3 ms·

A series of questions/answers I've had with doctors and nurses and quite a few intelligent and educated people. (PhD's, MD's and RN's included) Q: Does all med

A series of questions/answers I've had with doctors and nurses and quite a few intelligent and educated people. (PhD's, MD's and RN's included) Q: Does all medicine go through a rigorous efficacy testing that is certified by the FDA? A: Yes. Q: Do vaccines? A: No. Q: Why? A: It would be unethical. This is surprising to people who don't know how vaccines are made. edit: removed hyperbole

bondarchuk 6y ago
So what is the reason given for it being unethical? Of course I realize there is a tradeoff involved in delaying the rollout of a vaccine but I don't see how that is related to the way vaccines are made, specifically.
- RobertRoberts 6y ago
  To truly prove the efficacy of a vaccine you would have to intentionally give a test subject the virus to see if the vaccine actually works. It's not been done once by modern western medicine because it would be unethical by modern medical practices to intentionally infect a person.
  - crusso 6y ago
    Efficacy is still tested with vaccines because there is a statistical expectation of contracting a given disease. If you give 40,000 people a random mix of placebo and vaccines and then monitor whether or not they contract the target disease, you get an indication of efficacy by comparing the vaccinated group to the placebo group.
  - mombul 6y ago
    If it's never been done then I don't understand how this is specifically problematic for the covid vaccine then.
  - yreg 6y ago
    What, why would you need to do that? That's not how preventive medicine is tested. Please explain how would your proposal be any more valid than a proper controlled study where you do the treatment on portion of your participants and wait how it works out for them.
IfOnlyYouKnew 6y ago
Yeah, none of that is true. See today's news about pressure on the FDA to certify the vaccine.
- RobertRoberts 6y ago
  Show me one double blind efficacy study of any vaccine. It's never been done that I have seen. Edit: removed hyperbole
  - IfOnlyYouKnew 6y ago
    WTF? https://www.google.com/search?client=safari&rls=en&biw=2326&bih=1194&tbm=nws&sxsrf=ALeKk006qlJBFUilkGPeiiLVDVXmZoCqFg%3A1607725380339&ei=RPHTX_qVFJLWataLq7AD&q=double+blind+covid+vaccine&oq=double+blind+covid+vaccine https://www.google.com/search?client=safari&rls=en&biw=2326&...
    - RobertRoberts 6y ago
      Look up "efficacy" it has a specific medical meaning. Those tests are not about efficacy. Scientific method require each person be equally exposed to the virus under strict lab conditions.
      - viraptor 6y ago
        Scientific method uses statistics and can make reasonable assumption that for large enough randomised groups the collective exposure is the same without strict lab conditions. From the group size and number of infections, you can calculate the confidence of the result you find. Keep in mind that even under strict lab conditions your results would never be 100% certain.
  - deleted 6y ago
    [deleted]
  - petschge 6y ago
    There is double blind studies that tests efficacy of new vaccines for diseases that already had an approved vaccine. And those studies do find differences in efficacy (just because the old vaccine was 96% effective doesn't mean the new one can't do better) as well as in occurrence rate of side effects. There have even been studies where the vaccine that you get in the control arm of the study is the vaccine against Meningitis and then after a year or two they do give you what ever vaccine you had not received yet. (Sorry, forgot against which disease the vaccine under test was protecting.) And of course there is double blind studies where you get three injections, one of which is saline, two are active. They are given a few weeks apart, you don't know the order and they check antibody level in the blood every week.
ayroblu 6y ago
Is this an American thing? If you didn't have efficacy testing you'd have the vaccine available in March probably?
viraptor 6y ago
Vaccines go through phase 3 testing which is about efficacy. (And some other properties) What do you think is missing from them?
- RobertRoberts 6y ago
  None of them intentionally give the live virus to their subjects.
  - viraptor 6y ago
    That would speed up the test, sure. But as far as the quality of the results goes, why is that different from the existing test where a large number of vaccinated (real and placebo) subjects gets exposed/infected? It's still testing efficacy.
  - Kliment 6y ago
    Challenge studies get performed on non-human (animal) test subjects (this was done for the Biontech/Pfizer vaccine), and there's a volunteer human challenge study planned in the UK for January. A challenge study is one where you intentionally give a live virus to your subjects. Arguably, releasing your subjects into an environment full of live virus, such as the United States, is a kind of challenge study, which rapidly delivers efficacy data. This is why approval could happen so much faster than usual for these vaccines.
maxerickson 6y ago
This is some real forest for the trees bullshit here. It likely would have been good to do challenge trials with the vaccine groups (to speed up the testing). It would of course not be nice to do it with the placebo group. But you are plucking a single evidentiary standard out of some dark place and then asserting that it is the only useful one. Of course it is not, and Phase 3 vaccine trials are well designed to provide clear evidence of effectiveness. Go look up the Pfizer result going around on the memes if you don't believe that.

bondarchuk 6y ago

So what is the reason given for it being unethical? Of course I realize there is a tradeoff involved in delaying the rollout of a vaccine but I don't see how that is related to the way vaccines are made, specifically.

RobertRoberts 6y ago
To truly prove the efficacy of a vaccine you would have to intentionally give a test subject the virus to see if the vaccine actually works. It's not been done once by modern western medicine because it would be unethical by modern medical practices to intentionally infect a person.
- crusso 6y ago
  Efficacy is still tested with vaccines because there is a statistical expectation of contracting a given disease. If you give 40,000 people a random mix of placebo and vaccines and then monitor whether or not they contract the target disease, you get an indication of efficacy by comparing the vaccinated group to the placebo group.
- mombul 6y ago
  If it's never been done then I don't understand how this is specifically problematic for the covid vaccine then.
- yreg 6y ago
  What, why would you need to do that? That's not how preventive medicine is tested. Please explain how would your proposal be any more valid than a proper controlled study where you do the treatment on portion of your participants and wait how it works out for them.

IfOnlyYouKnew 6y ago

Yeah, none of that is true. See today's news about pressure on the FDA to certify the vaccine.

RobertRoberts 6y ago
Show me one double blind efficacy study of any vaccine. It's never been done that I have seen. Edit: removed hyperbole
- IfOnlyYouKnew 6y ago
  WTF? https://www.google.com/search?client=safari&rls=en&biw=2326&bih=1194&tbm=nws&sxsrf=ALeKk006qlJBFUilkGPeiiLVDVXmZoCqFg%3A1607725380339&ei=RPHTX_qVFJLWataLq7AD&q=double+blind+covid+vaccine&oq=double+blind+covid+vaccine https://www.google.com/search?client=safari&rls=en&biw=2326&...
  - RobertRoberts 6y ago
    Look up "efficacy" it has a specific medical meaning. Those tests are not about efficacy. Scientific method require each person be equally exposed to the virus under strict lab conditions.
    - viraptor 6y ago
      Scientific method uses statistics and can make reasonable assumption that for large enough randomised groups the collective exposure is the same without strict lab conditions. From the group size and number of infections, you can calculate the confidence of the result you find. Keep in mind that even under strict lab conditions your results would never be 100% certain.
- deleted 6y ago
  [deleted]
- petschge 6y ago
  There is double blind studies that tests efficacy of new vaccines for diseases that already had an approved vaccine. And those studies do find differences in efficacy (just because the old vaccine was 96% effective doesn't mean the new one can't do better) as well as in occurrence rate of side effects. There have even been studies where the vaccine that you get in the control arm of the study is the vaccine against Meningitis and then after a year or two they do give you what ever vaccine you had not received yet. (Sorry, forgot against which disease the vaccine under test was protecting.) And of course there is double blind studies where you get three injections, one of which is saline, two are active. They are given a few weeks apart, you don't know the order and they check antibody level in the blood every week.

ayroblu 6y ago

Is this an American thing? If you didn't have efficacy testing you'd have the vaccine available in March probably?

viraptor 6y ago

Vaccines go through phase 3 testing which is about efficacy. (And some other properties) What do you think is missing from them?

RobertRoberts 6y ago
None of them intentionally give the live virus to their subjects.
- viraptor 6y ago
  That would speed up the test, sure. But as far as the quality of the results goes, why is that different from the existing test where a large number of vaccinated (real and placebo) subjects gets exposed/infected? It's still testing efficacy.
- Kliment 6y ago
  Challenge studies get performed on non-human (animal) test subjects (this was done for the Biontech/Pfizer vaccine), and there's a volunteer human challenge study planned in the UK for January. A challenge study is one where you intentionally give a live virus to your subjects. Arguably, releasing your subjects into an environment full of live virus, such as the United States, is a kind of challenge study, which rapidly delivers efficacy data. This is why approval could happen so much faster than usual for these vaccines.

maxerickson 6y ago

This is some real forest for the trees bullshit here. It likely would have been good to do challenge trials with the vaccine groups (to speed up the testing). It would of course not be nice to do it with the placebo group. But you are plucking a single evidentiary standard out of some dark place and then asserting that it is the only useful one. Of course it is not, and Phase 3 vaccine trials are well designed to provide clear evidence of effectiveness. Go look up the Pfizer result going around on the memes if you don't believe that.