The protocol reveals that the trial will withhold the Hepatitis B birth dose from thousands—without placebos, without universal maternal screening, and with endpoints critics call indefensible.
As a 15 year veteran of several IRBs, I am gobsmacked and sickened by this. No undergrad designing such a study would pass their course: it's unethical, unable to demonstrate its stated goals, exploitive, unsafe - likely lethal on a large scale, incompetent. That our money will go to enable such corrupt and dangerous "research" is unacceptable. Senator Cassidy take note - you bear much responsibility for RFK and his sequellae. I am ashamed of our government.
What makes this so disturbing is not a single bad study or a disputed endpoint. It is the systematic bypassing of ethical and scientific safeguards that exist precisely to prevent this kind of harm.
A proven intervention is being placed at risk of withholding from newborns in a high prevalence setting, without universal maternal screening, without meaningful endpoints, and without the normal review processes that govern human subjects research. That is not innovation. It is ideological experimentation dressed up as science.
When public health leadership tolerates this, the failure is no longer technical. It is moral. This is why comparisons to Tuskegee are not rhetorical excess but structural accuracy.
Dispiriting news. The New Republic passed it on this afternoon with credit to Inside Medicine and I would be surprised if it does not show up on Stat news in the morning tomorrow. Hope you get a good night's sleep. Keeping the public informed is crucial given the fracture of the health care system and our relationship to the rest of the world.
This week I had the flu and it was a real wake up call to not be able to be tested in time for Tamiflu to be helpful. Fortunately, I did not have A or B and am hydrating my way back to normal at age 80! Don't burn yourself out! We need you!
Thank you, Dr. Faust and colleagues!! We need to know what our government is doing. As a non-medical professional with advanced degrees that did require research classes, I can add my voice in saying that this is a scientific and shocking humanitarian disgrace. It's hard to feel helpless when you see this happening!! Hopefully it is stopped.
Great article. I’m not completely following your math (for example, in the section about testing all mothers, 14500 x .19 actually = 2,755), but this trial is incredibly unethical, and the fact that the important long-term consequences (chronic hep B and its sequelae) of withholding the vaccine aren’t being studied is unbelievable.
As a 15 year veteran of several IRBs, I am gobsmacked and sickened by this. No undergrad designing such a study would pass their course: it's unethical, unable to demonstrate its stated goals, exploitive, unsafe - likely lethal on a large scale, incompetent. That our money will go to enable such corrupt and dangerous "research" is unacceptable. Senator Cassidy take note - you bear much responsibility for RFK and his sequellae. I am ashamed of our government.
What makes this so disturbing is not a single bad study or a disputed endpoint. It is the systematic bypassing of ethical and scientific safeguards that exist precisely to prevent this kind of harm.
A proven intervention is being placed at risk of withholding from newborns in a high prevalence setting, without universal maternal screening, without meaningful endpoints, and without the normal review processes that govern human subjects research. That is not innovation. It is ideological experimentation dressed up as science.
When public health leadership tolerates this, the failure is no longer technical. It is moral. This is why comparisons to Tuskegee are not rhetorical excess but structural accuracy.
Dispiriting news. The New Republic passed it on this afternoon with credit to Inside Medicine and I would be surprised if it does not show up on Stat news in the morning tomorrow. Hope you get a good night's sleep. Keeping the public informed is crucial given the fracture of the health care system and our relationship to the rest of the world.
This week I had the flu and it was a real wake up call to not be able to be tested in time for Tamiflu to be helpful. Fortunately, I did not have A or B and am hydrating my way back to normal at age 80! Don't burn yourself out! We need you!
Thank you, Dr. Faust and colleagues!! We need to know what our government is doing. As a non-medical professional with advanced degrees that did require research classes, I can add my voice in saying that this is a scientific and shocking humanitarian disgrace. It's hard to feel helpless when you see this happening!! Hopefully it is stopped.
Thanks for this. Paul Offit wrote a good piece about this the other day. Worth reading too. Just when you think they can’t stoop any lower. 😳
This study is a travesty on so many levels. It is also unethical. Thanks for reporting. How can we do something to stop it?
Great article. I’m not completely following your math (for example, in the section about testing all mothers, 14500 x .19 actually = 2,755), but this trial is incredibly unethical, and the fact that the important long-term consequences (chronic hep B and its sequelae) of withholding the vaccine aren’t being studied is unbelievable.
I’ll double check the math. I was up all night writing this, so there could be an error 🙃