Monday, December 01, 2008

The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

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, on Science-Based Medicine, 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 had supposedly provided the justification for the trial, failed to support any real promise for the treatment.

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 had been major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen had been 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 good 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 had 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; they include the fallacy of 'popularity,' which has been the NCCAM's primary rationale for human trials of implausible health claims. On June 2, 2008, one month after the last posting of the series, new information about the Gonzalez trial became available in the form of a determination letter from the federal Office of Human Research Protections (OHRP). In part, it stated:


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.



What this means, in summary, is that the trial must have found the Gonzalez regimen to be either much better or much worse than standard treatment for cancer of the pancreas. It is certain that it was much worse, of course, because otherwise we would have heard about it years ago. I have offered additional evidence for that conclusion, and an explanation for why this information has not been reported by the responsible investigators, in a longer version of this posting.

9 comments:

Anonymous said...

Unbelievable! I would recommend the longer version and the comments are more than appropriate.

Steve Lucas

Roy M. Poses MD said...

It seems incredible that the NIH would fund a clinical trial that included coffee enemas and castor oil skin cleaning. Even so, enrolling patients under at least the pretense that this was to be scientific study created an ethical obligation to those patients that a good faith effort would be made to disseminate the results.

That the trial was stopped early does suggest there were significant and possibly important differences among the trial groups. Yet in 3 years these results have not been made public.

Thus it appears these results were suppressed. I wonder if it was because they offended ideological sensibilities, or economic interests.

Nonetheless, suppressing these results, whatever the reason for it, is an ethical affront to the enrolled patients.

medicine girl said...

Didn't the NIH fund the trial b/c the survival rate in Gonzalez's patients appeared to be significantly higher than standard treatment?

Kimball Atwood, MD said...

@ medicine girl:

Well, no. Gonzalez claimed that his survival rates were significantly higher than those for standard treatment, but neither his "best case series" nor any of his other documentation was rigorous enough to be taken seriously. For a comprehensive review, please follow the links in the text above.

The NIH funded the trial because Rep. Dan Burton and other well-connected but misguided boosters of implausible medical claims, e.g., the "Harkinites," bullied it into doing so (the linked essays provide ample evidence of that). Gonzalez's case series, though inadequate, was hyped as the official reason.

Kimball Atwood, MD said...

@ Roy Poses:

In the "longer version" of the essay, linked above, I have argued that Gonzalez himself, or a surrogate, has been responsible for suppressing the results. I think it's safe to assume that this is for both ideological and economic reasons, because both are central to his claims.

Implied above, but explicitly stated in the series of linked essays, is how embarrassing it would be for all concerned (Gonzalez, the NIH, Columbia, and the New York medical board, among others) if the sordid truth were revealed: that the only reason for Gonzalez having narrowly avoided losing his medical license more than a decade ago has now been definitively shown to be a scam. That may be part of the reason that Columbia and the NIH haven't been heard complaining about Gonzalez trying to shut them up. The rest of the reason has to do with fear of Gonzalez's "friends in congress," beginning with Burton--who is no stranger to dirty tricks.

Anonymous said...

My brother in-law was enrolled in this trial. Despite the unorthodox treatment he decided that he wanted to try this as a last resort. He and my sister were led to believe this crap and the fact that it was part of a study made them think that there was some real science here. The earlier comment that this was torture is entirely correct. The treatment was poorly defined and impossible to adhere to. The diet had no real guidelines and it was impossible to maintain the calories required to even slow his weight loss. He was told throughout the study that he would begin to recover any time and that he would surely live many more years despite obvious signs to the contrary. No real attention was paid to pain management or associated symptoms. His quality of life during the treatment was terrible, this was far worse than doing nothing. He received a good report at his last visit despite a weight of about 100 lbs and clearly failing health just one week before his death. This was an incredibly sad event for our entire family and I have no respect for Mr. Gonzalez.

Kimball Atwood, MD said...

Anonymous:

You might want to cross-post your comment on my longer version of this essay at:

http://www.sciencebasedmedicine.org/?p=298

You might also be interested in the series of posts linked from that essay, especially two that recount the experience of an unfortunate man who submitted himself to the 'study':

http://www.sciencebasedmedicine.org/?p=97

And:

http://www.sciencebasedmedicine.org/?p=104

Anonymous said...

It's horrifying what happens.

I believe we ought to pay more attention to the signs of cancer. I read not too long ago on a internet site about indicators of pancreatic cancer, and there are a handful of truly confusing ones. The issue is with "silence", or well-known signals of various other conditions, and an individual could not consider, those symptoms might also suggest some kind of cancer. A lot of us really don’t recognize that the fact that reoccurring belly aches and pains for instance, could possibly be among the indicators we need to notice.

Sciatic Nerve Pain said...

Since Gonzalez admits that he was the one who filed a complaint that led to the OHRP investigation and determination letters (which to me look like much ado about nothing), I don’t think it is unreasonable for the others in the trial to keep him out of the loop in writing and submitting the paper. I don’t doubt that he would have done whatever he could to thwart the process of publication (I see filing the complaint to have been done with that in mind). If he is an author, then he has to agree to everything that is in the paper. If he wasn't going to agree to any publication that wasn't a puff-piece for his protocol, then all he needs to do is withhold agreement and there is nothing the co-authors can do except write a paper without him.