RICHARD Laing talks to Assistant Director-General, Dr Vladimir Lepakhin, who is responsible for the Health Technology and Pharmaceuticals Cluster at WHO Headquarters in Geneva.

V. Lepakhin

RL: Thank you very much for meeting with us to have this discussion. Who and what were the major influences in getting you where you are today?

VL: During my studies at Secondary College, I used to go to the University for lectures on physics and some other technical disciplines, but never thought that I would be a medical doctor. But just as I graduated from College my mother was taken to hospital urgently and had an operation. After it of course we were very nervous, and when the surgeon came from the operating room in his white gown, everybody looked at him as if he was a god and he told us "your mother will live". The whole atmosphere and this image of someone who could save lives were so impressive. The next day I was due to go to Moscow University Physics Faculty, but I took my papers and went to the medical school instead. I decided to be a surgeon.

RL: Did you ever do surgery?

VL: No, after four years study we had interns practice. I was on duty one night and a boy of about 12 was dying of chronic kidney failure, but he told us, "I will live and I will be a doctor, I will invent drugs to save people". This had a great impact on me and I decided that it would be better to treat diseases than to cut off something in surgery. It made me more interested in pharmacology, and probably this boy was responsible for leading me to pharmacology. So after graduating from medical school I went to postgraduate courses on pharmacology.

RL: And that was both standard pharmacology and clinical pharmacology?

VL: No, in those times clinical pharmacology was not a special discipline. It was in 1964 when I went for three years as a postgraduate student and obtained a PhD. I worked as a lecturer and an assistant professor for five years at the First Moscow Medical Institute.

RL: That was lecturing to medical students?

VL: Yes, and I did some research work as well. I was more interested in experimental pharmacology than in clinical pharmacology, and in 1972 I was invited to join the Pharmacological Committee. This is similar to the type of committee on safety of drugs that they have in the UK, which evaluates pre-clinical data, decides on clinical trials, evaluates their results and decides if the drugs should be approved. For maybe two or three months I was a staff member giving support to the Committee and then I was appointed as a Senior Clinical Officer, and rose to become Scientific Secretary of the Committee, then Deputy Chairman and finally Committee Chairman.

In 1985, I was invited to work at the University of Peoples' Friendship. I became Head of the Department of Pharmacology, which I renamed the Department of General and Clinical Pharmacology. So in reality I introduced clinical pharmacology at the University.

RL: When did you become involved with WHO?

VL: In October 1974 in the WHO Scientific Group on Guidelines for Regulation and Evaluation of New Drugs for Use in Man. I was the youngest member, I was 33, and all the others were well-known professors from many other countries. WHO wanted somebody from an Eastern Block, socialist country, not only for geographical representation but because we had a different system with its own advantages and disadvantages. WHO sent out an invitation to the USSR Ministry of Health and the Ministry nominated me because I had some experience of working in the area of drug evaluation. I am proud to say that this Scientific Group and the technical report it produced laid the foundations of Good Clinical Practice.

RL: Let's jump forward a little bit to ask, if you hadn't followed this career path, what would you have done?

VL: Who knows? I was interested in physics and at that time space discovery was very popular. The first sputnik was launched - Yuri Gagarin's trip was in 1962 so I was already at medical school, but before that I could probably have worked on developing sputniks or satellites and such things. I prefer research, when you are looking for something, when you create something, scientific work is much more interesting for me.

RL: In many ways your experience has been in academia, policy-making, research and administration at different times. When we look at the medical and pharmacy education system, I wonder what your thoughts are about how it should be changed to help new graduates meet today's needs?

VL: Well, I think that there should be more practice in the curriculum, and so-called problem-solving education, which has now been introduced in many countries, is very useful. Knowing about drug-related problems, I must say that there is a need for far more education on the rational use of drugs, and for more hours of clinical pharmacology in the curriculum. In the majority of countries, it is not studied enough, and often the system is for students to study pharmacology before they know clinical medicine. For example, they start pharmacology during their second or third year and they study psychotropic drugs, but they only do psychiatry in the fifth year. So it is theoretical study, just to pass the exam and then forget. Pharmacology shouldn't be taught as a theoretical discipline, it is applied. Many more hours are given to pharmacology than to clinical pharmacology in the majority of countries. It is so important to know more about the rational use of drugs, to know the different models, but as they are not going to be veterinarians to treat animals, medical students have to know how to treat patients and how to deal with people. I am sure that there is a need for far more hours on clinical pharmacology connected to the different disciplines. And what I introduced in my University, together with the Dean of the Medical Faculty, was that four professors of different disciplines presented lectures to students on one subject (for example, stomach ulcers), one topic after another, beginning with the professor of pathological physiology. Students were given information on diseases, the pathokinesis of diseases, the professor of pathology then spoke about diagnosis, about development of diseases and finally, I or my colleagues, as clinical pharmacologists, talked to them about drugs and how to treat.

RL: That seems such a logical approach.

VL: Well, previously we had no such thing, and we started this as an experiment and students liked it, in spite of having to sit for four hours.

RL: Can we take you to the next phase. You lived in interesting times, with the change in the Soviet system and the change in the pharmaceutical system that went along with that. I wonder what your insights are about those major changes and particularly what were some of the good things, and the lessons that may have been lost or forgotten in this transformation?

VL: When people say it was an interesting time, especially what happened in the Soviet Union, I would answer - and the majority of Russian people would probably answer - that for us it was not so interesting, it was a very difficult time because people had not been prepared to live in a different system. Before, everything was provided by the State, free of charge - health care, education, everything. We didn't live in luxury, we had some shortages, but it was enough to live, the basic things were there, and people were brought up with a more socialistic mentality from their childhood. People believed - they were taught - that we have to live for society, we have to help other people. It was less individualistic. The most respected people were scientists; doctors, teachers - and people did not care too much about money. Then when, overnight, this dramatic change happened, people were not prepared to struggle for their lives, and those people who were most respected became very poor because the State stopped paying salary. Can you imagine having to live several months without salary, or several years! And science suffered a lot. Many capable scientists left the country, especially those from theoretical science where there is nothing to sell immediately. For many people it was a tragedy. Of course now there are a lot of goods in the shops - in Moscow you can find anything - but the majority of the population cannot afford them.

RL: And that includes medicines?

VL: Yes, medicines became very expensive. People didn't care about the price of medicines in the former times because sometimes the prices were just symbolic. We had tablets for coughs that cost 1 ko-peck, 1 kopeck is almost nothing. Everything was subsidised by the State and treatment in hospitals was free of charge. Now, if somebody needs an operation and there is no money, unless it is an emergency it is a problem. Fortunately, the economic situation of the country is improving, so people's lives are improving.

RL: Can you tell us about your priorities for the Health Technology and Pharmaceuticals Cluster, and, of course, you are responsible not just for essential medicines but essential equipment. What do you see over the next five to 10 years for the Cluster?

VL: Well it is very difficult to choose priorities because the Cluster and the departments have very diversified areas of work. What I would like to mention is the new strategy of the Essential Health Technologies Department, which is very country oriented, and focused on countries' needs. The Department has developed a special basic operational framework, with tables showing the needs of countries and their priorities on one side and on the other side what WHO has and what it doesn't have to meet these priorities. So we invite countries to participate in choosing their priorities, as it should be the priorities not of WHO Headquarters, but the priorities of countries.

RL: Equipment has been somewhat neglected compared to essential medicines. Essential medicines have gone forward very rapidly.

VL: Yes indeed, and when I came to this job I realised that I had to concentrate first on the development of the Blood Safety and Clinical Technology Department. We renamed it Essential Health Technologies because it should provide essential technology, basic appropriate technologies, especially to developing countries. We are drawing on some experiences from EDM's work, for example, we are going to create a list of essential equipment.

RL: What about your family? Do you have children who are following in your footsteps?

VL: Well, my wife is also a medical doctor, we studied together, and she helps me a lot because she works in the area of pharmaceuticals too. She is well known in Russia and other CIS countries as Dr Astakhova. She was a member of the Centre for Adverse Drug Reactions in the Soviet Union, and then when the system was destroyed, she initiated reconstruction of the new centre in Russia - the Centre for the Control of Drug Safety/Drug Monitoring. For some years after the dissolution of the Soviet Union, the Russian Ministry of Health had no centre for pharmocovigilance, and in practical terms my wife was responsible for re-establishing one. Also, in 1994, she started to publish the Bulletin on Drug Safety on her own, and now she is Chief Editor.

My wife has always provided me with valuable information on drug-related problems and drug safety. She helped me a great deal in evaluating products by drawing my attention to the negative side of drugs, or of their use. When people have a lot of information on the efficacy of a product, they tend to focus only on the positive side. Every company, the television and the other mass media speak about how effective these drugs can be, how they can cure everything. We are both dedicated to working on drug safety issues, and I am very grateful to my wife for her constant support in my work. We have one daughter who is also a doctor.

RL: How do you relax?

VL: When I was younger, I liked sport very much, swimming, skiing, playing tennis, I played volleyball, but not now of course. Now I try to go to the swimming pool. I was a member of the swimming team at University. And I like classical music, I enjoy listening to records. I studied piano at the Musical School, but now I couldn't say that I play.

RL: To finish, WHO is a public health organization, it's a scientific organization but it deals with the political realities of the world. How do you reconcile these different forces, because at different times it seems to me, there are different levels of influence, of the public health community, the scientific community, the political forces?

VL: Of course there is great political influence or even pressure from different sources. But I believe that WHO has to act to help people, and this makes it easier to explain our policy to the politicians, and to others. We can explain our motives, and invite their participation in providing people with effective and safe drugs, and drugs of good quality. I think that nobody can object because this is clearly a humanitarian approach.

RL: So are you optimistic then about improving access to essential medicines to people around the world?

VL: Yes, I am a realistic optimist.

RL: Even with difficult medicines, like insulin requiring a cold chain or antiretroviral drugs, you think it will be possible to ensure access for most people?

VL: Yes, of course it is difficult, but I think that the development of society goes in such a direction that it will be increasingly driven by social interests, because otherwise the world will not survive. We are all in one boat, and either we help others, so that life in different countries will improve, or it may well lead to catastrophe. There is a critical mass of things that are good and things that are bad, and this critical mass of the bad may lead to disaster for us all. The HIV/AIDS pandemic causes suffering for everyone - in rich countries and in poor. I believe in our future, and I believe that those people who will decide our development will be intelligent enough to understand it.

RL: To ensure that access to all medicines becomes reality?

VL: Yes. We have to do our best to make this dream become reality, however difficult it is to reach the goal. In conclusion, one thing that I should have mentioned about what brought me to this area, is that in 1988/89 I was appointed as a Deputy Minister at the Ministry of Health of the Soviet Union and I was responsible for Medical Science, Health Technology and Pharmaceuticals. This is exactly what I am doing now at WHO.

RL: So you have done this before for a big country and now you are doing it for the world.

VL: Yes, as you know this big country has now become 15 countries, so it is a region, and of course this experience helps me to work here. But again, as I often say, it seems to me that, "Life is something that happens to you while you are busy planning other things". So when I retired from EDM, at the end of April this year, I was preparing to do my University teaching and research work, and unexpectedly I heard that Dr Lee was inviting me to become Assistant Director-General. I asked Dr Lee why, and he answered, "because I know you". This is why I feel such a responsibility to do my best - to help WHO, to help people here in the Department and in the teams to do their best, especially for those who are in great need. This is something new for me - fighting for funds, trying to find additional sources of money. There are a lot of very experienced and talented people here at WHO, and our limitation is funding. But I believe in the future, I believe in the new WHO administration, and I believe in the people in our Cluster.

RL: I think we have used enough of your time, thank you very much.