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While the patents of several important drugs are about to expire, the modest novelties put into circulation still come from traditional chemical synthesis. Let's see the reasons for the stalemate in which pharmaceutical research finds itself today, despite the continuous announcements of great discoveries in the new fields of biotechnology

There is much talk today about new therapies that will derive from genomics, pharmacogenetics, proteonics, biotechnology and stem cell research. But in practical terms, for several years, there have been very few truly innovative drugs that we see arriving on the pharmacy counter. Two contributions have come to shed a little light on this discrepancy, on this "gap" that we all touch with our hands: an international conference held in Erice last summer and an interview with Silvio Garattini, director of the Mario Negri, as well as coordinator of the Alfa Scientific Commission, which appeared shortly after in the "Affari e Finanza" supplement of the newspaper "La Repubblica". Don't be satisfied Already a research on pharmacological innovation, published in 2005 by Censis and by the Biomedical Research Forum, highlighted how doctors have now adapted to consider "innovative" a drug that is not new, but that is only better tolerated by patients , or an analogue that allows you to decrease doses. But in the same research, the 88% of the doctors, declared that the "improvement of the patients' quality of life" is the objective towards which innovation in medicines must tend. In today's reality, the pharmaceutical industry is experiencing a difficult transition. In fact, the patents of a good number of important drugs are expiring, while research fails to discover new molecules. And the modest innovations we see still come from traditional chemical synthesis. According to Garattini, there is the danger that companies end up in a financial crisis and are forced to slow down research which is instead vital for all of humanity. It's true, science is making enormous strides, but it takes a long time to put truly new drugs on the market. Expectations of imminent innovations, fueled by continuous news amplified by the "media", of discoveries made by researchers in search of notoriety (and funds) are illusory. Unfortunately, for some time now, "most of the new therapies arriving on the market are those against tumors. However, they are still partial and imperfect therapies", explains Garattini, "which at most allow the patient one or two months to live longer . However, they are launched all the same because they are very expensive, even in the order of tens of thousands of euros for each therapeutic session. A complete therapeutic treatment can reach 500,000 euros. It ends up that the industries aim for them precisely because of the lucrative margins they guarantee, and they neglect the search for more decisive drugs, which would have a much different impact on the fate of humanity". Again according to the illustrious pharmacologist, it must be recognized that the 20-year patent may be too short, given that at least half of the time is spent on the experimental and pre-clinical phase. On the other hand, some mechanism could be studied which discourages the tendency to make minimal changes to an old molecule in order to make it "new" and sell it more profitably. The Erice Document According to the Document resulting from the "Workshop on Drug Innovation" of Erice, a possible definition of an "innovative" drug could be this: "that process which determines an improvement by introducing something new, which potentially brings a benefit to users, with a tangi impact

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco