Italian stem-cell therapy: could have been worse

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.

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Senato della RepubblicaThe 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.

A-colony-of-human-embryon-001The 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.

italian lawWhy 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.

Luigi di Bella

Luigi di Bella

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.

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5 Responses to Italian stem-cell therapy: could have been worse

  1. Pingback: Cells Weekly – May 5, 2013 | Stem Cell Assays

  2. Pingback: Italian Stem-Cell law will be “substantially changed” | SciencePlug

  3. Pingback: 80 dottorati, ecco quanto costa testare il metodo Stamina | Prometeus - ANBI Magazine

  4. Una mezza verità è una menzogna intera. says:

    Since Di Bella Method has been improperly brought up in this blog, here is an article from an Italian national newspaper which shed a light on the attitude that the italian academy showed during the 1998 trial. There is a reason why italian researchers leave the country:
    PS: it takes more than a fresh degree to judge a man of 3 degrees and a lifetime of hard research…

    Di Bella Method, war among white coats
    http://www.ilgiornale.it/interni/metodo_di_bella_guerra_camici_bianchi/29-04-2012/articolo-id=585469-page=0-comments=1
    il Giornale.it interni
    by Gioia Locati – april 29, 2012 – 08:00

    «Combined effects of melatonin and all-trans retinoic acid and somatostatin on breast cancer cell proliferation and death.». Is the title of a research conducted by the University of Florence and just published on European Journal of Pharmacology.

    Evidence that all these substances stop breast cancer occurred in a laboratory of the department of human anatomy, on cells in vitro. The three substances, taken individually, have a large history of scientific literature as anti-cancer drugs. But the same active substances, used together, each strengthening the other, are part of the Di Bella method. That is the debated therapy developed by the Sicilian scientist Luigi Di Bella that was tried in 1998 and found to be ineffective by the committees responsible.

    The action of the Di Bella method is actually more complex than that of the three drugs tested in vitro but it is true that the Florentine researchers have focused on three key molecules of the Di Bella treatment without however making any mention of it.

    Says Professor Lucia Formigli head of the Department of Anatomy and head of the study:

    «I am a researcher, I want to stay out of polemics. We have an excellent laboratory of molecular biology and started two years ago to analyze cells: I must say that we got excellent results.»

    Such as?

    «The synergistic action of the three substances showed a reduction of the proliferation of breast cancer. It is effective the fact that all three are used together, but it is good to remind that ours is a work in vitro.»

    On the abstract there is a phrase that has infuriated Di Bella’s patients, you wrote that the three substances «have never been completely combined in the treatment of breast cancer.»

    «It wasn’t me who wanted that phrase – argues professor Formigli -. The idea to investigate the three molecules came from my pharmacy student, very good».

    The student is Nicola Pacini, 34, a new graduate in pharmacy and biology, that Il Giornale was able to interview

    Pacini, are you the author of that phrase?

    «If it were up to me I would not have put it in, but it’s true that the three molecules have never been tested together».

    Are you sure? Di Bella has published 122 cases of breast cancer regressed with these three substances combined, he has tested them on people, you on the slides ….

    «To have the consensus of the scientific community we had to start from scratch».

    Explain better.

    «The scientific community is too closed, they would have never accepted a work signed Di Bella».

    «Neuroendocrinology Letters and Gynecological Cancer» accepted them.

    «The scientific community considers them works too self referential and the magazines “biased”».

    But you copied them.

    «Di Bella was the first to have understood, in the 60s and 70s, that to stop cancer biological treatment is more effective than chemotherapy».

    You could have proved your gratitude by writing the name Di Bella in the biography.

    «I am a supporter of the Di Bella method, not a thief, I have not stolen anything».

    But is it normal that to be accepted by the scientific community one should conceal the paternity of a discovery?

    «It is not the first time, the world is what it is and we’re in the middle of it».

    Here we are talking about a cancer therapy.

    «I know very well, that is why I have behaved in this way: in order to make accepted a model in which I believe, I act in an aseptic way, starting from scratch».

    Is it true that you have already prepared a work on colon cancer?

    «Yes, the three molecules are also effective on colon cancer».

    And will you include the name Di Bella in the biography?

    «I will».

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