Russian scientists wrote the journal The Lancet
a letter in which they responded to criticism on the studies done on the Sputnik V anti-coronavirus vaccine that came from a group of scientist led by Enrico Bucci, who is involved in the fight against data falsification. The main argument put forth by its developers is that their critics did not comprehend exactly what they saw on the graphs, which had some coincidences that aroused suspicion.
On Friday, September 18th, the scientific journal The Lancet published the response delivered by Denis Logunov (on the photo), the deputy director for scientific work at the center, and his coworkers Inna Dolzhikova, Olga Zubkova, Amir Tukhvatullin, and Dmitry Scherbakov concerning the criticism of the anti-coronavirus vaccine Gamaleya Center studies.
Here is what happened. In the beginning of September, after The Lancet published the results of clinical trials for the Russian-produced Sputnik V anti-coronavirus vaccine, a team of scientists led by Enrico Bucci, an Italian fighter against data falsification who is a biology professor at Temple University in the United States, expressed doubts about how accurate the Russian studies were. The Lancet asked the Russian vaccine developers to write a response.
The N.F. Gamaleya National Research Center of Epidemiology and Microbiology is the organization developing the Sputnik V vaccine, and it is being financed by the Russian Direct Investment Fund (RDIF). Russia published the scientific data on the first two phases of testing Sputnik V on September 4th, and in The Lancet. Out of all COVID-19 vaccines, this was the first vaccine in the world that was registered after two testing phases. The third phase, during which safety and efficacy will be checked in different groups of people, is going on right now.
Some data that repeated itself was what elicited the greatest number of questions from Bucci and his colleagues: nine of the volunteers from day 21 to 28 in the vaccination process registered antibody indicators that were completely identical. Logunov stated that in small-sized groups of test subjects this possibility “cannot be ruled out”. “It is possible that immune system indicators could reach the kind of plateau that we observed during the research,” the letter states. Logunov also stated that all of the data obtained by scientists during the experiment was double-checked.
“We would like to emphasize that all the data presented that was obtained during the experiments was double-checked. The coincidences that emerged, especially for the points early on (values that are low and close to baseline), are associated with the data’s discreteness, as well as with the small number of participants in the groups. In the article’s discussion section, we highlighted these limitations inherent in the study,” the letter states.
Bucci also indicated in his letter that when the study’s results were published in The Lancet
it had not been completed, and “the data on safety was incomplete”. Logunov answered that in actuality, as per the study’s protocol, one more visit was planned for the patients, at 180 days after administering the vaccinations. “The data obtained at that point in time will be published as per established procedures,” he promised.
The authors of the letter assured Bucci and his colleagues that they are ready to make the data for each individual participant in the russian COVID-19 vaccine trials available upon request, through The Lancet. “We confirm that individual participant data will be made available by submitting a request addressed to Denis Logunov and, after the request has been approved, data can be shared through a secure online platform,” Russian researchers affirmed.
What the Russian response means. “One of the complaints put forth by Bucci was that the antibody titer values for participants in the study coincided. Logunov writes that these values can coincide, since they are discrete: during the study, Russian scientists did not obtain exact titer figures, but saw their values that involved certain intervals by virtue of the technological methods that were used, for example, 800, 1600, 3200, etc. The probability that the data will coincide for a small number of study participants, meaning that the antibody titers will fall within the same range, is indeed quite high, although to assess this probability qualitative modeling would be required that takes into account the specific features of the biological processes involved. Russian scientists did not need accurate data, since the task objective for Logunov and his colleagues was to show whether there is an effect produced by the vaccine,” Anton Gopka, a general partner and co-founder at ATEM Capital, told Forbes magazine.
Bucci and his colleagues did not offer any hypotheses of their own as to why the study could have produced similar antibody titer values, and did not consider the likelihood of that kind of coincidence occurring, bewails Gopka: "Their comments actually hinted at falsification, or that a technical error occurred.” There are topics for debate, but Bucci and his colleagues only paid attention to how graphs were similar, without even making any attempts to interpret them, says the expert.
“In my view, it would present much more interest to study how the vaccine worked in a cohort of military service personnel and civilians, and whether there were any anomalies in that data,” added Gopka. He says that the response from the Russian scientists was very articulate: it was professional, even-keeled, and disallows the questions in the same format in which they were asked. However, the criticism itself is quite superficial: if it had contained any analytics, then reading it would have been much more interesting, believes the co-founder of ATEM Capital.
Who is Bucci? First and foremost, Bucci is well-known for his work in combating attempts to falsify scientific work. In 2016, he founded the consulting company Resis Rsl, which is located in the north of Italy. Resis is hired by universities and institutes to check scientific publications: it provides services preparing scientific papers for release in specialized publications, including checking the data slated for publication for inconsistencies and errors. According to the Resis website, three people work there, but for large-scale contracts it contracts work out to international programmers, lawyers, forensic science experts, and other scientists. The company has its own software to help bring to light incidents involving falsification. Bucci affirms that it scans images in manuscripts to pick up on duplication or other inconsistencies.
For example, in 2017 the Leibniz Institute on Aging turned to Resis for help after it became known that 8 out of 11 scientific publications released by the institute’s director, Karl Lenhard Rudolph, contained gross errors.
As a result, scientists at the Leibniz Institute became obliged to send each article and doctoral dissertation first to Resis to be verified, and only after that for publication. The institute signed a contract with Resis to analyze images, check statistics, and search for acts of plagiarism in doctoral dissertations. Resis checks all manuscripts within 24 hours from the time it receives them, although if any problems come to light then the analysis process could take up to three days. The Institute allocates up to 50,000 Euro (55,000 USD) each year to pay for these services and process the information it provides.
What RDIF says. “Many of Bucci’s publications contain information about his potential conflict of interest that have to do with the commercial activities that he performs. But initially the open letter from Bucci and other experts addressed to those who developed Sputnik V did not contain any information about a conflict of interests, but rather was disclosed only as part of an official inquiry submitted to The Lancet,” states the RDIF press service. Resis’ clients could include both scientific research institutes and pharmaceutical companies involved in research. “Publishing open letters and expert opinions can, in this case, help promote sales for Bucci’s company,” emphasized an RDIF representative.
TRANSLATED FROM THE RUSSIAN
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