"At the millennium, Napoleone Ferrara, researcher of Italian origin (in the odor of the Nobel) in the U.S. who works for the industry Genentech - recalls Francesco Bandello, Director of Ophthalmology at the University Vita-Salute San Raffaele in Milan - discovered a molecule, bevacizumab, which is effective in the treatment of colon cancer: the drug works by blocking the formation of blood vessels supplying the cancer of nutrients needed for growth. " In 2004, the drug is registered by the Food and Drug Administration (FDA), the American authority for drug control, with the following indication: treatment of metastatic colorectal cancer. Meanwhile, Ferrara thinks of studying a molecule similar to use to stop the proliferation of blood vessels in the retina, which is the basis of exudative maculopathy (one of the most severe forms that affect the retina) and develop ranibizumab. while waiting for the approval of ranibizumab (which took place in 2006) some ophthalmologists (Philip Rosenfeld of Miami first) think, because bevacizumab injection into the eye, since the mechanisms of action of two drugs are similar? It would, however, an off-label use, that is, outside of official information (because, bevacizumab, in fact, been recorded only as anti-tumor). "The drug is effective and explodes an atomic bomb - continues Bandello -. One vial of bevacizumab It costs only 15 euros, compared with 1,500 euros of ranibizumab. Not only: the effectiveness of two drugs is comparable, as demonstrated by a study published in The New England Journal of Medicine in May of 2011. "
At this point the protagonists of history multiply : come into play companies, patient associations, scientific societies, health authorities, policy-makers. Meanwhile, what has happened in Italy? The AIFA, the Italian Medicines Agency, in 2006, says: using bevacizumab (without taking into account studies of EBM, Evidence Based Medicine, which demonstrates the benefits of ranibizumab in the treatment of macular degeneration, while there is nothing analogous to the bevacizumab) and the use of bevacizumab takes place (off label). Then the AIFA in 2008, is reversed: you must use the ranibizumab, he says, on the basis of efficacy trials. But there is a region, Emilia Romagna, which is counter and says, "we use Avastin", with a regional law, which goes against the provisions of a national body such as the AIFA. Curious. The justification, says Emilia Romagna, lies in the cost: an account is the product registration (which is a prerogative of AIFA), an account is a refund (which depends on the regions), then decides the region. In short, a mess mainly related to economic resources (increasingly scarce), which is complicated this year with the issue of security. In 'August, in fact, the FDA has sent an alert, warning that, specialists in ophthalmology, signaling an increase in serious eye infections and blindness in patients treated with Avastin. The cause? Improper handling of the drug. Some pharmacies in the area of Hollywood (Los Angeles) had prepared for ophthalmologists, Avastin vials are then revealed that "carriers" of bacterial infections.
The situation falls . In September, the U.S. Department of Veterans Affaires announced that it has renounced the use of bevacizumab, pending further studies. In Europe, four groups of patients asking for clarification, some cases of infection reported in Germany and warn that the phenomenon is underestimated, since there is no mandatory reporting of side effects of a drug used off-label. Even in Italy there are some cases. While in the U.S., these drugs are manufactured and marketed by Genentech-Roche in Europe are manufactured by Roche, but Lucentis is marketed by Novartis. But, apart from trade issues at the expense of the patients. "In some Italian companies ranibizumab is available - Bandello says - and the race is open to therapy. So it happens that, in some public hospitals, the "places" for ranibizumab are exhausted in two or three days. " And then the proposal becomes: Avastin today (with the risk of infection is difficult to assess in public and, worse still, in private clinics) or ranibizumab in two months. With a warning for bevacizumab off-label: the absolute obligation to inform the patient (which is required by law). From here said their doctors and health authorities. At this point, the word goes to the politicians. Who should have what? And based on results of scientific research which offers a cure? They expect answers.
