7 ms·

Sputnik V: fraudulent clinical trial data

102 points by renaudg 5y ago

hamburgerwah 5y ago
I think that what is sort of a sideline in this article is really a more important story. The Lancet and NEJM have completely debased themselves and destroyed centuries of institutional credibility in their handling of covid related research. I don't know where it goes from here but they have both burned themselves to the ground.
- harringtonjones 5y ago
  I thought that happened to the Lancet after the original vaccines -> autism paper...
  - erentz 5y ago
    And the PACE trial
- yyyk 5y ago
  The Lancet does this all the time. To add a few more examples to the sibling comments: The fraudulent HCQ paper*, the absurd Iraq war casualty calculation. In general, assume that whenever there's politics or the opportunity to shock, the Lancet won't be very thorough with its articles. * The conclusion being accidentally right doesn't cover for the fraudulent data.
- nayuki 5y ago
  And the letter dismissing the lab leak theory. https://en.wikipedia.org/wiki/The_Lancet#February_2020_letter_dismissing_lab-leak_theory https://en.wikipedia.org/wiki/The_Lancet#February_2020_lette...
DangsBaldHead 5y ago
Antivax propaganda.
ChrisMarshallNY 5y ago
The language the article uses, is a bit inflammatory. It may well be correct, but the tone gives me pause. Sounds like the author has an axe to grind.
- dangom 5y ago
  Same feeling here. Curiously enough the domain is called "For better science", where we'd have expected neutrality and impartiality to be the guiding principles of any report. Apart from that, it is hard to believe that any of the vaccine reports and clinical trials are unbiased. Unfortunately there are too many conflicts of interest and money on the table for any information to be taken at face value. The beauty of science is that now that the vaccines are out there it becomes easier to independently access them and move our knowledge further in the right direction. And on that note, regardless of the final outcome for Sputnik V, at least there will be lessons learned for the future development of vaccines and increased scrutiny in their manufacturing process.
  - higherup 5y ago
    >The beauty of science is that now that the vaccines are out there it becomes easier to independently access them and move our knowledge further in the right direction. Can you clarify what you mean by this?
    - dangom 5y ago
      I mean that groups without any conflict of interest can gather population level data and evaluate for themselves how effective the vaccines are, and how likely it is for the clinical trial data to have been correct. There is a reason publications and conferences require disclosure of conflicts of interest, and that is because those with a conflict of interest are biased to find positive results (and hide negative results) that align with their financial goals.
      - higherup 5y ago
        >I mean that groups without any conflict of interest can gather population level data and evaluate for themselves how effective the vaccines are, It won't work because for every such group, there will be 10 groups with high conflict of interest that can counter any finding of your hypothetical group, and journals with conflict of interests will reject the findings of that group, but instead give high visibility to the reports of high-conflict of interest groups.. Quickly no one will dare to research the said topic.
temporalparts 5y ago
I mean, not surprising. Here's an older hacker news thread about Brazil rejecting the Russian Vaccine.[0] It's so depressingly unsurprising in this post-truth era. [0] https://news.ycombinator.com/item?id=26975783 https://news.ycombinator.com/item?id=26975783
- _RPL5_ 5y ago
  Russia isn't the only country to have trialed Sputnik. From a recent Nature article (July 2021) titled "Mounting evidence suggests Sputnik COVID vaccine is safe and effective" [1]: --- Figures released by the United Arab Emirates Ministry of Health, on some 81,000 individuals who had received two doses of the vaccine, suggested 97.8% efficacy in preventing symptomatic COVID-19 and 100% efficacy in preventing severe disease. Since then, an as-yet unpublished study from the Buenos Aires health ministry in Argentina, involving 40,387 vaccinated and 146,194 unvaccinated people aged 60–79, found that a single dose of Sputnik Light reduced symptomatic infections by 78.6%, hospitalizations by 87.6% and deaths by 84.7%. --- Or, here is an article on Moscow Times published today reporting a trial from a different Russian group, independent from the manufacturer [2]: --- The study tracked outcomes for almost 14,000 patients who contracted Covid-19 in St. Petersburg between July 3-Aug. 9. It was led by Anton Barchuk, head of the Institute for Interdisciplinary Health Research at the European University in St. Petersburg, and eight other scientists from Russian universities. Of the 12,154 patients who tested positive for Covid-19 in the study and were not vaccinated, some 467 were hospitalized — a ratio of 3.8%. Meanwhile just 17 of the 1,291 vaccinated patients who caught the infection — 1.3% — were hospitalized. After adjusting for age and sex, the scientists assessed the vaccine’s effectiveness at preventing hospitalizaiton among those who were infected with Covid-19 at 81%. --- I am pretty sure Sputnik V is fine. It has been administered to tens of millions inside Russia itself. If there were massive problems with it, we would know by now. [1] https://www.nature.com/articles/d41586-021-01813-2 https://www.nature.com/articles/d41586-021-01813-2 [2] https://www.themoscowtimes.com/2021/08/24/sputnik-v-gives-strong-protection-against-delta-hospitalization-study-a74882 https://www.themoscowtimes.com/2021/08/24/sputnik-v-gives-st...
  - higherup 5y ago
xvilka 5y ago
This link overly politised and does not offer technical details about these problems. The Moscow Times article [1] makes a better job. [1] https://www.themoscowtimes.com/2021/08/20/leaked-sputnik-v-report-shows-more-inconsistencies-in-clinical-trial-data-a74847 https://www.themoscowtimes.com/2021/08/20/leaked-sputnik-v-r...
- Kinrany 5y ago
  Is there something even better? This article wastes a lot of text repeating over and over that there are problems without getting to the most important ones.
- chriszhang 5y ago
  Moscow Times article does not load on my phone. It appears to reload itself again and again. Then it error out. Anyone facing same issue?
- forgotpwd16 5y ago
  The submitted link considers the Moscow Times article and copies verbatim (in the leaked report section) the quotes regarding randomization and side effects.
m0zg 5y ago
Pfizer vaxed their control group at the beginning of 2021. So their long term clinical data is not just "fraudulent", it's non-existent [1]. And yet, it was FDA approved yesterday, without even knowing how many shots there are in the regimen, _and_ without dropping legal immunity for Pfizer for severe adverse effects. Some companies are more equal than others. Approved by the same person, by the way, who was responsible for Oxycontin debacle earlier [2]. [1] https://www.statnews.com/2021/01/01/pfizer-and-biontech-speed-up-timeline-for-offering-covid-19-to-placebo-volunteers/ https://www.statnews.com/2021/01/01/pfizer-and-biontech-spee... [2] https://www.usatoday.com/story/opinion/2021/02/03/janet-woodcocks-failure-fda-opioid-epidemic-column/4352787001/ https://www.usatoday.com/story/opinion/2021/02/03/janet-wood... For the record: I did get the Pfizer shot in May. Rather than downvoting, try to refute the facts.
- DangsBaldHead 5y ago
  Watch out, a gang of mouth breathing statists patrol HN silencing any dissent on western vaccines.
- sterlind 5y ago
  It's not really ethical to keep the control group unvaccinated once Phase III was over and the EUA was approved. Ethics aside, the control group would probably leave the trial to get vaccinated anyway.
  - m0zg 5y ago
    How do you establish long term safety of the vaccine if you don't have a control group of randomly chosen, unvaccinated people? And if you don't, then how did it get approved?
    - chomp 5y ago
      How long are you talking? I mean, nothing stops these people from going off and getting the vaccine themselves; what are you going to do, send mailers to them to never get a covid vaccine for the rest of their lives so that we can study them?
stefantalpalaru 5y ago
> In any case, the vaccine is likely to have very severe adverse effects and may be even unsafe, given the aggressive cover-up by the Russian authorities, statements from authorities abroad, and anecdotal reports from those who took the vaccine. "A preprint from the Italian Hospital of Buenos Aires in Argentina reported no cases of clotting disorders or adverse events of special interest among 683 health-care workers vaccinated with Sputnik V. And an analysis of 2.8 million doses of Sputnik V administered in Argentina reported no deaths associated with vaccination, and mostly mild adverse events. Furthermore, a study posted as a preprint in May, from the republic of San Marino, found no serious adverse events in 2,558 adults who received one dose of Sputnik V and 1,288 who received two doses." - https://www.nature.com/articles/d41586-021-01813-2 https://www.nature.com/articles/d41586-021-01813-2
Daishiman 5y ago
This is barely a critique of the science of the vaccine trial; it's 60% political pandering and inclusion of various public figures (completely irrelevant to the science) and their yappings about geopolitical context, peppered in with some potentially valid complaints about the approval process and the reporting by Gamaleya. But at this point it's all moot, because we have multiple (https://www.conicet.gov.ar/wp-content/uploads/Informe-Sputnik_Buenos-Aires-13.04.2021.pdf&usg=AOvVaw3UIxk7oEuXISJKo4dqCFGt https://www.conicet.gov.ar/wp-content/uploads/Informe-Sputni...) (https://www.fundacionfemeba.org.ar/blog/farmacologia-7/post/informacion-sobre-vacunas-contra-covid-19-48720 https://www.fundacionfemeba.org.ar/blog/farmacologia-7/post/...) (https://magazine.oceanomedicina.com/actualidad/respuesta-inmune-al-sars-cov-2-tras-la-aplicacion-de-la-vacuna-sputnik-v https://magazine.oceanomedicina.com/actualidad/respuesta-inm...) reports and production of Sputnik outside of Russia (https://www.batimes.com.ar/news/argentina/pharmaceutical-firm-produces-first-batch-of-sputnik-v-vaccine-in-argentina.phtml https://www.batimes.com.ar/news/argentina/pharmaceutical-fir...), which basically corroborate all of the findings of the Gamaleya Institute. So I'm wondering why exactly there's this tremendous conspiratorial thinking about a vaccine that made claims... that turned out be completely on target with both the trial data and its epidemiological impacts in the countries where it's being applied.
- trhway 5y ago
  because big politic. Covid is first and foremost a humongous wealth, resource and power redistribution and grab, at all levels, from local to global. It is being a pandemic is a distant second. https://brazilian.report/liveblog/coronavirus/2021/03/15/us-pressured-brazil-ditch-russias-sputnik-v-vaccine/ https://brazilian.report/liveblog/coronavirus/2021/03/15/us-... "OGA [The Office of Global Affairs] used diplomatic relations in the Americas region to mitigate efforts by states, including Cuba, Venezuela, and Russia, who are working to increase their influence in the region to the detriment of US safety and security. OGA coordinated with other U.S. government agencies to strengthen diplomatic ties and offer technical and humanitarian assistance to dissuade countries in the region from accepting aid from these ill-intentioned states. Examples include using OGA’s Health Attaché office to persuade Brazil to reject the Russian COVID-19 vaccine"
f32jhnjk33jj 5y ago
Putin is a pathological liar. He cannot imagine a life without lying.
deleted 5y ago
[deleted]
fithisux 5y ago
The article in reality reads, Russian certificates are not accepted by us. Cold War II escalates. No science involved here. Read the article about Apache Arrow / DataFusion 5.0 it is better.
networkid 5y ago
This kind of political wars are very harmful for vacination process. Of course there is a chance of the fraud but the same chance is for other vaccines as well and we need to talk about it. But is it a good time for such a fight?
sharken 5y ago
For a country like Venezuela they would probably still have liked to even receive the vaccine, but have received very few doses so far. https://www.laprensalatina.com/venezuelas-vaccine-drive-sputtering-due-to-lack-of-russian-doses/ https://www.laprensalatina.com/venezuelas-vaccine-drive-sput...
speransky 5y ago
As the tone of article is bit aggressive, I have own observations, my relatives who lives in Russia were fully vaccinated with Sputnik and all 4 of them (one family) got a very hard COVID with delta, two of them were on oxygen therapy. Doesn’t mean anything but my feelings are that there are some lie about that vaccine efficiency for no reason except political benefits.
rich_sasha 5y ago
The article shows evidence of sloppiness, not really of fraud. Neither would really surprise me, given the high political stakes. But I suspect that if Russia went for full-on fraud, they would do a much better job than this. Case in point: the doping scandal at the Sochi winter olympics. It was evil, yes, but you cannot help but admire how detailed and well-executed the operation was. They designed and built a whole building around the scheme! Supposedly, even the FSB (reincarnation of KGB) was involved. If not for a senior whistle-blower, I think we would never know. I'm sure that if there was some top-level prikaz to cook the books, there would be no discernible flaws in the data whatsoever.
moltar 5y ago
> deliberately shoddy way of manufacturing things The last article about Sputnik that I read on HN stated that many countries are awaiting their promised doses, because Korea and India cannot produce enough of it.

102 points by renaudg 5y ago

I think that what is sort of a sideline in this article is really a more important story. The Lancet and NEJM have completely debased themselves and destroyed centuries of institutional credibility in their handling of covid related research. I don't know where it goes from here but they have both burned themselves to the ground.

harringtonjones 5y ago
I thought that happened to the Lancet after the original vaccines -> autism paper...
- erentz 5y ago
  And the PACE trial
yyyk 5y ago
The Lancet does this all the time. To add a few more examples to the sibling comments: The fraudulent HCQ paper*, the absurd Iraq war casualty calculation. In general, assume that whenever there's politics or the opportunity to shock, the Lancet won't be very thorough with its articles. * The conclusion being accidentally right doesn't cover for the fraudulent data.
nayuki 5y ago
And the letter dismissing the lab leak theory. https://en.wikipedia.org/wiki/The_Lancet#February_2020_letter_dismissing_lab-leak_theory https://en.wikipedia.org/wiki/The_Lancet#February_2020_lette...

DangsBaldHead 5y ago

Antivax propaganda.

ChrisMarshallNY 5y ago

The language the article uses, is a bit inflammatory. It may well be correct, but the tone gives me pause. Sounds like the author has an axe to grind.

dangom 5y ago
Same feeling here. Curiously enough the domain is called "For better science", where we'd have expected neutrality and impartiality to be the guiding principles of any report. Apart from that, it is hard to believe that any of the vaccine reports and clinical trials are unbiased. Unfortunately there are too many conflicts of interest and money on the table for any information to be taken at face value. The beauty of science is that now that the vaccines are out there it becomes easier to independently access them and move our knowledge further in the right direction. And on that note, regardless of the final outcome for Sputnik V, at least there will be lessons learned for the future development of vaccines and increased scrutiny in their manufacturing process.
- higherup 5y ago
  >The beauty of science is that now that the vaccines are out there it becomes easier to independently access them and move our knowledge further in the right direction. Can you clarify what you mean by this?
  - dangom 5y ago
    I mean that groups without any conflict of interest can gather population level data and evaluate for themselves how effective the vaccines are, and how likely it is for the clinical trial data to have been correct. There is a reason publications and conferences require disclosure of conflicts of interest, and that is because those with a conflict of interest are biased to find positive results (and hide negative results) that align with their financial goals.
    - higherup 5y ago
      >I mean that groups without any conflict of interest can gather population level data and evaluate for themselves how effective the vaccines are, It won't work because for every such group, there will be 10 groups with high conflict of interest that can counter any finding of your hypothetical group, and journals with conflict of interests will reject the findings of that group, but instead give high visibility to the reports of high-conflict of interest groups.. Quickly no one will dare to research the said topic.

temporalparts 5y ago

I mean, not surprising. Here's an older hacker news thread about Brazil rejecting the Russian Vaccine.[0] It's so depressingly unsurprising in this post-truth era. [0] https://news.ycombinator.com/item?id=26975783 https://news.ycombinator.com/item?id=26975783

_RPL5_ 5y ago
Russia isn't the only country to have trialed Sputnik. From a recent Nature article (July 2021) titled "Mounting evidence suggests Sputnik COVID vaccine is safe and effective" [1]: --- Figures released by the United Arab Emirates Ministry of Health, on some 81,000 individuals who had received two doses of the vaccine, suggested 97.8% efficacy in preventing symptomatic COVID-19 and 100% efficacy in preventing severe disease. Since then, an as-yet unpublished study from the Buenos Aires health ministry in Argentina, involving 40,387 vaccinated and 146,194 unvaccinated people aged 60–79, found that a single dose of Sputnik Light reduced symptomatic infections by 78.6%, hospitalizations by 87.6% and deaths by 84.7%. --- Or, here is an article on Moscow Times published today reporting a trial from a different Russian group, independent from the manufacturer [2]: --- The study tracked outcomes for almost 14,000 patients who contracted Covid-19 in St. Petersburg between July 3-Aug. 9. It was led by Anton Barchuk, head of the Institute for Interdisciplinary Health Research at the European University in St. Petersburg, and eight other scientists from Russian universities. Of the 12,154 patients who tested positive for Covid-19 in the study and were not vaccinated, some 467 were hospitalized — a ratio of 3.8%. Meanwhile just 17 of the 1,291 vaccinated patients who caught the infection — 1.3% — were hospitalized. After adjusting for age and sex, the scientists assessed the vaccine’s effectiveness at preventing hospitalizaiton among those who were infected with Covid-19 at 81%. --- I am pretty sure Sputnik V is fine. It has been administered to tens of millions inside Russia itself. If there were massive problems with it, we would know by now. [1] https://www.nature.com/articles/d41586-021-01813-2 https://www.nature.com/articles/d41586-021-01813-2 [2] https://www.themoscowtimes.com/2021/08/24/sputnik-v-gives-strong-protection-against-delta-hospitalization-study-a74882 https://www.themoscowtimes.com/2021/08/24/sputnik-v-gives-st...
- higherup 5y ago

xvilka 5y ago

This link overly politised and does not offer technical details about these problems. The Moscow Times article [1] makes a better job. [1] https://www.themoscowtimes.com/2021/08/20/leaked-sputnik-v-report-shows-more-inconsistencies-in-clinical-trial-data-a74847 https://www.themoscowtimes.com/2021/08/20/leaked-sputnik-v-r...

Kinrany 5y ago
Is there something even better? This article wastes a lot of text repeating over and over that there are problems without getting to the most important ones.
chriszhang 5y ago
Moscow Times article does not load on my phone. It appears to reload itself again and again. Then it error out. Anyone facing same issue?
forgotpwd16 5y ago
The submitted link considers the Moscow Times article and copies verbatim (in the leaked report section) the quotes regarding randomization and side effects.

m0zg 5y ago

Pfizer vaxed their control group at the beginning of 2021. So their long term clinical data is not just "fraudulent", it's non-existent [1]. And yet, it was FDA approved yesterday, without even knowing how many shots there are in the regimen, _and_ without dropping legal immunity for Pfizer for severe adverse effects. Some companies are more equal than others. Approved by the same person, by the way, who was responsible for Oxycontin debacle earlier [2]. [1] https://www.statnews.com/2021/01/01/pfizer-and-biontech-speed-up-timeline-for-offering-covid-19-to-placebo-volunteers/ https://www.statnews.com/2021/01/01/pfizer-and-biontech-spee... [2] https://www.usatoday.com/story/opinion/2021/02/03/janet-woodcocks-failure-fda-opioid-epidemic-column/4352787001/ https://www.usatoday.com/story/opinion/2021/02/03/janet-wood... For the record: I did get the Pfizer shot in May. Rather than downvoting, try to refute the facts.

DangsBaldHead 5y ago
Watch out, a gang of mouth breathing statists patrol HN silencing any dissent on western vaccines.
sterlind 5y ago
It's not really ethical to keep the control group unvaccinated once Phase III was over and the EUA was approved. Ethics aside, the control group would probably leave the trial to get vaccinated anyway.
- m0zg 5y ago
  How do you establish long term safety of the vaccine if you don't have a control group of randomly chosen, unvaccinated people? And if you don't, then how did it get approved?
  - chomp 5y ago
    How long are you talking? I mean, nothing stops these people from going off and getting the vaccine themselves; what are you going to do, send mailers to them to never get a covid vaccine for the rest of their lives so that we can study them?

stefantalpalaru 5y ago

> In any case, the vaccine is likely to have very severe adverse effects and may be even unsafe, given the aggressive cover-up by the Russian authorities, statements from authorities abroad, and anecdotal reports from those who took the vaccine. "A preprint from the Italian Hospital of Buenos Aires in Argentina reported no cases of clotting disorders or adverse events of special interest among 683 health-care workers vaccinated with Sputnik V. And an analysis of 2.8 million doses of Sputnik V administered in Argentina reported no deaths associated with vaccination, and mostly mild adverse events. Furthermore, a study posted as a preprint in May, from the republic of San Marino, found no serious adverse events in 2,558 adults who received one dose of Sputnik V and 1,288 who received two doses." - https://www.nature.com/articles/d41586-021-01813-2 https://www.nature.com/articles/d41586-021-01813-2

Daishiman 5y ago

This is barely a critique of the science of the vaccine trial; it's 60% political pandering and inclusion of various public figures (completely irrelevant to the science) and their yappings about geopolitical context, peppered in with some potentially valid complaints about the approval process and the reporting by Gamaleya. But at this point it's all moot, because we have multiple (https://www.conicet.gov.ar/wp-content/uploads/Informe-Sputnik_Buenos-Aires-13.04.2021.pdf&usg=AOvVaw3UIxk7oEuXISJKo4dqCFGt https://www.conicet.gov.ar/wp-content/uploads/Informe-Sputni...) (https://www.fundacionfemeba.org.ar/blog/farmacologia-7/post/informacion-sobre-vacunas-contra-covid-19-48720 https://www.fundacionfemeba.org.ar/blog/farmacologia-7/post/...) (https://magazine.oceanomedicina.com/actualidad/respuesta-inmune-al-sars-cov-2-tras-la-aplicacion-de-la-vacuna-sputnik-v https://magazine.oceanomedicina.com/actualidad/respuesta-inm...) reports and production of Sputnik outside of Russia (https://www.batimes.com.ar/news/argentina/pharmaceutical-firm-produces-first-batch-of-sputnik-v-vaccine-in-argentina.phtml https://www.batimes.com.ar/news/argentina/pharmaceutical-fir...), which basically corroborate all of the findings of the Gamaleya Institute. So I'm wondering why exactly there's this tremendous conspiratorial thinking about a vaccine that made claims... that turned out be completely on target with both the trial data and its epidemiological impacts in the countries where it's being applied.

trhway 5y ago
because big politic. Covid is first and foremost a humongous wealth, resource and power redistribution and grab, at all levels, from local to global. It is being a pandemic is a distant second. https://brazilian.report/liveblog/coronavirus/2021/03/15/us-pressured-brazil-ditch-russias-sputnik-v-vaccine/ https://brazilian.report/liveblog/coronavirus/2021/03/15/us-... "OGA [The Office of Global Affairs] used diplomatic relations in the Americas region to mitigate efforts by states, including Cuba, Venezuela, and Russia, who are working to increase their influence in the region to the detriment of US safety and security. OGA coordinated with other U.S. government agencies to strengthen diplomatic ties and offer technical and humanitarian assistance to dissuade countries in the region from accepting aid from these ill-intentioned states. Examples include using OGA’s Health Attaché office to persuade Brazil to reject the Russian COVID-19 vaccine"

f32jhnjk33jj 5y ago

Putin is a pathological liar. He cannot imagine a life without lying.

deleted 5y ago

[deleted]

fithisux 5y ago

The article in reality reads, Russian certificates are not accepted by us. Cold War II escalates. No science involved here. Read the article about Apache Arrow / DataFusion 5.0 it is better.

networkid 5y ago

This kind of political wars are very harmful for vacination process. Of course there is a chance of the fraud but the same chance is for other vaccines as well and we need to talk about it. But is it a good time for such a fight?

sharken 5y ago

For a country like Venezuela they would probably still have liked to even receive the vaccine, but have received very few doses so far. https://www.laprensalatina.com/venezuelas-vaccine-drive-sputtering-due-to-lack-of-russian-doses/ https://www.laprensalatina.com/venezuelas-vaccine-drive-sput...

speransky 5y ago

As the tone of article is bit aggressive, I have own observations, my relatives who lives in Russia were fully vaccinated with Sputnik and all 4 of them (one family) got a very hard COVID with delta, two of them were on oxygen therapy. Doesn’t mean anything but my feelings are that there are some lie about that vaccine efficiency for no reason except political benefits.

rich_sasha 5y ago

The article shows evidence of sloppiness, not really of fraud. Neither would really surprise me, given the high political stakes. But I suspect that if Russia went for full-on fraud, they would do a much better job than this. Case in point: the doping scandal at the Sochi winter olympics. It was evil, yes, but you cannot help but admire how detailed and well-executed the operation was. They designed and built a whole building around the scheme! Supposedly, even the FSB (reincarnation of KGB) was involved. If not for a senior whistle-blower, I think we would never know. I'm sure that if there was some top-level prikaz to cook the books, there would be no discernible flaws in the data whatsoever.

moltar 5y ago

> deliberately shoddy way of manufacturing things The last article about Sputnik that I read on HN stated that many countries are awaiting their promised doses, because Korea and India cannot produce enough of it.