The Battle for a Fair Evaluation of the Gonzalez Therapy
For Immediate Release
In his highly anticipated new book, What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer, Dr. Nicholas J. Gonzalez sets the record straight over the serious mismanagement of the National Cancer Institute-NIH study set up to test his nutritional treatment method in patients diagnosed with pancreatic cancer.
When the National Cancer Institute first approved funding for the project in 1998, Dr. Gonzalez and his supporters hoped that this effort would be a landmark study finally bringing together conventional researchers and more alternative practitioners, for the benefit of science and of patients.Â But from its onset, many serious problems affected the project.Â The study design chosen by the academics in charge discouraged patient accrual, and nearly derailed the trial for good.Â Then, to avoid an alleged “bias,” the National Cancer Institute insisted Dr. Gonzalez be removed from any involvement with the approval of prospective study candidates, leaving all such decisions in the hands of the Principal Investigator (PI) at Columbia University, the actual site for the project. Unfortunately after assuming sole arbitrary control over patient selection, the PI repeatedly accepted patients for treatment with the Gonzalez regimen who did not meet the explicit entry criteria, and who were far too sick, or too unmotivated, to follow the self-administered nutritional treatment.Â After the study closed, Dr, Gonzalez began investigating the PI who as it turned out helped develop the chemotherapy regimen used in the project as the “control” treatment to the nutritional regimen.Â With such an obvious conflict of interest, the PI should never have been delegated any managerial responsibility.
As a result of Dr. Gonzalez’s concerns about the study’s mismanagement, the Office of Human Research Protections, a government oversight group, investigated the study and reported that 42 out of a total 62 patients had been improperly admitted by the Columbia PI. A follow-up evaluation by the Food and Drug Administration confirmed Dr. Gonzalez’s allegations that the PI did not follow the predetermined protocol, did not conduct consent properly, and did not keep complete or accurate records.
Despite the evident problems and the findings by two government agencies, the Columbia team succeeded in publishing an article in the Journal of Clinical Oncology implying the study was properly run, patients were appropriately admitted, and that the nutritional therapy had no effect.
Dr. Gonzalez, a former journalist, has written What Went Wrong to bring the truth of this project to light, and show how bias, indifference, and at times incompetence undermined a promising research effort that, if properly run, might have ushered in a new direction in cancer treatment.
Nicholas J. Gonzalez, M.D., graduated from Brown University, Phi Beta Kappa, magna cum laude with a degree in English Literature. He worked as a journalist, first at Time Inc., before pursuing premedical studies at Columbia University. He received his medical degree from Cornell University Medical College in 1983. During a postgraduate immunology fellowship under Dr. Robert A. Good, considered the father of modern immunology, Dr. Gonzalez investigated the nutritional cancer treatment developed by the dentist Dr. William Donald Kelley. Dr. Gonzalez’s subsequent research has been funded by The Procter & Gamble Company and NestlÃ©. Since 1987, Dr. Gonzalez has been in private practice in New York City, treating cancer and other degenerative diseases with an enzyme-based nutritional regimen. He is in the process of publishing a series of books, of which What Went Wrong is the third. For more information on his practice or his books, see his website at www.dr-gonzalez.com.
What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer by Nicholas J. Gonzalez, M.D. Original edition. 7 x 10, 600 pages with references. ISBN 978-0-9821965-3-3. $39.95. Available from Amazon.com and at www.newspringpress.com. Available to libraries from Quality Books, Inc.
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