> An ethical dilemma arises in a clinical trial when the investigator(s) begin to believe that the treatment or intervention administered in one arm of the trial is significantly outperforming the other arms. A trial should begin with a null hypothesis, and there should exist no decisive evidence that the intervention or drug being tested will be superior to existing treatments, or that it will be completely ineffective. As the trial progresses, the findings may provide sufficient evidence to convince the investigator of the intervention or drug's efficacy. Once a certain threshold of evidence is passed, there is no longer genuine uncertainty about the most beneficial treatment, so there is an ethical imperative for the investigator to provide the superior intervention to all participants.
> Without that we delay treatment, increase costs, and slow research. And people die while we wait.
This is for new vaccines: we're not halting administration of existing vaccines. And the time taken for testing new vaccines seems reasonable for safety purposes, as it would be for any other medicine.
"New vaccines" in this case includes, as an example, influenza vaccines that use the same mechanism that has already been proven safe and effective and which need to be developed and deployed in the (short) time between determining the most likely influenza strains for the year and the beginning of flu season.
If annual influenza vaccines cannot be approved in time for flu season and flu deaths increase significantly over the years to come, would you consider that justifiable?
That’s a good question. No I wouldn’t consider it justifiable. I think newer versions of existing vaccines shouldn’t qualify as ‘new vaccines’.
The article mentions ‘
four years ago is unacceptable so it sounds like they want to retest new versions every four years, rather than every new version.
> The article mentions ‘ four years ago is unacceptable so it sounds like they want to retest new versions every four years, rather than every new version.
Your choice of quote makes it seem like you are misunderstanding or deliberately misrepresenting the article. In more context:
> "As we've said before, trials from four years ago conducted in people without natural immunity no longer suffice. A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years," Nixon said in a statement he had earlier sent to The Washington Post. "The public deserves transparency and gold-standard science — especially with evolving products."
This states that a Covid vaccine passing the placebo-controlled study requirement 4 years ago will not suffice to accept updated versions of the same Covid vaccine -- not that vaccines and/or delivery mechanisms will only need to be tested every 4 years. More concisely: it's an upper bound, but not a lower bound.
> This states that a Covid vaccine passing the placebo-controlled study requirement 4 years ago will not suffice to accept updated versions of the same Covid vaccine
Yes. That is what the comment you were replying to states.
> More concisely: it's an upper bound, but not a lower bound.
You can’t say it’s any bound at all. Maybe more than two milliseconds old (less than four years) is unacceptable, maybe 16 millennia (more than four years) is unacceptable. They’re just thinking about four years as being unacceptable. Which sounds reasonable.
What if what you think of RFK is that he's clearly throwing up roadblocks to delay or prevent vaccines (ideologically) that the actually legitimate medical community is already on top of testing appropriately?
> "except for the COVID vaccine, none of the vaccines on the CDC's childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products."
What research have you made to refute the statement that more testing of medicines is a good thing? Please link to the published studies you have authored.
In case you are new to adult discourse, many people, including yourself have opinions on matters that they are not experts in.
Despite the question above, you are in fact allowed to have opinions on whether there should be more or less testing of medicine.
The same way you have opinions about geopolitics despite the fact that you don’t sit on private committees or serve in the military.
You can have opinions about tech products without having written their source code or even writing any of your own.
If you somehow haven't read either the article or any of the comments in this HN thread, many readers would prefer less testing than what was announced:
"none of the vaccines on the CDC's childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products"
I don't need to convince you or anyone else, my own hands, arms and legs were covered in bloody blisters a few hours after the J & J booster. Anecdotes aren’t data but the way I suggest we collect data is by: testing medicines.
> If you somehow haven't read either the article or any of the comments in this HN thread
Please don't comment on whether someone read an article. "Did you even read the article? It mentions that" can be shortened to "The article mentions that".
