Gonzalez, Beard and crimes against the sick at Columbia University

Ralph Moss PhD is a brilliant researcher in the cancer alternatives dispute (and beyond into many other issues). I do encourage you to subscribe to his newsletter, which you can do here.

Here is an abridged version of a recent newsletter, laying out what happened in the famous Gonzalez study (actually the William D. Kelley study, see Kelley Program).

Many readers have asked what happened to the National Institutes of Health-sponsored clinical trial of the Gonzalez regimen, the one that used orally administered enzymes for the treatment of pancreatic cancer?

In the 1980s, Nicholas Gonzalez, MD, was a disciple of Robert A. Good, MD, PhD, director of Sloan-Kettering Institute, New York. With Good's encouragement, he began a project (while still a Cornell medical student) to evaluate the enzyme treatment of cancer promoted by William Donald Kelley, DDS, of Grapevine, Texas.

Gonzalez felt this treatment was beneficial and eventually opened an office in Manhattan to treat patients using this protocol. He presented 25 of his best cases to the NCI's Division of Cancer Treatment (DCT) in July 1993. The pilot study was published in 1999 in the journal Nutrition and Cancer (Gonzalez 1999). Because of the positive findings of this pilot study, first the National Cancer Institute and then the National Center for Complementary and Alternative Medicine (NCCAM) proposed a formal clinical trial of the method.

The National Institutes of Health (NIH) awarded a grant of $1.4 million to Dr. Gonzalez. Alas, this clinical trial ran into trouble almost as soon as it was launched in March 1999. The trial was originally designed to randomize 90 pancreatic cancer patients to receive either gemcitabine (Gemzar) chemotherapy or a large daily dose of orally administered pancreatic enzymes. But the key word was 'randomize' – patients were to be randomly assigned to one or the other group by the computer equivalent of a coin toss. However, most people who were attracted to this trial wanted the enzyme therapy, and not a 50-50 chance of getting chemotherapy! So in the end only three eligible patients agreed to be randomized in this fashion.

So the design changed to a single-armed, non-randomized case-cohort study where patients will only be enrolled in what was the nutritional arm. In fact, the 'de-randomization' of the trial was a major blow to its credibility.

The  FDA clearly that it would not accept the results of any trial that was not fully randomized. Yet the NIH urged the changes anyway.
But controversy didn’t stop there. Dr. Gonzalez claimed that after Columbia was chosen as the site of the trial, "the money went into their bank account, all of it, never to be seen again" (personal communication, June 19, 2008).

Because of the radically different interpretations being put forward about the trial, Dr. Gonzalez submitted the dispute for adjudication to the Office for Human Research Protection (OHRP), a branch of the Department of Health and Human Services. On February 25, 2008 OHRP sent a letter to Steven Shea, MD, Vice President and Dean of the Columbia Center, which is now available online.

This letter from the OHRP confirms some of Dr. Gonzalez's accusations concerning the conduct of this failed trial. The most surprising government finding was as follows: "We note that Columbia University Medical Center (CUMC) found that for 40 of 62 subjects it appeared that informed consent was not documented with a signed written consent form prior to the initiation of research activities involving human subjects." Read that over-nearly two-thirds of the participants were not even properly informed of the risks and benefits of participation in the trial!

Dr. Gonzalez alleges much more widespread malfeasance on the part of his erstwhile academic collaborators. Given the fact that two-thirds of the subjects did not give proper informed consent - responsibility for which rested entirely with Dr. Chabot and Columbia - one wonders exactly what prospective patients were told about the relative merits of the two arms of the trial.

At least one Congressman, Dan Burton (R-IN), has taken an interest in the failure of this once-promising trial. It is certainly time for a full-scale Congressional investigation of this failure - of what exactly went wrong and, in the broader sense, whether the public is getting the truth about the potential benefits of alternative treatments for cancer.

NOTE: The formal title of the trial was "A Phase III Study of Gemcitabine Compared With Pancreatic Enzyme Therapy Plus Specialized Diet (Gonzalez Regimen) in Treating Patients Who Have Stage II, Stage III or Stage IV Pancreatic Cancer." The principal investigator was the aforementioned Dr. Chabot. The project number was P30-CA13696.

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