17 December 2010

Who benefits from strangling cellular technologies in Russia?

The privatization of stem cells is coming
Scientists compare the possible consequences of the adoption of the new law "On Biomedical Cell Technologies" with the defeat of genetics in 1948
Lyudmila Rybina, Novaya GazetaIn 1948, at the infamous session of the VASHNIL, the speech of Academician Lysenko, supported by Stalin, "closed" the most important field of scientific research in Russia for decades.

If a law is passed, which is still only "hanging" on the website of the Ministry of Health and Social Development for discussion, that scenario may repeat itself. The world's most rapidly developing field of biology and medicine will again be under attack.

The study of cells, cellular products and their use seem to be a very special topic. But fundamental biology is rapidly approaching medicine, to the patient. Unique operations are being performed, and there are already mass technologies. For example, the surgeon Macchiarini, the head of the clinic in Florence, managed to grow a trachea in the body of a sick woman instead of the damaged one with the help of the patient's own cells. This is an exclusive today. But stem cells from the bone marrow are transplanted en masse. Such transplants save patients during the treatment of oncohematological diseases. Bone marrow transplantation began in the 60s of the last century, the first transplantation of cord blood cells was done in 1988, and today in a number of laboratories around the world have learned to reprogram mature cells into heart cells (cardiomyocytes), nervous system cells (neurons) - into all types of blood cells, bypassing the stem cell stage.

Scientists have high hopes for cellular drugs and are exploring the possibility of their use in a variety of fields. In clinics around the world, preclinical and clinical trials are being conducted in the treatment of cardiovascular diseases, strokes, diabetes, resistant forms of tuberculosis, ulcerative colitis, and in the foreseeable future - multiple sclerosis, Alzheimer's disease, Parkinson's disease, glaucoma, cirrhosis of the liver, severe injuries and burns.

Duke University in the USA is monitoring the dynamics of stem cell treatment in 124 patients with cerebral palsy. New methods of therapy for myocardial infarction and the consequences of strokes are being developed.

But professionals get acquainted with the achievements of cellular technologies. Public opinion is more excited not by promising methods, but by myths and pseudo-facts about how "gray" centers are trying to treat people with stem cells. The new law is presented by the Russian Ministry as protection of the population from unscrupulous doctors. And it does not matter that the inhabitants for the most part do not quite understand on which such trunks these cells grow, but they have heard and agree that they have harmed someone: the law is needed. Horror stories also affect deputies, most of them are also people who are far from medicine and biological science.

That's where the trap is. The fight against the gray market of medical services should be led by the Prosecutor's office and the Ministry of Internal Affairs, and for this the legislative framework is sufficient even now. But officials, hiding behind concern for deceived patients, have prepared a new law in which specialists are not satisfied with everything, starting with the title: "On biomedical cell technologies."

"There is no law like the one proposed by the Ministry of Health and Social Development of the Russian Federation in any developed country in the world," says Mikhail Davydov, President of the Russian Academy of Medical Sciences (RAMS), director of the Blokhin Cancer Center, in a letter he sent to the government following a meeting of the Presidium of the RAMS. Academician Vladimir Smirnov, director of the Institute of Experimental Cardiology, explained to me why such a law is not needed. The fact is that the whole world is actively working in the field of biomedical research and cellular medicine, and all relations in the process of research, testing, production and application of cellular materials are described in existing laws. Cellular drugs are, in fact, medicines, and how they can be tested, produced and applied has long been explained. The law in general may consist of one article stating that cellular drugs are the same drugs," says Smirnov, "and in its current form it will generate corruption."

If the law is not needed to protect patients and can clearly interfere with scientists, what is it for?

The new law, it was noted at the meeting of the Presidium of the Russian Academy of Sciences, was written in the interests of commercially interested persons, to clean up the field where serious researchers are currently working. It will help to do only one thing: eliminate people and teams who have already done something, are close to serious discoveries, and in some areas are ready to provide real help to patients. New rules of the game will be established on the cleared field. This is a proactive redevelopment of possible government contracts and grants for research and a potential market for new medical services.

But the ministry is in a hurry: the bill should be submitted to the State Duma in December. Last Friday at 13.00, the RAMS and RAS received a request from the Deputy Minister of the Ministry of Health and Social Development Veronika Skvortsova to send an opinion on the bill to… 15.00 of the same day. Is this science in the service of an official?

Both the Academy of Medical Sciences and the Bolshoi Academy, followed by the Ministry of Economic Development, gave negative feedback on the bill. Anatoly Grigoriev, Vice President of the Russian Academy of Sciences, sent the official opinion of the Academy of Sciences to Minister Golikova: the law cannot be adopted in this form.

A law of indirect action has been prepared. In most of the articles, we are talking about some kind of authorized federal budget body that does not yet exist, which will be entrusted with legislative, executive and supervisory functions. At the same time, this body should carry out the examination of scientific projects, registration of "biomedical cell technologies", licensing of laboratories. All institutions of the country working with cellular drugs, regardless of departmental affiliation and forms of ownership, become dependent. What is this secret organ? Who will decide on its creation? Who will run it?

Professor Anatoly Konoplyanikov, head of the Department of Cellular and Experimental Radiation Therapy at the MRSC of the Russian Academy of Medical Sciences, notes: "If the coordination activity of the planned center concerns the financing of work in this direction, it is not difficult to predict the collapse of institutions in the country where work with stem cells is still underway." And Professor Vadim Repin, corresponding member of the Russian Academy of Medical Sciences, called this mythical center the New Vasyuki.

In the first version of the bill, which the Ministry of Health sent out for examination at the beginning of the year, this body was called the "stem cell Institute". The proposal to create a head stem cell institute is not the first time that it is being discussed. Academician Smirnov says that three years ago he was sent a document for review, in which the Ministry of Health was asked to make a decision on the transformation of the commercial organization CJSC "Remetex" into a federal state institution "Head Stem Cell Institute". Dmitry Goldstein, General Director of REMETEX, and Nikolai Bochkov, Academician of the Russian Academy of Medical Sciences, made this request. Veronika Skvortsova included Goldstein and the former rector of the 2nd med, Vladimir Yarygin, from all specialists in the field of cellular technologies in the commission on the creation of the bill. The conflict of interests is obvious: Goldstein dreams of a state stem cell institute, and Yarygin Skvortsova was the head of the department.

Does this not mean that the commercial organization "Remetex" will still become the "authorized federal executive authority" encoded in the bill, which will decide the fate of domestic cellular medicine? Perhaps this body will act as part of the Federal Medical and Biological Agency, where Academician V. Yarygin currently works.

Academician Smirnov does not hide his surprise: "Well, this authorized body will prohibit Academician of the Russian Academy of Medical Sciences Leo Bokeria from performing operations using stem cells? May he send everyone away. It is impossible to interfere with the normal development of science and the normal course of research. Otherwise, we will simply fall behind hopelessly."

In research, no one needs control without knowledge. The maximum permissive, not prohibitive regime is important here. You can send any project to the American Food and Drug Administration (Food and Drug administration) – for a cellular or other medical drug – and get a response in two months with a justification for permission or refusal. In our country, according to the new draft law, the registration period in an authorized body that does not yet exist should not exceed 210 working days – almost nine months.

People don't live so slowly in science today. That's how they kill her.

The bill is posted for discussion on the website of the Ministry of Health and Social Development. Academician Vladimir Smirnov told Novaya that he knows ten experts who wrote negative reviews and sent them to the department's website. During the week, none of these reviews appeared on the site. There is no discussion of the law, says Smirnov. In turn, the press center of the Ministry of Health and Social Development assured us that the reviews will be posted on the website, but after "generalization, with the answers of specialists."

Discussion is a matter for the scientific, medical, patient community, and an official filter is inappropriate here. Academician Smirnov wrote to President Medvedev about this.

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