August 28, 2012
A new book explains how the system trashed the groundbreaking NIH/National Cancer Institute clinical trial on this extremely promising therapy.
Integrative medicine pioneer Nicholas J. Gonzalez, MD, has been researching nutritional approaches to cancer since 1991. With his colleague, Dr. Linda Isaacs, they offer a profoundly individualized treatment program for patients with all kinds of cancer, as well as patients with a variety of other problems. All of their treatment protocols include diet, supplements, and detoxification.
In 1998 the National Cancer Institute approved funding for a large-scale clinical study in which this nutritional enzyme therapy for the treatment of patients diagnosed with inoperable pancreatic cancer—a treatment initially proposed in 1906—would be compared to the best available chemotherapy. Drs. Gonzalez and Isaacs’ initial enthusiasm turned to disappointment as they discovered that conventional medicine is still overwhelmingly biased against any treatment methods developed outside the mainstream, and that scientists and physicians at the highest levels of academia would do anything—even change the truth—to prove that 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 twenty-eight years of hard, determined research.
As Dr. Gonzalez reveals in his book What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer, poor trial design, poor implementation at the highest levels of the research, and improper supervision in the trial itself completely derailed the study.
The book also calls into question the validity of double-blind placebo studies as the gold standard of mainstream medicine. Dr. Gonzalez delves into biases of scientific health community that make the fair testing of unconventional treatments so difficult.
Gonzales graduated from Brown University, Phi Beta Kappa, magna cum laude, then pursued pre-med studies at Columbia before getting his medical degree from Cornell. During a postgraduate immunology fellowship under Dr. Robert A. Good, considered the father of modern immunology, he completed a research study evaluating an aggressive nutritional intervention in the treatment of advanced cancers, eventually focusing mainly on pancreatic enzymes.
During the NCI/NCCAM clinical trial at Columbia, Drs. Gonzalez and Isaacs repeatedly pointed out flaws in the study design, but their objections were ignored. Some of the problems in the clinical trial:
- The question of randomization. Conventional medicine believes that randomization is essential when selecting study participants. However, this doesn’t work for alternative medicine—“such a design most likely would create rather than prevent bias,” says Dr. Gonzalez in his book. With a strict nutritional regimen, compliance on the part of the patient is essential. It requires discipline and usually a preexisting interest in alternative medicine. Therefore selecting study participants requires some sort of screening—the opposite of randomization. In general, patients with an interest in following a strict nutritional regimen to treat their cancer are likely to quit the study once they realize that they have a 50% chance of being in the chemotherapy group rather than the alternative treatment group. By the same token, patients who prefer chemo are likely to quit when they realize that there is a 50% likelihood that they will be placed in the nutritional treatment group instead.
- The lack of a “lead-in.” A two-week lead-in (at minimum) is necessary to fully vet the patients in the nutritional regimen study group to make sure they follow the program. The chief investigators refused to allow for a lead-in period.
- Improper screening of study candidates. Contrary to the initial agreement, Drs. Gonzales and Isaacs were excluded from participating in the selection of study subjects. As a result, as many as 39 patients followed the nutritional regimen only for brief periods or did so inconsistently—with some not following the protocols at all—making the data meaningless.
- Sabotage attempts. Because of the controversial nature of nutritional therapy for cancer, many members of the oncology community were vocal in their opposition to the project and deliberately tried to undermine it.
- Delays. “Over the years, since my fellowship days…I have observed that when the NCI want to get a study done, it gets done….Our study proceeded along a completely different pathway….In our case, the [process] hardly ran expeditiously….Not a single delay involved some deficiency or non-compliance on our part.”
Without Dr. Gonzalez’s knowledge, a misleading article was published about the findings from the clinical trial. Despite his best efforts in dealing with NCI, NCAAM, the Office for Human Research Protections (OHRP), and the Office of Research Integrity, none of the parties responsible for mismanaging the clinical trail or disseminating the misleading information were held accountable. Even an FDA investigation and pressure from Congress was not enough to correct the situation.
Dr. Gonzalez’s experience is a testament to the failure of mainstream medicine. As noted in the foreword of his book, the “war on cancer” has been a failure due to a combination of politics, money, greed, and corruption—largely the result of an unholy alliance between the American Cancer Society, NCI, Sloan-Kettering, and the drug companies.
With such a powerful—and powerfully biased—medical system, all clinical trials of unconventional treatments are destined to fail. “This particular model of medicine—and it is just that, a model—lauds synthetic and high-tech creations as it relegates diet, food and nutrition to a very minor rule in any consideration of human health and disease,” says Dr. Gonzalez. “This cosmology dominates academic medical thinking, and certainly dominates all teaching in medical schools.”
Dr. Gonzalez’s book, What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer, is available from New Spring Press.