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Sometimes anti-vaxxers will point to the ostensibly high rate of serious adverse events exhibited by study participants in HPV vaccine trials. For example, in t

by ckw 2y ago

Sometimes anti-vaxxers will point to the ostensibly high rate of serious adverse events exhibited by study participants in HPV vaccine trials. For example, in the study 'A 9-Valent HPV Vaccine against Infection and Intraepithelial Neoplasia in Women' published in The New England Journal of Medicine in 2015, in which the 9-Valent HPV vaccine was compared to the Quadrivalent version, the rate of serious adverse events was 3.3% and 2.6% respectively. This objection can be dismissed, as the study authors found that 0.0% of those serious adverse events were vaccine related. Anti-vaxxers also sometimes object to studies like these on the basis that no placebo arm was included, and thus the true safety profile of the vaccine cannot be ascertained, but this can be flatly rejected because, as the study authors point out, '[s]ince HPV vaccination is widely recommended and has been shown to prevent HPV disease related to oncogenic HPV types, the use of a placebo was not considered to be acceptable for ethical reasons.'

tialaramex 2y ago
Because HPV vaccination is relatively modern, there's trail where maybe the trial for the vaccine you can get today A, was A vs B, but then the previous B has a trial B v Placebo, or it might go back twice, A v B then B v C and C v placebo. There were placebo trials for the early HPV vaccines decades ago. I had Hodgkins Lymphoma (many years ago now when I was young) and we've been treating that for so long that the earliest curative treatments pre-date scientific medicine. So the trail dries up - we have no proof that the cures are better than nothing except, you know, circumstantially it sure does seem like the freaks who reject treatment just drop dead and I didn't so... They're still doing research, as with the HPV vaccines they do A v B trials as a placebo would be unethical - it's basically a death sentence. I actually wasn't selected for a trial comparing Stanford V (a new potential therapy from Stanford) against the current gold standard (which I was getting) ABVD. That was a long time ago, but I think the gold standard today is still ABVD.
- User23 2y ago
  Calling cervical cancer a death sentence is a bit extreme. Regular pap smears and early treatment made it eminently survivable.
  - wbl 2y ago
    You can detect melanoma with the eyes. But when you don't get there early enough it was game over. Now it's a coin flip.
  - Spooky23 2y ago
    It’s a big deal. “Survivable” means intrusive treatment that is painful, not always effective and has side effects on things like fertility. Or you can eliminate it by vaccination and avoid the suffering and risk.
  - tialaramex 2y ago
    I can see how you'd end up with that interpretation but I was actually talking about Hodgkins, so in that case the placebo arm would in fact be basically a death sentence. You've got an aggressive cancer, and you've decided (or your treatment arm has decided) to just let it take its course.
lumb63 2y ago
How are the authors able to discern between vaccine related events, and non-vaccine related events? There is no oracle one can consult to determine this. That’s the entire point of having a second group which was not treated - to have a reference that one can compare against to determine if outcomes were correlated with the treatment. Even then, one cannot say with certainty if the events were caused by the treatment, or simply correlated; to say that all 231 distinct serious outcomes were not caused by the vaccine seems a very extreme statement to make, and can almost be disregarded prima facie; if the researchers were infallibly able to determine what adverse events were caused by the treatment, then why would they need another group to compare to? Similarly, while there may be ethical concerns with using a placebo, statistics and biology do not care about ethical concerns. There are real results which come from medical treatments, and ignoring them does not make them go away; it just makes us ignorant of them.
- mplewis 2y ago
  You can just read the text, you know. It's fully and freely available online. > None of the deaths were considered by the study investigators to be vaccine-related. The five deaths in the 9vHPV vaccine group were the result of suicide (15 days after vaccination dose 1), acute lymphocytic leukemia (diagnosed 27 days after vaccination dose 3), traffic accident (226 days after vaccination dose 3), hypovolemic shock and septic shock (531 days after vaccination dose 3), and sudden death (678 days after vaccination dose 3). The five deaths in the qHPV vaccine group were the result of accidental death (airplane accident 7 days after vaccination dose 3), spinal cord injury (141 days after vaccination dose 3), gastric adenocarcinoma (diagnosed 403 days after vaccination dose 3), cervical spinal cord injury (811 days after vaccination dose 3), and cerebral hemorrhage (1114 days after vaccination dose 3).
  - mtlynch 2y ago
    Sudden death and cerebral hemorrhage seem hard to declare as unrelated to the medication they took.
    - patmorgan23 2y ago
ekianjo 2y ago
> the use of a placebo was not considered to be acceptable for ethical reasons The same bullshit reason they used to not do a controlled trial for COVID-19 vaccines. That's pseudo science. I can't prove the efficacy and the safety so let me find a reason to remove any form of control to make more money and avoid class action lawsuits. The heath agencies have been completed hijacked.
deleted 2y ago
[deleted]
dennis_jeeves2 2y ago
>a placebo was not considered to be acceptable for ethical reasons This reason can also be used to cover up the side effects of the vaccine/drug. Complete BS.

by ckw 2y ago

tialaramex 2y ago

Because HPV vaccination is relatively modern, there's trail where maybe the trial for the vaccine you can get today A, was A vs B, but then the previous B has a trial B v Placebo, or it might go back twice, A v B then B v C and C v placebo. There were placebo trials for the early HPV vaccines decades ago. I had Hodgkins Lymphoma (many years ago now when I was young) and we've been treating that for so long that the earliest curative treatments pre-date scientific medicine. So the trail dries up - we have no proof that the cures are better than nothing except, you know, circumstantially it sure does seem like the freaks who reject treatment just drop dead and I didn't so... They're still doing research, as with the HPV vaccines they do A v B trials as a placebo would be unethical - it's basically a death sentence. I actually wasn't selected for a trial comparing Stanford V (a new potential therapy from Stanford) against the current gold standard (which I was getting) ABVD. That was a long time ago, but I think the gold standard today is still ABVD.

User23 2y ago
Calling cervical cancer a death sentence is a bit extreme. Regular pap smears and early treatment made it eminently survivable.
- wbl 2y ago
  You can detect melanoma with the eyes. But when you don't get there early enough it was game over. Now it's a coin flip.
- Spooky23 2y ago
  It’s a big deal. “Survivable” means intrusive treatment that is painful, not always effective and has side effects on things like fertility. Or you can eliminate it by vaccination and avoid the suffering and risk.
- tialaramex 2y ago
  I can see how you'd end up with that interpretation but I was actually talking about Hodgkins, so in that case the placebo arm would in fact be basically a death sentence. You've got an aggressive cancer, and you've decided (or your treatment arm has decided) to just let it take its course.

lumb63 2y ago

How are the authors able to discern between vaccine related events, and non-vaccine related events? There is no oracle one can consult to determine this. That’s the entire point of having a second group which was not treated - to have a reference that one can compare against to determine if outcomes were correlated with the treatment. Even then, one cannot say with certainty if the events were caused by the treatment, or simply correlated; to say that all 231 distinct serious outcomes were not caused by the vaccine seems a very extreme statement to make, and can almost be disregarded prima facie; if the researchers were infallibly able to determine what adverse events were caused by the treatment, then why would they need another group to compare to? Similarly, while there may be ethical concerns with using a placebo, statistics and biology do not care about ethical concerns. There are real results which come from medical treatments, and ignoring them does not make them go away; it just makes us ignorant of them.

mplewis 2y ago
You can just read the text, you know. It's fully and freely available online. > None of the deaths were considered by the study investigators to be vaccine-related. The five deaths in the 9vHPV vaccine group were the result of suicide (15 days after vaccination dose 1), acute lymphocytic leukemia (diagnosed 27 days after vaccination dose 3), traffic accident (226 days after vaccination dose 3), hypovolemic shock and septic shock (531 days after vaccination dose 3), and sudden death (678 days after vaccination dose 3). The five deaths in the qHPV vaccine group were the result of accidental death (airplane accident 7 days after vaccination dose 3), spinal cord injury (141 days after vaccination dose 3), gastric adenocarcinoma (diagnosed 403 days after vaccination dose 3), cervical spinal cord injury (811 days after vaccination dose 3), and cerebral hemorrhage (1114 days after vaccination dose 3).
- mtlynch 2y ago
  Sudden death and cerebral hemorrhage seem hard to declare as unrelated to the medication they took.
  - patmorgan23 2y ago

ekianjo 2y ago

> the use of a placebo was not considered to be acceptable for ethical reasons The same bullshit reason they used to not do a controlled trial for COVID-19 vaccines. That's pseudo science. I can't prove the efficacy and the safety so let me find a reason to remove any form of control to make more money and avoid class action lawsuits. The heath agencies have been completed hijacked.

deleted 2y ago

[deleted]

dennis_jeeves2 2y ago

>a placebo was not considered to be acceptable for ethical reasons This reason can also be used to cover up the side effects of the vaccine/drug. Complete BS.