Wife had Breast Cancer, now she does not.

jojo68

WOW!  Now, that is a vast sweeping statement with no studies you are citing to back it up!  You are on the alternative forum, so what I am going to say next is 'allowed'....What are you basing that on?  Did Big Pharma and FDA fund those studies?????  Kinda like how they fund their own studies to skew in their favor?  Please provide evidence for that statement as you had asked me to provide evidence for my statements yesterday on the conventional forum!  I belong to many yahoo groups where people are doing very well on vitamin C/Gonzalez/Gerson/Vincent gammill etc etc....I know two people who put their cancers into remission without chemo and with vitamin c/juicing/enemas and supplements!  Actually, coffee enemas were in the traditional Merck manual for many years and VERY accepted by the medical community! 

Again, please provide evidence to back up that statement that is NOT funded by the governmentt, please.

Chemotherapy, also, has never been proven to be effective....unless it was in a study funded by sources who only have money to gain.

Lily55

Chemo has never been subject to a proper clinical trial with humans as it is against the law to have a control group in cancer treatment but can we please have a discusión and not a row?

Momine

Vitamin C: 

The role of vitamin C in cancer treatment and prevention is unclear. Results from in vitro and animal studies showed that cancer cells preferentially uptake vitamin C ^(9) (10). But supplementation with vitamins C, E, and beta carotene was not beneficial in preventing cancer incidence or affecting cancer mortality ⁽¹¹⁾. Further, supplementation with vitamin C along with vitamins A E, and beta-carotene did not prevent gastrointestinal cancer ⁽¹²⁾, did not lower the risk of prostate cancer ⁽¹³⁾, and may actually increase overall mortality ⁽¹²⁾. Further, vitamin C and multivitamin use was associated with increased risk of liver cancer, but vitamin C and other vitamins obtained from dietary sources were not associated with liver cancer risk⁽³²⁾.
A study done in end-stage cancer patients showed no benefit from high-dose vitamin C ⁽¹⁴⁾. However, one study did find an association between the intake of vitamins A, C, or E and a reduced risk for cervical cancer (15). Vitamin C was also found to normalize thiobarbituric acid (an indicator of lipid peroxidation and oxidative stress) and antioxidant enzyme levels in breast cancer patients receiving tamoxifen treatment⁽¹⁶⁾. Use of intravenous vitamin C has been examined in cancer patients and clinical trials are underway to assess its efficacy ^{(18) (17) (30)}.

Vitamin C can render many chemotherapy drugs less effective ⁽¹⁰⁾. However, inadequate amounts of antioxidants including vitamin C were associated with increased adverse effects due to chemotherapy in children with acute lymphoblastic leukemia ⁽¹⁹⁾. Other potential adverse effects are gastrointestinal in nature, although hypoglycemia and hypotension are documented with doses higher than one gram per day. Patients with history of oxalate kidney stones, renal insufficiency, G6PDH deficiency, hematochromatosis, or those undergoing chemotherapy should consult their physicians before taking vitamin C supplements. http://www.mskcc.org/cancer-care/herb/vitamin-c

Momine

As for the effectiveness of chemo, there is no point in arguing against a belief. You do not believe that it does any good, and since you have already been given various studies to the contrary, I doubt I will change your mind.

As for people doing well on XYZ therapy, that is great. Seriously! Random good results do not, however, constitute proof.

As for the coffee enemas, yes, they were in the Merck manual as a "stimulating" enema to help against constipation, not as a cancer treatment. In the same line, the Merck manual also suggests the use of whiskey in the same way. http://www.coffee-enema.ca/merck.htm

new_direction

Joellelee- Interesting article, thanks.
Finding out conventional treatment is not right or optimal could be frightening, we all want to live so much, what if what ive done is not good enough, what should I do then, what are the right answers. Dont know if thats the case, but being threathened by this thought would be understandable.

jojo68

@momine...This is the alternative thread, so of course I am pretty much alternative minded and that is my belief, for the most part.  Sounds like you are pretty much conventional minded which is fine...I am wondering why you are over here checking things out?  Is it just to shoot down our beliefs?  Because, you seem to think all of your studies and references are like GOD and ours/mine are poop! 

We are going around in circles and will have to agree to disagree!  As to the PUbmed references you provided, I checked out all of the footnoted references and seems like the studies were done on oral vitamin C which is completely different than IV c AND Lipo C!  Do you know and understand the chemistry behind Lipo C?  The most effective vitamin C is one that combines many ways of administering it....ways the studies did not do. Also, the amounts they gave in the studies were not nearly the effective amounts used in successful treatment with vitamin C therapy.  AGAIN, I take everything into consideration...'random' groups of people doing well, studies, stats, doc recommendations etc etc...Do you mind sharing what you use to make your decisions?  Do you not take all of this into account as well?  You are very confusing to me....and all over the place.

And, you seem limited in your knowledge of coffee enemas.  Once you detox your body from cancer, whether it be from chemo, diet, supplements etc...the body has to get rid of it somehow!  I don't feel you can argue against a healthy liver!  And, yes it is true that antioxidants are not good with chemo...nobody argues that...many treatments conflict with one another.  I really feel we need to just come to a stop with this craziness between you and me.  If you disagree with alternatives so much, then why are you here...baffled.  Many women here have done chemo and then turned to alternatives with enemas etc to help strenghthen liver etc which can be damaged thru chemo...are you against that as well?

New direction....You make good points.  I am not completely against conventional treatment, I did surgery and am on the fence with tamoxifen.  I just really try to keep an open mind and the huge thing with me is looking to see who is funding certain studies.  I am sorry, but the cancer industry is a billion dollar a year industry with huge monetary gains...I find it so hard to fathom why some people trust them so much with everything! (not you...in particular)

Momine

I am interested in alternative therapies, provided they make sense. 

new_direction

joellelee dont worry.

I think the same way that you do - cancer INDUSTRY. With all the "poisening" food available just as one example its not really any surprise that some are in the cancer business for the wrong reasons. My heart breaks... whats WRONG with all this. Im really a gullible person, very open minded, and I usually find it easy to see points from all angles. Besides vit C have you found other interesting/promising things?

I think the right answer is to start FEELING over thinking so much. Find a living which I feel good about and in.

edwards750

How did those "alternative cures" work for Steve Jobs? I dont automatically dismiss stories like admittedly it just doesnt sound plausible. If it works for his wife happy for her but as a person posted maybe a revisit in a few years or even 5 years would be more telling. None of us wanted to go through chemo or rads or even have breast cancer to begin with. I am of the mindset that I might do something like that in addition to, but not in lieu of. I am too afraid not to. I think doing our homework and making up our own minds is the best we can do. We do what we think is right for us and that cant be a bad idea. Interesting story though. Diane

jojo68

Momine...which alternative ones make sense to you?  Any?  And, what do you base 'making sense' on?  Because, we can argue over studies, but we really need to just follow our gut...what life is really all about.

@new direction...I am sooo disheartened with all of the GMOs in the foods/conflict of interest with Monsato etc....Now, the dairy industry wants to lobby congress about putting nutrasweet into their milk WITHOUT having to label it as an ingredient...sickens me to no end.  I agree with you completely about feeling what is right for each of us.  I feel a combo of surgery and alternatives is what will be right for me.  I don't mind sharing at all what I am trying to do for my therapy....and, some may bash me, but I am fine with that.  Hopefully, I will be around 5 years from now to share my success, we shall see...I have two precious little girls, an adorable husband and a successful photography biz!!!.

1. iodine protocol

2. Lipo vitamin c/oral vitamin c...may look into IV down the road.

3. heavy juicing/raw diet/minimal dairy and meat (only RAW dairy and grassfed/organic meats.

4. I trust and follow some of Life extensions protocol etc on prevention of metastasis, so I take the following...

Bio-Curcumin/tagamet/Milk thistle/DIM/calcium D'glucorate/enzymes/melatonin time release)/Quercetin/Vit C/D/E/selenium/zeolite/reservaratol/only green pastures fermented cod liver oil/P73 oil of Oregano/Paul d'arco tea (very effective)/Modified citrus pectin

I am looking into Avemar, metformin, digitoxins, Coley's etc etc...My list is always changing as I continue to learn

I am going to start the coffee enemas soon, just had surgery and not up to it now.  I am also VERY interested in the Gonzalez/Kelley protocol and may visit Dr. Gonzalez in NYC.  He is such a gentleman and sometime doesn't even charge his patients who don't have the money to pay....quite the opposite from conventional medicine!

Momine

Joelle, as far as I can gather, a good diet high in veggies probably helps. Ditto for a pretty high level of exercise. As far as supplements, many things look good initially, but then prove to have some SE or draw-back. However, it is probably a good idea to take some magnesium as well as probiotics. There may be others, one of the reasons I read this forum. If I think of anything else, I will post again.

jojo68

Momine...many things have side effects conventionally and/or alternatively.  However, in my research I have found there are many more side effects from pharmaceuticals than herbs/supplements etc.

I forgot to mention I also do the magnesium therapy...Ancient minerals with MSM spary everyday plus the bath soaks.  Msm is also very effective therapy for cancer.  I had heart palpitations last year and was able to rid myself of them with the additon of high magnesium.  Magnesium is also a big part of the iodine protocol.  I also do take probiotics and B-17.

jojo68

I also take herbal mushrooms...RM 10 and Coriolus..The Japanese have started to trade chemo in favor of mush herbals.  And, these are on the Life Extension protocols as well...I am also looking into Immunepowerplus.

Again...chemo and tamoxifen have their drawbacks as well...I always weigh risk vs. benefit with everything in life.

jojo68

I am not familiar with the protocol Steve Jobs used...I did not know him personally to comment one way or another...did you?

I know many people who also did chemo and died...works both ways!  But, the conventional folks just love to bash any alternative therapy that doesn't work...nothing is written in stone.

new_direction

I feel like chemo nearly killed me. During chemo I have been afraid a few times that was it - was hospitalized twice and felt so weak. When it was my sons' birthday I wasnt able to participate, i wasnt even worrying about that, i was too tired. Scared me a lot. I think when we go at some point, the tiredness and/or pain will be so strong that you WANT to go.

I dont regret chemo but yes you pay a price. My body is like a bendy, old carrot, no strength. I got tibial stress fracture because I panicked and trained like an insane person when I was diagnosed. Its still aggrevated if I just go for a walk. I feel cribbled after surgery, chemo and soon radiation. You feel like your body has been targeted, a battlefield. The rest of your life you will have to try and make it up, revitalize, regrow.

thanks joellelee for sharing. I will look into it in detail later. Ive been doing so many things im trying to keep it at a minimum now. just been trying to do what I really enjoy lately. Im taking a teaspoon of baking soda as well - dont know if you could be interested in adding that.
Best wishes.

Mardibra

Joellelee - I believe you said you are considering an appointment with Nicholas Gonzalez in NY.  You may want to read this first.

http://scienceblogs.com/insolence/2009/09/17/nicholas-gonzalez-response-to-the-failed/ 

jojo68

@new direction....wow, you are so brave!  I just don't think I would ever be able to mentally handle chemo, especially since I don't believe in it 100%...I cannot even imagine what you have been through!  Surgery was enough for me...ugh.  I also do the baking soda thing...I add it with ACV, with my iodine morning and evening. 

@mardibra...your link would not open for me...Not sure what it was detailing?  I have researched Gonzalez/Kelley extensively and feel very confident in their success rate.  His last study was supposedly sabotaged and I don't believe everything I have read that's written against him...I know two ladies personally who are patients of his.  They speak VERY highly of him and they are doing very well....

Mardibra

sorry about the link....here is the text.  Like you, I have done a bunch of research on Gonzalez.  You appear convinced of his abilities.  I on the other hand, am not.  I dont think sabotage was happening.  I just dont think his approach has proven to be effective.  Thought you might want to read this...

Nicholas Gonzalez’ response to the failed trial of the Gonzalez protocol: Disingenuous nonsense

Posted by Orac on September 17, 2009

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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, andyours 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’sdiscussion 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.

Mardibra

and more.....

Cancer Quackery is Dangerous – The Gonzalez Treatment

Published by Steven Novella under Science and Medicine 
Comments: 12

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 tumorgrowth 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-Meieranalysis 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 anadjusted-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-therapypatients 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.

edwards750

joel - your comment was uncalled for. Of course I didnt know Steve Jobs personally so your sarcasm was obvious. Given who he was his story is well documented from the time he was dx in 2003 until he had his surgery in 2004 and liver transplant in 2009. He chose, his choice, to delay surgery for what some drs considered to be an operable tumor, by changing his diet. He already had a diet of no meat and fish every now and then. I am not saying the conventional method is always the right way to go - it is for me - maybe not for you. That doesnt make either one of us more right than the other. Some people believe it is playing Russian routlette with your life but its still your call. So we can agree to disagree but it certainly does not warrant a comment such as yours. diane

jojo68

You all win. You are all right and I'm wrong.

At the top of this alternative forum it states this is a safe forum to discuss alternative treatments without judgement. Why are some of you even here?

Again, this is crazy. I honestly don't care what treatment you all pursue...why do you all fear alternatives so much? It must be out of fear. Anger and judgement only comes from fear.

jojo68

I have this nagging question that has been really bugging me...I have followed these forums for awhile now. There are many women who do the conventional chemo and rads and, unfortunately do get Mets

and pass pretty soon or within 5 years or so. There is rarely any argument about how the treatment affected the outcome. BUT..I'm wondering if there would be major discussion if that person passed via alternative treatment. I'm thinking there would be and that'd unjust. Why is that OK? Nothing is perfect. Nothing works the same for each of us.

bedo

So, I guess the "big pharm" in Peru did not charge for this treatment, or maybe did not need to spend money on clinical trials? Is a trial of one statistically significant? I would love to see the evidence. It would be so great if this were true and documented, but I fear there will be no evidence or trial or even proof that this works.

*sigh*

Why did I get baited into this discussion.

We all have the choice to decide our own health care, whether it's based on fact, science, or fear or wishes. I know that people choose to believe things without understanding statistics or the different types of studies.  Please try to take some courses so that you know what it is you don't believe in. Whatever calms you is good, but when you calm down, try to see both sides. My Mom forced us to go to church until we were in 6th grade. We were shocked to learn then that she was atheist.  She told us that "you can't be Atheist unless you understand what it is you don't believe in, and can make an informed choice".

Momine

Mardibra, it should also be noted that the progenitors for the Gonzalez protocol, Kelley and Beard, date to the turn of the previous century and one of them was a dentist.

Joelle, It is not "judgment" to post factual information about Gonzalez. One of the purposes of this site is to share information, so that those new to DX and treatment can get a shortcut to info from those who have already sifted through some of this. When I first saw a ref to Gonzalez, I too was very excited. Then I checked him out and that was that.

Momine

New Direction, I am really sorry that you had such a rough time of it. A year ago I felt pretty much the same way. Walking up a flight of stairs, I had to stop twice to rest. I gave my onc such a hard time, along the lines of "how could you do this to me and HOW, young man, are you going to fix it?" He took it all calmly. Then a few months ago, it suddenly dawned on me that I was back. All limbs and brain cells operating again. Keep taking care of yourself. It DOES get better, I promise. Op med gejsten!

jojo68

Sorry, but the Gonzalez article is not factual...the FDA completely sabotaged any successful alternative practitioner and THAT is

A fact. I know two people personally who are doing much better on his protocol than with conventional treatment...they were told they were gonners and are still here. Doesn't matter who was a dentist or not...Weston Price was a dentist and is very very well respected for his work in nutrition!!!! We will have to agreed to disagree. I will report back to all of you with my progress on Gonzalez....not that it will matter much.

jojo68

And, as far as " sharing info" ...that was what I was doing on the conventional threads and I was bashed for saying anything against chemo and for showing any studies. They told me to come here instead. Soooo, why is it OK you come here and show anything against alternative docs like Gonzalez. I was told I was scaring people who are sensitive in their choices. Well, are not some of you doing the same here?

I find it funny that you say Kelley therapy dates back to turn of century...so does chemo! Study the scary history and initial intent of chemo and get back to me! Many of you also support your stance by saying how long chemo has been around, yet criticize any alternative therapy that has been around just as long...."None are so blind as those who will not see."

Mardibra

why is it that any negative attention for an alternative treatment is deemed "sabotage" or part of a big "conspiracy"?  Joellelee - what facts do you have to support that it was sabotage?  Im not judging you, because I couldnt care less which treatment you choose...its your choice.  However, I do take issue with people throwing out misinformation.  Let the guys record stand.  He is a snake oil salesman.  His protocol doesnt work.  Will all the juicing and veggies make you a healthier person?  Probably.  Will it cure cancer?  Hell no.  Will it even treat cancer?  No evidence of that either.

And please dont claim that you are being attacked.  Your not.  Someone disagreeing doesnt not equal an attack.

Enjoy your day!

Momine

No, sorry, that was not the point. Kelley's theories were wrong, and subsequent developments in science have told us that. This is the point of pointing out the age of the theory. 

jojo68

Agree to disagree....let's all report back in 5 years and leave it at that....Best of luck!!!!