Has the effectiveness been proven?
European medicine has been shaken by a scandal
Tatiana Pichugina, RIA Novosti
Studies of experts independent of the pharmaceutical industry, united in the authoritative international organization "Cochrane Cooperation", demonstrate that methods and drugs with questionable effectiveness are often used in mass medical practice. But one of the last reviews of the organization itself was subjected to harsh professional criticism. About the problems of evidence–based medicine and the Cochrane crisis - in the material of RIA Novosti.
Blind control
Before the drug is put into circulation, it is repeatedly tested in experiments. The final stage is clinical trials (human trials). The bigger and longer they are, the better. No less important is how the study is constructed, who interprets its results and how.
In 1972, the English epidemiologist Archie Cochrane urged colleagues to approach drug testing and analysis of their results from a strictly scientific standpoint. The most effective experiments are where, along with the participants taking the treatment, there is a control group in the same conditions, which is not given the drug.
The trial is called randomized (with a random effect) if the organizers do not know which of its participants is taking the drug and who is in the control group. This is the most reliable option.
"Such tests neutralize the human factor, random and systematic errors, allowing to avoid incorrect conclusions. A properly organized clinical trial provides the best result of treatment with less effort," Gleb Arslanov, an ophthalmologist from St. Petersburg, an employee of the Scientific Center of Evidence-based Medicine "Cochrane Russia" on the basis of Kazan Federal University.
Cochrane's ideas began to be realized in the scientific center of the same name, established in 1992 in the UK. Now it is a large non-profit organization with branches in 43 countries, uniting tens of thousands of specialists.
"In ophthalmology, randomized clinical trials have become the norm. With their help, more competent recommendations for treatment are being developed, the quality of care is improving," the expert says.
Checking on large data arrays
It takes several years to test a new medicine, a medical technique. This is a complex, expensive and multi-stage process, funded from various sources. The most qualitative clinical trials are those conducted with the support of the state, various ministries, foundations.
"The trials of pharmaceutical companies should be treated critically. For them, this is often just a way to promote their drug," Arslanov notes.
To understand which test is qualitative and which is not, it is necessary to thoroughly understand everything. It takes time to study a lot of disparate test results. Doctors and health care organizers do not always have such an opportunity. This is where the Cochrane Collaboration helps, summarizing data on the most important drugs. Each review answers a question relevant to physicians.
"The work of the Cochrane Collaboration and its authors is funded from sources independent of the commercial sector, this is its advantage," the doctor continues.
The authors of Cochrane reviews use the results of clinical trials from open sources, mainly from publications in scientific and medical journals. Low-quality articles are rejected. With the help of statistical analysis, patterns are identified from a heterogeneous data set, conclusions are drawn about the effectiveness of a particular method of treatment and prevention.
The methodology of work, the criteria for selecting data, the actual final reviews (these are documents of several hundred pages in different languages) – everything is published in the public domain in The Cochrane Library. Now there are more than six thousand materials on various fields of medicine.
The Cochrane Collaboration became world famous for reviews about the uselessness of vitamin C and echinacea for the treatment of colds, the ineffectiveness of taking antioxidants, the unprovenness of claims that reducing salt intake reduces the risk of death from a heart attack, that video surveillance cameras on the roads really reduce the number of accidents.
The vaccine scandal
Most Cochrane reviews, says Gleb Arslanov, end with the conclusion that there is insufficient evidence of the effectiveness of the drug or technique. "This should be taken as a call for further research," he believes.
This conclusion was also made in a review on vaccines against papillomaviruses from different manufacturers, published in May this year.
Papillomaviruses are responsible for about seventy percent of cervical cancer. There is no cure for them. Vaccination is carried out voluntarily to women before they have entered into sexual life in order to exclude infection. Then they monitor the health of the patients for many years.
After analyzing the results of clinical trials, the authors of the review noted that vaccination reduces the number of precancerous conditions. But is the incidence of cervical cancer decreasing? Are there any side effects? There is no definite answer to these questions.
This review was severely criticized by one of the founders of the Cochrane Collaboration, the Danish physician Peter Goetsche – for the imperfection of the methodology, incompleteness of data and a possible conflict of interest. He accused the leadership of the organization of scientific censorship and violation of democratic principles.
The answer followed immediately – in September, Getsche was expelled from the Cochrane organization, now he faces dismissal from The Royal Clinic at University of Copenhagen.
"I was looking into the situation, trying to understand both sides, and I was convinced that at the moment it was difficult to make a good review of vaccination against papillomaviruses. The authors have tried, their review contains some shortcomings, but the accusations of links with pharmaceutical companies are unfair. I think Peter Gotsche exaggerated. The effect of vaccination is, however, not fully understood. In my opinion, an obstetrician–gynecologist should inform patients about the pros and cons of this procedure. And a person makes a decision about vaccination on his own," explains Arslanov, emphasizing that he expresses a purely personal opinion.
Due to the scandal with Peter Goetsche, a wave of criticism of Cochrane cooperation has risen in the Western media. Journalists and bloggers even predict the organization's crisis and imminent collapse. In Russia, these events are being closely monitored, but they see no reason to join the HYPE.
"Of course, this is a blow to reputation. Some picked up: "This is a collapse, a split." In fact, there is no split. The Cochrane cooperation will continue to work as before," the expert concludes.
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