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Firstly, it wasn't produced in large quantities in February. They have to do trials against the mass produced article, not lab samples. Secondly, it would be e

Firstly, it wasn't produced in large quantities in February. They have to do trials against the mass produced article, not lab samples. Secondly, it would be extremely unethical to overlap phase 2 & 3 trials, when there are effective NPIs. The lessons of unethical medical science, like Tuskegee and experimentation on armed forces personnel, must not be ignored. And yet that is precisely what your ref Eyal[1] is proposing, because practically none of the safeguards can be achieved. Efficacy trials require a much larger participant group, given the still low infection rates. I don't see how one can justify giving a candidate to 100k people before safety screening, especially when the downside risk is significant risk of death if they ever catch COVID.

jbullock35 6y ago
> Firstly, it wasn't produced in large quantities in February. They have to do trials against the mass produced article, not lab samples. Yes, I’m not disputing this point. My claim is that even after we account for the difficulties of mass production, the FDA-controlled licensing process should have taken less time than it did. > Efficacy trials require a much larger participant group, given the still low infection rates. This is the major benefit of human-challenge trials [1]: if you intentionally infect healthy, well-informed, low-risk volunteers with low doses of a virus, the size of the requisite participant group falls dramatically. Note also that “Any volunteers in whom infection was confirmed would receive excellent care for COVID-19, including priority for any scarce life-saving resources, in state-of-the-art facilities.” You can say that it’s unethical to run such trials. But it seems hard to make that argument if the volunteers are informed about the risks and if safeguards are in place (e.g., limiting the dose to which volunteers are exposed). Consider also the cost -- many thousands of lives -- of refusing to run such trials and thus delaying the licensing of a vaccine by months. > The lessons of unethical medical science, like Tuskegee [...] must not be ignored. And yet that is precisely what your ref Eyal[1] is proposing No, not at all. In the Tuskegee experiment, people infected with syphilis were promised medical care that they were later denied. When they were diagnosed with syphilis, they weren't even told of the diagnosis. (One of the purposes of the experiment was to study what happens when syphilis isn't treated.) These conditions are a world apart from what Eyal et al. are proposing in [1]. You don't need to take my word for it: the article is short and easy to read. [1] https://academic.oup.com/jid/article/221/11/1752/5814216 https://academic.oup.com/jid/article/221/11/1752/5814216
orangecat 6y ago
Secondly, it would be extremely unethical to overlap phase 2 & 3 trials, when there are effective NPI. The NPIs have enormous costs in both dollars and quality of life, and are in fact not terribly effective.

jbullock35 6y ago

> Firstly, it wasn't produced in large quantities in February. They have to do trials against the mass produced article, not lab samples. Yes, I’m not disputing this point. My claim is that even after we account for the difficulties of mass production, the FDA-controlled licensing process should have taken less time than it did. > Efficacy trials require a much larger participant group, given the still low infection rates. This is the major benefit of human-challenge trials [1]: if you intentionally infect healthy, well-informed, low-risk volunteers with low doses of a virus, the size of the requisite participant group falls dramatically. Note also that “Any volunteers in whom infection was confirmed would receive excellent care for COVID-19, including priority for any scarce life-saving resources, in state-of-the-art facilities.” You can say that it’s unethical to run such trials. But it seems hard to make that argument if the volunteers are informed about the risks and if safeguards are in place (e.g., limiting the dose to which volunteers are exposed). Consider also the cost -- many thousands of lives -- of refusing to run such trials and thus delaying the licensing of a vaccine by months. > The lessons of unethical medical science, like Tuskegee [...] must not be ignored. And yet that is precisely what your ref Eyal[1] is proposing No, not at all. In the Tuskegee experiment, people infected with syphilis were promised medical care that they were later denied. When they were diagnosed with syphilis, they weren't even told of the diagnosis. (One of the purposes of the experiment was to study what happens when syphilis isn't treated.) These conditions are a world apart from what Eyal et al. are proposing in [1]. You don't need to take my word for it: the article is short and easy to read. [1] https://academic.oup.com/jid/article/221/11/1752/5814216 https://academic.oup.com/jid/article/221/11/1752/5814216

orangecat 6y ago

Secondly, it would be extremely unethical to overlap phase 2 & 3 trials, when there are effective NPI. The NPIs have enormous costs in both dollars and quality of life, and are in fact not terribly effective.