Enzymtherapie zou voor dramatisch slechte resultaten zorgen tegenover chemo bij inoperabelel alvleesklierkanker, maar er lijkt fraude gepleegd bij deze studie om dr. Gonzalez in diskrediet te brengen.

30 augustus 2015: Lees ook dit artikel: https://kanker-actueel.nl/NL/dr-nicolas-gonzalez-sterft-onder-verdachte-omstandigheden-dr-gonzalez-is-in-1-jaar-de-tijd-de-10e-complementair-werkende-arts-die-overlijdt-door-moord-of-onder-verdachte-omstandigheden.html

8 mei 2012: Voormalig huisarts Dr. Moolenburgh schrijft in zijn nieuwste boek: U kunt meer dan U denkt ook over de enzymtherapie van dr. Gonzalez. Ik weet dat dr. Moolenburgh bevriend is met dr. Gonzalez en hem regelmatig spreekt. Op de website van dr. Gonzalez vindt u meer recente informatie en ervaringen van patiënten over de aanpak van kanker met o.a. enzymen, maar ook met voedingsadviezen. Want enzymen worden zeker niet altijd gebruikt bij alle vormen van kanker. Dus als u dit wilt gaan gebruiken altijd een consult doen bij een goed gekwalificeerd orthomoleculair arts.

Lees ook het boek van Suzanne Somers: Knockout: Interviews With Doctors Who Are Curing Cancer--And How To Prevent Getting It In The First Place, waarin zij dr. Gonzalez interviewt. O.a. ook over onderstaande problemen met de studie

14 oktober 2009: Ik heb wat research gedaan en het lijkt er nu op dat heel bewust is geprobeerd dr. Gonzalez in diskrediet te brengen. Wat blijkt de onderzoeksleider was een werknemer van de producent van de chemo die aan de andere groep werd gegeven. Nog erger deze Dr. Chabot zat in het ontwikkelingsteam van deze chemo. En nog erger hij deelde de patiënten in voor de studie. Van de 62 patiënten uit de chemogroep voldeden er 40 niet aan de criteria die vooraf waren opgesteld. Er blijkt ook dat slechts een enkele patiënt de aanpak van dr. Gonzalez volbracht. Al in de eerste week !!!! haakten 11 patiënten af. Er hebben slechts enkele patiënten de studie van dr. Gonzalez afgemaakt. Maar werden wel mee geteld als deelnemers aan de enzymgroep. Bovendien beschuldigt Gonzalez dr. Chabot ervan dat patiënten geen steun ondervonden bij het volgen van de aanpak van dr Gonzalez. In tegendeel zij werden voorgehouden dat de aanpak van dr. Gonzalez maar kwakzalverij was. Nu weet ik natuurlijk niet of en wat waar is van deze beschuldiging maar het is wel opvallend dat getoetst aan andere studies over gemcitabine bij alvleesklierkanker de mediane overleving meer dan verdubbelde in deze studie en dit pas 5 jaar later wordt gepubliceerd. Dat is toch wel heel vreemd want successen worden door farmabedrijven altijd breed uitgemeten.

Hier paar citaten die mijn schrijven hierboven bevestigen:

..... the Office of Human Research Protections, the NIH agency in charge of investigating mismanagement on government funded studies, found that Dr. Chabot, who was in charge of admissions of patients, had improperly approved 42 out of a total of 62 patients, including 40 for whom he had failed to obtain appropriate written informed consent.
More recently, .....We have learned, for example, that according to the published medical literature, Dr. Chabot, who as Principal Investigator should have been a completely neutral manager with no ties to either treatment being evaluated, had worked closely with his Columbia colleague developing the very GTX chemotherapy regimen used against us in the study - an obvious conflict of interest that had never been declared to us. We suspect Dr. Chabot believed it was in his best interest to discredit our alternative therapy and instead prove the value of a treatment he helped develop.

.........., researchers agree that all patients qualified and entered into the study for any of the treatments under scrutiny will be considered as having been treated, regardless if they actually proceed with the prescribed therapy or not. Though such an approach on first glance might not make much sense, researchers justify such an "intent-to-treat" rule as necessary to evaluate fully a new drug. For example, if in a study 100 patients receive some new medication but 50 drop out after a week because of serious side effects, certainly it would seem prudent to include these patients as treatment failures rather than discount them, since they quit because of some negative reaction to the drug. On the other hand, such a design can be disastrous for a lifestyle intervention trial such as ours, since patients who might initially be enthusiastic but who can't or choose not to proceed with the self-administered dietary/nutritional regimen will be counted as having been fully treated.

11 oktober 2009:

Enzymtherapie tegenover chemo (Gemcitabine) zou bij alvleesklierkankerpatienten een dramatisch slecht resultaat geven in het nadeel van de enzymtherapie. Aldus de resultaten uit een afgebroken fase III studie in 2004 die nu in augustus 2009 zijn gepubliceerd. Als ik zo kijk wat er allemaal de afgelopen jaren is gepubliceerd verwonderen mij deze resultaten wel. Met chemo zouden alvleesklierkankerpatienten mediaan 14 maanden overleven t.o. 4,3 maanden met de enzymtherapie. Wat opvalt is dat de studie begon als een gerandomiseerde studie maar later is veranderd in de keuze te laten aan de patienten zelf. Ik heb ergens nog het adres van dr. Gonzalez zelf die notabene volgende week bij Larry Kng zit bij CNN en zal hem zelf om opheldering proberen te vragen. Dit is wel een heel vreemd verhaal omdat alle andere studies met enzymtherapie positieve uitkomsten gaven. En daar staat ook nog tegenover dat alleen met Gemcitabine de mediane overleving bij operabele alvleesklierpatienten slechts 11,4 maanden bedraagt tegenover 5 maanden alleen met operatie. Ook in augustus jl. gepulbliceerd. En dan zouden inoperabele alvleesklierpatienten met veelal uitzaaiingen alleen met chemo mediaan 14 maanden overleven. Sorry maar dit kan er bij mij niet in. Dit is echt heel vreemd. Hier de abstracten zoals dit is uitgegeven augustus jl. eerst de studie in vergelijking met de enzymtherapie en daaronder de studie met gemcitabine tegenover alleen operatie. En daaronder weer de studie met muizen met enzymtherapie van dr. Gonzalez.

JCO Early Release, published online ahead of print Aug 17 2009
Journal of Clinical Oncology, 10.1200/JCO.2009.22.8429

Received March 6, 2009
Accepted May 7, 2009

Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer

John A. Chabot, Wei-Yann Tsai, Robert L. Fine, Chunxia Chen, Carolyn K. Kumah, Karen A. Antman, and Victor R. Grann^*

From the Herbert Irving Comprehensive Cancer Center, Department of Medicine and Surgery, College of Physicians and Surgeons; and Departments of Biostatistics, Epidemiology, and Health Policy and Management, Joseph L. Mailman School of Public Health, Columbia University, New York, NY; Boston University Medical Center, Boston, MA; and Department of Statistics, National Cheng-Kung University, Taiwan.

^* To whom correspondence should be addressed. E-mail: vrg2@columbia.edu

Purpose: Conventional medicine has had little to offer patientswith inoperable pancreatic adenocarcinoma; thus, many patientsseek alternative treatments. The National Cancer Institute,in 1998, sponsored a randomized, phase III, controlled trialof proteolytic enzyme therapy versus chemotherapy. Because mosteligible patients refused random assignment, the trial was changedin 2001 to a controlled, observational study.

Methods: All patientswere seen by one of the investigators at Columbia University,and patients who received enzyme therapy were seen by the participatingalternative practitioner. All met strict clinical criteria foreligibility. Of 55 patients who had inoperable pancreatic cancer,23 elected gemcitabine-based chemotherapy, and 32 elected enzymetreatment, which included pancreatic enzymes, nutritional supplements,detoxification, and an organic diet. Primary and secondary outcomeswere overall survival and quality of life, respectively.

Results:At enrollment, the treatment groups had no statistically significantdifferences in patient characteristics, pathology, quality oflife, or clinically meaningful laboratory values. Kaplan-Meieranalysis found a 9.7-month difference in median survival betweenthe chemotherapy group (median survival, 14 months) and enzymetreatment groups (median survival, 4.3 months) and found anadjusted-mortality hazard ratio of the enzyme group comparedwith the chemotherapy group of 6.96 (P < .001). At 1 year,56% of chemotherapy-group patients were alive, and 16% of enzyme-therapypatients were alive. The quality of life ratings were betterin the chemotherapy group than in the enzyme-treated group (P< .01).

Conclusion: Among patients who have pancreatic cancer,those who chose gemcitabine-based chemotherapy survived more than three times as long (14.0 v 4.3 months) and had betterquality of life than those who chose proteolytic enzyme treatment.

1: Br J Cancer. 2009 Sep 15;101(6):908-15. Epub 2009 Aug 18. Links

A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer.

Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K.

Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan. hiueno@ncc.go.jp

BACKGROUND: This multicentre randomised phase III trial was designed to determine whether adjuvant chemotherapy with gemcitabine improves the outcomes of patients with resected pancreatic cancer. METHODS: Eligibility criteria included macroscopically curative resection of invasive ductal carcinoma of the pancreas and no earlier radiation or chemotherapy. Patients were randomly assigned at a 1 : 1 ratio to either the gemcitabine group or the surgery-only group. Patients assigned to the gemcitabine group received gemcitabine at a dose of 1000 mg m(-2) over 30 min on days 1, 8 and 15, every 4 weeks for 3 cycles. RESULTS: Between April 2002 and March 2005, 119 patients were enrolled in this study. Among them, 118 were eligible and analysable (58 in the gemcitabine group and 60 in the surgery-only group). Both groups were well balanced in terms of baseline characteristics. Although heamatological toxicity was frequently observed in the gemcitabine group, most toxicities were transient, and grade 3 or 4 non-heamatological toxicity was rare. Patients in the gemcitabine group showed significantly longer disease-free survival (DFS) than those in the surgery-only group (median DFS, 11.4 versus 5.0 months; hazard ratio=0.60 (95% confidence interval (CI): 0.40-0.89); P=0.01), although overall survival did not differ significantly between the gemcitabine and surgery-only groups (median overall survival, 22.3 versus 18.4 months; hazard ratio=0.77 (95% CI: 0.51-1.14); P=0.19).

CONCLUSION: The current results suggest that adjuvant gemcitabine contributes to prolonged DFS in patients undergoing macroscopically curative resection of pancreatic cancer.

PMID: 19690548 [PubMed - indexed for MEDLINE]

15 augustus 2005: Bron: Dr. Gonzalez

Dr. Gonzalez publiceerde in 2004 een studie naar het effect van pancreas enzymen therapie bij muizen. Ook uit deze dierstudie bleken de toegevoegde enzymen te zorgen voor een significant langere overleving (P < 0.002) en beduidend minder snelle tumorgroei dan bij de muizen in de controlegroep. Let wel bij mensen wordt door dr. Gonzalez aanvullend aan de enzymen therapie ook aandacht gegeven aan ontgiftiging en bepaalde extra voeding en andere extra voedingsupplementen. In deze dierstudie werden alleen enzymen gegeven. De studies bij mensen lopen nog steeds en er zijn nog geen nieuwe resultaten over bekend. Zie ook Studierapport dr. Gonzalez over enzymen therapie bij alvleesklierkankerpatiënten Voor OPS leden hebben we de directe adresgegevens van dr. Gonzalez beschikbaar. Zie onder actueel rapport alvleesklierkanker

Pancreatic Enzyme Extract Improves Survival in Murine Pancreatic Cancer
Saruc M, Standop S, Standop J, Nozawa F, Itami A, Pandey KK, Batra SK, Gonzalez NJ, Guesry P, Pour PM

Objectives:
The disappointing current therapeutic approaches for pancreatic cancer (PC) represent an urgent need for the development of novel methods to control the disease. Based on a recent report on the effectiveness of pancreatic enzyme therapy, we examined the effect of porcine pancreatic enzyme extracts (PPE) on human PC xenografts in nude mice.

Methods:
The malignant human PC cell line AsPC1 was transplanted into the pancreas of male beige XID nude mice that were treated or not with PPE in drinking water. The survival, size, and volume of tumors, plasma pancreatic enzyme levels, fecal fat, and urine were examined as were the expression of transforming growth factor alpha, insulinlike growth factor-I, epidermal growth factor, epidermal growth factor receptor, apoptosis, and proliferation rate of tumor cells.

Results:
PPE-treated mice survived significantly longer than the control group (P < 0.002). Tumors in the PPE-treated group were significantly smaller than in the control group. All mice in the control group showed steatorrhea, hyperglucosuria, hyperbilirubinuria, and ketonuria at early stages of tumor growth, whereas only a few in the treated group showed some of these abnormalities at the final stage. There were no differences in the expression of growth factors, epidermal growth factor receptor, or the apoptotic rate between the tumors of treated and control mice.

Conclusions:
The treatment with PPE significantly prolongs the survival of mice with human PC xenografts and slows the tumor growth. The data indicate that the beneficial effect of PPE on survival is primarily related to the nutritional advantage of the treated mice.

Pancreas, 28(4):401-412, May 2004.