Dr. Li-Chuan Chin, PhD, National Cancer Institute Scientist (1991-1997) talks about Dr. Burzynski and Antineoplastons

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The American Medical Establishment
——————————————————————
The medical establishment of the United States is very undemocratic – to put it mildly
Now, this is a guy coming from Taiwan in 1984
Under Chiang Kai-shek, we still had martial law at that time
So, you cannot speak your mind, otherwise you would find yourself in jail, or in a very “hot position”
So, in a way, I came to this country for higher education, is because I was quite vocal against “KMT” (Kuomintang), or Chiang Kai-shek
My parents and other relatives, they had managerial positions, and they all had to be members of the party
So they don’t like me to speak too loud about anything against the party
So I said, “alright, I’ll go to the United States anyway”
So, I come here
I went to University of Kentucky to get my PhD
And then, after writing the report on Burzynski, I suddenly find myself: Gee, it’s a “kiss of death” to my professional career — because, look at JAMA
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Special Communication
Journal of the American Medical Association (JAMA) – June 3, 1992
‘Antineoplastons’
An Unproven Cancer Therapy
Saul Green, PhD

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JAMA could print a comment criticizing Burzynski, and now I’m writing a report, a report saying that Antineoplaston has some merit to it, and you’ve got to look into it
——————————————————————
Evaluation of the Anticancer Activities of Antineoplastons and Related Compounds, Including Phenylacetate, Phenylacetylglutamine, 3-Phenylacetylamino-2, 6-piperidinedione and their respective Analogs

Li-Chuan Chin, Ph.D.
Office of Alternative Medicine
National Institutes of Health
October 24, 199?

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So halfway through writing the report, it suddenly dawned on me, that might be the end of my professional career, because they’re a bunch of academic professors, they wrote things ferociously bad
——————————————————————
Oncologists criticize methods used in researching cancer treatment

Published Thursday, October 1, 1998
——————————————————————
about Burzynski’s Antineoplastons, and I have evidence and a report to say: Antineoplaston worth a second look”
How would they view me – professionally ?
And so I know in my heart that that’s the end of my professional career
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NCI: The National Cancer Institute
NIH: The National Institutes of Health
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The National Cancer Institute and the National Institutes of Health:
I found it’s a place full of people with ego of titanic proportions
You know, they are all like working for their career, working for their fame and rich
Sometimes their hearts are not there for the patients
They are more interested in their own benefit, and in the end, that’s what I realized
So, it was a disappointment
You know, they say, NIH is the mega medical center
But when you look back at the past 10, 20 years — very few Nobel Prize winner come out of NIH
And they got all the budget
They got all the money to do research
So even if you give me $1 million dollars to go back to NIH, I won’t
I won’t
I wouldn’t do anything against my conscience
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A two-party medical system ?
——————————————————————
So, eventually what I found out is that the culture is “split in two”
One is “orthodox”
The other one is “alternative”
You’ve got this “orthodox culture,” and then there’s a culture living around it
And it’s fascinating
Politically, it’s like, well, you have the dominant party, and they rule the country, and there are fringe groups and opposition parties here and there, you know
And if the authorities are not too harsh on them, sometimes they got a niche — they are surviving (laughing)
You know, it’s, in some ways to me, it’s very interesting cultural phenomenon
Yeah
And finding that in a democratic country like United States, and you
have this medical tyranny there
In tyrannies, or in authoritarian societies, a lot of the time, people would refrain from speaking the truth
Ok
The atmosphere is there to prevent you speaking your mind
Even if you see the truth
The scare tactic is enough to force a lot of people not to speak the truth within the medical field
If that fear is there, people will do things to avoid harm to their professional life, to their family life, to them personally
And it’ll perpetuate the fear for ever and ever
So it’s very difficult to delineate, say, “ahhh, it’s because of the health industry,” “it’s because of pharmaceutical companies,” the (?) of whatever
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Utilizing the two-party medical system
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What is your opinion, like if we wanna sort of get ourselves out of this mess ?
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Well my opinion is this:
If I was President of a country I would split my health budget in research into two portions
One for the medical establishment
One for the alternative field
And I’d say, “in the end of the day,” or “in the end of the year, come and show me the result”
If you get better results than the other, then I’ll take the portion of budget out a little bit and put it into yours
Put into the winners
And if you continue to lose, you lose your budget
If there’s two-party system, like, in democracy, often time, let’s have two-party system in medicine, and let them run with the budget, and come back in the end and say: “Which cat catches the most mice” ?
And this is what the general population wants
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Clip from the 2nd DVD of
Burzynski Cancer Is Serious Business
2 DVD Extended Edition Set
7:44
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The War on Cancer (I don’t think it means, what you think it says it means) #Winning?

“In 1971, the ACS (American Cancer Society) aggressively campaigned President Nixon to declare the “War on Cancer,” claiming that this could be won, given increased funding for the National Cancer Institute (NCI)

“President Nixon responded by increasing its funding by $200,000”

“This was in excess of the funding that it then received as one of 30 other National Institutes of Health”

“In so doing, President Nixon effectively created an independent status for the NCI [0]
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American Cancer Society
——————————————————————
Cancer Facts & Figures 2002-2013
——————————————————————
Expected New Cancer Cases – USA
——————————————————————
2013☝1,660,290 – (21,380 more than 2012)
2012☝1,638,910 – (42,240 more than 2011)
2011☝1,596,670 – (67,160 more than 2010)
2010☝1,529,560 – (49,810 more than 2009)
2009☝1,479,350 – (42,170 more than 2008)

2008👇1,437,180 – ( 7,740 less than 2007)
2007☝1,444,920 – (45,130 more than 2006)
2006☝1,399,790 – (26,880 more than 2005)
2005☝1,372,910 – ( 4,870 more than 2004)
2004☝1,368,030 – (33,930 more than 2003)
2003☝1,334,100 – (49,200 more than 2002)
2002
1,284,900
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Expected to Die – United States
——————————————————————
2013☝580,350_-_(3,160 more than 2012)
2012☝577,190
_-_(5,240 more than 2011)
2011☝571,950
_-_(2,460 more than 2010)
2010☝569,490
_-_(7,150 more than 2009)
2009👇562,340_-_(3,310 less than 2008)
2008☝565,650_-_(6,000 more than 2007)
2007👇559,650_-_(5,180 less than 2006)
2006👇564,830_-_(5,450 less than 2005)
2005☝570,280_-_(6,580 more than 2004
2004☝563,700
_-_(7,200 more than 2003)
2003☝556,500
_-_(6,000 more than 2002)
2002
_-_555,500
——————————————————————
Deaths – United States of America
——————————————————————
2013almost 1,600 a day
2012 – 1,500+ a day
2011 – 1,500+ a day
2010 – 1,500+ a day
2009 – 1,500+ a day
2008 – 1,500+ a day
2007 – 1,500+ a day
2006 – 1,500+ a day
2005 – 1,500+ a day
2004 – 1,500+ a day
2003 – 1,500+ a day
======================================
Estimated Childhood Cancer Deaths (0-14 years)
——————————————————————
2013👇1, 310
2012☝1,340
2011👇1,320
2010👇1,340
2009👇1,380
2008👇1,490
2007👇1,545
2006👇1,560
2005☝1,585
2004☝1,510
2003☝1,500
2002
1,400
——————————————————————
Estimated New Childhood Cancer (0-14 years)
——————————————————————
2013👇11,630
2012☝12,060
2011☝11,210

2010👇10,700
200910,730
2008☝10,730
2007☝10,400

2006👇9,500
2005☝9,510
2004☝9,200

2003👇9,000
20029,100
======================================
Estimated Brain and other nervous system Cancer Deaths (Women)
——————————————————————
2013☝6,150 (2%)
2012☝5,980 (2%)

2011👇5,670 (2%)
2010☝5,720 (2%)
2009👇5,590 (2%)
2008☝5,650 (2%)
2007☝5,590 (2%)
2006☝5,560 (2%)

2005👇5,480 (2%)
2004👇5,490 (2%)
2003👇5,800 (2%)
20025,900 (2%)
======================================
Estimated All Cancer Deaths (Women)
——————————————————————
2013👇273,430 (100%)
2012☝275,370 (100%)
2011☝271,520 (100%)
2010☝270,290 (100%)

2009👇269800 (100%)
2008☝271,530 (100%)
2007👇270,100 (100%)
2006👇273,560 (100%)
2005☝275,000 (100%)
2004☝272,810 (100%)
2003☝270,600 (100%)
2002
_-_267,300 (100%)
——————————————————————
Estimated Lung and bronchus Cancer Deaths (Women)
——————————————————————
2013👇72,220 (26%)
2012☝72,590 (26%)
2011☝71,340 (26%)
2010☝71,080 (26%)

2009👇70,490 (26%)
2008☝71,030 (26%)
2007👇70,880 (26%)
2006👇72,130 (26%)
2005☝73,020 (27%)
2004👇68,510 (25%)
2003☝68,800 (25%)
2002
65,700 (25%)
——————————————————————
Estimated Breast Cancer Deaths (Women)
——————————————————————
2013☝39,620 (14%)
2012👇39,510 (14%)
2011👇39,520 (15%)
2010👇39,840 (15%)
2009👇40,170 (15%)
2008☝40,480 (15%)
2007👇40,460 (15%)
2006☝40,970 (15%)
2005👇40,410 (15%)
2004☝40,110 (15%)
2003☝39,800 (15%)
2002
39,600 (15%)
——————————————————————
Estimated Colon and rectum Cancer Deaths (Women)
——————————————————————
2013👇24,530 (9%)
2012☝25,220 (9%)
2011👇24,130 (9%)
2010👇24,790 (9%)
2009👇24,680 (9%)
2008👇25,790 (9%)
2007👇26,180 (10%)
2006👇27,300 (10%)
2005👇27,750 (10%)
2004👇28,410 (10%)
200328,800 (11%)
2002
28,800 (11%)
——————————————————————
Estimated Pancreas Cancer Deaths (Women)
——————————————————————
2013☝18,970 (7%)
2012☝18,540 (7%)
2011☝18,300 (7%)
2010☝18,030 (7%)
2009☝17,210 (6%)
2008☝16,790 (6%)
2007☝16,530 (6%)
2006☝16,210 (6%)
2005☝15,980 (6%)
2004☝15,830 (6%)
2003☝15,300 (16%)
2002
15,200 (16%)
——————————————————————
Estimated Ovary Cancer Deaths (Women)
——————————————————————
2013👇14,030 (5%)
2012☝15,500 (6%)
2011☝15,460 (6%)

2010👇13,850 (5%)
2009👇14,600 (5%)
2008☝15,520 (6%)
2007👇15,280 (6%)
2006👇15,310 (6%)
2005☝16,210 (6%)
2004☝16,090 (6%)
2003☝14,300 (5%)
2002
13,900 (5%)
——————————————————————
Estimated Leukemia Deaths (Women)
——————————————————————
2013☝10,060 (4%)
2012☝10,040 (4%)

2011👇9,040 (3%)
2010👇9,180 (3%)
2009☝9,280 (3%)
2008👇9,250 (3%)
2007👇9,470 (4%)
2006👇9,810 (4%)
2005👇10,030 (4%)
2004☝10,310 (4%)
2003☝9,800 (4%)
2002
9,600 (4%)
——————————————————————
Estimated Non-Hodgkin lymphoma Deaths (Women)
——————————————————————
2013👇8,430 (3%)
2012👇8,620 (3%)
2011☝9,570 (4%)
2010👇9,500 (4%)
2009☝9,670 (4%)
2008☝9,370 (3%)
2007☝9,060 (3%)

2006👇8,840 (3%)
2005☝9,050 (3%)
2004👇9,020 (3%)
2003👇11,200 (4%)
200211,700 (4%)
——————————————————————
Estimated Uterine corpus Cancer Deaths (Women)
——————————————————————
2013☝8,190 (3%)
2012👇8,010 (3%)
2011☝8,120 (3%)
2010☝7,950 (3%)
2009☝7,780 (3%)
2008☝7,470 (3%)
2007☝7,400 (3%)
2006☝7,350 (3%)
2005☝7,310 (3%)
2004☝7,090 (3%)
2003☝6,800 (3%)
2002
6,600 (2%)
——————————————————————
Estimated Liver and intrahepatic bile duct Cancer Deaths (Women)
——————————————————————
2013☝6,780 (2%)
2012☝6,570 (2%)
2011☝6,330 (2%)
2010☝6,190 (2%)
2009☝6,070 (2%)
2008☝5,840 (2%)
2007
5,500 (2%)
2006
2005
2004
2003
2002
——————————————————————
Estimated Multiple myeloma Cancer Deaths (Women)
——————————————————————
2013
2012
2011
2010
2009
2008
2007
2006👇5,630 (2%)
20055,640 (2%)
2004☝5,640 (2%)
2003☝5,500 (2%)
2002
5,300 (2%)
======================================
Estimated New Cancer All (Women)
——————————————————————
2013☝805,500 (100%)
2012☝790,740 (100%)
2011☝774,370 (100%)
2010☝739,940 (100%)
2009☝713,220 (100%)
2008☝692,000 (100%)

2007👇678,060 (100%)
2006☝679,510 (100%)
2005👇662,870 (100%)
2004☝668,470 (100%)
2003☝658,800 (100%)
2002
_-_647,400 (100%)
——————————————————————
Estimated New Breast Cancer (Women)
——————————————————————
2013☝232,340 (29%)
2012👇226,870 (29%)
2011☝238,480 (30%)
2010☝207,090 (28%)
2009☝192,370 (27%)
2008☝182,460 (26%)

2007👇178,480 (26%)
2006☝212,920 (31%)
2005👇211,240 (32%)
2004☝215,900 (32%)
2003☝211,300 (32%)
2002
_-_203,500 (31%)
——————————————————————
Estimated New Lung and bronchus Cancer (Women)
——————————————————————
2013☝110,110 (14%)
2012☝109,690 (14%)
2011☝106,070 (14%)
2010☝105,770 (14%)
2009☝103,350 (14%)
2008☝100,330 (14%)
2007☝98,620 (15%)
2006☝81,770 (12%)

2005👇79,560 (12%)
2004☝80,660 (12%)
2003☝80,100 (12%)
2002
79,200 (12%)
——————————————————————
Estimated New Colon and rectum Cancer (Women)
——————————————————————
2013👇69,140 (9%)
2012☝70,040 (9%)
2011👇69,360 (9%)
2010👇70,480 (10%)
2009👇71,380 (10%)
2008👇71,560 (10%)
2007👇74,630 (11%)
2006☝75,810 (11%)
2005☝73,470 (11%)

2004👇73,320 (11%)
2003👇74,700 (11%)
200275,700 (12%)
——————————————————————
Estimated New Uterine corpus Cancer (Women)
——————————————————————
2013☝49,560 (6%)
2012☝47,130 (6%)
2011☝46,470 (6%)
2010☝43,470 (6%)
2009☝42,160 (6%)
2008☝41,100 (6%)

2007👇39,080 (6%)
2006☝41,200 (6%)
2005☝40,880 (6%)

2004👇40,320 (6%)
2003☝41,00 (6%)
2002
39,300 (6%)
——————————————————————
Estimated New Thyroid Cancer (Women)
——————————————————————
2013☝45,310 (6%)
2012☝43,210 (5%)
2011☝36,550 (5%)
2010☝33,930 (5%)

2009👇27,200 (4%)
2008☝28,410 (4%)
2007☝25,480 (4%)
2006☝22,590 (3%)
2005☝19,190 (3%)
2004☝17,640 (3%)
2003☝16,300 (3%)
2002
15,800 (2%)
——————————————————————
Estimated New Non-Hodgkin lymphoma (Women)
——————————————————————
2013☝32,140 (4%)
2012☝31,970 (4%)
2011☝30,300 (4%)
2010☝30,160 (4%)

2009👇29,990 (4%)
2008☝30,660 (4%)
2007☝28,990 (4%)
2006☝28,190 (4%)
2005☝27,320 (4%)
2004☝25,520 (4%)

2003👇25,100 (4%)
200225,700 (4%)
——————————————————————
Estimated New Melanoma of the skin Cancer (Women)
——————————————————————
2013👇31,630 (4%)
2012☝32,000 (4%)
2011☝30,220 (4%)

2010👇29,260 (4%)
2009☝29,640 (4%)
2008☝27,530 (4%)

2007👇26,030 (4%)
2006☝27,930 (4%)
2005☝26,000 (4%)
2004☝25,200 (4%)
2003☝24,300 (3%)
2002
23,500 (4%)
——————————————————————
Estimated New Kidney and renal pelvis Cancer (Women)
——————————————————————
2013☝24,720 (3%)
2012☝24,520 (4%)
2011☝23,800 (3%)
2010☝22,870 (3%)
2009☝22,330 (3%)
2008☝21,260 (3%)
2007
19,600 (3%)
2006
2005
2004
2003
2002
——————————————————————
Estimated New Pancreas Cancer (Women)
——————————————————————
2013☝22,489 (3%)
2012👇21,830 (3%)
2011☝21,980 (3%)
2010☝21,770 (3%)
2009 21,420 (3%)

2008
2007
2006☝16,580 (2%)
2005👇16,080 (2%)
2004☝16,120 (2%)
2003☝15,800 (2%)
2002
15,600 (2%)
——————————————————————
Estimated New Ovary Cancer (Women)
——————————————————————
2013👇22,240 (3%)
2012☝22,280 (3%)
2011☝21,990 (3%)
2010☝21,880 (3%)

2009👇21,550 (3%)
2008👇21,650 (3%)
2007☝22,430 (3%)
2006👇20,180 (3%)
2005👇22,220 (3%)
2004☝25,580 (4%)
2003☝25,400 (4%)
2002
23,300 (4%)
——————————————————————
Estimated New Leukemia (Women)
——————————————————————
2013
2012
2011
2010
2009
2008👇19,090 (3%)
200719,440 (3%)
2006
2005
2004
2003
2002
——————————————————————
Estimated New Urinary bladder Cancer (Women)
——————————————————————
2013
2012
2011
2010
2009
2008
2007
2006☝16,730 (2%)
2005☝16,200 (2%)
2004☝15,600 (2%)
2003
15,200 (2%)
2002
15,200 (2%)
======================================
Estimated All Cancer Deaths (Men)
——————————————————————
2013☝306,920 (100%)
2012☝301,820 (100%)
2011☝300,430 (100%)
2010☝299,200 (100%)

2009👇292,540 (100%)
2008☝294,120 (100%)
2007👇289,550 (100%)
2006👇291,270 (100%)
2005☝295,280 (100%)
2004☝290,890 (100%)

2003👇285,900 (100%)
2002_-_288,200 (100%)
——————————————————————
Estimated Lung and bronchus Deaths (Men)
——————————————————————
2013👇87,260 (28%)
2012☝87,750 (29%)
2011👇85,600 (28%)
2010👇86,220 (29%)
2009👇88,900 (30%)
2008☝98,810 (31%)
2007👇89,510 (31%)
2006👇90,330 (31%)
2005👇90,490 (31%)
2004☝91,930 (32%)
2003👇88,400 (31%)
200289,200 (31%)
——————————————————————
Estimated Prostate Cancer Deaths (Men)
——————————————————————
2013☝29,720 (10%)
2012👇28,170 (9%)
2011☝33,720 (11%)
2010☝32,050 (11%)

2009👇27,360 (9%)
2008☝28,660 (10%)
2007👇27,050 (9%)
2006👇27,350 (9%)
2005☝30,350 (10%)
2004☝29,500 (10%)

2003👇28,900 (10%)
200230,200 (11%)
——————————————————————
Estimated Colon and rectum Cancer Deaths (Men)
——————————————————————
2013👇26,300 (9%)
2012☝26,470 (9%)
2011👇25,250 (8%)
2010☝26,580 (9%)
2009☝25,240 (9%)

2008👇24,260 (8%)
2007👇26,000 (9%)
2006👇27,870 (10%)
2005☝28,540 (10%)
2004☝28,320 (10%)
2003☝28,300 (10%)
2002
27,800 (10%)
——————————————————————
Estimated Pancreas Cancer Deaths (Men)
——————————————————————
2013☝19,480 (6%)
2012👇18,850 (6%)
2011☝19,360 (3%)
2010☝18,770 (6%)
2009☝18,030 (6%)
2008☝17,500 (6%)
2007☝16,840 (6%)
2006☝16,090 (6%)
2005☝15,820 (5%)
2004☝15,440 (5%)
2003☝14,700 (5%)
2002
14,500 (5%)
——————————————————————
Estimated Liver and intrahepatic bile duct Cancer Deaths (Men)
——————————————————————
2013☝14,890 (5%)
2012☝13,980 (5%)
2011☝13,260 (4%)
2010☝12,720 (4%)

2009👇12,090 (4%)
2008☝12,570 (4%)
2007☝11,280 (4%)
2006☝10,840 (4%)
2005☝10,330 (3%)
2004☝9,450 (3%)
2003☝9,200 (3%)
2002
8,900 (3%)
——————————————————————
Estimated Leukemia Deaths (Men)
——————————————————————
2013☝13,660 (4%)
2012☝13,500 (4%)
2011☝12,740 (4%)
2010☝12,660 (4%)
2009☝12,590 (4%)
2008☝12,460 (4%)

2007👇12,320 (4%)
2006👇12,470 (4%)
2005👇12,540 (4%)
2004☝12,990 (5%)
2003
12,100 (4%)
2002
12,100 (4%)
——————————————————————
Estimated Esophagus Cancer Deaths (Men)
——————————————————————
2013☝12,220 (4%)
2012☝12,040 (4%)
2011☝11,910 (4%)
2010☝11,650 (4%)
2009☝11,490 (4%)
2008☝11,250 (4%)
2007☝10,900 (4%)
2006☝10,730 (4%)
2005☝10,530 (4%)
2004☝10,250 (4%)
2003☝9,900 (4%)
2002
9,600 (3%)
——————————————————————
Estimated Urinary bladder Cancer Deaths (Men)
——————————————————————
2013☝10,820 (4%)
2012👇10,510 (3%)
2011☝10,670 (4%)
2010☝10,410 (3%)
2009☝10,180 (3%)
2008☝9,950 (3%)
2007☝9,630 (3%)
2006☝8,990 (3%)
2005☝8,970 (3%)
2004☝8,780 (3%)
2003
8,600 (3%)
2002
8,600 (3%)
——————————————————————
Estimated Non-Hodgkin lymphoma Deaths (Men)
——————————————————————
2013☝10,590 (3%)
2012☝10,320 (3%)

2011👇9,750 (3%)
2010☝10,710 (4%)
2009☝9,830 (3%)
2008☝9,790 (3%)

2007👇9,600 (3%)
2006👇10,000 (3%)
2005👇10,150 (3%)
2004👇10,390 (4%)
2003👇12,200 (4%)
200212,700 (5%)
——————————————————————
Estimated Kidney and renal pelvis Cancer Deaths (Men)
——————————————————————
2013☝8,780 (3%)
2012☝8,650 (3%)
2011☝8,270 (3%)
2010☝8,210 (3%)
2009☝8,160 (3%)
2008☝8,100 (3%)

2007👇8,080 (3%)
2006☝8,130 (3%)
2005☝8,020 (3%)
2004☝7,870 (3%)
2003☝7,409 (3%)
2002
7,200 (3%)
======================================
Estimated New Cancer All (Men)
——————————————————————
2013☝854,790 (100%)
2012☝848,170 (100%)
2011☝822,300 (100%)
2010☝789,620 (100%)
2009☝766,130 (100%)

2008👇745,180 (100%)
2007☝766,860 (100%)
2006☝720,280 (100%)
2005☝710,040 (100%)
2004☝699,560 (100%)
2003☝675,300 (100%)
2002
_-_637,500 (100%)
——————————————————————
Estimated New Prostate Cancer (Men)
——————————————————————
2013👇238,590 (28%)
2012☝241,470 (29%)
2011☝240,890 (29%)
2010☝217,730 (28%)
2009☝192,280 (25%)

2008👇186,320 (25%)
2007👇218,890 (29%)
2006☝234,460 (33%)
2005☝232,090 (33%)
2004☝230,110 (33%)
2003☝220,900 (33%)
2002
_-_189,000 (30%)
——————————————————————
Estimated New Lung and bronchus Cancer (Men)
——————————————————————
2013☝118,080 (14%)
2012☝116,470 (14%)

2011👇115,060 (14%)
2010☝116,750 (15%)
2009☝116,090 (15%)

2008👇114,690 (15%)
2007☝114,760 (15%)
2006👇92,700 (13%)
2005👇93,010 (13%)
2004☝93,110 (13%)
2003☝91,800 (14%)
2002
90,200 (14%)
——————————————————————
Estimated New Colon and rectum Cancer (Men)
——————————————————————
2013☝73,680 (13%)
2012☝73,420 (9%)

2011👇71,850 (9%)
2010👇72,090 (9%)
2009👇75,590 (10%)
2008👇77,250 (10%)
2007☝79,130 (10%)
2006☝72,800 (10%)

2005👇71,820 (10%)
2004☝73,620 (11%)
2003☝72,800 (11%)
2002
72,600 (11%)
——————————————————————
Estimated New Urinary bladder Cancer (Men)
——————————————————————
2013👇54,610 (6%)
2012☝55,600 (7%)
2011👇52,020 (6%)
2010👇52,760 (7%)
2009☝52,810 (7%)
2008☝51,230 (7%)
2007☝50,040 (7%)

2006👇44,690 (6%)
2005☝47,010 (7%)
2004☝44,640 (6%)
2003☝42,200 (6%)
2002
41,500 (7%)
——————————————————————
Estimated New Melanoma of the skin Cancer (Men)
——————————————————————
2013☝45,060 (5%)
2012☝44,250 (5%)
2011☝40,010 (5%)

2010👇38,870 (5%)
2009☝39,080 (5%)
2008☝34,950 (5%)

2007👇33,910 (4%)
2006☝34,260 (5%)
2005☝33,580 (5%)
2004 – 29,900 (4%)

2003👇29,900 (4%)
200230,100 (5%)
——————————————————————
Estimated New Kidney and renal pelvis Cancer (Men)
——————————————————————
2013☝40,430 (5%)
2012☝40,250 (5%)
2011☝37,120 (5%)

2010👇35,370 (4%)
2009☝35,430 (5%)
2008☝33,130 (4%)
2007☝31,590 (4%)
2006☝24,650 (3%)
2005☝22,490 (3%)
2004☝22,080 (3%)
2003☝19,500 (3%)
2002
19,100 (3%)
——————————————————————
Estimated New Non-Hodgkin lymphoma (Men)
——————————————————————
2013👇37,600 (4%)
2012☝38,160 (4%)
2011☝36,060 (4%)

2010👇35,380 (4%)
2009☝35,990 (5%)
2008☝35,450 (5%)
2007☝34,200 (4%)
2006☝30,680 (4%)
2005☝29,070 (4%)
2004☝28,850 (4%)
2003☝28,300 (4%)
2002
28,200 (4%)
——————————————————————
Estimated New Oral cavity and pharynx Cancer (Men)
——————————————————————
2013☝29,620 (3%)
2012☝28,540 (3%)
2011☝27,710 (3%)
2010☝25,420 (3%)

2009👇25,240 (3%)
2008☝25,310 (3%)
2007☝24,180 (3%)
2006☝20,180 (3%)
2005☝19,100 (3%)
2004☝18,550 (3%)

2003👇18,200 (3%)
200218,900 (3%)
——————————————————————
Estimated New Leukemia (Men)
——————————————————————
2013☝27,880 (3%)
2012☝26,830 (3%)
2011☝25,320 (3%)

2010👇24,690 (3%)
2009☝25,630 (3%)
2008☝25,180 (3%)
2007☝24,800 (3%)
2006☝20,000 (3%)
2005☝19,640 (3%)
2004☝19,020 (3%)
2003☝17,900 (3%)
2002
17,600 (3%)
——————————————————————
Estimated New Pancreas Cancer (Men)
——————————————————————
2013☝22,740 (3%)
2012☝22,090 (3%)
2011☝22,050 (3%)
2010☝21,370 (3%)
2009☝21,050 (3%)

2008👇18,770 (3%)
2007☝18,830 (2%)
2006☝17,150 (2%)
2005☝16,109 (2%)
2004☝15,740 (2%)
2003☝14,900 (2%)
2002
14,700 (2%)
======================================

20131113-231037.jpg

20131113-113632.jpg
——————————————————————
American Cancer Society
——————————————————————
Cancer Facts & Figures
======================================
REFERENCES:
======================================
[0] – AMERICAN CANCER SOCIETY

More Interested In Accumulating Wealth Than Saving Lives

Samuel S. Epstein, M.D.

Emeritus professor Environmental and Occupational Medicine

University of Illinois School of Public Health

and

Chairman, The Cancer Prevention Coalition
——————————————————————
http://www.wnho.net/acs.pdf
======================================
2013
——————————————————————
http://cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf
——————————————————————
http://m.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf
——————————————————————
http://cancer.org/research/cancerfactsstatistics/cancerfactsfigures2013/index
——————————————————————
http://m.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2013/index
——————————————————————
http://cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2013
——————————————————————
http://m.cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2013
======================================
2012
——————————————————————
http://cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-031941.pdf
——————————————————————
http://m.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-031941.pdf
——————————————————————
http://cancer.org/research/cancerfactsstatistics/cancerfactsfigures2012/index
——————————————————————
http://m.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2012/index
——————————————————————
http://cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2012
——————————————————————
http://m.cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2012
======================================
2011
——————————————————————
http://cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-029771.pdf
——————————————————————
http://m.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-029771.pdf
——————————————————————
http://cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2011
——————————————————————
http://m.cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2011
======================================
2010
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/acspc-024113.pdf
——————————————————————
http://m.cancer.org/acs/groups/content/@nho/documents/document/acspc-024113.pdf
——————————————————————
http://cancer.org/research/cancerfactsstatistics/cancerfactsfigures2010/index
——————————————————————
http://m.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2010/index
======================================
2009
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/500809webpdf.pdf
——————————————————————
http://m.cancer.org/acs/groups/content/@nho/documents/document/500809webpdf.pdf
——————————————————————
http://cancer.org/research/cancerfactsstatistics/cancerfactsfigures2009/index
——————————————————————
http://m.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2009/index
——————————————————————
http://cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2009
——————————————————————
http://m.cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2009
======================================
2008
——————————————————————
http://www.oralcancerfoundation.org/facts/pdf/worldcancer.pdf
——————————————————————
http://cancer.org/research/cancerfactsstatistics/cancerfactsfigures2008/index
——————————————————————
http://m.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2008/index
——————————————————————
http://cancer.org/research/cancerfactsstatistics/allcancerfactsfigures/index
——————————————————————
http://m.cancer.org/research/cancerfactsstatistics/allcancerfactsfigures/index
======================================
2007
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/caff2007pwsecuredpdf.pdf
——————————————————————
http://m.cancer.org/acs/groups/content/@nho/documents/document/caff2007pwsecuredpdf.pdf
——————————————————————
http://cancer.org/research/cancerfactsstatistics/cancerfactsfigures2007/index
——————————————————————
http://m.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2007/index
——————————————————————
http://cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2007
——————————————————————
http://m.cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2007
======================================
2006
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/caff2006pwsecuredpdf.pdf
——————————————————————
http://m.cancer.org/acs/groups/content/@nho/documents/document/caff2006pwsecuredpdf.pdf
——————————————————————
http://cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2006
——————————————————————
http://m.cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2006
======================================
2005
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/caff2005f4pwsecuredpdf.pdf
——————————————————————
http://m.cancer.org/acs/groups/content/@nho/documents/document/caff2005f4pwsecuredpdf.pdf
——————————————————————
http://cancer.org/research/cancerfactsstatistics/allcancerfactsfigures/index
——————————————————————
http://m.cancer.org/research/cancerfactsstatistics/allcancerfactsfigures/index
——————————————————————
http://cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2005
——————————————————————
http://m.cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-2005
======================================
2004
——————————————————————
http://www.pink-ribbon-pins.com/CancerRates2004.pdf
======================================
2003
——————————————————————
http://www.whyquit.com/studies/2003_ACS_Cancer_Facts.pdf
======================================
2002
——————————————————————
http://www.uhmsi.com/docs/CancerFacts&Figures2002.pdf
======================================

Pete Cohen chats with Richard A. Jaffe, Esq.

======================================
4/2012Pete Cohen chats with Rick Jaffe
(33:59) 11/9/2012
Richard A. Jaffe, Esq.
======================================
How did you meet Dr. Burzynski?

A long time ago in 1988, um, he hired us to represent him in his Medical Board case, so, uh, started working for him then, and then there got to be more and more work, and, uh, at some point it was so much work, it was just easier for me to be down here
So I moved from New York to Texas, mostly just to, to represent him, and my wife was in the oil industry, so, it was a “no brainer” for her to move down here too

And how, were you intrigued by this whole case ?
I mean, did you work out straight away that this guy was genuine, and there was really something here ?

No (laugh)
How do you know, you know ?
At the time we represented, uh, a number of a alternative health practitioners around the country, and we heard a lot about Burzynski, but you don’t really know
I mean, um, um, there are a lot of stories out there
Every doctor seems to have a few patients, uh, that were helped
So initially, I mean, how do you know ?
His operation was larger than most of any, uh, health practitioners, alternative health practitioners in the country, and, uh, seemed a lot more sophisticated, but, uh, it’s not really until you dig in the medical records of the patients that you really see what’s going on
I mean, that’s what you really need
I mean,
It’s not really even, it’s
’cause this whole thing about anecdotal evidence, that everyone has testimony
so every doctor
You know what I mean ?
anybody
Even charlatans have testimony
people
one or two people
or 3 or 4 that’ll come, and say w
they were cured, and maybe, maybe the patients really believe that to be the case, but, um, oftentimes there’s other explanations
Prior treatment, um, the nature of the disease
Sometimes it’s such that their natural, the natural history is not straight linear, um, but after looking at some of the medical records, I mean, you know, I think
it’s just,
uh, anybody would become a believer, and indeed, I mean, government, government doctors have come down here and looked at

some of the records, and they were convinced that, that the treatment was causing remissions in some brain cancer patients

So, I mean, obviously lawyers, I imagine many lawyers all over the world would often take on a case, when they know, possibly the guy isn’t telling the truth, but they can see there’s still a story, and they, they, they, they, uh, represent that person, but for you, I suppose
that when you realized that there really was a story here, did you kind of get, emotionally caught up in this whole thing and think: “Right, th this guy’s got a cure for cancer, and I I need to bring this to, bring him to just, not bring him to justice, but, clear his name
Well, I think with Burzynski, more so than any client I’ve ever represented
He represents a unique constellation of medical services
He’s the only guy in the world doing what he’s doing with antineoplastons and now with this treatment, so, it’s really different
Uh, you know, with Burzynski, most of the patients, are in bad shape
They’re either dying, uh, they, or they have a disease for which there is no known cure, you know, like a lot of these brain tumors
So, even from the beginning, what’s different is their are many, many patients back then who were on the treatment, that uh, that felt that without this treatment they were going to die, and so that, that’s much different, than the average, any kind of lawsuit
Right ?
So th th these lawsuits, the Burzynski cases back then and now, uh, these cases matter, in a, in a deeper, and fundamental, and personal way than most anything, well I think that any lawyer does
I mean, any criminal defense lawyer, who defends an individual, is defending that person’s, uh, liberty
Alright ?
Versus incarceration
But here it, it wasn’t so much, or, it wasn’t exclusively about Burzynski, it was really about all these other patients, and they certainly believe they needed him, and, uh, uh, many of them, obviously did
So, so that, that, that’s a whole ‘nother dimension, which typically we lawyers don’t get involved in
So, I mean, it’s a responsibility but also a great privilege to be working on these kinds of cases

You’ve been representing him for how long ?

For a long time
Since 1988, continuously

And can you believe this is still going on ?

Well, you know, uh, it’s, you know, it’s, it’s just ongoing
I mean, until there’s a cure for cancer, for all cancer, either done by acknowledged

or, uh, uh, to be Burzynski’s cure or somebody else’s
I mean, this is ongoing
And I guess the problem is, you know, ultimately, there’s nobody yet
Not even Burzynski has the cure for every cancer or
even every stage, or even ev, every, ev, ev, every person that had cancer
So, because it’s such a tough battle, and because, it doesn’t work on everyone
So you have these open questions
Ah, so, so,
Yeah, I mean, I guess, I, I can’t believe he’s still messing around with these clinical trials
I mean, I think that if the drug didn’t have his name attached to it, it’d probably would have been approved by now
So, and I think, so that, that’s unfortunate, I think, that when you fight the FDA, and even if you win, you know, the F, the repercussions, you know, you know I, you know I
Hopefully the drug will be approved, sometime in the future, but, but who knows ?

So, um, why do you think, why was it, I mean, obviously I came over here as you know, for this case, which is now not going ahead at the moment
Why, why, why is that ?
Wha, what has the judge, said ?

Well, of course, you have to (under)stand, this case involves a different type of treatment
It doesn’t involve antineoplastons,the drug Dr. Burzynski invented, and your friend is receiving, and it involves a new approach to cancer, which is sort of like personalized medicine, where they take a bunch of FDA approved drugs, that have shown some promise, on a particular cancer, but are not, uh, approved for that indication, and based on these early clinical trials showing promising results for genetic testing they give these combinations of FDA approved drugs, off-label to patients, and that’s really what the, this case is about, and, uh, you know I think, I don’t think they, they never had a case
I mean, they never had a case
The, the main allegation, in each, of the 2 patients involved, is that they used this treatment, which wasn’t sufficiently tested, and was non-therapeutic, and whatnot, and we had a, what I would call a dry run
We presented the evidence to the Board, or 2 members of the Board, in both of these cases
In each, in each case, the Board members felt that the treatment, was within the standard of care, given the advanced condition of the patient, or one patient, and given how rare the other patient’s tumor was
So, we had our dry run in each case, and the Board found in our favor on the main charge
They had some technical issues with medical records or whatnot, and, uh, the Board basically said, they took the position, ok, agree to some kind of sanction on these little charges, or, or we’re going to go after you on everything
So, we refused the honor, and, uh, the Board then charged him with the same thing that they already cleared him with, or on, and, and so we had to do, you know, basically the same case again, and, uh, the irony in, is in these 2 cases Burzynski wasn’t even in the country
He was, he was, he was away for, uh, in both, for both cases, when the patientscame
So, uh, the question is how do you hold someone responsible
Even if you own the clinic, for treatment administered and prescribed, by other doctors, and that concept of vicarious liability does not, uh, exist in jurisprudence, and in the law governing professional re, responsibility, anywhere in this country
So, the Board’strying to start that
You know, I think they just got in over their heads, they
Most people just knuckle under
You know, most people don’t, are afraid to go to court, so they’ll sign anything just to, you know, not to go forward, but, you know, Burzynski faced serious stuff
I mean, he set, faced, 5, 10, 15 years in jail
So he wasn’t going to be intimidated, by the Medical Board, and he refused to give in
So when I told the Board at the time, and I told them all along, they have no case, and o on the merits they have no case
We already won, and they have no case now, and, and slowly I think, the Board is starting to understand that

And what sort of a person would you say Dr. Burzynski is ?

Well I think he’s a complicated person
I mean, I think, uh, uh, you know, he, I think like a lot of mavericks; I represent a lot of mavericks around the, uh, uh, country
One of the main characteristics of these guys, is that they have absolute and total certainty, in what they believe in, in what they do, um, and no doubt
Uh, they all think they’re right
They all think that history is going to vindicate them
Now, I’ve represented some people where I personally doubt (laugh) that, uh, uh, that belief, but not in Dr. Burzynski’s case
I mean, I think he’s all, he’s definitely helping people
He’s definitely, uh, uh, uh, making, extending people’s lives, and curing some people that otherwise would have died, and so I think he, and so I think he happens to be right
So, uh, you know, so, but, but he’s a human
He’s got a big ego
He thinks he’s, uh, he thinks he has made an important, contribute to medicine, and he’s not shy about sharing that sentiment
So, uh, I think, and I think that he’s, uh, not American
So he comes with a completely different mentality towards, say, the government
Alright, he grew up in communist Poland, where everyone, where everyone, has to work around, the government, and I think that’s much harder here, and, you know, I think he has expectations that, that he would have a lot more freedom, than it turned out he had, too, and he thought he would not have to deal with the kind of government, uh, rigamarole that you have to deal with in communist, Poland

And, and how do you think it might all pan out for him ?
I mean, I know you don’t have a crystal ball, but if you could look, 5 or 10 years down into the future, and, do you think that he will have got somewhere, to be accepted in the medical (?) of oncology ?

Well, I certainly hope so
I mean, 5, 10 years from now
I mean, I think, at a minimum, what’s going to happen, there will be many, many patients who will be alive, and continue to be alive because of him
Some, will have their lives extended
Some will be cured
Some wi, won’t be cured, and will die
So, I think that’s for sure, going to happen
You know, is there going to be an end to, uh, all this ?
We had a period of maybe 10 years where there was very little action with the Board, but, uh, you know, it’s hard, frankly, I mean, just in, and again my perspective, like I’m in a, like a, a sergeant in the trenches, in trench (laugh) warfare
So, it’s hard for me to see the big picture
I mean, I just keep fighting these battles, and there’s one, after another, after another
So this is really just the latest, and on there’s civil lawsuits, and then there are people on the Internet, and then, you know, there could be more Medical Board investigations
So, lo, look there are a lot of people who don’t like what he’s doing
They think what he’s doing is either unethical or wrong, or shouldn’t be giving drugs, these drugs to people, except under clinical trial conditions, and, you know, he has detractors, and he has a lot of supporters
I mean, uh, mostly amongst the patients he’s cured
So, I don’t know that, that, that is gonna resolve itself
I mean, ultimately, he’s one of the few people in the country, that, or maybe the only person in the country that does what he does, and, it’s not the way medicine is practiced, in this country, typically
Right, and, you know, I think what he does, is, is more, is more patient oriented, in a sense that, once you’ve been told you’re terminal, why should you just get the palliative care that a medical oncologist thinks, you know, they should be given
even though when, no one ever gets cured of chemotherapy, once it’s palliative, once you have stage 4, solid tumor

Mmm

I mean, they give chemotherapy for what they call palliative reasons, which means, not curative
So, this concept of giving, just conventional chemotherapy to make you feel better, extend your life 9 weeks, I mean, y, not everyone wants to do that
Some people want a shot for a real cure, and, you know, based on the evidence with antineoplastons
, I mean, he seems to be giving people that shot, and curing some of the people
So, you, you know, I don’t see how, this thing gets resolved
Up until the time that the
treatment, the
antineoplastons is approved by the FDA and, you know,
it’s, it’s hard to see a clear path, for that, for a lot of reasons, not the least of which is financial
I mean, it takes dozens of 10’s of millions of dollars

Mmm

or 10, 100’s of millions
So, I mean, someone has to finance the clinical trials
The drug companies aren’t interested right now
They’d just as soon, buy a drug that’s been fully tested
So, I mean, the drug company response has not been overwhelming, because, even though this phase 2 phase, have resolved, and, and, uh, they have excellent results, the drug companies want to wait and see
So, uh, it’s, it’s big money
I don’t think there’s any way in the world Dr. Burzynski, himself, can fund phase 3
I mean, he, he funded everything else now, but phase 3 are, is a much bigger stage involving dozens and 100’s of patients, and that’s just within the financial means of any individual

it seems like it’s unlikely that its going to happen right
I mean, even from the point of view of, what, with phase 3 trials, they’ll be with children

with brainstem gliomas, right
and the FDA’s saying they’ve got to have radiation

Yeah I, um,
I unfortunately, I haven’t been involved in that process
I just see the result, and I, I, I just don’t see how any parent agrees to that, you know

I don’t see how any parent agrees to it
I don’t see how clinical investigator, agrees to do it
Um, I don’t know
I got so, I got some questions of the FDA as to, why they forced him into this particular protocol
I mean, I don’t know
I don’t have any facts or evidence, but I, I, just doesn’t make any sense to me

what’s you’re about that ?

I don’t know
I mean, I, it just doesn’t seem to me, that it’s a, that it’s a fair clinical trial that

Mmm

either an investigator would find ethical, or a patient, or a family, would agree to have their patient treat, their, their kid treated under
I mean, it just doesn’t make any sense to me
I mean, it’s worse than
I mean, both phases, both phases, both arms of the study, you get radiation
It’s radiation alone versus radiation with his stuff
So, I mean, it just doesn’t make any sense to me, given, given the clinical, the phase 2 clinical trial results

So just a, so just a few things, like, you know I’m going to talk about big Pharma, and then talk about the FDA

Right

They talk about the many people as if they’re one person, but, you know, they’re obviously a collective group of individuals who work for an organization, right ?

Well, I mean, I think, the concern is, that the FDA now, by statute is, in no small part funded, by the pharmaceutical industry
It’s like “Pay as you go”
So the, the pharmaceutical ind, industry now, pays for, the processing of the clinical trials by the FDA
So, and then you have the whole concept of the revolving door
You have a lot of government officials going into the drink, uh, drug companies
So I think that’s another problem
So, I mean, you know, I think conspiracy is too strong of a word, m, but, you know, I will say, I don’t think the system’s set up, for an individual like Burzynski, to get a drug approved
I, I, I just don’t see
There’s no support for that
I mean, the days
I mean, it’s like, Einstein, you know ?
He sat in a patent office, and, and doodled, and had his little theory
He could never get his, stuff published today, you know ?
Where did he go to school
?
Where was he teaching, you know ?
So Burzynski has a lot of the same problems
They say he doesn’t publish, but, they won’t let him publish
So, uh, or they won’t let him publish , in, in the mainstream journals
So, I, I, I think though, I think the, I think the system, has a strong bias, against a guy with a discovery
So, that’s not quite saying, there’s a conspiracy, but it’s, it’s sort of along the same lines, and, you know, the conspiracy implies some kind of, um, intentionality on the part of one or two, or some small group or coterie of people, and I don’t know, I don’t think that’s really the case
I think what happens is, the institutions are such that, they allow certain things, and disallow certain things
Alright ?
I think that’s just
there’s no
I don’t think there’s any 2, 3, 4, or some, coterie of Rocka, they’re like a Rockefeller conspiracy
People are saying that there are 12 industrials
That they control the world
I mean, I don’t see that happening, but, the whole system is such that, you know, it’s, it’s
I guess what, uh
The, there’s a book by, uh, a, a, Thomas Kuhn, the Structure of Scientific Revolutions, and he talks about, normal science, and how science progresses, in terms of paradigm shifts
So, normal scientific medicine, works, uh, by big institutions doing, studies about combinations of drugs, after drug companies, invent mostly, modifications of existing drugs, and, less commonly, completely new drugs, and, uh, less commonly, different classes of drugs
So, you have a whole, you have a whole pipeline from a drug company, a whole, uh, uh, mechanism of testing, by the universities, funded by the pharmaceutical company, uh, all the pharmaceutical companies, and that, that just doesn’t lend itself, to one guy, sitting someplace in Houston, or wherever, and having a drug, put through that process
That just doesn’t happen
Burzynski is, so far as I can tell, the only person, to ever completed, a phase 2 trials on a drug he invented
I don’t think that’s ever happened, before, and I don’t think it’ll ever happen again

Ah, was it ’98, was it the chairman, uh

Kessler ?

Kessler
I saw, an interview he gave, press, a press conference where he was explaining about, being able to fast-track
The FDA trying to make it possible to fast-track, you know, drugs that have shown, you know, positive, rather than going through all of this sort of clinical trial, and there’s a guy in the, in the press conference who started asking questions about Burzynski

Right

and you could just see quite clearly he was very uncomfortable

Right

asking questions about, uh, about Dr. Burzynski
How do you think someone like him,
would view, someone like Dr. Burzynski ?

Not favorably
I think that, uh,

Do you think they must know ?
Do you think they must, even he, let’s just say, if he were on his own, he, he knows there’s something there
That he’s obviously got something

I,
I don’t know, uh
I think, that, the guys in conventional medicine, because Burzynski came from orthodox medicine
He was at Baylor
He was a researcher at Baylor
So, I think, they’re not going to Burzynski, is that, he didn’t go about it, the way, other physicians would have done it, other scientists would have done it
So normally what would happen, is, uh, uh, I mean, I think the critical, point in his story is that, when he was at Baylor, and his, uh, professor was supporting him, this Unger, left, you know, they had space for him
They wanted him to go in the Oncology, uh, Department, but, they wanted the patent, to his drug, and he wouldn’t do it
So, that would have been the more conventional approach
You give up the patent rights, you become part of the team, then some big institution, uh, uh, shepherds the drug through, and then they find some drug company support, who will split the patent with the university
So, had he done that, uh, you know, I think the drug woulda been approved by now, but, you know, it was his drug
He came to America with it, and he wasn’t going to give it all away
So, I mean, I just think that’s, you know, I mean and that’s, you know, I think he wasn’t expecting that kind of thing in America
Maybe in communist Poland, but not in America
So I think that really, you know, set him down the path of being a, a, an alternative health practitioner

And wha, wha, what was it like for you when, uh, winning, the case, in was it, 199, 3, 1998 ?

’97

1997

Well, you know, there wasn’t just one case
I mean, I mean, it was everyone
I mean, I analogize it to, like whack-a-mole, or whack-a-rat, you know
You have, like a rat come out of, of a hole, and you bang him, and one comes out of this hole, and all of a sudden you’ve got 2, and then 3, and, so, you know, during the early ’90’s, I mean, I mean, there were 3 grand juries, uh, we had the Medical Board action, which went to hearing in ’93
The Texas Department of Health sued him in ’92
Half a dozen insurance companies had sued, uh, uh, sued him for, for some, for Racketeering
Uh, Texas Air Quality Department went after him
I’m trying to think who else
So, all of this happened, over the course of 3, or 4, or 5 years, and it was just, continuous, and so, one agency would, would get active, and then, they get beaten down
Then somebody else would come, uh, come up, and surface, and indeed, I mean, you know, it, you know, some of them flat out said they were waiting to see what happened, with this oth, wha, what happened with this other agency, and they weren’t gonna do anything, and then when they got tired, they decided, that this new agency had to do something
So, I mean, that was flat out, what happened
So, yeah, I mean, it culminated in the criminal case, I suppose, but even there it was up and down
I mean, the judge ordered, uh, ordered, prohibited him from giving the treatment to anybody else, because the Texas Medical Board case, ultimately went against us, and then we had to go Congress, and Congress forced the FDA to put all his patients on clinical trials which made the Medical B, Board case moot, and then we won the criminal case
So, after we won the criminal case in, uh, ’97, things got quiet for a little bit
So that, that, that was good
I mean, it was quiet
I mean, relatively quiet, and then, uh, lately in the last couple years it’s been very active again

So the worst case scenario would have been
What would have been the worst case scenario ?

For when ?

And this, this
What could have happened this week if the case had gone ahead ?

Well, the worst case scenario would be, there would be a finding, that, that it’s a depart, it’s a departure from the standard of care to use, uh, off-label drugs, that haven’t been approved by the
FDA for an indicated use, and you can’t use the combination of the drugs until someone gives the stamp of approval saying that their safe and effective, which means, you know, you couldn’t, it couldn’t, you couldn’t give the treatment anymore to patients
So you have 100’s of patients that are on this multi-agent gene-targeted therapy, and ultimately that form of treatment is only available at the Burzynski Clinic
I mean, I don’t think that even clinical trials
Burzynski, depending on how you look at it, he’s a few years ahead of, of, uh, well, even the clinical trials
I mean, they’re some clinical trials now on different kinds of cancer where they’re doing 1, 2, or 3 agents
He’ll use 4 or 5, albeit, lesser dosages
So he’s treated 1,000’s of patients like that, but there’s no place else in the world where people can get, the treatment
So it’s kinda the same thing as back in the ’90’s
We have people on drugs, uh, which are unavailable, uh, and, only available through Burzynski
So, if he couldn’t give them, to people, then they wouldn’t get ’em, and, they’re terminal, and, they’re doing well
I mean, or they’re not going to do as well, or they’re going to die
So, it’s, I guess it, it’s sort of the same thing here, ah, uh, only, uh, the irony is all these drugs are, approved by the FDA, and most cancer patients get off-label, uh, drugs
Drugs off-label
So that’s, very common in cancer
It’s just that not common with the drug used on these patients, and in the combinations used

So, this finally
Whe, when you’ve, uh, won these cases, I mean, there must be, it must be good, right ?
It must be good feeling

I had a good feeling last week
I mean, I mean, you know, or I’ve been working non-stop, for months, every day
I mean, there’s no day off in this kind of stuff
It’s just constant
It’s just, his war
There’s always something to do, and then I’m a solo practitioner
So, when the judge cut the heart of the Board’s case out, I’ve been telling the Board, that they can’t, that they have no basis to, to, to bring charges against him, for several years, since 2010
, 2009, and they’re not listening, and, and, I was pretty sure that once you had a judge look at the case, they would, rule in our favor, you know, but the problem is the Board is, like a law unto themselves, and they think they can do anything, and, uh, they just changed the law, in September
So actually, the Board has no recourse
They, they used to be able to change findings of facts, and conclusions of law, but as of September, 2011, they can no longer do so
So, if the, judges’ ruling s, uh, stands, as I think they will, their only remedy is going to be to appeal to a State District Court, and they’re not used to that, because they, like exercising, uh, complete authority
So, they’re in a new position, and I’m sure this is the 1st case, that they’ve ever, not gotten what they want to, from, from a judge, administrative law judge, and not being able to correct it
So, I mean, that, this is a good ti, completely new experience for the Board, and I feel bad for them (both: laughing)

You, you, you do
As a Board they all sit down, and as a group of people, and talk about Dr. Burzynski, and, and, and work out how they’re gonna bring him down, and then ?

Well, that’s more the conspiracy
I, I, I, I think that, some of the Board members, may know of him
He, but, but, but like I say, he’s appeared in front of these informal settlement conferences, and basically, individually they, I mean, exonerate him, of, of the main charges, but I, I, I think that, you know, when we talk about the Board, the Board other than these a, acting informal settlement conferences, where you have one Board member, and one member of some district disciplinary review committee, we’re not really talking about the Board members, these doctors, and lay members of the Board, we’re talking about the Board staff, and that’s the lawyers and administrators of the Board, and I think, you know, I don’t know
I have some, uh, uh, they need to clean house
I mean, they’re getting some very, very bad legal advice, and I, I just think the legal advice at the top, is, is, is horrible, and, and they need to make some dramatic changes, and I think it would be better for the people of Texas if they, just did some house cleaning with the administrative staff there

And what do you think about the way that, uh, Dr. Burzynski’s been , what’s the word, in England, he’s got a very bad press there

(Alright ?)

and, um, why do you think that is ?

Uh, why, well, I mean, look
I mean, I think, people have opinions
They’re,
they have the right to express opinions
I mean, I think, uh, some of his agents did some things that I think, were not wise, in retrospect
I mean

Mhmm

Uh,

The stuff with the, this kid, this blogger

Yes

(?)

And I think that, uh
I think you have to be very careful, about what you tell people that are expressing opinions, and, you know, I mean, I, I, I think, you know, I think there’s a reason why, lawyers get involved in these cases, and should be involved, and I think what happens is, you know, I think there was a, you know, a well meaning, individual, who just went too far, and I think stirred things up unnecessarily so
You know, I mean, I think someone who had some legal training, acting on Burzynski’s behalf, might not have made some of the, you know, just faux pas that were made
So, I mean, that stirred, some things up, and I think

(?) stirred something up that was already there ?
You know, ’cause, I know, I’ve spoken to so many people in the U.K., and, uh, and you find very few people that have anything positive to say
In fact, a friend of mine who’s a famous doctor on television, when I was here, he was on British television with a little girl, and her father, who were trying to, uh, raise money to, um, come over here and, um, in fact, they couldn’t come anywhere, come, they couldn’t come anyway, because, the, uh, FDA said that this type of brain tumor, she couldn’t be treated anyway
But this doctor, who’s a friend of mine said, uh, Dr. Burzynski is, you know, he’s a medical pioneer
He’s, uh, uh, he said that and then literally, for 2 months, non-stop, I think especially on Twitter, they said that he never should have said this, and the guy is a quack, and he’s a, he’s a fraud, and

So your, your friend got in trouble for saying that he’s a pioneer ?

He didn’t get in trouble, but I mean he got a lot of bad press, for speaking on television with this child next to him, saying that, Dr. Burzynski was, you know, a pioneer, and pioneers often have a hard time, and

Right, right

And, you know, you look at Twitter, uh, you probably don’t
You could be (laugh) and you just see, it’s probably, probably the only, 30, hard, hard core people, who spend, all of their time, trying to

Yeah, I think that’s right
I think it’s a very small group, of people, that are making pretend it’s a big movement
I mean, we’ve looked, at some of the traffic
We’ve analyzed some of the traffic
I don’t even think it’s 30
I think it’s more like, 3, or 4, or 5, that are creating things, and then someone had some friend who’s an actor, who has, you know, 3 million followers, and all
So it’s really a very small group of people, but historically, medical doctors who have stood up for Burzynski, have had negative consequences
We had, someone from the National Cancer Institute, NIH testify, this Nick Patronas, and he got in a lot of trouble for doing that
So, you know, it’s not, it’s, unfortunately, you know, speaking up for Burzynski can have, uh, negative career consequences, or, or just some bad P.R., but that’s, part of being a pioneer
It doesn’t mean that, uh, Burz, I mean, if anything, I mean, it shows, it shows that’s like the medical mafia
Yeah
So, that’s what I call, the church of medical orthodoxy
So, that’s what I call
So

Well I, I think it’s gonna be so interesting when I get this film broadcasted, to see what kind of reaction we get
It, it’s just a story I felt I had to (?)

Where are, where are you going to try and get it ?

I’m going to try and get it
I know people at the BBC

Right

I’ve worked in television
So I’m going to try

Oh really, (?)

I’m gonna try those avenues, but you know what ?
Even if it doesn’t

You have cable
You have some kind of public access ?

Yeah
I’ve, I’ve worked in television for years
So I’ve, I have a very good stab at getting it out there, but if I don’t, I’ll get it broadcasted on the Internet

Oh sure
You do, do a YouTube or something, or do what Merola did as a documentary

(?)

That’s had an amazing impact

Yeah
He’s making a sequel
Eric was just over in England

Oh really ?

I looked after him when he came over

Yeah
He wanted to talk to some of the patients and doctors

Eric, I said, ah, you know, so, we’ll see
But listen, I really appreciate the opportunity to ah

Ok, no problem

really, to be able to talk to you
======================================

======================================
http://www.richardjaffe.com
======================================

United States Food and Drug Administration (FDA): September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

20131021-200529.jpg

20131021-200553.jpg
[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
======================================
BB – Bob Blaskiewicz
——————————————————————
DJT – Didymus Judas Thomas
======================================
0:47:00
——————————————————————
BB“Ummm, o-kay”

“Uh, I want to turn this over to the people who are watching”

“Um, I want to give them a a chance to address you as well”

“Uhmmm, hi everyone”
——————————————————————
0:48:00
——————————————————————
0:53:00
——————————————————————
BB“A every time that I and and and and, and David (James @StortSkeptic the Skeptic Canary) points this out, that um, you you know you’re not going to speculate about the the FDA but then at every turn you’re invoking the FDA as being obstructionist
——————————————————————
0:54:02
——————————————————————
BB“I, I just find that to be contradictory and and self-defeating
======================================
DJT – Bob, exactly where did I invoke “the FDA as being obstructionist” ?
======================================
1:02:00
——————————————————————
BB“Um, it’s it’s it’s not the FDA’s, but you understand it’s not the FDA’s job to tell someone that their drug doesn’t work
——————————————————————
1:03:00
——————————————————————
BB“it’s it’s it’s up to Burzynski

“It’s up to Burzynski to show that his drug does work”

“And it’s always been his burden of proof

“He’s the one that’s been claiming this miracle cancer cure, forever”
======================================
DJT – Bob, Burzynski showed and proved what he needed to prove to the FDA in order to do phase 2 clinical trials, 9/3/2004 – FDA granted “orphan drug designation” (“ODD”) for Antineoplastons (A10 & AS2-1 Antineoplaston) for treatment of patients with brain stem glioma, .10/30/2008 – FDA granted “orphan drug designation” (“ODD”) for Antineoplastons (A10 and AS2-1 Antineoplaston) for treatment of gliomas, and FDA approved phase 3 [1-2]

Oh, and Bob, exactly when did Burzynski 1st claim “this miracle cancer cure” ?
======================================
1:04:02
——————————————————————
BB“Um, that we’d love to see, however we can’t see, however we can’t see it because of proti protri proprietary uh protections that the FDA is giving to Burzynski, right ?”

They’re not sharing his trial designs because they are his trial designs, right ?”

“That the makeup of his drug that he’s distributing are his, uh design, and his intellectual property

“So the FDA is protecting him, uh from outside scrutiny
======================================
DJT – Bob, you make it sound like it’s part of some grand “conspiracy” between Burzynski and the FDA to keep information from “The Skeptics™” [3]
——————————————————————
21CFR601

Subpart F–Confidentiality of Information

Sec. 601.50

Confidentiality of data and information in an investigational new drug notice for a biological product

(a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged
======================================
BB“While you may imagine that that, that that the FDA is is somehow antagonistic toward him

“They’ve given him every opportunity, over 60 opportunities to prove himself worth uh their confidence and hasn’t
======================================
DJT – Bob, that certainly explains the 9/3/2004 and .10/30/2008 ODD’s and phase 3 clinical trial approvals by the FDA – NOT [1-2]
======================================
1:05:00
——————————————————————
1:42:00
——————————————————————
BB“I don’t, the thing is though that, that that’s a inver, shifting the burden of proof off of Burzynski”

“Burzynski has to prove them wrong, has to prove him right”

“The FDA is not there to say this doesn’t work”
======================================
DJT – Bob, who initiated and put into place the clinical trial hold ?

Burzynski ?

FDA ?

Both ?
======================================
1:43:30
——————————————————————
BB“So, I mean, honestly, um, saying “Well, when the F, FDA tells you that it doesn’t work, the FDA’s never gonna say that because that’s not their job
——————————————————————
1:44:00
——————————————————————
BB“That’s not an option, because they’re never gonna do it

“They relinquish, a lot of authority, over to Burzynski, and his Institutional Review Board, which, I would mention, has failed 3 reviews in a row”
======================================
Bob, where are the “final reports” for those “3 reviews” ?
======================================
BB“Right ?”

“It is Burzynski’s job to be convincing”

“It is not our uh, uh, it it it he hasn’t produced in decades

“In decades”

“In hundreds and hundreds of patients, who’ve payed to be on this”

“Hell, we’d we’d we’d like a prelim, well when you’re talking about something that is so difficult as brainstem glioma, that type of thing gets, really does in the publishing stream get fast-tracked there”
======================================
DJT – Bob, Burzynski has provided numerous phase 2 clinical trial preliminary reports, which our #fave oncologist has chosen to ignore [4]
======================================
BB“they test it”

“Yeah, and they they they want uh, that was evidence of fast-tracking is what, that rejection was uh e was very quickly
======================================
DJT – Bob, have you checked The Lancet Oncology [5] to see what was so much more important than Burzynski’s “phase 2 clinical trial Progression-Free Survival (PFS) and Overall Survival (OS) re patients 8 – 16 years after diagnosis, results” [6] and the Japanese antineoplaston study ? [7]
======================================
BB“So, how long will it be before Burzynski doesn’t publish, that you decide that uh perhaps he’s he‘s, doesn’t have the goods ?

“Um, so, uh, uh again, the FDA is not the arbiter of this

“It’s ultimately Burzynski”

“You’ve been speculating about what the FDA’s motivation are like crazy”

“Why not speculate about Burzynski a little bit”
======================================
DJT – Well, how have I been speculating ?
======================================
1:46:00
——————————————————————
BB“Well actually I’m not even asking you to speculate about Burzynski, I’m only asking you to tell me, how long would it take, uh how, for him to go unpublished like this, um, for this long, before you would doubt it ?”
======================================
DJT – Note how, above, without proving it, Bob claimed “at every turn you’re invoking the FDA as being obstructionist”, and now, directly above, again, without proving it, Bob claims “You’ve been speculating about what the FDA’s motivation are like crazy”
——————————————————————
DJT – what the journals keep saying, in response
======================================
BB“What ?”
======================================
DJT – You know, are they going to give The Lancet response, like they did in 2 hours and such, saying, “Well, we think your message would be best heard elsewhere,” or they gonna gonna give The Lancet response of, “Well, we don’t have room in our publication this time, well, because we’re full up, so, try and pick another place” ?
======================================
BB“But these but but but that doesn’t have any bearing on

“That doesn’t”

“Oh I’m not asking you how long, how long, would it take you for you to start doubting whether or not he has the goods ?

“How long would it take ?”

“It’s a it’s a it’s a question that should be answered by a number uh uh months ?

“Years ?”

“How long ?”

“It’s been 15 years already”
======================================
DJT – Well, you like to jump up and down with the “15 year” quote, but then again I always get back to, Hey, it’s when, when the report, when the clinical trial is done
——————————————————————
1:47:06
——————————————————————
DJT – Not that he’s been practicing medicine medicine for 36 years, or whatever, it’s when the clin, clinical trial was done
======================================
BB – “I could push it back to 36 years”

“He hasn’t shown that it works for 36 years”

“I can do that”

“I was being nice”
======================================
DJT – Note how Bob acts like he’s been hit with “The Stupid Stick”

If he wants to go back “36 years”, I can refer back to 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI), sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network, which advised, in part:

It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate” [8]
——————————————————————
DJT – The FDA A believes there is evidence of efficacy
======================================
BB – “Perhaps based on bad phase 2”
======================================
DJT – Well, we don’t know that

We don’t have the Freedom of Information Act information
——————————————————————
DJT – Remember, Bob is the one who told me during the 9/28/2013 Google+ Burzynski Discussion Hangout:

“You’re you’re you’re assuming”

“You’re you’re you’re assuming that”

“You’re assuming that”

“Um, I’m not assuming that”

“There is a correct answer here”

“You don’t know”

“You don’t know”

“You need to look into it”

“Alright ?”

“Before you dismiss it you have to look into it”

“Everytime somebody throws uh uh something to me,
I have to look into it”

“That’s just, it’s my responsibility as a reader”

“T t and what I would honestly expect and hope, is that you would be honest about this, to yourself, and and and that’s the thing we don’t, we often don’t realize that we’re not being honest with ourself

“I try to fight against it, constantly”

Bob just ASSUMED that the FDA approved phase 3 clinical trials for Burzynski “Perhaps based on bad phase 2”, but tells me NOT to ASSUME ?
======================================
BB“He withdrew”

“He withdrew the the phase 3 clinical trial”

“I that before recruiting,
although I’ve seen lots of people say they were on a phase 3 clinical trial

“I wonder how that happened”
======================================
DJT – Well, we know what happened in the movie because Eric particularly covered that when they tried to get what, what, was it 200 or 300 something institutions to take on a phase 3, and they refused
======================================
1:48:01
——————————————————————
BB“Uh did do do you think that if they thought that he was a real doctor that they all would have refused like that ?
======================================
DJT – Well, Eric gave the reasons that they said they would not take a particular uh phase 3

And so using that excuse that you you just gave there, I’m not even gonna buy that one, because that’s not one of the reasons
——————————————————————
Note how Bob pulls out the old “if they thought that he was a real doctor” line ?

Is Bob now claiming that Burzynski is NOT even a “real doctor” ?
======================================
BB – “He’s changed things”
======================================
DJT – Eric said they gave
======================================
BB“That The Lancet is a top-tier journal like New England Journal of Medicine

“It’s basically be, besieged by uh 100′s of people submitting their, their, their reports”

“Um, it’s just, you know, let’s say he, someone has such a thin publishing record as Burzynski does, do you think that it’s likely that he will ever get in a top-tier journal ?

“What about the the Public Library of Science?”

“It’s not the only journal there”

“What about BMC Cancer ?”

“There’s lots of places that he can go”
======================================
DJT – We’ll I’m
======================================
BB“Um, and he doesn’t seem to to have evailed himself of that, as far as I can tell

“And I would know because he’d get rejected, or he’d be crowing, you know”
——————————————————————
1:49:02
——————————————————————
BB – “Either way, he’s gonna tell us what happens”

He told us what happened with The Lancet, you know”

“I don’t have any evidence that suggests to me that he’s even trying”
======================================
Note how Bob refers to Burzynski’s numerous publications as “such a thin publishing record”

Bob, do I need to count all of these for you ? [9]
——————————————————————
DJT – Well, I’m, I’m sure that they’re going to keep you appraised just like they have in the past, just like Eric has done in the past

So

I mean, we’ll see what happens with the Japanese study [7]
======================================
BB – “So let’s go back to this”

“How long will it take ?”

“How long will it take before you, the Japanese study’s interesting too because we should be able to find that in the Japanese science databases, and we can find, we can’t find it at all

“We can’t find it anywhere”

“And, and those are in English, so it’s not a language problem

“We can’t find that anywhere”

“We’ve asked”

“We asked Rick Schiff, for, for that study”

“And, and it hasn’t come to us

“He is now I believe on the Board of Directors, over there”
——————————————————————
1:50:00
——————————————————————
BB – “He should have access to this”

“We can’t get it”
======================================
Bob, did you ask:

1. Annals of Oncology 2010;21:viii221 ?

2. European Society for Medical Oncology (ESMO), Colorectal cancer, Abstract: 3558, May 17, 2010 ?

3. Colorectal Cancer Association of Canada, COLORECTAL CANCER RESEARCH, Month Ending June 19, 2009
11. Antineoplaston Therapy Doubles 5-Year Survival Rate Following Curative Resection of Hepatic Mets (May 27/09) pg. 5 of 20 ?

4. Kurume University School of Medicine (Japan) Department of Surgery ?

5. Hideaki Tsuda ? [7]
======================================
BB – “How how long will it take before you recognize that, nothing is forthcoming ?”

“How long would that take ?”
======================================
DJT – Well that’s like me asking “How long is it going to take for y’all’s, y’all‘s Skeptics to respond to my questions ?”

Because y’all haven’t been forthcoming
======================================
BB“Well, I mean, were talking about a blog here

“We’re talking about life”

“No, we’re talking about a blogger’s feelings in that case

“In in this case we’re talking about, 1,000′s of patients, over the course of of of generations, you know”

“This is important stuff”

“This is not eh eh equating what’s happening to to patients with what’s happening to you is is completely off-kilter as far as I can tell

“It’s nothing”

“It’s nothing like you not getting to say something on my web-site”

“You know”

“This is they they have thrown in with Burzynski, and they’ve trusted him, and he’s produced nothing

“Nothing of substance”
——————————————————————
1:51:00
——————————————————————
BB – “Nothing that that has made all of that um, uh, n nothing th th th that uh his peers would take seriously”

“The other thing that that that strikes me now is that, you know, you you you you keep saying that, well Eric is going to to share things with you”

“Does it ever concern you eh uh eh occur to you that Eric might not be reliable ?”
======================================
Bob, do you want to have a contest to determine which of you is more “reliable” ?
======================================
DJT – Well, he gave you The Lancet information and he posted the e-mail in the movie, and Josephine Jones posted a copy of it [6]
======================================
BB“He then, and then he”

“And then he he, you know, the the the the dialogue that sprung up around that was, well see, he’s never going to get to get published”

“Well you’re just setting yourself up for wish fulfillment”

“You want him to be, persecuted, so you are ecstatic when he doesn’t get to publish, which is unfortunate for all the cancer patients, who really thought that one day, all the studies were going to be published”
——————————————————————
1:52:00
======================================
DJT – Well, y’all are free to, you know, claim that all you want, because I don’t always agree with Eric, and uh, he’s free to express his opinion
======================================
BB – “Where has Eric been wrong ?”
======================================
DJT – Well I don’t necessarily believe, what Eric would say about, you know, The Lancet that refused to publish the 2nd one, for the reasons he stated, and which y’all have commented on, including Gorski

You know, I don’t necessarily agree with that

I am more agreeable to y’all, saying that, you know, they’re busy, they’ve got other things to do, but I’m kind of still laughing at their 1st response which he showed in the movie about how they felt about, you know his results would be better in some other publication

I thought that was kind of a ridiculous response to give someone
======================================
BB“It’s it’s it’s it’s a form letter

“You know”

“They’re just saying, “No thanks””

““Thanks, but no thanks” is what they were saying, in the most generic way possible”

“Like I said, they’re besieged by researchers trying to publish
——————————————————————
1:53:05
======================================
DJT – Well you would think that if its a form letter they would use the same form that they used the 2nd time

You know, they didn’t use the same wording that they used the 1st time

I would have think that, you know, their 2nd comment
======================================
BB“So, so, possibly”

“So possibly what you are saying is that they in fact have read it, and after having read it they’ve rejected it”

“Is that what you’re saying ?”

“Because that’s what peer-review is”
======================================
DJT – Nah, I’m not saying that they did that all

I’m just sayin’, you know, that they gave, 2 different responses, and I would think that the 2nd one they gave
======================================
BB – “Do you know it was the same editor, that it came from the same desk ?”

“You can’t make that assumption that that the form letter will be the same form letter every time”

“I mean you just can’t

“I mean in in some ways we have a lot of non-information that you’re filling in, with what you expect, as as opposed to what’s actually really there, and I I I just think you’re putting too much uh stock in one uh, uh, in in in in this uh the publication kerfuffle
——————————————————————
1:54:16
——————————————————————
BB“Um”
======================================
DJT – Well I find it funny, something along the lines of, you know, “We believe your message would be received better elsewhere, you know

I don’t see that as a normal response, a scientific publication would send to someone trying to publish something

I mean, to me that sounds, like, if you’re doing that, and you’re The Lancet Oncology, maybe you need to set some different procedures in place, ‘cuz you would think that with such a great scientific peer-reviewed magazine, that they would have structured things in as far as how they do their operations
======================================
BB“Well, not necessarily

“I’ve been in any # of professional groups where the organization is just not optimal, and publications certainly th there are all sorts of pressures from all sorts of different places”
——————————————————————
1:55:08
——————————————————————
BB“I I have no problems whatsoever with seeing that this might not be completely uh um uh streamlining uniform processes as possible

“The fact that it’s not uniform, doesn’t have anything to do with Burzynski not publishing, not producing good data”

“Not just going to a, you know, god, even if, even if, let’s put it this way, even if he went to a pay to play type publication where you have to pay in order to get your manuscript accepted; and he has the money to do this, it wouldn’t take that much, and he were to put out a good protocol, and he were to show us his data, and he would make his, his his stuff accessible to us, then we could validate it, then we could look at it and say, “Yeah, this is good,” or “No, this is the problem, you have to go back and you have to fix this””

“Right ?”

“So we really, every time we talk about the letter that he got, yeah that doesn’t have much to do with anything, really”
——————————————————————
1:56:02
——————————————————————
BB – “We wanna see the frickin’ data”

“And if he had a cure for some cancers that otherwise don’t have reliable treatments, he has an obligation to get that out there anyway he can

“And if if peer-review doesn’t, you know, play a, if peer-review can’t do it, you know, isn’t fast enough for him, then he should take it to the web, and he should send copies out to every pediatric, uh, you know, oncologist that there is

“That’s the way to do it”
======================================
DJT – Well, I’m sure, I’m sure Gorski would have a comment about that, as he’s commented previously about how he thinks uh Burzynskishould publish
======================================
1:57:10
——————————————————————
BB“It’s the, it’s the data itself

“If if Burzynski is is, is confident in his data, he will put it out there

“Right ?”

“One way or the other”
======================================
DJT – Like I said before

Like I said before on my blog, you know, even if Burzynski publishes his phase 2 information, Gorski can just jump up and down and say, “Well, that just shows evidence of efficacy, you know, it’s not phase 3,
so it doesn’t really prove it”

——————————————————————
1:58:04
——————————————————————
DJT – So then he can go on, you know, for however many years he wants to
======================================
2:01:00
——————————————————————
BB“Um, almost no treatment goes out without trials

“Massive amounts of data are required”
======================================
Bob, do you think that’s the 2.5 million pages of clinical trial data that Fabio said Burzynski sent to the FDA ? [10]
======================================
2:02:00
——————————————————————
BB“Uh, in in in that sense, you know, uh all the the the, you know, kind of back-peddling and and and trying to defend him is is going to, not going to help his case at all
======================================
Bob, exactly where did I exhibit any “kind of back-peddling” ?
======================================
2:03:03
——————————————————————
BB
“You are, honestly as far as I can tell you are doing the um, you know, you’re you’re ah throwing up uh, uh, uh, you’re giving me another uh invisible dragon in the garage, um”
======================================
DJT – Well y’all, y’all can call things what y’all want

I mean, y’all can give these, fallacy arguments and all that garbage that y’all like, because that’s what y’all like to talk about instead of dealing with the issues

I mean, Gorski doesn’t want to deal with the issues
======================================
2:04:11
——————————————————————
BB“Okay, so”

“What you’re telling me is that you trust the FDA to to be able to tell you when he’s not doing, good science, but also that you don’t trust the FDA”

“Do you see an inherent conflict there ?”
======================================
DJT – How did I say I, I didn’t trust them ?
======================================
BB“Well, when I, whenever I would ask about, like, why would these trials aren’t happening uh and, you know, you say well the the FDA’s arranged it

“The FDA’s in control”

“They sign off on these things”

“But they’re they’re they’re they’re at the same that they’re, they’re trustworthy they’re also not trustworthy depending on what you need for the particular argument at the time
——————————————————————
2:05:12
——————————————————————
BB – “You’re suggesting that they’re untrustworthy”
======================================
DJT – No, I’m just sayin’ that I’ve raised questions and none of The Skeptics wanna to uh talk about ‘em [11]
======================================
BB“Do you know that the FDA pulled out of the prosecution ?”

“Did you know that the FDA pulled out of the prosecution um of his criminal case, because they were backing a researcher ?”
======================================
Bob, would that “researcher” be Dvorit D. Samid, who was in Burzynski: Cancer is Serious Business (Part I) ?
——————————————————————
DJT – Well, we know a lot stuff they did, but that still doesn’t impress me that they pulled out of the prosecution

I mean
======================================
BB“Yeah, the the the it wasn’t the FDA who was pressing charges, it was a Federal prosecutor
======================================
DJT – Right
======================================
BB“Right”

“And and, they declined to provide information that the prosecution needed

“That’s important”

“That that that’s really important

“That he has been given the benefit of the doubt, and he has come up wanting, for decades now”
======================================
DJT – Well I find it interesting a lot of this uh, a lot of these letters that were provided between, you know, the government and Burzynski, when the uh phase 2 study was going on, at the behest of the NCI

You know, anybody who reads that stuff knows, that when you just ignore the person that’s been doing, do treating their patients for 20 something years, or close to 20 years, and you change the protocol without his approval, and you don’t use the drugs in the manner that he knows works
======================================
2:10:15
——————————————————————
BB“One of the interesting things about Doubting Thomas that I think you should definitely consider for yourself, is that at some point, when faced with the real opportunity to prove or disprove his assertions, he doubted himself”

“And that’s important”

“And that’s where you’re falling short in the analogy”
======================================
DJT – Well, I think The Skeptics, Skeptics are falling short because, you know, they don’t own up to
======================================
BB – “I’ve laid out exactly what it would take for me to turn on a fucking dime”

“I have, I have made it abundantly clear what I need

“Gorski has made it abundantly clear”

“Everybody else, Guy, and David, and Josephine Jones, uh, the Morgans, all of them have made it abundantly clear, what it would take to change our minds, and you’ve never done that”
——————————————————————
2:11:02
——————————————————————
BB“And even in this, this was an opportunity to do that

“To come up with a basis for understanding, where it’s like, you know what, If we can show this, you know, if we can show a this guy, that, that, there, that his standards are not being met, then, you know, we could possibly have some sort of ongoing dialogue after this”
======================================
DJT – So I can say that since the Mayo Clinic (Correction: M.D. Anderson) finished their study in 2006, and it took them until 2013, to actually publish it, then I can say, well, Burzynski finished his in 2009, which was 3 years later, which would give Burzynski until 2016
======================================
BB“Why wasn’t that study”
======================================
DJT – for me to make up my mind (laughing)
======================================
BB“Why wasn’t that, that that that, still . . again, it it doesn’t seem really to to approach the the the, main question here

“You know, um . . what are the standards that you have that it isn’t, what are your standards to show that it isn’t efficacious ?
——————————————————————
2:12:05
======================================
DJT – Well I can say, well I’m going to have to wait, the same amount of time I had to wait for Mayo (Correction: M.D. Anderson) to publish their study; which was from 2006 to 2013
======================================
BB“Why was the Mayo”

“Why was the Mayo (Correction: M.D. Anderson) study delayed ?”
======================================
Note how Bob ASSUMES that the publishing of the final results of the M.D. Anderson study were delayed
——————————————————————
DJT – How do you know it was delayed ?
======================================
BB“Well you said you had so many years before you finish it and go in”
======================================
DJT – I mean, has anybody
======================================
BB“Why, why did it take so long ?
======================================
DJT – done a review of when a clinical trial is studied, and completed, and how long it took the people to publish it ?

You know

If they could point to me a study that’s done that, and say, well here’s the high end, here’s the low end of the spectrum, here’s the middle
======================================
BB“I have something for you, okay ?”

“Send me that”

“Could you send me that study the way that it was published because um, just just send me the final study, um, to my e-mail address”
======================================
DJT – Sure
======================================
BB“Um, because, I can ask that question of those researchers, why was this study in this time, and what happened in-between”
——————————————————————
2:13:03
——————————————————————
BB – “Why did it take so long for it, for it to come out”
======================================
DJT – Sure, but that’s not gonna, you know like, answer an overall question of, you know, somebody did a comparative study of all clinical trials, and, when they were finished, and at, and when the study was actually published afterwards

You know, that’s only gonna be one, particular clinical study
======================================
BB“Right”

“Um, but it it would, perhaps, answer the question; because you’re using it as an example on the basis of which to dismiss criticism, whether or not, uh, it is the standard, and therefor you’re allowed to accept that Burzynski hasn’t published until 2016, or, um, it’s an anomaly, which is also a possibility, that most stuff comes out more quickly
======================================
DJT – Well, we know that the Declaration of Helsinki doesn’t even give a standard saying, You must publish within x amount of years,” you know ?

So, I’ve yet to find a Skeptic who posted something that said, “Here are the standards, published here”
======================================
2:14:07
——————————————————————
BB“I I, yeah, the other thing that David James points out is you know, why 2016 when he’s had 36 years already ?
======================================
DJT – Again, we get back to, when the clinical trial is finished, not when Burzynski started
======================================
BB“Treating people”
======================================
DJT – I mean, you would expect to find a results to be published after, the final results are in
======================================
BB – “You would expect the Burzynski Patient Group to be a lot bigger after 36 years, and in fact is
======================================
DJT – You would expect some people would want to have confidentiality, and maybe not want to be included
======================================
BB – “So, if you’re unsure about this stuff, if you’re unsure about the the time to publication, why are you defending it so hard, other than saying, “I don’t know, I really need to”
======================================
DJT – Why am I unsure ?
======================================
BB“Uh about the
======================================
DJT – (laughing) I just gave you an example
======================================
BB“The reasons, the reasons for which that he’s, no, why are you defending him so hard, when you’re unsure ?
——————————————————————
2:15:02
======================================
DJT – Oh, who said I was unsure ?

I just gave you an example
——————————————————————
Note how Bob ASSUMES that I’m “unsure” when I had the same answer since 0:32:07 [12]

Bob, who approves “Accelerated Approval” ?

1. FDA ?

2. A peer-reviewed scientific journal ?

3. The Skeptics™ ?

Bob, It’s your unlucky [13]
======================================
REFERENCES:
======================================
[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/04/september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[2] – FDA grants Orphan Drug Designation (ODD) for A10 and AS2-1:
——————————————————————
http://www.burzynskiresearch.com/assets/PressRelease_12022008_BZYR(2).pdf
——————————————————————
josephinejones (@_JosephineJones), D Nile ist http://josephinejones.wordpress.com/2013/01/23/happy-birthday-dr-burzynski-and-goodbye-antineoplastons/comment-page-1/#comment-8921
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/23/josephinejones-_josephinejones-d-nile-ist-httpjosephinejones-wordpress-com20130123happy-birthday-dr-burzynski-and-goodbye-antineoplastonscomment-page-1comment-8921/
======================================
[3] – The Skeptics @Majikthyse reveals madjik research skilz:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/26/the-skeptics-majikthyse-reveals-madjik-research-skilz/
======================================
[4] – Critiquing David H. Gorski, MD, PhD, FACS http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
======================================
[5] – The Lancet Oncology
——————————————————————
http://www.thelancet.com/journals/lanonc/onlinefirst
——————————————————————
http://www.thelancet.com/journals/lanonc/issue/current
======================================
[6] – FINALLY, one of “The Skeptics™” has the “Balls” to do what even Dr. David H. “Orac” Gorski would NOT do:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/12/finally-one-of-the-skeptics-has-the-balls-to-do-what-even-dr-david-h-orac-gorski-would-not-do/
======================================
[7] – Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study/
======================================
[8] – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
======================================
[9] – Stanislaw Rajmund Burzynski Publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/16/stanislaw-rajmund-burzynski-publications/
======================================
[10] – Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
[11] – QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/23/questions-the-critics-and-cynics-the-skeptics-do-not-want-to-answer/
======================================
[12] – The Biggest Loser: “The Skeptics™” Guy Chapman (guychapman @vGuyUK @SceptiGuy) http://www.chapmancentral.co.uk/blahg/ – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/the-biggest-loser-the-skeptics-guy-chapman-guychapman-vguyuk-sceptiguy-httpwww-chapmancentral-co-ukblahg-september-28-2013-the-skeptics/
======================================
[13] – Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/
======================================

Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”

[1] – 1995 (10/1995) – The National Cancer Institute (NCI) at the National Institutes of Health (NIH) issued its CancerNet “fact sheet”

The problem is that there were “factual issues” with the CancerNet “fact sheet”
——————————————————————
[0] – All Americans are “presumed to know the law:”

Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”
——————————————————————
Below is how the “fact sheet” looked before and after the “fact sheet’s” “factual issues” were fixed
======================================
BOLD = changes
======================================
[1] – 10/1995 – CancerNet from the National Cancer Institute

CANCER FACTS

National Cancer Institute
National Institutes of Health
——————————————————————
[2] – 5/20/2002 – CANCER FACTS

National Cancer Institute • National Institutes of Health Department of Health and Human Services
======================================
[1] – 10/1995 – National Cancer Institute-Sponsored Clinical Trials of Antineoplastons

Antineoplastons are a group of compounds originally isolated from urine by Dr. Stanislaw Burzynski, who claims that they inhibit cancer cell growth
——————————————————————
[2] – 5/20/2002 – Antineoplastons

Antineoplastons are a group of synthetic compounds that were originally isolated from human blood and urine by Stanislaw Burzynski, M.D., Ph.D., in Houston, Texas
======================================
[1] – 10/1995 – Dr. Burzynski has used these compounds to treat patients with various cancers
——————————————————————
[2] – 5/20/2002 – Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers
======================================
[1] – 10/1995 – In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical responses in a group of patients treated at Dr. Burzynski’s Houston facility
——————————————————————
[2] – 5/20/2002 – In 1991, the National Cancer Institute (NCI) conducted a review to evaluate the clinical responses in a group of patients treated with antineoplastons at the Burzynski Research Institute in Houston
======================================
[1] – 10/1995 – For this review, Dr. Burzynski selected from his entire clinical experience seven brain tumor patients whom he felt had a beneficial effect from antineoplastons
——————————————————————
[2] – 5/20/2002 – The medical records of seven brain tumor patients who were thought to have benefited from treatment with antineoplastons were reviewed by NCI
——————————————————————
[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[A] – Gives the reader the impression that in his entire clinical experience he had only 7 patients who benefitted from antineoplaston treatment

[B] – He prepared not 7, but dozens of cases for the NCI reviewers

[C] – The reviewers were able to spend just one day at the clinic–enough time to review only 7 cases

(averaging one case per hour)
======================================
[1] – 10/1995 – This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available patient information, and included only cases selected by Dr. Burzynski
——————————————————————
[2] – 5/20/2002 – This did not constitute a clinical trial but, rather, was a retrospective review of medical records, called a “best case series.”
——————————————————————
[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[D] – The patient medical records that NCI scientists reviewed were exhaustive and did contain “all available patient information.”

[E] – Michael Hawkins, M.D., leader of the site visit team, specifically complimented him on how complete and well-organized they were

[F] – 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI) sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network:, which advised, in part:

“Seven patient cases were presented at the site visit and the records, pathology slides and scans documenting response were reviewed”
======================================
[1] – 10/1995 – The reviewers of this series determined that there was presumptive evidence of antitumor activity and NCI then proposed that Phase II clinical trials be conducted to evaluate more definitively the response rate and toxicity of antineoplastons in adult patients with refractory brain tumors
——————————————————————
[2] – 5/20/2002 – The reviewers of this series found evidence of antitumor activity, and NCI proposed that formal clinical trials be conducted to further evaluate the response rate and toxicity of antineoplastons in adults with advanced brain tumors
——————————————————————
[F] – 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI)
sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network:, which advised, in part:

“It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate”

[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[G] – The statement of the NCI scientists who actually reviewed patient records was quite different from the above

Their report stated:

“The site visit team determined that antitumor activity was documented in the best case series and that the conduct of Phase II trials was indicated to determine the response rate

(minutes of Decision Network committee meeting)
======================================
[1] – 10/1995 – The decision by NCI to sponsor the study of an agent in a clinical trial does not indicate that the agent is or will be useful in the treatment of cancer patients, only that it merits further evaluation in a research setting

Efforts to study antineoplastons in a scientifically rigorous manner have required complex interactions among NCI, clinical investigators, the National Institutes of Health’s (NIH) Office of Alternative Medicine, the Food and Drug Administration, advocates from the alternative medicine community, and Dr. Burzynski
======================================
[1] – 10/1995 – Two protocols were developed by the participating Cancer Center investigators with extensive review and input from NCI and Dr. Burzynski
——————————————————————
[2] – 5/20/2002 – Investigators at several cancer centers developed protocols for two phase II clinical trials with review and input from NCI and Dr. Burzynski
======================================
[1] – 10/1995 – These studies began in 1993 at Memorial Sloan-Kettering Cancer Center, Mayo Clinic, and the NIH Clinical Center
——————————————————————
[2] – 5/20/2002 – These NCI-sponsored studies began in 1993 at the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the Warren Grant Magnuson Clinical Center at the National Institutes of Health
======================================
[1] – 10/1995 – However, accrual to these studies was very slow and only nine patients were enrolled
——————————————————————
[2] – 5/20/2002 – Patient enrollment in these studies was slow, and by August 1995 only nine patients had entered the trials
======================================
[1] – 10/1995 – On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes in the protocol to increase accrual, and there was no hope of completing the studies in a timely manner
——————————————————————
[2] – 5/20/2002 – Attempts to reach a consensus on proposed changes to increase accrual could not be reached by Dr. Burzynski , NCI staff, and investigators, and on 8/18/1995, the studies were closed prior to completion
——————————————————————
[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[H] – The only reason the clinical trials of antineoplastons were stopped is that NCI would not conduct them as per our written agreement

[I] – Even the NCI’s own previous “fact sheet” on antineoplastons, dated 2/17/1994, states that

“The NCI reviewed 7 cases of patients with primary brain tumors that were treated by Dr. Burzynski with antineoplastons and concluded that antitumor responses occurred

[J] – The NCI never made any effort to “reach a consensus.”

[K] – It simply violated the written protocol we had agreed upon

[L] – Without informing me, NCI changed the rules to allow patients with any size or number of tumors, low performance scores, and spinal cord metastases

[M] – When I found out and insisted that NCI either conduct the study as agreed or inform patients that I felt it was conducting the study improperly, NCI cancelled it
======================================
[1] – 10/1995 – Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons
——————————————————————
[2] – 5/20/2002 – Because of the small number of patients in these trials, no definitive conclusions can be drawn about the effectiveness of treatment with antineoplastons
======================================
[1] – 10/1995 – It is rare that this kind of NCI-sponsored clinical study cannot be successfully completed

The NCI is disappointed by this outcome but is continuing to evaluate related compounds in clinical trials in order to determine if they may be of benefit in the treatment of patients with cancer
======================================
REFERENCES:
======================================
[1] – Date Last Modified 10/1995
——————————————————————
CancerNet from the National Cancer Institute

CANCER FACTS

National Cancer Institute
National Institutes of Health

National Cancer Institute-Sponsored Clinical Trials of Antineoplastons

Antineoplastons are a group of compounds originally isolated from urine by Dr. Stanislaw Burzynski, who claims that they inhibit cancer cell growth

Dr. Burzynski has used these compounds to treat patients with various cancers

In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical responses in a group of patients treated at Dr. Burzynski’s Houston facility

For this review, Dr. Burzynski selected from his entire clinical experience seven brain tumor patients whom he felt had a beneficial effect from antineoplastons

This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available patient information, and included only cases selected by Dr. Burzynski

The reviewers of this series determined that there was presumptive evidence of antitumor activity and NCI then proposed that Phase II clinical trials be conducted to evaluate more definitively the response rate and toxicity of antineoplastons in adult patients with refractory brain tumors

The decision by NCI to sponsor the study of an agent in a clinical trial does not indicate that the agent is or will be useful in the treatment of cancer patients, only that it merits further evaluation in a research setting

Efforts to study antineoplastons in a scientifically rigorous manner have required complex interactions among NCI, clinical investigators, the National Institutes of Health’s (NIH) Office of Alternative Medicine, the Food and Drug Administration, advocates from the alternative medicine community, and Dr. Burzynski

Two protocols were developed by the participating Cancer Center investigators with extensive review and input from NCI and Dr. Burzynski

These studies began in 1993 at Memorial Sloan-Kettering Cancer Center, Mayo Clinic, and the NIH Clinical Center

However, accrual to these studies was very slow and only nine patients were enrolled

On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes in the protocol to increase accrual, and there was no hope of completing the studies in a timely manner

Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons

It is rare that this kind of NCI-sponsored clinical study cannot be successfully completed

The NCI is disappointed by this outcome but is continuing to evaluate related compounds in clinical trials in order to determine if they may be of benefit in the treatment of patients with cancer
======================================
[2] – This fact sheet was reviewed on 7/13/01

Editorial changes were made on 5/20/02
——————————————————————
CANCER FACTS

National Cancer Institute • National Institutes of Health Department of Health and Human Services

Antineoplastons

Antineoplastons are a group of synthetic compounds that were originally isolated from human blood and urine by Stanislaw Burzynski, M.D., Ph.D., in Houston, Texas

Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers

In 1991, the National Cancer Institute (NCI) conducted a review to evaluate the clinical responses in a group of patients treated with antineoplastons at the Burzynski Research Institute in Houston

The medical records of seven brain tumor patients who were thought to have benefited from treatment with antineoplastons were reviewed by NCI

This did not constitute a clinical trial but, rather, was a retrospective review of medical records, called a “best case series.”

The reviewers of this series found evidence of antitumor activity, and NCI proposed that formal clinical trials be conducted to further evaluate the response rate and toxicity of antineoplastons in adults with advanced brain tumors

Investigators at several cancer centers developed protocols for two phase II clinical trials with review and input from NCI and Dr. Burzynski

These NCI-sponsored studies began in 1993 at the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the Warren Grant Magnuson Clinical Center at the National Institutes of Health

Patient enrollment in these studies was slow, and by August 1995 only nine patients had entered the trials

Attempts to reach a consensus on proposed changes to increase accrual could not be reached by Dr. Burzynski , NCI staff, and investigators, and on 8/18/1995, the studies were closed prior to completion

A paper describing this research, “Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma,” appears in Mayo Clinic Proceedings 1999, 74:137–145

Because of the small number of patients in these trials, no definitive conclusions can be drawn about the effectiveness of treatment with antineoplastons

At present, the Burzynski Research Institute is conducting trials using antineoplastons for a variety of cancers
======================================
[1] – Date Last Modified 10/1995
——————————————————————

20130919-152521.jpg

20130919-152702.jpg
======================================
[2] – This fact sheet was reviewed on 7/13/2001

Editorial changes were made on 5/20/2002
——————————————————————

20130919-174650.jpg

20130919-174914.jpg
——————————————————————
[2]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
======================================
[3] – 10/27/1995 – Burzynski sent a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/18/24-1995-10271995-burzynski-to-dr-richard-klausner-7-pgs/
======================================
[0] – Title 18, Part I, Chapter 47, § 1001
——————————————————————
18 USC § 1001 – Statements or entries generally
——————————————————————
http://www.law.cornell.edu/uscode/text/18/1001
======================================
[F] – 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI) sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/17/5-1991-11151991-dr-michael-j-hawkins-to-decision-network/
======================================
[G] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/17/6-1991-12291-nci-decision-network-report-on-antineoplastons/
======================================
Critiquing: Dr. Michael A. Friedman, Dr. Mario Sznol, Robert B. Lanman,
Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================

Dr. Michael A. Friedman, DATA ?

[1] – 11/2/1993 – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, which advised, in part, on page 1:

7. “In accordance with your letter we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated”

“The Theradex database is also available … “
——————————————————————
[1] – 11/2/1993 – This makes it clear that: “review of data” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-161419.jpg

20130918-152526.jpg
[2] – 1995 (4/3/1995) – Dr. Mario Sznol, Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), National Cancer Institutes (NIH), sent a 2 page letter for Dr. Michael A. Friedman, to Burzynski, in response to his letter of 3/29/1995, which advised, in part, on page 1:

“We will forward the data on the 1st 5 patients in a separate mailing as you requested”
——————————————————————
[2] – 4/3/1995 – This makes it clear that: “We will forward the data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-134020.jpg

20130918-134632.jpg
[3] – 1995 (4/20/1995) – Burzynski sent a letter to Dr. Mario Sznol, Department of Health & Human Services (HHS), National Institutes of Health (NIH), in response to his letter of 4/3/1995, which advised, in part, on page 2:

“We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995″
——————————————————————
[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-162456.jpg
[4] – 1995 (5/16/1995) – Burzynski sent a letter to Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH), in response to his letter of 5/12/1995, which advised, in part, on page 2:

“I still have not received the complete data on the 1st 5 patients, which was promised in your letter of 4/3/1995″
——————————————————————
[4] – 5/16/1995 – This makes it clear that: “I still have not received the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-164323.jpg
[5] – 1995 (6/6/1995) – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, in response to his letters of 4/20/1995 and 5/16/1995, which advised, in part, on page 1:

“Also contrary to your statement, you have been sent monthly clinical summaries of these patients since 7/1994 directly from Theradex

(see 3/9/1994 letter)
——————————————————————
[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-165840.jpg
[6] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which he copied Dr. Michael A. Friedman on, which was in response to his letter of 7/21/1995, which advised, in part:

” … you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators”

“To our knowledge, Dr. Burzynski has received, on an ongoing basis, complete copies of the reports prepared by Theradex after the Principle Investigators submit their data”

“Dr. Burzynski has received precisely the same information that is provided to the National Cancer Institute (NCI)”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
——————————————————————
[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-154154.jpg
[7] – 1995 (9/19/1995) – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 2 page letter to Burzynski, which advised, in part:

“I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons”

“Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:”

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

“We have no individual patient records in our possession in addition to the Theradex reports”
——————————————————————
[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-160216.jpg

20130918-161029.jpg
[8] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which advised, in part:

“This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski”

“It is our understanding that NCI offered to allow Dr. Burzynski to participate in an interim and final meeting in which patient data from the study was to be reviewed”

“However, these meetings never took place because of the insufficient patient accrual and decision not to complete the study”

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center”

“We have learned that 2 patients were enrolled in the Sloan-Kettering study through the Clinical Center and hence, even though the Clinical Center did not have its own protocol, it has medical records for those 2 individuals”
——————————————————————
[8] – 10/5/1995 – This makes it clear that: “… these meetings never took place because of the insufficient patient accrual and decision not to complete the study”, is NOT Theradex, but the prior letters do NOT mention the word “MEETINGS”
=======================================
[1] – 11/2/1993 – This makes it clear that: “REVIEW OF DATA” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[2] – 4/3/1995 – This makes it clear that: “WE WILL FORWARD THE DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[4] – 5/16/1995 – This makes it clear that: “I STILL HAVE NOT RECEIVED THE complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-154926.jpg
Why would you advise Burzynski:

[2] – 4/3/1995 – “WE WILL FORWARD THE DATA” if you had FORWARDED “THE DATA” since

[5] + [8] – the 7/18/1994 Theradex Clinical Studies Summary ?

Dr. Michael A. Friedman, DATA ?

Where is the DATA ?
=======================================

DID Dr. Michael A. Friedman FIB ?

[1] – 6/6/1995 – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, in response to his letters of 4/20/1995 and 5/16/1995, which advised, in part, on page 1:

“I will 1st address the questions you raised about individual patients participating in the NCI-sponsored antineoplaston studies

“2 patients were treated at the National Cancer Institute”

Patient .26-77-03-9 … at the NCI

Patient .27-53-76-5 … “
——————————————————————
6/6/1995 we know “2 patients were treated at the National Cancer Institute” [1]

20130918-165840.jpg
[2] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division, sent a 1 page letter; which he copied Dr. Michael A. Friedman on, to Burzynski’s attorney, Richard A. Jaffe, Esq., which was in response to his letter of 7/21/1995, and advised, in part:

” … you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
——————————————————————
6/6/1995 we know per Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanman [2]

20130918-154154.jpg
[3] – 9/19/1995 – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 2 page letter to Burzynski, which advised, in part:

“I am replying to your 8/29/1995 letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons

Pg. 2

We have no individual patient records in our possession in addition to the Theradex reports”
——————————————————————
6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute”[1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …”[3]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2]

[0] – Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”

20130918-160216.jpg

20130918-161029.jpg
[4] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which advised, in part:

“This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski”

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center

“We have learned that 2 patients were enrolledthrough the Clinical Center and hence … the Clinical Centerhas medical records for those 2 individuals”
——————————————————————
6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …” in his letter to Burzynski [3]

10/5/1995 we know that Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals”, in his letter [4]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2], and / or would have advised Burzynski in his 9/19/1995 letter that the National Cancer Institutes Clinical Center had “medical records for those 2 individuals” [3]

20130918-154926.jpg
Dr. Michael A. Friedman

6/6/1995 you advised Burzynski that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 you were copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

8/23/1995 we know that you did NOT advise Burzynski that National Institutes of Health (NIH) Legal Advisor Robert B. Lanman’s written statement was NOT TRUE [2]

9/19/1995 you advised Burzynski that “We have no individual patient records in our possession …” [3]

10/5/1995 – Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals” [4]

Dr. Michael A. Friedman, I know that you would NOT break the law

Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”

Dr. Michael A. Friedman, please let me know why what you did was NOT a LIE

My primary obligation is to the American public, because, I know you would tell the TRUTH, since, in your words, you “could not responsibly act in any other manner”
======================================
[0] – Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally
——————————————————————
http://www.law.cornell.edu/uscode/text/18/1001
======================================

[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
——————————————————————
Department of Health and Human Services, Public Health Services, National Institutes of Health, National Cancer Institutes

Dear Dr. Burzynski,

Dr. Friedman asked me to respond to your letter of 3/29/1995 regarding the change we have been considering in eligibility criteria for the Memorial Sloan-Kettering and Mayo Clinic phase II studies of antineoplastons

At the investigator’s request, the amendments to modify the eligibility restrictions for size of tumor, number of tumors, and leptomeningeal spread, and to allow entry of patients with KPS of 60, have been approved

These amendments were initiated by the investigators when it became apparent that many good candidates for the study were being excluded because of what were perceived to be overly stringent and unnecessary eligibility restrictions

Approximately a year ago, we wrote to you asking for your concurrence to make similar changes to the protocol

(see enclosed letter)

We have documented that the revised eligibility criteria are consistent with those used in your very own protocols that employ identical or nearly identical treatment regimens

Furthermore, in a review of the 7 patients in the best case series presented to NCI, we have found that perhaps 4 of the 7 patients who apparently had tumor shrinkage would not have been eligible to enter the NCI phase II studies under the original stringent eligibility criteria

(see attached)

These types of patients will now be eligible for study using the revised eligibility criteria proposed by the investigators and recently approved by CTEP

Despite the difficulties in accrual, we are committed to completing the phase II evaluation of the antineoplastons

Our goals remain unchanged, that is, we wish to determine whether the drugs used in the similar manner as you recommend, and in the similar population of patients, will yield results consistent with those in the best case series

As noted above, our careful evaluation of the materials you have provided indicate that the amendments to the eligibility criteria do not deviate from the eligibility criteria and methods you have employed in your experience

We would appreciate the opportunity to review your data, alluded to in your letter, that support the contention that inclusion of theses patients requires a different treatment regimen or is unsafe

In the meantime, we will allow the amendments to stand, since all evidence you have provided to date indicates that these newly eligible patients may have a chance for benefit without undue risk of harm, and are appropriate candidates for evaluation of the drug

We will forward the data on the 1st 5 patients in a separate mailing as you requested

Pg. 2

However, you have asked that we suspend accrual while you review the data

There is no medical or regulatory reason to suspend accrual at this time

Suspending accrual will likely further damage the efforts the investigators have made to increase accrual to the trial

Mario Sznol, M.D.

cc:

Dottie Tisevich
Michael Friedman, M.D.
Mary McCabe
Office of Alternative Medicine

Pg. 3

Antineoplaston Cases

1. Histology partial lobe glioblastoma multiforme
Size 2.3 cm largest diameter
Response CR possible
prior Tx RT, surgery

2. Histology anaplastic astrocytoma stage IV grade 3
Size 3.0 tumor 3.5 tumor and edema
Response CR possible
prior Tx RT

3. Histology infiltrating glioma (astrocytoma or mixed astrocytoma / oligodendroglioma)
Size 4.4
Response good PR, possible CR
prior Tx RT and BUdR; Procarbazine, CCNU, VCR; B-Interferon; DFMO and MGBG

4. Histology well differentiated Stage IV astrocytoma, possible juvenile pilocytic astrocytoma
Size 5.5 X 3.3
Response 40-50% decrease of solid component
prior Tx vitamins and laetrile

5. Histology glioblastoma multiforme
Size 6.5 x 5.0
Response 39% decrease
prior Tx RT

6. Histology glioma consistent with anaplastic astrocytoma, differential: anaplastic astrocytoma or spindle cell variant of oligodendroglioma
Size 5.1 x 2.2
Response CR
prior Tx RT

7. Histology Infiltrating anaplastic astrocytoma
Size 4.0 (L) 4.8 (bifrontal)
Response good response – possible CR
prior Tx RT
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1995 (4/3/1995) – Dr. Michael A. Friedman to Burzynski [16]
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski [21] (3 pgs.)
1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman
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