Pity poor Nick Gonzalez.

Sorry, I couldn’t resist. After having used the same line when discussing the hugely enjoyable humiliation of the Godfather of HIV/AIDS denialism, Peter Duesberg, I couldn’t resist using the same line to introduce my response to Dr. Gonzalez’s woo-ful whine in response to the publication of the disastrous (for him and any patient unfortunate enough to be in the arm receiving his protocol) clinical trial that demonstrated about as unequivocally as it is possible to demonstrate that his “protocol” to treat pancreatic cancer is nothing more than as steaming and stinking a pile of excrement as the, well, “results” of the twice daily coffee enemas that are a part of his treatment, along with all sorts of raw vegetable juices and 150 supplement pills a day.

The first thing I have to wonder upon seeing this, which several of you sent to me and one or two others posted as comments, is: What took Dr. Gonzalez so long? After all, the Journal of Clinical Oncology article reporting the results of the study of the Gonzalez protocol versus the standard of care at the time, gemcitabine chemotherapy, was published nearly a month ago online. Complete and utter silence reigned; that is, until Kimball Atwood, Steve Novella, and yours truly posted deconstructions of this study and pointed out how it should, if there is any science left in academic medicine (or, if you’re a believer, if there’s a just and righteous God in heaven), be the last nail in the coffin of the misbegotten magical, mystical hodge-podge of woo known as the Gonzalez therapy, which turned out to be worse than useless.

It looks as though ol’ Nick is trying to take a crowbar to the coffin and pry open the cover. He begins, appropriately enough, by trying to throw the principal investigator of the study, Dr. John Chabot, under the bus, just as Chabot threw Gonzalez under the bus by publishing the JCO article in the first place:

Recently, to our astonishment we learned that the Journal of Clinical Oncology, considered to be one of the pre-eminent oncology journals in the country, published an article about our NCI-NIH clinical study which claimed that chemotherapy worked better than our treatment with patients diagnosed with inoperable pancreatic cancer.

Though I originally earned the grant from the NCI in 1998, though I was an investigator on this study throughout its existence, and though the clinical trial was set up to compare the efficacy of my treatment with chemotherapy, no one involved with the publication – not the Principal Investigator, Dr. John Chabot of Columbia Presbyterian Medical Center, nor any of his associates, informed me of their intent to publish this article, nor had I seen it. I learned of it serendipitously when the online version appeared on PubMed.

I suppose it’s possible that Gonzalez was so out of the loop that he was unaware that the paper was about to be published, but I tend to doubt it. He’s clearly known that the study was not going to make him look favorable for quite a while, so much so that he has written a book, and had a chapter pre-written and ready to run outlining all the evils he perceives in the study and how it is so badly designed and run, not to mention totally unfair to him. (He also in essence appears to admit elsewhere in his response that he was the one who sent the dogs after Dr. Chabot.) In response, Gonzalez has produced a huge pile of self-serving twaddle, mainly a lot of playing the martyr and complaining that it’s all a conspiracy to make him look bad in order for the principal investigators to save their academic reputations. Actually, Gonzalez may have a point there that I might even agree with. True, it’s just as self-serving of him to bring up this point, but it’s the one comment he makes in the entire torrent of verbiage in his response and all the linked files that isn’t utter twaddle:

In their official determination letter appearing on their website after a two-year investigation, the Office of Human Research Protections, the NIH agency in charge of investigating mismanagement on government funded studies, found that Dr. Chabot, who was in charge of admissions of patients, had improperly approved 42 out of a total of 62 patients, including 40 for whom he had failed to obtain appropriate written informed consent. Furthermore, the determination letter states that the Principal Investigator (Dr. Chabot) admitted he committed the managerial lapses, and in their letter the OHRP requires Columbia set up a program for training in appropriate research methodology – a serious indictment of a major academic medical center.

To my astonishment, the JCO article nowhere mentions the findings of the OHRP, as if this lengthy investigation never existed, leaving the reader with the impression this study was properly managed by Dr. Chabot. In that regard, the article is a gross misrepresentation of what actually transpired during the study’s sad eight year history.

As glad as I was that the results of this idiotic trial had finally been reported, I did retain a bit of ambivalence about it. The reason is, as Dr. Gonzalez discusses, there is no mention of the ethical and regulatory lapses that plagued the trial. Worse, Dr. Chabot, who was clearly an opportunistic fool to have undertaken a trial that was so clearly unethical from the very beginning, bungled the administration of the trial to the point where the Office of Human Subjects Research Protections investigated and issued a determination letter outlining a litany of mismanagement, failure to obtain proper informed consent, and other problems. Finally, after the trial was stopped because it reached a predefined stopping point due to how poorly patients in the Gonzalez arm were doing compared to those in the chemotherapy arm, Dr. Chabot waited nearly four years to publish the results. It rather makes me wonder what happened earlier this year to prod him to submit the results of the trial for publication after all that time. A stench still lies over this whole misbegotten, unethical mess of a trial, and I don’t like it that Dr. Chabot and his coinvestigators get a publication in a high impact clinical oncology journal like JCO to add to their CVs, even though I think the trial had to be published in a respectable journal in order to make sure that oncologists and other physicians take its results seriously.

That being said, the rest of Dr. Gonzalez’s little hissy fit boils down to a heapin’ helpin’ of special pleading. But first he threatens Chabot with his patron of woo in Congress, Dan Burton, an antivaccine loon who is also most responsible for prodding the NIH to fund this trial of the Gonzalez protocol:

More recently, Congressman Dan Burton of Indiana and I have requested that the Inspector General of the Department of Health and Human Services begin an investigation to determine if the supervisors of the study committed fraud in the mishandling of the project and its data. We have learned, for example, that according to the published medical literature, Dr. Chabot, who as Principal Investigator should have been a completely neutral manager with no ties to either treatment being evaluated, had worked closely with his Columbia colleague developing the very GTX chemotherapy regimen used against us in the study – an obvious conflict of interest that had never been declared to us. We suspect Dr. Chabot believed it was in his best interest to discredit our alternative therapy and instead prove the value of a treatment he helped develop.

Ah, yes, the “pharma shill” gambit. Personally, I had a hard time finding much evidence to back up this charge. A PubMed search of Dr. Chabot’s publications pulled up mostly articles about surgery, with only a couple of articles about neoadjuvant chemotherapy for pancreatic cancer. However, Gonzalez makes a lot of hay observing that partway through the trial the chemotherapy regimen used in the chemotherapy arm changed. The reason, of course, is that chemotherapy regimens were already evolving early during the course of the study. Gemcitabine alone had only resulted in marginal increases in survival; so it was quite reasonable to want to consider adding additional drugs. At the time the design of the trial was changed from a randomized trial to a nonrandomized design, a chemotherapy protocol known as GTX (Gemzar, Taxotere and Xeloda; Gemzar being the trade name for gemcitabine) had largely supplanted single agent gemcitabine protocols. Consequently, since only three patients had been enrolled, it made sense to change the chemotherapy arm to what was being given at the time at Columbia. Whether this change muddied up the trial (which it probably didn’t; the trial was muddied up enough to begin with) or not, it’s all a smokescreen thrown up by Gonzalez to distract attention from the fact that his therapy did no better than, in essence, untreated pancreatic cancer.

It’s also rather illustrative of Dr. Gonzalez’s “us against them” thinking for him to view someone as having a hopeless conflict of interest if he’s ever studied chemotherapy before. Here’s a clue: It is not a reportable “conflict of interest” to have studied before one modality that you’re studying in a clinical trial now unless there’s a financial interest in that modality. Academic surgeons and physicians study different drugs or treatments all the time. Just because they’ve studied one regimen doesn’t make them hopelessly biased to the point where they are ineligible to head a clinical trial of that regimen against anything else. It would be one thing if Dr. Chabot had expressed unrelenting hostility to the Gonzalez protocol before, but he didn’t. In fact, he put his reputation on the line to head up this study. Also, in marked contrast to Gonzalez’s complaint, Dr. Chabot himself clearly knew CAM-speak pretty well, although he was unhappy over the change of the trial to a nonrandomized design.

Be that as it may, the main strategy for complaining about the clinical trial utilized by Gonzalez is special pleading. Before I get to that, note how vociferously Gonzalez complains about Chabot’s referring patients he considered inappropriate for his trial. For example, Gonzalez points out that the patients who were to undergo the “nutritional” arm of the trial (a.k.a. the woo arm) had to be able to “eat normally.” Well, that’s cherry picking the best patients right there, because few patients with advanced pancreatic cancer can eat normally. I remember well Dr. Gonzalez’s discussion of his initial series of 11 patients who underwent his protocol. He argued again and again that the long survival of these patients compared to historical controls could not be explained by selection bias, but in essence right here he is admitting that he relied on selection bias for his results. He even admits this later when he laments that the chemotherapy protocol, because chemotherapy was given intermittently and could thus be easily given to patients who couldn’t eat while his regimen requires 150 pills a day and that even patients too ill to eat could receive the drugs in the chemotherapy regimen. Does Gonzalez realize that he’s basically saying that chemotherapy can be given to sicker patients and that the only patients who can do his protocol are the patients who are in the best shape and thus most likely to live the longest, regardless of therapy? it’s pure selection bias.

Gonzalez also complains ad nauseam that patients in the nutritional arm were not adequately screened for ability and motivation to follow the protocol. However, if one wants to avoid bias creeping into a trial, all patients would have to be screened using exactly the same criteria, regardless of which group they entered. That’s really hard to do with a trial in which patients can choose which arm of the study they want to be in. The patients choosing the chemotherapy arm would quite reasonably ask why they should be screened for the Gonzalez protocol, and screening too closely those choosing the Gonzalez protocol would allow the very cherry picking of the least debilitated patients that must be avoided. Of course, part of me wonders whether investigators intentionally cut Gonzalez out of the patient qualification and selection process for this trial because they knew he’d try to cherry pick the best patients. I also note that self-selection would similarly tend to funnel the least debilitated and most motivated patients to the nutritional arm, which would in turn tend to mean that the patients most likely to survive the longest would be most likely to end up in that arm. In essence, you’d expect that there would be an apparent survival advantage in the nutritional for that reason alone, but the results of the study were exactly the opposite–resoundingly so. Whatever shortcomings there were in the design and administration of the trial, they were not enough to explain why the patients in the nutritional arm had a median survival of only 4.3 months, in essence the expected survival of patients with untreated advanced pancreatic cancer. Robbed of his ability to pick the best patients, Gonzalez’s results were no better than no treatment at all, and certainly not the equal of chemotherapy.

Gonzalez reached his zenith of disingenuousness here:

Clinical trials lacking a lead-in period often – though not always – adopt an “intent-to-treat” format. With such a provision, researchers agree that all patients qualified and entered into the study for any of the treatments under scrutiny will be considered as having been treated, regardless if they actually proceed with the prescribed therapy or not. Though such an approach on first glance might not make much sense, researchers justify such an “intent-to-treat” rule as necessary to evaluate fully a new drug. For example, if in a study 100 patients receive some new medication but 50 drop out after a week because of serious side effects, certainly it would seem prudent to include these patients as treatment failures rather than discount them, since they quit because of some negative reaction to the drug. On the other hand, such a design can be disastrous for a lifestyle intervention trial such as ours, since patients who might initially be enthusiastic but who can’t or choose not to proceed with the self-administered dietary/nutritional regimen will be counted as having been fully treated.

In essence, Gonzalez is engaging in special pleading here. He is saying that the normal guidelines for what constitutes good clinical research shouldn’t apply to his protocol. Intent-to-treat analyses are very important because if a patient stops a treatment it can be because of disease progression or because the treatment is toxic or difficult. Either way, it’s important to know. Gonzalez seems to think that “lifestyle interventions” should be exempt from such an analysis for…no reason whatsoever. Excluding patients who couldn’t make it through Gonzalez’s protocol, which is, as has been pointed out before, quite onerous, would introduce bias in that the more debilitated patients, who couldn’t swallow 150 pills a day, along with the raw juices and various other dietary woo, and undergo coffee enemas twice a day, would be excluded, leaving patients in better shape for analysis.

I was also heartened, believe it or not to read that not a single oncologist referred a patient to the trial. This is truly good news because it tells me that there are actually still oncologists left in New York who haven’t bought into CAM:

Ultimately, only the oncology team at Columbia cooperated in any way only after much prodding by Dr. Antman and Chabot, and only for the admission of chemotherapy subjects to form the comparison “control” arm as we shall see. Even for this group their referrals proved not helpful.

Oncologists not only refused to refer patients to the trial, but at times actively discouraged their patients who might express an interest from seeking entry. A number of candidates suitable for the study who had learned about our treatment on their own informed our office that their oncologist had strongly argued against considering the project. One well-known Memorial oncologist warned a candidate interested in joining the study that I was a “quack” and the study a “fraud.”

Oncologists also frequently discouraged patients who actually entered the nutritional arm of the study from continuing with the prescribed regimen.

I’d love to know who that well-known Memorial Sloan Kettering Cancer Center oncologist was who called Gonzalez a quack and his trial a fraud, as I’d love to take him out to dinner and shake his hand. He called it exactly right, in my opinion. I’m also heartened that not even the oncology team at Columbia wanted anything to do with referring patients to this trial. It shows that there is at least some sanity at that institution. But it wasn’t just that oncologist at MSKCC. There are a lot of oncologists like him:

Unfortunately, a protocol provision against which we argued and that ultimately caused enormous damage required that each patient assigned to the nutrition arm consult with a physician monthly for an examination and blood work. On the surface, such visits would hardly seem to be the source of potential catastrophe, since, one might think, how can a visit with a doctor be a problem? And trials involving chemotherapy drugs often require frequent physician assessments to monitor closely the toxic side effects of the medications being tested, such as severe anemia or immune suppression.

For those subjects who lived in the New York area, Dr. Isaacs and I could satisfy this rule by meeting with the patient ourselves monthly. We had no problem with such an arrangement, of course. But as it turned out, only three of the patients ultimately entered into the nutrition arm lived in the New York area, with the great majority residing at great distance. Consequently, nearly all subjects assigned to us for treatment were followed by a local doctor, most frequently an oncologist completely unfamiliar with our treatment approach and usually hostile toward it, with only a few exceptions.

Repeatedly, we heard from our patients that during the required monthly meetings, the local physicians aggressively discouraged them from continuing their treatment with us, instead urging them to proceed with some standard approach – despite the fact that the conventional therapies for inoperable pancreatic cancer have proven largely worthless.

Help, help, I’m being repressed!

Put yourself in the position of one of those oncologists. What would you do? You took an oath to do your best for patients. Your training correctly tells you that this ridiculous regimen advocated by Gonzalez is based on no science and indeed so incredibly unlikely to do any good that medical ethics demands that you try very hard to persuade your patients not to engage in a course of action that your professional knowledge and understanding of science tell you to be harmful. Make no mistake, even if the Gonzalez protocol did not hasten the deterioration of the patient, it put the patient through hell for no benefit. Dr. Gonzalez scoffs at doctors who pointed out to patients who chose the Gonzalez protocol that they were choosing to spend the last months of their lives following a restricted diet, swallowing 130-170 pills a day, and subjecting themselves to coffee enemas, a protocol that couldn’t possibly help their disease, instead of enjoying themselves as much as they could with pizza and ice cream. I find nothing to criticize these doctors for; they were absolutely correct.

Finally, the most disturbing part of Dr. Gonzalez’s defense of his protocol is his admission to something I alluded to as a possibility in my previous post, namely that perhaps there were differences in palliative care between the groups. One of the most common causes of death from pancreatic cancer is biliary sepsis, namely infection of the backed up bile that accumulates behind the bile duct obstruction caused by the cancer. That’s why biliary obstruction is treated aggressively by drainage with stents, which can be placed endoscopically via the stomach and duodenum or through the skin directly into the main bile ducts in the liver. Infections need to be treated aggressively. Failure to do so can result in a patient dying even sooner than he had to.

Guess what? Gonzalez in essence admits that there were huge differences in supportive care between the two arms of the trial:

Of all the nutrition patients, only one – who ultimately survived 3.5 years – received anywhere near the level of intensive supportive care and encouragement given the chemotherapy patients. In this unique situation, the local doctors coordinated their treatment with me, realizing full well that he was sustaining a most unusual response. In no other case did the local doctors encourage aggressive intervention to keep the patients alive and also on the nutritional therapy.

Dr. Gonzalez just admitted a horrific lapse in clinical trial ethics. This lapse is not just his fault but the fault of each and every investigator in the trial. That both groups did not have access to the same level of palliative care is criminal–yes, criminal. The patients in the Gonzalez arm were condemned to suffer symptoms of progressive pancreatic cancer that were not treated with the latest and most aggressive palliative care: stents, antibiotics, laparoscopic gastrojejunostomy to bypas gastric outlet obstruction. If the investigators were unwilling or unable to make sure that patients in both arms had equal access to palliative care, then the trial should have been shut down until this glaring problem could be fixed. If the investigators couldn’t find a way to fix this disparity between groups, then the trial should have been scrapped. The reason? Simple. Medical ethics demands it. For example, the Helsinki Declaration, the international agreement governing human subjects research, which states, “In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests.” The Belmont Report, the guiding document for medical research in the U.S. states: “In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.”

Gonzalez, while trying to cover his tail, just admitted that this trial failed to maximize possible benefits and minimize possible harms–and failed miserably.

In a way, it’s fun to watch the flurry of charges and countercharges flying fast and furious back and forth between Dr. Chabot and Columbia University on the one side and Dr. Gonzalez on the other. However, we should never forget one thing, namely who suffered because of this trial. In the name of testing a ridiculously implausible “alternative medicine” therapy and an open-mindedness so wide that the investigators’ brains fell completely out, patients with a terminal illness were denied therapy that would have palliated their suffering. As much schadenfreude as I feel for Gonzalez’s discomfiture and frustration that Dr. Chabot managed to notch another publication in a high impact journal with apparently no harm to his career from his career, remember that it’s not about Gonzalez or Chabot or any other investigator. It’s about the patients with pancreatic cancer who were harmed in this study, which I view as the most unethical study done since the Tuskegee syphilis study. Never forget that as you’re buried in self-serving twaddle.

Comments

  1. #1 Chris
    December 23, 2010

    Gray Falcon:

    None of us actually accused anyone of lying, simply being mistaken. Your oddly specific denial is suspicious.

    Actually, yes, I did. Okay, I don’t think Jake is really lying, but it is odd that he is defending Gonzalez so vehemently even after being presented with evidence. He can deny the evidence if he wants, but has yet to produce any independent evidence to refute it.

    T.R.:

    Always churns out the same old supposed scientific crap over and over.

    Funny how that works. That is one thing I like about science, the rules don’t change. And when science changes, actual evidence supports that change.

    The same science is presented over and over, and then ignored, and in the return Jake has presented absolutely nothing. And who are you, and why should I care what you think?

  2. #2 squirrelelite
    December 23, 2010

    @T.R. (199),

    Actually, I think I’ll apply your advice to you and Jake. I think that comes under the category of exemplifying the behavior you expect (or at least wish for) in others.

    I actually enjoy reading Chris’s comments because, at least when appropriate, she actually presents a coherent argument in favor of something.

    That is, she does the following:

    1. State what you believe to be true.

    2. Present a logical chain of reasoning that leads to that conclusion.

    3. Back up the major points of that chain with evidence that cross-checked and evaluated.

    And, she has a lot more persistence than I do in trying to respond to people who can only answer with rhetorical dodgeball.

    Happy Holidays to Chris and my other Insolent Acquaintances!

  3. #3 squirrelelite
    December 23, 2010

    Oops!

    3. should have been “evidence that can be cross-checked and evaluated”.

  4. #4 Chris
    December 23, 2010

    Thank you, and Happy Holidays to you! We are finally decorating our tree. By the way, it turns out there is another “Chris” tonight… I have not commented on the modern Copernicus thread.

  5. #5 Jake
    January 2, 2011

    Thanks T.R. for giving me the history on Chris.
    Interesting piece in JCO:
    http://jco.ascopubs.org/content/28/12/1979

  6. #6 T. Bruce McNeely
    January 2, 2011

    Always churns out the same old supposed scientific crap over and over.

    …as opposed to the Alties churning out the same old non-scientific crap over and over?

    That was just too easy.

  7. #8 Chris
    January 2, 2011

    Jake:

    Interesting piece in JCO:

    That is just a hand waving commentary on a study. Here is another commentary on the same paper.

    Let’s make this simple: find out what exactly the benefits versus the risks are for coffee enemas.

    Go to the medical literature in PubMed and find something that shows a benefit from coffee enemas that is not from the Gerson Institute or any author associated with Gonzalez/Gerson/Kelly cancer treatment. Then come back with some real answers.

  8. #9 Chris
    January 2, 2011

    Oops, and now I realized I only read half of what Levine wrote!

  9. #10 Jake
    March 23, 2011
  10. #11 Antaeus Feldspar
    March 23, 2011

    Even if Gonzalez’s criticism of Dateline‘s coverage were correct, Jake, what would that matter? Dateline is hardly the only party who’s criticized Gonzalez’s protocol; in fact, you’re the first person to even mention it! Why do you feel the need to change the subject?

  11. #12 novalox
    March 24, 2011

    @210

    I wonder if your errant “citation” would fall under a variant of Scopie’s law?

    And, looking at that link you posted, the amount of stupid posted on there would give most people a migrane.

  12. #13 Jake
    March 24, 2011

    ANTAEUS: The subject is Nicholas Gonzalez, correct? The point was how Dr. Gonzalez’ treatment gets an unfair judgement. So much of the show displaying the opinions of a non MD from Sloan Kettering…a real expert, and another “expert”, Andrew Weil!!! Give me a break. Meanwhile the MD that did the job of investigating Gonzalez years ago and found his treatment to be “of value” (my words) got a cameo. But the big star was the woman who did the hair testing. I guess the sensational wins out over the substance!! Really ridiculous.
    NOVALOX: You missed the point. Go back to High School!!

  13. #14 Chris
    March 24, 2011

    Jake, I repeat:

    Go to the medical literature in PubMed and find something that shows a benefit from coffee enemas that is not from the Gerson Institute or any author associated with Gonzalez/Gerson/Kelly cancer treatment. Then come back with some real answers.

    So you took two months and came back with a link to an actor’s website? How is that medical literature? How does that show there is a benefit to consuming coffee the wrong way around?

  14. #15 Jake
    March 25, 2011

    Chris,
    As someone said a while back, you seem to have a fascination with the coffee enemas. Why don’t you just try them and report back to us??? 🙂
    Anyway, I have not seen anything to lead me to believe that coffee enemas are beneficial or not beneficial.
    Back to the show: Why did the MD that investigated Gonzalez and gave him a “thumbs up” (my words) get such a tiny part??
    Rather than relying on him, they relied on a PhD, doctor of sociology as an expert…what a joke. As I said before, why is Gonzalez not shut down????? Gerson was, as were many others, but he has not. When you do the enemas, I heard that Colombian grown coffee works better!!!! 🙂

  15. #16 Chris
    March 28, 2011

    Failure to answer questions duly noted. Now go up to the top of this two year old article and read about thetrial comparing methods, where those on the Gonzalez/Gerson/Kelly protocol did worse (there is a link early in the article, with links to several commentaries about it). They both died quicker and in more pain. Its authors are not just sociologists.

    The reason Gonzalez is not shut down is that there is a flaw in the system due to the liberties granted to living in the USA. Deal with it.

    While you are at it here a pair of books to help you understand the limits:
    Charlatan by Pope Brock, with that you can understand why quacks are so hard to shut down
    and
    Emperor of All Maladies, about cancer.

    With those books most of your answers will be found, and hopefully you’ll find a better hobby than being necromancer on an old thread.

  16. #17 novalox
    March 28, 2011

    @213

    Was that supposed to be an insult? Because that was as weak as they come.

    I guess with the way you post, I wouldn’t expect much intelligence from you.

  17. #18 Jake
    March 28, 2011

    Chris:
    I did answer the question about your favorite activity…the coffee enema. I said:
    “I have not seen anything to lead me to believe that coffee enemas are beneficial or not beneficial.”
    What else do you want?
    As far as why Gonzalez is not shut down, I don’t buy your answer. Nobody can put him in the same class as snake oil salesmen. He had an oncologist investigate him years ago and the oncologist came away impressed enough that he said that there is a place for him in treating cancer…that’s quite an endorsement. This was mentioned briefly on dateline. As I mentioned in another post, I’ve spoken to two of his patients, and they both had nothing but great things to say about the man.

  18. #19 Sidney
    April 25, 2011

    Chris & Jake:
    I can’t believe you two engineers are still arguing about medical procedure and research. As a retired research scientist, I can give you a little advice: DON’T believe everything you read in a scientific journal. Studies are often flawed and theories are constantly evolving. Part of the beauty of science is that our peers can suggest ideas that fly in the face of our results, test them, and expand knowledge. It is not a perfect system, but the best we have right now. The Chabot/Gonzalez study has flaws, so be wary of drawing any conclusions one way or the other. Just as an aside, trials such as this one will have gone through different “stages”, such as animal model testing, before human testing is approved. This suggests to me that there must have been reasonable evidence that Gonzalez’s method had potential before human patients were put at risk. From my perspective, another study is warranted in which ALL patients are pre-screened for willingness/ability to try either treatment protocol. This may seem like bias, but the results will tell you if a willing & able cancer patient does better with Gonzalez’s protocol or conventional chemo.

  19. #20 Chris
    April 25, 2011

    Sure, Sidney. Anything you say, Sidney.

    Do you mind telling us why another study is needed? It has already been shown that Gonzalez’s patients die quicker and with less quality of life. The getting coffee directly through the colon is guaranteed to put a stress on their liver, and to keep them from getting the healing rest they need. The hair diagnostic tests are pure fantasy, so there isn’t any science there to even study.

    Can you tell us exactly why we should care about what Dr. Gonzalez says when he sends hair samples to a woman who uses a DelaWarr radionics machine, that operates not on electricity but “intuition”?

  20. #21 Beamup
    April 25, 2011

    Just as an aside, trials such as this one will have gone through different “stages”, such as animal model testing, before human testing is approved. This suggests to me that there must have been reasonable evidence that Gonzalez’s method had potential before human patients were put at risk.

    Should have been. Wasn’t.

  21. #22 Keith
    April 26, 2011

    I totally agree with Sidney. Another trial is needed. And, it needs to be comprised of patients with the same stage of disease who are willing and able to comply with either treatment protocol. It is THE ONLY WAY to determine which protocol is superior. As long as there is room for Gonzalez and his proponents to argue that the current results are skewed because many patients were unable to comply with his protocol, we will never know the answer. And, it’s a legitimate argument. To those who argue that his treatment is inhumane and leads to patient suffering, I say let the patients decide. If, after being fully informed, they agree to his protocol, then so be it. Any patient always has the option to drop out of a trial if they so desire. Is Dr. Gonzalez’s protocol equal to or better than conventional chemotherapy? I have no idea. But, why be afraid to find out?

  22. #23 Beamup
    April 26, 2011

    The protocol is already doomed and useless if such a small fraction of patients can follow it, even if it worked for them. Which the evidence indicates it doesn’t. And there’s no basic science or preclinical studies suggesting otherwise.

    Another study would be almost as unethical as Tuskegee at this point. We know the protocol kills for no plausible benefit. The ONLY way it could possibly become credible to even consider another study would be if Gonzalez went back to the beginning and actually did the basic science and preclinical work, and it were sufficiently positive to outweigh the existing evidence.

  23. #24 Keith
    April 26, 2011

    Beamup – you and others are ready to dismiss Gonzalez and his work (along with the work of his predecessors) without any more evidence than a flawed trial. As I said earlier, why be afraid to find out if Gonzalez’s protocol is more than snake oil? How can it be unethical to give patients an informed choice? And, what do we say to the patients already treated by Gonzalez and who have responded well to his therapy? Do we tell them it was pure luck that their results were much better than conventional therapy could deliver?
    Maybe it was pure luck. But if I have stage 4 pancreatic cancer, I’ll take that chance because with conventional treatment, I doubt I’ll be around in 6 months to argue. As to your suggestion that Gonzalez go back and to the pre-clinical work, you may not be familiar with the work of Dr. William Donald Kelley who documented the treatment of thousands of cancer patients, and on whose work, Dr. Gonzalez’s subsequent work and protocal is based. While completing his fellowship in cancer, immunology and bone marrow transplantation at Sloan-Kettering, Dr. Gonzalez put together a tome detailing the case histories of 50 patients diagnosed with late stage cancers still alive 15 years later and whose survival was attributed to Kelley’s program. Interestingly, Gonzalez couldn’t get the findings published in the medical journals, and apparently not because they lacked substance or validity. Dr. Robert Good, president of Sloan-Kettering (nominated for the Nobel prize 3 times) and also Gonzalez’s mentor, was also unable to get the findings published (even though he had already published over 2000 articles). I would think most physicians would love to read about a patient or two with advanced pancreatic cancer alive after 15 years. And these guys had documented histories of numerous patients still alive. Yet, they couldn’t get the cases published. The results were dismissed out of hand as quackery. Yet, everything Dr. Good had done to that point was highly regarded, including doing the very first bone marrow transplant.
    Lastly, to your point that even if Gonzalez’s protocol works, it is doomed and useless if it is only appropriate for a small portion of the total patient poplulation (I hope I have interpreted your comment correctly), this is unequivocally not true. We segment patients all the time for different treatements based on degree and characteristics of disease. IF the Gonzalez protocol is effacacious and IF it only works for a small percentage of patients with particular disease characteristics (e.g. 10-30%), I have no doubt that all those stricken with the disease will pray they are in that small percentage rather than roll the dice with conventional treatment.
    I ask again, why be so afraid to find out? Unless you work for Lily, what have you got to lose?

  24. #25 Beamup
    April 26, 2011

    you and others are ready to dismiss Gonzalez and his work (along with the work of his predecessors) without any more evidence than a flawed trial. As I said earlier, why be afraid to find out if Gonzalez’s protocol is more than snake oil?

    The flaws aren’t significant enough to reverse the results. Coupled with the lack of reason to consider it plausible, a provisional rejection is the only logical conclusion.

    As I said earlier, IF the proper groundwork were laid, and that groundwork was sufficiently compelling to offset these results, then it would be reasonable to revisit it.

    How can it be unethical to give patients an informed choice?

    You’re not advocating “an informed choice.” You’re advocating more trials. Which are unethical because (a) Gonzalez does not provide an informed choice, (b) accepted clinical trial ethics require that there be proper preclinical foundation before subjecting patients to risk in the course of a study, (c) the evidence currently suggests that the treatment is not just useless but counterproductive.

    And, what do we say to the patients already treated by Gonzalez and who have responded well to his therapy? Do we tell them it was pure luck that their results were much better than conventional therapy could deliver?

    First, one would have to demonstrate that such patients actually existed. And if they did, then yes, that would be the true thing to tell them.

    For the rest of your supposed points, read the original post and those linked from it. Been done over ad nauseum.

  25. #26 Calli Arcale
    April 26, 2011

    As I said earlier, why be afraid to find out if Gonzalez’s protocol is more than snake oil?

    Because the balance of the evidence available to date says that some people will probably die in more pain than necessary if another trial is performed, with no clear evidence that any will be helped. Simple as that. If you care more about having a point proven than you do about patients’ welfare, then perhaps that doesn’t matter to you.

    There are a great many things which *might* be true but which we do not study. We do not study whether flapping your arms vigorously will save your life if you jump out of an airplane without a parachute, for instance, because the evidence is overwhelmingly against it working and so we’re pretty sure people will die if we are so stubborn we have to have a double-blind controlled trial before we’ll admit we don’t actually have any positive evidence. Now, the Gonzalez Protocol is not as ridiculous as trying to fly when you leap out of an airplane, but not much. One might compare it to an untrained person attempting to fly out of an airplane using a wingsuit and landing on a specially prepared ramp. (There is a guy preparing to attempt such a feat. It has never been done, and there is considerable suspicion that he will become a long buttery smear down the ramp, though if anyone can do it, it’s him. He’s far from untrained, though.)

    How can it be unethical to give patients an informed choice?

    It’s not, but you’re not really proposing an informed choice. You want to present the Gonzalez Protocol as just as plausible, based on the current state of the evidence, as existing chemotherapeutic regimens, and that is not what the current state of the evidence says. You cannot just pretend that trial never happened. You’d have to disclose that it happened, was unfavorable, and that the purpose of the current trial is to collect more evidence. But given that the Gonzalez trial was halted because it was failing to help, I think you’ll have a tough time recruiting if you’re really honest about the state of the evidence.

  26. #27 Martha
    June 23, 2011

    Dr Nicholas Gonzalez is a contraversial figure because anyone who decides not to worship at the sacred cow of modern medicine, ie, drugs and more drugs, will be considered a threat.
    My husband was a patient of Dr. G. This doctor is brilliant, unusually energetic (as he follows he own advice), compassionate, and OPEN-MINDED.
    The pharmaceutical industry seems largely greed-driven. It’s long arm of influence is felt in medical schools and doctor’s offices. If they can’t patent it, then they aren’t interested. Follow the money.
    The modern medical industry seems incapable of investigating anything that lands outside the self-imposed small world in which they confine themselves. Should a mere layman dare to imply a world exists outside of their little box, they immediately rise up to villify and condemn. Meanwhile, hundreds and thousands are cured of cancer through a variety of modalities that fall outside the understanding of orthodox medicine.
    Thank God for some freedom of the press….. for great books and the internet that allow us options that the medical world refuses to investigate with an open mind!! Thank God for brilliant doctors like Nicholas Gonzalez who with truth on their side are willing to face the ire of the medical establishment.

  27. #28 Vicki, Chief Assistant to the Assistant Chief
    June 23, 2011

    Why is your husband not posting about how much Dr. Gonzalez did for him? Not because he died after trying Gonzalez’s treatment, surely.

    As for “greed,” how many charity cases does Gonzalez take, and how much does he charge the rest of his patients? (When I was in an emergency room a few years ago, one of the forms I was given was instructions on how to apply for charity care if I didn’t have insurance.)

  28. #29 Dedj
    June 23, 2011

    “Dr Nicholas Gonzalez is a contraversial figure because anyone who decides not to worship at the sacred cow of modern medicine, ie, drugs and more drugs, will be considered a threat.”

    Given that this would include nearly all of the professions allied to medicine and all the allied health professions, as well as significant portions of the main medical community itself, we can safely say that this is a made up reason with no basis in reality or observable facts.

  29. #30 JayK
    June 23, 2011

    @Martha:

    Meanwhile, hundreds and thousands are cured of cancer through a variety of modalities that fall outside the understanding of orthodox medicine.

    Obligatory [citation needed] is obligatory.

  30. #31 James Street
    September 10, 2011

    All of these controversies would be eliminated if there were less expensive ways to test for efficacy of therapies.

    We can imagine a future where nano-devices can be implanted in tumors to test, in real time, for apoptosis, angiogenesis, metastasis rate, etc. Then we could test, in real time, anything from shark liver oil to hemp oil for efficacy.

    Better, less expensive, testing methods should be our top priority. We should abandon the antiquated FDA testing rules that are dominated by Big Pharma. We could test for many things that we don’t test for now because the testing process is far to expensive, long and poorly regulated.

    Since we have a large pool of terminally ill cancer patients who are condemned to die within a few months, qualified medical practitioners should be allowed to test a wide array of possible cures within a set of legal constraints which have been debated elsewhere and for a long time.

    The legal/ethical debate bottleneck is surely the biggest problem. Until we solve it, desperate people will be left to grasping at straws.

    Criticizing doctors like Dr. Gonazalez is probably futile given the history of science and all the persecutions and prosecutions of scientists who have given us our greatest scientific discoveries, from Galileo and Giordano Bruno to Louis Pasteur and Linus Pauling.

    If they can be shown to be hypocrites and liars whose goal is to make money from dying people then they should be put in jail. Otherwise, they are simply benighted, deluded scientists who are trying desperately to help desperate people.

  31. #32 Chris
    September 10, 2011

    James Street:

    Criticizing doctors like Dr. Gonazalez is probably futile given the history of science and all the persecutions and prosecutions of scientists who have given us our greatest scientific discoveries, from Galileo and Giordano Bruno to Louis Pasteur and Linus Pauling.

    Ah, the Galileo Gambit! Except the difference was that they were correct (well, except Pauling when it came to Vitamin C).

    One reason we know Gonzalez is wrong is that his protocol was tested, and it failed. And yes, he is a hypocrite and lying. He should lose his license to practice medicine for both advocating coffee enemas and paying a woman at a spa to analyze hair samples by intuition (the DelaWarr radionics machine).

    If you have any real science that shows coffee enemas are beneficial and do not put stress on the liver, plus keep patients awake when they should be resting, please present it. If you have any real science that a machine that uses no electricity and works on intuition is a valid diagnostic tool, then present. Until then, keep your idle speculations to yourself.

  32. #33 George
    October 9, 2011

    The unnecessarily vicious tone of your comments and the personal attacks totally derail whatever it is your are arguing. You do not need to insult Gonzalez to argue that his methodology is ineffective. Learn some manners!

  33. #34 Chris
    October 9, 2011

    George, anyone who thinks the DelaWarr radionics machine is a valid medical diagnostics device deserves to be mocked. Especially if he promotes torturing sick people with coffee enemas and hastens their deaths.

    The data showed his methodology was ineffective. His treatment and disregard for his both the data and the patients makes him deplorable.

    George, learn to understand the evidence!

  34. #35 TBruce
    October 9, 2011

    You do not need to insult Gonzalez to argue that his methodology is ineffective.

    No we don’t, but a bonus is a bonus.

  35. #36 Travis
    October 9, 2011

    The unnecessarily vicious tone of your comments and the personal attacks totally derail whatever it is your are arguing. You do not need to insult Gonzalez to argue that his methodology is ineffective. Learn some manners!

    Does it really derail it? Are you incapable of reading for content and unable to ignore tone? That seems like a personal problem you might want to deal with.

    One can argue that there is perhaps a problem with ridicule and tone when it comes to convincing some people. There are people such as yourself who apparently turn off when they read something biting and less than codling and refuse to address the arguments that are present. However, how correct the argument is really has nothing to do with the tone and how nice it is. But there are others that learn from it, that need someone to take a harsh tone to snap them out of their mistaken thoughts. It is also just really enjoyable to write like that and to read it. I get a kick out of it.

  36. #37 Denice Walter
    October 9, 2011

    @ Travis: Interesting, as I seem to recall that many critiques of SBM ( e.g. Mike Adams’ new article on Swine Flu Vax) seem to use invective rather freely, albeit clumsily. You would think that by now supporters of woo would be rather inured to nastiness.

  37. #38 Chris
    October 9, 2011

    Since my comment was the one just before George’s, I would like him to tell me exactly what was particularly vicious about it. I first note that the Galileo Gambit was employed, then explain that Dr. Gonzalez’s protocol was tested and it failed, followed up by a request for data that shows that there is evidence for the validity of some parts of the protocol.

    Do tell, George, how my tone was vicious. Be particular about which phrase qualified for your pointed critique.

  38. #39 Travis
    October 9, 2011

    Denice Walter,
    Perhaps they hold science based medicine proponents to a different standard as they realize that behind our arguments there normally is a logical, careful evaluation of evidence whereas they really only have the anger, accusations, vitriol and generally made up stuff. We could drop biting attacks and there would still be content. If they were to drop it there would be nothing left.

  39. #40 Ken
    November 19, 2011

    I have no bias as to whether Dr. Gonzalez’s works or not, I would only like to know the trueth as my wife (30yrs old) has undergone a mastectomy, chemo and radiation. She has read Suzanne Somers’ book along with some other and is scared sick that she made the wrong choice. As a forensic auditor I am trained in statistical analysis and non-biased sampling probably more than most medical scientists. The problem with this entire situation is that it was doomed to fail from the beginning because of bias. Dr’s from both sides of the experiment were too closely involved in the set up of the trial and the interpretation of results, leaving a reasonable observer of the findings to question the objectivity of the experiment. If there is ever to be an answer to the claims of Dr. Gonzalez then the only way to do this is to set up a true trial which should be supervised by a non medical body. I would suggest the following format

    1) Have a mutually agreed upon testing procedure and protocol by Dr G. and the Chemo side
    2) Let Dr G select all patients for the test and then have them randomly split in to the two groups. Dr G will not know which of the sample population will be receiving his treatement. Now we are comparing aples to aples. (the patients must know in advance what they are signing up for and be willing participants, unlike before)
    3)Treatement is administered by Dr. Gonzalez himself and the best chemo Dr possible

    Now we’ve removed all the “what if’s” and it is a fair test. Results will stand irrefutable and everyone can move on.

    This is what I think anyways.

  40. #41 Krebiozen
    November 19, 2011

    Ken,
    Since the results of the clinical trial discussed here were so clear cut, I think it is very unlikely that the trial you suggest will ever happen. It would be unethical to offer any patients a treatment that is so much less effective than conventional treatment.

    Since you are an expert in non-biased sampling, I assume you are suggesting that selection bias might have been responsible for the results of this trial.

    At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. Kaplan-Meier analysis found a 9.7-month difference in median survival between the chemotherapy group (median survival, 14 months) and enzyme treatment groups (median survival, 4.3 months) and found an adjusted-mortality hazard ratio of the enzyme group compared with the chemotherapy group of 6.96 (P less than .001). At 1 year, 56% of chemotherapy-group patients were alive, and 16% of enzyme-therapy patients were alive. The quality of life ratings were better in the chemotherapy group than in the enzyme-treated group (P less than .01).

    It is a remarkable kind of selection bias that does not affect “patient characteristics, pathology, quality of life, or clinically meaningful laboratory values”, yet results in an adjusted-mortality hazard ratio of nearly 7.

  41. #42 TBruce
    November 19, 2011

    Now we’ve removed all the “what if’s” and it is a fair test. Results will stand irrefutable and everyone can move on.

    This is what I think anyways.

    The woo brigade will not move on. They would find some way to invalidate the test you propose and claim that their treatment does work, it just hasn’t been studied appropriately.

    I am sorry to hear about your wife’s cancer. It’s awful to have to face this at any age, let alone at 30 years old. I hope her treatment is successful.

    You both may find this article to be helpful.

  42. #43 Ken
    November 19, 2011

    Thank you both for your comments (I sincerely mean that). I respect what you have said a great deal. I don’t mean to sound like I disagree with you because I don’t, I just wonder if the test was appropriately designed to analyze the claims of Dr G’s therapy. Basically, I am still left with questions.

    I’ve read his part in Suzanne Somer’s book (which I neither support nor oppose -but let me at least say that I have my concerns about it’s accuracy). But what I read was that Dr G himself claimed that his treatment wouldn’t work on some patients (with eating problems etc). So the only question I have remaining is whether the test parameters were adequately set up to analyze the treatment success of Dr. G’s regime.

    It is obvious that the original test results were cut and dry but I am still left wondering (as an objective by-stander) if it really tested what it was meant to test, which was to see if, based on Dr. G’s ideal patients, his treatement would work better than conventional medicine. Because even if his treatement will only work on a very specific type of person that is at least better than nothing and the people that fall in to that category could benefit from it.

    It would be like someone claiming that red-heads living under power lines have a higher likelihood of getting cancer and then testing the general public (all hair colors) and say that there is no evidence that living under a power line significantly increases the likelihood of cancer.(I realize the analogy is stupid but I think it gets my point accross)

    Again, I am not supporting Dr G but I am left wondering if the trial really tested his claims.

  43. #44 ken
    November 20, 2011

    TBruce,

    I tried the link to the article but it didn’t work. Could you try and send it again? I would really like to read it and any other materials you have on the issue. It seems like all books and articles these days are the ones about why mainstream medicine is not working. I would like to balance out the arguments by hearing more from the other side.

  44. #45 Narad
    November 20, 2011

    I tried the link to the article but it didn’t work.

    Delete the ” rel=” at the end if you want to follow it.

  45. #46 Krebiozen
    November 20, 2011

    Ken,
    This blog is a great resource for accurate information about the relative merits of conventional and alternative medicine. This website is also a very valuable resource.

    Your wife has sensibly chosen the treatment that offers her the very best chance of a full recovery. I am disgusted that people like Suzanne Somers spread disinformation that leads people to make foolish and life-threatening decisions. I am glad that your wife was not exposed to this nonsense before she decided what course of treatment to accept, but sad and angry that she has been made to feel “scared sick that she made the wrong choice”. She hasn’t, and I hope she makes a rapid and complete recovery.

    By the way, it seems very likely that Somers suppressed her immune system by taking “bioidentical cortisol replacement therapy”, leaving her vulnerable to disseminated coccidioidomycosis which nearly killed her. I wouldn’t take medical advice from a person who doesn’t know that cortisol, bioidentical or not, is a steroid hormone. If you search for her name using the search box on the left of this page you will find plenty of information about Somers and her book.

  46. #47 Jane Richard
    January 22, 2012

    insolent, yes. but neither respectful nor truthful.

  47. #48 novalox
    January 22, 2012

    @jane richard

    Any reason to necro a thread, idiot?

  48. #49 lilady
    January 22, 2012

    @ novalox:

    “Any reason to necro a thread, idiot?”

    I dunno, perhaps because Jane is having a boring day and is shilling for Big Coffee.

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