Historical Archive


Research and profits Some molecules that have been on the market for some time, created for other diseases, are now discovering unexpected properties. In other cases it is the industry that regenerates medicines with new and wider indications. Also to extend the patent and slow down the arrival of generics.

The pharmaceutical industry has been going through a creative crisis for some time, according to financial analysts. Despite the billions invested each year in the research and development of new drugs, few are truly innovative ones that enter the market. Thus companies, which today spend more than double their budget on marketing, have become skilled in another technique to ensure profits: giving a second life to old drugs. In some cases these are molecules born and designed with a therapeutic indication of which other properties are then discovered, sometimes by chance. Among the examples, emblematic is that of thalidomide, the anti-nausea withdrawn from the market in 1961, after having made victims among children: because of the drug it is estimated that over 10,000 phocomelics were born in the world, i.e. with very serious fetal malformations; many died within the first year of life. As the protagonist of one of the most tragic events in the history of medicine, thalidomide was reborn from its own ashes as hope for thousands of sick people. Numerous studies in the last 6-7 years have shown its unsuspected positive side which has opened a breach in the treatment of a tumor of the bone marrow, multiple myeloma (from 3 to 4 thousand new cases each year in Italy), for which the research had so far proved stingy with solutions. Viagra (sildenafil) belongs to the list of drugs approved for one use that turn out to be useful for other purposes. It entered the market in 1998 for erectile dysfunction disorders, with 7 billion dollars in sales and 35 million users worldwide (according to estimates). Now it turns out that it has unsuspected pharmacological virtues. A study in the New England Journal of Medicine already reported in 2005 that it has been used with positive results in pulmonary arterial hypertension: thanks to its vasodilator effect, it increases blood flow. And a May article in PNAS reported that daily subcutaneous injections of Viagra in mice used as animal models for muscular dystrophy protected the heart from the progressive degeneration of voluntary muscles caused by this disease. Unsuspected properties also have miltefosine, an anticancer drug used unsuccessfully for breast cancer, which has also proved effective in leishmaniasis, a parasitic disease transmitted by the bites of various species of insects, the sand flies. In June, informs PloS online, tamoxifen, another anticancer drug of the family of selective estrogen receptor modulators, also entered the arsenal of possible drugs for leishmaniasis (the study is on mice), used to combat recurrences. An analysis by the Journal of Health Economics indicates that out of 68 new drugs, the average time to approval is 15 years. And for each of them to go on the market, the cost is 800 million dollars (about 600 million euros). Although the National Institute of Health (NIH) has doubled its investments in research, according to Nature, the number of drugs that pass the scrutiny of the Food and Drug Administration (FDA) remains unchanged: 20-30 a year. At this rate, it will take more than 300 years for the number of available medicines to double. As emerges in Farma&Co, a book by Marcia Angell, former editor of the New England Journal of Medicine, the pharmaceutical industry, distracted by other interests that have nothing to do with the knowledge and discovery of new molecules,

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