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

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Review

One of the more bizarre and unpleasant “CAM” claims, but one taken very seriously at the NIH, at Columbia University, and on Capitol Hill, is the cancer “detoxification” regimen advocated by Dr. Nicholas Gonzalez:

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.

Veteran SBM readers will recall that in the spring of 2008 I posted a series of essays* about this regimen and about the trial that compared it to standard treatment for subjects with cancer of the pancreas. The NIH had funded the trial, to be conducted under the auspices of Columbia, after arm-twisting by Rep. Dan Burton [R-IN], a powerful champion of quackery, and much to the delight of the “Harkinites.”

In the fall of 2008 I posted an addendum based on a little-known determination letter that the Office for Human Research Protections (OHRP) had sent to Columbia during the previous June. The letter revealed that the trial had been terminated in October, 2005, due to “pre-determined stopping criteria.” This demonstrated that Gonzalez’s regimen must have been found to be substantially worse than the current standard of care for cancer of the pancreas, as ineffective as that standard may be. I urge readers who require a review or an introduction to the topic to read that posting, which also considered why no formal report of the trial had yet been made available.

Now, finally, the formal report has been published online by the Journal of Clinical Oncology (JCO):

Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-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

JCO Early Release, published online ahead of print Aug. 17, 2009. Journal of Clinical Oncology, 10.1200/JCO.2009.22.8429

The Results of the Gonzalez Trial

The abstract can be read here. First, the punch line:

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 [Gonzalez's] treatment.

According to the article proper,

Twelve months after enrollment, 56% of chemotherapy-group patients were alive; 16% of the enzyme-group patients were alive. The longest survivors were one chemotherapy-group patient who died at 39.5 months and one chemotherapy-group patient who was censored at 37.5 months (ie, the closing date of the data analysis) and, at the time of manuscript submission, was still alive at 40 months.

The Gonzalez regimen was not only much worse than standard treatment in this study; it was also substantially worse than the experience of more than 20,000 comparable patients in the US between 1988 and 2001, as reported by the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute. This is illustrated in a self-explanatory figure from the JCO paper:

Snapshot 2009-09-11 16-16-15

The Columbia trial also looked at ’quality of life’:

In this study, patients in the enzyme-treatment and chemotherapy groups had similar scores in quality of life at enrollment, but the enzyme group fared much worse than the gemcitabine group in the subsequent year…Pain levels appeared to diverge during the initial 6 months of the study and were more severe among the enzyme group.

Discussion

This is a slam-dunk condemnation of the Gonzalez regimen. For more than 20 years, Gonzalez has claimed near-miraculous survival times—measured in years-to-decades, rather than in months—for patients with life-threatening cancer, including pancreatic cancer. His “case series,” upon which the NIH’s decision to fund a large trial was purportedly based, had included 11 patients. According to the National Cancer Institute (NCI):

The investigators reported a median survival time of 17 months and a mean survival time of 25.2 months for these patients. Nine patients (82%) survived 1 year, five patients (45%) survived 2 years, and four patients (36%) survived 3 years. At the time the study was reported, two patients were alive: one who had survived 3 years, and one who had survived 4 years. The researchers concluded that the 1-year and 2-year survival percentages for this group of patients were superior to those observed for other U.S. patients diagnosed with adenocarcinoma of the pancreas (1-year survival, all stages = 25%; 2-year survival, all stages = 10%).

I have previously explained (here and here), as has Dr. Peter Moran (here), why that case series was unreliable and was not a worthy basis for conducting a larger trial.

Dr. Gonzalez has also claimed that patients who use coffee enemas “report an increased sense of well being.” He reportedly told at least one subject in the Columbia trial

that pain might be an indication that the tumors were being dissolved, and that he could expect weight loss as he was detoxifying his body.

The JCO report soundly refutes Gonzalez’s claims. The treatment does not prolong the lives of patients with cancer of the pancreas; it substantially shortens their lives. It does not increase patients’ sense of well being; rather, it makes their quality of life “much worse.” The fate of the typical subject in the “enzyme” group appears to have been similar to that of a young man whose tragic story was told by his friend, Susan Gurney, and recounted here.

Is this the last word on the Gonzalez regimen? Are there weaknesses in the study that might save it, at least for now? I raise this question for completeness’ sake only, for in my opinion there was never a justification for performing the trial. Nevertheless, I’ll mention the only obvious methodologic flaw: As previously discussed, the trial was not randomized because at its outset too few prospective subjects were willing to take a chance on not being in the “Gonzalez” group. Thus allocation to that group was chosen by the subjects themselves. They were compared to a cohort of patients who chose standard treatment. Although not randomly allocated, the subjects in the two groups were reported to be well matched:

Fifty-five patients, 23 on the control arm and 32 on the experimental arm, enrolled on the study and were available for analysis… The patients in both the control and experimental arms were carefully enrolled according to identical entry criteria. There were no statistically significant differences at the time of enrollment in age, sex, weight, ECOG performance status, stage of disease, pathology, quality of life, or CA19-9. Bilirubin and albumen were significantly higher in the chemotherapy group, but all values were clinically within normal limits and met eligibility criteria.

All but two subjects in each group, moreover, were judged Grade 0 (“Fully active, able to carry on all pre-disease performance without restriction”) or Grade 1 (“Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work”) by the Eastern Cooperative Oncology Group (ECOG) Performance Status assessment. This is important because, as I reported last year, someone (probably Gonzalez or a surrogate) had complained to the OHRP that several subjects who would not be capable of adhering to the “enzyme” regimen had been enrolled in the trial (see points 5-7 in the OHRP letter).

The lack of randomization (and blinding), then, seems insufficient to cast doubt on such a definitive outcome. It is likely, moreover, that any bias resulting from self-selection of subjects to the Gonzalez group would have skewed the results in favor of that regimen—the opposite of what was ultimately found. Gonzalez himself seemed to realize this back in 2000, when the trial had barely begun:

DR. GONZALEZ: Interesting question. I didn’t have time to go into the details of how it was going. Initially, it was set up as a randomized trial about a year ago, and Jeff and I kind of struggled with that and I always knew there would be problems.

And—–going back to this gentleman’s question, I’m the first person on Earth to say that the belief system of the patient is really important in how they do. Randomized trial patients have no choice and the study was set up when my therapy was being compared to the best available chemotherapy for inoperable pancreatic adenocarcinoma.

Well, patients know in this day and age chemotherapy is a death sentence for inoperable pancreatic adenocarcinoma and our first study had already been published.

Over a period of several months, Columbia got 200 phone calls. A hundred and ninety-seven patients, who would have been perhaps appropriate for the study, refused to enter unless they could be guaranteed my arm of the study.

Now a randomized study is considered the gold standard and I felt we had to at least try. Dr. Klausner thought we had to try. Dr. White thought we had to try. After a year of trying that we all realized it wasn’t going to work that way, so we set it up as a case control where patients have choice. If they want chemo, they get chemo; if they want me, they get me.

Hopefully, their belief in chemo will be as strong as the patients’ belief in my therapy. We’re going to try and match them evenly.

Now in terms of technical methodology it’s maybe a little less rigorous than a randomized study, but it’s raised all kinds of issues about how you test an alternative therapy where belief is important and a patient who doesn’t care whether they get chemo or my therapy for pancreatic cancer is going to be a very unusual patient.

Patients who come to me usually believe in this. They would seek alternatives. By definition, they’re seeking something different.

At the same conference, Gonzalez opined that in order to validate his regimen, the trial would eventually need to demonstrate outcomes virtually the inverse of what have now been reported:

DR. GONZALEZ: It’s set up as a survival study. We’re looking at survival.

SPEAKER: Do you have an idea of what you’re looking for?

DR. GONZALEZ: Well, Jeff and I were just talking a couple weeks ago. You know, to get any kind of data that would be beyond criticism is—-always be criticism, but at least three times.

You would want in the successful group to be three times — the median to be three times out from the lesser successful groups.

So, for example, if the average survival with chemo, which we suspect will be 5 months, you would want my therapy to be at least — the median survival to be at least 15, 16, 17 months, as it was in the pilot study.

We’re looking for a median survival three times out from the chemo group to be significant.

To save you the trouble of scrolling upward, let me repeat the JCO report’s 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.

There is More to This Story

I am happy that the results of the Gonzalez trial, such as they are, have finally been made public. Nevertheless, the report is full of troubling information, both stated and unstated. There is substantial evidence of ethical breaches, including some that might elude readers who are not familiar with the topic. A compelling argument can even be made that the JCO should not have published the report—as paradoxical as that sounds. I’ve previously discussed several of these issues (also here), but the JCO report demands that they be revisited. I’ll do that next week.

* 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 

REFERENCE:

John A. Chabot, Wei-Yann Tsai, Robert L. Fine, Chunxia Chen, Carolyn K. Kumah, Karen A. Antman, & Victor R. Grann (2009). Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer Journal of Clinical Oncology : 10.1200/JCO.2009.22.8429 (E-pub ahead of print)

Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

Leave a Comment (72) ↓

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

  1. kausikdatta says:

    Can Rep Dan Burton and Senator Tom Harkin be sued now, based on their active involvement in this fraud involving human lives and NIH funding? Someone in this litigious country should take up that cudgel, this time for the right reasons. I call it ‘fraud’ straightaway because I agree with you that the initial case series should never have gone on to the clinical trial.

    Your earlier posts and reports surrounding this trial also reveals another disturbing trend, which has a bearing upon the discussions after the two or three previous posts in SBM. During the initial randomization process, most of the patients asked to be in the Gonzalez arm. To me, this casts serious doubts over the entire informed consent process. The patients who wished to take part in a therapy of dubious provenance – were they really making “informed” choices? Were they told, did they understand, or were they capable of understanding the seriousness of the situation regarding their cancer treatment – the fact that they were choosing a therapy for which there was no empirical evidence, that they were liable to have a poor quality of life and die with this line of ‘treatment’?

    I don’t know if my question sounds naive, in the sense that this may bias the patients against any new prospective therapy for anything – making RCTs impossible to conduct. But since we are dealing with human lives, is there a mechanism to ensure that the patients understand fully what they are getting into, when they sign the consent form?

    Kindly excuse my becoming emotional (therefore, perhaps less rational) about this.

  2. qetzal says:

    But since we are dealing with human lives, is there a mechanism to ensure that the patients understand fully what they are getting into, when they sign the consent form?

    Sure, in theory. All human clinical trials in the US have to be approved by an Institutional Review Board (IRB). The IRB is supposed to ensure the following (among other things):

    1. There is adequate scientific rationale to justify conducting the study.

    2. The study is adequately designed to answer the question being posed.

    3. The consent form adequately discloses all known and reasonably forseeable risks associated with the trial.

    4. The trial investigators have proper procedures in place to make sure those risks are properly communicated to trial participants. (E.g., it’s not enough to just hand the consent form to the subject and have them sign it. You’re supposed to discuss it with them, answer any questions, and try to be sure they understand it before they sign.)

    However, I don’t know what recourse a trial participant (or in this sad case, their next of kin) may have if these rules are not followed. There can be various federal sanctions and even criminal penalties for the investigators, but that doesn’t help these victims. And they are indeed victims.

  3. Harriet Hall says:

    The thing that really amazes me is the huge number of interventions involved in this protocol. How did he ever come up with them all? Why would he think all of them were simultaneously necessary? If it worked, how would you know whether all the interventions were essential?

    You might call this “kitchen sink” medicine. Try everything you can think of and throw in the kitchen sink.

  4. Prometheus says:

    Well! This was certainly an unexpected outcome! (NOT!)

    Any idea how much of our tax money was wasted showing that giving coffee enemas and papaya to pancreatic cancer patients is inferior to real medicine? On second thought, I don’t want to know – it will just depress me.

    I’m not a cancer researcher, but even I could tell that the “Gonzalez Regimen” was going to turn out this way. In fact, I’ll further show off my psychic abilities and predict what the response of Gonzalez’ supporters will be:

    I predict that there will be an outpouring of anecdotes and testimonials of how they were “cured” by the Gonzalez Regimen. I further predict that someone will claim that the data was tampered with. Finally, I predict that Dan Burton and Tom Harkin will later use this outcome as further “proof” that the NIH is hostile to “CAM”.

    I bet I do better than Sylvia Browne with these predictions!

    Prometheus

  5. TsuDhoNimh says:

    a clean sweep and purge

    What the heck is “a clean sweep and purge”?

  6. Eric Jackson says:

    Prometheus -

    The NIH grant was between 1.4 and 1.5 million dollars, I’ve seen both quoted. One of the above posts mentions the 1.5 figure.

    And yes, it does seem quite painfully obvious that the Common Rule/45 CFR 46 was violated on several fronts in this study: http://www.casewatch.org/fdawarning/rsch/shea2.shtml and that they more or less totally ignored any regulations about informed consent that are on the books.

    The amount of post material on SBM, as well as the number of OHRP letters is pretty staggering. I just have to wonder how this trial even got off the ground, let alone continued.

  7. DevoutCatalyst says:

    Coffee enemas, what a way to cap off one’s life. I think of a proud and tough guy like Steve McQueen being subjected to this silly thing many years ago, this ridiculous oddball notion that never goes away.

    From the mind of man springs amazing and beautiful things, counterbalanced by abjectly stupid and irresponsible things — the Gonzalez regimen is a great example of the latter.

    I heard Francis S. Collins on NPR’s Science Friday today, and I get the impression that we can expect a further nurturing of this type of wasteful stupidity from our government.

  8. Ben Kavoussi says:

    Did I read “Courses repeat every 21 days until death despite relapse?” No! This is outright outrageous.

  9. Wholly Father says:

    To Qetzal:

    IRB’s primary function is to ensure the safety and well-being of human research subjects (items 3 and 4 of your list). IRB’s are not formally chartered to review the scientific merit of the research (your items 1 and 2).

    In the real world, however, scientific merit must be considered in order to assess the risk/benefit to research subjects

  10. Wholly Father says:

    Couldn’t resist the temptation to check out Dr. Gonzalez’s website. There is no mention of the results of NIH study.

  11. Wholly Father says:

    I just looked at Dr Gonzalez’s website. Still pitching has protocol. The site is loaded with anecdotes of success, but no mention of the NIH study.

  12. qetzal says:

    Wholly Father,

    I agree that IRBs’ primary function is to ensure safety. Nevertheless, one of the statutory requirements for approval is that “Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.”link.

    A study that has inadequate scientific justification and/or design cannot reasonably be expected to result in important knowledge or provide benefit to its subjects.

    In my (limited) experience, most IRBs set that bar extremely low, but that doesn’t make it OK.

  13. David Gorski says:

    This whole trial is appalling. I asked Kimball to comment on it first because of his long history of opposing this trial, but I think I’ll probably have to comment on it myself in detail on Monday.

    One thing that is most remarkable is that this study was released without any fanfare whatsoever. You can bet that, had the results been positive, it would have been trumpeted with press releases. I bet that even if the results had shown that the Gonzalez protocol was no worse than “conventional” therapy, it would have been trumpeted as “Gonzalez therapy as good as conventional chemotherapy!” to the press. Yet, here we have exceedingly striking results, and what do we hear? Nothing.

    One reason I wanted to wait until Monday to post about this instead of posting on my other blog or doing a “bonus” post last week is because I had hoped to wait to see what the alt-med crowd says about this. Thus far I haven’t heard or seen anything. The silence is truly deafening.

  14. qetzal says:

    We could have a contest – who can be the first to find a prior supporter of the Gonzalez protocol that now agrees that the data proves it doesn’t work, beyond any reasonable doubt?

    Not sure anyone would ever win though.

  15. Harriet Hall says:

    What amazes me is the sheer number of interventions in this protocol. How on earth did he come up with this particular combination? How did he justify each intervention? And if the protocol worked, how would you ever know whether it was due to one or a subset of components or whether the entire rigamarole was necessary?

    You might call this “Kitchen Sink Medicine.”

  16. nitpicking says:

    kausikdattaon 11 Sep 2009 at 5:23 pm

    Can Rep Dan Burton and Senator Tom Harkin be sued now, based on their active involvement in this fraud involving human lives and NIH funding? Someone in this litigious country should take up that cudgel, this time for the right reasons.

    No, they can’t be sued. In the USA, government officials from the President to the lowliest bureaucrat are protected from lawsuits for actions taken in the pursuit of their official duties.

    The only way Burton could be sued would be if you could prove he took these actions because of bribes from the papaya and coffee growers. Since he’s a sincere loon rather than a crooked one, he’s safe.

  17. Wholly Father says:

    “this study was released without any fanfare whatsoever”

    I was once an investigator in a study terminated early because of imbalance in mortality. There was an emergency meeting of the investigators, An expedited data data dissemination plan was initiated. First surviving patients were notified. Because of the significance of the outcome, there was a press release. An expedited publication came out within a few months.

    How many patients were victims of this snake oil during the 4 years when the results are known to only a few? In the opinion of the Data and Safety Monitoring Board, it was unethical to continue the study. What about the ethics of embargoing the results for 4 years?

  18. David Gorski says:

    Well, given that the disease studied was unresectable pancreatic cancer, after four years you can be close to 100% certain that none of the study subjects will be alive in either the control group or the Gonzalez protocol group.

  19. Dr Benway says:

    I sure hope the investigators can explain their delay in reporting their results. Dead witnesses aka litigants are too convenient.

    If they’ve got nuthin’, then we need to seriously hurt these dudes. They’re not doctors. They don’t even get what being a doctor means.

    RE: Going after Harkin or Burton. As awesome as that sounds, it’s wrong-headed. The buck has to stop with the highly educated MD caring for the patient.

    Bad idea to let MDs delegate or share their responsibility to weight risks and benefits appropriately. They’re only human, and they’ll turn into corporate sallaryman pussies who shrug and go, “boss says…” if allowed to do so.

  20. Wholly Father says:

    I’m talking about the patients treated by Dr Gonzalez (and possibly elsewhere) who decided to forgo conventional treatment. If the results of the clinical trial had been public knowledge, perhaps they would have decided otherwise.

  21. qetzal says:

    Wholly Father,

    That’s a great point. Is there any evidence that people who were privy to the results prior to publication continued to offer the Gonzalez regimen?

    Gonzalez himself is not an author of the study publication. I assume he had no direct role in the trial?

  22. kausikdatta says:

    Wholly Father,
    RE: going after Harkin or Burton. I understand that my first response was rather an emotional one than a logical one. It is true that going after them would not directly do anything. But as mentioned in Kimball’s earlier posts on this issue, Rep Dan Burton was directly responsible for the political arm-twisting of NIH into funding this study.

    I feel frustrated that there is no mechanism to prevent political pressures from bearing down upon NIH, thereby harming two concepts critical to its mission – objectivity and scientific reason.

  23. daedalus2u says:

    These ethical lapses are quite disturbing. Dr Atwood alluded to the sense that because the trial was so unethical and violated the Declaration of Helsinki, that it should not have been published.

    I think that is correct in the sense that no one should profit or derive a benefit from their unethical treatment of another. To the extent that an author receives citations and career kudos for participating in the exploitation of these poor patients I think that is correct. However, letting the perpetrators be the gatekeepers for any discussion of their unethical exploitation of patients in such a trial is problematic.

    Not informing the community about the results of the trial is problematic too. Individuals volunteer for trials knowing that they may not get optimum therapy and that the trial is supposed to demonstrate which leg of the trial is better than the other so that other individuals can benefit from their experience. To not publish the trial is to also exploit the participants.

    Using the meme that no one should profit by exploiting another, I think it is unethical for the journal to charge for the paper, it should be open access. The cost of publication is tiny compared to the cost of the trial which is negligible compared to the human cost of the exploited subjects.

    I hope that this paper does lead to a discussion of the ethics of the trial in the journal that published it. Including discussions of the politics behind it.

  24. Gonzalez himself is not an author of the study publication. I assume he had no direct role in the trial?

    Gonzalez had a direct role in the trial. He treated the subjects in the “enzyme” group. That he was neither an author nor identified in the paper as the treating physician for that group is one of the pieces of “unstated” information mentioned above. It has several ramifications that I’ll discuss on Friday.

    Other points that you’ve all mentioned are also on the agenda; not the least is the four years that lapsed between study termination and publication: a clear violation of medical ethics, for exactly the reason stated by Wholly Father.

  25. pmoran says:

    Harriet: “What amazes me is the sheer number of interventions in this protocol. How on earth did he come up with this particular combination? How did he justify each intervention? ”

    I know the question is rhetorical. Of course, AM has no internal standard through which successful “alternative” methods could rise above the pack or useless ones could be discarded.

    So the quack simply hedges his bets by using as many as feasible. He are also more or less obliged to incorporate any that the patient is interested in through through their own “research”, for fear of recrimination when things go badly.

    So within wide limits alternative cancer protocols inevitably converge on a cluster of currently fashionable methods.

    Hulda Clark demonstrates this. She never had an original idea. She took many presently popular themes in alternative cancer theory and simply elaborated upon them to a ridiculous level of detail.

  26. Harriet Hall says:

    The convenient thing for the quack is that the regimen is so complicated that if it fails he can blame the patient for not following his instructions to the letter.

  27. Wholly Father says:

    The publication clarifies the timeline:

    “On February 17, 2005, because of the number of events in the enzyme arm, the data safety monitoring committee established the following stopping rule: At the 10th death among patients in the chemotherapy arm, if the two-sided, adjusted, log-rank test rejected the null hypothesis at a type I error rate of .001, the study was to be closed to accrual”

    “On October 17, 2005, the stopping rule criterion was met, and the
    “study was closed to accrual”

    It is a testament to how dismally the Gonzalez patients did that a P value of .001 was achieved after only 10 events in the chemotherapy group.

    The paper does not say what happened to surviving patients who chose the Gonzalez protocol. Hopefully they were notified and treated with conventional therapy.

    The next priority should have been dissemination of the study results to the public.

  28. pmoran says:

    I am puzzled by the very high early mortality in the Gonzales-treated patients (see graph), considering the patients all supposedly still had quite reasonable performance status. This looks to be the main difference in outcomes, and I wonder why. It makes me a little nervous as to whether there was some unknown selection bias.

    It is nonetheless clear that the Gonzales’ regime doesn’t work, as we all predicted.

    Regardless of how we may feel about such studies, a lot of patients will be grateful for this information. It is even reassuring for those who stick with conventional care, while being constantly assailed by “alternative” advice. This may yet prove to be money well spent.

    The high early mortality in the SEERS study is to be expected, since this is a less selected population.

  29. trrll says:

    So the quack simply hedges his bets by using as many as feasible. He are also more or less obliged to incorporate any that the patient is interested in through through their own “research”, for fear of recrimination when things go badly.

    And of course, the more “stuff” you are doing, the more it seems reasonable to charge….

  30. overshoot says:

    One reason I wanted to wait until Monday to post about this instead of posting on my other blog or doing a “bonus” post last week is because I had hoped to wait to see what the alt-med crowd says about this. Thus far I haven’t heard or seen anything. The silence is truly deafening.

    Someone posted this to MHA in a series of messages yesterday. Nothing but cricket chirps.

  31. overshoot says:

    The paper does not say what happened to surviving patients who chose the Gonzalez protocol. Hopefully they were notified and treated with conventional therapy.

    I don’t get that impression. Looking at those curves, by the time the deaths in the chemo branch hit ten, the “enzyme” branch would be down to fewer than six survivors, assuming approximately equal rates of recruitment in each branch. Given some of the quotes, I gather that if anything the “enzyme” branch led the “chemo” branch by quite a bit numerically, so this would be quite conservative.

    What really strikes me, though, is that they closed the trial when the chemo fatalities hit a preset limit. Not the “enzyme” fatalities — which any rational risk analysis would have set as the cutoff. Look at those curves again! Six months in, the “chemo” branch had lost less than 10%, the “enzyme” branch had lost more than 60% What kind of study doesn’t have a “we’re killing our subjects!” cutout?

    “I know we’ve lost every subject on the enzyme branch within weeks and the chemo branch hasn’t lost any yet, so keep recruiting more to the certain agonizing death side.”

  32. daedalus2u says:

    In reading the OHRP determination letters again and their responses to the complainant, it sure reads like an attempted hack job by the complainant, an disingenuous attempt to find any thing to complain about, throw it up and see if it will stick.

    When I got to (7) complaining about individuals with “significant histories of psychiatric illnesses” not being excluded, I had a “Catch-22” moment. Only someone who was “crazy” would consent to the Gonzalez regimen, but if you are “crazy” you are not allowed to enter the trial. Therefore results from anyone who is willing to undergo the Gonzalez regimen can’t be used to show the Gonzalez regimen doesn’t work.

    It is a sign of someone trying to “game” the system, not trying to find out what reality is and then conform to it.

  33. TsuDhoNimh says:

    because of the number of events in the enzyme arm

    Were those “events” perhaps “clinically adverse events” … you know, what the general public might call “deaths”?

  34. David Gorski says:

    I am puzzled by the very high early mortality in the Gonzales-treated patients (see graph), considering the patients all supposedly still had quite reasonable performance status. This looks to be the main difference in outcomes, and I wonder why. It makes me a little nervous as to whether there was some unknown selection bias.

    I’m doing my own commentary on this study for tomorrow. I think I have one idea why this might have happened. It’s a bit speculative and tenuous, but consistent with known prognostic factors for survival in pancreatic cancer. It is not surprising that Dr. Atwood might not have picked up on it, but it is rather surprising that the investigators did not, given that it might have allowed them to make their results seem ever so slightly less disastrous.

  35. pmoran says:

    Ralph Moss has written a lot about the Kelley/Gonzales enzyme therapy, and must be getting very depressed at not yet coming up with any winners from the methods he has been supporting over the years. He has so far left comment to someone else, but seems to be accepting the results.

    See–

    http://www.cancerdecisions.com/content/view/232/2/lang,english/

    So far no mention on a hard core alternative cancer list I monitor. It will eventually appear, but that mailing list has a strong in-built resistance to negative news about AM methods and this study undermines many presently popular methods (diet, a broad spectrum of “supplements” , “detox”, enzymes, “animal glandulars” etc).

  36. David Gorski says:

    An online friend of mine has posted links to it on misc.health.alternative. He’s reported deafening silence.

  37. I am puzzled by the very high early mortality in the Gonzalez-treated patients…

    I had planned to comment on this in Part II, but since you’ve both mentioned it, here are my thoughts. First, whatever benefit the chemotherapy had would have been at its maximum at first, when the subjects were in their best shape and when the cancer cells were most sensitive to the chemo. The ‘enzyme’ group, obviously, lacked that benefit. Second, there is a sentence in the discussion (Dr. Moran, you won’t have seen it if you haven’t got the full paper) that is intriguing:

    The unexpectedly long survival observed in the gemcitabine group also may have been due to the selection criteria and changes in supportive care (eg, better use of surgical procedures, antibiotics, pain medication, and non-invasive placement of biliary stents).

    I think that the authors were referring to the unexpectedly long survival of the chemo group in this trial compared to other chemotherapy trials. The wording, however, is not entirely clear. If they meant ‘compared to the Gonzalez group’, then we must wonder: What implied differences in selection criteria? Didn’t the authors go out of their way earlier to show that they were similar for the two groups (other than subject preference)?

    Regarding ‘changes in supportive care,’ the authors were EITHER suggesting that supportive care in this trial was superior to that in previous trials, OR that in this trial it was superior in the chemo group relative to the Gonzo group. I suspect they meant the former, but they may have inadvertently shed some light on the early mortality difference.

    Their examples of supportive treatments could all have affected mortality. For both scientific and ethical reasons there should not have been important differences in supportive care between the two groups in this trial, but I’d be very surprised if there weren’t. If so, this is another, likely reason for the difference in early mortality. Glaring differences in treatments such as biliary stents should have been stated in the results, of course, but they were not, so we can’t know for sure.

  38. DevoutCatalyst says:

    “An online friend of mine has posted links to it on misc.health.alternative. He’s reported deafening silence.”

    This was an elaborate kitchen sink thrown at a problem. A small plumbing store of kitchen sinks, believed to synergistically kick major butt. Instead, a number of pet therapies went down the drain, but these are little Phoenixes, and will regroup to kick butt again another day.

  39. Dr Benway says:

    “…synergistically kick major butt.”

    Yeah, I’m getting tired of that one.

    I don’t understand how research MDs can get away with using a word like “synergy” so erroneously.

    One must document the effect of interventions A, B, and C separately first. Then one can calculate the presumed additive benefit of A + B + C as a basis for comparison to a study of ABC used simultaneously.

    Sometimes the effect of ABC is less than A + B + C; sometimes it’s the same; sometimes it’s more. Only when it’s more can one claim synergy.

    These alties never seem to study one thing at a time. Yet they love that word “synergy.”

  40. Wholly Father says:

    Dr Benway,

    But “synergy” sounds so Kumbaya, but so science-y at the same time. Please don’t burden these words with the expectation that they actually have a specific meaning. That takes away the magic.

  41. oderb says:

    I have commented before on Gonzalez posts on this site. I am a 20 year long patient of Gonzalez. I had metastatic cancer in the liver when I saw him and here I am in excellent health.

    I am of course dismayed at the results. I will be seeing Dr Gonzalez very soon for my semi annual checkup and the study and his response to the study will be the primary topic I’ll want to discuss with him. Based on what he says I will have to decide whether to continue to follow his protocol.

    However he has made claims about the study that I don’t believe have been reported on this site. They are contained in the last of 7 CD’s recorded at an all day talk at a conference in London this past Spring. What he says there about the data and results of the trial as he understood them at the time is utterly
    contrary to the study results. He also indicates that he will be publishing a 600 page analysis of the 10 year study effort. I look forward to reading it as should you.

    I am not going to quote from the tape concerning the perspective he has (or had) on the study, as his words should speak for themselves. The recordings are available for purchase from
    http://www.newspringpress.com/lectures.html

    I hope someone here does purchase the CD’s and listens them in their entirety as they are as far as I am aware the most comprehensive description of the history, science and efficacy of his work ever presented by Dr. Gonzalez.

    On a personal note I had naively I guess hoped to read even one comment here where someone spoke not as a scientist or physician but as a human being and said essentially they take no satisfaction from the results and that they wished Gonzalez had proven them wrong and had come up with a effective treatment for metastatic pancreatic cancer. Millions of people would have been given hope, and new avenues for further research would have opened up.

    Fair or unfair, I can’t help but believe that the majority of people posting were consciously or unconsciously delighted to see him fail, whatever their reservations about the study protocol or the pros and cons of publication.

    We have spent tens of billions of dollars and are little closer to treatments that significantly – by multiple years – extend lives with most of the common adult metastatic cancers. What a tragedy.

  42. pmoran says:

    Oderb, I know what you mean, but remember we already KNEW the methods would not work if examined under tighter conditions. I and others predicted that on this very blog. There was nothing to be disappointed about.

    I think I also asked you for details of your history, especially as to your diagnosis and staging. Looking back at that may provide further understanding of what went on in your case, and help with your decision as to whether to continue this regime.

    I would not be surprised if Gonzales enountered prejudice and other obstructiveness during the conduct of the trial because there were ample reasons for regular doctors to be biased against him.

    But let the facts speak for themselves. So far as we can determine the last 43 patients that Gonzales has treated for pancreatic cancer have died within the usual time frame.

  43. Chris says:

    oderb:

    We have spent tens of billions of dollars and are little closer to treatments that significantly – by multiple years – extend lives with most of the common adult metastatic cancers. What a tragedy.

    Doesn’t that depend on the particular type of cancer?

    Also, exactly how does two coffee enemas a day supposed to help?

  44. pmoran says:

    I now have the full study. There were proportionately more metastatic cancers in the Gonzales group. This would well have contributed to that group’s higher early mortality, but also not fully account for the loss of 50% of its members within 4-5 months while the chemotherapy group lost almost none.

    I guess the chemo will account for some.

  45. pmoran says:

    Oderb, you forget that we predicted the results. There was nothing for us to be disappointed about.

    Gonzales undoubtedly would have experienced medical antagonism, bias, and possibly even some obstructiveness, for the very same reasons that enabled us to predict the results. So I am sure has plenty to complain about.

    What he cannot deny is that the last 41 patients he has treated for presumed pancreatic cancer have died, and without any obvious survival or symptomatic benefits.

    I believe I asked you once before for details of your own case, especially those relating to diagnosis and staging, but I cannot recall you providing them. Reviewing that material may help us understand what happened with your case, and help you know whether it is worth your while continuing with the treatment.

  46. daedalus2u says:

    I have an idea why more patients died quicker on the Gonzalez regimen and by metastases. I think it may have been too much nitric oxide. One of the mechanisms that prevents metastasis is anoikis, detachment-induced apoptosis, and higher levels of NO inhibit that at least for some types of cells.

    http://www.ncbi.nlm.nih.gov/pubmed/19706615

    In poking around a bit on PubMed, there are some associations between iNOS in pancreatic tumors and increased metastasis. iNOS makes both NO and superoxide, so which it is making more of is not always clear. The right amount of NO is necessary for angiogenesis which is necessary for growth of metastases.

    A vegetarian diet is rich in nitrate, and nitrate is reduced to nitrite by commensal bacteria on the tongue. There is considerable crosstalk between NO and nitrite, especially in regions of hypoxia and anoxia (which often typify tumors). There are many nitrite reductases which are inhibited by O2 and become very active during anoxia and generate copious NO. A diet rich in nitrate may not be a good idea if you are trying to prevent metastases.

    This might be one of the few instances where you can have too much NO. If dietary nitrate is affecting metastasis, it might have an effect on where the metastases show up. The effect is probably more of an increase in number rather than skewing the site where they show up.

  47. Oderb,

    I take no satisfaction from the results in the sense that they reflect the horrible fates of many people. That is why I wrote “such as they are” in the first sentence of my last paragraph above. The only satisfaction I take is that the results were finally made public. As Dr. Moran wrote, we predicted those results. I hope, but I doubt, that this report results in fewer people having to endure what those poor subjects endured. Their fates were miserable and tragic, and in my opinion were made all the worse by their having been treated by Gonzalez. Please re-read the account by Susan Gurney, linked above.

    Regarding “new avenues for further research,” there are some very promising ones (see this year’s Lasker Awards), but they have absolutely nothing to do with pancreatic enzymes or coffee enemas or Gonzalez or Gerson or antineoplastons or Hoxsey or any other “alternative” claim or claimant, and it’s virtually certain that they never will. The real action is in the science of cancer, which is far more complex and esoteric than any of these pretenders could possibly understand.

    And yes, clinicians and biomedical scientists are fully aware of the limits of current treatments. Here’s another recent opinion from a real scientist. He may or may not be right, but this sort of thinking is where the action is. It is not with “alternative” methods.

    The only question we are left with, Oderb, is “what about you?” What’s surprising to us is not that Gonzalez failed; it’s that there are still people claiming to have first-hand knowledge of his purported successes. You state that you are one of those people. Please help us understand by answering Dr. Moran’s request for more information.

  48. Dr Benway says:

    As medical horror stories go, I’d count this just under the Tuskegee syphilis study.

    If anyone is on this protocol via Dr. Gonzalez’ clinic right now, the cops need to get in there right away with a warrant, shut the place down, and confiscate all the records before they vanish.

  49. David Gorski says:

    Dr. Gonzalez has responded.

    Not surprisingly, he claims it’s all a conspiracy and he’s going to get Dan Burton to look into it. He also whines about using an “intent to treat” analysis for his nutritional therapy, in essence, special pleading. It’s pretty much the usual self-serving twaddle. One point Gonzalez makes that is actually valid is that there was no mention in the manuscript of the OHRP letter that outlined several serious problems with the administration of the trial, including informed consent issues, etc. Not that his complaint there isn’t also self-serving, but it’s one of the very few things in the copious verbiage in Gonzalez’s defense that isn’t obvious twaddle.

    I hope Kim will address this in his next post. I may have something to say about it, either here or elsewhere, myself. I just haven’t had time to wade through the whole thing yet.

  50. Dr Benway says:

    Dr. Gonzalez,

    I recommend you look up the word “onus” on the Internets. In short: the onus is on the person promoting a therapy to publish evidence of its benefit prior to promoting it.

    Had you understood the meaning of “onus” and borne its burden, you might not now stand in danger of multiple murder, manslaughter, or wrongful death charges.

    Cheers,
    titmouse

  51. Dr Benway says:

    Just FYI:

    NY District Attorney
    Special Prosections Unit
    Thomas Wornom, Bureau Chief
    212-335-8900

    “If you have been a victim of a crime involving any fraudulent activity or would like to report allegations of criminal activity that may require further investigation, please contact the Special Prosecutions Unit.”

    Someone better immersed in the facts than I might want to let the NY DA know that patients are having their lives shortened right now, today, at this very moment, by Dr. Gonzales.

    I’d bet money that Dr. Gonzales hasn’t explained the meaning of the graph above to his patients.

    Doctors are smart. Evidence that might help to convict of criminal (“knowingly”) vs civil (“should have known”) wrongdoing is likely getting buffed as we chat.

  52. daedalus2u says:

    I find Gonzalez’s response completely disingenuous. Out of 32 patients not a single one was capable of following his protocol and then be cured of their pancreatic cancer? I thought that CAM was supposed to be “individualized” to the patient. If the patient can’t follow the protocol, is it the fault of the patient?

    Why was there no measure of protocol compliance? such as counting the number of pills that were taken as opposed to the number that were supposed to be taken. Counting the number of coffee enemas, the number of liver flushes, the volume of vegetable juice taken.

    If the patients were not compliant, why were they left to die because of that non-compliance? Why was there no follow-up during the trial? People can be feed via tubes, they can be fed anything via tubes including 150 supplement pills per day. Why weren’t they?

    If half the patients on the Gonzalez regimen died in 4.3 months, isn’t that a “clue” that the patients in the trial were not following the disease course that Gonzalez expected?

  53. Harriet Hall says:

    That’s the way it works. Make the protocol so complicated that no one could possibly be 100% compliant. Say those who survive were treatment successes. Say those who didn’t were not treatment failures because they weren’t compliant. Win-win.

  54. Wholly Father says:

    I read through Dr Gonzalez rebuttal, and some of the linked documents. My take: a fundamentally flawed study, run without adequate adult supervision.

    Gonzalez argues over and over that patients entered in the nutrition arm needed to be more carefully screened for suitability, mental health, dedication to the regimen, etc. In order to avoid major bias, patients in both arms have to be screened according to exactly the same criteria. This is very difficult to do in a study in which patients choose their own treatment regimen. It seems clear that Dr Gonzalez was excluded from the screening process to avoid preferential screening (cherry-picking) for the “nutritional arm”.

    He also argues that patients who did not comply with the demanding nutritional protocol be excluded from the analysis. One possible reason for noncompliance is progression of the cancer Excluding these patients would introduce certain bias. This is exactly why an Intent-to-Treat analysis is necessary. A per-protocol analysis is sometime done as a secondary analysis, but this would be hugely problematic for this study.

  55. oderb says:

    After reading the Gonzalez rebuttal, as it were, I am incredulous that none of the commenters above mention the fatal flaw that discredits the entire study process and results – and that is the blatant and egregious conflict of interest of the PI Dr. Chabot.

    Here is a PI who helped develop the unique chemotheraputic protocol at Columbia being tested as the ‘control’ arm, who apparently never declared that was the case, and who also had sole jurisdiction over admitting patients to the Gonzalez arm (and by the way violated informed consent procedures).

    As for the claim Harriet that the protocol was intentionally made too complicated for people to follow, that’s just false and malicious. What proof do you have of that? As I wrote in an earlier post if you listen to the tapes of his lecture in London, as well as other materials on his website he provides the rationale for his entire program. You may utterly disagree with his rationale but don’t impugn his motives.

    There is also much more in the Gonzalez rebuttal materials that go well beyond ‘whining’, but I’ll leave it at that.

    That said, one certainly can’t say that the his rebuttal showed that his protocol is superior to chemo. Just that this study is fatally fatally flawed.

  56. Chris says:

    So, oderb, instead of answering Dr. Moran’s question you resort to accusations of conflict of interest. That is interesting.

    It is also a fatal flaw if you wish to be taken seriously.

  57. Dr Benway says:

    Dr. Gonzalez graduated from quack to murderer the day this study met its stopping criteria and he continued to promote it and use it with his patients.

  58. pmoran says:

    Oderb: “That said, one certainly can’t say that the his rebuttal showed that his protocol is superior to chemo. Just that this study is fatally fatally flawed.”

    Well, yes and no.

    If you very generously compensated for Gonzales 50% early mortality by doubling his survival rates at 10 months you would still barely improve on SEER survival data. Yet those figures include all-comers, no matter how sick they are and no matter how many special diets, supplement capsules and unpalatable enzymes they are unable to consume.

    So these are disastrous results. They cannot be negated by pointing out a few patients who may have been wrongly assessed.

    It is also not a plus if you have to be an unusually healthy patient with inoperable pancreatic cancer in order to be able to endure the regime. That doesn’t apply to chemo with its admittedly modest benefits.

    Even if unintended selection biases, such as Gonzales having to treat a few more patients with metastatic cancer, explained some of the exceptionally poor result, they just as surely negate the results of the pilot study that prompted this study in the first place. That study included patients with obviously better prognosis than average, even one case with operable cancer. And they all died, with none having objective remission.

    So why should we be bothered further with this nonsense? Others have tried proteolytic enzyme treatment without obvious success (e.g. Contreras). No treatment would survive for a microsecond within the mainstream with so little going for it.

    The complexity of the regime attests to the characteristic desperation of the quack as he tries to find some combination of measures that actually does anything with any consistency. He has to strive constantly for the next case that seems to do better than expected, amidst that sea of failure.

    I am sure this study will be followed by the usual wave of paranoia and excuse-making within “alternative” circles.
    As I have said, there is no internal standard within AM through which successful methods could be detected or useless ones discarded.

  59. oderb says:

    Dr. Moran and Dr Atwood,

    With all due sincerity, I don’t understand your request for more detailed information on my medical history vis a vis Dr Gonzalez. If you’re truly trying to give me advice, I genuinely appreciate the offer, but I have a trusted conventional oncologist who I can and most likely will see – and I’m sure you would agree that it is better for me to get advice from someone in person who knows me rather than over the internet.

    If you’re interested in my case to determine whether I’m truly a Gonzalez success study, then I also don’t understand. In the months since I found this site, the mantra I hear over and over again is that the plural of anecdote is not data, so my story is surely irrelevant to the larger questions raised about the efficacy or lack thereof the Gonzalez protocol.

    I am happy to provide more narrative regarding my experience with Dr Gonzalez, the specifics of the program and so forth but that doesn’t seem to be what you’re requesting.

  60. Todd W. says:

    One thing I would add to this discussion about whether more people would have survived if they’d been screened properly, etc., is that the quality of life was lower for the Gonzalez arm than the chemo arm.

    If a treatment is too aversive, people are not likely to use it, even if it’s the most effective treatment in the world. 150+ pills a day, coffee enemas, mineral baths, skin scrubbing, etc. is likely going to be too much for just about anyone except those who feel they have no other option. And even then it would be tough. The aversive quality of the protocol alone renders it impractical to offer to patients.

  61. pmoran says:

    Oderb, my position is that anecdote varies greatly in quality. It can be useful, but that arising in relation to alternative cancer cures is almost invariably of such abysmal quality as to be worthless, despite the fact that cancer is generally a highly predictable condition that can be easily measured in most cases.

    Partly through consideration for the feelings and hopes of cancer patients supplying testimonials, but also because it is easier to just dismiss it all as “just anecdote”, most skeptics have avoided tackling testimonial head-on. This has probably been a mistake, allowing a huge alternative cancer industry to thrive on this very shaky basis.

    I have proposed a different approach on my web site. I am forced now to constantly test out my view that there are nearly always very probable alternative explanations for the outcomes described in testimonial.

    Hence my request. It is not unreasonable. You are making an extremely important medical claim, that has the ability to rightly or wrongly influence others. You should yourself want to be certain that there is no room for error. I would also wonder why Gonzales has not published your case, if it is as you describe.

  62. Chris says:

    Here is an old blog posting by a friend of this blog: Understanding alternative medicine “testimonials” for cancer cures. Near the end are these informative words as to why the testimonials are hard to believe at face value:

    So, in conclusion, be very skeptical of alt-med testimonials. If you look at them closely, you will often find that the patient did have significant conventional treatment (such as surgery); that the story is vague (often omitting, for example, the stage or histology of cancer or even whether the cancer was biopsy-proven); that there is no objective data, just references to other testimonials; or that the data mentioned either comes from alt-med websites selling a product rather than peer-reviewed medical journals or is a non sequitur about studies in peer-reviewed sources.

  63. RebeccaF says:

    I am not going to quote from the tape concerning the perspective he has (or had) on the study, as his words should speak for themselves. The recordings are available for purchase from http://www.newspringpress.com/lectures.html

    Oh, why am I not surprised that people are supposed to pay money to get his perspective on that? Can you imagine the doctor that led the chemotherapy part of this study wanting $55 for hearing his reasoning for using chemotherapy?

  64. oderb says:

    Dr Moran,

    I appreciate your comment above and your respectful and compassionate tone – unlike Rebecca’s snarky comment – whose tone is all too common on this blog. The reason I waited until now to respond is because I had my semi annual appointment with Dr Gonzalez earlier this week and wanted to question him personally about the study.

    As I said in previous posts I don’t support Dr Gonzalez because of the course of my illness per se. I had a typical bronchial carcinoid – which spread to the liver and caused me to develop carcinoid syndrome.

    I am well aware that a carcinoid – particularly the typical as opposed to the atypical type – can grow very very slowly -even after it spreads to the liver, and so while I believe that the odds of being alive and well 21 years after its spread are quite low they are definitely a fair amount higher than zero, and so I am prepared to accept that I cannot with 100% certainly (maybe 80-90% certainty) credit Dr Gonzalez with a definitive cure ( I have had no other conventional treatment other than surgery for the primary tumor). I noticed with some regularly – particularly in the early years with him – that when I slackened off on compliance with his protocol the carcinoid syndrome symptoms – diarrhea and flushing – would come back, and as soon as I resumed the protocol they would gradually resolve. I don’t consider this ironclad “proof’ that the enzymes caused the resolution, but it sure convinced me that something special was happening on his protocol and that it was worthwhile to continue on his arduous regimen. (Certainly it could have been a placebo response on my part).

    My support for him comes more from getting to know the man quite well after 21 years and dozens of hours of office visits with him and seeing his amazing knowledge, reassurance and compassion, dedication and patient explanation of all aspects of his protocol – the mechanics of it and the rationale as well.

    The picture that is painted of him by so many on this blog – of a charlatan, a quack, and worse is so contrary to my experience with him, and the experience of other of his patients who I have known over the years. I – naively I know – wish that some of you could sit with him and have a civil discussion of your skepticism and his beliefs.

    As I’ve written before as well, why would a doctor with such a controversial protocol spend 20 years fighting to have it tested unless he saw the good that it was doing with his – yes – carefully selected patients? He could have continued his busy practice indefinitely, keeping a low profile but he chose to engage with the conventional medical community. For that he deserves credit in my opinion.

    I have a bit more to say about the study and my visit to Dr Gonzalez which I just posted to orac’s blog at

    http://scienceblogs.com/insolence/2009/09/the_gonzalez_protocol_worse_than_useless.php

    For those who don’t choose to view that post my conclusion after questioning him and closely reading the rebuttal on his website is that the JCO study is fatally flawed. There is evidence I personally saw in the form of a chart from the 2006 article by Dr Chabot that was attempted to be published behind Dr Gonzalez’ back in JAMA – that several of his patients lived longer than the longest surviving chemo patients -evidence contrary to what was presented in the JCO article – despite the fact that he believes that only a handful of patients complied with his protocol – a much much lower percentage of compliance than those who he chooses to treat in his practice.

    I certainly can’t conclude that the study vindicated his work – just that the Gonzalez protocol has – sadly in my opinion – not been validly tested.

    For those with an a sliver of an open mind stay tuned in the coming months for the results of the fraud investigation and the publication of Dr Gonzalez’ narrative of the study.

  65. oderb says:

    I guess interest in Gonzalez had evaporated. But I just found out that Gonzalez will be on a panel with conventional doctors on Larry King this coming Monday night.

    Your chance to see the ‘quack’ in action….

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