22 October 2014

Money against Cancer

Science or healthcare – who should I give money to

Daria Sarkisyan, Copper NewsVladimir Bogin, an expert in the field of clinical research, medical director of the charity movement "Together against Cancer", told Mednovosti which cancer drugs are the future, whether it is worth investing money in Russian science and why a lot of tests is bad.

– Why has humanity been actively fighting cancer for so many decades, but people are still dying from this disease?

– In fact, there are huge successes in the treatment of oncological diseases, discoveries occur literally every year. I do not know of any other specialty where science would develop so rapidly. If we compare oncology with cardiology, then nothing relatively grandiose has happened in the latter recently. Yes, we are now better at making stents and placing them more skillfully, covering them with various drugs, and have made some progress in drugs that prevent thrombosis. But all this is working with the same targets and receptors – there is no such "wow" yet. In oncology, everything is much more interesting.

– News about discoveries really appear all the time. But success is mainly achieved on mice, and fans of conspiracy theories believe that everything has been invented for a long time, and pharmaceutical companies prefer to imitate violent activity and sell expensive drugs for long courses of treatment. It seems to be more profitable this way.

– In fact, 50 percent, or even more, of knowledge in oncology has appeared over the past ten years due to the development of genetics and molecular biology, as well as finding new targets for drugs. We have only recently learned what cancer stem cells are, which keep the tumor organized. Any pharmaceutical company will be happy to sell a drug that will be better than a competitor's. Another thing is that the process of evaluating the effectiveness of the drug is very long, today it takes 15-17 years – "from the molecule to the market". First, the new tool is tested on mice or rats, then on large animals: dogs or monkeys. And if the results on animals are even very encouraging, this does not mean at all that such a drug will work in humans. In America, less than 60 percent of the funds that reach clinical trials involving people enter the market. In other cases, either unacceptable side effects are detected, or it turns out that the remedy is not effective enough.

– And there is no way to shorten the verification process?

– Attempts are being made. Clinical trials involving humans are the longest stage of drug development and if it is shortened, it will help significantly reduce the duration of the entire process. Traditionally, clinical trials are conducted in phases: at the first stage, the drug is tested for safety, most often on healthy people. After completing this phase and providing all the data obtained to regulators, scientists receive permission for the second one. Here the dose is selected, several tens or hundreds of patients take part. And again, counting, submitting data to regulators, obtaining permission for the third phase. At this stage, up to several thousand patients already take part, and often the study is carried out simultaneously in many countries. Only after that, the drug can be allowed for sale. All this takes time. How is this process being accelerated now? During the first phase, several groups of patients (cohorts) are given either different doses of the drug, or in some unequal combination. And gradually those who are not affected by the drug are eliminated. As a result, only the cohort that has the most interesting result remains. That is, these patients continuously participate in the study from the first day to the last. This approach is called "adaptive", and it can shorten the study period by several years. But there are still questions about its universality.

– It is clear that this is all very expensive. It turns out that science living at public expense will not help in the search for cancer cures?

– You know, I am not a fan of pharmaceutical companies, there are also ambiguous moments in their activities, it happens that they do not promote the most effective drugs. But at the same time, over the past 40 years there has not been a single breakthrough drug in the world that was not created by pharmaceutical companies. States are not yet able to create innovative medicines. The US National Institutes of Health often conducts interesting research, tries to test certain theories, but they have not yet come up with anything breakthrough. The main work is still carried out by pharmacological companies, which often cooperate with university research centers. But along with pharmaceutical giants, a lot of startups are constantly emerging in America. The most recent example is the Ebola vaccine. Who made this drug? A San Diego company that had 10 or 15 employees. That is, on the one hand, there should be a desire to help people, on the other – money and the opportunity to make a profit. Innovations are very expensive, and therefore pharmaceutical companies often do not take risks, but simply optimize what brings them financial success for many years. In this sense, it is very interesting what Stand Up To Cancer does ("Together against Cancer"). This charity initiative finds talented scientists with burning eyes all over the world and gives them money for research on cancer drugs. In 2012, she came to Russia, MasterCard conducted two major charity campaigns in support of the initiative. Last year, scientists received 34 million rubles in this way. Some of these funds were used to support projects in Russia, some for international research in the field of oncology. This year, the cooperation continued, the company transferred one ruble to the fund "Together against Cancer" for each transaction using contactless PayPass technology. The result was 30 million rubles.

– And how is the selection of researchers going?

– The organization Translational Research In Oncology (Translational Research in Oncology), which includes world-renowned scientists, and where I have the honor to act as a scientific consultant, helps in this.

– But you can see that the drugs created in Russia are mainly drugs that do not have proven effectiveness. Why is this happening? Where do you get people who are able to create something worthwhile?

– If you look at the final result, it is still disappointing. I personally do not know of any domestic drug that would enter the world market. The problem is that even talented, progressive-minded pharmacologists work in research institutes that are in a difficult financial situation. We must admit that we have never been world leaders in pharmacology. And the school of drug creation is very complex, and the infrastructure of research (preclinical, clinical) is not being built soon, not for one generation. Unfortunately, there is very little basic breakthrough science in Russia. And in order for it to appear, you need to invest in this industry, nurture professionals.

– Nevertheless, there are people? Do you have someone to invest money in?

– Firstly, we invest not only in theoretical scientists, but also in doctors. They are not so difficult to find. Secondly, there are certainly some talented pharmacologists in Russia. Many of them come to America, study with good specialists, start working on modern equipment for good money and give out such things!

– And what kind of research is a priority for Stand Up To Cancer? After all, cancer treatment can be approached from very different sides.

– We used to shoot at all the cells, now we try not to do it. One of the founders of Translational Research in Oncology, which helps in finding talented researchers, is Dennis Slamon. He worked in a group of scientists who created the drug Herceptin. This is probably the first targeted breast cancer drug, meaning it only works on cancer cells. And not in all cases, but when the HER2 receptor is present on the cells. This can be determined before the start of treatment. And this not only increases the number of recovered patients – with the fourth stage of breast cancer, they now live up to 10-12 years, when before it was a maximum of a year or two.

In other words, personalized medicine is extremely promising in the treatment of cancer, that is, finding receptors that are specific to this type of cancer and influencing them. Healthy cells do not suffer at the same time. So it is possible, if not to get rid of the disease completely, then to suppress it and live with it for a very long time – as, for example, is happening now with people infected with HIV. Therefore, researchers who are engaged in targeted drugs are of interest to us first of all.

– It's all fine. But wouldn't it be better to direct these millions of rubles to the education of doctors? Then doctors will "catch" cancer earlier and it will be easier to treat it with existing drugs.

– Firstly, the research that is carried out with the money of Stand Up To Cancer still helps to educate doctors. Russian doctors get access to a huge amount of information about the latest achievements in their fields of medicine. They communicate with foreign colleagues, go to international conferences. In order to conduct research, you need to know a lot: treatment standards, diagnostic standards, you need to understand what a comparison drug is, how it works. That is, the erudition of the doctor increases very significantly. And the Russian doctors with whom I communicate hold the same opinion. I am convinced that the more specialists from Russia take part in international research, the higher the level of healthcare will become.

Secondly, 64 million rubles will not be enough to increase the level of education of doctors across the country. With this money, a small study is being conducted now: we are trying to understand how breast cancer is treated in different parts of the country. Our hypothesis is that in Moscow they fight it with some methods and drugs, and in some remote region it is completely different.

– It seems to be understandable. What can this research lead to?

– When we have concrete data on hand, it may be some kind of a call to action for our health authorities to standardize treatment: why are they not being treated properly? Maybe they bought the wrong thing, and doctors have no other options. Perhaps doctors simply do not know that there are better drugs and there is an opportunity to test for a specific receptor for more effective treatment. Our research will provide answers to these important questions.

– I think you know that we are first treated in a city hospital, then in a regional hospital, then, if there is no effect, they are sent to the federal center. And a sick person flies from Irkutsk to Moscow, is treated, and then returns to the federal center again and again to be checked or to undergo treatment again. Is that right?

– You know, America's healthcare system is far from perfect. But the chances that the patient will receive at least average treatment in any city are quite high. Both in Nebraska and in New York, the cocktail of drugs that you will be given will be 99 percent the same.

If a patient has a very complex, rare case and needs treatment that is simply not carried out in a local hospital (for example, a gamma knife for the treatment of a brain tumor), of course, he is sent to a nearby university. But there are more than a hundred such institutions in America. Therefore, it is not necessary to go far: it does not happen that everyone is treated exclusively at Harvard or Yale.

– What prevents Russia from making the same system?

– Of course, much less money is spent on medicine in Russia, but it's not even about money. In America, more is invested in healthcare than anywhere else. So what? Do people in the States live longer than in Canada or Sweden? No. What will definitely help Russian doctors work better is the standardization of diagnostic and treatment methods based on evidence-based medicine, when there are reliable statistics indicating that this pill can be treated, but this one cannot. It is better to have middle-class people who know what is done first A, then B, then C, then D, than to rely on a few high-level professionals.

– Maybe the creation of standards is not the work of the state, but of professional communities? In the USA, medical associations issue licenses to doctors, approve treatment recommendations.

– What works there does not necessarily have to be effective in Russia. That is, yes, in the United States there are associations in all major specialties, they are certifying organizations, and they develop algorithms, standards of treatment and certification of doctors. A doctor must take exams every ten years to maintain his qualifications and practice. Russia probably has a more centralized system of government, and people listen more to state bodies. Therefore, I do not know what weight the associations have here and I will not say for sure. In any case, whatever path is chosen to improve the health care system, this path will be long and difficult.

– And where should these changes begin?

– The basic thing is preventive medicine. And we are not talking about countless expensive tests and procedures, but about basic things, such as: vaccination of children and adults, Pap smear for women after 18 years (in the XXI century, a fatal outcome from cervical cancer is simply unacceptable), periodic colonoscopy after 50 years and a number of other tests. These procedures must be put on stream: to provide good equipment and high-quality training for pathologists so that they can competently evaluate the samples obtained, explain to therapists and specialized specialists in which cases to conduct this or that testing. After the collapse of the USSR, the medical examination system, which had previously functioned quite well, practically ceased to exist. And although attempts are currently being made to recreate it, great success has not yet been achieved. In my opinion, the classic example illustrating the effectiveness and necessity of screening is the practice of the Japanese. Thanks to the annual gastroscopy in the country with the highest incidence of stomach cancer, they managed to reduce the mortality associated with the disease to the lowest rates in the civilized world.

– There are standard tests, but a certain percentage of oncological diseases are detected on a random examination. The man came with a runny nose, and the doctor noticed he had a "bad" mole. Not everyone is recommended annual visits to a dermatologist. And it turns out that the more you are examined, the better it is for you? Full body MRI every year?

– Let's start with the fact that it is practically impossible from the point of view of pharmacoeconomics. I am convinced that surveys of such a plan cannot be carried out at intervals once a year and more often at the expense of the state in any country. What you have described, for example, can happen in the USA for a completely different reason: in order not to miss a "one in a million" case and to protect themselves from litigation, doctors prescribe a large number of expensive and, as a rule, unnecessary studies. Both in Russia and in the USA, this sometimes happens due to the commercial interest of some doctors: the more appointments, the greater the compensation. I'll give you an example: not so long ago, I was asked to consult a healthy young man who was examined in one of the private clinics, revealing the level of female hormones. When I began to delve into why it was assigned, I did not find any other explanation other than "just like that". Of course, there is always some minimal chance of "catching" a serious disease at an early stage if a lot of diagnostic tests are carried out. But when we once again perform invasive procedures to understand the nature of this spot, fixed with an MRI, it is also not always safe. When you're driving, you don't stop at every pole to check the tire pressure, do you? Although, perhaps one day you would have "diagnosed" a half-flat tire in this way and prevented an accident.

We thank the MasterCard press service for their help in preparing the material.

Portal "Eternal youth" http://vechnayamolodost.ru22.10.2014

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