Dr. Kelley/Dr. Gonzalez — Are all medical studies created equal?

This blog is the final chapter on my discussion on alternative cancer practitioner Dr. William Kelley. In my opinion, Dr. William Kelley is probably the greatest practitioner of cancer therapy in human history (Alternative or Orthodox). In my recent blogs I have discussed his cancer therapy at great length, and I have evaluated the credibility of his medical records. Unfortunately, to Dr. Kelley’s chagrin, his cancer therapy was never tested in clinical trials in an official study.

His anecdotal (testimonial) evidence from his medical records were exhaustively investigated by a young 2nd year medical student from Cornell University named Dr. Gonzalez under the supervision of world renown doctor from the Sloan-Kettering Cancer Centre, Dr. Good. Dr. Gonzalez was amazed at the success he found in Dr. Kelley’s protocol while examining over 10,000 medical records and interviewing over 1000 patients. After Dr. Gonzalez completed his final report on his findings, strangely no medical journals would publish even small parts of his report for a peer review process. Other than a minor investigation from the Office of Technology Assessment (OTA), Dr. Kelley’s cancer protocol has never received proper scientific evaluation from the medical establishment and therefore has never been given proper credibility. This is an odd occurrence considering the success that Dr. Gonzalez found.

This task is now being pursued by Dr. Kelley’s one-time investigator and now padawan of his cancer protocol, Dr. Gonzalez. Instead of pursuing various opportunities in the medical world, Dr. Gonzalez decided to carry on Dr. Kelley’s “Enzyme Therapy” because of the success he found through his investigation. Dr. Gonzalez began to find similar success in his own practice which eventually qualified for a $1.4 million sponsored study from the National Cancer Institute (NCI) and National Center for Complementary and Alternative Medicine (NCCAM). This famous or infamous study (depending on how you look at it) is widely quoted throughout the internet as the final word on Dr. Gonzalez’s “Enzyme Cancer Therapy”. Here is some of what you find on the internet.

On the NCI website they give this summary of this study,

In this study, one group of patients followed the Gonzalez regimen while another group was given standard treatment (chemotherapy). Results in the two groups were compared to see if the Gonzalez regimen works better than the standard treatment and if it has bad side effects. Results of the study were reported in the peer-reviewed Journal of Clinical Oncology in April 2010. Patients treated with standard chemotherapy survived a median of 14 months and patients treated with the Gonzalez regimen survived a median of 4.3 months. Patients treated with chemotherapy reported a better quality of life than those treated with the Gonzalez regimen. Dr. Gonzalez published comments Exit Disclaimer on his Web site to express concerns about how the trial was conducted. One concern was how well patients in the Gonzalez regimen group actually followed the regimen.”

So according to the NCI, this study seems to have been “peer-reviewed” and clearly demonstrates that chemo produces results 3 times better than Dr. Gonzalez’s regimen. The NCI does note that Dr. Gonzalez had “concerns about how the trial was conducted”, but basically leaves it at that. Quackwatch sites attest that this study delivers a case-closed verdict. Dr. Steven Novella MD writes in his NeuroLogica Blog,

“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.”

After a supposed thorough investigation of this study Dr. Novella finds little wrong with this study other than “there is only one weakness to the trial that I can detect – it was not randomized”. This is the only weakness he found in the study??? As we shall soon see, if this is the only thing he found upon investigation that was worrisome, he must have been smoking something pretty strong to come up with this conclusion. This type of conclusion by Dr. Novella explains why my faith in MD’s investigational practices has eroded over the past few months during my alternative cancer research.

My Evaluation of this Study

Dr. Gonzalez has provided an extensive overview of his opinion of how this study was conducted on his website http://www.dr-gonzalez.com/research.htm. I will try to summarize his concerns with the study as well as adding a few cents of my own take on the study.

The original goal of this study was to compare the effectiveness of Dr. Gonzalez’s Enzyme therapy against a standard chemotherapy drug called GTX on patients with pancreatic cancer, the most deadly of all cancers. Dr. Gonzalez was awarded $1.4 million of funding from the NCI and the NCCAM to conduct this study because of the success Dr. Gonzalez had with a smaller pilot study of 11 patients with pancreatic cancer. Here are the results of this pilot study that was published in the peer-reviewed journal Nutrition and Cancer 1999:

“As of 12 January 1999, of 11 patients entered into the study, 9 (81%) survived one year, 5 (45%) survived two years, and at this time, 4 have survived three years. Two patients are alive and doing well: one at three years and the other at four years. These results are far above the 25% survival at one year and 10% survival at two years for all stages of pancreatic adenocarcinoma reported in the National Cancer Data Base from 1995.”

As you can see Dr. Gonzalez’s pilot study continued to show similar results to that of his mentor Dr. Kelley and better than expected results as compared to standard therapies (ie. chemo). Based on these results Dr. Gonzalez was able to get approval from NCI director, Dr. Richard Klausner to pursue this $1.4 million clinical trial under the direction of a team from Columbia University.

Some Initial Points to keep in Mind

It must be understood here right off the bat that GTX chemotherapy and Dr. Gonzalez’s Nutritional Enzyme Therapy are completely different modalities and require significantly different levels of commitment to follow each respective therapy. For one to successfully follow GTX chemo, one only needs to show up at the doctor’s office to receive the drug intravenously and injest pills orally. Not much else is expected of the patient. Conversely, for one to properly follow Dr. Gonzalez’s therapy, the patient must exert a high level of discipline to follow the strict diet, supplements, and detoxification strategies. Anyone who has attempted any type of special diet can attest that strict adherence to the diet requires some “gumption” to keep at it. Here’s how Dr. Gonzalez describes his protocol,

“Patients must diligently follow a prescribed diet, and ingest some 150 or more supplements to be taken at precise times throughout the day ….. the regimen requires discipline and some determination, as does any lifestyle intervention; patients must be motivated, or else, as we learned long ago, they will not follow through with its day-to-day application.”

Thus, to fairly judge the effectiveness of GTX chemo versus Dr. Gonzalez’s (I will call him Dr. G, for brevity) therapy, patients selected to Dr. G’s therapy must be those who are disciplined enough, healthy enough, and be given the proper amount of support to follow through with the program. In short, the patient enrolled in Dr. G’s therapy must believe enough in the protocol to faithfully follow through with it. It is similar to someone joining a Weightwatchers diet program versus dieting by one’s self. Some may argue, “If following a chemo regimen is much easier to adhere to than Dr. G’s therapy, shouldn’t chemo be the better option then?” I agree that ability to adhere is a valid consideration, but my opinion would be that the therapy which produces the best results is the one that should be followed, no matter how difficult it is to adhere to. “No pain, no gain” as they say.

What are the problems with the study?

1) To start, one of the initial problems was the decision by the NCI-Columbia team to “randomize” the study. What is a randomized study? Basically, what happens is patients are not given a choice as to what therapy they want to use, instead they are randomly designated to one of the assigned therapies. Also the doctors performing the treatments are not allowed to pre-select patients in any way. Randomization, essentially is supposed to eliminate biased selection. From an academic standpoint this seems like a very logical method to avoid biased results.

The problem is, we are dealing with real life patients who are desperately trying to beat pancreatic cancer. As I already mentioned, it is critical for a cancer patient to believe in the therapy that they are doing. If not, there is very little chance they will follow through with it, especially Dr. G’s. Also if someone who wants to do Dr. G’s therapy is forced to do the GTX chemo therapy instead, that patient probably will not comply and an ideal candidate for Dr. G’s therapy will be lost. Contrarily, if someone is assigned to Dr. G’s therapy that has an anti-alternative bias and wanted the GTX chemo treatment, the odds of them following through with Dr. G’s treatment is close to nil. Compliance and informed consent are critical elements to developing a good study.

Initially 260 patients with pancreatic cancer contacted Columbia to join the trial, but after learning that the trial would be randomized, only a measly 3 patients agreed. Of these 3, two later quit when they were told they had to do chemo. What a waste of eager pancreatic cancer patients and many good potential candidates. Because of this, the Columbia team was forced to get their heads out of the intellectual sand, and eliminate the randomization parameter from the study. Too late though, as the damage was already done and many good potential candidates were gone.

2) Now, having eliminated the randomization component, it was important to develop an unbiased selection process. The person who was given charge of this selection process was Dr. John Chabot of Columbia Presbyterian Medical Center. What Dr. Gonzalez later found out is that Dr. Chabot was not an unbiased supervisor. Dr. Gonzalez stated,

” 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.”

It bewilders me how the Columbia team who initially wanted to avoid bias by making the study randomized, then selects as principal investigator of the study, someone who clearly has a conflict of interest. Was this just an oversight? Did Dr. Chabot fail to declare this obvious conflict? Whatever the answer, it smells like monkey business to me. This alone should have thrown this study into the “wasted money on research” garbage pile. As we look further into the details of the study you will see this conflict of interests come to the surface.

3) Clearly Dr. Gonzalez had concerns about the selection process under the direction of Dr. Chabot. Dr. G requested that the Office of Human Research Protections (OHRP), a research watchdog, investigate Dr. Chabot’s selection process. Here’s what the OHRP found,

We note that Columbia University Medical Center (CUMC) found that for 40 of 62 subjects it appeared that informed consent was not documented with a signed written consent form prior to the initiation of research activities involving human subjects.”

As already mentioned, having “informed consent” is critical to the success of any study and is especially critical for someone entering Dr. G’s therapy. A patient must clearly know what there are getting into so as to determine whether or not they will be able to comply with the program. The OHRP states in their article,

“HHS regulations at 45 CFR 46.117(a) require that informed consent be documented by the use of a written consent form approved by the IRB and that is signed by the subject.”

Having informed consent is a clear regulation of the HHS (Department of Health & Human Services) that Dr. Chabot, as principal investigator, should have been aware of. So Dr. Chabot incorrectly selected 40 of 62 patients, over half of the patients!!! Yes, you can see the conflict of interests starting to show.

4) The initial grant of $1.4 million was awarded to Dr. Gonzalez because of his results from his pilot study. It is only fair then that he be involved in the selection process of the candidates. After all it is his therapy that is “on trial” here so he should be involved in the process. Dr. Gonzalez noted,

“Trouble began in earnest in July 2000 when at the insistence of the National Cancer Institute, Dr. Isaacs and I were removed from any involvement with the evaluation and admission of candidates into the nutritional arm of the trial, leaving the Principal Investigator, Dr. John Chabot, with absolute total dictatorial control over patient admission to both groups, with no appeal possible

The NCI justified this decision by saying that restricting Dr. G’s involvement eliminated bias. HUH!!! Eliminate bias?? Having Dr. Chabot, mister conflict of interest, in complete charge without some balanced input from Dr. Gonzalez clearly does not eliminate bias on the other side. Why do I continually have the aroma of monkey business passing by my notrils??

5) An important part of the selection process into Dr. G’s protocol requires that the patients be physically and mentally able to follow the program. For instance, the patient must be healthy enough to eat and be able to injest the large amount of supplements. The patient must also be mentally stable enough to be able to follow the details of the therapy. And again the patient must have the proper belief, motivation, and support to be able handle the rigors of this nutritional therapy.

One might argue that Dr. G’s requirements are much stricter than the requirements for the GTX therapy and is in a sense is “cherry picking” his patients. It is true that chemotherapy is an easier protocol to follow than Dr. G’s, but again I feel that ability to adhere is a secondary consideration as to the primary objective, overall therapy effectiveness. If we are going to judge one therapy to another, candidates selected must be able to follow either therapy in its entirety to fairly compare the two different therapies.

Here is what Dr. G found with the 39 patients that were assigned to his protocol,

We have identified 11 patients entered into the nutrition arm whose appetites were so poor they could never possibly have adhered to the prescribed regimen…..Dr. Chabot admitted three patients who, because of mental disability, we believe should have been disqualified, and one with no family or social support….We estimate that another 10 of the admitted patients lacked the drive, motivation, or faith in the treatment to stick with it for any length of time….Discounting overlap – several patients should have been disqualified for more than one reason – we estimate conservatively that 16 individual patients of the 39 admitted into the nutrition arm did not fulfill the written entry criteria.”

So almost half (16 of 39) of the candidates selected were simply not able to follow the protocol, yet they were included in the final statistical analysis which clearly skewed the results. If we are judging Dr. G’s protocol fairly, his patients must be able to do to therapy. It’s as simple as that.

6) It is one thing to not be able to follow the protocol. Another consideration is, for those who have ability to follow the rigors of the protocol, did they actually fully follow the therapy? From a statistical viewpoint, only those patients who sufficiently comply with Dr. G’s therapy or any therapy for that matter, should be included in the final statistical tally. If the therapy is being tested, then it must be sufficiently adhered to. Otherwise the results do not truly reflect the therapy.

Here’s what Dr. G found in this regard,

“For a number of reasons, including physical disability, psychiatric instability, lack of social support, poor motivation and physician harassment, we have calculated that 30 of the 39 patients ultimately entered into the nutrition arm followed the prescribed regimen not at all, for only brief periods of time, or incompletely.”

This amounts to a 77% non-compliance rate, yet all were included in the final statistical analysis!! It is quite irresponsible of Dr. Chabot to have included these individuals in the final tally. But if these individuals were excluded, there really wouldn’t be much of a sudy left, so Dr. Chabot couldn’t let that happen. After all, it is his GTX therapy on trial here too. Dr. Chabot clearly was not an unbiased director of this study.

You may notice that Dr. G mentioned “physician harassment” as one of the reasons for non-compliance with his therapy. It is important to note here that of the 39 patients enrolled in Dr. G’s therapy, only 3 of them actually lived in the New York area, and were able to see Dr. G for regular monthly assessments. The remaining 36 patients lived too far away and were forced to receive follow-up from a local doctor unfamiliar with Dr. G’s therapy and very often hostile to it. Dr. G notes,

“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.”

In our culture, oncologists and doctors in general, receive an almost “god-like” status when they give medical advice. Though doctors have studied their trade for many years, the most honest of doctors will readily admit that there is still much in the treatment of disease that they do not know. Yet when frightened pancreatic cancer patients are pressured to give up on treatments like Dr. G’s, only a select few have enough gumption to stick with it. This is what makes clinical trials on alternative cancer therapies so difficult to properly assess, because most doctors have been anti-alternative indocrinated.

This supervision by local doctors instead of Dr. G himself brings up another area of concern for me. If Dr. G’s therapy is on trial here, should not all patients accorded to his final statistical tally, be patients who received regular treatment and assessment from Dr. G personally or someone certified by Dr. G. Oncologists who are unfamiliar or unsympathetic to Dr. G’s therapy cannot possibly employ the same level of adherance as Dr. G? If we are going to judge Dr. G’s therapy, then his statistics should be based on patients he actually treats, not doctors unfamiliar and untrained in the execution of his protocol. This is a clear weakness which would inevitably skew the results.

Conversely, those enrolled in the GTX “arm” of the study, all 23 of them, received direct and intensive care under the very determined, skilled, and well-respected Dr. Robert Fine. Patients in this arm were spared no expense and many times treated 2-3 times per week. Dr. G puts is like this,

Those under Dr. Fine’s charge could not ask for more intense or sophisticated care, from an enthusiastic, supportive staff at a major academic institution. Our patients, on the other hand, faced quite a different and often grim situation at the hands of local doctors at best indifferent and frequently hostile to our therapy

This may sound like sour grapes, but as mentioned earlier, support is critical if one is going to properly follow any type of cancer therapy. Clearly, patients did not receive equal levels of support, yet we are supposed to trust the results?

7) At the beginning of the study, the experts at Columbia determined that for the study to “achieve statistical legitimacy” the number of patients participating needed to be at least 72. At the conclusion of the study, only 58 patients had participated. Dr. Chabot and the other Columbia didn’t see this as a problem and felt the numbers were adequate enough, even though they never achieved their original determination of legitimacy. It seems like Dr. Chabot was willing to change any rules he felt necessary to prove his GTX chemotherapy.

In addition to the insufficient numbers enrolled in the study, of the 58 patients entered you would expect an even distribution of the patients. This did not occur. 39 patients were entered in Dr. G’s regimen, and only 23 were admitted to the GTX therapy. For unknown reasons 4 patients were disqualified from Dr. G’s therapy, which then gave a grand total of 58 participating patients. Again Dr. Chabot didn’t feel the discrepancy between the numbers enrolled in either therapy represented a problem. Rule bending appears to have been a regular thing for Dr. Chabot during this study.

8) Another very important consideration when comparing pancreatic cancer therapies, is that the health of the patients enrolled in either therapy should be a similar as possible to produce accurate results. In other words, one therapy should not be receiving sicker patients than the other. If we are comparing apples to apples, the stage of the cancer must be closely similar.

With pancreatic cancer there are 4 stages which measure how progressed and widespread the disease has become at the time of diagnosis. Stage I pancreatic cancer is the least virulent, whereas Stage IV would be the most dangerous. Most people (about 75%) diagnosed with pancreatic cancer are already at the very advanced Stage IV. So for any clinical trial, one would expect to find this type of percentage to be fairly similar.

According to Dr. G by 2004,

“38 patients had been admitted for nutrition treatment, and of these, approximately 76% by our accounting had been initially diagnosed with the most advanced (stage IV) disease, the other 24% with earlier stage II or III. This pattern approximated, as did our pilot study, the usual distribution of newly diagnosed pancreatic cancer patients as reported in the literature.”

Dr. G’s focus was on his own patients, not the ones from the GTX “arm” of the study. So it was until the study was almost finished that Dr. G was given charts from Dr. Chabot about the GTX “arm”. Here’s what Dr. G became aware of,

“First, I was surprised that he had tabulated the numbers incorrectly for our group, which he reported incorrectly consisted of 35% at stage II and III and 64.7% at stage IV. But I was even more surprised to learn that the chemotherapy arm of the study, created under the direction of the Columbia oncologists, consisted of only 14 patients, 61.5% with earlier stage II and III disease, with only some 38% as advanced stage IV – a near reversal of the distribution in the nutrition group, and a reversal of the usual breakdown reported among patients diagnosed with pancreatic cancer.”

So according to charts given by Dr. Chabot himself, Dr. G as a whole was treating much sicker patients than the ones assigned by Dr. Chabot to the GTX arm. What is even more troubling is that having 61.5% Stage II & III and only 38% Stage IV patients being enrolled in the GTX therapy, doesn’t correspond to the norm of approximately 75% of patients diagnosed with pancreatic cancer are stage IV. This indicates “cherry-picking” by Dr. Chabot by having an abnormally high percentage of Stage II & III patients and abnormally low percentage of Stage IV patients enrolled in the GTX arm of the study. Can you say, conflict of interest? Yesiree!!

When Dr. G informed Dr. Chabot about his concerns with these numbers, he began to add, delete, and change patient numbers to make them more palatable for the final statiscal tally. This is otherwise know as number-fudging. I don’t know Dr. Novella, but I think this is a problem don’t you think?

9) Another discrepancy in the way patients were treated in each “arm” was the opportunity to modify the treatment when a patient was not responding to treatment or getting worse. Any good doctor, when diagnosing a problem with the treatment, will change it up by altering the dosage, change scheduling of the drugs or supplements, or changing many other variables in the treatment.

Dr. Fine was one of those doctors who would not give up on patients when they worsened during the GTX therapy. He would make alterations and do whatever he felt necessary to intensify the treatment. According to Dr. G, patients in his “arm” were not given the same flexibility,

“Yet as we came to learn, it seemed that Dr. Chabot believed our patients needed to be handled quite differently, as if two standards governed the trial – at the first sign of worsening, our nutrition patients were to be sent elsewhere for different treatment.”

At the first sign of trouble, those in Dr. G’s therapy were removed from the study and considered a failure in the final statistics. The local doctors clearly had no faith in Dr. G’s nutritional protocol for treating pancreatic cancer and would not go the extra mile and contact Dr. G for further advice on how to “ramp” up his therapy. Dr. G , in his regular practice, like Dr. Kelley would assess each patient regularly and if a patient was not responding to the therapy, he would alter the dose of enzymes, change the supplement scheduling, and/or change the diet.

It is clearly not fair for Dr. Fine to have full autonomy to alter his GTX treatments as needed, and Dr. G’s patient to have no adaptable support from their local doctors when they are not responding to therapy. Dr. G’s therapy requires regular assessment and alteration, so if this variable is not afforded to his patients by local doctors, his patients in effect are not doing his therapy and therefore should not be included in the statistics. Yet, Dr. Chabot included them all.

10) One more final consideration about this study is the length of time between diagnosis of the pancreatic cancer and the eventual initiation of the treatment. This is critically important with pancreatic cancer, as it is a very aggressive and deadly disease. So the sooner you can start the treatments the better. With regards to this study, for equal comparison the delay time between diagnosis and treatment should be the same for both therapies.

Dr. G became aware that this equal “delay time” was not equal after all. He found those enrolled in his therapy were experiencing great delays in their treatment after being diagnosed. Here’s what he found,

“Overall, we have calculated that 26 of the total of 39 patients admitted into the nutrition arm had been diagnosed by biopsy four or more weeks before meeting with us for their initial consultation, and 17 had been accepted six or more weeks from biopsy. We have calculated for all 39 nutrition patients an average delay between biopsy diagnosis and entry into the study of 36 days, or slightly more than five weeks – not insignificant for a disease as relentlessly aggressive as pancreatic adenocarcinoma.”

So the average delay between diagnosis and treatment for Dr. G’s therapy was about 5 weeks!! On top of the that, Dr. G’s therapy requires orders for supplements which take another week or so. With this delay, Dr. G noted that some patients then became too sick to comply with the therapy.

With regards to the GTX therapy, Dr. Chabot never gave Dr. G the details on delay time in this regimen, but Dr. G notes that with his extensive experience with cancer patients, chemotherapy is usually employed very soon after diagnosis (24-48 hours). Because pancreatic cancer is so deadly, most oncologists waste little time to begin treatment. I see no reason why Dr. Fine would be any different in his application of GTX chemotherapy.

So, this study is supposed to compare each therapy’s effectiveness on a level playing field, yet the delay time for treatment for Dr. G’s therapy was on average 5 weeks, and most likely the delay time for GTX was less than 48 hours. Time and time again we have seen that Dr. G’s regimen gets the short end of the stick. Dr. Chabot didn’t make this delay time a priority for Dr. G’s patients, and I venture to say that considering his conflict of interests from the very beginning, this delay had as Shakespeare said “method in his madness”. What makes this all the more distressing is that patients lives were in the balance here, and Dr. Chabot seemed to be playing them like pawns in a chess game. It’s actually disgraceful!!

Conclusion

So what can we conclude here. I have given 10 points which all represent significant flaws in how this study was carried out. I could have given more points, but I feel I have given sufficient evidence that this was a fatally flawed study from beginning to end. The director of the study, Dr. Chabot, had a clear conflict of interest having been a developer of the GTX chemotherapy. This conflict of interest became evident time and time again. To me the most significant problem was that 92% (36 of 39) of the patients assigned to Dr. G’s therapy were not actually treated by Dr. G or someone certified by him. Instead this was done by doctors unfamiliar with, untrained in, and often hostile to Dr. G’s therapy. Yet the lack of success of “his patients” was blamed on Dr. G!!! Clearly this study is not anywhere close to a true reflection of Dr. G’s enzyme therapy.

Dr. Engel, the official spokeswoman for NCCAM and this study, evaluated the concerns brought up by Dr. Gonzalez and came up with this conclusion,

“Given all of the challenges, the surprising outcomes, and the uncertainties about balance between the two arms, it is highly likely (if not certain) that reviewers of the data from this study will raise substantive and legitimate concerns about the comparability of the two populations. As a consequence, it is virtually certain that the controversy surrounding the study will not be settled by the data from it.”

” It was our impression that everyone in the room basically agreed that, despite best efforts, there is in fact, reason to be concerned about this issue, and that it clouds interpretation of the data.”

So “it is highly likely (if not certain)” that the data from the study basically cannot be trusted according to Dr. Engel. There are so many problems with the study that “it clouds interpretation of the data”. If the data cannot be trusted and the interpretation is clouded, why is it presented as a valid study on the NCI website? Why do quackwatch sites widely quote this study on the internet as the final word on Dr. Gonzalez’s & Dr. Kelley’s Enzyme Therapy? Why can’t doctors like Dr. Novella admit there are insurmountable problems with this study or even any problems at all?

Money, Anti-alternative indoctrination, pride, control, –you take your pick. It’s probably all of the above, but at the end of the day the core issue I believe is money. Billions of dollars are made and have been invested in chemotherapy drugs, radiation machine, surgeries, and cancer diagnostics. This became quite a shock to me when it first hit me several months ago, but it becomes truer each time I look under another cancer “rock”.

It is also very suspicious to me that Dr. Beard, Dr. Kelley, and Dr. Gonzalez have found great success with their practice of this enzyme therapy, yet the results of this study give a completely different and quite unique message. In figure skating, when a performance is judged, the top and bottom scores are not included in the final tally to avoid biased, hometown judging. Because this study is so off the baseline from what Dr. Beard, Dr. Kelley, Dr. Gonzalez, and others have found when using enzyme therapy, we must seriously question its validity. Dr. Beard was nominated for the Nobel Prize for his work. Dr. Gonzalez investigated Dr. Kelley and he became a believer. Dr. Gonzalez’s pilot study convinced Dr. Richard Klausner enough to award Dr. G with the $1.4 million to complete this study. Now strangely the results of the this study are completely at odds with the results of Dr. Beard, Dr. Kelley, and Dr. Gonzalez. So we have only 2 options

1) Dr. Beard, Dr. Kelley, Dr. Gonzalez and others have been fudging their numbers with enzyme therapy all these years

or

2) Dr. Chabot and the NCI fudged the numbers in this study to discredit enzyme therapy and therefore maintain the popularity of current money-making therapies chemotherapy, radiation, and surgery.

If you have been reading my blogs, including this one, it is no secret which option I would select. I believe there is clearly some monkey business going on behind the scenes and I’m not quite sure who or what is behind it all. All I know is that people are what is important, and people with cancer need to be told the truth and be given the therapies that produce the best results with the least collateral damage.

So Brent are you saying that we can’t trust medical studies anymore? No, but we do need to be much more vigilant in our evaluation of them. Brent, there is only so much time in the day, we can’t evaluate every medical study like what you have done in this blog. Eventually we have to show some trust don’t we? I guess we all have to activate our own “spidy senses”, check our gut feelings and then follow them up with research. Now, I would be extra skeptical about any study which denigrate an alternative cancer therapy that has a lot of successful anecdotal evidence behind it. Truth is not an easy road to follow, and I wish I was wrong on this, but the serious truth seeker in this day and age must be willing to go the extra mile and work much harder than the average person. At the end of the day though, truth-seeking is worth the extra effort.

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Cancer & the Big 3 therapies–opening a can of worms

Recently a good friend of mine for 20+years lost her battle with ovarian & colon cancer.  She followed the direction of her oncologist who prescribed the BIG 3 standard protocols for fighting cancer in conventional medicine.  Surgery, Chemotherapy, and Radiation therapy.  She fought this battle valiantly for about 2 years, and at times we thought she was on the road to recovery, yet in the end conventional medicine left her with no more options.  About 2 months before she passed away her oncologist told her that they had tried everything, and now there was nothing they could do for her.  What terrible news to receive.  I came to visit and pray for her one evening when this was all hitting the fan, and she told me that the worst part was that she had trusted her doctors direction all along the way, and now she was left to die.  What a feeling of abandonment.  She remained strong in her christian faith, but this sentence from the oncologist clearly took its toll. When I received this report via email, something inside me said, “I don’t accept that there is nothing that can be done!!”   I prayed to the Lord to give me wisdom about what I could do, and this sparked a fire in me to investigate the roots of cancer and alternative methods of therapy.  Previously, if I had contracted cancer myself I would have done exactly what my friend did–follow the advice of a trained oncologist without the thought of anything else.  After looking more closely at the big 3 protocols and alternative cancer therapies I realized I had just opened a can of worms.  I encountered what I believe to be a TRUTHBREAKDOWN.

What my research has uncovered is that there are over 400 conventional & alternative cancer treatment protocols that have been in use over the past few centuries and that there are over 200 more in the testing phase according the Independent Cancer Research Foundation.  So my question was and still is, why have our oncologists chosen the Big 3 cancer therapies (Surgery, Chemotherapy, Radiation) as the most common protocols for fighting cancer out of all the other options?  Surely they have been proven to greatly enhance 5 year survival rates?  My research has shown me that the success of the Big 3 is quite controversial.  The controversy surrounds whether these therapies actually do more harm than good and are they attacking the roots of the problem or just the symptoms.  Lets take a closer look at each:

**As a disclaimer, my research and opinions below are there as a commentary on conventional medical practices, and are not meant to be used as medical advice outside of the opinion of a medical doctor, which I am not.  Use the information to discuss with your health professional.

1) Surgery—          

 Photo of a breast biopsy.Stephen McCulley

This involves removing tumors by themselves, removing the tumor and surrounding tissue, or removing an entire body part (ie. breast) where the tumor resides.  The philosophy here is, the tumor is the enemy and must be removed.  If the tumor is removed without metastasis (spreading), it is considered a success.  What caused the tumor to develop in the first place is not addressed with surgery.  My research has shown me that a tumor may not be the enemy we’ve made it.  Some consider the tumor as our body’s way of protecting itself by localizing  the cancer cells, fungi, and microbes in a secure coating to keep it from spreading.  The tumor is actually saving the person from cancer metastasis.  Understanding this, one must seriously question the use of tumor biopsies which poke holes in the tumor to collect samples for testing.  I’ve found that many alternative practitioners vehemently oppose biopsies because they cause tumors to leak out the cancer cells, fungi, and microbes which then spread to another area in the body (metastasis).  There is concern that Mammograms (breast x-rays) may squish tumors to the point of breaking them, causing leakage as well.  There are alternatives to biopsies which test your cancer status by examining certain  antibodies or hormone levels in your blood (ie.  AMAS test, HCG hormone test, etc…).  See http://alternativecancer.us/cancer_testing.htm

  Another consideration I’ve found with surgery is that oncologists tend to be a little ‘trigger happy’ with regards to removing body parts.  My mother-in-law had a cancerous tumor in her breast about 20 years ago and her oncologist suggested a mastectomy (complete breast removal).  Using her own common sense, she challenged her doctor saying that if her tumor was secure and localized, why not just remove the tumor instead of the entire breast!!  The oncologist relented and she still has her breast today.   One must wonder if surgery profit has some relation to this “trigger happiness”.   So Brent, what are you saying about tumors then, just leave them alone?  Well, surgery seems to make sense if the tumor growth is interfering with an essential organ (ie. digestive colon blockage), but if no imminent problem exists, it seems sensible to leave it alone and use alternative therapies known to attack the roots of tumor growth first–and yes there are many (I will save this for future blogs).  Remember tumors are  protecting the rest of your body, so you need to protect them from leaking.  With surgery there is always a chance of leakage.  Not only that, surgery of any kind has inherent risks such as blood clots which can travel to the heart, lungs, and/or brain causing a stroke or even death.  My mother-in-law (yes she has been through a lot)  had an operation on her heart valve, and consequently she had a stroke due to a blood clot from the operation.  Thank God she has recovered for the most part but it took time.  So if you can shrink your tumor(s) without surgery, that is the ideal scenario.  As you can see, I feel conventional oncology has been somewhat haphazard in their use of surgical methods.

2) Radiation Therapy

Computed Tomography Scanner  

According to the National Cancer Institute, “Radiation therapy uses high-energy radiation to kill cancer cells by damaging their DNA”.  They also acknowledge “Radiation therapy can damage normal cells as well as cancer cells.”  Just like surgery, radiation therapy does not address the root cause behind the cancer and its focus is on killing the “bad” tumor.  So if the cancer cells are destroyed by DNA damage from the radiation, what about the DNA in the normal cells that become collateral damage?  According to Dr. Mark Sircus,

it is well established that exposure to ionizing radiation can result in mutations or other genetic damage that cause cells to turn cancerous but that has not stopped oncologists from using radiation therapy.” 

 News stories over the years from Chernobyl and the Fukushima nuclear disasters have generally educated the public about the dangers of radiation and its link to cancer.

  So lets reiterate, radiation clearly causes cancer, yet at the same time radiation therapy is one of the most common treatments to cure cancer?  To me, this type of logic is like someone trying to put a fire out with gasoline!!  Yes, radiation therapy does shrink tumors and kill cancer cells.  And to be fair, my research has shown that newer technology is making radiation beams much more precise, thus a patient receives less radiation.  But, if we have options that shrink tumors without risking collateral radiation, should not that be the therapy used?

 Much controversy has developed due to the interpretation of “response rate” vs. “survival rate”.  Yes, radiation therapy may have a very successful “response rate” with cancer tumors, meaning it is effective at shrinking tumors.  An oncologist may tell their patient that radiation may have a very high “response rate”,  and the patient may agree to the therapy thinking that what the doctor is talking about is “survival rate”.  They are definitely not the same.  My research has shown me that most studies on cancer therapy success are based on “response rate” or “5 year survival rates”.  To a nervous and fear ridden cancer patient, they probably do not realize there is a difference between the two.  My opinion  is, what good is it if my tumor shrinks if I do not survive the treatments or die shortly after?  Those who are very successful a fighting cancer through alternative therapies focus on building up the body’s natural defences by strengthening the immune system.  Radiation, similar to chemotherapy, does the complete opposite by killing cancer cells as well as the white blood cells which make up our immune system.  Many cancer patients, after receiving radiation therapy and chemotherapy, have little of any immune system left to fight any disease.  S.L. Baker writes. ”

Stephan Gripp, MD, of the University Hospital in Dusseldorf, Germany, and his colleagues investigated the treatment of terminally ill cancer patients who were referred for palliative radiotherapy at the University Hospital between December 2003 and July 2004. In all, they studied 33 of these patients, all of whom died within 30 days of receiving radiation therapy.”Learn more: http://www.naturalnews.com/028764_cancer_patients_radiation.html#ixzz1rnWGjyC4
 
Its not only the white blood cells that are killed, normal red blood cells are killed as well.  Many successful cancer therapies focus on increasing the amount of oxygen in the body, but when red blood cells (the carriers of oxygen) are killed, less oxygen is carried in the blood and the patient becomes anemic.  This further weakens the body’s ability to fight off disease. 
 
 According to the Independent Cancer Research Foundation, “Dr. William D. Kelley, a dentist by training, treated more than 33,000 cancer patients with natural medicine. His cure rate on newly diagnosed cancer patients, who went to him first, was over 90%.”   BUT!! when patients who have done conventional radiation, surgery, and chemotherapy first, then come to these type of alternative practitioners “the true cure rate of the best experts in alternative cancer treatments, on these types of patients, is between 40% and 50%.”   Though 40-50% is still pretty good in comparison to conventional methods, one can see the effect of how damaging radiation therapy and chemotherapy really are. 
 
So Brent, are you saying radiation therapy should be totally avoided?  My research has shown that there may be times when radiation therapy may have some beneficial use.  For instance, if a tumor is growing very fast and intruding against a vital organ (ie. brain), because radiation can shrink tumors quicker than natural methods, a very precise beam directed only at the tumor may “buy some time” while a person is taking alternative therapies like Dr. Kelley.  Conversely, given all the harm that radiation therapy produces, I would not use radiation therapy unless there was an immediate need for it.   I would not view radiation therapy as curative, but maybe as a “life-raft” to buy time.  One must use common sense here. 
 
 I would also be wary of submitting to CT (“cat”) scans, Mammograms and X-rays which also emit radiation.   Jennifer Bails writes,
 
 “a CT scan can deliver doses of ionizing radiation at least 50 to 250 times greater than a traditional X-ray, found a report published last November in the New England Journal of Medicine by researchers David Brenner and Eric Hall of Columbia University Medical Center. As a point of comparison, a CT scan of a child’s abdomen can supply the radiation equivalent of 600 chest X-rays. “
 
Instead I would push for thermal imaging, MRI, or ultrasound methods for analysis needs.  All doctors are supposed to abide by the Hippocratic oath, “I will keep them from harm and injustice”.  Knowing this, I feel Oncologists need to rethink their use of radiation therapy and radiation diagnostics.
 
3) Chemotherapy–
 
Chemotherapy : Breast cancer ribbon - portrait of patient undergoing chemotherapy. Real woman, diagnosed with breast and ovarian cancer.   Chemotherapy : Nurse Giving Patient Injection Through Tube Stock Photo  Chemotherapy : Close up of an infusion bottle  Stock Photo  Chemotherapy : Drugs in a Daily Pill Dispenser
 
According to the National Cancer Institute, “Chemotherapy (also called chemo) is a type of cancer treatment that uses drugs to destroy cancer cells.  Chemotherapy works by stopping or slowing the growth of cancer cells, which grow and divide quickly. But it can also harm healthy cells that divide quickly, such as those that line your mouth and intestines or cause your hair to grow.”  Again like radiation therapy, chemotherapy do not address the root cause behind the cancer, and it is responsible for collateral damage to healthy cells.  It is a Kill, Kill, Kill approach which may have some success at “response rate” but there is great debate as to whether it has any success at “5 year survival rate”.
 
So what’s really go on here?  Biochemists have discovered cancer cells grow at a much faster rate than regular cells, so if a chemical can be injected that only kills fast-growing cells (cytotoxic), cancer cells and tumors will get killed.  The problem is cancer cells aren’t the only fast growing cells in the body.  Anywhere where there is cellular rejuvenation occurring gets hit with chemo including hair, mouth, digestive tract, and our all-important white blood cells.  Like radiation therapy, the loss of white blood cells is the part of chemo that doctors are most concerned about when administering it.  The immune system basically gets toasted, yet this is considered acceptable collateral damage.

As Gary Null and James Feast write,
 
“(After chemotherapy,) the hope is the cancer is going to be totally dead and you are only half dead and recover.”Learn more: http://www.naturalnews.com/012727.html#ixzz1rwnwusUx
 
Most successful alternative cancer protocols focus on building the body’s immune system and removing toxic chemicals from the body.  Chemo does the exact opposite, injecting highly toxic chemicals into body which destroy our immune system.  How toxic are these chemo drugs? According to Dr. Tim O’Shea,
 
When any chemotherapeutic drug is spilled in the hospital or anywhere en route, it is classified as a major biohazard, requiring the specialists to come and clean it up with their space-suits and all their strictly regulated protocols.”
 
 
 So to heal people from cancer we are injecting “major biohazards” into them, and we are expecting them to get well?  Trying to put out a fire with gasoline comes to mind again.  But Brent, chemo wouldn’t be so widely used around the world for cancer therapy if it wasn’t a proven way to fight and cure cancer.  Sure, there may be some success stories but the more common testimony I read on the internet is someone who endures an awful period of grueling side effects only to be left in an incredibly weakened state.  The National Cancer Institute readily lists the side effects of chemo are anemia, loss of appetite, bleeding problems, constipation, diarrhea, fatigue, hairloss, infection, memory changes, mouth and throat changes, nausea and vomiting, nerve changes, pain, sexual and fertility changes, skin and nail changes, swelling (fluid retention), and urination changes. These potential symptoms are not what you would want to wish on anyone.  If the patient survives the chemo treatments, the cancer may go into a short period of remission and then come back like a freight train.  Linda Marsa, from the L.A. times, writes on the findings of Dr. Jonathan Berek on ovarian cancer,
 
Chemotherapy follows the surgery, and about 90% of patients then go into remission, a period of “watchful waiting.” “The problem is that over the next five to 10 years, as many as 90% of women will relapse and die,” says Berek.  When the cancer returns, in other surrounding tissue, the cancer is more virulent and resistant to chemotherapy.
 
This is exactly what my friend, mentioned at the beginning of this blog, experienced.  But Brent, even if chemo damages the body, it’s better than doing nothing?  Well, actually according to Dr. Allen Levin,
 
“Most cancer patients in this country die of chemotherapy. Chemotherapy does not eliminate breast, colon, or lung cancers. This fact has been documented for over a decade, yet doctors still use chemotherapy for these tumors.”
 
Did you catch that? Most cancer patients die not from the cancer but from the chemotherapy!!  Come on Brent, today’s chemo drugs are much more advanced now and you are making chemo seem worse than it really is.  Well, my friend just passed away a little over a month ago in 2012 and everything I’ve presented here in my research, I saw happen to her with own eyes.  So if chemo is so much more advanced now, why did the same terrible process I read about show up in her involvement with today’s modern oncology. 
 
Here’s the facts, conventional oncology has made minimal advances in 5 year survival rates and has delivered a poor quality of life for those who endure the Big 3 cancer therapies.  There are literally hundreds of other options for cancer therapies that are termed “alternative”.  Most of these methods do little if any harm the body, are far less expensive, and have much higher success rates.  They focus on building up the body and treating the roots of cancer, not destroying patients bodies and treating symptoms.  Modern oncologists may term alternative practitioners as “quacks” because some have died in their care.  If death rates are how we judge doctors, modern oncologists should be considered “quacks” of the highest order. 
 
 My problem is not actually with doctors and oncologists, I have many friends in the profession.  Most doctors I’ve met are very kind and do genuinely care about their patients.  My problem is with the “system” they’ve inherited and the training they’ve been given at medical school.  When you take a closer look at our medical system, there are certain therapies that physicians are allowed to use, and alternative therapies that they are not allowed to use.  Doctors risk losing their licence to practice medicine if they use “alternative” methods.  No way Brent!! yes way.  Almost all of the best alternative cancer practitioners of the past & present have received some sort of backlash from the medical elite (I will save this for a future blog).  These Elite will say these alternative methods have not received proper testing or that patients have died using them.  A closer examination will reveal that it almost impossible to get proper funding and acceptance to carry out official testing on cheaper alternative methods.  The only therapies accepted are the expensive ones that have patents from pharmaceutical companies.  If money cannot be made to compensate Big Pharma for their “synthetic” drugs, they are not approved for testing.  Big money cannot be made on “natural” cancer fighting substances because they are ineligible for patents. 
 
Make no mistake about it, cancer is big money.  According to the National Cancer Institute, in 2007 the cost (or should I say money earned) of cancer was $226.8 billion.  According to a study done by Harvard University, National Cancer Institute, and National Bureau of Economic Research in December 2007, the average cost/year/lung cancer patient (called cost effectiveness ratio) was $403,142/life year gained.   This comprised $143,614 for localized cancer, $145,861 for regional cancer, and $1,190,322 for metastatic cancer.  According to Sandra Boodman in the Washington Post, the annual cost of cancer pills can be well over $75000/year.  Add in surgery, CT scans, PET scans, radiation therapy, blood tests, medications, x-rays, and physician fees and you get the picture here. 
 
Conversely, according to Mark Sircus who is a natural allopathic cancer practitioner,
 
 The full cost for all the natural healing substances you will need will not exceed $6,000 a year. Instead of paying a fortune for a single pharmaceutical with toxic effects offering limited results one can nourish the body and attack the cancer with:

  • Magnesium Chloride
  • Iodine
  • Selenium
  • Alpha Lipoic Acid (ALA)
  • Sodium Bicarbonate
  • Natural Vitamin C
  • Cesium Chloride
  • Sodium and Calcium Bentonite Clays
  • Natural Chelation Formula
  • Sodium Thiosulfate
  • Spirulina
  • Zeolite

Canadian and American politicians are struggling with the ever increasing healthcare costs and how to find ways to decrease waste in the system.   If natural cancer therapies cost $6000/year and conventional therapies cost $400,ooo++/year, why do we continue to throw billions of dollars at methods which are antiquated and barbaric.  The Big 3 cancer therapies give you taste of how Big Pharma and profit-driven protocols are destroying our healthcare system.  Of course, for most the main concern is the health of people, but when finances are misappropriated to wasted protocols, services are lessened to other well-deserving and life-giving healthcare. So here’s our decision.

Support expensive, barbaric, immune destroying, profit-driven cancer protocols OR cheaper, humane, immune-building, and body nourishing cancer protocols.  The choice seems simple, but our society has entered a truthbreakdown and only the brave can change the powers that be.

Here is a good summary analogy of the Big 3 cancer therapies that I found on the Independent Cancer Research Foundation website which they used from cancertutor.com,

Suppose you are very rich and own a very rare, priceless antique dining room table formerly owned by English royalty. Suppose your butler tells you that there are dozens of cockroaches crawling around on your priceless table and you will be having dinner guests in one hour.

Your butler tells you his job description does not include killing cockroaches and as he is leaving your house, he gives you four suggestions for getting rid of the cockroaches:


1) He offers you a chainsaw to “slash” the little critters to pieces,
2) He offers you a large and powerful flamethrower to “burn” the critters to pieces,
3) He offers you 2 gallons of a highly, highly toxic liquid chemical to “poison” the critters, and
4) He offers you an old $1 flyswatter.

Which of the four options would you pick? Would you choose one of the first three options (slash, burn and poison) because they are highly potent at killing cockroaches or would you choose the cheap, wimpy flyswatter?

 This example may seem a little ridiculous, but it gives a reasonable analogy of the choices conventional oncologists give cancer patients.  Your body is worth much more than an antique dining table so you should consider that when choosing your treatments. 
 
I will dedicate some of my future blogs to kinder, gentler, humane, and more effective natural treatments and alternative practitioners who have had success in battling cancer and chronic disease. 
 
God Bless,