Sputnik V: fraudulent clinical trial data | Hacker News Reader

Sputnik V: fraudulent clinical trial data

forbetterscience.com

102 pointsrenaudg54 comments

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-r...

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.

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?

The submitted link considers the Moscow Times article and copies verbatim (in the leaked report section) the quotes regarding randomization and side effects.

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.

For what's worth, Brazilian regulators also had a bunch of issues with data provided for Sputnik. Issues were also raised when facilities were inspected.

https://www.nytimes.com/2021/04/26/world/covid-vaccine-brazi...

The vaccine was being "touted" by Bolsonaro? He publicly disparaged it several times.

Indeed, Bolsonaro doesn't like non-Western shots. For instance, his supporters are calling Chinese offerings vachinas.

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.

>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?

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.

>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.

For what it's worth, the blog has a pretty similar tone even when writing about less politically-fraught topics; it's usually focused on fraud in the life science literature.

> at least there will be lessons learned for the future development of vaccines and increased scrutiny in their manufacturing process.

I’m nagging, but we’ve gone to extraordinary lengths to set a precedent where pharmaceutical companies are relieved of the burden of demonstrating the safety of their products and also relieved of the risk of providing relief to anyone harmed by said products.

20 years later, emergency measures to protect Americans from terrorism are in effect today. I doubt Pfizer will be vulnerable to class-action suits ever again.

He obviously does, but the things he says about Putin are basically true.

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.

I thought that happened to the Lancet after the original vaccines -> autism paper...

And the PACE trial

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.

And the letter dismissing the lab leak theory. https://en.wikipedia.org/wiki/The_Lancet#February_2020_lette...

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.

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.

> 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.

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.

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-sput...

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?

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

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]:

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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]:

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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

[2] https://www.themoscowtimes.com/2021/08/24/sputnik-v-gives-st...

>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.

No, we wouldn't. Because most of the Vaccine AEFI tracking is based on voluntary reporting, and is known to only report around 1% of the events.

Even if it was not the case, we wouldn't still know without a control group. Basically this is why systematic trials are done to measure these things.

So this logic does not absolve Sputnik vaccine, or any other current vaccines in use.

https://www.nejm.org/doi/full/10.1056/NEJMp2033538

You are right. We do need systematic trials to confidently makes statements like the one I made. Thank you for pointing out the error in my logic.

> 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

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

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-Sputni...) (https://www.fundacionfemeba.org.ar/blog/farmacologia-7/post/...) (https://magazine.oceanomedicina.com/actualidad/respuesta-inm...) reports and production of Sputnik outside of Russia (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.

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-...

"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"

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