What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer

A review of Dr. Nicholas Gonzalez's recent book

By Greg Nigh, ND, LAc

Printer Friendly PagePrinter Friendly Page

A rigorously and meticulously documented crime shares with an autopsy at least two qualities. The first is that the important story is revealed in the details. The second is that, if it carries on for too long, the subject runs the risk of becoming somewhat stale.
 
With that in mind, Nicholas Gonzalez, MD, has done us a great service in writing his recent book What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer (New Spring Press, 2010). The book serves a dual function. First, it is a detailed account of a tragic chapter in the historic assault on nonconventional therapies by the scientific establishment. Second, the book is an invaluable, step-by-step manual for anyone assigned the arduous task of conducting a fraudulent, pseudoscientific clinical study in order to discredit a valuable and highly promising nonconventional therapy.
 
A brief history will have to suffice. Gonzalez is the New York physician whose name is now almost synonymous with the use of high-dose enzymes in the treatment of cancer. He would, I suspect, ask that I refer to his program as a nutrition protocol, not simply an enzyme protocol, because an individualized diet is an essential component to each treatment program. While that may be more accurate, it is the enzymes that have come to define his work for the interested public. 
He came to the therapy after his review of nearly 500 advanced cancer patients who achieved long-term survival utilizing the enzyme therapy developed by William Kelley, DDS. Modifying Kelley’s protocol and taking it into practice, Gonzalez and his colleague Linda Isaacs, MD, began accruing their own large and growing set of long-term survivors, many diagnosed with the worst of the worst: adenocarcinoma of the pancreas. 
 
Largely due to his conventional training, Gonzalez had connections to physicians and scientists who took an interest in his results and encouraged him to pursue a clinical trial. And, as fate would have it, the National Institutes of Health (NIH) had recently established a division devoted to the study of alternative therapies, the National Center for Complementary and Alternative Medicine (NCCAM). Even better, the National Cancer Institute (NCI) took an interest and agreed to come aboard to implement the study. It seemed like a perfect storm. 
And storm it was. The first 47 pages of What Went Wrong document the problems with the study’s execution in an itemized, extended summary format. And the problems are legion:
  • Improper study design
  • Endless—and entirely preventable—delays
  • Inefficient and improper screening of study candidates by Columbia Medical School (the institution affiliated with the study)
  • Failure to abide by standard clinical trial protocols
  • Failure to reimburse Gonzalez and Isaacs in a timely manner for their personal expenses related to the study (which totaled more than $20,000)
  • Failure to obtain informed consent from several study participants (against federal law)
  • Recruitment of patients unqualified for the study
  • Change in the chemotherapy treatment protocol during the course of the study
And so on. In the end, the book makes it clear that nothing, in reality, got studied. Nevertheless, those who did the botching heaped insult upon injury by publishing a paper on it. The paper concluded that enzymes were ineffective, while a triple chemo combo was of significant value in the treatment of pancreatic cancer. No one should be shocked to learn that the study’s director, against explicit guidelines prohibiting it, had a vested interest in the success of the experimental triple chemo combo. The published paper is now regularly cited as evidence that enzyme therapy is ineffective against pancreatic cancer. 
 
Mission accomplished.
 
If this were the end of the story, we would all have good reason to be both sad and angry. But it is in the 524 pages that follow the summary where the story becomes both infuriating and, well, tedious. In true journalistic style it is a tell-all extravaganza, where internal emails are revealed, names are named, and lies are exposed. In these pages the institutions we believe might be on our side are revealed as trojan horses. The NCCAM, for example, was, at least at the time of this debacle, clearly dedicated to not studying the efficacy of this alternative therapy. That deck had been stacked. 
 
When it finally came to an official accusation of fraud based upon the multiple failings of implementation, Gonzalez filed a formal complaint with the Office for Human Research Protections (OHRP). But that deck was stacked, too. It’s yet another set of revolving doors between NIH and NCCAM and OHRP. Gonzalez reveals, through emails and other documents and even background research of his own, that all these agencies worked with a common goal, personnel seemingly hand-picked for the job: to discredit enzyme therapy and do it under the auspices of a legitimate clinical trial.
 
And after 300 or so pages of details, this autopsy becomes a bit stale. The attention to detail, which is where the story really gets told, also requires a reader as equally committed to understanding those details. Gonzalez’s line-by-line responses to the various lies in meeting minutes and emails, his cataloguing of unreturned phone calls and unpaid expenses, his itemized unanswered questions and unresponded-to documentation of misconduct—this meticulousness runs the risk of bringing a fatigued glaze over the reader’s eyes.  
The attention to detail, which is where the story really gets told, also requires a reader as equally committed to understanding those details.
 
 
The fatigue is no fault of Dr. Gonzalez. He simply documented a complex and sordid event, and did it at a level of detail necessary to expose the various lies, incompetencies, and distortions for what they were. As the pages roll on, though, it seems that it was written more “for the record,” perhaps as fodder for future medical anthropology students writing future theses on the curious and self-defeating institutional resistance that once existed toward obviously effective cancer therapies.
 
A majority of readers of this book will likely get what they came for within the first 50 pages. And the message those pages convey is tantamount: Enzyme therapy is highly promising in the treatment of (at least) pancreatic cancer, and the study of that therapy by Columbia Medical School was riddled with errors. It will take a bit more reading to discover the deceits and distortions surrounding the resulting paper published in the Journal of Clinical Oncology. The bulk of the book, though, is for those seeking a deeper understanding of the true nature of the conventional medical beast.
 
I highly recommend What Went Wrong. Tedious though it can be, Gonzalez's book shows us the deeply rooted institutional backlash that infuses the study of an effective, individualized, nonconventional therapy—the type that naturopathic physicians and other holistically minded healthcare practitioners implement every day as a matter of course. His experience is a shot across the bow of all nonconventional practitioners who strive to see their methods authentically evaluated and validated. It is a contemporary history that we would all be wise to study.

About the Author

Greg Nigh, ND, LAc, is a 2001 graduate of the National College of Natural Medicine. He is currently practicing at Nature Cures Clinic in downtown Portland, Ore., where he specializes in naturopathic oncology.