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Biotechnologies and biosafety: problems and prospects



REMSH1SHM September, 2005

BIOTECHNOLOGIES And BIOBEZOPASNOST: PROBLEMS AND PROSPECTS

In the last decades the progress in the field of biotechnologies offered big prospects in development of sciences about the person and in the most various industries of human activity, having transferred scientific and technical developments of molecular fundamentals of medicine to the practical area. About these and other problems of an interview with the RAS academician and the Russian Academy of Medical Science, the rector of MMA of I.M. Sechenov MA.PALTSEVYM.

t — Mikhail Aleksandrovich, kind of you estimated the current state and the prospects of development of biotechnologies in Russia?

— Russia from Soviet period kept rather high scientific potential and though many perspective scientists left abroad, there are many laboratories which are intensively working in the field of creation of biotechnologies. The number of scientific conferences with the good scientific program now much more, than at the time of the USSR. It is possible to tell that explosion of interest in modern achievements of biotechnology from scientists is observed. At the same time realization of biotechnological developments, today, unfortunately, is neglected. I would tell that Russia lost the modern biotechnological industry. If, say, 20 years ago when there was a special state program on biotechnologies in which development invested big

means, Russia was among world leaders of this direction, now we actually have no implementation of biotechnological programs. As sadly to realize it, but the innovative mechanism, despite all efforts of scientists, does not work. We in the country have no susceptible industry which could reproduce these technologies. We can create nothing commercially also because the human resource which is engaged in production is lost. Almost such category of educational institutions as technical schools and technical schools disappeared — the link connected with training of highly skilled workers and technicians for production. But impetuous increase in number of higher education institutions with very bad education is observed. If the state promotes to make all engineers, then, naturally, production suffers. It is also not necessary to forget that for the last decades in MMA biotekhnologirektor of I.M. Sechenov MA.PALTSEV.

the chesky sphere the enormous jump is made. If 20 — 30 years ago biotechnology was considered mainly as an opportunity to fill the poor countries with a large number of cheap food products to avoid hunger, then now it is considered as a way of production in large amounts of the cheap drugs constructed generally on gene technologies. And yes this objective substantially too is already achieved. Today scientists develop ways of treatment of many diseases with application of biotechnologies, but is thought, as it is not a limit. Not without reason say that over what

During the last decades the progress of biotechnology opened wide prospects for biological science, making the scientific and technical achievements of molecular medicine practical. M.A. PAL&CEV, academician, member of Russian Academy of Sciences and Russian Academy of Medical Sciences, head of Sechenov Medical Academy in Moscow (MMA), tells about current state and prospects of biotechnology in Russia, possibility to influence the population at the gene level, opportunities missed by Russian science and other vital problems.

Biotechnology and biosafety: problems and prospects.

2005 September of RShShShSh

the scientist worked, as a result weapon always turns out. Scientists and politicians understood soon that biotechnologies give the chance of production of biological weapon which, according to U.S. State Department, potentially more dangerously, than nuclear as live is capable to destroy all but to keep the equipment and resources, does not destroy the environment.

the t — whether Is an opportunity to influence population at the gene level and to alter the population at discretion?

— It is, of course, a fantasy, but if to set such task, then it can quite be reached. I am sure that scientific approaches to development of biological weapon which influences certain races already exist. To me publications occurred in the American magazines on this subject, however, more than once it was talked that such weapon is created in Russia. But if Americans say what is created in Russia, so they for certain already have it. And it especially means that it is impossible to lose track of the biotechnological sphere of the state in any way. At the same time we see that management decisions in the field of biotechnologies are not made and if are accepted, then do not lead to rather big effects.

t — So in what after all business — in insufficient financing or in someone's unwillingness to penetrate into a problem?

— I think, as in that, and in another. The scientific laboratories existing from Soviet period at the very least work though money for science is allocated small. If not to strengthen them, they long will not sustain. In parallel it is necessary to create new laboratories between which there has to be a competition, as well as in any other environment. But it is only a part of a problem. Laboratory developments are followed by laboratory regulations, that is it is necessary to arrange laboratory production of a product. And it

already demands considerably large sums, than the maintenance of usual scientific laboratories. These are big investments, and investments on prospect.

And our state considers itself as high-ranking manager whose task to regulate the cash flows got from natural resources and no more. It is clear, that economic categories and the movement of finance are very important, but not they define prospects of the country. We have not only no long-term forecast, but even elementary statistics! We do not know, than our population and how many in general patients, we use the average world statistics by comparison is ill. I consider that it is the main mistake and if it is not realized in time if financial resources do not begin to be distributed more rationally, accidents not to avoid. Unless again we will connect ability of the Russian population to be mobilized in short terms for the solution of large national objectives and the national ideas as more than once was in the history.

Modern science extremely expensive. If seriously to think of the future, it is necessary to invest big money in it. And the susceptible biotechnological industry by itself will not develop, it should be formed purposefully.

— And you could not call at least an approximate order of means?

— The USA invests tens of billions of dollars in science. We — much, and are in certain cases two orders less. Certainly, it is about very big money, but Russia has them. There is no other — understanding that it is the paid-back money. Development of biotechnologies and the biotechnological industry by all means will lead to increase in health of the population, to increase in human resources of the country. Unfortunately, politicians discuss an issue today not how to raise a human resource of the country, and about that how many to deliver

Chinese and Tajiks, to provide with labor still the live Russian enterprises. Absolutely perverted psychology, in my opinion. Well, let's deliver, but for a year or two, no more. And during this time we will increase birth rate, we will strengthen health of own population, we adapt disabled people to work, we will return early pensioners for work, we will reduce the number of admissions by diseases, we will reduce the level of mental diseases and stressful situations on which number Russia is in the lead around the world — here about what it is necessary to speak. All this reparable situations, but we have no understanding that big investments into human resources are necessary yet. And not only in salary, but also in technologies which provide both food, and drugs, and biological safety.

Today for the Russian scientists our industrialists do not go. But western go: I as the scientist, as the rector of the leading higher education institution, accept every month representatives of the foreign companies and firms, representatives of the scientific organizations which look for new scientific developments in Russia to introduce them at themselves. And of course, they will also sell them then to us, and all of us will buy it extremely expensively. I assure you: at the heart of much of what is bought now by Russia the Russian developments lie. A lot of time and opportunities is missed inadmissibly, and now the state has to shift focus of investment in favor of science and define priorities of its development.

t — you could not give several examples of such missed opportunities?

— A huge sphere of application of scientific knowledge are the drugs based on biotechnologies for treatment of socially important diseases. Today the drugs produced with use of biotechnologies generally are brought to Russia from abroad. For example, we have no genetically engineered insulin, the market is filled PRODUKTSIBIOTEKHNOLOGII I BIOBEZOPASNOST: PROBLEMS AND PROSPECTS

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it western firms. In Russia about 20 million people have diabetes, about 30 percent from them are insulin-dependent, and they still use pork insulin. At the same time Russia was among the first who made a strain for receiving genetically engineered insulin. Pilot production was created at Institute of bioorganic chemistry of M.M. Shemyakin and Yu.A. Ovchinnikov of RAS about 10 years ago, large sums are made in researches, but at an industrial stage everything clogged. And just now, after Yu.M. Luzhkov's intervention and financial support of Moscow, the skilled production of insulin is begun. Will receive it tuberculosis dalrobakteriya on the basis of which it is possible to receive vaccine, and by means of this vaccine authentically to make the diagnosis of tuberculosis, in time to carry out necessary treatment and vaccination. Especially it is important for children.

There are also other very good Russian biotechnologies which we cannot realize, as a result losing on it enormous money.

Go1 — As it affects biosafety of the country?

— The biotechnological dependence of Russia on many western countries is already formed. On the one hand, it is not terrible if it is about scientific

neyshy development or not — a big question. 5 plants manufacture genetically engineered insulin which we buy in large numbers in China, and, as far as I know, plasmids for production of insulin are brought from Russia there. The Canadian genetically engineered insulin too, most likely, has the Russian source. Or we will take tuberculosis. In our country nearly a third of all TB patients is infected with a multi-drug resistant strain which is not treated by antibiotics. Russia already begins to constitute danger to other countries as a source of spread of multi-drug resistant tuberculosis. At the same time our scientists found specific proteins of a mikintegration — with Russia reckon in respect of scientific works and achievements so far — but in terms of biological safety it, of course, is bad. If, say, nuclear safety can be ensured with participation of the third countries, then the country has to ensure biological safety independently. Because the concept of biological safety includes not only threat of developing of various infections, epidemics, an epizooty, but also medicinal safety. And at us today, by different estimates, from 10 to 40 percent of counterfeited medicines — a sure sign of the fact that medicinal safety is in the country at very low level.

RShShi and M September, 2005

Biological safety in respect of food too though is not lost by Russia irrevocably, but already begins to be lost. But I think that the problem of forming of biological safety will rise in the conditions of the WTO - it is a future question. The first that is done by any developed country, joining WTO, it provides protectionist measures for those industries which form biological safety of the state. It concerns, first of all, drugs, food, education. Therefore issues of biotechnology are very important today, the future of the country in many respects depends on their decision.

t — Mikhail Aleksandrovich, and kind of you estimated our scientific potential in comparison with western?

— I would not begin to carry out direct comparisons with the West where everything is very motley and peculiar. It is necessary to understand the scientific environment correctly. The physicist Lev Artsimovich told somehow that science — the best way of satisfaction of personal curiosity at the expense of the state budget. There are no people who would go to science to earn money and to become the wealthy person — it happens extremely seldom and is an exception to the rules.

Usually at globalization of the world the scientific environment migrates there, where not pay simply more, and create conditions for work: invest more money in purchase of mechanisms and devices, in creation of laboratories and schools of sciences. In the USA in Silicon Valley Russian is state along with English. The scientists working there keep in touch with the Russian colleagues, conduct quite intensive exchange of the new ideas and new scientific achievements. If Russia correctly understands it and will create favorable conditions for development of science at home, I assure you that those 300,000 scientists who left the country will return.

But if we one more generation do not come round and we will not return this scientific

2005 September of RShShShSh

Wednesday, finally we will lose it. By estimates of RAS, we have 5 — 7 years in a stock to take the plunge on return of scientists to Russia. But to provide reproduction and susceptibility of technologies is already the problem of the state, but not the scientific environment.

t — And what laws concerning the sphere of biosafety in your opinion, it is necessary to adopt in the nearest future?

— There are several laws which demand improvement. For example, Law "About Organ and Tissue Transplantation". Doctors suffer, patients suffer, in the country the transplantation of organ and fabrics is almost stopped — it already cries out, and it is necessary to bring order to this area immediately. The similar picture is observed also with cellular technologies. All civilized Europe and many Asian countries entered legislative regulation of this sphere. Russia still did not make it. We are in this sense somewhere at the level of the African states now. However, there was very shy initiative of the State Duma Committee on health protection to create the working group and to carry out parliamentary hearings on this subject, but they did not take place. In October of this year it is supposed to return to this question. Meanwhile in Russia there was very large underground market constructed on use of embryonic cages which can be both are very effective, and are extremely dangerous. This shadow business brings huge dividends to owners of these technologies, but patients at the same time are absolutely unprotected. According to our data, at control check of culture of fibroblast which deliver for beauty shops had only 2% of living cells. At the same time each expert knows that illiterate use of stem cells can lead to very serious consequences and heavy complications. What we, as a matter of fact, already have.

— As the situation with the international integration in is

the fields of biotechnologies whether there are joint projects?

— My deep belief that questions of biological safety and development of biotechnologies should be solved together with the developed countries — with the USA, Germany, Great Britain and France. Finally not to lag behind and to lose control over a situation. And today, fortunately, our colleagues abroad, paying tribute to uncommon scientific abilities of Russians to achieve success in science with the minimum expenses, willingly go for such cooperation. In particular, we adjusted effective collaboration with Germany and the USA. We have small financial support, but the main thing from their party, we have an opportunity to send our experts, especially youth, to conferences, to jobs on a training. Together with scientists from Germany we develop the joint project on stem cells, and I think that it will quickly develop. In any case, we consider that in 3 — 5 years the first joint technologies with the prospect of use of stem cells for treatment of patients with socially important diseases will appear.

— Mikhail Aleksandrovich, to Institute molecular

medicine at MMA of I.M. Sechenov whose research supervisor you are 5 years were executed. What managed to be made during this time?

— Today it is possible to tell with confidence that during this time the Institute of molecular medicine quite developed. The main collective and scientific laboratories are created, the main directions of scientific research are defined: molecular diagnostics, gene diagnostics and cellular technologies. Several patents are taken out, a large number of scientific articles is published. Very well molecular diagnostics, generally gene preimplantation diagnostics which is extremely important in clinic of obstetrics and gynecology for early determination of congenital genetic defects at children develops.

Successfully the biotechnological direction develops — several new medicines, both original, and medicines analogs are developed and already brought to the level of preclinical or clinical trials. These are antineoplastic and antitubercular medicines and also drugs for treatment of cardiological diseases, and all this purely Russian developments. They are already estimated by clinical physicians and at a certain demand can enter the market. Three years ago the Molekulyarnaya Meditsina magazine began to appear. Level of its publications is rather high and the magazine is demanded though the number of subscribers grows slowly, as at all scientific magazines. At the initiative of institute in October of this year there will take place the II International conference "Molecular Medicine and Biosafety". But the main thing, to us came to institute a lot of youth. It is very important indicator of prospects and overall performance of any scientific institution. The youth goes there where interestingly where there is a prospect, and it is natural, it should be supported financially, at least reasonably. Therefore we constantly are in fight for grants, for additional financing, we take hi-tech self-supporting and custom works. In plans of institute creation of bank of stem cells from umbilical blood. We consider that this the most perspective and the direction meeting the modern requirements. We also intend to open the Center for Molecular Diagnostics and we already conduct early studies, mainly in oncology and obstetrics and gynecology. The main areas of work of institute are that. I consider that for 5 years of its existence it is a lot of.

Talked

Olga FEDOTOVA, "Remedy allowance"

Clausen Johannes
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