After a global outcry over ethics, a demand for answers from a US congressional committee, resignations from a Danish ethics committee and sustained reporting from rolling stone and other media, a clinical trial of a hepatitis B vaccine in Guinea-Bissau, championed by Health Secretary Robert F. Kennedy Jr., and which was to be funded by the Centers for Disease Control and Prevention, “will not proceed,” one of the Danish researchers announced Wednesday on LinkedIn.
The study did not obtain “the necessary government approval” from Guinea-Bissau health authorities, wrote researcher Frederik Schaltz-Buchholzer.
The trial, which would have delivered a life-saving dose of hepatitis B vaccine at birth to only half of the 14,000 newborns enrolled in the study even though nearly one in five adults in Guinea-Bissau were infected with the disease, led public health experts to compare it to the infamous 40-year Tuskegee study, which denied syphilis treatment to African-American subjects.
Leading Danish researchers Christine Stabell Benn and Peter Aaby of the University of Southern Denmark, long praised by Kennedy for their research into the nonspecific and potentially harmful effects of vaccines, have consistently rejected this criticism. As recently as October 17, they asserted that no child would be deprived of a vaccine they would otherwise receive, as the hepatitis B birth dose will not become the norm in Guinea-Bissau until 2028: “In fact, the study expands access to the hepatitis B vaccine while it is not yet part of the national program,” they wrote. “This is very different from the frequently repeated suggestion that the trial would take vaccines away from children”
The protocol, which they revised in August after criticism from the World Health Organization, would screen expectant mothers for hepatitis B, provide vaccine doses to all participants starting at six weeks of age and was designed independently of Kennedy, they stressed. But that would still put newborns at risk of infection that could lead to lifelong consequences like cirrhosis or liver cancer, hepatitis B experts say.
Internal CDC emails first reported by rolling stone in January showed that the Guinea-Bissau study was a “funding priority” for Kennedy’s allies at the CDC. They pushed the study through as a no-bid contract, sparking alarm within the agency. Additionally, the study never underwent a full review by a CDC ethics committee, a lengthy but customary process designed to protect human subjects.
Critics feared that Kennedy would use the study to help support his efforts to end the birth-dose hepatitis B vaccine in the United States, although it has been proven safe and effective for decades. Last week, the WHO said that even with a revised protocol, the study remained unethical, rolling stone was the first to report.
As the government of Guinea-Bissau refused to give the green light this week, the study became a symbol of cratering medical ethics and misappropriation of funds by Kennedy’s CDC. “The excessive willingness of Secretary Kennedy and CDC political leaders to use CDC funding for a scientifically unfounded project that could result in harm and delay treatment of children should be examined by Congress,” said former CDC Surgeon General Dr. Debra Houry. “The use of these scarce federal funds should be focused on health threats, as intended.”
In February, rolling stone reported revelations of irregularities in Guinea-Bissau’s ethics review, including a signature on an approval letter used without the knowledge or consent of the appointed medical official, leading the University of Southern Denmark to halt the trial.
But by October 7, the study had been resurrected and was to be funded with Congressionally designated CDC money for global health security. A budget deadline sent the CDC scrambling for funds and led an ethics committee at the University of Southern Denmark, where the researchers are based, to rush its review.
From the beginning, the study has faced scrutiny due to its reliance on a single ethics review committee in Guinea-Bissau and the omission of a full CDC ethics review. A gap in Danish law meant that due to the ethics review being carried out abroad in Guinea-Bissau, the country’s national and regional committees could not review it separately.
After unsuccessfully trying to get the WHO or another European ethics committee to conduct an independent review, the University of Southern Denmark conducted its own, with a vote so hastily scheduled that committee members opposed to approval were not present.
On October 12, amid questions from rolling stone Regarding this regulatory gap, the rector of the University of Southern Denmark, Jens Ringsmose, wrote to the Danish Minister of Health to raise the question of “whether the minister will consider whether the principle of the Declaration of Helsinki should be reflected in Danish legislation”, to ensure that research protocols are reviewed by both sponsoring and host countries.
On Wednesday, researcher Frederik Schaltz-Buchholzer wrote: “In the English-speaking media, our proposed investigator-initiated trial has been misrepresented as the ‘Kennedy trial.’ He described the study as “the noblest and most valuable I have ever participated in.” »
To medical ethicists, the study was revealed from the start to be both ethically and scientifically compromised. “What worried me was that they were using the study and the Guinea-Bissau infants for their own purposes,” says Seema Shah, a bioethicist at Lurie Children’s Hospital in Chicago. “If you don’t look at the benefits of hepatitis B prevention, you’re looking at half the story and leaving out the other half.”
Gn Health
