Shameful obscurantism
Alexander Panchin, "The Attic"
"Release-active drugs" – are you familiar with this term, sometimes found in the description of drugs? What lies behind the words that the content of the active form includes no more than 10-16 ng / g of the active substance? What scientific studies can confirm the effectiveness of the relevant active substances and, in particular, similar degrees of dilution? Alexander Panchin, biologist, popularizer of science and member of the RAS Commission on Combating Pseudoscience, tells about all this, at the request of the Attic.
"Anaferon for children" is one of the many drugs of the Materia Medica company that can be bought without a prescription at any pharmacy. I am sure that the reader has heard about this remedy for colds, flu and other acute respiratory diseases, and maybe even been treated with it.
The description of this "medicine" says that it contains active components – "antibodies to human gamma interferon, affine purified – 0.003 g". Then in small print: "active form with a content of no more than 10-16 ng / g of active substance." A nanogram is one billionth of a gram, and if you multiply all these numbers and take into account the mass of the tablet, it turns out that there should not be a single molecule of any antibodies to interferon or other active substance in it. For 200 rubles, a concerned parent buys his child 20 tablets consisting of excipients: lactose monohydrate (0.267 g), microcrystalline cellulose (0.03 g) and magnesium stearate (0.003 g). In other words, you buy milk sugar at a price of 37,400 rubles per kilogram.
The company calls its drugs "release-active". They are sold exclusively in Russia (and a number of other CIS countries), Mexico, Mongolia and Vietnam. Moreover, only Russians spend several billion rubles a year on them. Someone will decide that if the drugs didn't work, they wouldn't be so popular! But it's very easy to explain.
While conscientious drug manufacturers need to look for new active substances, produce them and conduct expensive clinical trials, sugar merchants have only one significant item of expenditure – advertising. Therefore, praise for the preparations of "Materia Medica" can be found everywhere: from newspapers to central TV channels. Now imagine that someone believes such an advertisement and starts treating the flu or cold with sugar. In most cases, the disease will pass by itself (as in the joke: with treatment, the cold passes in a week, without treatment in seven days). In this case, the patient may mistakenly assume that the drug helped him. He doesn't know that he would have recovered just as quickly without the miraculous medicine. Therefore, some people will continue to be treated with Anaferon, sincerely confident that the drug helps them. Well, we will not hear the voices of those who still could not defeat the disease.
Due to the complex dynamics of well-being in many diseases, it is very difficult for a person to understand which remedy works and which does not. Especially if it is based solely on personal experience. Let me explain with an example that I used in the book "Defense against the Dark Arts".
"In 2011, The New England Journal of Medicine published an article comparing the effectiveness of four approaches for the treatment of asthma: the bronchodilator drug Salbutamol, placebo inhalation, imitation of acupuncture and lack of treatment. Each patient was treated using all four approaches separately, in random order. Objective spirometry data (volume and speed indicators of respiration) showed that the drug helps, while the other three approaches are equally ineffective. However, according to the subjective feelings of patients, all three methods of active therapy helped equally well compared to the complete absence of treatment."
Therefore, carefully planned clinical trials involving a large number of patients are needed to understand which drugs work and which do not.
Of course, there are a lot of companies that sell pacifiers and use the aforementioned ignorance of citizens. And it would be strange to single out only "Matter to the Medic." Those interested can get acquainted with the list of popular drugs that do not have proven effectiveness. But the indignation of scientists is connected not only with misleading patients, but also with the fact that their manufacturing company is trying to promote dubious studies of "release activity" and pass them off as science.
Most of the "scientific" articles devoted to the release-active drugs of "Materia Medica" were published in the domestic journal included in the list of the Higher Attestation Commission – "Bulletin of Experimental Biology and Medicine". Director of the company, Corresponding member of the Russian Academy of Sciences Oleg Epstein in 2003 became the author of 49 articles (!) in this magazine. All of them came out under the cover of a special issue, the editor of which was also Epstein. Soon he defended his doctorate.
A detailed critique of the phenomenon of "release activity" can be read in the article "Epstein's Challenge" by Nikita Khromov-Borisov and Mikhail Arkhipov. International peer-reviewed scientific journals have also published criticism of some of Epstein's works, for example, our joint article with medical chemist Evgenia Dueva in the Journal of Medical Virology. But today I will limit myself to just a few quotes from Oleg Epstein's article "The phenomenon of release activity and the hypothesis of "spatial" homeostasis", which probably shock any biologist. For the rest, I will explain that an absolutely meaningless combination of real and fictional terms will follow below.
"... We believe that the genome does not generate a new physical entity – the "field", but integrates the organism into the supramolecular "ether", which provides the structural basis for the holistic regulation of the organism." "The genetic code of any individual is not just a primary sequence of nucleotides, but their unique holistic (holographic) spatial organization, which has its own set of subtle – supramolecular – vibrational characteristics." "The DNA transmitted from generation to generation is capable of preserving general-species spatial parameters in its vibrational structure and, in fact, provides a "connection" of the future organism to the evolutionarily developed general-species spatial matrix at the supramolecular level."
In some ways, this resembles the reasoning of another well-known figure of pseudoscience – Peter Garyaev, the author of the concept of the "wave genome", spreading the idea that mate destroys DNA. Alas, as it was shown in the article by psychologist Gordon Pennycock and his colleagues from the University of Waterloo "On the perception and recognition of pseudo-deep nonsense", people easily take scientific meaningless reasoning (obtained even with the help of a random quote generator) for something reasonable. This, apparently, is the calculation.
On its website, Materia Medica claims to have thirty completed clinical trials. Under the same names as in the State Register of Medicines, 20 of them are registered on the American website clinicaltrials.gov . Nine of them are recognized as completed, but only for one of them the results are presented. There can be two explanations for the fact that the results are not presented for the rest of the completed studies. Either these results did not pass proper quality control and did not satisfy independent experts, or the authors wanted to hide the results from the regulator.
In the completed study with the presented results, it is stated only that the effectiveness of Ergoferon (another antiviral "release-active" drug of Materia Medica) is comparable to the effectiveness of Oseltamivir (aka Tamiflu). But this hardly speaks about the effectiveness of Ergoferon. The fact is that "Oseltamivir" It was recently excluded from the list of vital drugs according to the World Health Organization. It turned out that initially the manufacturer did not provide all the research data, but only a part, thereby significantly overestimating the effectiveness of the drug. The sample size used in the study of "Materia Medica" is small, so it could reveal only very big differences between "Ergoferon" and "Tamiflu", and they may not be due to the fact that "Tamiflu", if better than sugar, then not much. In addition, the experimenters and patients knew who was receiving which drug, which means that the study was not blind and clean.
Distorted presentation of data on clinical trials is a typical admission of sugar–based drug manufacturers. I will quote the website of the company "Boiron", which produces "Ocillococcinum":
"On the website of the Cochrane Society for Evidence-based Medicine, you can find blind randomized placebo-controlled studies on a number of homeopathic medicines showing positive results. In particular, "Ocillococcinum" appears there with the meta-analysis of six RCTs (randomized controlled trials), being one of only five mentioned antipruritic drugs (besides Remantadine, Amantadine, Zanamivir and Oseltamivir)."
But if you do not be lazy and open the mentioned meta-analysis on the Cochrane website, then you can read the following:
"In general, the presentation of the study results was insufficient, and therefore many aspects of the test methods and results had an unclear risk of bias. In this regard, we assessed the quality of these testimonies/evidence as generally low, so it is not possible to draw clear conclusions regarding the use of "Ocillococcinum" for the prevention or treatment of influenza and flu-like diseases."
Here it is necessary to explain that "Ocillococcinum" in composition is also sugar, which is traded under the guise of medicines for flu and colds. The active substance in it is an extract from the liver of a duck, which has been consistently bred a hundred times two hundred times. This is an even more incredible dilution than the antibodies in Anaferon. The liver of one duck would be enough to treat all people on our planet with "Ocillococcinum" until the Sun swallows it. Moreover, even a trillionth of this liver will not be used up by that time. However, "Materia Medica" has a drug for alcoholism – "Proproten-100", where the active substance is applied to lactose after dilution of 10-1991 ng / g. So the battle of the sugar titans is almost equal.
The law does not prevent this state of affairs in any way. The general Pharmacopoeia article "Medicinal forms of OFS for homeopathic medicines", in accordance with the requirements of which, according to the Federal Law "On the Circulation of Medicines" (Federal Law No. 61-FZ of April 12, 2010, the current version of December 28, 2017), such a drug must be produced, contains the following indulgence: "If the degree of dilution of the active component does not allow to determine the authenticity or quantitative content, the quality of the drug is evaluated by auxiliary substances. " I am sure that high-quality sugar is used in these products.
In these incredible dilutions (allegedly enhancing the effectiveness of the remedy) – the whole essence of homeopathy (not to be confused with herbal medicine – herbal treatment). But if "Ocillococcinum" is openly called a homeopathic remedy, then "Materia Medica" has taken a different path. At least two of the company's drugs (Anaferon and Impaza) were initially registered in Russia as homeopathic, but in 2009 the word "homeopathy" disappeared from their name. Therefore, as a joke, we will call "release-active" drugs "shameful" homeopathy.
But the joke no longer seems so funny when you find out that such drugs are supposed to treat not only colds, but also tick-borne encephalitis, impotence, diabetes, joint diseases, erectile dysfunction, sleep disorders, obesity, attention deficit disorder, chronic cerebral ischemia, alcoholism, allergies, benign prostatic hypertrophy, as well as solve many other health problems.
Classical homeopathy is guided by the principle of "like to treat like": the patient is prescribed a diluted drug, which in undiluted form causes symptoms similar to what he is experiencing. In "bashful" homeopathy, this magical ritual has been overgrown with science and terms from molecular biology. For example, for the treatment of diabetes, it is necessary to dilute antibodies to insulin receptors. For the treatment of erectile dysfunction – antibodies to the enzyme NO-synthase, which produces nitric oxide – a signaling molecule that causes relaxation of the smooth muscles of blood vessels. For the treatment of viral infections – the already mentioned antibodies to interferon – a molecule involved in the antiviral response of the body. The funny thing is that even if the dilutions of antibodies were not so fantastic, their most likely fate, with oral administration, is simple digestion.
For all the anti-scientific nature of such principles, Epstein's logic is extremely simple. Do you want to come up with your pseudoscientific release-an active drug and earn billions? Keep the recipe! Choose some molecule in the human body that is involved in some process related to the disease. Take the antibodies to it and dilute them many, many times, put them on a sugar ball and eat. For example, HIV penetrates the cells of the immune system by interacting with certain receptors on their surface. We take antibodies to these receptors, dilute them – and the cure for HIV is ready! A cure for cancer? No problem! Often, the gene encoding the p53 protein breaks down in cancer cells – it restricts cell division when their DNA is damaged. So, we need antibodies to it. It remains only to cure old age with antibodies to telomerase, an enzyme that lengthens the tips of chromosomes that shorten in the cells of an aging organism.
The fact that release-active drugs are registered and sold in Russia, alas, speaks of a deep crisis in the domestic healthcare system and the need to revise the criteria for approval of medicines. When the Commission on Combating Pseudoscience and Falsification of Scientific Research issued a memorandum on the pseudoscience of homeopathy, the Ministry of Health announced plans to create a special expert group that will consider the objections raised. Such a group has never been created – in any case, the members of the Commission on Combating Pseudoscience have not heard anything about it. We are afraid that the inaction of the Ministry of Health may be due to the fact that the influence of sugar pill manufacturers turned out to be too great.
But the Ministry of Education and Science of the Russian Federation recently awarded "Materia Medica" an "Anti-award" for the spread of pseudoscience. This is not the first scandal involving this company. In 2017, under a flurry of angry letters from scientists and students, the organizers of the Biologist's Day (a traditional holiday of the Faculty of Biology of Moscow State University) the invitation of the representatives of "Materia Medica" was withdrawn with the following words: "Your comments awakened the spirit of justice in the team, we checked the information and came to a collective decision, which was also supported by the administration, that the performance of a company with such a reputation at the Faculty of Biology is unacceptable."
It's good that at least someone opposes the magic of the XXI century, posing as science and medicine. Every patient has the right to know whether the drug has proven effectiveness or is a dummy, which, according to modern scientific ideas, cannot work. The Commission on Combating Pseudoscience is a public organization that does not have funding, so it is difficult for us to oppose something to the advertising capacities of homeopaths and "shy homeopaths". All hope is that readers will tell their friends and relatives about this problem themselves. Only together we can defeat the shameful obscurantism.
Portal "Eternal youth" http://vechnayamolodost.ru