Nature pubblica due Comments sullo scandalo Vannoni & Co. Elena Cattaneo e Gilberto Corbellini raccontano la fatica di “lottare per quello che è giusto”
Our crusade has come at a high personal cost. The past 18 months have been a roller coaster of hope, disappointment, triumph and outrage. We have spent countless hours talking to each other and to politicians on the phone, in person and on video conferences. We prepared and shared at least six dossiers and dozens of slides. We have given interviews to newspapers and written commentaries almost weekly. We exchanged letters and comments with patient organizations; we established relationships with doctors at the public hospital that had housed Stamina, which has now distanced itself from Vannoni.
Hanno imparato a costruire alleanze con colleghi onesti e a districarsi nei media,
We learned to avoid appearing on television shows on which cool reason is drowned out by strong emotional messages. Over several months, some of us received threatening letters and insults from people who felt that we lacked compassion for dying patients. Several of these letters were serious enough that we forwarded them to police. Our institutions filed complaints against unknown people hanging around our labs. Our universities were the target of e-mail and other cyberattacks.
Come Paolo Bianco che ha un gruppo di ricerca, Elena ha dovuto sacrificare “lab time”,
But it has all been worth it. Now, thanks to the European Court ruling and a Senate investigation into the case that launched three months ago, we are hopeful that these dubious treatments will soon be banished from Italy; they were displaced from Switzerland in 2011 and from Cape Verde earlier this year. We recommend that all scientists stand up for the scientific method. Science depends on public institutions and is done in the public interest — we have a duty to defend both.
Paolo Bianco, alleato della prima ora, e Douglas Sipp hanno seguito la lobby americana per la “libera scelta in libero mercato” a cura dei soliti venduti al miglior offerente:
Three key documents give a sense of what is at stake. Under the Free to Choose Medicine campaign put forward in 2010 by the Heartland Institute in Chicago, Illinois, US companies would be able to sell drugs after small clinical trials that are insufficient to establish either safety or efficacy.
In altre parti del mondo, i “mercati” sono già “rilassati”
Several countries in Asia, Latin America and the Caribbean have already punted stem cells straight onto the market, often in concert with state-backed initiatives to promote medical tourism. Australia has exempted autologous cells from the purview of its drug regulatory agency, the Therapeutic Goods Administration, unleashing offers of unproven treatments from at least a dozen clinics.
Stamina era un cavallo di Troia della Heartland Foundation e altri “think tanks” finanziati da Big-Biotech. Doveva rilassare le regole UE e della convenzione di Helsinki che vietano di usare i malati come cavie
In the controversy surrounding the Stamina Foundation in Italy, which offers an unproven stem-cell treatment for a range of conditions, US advocates of free-to-choose-medicine last year pressed the Italian government to allow entities to market stem cells for diseases such as ischaemic heart disease and multiple sclerosis without requiring any proof of efficacy, and only a small phase I clinical trial to evaluate safety. This prompted alarm and counter-arguments from scientists. Earlier this year, a nearly identical deregulatory proposal was published as a call for stem-cell products to be placed on the market first, and tested for clinical effectiveness later.
But it is a business model that removes the incentives to make drugs and treatments ever better. It offloads financial risk from investors and companies to patients, and requires the very ill to pay for interventions that are unlikely to work.
C’è una soluzione migliore
The pressure to deregulate comes from the failure of current business models as engines of innovation. In the United States and Europe, regulatory structures actively support therapeutic development, even for rare or orphan diseases. The gene-therapy product Glybera (alipogene tiparvovec), approved by the European Medicines Agency in 2012 for a condition that can cause life-threatening pancreatitis, is an example of establishing efficacy for a complex, innovative product with a small, but rigorous trial.