20 July 2020

With the letter "G"

Potentiation does not improve potency

On June 23, the International Journal of Impotence Research (impact factor 1.5) withdrew [1] an article about Impaza, a drug for erectile dysfunction produced by Materia Medica Holding. One of the authors of the article, corresponding member of the Russian Academy of Sciences Oleg Epstein is the owner and director of this company.

The "active substance" in Impase is antibodies to human endothelial NO-synthase. At first glance, it may seem that this is something scientific. Indeed, endothelial NO synthase produces nitric oxide, which relaxes the muscles of the walls of blood vessels, which increases blood flow to the genitals. The mechanism of action of many drugs for the treatment of potency problems is associated with the effect on the molecular signaling pathway in which nitric oxide is involved.

The problem is that "Impase" uses antibodies to the enzyme, which "are applied to lactose monohydrate in the form of a water-alcohol mixture with a content of no more than 10 in minus the fifteenth ng / g of the active form of the active substance." This means that there is no active substance in the preparation. As in other popular drugs of "Materia Medica": "Anaferon", "Ergoferon", "Tenotene", "Subette", "Proprotene", the total sales of which amount to billions of rubles a year.

Now the following message appears in place of the article: "The editor withdrew the article because there were doubts about the scientific reliability of the study. The reagent was diluted to such an extent that there should have been no active substance left. No molecular analysis confirming the presence of molecules was carried out. As a result, the editor lost confidence in the reliability of the research results. All authors disagree with this review."

The drugs of "Matter Medics" are called release-active, but this is just another word for homeopathy, which in 2017 was criticized in detail by the RAS Commission on Combating Pseudoscience in its memorandum [2]. Supporters of homeopathy believe that the drug is more effective the more it is diluted. The sequential dilution of the active substance in homeopathy is called potentiation.

In the withdrawn article, the word "homeopathy" is mentioned once in the methods section, where it is indicated that homeopathic technology is used in the production of the drug. Most likely, the reviewers did not notice this mention, as has already happened in some other cases.

It is worth noting that this is not the first, but already the fifth withdrawn article by Oleg Epstein, MD. Not counting two more that have not yet been recalled, but have been marked as questionable [3]. Detailed criticism of release-active drugs and studies allegedly confirming their medicinal properties is also published, for example, in the journal BMJ Evidence Based Medicine [4]. The Materia Medica Holding company itself had previously received an anti-award from the Ministry of Education and Science for "the most harmful pseudoscientific project of 2017" [5].

But if the journals have a procedure for revoking publications devoted to a deliberately non-working method of treatment, then, unfortunately, today there is no procedure that would allow the author of such articles to be excluded from the Russian Academy of Sciences.

It seems to me that this has a negative impact on the reputation of Russian science both domestically and internationally. There is another question: why are medicines registered in Russia that do not contain an active substance, articles about which are reviewed from scientific journals? How can you believe in the reliability of the registration system, in the quality of clinical trials, if even ordinary sugar is recorded in medicines? And what could be the consequences of making incompetent decisions?

In particular, we remember how, at the height of the epidemic, the Moscow Department of Health issued a manual with recommendations for the treatment and prevention of coronavirus infection COVID-19, which also mentioned release-active drugs: "Among the immunotropic drugs that have an antiviral effect, Anaferon, Ergoferon, Kagocel are recommended. At the same time, it was noted that the antiviral effect of "Anaferon" and "Ergoferon" on seasonal human coronaviruses has an evidence base" [6]. Fortunately, the release-active drugs were not mentioned in the official recommendations of the Ministry of Health, and the manual soon disappeared from the site.

Meanwhile, the news about the withdrawal of the article has already been covered by some foreign publications. The Discover Magazine website [7] joked about the "G-word", and the Retraction Watch website, covering the problem of low-quality scientific publications, called the note as follows: "It did not grow: the magazine withdrew an article about penis enlargement, realizing that it was about homeopathy" [8]. They are amused, but we should be sad.

Literature:

1. Retraction Note: Effects of chronic treatment with the eNOS stimulator Impaza on penis length and sexual behaviors in rats with a high baseline of sexual activity // International Journal of Impotence Research.2020.

2. About the pseudoscience of homeopathy: Memorandum No. 2 of the Commission on Combating Pseudoscience and Falsification of Scientific Research under the Presidium of the Russian Academy of Sciences // Commission website, February 7, 2017.

3. The Retraction Watch Database. Author(s): Epstein, Oleg I.

4. Panchin A. Y., Khromov-Borisov N. N., Dueva E. V. Drug discovery today: no molecules required // BMJ Evidence-Based Medicine. 2019. V. 24. No. 2.

5. The Ministry of Education and Science awarded an anti-award to the manufacturer of homeopathy // RIA Novosti. February 6, 2018.

6. Department of Health Moscow gave recommendations on the prevention of coronavirus // <url>. March 20, 2020.

7. Neuroskeptic. The Strange Case of the Homeopathic Sex Enhancer // Discover Magazine. June 30, 2020.

8. Coming up short: Journal retracts penis enlargement paper after realizing it was homeopathy // Retraction Watch. January 7, 2020.

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