Individualized Nutritional Protocols

Journal of Clinical Oncology Article Rebuttal

In August 2009, to our astonishment we learned that the Journal of Clinical Oncology, considered to be one of the pre-eminent oncology journals in the country, published an article about our NCI-NIH clinical study which claimed that chemotherapy worked better than our treatment with patients diagnosed with inoperable pancreatic cancer.

Though I originally earned the grant from the NCI in 1998, though I was an investigator on this study throughout its existence, and though the clinical trial was set up to compare the efficacy of my treatment with chemotherapy, no one involved with the publication – not the Principal Investigator, Dr. John Chabot of Columbia Presbyterian Medical Center, nor any of his associates, informed me of their intent to publish this article, nor had I seen it. I learned of it serendipitously when the online version appeared on PubMed.

I believe the article to be deliberately misleading in many regards, seeking to discredit me and salvage the reputations of those involved in supervising the study in the face of devastating findings of mismanagement on their part determined after official government investigations instigated at my request. In their official determination letter appearing on their website after a two-year investigation, 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. Furthermore, the determination letter states that the Principal Investigator (Dr. Chabot) admitted he committed the managerial lapses, and in their letter the OHRP requires Columbia set up a program for training in appropriate research methodology – a serious indictment of a major academic medical center.

To my astonishment, the JCO article nowhere mentions the findings of the OHRP, as if this lengthy investigation never existed, leaving the reader with the impression this study was properly managed by Dr. Chabot. In that regard, the article is a gross misrepresentation of what actually transpired during the study’s sad eight year history.

Furthermore, Dr. Chabot's JCO article also completely ignores a letter 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, written as the official spokesperson for the NIH, Dr. Engel concurs, stating that:

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.

Later, she writes:

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.

More recently, Congressman Dan Burton of Indiana and I have requested that the Inspector General of the Department of Health and Human Services begin an investigation to determine if the supervisors of the study committed fraud in the mishandling of the project and its data. 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.

Ironically, with no knowledge of the pending JCO article, I had only recently completed a lengthy book detailing the problems with the study and the gross mismanagement committed by the so-called conventional academic researchers assigned to run the project, and the attempts of myself and my colleague Dr. Isaacs to abide by the tenets of appropriate scientific investigation. It makes a good story of deceit, collusion, and disregard for patient safety that reaches right into the highest levels of the academic medical community

Below I include a number of documents, several extracted from the book itself, that summarize the study’s history, and its various well-documented problems.

An article entitled "Some Thoughts about Scientific Bias," also extracted from my upcoming book, discusses at length two examples of fraud perpetuated at the highest levels of the academic research community; the promotion of bone marrow transplantation as a treatment for breast cancer, and the HIV-nevirapine clinical trial in Africa. These examples illustrate that conventional scientists will often stop at nothing to promote their cherished theories, and without hesitation will ruthlessly attack those who insist on speaking the truth.

Copyright © Nicholas J. Gonzalez, M.D.
All Rights Reserved

Nicholas J. Gonzalez, MD PC
Linda L. Isaacs, MD
36A East 36th Street
Suite 204
New York, N.Y. 10016
Phone: 212-213-3337
Fax: 212-213-3414
E-mail policy

Last Modified: