The Gonzalez Trial – The Cost of Studying The Unlikely

 First, I just wanted to point out that I have added another example to the list of harm done by use of CAM. In this case, it’s a tragic story about a young women suffering needlessly yet unwilling to give up on useless therapy.

On a larger scale, but just as tragic and infuriating, the results are available for the NCCAM-funded study of the Gonzalez cancer therapy.* Dr. Kimball Atwood has written extensively about the therapy and the NCCAM trial (The Ethics of “CAM” Trials: Gonzo Part I, II, III, IV,V, VI, and VII). Despite a host of serious ethical concerns, which Dr. Atwood has detailed extensively, the government funded a study in which people were allowed to elect a CAM therapy with no scientific plausibility or standard chemotherapy for their pancreatic cancer. It should surprise no one that the outcome clearly shows the Gonzalez regime to be ineffective. People on conventional chemotherapy lived 3 times longer than those on CAM treatment (14 months vs 4.3 months), and contrary to the usual CAM propaganda about cancer therapy, those who elected the alternative regime had a significantly poorer quality of life for those 4 short months.

It is true that the conventional therapy for this disease does not offer great hope for people with this disease. And the patients who followed the Gonzalez treatment did so by their own choice (the trial was originally randomized, but most patients refused to accept random allocation to treatment groups). But as I’ve argued before, the understandable desperation of people in this situation does not justify giving them false hope for help from methods unlikely to be of any real benefit. And the irrational pursuit of such hope cost the people in the CAM arm of this study almost a year of life on average and a great deal of suffering. Of course, it is difficult to argue that people should not be permitted to choose irrational hope over bleak reality. but it seems obvious that doctors who encourage such a choice by promoting, or refusing to critique, such therapies are failing in their duty to their patients. And this study illustrates nicely how NCCAM is complicit in this by giving a patina of legitimacy to bogus treatments.

CAM proponents frequently argue that unless their methods have been thoroughly investigated by large, well-designed and well-conducted clinical trials, critics of them are not adhering to their own standards of evidence. Because some ideas which seemed implausible in the past turned out to actually be true, they argue that any attempt to focus our research efforts based on scientific plausibility is mistaken. Such an argument seems very effective in supporting the work of NCCAM and in getting a foothold for unlikely therapies in mainstream medicine, but it is riddled with weaknesses.

Firstly, it ignores the fact that most ideas which seem implausible at first really are wrong, and they fail when tested. The fact that there are exceptions, and that the availability bias makes them seem more representative than they really are, does not support investigating anything and everything regardless of its provenance or consistency with well-established scientific principles. The argument also would require our desperately limited resources for scientific research to be spent indiscriminately, especially on popular or catchy ideas rather than the more mundane concepts that have a solid foundation in basic science and pre-clinical research.

As this study shows, testing anything and everything also exposes test subjects to avoidable risk and suffering. Even in cases where there is little hope in mainstream, scientific therapy there is no reason to think the false hope CAM offers is the better choice. No CAM therapy which is implausible or mysterious in its principles, or outright contrary to what we understand about the universe, has demonstrated under rigorous clinical testing to be the miracle its proponents have claimed for it. Progress comes far more often from laborious and careful work building on what is known than from wild guesses by lone geniuses.

Lastly, the clinical testing of implausible CAM methods seems likely to be futile even when the results are as clear and stark as in this trial. One might hope that this study will dissuade people from pursuing the Gonzalez therapy, and even cause them to question the underlying marketing of CAM methods, which use anecdote and the limitations of scientific medicine to claim far more than they can really provide to sick people or animals. But the past does not suggest this will be true. Faith-based medicine ultimately does not rely on empirical validation, and its followers rarely accept any evidence that they are mistaken. The spinning of these trial results will likely begin shortly, and the proponents of the method will continue to offer it, and it’s false hope, to vulnerable cancer patients without a qualm.

 

*Pancreatic Proteolytic Enzyme Therapy Compared with Gemcitabbine-based Chemotherapy for the Treatment of Pancreatic Cancer

John A. Chabot, Wei-Yann Tsai, Robert L. Fine, Chunxia Chen, Carolyn K. Kumah, Karen A. Antman, and Victor R. Grann*

From the Herbert Irving Comprehensive Cancer Center, Department of Medicine and Surgery, College of Physicians and Surgeons; and Departments of Biostatistics, Epidemiology, and Health Policy and Management, Joseph L. Mailman School of Public Health, Columbia University, New York, NY; Boston University Medical Center, Boston, MA; and Department of Statistics, National Cheng-Kung University, Taiwan.

* To whom correspondence should be addressed. E-mail: vrg2@columbia.edu

Purpose: Conventional medicine has had little to offer patients with inoperable pancreatic adenocarcinoma; thus, many patients seek alternative treatments. The National Cancer Institute, in 1998, sponsored a randomized, phase III, controlled trial of proteolytic enzyme therapy versus chemotherapy. Because most eligible patients refused random assignment, the trial was changed in 2001 to a controlled, observational study.

Methods: All patients were seen by one of the investigators at Columbia University, and patients who received enzyme therapy were seen by the participating alternative practitioner. All met strict clinical criteria for eligibility. Of 55 patients who had inoperable pancreatic cancer, 23 elected gemcitabine-based chemotherapy, and 32 elected enzyme treatment, which included pancreatic enzymes, nutritional supplements, detoxification, and an organic diet. Primary and secondary outcomes were overall survival and quality of life, respectively.

Results: At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. Kaplan-Meier analysis found a 9.7-month difference in median survival between the chemotherapy group (median survival, 14 months) and enzyme treatment groups (median survival, 4.3 months) and found an adjusted-mortality hazard ratio of the enzyme group compared with the chemotherapy group of 6.96 (P < .001). At 1 year, 56% of chemotherapy-group patients were alive, and 16% of enzyme-therapy patients were alive. The quality of life ratings were better in the chemotherapy group than in the enzyme-treated group (P < .01).

Conclusion: Among patients who have pancreatic cancer, those who chose gemcitabine-based chemotherapy survived more than three times as long (14.0 v 4.3 months) and had better quality of life than those who chose proteolytic enzyme treatment.

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2 Responses to The Gonzalez Trial – The Cost of Studying The Unlikely

  1. Pingback: The Gonzalez Trial – The Cost of Studying The Unlikely « The … - Devangi Shah’s Blog

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