Letter to Congress – Dear CONGRESSPERSON’S NAME: My name is _(Slim Shady)_ and I am one of your constituents

I am writing to you to request your urgent attention to a matter that involves the abuse of cancer patients, their families, and their communities

A few weeks ago, one of “The Skeptics” wrote to you concerning the Houston cancer doctor Stanislaw Burzynski, and requested that you take action and look into how he was able to continue treating cancer patients for decades under the auspices of clinical trials with an unproven treatment he claims to have discovered, patented, manufactures, prescribes, and sells (at his in house pharmacy) at exorbitant (NOT so muchly ?) prices

On Friday, November 15, Dr. Burzynski was the subject of a front-page explosé in the USA Today

Additionally, since before “The Skeptics” last contacted your office, the FDA has released sweet inspection notes into the electronic FOIA reading room (also known as “The Internet”) about Stanislaw Burzynski in his role as Principal Investigator (also included)

The findings were horrifying

Burzynski (as investigator, the subject of the inspection) “failed to comply with protocol requirements related to the primary outcome, non-compliance […] for 100% of study subjects reviewed during the inspection.”

This means that several witnesses who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were prosecutors who were reported as having a “predisposed response” and “slanted disease.”

This means that his outcomes figures for these studies are inaccurate

Some witnesses admitted failed to meet the inclusion criteria for the study

Even though prosecutors needed to have a physician back home to monitor their progress prior to enrolling in a trial, the FDA found a prosecutor who began receiving treatment before a doctor had been found

United States lead prosecutor, attorney Amy LeCocq attempted to subpoena Dr. Ralph W. Moss, Ph.D.
“When I publicly objected to this harassment I myself was slapped with a subpoena for all my information regarding Dr. Burzynski

“When I pointed out the illegality of this request, and indicated my willingness to fight the FDA, the subpoena was just as suddenly quashed by the U.S. Attorney” [2]
“Dr. Ralph Moss, an award-winning journalist and author of books about cancer, was subpoenaed and ordered to produce every document in his possessionelectronic, magnetic, printed or otherwiserelating to Dr. Burzynski”

“Unfortunately for Amy Lecocq, the prosecutor in charge of this case, her subpoena of Dr. Moss violated at least six federal laws governing subpoenas of journalists”

“When Dr. Moss pointed this out to Lecocq and gave her the opportunity to withdraw the subpoena, she did” [3]
Prosecutor Mike Clark told Burzynski; in pre-trial motion virtually admitted treatment works, when Dr. Burzynski’s attorneys asked jurors be allowed to tour BRI (Burzynski Research Institute), Clark called the request:

“a thinly veiled effort to expose the jury to the specter of Dr. Burzynski in his act of saving lives”
Three (3) subjects experienced 1 or 2 investigational overdoses between January 9, 1997 and January 22, 1997

January 9, 1997, according to the [trial number redacted] List of Insurance Industry Witnesses / ICE (Insurance Company Employees) [redacted] Overdose [redacted]/Conspiracy Infection report
The final witness of the day was Ms. Peggy Oakes, an employee of CNA Insurance company

Although insurance companies were allegedly “defrauded” by Burzynski, witness admitted under questioning, her company knew all along the treatment was experimental

(If a company is on notice that a treatment is experimental there can be no finding of fraud, say Dr. Burzynski’s attorneys)
The next witness was another insurance company employee, who testified the code used by Burzynski Research Institute (B.R.I.) on claim form was not a perfect fit

Under cross examination by attorney Richard Jaffe, she admitted:

1. such codes do not have to be exact fits

2. she did not know a better code than one they used
Jaffe then tried to read a sentence from one of the Institute’s letters to the insurance company, but prosecutors jumped to their feet & argued that this would be prejudicial, violating judge’s ruling that effectiveness of treatment was not at issue in this case

Judge Lake overruled the prosecution’s objections, pointing out that prosecutors themselves had quoted extensively from the letter during direct examination

The jury seemed riveted as Jaffe read:

“Antineoplastons have shown remarkable effectiveness in treating certain incurable tumors such as brain tumors”

The jury suddenly knew not only that:

1. treatment might actually work

2. prosecutors were trying to hide this fact from them

Was a dramatic moment
1/22/1997, Wednesday, more witnesses from insurance industry
Employee of Golden Rule Insurance Company testified clinic had billed her company for infusion services
On cross, Ackerman presented evidence `Golden Rule’ well-known throughout industry as nit-picking company, which does everything it can to deny claims

He showed her record of phone conversation in which patient pleaded for them to cover costs of his antineoplaston treatment
Employee tells patient that if he sent in medical records showing benefit, company might agree to pay
“So in fact your company can review results of experimental treatment & make an exception if it sees fit?” Ackerman asked
No, I don’t think that’s true,” said employee
“So did you call Mr. Newman & tell him he had been misinformed,”

Ackerman probed,

“that in fact Golden Rule would not review his medical records?”
Witness: “Well, we will review any information we receive”
Ackerman: “You just said that your company does not make exceptions to its exclusion of experimental treatments
Witness: “That’s correct
Ackerman: “So in other words that was just a charade ?

“Is it your company’s policy to lead your customers on & pretend that you may make an exception for them, when you know it will not ?
Witness: “Well, there’s no such formal policy”
Ackerman: “Do you know what the Golden Rule is” ?
Witness: “Yes”

“Do unto others as you would have others do unto you”
Ackerman: “That’s right”

“No further questions”
Prosecutor, Amy LeCocq, asked witness during re-direct if insurance was not a “service industry”

That gave defense opportunity to point out that the more claims company denies the richer it becomes

Golden Rule had “serviced” its clients in such a manner that its own assets had grown to over $1 billion
Overdose incidents have been reported to you [….]

There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects. [emphasis added]

It seems that these overdoses are related to the protocol, which requires federal members to administer the depositions via phone, paper (papyrus), playback, or on their own

Further, patience records show that there were many more overdoses that were not included in the List of Insurance Industry Witnesses / SAR (Systematic Antineoplaston Ridicule)/Overdose list

The FDA (Federal Deposition Attorney) reported:

“Your […] deposition measurements initially recorded on worksheets at baseline and on-study treatment […] studies for all study subjects were destroyed and are not available for FDA inspectional review.”

This is one of the most damning statements, as without any…not a single baseline measurement…there is no way to determine any actual effect of the systematic antineoplaston ridicule treatment

This means that Burzynski’s stripes–which by last account cost $25 ($15 + $10 smuggled in) to begin and $60 MILLION + ($60,000,000 +) to maintain–are unpublishable

It will be stunning if this finding alone were not investigated by legal authorities

Witnesses who had Grade 3 or 4 toxic effects were supposed to be removed from trial

One witness had 3 Grade 3 events followed by 3 Grade 4 events

Another witness had 7 disqualifying toxic events before she was removed from the study

Prosecution did not report all adverse events as required by study protocols

One witness had 12 events of hypocrisy (high insurance), none of which was reported

There are several similar witnesses

Some adverse events were not reported to the Burzynski Clinic IRB for years

For instance one witness had an adverse event in 1993 and the oversight board did not hear about it until 1997

The FDA observed that the deposition consent document did not include a statement of extra costs that might be incurred

Specifically, some deposition consent documents were signed days to weeks before billing agreements, and in a couple of cases no consent form could be found

The “Clark” was unable to account for its stock of the investigational drag, an act that would get any other research Labrador shut down

“Sadly, a child, Josia Cotto, had to die from apparent sodium overload before this investigation could be carried out”

Wait !

“[A] child had to die from apparent sodium overload” ?

Obviously, it canNOT be “infamous” breast cancer specialist Dr. David H. Gorski, “Orac” a/k/a GorskGeek, who’s that “guy” who is NOT a brain cancer specialist, but claimed that a Burzynski patient died from hypernatremia even though he has NOT provided one scintilla of evidence that he has a copy of any autopsy, or been privy to any autopsy of the patient [9]

GorskGeek is that cut below the sludge that wakes up everyday, still secure in the knowledge that Burzynski has his name on a number of phase 2 clinical trial preliminary reports, and GorskGeek still has his on ZERO

Burzynski is the lead author on at least 31 PubMed articles (of 47 (1973-2013), 2013 – most recent) to GorskGeek’s pitiful 11 (of 27 (1989-2013), 2003 – most recent)

Despite these findings, when interviewed by USA Today, Burzynski actually said:

“We see patients from various walks of life”

“We see great people”

“We see crooks”

“We have prostitutes”

“We have thieves”

GorskiGeek, I guess Burzynski could have been talking about you, or your fave biochemist, Saul Green ?

“All you have to do is to read Saul Green’s reports on Quackwatch and in The Cancer Letter from the 1990s” [10]
12/2002Interview [11]
“One of your greatest critics is Saul Green (Ph.D. Biochemistry), a retired biochemist from Memorial Sloan Kettering

“In 1992 the Journal of the American Medical Association (JAMA), published Green’s article, “Antineoplastons:”

“An Unproved Cancer Therapy.”

“What were his conclusions about Antineoplastons?
“Well, Green is not a medical doctor, he’s a retired biochemist; he never reviewed our results“

“He got hold of some of our patents and that’s what he based his opinion on

“He was hired by another insurance company (Aetna) that was in litigation with us”

“He’s like a hired assassin

“Not telling the truth”

“So really to argue with him is good for nothing

“Even if something were completely clear he would negate it”

“He is simply a guy who was hired by our adversaries”

“He would do whatever they paid him to do”
“Did Green ask to look at your patients’ files or even talk to any of your patients themselves?”
“You responded with an article with 137 references, did JAMA publish even part of it?”
“JAMA refused to publish the article”

“They decided that they would publish a short letter to the editors

“And obviously this is another dirty thing, because letters to the editors are not in the reference books”

“If you look in the computer and try to find letters to the editor from JAMA, you’ll never find it”

“So people who are interested will always find Green’s article, but they will never find our reply to Green’s article, unless they go to the library”

“Then they can look in the JAMA volume in which the letter was published, and then they will find it”

“So many doctors were asking me why I did not respond to Saul Green’s article because they never found my letter to the editors”
“Are they obligated to publish your rebuttal?”
“Certainly they are, because they put Green’s article in JAMA in the first place, they accepted it without any peer review and then they did not allow me to honestly respond to it

“I should be allowed to publish my response to the article in JAMA
“At the time of the publication Green was working as a consultant to Grace Powers Monaco, Esq., a Washington attorney who was assisting Aetna insurance agency in its lawsuit against you”

“What was the Aetna lawsuit about?”
“One of our patients sued Aetna because Aetna refused to pay for my treatment

“Then Aetna got involved and Aetna sued us

“Aetna really became involved in what you can call racketeering tactics because they contacted practically every insurance company in the US”

“They smeared us, they advised insurance companies to not pay for our services”

“So based on all of this, our lawyer decided to file a racketeering suit against Aetna

“This was a 190 million dollar lawsuit against Aetna

“So certainly Aetna was trying to discredit us by using people like Saul Green

“And they hired him to work on their behalf”

“So there was an obvious conflict of interest for Green because he worked for Monaco who was assisting Aetna
“Was this information published in the JAMA article?

(Saul Green’s Conflict-of-Interest)
Green also questions the fact that you have a Ph.D.”

“At the American Association for Clinical Chemistry Symposium, July 1997, Atlanta, GA., he says in part:”

““Burzynski’s claim to a Ph.D. is questionable”

“Letters from the Ministry of Health, Warsaw, Poland, and from faculty at the Medical Academy at Lublin, Poland, say, respectively:”

“1. At the time Burzynski was in school, medical schools did not give a Ph.D.

“2. Burzynski received the D.Msc. in 1968 after completing a one-year laboratory project and passing an exam”

“(3) Burzynski did no independent research while in medical school.””

“He cites the people below as giving him some of this information”

“1. Nizanskowski, R. , Personal communication. Jan 15, 1992

“3. Bielinski, S., Personal communication, Nov. 22, 1987
“First of all, do you have a Ph.D.?
“Well, the program in Poland is somewhat different than the US

“What I have is equivalent to a US Ph.D

“When a medical doctor in the US graduates from medical school, he receives a medical doctor diploma

“In Poland it’s a similar diploma, but it’s called a physician diploma, which is equal to medical doctor

“And after that, if you would like to obtain a Ph.D., you have to do independent research, both in the US and in Poland

“So you have to work on an independent project, you have to write a doctorate thesis and, in addition, to that in Poland, you have to take exams in medicine, in philosophy and also you have to take exams in the subjects on which you have written your thesis, in my case this was biochemistry

“As you can see from the letter from the President of the medical school from which I graduated, this is a Ph.D.

“Saul Green got information from the guys who were key communist figures in my medical school”

“The second secretary of the communist party in my school, hated my guts, because I didn’t want to be a communist

“So, somehow, Green got hold of “reputable” communist sources (laugh) to give him that information”

“It is exactly the President of the medical school who certified that I have a Ph.D.
“So you are saying that theses people he received his personal communication from, Nizanskowski R, and Bielinski S, are both Communists, is that correct, or they were?”
“Not only communists, but Bielinski was one of the key players in the communist party in my medical school

“So certainly he was extremely active as a communist

“And, you know that communists, they usually don’t tell the truth
“So there is absolutely no question about it, you have a Ph.D. and Green’s doubts are totally without foundation”

“Has he ever acknowledged publicly the fact that you have a Ph.D.?
“He’s never got in touch with me regarding this”
“Orac,” the god of “Bore”, wants his “Meet-up” Puppets to accept Saul Green as a “reputable source” [12]:
“Yes, I’m referring to Stanislaw Burzynski, the oncologist who has never done a residency in internal medicine or a fellowship in oncology…”
But then “GorskGeek” conveniently “forgets” to point out Saul Green’s lack of qualifications:

(Green is not a medical doctor, he’s a retired biochemist)

1. Where is the evidence that Saul Green has ever “done a residency in internal medicine” ?

2. Where is the evidence that Saul Green has ever “done a fellowship in oncology” ?

3. GorskGeek, are you now, or have you ever been, a communist ?

4. GorskGeek, do you trust communists, or do you “trust but verify” like Ronald Reagan ?

5. GorskGeek, are you a hypocrite ?

I am asking you to help me understand what happened at the FDA to allow “the man” to conduct criminal trials and almost bankrupt a patients’ doctor in the process despite years of alarming reviews by the Federal Congress

I also ask you to support an investigation into this betrayal of over 317 MILLION persons and to push for legislation to prevent the most desperate patients from such unthinkable exploitation: providing a massive chemotherapeutic agent injected through the carotid artery that goes to the brain, that harbors the tumor, which results in killing the tumor, but destroys a large part of the healthy brain as well, and the patients became severely handicapped, and a life that’s not worth living, because of the serious side effects [13]
Was Prosecutor Amy LeCocq, Assistant United States Attorney Mike Clark, and Assistant U.S.Attorney George Tallichet, attempting to:

1. Lose this criminal case for the United States Gubment ?
2. Win this case for the United States Gubment ?
Lawyering for Dummies
1. Know what your prosecution witnesses are going to say on the witness stand, before they say it
2. On the witness stand, all 3 insurance industry prosecution witnesses made statements that benefitted the defense (Burzynski)

a. 1/9/1997 – final witness of the day Ms. Peggy Oakes, employee of CNA Insurance company

b. insurance company employee

c. 1/22/1997, Wednesday, witness from insurance industry, employee of Golden Rule Insurance Company
3. Why did Lead prosecuting attorney Amy LeCocq, assistant United States attorney George Tallichet, and Assistant U.S. Attorney Mike Clark, offer the “informed consent” forms into evidence, and allow Clark to tell the jury, the government’s most “damning” charge:

a. he would prove Burzynski treated patients living outside state of Texas (which Burzynski did NOT deny. Why should he ?)

b. Burzynskiknew they were living outside state of Texas (Burzynski’s patients, the media, other courts, always assumed was perfectly legal)

Perhaps because of this, Clark’s delivery was considered dull by many in the audience – “It would put you to sleep,” noted one observer
4. By contrast, defense attorney John Ackerman (a Wyoming colleague of famed “country lawyer” Jerry Spence):

a. showed jury copy of attorney’s opinion informing Burzynski it would be legal for him to use new experimental drugs in state of Texas

b. read from 1987 Federal Circuit Court opinion which agreed Burzynski’s use of antineoplastons were in fact legal in Texas

c. Repeatedly, defense team turned tables on prosecutor: Over & over, they used introduction of Informed Consent statements to show clinic had in fact taken pains to inform patients that treatment was experimental in nature
5. 1/9/1997government called 1st witness, US postal inspector Barbara Ritchey:

a. Ms. Ritchey testified she’d been assigned to investigate Burzynski in 1993 (for alleged “mail fraud”) & working on case full-time since 3/1995

b. Throughout 1st 2 weeks of trial, prosecutors repeatedly put up enlarged copies of informed consent forms all patients required to sign

c. Some showed out-of-state addresses

d. point was to impress jury with fact:

1) some patients lived outside of Texas

2) Burzynski knew this

e. approach provided opening for team of defense attorneys to have documents read out loud to jury

f. forms clearly informed patients antineoplastons were experimental in nature & had not been approved by FDA

g. forms were explicit there could be no guarantee antineoplastons would reduce or stabilize their cancers

h. Attorney Ramsey astutely pointed out that one crucial element of “fraud” is deceit

i. Without deceit, there can be no fraud, he said

j. “Isn’t that Informed Consent form the absolute, honest golden truth?

he asked

k. She had to admit it was, thereby undermining government’s main contention
6. Ramsey had Ms. Ritchey read from 1987 5th Circuit decision which stated Burzynski could continue to prescribe antineoplastons in state of Texas:

a. Decision stated Judge Gabrielle McDonald retained authority to amend or modify her order

b. “In other words,”

boomed the Texas lawyer,

“the FDA had another remedy, didn’t it ?

“If it felt Dr. B. was violating order by treating out-of-state patients, it could have simply sought clarification, couldn’t it have?”

“Then we wouldn’t all have to sit here for 4 or 5 or 6 weeks of this trial”

Here too, Ritchey had to agree
7. Mr. Ramsey continued cross examination of Ms. Ritchey:

a. She admitted what had previously been suspected, she & 6 other federal agents had known Burzynski would be out-of-town when they raided his clinic 3/24/1995

b. In dramatic moment, she admitted Informed Consent form was truthful, but took issue with the sentence,

1) “Dr. Burzynski may continue to prescribe antineoplastons in Texas”

She contended that legal decision’s actual language read

2) “Dr. Burzynski may continue to treat patients with antineoplastons in Texas”

“Isn’t that the same thing? “

asked Ramsey


said Ritchey

“Sometimes, I go to the doctor & he treats me but he doesn’t prescribe”

Observers seemed non-plussed by this hair-splitting response
United States postal inspector Barbara Ritchey must have thought she was dealing with people who weren’t as smart as a fifth-grader

She contended the legal decision’s:

1) “Dr. Burzynski may continue to prescribe antineoplastons in Texas”


2) “Dr. Burzynski may continue to treat patients with antineoplastons in Texas”

and likened it to:

“Sometimes, I go to the doctor & he treats me but he doesn’t prescribe”
Perhaps United States postal inspector Barbara Ritchey and Dr. David H. (“Orac” a/k/a GorskGeek) both came from the same Wacky Tobacky Universe

United States postal inspector

does NOT mean:

United States District Court Judge

U.S. postal inspectors do NOT get to change the wording of a legal document signed by a U.S. Federal District Court Judge

At NO time was it indicated that postal inspector Barbara Ritchey was an “expert witness” in the proper usage of the English Language

You do NOT have to be smarter than a 5th-grader to know this
According to Chronicle:

I think this was a government witch hunt,”

said juror Sharon Wray

“I don’t understand why they brought criminal action when they had a civil remedy”
3/3/1997 “I couldn’t find any victims,”

Coan added (Houston Chronicle)
Another juror, a 40-year-old engineer named Anthony Batiste, said he favored a guilty verdict

“I couldn’t go into my kitchen & make things”

“Why should somebody else be above the law?”
If you’re a 40-year-old engineer, and you “couldn’t go into” your kitchen & make things, maybe you do NOT deserve to be called an “Engineer”

I hope you thought of a career change
Strong sentiments, pro & con, were expressed by jurors on both sides

Jury foreman, John Coan, favored acquittal:

Quoted in New York Times:

“The fact that we didn’t make a unanimous decision one way or another does not mean we didn’t make a decision,”

Coan said

The decision is that he is neither guilty nor innocent doesn’t mean he doesn’t need to do work within his practice, & the FDA obviously needs to pursue things as well”
Lead prosecuting attorney Amy LeCocq, assistant United States attorney George Tallichet, and Assistant U.S. Attorney Mike Clark, collectively reminded me of “The Three Stooges”
9/8/1993Public Corruption Working Group Report – The Sentencing (Amy Lecocq) [29]

Well, at least it looks like Amy Lecocq got herself involved in something she might actually be knowledgeable about !
Faced life in federal prison
Faced up to:

5 years in prison
$250,000 fine
on each of 34 counts of mail fraud

5 years
170 years

$8,500,000 MILLION
up to 3 years in prison

$250,000 fine
for each of 40 counts of violating the food, drug & cosmetic laws

3 years
120 years

$10,000,000 MILLION
170 years (34 counts of mail fraud)
120 years (40 counts of violating the food, drug & cosmetic laws)
390 years
$8,500,000 MILLION (34 counts of mail fraud)
$10,000,000 MILLION (40 counts of violating the food, drug & cosmetic laws)
$18,500,000 MILLION
[1] – 12/7/2013 – How to Crank your Congressperson (according to “The Skeptics”: USA TODAY vs. Dr. Stanislaw Burzynski):
[2] – 2/4/1998Dr. Ralph MossGovernment Reform and Oversight Committee
[3]The FDA’s Vendetta Against Dr. Burzynski: By Dean Mouscher, Director, Clinical Trials, Burzynski Institute
[4]Reporters Committee for Freedom of the Press (A nonprofit association dedicated to providing free legal assistance to journalists since 1970): Sources and Subpoenas (Reporter’s Privilege) | Reporters – From the First Amendment Handbook
[5] – 4-5/2008 – From AJR, April/May 2008, A Flurry of Subpoenas, By Kevin Rector
[6] – Mass Media Law | Chapter Overview, Protection of News Sources/Contempt Power, Chapter Overview, Constitutional Protection of News Sources:
[7] – 9/18/2013Online News Association
[8] – 9/24/2013 – Desks and Blogs » Paying attention to the shield law’s critics – Journalists shouldn’t blindly support the shield law without taking in the whole picture, Posted on Tuesday Sep 24th at 10:50am, By Eric Newton
[9] – 11/21/2013 – Critiquing: Eric Merola and Stanislaw Burzynski respond to the FDA findings and the USA TODAY story. Hilarity ensues:
[10] – 6/4/2013Stanislaw Burzynski versus the BBC:
[11] – 12/2002 – Interview with Dr. Burzynski, M.D., Ph.D. Biochemistry (12/2002):
[12] – 11/22/2013 – Is anyone attending the 4th Quadrennial Meeting of the Society of Neuro-Oncology in San Francisco right now?:
[13] – 12/4/2013 – USA TODAY and “The Skeptics” selling false hope to cancer patients:
[14] – 9/1986 and 1/1987 – THE DISEASE OF INFORMATION: AN INTERVIEW WITH STANISLAW BURZYNSKI (The following interview was conducted in Sept., 1986, and January, 1987, and was first published in the Townsend Letter for Doctors, June 1989 – Reprinted with permission from the author):
[15] – 7/4/1996– Cameron Frye Has a Big Idea (Bob Burtman):
[16] – 1996 – Cancer doctor disregarded warnings, prosecutor says (Lubbock Avalanche-Journal):
[17] – 2/22/1997 – Trial of Houston Doctor Linked to Unapproved Drugs Goes to Jury:
[18] – 2/24/1997 – Houston cancer doctor’s trial resumes (The Victoria Advocate):
[19] – 3/4/1997 – Deadlocked jurors force mistrial in case of cancer doctor (By TERRI LANGFORD Associated Press Writer):
[20] – 5/27/1997 – Long legal squabble ends for Burzynski: Embattled cancer doctor acquitted (Lubbock Avalanche-Journal):
[21] – 5/28/1997 – Embattled cancer doctor acquitted of contempt charge (By JOAN THOMPSON / Associated Press Writer):
[22] – 6/1997Burzynski Acquitted Of Fraud Judge Declares Mistrial on Other
Prosecutor George Tallichet said that Burzynski had not conformed to the standards of the Food, Drug …
[23] – 7/7/1997 – Free Market Medicine:
[24] – 12/15/1997 – FDA vendetta against cancer doc:
[25] – 1/1/2002 – Cancer Patient Thomas Navarro Dies at Age Six [medical freedom case]:
[26] – Praktikos Institute

Click to access Selections-from-FDA.pdf

[27] – Dr Stanislaw Burzynski — Antineoplaston Therapy — Articles:
[29] – 9/8/1993 – Public Corruption Working Group Report – The Sentencing (Amy Lecocq)

Click to access ussc_report_publiccorruption_19930908.pdf



guychapman (Guy Chapman) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 9)



Didymus Judas Thomas, Contributor

Musings on the intersection of Articles, Bias, and Censorship

(The Big 3: A.B.C.)

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

guychapman 5 days ago

“Well, this has flushed out i the comments most of what we’ve seen on Twitter and the blogs over the past year or two.”

guychapman, hardly
Forbes censors Peter Lipson
“Speech is best countered by more
speech” article comments:
"On the one side we have the true believers claiming that there is a cure, that it’s being denied, that people would “otherwise die” (begging the question), and asking for “respect” and “decency”"

guychapman, THIS cure ?

Click to access BurzynskiTriesToExposeNCI.pdf

"(as if it is respectful and decent to claim to cure cancer without good evidence)."

guychapman, THIS “good evidence” that you’re “without” ?

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
"On the other side we have one really very simple point: show me the evidence."

guychapman, THIS “good evidence” that you’re “without” ?

The FDA’s Drug Review Process:

Ensuring Drugs Are Safe and Effective

“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″

“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
“61 registered human trials, one completed, zero results published, from any of them.”

guychapman, do you mean THIS ?

clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:

1 – Not Yet Recruiting (Open)(Phase 3)
1 – Closed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

The below 1st link: 10 Active (Open):
The below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
NONE of the above are “UNKNOWN” per the above 2 National Cancer Institute (NCI) at the National Institutes of Health (NIH) links:

10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

11=1 Not Yet Recruiting / 10 Recruiting

“The Burzynski fans’ snowstorm of irrelevant, low-grade publications in low impact journals and conference abstracts that aren’t even peer-reviewed, do not address this at all.”

guychapman, are you referring to THIS ?

The “National Cancer Institute (NCI) at the National Institutes of Health (NIH)

Cancer Clinical Trials,

15. What happens when a clinical trial is over?”

“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”

” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “
This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”

“The Helsinki Declaration states the obligations of those conducting trials in humans, and getting the results (good or bad) published and available is a core requirement.”

guychapman, WHERE does the Declaration of Helsinki indicate WHEN the final results of human clinical trials MUST be published?

Burzynski: Declaration of Helsinki
guychapman 5 days ago

“I have some questions for the Burzynski fans.”

guychapman, I have some questions for you

Is it just me, or does it seem like I’m repeating what I already provided HERE?

Critiquing “The Skeptic”
Burzynski Critics: A Film
Producer, A Cancer
Doctor, And Their Critics (page 9)
“1. Burzynski’s claims are superficially similar to those of Max Gerson.”

“Gerson’s therapy is known to be ineffective and potentially harmful, but he used patient anecdotes – people sincerely convinced they had undergone a miracle cure – to promote his business.”

“What *objective* mechanism do you propose we use to distinguish between Burzynski and the quack Gerson?”

guychapman, how about the publications and Securities and Exchange (SEC) filings cited on my page 9 critique?

“2. Burzynski has registered 61 clinical trials in humans, completed one and published no useful data from any.”

guychapman, you obviously have a very “fast and loose” definition of “no useful data”

Exactly WHAT is your definition of “no useful data”?

“Can you name any mainstream cancer research operations that have similar rates of failure to compete and publish?”

guychapman, can you name any mainstream publications like Forbes that have similar rates of failure to “compete” and publish my 15+ comments in reply to your 18 comments?

Do you think it was because they knew that I would “rip you a new one” and you would be left there as the proverbial “Emperor (who) has no clothes”?

“3. How many people do you estimate are involved, globally, in the conspiracy to suppress Burzynski’s treatment?”

“My rough guess is a few hundred thousand.”

“Can you give a better estimate with reasons?”

guychapman, let’s start with YOU, guychapman (Guy Chapman, @SceptiGuy, @vGuyUK,
your pals at Wikipedia; Jimmy (Jimbo) Donal Wales,
(@jimmy_wales – whom you re-twit on Twitter), JzG|Guy, Guy, Anthony (AGK) BASC, Alexbrn, Dave Dial, Drmies, NE Ent, fluffernutter, foxj, jpgordon, Guerillero, Ironholds, John, Lord Sjones23, Tom Morris, Nstrauss, Steve Pereira/SilkTork, Rhode Island Red, Arthur Rubin, Choyoołʼįįhí:Seb az86556 (Seb az86556), Sgerbic, IRWolfie, Six words, Yobol, @RudyHellzapop, @_JosephineJones, @JCmacc1, @Malboury, @DianthusMed, @medTek, @StopBurzynski, @StortSkeptic, Dr. Peter A. Lipson (@palMD), #Forbes censor(s), Dr. David H. Gorski (@gorskon, @oracknows, @ScienceBasedMed, #sciencebasedmedicine,
The Faux Skeptic Revealed! Bob Blaskiewicz (@rjblaskiewicz, R.J. Blaskiewicz, Blatherskitewicz), C0nc0rdance, Boris Ogon, lilady, JGC2013, claire G, Sharon Hill, Allen Jones, Lynne, @JCmacc1, Paul Morgan (@drpaulmorgan), oval wooki, Vered Yasur, (the Forbes group) and
http://burzynskimovie.com/images/stories/transcript/Documents/BurzynskiTriesToExposeNCI.pdf, etc.

“4. When you talk about Antineoplastons not being chemotherapy, what, in your mind, distinguishes the intravenous administration of one chemical from the intravenous administration of another, other than the fact that it’s Burzynski doing it?”

guychapman, THIS:

“High Dose ANPA chemotherapy IV drip”

“…an unapproved drug, not ordinary “chemotherapy”
“5. When you speak about ANPs not being toxic, what, in your mind, distinguishes the side effects of “non-toxic” ANPs”

“(nausea, hypernatraemia, stroke etc)”

“form the side effects of other, “toxic” drugs?”

guychapman, THIS:

FACT: Is “HYPERNATREMIA” listed on the National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect” of antineoplastons?:
I do NOT see HYPERNATREMIA or STROKE on the list

2/13/2013 – The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center
Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay

Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA

Department of General Internal Medicine, University of Texas MD Anderson Cancer Center

Division of Endocrinology, Mayo Clinic

Support Care Cancer. 2013 Feb 13. [Epub ahead of print]

Supportive Care in Cancer
February 2013


“HYPERNATREMIA is the most common electrolyte disorder in the United States”

“In some cases, CANCER may cause the condition …”
“A Burzynski critic has posted:”

“In order to maintain their doses of ANP, patients are required to drink obscene amounts of water every day (some report up to 12 quarts or more)”

“If they fail to do so, they may lapse into unconsciousness or die”

Let’s put this in perspective

FACT: Some sources indicate:

1) A man should drink about
3 liters (101.44 ounces / 3 quarts 5.44 ounces) per day

{12 quarts = 384 ounces = 11.356 liters}

[12 quarts in 24 hours = 1/2 quart or 16 ounces per hour]

2) Extremely healthy kidneys could process about 30 ounces (approx .9 liters) of water in an hour

{30 ounces in 24 hours = 720 ounces}

[720 ounces = 22.5 quarts per day]

3) A person with healthy kidneys could develop water intoxication by drinking about 2 to 3 times what their kidneys can process

So, if extremely healthy kidneys could process about 30 ounces per hour and 12 quarts per day would require one to only drink 16 ounces per hour, that means one is being asked to drink 14 ounces less per hour than what extremely healthy kidneys could process

So even if one drinks more than 16 ounces per hour so that one does not have to be awake hourly, there is still opportunity to do that

Of course, there are certain other factors that might have to be taken into consideration depending on the patient

“6. Burzynski has convinced you that he can cure incurable cancers.”

“What figures has he given you for his five-year survival versus standard of care?”

guychapman, HERE:

2003 – Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma:

a preliminary report
Drugs R D. 2003;4(2):91-101

recurrent diffuse intrinsic brain stem glioma

of all 12 patients
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis

from the start of treatment
5 years – 1 alive for more than
4 years – 1 alive for more than

Protocol – recurrent diffuse intrinsic brain stem glioma
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease

2004 – Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma :

a preliminary report
Drugs R D. 2004;5(6):315-26

incurable recurrent and progressive multicentric glioma

6 patients were diagnosed with pilocytic astrocytoma

4 with low-grade astrocytoma
1 with astrocytoma grade 2

1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans

1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

10 patients are alive and well from 2 to >14 years post-diagnosis

Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
– Evaluable Patients
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

2005 – Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1
Integr Cancer Ther. 2005 Jun;4(2):168-77

13 children with recurrent disease or high risk

6 (46%) survived more than 5 years

Protocol – recurrent disease or
high risk
– Patients Accrued
– Evaluable Patients
23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – % of Patients Showing Progressive Disease

2006 – Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma
Integr Cancer Ther. 2006 Mar;5(1):40-7

Brainstem glioma carries the worst prognosis of all malignancies of the brain

Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years

Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)

patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients

18 – evaluable

Protocol – high-grade pathology (HBSG)
– Patients Accrued
18 – Evaluable Patients
11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease

2007 – Recent clinical trials in diffuse intrinsic brainstem glioma

Review Article
Cancer Therapy Vol 5, 379-390, 2007


Boris Ogon 1 week ago

(citing AstroturfWatch)

“They refuse to fact check anything. Namely Phase 2 results showing a 25% cure rate for brainstem glioma, never accomplished in medical history—ever.”

“Published plan as day in a ‘internationally peer-reviewed’ article.”

“You mean PMIDs 12718563 and 16484713? (These, at least, are the ones that Merola cites, which I assume is the sum total of your “fact checking.”)”

“Namely Phase 2 results showing a 25% cure rate for brainstem glioma, never accomplished in medical history—ever”

“Notice the chart on page 172 (page 8 of PDF).”

“Find just one, any single cure for this tumor type and you can’t, outside of Antineoplastons FDA sanctioned clinical trials:”

Click to access 1252.pdf

“The first reference is to Drugs in R&D 4:91 (2003).”

“The second reference is to Integrative Cancer Therapies 4:168 (2005).”

The “chart on page 172 (page 8 of PDF):”

Click to access 1252.pdf

refers to:

2006 Adis – Pediatr Drugs 2006; 8 (3)

pg 172

Treatments for Astrocytic Tumors

Table II. Treatment of diffuse, intrinsic brainstem glioma in children

Burzynski et al. [88] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RP (30) – RP = recurrent and progressive tumor – Tumor type
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y]
46.7; 30 – Efficacy
MST (mo)
19.9 – MST = median survival time
[% (no. )]
27 (8) – CR – CR = complete response
[% (no. )]
20% (6) – PR – PR = partial response
[% (no. )]
23% (7) – SD – SD = stabile disease
30% (9) – PD = progressive disease

pg 177

88. Burzynski SR, Weaver RA, Janicki T. Long-term survival in phase II studies of antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic brain stem glioma [abstract]. Neuro-oncol 2004; 6: 386

This is the 2004 publication, NOT 2003

Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report.
Drugs R D. 2004;5(6):315-26

pg 172

Burzynski et al. [89] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RPS (10) – RPS = recurrent and progressive tumors in children aged <4y – Tumor type {(66) = most in a study}
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y] – Efficacy
60; 20 {46.7 (30) = next best study}
MST (mo)
26.3 – MST = median survival time – {19.9 = next best study}
[% (no. )]
30% (3) – CR = complete response – {27% (8) = next best study}
[% (no. )]
0% (0) – PR = partial response – {56% (1) = next best}
[% (no. )]
40% (4) – SD = stable disease – {44% (25) = best}
[% (no. )]
30% (3) – PD = progressive disease – {23% (13) = best}

(Above, I also provide the best next case to compare to)

pg 177

89. Burzynski SR, Weaver RA, Janicki TJ, et al. Targeted therapy with ANP in children less than 4 years old with inoperable brain stem gliomas [abstract]. Neuro-oncol 2005; 7: 300

Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1.
Integr Cancer Ther. 2005 Jun;4(2):168-77

pg 173

1.4.3 Targeted Therapy

“…multi-targeted therapy with ANP has shown promising results [12;88-91]”

pg 176

90. Burzynski SR, Lewy RI, Weaver RA, et al. Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report. Drugs R D 2003; 4: 91-101

Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report.
Drugs R D. 2003;4(2):91-101

91. Burzynski SR, Weaver RA, Janicki T. et al. Targeted therapy with antineoplastons A10 and AS2-1 (ANP) of high-grade, recurrent and progressive brain stem glioma. Integr Cancer Ther 2006 Mar; 5 (1): 40-7

Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.
Integr Cancer Ther. 2006 Mar;5(1):40-7

30 evaluable patients with recurrent and progressive DBSG

“>40% of patients survived for more than 2 years
30% more than 5 years.”

27% – CR – Complete Response
20% – PR – Partial Response
23% – SD – Stable Disease
30% – PD – Progressive Disease

pg 175

12. Burzynski SR Targeted therapy for brain tumors In: Columbus, F editor. Brain cancer research progress. New York: Nova Science Publishers Inc 2005

pg 173

10 evaluable children
aged <4 years diagnosed with DBSG treated with ANP
youngest 3-month-old infant

60% – 2-year survival rate
20% – 5-year survival rate
maximum survival more than 7 years

30% – CR – Complete Response
40% – SD – Stable Disease
30% – PD – Progressive Disease

“The results are compiled in table II.”

pg 174

2.3. Targeted Therapy

Multi-targeted ANP therapy is free from chronic toxicity in children and adults based on the results of numerous clinical studies involving

1652 adults
335 children

pg 178

147. Burzynski SR. Annual report to the FDA, IND 43,742, 2006

pg 174

Long-term follow-up of children treated with ANP for astrocytomas revealed:
normal development
no cognitive or endocrine deficiencies
normal fertility

>5 years – substantial number of patients tumor free
>17 years – follow-up period for some patients

pg 169

1.1.4. Targeted Therapy

Clinical trials with agents affecting single targets are in progress and the preliminary results of multi-targeted therapy with
antineoplastons (ANP) A10
AS2-1 have been reported

small group of patients with progressive LGA, ANP
60% – CR rate – Complete Response
10% – PR rate – Partial Response
median survival 7 years 9 months
maximum survival of more than 15 years

LGA = Low-Grade Astrocytomas

Table I. Selected chemotherapy regimens for the treatment of low- grade astrocytoma in children

Burzynski [39] – Reference
Phase II d – d = Preliminary results – Study type
P – P = progressive tumor – Tumor type
(no. of pts) – pts = patients
ANP (10) – ANP = antineoplastons A10 and AS2-1 – Treatment {(78) = most in a study}
OS [%] – OS = overall survival
100% (1 yr) – 90% (3 yr) – Efficacy
93 mo – MST = MST = median survival time – {96 (1 y) next closest}
CR [% (no.)]
60% (6) – CR = complete response {24 (11) next closest}
PR [% (no.)]
10% (1) – PR = partial response {60% (9) best other study}
[% (no.)]
30% (3) – SD = stable disease + MR = minor response {70% (14) best other study}
[% (no.)]
0% (0) – PD = progressive disease {4% (2) next closest}
PFS (%)
90 (1 y) – 90 (3 y) – PFS = progression-free survival {100 (1 y) – 68 (3 y) best other study

(Above, I also provide the best next case to compare to)

pg 176

39. Burzynski SR Clinical application of body epigenetic system: multi-targeted therapy for primary brain tumors. World and Ehrlich Conference on Dosing of Magic Bullets; 2004 Sep 9-11 Nurnberg

Burzynski Clinical Trials (The SEC filings):
Who has audited these figures?

guychapman, YOU just did

Otherwise, check with the Food and Drug Administration (FDA)

Where are they published?

guychapman, if you have NOT yet figured THAT out…

“7. There are numerous cases where the Burzynski clinic has said a tumour is “dying from the inside”, but where it turns out that it is growing aggressively and suffering necrosis due to outstripping its blood supply; this is usually a precursor to the death of a patient only weeks after being told they were on the way to a cure.”

“How do you account for this repeated error?”

guychapman, WHERE is the documentation?

Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “


Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM

Peter Lipson: “Speech is best countered by more speech”