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What Went Wrong: A Review by Howard Straus

What Went WrongWhat Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer, by Nicholas Gonzalez, M.D., 583 pp., New Spring Press, 2012.

Reviewed by Howard D. Straus of the Gerson Institute, reprinted with the permission of the author and The Townsend Letter for Doctors and Patients, published there December 2012.

Dr. Nicholas Gonzalez, a regular contributor to TLDP, has written a book chronicling the ins and outs of the much-awaited NCI/NCCAM clinical trial of his holistic, enzyme- and nutrition-based treatment for pancreatic cancer. Many of us in the alternative medicine world had waited for years with bated breath for the results, which ended up disappointing at best. Now, we can find out What Went Wrong.

Though the trial began with the major parties in general agreement that significant preliminary results warranted a full-scale, federally funded, controlled trial, the implementation left much to be desired from the very beginning. The difficult start was exacerbated over the first couple of years of the study when the administrators who were originally positive or enthusiastic about the trial moved on to other positions in government or private foundations, and were replaced by officials who were either neutral or openly hostile to the protocol being tested.

Dr. Gonzalez and his partner, Dr. Linda Isaacs, found themselves constantly battling their “colleagues” on the trial’s steering committee on points of enrollment, a key parameter when the treatment to be tested depends on the cooperation and support of family and local physicians. In addition, a ludicrously inappropriate provision (one of many) was added over Gonzalez’ vigorous objections. If a patient who was enrolled in the study, appropriately or not, and sent by the chief investigator to the “nutritional” arm of the trial, in other words, to Dr. Gonzalez for treatment, failed for any reason, the patient was considered a “Gonzalez failure,” because of his “intent to treat.” This ridiculous provision was enforced rigorously, as opposed to the rules that might have benefited the nutrition arm of the trial. Time and again, patients were enrolled inappropriately and excessively late to the study (a virtual death sentence for an advanced pancreatic cancer patient), making it impossible for them to ever take a single treatment, yet these were considered “Gonzalez failures.” This provision clearly has far more to do with politics than with a dispassionate and honest test of a medical procedure. There is no parallel in any other science for this kind of nonsense. (Imagine a breaking strength test on a steel beam, except that the beam was not properly delivered to the testing facility. The result would never be recorded as “beam failed.”)

Lest the reader think that was the only, or even the worst roadblock, there were many more, and more serious breaches of scientific protocol by the chief investigator, Dr. John Chabot of Columbia University, some rising to the level of federal crimes. Dr. Gonzalez has documented these breaches in his book in painful detail, dispassionately and exhaustively, quoting directly from official correspondence with government regulatory agencies, investigators, even congressmen and other government officials, asking them to enforce, even obey, their own rules and laws. None of these pleas for fairness, or even enforcement of the regulations concerning research integrity or trial participant safety, were heeded.

There is no doubt about the complaints. In many cases, the violations were admitted to in writing by the very agencies responsible for enforcing the rules and regulations. Still, there were no enforcement actions, no sanctions against the violators, no adverse consequences, and the infractions continued unabated, unpunished. The Office of Research Integrity (ORI), charged with guaranteeing the integrity of scientific research funded by the federal government, failed to take any substantive action despite the thoroughly documented lack of integrity by the principal investigator. The Office for Human Research Protections (OHRP), whose task it is to ensure the subjects of human trials funded by the federal government are treated with maximum safety consistent with the experiment, failed repeatedly to protect the patients so callously treated by the Columbia team. When the violations of the patients’ safety and survival were documented, the OHRP left it to the University to investigate itself! Of course, nothing came of that, either.

Probably the most egregious failure of the entire trial, and the one that explains much of the blatant bias in the way the trial was conducted, was appointing Dr. John Chabot as principal investigator of this trial. Despite his complete ignorance of any aspect of the treatment being tested, Dr. Chabot was charged with scientifically comparing a complex nutritional and enzyme therapy for advanced pancreatic cancer against a novel chemotherapeutic regime as a control. But Dr. Chabot was one of the main developers of the very protocol against which the nutritional therapy was being tested, a fact that was never brought to the attention of Drs. Gonzalez and Isaacs, and only came to light some years into the trial. None of the federal or university organizations seemed to have any problem with this most blatant conflict of interest, a fact that alone should have disqualified him as the principal investigator. None of the agencies that were supposed to protect patients seemed to care that advanced, pancreatic cancer patients were left untreated for weeks, a period of time that anyone familiar with the rapid progression of the disease knows, like Dr. Chabot does, would lose the “window of opportunity” for treatment, and condemn the patient to a painful and hopeless death. In the majority of the cases assigned to the nutrition arm by Dr. Chabot, patients were kept waiting for weeks beyond their availability for treatment, untreated by any means. No explanation was offered for the unreasonable and unconscionable delays.

This book offers copious extracts from years of correspondence and patient records, and should be a warning to any alternative practitioner, or any physician who goes against the immensely profitable pharmaceutical paradigm, that they will not be treated well, they will not even be treated fairly by government or by their colleagues, whether the actions of the establishment are ethical or even legal. But even more chilling is the callous and cynical disregard with which the desperate pancreatic cancer patients were casually tossed under the bus for the agendas and egos of the investigators. These patients, who had faith that the medical profession was trying to cure their cancer, or at least do ethical research, were abandoned to their disease so the allopathic physicians could prove a point, sabotage a competitive treatment, or destroy a reputation. They were left hanging by their government, by the medical establishment, by the research organizations set up to protect them. It should give pause to any patient hoping for anomalous results from a clinical trial, as the documentation shows they were simply being used as expendable ammunition, rather than being treated with the honesty, human dignity and care expected from physicians. I would never advise anyone to submit to such organizational and official abuse.

Oh, and incidentally, despite the systematic, long-term and thorough sabotage of the nutritional treatment (it is tempting to call it “Chabotage”), deeply buried in the final report is the noteworthy result that the two longest surviving patients in the clinical trial were enrolled in the nutritional arm, treated by Drs. Gonzalez and Isaacs. Neither Gonzalez nor Isaacs was given the “guaranteed” opportunity to contribute to the final report.

If I have any criticism of this book, it is that the complaints eventually became somewhat repetitive. I can understand why, since they were submitted to a whole alphabet soup of government regulatory agencies over the course of nearly ten years, and had to be repeated and documented in detail each time. My criticism does not have to do with a lack of careful and thorough documentation; but with a surfeit. Still, skipping repetitive areas is preferable to lacking the proof one might need. It is the reviewer’s hope that some federal agency could use this very thoroughly documented book to prefer charges against physicians and administrators who violated the law, and/or tortured trusting patients to death, if only to ensure that they don’t continue to do it, and that others conducting such highly manipulated “trials” might have a second thought about the consequences.

What Went Wrong is a cautionary tale for alternative practitioners, for desperate patients and their families. It is painfully obvious that many agencies in and out of our government do not want a cure, much less a prevention, for the immensely profitable disease of cancer, and they are willing to sacrifice anyone they need to make sure no cure is discovered.

For more on this, listen to Howard Straus radio interview with Dr. Gonzalez.