Sep 11 2009

Cancer Quackery is Dangerous – The Gonzalez Treatment

Nicholas Gonzalez is a controversial doctor practicing in New York.  He has been promoting for years a largely dietary treatment for cancer including an individualized organic diet, large amounts of supplements, and pancreatic enzymes. He is a case study in why we need rigorous science to decide which treatments are safe and effective, of the lure of quack claims, the power of bias, and the inadequacy of our current regulations.

Dr. Gonzalez has managed to have a thriving practice despite, in my opinion, violating the basic standard of care and medical ethics. He has done so partly by riding the wave of so-called “health care freedom” which confuses (I think deliberately) the public about the nature of standards in medicine.

The Gonzalez treatment, which is based on prior claims made by James Beard and William Kelley, lacks plausibility or basic science support. While you can find studies to show that an individual supplement may have some effect that potentially could have some clinical effect, you have to extrapolate wildly and recklessly from such information to clinical claims. Such information is at best a source of hypotheses – not treatments.

And in the final analysis Gonzalez’s claims are just recycled CAM propaganda – claiming that supplements will boost the immune system and detoxify the body.

Medical ethics also requires that before we subject patients to new treatments we at least test them in animals to have some idea about safety and at least the hope of benefit. There have been animals studies on the pancreatic enzymes, but not the treatment as a whole. The National Cancer Institute reports:

  • In 1999, an animal study tested the effect of different doses of pancreatic enzymes taken by mouth on the growth and metastasis (spread) of breast cancer in rats. Some of the rats received magnesium citrate in addition to the enzymes. Rats receiving the enzymes were compared to rats that did not receive the enzymes.
    • Results showed that the enzyme did not affect growth of the primary tumor (where the cancer started).
    • The cancer spread to the most places in the rats that received the highest dose of enzymes.
    • The cancer spread to the fewest places in the rats that received the lowest dose of enzymes plus magnesium citrate.
  • Another animal study looked at the effects of pancreatic enzymes on survival rates and tumor growth in rats with pancreatic cancer. Rats receiving the enzyme treatment lived longer, had smaller tumors and fewer signs of disease, and were more active than the rats in the control group, which did not receive the enzyme.
  • So results are mixed at best, but the study showing a worsening of cancer with the treatment should have been cause for extreme caution before giving the therapy to humans.

    Dr. Gonzalez did publish a case series of his treatment for pancreatic cancer, which is a particularly deadly form of cancer with a 1 year survival of only 2%. He reports that in his case series of 11 patient their average survival with his treatment was 17.5 months.  That is very impressive, if true. Proponents used this data to support the Gonzalez treatment and dismiss critics, while science-based physicians pointed out the fatal weaknesses of case reports – namely they are not controlled, and therefore are subject to a host of biases.

    To resolve the dispute a prospective trial was planned, and the results of this trial have now finally been reported – four years after the trial was complete. Kimball Atwood gives a thorough discussion of the trial itself at Science-Based Medicine, so I won’t go into detail about the trial’s history. Suffice it to say it was controversial. There were significant ethical concerns about studying an implausible treatment with inadequate pre-clinical justification in a disease as serious as pancreatic cancer. Most curious and disturbing is, considering the results, the four year delay in making the results public. This is a scandal, in my opinion.

    But finally we have the results and they show:

    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 < .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 < .01).

    That’s right – standard therapy mean survival was 14 months and on the Gonzalez treatment 4.3 months. That is a dramatic difference, and supports what critics have been saying for years.

    There is only one weakness to the trial that I can detect – it was not randomized. The reason is that too many patients refused to be randomized. They did not say if patients refused to go on the Gonzalez treatment, refused not to go on the treatment, or both. Regardless, this opens the door for the claim that patients who self-selected to go on the Gonzalez treatment were sicker. There is no evidence to support this claim in the study and the researcher tried to compensate for the lack of randomization by making sure the two groups were as comparable as possible. So while this criticism is legitimate it is highly unlikely to explain the dramatic difference in  survival between the two groups.

    The bottom line is this – that Gonzalez treatment is not only worthless it is harmful and reduces quality of life. This is an important cautionary tale. But first this raises an interesting question – how did Gonzalez get his impressive 17.5 month survival in his case series when a prospective study shows a 4.3 month survival? We will never know for sure – the possibilities include that some of the patients did not have pancreatic cancer (he says they were biopsy proven), but most likely is that he simply cherry-picked the cases that did well.

    In any cases, this shows the relatively low value of case series. They are useful for detecting new phenomena and for generating hypotheses – but not for testing hypotheses, not for telling if a treatment works. This is a dramatic example of why we don’t rely on anecdotal evidence, and why science-based practitioners are appropriately dismissive of anecdotes.

    But further, the Gonzalez case taken as a whole shows us that you can promote a treatment that actually causes harm and yet still create a faithful following, bamboozle regulators, charm the media, and delay (sometimes indefinitely) definitive testing of your claims.

    It further justifies why many science-based physicians believe such trials are themselves unethical. The 32 patients in this study that selected the Gonzalez treatment were victims – they lost quality of life and on average 10 months of life. Was their sacrifice justified? I and others say no – before the Gonzalez treatment was given to a single person far more basic science and animal testing should have been done. Then, if the treatment looked promising and safe (at least equivalent to current standard treatment) small pilot studies in humans would be next, and then definitive clinical trials.

    We use this sequence for a reason – because most new ideas in medicine are wrong. Because in order to “first do no harm” we need to proceed carefully with experimental treatments and only give them to people when there is sufficient plausibility and pre-clinical data to justify it. This is the ethical standard in medicine, but the public has fallen victim to the successful creation of a double standard with clever marketing of terms like “alternative,” “holistic,” “natural,” and “detoxify.”

    Finally, I want to know where the media attention is on this issue. I only heard about it because of my involvement as a proponent of science-based medicine. This study was published online on August 17th and I have seen no mainstream coverage of it. (I’m sure it’s out there, but it certainly did not grab my attention.) The National Cancer Institute needs to update their website with this information yesterday. And I would really like to hear why there was a four year delay in the results being published at all – four years during which Gonzalez continued to use his therapy. He still is, and his website gives no hint that his claims have just been blown out of the water.

    Now we have to wait and see what the response will be from Gonzalez and regulators. The true test of an ethical science-based practitioner is what they do in the face of evidence against a treatment they currently favor. The Gonzalez treatment, in my opinion, was never ethical and now it is outrageously unethical. It needs to stop immediately.

    Share

    12 responses so far

    12 Responses to “Cancer Quackery is Dangerous – The Gonzalez Treatment”

    1. Jim Shaveron 11 Sep 2009 at 10:38 am

      [Dr. Gonzalez] reports that in his case series of 11 patient their average survival with his treatment was 17.5 years.

      Whoa! That sounded quite incredible to me when I first read it, but now I believe you meant 17.5 months. Right?

      Also, while I’m at it…

      Proponents used this data to support the Gonzalez treatment and dismiss critics, while science-based physicians pointed out the fatal weaknesses of case reports – names they are not controlled, and therefore are subject to a host of biases.

      I think that should be “namely”.

      Thanks as always for your diligence and expertise in reporting here on this type of inexcusable medical quackery.

    2. MollyNYCon 11 Sep 2009 at 11:39 am

      So basically, the OAM (and if I’m reading this right, the NCI) are giving money to this guy?

    3. Steven Novellaon 11 Sep 2009 at 3:15 pm

      corrections made – thanks

    4. HHCon 12 Sep 2009 at 1:03 am

      I had a close female and male relative both die from pancreatic cancer. They were lifelong smokers. A strong social support system kept them alive and coherent to the end of life. My female relative became suicidal with the cancer therapy. Is the Gonzalez treatment better than suicide, or a quick ends to the means of release from life’s pain?

    5. Joeon 12 Sep 2009 at 5:36 am

      @HHC The Gonzo therapy is an arduous process. You can read an account here: http://www.sciencebasedmedicine.org/?p=97 Scoot down to “A Troubling Case History.” In short, one is occupied all day making vegetable juices, taking enemas, swallowing large numbers of pills, and cooking.

    6. tmac57on 12 Sep 2009 at 8:56 am

      HHC- I know many cancer patients who are either in treatment or are post treatment. I have never known any of them to be suicidal because of the treatment itself. Maybe your relative’s experience was not typical.

    7. HHCon 13 Sep 2009 at 1:07 am

      Joe & tmac57, Read Gurney’s account of a victim of Gonzalez’s treatment. Definitely, the victiim reveals the course of the illness sans treatment. I think coffee enemas are little extreme. This must be a What’s Up Doc Joke…my deceased relatives wouldn’t stand for rectal coffee breaks. As for cooking, cancer treatment can make you extremely nauseous, such that the smell of food aggravates your condition. Besides, the weakened condition caused by the cancer progression prevents extensive participation in such a “medical” regimen.

    8. Oracon 13 Sep 2009 at 5:32 pm

      The bottom line is this – that Gonzalez treatment is not only worthless it is harmful and reduces quality of life.

      Actually, that’s not strictly true, at least whether the Gonzalez protocol is actively harmful. Pancreatic cancer sucks. When it’s unresectable, it will kill you and fairly quickly. Consquently, it’s not clear whether the increased death rate in the Gonzalez protocol arm of the study is because of active harm or because the therapy is utterly worthless, resulting in, essentially, a survival curve undistinguishable from that of patients with untreated unresectable pancreatic cancer. Generally, that median survival is expected to be around 3-4 months–essentially the same as the Gonzalez arm. That’s not a defense of the Gonzalez therapy; rather it’s simply cautioning that this data is consistent with no effect due to the Gonzalez protocol, which is plenty bad. Remember, the comparison was not with untreated patients; it was with patients receiving treatment.

      What surprised me more is that the survival of the chemotherapy group. That was much higher than the usual reported survival in gemcitabine-alone groups. I wonder what’s going on there.

    9. Zelockaon 14 Sep 2009 at 3:17 pm

      I am sure if you ask most that try this you will get the same response. In essence it’s a dead if I do or dead of a don’t feeling and at that point it’s any port on a storm. Despite being more effective than anything else, radiation therapy has a major strike against it because people that to it look sicker than people that try these quack remedies. We are a society that is pretty reactionary about most things so that negative is going to scare people off even if there is limited to no underlining logic behind it.

      If cancer treatment was something that didn’t make you look and feel worse than not doing it, I do not think we would see this much quackery around it still.

    10. Steven Novellaon 15 Sep 2009 at 8:08 am

      Orac – thanks. I thought survival was a bit longer untreated. But of course, worthless does cause the indirect harm of deferring standard therapy that is effective, and it did appear to have a negative effect on quality of life.

    11. TsuDhoNimhon 17 Sep 2009 at 9:35 pm

      Orac said What surprised me more is that the survival of the chemotherapy group. That was much higher than the usual reported survival in gemcitabine-alone groups.

      They changed to a 3-drug mix early on, because the gemcitabine had been shown (in other trials, of course) to be less effective than the mix.

      It was “state of the art” chemo compared to the enzyme treatment from the 1980s or whenever.

    12. [...] Cancer Quackery is Dangerous – The Gonzalez Treatment [...]

    Trackback URI | Comments RSS

    Leave a Reply

    You must be logged in to post a comment.