MENTALHEALTH.INFOLABMED.COM - A controversial clinical trial investigating the birth dose of the hepatitis B vaccine in Guinea-Bissau has advanced, driven by the urgent need to utilize $1.6 million in grant funding from the Centers for Disease Control and Prevention (CDC) before its expiration. This development, revealed by Rolling Stone, comes despite significant ethical objections raised by global health authorities and experts.
The Study's Objectives and Ethical Concerns
The research, spearheaded by Danish scientists from the Bandim Health Project, aims to scrutinize potential negative health effects, such as skin conditions or neurodevelopmental issues, linked to the hepatitis B birth dose.
This vaccine, widely used and considered safe for decades, is administered at birth in many countries.
However, this study proposes to give the birth dose to only half of the 14,000 enrolled newborns in Guinea-Bissau.
This approach carries a significant risk, as hepatitis B is endemic in the region, potentially exposing the 7,000 infants not receiving the immediate birth dose to infection and long-term health consequences like cirrhosis and liver cancer.
While Guinea-Bissau is set to implement the hepatitis B birth dose as standard practice in 2028, the current protocol involves vaccinating all participants from six weeks of age.
The study's design to withhold the birth dose from a randomized group has drawn sharp criticism.
World Health Organization's Stance and Protocol Revisions
The World Health Organization (WHO) has unequivocally denounced the study, labeling it as unethical.
In response to the WHO's critique, researchers revised the study protocol in August, introducing enhanced screening for hepatitis B among pregnant mothers.
The updated protocol, accessible on the Bandim Health Project website, states that infants born to mothers with known or positive hepatitis B status, or whose status is uncertain, will not be randomized and will receive the birth-dose vaccine promptly.
Despite these modifications, the WHO maintains its stance.
"Even with the new protocol," stated WHO spokesperson Tarik Jašarević, "the study is unethical."
Researchers and Institutions Defend the Study
Dr.
Christine Stabell Benn, the lead Danish researcher, defended the study's ethical framework, asserting that ethics is subjective and that reasonable individuals and independent committees can interpret risks, benefits, and scientific value differently.
She emphasized that the revised protocol underwent independent review and approval by ethics committees in both Guinea-Bissau and the University of Southern Denmark (SDU).
Jakob Grausland, Dean of the Faculty of Health Sciences at SDU, noted that the WHO had previously declined SDU's request for an independent ethics review, making their current assessment noteworthy.
SDU has also petitioned the Danish Minister for Health to amend Danish law to align with the Helsinki Declaration, potentially enabling the national ethics review committee to assess overseas clinical trials.
Expert Opposition and Funding Pressures
Medical experts remain unconvinced by the revised protocol.
Dr.
Robert Gish, director of the Hepatitis B Foundation, argued that maternal screening alone is insufficient to prevent transmission, leaving infants vulnerable to exposure through various routes.
The urgency to proceed with the study was compounded by the looming expiration of $1.6 million in CDC grant money.
Internal emails reveal that CDC officials were actively seeking alternative funding by September 30, 2020, to avoid losing the funds, which were designated for global health security and could have been allocated to other critical initiatives like Ebola response or pandemic prevention.
Dr.
Arthur Caplan, founding head of medical ethics at NYU Grossman School of Medicine, criticized the accelerated review process, stating that expediting evaluations when participants are at risk in a low-income nation, facing accusations of exploitation, is inappropriate, especially when effective treatments exist.
Questions Surrounding the Ethics Review Process
The timeline imposed by the expiring grant also placed pressure on the ethics research committee at the University of Southern Denmark.
With approximately one month to review the study, a process that included a safeguard for irregularities found in the Guinea-Bissau ethics review, the committee's deliberations were reportedly shortened.
Two committee members shared with Rolling Stone concerns that the panel's independence might have been compromised to facilitate the acquisition of grant money.
On September 30, the committee voted five to four to affirm the study, with SDU Dean Jakob Grausland granting final approval on October 7.
A spokesperson for SDU stated the committee's decision was based on the revised protocol, identified ethical issues, and external expert input, asserting the review was independent despite the research being conducted by SDU researchers.
However, committee member Søren Birkeland, who could not vote, described the decision as "hasty." Stig Børsen Hansen, another committee member who voted against approval, indicated a direct link between the funding deadline and the rushed vote, stating, "Working and reasoning under the pressure of knowing that people might lose their funding short-circuited the process." Four committee members, including Hansen and Birkeland, resigned in protest, as initially reported by The Guardian.
Uncertainty Over Final Approval and Future Steps
The University of Southern Denmark initially stated that the study required final approval from health authorities in Guinea-Bissau.
While a news report on October 9 suggested the study had been signed off, Guinea-Bissau's health minister, Quinhin Nantote, denied this in a press conference on Tuesday, indicating further review is necessary.
Neither the CDC nor Guinea-Bissau's Ministry of Public Health responded to requests for comment.
The CDC's reliance on the University of Southern Denmark's ethics office for approval, without conducting its own independent ethical assessment, raises questions about the agency's standard practices, particularly given its reputation as a global leader in ethical oversight in health research.
As uncertainty persisted regarding the Danish ethics panel's timeline, CDC officials explored alternative funding mechanisms, including potentially reallocating funds designated for other global health initiatives.
