What does the coming law have in store for us?
The cage opens
Unique medical technologies come out of the shadows:
experts and journalists managed to stop the stupid billLyudmila Rybina, Novaya Gazeta No. 37-2013
On the website of the Ministry of Health, professionals discuss the draft law "On the circulation of biomedical cell products". And the first version of this law appeared on the agency's website in 2010. And it was defeated by specialists after publication in Novaya Gazeta (see No. 142 of 17.12.2010 – "The privatization of stem cells is coming"). The bill was then postponed.
And here is a new document. It no longer has the main danger that experts talked about two years ago. The law does not apply to research work, which is regulated worldwide by the ethics committees of the institutions where the research is conducted, their academic councils and research plans. For the rapid development of science, the maximum permissive, not prohibitive regime is important. And biomedicine, cellular technologies are today the cutting edge of world science, where changes occur literally every day.
What can we expect from cellular technologies, the path to the development of which is paved by the law "On the circulation of biomedical cell products"? I asked this question to Andrey VASILIEV, Deputy Director of the Department of Analysis, Prognosis, Development of Healthcare and Medical Science of the Ministry of Health.
– It turned out to be possible to repair the affected and even recreate the lost tissues and organs. The main building material is stem cells. Managed regeneration is a dream that hundreds of laboratories and thousands of scientists around the world are working on today.
Before joining the Ministry, Professor Vasiliev, Doctor of Biological Sciences, was Deputy Director for Science at the N.K. Koltsov Institute of Developmental Biology of the Russian Academy of Sciences. His research interests include regenerative medicine, tissue repair mechanisms.
What is possible today with the help of cellular technologies to fix in a person? It turns out that in a number of countries there are methods that are already widely used. The very first cell transplants were bone marrow transplants to cancer patients. They began in the 60s of the last century. This is still the most common cellular technology. In the late 80s, cord blood began to be used.
The cartilage restoration technology is effective. And of course, the skin. In the USA, Germany, and many other countries, every major burn center has a laboratory where the skin is "grown". Result: not so long ago, a burn of 30% of the skin was considered fatal, today 80% and even 90% of the lesion is not a verdict.
Scientific articles about new research appear daily. Biomedical laboratories of the world are simply storming neurodegenerative diseases: amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease, Alzheimer's disease. Diabetes is being actively investigated. Stem cells are also used for recovery after heart attacks and strokes. They are trying to use them to make the liver function, affected by fibrosis and cirrhosis. Another area of research is cellular anti–cancer vaccines, which should prevent metastases. But for this whole group of developments, research is still at the preclinical stage.
There are also quite exclusive regenerative operations. Dr. Paolo Macchiarini, the head of the clinic in Florence, grew a new trachea instead of the damaged one using the patient's cells on a donor frame. And then he brought to Moscow a trachea grown in a biocontainer, which is in the Russian Scientific Center of Surgery named after him. Petrovsky was transplanted to a young woman by surgeon Vladimir PARSHIN (see Novaya Gazeta No. 145 of December 24, 2010 – "New Year as a gift"). And there are already people in the world who live with grown organs (bladder, blood vessels).
The absolute leader in regenerative medicine is the USA, where up to 80% of all research is conducted. Another 10% is in Japan, and 10% is in Europe, South Korea and all other countries. Research is also being conducted in Russia, but it is still impossible to bring them to clinical practice, to bring a new product to the market due to the lack of a regulatory framework and, as a result, long-term funded programs.
But Western colleagues are very actively interested in what is happening in Russian laboratories. They know that stem cells have been studied in our country for 20 years. Will the new law create such conditions that it would be profitable for researchers to implement their developments? What scientific secrets, hidden so far in laboratories, will begin to help patients?
So far, without appropriate legislation, cellular technologies that can earn money even today are not being widely used, but clearly questionable proposals appear. A multidisciplinary medical center has been opened at the Pokrovskaya Hospital in St. Petersburg. The center has a license for medical activity, but the price list No. 9 is stunning: regenerative therapy of 19 diseases is offered, among which: diabetes mellitus, cirrhosis of the liver, stroke, cerebral palsy, condition after chemotherapy… However, a footnote has been made: the cost of regenerative therapy services is determined after consultation. And the diseases listed are the most severe, people will be willing to pay. What is it: The Pokrovsky Stem Cell Bank was the first in the world to bring research in the field of regenerative therapy of the most severe diseases to practical use? But this requires clinical trials. They are carried out in a number of countries, but nowhere else is there a permit for clinical use.
These are the obvious costs of uncontrolled use of cellular products. A well-known biochemist, academician of the Russian Academy of Medical Sciences Vladimir SMIRNOV, head of the scientific and practical laboratory of Human Stem Cells at the Institute of Experimental Cardiology, is extremely upset by this behavior of colleagues: "Regenerative medicine is a promising field, but it is very easy to discredit the new. It should not be allowed that, following irresponsible doctors, everyone who works in this field at the cutting edge of science should be considered charlatans."
Cellular products should be tested for infectious and oncogenic safety, genetic stability. So far, there is not a single laboratory in the country for appropriate checks. Testing methods have not been developed, there are no regulatory documents.
As explained in the Ministry of Health, experts have already determined that the draft law "On the circulation of biomedical cell products" will entail the development of almost three dozen by-laws. A significant part of them are documents regulating the ethical side of cell donation and transplantation, the relationship between the donor and the recipient. The bill clearly defines: biomaterial cannot be the subject of purchase and sale. Donation of cells and tissues in our country, as in the whole world, will be free and voluntary. The principle of preventing harm to the donor is approved (the bill will create a precedent for the regulation of live donation). Posthumous donation will also be possible only with the consent of relatives or if there is a lifetime order. It is forbidden to take organs, tissues, and cells from unidentified corpses. It is also impossible to take organs from incapacitated citizens. But the willingness to become a donor during life or to consent to donating tissues and organs after death in order to save someone's life has yet to be developed. Andrey Vasiliev said that he has a green ribbon – a sign worn in the United States by those who agree to be "disassembled for spare parts" after his death.
– Having finished the earthly journey, everyone wants to leave something behind here: houses, books, paintings, scientific discoveries, - says Vasiliev. – What is the point of taking the mortal remains with you if they can serve someone else, prolong someone's life? In Spain, Italy, and France, the presumption of consent has been adopted: if a person did not leave a special order with a refusal during his lifetime, then in the event of his death, his organs can be used to save patients. In the USA, on the contrary, there is a presumption of disagreement, that is, a person must "bequeath" himself during his lifetime. Such consent is given there (or not given), getting a driver's license. Those who give are entered into the register and receive a green ribbon. This is a sign of mental maturity and physical health.
For us, this is all new, but the development of biomedicine will force us to grow up to this.
Portal "Eternal youth" http://vechnayamolodost.ru05.04.2013