Dr. Lipson’s “detoxification” post on Thanksgiving Day and Dr. Gorski’s recent post about “Gerson Therapy” were timely, because last weekend I noticed something that I should have noticed months ago. Before delivering the punch line, let me remind you, Dear Reader, of the nature of the topic. The regimen advocated by Nicholas Gonzalez is a variation of a “detoxification” treatment for cancer that has been around, in one form or another, for more than 50 years (“Gerson Therapy” is another example).† Here is the National Cancer Institute’s (NCI) description:
Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.
As unlikely as it may seem, in 1999 American taxpayers began paying for people with cancer of the pancreas to be subjected to that regimen, in a trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the NCI, conducted under the auspices of Columbia University. Gonzalez provided the treatments. A few months ago I presented a multi-part treatise on the “Gonzalez regimen” and the trial. It demonstrated that all evidence, from basic science to clinical, including the case series that supposedly provided the justification for the trial, had failed to support any real promise (the case series had previously been considered by reader Dr. Peter Moran, who also found them wanting).
It showed that the impetus for the trial, as has been true for other regrettable trials of implausible health claims, can be traced not to science but to the reactionary politics of anti-intellectual populism: initially to Laetrile and to the “Harkinites,” and more recently to the Honorable Dan Burton (R-IN). It reported that there were major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen was more torture than therapy. It reported that for unclear reasons the trial had come to a halt a couple of years ago, and that it appeared that there would never be a report of its findings.
That series of posts also argued what was later summarized here: that, for clear-cut reasons, the New York State Board for Professional Medical Conduct had nearly revoked Dr. Gonzalez’s medical license during the 1990s—only to retreat from that position after two misguided academics testified that his regimen might benefit cancer patients.
The apparent “non-outcome” of the Gonzalez trial would be the final insult among its numerous, serious ethical violations. These were discussed, at some length, here and here. Several readers subsequently lamented that the results might never be made public: these included Drs. Moran and Gorski, and even an admirer of Nicholas Gonzalez, who identified himself as one of his patients.
The Outcome Revealed
The last post in that series occurred on May 2, 2008. One month later, the federal Office for Human Research Protections (OHRP) issued yet another determination letter regarding the Gonzalez trial. I gave it a cursory look in June, but I must have been distracted by other topics at the time; last weekend I hauled it out and couldn’t believe what I saw at point number “4” (emphasis added):
The complainant alleged that a minimum of 72 subjects were to be enrolled under the IRB-approved protocol, but that the study was terminated with only 62 enrolled subjects, in violation of HHS regulations… CUMC [Columbia University Medical Center] reported that the Data Safety and Monitoring Committee (DSMC) for this protocol recommended that the study be terminated before it reached its full enrollment of 72 subjects. At its September 30, 2005 meeting, the DSMC recommended that the study be terminated due to predetermined stopping criteria. This information was submitted to the CUMC IRB on October 17, 2005, and the study termination was approved by the IRB. Termination of the study in response to the DSMC recommendation was appropriate.
Most of you will immediately recognize the significance of those words. For those who don’t, let me explain, with slight oversimplification. A human trial of an investigational treatment is “terminated due to predetermined stopping criteria” for only one of two possible reasons:
A. At some point during the trial the investigational treatment is found to be superior to the standard (control) treatment, to an extent sufficient to render the remainder of the planned trial incapable of refuting this finding. Thus the trial is halted because the favorable outcome is certain and it would now be unethical to withhold the investigational treatment from the control group. It would also be unethical not to make this information public as soon as is realistically possible.
B. At some point during the trial the investigational treatment is found to be inferior to the standard (control) treatment, to an extent sufficient to render the remainder of the planned trial incapable of refuting this finding. Thus the trial is halted because the unfavorable outcome is certain and it would now be unethical…you know the rest. “Inferior,” by the way, needn’t mean merely “not as effective.” More commonly, it means “more dangerous.”
At the risk of belaboring the obvious, I ask the reader to imagine which outcome applied to the Gonzalez trial. If “A” had been the case, wouldn’t it have been splashed all over the front pages of newspapers everywhere, way back in 2005? Of course it would have. It is certain that “B” was the explanation for the trial having been halted. This is not the least bit surprising, in light of what we already knew about the onerous regimen.
For the benefit of paranoiacs who believe that modern medicine is in cahoots with drug companies to deprive honest people of effective therapies, let’s consider more evidence that “B” above must have been the trial’s outcome. In Part VI of my original series on the Gonzalez matter, I quoted from a 2007 interview published in Alternative Therapies:
AT: Let’s talk about the NCI study on your work. Has that been completed?
Dr Gonzalez: …We ran into many other problems, including the predictable bias from the oncology profession. Many patients were discouraged from considering this study by their original oncologists, and a number were discouraged from continuing even after they had entered.
There was a constant undercurrent of hostility toward the study that really had a deleterious effect. Right now, the project is on hold, and government officials are looking into the way the study was set up and run by the people at NCI and Columbia. I can’t go into the details at this point, but I certainly would have run it differently. Our input regarding the design was very often ignored, so there were design flaws in the study that I believed helped undermine the study.
AT: You’re not hopeful some of those issues will be resolved and you’ll be able to move forward with the study?
Dr Gonzalez: I don’t think so. Right now, as far as I’m concerned, it won’t happen. What the NCI or the National Institutes of Health will decide to do, I can’t say, but I’ll tell you, after spending 7 years trying to get the study to work and fighting at every step, I would not want to go through that again…
…Natural treatments like mine are not just another chemotherapy, and you can’t design clinical studies to test them as if they were. We don’t offer a chemo drug, where the patient shows up and gets to watch TV and eat ice cream while nurses inject the medication. In our case, the patient has to change his or her entire life, so compliance becomes a major issue. You’re held hostage by patient compliance…
…With our therapy, patients have to change their whole life. Should the NCI ever wish to test an alternative dietary or nutritional approach again, they must ensure that the bias of the oncology profession, which in our case influenced accrual and compliance of accepted patients, be effectively countered.
AT: Have you considered writing a book about your treatment plan?
Dr Gonzalez: We’ve just finished a book about the NIH clinical study because so many people wanted to know what happened after 7 years of work. I was asked by some of my congressional supporters to document all the mistakes that were made, and it turned into a book. And we think that should be published.
Do those sound like the words of someone whose mavericky treatment has recently been exonerated?
The Complainant Probably Revealed
Within that quotation is a statement that is interesting for another reason:
…government officials are looking into the way the study was set up and run by the people at NCI and Columbia. I can’t go into the details at this point, but I certainly would have run it differently.
Dr. Gonzalez appears to have been referring to the OHRP’s investigation that eventually resulted in its determination letter of June 2, 2008, quoted above. Further evidence for this is the preliminary determination letter of Feb. 25, 2008, which was part of the same investigation. The June 2 letter, moreover, includes several “complainant allegations”—numbers 3-7—that, in summary, charge that Columbia University had enrolled subjects who were either too sick or too emotionally unstable to comply with the “Gonzalez Regimen,” and that the DSMC’s decision to stop the trial had been wrong. The OHRP found, however, that each of these allegations was without merit.
All of this suggests that the complainant in this case was not someone who recognized the trial as unethical for all the reasons discussed here months ago, but rather someone who knew that the results of the trial were not flattering to the “Gonzalez Regimen,” and was rather desperately trying to make that inconvenient fact go away. Someone, that is, such as Gonzalez himself, or a surrogate believing himself to be acting in Gonzalez’s interest.
Another relevant statement, previously quoted but now perhaps more revealing than it seemed then, is from mathematician Susan Gurney, who had written an account of one subject’s unfortunate experience in the trial:
…for the record, although Sherman warned me about the trial to begin with – in the end nobody would come forward. I will be happy to be quoted about the sad situation – I have spoken to Chabot in person, who will not come forward and say anything publicly ‘according to the advise of his lawyers’ -which from what I understand are the Columbia Institution lawyers. This is simply being covered up – and the data are not going to be released- publicly – is what I believe. As well, they think that Gonzalez has friends in Congress – so they claim that he would only make Columbia look bad again and they wouldn’t defeat him – only end up taking the blame.
‘Enlightened self-interest’ I believe is the term I heard used.
‘Spineless wonders’ is the phrase that I myself would use.
Finally, consider this excerpt from a comment by a reader calling himself “CAMCENTRAL.” It appeared in October, months after the final posting of my original series:
The reason there has been no data published is that the study was poorly managed by the NIH and Columbia. The principal investigator at Columbia has been found guilty by the Office of Human Subject Protections for among other things failing to follow federal guidelines on obtaining written informed consent from patients for a majority of the patients. Among the many problems that doomed this study were that the principal investigator, Dr. John Chabot, not Dr. Gonzalez was in complete charge of patient referral to the nutritional arm and repeatedly referred patients who did not fit within the protocol and who never fully participated in the treatment. The truth on this will one day come out, but the fault on this study lays clearly at the fit [sic] of the NIH staff responsible for managing this study and of the principal investigator Dr. John Chabot…that he continues to be allowed to be involved in clinical trials is a real travesty.
A New Epilogue
We now know considerably more than we did in May. The Gonzalez trial was stopped early, in 2005, after the DSMC found that the data convincingly demonstrated that the regimen was inferior to standard treatment for cancer of the pancreas. This information has been available to the public since June 2, 2008, but until now could be found only in the esoteric OHRP determination letter. The reason that the results of the trial have not been reported in the usual way, or otherwise made public by the relevant sponsoring and investigating institutions or individuals, appears to be that Gonzalez or someone close to him, likely with the aid of lawyers and “friends in Congress,” has managed to suppress them. Ironically, Gonzalez (or his surrogate) seems to have shot himself in the foot: the unsuccessful appeal to the OHRP to cast doubt on the trial results is the only reason we know that the trial was “terminated due to predetermined stopping criteria.”
Isn’t it odd that government websites, including the National Cancer Institute and ClinicalTrials.gov (“Last updated: October 18, 2008″), continue to portray the Gonzalez trial as ongoing? Time to come clean, fellas: your cover is blown. We the taxpayers, not Gonzalez or Burton or Columbia University or the NCI or the NCCAM, own this trial. We know the main outcome in spite of Gonzo and/or his friends attempting to silence it, and in spite of spineless wonders who seem all too willing to be silenced. Now we want the details.
†The “Gonzalez Regimen” Series: