Who will get the medicines from the shelf?
According to Evgeny Sverdlov, the project manager for the development of the first domestic gene therapy drug against cancer, the appearance of innovative drugs under the brand "Made in Russia" in the coming years is unlikely. Prototypes of drugs that have already been created in our laboratories, which theoretically could compete with Western developments, are being shelved due to the lack of funds for clinical trials, patenting, licensing, production and promotion of drugs to the market.
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Sverdlov Evgeny Davidovich, Head of the Laboratory of the Structure and function of Human Genes at the Institute of Bioorganic Chemistry. Academicians M.M. Shemyakina and Yu.A. Ovchinnikova of the Russian Academy of Sciences, head of the project "Creation of differential proteomics technology and its use for obtaining new anticancer drugs" in the priority direction "Living Systems" within the Federal Target Program "Research and Development in priority areas of development of the scientific and Technological complex of Russia for 2007-2012", Academician of the Russian Academy of Sciences.
Wrestling Made in…You are in charge of one of the largest and most promising projects of the Federal Target Program – the development of a gene-therapeutic method for creating anti-cancer drugs, which our publication has already written about.
How is the research developing today?– We have already developed a gene-therapeutic anti-cancer drug and are conducting preliminary tests on cell cultures and on animals.
So far we have positive results, but at the same time we also face difficulties related to the unresolved nature of some practical issues. For example, we did not assume that it would be extremely difficult to test the drug for toxicity, because it works at very low concentrations, whereas according to the rules it is required to show its lethal dose. We simply do not have such a huge amount of money and cannot have it.
The second fundamental problem is related to the human specificity of the drug, that is, the inability to test its positive effect on model animals. We had to contrive to make its analogues for mice, but in this case it turns out that we are testing a substance different from the one that we offer to clinics. Of course, we also test the drug on cell culture, as well as plant a human tumor in animals, and see how the substance we have developed responds to it. In general, we are doing everything in our power. But, unfortunately, neither in Russia nor abroad have yet come up with ways to ensure the complete purity of the preclinical experiment of gene-therapeutic anticancer drugs.
Do you follow the development of such research abroad? And how do you assess their level?– A ready-made medicine similar to ours has not yet been presented on the world market, but I know a significant number of test protocols for gene therapy drugs against cancer, the creation of which is based on a principle identical to ours – the destruction of a tumor with the help of virus nanoparticles.
The laboratories that conduct these studies are at different stages of work. Initially, American scientists were considered the leaders, but in 2003, unexpectedly for the entire scientific and medical community, the Chinese gene antitumor drug Gendicin "surfaced. In the West, it was called the "Chinese mini-satellite" because it shocked science no less than the Soviet satellite launched into space once amazed the world. After all, the Chinese were not the first in these developments. The Americans already had a ready-made drug by that time, but because of the draconian rules of clinical trials in force, it "hung up" at the second or third stage of the clinic. And in China, the licensing system is relatively soft, which, in fact, led to the appearance of the world's first gene-therapeutic drug against cancer under the brand Made in China. And the Chinese were ahead of the whole planet…
As for our project, we are moving at a good pace, almost keeping pace with Western laboratories. To work on the creation of the drug, a consortium was organized, which includes the N.N. Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences, the N.F. Gamalei Research Institute of Epidemiology and Microbiology of the Russian Academy of Medical Sciences, the Research Institute of Molecular Genetics of the Russian Academy of Sciences, the Institute of Gene Biology of the Russian Academy of Sciences and the Institute of Bioorganic Chemistry. Academicians Yu.A. Ovchinnikov and M.M. Shemyakin of the Russian Academy of Sciences and several other organizations. About once a quarter, the heads of the consortium gather to discuss, coordinate, and adjust research taking into account the development of science. We constantly monitor the progress of similar projects in Western laboratories, and depending on their results, we can change our views on a particular issue, which allows us to move faster towards the goal.
And does it make sense to continue research if the drug has already appeared in China?– If we talk about exactly the same drugs, of course, there is no sense – it's easier to buy them in China.
But we set the task to get more effective means, because the Chinese medicine, for all its advantages, has a number of fundamental drawbacks, in particular, not one hundred percent effectiveness. For example, when used against head and neck cancer in combination with radiotherapy, it helped only in 64 percent of cases. Of course, this is a lot from the point of view of today, but not enough from an absolute point of view. Medicine requires more versatile and effective drugs. We focus on creating exactly such tools.
In your opinion, does the Chinese licensing system justify itself?– This question has two sides of the coin.
From the point of view of safety, of course, it is better to check the drug as thoroughly as possible before its introduction into medical practice.
But on the other hand, there are people who, for vital reasons, cannot wait for the end of the tests. Let me give you a simple example: there is an American website where advertisements are posted about recruiting volunteers for clinical trials, to which thousands of seriously ill people respond. However, only a limited number of patients are allowed to be tested, say, 100 people, and thus deprive the rest of the volunteers of the opportunity to take a new treatment, which, perhaps, would be their only salvation.
It seems to me that softening the licensing system for the introduction of drugs in the United States would increase the chances of many already desperate people to recover. At the same time, there is no great risk for volunteers, since previously the drugs undergo a very serious toxicity test. Another thing is that they may not help or not help everyone, but this is more or less a standard situation for all medicines.
Do you think Russia can borrow the Chinese experience?– I do not know the answer to this question, I just think that such an option would be possible.
At the same time, I understand perfectly well that medicine should be conservative in a good way, otherwise we will have healers like Grabovoi. It often happens when an author gets carried away working on a drug and forgets about the general principle: to look for ways to refute, and not to confirm the usefulness of his brainchild. It is necessary to make sure clearly whether you have done everything so that the drug is harmless and really helps people? Because if it is harmless and at the same time useless, it will turn out "zilch". People will simply stop believing in the new medicine, they will say that all this is nonsense and nonsense.
So before answering the question of which system – Western or Chinese – is preferable, we, developers, need to sit down at a round table with professionals in the field of preclinical and clinical trials, and think together about where the long path of the drug to the drug can be shortened without harm to people, create favorable conditions for the release of new ones drugs.
"I don't hope for Deripaska's altruism"Let's get back to your project.
Let's say the preclinical tests will be successful. And what's next?– Upon completion of preclinical tests, we will face a number of even more complex problems related to the fact that the previous system of interaction between scientists and production has been destroyed.
I remember very well how things were in the USSR. In the 1980s, when we created the first genetically engineered drug in the Union, we had a clear task: to issue a prototype, after which other departments picked up the baton to bring it to the consumer. Now there are no "other departments", and it turns out that no one seems to need a ready-made development. We, the performers, received money only for the creation of the drug and initial trials – this is good money that allows us to work at a very high level. But even more costly stages of work – clinical trials, patenting, licensing, production and the actual promotion of drugs to the market, which are paid for by the manufacturer in the West, there is no one to finance in Russia. Domestic firms prefer not to get involved with new developments, realizing that this is a big risk. A new drug may be useless even when almost all clinical trials have been conducted. After all, it often happens that at first everything goes well, and at the last phase something is revealed in the drug that makes you either abandon it or go back to the origins of development and redo something. It turns out that the company is wasting money. And the price of clinical trials is crazy, in the USA it varies from 200 to 500 million dollars.
That is, there is no structure in Russia at all that can take on such risks?
– At least, I don't know it. Our companies are willing to produce generics, that is, already tested drugs with expired patent protection. In this case, it is known for sure that the drugs are good and will bring some profit. And the path to innovative means is practically closed. And how to get out of this, I do not know. Maybe the state should develop tax or other incentive measures for manufacturers who take on the risks of promoting new drugs to the market, and share these risks with them to some extent. In general, we need to make sure that manufacturers see their interest. The market is based on interest! He works on altruism only within extremely narrow limits, and then when very rich people like Deripaska, who generously financed university projects before the crisis, are doing it. Unfortunately, there are no such rich investors in the domestic pharmaceutical industry.
But if several parties are involved in the creation of the drug at once – developers, a manufacturing company, the state - then each of them will claim compensation for their risks ...
– This simplest question can be solved as follows: the developers are the authors of the patent, the manufacturer is the owner of the patent. The company makes a profit from the production of products, and each of the authors, depending on their contribution to the development, receives a certain percentage of this profit, that is, royalties. The state compensates for its risks by receiving taxes from the sale of products, and in general by satisfying state interests, such as the development of production, the creation of new jobs, and improving the quality of medical care. In addition, the state may conclude an agreement with the firm that it claims some part of the profit. I have already collaborated in this way with a Western firm that bought American and European patents for my drug for laboratory research and then, until the patent expired, paid me royalties.
Is the state also involved in such risky projects in the West?– No, in the West, the role of the state in these processes is minimal.
The system there is something like this: a small company creates a drug and conducts its preliminary tests, showing, for example, good results. Then this firm is bought by a huge pharmaceutical company like Merck or Roche, which invests millions of dollars in the final stages of work. If one of the dozen funded drugs proves successful, the pharmaceutical giant receives multibillion-dollar profits and fully compensates for all its costs. It's just that there are no pharmaceutical giants in Russia…
And who in your project will finance the stage of clinical trials?– Our project provides only preclinical tests.
There is a company that will produce experimental batches of the drug, but the next stage will be clearly too tough for it. Do I understand correctly that the project to develop a Russian gene-therapeutic anti-cancer drug does not involve the creation of a drug that would be delivered to medical institutions and pharmacies?
– I do not exclude that in the current conditions, all new developments will be on the shelves for some time.
Before the crisis, I still had thoughts about further work on the drug (as an option, I planned to look for a Western partner and immediately enter the world market), and now I am completely disoriented. In the West, firms are shutting down expensive investment projects, production is falling. I think they are also not up to new developments right now. Most likely, they will bring to the end drugs that are already being selected to the market, that is, they are at the exit from the so-called pipe line (pipe line in this case means a virtual pipeline through which new drugs are continuously coming from laboratories to the world pharmaceutical market. – ed.), and slow down what is just coming off the laboratory table. Then, when the crisis passes, the "pipeline" will work in full force. In Russia, there is no pipe line, so we have nothing to bring to mind, we just have to slow down.
In which part of the "pipeline" are the projects of your Western colleagues on the creation of gene-therapeutic anti-cancer drugs?– Mostly in the middle, that is, approximately in the second or third phases of clinical trials.
Then your medications will seriously lag behind...
– There is no need to take everything so literally. Our drugs will appear later than Western ones, which they already have at the outlet of the "pipe", but they will have different properties and, I hope, will be more affordable. The delay here will not be so significant.
Natalia Bykova talked, STRF.ruPortal "Eternal youth" www.vechnayamolodost.ru