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As experts questioned the ethics of the study, documents show that expiring funds forced a rushed vote in Denmark, where the researchers’ university is based
Despite widespread criticism, a halted clinical trial of the hepatitis B vaccine in Guinea-Bissau moved forward last month for the most quotidian of reasons: $1.6 million in grant money needed by the Danish researchers conducting the study was expiring in the Centers for Disease Control and Prevention’s budget, Rolling Stone has learned.
The study seeks to examine whether the birth dose of the hepatitis B vaccine, used safely for decades, has potential negative health effects such as skin ailments or neurodevelopmental disorders. To do so, it plans to give the birth dose to only half of the 14,000 newborns enrolled, raising the risk that in a country where hepatitis B is endemic, the other 7,000 not provided the birth dose could face infection and lifelong consequences, including cirrhosis and liver cancer.
Though not routinely administered in Guinea-Bissau, the birth dose of the hepatitis B vaccine will become standard there in 2028. The study would provide vaccinations to all participants starting at six weeks of age, as is the current practice in Guinea-Bissau.
After the World Health Organization denounced the study, researchers revised the protocol last August to provide pregnant mothers with more advance screening for hepatitis B. The new protocol, posted on the website of the Bandim Health Project, the research organization leading the study, states, “Babies of mothers who are known to have hepatitis B, test positive, or whose status cannot be determined will not be randomized and will be offered the birth-dose vaccine promptly.”
Hepatitis B experts say the revisions do not resolve the study’s underlying medical and ethical problems, especially given Guinea-Bissau’s high rates of the disease. “Maternal screening alone cannot prevent transmission, and this study will leave infants vulnerable to exposure through undetected maternal infections, household contacts, or other routes of early childhood transmission,” says Dr. Robert Gish, director of the Hepatitis B Foundation.
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Rolling Stone was the first to report last week that the study had been resurrected and was on a path to final approval.
Given the ethics issues and risks to patients, the effort to evaluate the study should have been slowed down, not speeded up, says Dr. Arthur Caplan, founding head of the medical ethics division at NYU Grossman School of Medicine. “When subjects are in peril, in a dirt-poor nation, where charges of exploitation are flying, and knowing we have a treatment” that can help subjects, “that is the wrong place to hurry the review.”
But the ticking clock of expiring funds also placed members of an ethics research committee at the University of Southern Denmark (SDU) under time pressure with only about a month to consider whether to affirm the study, a safeguard subsequently added after irregularities in a Guinea-Bissau ethics review emerged.
That pressure led the SDU committee to shorten deliberations and schedule a vote before all members could be present, raising questions about whether the panel’s independence, as required by international ethics principles, was compromised to enable colleagues to obtain grant money, two of the committee members tell Rolling Stone.
On Sept. 30, the committee voted five to four to affirm the study, and the SDU dean of the faculty of health sciences gave final approval on Oct. 7.
“The committee’s assessment in this case was based on the revised protocol, the ethical issues identified during its deliberations and input from external experts,” a SDU spokesperson says. “The fact that the research was conducted by SDU researchers did not alter [the Research Ethics Committee’s] responsibility to carry out an independent” review.
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But Søren Birkelund, one of the committee members who was not able to vote, says, “The final decision by the board was far too hasty — not permitting me and the remaining board members being present at the final discussions.” He adds that he was “strongly against an approval,” as he had made clear in a previous post in a Danish medical news site.
Another committee member, who voted not to approve the study, Stig Børsen Hansen, tells Rolling Stone, “There was a clear connection between the deadline and us going straight to a vote.” He adds, “Working and reasoning under the pressure of knowing that people might lose their funding short-circuited the process. We reached a bad decision in a bad way.” Four members of the committee resigned in protest, as first reported by The Guardian. Hansen and Birkelund were among them.
Inside the CDC, as officials in the director’s office waited for a decision from the SDU ethics panel, the expiring funds led officials in the chief of staff’s office to search for alternate funding. On Sept. 17, an official there informed Stuart Burns, a senior advisor in the director’s office and ally of Health Secretary Robert F. Kennedy Jr. who had championed the study, “If we don’t obligate these funds by 9/30, we lose them and would need to request funding in FY27 to support this work if it moves forward.”
Ultimately, officials found funds that had been designated by Congress for global health security, according to interviews and documents obtained by Rolling Stone. Those funds could have been used to respond to the ongoing Ebola outbreak in the Democratic Republic of Congo, or to aid in pandemic prevention as a lab accident in Eastern Siberia has raised fears about a possible plague outbreak.
Last week, the University of Southern Denmark’s dean of the faculty of health sciences said the study could not move forward without final approval from health authorities in Guinea-Bissau. A news report on Friday, Oct. 9th, said Guinea-Bissau authorities had signed off on the study. But in a Tuesday press conference, the country’s health minister Quinhin Nantote denied this, Reuters reported, saying that the study would require further review. The CDC and Guinea-Bissau’s Ministry of Public Health did not respond to requests for comment.
The Danish researchers have vehemently defended the ethics of the clinical trial, asserting that no child would receive less than the standard of care in Guinea-Bissau, and no participant would be denied treatment they would otherwise receive. “The trial complies with current national policy in Guinea-Bissau and has been reviewed and approved by the competent national ethics committee,” Christine Stabell Benn, the lead Danish researcher, previously told Rolling Stone. She and her research partners did not respond to a request for comment for this story.
On Sept. 2, one of the Danish researchers, Frederik Schaltz-Buchholzer, emailed members of the SDU ethics committee, explaining that the research team had revised the protocol following the WHO’s critique of the trial.
He also noted that the researchers would allow the university’s committee to seek guidance from outside experts to assess the study. But he added, “Given the project’s time-limited policy context, we respectfully ask that the external consultation be initiated immediately.”
On Sept. 16, the committee’s administrator Jakob Ousager wrote in Danish to committee members, saying the researchers “expressed concern about what the involvement of external experts would mean for the time frame” of the committee’s deliberations. “According to the researchers, the project’s grant expires at the end of September, if at that time they do not have the green light to start.”
The next day, an official with the CDC’s chief of staff noted in an email to colleagues that if funds were not obligated by Sept. 30, they would be lost due to the end of the fiscal year.
In the back and forth that followed, the official in the chief of staff’s office wrote, “It’s my understanding from Stuart that we are waiting for University of Southern Denmark’s ethics office to approve this. If they approve, we can move forward with the award.”
It is not clear why the CDC, long viewed as a global leader in ethical standards, was relying wholly on the university whose researchers stood to benefit from the award.
By Sept. 21, as uncertainty over the timetable of the Danish university’s ethics panel persisted, CDC officials began to consider what other funds they should use. “Could we swap the annual measles fund for multi-year funds?” the official in the chief of staff’s office emailed an Office of Budget Services staffer. “This would allow [the Global Health Center] to redirect the measles annual funding to other priorities, and we’d have multi-year funds to use for the grant, if it ever gets approved.”
In addition to the problem of expiring funds, the researchers had faced an even more inexorable deadline. Starting in 2028, Guinea-Bissau will be providing the birth dose of the hepatitis B vaccine to all newborns and so one of the researchers’ central justifications for the study — that not providing the birth dose aligned with the current standard of care in Guinea-Bissau — will expire with that change.
However, the Helsinki declaration, a global set of ethical principles for research on human subjects, discourages a clinical trial from simply matching a local standard of care, if a higher, proven standard is available elsewhere.
On Sept. 30, the SDU ethics panel voted to approve the study and the CDC committed $1.6 million in global health security funds. The Pershing Square Foundation — established by billionaire hedge-fund manager Bill Ackman — had previously pledged $1.8 million.
As global public health experts renewed their criticism, Dr. Gavin Yamey, professor of Global Health and Public Policy at Duke University, tells Rolling Stone, “It doesn’t surprise me that the federal health leadership would take money away from where it is sorely needed and put it towards a study that is unrequired and deeply unethical and puts some of the world’s most vulnerable babies at risk of infection, suffering and early death.”
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But he asks of the researchers, “If there is a worldwide outcry among ethicists, why wouldn’t you listen to your critics?”
As medical ethicist Dr. Arthur Caplan puts it: “$1.6 million would go a long way in Guinea-Bissau if you just vaccinated everybody.”