Over the last few years, leading pharmaceutical companies have increased their pace of R&D programme to bring drugs that help control diabetes or prevent it. This increasing thrust is being given as diabetes is emerging as a major health concern worldwide. Dr. David Horwitz, Vice President, Medical and Clinical Affairs, LifeScan, a unit of Johnson & Johnson, is one among the many crusaders taking on diabetes. His current responsibilities at LifeScan include clinical research, medical affairs, product surveillance and technical field support.
Prior to LifeScan, he served as Senior Vice President for Technology at Advanced Tissue Sciences, a tissue engineering company in La Jolla, California, where he was responsible for basic research, process development, clinical research, regulatory affairs, and medical affairs. Previously, he was Executive Vice President at SciClone Pharmaceuticals.
He joined the company when it was a start-up company of seven people and built the medical and regulatory departments. He also developed a worldwide network of clinical investigators and conducted Phase I, II, and III clinical trials in the US, Europe, Asia and Latin America with successful submissions of INDs to the US FDA and NDAs to several
international governments.
Dr. Horwitz says that promising research in the area of diabetes is under way. In an exclusive interview with K Santosh Nair of Pharmabiz.com, he discusses these possibilities and other challenges researchers are taking up. Excerpts:
There are spate of R&D being carried out by pharmaceutical companies in the field of diabetes. Will this help bring out drugs that will eventually be a cure for diabetes moving away from the present approach of preventing and controlling the disease?
It is very difficult to answer this question at the present juncture. We are better off than what we were 20 years before and much research has only improved the way the drugs act and react. It is easy for us now to prevent and control diabetes than what we could do 20 years back. The ultimate aim of these R&D programmes at various pharmaceutical companies is towards finding a cure for diabetes. But one must note that diabetes is a complicated disease and it will not be correct at this stage to hold the fact that we are on the way to finding a cure for diabetes.
It will be preventing and controlling diabetes as of now for maybe another 10 to 15 years before a successful breakthrough can be achieved vis-à-vis cure for diabetes. One can easily conclude that these R&D activities have helped improve the quality of life of many diabetics the world over.
The R&D being carried out have only helped the way the drug is administered and how it reacts in the body. It has so happened that a person's body gets resistant to some of the drugs over a period of time. We then need to come out with newer drugs that will remove this resistance. Over the last few years, the R&D activities have only increased the pace at which such drugs have come out into the market, so also drugs for treating various complications arising out of diabetes.
Projects involving some of the newer drugs have increased over
the last five years for finding the efficacy of such drugs. Do you approve of such projects?
It is again difficult to answer this. Projects involving volunteers have helped the pharmaceutical companies, the medical practitioners and others directly or indirectly involved in treatment of diabetes to understand the mechanism of working of some of the drugs on patients. This has helped in compilation of the feedback from volunteers into useful reports that can be incorporated in development of new drugs.
Such projects have also helped us to understand the nature of diabetes and its characteristics in people of different races and countries. In a way such projects cannot be done away with while on the other such projects have also not resulted in any useful feedback. So it is very difficult to pinpoint whether one needs to have such projects or not. It depends on the prevailing scenario.
Work is also on toward administering insulin orally instead of the injecting the same as is being done at the present. How do visualize the same?
There could be a potential breakthrough but again the time factor comes into play. Companies are very optimistic about the possibility of administering insulin orally and I am sure that one day it will happen.
However one must note here that there has been constant development on syringes for administering insulin. These syringes have become more state-of-art and if one can ask an insulin dependent diabetic about the syringes, he or she would without doubt claim that injecting insulin using these syringes are no more painful that it was a few years back.
So on one hand companies are working towards the aim of having insulin orally administered on the other they are improving upon the present way of injecting insulin.
The medical fraternity is now coming out with the theory of transplant of pancreas and Islet of Langerhans as a possible method of finding a cure for diabetes. Some medical institutions have claimed that the transplants have had a good result on those who have had the same. This means developing new immuno-suppressants for preventing rejection of the new organs. Pharmaceutical companies have also looked at these transplants for developing new immuno-suppressants. How do you view the same?
You are right when you say that these transplants have prompted the pharmaceutical companies to develop new immuno-suppressants. One must note here that such transplants have been done only in few numbers and in few medical institutions in the world, which is not enough to provide more insight to what immuno-suppressants is required. As I have already told pharmaceutical companies have been striving hard to come out with newer drugs, be it for control and prevention of diabetes or immunosuppressants.
The pharmaceutical companies are only looking at improving the quality of life of diabetics. The immuno-suppressants in another segment that pharmaceutical companies are looking at improving the quality of life. They aren't leaving any stone unturned in finding a cure for diabetes.
Pharmaceutical companies are also coming out with personal diagnostic equipments for diabetics to test their glucose level and related aspects. The diagnostic equipment segment is also growing at a faster pace. Do you visualize further growth of the segment?
Yes certainly. As a matter of fact the awareness level of diabetes among diabetics and also non-diabetics has also increased, and this has translated into the need for checking out whether one is diabetic or not, or whether one has a high glucose level in the blood. This awareness level has led to a spurt in growth of the diagnostic equipment segment though it may vary from country to country.
Sophisticated equipment is in the market, which can give results within a few seconds to few minutes. They are also part of the R&D activities of the pharmaceutical companies.
Has the Human Genome Project been of help to find out a cure for diabetes?
The Human Genome project has helped us to get a better insight of
the working of the genes and other factors responsible for diabetes. But more study is to done if one were to say that the Human Genome project has helped in diabetes care.