Medications with unproven efficacy: truth and myths exemplified by Tamiflu
Jul 04, 2018
How often do patients, when referring to a doctor, doubt his professionalism?How often do patients do not trust known medicines, whose effectiveness is indicated by people who have an impeccable reputation in the scientific world?It seems that these questions are inappropriate - after all, the benefits of medicines, and modern methods of treatment are not talked about by the townsfolk and yesterday's medical students, but by "learned men"!
Unfortunately, this is not entirely true - the editor-in-chief of one of the most famous and authoritative medical journals "Lancet" Richard Horton in his author's article made literally a sensational statement: 50% of published data on the effectiveness of drugs are unreliable.
This statement was really shocking for both patients and most medical professionals, especially since it was done not by some young journalist chasing sensations.What do the words of Richard Horton mean?In this article, we will try to understand his statement on the example of all the known anti-influenza drug Tamiflu( Tamiflu).
Steps to disprove the effectiveness data Tamiflu
Tamiflu is a product that acquired special demand in 2009.It was then that a warning was issued about the impending pandemic of swine flu - worldwide and private companies spent more than $ 2 billion to purchase it.Countries did just astronomical reserves of Tamiflu, but the pandemic did not happen - fortunately, the statements of physicians and scientists were erroneous.
In 2009, the manufacturer Tamiflu Roche conducted a series of studies on the basis of which the Cochrane Group of Experts made an open statement - the drug reduces the risk of complications against the influenza virus.And nobody doubted the veracity of the conclusion - the Cochrane group of experts is considered a "gold" standard in the world medicine and there is no reason to distrust such a guru.What happens next?
The governments of Britain and Australia, which spent the largest amount of money to buy Tamiflu, attracted Dr. Tom Jefferson( an English epidemiologist, a member of the Cochrane Group of Experts) to conduct additional studies on the effectiveness of the drug.And here there was an incident - Tom Jefferson sincerely believed that nothing new research would show, to revise the earlier results does not make sense.The dear doctor and the well-known expert hoped for the publication in well-known medical journals, being sure that the true research data are displayed in them.
And if it were not for the Japanese doctor Keiji Hayashi, who prescribed the given drug to his small patients and doubted his effectiveness, no one would have known the results already known.Keiji Hayashi, in order not to be unfounded in his statements, independently studied all available medical literature about Tamiflu.As a result, it was clarified that the data used by Jefferson during the control meta-analysis of the drug in question were based on 10 clinical trials, but only 2 of them were reported in medical publications.At once there was a question - whether it is expedient to trust results if 8 of 10 clinical experiences in general have not been promulgated, which has been set by the Japanese doctor to the Cochrane group of experts.
Tom Jefferson had to admit his mistake, and in order to restore confidence in himself as a high-level specialist, he began to gradually search for the truth about the effectiveness of Tamiflu.After giving a telephone interview to reporters, Jefferson announced the maintenance of a personal diary of observations, which would allow him to restore the undermined confidence. The famous expert went the following way:
- Found the authors of the publication in medical journals on the effectiveness of Tamiflu and asked about the available research data.But the authors said that they did not see any results of scientific research, and the data were obtained from the manufacturer.
- Jefferson turned to producer Tamiflu to provide him with 8 clinical trials of the drug, which were not published anywhere.And at this point the manufacturer behaved, to put it mildly, strange - he invited the expert to sign documents on the non-disclosure of data.When Jefferson refused to do this, he was refused assistance.
The result of all this "activity" was the published data of the new meta-analysis of Tamiflu, in which its effectiveness was assessed as "modest", and the ability of the drug to reduce the risk of complications against influenza in general were disproved.The Cochrane Group of Experts refused to give an opinion in favor of high efficacy of the study drug without obtaining the results of those "hidden" 8 clinical trials.
The apogee of this whole story was the publication of material in the British Medical Journal - it described the identification of unknown writers who were employed by the manufacturing company Tamiflu and under pressure gave exceptionally positive results from clinical studies.However, this fact was rejected by the manufacturer, although he admitted that he attracted third-party pharmacists to write the conclusions.
This material has made another furore in the society - the confidence in the Cochrane Group of Experts and in particular to Tom Jefferson returned, but the reputation of Tamiflu was completely ruined.That is why in 2011 the manufacturing company provided Jefferson and the Cochrane Group of Experts with all the clinical trial data of the drug in question.Very interesting conclusions were drawn. ..
Modern data on the effectiveness of the anti-influenza drug
Scientists, experts studied 20 results of Tamiflu research and questioned the conclusions made by the manufacturer - there were too many medical deficiencies. Conclusions resulting from the work of experts from the Cochrane Group:
- Tamiflu can reduce symptoms of flu and cold symptoms for a maximum of 1 day;
- does not affect the number of hospitalized patients diagnosed with influenza or acute respiratory disease;
- can have side effects - nausea, vomiting, headaches, heart rhythm disturbances, acute kidney and liver pathology;
- the effect of Tamiflu on the development of complications of influenza is exaggerated.
Naturally, the effectiveness of the drug in question with respect to swine flu is not worth mentioning - this fact is not simply questioned, but simply not considered.
Unfortunately, the story outlined in this material is not the only one of its kind.And the society concluded that in the distortion of the facts about the results of research, the. .. printed publications are to blame.
Distortions in publications
To understand how and why there is a distortion of facts when publishing research results, you need to imagine a conscientious psychiatrist who is actively interested in new drugs and discoveries in his field of activity.What does he see in the publications?In medical journals, there are data on the conduct of 37 scientific studies that prove the effectiveness of any specific antidepressants, and about 14 studies that disprove this fact.
What does not the doctor consider?And the fact that the positive result of the studies was recorded in 38 cases, but negative in 36. The medical journal simply did not publish 22 results of the study - a shift in the direction of the effectiveness of the studied drug.
That is why the Cochrane Group of Experts' control analyzes always contain dissatisfaction with research methods, even there is a direct statement that it is sometimes very difficult to draw any truthful conclusions from them.For example, the meta-analysis of the MMR vaccine( measles, rubella and mumps) does not allow a concrete conclusion about the relationship between the vaccine and developing diseases after its introduction into the child's body.But immediately the experts state that most of the studies related to the safety and effectiveness of the MMR vaccine were carried out with violations, a methodical weakness is noted, so it is impossible to make sure of a confident conclusion.
Why do such distortions occur in publications?It's all just a matter of conflict of interest.For example, the rules of the International Committee of Medical Journal Editors have this( quote):
" Editors taking the final decision to publish manuscripts should not have any personal, professional or financial interest in any of the journal numbers that they evaluate."
And yet, the British medical journal once was in the center of a very unpleasant story - the editor published a material on the effectiveness of the drug, the manufacturer of which was the chief snnsorom educational institution where he worked, and this is the editor.And this is not the only case!There are publications of the results of unfair studies, which were promoted by editors who previously worked in pharmaceutical companies.
But that's not all!Richard Horton says that in this situation, absolutely everything is to blame - scientists who are chasing after productivity and novelty, editors who receive material benefit from each publication.A vicious circle, which leads to the fact that the goal is not to reveal truth, but to strengthen its material well-being.
Even at the symposium of medical bio-research in April 2015( it was held in London), the fact was unanimously acknowledged that science is going through a serious phase of failure.Calms only one thing: medical science has become more serious about its own mistakes / miscalculations.True, no one wants to take the first step on the path to finding the truth, but perhaps this is only a matter of time.
Tsygankova Yana Aleksandrovna, medical reviewer, therapeutist of the highest qualification category.