Antonio Saia  -  As expected, your therapeutic method is arousing great hopes in our country, maybe even some illusions; however it is arousing curiosity in me, as in many other people, as a man, as a physician and as a representative of the law.  
We have no sure elements to assess the efficacy of your treatment, to ascertain what kind of tumours it is more efficacious with and useful for with respect to the traditional therapies. To eliminate all doubts about our position, I would like to say first of all that we believe that science has maade huge breakthroughs in this field: tumours treated with hormonal therapies like Hodgkin's disease, and some types of leukemia, can today be almost completely cured by resorting to traditional methods. However, it is our duty to shed light on this issues in order to meet the Italian patients and people's needs.  
We must make sure that a new possible way is investigated. Your words said extremely interesting things; currently, the human body is already living with some tumours - I am referring to benign tumours - so why don't we try and live with the metastases of other tumours? We do not think it would be useful, however,  to neglect new ways that often made a complete recovery possible, such as surgery: I am thinking of colon cancers where early diagnosis makes it currently possible to obtain a recovery equal to 70 or 80%. Thus,  - this is our duty, too - we must prevent people, who could be cured well, with tested and efficacious therapies, from beginning to use a method that has not yet officially and finally been tested.  
It is necessary to know how this therapy works in order to understand whether it can actually be useful even as regards a low percentage of tumours - it would be a very important result, anyway - avoiding the opposite risk.  
To do this I think it would be necessary, Prof. Di Bella, to pull down the wall between you and your collaborators on one side and the CUF (the Drugs Single Commission), the Government and the Oncological Commission on the other. It would be necessary to start a clinical control instead of a trial, because it is a fact that tens of thousands of people are now following your therapeutic protocol.  
We are very interested to know the final outcome of such control and, to that end, we would like to ask you to allow us to do it; we think it is fundamental for you  and your group to co-operate in the research and this is what we intend to ask the Minister.  
It is on behalf of those patients to whom you devoted your life that we ask you to co-operate with the minister, who is just using, and couldn't do otherwise, the facilities and the regulations which have ruled this field up until today.  

Vasco Giannotti - Many of us - let me underscore that when I say “many of us” I am not speaking on behalf of a specific group as I think that opposing a group against another pertaining these issues would be childish and wrong - acted to grant you the best possible conditions to demonstrate the efficacy of your method. I am glad that we have now come to the real point of the whole question that is trial, also thanks to your help (and I'd please ask you to be completely helpful) and your measured attitude (and I hope that such an attitude will continue - as we saw during most of the TV programme yesterday night).  
The question that is of great concern to me is the following: I understand that trials are not easy to carry out; I would like to ask you - as I will ask the others - what are the necessary things, the time required, what is needed to give the citizens what they are asking for and that should be our duty as lawmakers to provide, that is whether your method can test the efficacy and the effectiveness of the results. I am asking you the rules, the time and the ways we need to follow.  
You outlined two concepts that will stir much debate and this is a good thing. The first concept is freedom of therapy: the citizen - as you said - must be properly informed in order to decide along with his doctor the kind of treatment to carry out. But you claimed, Mr. Professor, that for this freedom to be real it is necessary for a doctor to know how to propose effective therapies. I hope that your method, after the scientific trial (as proven by many facts), may prove effective: this is what Italy is expecting.  
The second concept you mentioned is that of living with a tumour.  
This is another  fascinating arguing point, but in this case too we must be careful: let's try and work with wisdom and moderation, as you often told us.  
Living together means to keep into consideration all the results obtained. In my view the fact that the mortality rate went from 70 down to 50% over the past twenty years is a very important result, too (I am here referring to the official data so I am open to denials). Finally, there is the great chapter that you mentioned concerning the quality of life: this is another important point.  
I think then that the members of the Parliament's task is not to speak of the various methods; the essential point consists in providing the citizen with the best possible treatments and that is why the time and the method of the trial are important.  
Piergiorgio Massidda - I agree that no one can deal with a problem concerning an individual from a political standpoint, although there may be a higher or lower sensibility.  
As I am one of the signatories of the agenda which was rejected when the financial law was examined, I am clearly a supporter of your needs and requests. However, as lawmakers, we also have other duties and, among them, in this particular moment, that of lowering the tones. We are assessing with you the effectiveness of the therapy you developed but, at the same time, we cannot throw discredit on other therapies which have given extremely good results so far. We fear that today's debate may create problems for the sick and protecting this principle is our duty.  
Here is the reason for this hearing and for our interest: as lawmakers, we must help the citizens, and you researchers must clearly provide the therapeutic arsenal with as many weapons as possible. I am a doctor myself and, ideologically speaking, I completely agree with you about freedom: we are fighting for physicians to be allowed to keep this freedom especially as far as the therapeutic method and their relationships with their patients that nobody can decide by resorting to a law are concerned. At the same time, as a doctor, I would like to ask you some questions; you probably already answered some of them but I want to be precise. Could you precisely outline the pathologies the use of your protocol may be appropriate for? Could you show us comparative data between the results obtained with the application of your method and those obtained with the application of chemotherapeutic protocols? Do you have data pertaining the survival rates, the controls and the number of years after the therapies are administered according to your reference protocol?  These questions are important to us; we can guarantee you that, as it is our major duty towards the citizens, we will give you as much support as you need: I am not speaking of trial but of clinical control and assessment that for us - independently of who we like or dislike - is a duty towards the citizen.  

Giuseppe del Barone - I carefully listened to Professor Di Bella and I must be frank:  when he says “nobody ever died with my treatment” I immediately think that my friend Massidda's question is answered. If nobody died then the comparison with chemotherapy should not be made, as many people died with it.  
Thus I would like to be precise about this aspect because Professor Di Bella spoke a lot about breast tumours and devastating therapies, about mastectomy and so on.  
I would also like Doctor Giuseppe Di Bella to listen to me so that we will be able to exchange ideas. Professor Di Bella, my question is specific: you know the situation much better that I do (I have been a doctor for about forty years). You'll certainly know about quadrantectomy, statistics concerning recovery after a non-devastating operation are very wide. Would your method, that we are here to learn, replace even such operations or improve the quality of life that these operations can already make good? Basically, when you say that nobody dies, you are automatically stating that this treatment is in complete contrast with the improvement of life because if there is no death, such improvement is almost negligible. On the other hand I am deeply convinced that your treatment will have even miraculous results especially as regards an improvement of life; but if we are talking of the fact that no people die, you put your treatment in complete contrast with past positions that had negative but also positive results. I would like to tell my great friend Gramazio to relax: I am a member of the FNOM (National Federation of the Medical Association) central committee and I can assure you that freedom of prescription does exist; there can be no doubt about it.  
Giuseppe Del Barone - What I am saying is that one thing is making a private prescription that is also approved by the patients after properly being informed (and is thus legitimate), and quite another is speaking of a prescription issued by the National Health Care System, about which we heard the disquisition of magistrate Maglie and of all Italy. I will now end my speech: I would like Professor Di Bella - that I esteem deeply - to tell us whether his therapy intends to replace traditional treatments or assure an improvement in the patient's quality of life with this trial, more than with clinical records, because what we need is a trial carried out by others and not by ourselves. I believe this is the basic question.  

Alessandro Cé - First of all, the Professor's considerations always start from the assumption that a doctor practising this profession basically is an honest, ethically well-balanced person and so on. Diverging information, furthermore, exists. Although there is talk of the patients' informed approval, it is clear that if they can test the effectiveness of the therapy, they will never be able to prefigure the mechanism underneath.  
My question then is the following: don't you think that, in any case, even with the freedom of treatment and of choice as the fundamental principle, it would be ethically important to have a body to assess the reliability of the trial under way? The Federation of the Medical Association certainly showed an unbelievable malpractice by forcing general practitioners not to prescribe that substance, which is an incredible and unacceptable thing.  
Don't you think, however, that, from an institutional standpoint, a body delegated to carry out a similar task should be established? Furthermore, although neglecting the drugs' economic aspect, as the allocations are to be paid by the National Health Fund, shouldn't there be a analysis of the financial repercussions that are a direct consequence of the therapy's suitability? In this case, should repercussions be seen, it would be possible to insert those products within the therapies to be carried out by the National Health Care System.  
In the light of this important preamble, I would like to ask you the reasons which hampered the spreading of information pertaining your trial, especially in the academic circles, and stirred so much the institutions' hostility.  
Finally, I would like to ask you to be absolutely frank with yourself before than with the others, and I'd like to know whether there is something in your trial, apart from the fact that it does not comply with the specific criteria of international trial, that cannot today be used by other people who can assess the authenticity and effectiveness of your method.  

Antonino Mangiacavallo - I would immediately like to underline how puzzled I am to tackle this problem: not so much as a member of the Parliament but as a doctor and as an M.P., not just as the scientific implications that this issue entails but also for the social and journalistic uproar that we saw in the past few days with the involvement of the mass media, of the magistracy and of a large part of the public opinion. Thus, I will try to make some considerations in this short time available, although I will not miss the opportunity to ask you some specific questions.  
First of all, I would like to start from two things you said, one being that it is necessary to support the freedom of treatment and the other that when assessing a therapy's effectiveness, the economical aspect, at least initially, should not be considered. I firmly believe that the freedom of treatment is a cornerstone in the respect towards the citizen and I presently see no reason to worry about the lack of such freedom. I would start to worry if some form of libertinage or anarchy in prescription should be advanced instead of freedom. I perfectly agree with you when you say that a therapy's economical evaluation cannot absolutely be taken into consideration, especially when facing tragic pathologies as the neoplastic ones. To be honest, however, I must tell you that I am a little puzzled about some of your scientific statements. In particular, I am referring to your statement that the goodness of the therapy you tested could also be assessed by that fact that it never caused any deaths. This could be considered like any other symptomatic therapy; I clearly do not intend to underestimate the potentiality of your therapy that, however, I don't know from the biochemical, electrophysiological and strictly scientific standpoints.  
I get further worried when I see that patients or citizens can be psychologically influenced in order to make them carry out a particular kind of therapy that no elements can help determine whether it is effective or not. In this way illusions would arise and would make the neoplastic patients' situation even more tragic.  
Finally, Mr. Professor, considering that a clinical trial must not be based on subjective but rather objective evaluations, I would like to ask you the following question: were the studies that your team made carried out by double blind versus placebo or versus other therapies, as laid down by international directives and by science that many people harshly judged even during yesterday night's television programme? Did your researchers carry out a clinical follow-up in a rigorous, precise, scrupulous way and with statistically reliable data, as my colleague Massidda asked before, or were the evaluations merely based on a limited and non-selected survey? You claim that it is impossible to use a standard therapy for all types of existing tumours. I can assure you, in fact, my medical experience taught me this, that there are patients suffering from a pancreas or breast carcinoma that are treated only surgically and who are perfectly healthy even after many decades.  
I would like to ask you another specific question. We have often heard that your group, Professor Di Bella, is opposing the control of the trial by judicially-authorised bodies as they would have prejudices against your therapy and your team. What are the elements that induced you to decide beforehand that the involved bodies were prejudiced against you? If such elements do exist, I would like them to be discussed openly.  
Finally, excuse my presumption that is particularly respectful of your experience, competence and academic past, it is not possible to say that science destroys common sense. I am afraid that when looking for the truth - and we're all here to do that - presumption (mine, not the others') sometimes may frustrate science's breakthroughs.  

Annamaria Procacci - I truly believe that today's hearing, in this institutional seat, can strongly contribute to re-establish serenity and help us join efforts again, which is what we all need.  
The main protagonist is always the sick person: I think that none of us can or want to forget it. I believe it is necessary to hurry up and start the controls, or trials, as they are called, immediately, according to rules having the highest objectivity possible. We have always believed that, Mr. Professor, (and I think I perfectly understood the cultural message your brought us this morning, as that pertaining the principle of living together with cancer), the patient and the physician's therapeutic freedom is man's unavoidable duty. We also believe that doing whatever we can in the field of prevention is a duty of society, and our own duty too: we have been fighting this battle for the prevention of cancers by trying to improve the quality and the style of our life, as well as the air we breath and the food we eat.  
We also believe it is necessary to create a greater opening towards the research of “new” therapeutic methods, although they actually are not very new. However, in order to dispel the doubts I as well as other people have, as they were put forward in other seats, I would like to ask you this question: your protocol, as far as I know, is the outcome of a mixture of elements, somatostatin being the main one, obtained through their variable dosage, if I am allowed to use this non-technical term. So how is it possible to scientifically reconcile (I am interested in this point as it would allow me to understand which trial to carry out) this variability of the therapeutic elements with the reproducibility of the experiment? I think that this is currently one of our major doubts.  
Furthermore, Mr. Professor, the roads you walked on for your research during your long experience crossed those of researchers from other countries and I believe that this could be another interesting point, at least as far as I am concerned.  
I would finally like to ask you to what extent your methods could be used for children affected by tumoral pathologies.  
These are the points that mostly interest me and I can assure you that we are, as well as everyone else here, I believe, interested to follow the therapeutic method that you developed even in its subsequent phases.  

Giuseppe Fioroni - First of all I would like to thank Professor Di Bella for his speech. Mine is made up by three rapid considerations. At the beginning of his speech, the Professor underlined the importance of the freedom of treatment, the freedom for physicians to prescribe a therapeutic method apart from instructions or diktats. The problem is then the following, I believe: the therapeutic freedom must fall within the context of precise criteria; I think that a scientist who has an academic background surely remembers his first university lessons where he is taught to make sure that the therapeutic freedom with the administration (testing the products on man and not on guinea-pigs) does not risk becoming freedom of damage. It is for this reason that I believe it should be kept in mind that in the past, even in the recent past (I'm not speaking of your method as I do not know it exhaustively), whenever the mass media focused their attention on people suffering from cancers, we have had a long series of the so-called “hope journeys” that led sufferers, not just terminally-ill patients but also those at the initial stages of the disease, to follow methods that were allegedly considered to be, certainly in good faith, useful for some pathologies.  
My second question to you then, which I will ask you with the same humility Mangiacavallo referred to earlier is this: shouldn't a knowledgeable scientist give the scientific community, both national and international, data, protocols and other elements that would be used to go more in depth of and actually achieve results?  
Massidda mentioned another aspect: when speaking of comparative methods, I think that it is important - and you underlined this several times - that the drug that is administered with the new method does nor cause any damage (primum non nuocere). In the second place, however, one must make sure that it also adds something more with respect to the currently used and tested therapies. In the third place, when an old therapy is discontinued and a new one started (that might be particularly aggressive or not be able to solve every single case), it is necessary to be sure, both professionally and ethically, that the patients who discontinue a treatment choose a better and not a worse one, even though they are aware that they are following a hope and that they are not able to cope with their own problems.  
There is another consideration to be made: I don't think that the costs of the therapy may be a problem because if we were sure that a new method could cure even just a limited number of cases, we couldn't certainly avoid the need to spend any figure to save a life.  
There is another problem concerning a case which I personally experienced and that is connected to one of the issues that Procacci put forward: the case of a child suffering from an acute haemopathy, He was in intensive care and his parents decided to make him follow your method. When a doctor has to decide whether to continue with the conventional therapy (whose remission, or recovery, rate was 60% as final datum) or interrupt that treatment and choose another one without having sure statistical data, do you think that he should also be held ethically, as well as experimentally, responsible for his professional capability of freedom?  
My last remark concerns an aspect that I don't think was correctly interpreted by some of my colleagues: Professor Di Bella clearly said that his method is not toxic, and that it never caused any patient's death, so that it presumably accompanied the patients' deaths, if any, by assuring them a better quality of life. I believe that this is the reliable data; the data that we would like to get, though, are the recovery rates and the pathologies they refer to.  

President -The first round of questions is over. Professor Di Bella may now please start to answer.  

Prof. Luigi Di Bella - Many questions are fundamentally the same so that they can be given one single answer.  
One of them concerns the clinical trial and I would like to talk about it briefly as we have here a great deal of colleagues physicians (Some deputies say: “Too many!”). I don't think that any of us, when we have to prescribe an antispastic drug, will ask its clinical trial first. One could object that this drug was already tested: ok; and if I prescribe drugs that were tested and that are good in fighting cancer, why should I carry out a trial? The protocol which I developed is made up by drugs which have already been tested although their trial did not involve the field of practical medicine. Take retinoic acid for example: who has ever thought of prescribing it? Yet, rigorous scientific surveys proved its usefulness. Scientific reports continually demonstrate this. Why should I start to carry out a clinical trial of retinoic acid when I already know everything about the compound, I know how to prepare it, I know its composition, I know all this compound's chemical and physical properties, I know its toxicity and the way it acts? What should I test about it? Should I test it to give tens of millions or maybe some billions to institutes that claim to carry out clinical trials?  
What I have just said for retinoic acid is also true for beta-carotene. Wailer began to talk of the possibility of transforming beta-carotene into vitamin A already in 1932. Then we had Coon's research who saw that one molecule of beta-carotene was necessary to give two molecules of vitamin A. Everything was later confirmed and today we know that beta-carotene is a provitamin A, we know its solubility and absorption. What should I test in this case again? Retinoic acid, beta-carotene; and there are tens of volumes about vitamin E: what else should I test again?  
And let's speak of another substance, bromocriptine, which I use as well. Who does not know that bromocriptine is a key element to secrete prolactin and all the things it does for mesencephalic nuclei? And finally there is somatostatin.  
What should be known about somatostatin is not known. I happened to show, and the experiment actually was successful, that the stimulation of habenulas' ganglions increases the number of platelets in the bloodstream: I went from 200 thousand that are normally in the bloodstream up to 600 thousand. Then within 72 hours, platelets return to the previous levels. I tested it on man and I know it is continually done. So, should I test what was already the object of a huge number of tests and experiments as well as being described in the literature?  
Let's now get to the sore point: somatostatin is a principle secreted by the diencephalon that can stop the production of the somatotropic hormone.  
We have already known this for at least fifty years, because researchers had problems in isolating the somatotropic hormone, but it is made up by a good 91 amino-acids. Carrying out a synthesis of so large a polypeptide is not an easy thing.  
If the methods that were discovered later hadn't been used, we would not be where we are now. I know that research is still being carried out, even in America, to prove that somatostatin affects only the elements of the APUD system, a striking, nice term: amino-processor-upted-decarbosilation.  
So somatostatin's only function would be limited to the APUD system. But what about its effect on gigantism or acromegaly? They have been forgotten although we have known these things for various decades now. We know all the effects when it is in excess and when it lacks, and we still have to test somatostatin? Why? Because Gebion suddenly felt like speaking of the APUD system.  
The basic problem of this deduction consists in believing that an injected substance's only function is the one known by the person using it. The only function that he knows, he believes, is the substance's action.  
The fact that somatostatin affects the production of the somatotropic hormone rules out the possibility of having even other effects. But when do we ever use a substance and know that it acts in only one way? Just read the various handbooks, now more than one hundred, and maybe give a look at the monographic parts which have recently been published. But when is a substance used for just one effect? How many effects does it have? And does its having many effects mean that I cannot use it? I use it trying to monopolise the effect that I obtain in that moment of the day in which I must do it, through the combined action of many substances that can enhance an effect and weaken others and so on. In other words, I feel that we are trying to engage in fruitless discussions, pointless discussions and questions which have already been analysed with an almost molecular, I'd say, precision.  
So we have reached a point in which the objection raised to me is: the problem is not the substance but the protocol. This fantastic word “protocol” now comes out. I did not mention the word protocol, I spoke of a four-principle substance, and not because I wanted to change things but because I wanted to be a little more specific. Four. Well actually the principles are more than four, but we can talk of four groups or categories. The reason is the following, and is strictly physiological at first, then it becomes physical and chemical and even mathematical and it even involves combinatorial analyses, differential calculus and so on. I am just briefly mentioning them. The remedies belonging to this four-principle substance... It is not just retinoic acid or beta-carotene, or bromocriptine or melatonin, or somatostatin: no, none of them, but them all together.  
If no combined action of these substances exists then there is no effect, and if there is it would be limited or delayed. So my use of the four-element substance formula has a specific reason underneath. I am just briefly mentioning this aspect because there are doctrinaire limits to be respected here. Our insight into this field is very deep. What do we still have to test?  
Besides retinoic acid, there are other acids that act similarly, but the retinoic acid has at least three receptors. But the three receptors are in the nucleus. Having a receptor in the nucleus means that things are starting to change a little. They also are three different receptors and we know how they affect the production of melatonin, too. So what do I have to find out if this is already a scientific truth? There are incontrovertible data that we all know. It would be as if, in order to prescribe some bicarbonate, I'd test its effects first or ask the protocol of its action. I don't think that such a thing might make much sense. The important thing, on the other hand, is to determine the protocol, that is the four-principle substance, as the action of one of them that is not subordinated to that of the other (the action of the alpharetinoic acid, for example, is not subordinated to the action of beta-carotene or of bromocriptine) gets enhanced and thus becomes effective.  
I would like to give an example. Yesterday night I was the guest of a television programme and I tried to speak but I was told that I was not understood (which may happen); for this reason I will only repeat very few things.  
Let's say that I administer some retinoic acid or just the retinoids and that I get a specific effect; let's say - second hypothesis - that I also administer some bromocriptine besides the retinoids. I can administer these two substances together, or bromocriptine first because the temporal factor may also change the effect. I can have two methods of action with two substances but if I administer a third substance I can decide to introduce it at the beginning, in the middle or at the end.  
According to the binomial, I can have three combinations available and if I have four, I can have as many for each of them. How do you call this? We call it factorial in the combinatorial analysis.  
If I have four substances that make up my formula, I may have the action of one by two and two, by three, six; by four, twenty-four, that is I may have twenty-four methods of action with just four substances.  
Most of the objections raised to me involved my using a substance, while the real objection that should be raised and that would more serious should involve the moment in which it is produced and its combination with other substances.  
And this is just the material part.  
But if I take into consideration the temporal element, my factorial will also be of five or six and so on; the methods of action that it would be possible to achieve would thus become almost incalculable.  
I won't dwell upon all the rest...  

(to be continued)