Life Extension Magazine July 2014
Restoring The Human Body With Dr. Sergey Dzugan
By Nicholas Gonzalez, MD
As a long-time and avid follower of Life Extension Magazine®, I realize its knowledgeable readers won’t be surprised to hear of another example of academic bias toward a promising “alternative” cancer therapy that doesn’t fit the prevailing medical model. But I am in a unique position to write about this subject because my colleague Linda Isaacs, MD, and I battled for eight years against the entrenched interests of the National Cancer Institute (NCI), the National Institutes of Health (NIH), and unfortunately, even the National Center for Complementary Medicine (NCCAM) to have our nutritional approach to cancer fairly tested in a controlled clinical study. In my latest book What Went Wrong, I document how bias, indifference, and incompetence at the highest levels of the academic medical world nearly allowed our promising therapy to be discredited.1
To sum up our therapy, we offer an aggressive nutritional approach for the treatment of cancer and other degenerative diseases. Our program involves three basic components: individualized diet, individualized supplement programs with large doses of specially formulated pancreatic enzymes for cancer patients, and detoxification routines such as coffee enemas—which, despite the controversy, come right out of the traditional medical literature.2-4
We base our therapy on the work of the controversial alternative practitioner William Donald Kelley, DDS, who during the 1960s developed his enzyme-based nutritional approach to cancer. My book One Man Alone details my formal five-year investigation of Dr. Kelley’s work, begun in 1981, and includes 50 case reports of patients who experienced long-term survival (and in many cases complete tumor regression) while under Kelley’s care.5 For example, one patient had been diagnosed at surgery in August 1982 with stage IV adenocarcinoma of the pancreas with a liver biopsy confirming metastatic cancer, all later confirmed at the Mayo Clinic. This patient is alive and well today, some 31 years from her original diagnosis, far exceeding the typical three- to six-month survival expectancy reported for the disease.
Despite such findings, in the mid-1980s I was unable to get support for further research. Kelley, in great frustration (and not a little anger) closed his office down. In 1987, intending to keep Kelley’s therapy available for those who wanted it, Dr. Isaacs and I opened a practice in New York, and from the beginning we witnessed the same type of successes I had uncovered in Kelley’s files. For example, just recently I saw for routine follow-up a patient who started with me in early December 1987. Initially diagnosed with inflammatory breast cancer with 17/17 positive nodes, she had developed skeletal metastases while on aggressive multi-agent chemotherapy. She decided to try our approach and today, more than 25 years later, she is alive and well, her disease having long ago completely regressed.
In 1993, after presenting a series of case reports at the National Cancer Institute, the then-Associate Director, Dr. Michael Friedman, suggested Dr. Isaacs and I proceed with a phase II pilot study, evaluating our therapy in patients diagnosed with advanced pancreatic cancer. We eventually published the findings of this effort in 1999, in the peer-reviewed research journal Nutrition and Cancer, describing, to our knowledge, the most positive data for the treatment of inoperable pancreatic cancer in the history of medicine.6
Even before this article appeared, in 1998, based on the preliminary data, the then- National Cancer Institute Director, Dr. Richard Klausner, approved funding for a large-scale controlled Phase III study, in which my therapy would be compared to the best available chemotherapy in the treatment of patients diagnosed with inoperable pancreatic cancer. The trial was to be supervised by the NCI and run out of Columbia University in New York City.
Initially, we had great hope that the study would be a fair, honest, and comprehensive evaluation of our treatment, as well as an opportunity to bridge the gap between conventional and alternative medicine. But from the beginning, problems plagued the study. The initial randomized design of the trial alienated potentially suitable study candidates who feared they would be told to get chemotherapy. Dr. Isaacs and I had no say on patient entry, many approved patients did not meet the entry criteria, and most patients sent to us for treatment could not or would not follow the protocol. And, many patients were kept waiting weeks as their disease progressed, before a decision about their eligibility was rendered at Columbia. The problems with the study’s management were so pervasive that after a particularly contentious meeting and exchange of letters, Dr. Linda W. Engel, the Program Officer at NCCAM in charge of overseeing the project grant, wrote in her official capacity:
There have been numerous and very difficult scientific, operational, and procedural challenges in carrying out this trial. These have been well documented and frequently discussed…
We discussed at considerable length his [my] concerns about the probable accrual of patients unable to comply fully with the nutrition arm of the protocol. It was our impression that everyone in the room basically agreed that, despite best efforts, there is in fact, reason to be concerned about this issue, and that it clouds interpretation of the data…7
Said differently… many of the enrolled patients who were supposed to follow my protocol did not follow my protocol.
Despite these admitted shortcomings, the researchers at Columbia eventually terminated the trial, stating that the data demonstrated the superiority of the chemotherapy regimen used—which we later discovered had been developed by a group at Columbia that included the Principal Investigator of our trial, a clear conflict of interest.8-11
Principal Investigators on a clinical trial are chosen to be the ultimate managers and referees of the study, and to be fair and objective, should have no tie intellectually or financially to any treatment under evaluation.
The Principal Investigator of our clinical trial, as we were to learn, worked closely with the Columbia research team developing the very chemotherapy regimen being used as a counter to our treatment. This relationship should have disqualified him from serving such an important role.
This connection had never been declared to us...we had to discover on our own. As the study drew to a close, my colleague Dr. Isaacs and I became increasingly concerned that the Principal Investigator seemed far too enthusiastic about the chemotherapy regimen. We began searching the peer-reviewed literature and discovered multiple articles directly linking him to the chemotherapy researchers, and specific treatment, used in our trial.
We also discovered he had failed to obtain proper informed consent for many patients, a basic requirement for any legitimate clinical study.12 Two federal agencies, the Office of Human Research Protections and the Food and Drug Administration, largely as a result of our complaints, have investigated the trial and reported serious mismanagement by the Columbia team. Because of these investigations, an article written by the Columbia group about the study—without, I might add, our knowledge—was rejected by the Journal of the American Medical Association. Nonetheless, they were able to get the paper into the Journal of Clinical Oncology,13 a journal previously distinguished by its publication of a fraudulent article supporting bone marrow transplantation for breast cancer.14
In my book, What Went Wrong, I describe in detail the study’s development beginning in 1997, our initial hope for a fair and honorable study, its gradual deterioration, and our dogged fight to keep our promising therapy from being tarnished by a poorly conceived, poorly executed clinical trial. Our experiences provide yet another cautionary tale of bias and indifference toward a therapy that doesn’t fit the academic model, coupled with mismanagement and incompetence at the highest levels of the conventional medical world. For anyone wishing to learn what it’s like to battle the powers that be, this book will be an eye-opener.
Editor’s note: Compliance with Dr. Gonzalez’s program is challenging and the digestive problems encountered by pancreatic cancer patients can preclude them from being able to take the 200 pills a day that may be prescribed.
Those with pancreatic cancer are urged to review Life Extension’s pancreatic cancer protocol that involves a somewhat different treatment regimen. This can be accessed at www.lef.org/pancreatic
If you have any questions on the scientific content of this article, please call a Life Extension® Health Advisor at 1-866-864-3027. To order a copy of What Went Wrong, visit www.amazon.com.
- Gonzalez NJ. What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer. New York, NY: New Spring Press; 2012.
- Bedside procedures. In: Lyght CE, Keefer CS, Lukens FDW, Richards DW, Sebrell WH, Trapnell JM, eds. The Merck Manual of Diagnosis and Therapy. 11th ed. Rahway, NJ: Merck Sharp & Dohme Research Laboratories; 1966:1682-3.
- McClain ME. The patient’s needs: Enemas. Scientific Principles in Nursing. St. Louis, MO: The C.V. Mosby Company; 1950:168.
- Stajano C. The concentrated coffee enema in the therapeutics of shock. Uruguayan Med Surg Special Arch. 1941;29:1-27.
- Gonzalez NJ. One Man Alone; An Investigation of Nutrition, Cancer, and William Donald Kelley. New York, NY: New Spring Press; 2010.
- Gonzalez NJ, Isaacs LL. Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer. 1999;33:117-24.
- Available at: http://www.dr-gonzalez.com/engel_1_05.pdf. Accessed July 29, 2013.
- Allendorf JD, Lauerman M, Bill A et al. Neoadjuvant chemotherapy and radiation for patients with locally unresectable pancreatic adenocarcinoma: feasibility, efficacy, and survival. J Gastrointest Surg. 2008;12:91-100.
- Fine RL, Fogelman DR, Schreibman SM, et al. The gemcitabine, docetaxel, and capecitabine (GTX) regimen for metastatic pancreatic cancer: a retrospective analysis. Cancer Chemother Pharmacol. 2008;61:167-75.
- Fine RL, Moorer G, Sherman W, et al. Phase II trial of GTX chemotherapy in metastatic pancreatic cancer [abstract 4623]. J Clin Oncol. 2009;27(suppl):15s
- Fogelman DR, Chen J, Chabot JA et al. The evolution of adjuvant and neoadjuvant chemotherapy and radiation for advanced pancreatic cancer: from 5-fluorouracil to GTX. Surg Oncol Clin N Am. 2004;13:711-735.
- Available at: http://www.hhs.gov/ohrp/detrm_letrs/YR08/jun08a.pdf. Accessed July 29, 2013.
- Chabot JA, Tsai WY, Fine RL, et al.Pancreatic proteolytic enzyme therapy compared with gemcitabine-based chemotherapy for the treatment of pancreatic cancer. J Clin Oncol. 2010;28:2058-63.
- Rettig RR, Jacobson PD, Farquhar CM, Aubry WM. False Hope: Bone Marrow Transplantation For Breast Cancer. New York, NY: Oxford University Press; 2007.