Comments on: The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed http://www.sciencebasedmedicine.org/?p=298 Exploring issues and controversies in the relationship between science and medicine Fri, 10 Sep 2010 02:13:51 -0700 http://wordpress.org/?v=2.8.4 hourly 1 By: Science-Based Medicine » Senator Tom Harkin and Representative Darrell Issa declare war on science-based medicine http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-28511 Science-Based Medicine » Senator Tom Harkin and Representative Darrell Issa declare war on science-based medicine Mon, 27 Jul 2009 11:31:10 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-28511 [...] of chelation therapy in which convicted felons were listed among the investigators and a totally unethical trial of the Gonzalez therapy for pancreatic cancer. It’s not for naught that Wally Sampson called for the defunding of [...] [...] of chelation therapy in which convicted felons were listed among the investigators and a totally unethical trial of the Gonzalez therapy for pancreatic cancer. It’s not for naught that Wally Sampson called for the defunding of [...]

]]> By: Macy Pages http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-23017 Macy Pages Thu, 02 Jul 2009 12:02:51 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-23017 <strong>Pancreatic Cancer Symptoms...</strong> Pancreatic cancer symptoms are sometimes non-specific and varied. Pancreatic cancer is a type of cancer that affects the pancreas. It is a malignant neoplasm of the pancreas. This type of cancer is usually diagnosed in the advanced stages because the p... Pancreatic Cancer Symptoms…

Pancreatic cancer symptoms are sometimes non-specific and varied. Pancreatic cancer is a type of cancer that affects the pancreas. It is a malignant neoplasm of the pancreas. This type of cancer is usually diagnosed in the advanced stages because the p…

]]> By: Science-Based Medicine » The Ethics of “CAM” Trials: Gonzo (Part I) http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-17827 Science-Based Medicine » The Ethics of “CAM” Trials: Gonzo (Part I) Sun, 19 Apr 2009 22:21:31 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-17827 [...] 1. The Ethics of “CAM” Trials: Gonzo (Part I) 2. The Ethics of “CAM” Trials: Gonzo (Part II) 3. The Ethics of “CAM” Trials: Gonzo (Part III) 4. The Ethics of “CAM” Trials: Gonzo (Part IV) 5. The Ethics of “CAM” Trials: Gonzo (Part V) 6. The Ethics of “CAM” Trials: Gonzo (Part VI) 7. The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed [...] [...] 1. The Ethics of “CAM” Trials: Gonzo (Part I) 2. The Ethics of “CAM” Trials: Gonzo (Part II) 3. The Ethics of “CAM” Trials: Gonzo (Part III) 4. The Ethics of “CAM” Trials: Gonzo (Part IV) 5. The Ethics of “CAM” Trials: Gonzo (Part V) 6. The Ethics of “CAM” Trials: Gonzo (Part VI) 7. The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed [...]

]]> By: Science-Based Medicine » Yes We Can! We Can Abolish the NCCAM! Part III http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-12817 Science-Based Medicine » Yes We Can! We Can Abolish the NCCAM! Part III Fri, 06 Feb 2009 05:44:11 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-12817 [...] who heads Columbia University’s “CAM” program, was unaware of the origins or the fate of the Gonzalez trial, as we wondered last week about Straus himself? It was Kronenberg who, [...] [...] who heads Columbia University’s “CAM” program, was unaware of the origins or the fate of the Gonzalez trial, as we wondered last week about Straus himself? It was Kronenberg who, [...]

]]> By: Science-Based Medicine » Yes We Can! We Can Abolish the NCCAM! Part II http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-12696 Science-Based Medicine » Yes We Can! We Can Abolish the NCCAM! Part II Sun, 01 Feb 2009 14:35:36 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-12696 [...] the planned 90 subjects had been enrolled, and that the study had been so terminated. As discussed here, this must have meant that the outcomes had been so bad that [...] the planned 90 subjects had been enrolled, and that the study had been so terminated. As discussed here, this must have meant that the outcomes had been so bad that

]]> By: Science-Based Medicine » Yes We Can! We Can Abolish the NCCAM! http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-12335 Science-Based Medicine » Yes We Can! We Can Abolish the NCCAM! Fri, 23 Jan 2009 12:56:04 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-12335 [...] retrospect, that Straus must have known that the Columbia Data and Safety Monitoring Committee had stopped the Gonzalez trial months before, almost certainly because the regimen had been shown to be vastly inferior to [...] [...] retrospect, that Straus must have known that the Columbia Data and Safety Monitoring Committee had stopped the Gonzalez trial months before, almost certainly because the regimen had been shown to be vastly inferior to [...]

]]> By: pmoran http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-11133 pmoran Tue, 09 Dec 2008 21:23:26 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-11133 Yes, oderb, I agree. It is incomprehensible to me also that the raw results might not be published. No matter how flawed they may have become in terms of an ill-advised RCT format, the Gonzales arm alone will provide a valuable ball-park impression of what cancer patients can expect of this very arduous regime. And it is not a positive for his method if it is found that most pancreatic cancer patients aren't fit enough to undergo it. If, as predictable from Gonzales' own pilot study, all cancers progressed and his patients all died within 2-3 years, that is valuable information -- for the public and for cancer patients, rather than to scientists who never expected that the methods used could materially affect cancer. (And it would explain Gonzales' own apparent passivity concerning possible non-publication). We rarely have such precise information as to the (non)-effects of an "alternative" cancer treatment on a carefully diagnosed and staged cancer state. Do you wish to discuss your own case? Yes, oderb, I agree. It is incomprehensible to me also that the raw results might not be published. No matter how flawed they may have become in terms of an ill-advised RCT format, the Gonzales arm alone will provide a valuable ball-park impression of what cancer patients can expect of this very arduous regime. And it is not a positive for his method if it is found that most pancreatic cancer patients aren’t fit enough to undergo it.

If, as predictable from Gonzales’ own pilot study, all cancers progressed and his patients all died within 2-3 years, that is valuable information — for the public and for cancer patients, rather than to scientists who never expected that the methods used could materially affect cancer. (And it would explain Gonzales’ own apparent passivity concerning possible non-publication). We rarely have such precise information as to the (non)-effects of an “alternative” cancer treatment on a carefully diagnosed and staged cancer state.

Do you wish to discuss your own case?

]]> By: oderb http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-11116 oderb Tue, 09 Dec 2008 13:02:33 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-11116 As the long time patient (24 years) and admirer of Dr. Gonzalez whose comment on one of the earlier Gonzalez posts was referred to above I am dismayed to say the least at the strong circumstantial evidence discussed here suggesting the trial showed his protocol to be inferior and further that it appears that the trial was not biased by inappropriate referral of patients to him. I now don't know what to believe - my own very positive experience with Dr Gonzalez and my belief that my long term survival is due to his program or the information presented here in SBM. If my survival is independent of his program I would be deeply disillusioned on the one hand, but quite happy to abandon the cost and arduous effort of his program on the other. My question is simple. How can the government suppress the full results of the study and get away with it? Is someone willing to file a Freedom of Information request or formally petition the appropriate parties or at least describe the legal pathway to achieve publication? There are hundreds of Gonzalez patients like myself who believe in him and thousands of others who will no doubt start on his protocol in the coming years. We deserve - as does the entire cancer world - to know the full story of what happened and why. I am not prepared to give up on the Gonzalez protocol as yet, but I am willing to be convinced that I have been following an ineffective therapy. In that respect I am both a true believer in him and a believer in SBM. I almost feel like Arthur Koestler as he became increasingly disillusioned with communism and agonized at the thought of discarding a way of living that defined much of his life. I hope that someone will respond to this post and help. Thank you. As the long time patient (24 years) and admirer of Dr. Gonzalez whose comment on one of the earlier Gonzalez posts was referred to above I am dismayed to say the least at the strong circumstantial evidence discussed here suggesting the trial showed his protocol to be inferior and further that it appears that the trial was not biased by inappropriate referral of patients to him.

I now don’t know what to believe – my own very positive experience with Dr Gonzalez and my belief that my long term survival is due to his program or the information presented here in SBM. If my survival is independent of his program I would be deeply disillusioned on the one hand, but quite happy to abandon the cost and arduous effort of his program on the other.

My question is simple. How can the government suppress the full results of the study and get away with it? Is someone willing to file a Freedom of Information request or formally petition the appropriate parties or at least describe the legal pathway to achieve publication? There are hundreds of Gonzalez patients like myself who believe in him and thousands of others who will no doubt start on his protocol in the coming years. We deserve – as does the entire cancer world – to know the full story of what happened and why.

I am not prepared to give up on the Gonzalez protocol as yet, but I am willing to be convinced that I have been following an ineffective therapy. In that respect I am both a true believer in him and a believer in SBM. I almost feel like Arthur Koestler as he became increasingly disillusioned with communism and agonized at the thought of discarding a way of living that defined much of his life.

I hope that someone will respond to this post and help. Thank you.

]]> By: Kimball Atwood http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-10927 Kimball Atwood Tue, 02 Dec 2008 18:34:32 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-10927 "who in congress could possibly be giving gonzalez this type of support?" The answer is Dan Burton (R-IN), the former chairman of the House Committee on Government Reform. See: http://www.sciencebasedmedicine.org/?p=92 and http://www.sciencebasedmedicine.org/?p=104 Also see <a href="http://www.ncbi.nlm.nih.gov/pubmed/18596934?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum&log$=freepmc" rel="nofollow">here </a>for an example of Burton's influence over another dangerous and unethical trial of an implausible claim. KA “who in congress could possibly be giving gonzalez this type of support?”

The answer is Dan Burton (R-IN), the former chairman of the House Committee on Government Reform. See:

http://www.sciencebasedmedicine.org/?p=92 and

http://www.sciencebasedmedicine.org/?p=104

Also see here for an example of Burton’s influence over another dangerous and unethical trial of an implausible claim.

KA

]]> By: MedsVsTherapy http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-10905 MedsVsTherapy Mon, 01 Dec 2008 18:27:41 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-10905 please stay on the story. this is great. who in congress could possibly be giving gonzalez this type of support? i seriously doubt the coffee cartel and papaya interests are "in" on this one. the sad thing is the vague things gonzalez sez: you just don't understand - this intervention is so complex, blah blah blah. same story. at first, some CAM person makes spectacular claims. Then, as you try to measure this supposed dramatic effect, or ask how it is supposed to work, up comes the obfuscation. is the original NIH grant application available? i would love to see how they fit scientific justification for this "treatment" into the alloted page space. Otherwise, why not simply do coffee enemas? Or evaluate coffee versus tea enemas, etc? please stay on the story. this is great.

who in congress could possibly be giving gonzalez this type of support? i seriously doubt the coffee cartel and papaya interests are “in” on this one.

the sad thing is the vague things gonzalez sez: you just don’t understand – this intervention is so complex, blah blah blah.

same story.

at first, some CAM person makes spectacular claims. Then, as you try to measure this supposed dramatic effect, or ask how it is supposed to work, up comes the obfuscation.

is the original NIH grant application available?

i would love to see how they fit scientific justification for this “treatment” into the alloted page space.

Otherwise, why not simply do coffee enemas? Or evaluate coffee versus tea enemas, etc?

]]> By: Wallace Sampson http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-10894 Wallace Sampson Sun, 30 Nov 2008 18:23:11 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-10894 DLC: Yes, your "what's next" examples are exactly what the NCCAM and Evidence-Based Medicine are about - in the case of EBM, what it has become since the invention of EBM by its well-intentioned founders. Both assume that little to nothing is known about whatever idea arises in one's mind. Previous knowledge does not count in those worlds. And the astounding part is that medical academicians at highest levels agree. DLC:
Yes, your “what’s next” examples are exactly what the NCCAM and Evidence-Based Medicine are about – in the case of EBM, what it has become since the invention of EBM by its well-intentioned founders. Both assume that little to nothing is known about whatever idea arises in one’s mind.
Previous knowledge does not count in those worlds. And the astounding part is that medical academicians at highest levels agree.

]]> By: DLC http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-10890 DLC Sun, 30 Nov 2008 09:14:40 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-10890 Gee, you mean taking vitamins, having enemas, giving yourself the trots from citrate of mag and bathing in .... salt and baking soda ? or salted soda water? did not do as well as conventional treatment for pancreatic cancer ? Who'da thunkit ? What next, finding out that morphine is better for severe pain than staring at a picture of pink bunnies ? The landmark discovery that cutting into the skin can cause blood loss ? Your tax dollars at work. Gee, you mean taking vitamins, having enemas, giving yourself the trots from citrate of mag and bathing in …. salt and baking soda ? or salted soda water? did not do as well as conventional treatment for pancreatic cancer ?
Who’da thunkit ?
What next, finding out that morphine is better for severe pain than staring at a picture of pink bunnies ?
The landmark discovery that cutting into the skin can cause blood loss ?

Your tax dollars at work.

]]> By: Wallace Sampson http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-10885 Wallace Sampson Sat, 29 Nov 2008 09:59:19 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-10885 Congratulations to Dr. Atwood for digging and reasoning this thing through. In 2000-2004 when we were working out the detils of Susan Gurney's article for Scientific Review... we were bemoaning CU's decison to give credence to this twice-defeated-in-court program of methodological nonsense. The vehicles for promotion at that time were the administration and staff at Columbia. At the time, the dean had given a keynote address to the NCCAM (then OAM) meeting on "CAM" education, Mehmet Oz began "Therapeutic Touch for his cardiac surgery patients, and Columbia had established its "CAM" center with a generous grant from the R and H Rosenthal Foudation, and then came the infamous Cha/Wirth study on prayer for in vitro fertilization. Morningside heights sunk into swamp. It was hard to keep one's head above bilge. Last we heard, the Gonzo study had been amended to cease accrual because, we thought, accrual was inadequate. But I doubt the monitoring committe would fib, so Dr. Atwood's detective work stands as the best fit with the data at hand.. Wow. Congratulations to Dr. Atwood for digging and reasoning this thing through. In 2000-2004 when we were working out the detils of Susan Gurney’s article for Scientific Review… we were bemoaning CU’s decison to give credence to this twice-defeated-in-court program of methodological nonsense. The vehicles for promotion at that time were the administration and staff at Columbia.
At the time, the dean had given a keynote address to the NCCAM (then OAM) meeting on “CAM” education, Mehmet Oz began “Therapeutic Touch for his cardiac surgery patients, and Columbia had established its “CAM” center with a generous grant from the R and H Rosenthal Foudation, and then came the infamous Cha/Wirth study on prayer for in vitro fertilization. Morningside heights sunk into swamp. It was hard to keep one’s head above bilge.
Last we heard, the Gonzo study had been amended to cease accrual because, we thought, accrual was inadequate. But I doubt the monitoring committe would fib, so Dr. Atwood’s detective work stands as the best fit with the data at hand.. Wow.

]]> By: David Gorski http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-10875 David Gorski Fri, 28 Nov 2008 17:10:20 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-10875 Why am I not surprised? Dr. Kimball is almost certainly correct. When a trial is stopped because of predetermined stopping criteria, it virtually always means that an interim analysis has revealed that one arm of the trial is clearly superior to the other, so much so that even if patients were accrued right up to the target accrual number, it would be mathematically impossible or highly unlikely that their inclusion would alter the results of the analysis significantly. With such a result, it is considered unethical to continue the trial, because the question that the trial is asking has been answered and one treatment demonstrated to be superior to the other. (Subjecting further subjects to the risk of being assigned to a category now known to result in inferior outcomes cannot be ethically justified.) These interim analyses and predetermined stopping criteria are decided and agreed upon prospectively and built into the design of the clinical trial in order to protect patients from being subjected to risk with no likelihood of benefit. In this trial, I think it's very reasonable to conclude that almost certainly a major interim analysis of the results of the Gonzalez regimen showed it to be significantly inferior to conventional therapy. After all, if that interim analysis had shown the Gonzalez protocol to be so much superior to conventional therapy that it met the predetermined criteria for stopping the trial, it's a safe bet that Dr. Gonzalez and all the advocates of his protocol and "alternative" medicine in general would have published the results, probably in the <em>New England Journal of Medicine</em> because they would have been that striking and important, and would have been trumpeting them to high heaven as vindication. That no such thing happened is strong evidence that the trial likely showed Gonzalez's woo to be significantly inferior to conventional therapy. Why am I not surprised? Dr. Kimball is almost certainly correct. When a trial is stopped because of predetermined stopping criteria, it virtually always means that an interim analysis has revealed that one arm of the trial is clearly superior to the other, so much so that even if patients were accrued right up to the target accrual number, it would be mathematically impossible or highly unlikely that their inclusion would alter the results of the analysis significantly. With such a result, it is considered unethical to continue the trial, because the question that the trial is asking has been answered and one treatment demonstrated to be superior to the other. (Subjecting further subjects to the risk of being assigned to a category now known to result in inferior outcomes cannot be ethically justified.) These interim analyses and predetermined stopping criteria are decided and agreed upon prospectively and built into the design of the clinical trial in order to protect patients from being subjected to risk with no likelihood of benefit.

In this trial, I think it’s very reasonable to conclude that almost certainly a major interim analysis of the results of the Gonzalez regimen showed it to be significantly inferior to conventional therapy. After all, if that interim analysis had shown the Gonzalez protocol to be so much superior to conventional therapy that it met the predetermined criteria for stopping the trial, it’s a safe bet that Dr. Gonzalez and all the advocates of his protocol and “alternative” medicine in general would have published the results, probably in the New England Journal of Medicine because they would have been that striking and important, and would have been trumpeting them to high heaven as vindication. That no such thing happened is strong evidence that the trial likely showed Gonzalez’s woo to be significantly inferior to conventional therapy.

]]> By: weing http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-10873 weing Fri, 28 Nov 2008 16:52:55 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-10873 How the hell do we stop this from happening again? How the hell do we stop this from happening again?

]]> By: DavidCT http://www.sciencebasedmedicine.org/?p=298&cpage=1#comment-10869 DavidCT Fri, 28 Nov 2008 16:02:06 +0000 http://www.sciencebasedmedicine.org/?p=298#comment-10869 One can be appalled on behalf of the patients whose quality of life was reduced by "quackademics". Not only were they subjected to these useless and unpleasant treatments, but the data documenting the uselessness of these treatments were suppressed. The "integrative" mindset that is invading our Medical schools hurts real people. It is no more benign than any other cancer. I thank the authors of this blog for doing something to raise awareness levels. One can be appalled on behalf of the patients whose quality of life was reduced by “quackademics”. Not only were they subjected to these useless and unpleasant treatments, but the data documenting the uselessness of these treatments were suppressed. The “integrative” mindset that is invading our Medical schools hurts real people. It is no more benign than any other cancer.

I thank the authors of this blog for doing something to raise awareness levels.

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