FMBA And Skvortsova Were Accused Of Systematic Misinformation Of The Media

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FMBA And Skvortsova Were Accused Of Systematic Misinformation Of The Media
FMBA And Skvortsova Were Accused Of Systematic Misinformation Of The Media

Video: FMBA And Skvortsova Were Accused Of Systematic Misinformation Of The Media

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FMBA and Skvortsova were accused of systematic misinformation of the media

A special statement in this regard has been issued by the Association of Clinical Research Organizations (ACOI), of which Bayer, AstraZeneca and Bristol Myers Squibb, among others, are members. The reason was the statements of Veronika Skvortsova on May 15 about the effectiveness of the antimalarial drug mefloquine in the treatment of coronavirus.

FMBA and Skvortsova were accused of systematic misinformation of the media
FMBA and Skvortsova were accused of systematic misinformation of the media

Veronika Skvortsova / Photo: kremlin.ru

We are talking about a press conference held at TASS on May 15. The Association drew attention to the fact that the study of the FMBA drug, according to the agency itself, was carried out in accordance with the Decree of the Government of the Russian Federation of April 3, 2020 No. 441, that is, "in a special order, different from the order adopted in the organization and conduct of clinical trials", therefore, it cannot be considered a clinical trial. AOKI stressed that this is not the first time that FMBA has drawn attention to the inaccuracy of the wording in matters of clinical trials.

The Association also stated that "the study of mefloquine in accordance with Resolution No. 441 did not undergo an independent assessment of the study design, scientific substantiation of the hypothesis, statistical methods of analysis," and therefore "the quality of the obtained and sounded results is in great doubt."

“According to Veronika Skvortsova herself, the study of mefloquine is just beginning:“Now we have included more than 420 patients, in fact we are completing the enrollment.”And although the head of the FMBA stipulates that these are intermediate, this reservation is completely lost against the background of neighboring categorical statements about the proportion of patients We would like to emphasize that in these early stages, when recruitment has not yet been completed, it is premature to draw conclusions about the effectiveness of the drug, and any results announced in advance may only be the hopes of the developers, "the AOKI said in a statement.

The Association again urged FMBA not to use the term "clinical trials" to mean "dubious experiments with human participation and not to refer to the results of such experiments in the public space as evidence of the effectiveness of drugs developed with the participation of FMBA."

Due to the extensive media coverage of this press conference, the AOKI specialists asked the media to use the term "clinical trials" only if the Russian Ministry of Health issued the appropriate permission for such trials.

"Due to the systematic incorrect presentation of FMBA information, we ask journalists and editors to publish the statements of the FMBA head and excerpts from the department press releases only accompanied by comments from specialized experts who are not related to the Agency and who can help readers, listeners and viewers to form an adequate picture of what is happening in drug development, "the authors of the statement noted.

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