So far inaccurate medicine
Bioinformatician Sergey Musienko – that Russia is lagging behind in the development of personalized healthcare
A personalized approach to the prevention and treatment of diseases is a global trend in healthcare. The general methods of treatment are replaced by individual therapy, which takes into account all the features of the body of a particular patient. It has been developed thanks to advances in molecular biology and technologies for reading the human genome, including Next Generation Sequencing (NGS).
Decoding the genome, which contains important biological information about the body, will allow doctors to more accurately predict the development of various pathologies and select a personalized treatment plan, and healthcare systems will reduce budgets for the treatment of complex forms of diseases.
In the USA, for example, in 2015, a program for the development of "Precision Medicine" (Precision Medicine Initiative) was launched, which is an intermediate stage between classical and personalized approaches. It does not involve targeted treatment for each individual, but unites people into groups based on biological markers, for example, the same genotype. But they may have a different reaction to drugs, and the disease will proceed according to different scenarios. Experts call various figures on the effectiveness of this approach. For example, choosing the right therapy for cardiovascular diseases will help to avoid 17,000 heart attacks, which is more than $1 billion in savings annually for the United States alone. In 2015, $215 million was allocated from the budget for this intermediate stage. Of these, $130 million was received by The National Institutes of Health (The National Institutes of Health) to create a cohort of 1 million people, within which any citizen is given the opportunity to undergo genetic testing and become a volunteer in long-term monitoring of their health. Another $70 million was allocated to the National Cancer Institute to test targeted therapy drugs, develop new laboratory research models and form a national knowledge base in oncology.
In France, the main focus was on the educational component: genetics and "health information technologies" should become a mandatory part of study programs at universities and colleges. In the first five years alone, 670 million euros ($760.8 million) will be allocated for these purposes. Another 230 million euros ($256.6 million) will be allocated to support R&D projects for the collection and analysis of large amounts of genetic data, implemented jointly with private companies. In addition, this year the French government decided to launch the state program "Genomic Medicine 2025", the purpose of which is to make DNA sequencing a common clinical practice for every medical and preventive institution. To do this, a network of 12 sequencing platforms, two centers of national expertise and a common database will be created throughout the country. The plans are to study 230,000 genomes over 10 years, primarily in order to find effective ways to combat cancer and diabetes.
The UK Ministry of Health has launched a similar project – "One Hundred Thousand Genomes" (100,000 Genomes Project), which will work with a narrow list of oncological and rare diseases. The aim of the program is to bring the UK to a leading position in the study of genomic data, as well as to improve methods of early diagnosis and personalized cancer treatment. Private business also contributes to the development of personalized medicine and sometimes even has a greater impact on the industry than large-scale government programs. For example, in 2000, American geneticist and entrepreneur Leroy Hood formulated the concept of "4P medicine" based on the principles of predictivity, prevention, personalization and participativeness. This idea later became the basis for his creation in 2014 of the Arivale company, which develops individual health preservation programs: selects treatment based on data from genetic tests, blood tests, the composition of the intestinal microbiota and other indicators. Another American company, Human Longevity, has identified a new trend in personalized medicine – the use of genomic and clinical data to develop methods for prolonging life and combating aging. This allows doctors to work with a healthy population, trying to keep each individual from a gradual loss of physical fitness and deterioration of general health, which occurs under the influence of the stresses of everyday life.
In Russia, the issue of the development of personalized medicine was taken care of in 2012, when the government approved the strategy for the development of medical science until 2025, which included the direction of personalized medicine. Later, at the end of 2014, by the decree of President Putin, the National Technology Initiative program was created, the purpose of which is to identify the most promising markets of the future with a capitalization of $100 billion in the future for 10-15 years. One of these areas has become HealthNet, which includes the development of personalized medicine and the expansion of the use of postgenomic technologies in clinical practice. In 2016, 10 billion rubles ($153.2 million) should be allocated to finance projects. The real effect of these initiatives will be felt in the next 15-20 years.
The Russian personalized medicine market is in its infancy – the first government projects are emerging, and private companies are adapting modern DNA research technologies, providing patients with access to advanced medical solutions and techniques. A comprehensive genetic study developed by various private companies was conducted by about 20,000 people, which indicates the early stage of technology development and the emergence of the market. According to statistics, the results of testing are most in demand in prenatal diagnostics, oncogenetics, pharmacogenetics, consumer genetics (assessment of predispositions to diseases, the status of hereditary diseases, features of metabolism, sports genetics).
In order for Russian healthcare to catch up with the leaders in the field of personalized medicine, it is necessary to solve three main tasks in the next 10-15 years. The first is related to the creation of a legal framework where all players could work effectively and comfortably – medical and preventive institutions, laboratories and research centers. In particular, the introduction of accelerated accreditation of laboratories bringing advanced screening solutions to the market will allow for the rapid implementation of constantly updated diagnostic methods. A similar approach – CLIA (Clinical Laboratory Improvement Amendments) – has been used in the USA since the late 80s. Thanks to these steps, several dozen laboratory centers can start operating on the market in 3-5 years, which will solve the second important problem - the lack of large–scale projects to accumulate human health data for a long period of time. These data on the human genome, the genomes of intestinal bacteria, as well as the results of various medical tests should be properly collected, stored and interpreted in a form accessible to the doctor. In order for these accumulated data to be used in practice as efficiently as possible, it is necessary to train a new generation of doctors who are able to work with a full array of information about the patient.
Without changing the system of training medical specialists, it is impossible to introduce a personalized approach nationwide. The Russian healthcare system also faces the question of who and how should begin to introduce new technologies into daily clinical practice. So far, the state – as in other promising industries – is the main driver and invests huge amounts of money in the form of grants for exploratory and applied research. As international practice shows, attracting private money in the form of co-investments will not only reduce government spending on the creation of specific medical solutions, but at the expense of an interested contractor to increase the efficiency, quality and reliability of the results of a project. And the main problem for Russia today is that the healthcare system as a whole is ready to implement a personalized approach: the professional community could use all the information in practice, laboratories and medical institutions had the necessary equipment. Otherwise, at the initial stage, personalized medicine can repeat the path of high–tech medicine - it will slip due to the fact that doctors simply cannot work with new solutions and technologies.
The author is a bioinformatician, General Director of the Atlas Biomedical holding
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07.12.2016