Clarifications from M.D. Giuseppe Di Bella regarding Temodal (Temozolomide) and others chemotherapeutic drugs
To reassure some doubtful and perplexed patient, and to reply to some unfounded false and duplicitous criticism.
We report here some sentences taken from symposium proceedings by Prof. Luigi Di Bella to better explain some concept.
If the tumor is growing, and if the growth is regulated by growth factors that the DBM inhibits, is pointless to ask a protocol to confirm it. The DBM was born from scientific data and from truths acquired from the official science (i.e. numerous publication that support it!).
It is essential, instead of the impracticable and imaginary destruction of all the neoplastic elements, the realization of all the known possible conditions, that will hinder the development. It is essential to activate all the inhibitors of the known growth factors, with appropriate doses, and with the right timing.
The DBM protocol was born in this contest, the contest of life and not of poisoning and cellular death, and the method that panders or enhances vital reactions, without looking for, with statistical precision, the right doses to kill.
The tumor is the deflection from the day-to-day life, and for this reason is important to bring these deflection back to normal, though the magnification of all those instruments that the conventional Physiology treat as essential for a normal life. The DBM panders and magnify the vital reactions and the antitumor homeostasis to put this in a condition opposed to the onset and progression of the tumor.
The DBM continues this goal through new formulation and criteria of use of the Melatonin (MLT, in hydrogen bond, with Adenosine and Glycine, see "Melatonin conjugated, why?") Retinoids solubilized in Vitamin E, but also Vitamin C, Vitamin D3 and other components of the extracellular matrix (ECM).
Adding non-polar components like the Beta-carotene and the Vitamin E between the phospholipids of a cellular membrane, it results stabilized, keeping it free from oxidative damages and free radicals.
In both situations that predisposes to the tumor, but also during the neoplastic disease, it is possible to subvert structure and potential of the cellular membrane and in turn the expression and the receptor functionality, through the exasperation of the oxidative processes, and the peak of production of free radicals. The doses of Retinoids and Vitamin E provided with the DBM of, allow a protection and therapeutic effect, zeroing the chances that the free radicals make damages.
Retinods and Melatonin , have the ability to keep and enhance the trophism, the vitality and the efficiency of the healthy cells, but in the same time, they act to reduce the progression the vitality and the mutagen tendency of the neoplastic phenotype. This apparent contradiction, comes from the fact that the Retinoids are the most powerful, non hormonal, activators of the ordered growth, functional and finalized at the biologic equilibrium, however, at the same time, they strongly inhibit the aimless and unordered neoplastic growth, starting the tumor cell to the apoptosis.
The vitamins are physiological catalysts between energy and matter. Every change in the living matter cannot be not linked to an adjustment of the energetic state. Only minimal variation, quantitative of production, absorption, which means the elaboration of the biologic soil, and of its corresponding energetic state, are compatible with life, and for this reason the reaction have to go step-by-step, with small matter-energy amount, reciprocally compensated with the time. These conditions, realize with extreme gradualism, the production and absorption of energy and matter, with an equivalence matter/energy.
This cycle, for the exceptional purpose, must be slowly modulated and fining regulated, and in its essential lines, will be impossible, without vitamins, which role is the conditioning and the regulation of the equilibrium matter/energy on the base of life. The full knowledge of vitamins, is equal to the knowledge of the finest equilibriums and the ration energy/matter and their effects on the vital activity.
The knowledge of the chemical composition, of the formation and localization within the cell, of the timing of their action, of the regulation and activity entity, allows to understand the meaning of the physiological life and to correct its pathological changes. For these reasons, from its original biochemical role, the vitaminology is elevated in the DBM to that rational and therapeutic, but also in the prevention and in the therapy of several pathologies.
Therefore, a deep knowledge of the mechanisms that regulate regular physiologic life, allows the predisposition of effective countermeasures to avoid degenerative or neoplastic deviations. This is, to explain the biochemical and molecular mechanisms whereby the reduced chemotherapy drug doses in the DBM are tolerated, or anyway, have contained side effects, they do not induce mutations, and not even an increased rate of free radical, especially if high doses of Melatonin soluble Retinoids and Vitamin E are administrated.
It is important to know in synthesis the real possibility of the DBM: in prostate carcinomas, breast cancer, in the limpho-proliferative diseases novel and innovative results were obtained, up to the total remission, in some iper-metastatic case at the IV stadium, and at the recovery of lymphomas after the failure of several lines of chemotherapy and marrow transplantation. The progress in the oncologic therapy of the DBM, is also documented from the total and stable remission of the tumor, in cases of prostate and breast cancer, or surgically removed or treated with chemotherapy, data absolutely pristine and not known in oncology, as the remission of cancers at the IV state.
I believe that is necessary to make clear and to underline a fundamental concept, in order to avoid misunderstandings and delusions: in other tumors, mainly lung, ovary and gut cancer etc., it is possible to considerably increase, either the intervals clear from the disease, but also the average survival time, but we are not yet able to obtain the same results obtained in cases of breast, lympho-proliferative or prostate cancer, that however, represent the most common neoplasms.
Therefore, the progression of lung, liver, pancreas brain tumor of peritoneal cancer etc (with very rare exception that are not present at the beginning of the disease), after stabilization obtained with the DBM, it is predictable, and it should not surprise and disconcert. Saying again that in these situations, the DBM, represents a progress, because increase the life expectancy and the interval free from the disease (compared to the official data found in literature for pathologies with the same stage). But even in these neoplasms, we are obtaining, gradual, but slow improvement, through the increase of the Melatonin doses, but also through the introduction of aerosols of Somatostatin, and the activation of the immunity.
The cost (speculative) of the drugs, do no allow to make prescription with full doses, and to associate to the Somatostatin to the slow release Octreotide (LAR). The coercive suspension of the DBM during the hospitalization for emergency, ostracism and hostility encountered in hospital environment, and the lack of information and censure, like a sort of terrorism exercised on the ill people. The lack of departments where to host people during the emergencies, limited the chances of the DBM.
Owning the chances to hospitalize at least for the time strictly needed for intensive treatment with Somatostatin and Melatonin at high dosed through in vein injection and weekly intramuscular injections of LAR 10mg, and if these treatment could be started at the beginning of the disease, would be possible to save or to elongate many lives and to attenuate the pain.
We are studying the peculiarity, compered to the classical Cyclophosphamide (Trade names Endoxan, Cytoxan, Neosar, Procytox, Revimmune) and/or Hydroxyurea (Brand names include Droxia, Hydrea and Oncocarbide), of other molecules in specific neoplasms that we are not able yet to eradicate, but only to slow down, uniformly reporting the doses and the criteria of use and the posology of Cyclophosphamide/Hydroxyurea.
In every neoplasm, we are trying to evaluate every solution that has a rational and scientific base, ant that meet the criteria of tolerability and efficacy of DBM. For these reasons, we did not ever recommended to undertake the canonical chemotherapy through in vein injection, cytoreductive and cytolytic at high doses and high toxicity and with mutagen effects.
In rare cases and specific situations (at the moment 7 cases on more the 1200 patients cured in the last two years) we used in breast cancer, with the criteria of Prof. Luigi Di Bella, and now called metronomic therapy, reduced dosed of products used per os in oncology, such us the Capecitabine (Trade name Xeloda).
They are usually used from oncologists as support therapy with mutagen effects and reduced toxicity compared to in vein infusion of Taxanes or Platinum compounds. Using reduced fractions of these posology, already more tolerated when compared at the classical in vein injections of the same drug, we obtained, in some specific situations positive results, that we are observing and monitoring, respecting the guidelines of Prof. Luigi Di Bella, which envisages reduced daily doses but continued.
In oncology it is not possible to administrate continuously, but it is possible in the DBM, for the antitoxic effects , myelo-protective and differentiating of Retinoids , Vitamin E, Vitamin D3 , Vitamin C, Calcium, Melatonin , interactive with those cytostatic of Somatostatin and prolactin inhibitors. We are not constrained in our protocols, saying again to be more clear:
- We apply a method, not fixed schemes, respecting the efficiency/toxicity relationship of Prof. Luigi Di Bella reporting the doses of some molecule with the criteria, doses and posology and mode of use of the classical Cyclophosphamide/Hydroxyurea.
Just for the innovative properties of the component of the DBM to improve the efficiency and vitality of healthy cells and to protect them from the toxic effects of the chemotherapy drugs, the latter in the DBM can be continuously administrated. It includes a slow and progressive conclusion of the physiologic life cycle, making the ageing and death of the neoplastic cells with physiologic mechanism (apoptosis) and not due to chemotherapy drugs.
This is also valid for those shocked and for the luminaries and respective followers, that with hypocrisy were shocked that we use Temodal (Temozolomide, C6H6N6O2 - Brand names Temodar, Temodal and Temcad).
In the past, only in rare cases, we managed to obtain for Glioblastoma, discrete results regarding quality of life and expectancy and only in patients that could afford to regularly associate Octreotide LAR to the Somatostatin . We obtained an improvement, adding in brain tumors, as an anticonvulsant, the Valproic Acid (in substitution of other anticonvulsants like Levetiracetam - Trade name Keppra -, usually prescripted) endowed with documented antitumoral activity, differentiating and incrementing considerably the doses of Melatonin .
It is essential to consider that the average time of survival for Glioblastoma with “Temodal + Radiotherapy”, slightly exceed a year and there are not in scientific literature, not even in the case of improvement, volume reduction of Glioblastoma tumors with Temodal, associated or not with the classic pan encephalic radiotherapy and even less of healing.
Temodal is produce in different dosages of 5mg, 20mg; 100mg; 140mg 180mg 250mg and in solution for in vein infusion. It is usually associated to radiotherapy and only subsequently it is used on its own. The dose of Temodal is calculate on the base of the body surface and generally, in monotherapy is around 200 mg/m^2 (square meter), once a day. In the organism the Temozolomide is converted in another compound called MTIC. The MITC bonds to DNA with inhibiting effect in the phase of cellular reproduction and therefore cytostatic.
Notorious for not giving any substantial results, the Temodal is used in oncology with scarce confidence and at dosages certainly limited compared to chemotherapy drugs used in other tumor types. In addition it is regularly associated to radiotherapy and frequently to other treatments monoclonal antibody based and/or immunotherapy.
But a prescriber doctor of DBM casually noticed that a patient in DBM that associated 200mg day of Temodal, tolerated perfectly the drug that the oncologist use in cycles to avoid the toxicity mainly to marrow level. The reoccurred lesions of the Glioblastoma after surgery, were progressively reduced till completely disappeared at the last MRI scan. Due to this unique event never seen in the scientific literature!
From that moment, considering the high aggressiveness and the poor prognosis of this type of tumor, we started to prescribe Temodal. An innovative data is that between all the chemotherapy drugs, Temodal if associates to the DBM are better tolerated! The DBM is demonstrating the maximum containment of the side effects of this drug, together with the strengthening of the antitumoral activity, that when is used on its own was not seen.
Perhaps, a certain “affinity” of the molecule with Melatonin can help to understand this mechanism of action. In fact both Melatonin and Temozolomide have a benzene ring chemically bonded to a pyrrole ring and an amine group.
I inform those interested to an application and development of the research on the DBM, that has already started, an evident action of the media of defamation, de-legitimation, misinformation on the DBM that anticipate the total block and prohibition of administration. There are many precedent case:
- In 1997 in Italy, the order of doctors, with a press communication, did warm the doctors to not prescribe the DBM and...
- ...previously in the april 1996, to the increasing number of patients treated with the DBM, was forbidden the use of Melatonin through the ordinance of the 25th March 1996 number 161, promoted from the president of the drug commission Prof. Garattini. Prescription of Melatonin was treated as criminal offence!
- At the same time, the Somatostatin initially supplied from the sanitary service, was available only under charge at a cost of 516.000 Lire (about 256€) for 3mg, the daily dose of 3mg as chemical product did cost 3000 Lire (about 1,5€!);
- Not other therapy has been, hated defamed, censored like the DBM, that had the "honor" to have ordinances to avoid the use of the essential components;
- No therapy has been the subject of anathemas, excommunications press releases derogatory and intimidating, ministerial and medical associations and major health institutions;
- No therapy has had sanctions, appeals warnings of doctors orders (almost no one of the doctors prescribing the DBM starting with my father and myself has gone free)!
This method undermines the turnover of multinationals, constitutes an unacceptable lack of respect towards the great benefactors of humanity, the pundits of medicine, KOLS (Key Opinion Leaders) that with so much effort and money the multinationals impose obsessively to public opinion.
The refusal of the Guidelines and Handbooks zealous ministerial committees that require political appointees, is seen as insubordination, a sacrilege, a crime of high treason to the spotless, holy disinterested vestal of medicine.
In the absence of mobilization and of awareness on the part of those who are not willing to be subjected to coercive treatment the end of freedom of cure is imminent. Except some rare exceptions few have really and truly activated, in practice we were left almost alone to fight this battle. This may be the last call!
M.D. Giuseppe Di Bella
Translated by: Angelo Bella