The science journal Nature, one of the most widespread in the world, dedicates three pages of its last issue (June 19) to Elena Cattaneo, biologist and senator for life, and Gilberto Corbellini, historian of medicine, for a comment on the Stamina case and the attempt to impose a therapy with no scientific basis. Both of them are Italian and the Stamina case is also Italian (we were about to write, typically Italian). However, Cattaneo and Corbellini warn, it should not be considered an exclusive of the Bel Paese. Because the phenomena has already passed the mountains (two years ago Stamina arrived in Switzerland) and the seas (this year Stamina landed in Cape Verde). We could add few other attempts in Florida and the Ukraine origin. In other words, Elena Cattaneo and Gilberto Corbellini are launching an appeal to the international scientific community: let’s be on guard, as this is not Italian folklore.
Nature acknowledges the alarm. Not just by offering a lot of space and visibility. But also because, in the same issue, the journal publishes another comment signed by another Italian, Paolo Bianco, biologist expert in stem cells, and Douglas Sipp, Head of the Office for Research Communication of the RIKEN Center for Developmental Biology in Kobe, Japan.
And they say that Stamina is not an isolated accident at all. On the contrary, it is the expression – perhaps extreme, perhaps out of hand – of a more general and deeper process that we might define by using just one word: deregulation. A word that evokes a political season (Margaret Thatcher in the UK and Ronald Reagan in the US) which has also been a long and profound cultural season, not yet concluded. And that now is trying to extend its arm to biomedicine too. Even to medical practice. And has its avant-garde in stem cells.
The idea of deregulation in the medical field – which is already practiced in several countries – is quite simple: less ties. More (illusory) freedom. The introduction of new medical technologies (drugs or more) – states the supporters of deregulation – is long and expensive. It requires four exhausting phases (a preliminary one, called phase 0, has been recently introduced in the US). It entails unbearable investments and, in conclusion, prevents innovation. In the name of freedom of cure and demand for innovation, we allow, who is willing to, to access medical technologies (drugs or more) not yet passed through the four canonical phases. Perhaps they might have passed Phase I only, which tests on small groups of healthy people or patients (from 20 to 80 subjects) whether the treatment is not toxic or harmful.
The idea, therefore, is simple. It is enough to show that a new medical treatment is not evidently harmful and anyone, at his own risk and previous informed consent, can use it. This procedure cuts time and costs. And if the users share their data on the effects of the technology, deregulation becomes a big mass experiment and allows to conclude in shorter time and with lower costs Phase II, III and IV of clinical trials.
The idea is simple and is spreading quite rapidly. Paolo Bianco (who, we would like to remind, fought against the use of Stamina, demonstrating with Michele De Luca, its groundlessness) and Douglas Sipp cite a data from ClinicalTrials.gov, the database of the US National Institutes of Health where clinical trials conducted all over the world, funded with public or private money, are recorded: at the moment, besides Stamina, there are more than 360 attempts for applications of mesenchymal stem cells (the same cells used by Stamina). Well, none of these studies has produced some published results yet.
The idea of deregulation, then, is as simple as dangerous, state Bianco and Sipp. Because it transforms patients in guinea pigs, whom even pay. And drags scientific progress in medicine back in the past. And the principle upon which the idea is based, freedom of cure, is a false freedom. Because a patient who has (or believes to have) few hope to live or even just to be cured, has no much choice and would try anything.
However, on the other hand, the problem is real. How can we develop new clinical technologies in less time, in order to satisfy the unsatisfied requests of patients?
Paolo Bianco e Douglas Sipp answer to this question with the only possible answer. We cannot lower down safety standards and erode scientific practice. We must, however, modify the model, mostly supported by private funds, on which the innovation process for medical technologies is based nowadays in the Western countries and not only. Governments must take charge of it. Only States can allow the necessary resources and guarantee researchers the needed serenity for producing authentic innovation.
In fact, innovation has always been guaranteed by public funds. Few years ago a book (The Truth About the Drug Companies: How They Deceive Us and What to Do About It, Random Editions), by the US physician Marcia Angell, first woman director (for 10 years) of The New England Journal of Medicine – one of the most authoritative medical journal in the world – demonstrated that at least 80% of the really new and innovative formulae in pharmacology are produced by research projects supported with public funds.
It seems most likely that new ideas arise in serene environments with no immediate interests. Where creativity is free to explore and nobody chases you for results here and now.
And if we look better, this was the idea – only the State can support free research, primum movens of innovation – promoted by Vannevar Bush when, in 1945, he published the Science report: the Endless Frontier. A report that launched and informed about the modern research politics in the US and all over the world. Let us remember the lesson of this great mathematician, who collaborated with the democratic Franklin Delano Roosevelt, but was politically a conservative.
The debate about deregulation is a major
issue in medicine and health policies. The Stamina
affaire is deep-rooted within such a tangled context; knowing its story, even
its most obscure details, is thus important to understand how these topics may
impact on citizens, and most of all on patients, if they are not faced
properly. This is one of the reasons behind the Scienza in rete’s investigative
journalism project about the Stamina affaire, carried out by Roberta Villa
and Antonino Michienzi. The resulting report will be available for free as an
e-book at the beginning of July.
Stay tuned, because it is time to shed light on the Stamina affaire.