The italian Governments keep falling in the same mistake: disregarding evidence-based policy in favor of populistic decisions. But policy makers are not to be blamed (entirely) for such poor political performances.
The High Chamber of the italian Parliament has recently approved the draft of a controversy law that (essentially) supports the use of a yet unapproved stem-cell therapy to treat neurodegenerative diseases. The ministerial decree now passes to the Low Chamber that may convert it into law by the end of the month.
Back on March, the italian Public Health Minister Renato Balduzzi allowed the use of a mesenchymal stem cells-based therapy to treat children with no traditional/approved cures for their maladies. This happened in response to the overwhelming media coverage of the case of Sofia, 3.5 years old girl that suffers from metachromatic leukodystrophy (MLD), to which the cure seemed successful but was denied because the lab administrating the cells didn’t have permissions.
The treatment proposed to Sofia and to hundreds of other children comes form Davide Vannoni, psychologist at the University of Udine and president of Stamina Foundation, an Italian biotech company based in Turin. The no-profit organization seems asked the EU Patent Office to deposit the methodology behind the cure, but after journalistic investigation and legal inspection at the laboratories, the company is forced to suspend the cures in 2009.
Despite the presence of EU established channels for drug and therapy approval both for research and commercialization purposes, the new law (298/2013) grants the possibility for stem cell researchers to administrate cells to patients overcoming the Italian Pharmaceutical Authority, trigging national and international expert concerns.
Last week the ISSCR (International Society for Stem Cell Research, headed by MD and Nobel winner Shinya Yamanaka) worries about the “Italian case”.
ongoing research will eventually lead to new therapies [but] rigorous clinical trials are required to deliver safe and effective therapies to patients.
The Society also reminds that
“regulatory oversight were developed over several decades, largely in response to instances where people were harmed during human experimentation”
In response to ISSCR and the scientists community in general, I want to make clear the following:
- The law doesn’t approve any commercial stem cell therapy.
- The law supports the use of stem cells therapy exclusively within controlled trials, where data should be constantly reported to authorities
- The experimentation can be performed only in public research infrastructures
- The law allows a maximum of 18 months of trials and under “extreme circumstance”, therefore only as last choice
The decision, obviously, has defects:
- The law set stem-cell therapy at the same level of regulation as tissue transplant, differntly from EU and US regulations (that compare them to drugs)
- Patients that have already started treatments will continue even if cells are prepared in labs not in line with EU and Public Health guidelines (opening a crack in the regulations).
- Thought the treatments will be given “under the responsibility of the operative doctor”, the MD legal responsibility (jail or fees) has been proposed but unapproved.
Why this law is coming to action? What this law really does is fixing another italian mistake: the fact that different Courts in different cities have granted unevenly access to Stamina’s treatment, even though its laboratories have been shut down after sanitary inspection.
Giving such inequality between patients across the country, where some could and other couldn’t obtain a “hope for a cure”, this law settle the problem and move on to fetch a solution to an already unstoppable situation: on one side, granting the therapy to everyone, evening what the judgers have transformed in a “Swiss cheese” State will; on the other hand, creating the conditions to make such shameful and unjustifiable national human experiment into science, collecting data and restricting its applications within Universities or public hospitals.
This law will do what Stamina Foundation have failed to accomplish from the very beginning: make a randomized control trial that will (eventually) settle the debates on whether the treatment is really effective.
Unfortunately, Italy is not new to such episodes. At the end of the ’90s, the Ministry of Health covered the expensive of a phase II clinical trial for the Di Bella multi-treatment (DBM), a daily cocktail of components such somatostatin and bromocriptine, which became known worldwide as a quack cancer cure. Again, after extensive media coverage that reported episodes of improved patients from different tumors (all scientifically unreported) the Government was “forced” by the public opinion to take action. The investigation concluded with an article in BMJ signed by the italian National Institute of Health proving the cure to be ineffective (therefore harmful, since depriving patients from the first line of treatments).
In my view, in a country where the Scientific Method have been repeatedly bitten from both the public opinion and Courts, the room for political action is so narrow that this law is the least we should expect. Parliament have been set into a corner where, if the decision were different, it would have been impossible to justify.
As it wasn’t bad enough, intrusions comes also from a third, omnipresent italian character: Vatican. On April 11-13, the Second International Vatican Adult Stem Cell meeting, with shamelessly choreography of sick children, was reported by a Nature Editorial this week.
Italy has never solved the problem of proper science communication to its citizens, as efforts from major italian media are way lower then necessary. Italians feel stitch up by mainstream scientists or companies, and “withhold cures due to economical interests” is sickly embedded in the cultural conversation. Moreover, the lack of trust in experts has also led to a large use of alternative medicine.
If a long-term action to revert the disastrous condition of science in Italy doesn’t take place soon, there will be worse to come.