The Ethics of “CAM” Trials: Gonzo (Part IV)

A Review; then Back to the Gonzalez Regimen†

Part I of this blog introduced the topic of the “Gonzalez regimen” for treating cancer: “Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support” and “detoxification” with twice daily coffee enemas, daily “skin brushing,” “a complete liver flush and a clean sweep and purge on a rotating basis each month,” and more. The topic was occasioned by the federal Office for Human Research Protections having recently cited Columbia University, for the second time, for violations of human subject protections in its NIH-funded trial of Gonzalez’s method as a treatment for cancer of the pancreas.

Part I discussed the implausible and bizarre regimen and cited Gonzalez’s troubles with malpractice suits and with the New York medical board during the 1990s. It ended by wondering what could have induced the NIH to give a $1.5 million grant to Columbia University to study the method.

Parts II and III began to answer that question, tracing some of the key events and individuals from the Laetrile wars in the 1970s to the NCI-funded trial of Laetrile reported in 1982, to the “immuno-augmentative therapy” (IAT) battles of the mid-’80s, to the Report on “Unconventional Cancer Treatments” by the Congressional Office of Technology Assessment (OTA) in 1990, which in turn led to the NCI adopting its “Best Case Series Program” in 1991.

The end of Part III hinted that the conspiracy mongering that had greeted every attempt by the government to explain its positions on implausible cancer treatments, from Laetrile to the OTA report, ultimately led to the creation of the Office of Alternative Medicine (OAM) at the NIH, also in 1991. There is plenty of evidence for that, both from the conspiracy mongers themselves and from more level-headed observers. Each time the government acted—to fund a trial of Laetrile, to solicit the OTA report and propose a study of IAT, to establish the NCI “Best Case Series” program, and to establish the OAM—it was not because of scientific or medical considerations, but because of political pressure. More on that from time to time, but now back to Dr. Gonzalez.

A Helping Hand from the OAM

In September, 1992, the nascent OAM convened a “Workshop on Alternative Medicine.” The resulting report, “Alternative Medicine: Expanding Medical Horizons,” has correctly been called “an uncritical catalog of virtually every dubious and unproven treatment method of the past 100 years.” Physicist Robert Park called it “surely the most credulous document ever offered in the name of medical science” (NY Times, 7/9/1995). The report referred to Gonzalez’s unpublished, 500 page manuscript describing cases culled from the records of his “mentor,” the Texas dentist William Donald Kelley (discussed in Part I of this blog):

This case series has been singled out by proponents as one of the most convincing in support of an unconventional cancer treatment.

No surprise, then, what happened next. According to Dr. Gonzalez,

In July of 1993, the National Cancer Institute (NCI) invited me to present case reports from my practice, detailing patients with appropriately diagnosed poor-prognosis cancer who had enjoyed tumor regression or unusual survival while following my therapy. Dr Isaacs and I put together 25 cases for the session, which was attended by a large group of NCI scientists and lasted 3 hours. After the meeting, I was asked to pursue as a next step a pilot study evaluating my approach in 10 patients diagnosed with advanced adenocarcinoma of the pancreas.

Curiously, although the OAM report was dated September 14-16, 1992, it also has this:

Gonzalez recently submitted to NCI a meticulously documented best case series (Friedman 1993).”

Suddenly, Dr. Gonzalez had become a minor celebrity. According to Victor Herbert, it happened just in time:

The New York State licensing agency attempted to revoke [Gonzalez’s] license [in 1994]. Revocation was prevented by testimony from defenders, such as Harvard’s George Blackburn, MD, and American Health Foundation’s Ernst Wynder, PhD. Blackburn and Wynder testified that Gonzalez’s cancer therapy, particularly his oral pancreas-extract supplement, was promising as a cancer cure. The testimony and the licensing board ignored the 1990 Congressional Office of Technology Assessment (OTA) report to Congress that Gonzalez’s claims have no basis in fact.¹

Perusing the documents generated by the New York State Board for Professional Medical Conduct, in the matter of Dr. Gonzalez, is not for the faint of heart. The Findings of Fact reveal a practitioner who is beyond incompetent. In the cynical vernacular of medical shop talk, he is “007: licensed to kill.” That the eventual consent order let him off scot-free, for practical purposes, is a sad commentary on the capacity of the medical profession to regulate itself and to protect the public. Gonzalez himself learned nothing, as evidenced by his words at the White House Commission on Complementary and Alternative Medicine Policy in 2000:

…the very day I was in Switzerland presenting to Pierre Gastri’s [ph] group was the very day the medical board served my office with a subpoena announcing they were going to try and close my office down because to sum it up in non-legalese terms, I basically represented a subhuman pond scum that was, you know, taking money from unsuspecting cancer patients. All the time while I was trying to present my work and getting funding and doing clinical trials, the medical board relentlessly tried to basically close my office down. We eventually prevailed…

According to Victor Herbert, Columbia University opened its arms to Gonzalez at about the same time:

Gonzalez was subsequently hired by Fredi Kronenberg, PhD, director of Columbia University College of Physicians & Surgeons’ “alternative” medicine course. Gonzalez and other advocates of pseudoscience-based medicine were hired by Dr. Kronenberg to give one-hour lectures promoting their practices as legitimate. Kronenberg and Medical School dean Herbert Pardes refused requests to withdraw the invitation or to allow alumni Stephen Barrett or me to be present when Gonzalez spoke, for rebuttal.¹

The Pilot Study Considered Again

Dr. Gonzalez eventually reported his “pilot study” of cancer of the pancreas in 1999, as discussed in Part I. He claimed that his outcomes for 11 patients had been markedly better than those typically found for comparable patients who receive “conventional” treatments. His report is vulnerable to several objections, the most obvious of which is that he selected the “best cases” from a larger pool, possibly a much larger pool—as mentioned in Part I. Other objections have to do with the cases themselves. Intrepid reader Dr. Peter Moran (thank you for calling my attention to this, pmoran) examined Gonzalez’s report and observed:

Case H was almost certainly a bile duct cancer, which has a far better prognosis than cancer of the pancreas. . .

Case J had a Whipple’s procedure for an early pancreatic cancer. This case should not have been included, as the fact that the cancer was deemed operable indicates a more favourable prognosis…

Case K is not certainly pancreatic cancer. The diagnosis rests upon a surgeon’s opinion from palpation of an unbiopsied pancreatic mass…

Case L could well be a better prognosis duodenal or ampullary adenocarcinoma…

Some may regard these concerns as trivial, but those four cases happen to have the more prolonged survivals (37-47 months).  The 10-29 month survival in the other seven patients is good but not overly convincing evidence of a treatment effect in a such a highly selected group.

Similar objections apply to cases that Dr. Gonzalez reported in Alternative Therapies in 2007. Six patients, designated “#26-#31,” were said to have presented with cancer of the pancreas. They were alive and well 15, 10, 10.5, 6, 5.5, and 24 years later, respectively. Patient #26, however, reportedly had a biopsy of a lung nodule but not of his pancreas; the presumption that his cancer had begun in the pancreas had been based on uncertain CT findings. Dr. Gonzalez gave no details about where this man’s diagnostic work-up had been done. Patient #27 also lacked a biopsy to prove cancer of the pancreas; the diagnosis was based on even flimsier radiologic evidence than in the previous case.

Patient #28 reportedly had a biopsy of a mass in the pancreas, but it was reported to be a rare “carcinoid-islet cell” tumor—a very different sort from the standard adenocarcinoma of the “exocrine” pancreas, and one that, according to the Washington Manual of Oncology, can have “long periods of disease stability.” Patient #30 had no biopsy of his pancreas, only radiologic evidence of a pancreatic mass. Prior to pursuing Dr. Gonzalez’s regimen he had completed 3 of the 4 cycles of chemotherapy that had been recommended to him, and a CT scan had shown “marked improvement” after only the second cycle. Patient #31 was a “24-year Kelley Survivor,” i.e., a case report that Gonzalez had taken from Kelley’s records. We can therefore assume that in the case of patient #31, “…documentation…was inadequate to confirm critical details of the narrative….”

Dr. Gonzalez Goes to Washington—Again

Representative Dan Burton (R-IN), the former chairman of the House Committee on Government Reform, has been one of the most virulent and influential proponents of implausible cancer treatments and other IMCs. Burton had fought to legalize Laetrile in his home state of Indiana during the 1970s, and later used his committee chairmanship for the advocacy of homeopathy for bioterrorism and other purposes, “detoxification” and “supporting the vital force” for cancer, the herbal mixture “PC-SPES” for prostate cancer (since found to be adulterated by prescription pharmaceuticals), acupuncture for “end of life” care, and “antineoplastons” for medulloblastoma.

Burton has also championed the cause of those who claim that vaccinations and mercury amalgams cause autism and ADHD, argued against FDA regulation of “dietary supplements,” including ephedra, and argued that the Department of Health and Human Services (HHS) should have an “Associate Secretary for Complementary or Alternative Medicine.” For his many hearings on these topics he has invited such expert witnesses as actress Jane Seymour, whose advocacy of homeopathy on the national stage followed her experience as Dr. Quinn, Medicine Woman.

“Dr.” Ralph Moss, introduced in Part III, is one of the original “Harkinites” (a term coined by Joseph Jacobs, the first full-time Director of the Office of Alternative Medicine). His degree is in classics, but he has styled himself as an expert in cancer—mainly “alternative” cancer treatments. Moss was a long-time member of the NCCAM’s Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM). In 2004 he wrote a glowing eulogy for rabid Laetrile promoter Michael Culbert, who had been a vice-president of the Committee for Freedom of Choice in Medicine, the major Laetrile advocacy organization. Moss has recently written approvingly of Mexican cancer clinics that continue to peddle Laetrile, although he is careful to add that “there are no reliable ‘miracle cures’ for cancer in Tijuana or elsewhere.”

In 2000 Moss recounted, with considerable satisfaction, how the Director of the National Cancer Institute (NCI) had caved to political arm-twisting:

After stormy hearings of Rep. Dan Burton’s House Committee on Government Reform and Oversight, NCI Director Richard Klausner, MD, changed NCI’s direction and asked members of the CAM community to advise NCI on the evaluation of new therapies.

Elsewhere we find that one of those “stormy hearings” had apparently taken place in the relative privacy of Burton’s office:

In his campaign to win federal support, Gonzalez got a boost from Rep. Dan Burton (R-Ind.), the chairman of the House Government Reform and Oversight Committee and a longtime alternative medicine ally. Burton held a June 1998 meeting in his office that brought together Gonzalez and NCI Director Richard Klausner to discuss a study of the regimen.

Shortly thereafter, the NIH announced its grant of $1.4 million for a controlled trial of the “Gonzalez Regimen.” It was in trouble almost immediately, as will be discussed next week.

[1] Herbert V. The Continuing Case of Nicholas Gonzalez. Scientific Review of Alternative Medicine 1998;2(2):43-44


†The “Gonzalez Regimen” Series:

1. The Ethics of “CAM” Trials: Gonzo (Part I)

2. The Ethics of “CAM” Trials: Gonzo (Part II)

3. The Ethics of “CAM” Trials: Gonzo (Part III)

4. The Ethics of “CAM” Trials: Gonzo (Part IV)

5. The Ethics of “CAM” Trials: Gonzo (Part V)

6. The Ethics of “CAM” Trials: Gonzo (Part VI)

7. The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

8. “Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results)

9. “Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part II: Loose Ends)

10. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1

11. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Medical Ethics

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