from the tiny-little-coffins dept

In all of our coverage of the disastrous tenure RFK Jr. has had as Secretary of HHS, we have not yet discussed a bonkers study the CDC planned to fund in Guinea-Bissau. This hepatitis B “vaccine trial” was supposed to already have been kicked off, but it has been suspended since January instead because of the plainly unethical methodology for the trial, combined with the understanding that the two researchers employed to run it are virulent anti-vaxxers.

The trial was suspended in January after its unethical design came to light and drew international outcry. Although the trial is still halted, staff of the CDC director’s office told the agency’s budget office in late September to set aside $1.6 million to fund the trial, according to a report by Rolling Stone. The money was to be pulled from funding for the CDC’s global health security programs, which might otherwise go toward efforts like combating the Ebola outbreak currently raging in the Democratic Republic of the Congo.

If the trial moves forward, it would be funded by the US but run by Danish researchers, who have separately been accused of misconduct. In December, the CDC announced the award of an unsolicited grant for $1.6 million to a research group at the University of Southern Denmark, led by married couple Christine Stabell Benn and Peter Aaby. The pair have produced numerous studies that have been promoted by anti-vaccine advocates, drawing concern and criticism from researchers. Stabell Benn and Aaby are currently under investigation by Danish authorities over allegations of “falsification” and “scientific misconduct” related to previous vaccine research.

So, what makes the design of the trial unethical, beyond the notion that the two researchers are known bad-actors on the topic of vaccines? Well, let’s start with the fact that this trial is not designed to study the efficacy of the hepatitis B vaccine at all. We already have plenty of data on that that suggests the vaccine is safe and effective overall. No, this study is designed specifically to find harmful outcomes from the vaccine. To do that kind of study, the researchers planned to enroll 14,000 newborns in Guinea-Bissau in the trial and give half of them the vaccine and withhold it from the other half to study the health outcomes of the children.

In case that didn’t land properly: The study is designed to knowingly expose 7,000 children to hepatitis B, which can have immensely deleterious long-term health outcomes if exposed.

But wait, you might say. Are these children that would otherwise have ready access to the hep B vaccine? The answer is, in large part, no they would not. The government in Guinea-Bissau is born of a recent coup and it’s ability to deliver on basic government services has been wanting, to say the least. But that does not, in any way, make this trial more ethical.

Stabell Benn and Aaby have argued that the trial is not unethical because newborns in Guinea-Bissau are currently not routinely given a dose of hepatitis B vaccine at birth. But outside experts point to ethical guidelines, such as the Declaration of Helsinki, which requires trials to provide the “best proven intervention”—which is a birth dose of hepatitis B vaccine—regardless of whatever the current standard is in the country hosting the trial. Placebos may only be used when there is no proven intervention or there is “compelling and scientifically sound methodological reasons” to withhold a proven intervention.

In a scathing rebuke in February, the World Health Organization laid out a bullet-point list of “why withholding the vaccine is unethical.” The WHO notes that the entire premise of the trial is based on “hypothetical safety outcomes without sufficient credible evidence,” which don’t justify putting newborns at risk. The agency also blasted Stabell Benn and Aaby’s defense of the trial, saying: “Resource constraints cannot be used to justify withholding proven care in a research study involving people. Ethical obligations require minimizing risk and ensuring a prospect of benefit for participants.”

RFK Jr. has a pattern building of this sort of thing. Emails released show that he almost certainly lied in congressional hearings about his adventures in Samoa in 2019, after which the country experienced a tragic outbreak of measles that claimed over 83 deaths. Brown people are fit for experiments designed to boost Kennedy’s ego, it seems.

The CDC recently planned to grant even more taxpayer money to Stabell Benn and Aaby, but they’ve now run into an even bigger problem that worldwide condemnation: a police raid by the government of the study’s offices.

Police in Guinea-Bissau raided the offices of Danish researchers on Monday, seizing doses of hepatitis B vaccine intended for a vaccine trial for newborns. International health experts have called the trial “unethical,” but anti-vaccine Health Secretary Robert F. Kennedy Jr. has attempted to fund it with US taxpayer dollars.

Now it appears that officials in Guinea-Bissau have opened an investigation into Aaby and Stabell Benn’s work. In a Facebook post Monday, translated from Portuguese, the judicial police announced they carried out a “search operation at the facilities of the Bandim Health Project in Bissau, which culminated in the seizure of a batch of hepatitis B vaccines intended for vaccination of children in the country.”

I’ll just say that I hope the government there has access to enough quality scientists to do a very thorough investigation as to what precisely is in the hep B vaccines that were intended for use in this study. I’d be very curious to know just what is in them. Call it a hunch.

But, regardless, it should horrify us all that our own tax money is being used to fund this kind of unethical study. The trolley problem is famous for a reason, after all, and the idea is not generally to want to purposefully put yourself at the switch in that problem. That’s precisely what these “researchers” intended to do, all to go looking for any evidence for a conclusion they reached long ago.

Filed Under: anti-vaxxers, cdc, christine stabell benn, guinea-bissau, hepatitis b, hhs, medical ethics, peter aaby, rfk jr., vaccines, who