What my friend, who has been in the pharmaceutical business for decades, tells me is a drug company can't conduct a clinical trial of a drug unless the ethical oversight committee approves it. But get this. The committee is required to have a member who knows nothing about medical care, drugs, and clinical trials. This person is supposed to represent the regular guy on the street. And yet how can an ignorant committee member help evaluate clinical trials?
I am still awaiting a response from the IRB on whether it is ok to ask my kids what they want for dinner. Fortunately the little ones figured out how to find the crackers.
While there were certainly bioethicists who opposed challenge trials, there were also many prominent ones, such as Peter Singer and Julian Savulescu, who supported them. But the biggest problem with this argument is that Caplan’s “prime example” isn’t a bioethicist. Nowhere does his bio list any affiliation with a bioethics department, nor does he identify as a bioethicist or have any bioethics publications. His Harvard bio says “Michael Rosenblatt is an eminent physician, biomedical scientist, academic leader, and health care executive”. I’m sure Rosenblatt also has some economics takes, but they wouldn’t justify conclusions about what economics as a field believes.
Maybe somebody should do an estimate of how many people bioethicists have killed. Fewer than the Nazis, more than the Khmer Rouge?
On the Tuskegee Study: I don't think they did anything illegal. The scandal was in not telling the subjects that new treatments had been discovered for the syphilis they had. That surely offends medical ethics, but it isn't criminal.
At the time the Tuskegee experiment began there were no effective treatments for syphilis. Penicillin had not yet been discovered. The standard treatments were arguably worse than useless.
Tuskegee is brought up because the people who wrote the original US regulations cited it as an inspiration and only one of them was a bioethicist. More importantly though, I'd like to see some evidence that any major US pharma company involved in developing the COVID-19 vaccine every seriously considered conducting a challenge trial. I would surprised to hear that IRBs and bioethicists, not corporate fear of laiblity and bad publicity, were the real reason we didn't implement a significant challenge trial. Beyond that, no one was gonna challenge the elderly or the medically frail which limits the value of the data they could have collected this way.
> How come no country on Earth tried voluntary paid human experimentation?* As far as I can tell, the most important factor was the formal and informal opposition of bioethicists.
is this just vibes or is there strong evidence of this?
> In the end, researchers discovered that the vaccines were highly effective
All cause mortality was higher in the vaccine group. Not statistically significant but warranting further investigation which was not done:
"From Dose 1 through the March 13, 2021 data cutoff date, there were a total of 38 deaths, 21 in the COMIRNATY group and 17 in the placebo group." https://www.fda.gov/media/151733/download#page=23
I did not trust mRNA vaccines yet the Astra Zeneca vaccine which was more traditional was pushed to the side. How was the media fed and governments grabbed by the wallet? Pfizer executives deserved a massive bonus!
Having served as Chair of an IRB for several years, I would agree that the regulations are overly burdensome. But it would be quite the experiment you propose: inject people with COVID, knowing that there is a reasonable likelihood that you will thereby kill some of the subjects. Surely you would have to be explicit about that risk—not just say, “This is a very new disease, so there could be all sorts of unforeseen complications. Do you still consent?”
Of course we don’t know what probability there would have been of death, but the very fact that you say a million people could have been saved implicitly acknowledges the high likelihood that some of the subjects would die. One could lessen that probability by requiring that subjects be young and healthy, but even then there might have been, for all we could determine, a reasonable likelihood of death. One might think that it is not being too paternalistic not to allow subjects simply to sign on to something like that, even granting that you might save more lives in the end by allowing a few people to sign on to significant risk of death.
No, it's not reasonable to say people can't accept some risk of death. People risk death for money routinely. Loggers, fishermen, roofers, pilots, etc., not to mention soldiers, consciously accept risk of death in their occupations and they are compensated for that risk. There's no meaningful difference between that risk and the risk a participant in a human challenge trial accepts.
"Yes but covid could cause some unknown long-term disability other than death" is no response either, the same applies to all of those occupations equally.
People do rock climbing without ropes — they even make movies about them. I know someone whose brother worked for a utility as a lineman. He was killed in a workplace accident. That is a known risk of that job, which we allow people to accept and perform.
I might very well agree to accept a 1% chance of death for $1 million.
Do you realize the hate and disgust scholars feel for people like you who run IRB's and stall research uselessly ? You should be ashamed of yourself, unless you were the rare rational member who was always fighting the rest.
I had no choice. I am a professor at a liberal arts college where the IRB consists mostly of faculty, and I was appointed. And the college has no choice but to have such a committee, since it is mandated by federal law.
What my friend, who has been in the pharmaceutical business for decades, tells me is a drug company can't conduct a clinical trial of a drug unless the ethical oversight committee approves it. But get this. The committee is required to have a member who knows nothing about medical care, drugs, and clinical trials. This person is supposed to represent the regular guy on the street. And yet how can an ignorant committee member help evaluate clinical trials?
I am still awaiting a response from the IRB on whether it is ok to ask my kids what they want for dinner. Fortunately the little ones figured out how to find the crackers.
Bioethicists delenda est.
While there were certainly bioethicists who opposed challenge trials, there were also many prominent ones, such as Peter Singer and Julian Savulescu, who supported them. But the biggest problem with this argument is that Caplan’s “prime example” isn’t a bioethicist. Nowhere does his bio list any affiliation with a bioethics department, nor does he identify as a bioethicist or have any bioethics publications. His Harvard bio says “Michael Rosenblatt is an eminent physician, biomedical scientist, academic leader, and health care executive”. I’m sure Rosenblatt also has some economics takes, but they wouldn’t justify conclusions about what economics as a field believes.
Maybe somebody should do an estimate of how many people bioethicists have killed. Fewer than the Nazis, more than the Khmer Rouge?
On the Tuskegee Study: I don't think they did anything illegal. The scandal was in not telling the subjects that new treatments had been discovered for the syphilis they had. That surely offends medical ethics, but it isn't criminal.
At the time the Tuskegee experiment began there were no effective treatments for syphilis. Penicillin had not yet been discovered. The standard treatments were arguably worse than useless.
"for allowing over a million people die"
WHATEVER HAPPENED to little, two-letter prepositions, like "to"?
Tuskegee is brought up because the people who wrote the original US regulations cited it as an inspiration and only one of them was a bioethicist. More importantly though, I'd like to see some evidence that any major US pharma company involved in developing the COVID-19 vaccine every seriously considered conducting a challenge trial. I would surprised to hear that IRBs and bioethicists, not corporate fear of laiblity and bad publicity, were the real reason we didn't implement a significant challenge trial. Beyond that, no one was gonna challenge the elderly or the medically frail which limits the value of the data they could have collected this way.
> How come no country on Earth tried voluntary paid human experimentation?* As far as I can tell, the most important factor was the formal and informal opposition of bioethicists.
is this just vibes or is there strong evidence of this?
> In the end, researchers discovered that the vaccines were highly effective
All cause mortality was higher in the vaccine group. Not statistically significant but warranting further investigation which was not done:
"From Dose 1 through the March 13, 2021 data cutoff date, there were a total of 38 deaths, 21 in the COMIRNATY group and 17 in the placebo group." https://www.fda.gov/media/151733/download#page=23
Covid vaccines were "highly effective"? I guess it depends on how those words are defined.
I did not trust mRNA vaccines yet the Astra Zeneca vaccine which was more traditional was pushed to the side. How was the media fed and governments grabbed by the wallet? Pfizer executives deserved a massive bonus!
Thank you for this. My position better articulated.
Having served as Chair of an IRB for several years, I would agree that the regulations are overly burdensome. But it would be quite the experiment you propose: inject people with COVID, knowing that there is a reasonable likelihood that you will thereby kill some of the subjects. Surely you would have to be explicit about that risk—not just say, “This is a very new disease, so there could be all sorts of unforeseen complications. Do you still consent?”
Of course we don’t know what probability there would have been of death, but the very fact that you say a million people could have been saved implicitly acknowledges the high likelihood that some of the subjects would die. One could lessen that probability by requiring that subjects be young and healthy, but even then there might have been, for all we could determine, a reasonable likelihood of death. One might think that it is not being too paternalistic not to allow subjects simply to sign on to something like that, even granting that you might save more lives in the end by allowing a few people to sign on to significant risk of death.
No, it's not reasonable to say people can't accept some risk of death. People risk death for money routinely. Loggers, fishermen, roofers, pilots, etc., not to mention soldiers, consciously accept risk of death in their occupations and they are compensated for that risk. There's no meaningful difference between that risk and the risk a participant in a human challenge trial accepts.
"Yes but covid could cause some unknown long-term disability other than death" is no response either, the same applies to all of those occupations equally.
People do rock climbing without ropes — they even make movies about them. I know someone whose brother worked for a utility as a lineman. He was killed in a workplace accident. That is a known risk of that job, which we allow people to accept and perform.
I might very well agree to accept a 1% chance of death for $1 million.
Do you realize the hate and disgust scholars feel for people like you who run IRB's and stall research uselessly ? You should be ashamed of yourself, unless you were the rare rational member who was always fighting the rest.
I had no choice. I am a professor at a liberal arts college where the IRB consists mostly of faculty, and I was appointed. And the college has no choice but to have such a committee, since it is mandated by federal law.
Yes it is paternalistic. There is a persistent group of people very willing to take those risks.
https://www.astralcodexten.com/p/your-review-participation-in-phase