outlets that might enjoy the attention that a prominent scandalous research project would attract. But that does not change the duties of responsible publication outlets. The community of legitimate journal editors recognized by their peers as upholding moral standards must, to maintain their legitimacy, draw a bright line. 

Art Caplan is soon to retire as a Professor at NYU Grossman School of Medicine.

Jonathan D. Moreno is the David and Lyn Silfen University Professor Emeritus at the University of Pennsylvania.

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