Evidence-based medicine as a means of promoting medicines

V.V.VLASOV, Director of the Russian Branch of the Cochrane Cooperation

Evidence-based medicine (DM) was formed as such in the late 1980s and quickly attracted the attention of all professionals working in and around medicine, as well as consumers of medical care. According to the simplest and most correct definition of DM, there is a kind of medical practice that differs in the conscious and consistent use of only those interventions in the management of the patient, the effectiveness of which has been proven in benign studies. Meanwhile, the idea of correctly evaluating the effectiveness of drug therapy by comparing the results of drug use in similar patients has at least a century-old history. Almost in its purest form, the content of the practice of DM in the 1960s was formulated by Henrik Wolf under the title "rational medical practice". Indeed, the use of means tested in a good scientific experiment – from the point of view of an educated doctor or consumer – is nothing more than rational behavior.

Manufacturers of medicines, materials and devices are exploring any niche, any new aspect of medical practice or its legislative regulation to increase sales of their drugs. The ideas of DM were mastered mainly in two directions: in strengthening the influence on the process of creating evidence (primarily on clinical trials) and in influencing the process of mastering evidence by doctors. In this article, we will look at the main methods used in the second direction, which is relatively harmless.

It's proven!The most primitive method of using the idea of DM was the placement on advertising booklets and magazine tabs in large font of slogans: "It's proven!", "Evidence-based medicine", "Reliable evidence" and the like.

For those who have not heard anything other than the phrase "Evidence-based medicine", this technique may have worked, but in general, apparently, it helped sales slightly. Indeed, most of the people who make purchasing decisions, if they look towards evidence, then it is on the merits, and not on the presence of a slogan. But there are many private buyers who are ready to believe that experience has proven that eggs are protected by toothpaste, or that studies have confirmed an increase in fluffiness by 150%. By the way, my experience says that a significant part of the population, even among those with a full secondary education, cannot explain what "an increase of 150%" means. But this does not prevent people from being impressed by this indicator.

In fact, there are several such slogans associated with DM. In addition to the actual statement that the above is proven, the most popular are GCP, GPP. Other foreign-language spells are also used, for example, "targeted drug". A striking example is the Chinese manufacturer of a plant–based emulsion for intravenous administration called "Kanglight". On his website on the Internet and on the pages with anonymous review and advertising articles, "photos" of giant spacious workshops shining with stainless steel and delightful, equally photoshopped buildings surrounded by fountains are reproduced. The reader should believe that a wonderful anti-cancer drug, which came from China and was registered in Russia after testing in a cancer center on two dozen patients, was made in accordance with the requirements of good manufacturing practice. There is no doubt about the economic effectiveness of the strategy: among the many thousands of people dying of cancer every year, there are enough willing to pay money for the "Chinese miracle". Especially verified by scientists of the national cancer center. The moral damage, however, is great. The leading oncologists of the country participated in the kanglight advertising campaign, although it was no secret to them that the drug had not passed the first phase tests in the USA, and those tests that were presented by the manufacturer or conducted in Russia would not turn the tongue to call benign. Li Dapeng, who is called the author of kanglight, was accepted as an honorary member of the Russian Academy of Medical Sciences and published his review of Chinese studies (which no one apparently saw in the original) on the pages of the Bulletin of the Russian Academy of Medical Sciences.

Evidence-based advertisingThe requirements for the content of advertising publications began to change back in the 80s, taking into account the DM movement and respect for the right of doctors to information, as well as awareness of the importance of full-fledged information for the correct prescription of drugs.

Not the least role was played by consumer lawsuits against drug manufacturers in connection with incorrect information. Such advertising requirements were created by WHO and, more modestly, IFPMA. The minimum requirements of the IFPMA Code in the advertising of drugs provide for the provision of information about:

• trade name;
• approved name;
• the name and address of the company or its agent responsible for distributing the product;
• a simple statement of testimony;
• clear notification that further information is available upon request.

In addition to these requirements, WHO considers it necessary to provide information about:

• side effects and major complications;
• caution requirements, contraindications and warnings;
• basic interactions with other drugs;
• references to the main literature in accordance with the above statements.

From the DM's point of view, the main thing in regulating the content of advertising is the obligation to confirm statements with references to scientific research (evidence!), including unpublished ones, and the obligation to send documents to the doctor upon request. Under the influence of such requirements, the very image of advertising has changed, primarily in medical journals. Graphs from clinical trial reports and links to meta-analyses have become common in it. In addition to the color tab, it has become common practice to print several more pages of detailed information – this is the only way to report everything you need. In a sense, such an advertising publication can be a comprehensive overview of the information on the drug performed by the manufacturer. So the advertisement became "evidence-based" from the draft picture.

This was facilitated by a previously well-known fact: doctors, like all people, are influenced by even the simplest advertising, but they also consider it as a source of professionally useful information! Alas, studies conducted in the last 20 years have repeatedly confirmed the worst fears. Advertisers do not report in advertising not only all the necessary information, but even the minimum necessary; do not send information on request; place statements in advertising that are not supported by research; give links to non-existent publications. In the developing countries of the post-Soviet space, advertisers do not meet these minimum requirements either.

It is precisely because doctors trust advertising, and advertising contains incomplete or distorted information, that it has become common to teach doctors to critically use advertising information, and not just research reports on diagnostic and therapeutic interventions, as part of DM training.

Systematic reviewAs you know, the volume of scientific data published daily is so large that a doctor, even with access to journals, cannot read them.

Moreover, he cannot generalize the results of dozens of studies of one drug in order to independently form his own idea of effectiveness. He cannot do this, in particular, because he does not have and, as a rule, cannot have sufficient knowledge to synthesize the results of individual tests, which often do not coincide with each other. That is why, at the end of the twentieth century, systematic reviews began to be increasingly used in medicine to generalize disparate scientific information. Recall that systematic reviews are called, in which efforts are made to detect all studies, those that meet predetermined criteria are selected from these studies, and the results of such benign studies are summarized. Sometimes the results of individual studies are summarized using statistical methods, which is called meta-analysis. In the 1990s, the Cochrane Collaboration emerged, an international organization that unites specialists who prepare systematic reviews and regularly update them. In recent years, systematic reviews have been recognized as the most reliable way of summarizing scientific information, the most sound way of analytical work. But before they were fully recognized, remarkable events occurred.

In 1998, a group of authors of the Cochrane Trauma Group summarized the test data of albumin as a means of infusion therapy in severe trauma. It was found that, despite the fact that albumin really effectively maintains blood pressure, patients who received an infusion die no less often than those who received an infusion of isotonic sodium chloride solution, and even a little more often. In some countries, sales of albumin have collapsed. In others, they have noticeably decreased. Thirdly, as in Russia, they have not changed in any way.

The global albumin industry reacted to this in a new way. The Association of Albumin Producers developed a plan in which, along with a program to discredit the Cochrane collaboration, a systematic review was ordered. This is the most famous case of the "struggle of reviews". A group of hired experts changed the criteria for including studies in the review and concluded that the harm of albumin has not been proven, and therefore the results of the Cochrane review can be rejected. The authors and customers were not particularly embarrassed that drugs, as a rule, are used not so that there is no harm from them, but in order to benefit. If you carefully read these systematic reviews, you can get confused. But if we remember the principle of DM – to treat with what has been proven useful, then the issue is solved quickly and unambiguously.

Playing on the good old stringsIf the results of evidence-based studies are absolutely inexorable, then it remains possible to bypass these results "from the flanks".

It is well known that in order to obtain quantitatively noticeable and understandable results for interpretation, homogeneous groups of patients are included in clinical trials and a protocol is formed in such a way that the dosage, the mode of use of drugs and other concomitant conditions are clear and definite. As a side effect, it becomes possible to declare this result private, not solving the problem as a whole for this drug and certainly not able to influence the assessment of the entire group of drugs.

A typical example is dozens of comments published in all languages after the discovery of estrogens taken for the prevention of chronic diseases in postmenopause, the properties of these diseases increase. These comments were similar to each other. Their goal was to prevent the collapse of the hormone replacement drugs market. The comments urged doctors not to rush to conclusions, to think before canceling hormone therapy. Think about the results of observational, non-experimental studies, about what can explain the preventive effect of estrogens? How, you ask, what is the effect? And everything is very simple: in these articles, the authors pretended that in addition to the facts of clinical trials, there are other serious facts: cholesterol is decreasing, blood glucose…

Similarly, the defenders of albumin appealed to evidence-based medicine. After the landmark review mentioned above, a study was conducted that was supposed to give a decisive answer to the question of the usefulness of albumin in trauma (SAFE). It was specially planned so as to take into account all the shortcomings of previous studies. And everyone nodded in agreement: oh, yes, THIS study will solve the question! Conducted it, the result is published. No miracles. Does not increase survival albumin in severe trauma. What happened next – you can easily tell yourself. It turned out that children were not included in the test, and therefore it is impossible to extrapolate the results to them, etc. That is, in general, everyone understands that it is necessary to prove the effectiveness of drugs so that they can be used, and to prove the ineffectiveness of drugs, and even in every possible subgroup of patients (age, gender, pregnant, elderly ...), no one has ever asked and never will. But since factories are working, making albumin – well, you know what it is like with us – who has gray, who has brown – so far there are not enough reasons to reconsider the attitude to the use of albumin solution in case of injury. And all the arguments also bypass the main thing: about circulation, about osmotic pressure, but not about the fact that it does not help patients to survive.

In the twentieth century, one of the main reasons for the creation of DM was dissatisfaction with the effectiveness of interventions based on physiological considerations. These considerations can be a support for the doctor in a situation where there is no direct evidence of the effectiveness of the intervention. But if there is evidence of uselessness or danger, then they override all considerations. On the other hand, the presence of information about the danger itself does not give a decision about the usefulness of the intervention, the balance of benefit and harm is important. For example, the use of thrombolytics can lead to adverse effects, but the increased survival of patients with myocardial infarction is such that these side effects overlap. In other words, more people survive from thrombolysis than die from its complications. Another example: misoprostol in the experiment and in the clinic effectively stimulates uterine contractions, but in clinical trials convincing evidence of excessive stimulation threatening rupture has been obtained. So, no matter how convincing the knowledge about the mechanisms of action of prostaglandins is, it cannot be used.

A special aspect of the problem of extrapolation of knowledge is the transfer of the results of experiments performed on animals to people. That is, everyone knows that the results of experiments on animals cannot be directly transferred to people. But from time to time, remarkable results are obtained in animal experiments, for example, to slow down aging, and these results splash out even on the pages of tabloid newspapers. Meanwhile, it seems that the results obtained in animal experiments provide extremely little to predict the effect of the intervention in humans. This is another reason for the weakness of explanations as grounds for intervention. After all, many physiological knowledge in detail was obtained on animals, not on humans, not in a clinic. The main thing is whether there is direct evidence of the usefulness of intervention in the clinic.

Full packageSince studies of the information needs and behavior of doctors invariably point to the high authority of scientific medical journals, this area has come under special attention.

Actually, at all times, advertising in professional publications has been one of the most important areas of marketing efforts. However, the impact through the content of scientific articles should be greater. Therefore, as the share of clinical trials conducted by manufacturers of medicines and devices increases, the totality of what has been published in the press has increasingly begun to depart from the "truth". As it now seems, the main mechanism for the emergence of such a "publication bias" is the selective publication of only those results that correspond to marketing objectives. One of the most famous examples of recent times is the scandal with the concealment of data on the ineffectiveness of antidepressants in children while promoting them to pediatrics "off label". Very recent, still developing – with the concealment of the side effect of an antipsychotic drug, the effect of severe obesity and diabetes. If the assumption is confirmed, then the remarkable success of a large company in the market can be replaced by a catastrophe.

Most of the marketing efforts of this kind are on a smaller scale and remain unnoticed. A group of St. Petersburg researchers at the very beginning of the XXI century decided to conduct a systematic analysis of the data obtained in trials of angiotensin inhibitors in Russia. It turned out that 1) the effect in domestic trials is very large; 2) the spread of results is very large; 3) all tests were performed on approximately the same (and small) number of patients. This combination of signs allows us to say with great confidence that many studies were conducted using standard conditions and a package of a drug, and then what "turned out" was mainly published.

From such "small" studies of the fourth phase grows a wonderful practice of "scientific support" of advertising publications. Open any domestic medical journal, and you will find in almost every issue a colored tab adjacent to such a "scientific article". Naturally, such articles cannot contain negative or neutral information about the drug – only positive, more often in superlatives. I recently researched how much the content of medical journals is built in support of advertising. It turned out that this is the rule, not the exception. One of the largest marketing agencies in Russia even specifically analyzes the content of magazines and can, at the request of the customer, present this situation in connection with the content of advertising.

Meanwhile, the formation of journals "for advertising" is categorically unacceptable for scientific journals. Actually, this is the main difference. In the US National Library of Medicine, the rule according to which journals are included in the MEDLINE database clearly states: the connection of content with advertising is unacceptable. Sooner or later, this problem will arise before our leaders, such as the "Therapeutic Archive" and "Cardiology". What will then remain of the Russian scientific medical periodicals?

Destruction of scientific periodicalsScientific periodicals are subject to an even more destructive influence from commercial journals.

Only at first glance they occupy a special niche of obviously advertising publications distributed for free. In fact, all such journals more or less successfully imitate "real peer-reviewed" journals. If the "Russian Medical Journal" has already settled into this niche and everyone knows it, then other similar publications are more or less trying to avoid such recognition.

On the other hand, commercial publications grow out of the environment of "real" magazines. For example, as if "Arterial hypertension" and "Heart failure" grew out of "Cardiology". Not only does their content largely repeat "Cardiology", but the editor-in-chief is the same. These magazines have been successfully existing on the market for more than one year. Without any special claims to scientific knowledge, but they bring their own piece of bread with butter and caviar to the owners.

Recently, a miracle appeared on the magazine market. The new publishing house, which immediately announced dozens of magazines for subscription, is Medkniga. Some of these announced magazines have even been published. They turned out to be quite funny crafts, similar to magazines, but filled with anything. Mostly stolen texts "from the Internet". I also found my article there, but with a link not to the magazine from where it was taken, but to the publisher's website. This company is part of the publishing empire Pleiades Publishing Inc. is actively developing. It can be assumed that it is aimed not only at advertisers' money, but also at some other resources, perhaps at the funds of the National Project "Health".

Such examples could be multiplied, but it is clear: established scientific journals are degraded under the pressure of advertisers who want to support the publication of advertising with articles with "scientific evidence". At this time, new ones are breeding nearby, mimicking the real ones and gnawing off their piece of advertising pie. Naturally, in a situation of competition for the advertising budgets of pharmaceutical and other companies, magazines agree to provide new, more flexible services. As a result, the credibility of magazines in the eyes of doctors has fallen extremely low. It will not seem surprising to me if advertisers soon discover that magazines have lost their influence on doctors and consider advertising in magazines unprofitable. So fleas leave the cooling corpse in search of a new owner.

It is obvious that the behavior of advertisers and editorial offices is dictated by a short-sighted understanding of only short-term interests. At the same time, there is almost no competent control over this aspect of advertising practice. Indeed, in order to exercise control in this area, not only authority is needed, but also competence. Not in the sense in which they speak of "competent authorities", but in the original sense of the word – in the sense of the ability to compete with other specialists in this field. This is the role that the WAC undertakes to play in our country. He even prepares lists of scientific journals in which they should be published (in another place the requirement sounds different – they can be published) materials of dissertations. And what are these lists? Until November 2006, the journals "Bulletin of Young Scientists" and "Valeology" were on this list. There could also be "Astrology", since the principles of compiling these lists do not exist in nature, and the competence of the compilers is striking. If the list of foreign journals where future applicants for academic degrees are allowed to publish contains international journal numbers (ISSN), then the list of Russian journals contains numbers according to the Rospechat catalog. I.e., the compiler of the list – the HAC – does not understand the difference between the standard of unique international registration of periodicals and momentary registration in the commercial catalog. As the hero of a popular joke about his parents remarked: "And these people forbid me to pick my nose!"

In fact, the process of destroying scientific periodicals through "evidence-based advertising" can hardly be stopped "from above". I can hardly imagine a situation in which the US National Library of Medicine will begin to exclude "therapeutic archives" and "military medical journals" because they will reveal a connection between the content in them and advertising. Rather, these are quite secondary by world standards magazines (the word is – "gray" literature!) they will die by themselves. World science will not notice. It can't be! – you say. Exactly. Recently, a thematic group in the Cochrane Collaboration, whose participants compile systematic reviews of the effects of medical interventions for a very common disease, analyzed the Russian literature. It turned out that if the world collection of controlled clinical trials of interventions for this disease is more than 10,000 articles, then only a dozen have ever come from Russia and the USSR. Here it is – the real contribution of our country to the DM.

From this it is clear that the scientific community of the country has only one way out – to fight for the quality of our journals themselves. High–quality magazines that carry evidence-based research will always remain attractive to advertisers - as long as magazine advertising exists.

Clinical recommendationsOne of the greatest achievements of DM is the formation of the practice of making evidence–based recommendations.

Today it is already difficult to imagine that some 20 years ago, recommendations on the management of patients were composed by respected specialists in accordance with their ideas about correctness, i.e. they were equipped with references to scientific research, but nevertheless were a description of the views of one or more authors-compilers. They could have been university recommendations or approved by the USSR Ministry of Health – it doesn't matter, they were primarily the private views of more or less knowledgeable people.

Today, there are reliable technologies for drawing up clinical recommendations (CR), i.e. documents developed on the basis of evidence-based methodology describing a more or less wide range of issues regarding the management of patients with certain conditions in order to assist doctors, administrators and patients. A key element of evidence-based research is the use of systematic reviews as the main tool: searching for all available information, critically evaluating it, making recommendations based on only the most reliable information.

This process has two vulnerable points: firstly, there is not always enough reliable data to formulate unambiguous recommendations; secondly, there is always the possibility of manipulating the really available data.

The lack of information about the effects of medical interventions has always been felt, but it turned out to be approximately measured only after a lot of systematic work on the evaluation of evidence. Probably the most reliable data were obtained during the development of the publication "Clinical Evidence" (see figure).

As we can see, about most of the interventions widely used in medicine, considered in the handbook, benign information is either absent or insufficiently defined. If the information is uncertain, then the formulation of recommendations also becomes less definite, depending on incoming factors, often on factors that lie outside the actual field of scientific data. From the point of view of DM, if you practice it "in its pure form", in a situation where there is no convincing data on interventions, no interventions should be undertaken. However, this is possible, albeit with difficulty, only in a single case, in relation to an individual patient who has been informed and agreed to such treatment due to its at least least harmfulness.

In clinical recommendations, there is a need to formulate recommendations for the management of patients in any case, moreover, doctors need recommendations precisely in situations where they do not have sufficient knowledge. Naturally, this situation is considered in the guidelines for the preparation of clinical recommendations, but it cannot be considered completely safe, protected from manipulation.

Manipulations of the content of recommendations seem very attractive to an unscrupulous market participant, since recommendations directly affect the prescribing of drugs and all other features of the behavior of doctors, administrators and patients. Of course, they had a particularly big influence before DM became dominant. At the same time, it was sometimes possible to form a policy of using drugs directly contrary to scientific evidence. The most famous and even tragic example for our country is the promotion of "genetically engineered" insulins. As you know, the USSR almost completely provided diabetic patients with animal-derived insulins produced by domestic enterprises. Leading specialists of the country at the turn of the 1990s actively began to promote new insulins, focusing on their technological novelty and better regulation of carbohydrate metabolism. Gradually, animal insulins were not only forced out of the market, but also production ceased to exist. It is well known that "new" insulins are many times more expensive than "old" ones. And this switch happened in our country when there were the least funds in healthcare. At that moment, in some regions of the country, almost all funds were spent on the purchase of insulins. At that time, tuberculosis patients did not receive their free treatment, psychiatric patients did not receive medications and lost their jobs... Meanwhile, at that moment there was enough evidence that "human" insulins had no advantages over animals. Moreover, at that moment there were WHO recommendations, which clearly stated this, and recommended that poor countries (readers remember, our country was like this in the 1990s) use animal insulins. There is no way to fix the situation now. The Ministry of Health has approved clinical guidelines for the management of patients with diabetes. Indeed, they do not mention the preferred type of insulin. But all patients have already been "switched" to genetically engineered drugs, and it would be wrong to transfer them back to animals due to the fact that the transition process itself is not easy. However, no one knows how long oil prices will remain high. Perhaps life will force us to return to the choice of what we have money for.

There is another, more recent example, and not from Russian life. Perhaps it is unique in scope. The manufacturer of the new drug, as part of an advertising campaign, funded the development of a whole series of clinical recommendations for the treatment of sepsis. The beauty of the situation with evidence-based recommendations is that they are developed taking into account and even sometimes mainly on the basis of data from benign studies. But if there is little or no evidence about most of the interventions under consideration, then the one about which there is such data is in the first place. This is exactly what happened with protein C for sepsis. In sepsis, most of the interventions have no proven usefulness. And one test confirming the effectiveness of protein C made him a "champion".

On the other hand, the provisions of the recommendations become a rule that cannot be deviated from. Based on such recommendations, insurance companies decide to cover the costs of expensive medicines, and the audit makes decisions about the correctness of the clinic's work. Naturally, when such recommendations appear, sales of the recommended drug grow almost regardless of its price.

An important opportunity is open to such a process of manipulation by doctors. As is known, drugs can be allowed for clinical use even after one successful clinical trial. In any case, this is what the FDA does in the USA – in Russia, drugs are often allowed without the results of benign tests at all. After the results of one trial are available, you can start the process of reviewing the set of clinical recommendations for the entire process of managing a patient with this disease. Then there may be evidence that the drug is not as effective as it should be from the first test, or ineffective at all – this happens. It is important that if clinical recommendations are developed quickly and accepted by regulatory organizations, then the effect can be significant and fully justify all costs. Actually, this is what happened in this case with recombinant human activated protein C for the treatment of sepsis. The PROWESS trial revealed a significant clinical effect along with side effects of the drug. New tests have shown that there is no noticeable benefit in the balance of outcomes. However, the results of these unfavorable marketing tests were not adequately reflected in the recommendations. The drug continued to be widely used. Professional medical societies were involved in the implementation of these recommendations, the manufacturer of the drug allocated funds for incentive grants to doctors who were more successful than others in implementing the recommendations.

Already in 2007, the US National Institutes of Health (NIH) canceled the meeting on the preparation of clinical recommendations, because it was revealed that most of the experts invited to participate in it have a hidden or declared conflict of interest. It should be noted that in the USA and some other developed countries (here the word "developed" is the key, in the direct meaning), the conflict of interests of experts making important decisions is the object of serious attention, and there are procedures for identifying it and eliminating possibly interested experts from making appropriate decisions. Unfortunately, in our country, no one knows the composition of those commissions that make decisions, and no one asks experts about the conflict of interests. It's almost obvious that everyone has it, but we don't know about everyone. Recently, one head of domestic medicine, hearing from me about a similar practice in the United States, said that this is impossible in our country – all experts are connected with someone, and as a result we will be left without specialists in the most important councils. Or maybe it's better without such specialists?

Postgraduate educationIf in Russia the postgraduate education of doctors began to be called continuous and lifelong in a foreign manner, in reality it remains intermittent (once every 5 years), and even this, as is known, has never been fully implemented.

In the countries where the system of continuous education of medical workers was created, its very idea was closely connected with DM. Indeed, it has been shown that compulsory and standard courses are not only boring, but they do not meet the interests of doctors, do not meet their needs and do not help to close the gaps in doctors' knowledge. On the contrary, if the doctor himself identifies a defect in his knowledge and learns what he is interested in, this increases the efficiency of knowledge acquisition.

With many defects, the Soviet system of "intermittent education" has one advantage. It is easy to finance from the budget. Accordingly, educational institutions are pleased to receive funds for this activity. As a result, a situation has been created that preserves itself: it is pleasant for teachers of "postgraduate" departments to work a little, and doctors are even happy to give them their money, just not to sit for months on standard courses.

On the other hand, in a system of continuing education with a periodic assessment of doctors' knowledge, similar to the American one, there is a problem of the payer. It is, at least theoretically, solved by the ability of doctors with sufficient income to pay for educational programs of various kinds – from subscribing to magazines to buying computer programs – out of their own pocket. Employers also provide great help. However, this is not enough, and I usually don't want to spend my money on something that can be obtained for free. That's why industry-funded educational programs of various kinds have become so widespread. From the most expensive – field sessions, participation in conferences, to relatively cheap – short seminars with free lunch. That's where the popularity of the saying "there are no free lunches" came from. To explain to doctors why it is bad to agree to free courses with pleasant feeding.

In general, the code of marketing practice prohibits the use of funding for educational programs to promote drugs or devices, but this is done almost everywhere. In Russia, sponsors, as a condition for supporting an educational program, set up the provision of time for a pharmaceutical representative to speak or the invitation of a specific lecturer. The latter is usually not bad, if not one of the best, but his performance is obviously planned for the purposes of the sponsor's marketing efforts. Previously, in our country and still in other countries of the former USSR, one can see professors rising to the podium one after another, and as their presentation they demonstrate sponsor slides, which are quite well known to the advanced part of the audience, right with logos.

The influence of sponsors on the educational process is comprehensive, starting with the choice of seminar topics (usually drug therapy) and ending with their content. The latter is often disguised as the use of the best evidence in the management of patients on the example of the results of an epoch-making trial. The presentation of the test results is often taken out of context or incomplete. The most famous example of incomplete presentation of information from trials is the limited provision of information about the side effects of taking statins. A systematic review of the safety of statin use in hyperlipidemia has recently been published. The authors collected all possible information published in English and found no statistically significant difference in the frequency of side effects when taking statins and when taking placebo. However, out of 1,142 relevant studies, only 39 were included in the review – the rest fell away, primarily because they reported nothing about side effects. Based on such results, which are available in print and available to doctors, it is possible, of course, to conclude about the safety of statins. But the very fact of concealing information about side effects in 9/10 trials makes you think about what kind of evidence this is, why the information has not been made public.

And I don't care!The simplest strategy of using evidence in promoting drugs, materials and devices is to ignore the evidence. I.e. if the evidence does not exist, then fine.

In a country where drugs are registered successfully, despite the lack of evidence in the form of randomized controlled trials, it is not difficult. The most striking example is closely related to the most famous example from DM. In the history of medicine, there have been many cases when a method of treatment or drugs were offered on quite reasonable grounds and widely used in practice, and then it turned out that this intervention was useless or harmful. When it comes to interventions that came from the past, such as mustard plasters on the precardial region for angina pectoris or blood-sucking cans on the back for pneumonia, then abandoning them looks natural and does not particularly bother anyone. If the author of the proposal is known, if the drug has been introduced recently, then the continuation of this practice has many defenders. But how else: after all, people defended their dissertations only last year, or they filed an application for the invention of a special device for administering the drug – and here, on you – St. George's Day!

Such a striking example is the use of lidocaine prophylactically for myocardial infarction. Quite logically justified use of lidocaine for the prevention of ventricular fibrillation was put into practice without full-fledged clinical trials. However, as such tests were carried out, it turned out that lidocaine only slightly reduces the frequency of ventricular fibrillation, but slightly increases mortality. Naturally, this result is the best proof that lidocaine should not be used prophylactically. Of course, there are also quite plausible explanations for why the mortality rate is increasing. But they are not very important for the substance of the proven recommendation: do not use lidocaine prophylactically.

I must say that the cardiology community has been extremely slow to respond to this evidence. Until now, cardiology books are on the shelves of our stores, in which it is directly recommended to use lidocaine prophylactically for myocardial infarction. Some of these manuals were even written after 2002. When analyzing the information provided on the Internet, it was found that most of the texts contain a recommendation to use lidocaine prophylactically. Moreover, some lidocaine manufacturers have an indication in the official information about the drug – preventive use in myocardial infarction. The only rational explanation for this state of affairs is that manufacturers have approved the text of the information and do not care about updating it for decades. The supervisory authority is equally indifferent to this.

Alas, DM turned out to be a concept and practice simple enough for a student to understand, but not strict enough to radically change the state of affairs in medicine. However, the history of medicine teaches that there have never been and probably never will be universal and absolutely effective means and approaches. As for the use of DM terminology in the promotion of drugs, here we are dealing with more or less inventive attempts to use the new situation for the usual purposes of the industry. Its result, of course, is the misinformation of professionals and consumers. But at the same time, regulatory processes are being improved, which will probably improve the situation. In any case, I hope for changes for the better in the field of information content of drug advertising in Russian magazines and for a departure from the publication of commissioned articles in support of advertising. After all, advertisers have been ill with "hotlines"? I think the evidence is quite clear in favor of the ethical promotion of any products in the long term.

Source: Remedium Magazine No. 4 2007.

Portal "Eternal youth" www.vechnayamolodost.ru17.03.2008