Opposition from Physicians and Media
By Linda L. Isaacs, M.D.
If you are a newcomer to the world of cancer treatment, you might find it difficult to believe the level of opposition from the medical community and the press that the late Nicholas J. Gonzalez, M.D., and I endured when we set out to investigate an “alternative” cancer therapy. Today, many major cancer centers have “integrative medicine” departments where patients can learn about such things as diet, meditation, or Tai Chi. But twenty years ago, there was tremendous opposition from physicians and the media to the pivotal clinical trial about our work. That opposition from authority figures impaired patient recruitment and adherence.
Why does that matter, decades later? Because of a published negative paper, a potentially promising way of dealing with cancer has been dumped in the wastebasket of medicine.
As background, the method Gonzalez and I used is based on that of Dr. William Donald Kelley, an unorthodox cancer practitioner. Gonzalez had investigated Kelley’s work and found remarkable case histories of patients with long-term survival after diagnoses of deadly cancers. (1) The self-administered regimen involved dietary changes such as avoidance of refined and processed foods; large amounts of nutritional supplements, including freeze-dried animal pancreas, naturally rich in pancreatic enzymes; and detoxification routines such as coffee enemas. The treatment method is rigorous, but not impossible for a motivated patient and family.
After concluding the review of Kelley’s work, Gonzalez set out to recreate it. In 1993, after six years in practice, Gonzalez presented a “Best Case Series” of 25 patients with exceptional outcomes at the National Cancer Institute (NCI). (2,3) As a result of that session, the NCI scientists suggested we proceed with a pilot study evaluating this approach in the treatment of inoperable pancreatic cancer. Gonzalez and I published the results in the peer reviewed journal Nutrition and Cancer in 1999. (4) On the basis of that study, which documented outcomes far beyond what had previously been reported for the disease, the NCI and the National Center for Complementary and Alternative Medicine (NCCAM) then agreed to support a controlled trial, comparing chemotherapy to our approach in the treatment of inoperable pancreatic adenocarcinoma. The trial was administered through an academic medical center in New York City.
Unfortunately, the trial was poorly run and ended in discord, with what Gonzalez and I believed to be meaningless data published in 2010 by the academic researchers involved. (5) Dr. Gonzalez’s book What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer goes into great detail about the problems with the trial. (6) In a 2015 article, I focused on issues in protocol design that doomed the trial almost from the outset. (7) Poor adherence was a major concern; of 39 patients assigned to our arm of the trial, 16 were not following their programs within one month of beginning treatment. A letter from one of the NCCAM supervisors of the trial stated that “everyone in the room basically agreed” that lack of adherence “clouds interpretation” of the data, yet the published article about the trial did not discuss it. (8)
Opposition from the oncology community and the media contributed to the difficulties with accrual and adherence that made the trial data meaningless. An example of this is an article published in the Washington Post in 2000, as patient accrual was in its early stages. (9)
The article leads off with two paragraphs about the treatment method, then states: “Some cancer specialists believe Gonzalez’s treatment is ludicrous.” This is followed by a lengthy discussion of how some Congressmen pressured the NCI to investigate alternative cancer treatments, implying that politics was the only reason the trial was funded.
The article then launches into a discussion of Gonzalez’ issues with malpractice cases and the New York State Medical Board, making sure to characterize them in the worst possible light. Given the antagonism of the oncology community to this treatment method, patients who did not do well for any reason were frequently advised by other doctors to file suits or complaints. I have written elsewhere about that era and those issues. (10)
Not until the 15th paragraph does the article mention the publication of the pilot study results in Nutrition and Cancer. Very few readers would persevere long enough to find the reason the follow-up trial was being done.
Next, the author mentions that Gonzalez completed his internship at Vanderbilt University Medical Center, but then did not complete his internal medicine training. Immediately after his internship, Gonzalez began a fellowship in immunology under the guidance of one of the preeminent immunologists in the world, the former head of Memorial Sloan-Kettering, Dr. Robert A. Good. That information is left out. And did the author mention that I, Gonzalez’ co-author and co-investigator, completed an internal medicine residency and am certified by the American Board of Internal Medicine? No, that was left out as well.
Then, a number of methodologic critiques are followed by a rehashing of one of the malpractice cases Gonzalez lost. The patient had uterine cancer that spread to her spine, but few details beyond that are provided. Metastatic uterine cancer is an incurable disease, regardless of treatment, and the patient had a particularly aggressive form with a poor prognosis. The patient was alive years after diagnosis when the Washington Post article was published (she eventually died 20 years after diagnosis). The article states: “Gonzalez maintains that [the patient's] cancer had spread to her spine by the time she started her treatment, and that he extended her survival.” But the article does not include the context that her survival is remarkable; the author, a physician, should have known that.
The article then launches into its most damning section, a critique of the pilot study that was published in Nutrition and Cancer. A prominent physician, Dr. Robert Mayer from Dana Farber Cancer Institute, stated that he did not believe the patients in our pilot study actually had pancreatic cancer.
Mayer never contacted our office to ask for documentation of the diagnoses, nor did the author of the Washington Post article. Were Gonzalez and I the ones who made the diagnoses? No, of course not. They were all diagnosed at various medical centers and hospitals where the imaging and biopsies were done.
When the Washington Post article came out, the academic physicians supervising the trial were deluged with calls from journalists asking whether the patients in our pilot study had been properly diagnosed. I can still remember the sudden demand for documentation, which we faxed over immediately. We would have been happy to extend the same courtesy to Mayer had he contacted us. While medical records cannot be sent to anyone who asks for them, with an appropriate agreement for confidentiality from a fellow medical professional, accommodation could have been made. But he never asked.
The Washington Post article then reports that the journal editor did not independently verify the diagnoses – with the implication that they should have. In fact, journals do not routinely fact check every piece of data in published articles. If they did, it would be incredibly time-consuming and expensive. Had the journal editors demanded proof of the diagnoses of the patients in the pilot study before publication, we would have provided it. But they did not.
By this point in the article, most patients would decide to pursue some other treatment, any patient already on the trial would be discouraged and decide to quit, and any doctor who happened to have a patient on the trial would do their best to get the patient to quit. And this article is just an example of the negativity we had to deal with as we attempted to demonstrate efficacy for a lifestyle modification treatment. We had epidemic non-adherence, which was not discussed in the article that the academics finally published.
What is my perspective on this, looking back decades later? I still react to the Washington Post article with disbelief and frustration. Gonzalez and I were trying to do the right thing, trying to get this work properly tested, and I cannot understand why that precipitated this petty attack.
The most infuriating claim, then and now, is that the patients in our pilot study did not have cancer in the first place. It makes me wonder whether people think that we simply made up all the cases, in the review of Kelley’s files, in the presentation at the NCI in 1993, in the pilot study, in the articles we have published since the collapse of the federally funded trial and in the books published after Gonzalez’s death. (1,2,4,11-16) Do people think we just made it all up? What possible reason could we have for doing that?
I personally reviewed the medical records for every single case report, from the Kelley manuscript onwards, and I know that the cases are real. With my credentials, at any point I could have found work doing something less controversial and more lucrative. Gonzalez was a brilliant doctor who could have done anything he wanted to do. The only possible reason to subject ourselves to the harassment and petty nastiness we endured was that the cases are real and the work needed to be properly evaluated.
I continue to hope that one day, the attitude of the oncology community will change so that proper evaluation will be possible. In the meantime, I will continue to treat patients with no curative options in orthodox oncology, and publish case reports and review articles. (14,17,18)
References
1. Gonzalez NJ. One Man Alone; An Investigation of Nutrition, Cancer, and William Donald Kelley. New York, NY: New Spring Press; 2010. [Amazon]
2. Gonzalez NJ. Proof of Concept: 25 Best Cancer Cases Presented to the National Cancer Institute. Sanibel, FL: New Spring Press; 2019. [Amazon]
3. Gonzalez NJ. Exemplified Case: Best Case Series. In: Primack A, Spencer J, eds. The Collection and Evaluation of Clinical Research Data Relevant to Alternative Medicine and Cancer: a workshop sponsored by the Office of Alternative Medicine. Bethesda, MD: National Institutes of Health; 1996:12-13.
4. Gonzalez NJ, Isaacs LL. Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer. 1999;33(2):117-124. [Abstract]
5. Chabot JA, Tsai WY, Fine RL, et al. Pancreatic proteolytic enzyme therapy compared with gemcitabine-based chemotherapy for the treatment of pancreatic cancer. J Clin Oncol. 2010;28(12):2058-2063. [Full text]
6. Gonzalez NJ. What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer. New York, NY: New Spring Press; 2012. [Amazon]
7. Isaacs LL. Research Battles: Survival Tips From a Veteran. Integr Med (Encinitas). 2015;14(5):30-32. [Full text]
8. Engel LW. 2005. Available at: https://www.drlindai.com/engel.pdf
9. Okie S. The clout behind a cancer maverick. The Washington Post. Jan 18, 2000: A1.
10. Isaacs LL. In memoriam: Nicholas J. Gonzalez, MD. Townsend Letter. 2016;390:14-19. [Full text]
11. Gonzalez NJ, Isaacs LL. The Gonzalez therapy and cancer: a collection of case reports. Altern Ther Health Med. 2007;13(1):46-55. [Full text]
12. Gonzalez NJ. The history of the enzyme treatment of cancer. Altern Ther Health Med. 2014;20(S2):30-44. [Full text]
13. Isaacs LL. Linitis plastica gastric cancer: a case report. Townsend Letter. 2016;397:68-69. [Full text]
14. Isaacs LL. An enzyme-based nutritional protocol in metastatic cancer: case reports of a patient with colon cancer and a patient with lung cancer. Altern Ther Health Med. 2019;25(4):16-19. [Full text]
15. Gonzalez NJ. Conquering Cancer: Volume One. New York, NY: New Spring Press; 2016. [Amazon]
16. Gonzalez NJ. Conquering Cancer: Volume Two. New York, NY: New Spring Press; 2017. [Amazon]
17. Isaacs LL. Coffee enemas: a narrative review. Altern Ther Health Med. 2021;27(3):46-49. [Abstract]
18. Isaacs LL. Pancreatic proteolytic enzymes and cancer: New support for an old theory. Integr Cancer Ther. 2022;21:15347354221096077. [Full text]