Di Bella experimentation: Why did it fail?
31/May/2000 - National State TV program "Report" (Rai Tre)
[ Di Bella Method - Di Bella experimentation: Why did it fail? - 31/May/2000 ]{jumi [jumi/Player.html]}
Journalist Milena Gabanelli in the study:
Exactly two years ago the Di Bella experimentation wanted by the people, was declared unsuccesfull. But why did it fail? What didn't work? Journalist Sabrina Giannini reconstructed the highlights of that story.
VOICE OFF SCREEN OF TG1 JOURNALIST (with images of news):
The Di Bella method was rejected. The first final results were disappointing but the supporters of the Modena physician do not give up.
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
So It's over the story of the Di Bella Method. It started somewhat anomalous, if not unique, in the history of clinical trials: an emergency decree!
Images from the Senate, Italian Republic - Sitting on 19 March 1998:
"17 February 1998 n° 23rd, on urgent measures concerning clinical trials in oncology and other measures relating to health. Who approves it? The Senate approves!".
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
The official oncology community who has been entrusted with the task of experiencing the Di Bella Method in 60 centers throughout Italy, after three months reached these results: from 386 patients who had undergone voluntarily in the trial, only 3 had recorded a partial reduction of the tumor. In 47 cases, the disease remained stable, half of the patients had a progression of the disease and a fourth died during the trial. They were all diagnosed with terminal cancer, without treatment options, almost all already subject to traditional therapies! Here ends the trial but drugs continue to be administered to patients who are better thanks to the Di Bella therapy.
Mr. Giovanni Giovannini - Patient of the observational study:
While the press said this, they continued to give us drugs.
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
Mr. Giovannini, since he started the Di Bella therapy, saw completely regress his Non Hodgkin Lymphoma and today he continues to receive medication free of charge, as long as he provides every month medical records that prove that the disease is stable or regressed, as it foresees a ministerial disposition. Mr. Giovannini was not in the group of 386 that was to test the antitumor activity of the drug but in the observational one which aimed to evaluate the survival of patients and the toxic effects of the treatment. But today, how many patients receive for free the medicine for the Di Bella therapy? About 2%!
Mr. Giovanni Giovannini - Patient of the observational study:
How is it that if a trial is declared unsuccessful by the Ministry of Health they continue to administer the drugs free of charge to a number of people who, after all, are better?
M.D. Natale Cascinelli - Scientific Director of the Cancer Institute of Milan:
The reason is essentially a compassionate one.
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
And now how many are the patients that you follow?
M.D. Natale Cascinelli - Scientific Director of the Cancer Institute of Milan:
11 patiens, on an initial group of 181.
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
But besides the sick that continue the treatment, because in their case it is effective, a year and a half after the end of the experiment there are terminally ill still alive! And they are more than 20%! But according to the experts the datum is not interesting!
M.D. Francesco Cognetti - Head physician of the Oncology Department of Hospital Regina Elena - Rome:
In each tumor disease there is a small percentage of patients who survive long-term. The thing would be different if these figures were 30, 40, 50%.
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
But some aspects of experimentation brought the case on the table of judges. Aspects related to the preparation of medicines distributed to the patients who followed the tretment. On 2 December 1998, the Nucleo Antisofisticazione (Fraud Squad!) of the Carabinieri in Florence confiscated 1,048 bottles of solution retinoids that have been distributed over the term of expiration of three months to 28 centers that where testing the Di Bella method. I quote: "This implies that 1048 patients have taken, for a period between 20 and 30 days, a potentially imperfect drug that no longer possessed the initial therapeutic characteristics. Without excluding that the degradation and decomposition of the active ingredients can produce severe side effects, especially in subjects suffering from neoplastic diseases. It follows then that the results obtained from the experimentation are definitely unreliable and that the same experimentation should be, at least, revised!". On the basis of this report were initiated judicial investigations. The Public Prosecutor offices in Florence and Rome have decided to close the case. At least for now, the one in Turin has not done it But did it came out, the history of expired drugs? From two patients.
WOMAN - Patient:
When i retired the parcel I realized that the product had already far exceeded six months. I noticed this to the hospital pharmacy that send me to the Institute Regina Elena's pharmacy, which is the one that dispenses the package of drugs.
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
The lady, thanks to the stability of the disease, was recruited in the observational study but it's 5 years since she cures her lymphocytic leukemia with the Di Bella Method. On 5 August 1998 she retires the first package at the Hospital S. Giovanni in Rome.
WOMAN - Patient:
Initially, the doctor asks: "How do you know these things?". So I answer that I use them since a long time and I know that they're valid for six months. She says that she must ask the Institute of Health, and that I have to call them after a while. I call after half an hour and the doctor alarmed tells me: "...not to take it because there was a misunderstanding and the medication, in fact, has expired!".
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
The retinoid solution, or the mixture of vitamins not on the market which can be made by pharmacists, is highly sensitive to light and its preparation is extremely delicate!
Mr. Giovanni Giovannini - Patient of the observational study:
The month of July of the last year I wasn't well, I had diarrhoea, nausea, and someone told me that it could be the multivitamin if it is not freshly prepared. No one has been able to say anything specific, so I turned to the National Institute of Health.
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
The Superior Institute of Health returns the bottle to The General Hospital from Modena.
Mr. Giovanni Giovannini - Patient of the observational study:
I said that I would have picked up the bottle if they had told me why it has been replaced!
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
In fact, after many reminders, Mr. Giovannini receives a letter from the National Istitute of Health in which the director wrote with his own hand that the tests of expiration have not been done as it should before beginning an experimentation. But another document contradicts what has been told to Mr. Giovannini. The National Institute of Health, to the Director of the Pharmacy of the Hospital S. Giovanni in Rome who wanted to know if the solution had a expiration date, replies that they undertook studies on the stability of the preparation according to which it lasts three months but if opened and closed several times only 20 days! On the bottles, however, it has never been put the expiration date. We asked for an explanation to the National Institute of Health, but on this particular issue, they preferred not to comment! We conclude that perhaps the studies have been done, but late! We received confirmation from the director of the pharmacy from the Milan Cancer Institute, M.D. Ascani.
Call between the author (Journalist Sabrina Giannini) and M.D. Ascani - Voice of M.D. Ascani:
Towards the end, after the trial, it came out that the expiration of the retinoids was four months if kept in the fridge, otherwise three months!
Author (Jornalist Sabrina Giannini):
It came out by whom?
Voice of M.D. Ascani:
By the Ministry!
Author (Jornalist Sabrina Giannini):
So it means that during the trial in reality there had not been made any tests or presumably they haven't told you anything!
Voice of M.D. Ascani:
It was made quickly so... (END OF CALL)
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
Expired drugs may have been distributed, so they were not effective? So we asked ourselves: "Who prepared the retinoid solution that is the main medicine of the Di Bella Method?". It was the Military Chemical Establishment in Florence that we asked for an interview that has been denied! There would be another issue on the table of the judge: acetone, or the solvent used to prepare the retinoid solution. Professor Di Bella asked to remove it completely and, according to the standards of good clinical practice, when one experiences a drug, you have to follow the instructions of the inventor of the therapy! So, acetone, although still present in doses considered non-toxic, may have caused side effects in people who were already seriously ill? It would not be irrelevant if you think that in the final statistics that reject the treatment, patients were excluded at the minimum worsening of arise of side effects!
M.D. Maurizio Pianezza - Physician Hospital S. Martino - Genoa:
From this experiment, there have been rejected people that according to me could have continued the treatment, and I have proof (pictures on file)! For example to a lady who followed the Di Bella therapy at some point it was removed because she had diarrhoea! She came to me to ask for an opinion in this sense. They gave her the therapy and then they took it away. That person is still alive!
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
And according to the authoritative scientific journal the British Medical Journal, in the trial has not been made a comparison with other treatments, and the patients were not choose at random. So, I quote: "...the experimentation could be designed better!". Time was perhaps the most influential factor because there was a growing public pressure.
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
According to you there was no adequate scientific curiosity?
M.D. Maurizio Pianezza - Physician Hospital S. Martino - Genoa:
Zero! Scientific curiosity zero!
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
It's probable, but in the substances of the Di Bella Therapy, Prof. Veronesi had shown interest, and in Italy he is considered the most authoritative voice in oncology.
TAKEN FROM THE PROGRAM "ELIXIR" (Raitre) of 7 November 1999 - Phone call from a televiewer that addresses to Prof. Veronesi - VOICE OF THE TELEVIEWER:
Professor, I've heard talking of preventive drugs for breast cancer. I would like to know to whom they are assigned and eventually to who can I address.
Prof. Veronesi:
For the time (7 November 1999) being they are research drugs, and are not yet available, however, they are very promising. These are new molecules that are called retinoids, derived from retinoic acid, so from vitamin A. They have very good efficacy but are still in an experimental phase. We have to wait at least another year or two.
VOICE OFF SCREEN of the author (Jornalist Sabrina Giannini):
The retinoic acid is the main substance of the Di Bella therapy but the protocol proposed by the professor Veronesi, who among other things was in the Committee, has never been implemented. We would have liked to ask him. We waited for a few months that the Professor had time for us, before he became Minister of Health. He was ment to receive us the first week of April but with a fax he informed us that that week he would have been instead out of Italy, really that week, we have seen him interviewed in Milan by TG 3 on the issue Genoma. We deduce that Prof. Veronesi does not want to talk about the Di Bella method! Of course he had to talk about a trench experimentation, a compromising and delicate topic, torn between opposing "fanaticisms", with in between 280,000 people that each year are told: "You have a cancer!".
Journalist Milena Gabanelli in the study:
That badly done experimentation costed us 70 billion (35 million €)!
Translated by: Anna Mina Leonard