The Truth about the NCI-NCCAM Clinical Study

By Nicholas J. Gonzalez, M.D.

Many of you are aware that in 1998, the NCI approved funding for a large scale clinical study, in which my nutritional-enzyme therapy would be compared to the best available chemotherapy in the treatment of patients diagnosed with inoperable pancreatic cancer. My colleague Dr. Linda Isaacs and I initially approached this project with enthusiasm, believing it to be a wonderful opportunity to bring the conventional academic world and alternative researchers, so often at odds, together for the benefit of science and for patients suffering terrible illness. But as the years passed we came to realize with some disappointment that there was no new dawn breaking, no new age of cooperation between the academic and alternative universes, that the same biases against treatment methods developed outside of the mainstream still reigned supreme, and that scientists and physicians at the highest levels of academia would do anything, even change the truth to prove an unconventional therapy has no value. Eventually, under the direction of the supervisors from Columbia (the site for the project), from the National Cancer Institute (NCI) and the National Center for Complementary and Alternative Medicine (NCCAM), the study degenerated into a morass of mismanagement, meaningless and manipulated data, the welfare of patients put at risk, and sadly, cover-up of the mismanagement right into the office of Dr. Elias Zerhouni, former NIH Director. Repeatedly now we’ve seen the meaningless data of a mismanaged study used in the effort to prove my treatment worthless, and undermine my 28 years of hard, determined research.

Journal of Clinical Oncology Article

In August 2009, I learned quite serendipitously that Dr. John Chabot, the Principal Investigator at Columbia, along with his Columbia cohorts had managed to publish an article in the Journal of Clinical Oncology that stated the study proved chemotherapy more effective than my treatment. But the truth is quite different from what the JCO article incorrectly claimed. As a start, the clinical trial illustrated only that a group of patients intensively treated with the triple agent chemotherapy regimen GTX (Gemzar, Taxotere and Xeloda), and provided the most aggressive high-tech supportive care available in the US, fared better than a group of largely untreated or minimally treated patients with advanced pancreatic cancer given little supportive care, who were dubbed Gonzalez or enzyme patients. In fact, the majority of patients Dr. Chabot, in charge of recruitment into the study, assigned to the nutrition arm actually failed to meet the entry criteria, and were far too sick physically, or not sufficiently committed, to comply with the prescribed regimen.

National Institutes of Health - letter by Dr. Linda Engel

Dr. Chabot's JCO article completely ignored the points raised in a letter by Dr. Linda Engel of the National Institutes of Health (NIH), dated January 27, 2005, written in response to my ongoing complaints that because Dr. Chabot had admitted so many patients into the nutrition arm of the trial who could not or did not comply, any comparison between the two groups was meaningless. In her letter (click here for the PDF file) written as the official spokesperson for the NIH, Dr. Engel stated:

In spite of everyone's best efforts, it appears as if the current design and implementation of the study may have resulted in accrual into the two study arms of patient populations that are not comparable. As a consequence, it is very difficult (if not impossible) to ascertain treatment effect with certainty. …

We discussed at considerable length his 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.

Office of Human Research Protections Findings

Furthermore, the article failed to mention that the Office of Human Research Protections (OHRP), an oversight group at the NIH, at our request conducted a two-year investigation of the study’s supervision by Dr. Chabot. The OHRP findings, click to view on their website, revealed that Dr. Chabot had admitted 42 out of 62 total patients improperly, including 40 who were not appropriately consented, a devastating finding of managerial failure. Appropriate informed consent is of course a basic tenet of any legitimate clinical exercise, yet Chabot failed even to mention the OHRP investigation or findings in his JCO article.

Though the grant was originally approved at the NCI solely because of my efforts, though the grant was awarded to study my treatment, though Dr. Isaacs and I were in charge of treating all nutrition patients and remained investigators throughout, I was unaware that the Columbia team was attempting publication in JCO.

US Food and Drug Administration (FDA) Investigation

After the JCO publication, the US Food and Drug Administration (FDA) completed an investigation of the study and vindicated my main allegations. On its website the FDA reported the Principal Investigator of the trial, Dr. John Chabot of Columbia, failed to perform informed consent properly, failed to follow the investigation plan, and kept inadequate and inaccurate records. All these indicate serious deviations from appropriate clinical trial management on the part of Dr. Chabot. The FDA findings can be found by clicking here and looking under the line Chabot, John A.

US Congressional Record: Congressman Dan Burton Statement

Congressman Dan Burton (R-IN), in his final words in the Congressional Record before retirement, criticized the management of the study and the failure of the NCI to appropriately investigate. Click here to read his full statement, which starts at the bottom of the middle column on the first page.

Excerpt: "I hope my colleagues in 2013 will continue to protect access therapies and products so that Americans can continue to make their own choices in health care and retain their health freedom. I also believe a hard look at the management of resources provided to these issues is overdue. For instance, the first ever head to head research study looking at an alternative cancer treatment for pancreatic cancer as compared to the mainstream therapy was an absolute management disaster. Ten years, millions of dollars, and several federal investigations validating violations of patient protections by the academic conventional cancer therapy principal investigator has been swept under the rug by the National Institutes of Health’s National Cancer Institute and the National Center for Complementary and Alternative Medicine. Too often, I hear that the studies that are funded, especially those on herbs are ‘‘designed to fail’’. After 20 years and more than a billion dollars, too little quality research on the therapies Americans are most interested has in has been conducted. When my colleague Senator TOM HARKIN gave the initial instruction to the National Institutes of Health to ‘‘investigate and validate’’ therapies being used around the world, we all envisioned an aggressive campaign to go into the field and look at what is working an report this to the American people. Former Congressman Berkley Bedell championed this issue after being successfully treated with alternative therapies for Lyme disease and Prostate Cancer. Much good has been accomplished, but better work can and should be done."

Methodological Flaws in the Chabot Trial

Colin A. Ross, MD published a paper entitled Methodological Flaws in the Chabot Trial of Pancreatic Enzymes for Cancer Therapy in ARC Journal of Cancer Science. Click here.

What Went Wrong

In Dr. Gonzalez's book What Went Wrong, he explores the various managerial failings and misrepresentations that made the study's data meaningless, and document how bias and mismanagement at the highest levels of the research community helped thwart a promising clinical trial. Dr. Isaacs also published this paper on Research Battles: Survival Tips From a Veteran.