ABOUT US - THE FOUNDATION
Our Staff includes physicians who prescribe the Di Bella Method (MDB)and who have helped or are willing to help disseminate, explain and establish the MDB treatment by means of medical conferences, symposia, workshops and publications. The collection, processing and organization of accurate clinical, scientific and documentary data is of paramount importance if the MDB approach is to be recognized, disseminated and widely employed in public facilities.
We are aware that MDB often clashes with strong systems of power and privilege, yet we are strongly committed and seek cooperation with any physician, biologist and/or pharmacist interested in the new lines of research on cancer initiated by Prof. Di Bella.
This website reports published cases and summaries of symposia on MDB which saw the participation of Staff physicians. Scientifically speaking these symposia turned out to be particularly useful and raised the awareness that real freedom of treatment is closely linked to the availability of MDB treatment. In fact, only if MDB therapy is granted by the National or Regional Health Service can there really be free choice of treatment for all, including those who cannot afford an alternative treatment, like MDB, and have chemotherapy as the only option.
In order for patients under MDB therapy to obtain legislative measures granting MDB treatment, we invited politicians - without distinction as to their party allegiance - to attend the above-mentioned symposia and supplied them with medical and scientific evidence of MDB therapeutic effectiveness in the absence of relevant toxic effects.
The goal was successfully attained: each symposium brought about a relevant Regional Resolution (go to Documentation => Patient Area):
The Bologna meeting of 4 Dec. 2000 led to the Resolution of the Emilia Romagna Region
The Rome meeting of 28 Feb. 2001 led to the Resolution of the Lazio Region
The Cascina meeting of 7 April 2001 led to the Resolution of the Tuscany Region
The Milan meeting of 6 May 2001 to the Resolution of the Lombardy Region
Introduction
This section of the website describes in summary form the logic and strictly rational approach taken by Prof. Di Bella in employing any single component of his multi-therapy, e.g. the concept of synergy of a multi-therapy, a concept which is clearly emerging from a review of scientific literature worldwide.
Thinking that there exists a single drug ideally capable of acting at all stages of cancer – onset, progression, proliferation, metastatic dissemination – and countering their manifold etiologic mechanisms, would be naïve and nonsense.
Single active drug ingredients, their therapeutic use and pharmacological aspects, patients monitoring criteria, side effects and most frequently asked questions by patients and their relatives are described and discussed in this website. Many references are also provided of how the anti-tumoral effect of MDB principles has been widely recognized in world scientific literature: mention is made of hundreds of published case reports, with a summary or abstract for the most significant ones. More extensive papers will be made available soon, dealing with the diverse chemical, biochemical, pharmacological, biological and therapeutic findings on MDB components and their action mechanism. These papers are taken from the book entitled “The Di Bella Method” which Dr. Giuseppe Di Bella is writing following his father Prof. Luigi Di Bella’s will.
The section named “MDB Clinical Trials” provides a list of reported irregularities and twisted truths that deprived MDB clinical trials of any scientific significance in particular the parliamentary questionings made on the subject which harshly criticized the ways such trials were arranged and conducted.
The “Rediscovery” section reports a number of clinical studies, symposia and publications that have gradually supported and corroborated the anti-tumoral effectiveness of each MDB component with a delay of decades as opposed to Prof. Di Bella’s first studies.
The Therapy
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The Di Bella method stemmed from the need to change approach to cancer prevention and treatment in consideration of the growing number of tumor cases which, alas, unequivocally demonstrate that modern preventive measures are still inadequate and insufficient.
Successful treatment options selected from among the best currently available result in a 29 per cent survival rate at 5 years according to the British Medical Journal (BMJ.COM). Survival rate progressively diminishes after 5 years. These data clearly show that the approach to cancer treatment needs radically changing.
The Di Bella Method (MDB) suggests causal treatment, that is treatment aimed at eradicating the etiopathogenic (causal) factors of tumor onset, by restoring an upset biological terrain which allowed cancer to form.
Chemotherapy, conversely, does not act on the cause of tumor but on its consequence, i.e. the tumor cell.
However, failure of chemotherapy to totally annihilate tumor cell populations allows most of residual tumor cells to resume proliferation and invasiveness in a less resistant biological terrain due to chemotherapy formerly received.
Moreover, tumor cells themselves tend to become less drug-sensitive and more drug-resistant after several chemotherapy cycles.
By employing somatostatine, MDB treatment inhibits some of the most powerful tumor factors, like GH (main growth factor), IGF and many others. Such action is further strengthened by the use of prolactin inhibitors.
The employment of retinoids helps bring tumor cells back to normality, i.e. differentiated cells. Combined with vitamin D, melatonin and vitamin E, they exert a synergic action with powerful antitumor and antioxidant effects, strengthening the immune system, inducing apoptosis (tumor cell planned death), and exerting antiproliferative, pro-differentiating and antimetastatic action without the toxic effects of chemotherapy.
MDB Criteria
The fact that conventional medicine is currently still unable to effectively treat and cure cancer is quite discouraging. Sadly, while sudden and acute diseases, like ictus or infarct, objectively leave little time for effective treatment, slowly growing illnesses like tumors demonstrate that modern therapies are still of little help.
The increasing number of tumor cases and the death rate reported every year (almost 300,000 in Italy), clearly indicate that current chemotherapy protocols are inadequate.
Tumor etiopathogenesis has not been fully explained yet, although manifold causes of tumor onset and proliferation are known.
Conventional cytotoxic and cytolytic therapies do not eradicate the agents responsible for tumor onset, but merely cause tumor cells to die. However, some tumor cells always survive and become drug resistant, as they “adjust” to heavy and prolonged chemotherapy treatments and give rise to stronger tumor cell populations.
Sadly, the side effects of chemotherapy are known to adversely impact the immune system, as well as trophism and integrity of biological terrain, which are key to effectively defend the body from tumor aggression.
Other negative effects of chemotherapy include a considerable increase in free radicals – known to be carcinogenic factors – and the induction of cell mutations that are potentially cancerous.
The failure of cancer research campaigns like the National Cancer Act – funded with unprecedented allocations and signed by President Nixon on Dec. 23, 1971 – was compared by the American press to the devastating outcome of the Vietnam war.
Such failure, after several announced medical breakthroughs in the fight against cancer, leveled harsh criticism and eventually led the American press to define the outcome of the war on cancer as the “Vietnam war of medicine””.
In Ralph Moss’ opinion “the direction of cancer management appears to be shaped by those forces financially interested in the outcome of the problem”. He tells of the enormous financial and political corruption in the "cancer establishment" and indicates that the motivating forces in cancer research and treatment in the United States are often power and money, and not the cure of cancer patients. The funds for cancer research are allocated by the National Institute of Health. All legislation aims at concentrating power in the hands of a few and increasing a conservatory attitude in respect of new therapies.
The fact that surgery -which plays a major role in cancer treatment - tends to be radical and to remove all cancer localizations as much as possible, is seldom reckoned as an indication that effective cancer treatment and cure are not yet ensured by conventional methods, e.g. chemotherapy. If this was the case, there would be no need for extended and mutilating surgical interventions.
Moreover, any tumor should always be examined and considered as a systemic disease the onset of which has been caused by a biological and physiological distress or imbalance. This holds true even when a single tumor lesion is detected, which should therefore be viewed as the maximum concentration in one point of cancer cells that are potentially ubiquitous.
Therefore, rational and causal treatment should aim at restoring biological and physiological balance on the one hand, and eradicating identified causal factors on the other.
Molecular biology is an essential component in the fight against cancer and thinking that there exists a single active ingredient capable of defeating cancer is naïve because of the many etiopathogenic causes involved.
Conversely, a multi-therapy like the Di Bella Method enables to safeguard the biological terrain, strengthen the body’s natural defense mechanisms and counter tumor growth and proliferation by inhibiting growth factors.
Biological and physiological balance may be restored by administering retinoids, Vitamins E, C, D3 and melatonin. These drugs strengthen the physiological (differentiated) cell growth of healthy tissues as opposed to neoplastic ones, and exert activity which is anti-oxidant, anti-free radicals, pro-differentiating (e.g. they convert tumor or undifferentiated cells back to normal cells) and pro-apoptotic (e.g. they cause tumor cell death without being cytotoxic). The activity exerted is also immunostimulant, anti-proliferative, anti-metastatic and anti-angiogenic, and these drugs become even more effective inhibitors of growth factors if combined with other drugs like somatostatine and bromocriptine-cabergoline.
Such inhibitors act not only on GH, recognized by international literature as the primary carcinogenic factor, but also on many other important growth factors, like somatomedine, IGF I-II, EGF, FGF, NGF, prolactin, hPL, TGF-? and -?, PDGF and VEGF, that play a major role in cancer development, as much is more and more scientifically evidenced.
DRUGS
The therapeutic ingredients of Di Bella’s multi-therapy (MDB) include somatostatine, octreotide, retinoids, Vitamins E, D, C, melatonin, bromocriptine, micro-doses of anti-blastic drugs (at dose levels 100-200 times lower than chemotherapy). Differently from cytotoxic and cytolytic chemotherapy, the mechanism of action of MDB treatment is a pro-apoptopic one.
The absolute majority of the 34,508 published reports on such ingredients – available as of Dec. 22, 2002 on MedLine - National Library of Medicine, and on this website under the section entitled ”MDB-Active Ingredients” – describe MDB effectiveness in countering the key features of cancer biology from onset to progression, that is: high proliferative rate, lack of cell differentiation, hence failure of apoptosis i.e. the main natural anti-blastic mechanism. These features are common to all cancer types.
Even in prevention MDB has proved to be effective in respect of major factors of tumor etiopathogenesis, like oxidant agents and free radicals. MDB components like retinoids and other vitamins that help protect the epithelium, like vitamins E and D, are especially recommended in treating epithelial tumors. These vitamins, besides powerfully improving trophicity, integrity and functional recovery of epithelia, strongly limit - together with melatonin - cytotoxic damage caused by ionizing radiations of radiotherapy to neighboring epithelial tissues, as well as oxidative and free radical damage on nuclear DNA, cytosolic organelles and cell membranes.
MDB is therefore an effective, causal solution to cancer, while chemotherapy does not act upon the cause, but rather on the product of the cancerous process, i.e. the tumor cells. Chemotherapy deludingly aims at destroying all tumor cell populations: in fact some of these cells mutate and adjust, becoming more and more drug resistant, and rapidly proliferate in an increasingly weaker body whose anti-blastic, homeostatic and immune mechanisms have been severely, often irreversibly, compromised by chemotherapy.
By countering the manifold and changing etiopathogenic chains of cancerogenesis, MDB treatment helps redress the biological and physiological balance, the upsetting of which allowed the onset of cancer – even in the presence of solid tumors, cancer should always be considered as a systemic disease, with cancerous mass being only the maximum evidenced concentration. With MDB treatment, notably the interaction and synergy of its components, cancer biology reverts to physiological biology. While every single molecule exerts an anti-blastic action, their synergy powerfully improves MDB anti-tumor effectiveness. Somatostatine, bromocriptine and melatonin inhibit both pituitary hormones - like GH, prolactin, powerful and ubiquitous growth factors whose role in cancerogenesis is well documented - and IGF1, TGF, EGF, VEGF, PDGF, NGF, gastrin, FGF, colecistokinin – major factors in cancer etiopathogenesis.
The Di Bella method stems from the need to remedy the substantial inability of chemotherapy to cure cancer, as much is evidenced by the employment of oncological surgery, which would be pointless if chemotherapy were really effective.
RETINOID SOLUTION
The drug is not available for sale like other chemical medications but has to be prepared by a pharmacist. As a galenical preparation it requires special equipment and scientific expertise. Non-polar, hence water insoluble molecules like beta-carotene, retinol, retinoic acid and vitamin E require the use of an organic solvent that must be eliminated at the end of the preparation. The whole process must occur in the presence of nitrogen to avoid oxidation of active ingredients. (read the “Trials” chapter in the “Di Bella Method” section).
Complete removal of the organic solvent, e.g. acetone or alcohol, is essential to avoid toxic effects and denaturation of active ingredients. Notably acetone has to be removed totally because of its proven carcinogenic effects triggered by manifold mechanisms, including the induction of cytochrome P450 2E1 (CYP2E1), very active in biologically inducing pro-carcinogenic substances. Other acetone-induced effects include a rise in free radicals and a drop in cellular ATP, which is key to cell apoptosis. The retinoid solution may be properly prepared following Prof. Di Bella’s indications (again read the “Trials” chapter under the “Di Bella Method” section). During the 1998 MBD trials traces of acetone were found in all retinoid solutions prepared by the Italian Health Institute, with concentrations in some cases up to 850 mg per liter. These concentrations not only have carcinogenic effects but are also toxic, as much is evidenced by attached reports.
VITAMIN D3
The preparation is commonly found on sale. Dose levels must be adjusted to patient’s weight, blood calcium response and stage of disease.
VITAMIN C
Vitamin C may be administered both as a galenical product (much cheaper) or a chemical medication at dose levels of at least 2 g or more per day.
SOMATOSTATINE- OCTREOTIDE
The biological product somatostatine-14 (tetradecapeptide) may be administered subcutaneously by means of a syringe pump over ten hours’ time, during the night. Intravenous administration, always by means of a syringe pump, is also possible and definitely more effective in some cases, though more laborious. Average dosage in adults is approximately 3 mg per day.
Somatostatine is available for sale as a chemical preparation and thanks to initiatives promoted by patients treated with MDB, the average price dropped from 516,000 lire (approx. 260.00 euros) per vial in 1998, to the current 18.00 euros (with daily administration). The 8 amino acid synthetic analogue of somatostatine, namely octreotide, is also commonly available as a chemical preparation. Octreotide is employed with the same criteria of somatostatine-14, but at dose levels of 1 mg per day. Because the half-life (period during which the drug exerts its action) of somatostatine-14 is only a couple of minutes, continuous intravenous infusion is needed to keep drug concentrations effective for at least 8-10 hours.
While the half-life of octreotide well exceeds one hour, this nonetheless administration by means of a rate controlled infusion device is essential to avoid, or considerably limit gastro-intestinal symptoms like nausea, abdominal pain, etc. typically caused by rapid administration.
During MDB trials, as much was stated by officials of the Italian Health Institute (see the “Trials” chapter under the “Di Bella Method” section), only very few patients were granted the use of a syringe pump. Yet, their gastro-intestinal symptoms were disgracefully attributed to the substance rather than to its mistaken administration, no to speak of the impaired effectiveness of the drug.
Up until relatively recent times slow-release somatostatine analogues were produced in 10 mg, 20 mg, 30 mg packages and entailed a very high cost of about 1,700 euros per month. A single intramuscular injection of these analogues allows to cover 10, 20 and 30 days respectively. Because the drug remains dormant until it reaches effective concentrations, shorter intervals between injections are advisable (e.g. 27 days rather than 30 days for 30 mg injections).
More and more published reports on somatostatine, its receptors, radio diagnosis and immune-histochemical methods and RT-PCR techniques to identify such receptors, have been helpful to better clarify the mechanisms of action of both somatostatine and its analogues. There are also numerous scientific reports describing receptor properties and characteristics of the various cancer types. Since octreotide is definitely more effective on receptors 2 and 5 than somatostatine-14 and considering the latter’s receptor affinity, an ever greater definition of receptors for every cancer type would be desirable to devise more targeted and effective treatment.
MELATONIN
In order to obtain maximum bioavailability melatonin is prepared galenically in capsules with adenosine and glycine. Natural melatonin is “connected” to adenosine by hydrogen. Average dose levels are about ten 2 mg capsules daily, to be ingested during the day with a greater concentration in the evening. The antioxidant, anti-free radicals, anti-proliferation, anti-metastatic and pro-apoptotic effects of this molecule have been extensively described in world medical literature thus confirming the rationale of melatonin in the context of a multi-therapeutic approach to treat cancer.
BROMOCRIPTINE
Bromocriptine – included in the fixed therapy module – is employed at dose levels of 2.5 mg administered 2-3 times a day during meals. It is recommended in treating all types of cancer because it is a strong inhibitor of growth factors and interacts synergically with somatostatine, its synthetic analogues and melatonin. It is especially effective in tumors mostly influenced by prolactin as a growth factor. Side effects include nausea, which mainly occurs with a single and fasting administration per day. Such side effects may be avoided by fractioning drug administration during meals.
CABERGOLINE
Cabergoline – included in the fixed therapy module – is employed in the place of bromocriptine when the latter is not tolerated, at dose levels of 0.5 mg. per week, which can be increased in special cases of tumor progression and metastatic dissemination, especially in prolactin-dependent and hormone-dependent tumors. It is recommended in treating all types of cancer because it is a strong inhibitor of growth factors and interacts synergically with somatostatine, its synthetic analogues, and melatonin. It is especially effective in tumors mostly influenced by prolactin as a growth factor.
CYCLOPHOSPHAMIDE
Cyclophosphamide – included in the variable therapy module – is employed at dose levels of 50 mg once a day during meals, up to a maximum of 2 administrations per day. It is a nitrogen mustard alkylating agent, used at minimum dose levels in MDB treatment as opposed to those usually employed with chemotherapy. Conventional treatment of certain types of cancer may even envisage direct intravenous infusion of cyclophosphamide up to 10 g. In comparison, MDB dose levels are 50-100 mg per day, that is 100-200 times lower than in chemotherapy. Even the ways of administration, exclusively oral in MDB, and preferably intravenous in chemotherapy, radically change therapeutic response. In fact, 50-100 mg dose levels produce a pro-apoptotic effect on the tumor cell, i.e. induction of programmed cell death.
HYDROXYUREA
Hydroxyurea – included in the variable therapy module – is employed at dose levels of 500 mg daily (up to 1000 mg under special circumstances). It has cytostatic properties and is mainly employed in hematology to treat chronic myeloid leukemia at much higher dose levels than those used in MDB (in the order of 30 mg per kg per day). The drug is also recommended to treat other chronic myeloproliferative syndromes like essential thrombocythemia, polycythemia and homozygote sickle cell anemia. MDB employs hydroxyurea at much lower dose levels than conventional oncology, since the pro-apoptotic and cytostatic properties of the drug can be obtained even with modest, hence better tolerated dosage. The cytotoxic and cytolytic action typically obtained in chemotherapy with higher dose levels is totally foreign to MDB therapy, where hydroxyurea is above all used because it is able to cross the blood-brain barrier (hence treat brain tumors and other solid tumors). Toxic effects of the drug include medullary depression with anemia, leukopenia, plateletpenia. These can be limited and mitigated to a large extent by other MDB components like vitamins and melatonin. However, severe medullary depressions discourage use of hydroxyurea even in MDB.
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