How to measure success with Provenge

[Guest guest]

I confess that I have not paid too much attention to

all the detail of Provenge since there is no chance, as far as I can see, of my

ever using the drug. But I have had a couple of questions put to me off my site

and feel I’d better get up to speed and perhaps put some basic

information on my site.

One of the first questions I had was “How will

I know if Provenge is working if PSA is no longer a measure of success?” In

starting to look for the answer to that I came across this comment on the June

2011 ASCO meeting item <snip> Knowing more specifically how Provenge

extends survival without causing remissions is one of the pivotal new questions

in prostate cancer oncology. <snip>

I am not too sure just what this means – can anyone

enlighten me? If there is no remission, is it possible that the observed extended

survival is merely be another dot in the range of survival periods in men

taking Provenge?

Does anyone know of a site – preferably not a

Dendreon funded one – that sets out the basic information for Provenge to

save me a bit of a search?

All the best

Prostate men need enlightening, not frightening

Terry Herbert - diagnosed in 1996 and still going

strong

Read A Strange Place for unbiased information at http://www.yananow.org/StrangePlace/index.html

[Guest guest]

Not sure I can actually answer your question but the best place to start is to get a hold of an issue of Dr. Strum's PCRI in which he dedicated it almost entirely to the recruitment of patients for the first Phase III clinical trial of Provenge. Once you have located and read that, I think it might be worth contacting Strum's organization directly and see if you can get an answer from him , Strum, because he was closely involved with both the clinical trial itself and the company and would have access to information and perhaps company personnel that none of us would. People at the company would perhaps be able to answer such questions, and might be willing to answer such questions if the right people were asking.

The statement itself that you refer to appears to be saying that Provenge is intended to extend life of PCa patients who are in the final stages of their disease but it does not, and has not been observed to provoke a remission in any of the patients in which it has been tested or used. Which I believe to be a statement of fact admitted to by the company. The issue of PSA and the mechanism by which Provenge extends life is an issue that the FDA had to wrestle with when Provenge completed it's first Phase III trial and why the FDA ordered a second Phase III trial. The company , Dendreon, was unable to explain how and why Provenge worked in the papers they submitted to the FDA when they sought approval of Provenge. They could only explain and show conclusively that it did work in extending life.

The FDA was expecting to see the drugs performance measured in terms of PSA levels but that was not to be the case. They used other data to make their points and I think that understanding that data may provide some explanations. I called Strum's PCRI publication myself prior to the first Phase III trial because after reading it over, it was apparent that the acronym PSA had not been mentioned even once. Which seemed very strange to me as Strum is a very strong supporter of PSA testing at all stages of the disease process. And I myself was specifically searchiing to see what was to be said about PSA levels of the men involved in the Phase I and II trials. Even though such trials were not performed to observe the effect on their PSA's, I merely assumed that as part of any clinical trial with respect to PCa that PSA measurements would have been meticulously measured and recorded. Yet none appeared in

Strums presentation. What I found even more confounding is that in that same issue, Strum found space to once again write a 2 paragraph article lambasting the British Medical Authorities for not making PSA testing a standard test for all men as it has become here in the U.S.. That made the Provenge presentatioin seem all the more strange for it's lack of mention or reference to PSA. Strum has written many articles over the years criticizing British Medical Authorities for not making PSA testing a standard test of the National Health Service for men over a certain age.

Yes, how Provenge works to extend life without regard to PSA is a pivotal question. One which Dendreon to my knowledge has been unable itself to explain. Yet, in two clinical Phase III trials it has been shown to have a median extension of life of 4 1/2 months compared to standard treatment alone. I believe that if PCa had been a lesser disease , and by that I mean something not as serious in it's dimensions as cancer, that the FDA would have been very likely not to have approved Provenge. But because PCa is such a serious illness , and by the time they give you Provenge it has actually become a terminal illness, I think that the FDA would have had a very difficult road ahead of itself had it not approved it. Sometimes not everything can be explained and I would hope that in the future should another treatment appear that successfully treats PCa and extends life and similarly cannot be

explained with reference to standard markers like PSA, that it too is approved. Yet the fact that PSA does not seem to play a role in the effectiveness of Provenge or the mechanism by which it works actually is quite promising as it seems to be suggestive that there are ways to treat PCa other than blunt protocols like hormonal manipulation, surgery and radiation. . I'm hopeful that Provenge respresents a new path in the treatment of PCa that is a radical departure from current medical definition of definitive treatments.

As for using the drug , to my knowledge , and what had been hoped for by the company, is that after proving that Provenge could extend the lives of men with terminal stage cancer that trials could be conducted with men at much earlier stages of the disease. However the same questions the FDA has asked would plague the researchers even more , which is how would you track the progress of the patient? In the trial that was approved by the FDA the researchers were able to show that it extended life in the sickest of PCa patients at the end stage of their disease. This was easily measurable by comparing them with men in the same stage of the disease that did not get Provenge. However, giving Provenge to men at much earlier stages of the disease presents unique problems. The most obvious of which is the one you yourself brought to the fore as to my knowledge no one

has as of yet figured out the mechanism by which it actually works it's magic. If PSA is not relevant, than what marker do you use to show that Provenge is doing something beneficial for the patient? I think that this is still a question that the company has been unable to answer. And it is a very important question as the only other methods to track the patients success or failure would have to be other measurable lab tests and imaging studies of tumors. The problem with imaging tests of course has to do with how reliable and how detailed they could be in order to be able to measure tumors that were almost microscopic and yet determine if they are growing or shrinking. Despite the fact that such imaging studies have gotten much better than those that were available 10 years ago, i'm not sure if they are yet good enough to measure tumors down to the cellular level. Which would be needed to be able to track the effectiveness of any

treatament. Ten years ago I had socalled medical experts and patient experts telling me that this was possible then. Yet it was not possible then and I do not think that it is possible now. And i'm sure that there are going to be men who will insist that yes we are that technologically advanced today. All I know is that on several occasions when I have taken MRI''s and Ultrasounds to medical facilities other than the ones at which they were done the new doctors and technicians always smiled and told me that they would not know what they were looking at had I not told them what the films were a representation of. Which told me what I needed to know. We are not there yet but i''m forever hopeful that we could be soon.

I know that this does not answer your question Terry but that is my two cents of it and i'm sure that perhaps others may join in with theirs which I am very eager to read. Strum has yet to give a presentation regarding the use of PSA testing and patients getting Provenge and explain why PSA was not relevent to the use of Provenge. I think he could have and should have dedicated an entire issue of PCRI to answering those questions as i'm sure that I was not the only one who noticed. I do believe that giving Provenge to men at the earliest stages of their disease is what most men want to have happen. Also, I still cannot understand why such trials with Provenge of early stage PCa have not been conducted with dogs, the only other creature on earth that naturally develops PCa. That is afterall how Huggins and Labrie made their breakthrough observations on androgen

deprivation 60 years ago. To my knowledge there was only one dog involved. They did not use many dogs in their experiments. I see an urgency and I too often fail to understand why companies like Dendreon do not. These are trials that could have been done even before the Phase III trials on humans as the restrictions are few and the cost minimal in the testing of animals.

I do not know if you Terry will ever have the occasion to use Provenge or one of it's follow on cocktails that are sure to come in due time. What I do know from my extensive travels about the globe is this: although a course of treatment with Provenge will cost Americans about 93,000 dollars per patient, you as an Australian will probably be able to get it for 5 to 6 times less. And people living in the developing world will get it for 10 times less. So, cost will not be a factor as the Australian government's health authorities work on your behalf and negotiate Pharamceutical prices directly with Phama firms for it's citizens. As do most other countries on the planet. That is a process which is actually illegal here in the U.S. as our congress has passed laws at the behest of the Pharma industry lobbyists (I call it bribery myself) to prevent any U.S. government agency from doing

so. The Pharma industry cliams that unless they can charge Americans such fantastic sums of money, they will not have the resources to do the kinds of cutting edge research that they do. They make no mention of the fact that this does not occur anywhere else on the planet. Nor do they mention that the the same drugs they sell overseas are marketed at greatly reduced prices.

A few years back there was this huge debate here regarding the importation of drugs from Canada where they are often 10 times cheaper than they are here. Actually, Glaxokiline, the big British drug firm threatened the country of Canada two years ago with not sending any drugs to Canada if they continued to allow those drugs to be sold to Americans across the border. Glaxo was exporting it's drugs to both Canada and the U.S. with Canada paying one price and Americans paying another. Americans were told by our media that drugs from Europe were inferior and not to be trusted. It got to the point of irrational hyseria as I recall. No one ever mentioned that 100 pct of all of our flu vaccines are produced in just two countries and neither one of them is the U.S.. All flu vaccines are produced in the U.K. and France with licensing agreements for importation into the U.S..

So there are a whole lot of questions surrounding the drug industry and most of them revolve around money. The issues with regards to Provenge involve money and of course technical medical explanations as to the mechanisms by which it is supposed to work. The money issues we are not even involved in but we are capable of tackling the technical medical explanations if we can get access to the right people at Dendreon.

I still think that on that issue, Strum is the man.

Cheers, BOB

Subject: How to measure success with ProvengeTo: "'Prostate Problems Mailing LIst'" , ProstateCancerSupport Date: Friday, July 22, 2011, 6:23 PM

I confess that I have not paid too much attention to all the detail of Provenge since there is no chance, as far as I can see, of my ever using the drug. But I have had a couple of questions put to me off my site and feel I’d better get up to speed and perhaps put some basic information on my site.

One of the first questions I had was “How will I know if Provenge is working if PSA is no longer a measure of success?†In starting to look for the answer to that I came across this comment on the June 2011 ASCO meeting item <snip> Knowing more specifically how Provenge extends survival without causing remissions is one of the pivotal new questions in prostate cancer oncology. <snip>

I am not too sure just what this means – can anyone enlighten me? If there is no remission, is it possible that the observed extended survival is merely be another dot in the range of survival periods in men taking Provenge?

Does anyone know of a site – preferably not a Dendreon funded one – that sets out the basic information for Provenge to save me a bit of a search?

All the best

Prostate men need enlightening, not frightening

Terry Herbert - diagnosed in 1996 and still going strong

Read A Strange Place for unbiased information at http://www.yananow.org/StrangePlace/index.html

[Guest guest]

> Not sure I can actually answer your question but the best place

> to start is to get a hold of an issue of Dr. Strum's PCRI in

> which he dedicated it almost entirely to the recruitment of

> patients for the first Phase III clinical trial of Provenge.

Small correction: Dr. Strum has not been associated with PCRI for

several years.

His former partner, Dr. Scholz, is Director.

Regards,

Steve J

PS: Dr. Strum has announced his retirement at the end of the

year. He deserves a rest, but it is a loss to so many who rely

upon his wisdom.

[Guest guest]

Well, on the Burzynski front there is some good news after almost 40 years of court cases and other questionable behavour by some government officials. And the fact that he has had the singlemindedness to adhere to this course and stay focused on what has become a lifetime endeavour despite everything that has happened to him over the years says something about his character. He is in the process right now of conducting several clinical trials, authoriized by the FDA , and some of them are in the Phase III stage. As for Quackwatch and Barrett , it will surfice to say that I will let the conclusion of the Phase III trials Burzynski is conducting speak for themselves. They are

legitimate trials both authorized and approved of by the FDA. Since we have finally reached this juncture in the Burzynski saga, it makes little sense at this point to further malign him or his work. I think that we can all agree that if the FDA has authorized Phase III clinical trials on antineoplastins for Burzynski and his hospital to conduct , then they are in fact legitimate trials despite anything that Barrett may have to say about them. Mr. Barrett by the way does not hold a license to practice medicine and the last one he did hold was in the field of Psychiatry many years ago. Hardly a specialty for him to be second guessing someone of Stanislaw Burzynski's stature as a doctor and cancer researcher (you can access his biography onliine and read it for yourself) , the U.S. Congress which held hearings on the matter, and the FDA and it's esteemed review panel of qualified

experts. It is what it is and we shall someday see what it's all about. So, stay tuned. I for one am hopeful that something very positive will come from the work of this man which has spanned almost half a century. .

As for the Mayo Clinic trial, I suggest that you watch the Burzynski movie in which it is documented that the NIH actually patented his discoveries without his knowledge (patents which were already in his name by the way) while at the same time attempting to put him in prison where he would be unable to defend his ownership of them. According to Burzynski, the patients in the government run trial were given drugs that were inferior to his and that the governemt researchers did not understand what they were doing with his discoveries but were too arrogant to look to him for guidance. He has encouraged the families of these patients (they died) on that basis to seek wrongful death lawsuits against the government. His words, not mine. If the government did not believe in his work or his theories, it makes little sense for the NIH to attempt to patent

discoveries which he had already claimed ownership. Why patent what you believe to be useless information? In a postscript, the patents filed by the NIH were recinded by the patent office on the basis that they were already the property of Stanislaw Burzynski and that the government of the U.S. had no right to them or to attempt to patent them.

Stanislaw Burzynski's medical credentials are beyond reproach and I don't know why bringing up his name and his work invokes so much invective. We all know that there are dozens and perhaps dozens of dozens of let us say questionable doctors whom members of this group have reported on directly to us with regards to their own treatments. They have not named names but they certainly have shared their misfortune and disappointment with us. All I have seen of Burzynski with regards to his patients is most often praise and a deep sense of gratitude towards him from them. He may ultimately prove to be in a class by himself so let us not be too quick to judge the outcome. I'm hopeful of anyone who is working on our behalf and cheer for them on the sidelines.

Now, in a similar vein as the Provenge trials and the issue of PSA are the most recently concluded Niaspan (Merck) FDA Phase III trails with regards to cholesterol and heart disease. Because it challenges yet another medically accepted conceptual relationship between a disease and a disease marker. And just as importantly , the FDA seems to have handled it in a similar manner as they handled the PSA and Provenge issue. They made the conflict pubicly known by expressing it in their review of the trial, but made no attempt to resolve the contradictions raised. We all know about cholesterol and its implications with regards to heart disease. It has been known for a very long time that Niacin lowers serum cholesterol . The problem is that the flushing reaction was something a lot of people could not handle so

they refused to take it. And even though supplement companies have since figured out how to produce a non-flushing form of Niacin which is sold in supermarkets and drug stores everywhere today, Merck embarked on a formulation of non-flushing Niacin of it's own and named the new drug Niaspan. They then got this product into an FDA approved Phase III clinical trial. The results on the cholesterol side of the equation were very , very successful, as was expected and anticipated. Niaspan lowered cholesterol and did so consistently in the trial patients. Yet the FDA deemed the trial a failure because despite lowering cholesterol levels considerably in those who participated in the trials, the study did not meet it's end point of lowering the rate of Cardiac events (heart attacks) amongst trial participants compared to controls. So, although the FDA has recognized that that Niaspan lowered cholesterol, they have also

recognized that doing so did not prevent Cardiac events which was the end point of the trial. Consequently they did not approve the drug. In this case as in the PSA - Provenge case they did not comment on the obvious contradictions and questions that the trials were raising about commonly held lay and medical assumptions and beliefs.

I brought up the Niaspan trial because I thiink that it , and the Provenge trial point to the mission of the FDA. The FDA ultimately acts as a judge in the approval process of drugs and medical devices making it's final decision based on the end points of Phase III trials whose design they have approved. They seldom venture beyond that or attempt to answer the kinds of contradictions revealed in these two trials. That they leave up to the reasearch community and the manufacturers of these products to answer because answering such questions are not part of their function or mission. The FDA does not have a clue as to why PSA is not relevant to the effectivness of Provenge any more than anyone at the FDA knows why although Niaspan consistently and effectively lowers cholesterol (both LDL and HDL) , does not prevent

cardiac events in patients at risk in accordance with the cholesterol -cardiac event theory espoused by everyone in the medical industry from doctors , hospitals and particularly drug manufacturers. The theory is that controlling PSA is the same as controlling cancer activity and that controlling cholesterol is the same as controlling and reducing cardiac events. In both of these trials the FDA has left it up to the medical research community and the medical industry to answer the questions raised in these trials. It's not the FDA's job to do so. But , they certainly made note of those contradictions and made them known publicly for us to ponder.

BOB

----- Forwarded Message -----To: ProstateCancerSupport Sent: Sunday, July 24, 2011 7:24 PMSubject: RE: How to measure success with Provenge

Whenever I read remarks like this one <snip> Burzynski has for years been well-known for his antineoplaston garbage.<snip> I am reminded of the radiologist in Houston who was good enough to help me in the early days of my diagnosis. He did a very through series of scans, free of charge because he was a pal of my brother’s, and who put me and my wife up in his house for the best part of a week while I consulted, free of charge thanks to his introductions, three local prostate cancer specialists.

During the corse of one conversation over dinner, I asked him about Burzynski and his claims. He told me that he had scanned some children with brain tumours before and after they were treated by Burzynski and was absolutely amazed at the outcome. The tumours simply disappeared.

Now of course this is anecdotal evidence, and Steve does not like anecdotal evidence, but I wonder why that good man would have lied to me about what he had seen and experienced. Could it be that, as he claims and as seems to have been demonstrated in two FDA approved studies, Burzynski’s approach has some merit and the opposition to him is based on the fact that he appears to be an arrogant man who despises the attitudes of his colleagues? So I am personally still in two minds about Burzynski – on balance I think his therapies may be better than they are made out to be.

All the best

Terry Herbert

in Melbourne Australia

Diagnosed ‘96: Age 54: Stage T2b: PSA 7.2: Gleason 7: No treatment. Jun '07 PSA 42.0 - Bony Metastasis: Aug '07: Intermittent ADT: PSA 3.4 May '11

It is a tragedy of the world that no one knows what he doesn’t know, and the less a man knows, the more sure he is that he knows everything. Joyce Carey

From: ProstateCancerSupport [mailto: ProstateCancerSupport ] On Behalf Of Steve JordanSent: Monday, 25 July 2011 9:05 AMTo: ProstateCancerSupport Subject: Re: How to measure success with Provenge

> <wiech89@... <mailto:wiech89%40yahoo.com>>>> That was a very interesting discussion of Provenge. Comments> below:>> > .. I can think of Stanislaw Burzynski and he has a lot more> > credible scientific data and proof than does Dendreon for it's> > product.>> Let me take some time out from Provenge to talk about Burzynski.>> I won't get on my soapbox here, I'll just point you to the> quackwatch site:>> http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski> <http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski>>> and to the one trial run by the Mayo Clinic that attempted to> replicate his findings:>> http://www.ncbi.nlm.nih.gov/pubmed/10069350I thank Alan for his research and his post.Burzynski has for years been well-known for his antineoplaston garbage.Regards,Steve J"A man's most valuable trait is a judicious sense of what not to believe."-- Euripides

[Guest guest]

Well, on the Burzynski front there is some good news after almost 40 years of court cases and other questionable behavour by some government officials. And the fact that he has had the singlemindedness to adhere to this course and stay focused on what has become a lifetime endeavour despite everything that has happened to him over the years says something about his character. He is in the process right now of conducting several clinical trials, authoriized by the FDA , and some of them are in the Phase III stage. As for Quackwatch and Barrett , it will surfice to say that I will let the conclusion of the Phase III trials Burzynski is conducting speak for themselves. They are

legitimate trials both authorized and approved of by the FDA. Since we have finally reached this juncture in the Burzynski saga, it makes little sense at this point to further malign him or his work. I think that we can all agree that if the FDA has authorized Phase III clinical trials on antineoplastins for Burzynski and his hospital to conduct , then they are in fact legitimate trials despite anything that Barrett may have to say about them. Mr. Barrett by the way does not hold a license to practice medicine and the last one he did hold was in the field of Psychiatry many years ago. Hardly a specialty for him to be second guessing someone of Stanislaw Burzynski's stature as a doctor and cancer researcher (you can access his biography onliine and read it for yourself) , the U.S. Congress which held hearings on the matter, and the FDA and it's esteemed review panel of qualified

experts. It is what it is and we shall someday see what it's all about. So, stay tuned. I for one am hopeful that something very positive will come from the work of this man which has spanned almost half a century. .

As for the Mayo Clinic trial, I suggest that you watch the Burzynski movie in which it is documented that the NIH actually patented his discoveries without his knowledge (patents which were already in his name by the way) while at the same time attempting to put him in prison where he would be unable to defend his ownership of them. According to Burzynski, the patients in the government run trial were given drugs that were inferior to his and that the governemt researchers did not understand what they were doing with his discoveries but were too arrogant to look to him for guidance. He has encouraged the families of these patients (they died) on that basis to seek wrongful death lawsuits against the government. His words, not mine. If the government did not believe in his work or his theories, it makes little sense for the NIH to attempt to patent

discoveries which he had already claimed ownership. Why patent what you believe to be useless information? In a postscript, the patents filed by the NIH were recinded by the patent office on the basis that they were already the property of Stanislaw Burzynski and that the government of the U.S. had no right to them or to attempt to patent them.

Stanislaw Burzynski's medical credentials are beyond reproach and I don't know why bringing up his name and his work invokes so much invective. We all know that there are dozens and perhaps dozens of dozens of let us say questionable doctors whom members of this group have reported on directly to us with regards to their own treatments. They have not named names but they certainly have shared their misfortune and disappointment with us. All I have seen of Burzynski with regards to his patients is most often praise and a deep sense of gratitude towards him from them. He may ultimately prove to be in a class by himself so let us not be too quick to judge the outcome. I'm hopeful of anyone who is working on our behalf and cheer for them on the sidelines.

Now, in a similar vein as the Provenge trials and the issue of PSA are the most recently concluded Niaspan (Merck) FDA Phase III trails with regards to cholesterol and heart disease. Because it challenges yet another medically accepted conceptual relationship between a disease and a disease marker. And just as importantly , the FDA seems to have handled it in a similar manner as they handled the PSA and Provenge issue. They made the conflict pubicly known by expressing it in their review of the trial, but made no attempt to resolve the contradictions raised. We all know about cholesterol and its implications with regards to heart disease. It has been known for a very long time that Niacin lowers serum cholesterol . The problem is that the flushing reaction was something a lot of people could not handle so

they refused to take it. And even though supplement companies have since figured out how to produce a non-flushing form of Niacin which is sold in supermarkets and drug stores everywhere today, Merck embarked on a formulation of non-flushing Niacin of it's own and named the new drug Niaspan. They then got this product into an FDA approved Phase III clinical trial. The results on the cholesterol side of the equation were very , very successful, as was expected and anticipated. Niaspan lowered cholesterol and did so consistently in the trial patients. Yet the FDA deemed the trial a failure because despite lowering cholesterol levels considerably in those who participated in the trials, the study did not meet it's end point of lowering the rate of Cardiac events (heart attacks) amongst trial participants compared to controls. So, although the FDA has recognized that that Niaspan lowered cholesterol, they have also

recognized that doing so did not prevent Cardiac events which was the end point of the trial. Consequently they did not approve the drug. In this case as in the PSA - Provenge case they did not comment on the obvious contradictions and questions that the trials were raising about commonly held lay and medical assumptions and beliefs.

I brought up the Niaspan trial because I thiink that it , and the Provenge trial point to the mission of the FDA. The FDA ultimately acts as a judge in the approval process of drugs and medical devices making it's final decision based on the end points of Phase III trials whose design they have approved. They seldom venture beyond that or attempt to answer the kinds of contradictions revealed in these two trials. That they leave up to the reasearch community and the manufacturers of these products to answer because answering such questions are not part of their function or mission. The FDA does not have a clue as to why PSA is not relevant to the effectivness of Provenge any more than anyone at the FDA knows why although Niaspan consistently and effectively lowers cholesterol (both LDL and HDL) , does not prevent

cardiac events in patients at risk in accordance with the cholesterol -cardiac event theory espoused by everyone in the medical industry from doctors , hospitals and particularly drug manufacturers. The theory is that controlling PSA is the same as controlling cancer activity and that controlling cholesterol is the same as controlling and reducing cardiac events. In both of these trials the FDA has left it up to the medical research community and the medical industry to answer the questions raised in these trials. It's not the FDA's job to do so. But , they certainly made note of those contradictions and made them known publicly for us to ponder.

BOB

----- Forwarded Message -----To: ProstateCancerSupport Sent: Sunday, July 24, 2011 7:24 PMSubject: RE: How to measure success with Provenge

Whenever I read remarks like this one <snip> Burzynski has for years been well-known for his antineoplaston garbage.<snip> I am reminded of the radiologist in Houston who was good enough to help me in the early days of my diagnosis. He did a very through series of scans, free of charge because he was a pal of my brother’s, and who put me and my wife up in his house for the best part of a week while I consulted, free of charge thanks to his introductions, three local prostate cancer specialists.

During the corse of one conversation over dinner, I asked him about Burzynski and his claims. He told me that he had scanned some children with brain tumours before and after they were treated by Burzynski and was absolutely amazed at the outcome. The tumours simply disappeared.

Now of course this is anecdotal evidence, and Steve does not like anecdotal evidence, but I wonder why that good man would have lied to me about what he had seen and experienced. Could it be that, as he claims and as seems to have been demonstrated in two FDA approved studies, Burzynski’s approach has some merit and the opposition to him is based on the fact that he appears to be an arrogant man who despises the attitudes of his colleagues? So I am personally still in two minds about Burzynski – on balance I think his therapies may be better than they are made out to be.

All the best

Terry Herbert

in Melbourne Australia

Diagnosed ‘96: Age 54: Stage T2b: PSA 7.2: Gleason 7: No treatment. Jun '07 PSA 42.0 - Bony Metastasis: Aug '07: Intermittent ADT: PSA 3.4 May '11

It is a tragedy of the world that no one knows what he doesn’t know, and the less a man knows, the more sure he is that he knows everything. Joyce Carey

From: ProstateCancerSupport [mailto: ProstateCancerSupport ] On Behalf Of Steve JordanSent: Monday, 25 July 2011 9:05 AMTo: ProstateCancerSupport Subject: Re: How to measure success with Provenge

> <wiech89@... <mailto:wiech89%40yahoo.com>>>> That was a very interesting discussion of Provenge. Comments> below:>> > .. I can think of Stanislaw Burzynski and he has a lot more> > credible scientific data and proof than does Dendreon for it's> > product.>> Let me take some time out from Provenge to talk about Burzynski.>> I won't get on my soapbox here, I'll just point you to the> quackwatch site:>> http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski> <http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski>>> and to the one trial run by the Mayo Clinic that attempted to> replicate his findings:>> http://www.ncbi.nlm.nih.gov/pubmed/10069350I thank Alan for his research and his post.Burzynski has for years been well-known for his antineoplaston garbage.Regards,Steve J"A man's most valuable trait is a judicious sense of what not to believe."-- Euripides

[Guest guest]

http://clinicaltrials.gov/ct2/results?term=burzynski

Further to the point, there have been 61 FDA approved trials for Burzynski's protocols.

Eleven are actively recruiting patients, some have been terminated or withdrawn, many have a status listed as unknown and three were listed in reference to Prostate Cancer and one of those has been withdrawn. I think what is obvious about the PCa trials is that all of the men in them are in the very late stages of their disease. In fact the FDA requires in many cases that men in these trials to have failed all conventional treatments before availing themselves of Burzynski's protocol. In all fairness, I believe that if you set up the same set of requirements for patients to receive surgery, radiation or any other form of PCa treatment that it would be tough to assess the value of those regimens too and for obvious reasons. No one imagines or would think of suggesting that PCa patients not be allowed to have surgery until they had first failed hormone ablation

treatment. If that were the case , surgery would have been deemed an dismal failure long ago and would never have been an option of treatment for PCa . The bar for a new entry in the treatment of cancer with anything other than surgery and radiation has been set very , very high.

If one were to have an infection newly aquired, antibiotics are a lifesaver of a treatment and patients are ordinarily cured and make a complete recovery. However, if one has the same infection for a considerable length of time before beginning antibiotic treatment, the odds of a cure and survival diminish. They diminish to the point where massive amounts of antibiotics become useless in treating an infection that if had been treated much earlier would have been easily cured. Organs begin to shut down, a condition of sepsis sets in as the infection spreads throughout the body and at some point death is assured no matter what interventions are attempted. In a similar sense the FDA sets up some very unreasonable hurdles for those who wish to enter the

arena of cancer treatment. As little as Provenge has appeared to have accomplished at first glance, we must not forget that this treatment was applied to patients who were in the terminal stages of their disease and had no hope of survival. The question that now needs to be asked and answered is when will the FDA allow men with earlier stage cancer access to Provenge.

bob

----- Forwarded Message -----To: ProstateCancerSupport Sent: Sunday, July 24, 2011 7:24 PMSubject: RE: How to measure success with Provenge

Whenever I read remarks like this one <snip> Burzynski has for years been well-known for his antineoplaston garbage.<snip> I am reminded of the radiologist in Houston who was good enough to help me in the early days of my diagnosis. He did a very through series of scans, free of charge because he was a pal of my brother’s, and who put me and my wife up in his house for the best part of a week while I consulted, free of charge thanks to his introductions, three local prostate cancer specialists.

During the corse of one conversation over dinner, I asked him about Burzynski and his claims. He told me that he had scanned some children with brain tumours before and after they were treated by Burzynski and was absolutely amazed at the outcome. The tumours simply disappeared.

Now of course this is anecdotal evidence, and Steve does not like anecdotal evidence, but I wonder why that good man would have lied to me about what he had seen and experienced. Could it be that, as he claims and as seems to have been demonstrated in two FDA approved studies, Burzynski’s approach has some merit and the opposition to him is based on the fact that he appears to be an arrogant man who despises the attitudes of his colleagues? So I am personally still in two minds about Burzynski – on balance I think his therapies may be better than they are made out to be.

All the best

Terry Herbert

in Melbourne Australia

Diagnosed ‘96: Age 54: Stage T2b: PSA 7.2: Gleason 7: No treatment. Jun '07 PSA 42.0 - Bony Metastasis: Aug '07: Intermittent ADT: PSA 3.4 May '11

It is a tragedy of the world that no one knows what he doesn’t know, and the less a man knows, the more sure he is that he knows everything. Joyce Carey

From: ProstateCancerSupport [mailto: ProstateCancerSupport ] On Behalf Of Steve JordanSent: Monday, 25 July 2011 9:05 AMTo: ProstateCancerSupport Subject: Re: How to measure success with Provenge

> <wiech89@... <mailto:wiech89%40yahoo.com>>>> That was a very interesting discussion of Provenge. Comments> below:>> > .. I can think of Stanislaw Burzynski and he has a lot more> > credible scientific data and proof than does Dendreon for it's> > product.>> Let me take some time out from Provenge to talk about Burzynski.>> I won't get on my soapbox here, I'll just point you to the> quackwatch site:>> http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski> <http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski>>> and to the one trial run by the Mayo Clinic that attempted to> replicate his findings:>> http://www.ncbi.nlm.nih.gov/pubmed/10069350I thank Alan for his research and his post.Burzynski has for years been well-known for his antineoplaston garbage.Regards,Steve J"A man's most valuable trait is a judicious sense of what not to believe."-- Euripides

[Guest guest]

http://clinicaltrials.gov/ct2/results?term=burzynski

Further to the point, there have been 61 FDA approved trials for Burzynski's protocols.

Eleven are actively recruiting patients, some have been terminated or withdrawn, many have a status listed as unknown and three were listed in reference to Prostate Cancer and one of those has been withdrawn. I think what is obvious about the PCa trials is that all of the men in them are in the very late stages of their disease. In fact the FDA requires in many cases that men in these trials to have failed all conventional treatments before availing themselves of Burzynski's protocol. In all fairness, I believe that if you set up the same set of requirements for patients to receive surgery, radiation or any other form of PCa treatment that it would be tough to assess the value of those regimens too and for obvious reasons. No one imagines or would think of suggesting that PCa patients not be allowed to have surgery until they had first failed hormone ablation

treatment. If that were the case , surgery would have been deemed an dismal failure long ago and would never have been an option of treatment for PCa . The bar for a new entry in the treatment of cancer with anything other than surgery and radiation has been set very , very high.

If one were to have an infection newly aquired, antibiotics are a lifesaver of a treatment and patients are ordinarily cured and make a complete recovery. However, if one has the same infection for a considerable length of time before beginning antibiotic treatment, the odds of a cure and survival diminish. They diminish to the point where massive amounts of antibiotics become useless in treating an infection that if had been treated much earlier would have been easily cured. Organs begin to shut down, a condition of sepsis sets in as the infection spreads throughout the body and at some point death is assured no matter what interventions are attempted. In a similar sense the FDA sets up some very unreasonable hurdles for those who wish to enter the

arena of cancer treatment. As little as Provenge has appeared to have accomplished at first glance, we must not forget that this treatment was applied to patients who were in the terminal stages of their disease and had no hope of survival. The question that now needs to be asked and answered is when will the FDA allow men with earlier stage cancer access to Provenge.

bob

----- Forwarded Message -----To: ProstateCancerSupport Sent: Sunday, July 24, 2011 7:24 PMSubject: RE: How to measure success with Provenge

Whenever I read remarks like this one <snip> Burzynski has for years been well-known for his antineoplaston garbage.<snip> I am reminded of the radiologist in Houston who was good enough to help me in the early days of my diagnosis. He did a very through series of scans, free of charge because he was a pal of my brother’s, and who put me and my wife up in his house for the best part of a week while I consulted, free of charge thanks to his introductions, three local prostate cancer specialists.

During the corse of one conversation over dinner, I asked him about Burzynski and his claims. He told me that he had scanned some children with brain tumours before and after they were treated by Burzynski and was absolutely amazed at the outcome. The tumours simply disappeared.

Now of course this is anecdotal evidence, and Steve does not like anecdotal evidence, but I wonder why that good man would have lied to me about what he had seen and experienced. Could it be that, as he claims and as seems to have been demonstrated in two FDA approved studies, Burzynski’s approach has some merit and the opposition to him is based on the fact that he appears to be an arrogant man who despises the attitudes of his colleagues? So I am personally still in two minds about Burzynski – on balance I think his therapies may be better than they are made out to be.

All the best

Terry Herbert

in Melbourne Australia

Diagnosed ‘96: Age 54: Stage T2b: PSA 7.2: Gleason 7: No treatment. Jun '07 PSA 42.0 - Bony Metastasis: Aug '07: Intermittent ADT: PSA 3.4 May '11

It is a tragedy of the world that no one knows what he doesn’t know, and the less a man knows, the more sure he is that he knows everything. Joyce Carey

From: ProstateCancerSupport [mailto: ProstateCancerSupport ] On Behalf Of Steve JordanSent: Monday, 25 July 2011 9:05 AMTo: ProstateCancerSupport Subject: Re: How to measure success with Provenge

> <wiech89@... <mailto:wiech89%40yahoo.com>>>> That was a very interesting discussion of Provenge. Comments> below:>> > .. I can think of Stanislaw Burzynski and he has a lot more> > credible scientific data and proof than does Dendreon for it's> > product.>> Let me take some time out from Provenge to talk about Burzynski.>> I won't get on my soapbox here, I'll just point you to the> quackwatch site:>> http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski> <http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski>>> and to the one trial run by the Mayo Clinic that attempted to> replicate his findings:>> http://www.ncbi.nlm.nih.gov/pubmed/10069350I thank Alan for his research and his post.Burzynski has for years been well-known for his antineoplaston garbage.Regards,Steve J"A man's most valuable trait is a judicious sense of what not to believe."-- Euripides

[Guest guest]

Alan, I think you should believe that there are 61 FDA authorized clinical trials currently with regards to Burzynski's antineoplastins. That Burzynski is the acknowledged discoverer of antineoplastins with no co-discoverers. That the NIH and the FDA have accepted that antineoplastins exist and they do not consider them alternative medicine and they do not consider them quackery. They consider them legitimate compounds for investigation of use in cancer research. . For a long time the NIH denied they existed but that has all

changed. I think if you do some research on the matter you will find that antineoplastins are mainstream research medicine and that Dr. Burzynski's credentials are beyond reproach and considerably above and beyond those of the owner of Quackwatch. And that it is a fact that the NIH attempted to patent, correction, did patent , many of Burzynski's discoveries but failed when the patent office became aware that the patents for antineoplastins already existed in the name of Burzynski. I say these things not in the form of an argument but your message seems to suggest that no such clinical trials exist when there have been at least 61 such trials authorized by the FDA already. If the FDA had believed that this was all some

kind of farce, they would not authorize such trials.

If you do a search of antineoplastins on PUBMED there are over 770,000 abstracts, an astonishing amount by any ones standards. This is a link to the NCI, National Cancer Institute and their presentation on antineoplastins. They also acknowledge that Burzynski is the discoverer and chief investigator.

http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/allpages/print

One of the problems that has plagued Burzynski all along has been his insistence that things had to be done his way and that he be recognized as the discoverer and the expert. . He was unwilling to work with others and unwilling to work beneath others and simply turn over his research to some Pharma firm and be one of their employees. Something by the way that has been offered to him many, many times. For years antineoplasins were denied to even exist by NIH and the FDA but like I said, that has all changed. Because the man is and has always been eccentric does not mean that he is wrong. And rightfully so he should not be forced to turn over his research either to the government or to the Pharma industry and be satisfied to be in their employ and I believe this has also been one of Burzynski's problems from the very beginning. However, after the congressional hearings a lot of this has gone by the boards and if you look at the clinical trials site you will see what I mean. It is not as though Burzynski has been trying to pull a fast one over on us and get us to accept antineoplastins at face value and on his word. What he has been fighting for is the right to be able to do his research and treat his patients without being branded a Quack and everything else he has been called. The man is more educated in the field of medicine and research than most doctors out there. He's a brilliant man and a brilliant researcher.

Will antineoplastins ultimately prove to cure cancer? I do not know, but that is why all the FDA trials that have been approved and the reason he has spent decades going to court over , so that these questions can be answered . I for one am glad that he has had the opportunity and I of course wish him luck as I do all researchers working on cancer projects. ly, I do not understand why anyone who has cancer or a relative with cancer would want to see him fail or to be denied the right to do the research he is doing which ultimately may benefit us all and even turn the page on existing treatments. . It makes no sense at all to me to deny someone like him the

ability to conduct these trials based on the opinions of people who have prejudged his work and in many cases are people who do not understand his work and incapable of making an unbiased opinion. Which again is why he is about the only working oncology researcher whom the government actually had to have congressional hearings in order to allow him to continue with his work.

I am neither a supporter or detractor of Burzynski's work and although I want his reserach to continue, I accept that his efforts may not ultimately be a success. What I am a supporter of is independent research and a widening of the field of research to include anyone who wants to do research providing that when it comes to actually giving medicine to humans that those doing so have the necessary minimum educational requirements to do so. That the research be conducted openly and with the necessary safeguards. The fact that antineoplastins are completely nontoxic add a very pleasant dimention of the discussion in my opinion. Ordinarily much of what constitutes chemotherapy is as deadly as

or even more deadly than the cancers they are supposed to treat. We have always been led to believe that it must be this way because cancer is such a horrible disease. However, the idea that the treatments have to be just as horrible or even more horrible than the disease is now being proven not to be the case with many drugs and that has been a pleasant surprise. Whether or not antineoplastins will ultimately be proven to be theraputic is still open to debate but as Terry has said and as others have reported, there are patients who have recovered from their cancers who have been treated by Burzynski for which there are no other logical explanations to their recovery. I think it's good that we are skeptial but what Quackwatch and some

others have involved themselves in with regards to Burzynski and antineoplastins goes well beyond anything remotely resembling skepticism. It's been more like a Witch hunt and it bothers me because I have PCa and I want to see a cure, and I don't care where that cure comes from so long as it is a legitimate cure. This idea that cures can only come from annointed people and annointed sources is what has hobbled medical research right from the beginning. It excludes even the possibility that treatments could originate from other fields of knowledge. Back in the 1970's when Americans first become introduced and aware of Acupuncture it was also treated as a form of Quackery. Well, my Harvard University trained Internist has a nice Diploma from some Acupuncture school that he attended in China and he's quite

proud of it and it sits right next to his harvard Diploma on the wall. A far cry from where thinking was back in 1976. We need the FDA trials that Burzynski is conducting on antineoplastins to play themselves out and hopefully we here on this board will be around to discuss their merits when that day comes.

Good health to all, BOB

----- Forwarded Message -----To: "ProstateCancerSupport " <ProstateCancerSupport >Sent: Tuesday, July 26, 2011 4:36 PMSubject: Re: How to measure success with Provenge

Terry Herbert wrote:> Whenever I read remarks like this one <snip> Burzynski has for> years been well-known for his antineoplaston garbage.<snip> I> am reminded of the radiologist in Houston who was good enough> to help me in the early days of my diagnosis. He did a very> through series of scans, free of charge because he was a pal of> my brother’s, and who put me and my wife up in his house for> the best part of a week while I consulted, free of charge> thanks to his introductions, three local prostate cancer> specialists.> > During the corse of one conversation over dinner, I asked him> about Burzynski and his claims. He told me that he had scanned> some children with brain tumours before

and after they were> treated by Burzynski and was absolutely amazed at the outcome.> The tumours simply disappeared.> > Now of course this is anecdotal evidence, and Steve does not> like anecdotal evidence, but I wonder why that good man would> have lied to me about what he had seen and experienced. Could> it be that, as he claims and as seems to have been demonstrated> in two FDA approved studies, Burzynski’s approach has some> merit and the opposition to him is based on the fact that he> appears to be an arrogant man who despises the attitudes of his> colleagues? So I am personally still in two minds about> Burzynski - on balance I think his therapies may be better than> they are made out to be.I apologize for the length of this posting but

it's a difficultsubject and I don't believe it can be adequately discussed in ashort one.I've given some thought to the issue of Dr. Burzynski'scredibility and I want to be as objective as I can be. It's adifficult problem because there are such wildly conflicting viewsabout the man.One problem that clouds the issues is that each side accuses theother of lack of objectivity and/or ulterior motives. Thedefenders of the "alternative" medicines are often thought to bequacks and their shills who are in it for the money, or desperatepatients and families who are grasping at straws. The opponentsare often thought to be drug company monopolists or their shillsin the FDA who are in it for the money, or deluded members of thepublic who are too trusting of "authoritative" sources.At the same time however, I have no doubt whatsoever that

thereare honest and intelligent supporters of both sides. I'm fullyprepared to believe that the story that the Houston radiologisttold to Terry was sincere and that the radiologist was not afool, a naif or an interested party. And I'd argue that the sameis true for at least many of the FDA and university scientistswho have insisted that there is no credible evidence for thesealternative approaches.So what should we believe? Is there a rational way to come to anobjective conclusion? What should we do as patients? If we havenot seen conclusive evidence one way or the other, should we justbelieve what we want to believe?Here are some of my thoughts on those question:1. There is a great deal of disinformation around. Although there are a great many honest people in the world, there are also dishonest people, some in alternative

medicine, some in what I'll call established medicine, some in drug companies. There are lots and lots of such people and they will look very sincerely into your eyes and tell you an outrageous lie that could end your life just in order to get some money from you. In addition to the dishonest people there is also a lot of disinformation spread by well meaning but ignorant people. We have all met people who believe that astrology or palm reading or other pseudo-sciences are reliable guides to making medical decisions. And even among the people who don't believe such things there are a great many, I'd venture to say a solid majority in the United States, who don't have enough scientific understanding to successfully evaluate

medical claims. Such people can be misled or simply mistaken in supporting statements that are not correct.2. However, although there is a great deal of disinformation, there are also rules of evidence that we can use to distinguish sound information from disinformation. The National Cancer Institute uses two sets of rules to determine the soundness of cancer treatments. The two sets are: - Strength of Study Design. These include: Randomized clinical trials Non-randomized trials Case

series There are sublevels within each of those three. - Strength of Endpoints. These include: Total mortality Cause-specific mortality Carefully assessed quality of life Indirect surrogates In addition, to these, we can use rules of study design to see how well such things as randomization was conducted or mortality measured, and rules of statistics to tell us

how significant any endpoint numbers are likely to be. To see the NCI Levels of Evidence for different areas of interest (treatment, screening, genetics, etc.) go to: http://www.cancer.gov and type "levels of evidence" in the search box.Now where does Dr. Burzynski fit into this?I'm not an expert on Dr. Burzynski. I haven't spent weeksresearching him. I have read some abstracts of his papers (mostof which were published in what looked to me like fairly dodgyjournals) but I'm not qualified to fully evaluate the articlesand have better things to do with my time than to try. So Ican't say that I personally know that Dr. Burzynski is a fraud.What I think I can say however is that, despite his running"trials" for almost 20 years, his having plenty of patientsplaced in those trials, and his having had many, manyopportunities both to produce standard protocol trials and tocooperate with other scientific centers offering to test hismethods, the standard institutions that do professionallyevaluate trial results, including the U.S. National CancerInstitute and the U.S. Food and Drug Administration, have notfound what they consider to be credible evidence of benefit fromhis methods.Terry knows a radiologist in Texas whom he has no reason todistrust. That's fair. It's a good observation. I have metdozens of scientists at the National Cancer Institute whoseintelligence and knowledge have tremendously impressed me andwhom I would trust (and have trusted) with my life.

These arepeople who, collectively, came up with the levels of evidence Idescribed above, have trained at top institutions around theworld, seen thousands of patients, conducted hundreds ofthousands of hours of research, discovered new principles ofcancer biology, written thousands of articles in leadingjournals, and saved many lives.These people have looked at Burzynski's output and found itwanting.I'm not just appealing to authority here. I'm appealing to thejudgment of the people whom I consider to be using the best andmost rational rules for evaluating treatments, and who have themost demonstrated knowledge and experience in applying thoserules. It's not because the have PhDs or work for NCI that givesthem credibility in my eyes. It's that they demonstrate everyday that they have the

most knowledge and experience about cancerof anyone at the current time.The NCI and FDA have been careful to NOT say that Burzynski is afraud or even that his methods don't work. What they have saidis that he has not produced credible evidence that they do work.They won't go beyond the evidence and neither should I. I alsocan't say for sure that Dr. B is a fraud. It's possible thathe's not. I can't prove it one way or the other. But I wouldnot leave my family and travel to Texas to see him. I would notpay his required $5,000 down payment on treatment, followed bywho knows how much. I would not allow him to inject me with hisurine extract if, after all these years of "trials", he has notbeen able to demonstrate to the trials evaluation bodies that hecan do what he says he can do.I wouldn't

see him even if I knew that I was going to die ofcancer. There are any number of unproven cancer treatments tochoose from, many of which are cheaper than his and can brandishtons of "success" stories in their support. I would prefer tospend my time with my family and leave my money to my childrenthan to spend either time or money with him.It is possible that one day we will know the truth aboutBurzynski. Perhaps a lab somewhere in the world will study histreatment and prove it effective or ineffective. Or perhaps anFBI agent with a search warrant will seize his records and we'llfind out exactly what the real statistics are for his treatments.If it turns out that he was a far thinking genius, I and SteveJordan and many others will owe him something of an apology. Ifit turns out that he's a fraud and a criminal, then he has a lotto

account for.Either way, the whole circus of unproven treatments, doctors whoare either devils or saints, patients who offer their lifesavings with stars in their eyes, testimonials from survivors,and silence from non-survivors, will continue on into the future.As long as people fear death and others sell hope, there will besellers and buyers. Alan

[Guest guest]

Alan, I think you should believe that there are 61 FDA authorized clinical trials currently with regards to Burzynski's antineoplastins. That Burzynski is the acknowledged discoverer of antineoplastins with no co-discoverers. That the NIH and the FDA have accepted that antineoplastins exist and they do not consider them alternative medicine and they do not consider them quackery. They consider them legitimate compounds for investigation of use in cancer research. . For a long time the NIH denied they existed but that has all

changed. I think if you do some research on the matter you will find that antineoplastins are mainstream research medicine and that Dr. Burzynski's credentials are beyond reproach and considerably above and beyond those of the owner of Quackwatch. And that it is a fact that the NIH attempted to patent, correction, did patent , many of Burzynski's discoveries but failed when the patent office became aware that the patents for antineoplastins already existed in the name of Burzynski. I say these things not in the form of an argument but your message seems to suggest that no such clinical trials exist when there have been at least 61 such trials authorized by the FDA already. If the FDA had believed that this was all some

kind of farce, they would not authorize such trials.

If you do a search of antineoplastins on PUBMED there are over 770,000 abstracts, an astonishing amount by any ones standards. This is a link to the NCI, National Cancer Institute and their presentation on antineoplastins. They also acknowledge that Burzynski is the discoverer and chief investigator.

http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/allpages/print

One of the problems that has plagued Burzynski all along has been his insistence that things had to be done his way and that he be recognized as the discoverer and the expert. . He was unwilling to work with others and unwilling to work beneath others and simply turn over his research to some Pharma firm and be one of their employees. Something by the way that has been offered to him many, many times. For years antineoplasins were denied to even exist by NIH and the FDA but like I said, that has all changed. Because the man is and has always been eccentric does not mean that he is wrong. And rightfully so he should not be forced to turn over his research either to the government or to the Pharma industry and be satisfied to be in their employ and I believe this has also been one of Burzynski's problems from the very beginning. However, after the congressional hearings a lot of this has gone by the boards and if you look at the clinical trials site you will see what I mean. It is not as though Burzynski has been trying to pull a fast one over on us and get us to accept antineoplastins at face value and on his word. What he has been fighting for is the right to be able to do his research and treat his patients without being branded a Quack and everything else he has been called. The man is more educated in the field of medicine and research than most doctors out there. He's a brilliant man and a brilliant researcher.

Will antineoplastins ultimately prove to cure cancer? I do not know, but that is why all the FDA trials that have been approved and the reason he has spent decades going to court over , so that these questions can be answered . I for one am glad that he has had the opportunity and I of course wish him luck as I do all researchers working on cancer projects. ly, I do not understand why anyone who has cancer or a relative with cancer would want to see him fail or to be denied the right to do the research he is doing which ultimately may benefit us all and even turn the page on existing treatments. . It makes no sense at all to me to deny someone like him the

ability to conduct these trials based on the opinions of people who have prejudged his work and in many cases are people who do not understand his work and incapable of making an unbiased opinion. Which again is why he is about the only working oncology researcher whom the government actually had to have congressional hearings in order to allow him to continue with his work.

I am neither a supporter or detractor of Burzynski's work and although I want his reserach to continue, I accept that his efforts may not ultimately be a success. What I am a supporter of is independent research and a widening of the field of research to include anyone who wants to do research providing that when it comes to actually giving medicine to humans that those doing so have the necessary minimum educational requirements to do so. That the research be conducted openly and with the necessary safeguards. The fact that antineoplastins are completely nontoxic add a very pleasant dimention of the discussion in my opinion. Ordinarily much of what constitutes chemotherapy is as deadly as

or even more deadly than the cancers they are supposed to treat. We have always been led to believe that it must be this way because cancer is such a horrible disease. However, the idea that the treatments have to be just as horrible or even more horrible than the disease is now being proven not to be the case with many drugs and that has been a pleasant surprise. Whether or not antineoplastins will ultimately be proven to be theraputic is still open to debate but as Terry has said and as others have reported, there are patients who have recovered from their cancers who have been treated by Burzynski for which there are no other logical explanations to their recovery. I think it's good that we are skeptial but what Quackwatch and some

others have involved themselves in with regards to Burzynski and antineoplastins goes well beyond anything remotely resembling skepticism. It's been more like a Witch hunt and it bothers me because I have PCa and I want to see a cure, and I don't care where that cure comes from so long as it is a legitimate cure. This idea that cures can only come from annointed people and annointed sources is what has hobbled medical research right from the beginning. It excludes even the possibility that treatments could originate from other fields of knowledge. Back in the 1970's when Americans first become introduced and aware of Acupuncture it was also treated as a form of Quackery. Well, my Harvard University trained Internist has a nice Diploma from some Acupuncture school that he attended in China and he's quite

proud of it and it sits right next to his harvard Diploma on the wall. A far cry from where thinking was back in 1976. We need the FDA trials that Burzynski is conducting on antineoplastins to play themselves out and hopefully we here on this board will be around to discuss their merits when that day comes.

Good health to all, BOB

----- Forwarded Message -----To: "ProstateCancerSupport " <ProstateCancerSupport >Sent: Tuesday, July 26, 2011 4:36 PMSubject: Re: How to measure success with Provenge

Terry Herbert wrote:> Whenever I read remarks like this one <snip> Burzynski has for> years been well-known for his antineoplaston garbage.<snip> I> am reminded of the radiologist in Houston who was good enough> to help me in the early days of my diagnosis. He did a very> through series of scans, free of charge because he was a pal of> my brother’s, and who put me and my wife up in his house for> the best part of a week while I consulted, free of charge> thanks to his introductions, three local prostate cancer> specialists.> > During the corse of one conversation over dinner, I asked him> about Burzynski and his claims. He told me that he had scanned> some children with brain tumours before

and after they were> treated by Burzynski and was absolutely amazed at the outcome.> The tumours simply disappeared.> > Now of course this is anecdotal evidence, and Steve does not> like anecdotal evidence, but I wonder why that good man would> have lied to me about what he had seen and experienced. Could> it be that, as he claims and as seems to have been demonstrated> in two FDA approved studies, Burzynski’s approach has some> merit and the opposition to him is based on the fact that he> appears to be an arrogant man who despises the attitudes of his> colleagues? So I am personally still in two minds about> Burzynski - on balance I think his therapies may be better than> they are made out to be.I apologize for the length of this posting but

it's a difficultsubject and I don't believe it can be adequately discussed in ashort one.I've given some thought to the issue of Dr. Burzynski'scredibility and I want to be as objective as I can be. It's adifficult problem because there are such wildly conflicting viewsabout the man.One problem that clouds the issues is that each side accuses theother of lack of objectivity and/or ulterior motives. Thedefenders of the "alternative" medicines are often thought to bequacks and their shills who are in it for the money, or desperatepatients and families who are grasping at straws. The opponentsare often thought to be drug company monopolists or their shillsin the FDA who are in it for the money, or deluded members of thepublic who are too trusting of "authoritative" sources.At the same time however, I have no doubt whatsoever that

thereare honest and intelligent supporters of both sides. I'm fullyprepared to believe that the story that the Houston radiologisttold to Terry was sincere and that the radiologist was not afool, a naif or an interested party. And I'd argue that the sameis true for at least many of the FDA and university scientistswho have insisted that there is no credible evidence for thesealternative approaches.So what should we believe? Is there a rational way to come to anobjective conclusion? What should we do as patients? If we havenot seen conclusive evidence one way or the other, should we justbelieve what we want to believe?Here are some of my thoughts on those question:1. There is a great deal of disinformation around. Although there are a great many honest people in the world, there are also dishonest people, some in alternative

medicine, some in what I'll call established medicine, some in drug companies. There are lots and lots of such people and they will look very sincerely into your eyes and tell you an outrageous lie that could end your life just in order to get some money from you. In addition to the dishonest people there is also a lot of disinformation spread by well meaning but ignorant people. We have all met people who believe that astrology or palm reading or other pseudo-sciences are reliable guides to making medical decisions. And even among the people who don't believe such things there are a great many, I'd venture to say a solid majority in the United States, who don't have enough scientific understanding to successfully evaluate

medical claims. Such people can be misled or simply mistaken in supporting statements that are not correct.2. However, although there is a great deal of disinformation, there are also rules of evidence that we can use to distinguish sound information from disinformation. The National Cancer Institute uses two sets of rules to determine the soundness of cancer treatments. The two sets are: - Strength of Study Design. These include: Randomized clinical trials Non-randomized trials Case

series There are sublevels within each of those three. - Strength of Endpoints. These include: Total mortality Cause-specific mortality Carefully assessed quality of life Indirect surrogates In addition, to these, we can use rules of study design to see how well such things as randomization was conducted or mortality measured, and rules of statistics to tell us

how significant any endpoint numbers are likely to be. To see the NCI Levels of Evidence for different areas of interest (treatment, screening, genetics, etc.) go to: http://www.cancer.gov and type "levels of evidence" in the search box.Now where does Dr. Burzynski fit into this?I'm not an expert on Dr. Burzynski. I haven't spent weeksresearching him. I have read some abstracts of his papers (mostof which were published in what looked to me like fairly dodgyjournals) but I'm not qualified to fully evaluate the articlesand have better things to do with my time than to try. So Ican't say that I personally know that Dr. Burzynski is a fraud.What I think I can say however is that, despite his running"trials" for almost 20 years, his having plenty of patientsplaced in those trials, and his having had many, manyopportunities both to produce standard protocol trials and tocooperate with other scientific centers offering to test hismethods, the standard institutions that do professionallyevaluate trial results, including the U.S. National CancerInstitute and the U.S. Food and Drug Administration, have notfound what they consider to be credible evidence of benefit fromhis methods.Terry knows a radiologist in Texas whom he has no reason todistrust. That's fair. It's a good observation. I have metdozens of scientists at the National Cancer Institute whoseintelligence and knowledge have tremendously impressed me andwhom I would trust (and have trusted) with my life.

These arepeople who, collectively, came up with the levels of evidence Idescribed above, have trained at top institutions around theworld, seen thousands of patients, conducted hundreds ofthousands of hours of research, discovered new principles ofcancer biology, written thousands of articles in leadingjournals, and saved many lives.These people have looked at Burzynski's output and found itwanting.I'm not just appealing to authority here. I'm appealing to thejudgment of the people whom I consider to be using the best andmost rational rules for evaluating treatments, and who have themost demonstrated knowledge and experience in applying thoserules. It's not because the have PhDs or work for NCI that givesthem credibility in my eyes. It's that they demonstrate everyday that they have the

most knowledge and experience about cancerof anyone at the current time.The NCI and FDA have been careful to NOT say that Burzynski is afraud or even that his methods don't work. What they have saidis that he has not produced credible evidence that they do work.They won't go beyond the evidence and neither should I. I alsocan't say for sure that Dr. B is a fraud. It's possible thathe's not. I can't prove it one way or the other. But I wouldnot leave my family and travel to Texas to see him. I would notpay his required $5,000 down payment on treatment, followed bywho knows how much. I would not allow him to inject me with hisurine extract if, after all these years of "trials", he has notbeen able to demonstrate to the trials evaluation bodies that hecan do what he says he can do.I wouldn't

see him even if I knew that I was going to die ofcancer. There are any number of unproven cancer treatments tochoose from, many of which are cheaper than his and can brandishtons of "success" stories in their support. I would prefer tospend my time with my family and leave my money to my childrenthan to spend either time or money with him.It is possible that one day we will know the truth aboutBurzynski. Perhaps a lab somewhere in the world will study histreatment and prove it effective or ineffective. Or perhaps anFBI agent with a search warrant will seize his records and we'llfind out exactly what the real statistics are for his treatments.If it turns out that he was a far thinking genius, I and SteveJordan and many others will owe him something of an apology. Ifit turns out that he's a fraud and a criminal, then he has a lotto

account for.Either way, the whole circus of unproven treatments, doctors whoare either devils or saints, patients who offer their lifesavings with stars in their eyes, testimonials from survivors,and silence from non-survivors, will continue on into the future.As long as people fear death and others sell hope, there will besellers and buyers. Alan

[Guest guest]

Alan, this will be my last on the current subject. I will just await the final outcome of the FDA trials and for the benefit of all hope that he is successful. I do understand the difference between antineoplastons and antineoplastic. Sorry for the mistake on my part and thank you for correcting it for my benefit and anyone else's. Eighty three abstracts are good enough. I'm certain there will be more in due time. You must understand that when you read statements that something is ''garbage'' or that so and so is a ''crook'' with no factual basis upon which to make such a statement then naturally some people will feel compelled to respond. I do not find this a boring subject but expect that some do so

like I said, this will be my last missive on the subject unless someone else wants to keep it going.

For example, no one would think of calling Lupron garbage or Abbott Labs and Takeda Industries , the makers of Lupron, crooks without invoking the ire of many of it's defenders and some on this message board. Yet, there are men who do feel that Lupron is garbage and that those two drug firms are in fact crooks. The difference being that in regards to antineoplastons and Burzynski, the jury is still out whereas in the case of Lupron, there are whole websites and support groups based on the injuries that this drug, Lupron, has caused them and most of it to very young girls as well as men with PCa. Yahoo has a Lupron Victims support group that you can visit and read endlessly of the many side effects and injuries caused by this drug. As for calling Burzynski a crook or Abbott Labs and Takeda Industries, well,

I have never heard of Burzynski ripping anyone off and none of his patients to my knowledge have filed lawsuits against him for stealing their money. However, just 3 years ago Both Abbott Labs and Takeda Industries shared the dubious distinction of having paid the largest civil fine in the history of the United States for bribing Urologists to prescribe Lupron to their patients. And, although much was made of the Boston doctor who heroically and single handedly brought this scheme to the attention of the authorities, no mention was made of the fact that he was the only doctor of the thousands approached to do so and refuse the bribes. . What that means I will let someone else characterize. I mean it's easy to say a whole lot of things about Burzynski because he has limited resources and time with which to defend himself. Unlike Abbot and Takeda which both spent millions of dollars in legal fees and still lost their cases.

The judge in the case having stated he set the fine so high as to act as a deterrent of future behaviour. Yet despite being the highest fine ever, it was still actually 200 million dollars less than just one year's revenue on Lupron. Well, this is the way things are because it's the mainstream media ,mainstream medicine and the federal bureaucracy and all of it's agencies that gets to shape and characterize the message and the discussion.

As for the FDA trials, they are FDA trials that have been authorized by the FDA. I mean I do not know how else to frame the issue? He didn't just make something up and call them FDA trials because if he did they would not be there for you to see at clinicaltrials.gov. Your clinical trials have to be authorized and approved by the FDA to show up on the clinicaltrials.gov site. Not just anyone can make something up and post it there. What has happened is that at those congressional hearings some congressmen were pretty upset and in so many words told the FDA to stop bothering the man and allow him to get things moving along. So, they have finally allowed Burzynski to conduct his authorized trials in the manner that he feels they should best be conducted. I understand that this may upset some people but prior to this happening there had been serious

allegations made by Burzynski against NIH which included NIH illegallly patenting Buzynski's discoveries and the FDA (at the behest of NIH) attempting to put him in prison. Not a place to be from which to defend one's property and reputation. I mean you may not like the way the FDA has allowed him to do these trials but it's not up to you or me. It's up to the FDA and Burzynski to sort those details out between them and apparently they did. Ultimately he will be allowed to market his compounds to the public only if the FDA gives it's final approval and I doubt that the FDA is going to do that without ample proof. The reason you are seeing so many FDA trials is because Dr. Burzynski is no spring chicken. He's gotten well on in years and he wants to conduct as many trials as he can, while he is physically capable of doing so. And I think that perhaps before he dies he would like to see something of his life's

work come to fruition. He's got 10 times as many authorized FDA trials currently going on than most Midsized multimillion dollar biotech companies. However, his research has been leading up to this now for many decades and he's had quite a backlog of trials that he was waiting to do and that is why you see so many. . I actually find it quite impressive. Most biotech companies have 1, 2 or 3 trials at most running concurrently, not 61 of them.

I think what it really comes down to is this; No matter how the trials are designed, Burzynski is ultimately going to have to satisfy the FDA that his antineoplastons are effective in some measurable way in treating cancer and are a benefit over surgery, radiation and toxic chemotherapy. There is no getting around that and that is why I am not worried about it at all and why I do not think that anyone else should feel threatened. I mean if it works, we have a chance of benefiting from this and I cannot understand why any cancer patient would not want to. . It's not as if he is going to be able to market his compounds without FDA approval and no one is suggesting he get to bypass that approval. He has been given an opportunity to prove his compounds and his methods which is really all he ever wanted from them in the first place. The FDA will

be the final arbeiter as to whether or not these compounds are approved and i'm sure they will not approve them if they do not work in some fashion. So there is nothing anyone has to fear from Burzynski, his compounds or the outcome of the trials other than the purveyors of those treatments which his may ultimately replace . You can be sure due to the past history between Burzynski , the FDA and NIH that they will be looking over his data with a fine tooth comb.

What I have learned over the years is that cliinical trials are a very slow and painstakinglhy drawn out process , often taking decades. The companies that take shortcuts or try to rush things are the ones who usually see what were promising drugs never complete their trials. A fact that upsets a lot of people and for understandable reasons. People with cancer are dying now and they don't want to have to wait 10 or 20 years. They want to see action now. Surgery, radiation and toxic chemotherapies have been the mainstay of cancer treatment for over 100 years. They are the current standards against which all new treatments will be judged . I for one am perfectly satisfied that the FDA is not going to approve any of Burzynski's compounds unless and until they show that they can perform. I think that this is an

exciting time in cancer research for a whole lot of reasons. And I think it's wonderful that the mainstay standard treatments are being challenged. I don't know of anyone in their right mind who would not want to see them challenged and replaced other than perhaps that minority who have an existing financial interest to see them continue. I do not see them as modalities and protocols to be defended by anyone who does not have a financial interest in them, but as modalities to hopefully be replaced by better and more effective ones. I assume that this is the goal of all cancer patients. I know that it's mine.

Cheers Alan, BOB

----- Forwarded Message -----To: "ProstateCancerSupport " <ProstateCancerSupport >Sent: Wednesday, July 27, 2011 5:58 PMSubject: Re: How to measure success with Provenge

,I'm sure everyone else is bored by our lengthy discussionbut, if you'll bear with me, I'll make one more posting about itand then shut up.A lot of what you have written makes a great deal of sense to me.Prior to yours and Terry's defense of Burzynski I considered himdefinitely to be a quack and a criminal, but the two of you haveconvinced me that I had a prejudiced view. As a result of yourlast couple of postings in particular, I think I have moved fromconsidering him a quack into not knowing what to make of him -but not classifying him certainly as a quack until I see moreevidence.I'm not ready to call him a great doctor or to say that hismethods work, or even to assert that he's an honest man. It isstill my gut feeling that the man is a crook. But I can't provethat and I really don't know. However you're only arguing thathis methods _might_

work and that they have shown enough promisethat they should be encouraged, not suppressed. It is a fairposition.I'd like to respond to some of the points you made individually. wrote:> Alan, I think you should believe that there are 61 FDA> authorized clinical trials currently with regards to> Burzynski's antineoplastins.Yes, I do understand that Burzynski has registered 60 or 70trials. I can tell you for sure that these are NOT the trialsthat the FDA had in mind when they ordered him to stop treatingpatients with unapproved drugs outside the clinical trialsprocess. But they have duly registered the trials that he hassubmitted since he has not violated the letter of the law.One of the problems I'm having is that

Burzynski has been doingthis since the 1990's, yet he has never once organized arandomized trial. It is my understanding that you have to have arandomized trial, it has have enough patients for statisticalsignificance, and it should be double blind (neither patient nordoctor knows which patients are getting the experimentaltreatment) in order to prove the efficacy of the drug.The FDA will not approve any new treatment without a randomizedtrial. It's an ironclad requirement. Randomized trials havetime and again shown that much hyped drugs don't actually work,or sometimes that they do. They are the gold standard ofevidence.Antineoplastons are not FDA approved. It is illegal toadminister them in any context other than a clinical trial -which is why Burzynski runs so many trials. He needs the aegisof a trial in order to avoid being arrested for treating

peoplewith unapproved drugs. But he keeps avoiding doing what a trialought to do.Why won't he do it? If the drugs work, what has he got to lose?If I were him, and I believed in this treatment, I'd organizesuch a trial and I'd invite people whose credentials are widelyrespected to observe and participate in the trial organization,implementation and evaluation.The explanation you gave that Dr. B. is an eccentric person mayfully account for the problem. But it's still disturbing becausewe know that there is a long history of quacks who publishdistorted results of studies they have done in order to attractpatients. The laetrile story is full of such events.> That Burzynski is the acknowledged discoverer of> antineoplastins with no co-discoverers. That the NIH and the> FDA have accepted that antineoplastins exist and they do not> consider them

alternative medicine and they do not consider> them quackery. They consider them legitimate compounds for> investigation of use in cancer research.The correct spelling is antineoplaston, ending in "on", not "en".That's important as I'll describe in a moment.Yes, the NIH does regard the compounds that Dr. B. uses to belegitimate compounds for investigation. I have seen articles bywell regarded researchers that take them seriously....> If you do a search of antineoplastins on PUBMED there are over> 770,000 abstracts, an astonishing amount by any ones standards.I tried some PubMed searches. Here are the results as of July27: antineoplastic: 794660 antineoplaston: 83"Antineoplastic" is an adjective that simply means againstneoplasms, where a neoplasm is an abnormal growth of cells. Allof the

anti-cancer drugs are, by definition, "antineoplastic". Asearch on that term retrieves articles about every anti-cancerdrug you can think of and many more besides.There are only 83 articles, about "antineoplastons" includingmost of the 45 articles published by SR Burzynski himself.People other than Burzynski have indeed looked atantineoplastons, but not so many.> This is a link to the NCI, National Cancer Institute and their> presentation on antineoplastins. They also acknowledge that> Burzynski is the discoverer and chief investigator.> http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/allpages/printThat was an interesting article that I read thoroughly frombeginning to end. As with all NCI publications on

controversialsubjects, it attempts to be scrupulously neutral and not sayanything that goes beyond documented evidence.They report the positive results reported by Burzynski, thenegative results reported by the Mayo Clinic, and the mix ofpositive and negative results by other researchers, mainly by agroup in Japan. They also report the _in vitro_ (test tube)studies.They don't argue that the drug works or that it doesn't.> One of the problems that has plagued Burzynski all along has> been his insistence that things had to be done his way and that> he be recognized as the discoverer and the expert. . He was> unwilling to work with others and unwilling to work beneath> others and simply turn over his research to some Pharma firm> and be one of their employees. Something by the way that has> been offered to him many, many times.One of the biggest

problems with Burzynski's work is that we haveto take his word for everything. Did X number of patients get Ybenefit? Burzynski says so. But did it really happen?Is what he's done a scientific breakthrough, or is it a house ofcards, or is it something in between - a solid approach thatshows some benefit but which has been magnified in the telling.As you say, he's an eccentric character. Maybe that's all it is.There are a lot of red flags but still no smoking gun.One of the problems in the cancer community is that it's full ofbullshit artists who have discovered that, if you can offer acure for cancer, whether or not you have one, you can get hugeamounts of money from desperate patients. It's a wonderfulopportunity for an unscrupulous person because it can take monthsbefore anyone can discover that a quack treatment didn't work,and it's easy to convince

people either that it did work and theylived longer than they would have, or that it's just hard luckthat the treatment failed.There are plenty of people with MDs who do this. It's not justalternative medicine practitioners. There are urologists whotell their new patients: "I can offer you a 98% chance of a cureand a 98% chance of full potency at the end." And when you comeback with a recurrence and impotence they say, "Oh bad luck!You're one of the 2%!"It's a dog eat dog world and I've gotten very frustrated with thevicious dogs that use it to make big bucks on the backs of cancerpatients.... Alan