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 ?
——————————————————————

20131209-192845.jpg
——————————————————————
“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?”
——————————————————————
“No”
——————————————————————
“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)
——————————————————————
“No”
——————————————————————
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 ?

20131209-234700.jpg
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 ?
or
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

“No,”

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”

MEANT:

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
x
34
=
170 years

$250,000
x
34
=
$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
x
40
=
120 years

$250,000
x
40
=
$10,000,000 MILLION
——————————————————————
TOTAL
——————————————————————
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
——————————————————————
======================================
REFERENCES:
======================================
[1] – 12/7/2013 – How to Crank your Congressperson (according to “The Skeptics”: USA TODAY vs. Dr. Stanislaw Burzynski):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/12/07/how-to-crank-your-congressperson-according-to-the-skeptics-usa-today-vs-dr-stanislaw-burzynski/
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[2] – 2/4/1998Dr. Ralph MossGovernment Reform and Oversight Committee
——————————————————————
http://www.forhealthfreedom.org/Publications/Monopoly/Moss.html
——————————————————————
http://archive.is/gKNcL
======================================
[3]The FDA’s Vendetta Against Dr. Burzynski: By Dean Mouscher, Director, Clinical Trials, Burzynski Institute
——————————————————————
http://www.freerepublic.com/focus/fr/602961/replies?c=24
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[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
——————————————————————
http://www.rcfp.org/digital-journalists-legal-guide/sources-and-subpoenas-reporters-privilege
======================================
[5] – 4-5/2008 – From AJR, April/May 2008, A Flurry of Subpoenas, By Kevin Rector
——————————————————————
http://ajrarchive.org/article.asp?id=4511
======================================
[6] – Mass Media Law | Chapter Overview, Protection of News Sources/Contempt Power, Chapter Overview, Constitutional Protection of News Sources:
——————————————————————
http://highered.mcgraw-hill.com/sites/0072492171/student_view0/chapter10/chapter_overview.html
======================================
[7] – 9/18/2013Online News Association
——————————————————————
http://journalists.org/2013/09/18/ona-working-to-ensure-federal-shield-law-truly-protects-journalists/
======================================
[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
——————————————————————
http://cjr.org/303546/show/e0254cdea27dd5aabd57553cc5190110/?
——————————————————————
http://m.cjr.org/303546/show/e0254cdea27dd5aabd57553cc5190110/?
======================================
[9] – 11/21/2013 – Critiquing: Eric Merola and Stanislaw Burzynski respond to the FDA findings and the USA TODAY story. Hilarity ensues:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/21/httpscienceblogs-cominsolence20131118eric-merola-and-stanislaw-burzynski-respond-to-the-fda-findings-and-the-usa-today-story-hilarity-ensues/
======================================
[10] – 6/4/2013Stanislaw Burzynski versus the BBC:
——————————————————————
http://scienceblogs.com/insolence/2013/06/04/stanislaw-burzynski-versus-the-bbc/
======================================
[11] – 12/2002 – Interview with Dr. Burzynski, M.D., Ph.D. Biochemistry (12/2002):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/12/httpwww-cancerinform-orgaburzinterview-html/
======================================
[12] – 11/22/2013 – Is anyone attending the 4th Quadrennial Meeting of the Society of Neuro-Oncology in San Francisco right now?:
——————————————————————
http://scienceblogs.com/insolence/2013/11/22/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:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/12/04/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):
——————————————————————
http://www.encognitive.com/node/4174
======================================
[15] – 7/4/1996– Cameron Frye Has a Big Idea (Bob Burtman):
——————————————————————
http://www.houstonpress.com/1996-07-04/news/cameron-frye-has-a-big-idea/full/
======================================
[16] – 1996 – Cancer doctor disregarded warnings, prosecutor says (Lubbock Avalanche-Journal):
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http://lubbockonline.com/news/010997/cancer.htm
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[17] – 2/22/1997 – Trial of Houston Doctor Linked to Unapproved Drugs Goes to Jury:
——————————————————————
http://www.nytimes.com/1997/02/22/us/trial-of-houston-doctor-linked-to-unapproved-drugs-goes-to-jury.html
======================================
[18] – 2/24/1997 – Houston cancer doctor’s trial resumes (The Victoria Advocate):
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http://news.google.com/newspapers?nid=861&dat=19970224&id=l08KAAAAIBAJ&sjid=3UoDAAAAIBAJ&pg=3982,4466569
======================================
[19] – 3/4/1997 – Deadlocked jurors force mistrial in case of cancer doctor (By TERRI LANGFORD Associated Press Writer):
——————————————————————
http://www.texnews.com/texas97/mistrial030497.html
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[20] – 5/27/1997 – Long legal squabble ends for Burzynski: Embattled cancer doctor acquitted (Lubbock Avalanche-Journal):
——————————————————————
http://lubbockonline.com/news/052897/long.htm
======================================
[21] – 5/28/1997 – Embattled cancer doctor acquitted of contempt charge (By JOAN THOMPSON / Associated Press Writer):
——————————————————————
http://www.texnews.com/texas97/doc052897.html
======================================
[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 …
——————————————————————
http://m.lef.org/magazine/mag97/june-report97.htm
======================================
[23] – 7/7/1997 – Free Market Medicine:
——————————————————————
http://www.thenewamerican.com/usnews/health-care/item/1895-free-market-medicine
======================================
[24] – 12/15/1997 – FDA vendetta against cancer doc:
——————————————————————
http://www.science-bbs.com/117-life-extension/9624d6ce44477915.htm
======================================
[25] – 1/1/2002 – Cancer Patient Thomas Navarro Dies at Age Six [medical freedom case]:
——————————————————————
http://www.freerepublic.com/focus/fr/602961/posts
======================================
[26] – Praktikos Institute
——————————————————————
http://www.praktikosinstitute.org/wp-content/uploads/2011/08/Selections-from-FDA.pdf
======================================
[27] – Dr Stanislaw Burzynski — Antineoplaston Therapy — Articles:
——————————————————————
http://www.rexresearch.com/burzynski/burzynski.htm
======================================
[28]
——————————————————————
http://www.pdfio.com/k-2065004.html
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[29] – 9/8/1993 – Public Corruption Working Group Report – The Sentencing (Amy Lecocq)
——————————————————————
http://www.src-project.org/wp-content/uploads/2009/08/ussc_report_publiccorruption_19930908.pdf
======================================

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Pete Cohen chats with Richard A. Jaffe, Esq.

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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
======================================

WHAT IS MISDIRECTION? Critiquing “Antineoplastons: Has the FDA kept its promise to the American people ?”

March 29, 1996

Then United States Food and Drug Administration Commissioner, David Kessler told the American people:

1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators

2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trialsfewer patients … if there is evidence … of partial response in clinical trials

I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials

3. We will accept … less informationup front

4. we’re going to require further study AFTERapproval … because the science … has matured

5. The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point

You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works

6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons

7. We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work
——————————————————————
BOTTOM LINE:
——————————————————————
Everything else is MISDIRECTION
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
——————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?

B. What is the FDA’s definition of “smaller trials”?

C. What is the FDA’s definition of “fewer patients”?

D. What is the FDA’s definition of “evidence … of partial response“?

E. What is the FDA’s definition of “less information … up front”?

F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?

G. What is the FDA’s definition of “We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work”?
======================================
2003 – 2009 Phase II preliminary
——————————————————————
2003 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
(Drugs in R and D / Drugs in Research and Development)

2003: 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
2 / 20% – # and % of Patients Showing Progressive Disease
======================================
http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:

1. 10/2003

NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R.A., Bestak, M., Lewy, R.I., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I.

Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive MULTICENTRIC GLIOMA

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf
Neuro-Oncology. 2003; 5: 358
Volume 5 Issue 4 October 2003

10/2003 – Protocol – MULTICENTRIC GLIOMA

12 – Children Patients Accrued
10 – Evaluable Patients
(9 months-17 years / 9 – median age)

4 / 33% – # and % of Patients Showing Complete Response
2 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
1 / 9% – # and % of Patients Nonevaluable due to only 4 weeks of treatment / lack of follow-up scans
======================================
Interim Reports on Clinial Trials:

16. 2003

DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)

BT-11
BRAIN STEM GLIOMA

Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:

a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Burzynski, S.R., Lewy, R.I., Weaver, R.A., Axler, M.L., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I., Bestak, M.
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf

Pgs. 91-92 and 95

3/1996 – Protocol – recurrent diffuse intrinsic BRAIN STEM GLIOMA (3/1996 – 5/1999 enrolled / Pg. 94)

12 – Patients Accrued (6 males / 6 females)
(4-29 years / 10 – median age)
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
2 / 20% – # and % of Patients Showing Progressive Disease
======================================
2004 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
(Drugs in R and D / Drugs in Research and Development)

2004: Protocol – incurable recurrent and progressive multicentric glioma

12 – Patients Accrued
(9 – median age)
11 – Evaluable Patients

4 / 33% – # and % of Patients Showing Complete Response
3 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

2. 10/2004

NEURO-ONCOLOGY

BT-20
Patients With GLIOBLASTOMA MULTIFORME (GBM)

Weaver, R.A., Burzynski, S.R., Bestak, M., Lewy, R.I., Janicki, T.J., Szymkowski, B., Jurida, G., Khan, M.I., Dolgopolov, V.

Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent GLIOBLASTOMA MULTIFORME
http://www.burzynskiclinic.com/images/stories/Publications/1218.pdf
Neuro-Oncology. 2004; 6: 384
Volume 6 Issue 4 October 2004
Abstracts from the Society for Neuro-Oncology Ninth Annual Meeting, Toronto, Ontario, Canada, November 18-21, 2004

Pg. 385

10/2004 – Protocol – glioblastoma multiforme (GBM) which recurred or progressed post surgery, radiation therapy, and / or chemotherapy

22 – Evaluable Patients
(6 men / 16 women / 27-63 /47 – median age)

1 / 4.5% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
12 / 54.5% – # and % of Patients Showing Stable Disease
8 / 36.5% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

3. 10/2004 (DBSG)

NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA
http://www.burzynskiclinic.com/images/stories/Publications/1219.pdf
Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004

60 patients
(31 didn’t meet admission criteria to the study and were treated under Special Exception (SE))

10/2004 – Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG)

29 – Evaluable Patients

7 / 24% – # and % of Patients Showing Complete Response
6 / 21% – # and % of Patients Showing Partial Response
6 / 21% – # and % of Patients Showing Stable Disease
10 / 34% – # and % of Patients Showing Progressive Disease
——————————————————————
31 – Evaluable Patients: Special exception (SE)

5 / 16% – # and % of Patients Showing Complete Response
2 / 6% – # and % of Patients Showing Partial Response
16 / 52% – # and % of Patients Showing Stable Disease
8 / 26% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

4. 10/2004 (AT/RT of CNS)

NEURO-ONCOLOGY

BT-14

CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

Phase II studies of antineoplastons A10 and AS2-1 (ANP) in children with atypical teratoid/rhabdoid tumors (AT/RT) of the central nervous system

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf
Neuro-Oncology. 2004; 6: 427
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology, Boston, Massachusetts, June 13-16, 2004

10/2004 – Protocol – children with atypical teratoid / rhabdoid tumors (AT / RT) of the central nervous system

11 – Children Patients Accrued
8 – Evaluable Patients
(7 treated under Special Exception (SE))

2 / 25% – # and % of Patients Showing Complete Response
1 / 12.5% – # and % of Patients Showing Partial Response
1 / 12.5% – # and % of Patients Showing Stable Disease
4 / 50% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

5. 10/2004

NEURO-ONCOLOGY

BT-12

CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.

Treatment of PRIMITIVE NEUROECTODERMAL TUMORS (PNET) with antineoplastons A10 and AS2-1 (ANP)

Preliminary results of phase II studies
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf
Neuro-Oncology. 2004; 6: 428
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology

10/2004 – Protocol – PRIMITIVE NEUROECTODERMAL TUMORS (PNET)

17 – Patients Accrued
15 – Evaluable Patients
(12 months – 23 years / 6 – median age)

3 / 20% – # and % of Patients Showing Complete Response
2 / 13.4% – # and % of Patients Showing Partial Response
5 / 33.3% – # and % of Patients Showing Stable Disease
5 / 33.3% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

17. 2004

DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)

Burzynski, S.R., Weaver, R., Lewy, R., Janicki, T. Jurida, G., Szymkowski, B., Khan, M., Bestak, M.

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

A Preliminary Report.
http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs R&D 2004;5(6):315-326.
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf

incurable recurrent and progressive multicentric glioma

Pg. 320

3 – treated under Special Exception (SE) granted by the US FDA

Pgs. 317 and 320

7/31/1996 – (7/31/1996 – 4/3/2002 as of 3/1/2004) Protocol – children with recurrent and progressive multicentric glioma (MCG)

Pg. 317

BT-13

children with low-grade astrocytoma

BT-23

children with visual pathway gliomas


Pgs. 317 and 320-321

12 – Children Patients Accrued (Pgs. 315-316)
(9 months – 17 years / 9- median age)
(6 – male / 6 – females)
10 – Evaluable Patients (Pg. 315)

4 / 33% – # and % of Patients Showing Complete Response
3 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
1 / 9% – # and % of Patients Non-evaluable
——————————————————————
Pg. 325

Compare: Chamberlain and Grafe. [38]

1995 – Protocol – solitary recurrent chiasmatic hypothalamic gliomas treated with oral etoposide


14 – Patients Accrued
14 – Evaluable Patients

1 / 7% – # and % of Patients Showing Complete Response
4 / 29% – # and % of Patients Showing Partial Response
3 / 21% – # and % of Patients Showing Stable Disease
6 / 43% – # and % of Patients Showing Progressive Disease

Pg. 326

38. Chamberlain MC, Grafe MR. Recurrent chiasmatic-hypothalamic glioma treated with oral etoposide. J Clin Oncol 1995; 13: 2072-6
http://www.ncbi.nlm.nih.gov/pubmed/7636550/
J Clin Oncol. 1995 Aug;13(8):2072-6.
http://www.ncbi.nlm.nih.gov/m/pubmed/7636550/
Department of Neurosciences, University of California, San Diego, La Jolla, USA.
http://m.jco.ascopubs.org/content/13/8/2072.long
Arch Neurol. 1995 May;52(5):509-13.
http://www.ncbi.nlm.nih.gov/pubmed/7733847/
Department of Neurosciences, University of California-San Diego, USA.
http://www.ncbi.nlm.nih.gov/m/pubmed/7733847/
Arch Neurol. 1995;52(5):509-513. doi:10.1001/archneur.1995.00540290099024.
http://archneur.jamanetwork.com/Mobile/article.aspx?articleid=593460
——————————————————————
Compare: The Pediatric Oncology Group. [39]

10/2000 – Protocol – solitary progressive optic pathway tumors with carboplatin

50 – Patients Accrued
50 – Evaluable Patients

2 / 4% – # and % of Patients Showing Partial Response
37 / 74% – # and % of Patients Showing Stable Disease
11 / 22% – # and % of Patients Showing Progressive Disease

39. Mahoney DH, Cohen ME, Friedman HS, et al. Carboplatin is effective therapy for young children with progressive optic pathway tumors: a Pediatric Oncology Group phase II study. Neuro-oncol 2000; 2: 213-20
http://www.ncbi.nlm.nih.gov/pubmed/11265230/
Neuro Oncol. 2000 Oct;2(4):213-20.
http://www.ncbi.nlm.nih.gov/m/pubmed/11265230/
Baylor College of Medicine, Houston, TX, USA.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1920597/

http://neuro-oncology.oxfordjournals.org/content/2/4/213.full.pdf
======================================
2005 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
(Integrative Cancer Therapies)

2005: Protocol – recurrent disease or high risk

13 – Patients Accrued
(1-11 – age / 5 years 11 months – median age)
13 – Evaluable Patients

3 / 23% – # and % of Patients Showing Complete Response
1 / 8% – # and % of Patients Showing Partial Response
4 / 31% – # and % of Patients Showing Stable Disease
5 / 38% – # and % of Patients Showing Progressive Disease
——————————————————————
(Updated 2007)
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html
2005 – Protocol – incurable recurrent and progressive multicentric glioma

13 – Patients Accrued

3 / 23% – # and % of Patients Showing Complete Response
1 / 8% – # and % of Patients Showing Partial Response
4 / 31% – # and % of Patients Showing Stable Disease
5 / 38% – # and % of Patients Showing Progressive Disease
======================================
2006 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
(Integrative Cancer Therapies)

2006: Protocol – high-grade pathology (HBSG)

– Patients Accrued
18 – Evaluable Patients

2 / 11% – # and % of Patients Showing Complete Response
2 / 11% – # and % of Patients Showing Partial Response
7 / 39% – # and % of Patients Showing Stable Disease
7 / 39% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

BT-03


BT-11

BRAIN STEM GLIOMA (BSG)

BT-18

6. MIXED GLIOMA

ADULT PATIENTS WITH MIXED GLIOMA

“mixed glioma”, a type of primary malignant brain tumor (PMBT)

BT-22

8. CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS

CAN-01 (CAN-1)

PATIENTS WITH REFRACTORY MALIGNANCIES

19. 3/2006

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B. Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive BRAINSTEM GLIOMA. Integrative Cancer Therapies 2006;5(1):40-47
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
DOI: 10.1177/1534735405285380
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf

http://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713
Pgs. 40-41

4 phase 2 trials

BRAINSTEM GLIOMA (BSG)

patients with inoperable tumor of high-grade pathology (HBSG)
glioblastoma

recurrent diffuse intrinsic glioblastomas and ANAPLASTIC ASTROCYTOMAs of brainstem

Pg. 43

BT-03 – 1 / female
BT-11 – 13 (8 males/5 females)
BT-18 – 1 / female
BT-22 – 2 / females
CAN-01 – 1 / female

Pg. 44

High-grade, recurrent, and progressive brainstem gliomas

Pgs. 40-42 and 44-45

7/12/1988 (7/12/1988 – 11/13/2003 as of 6/10/2005) – Protocol – recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem high-grade pathology (HBSG)

18 – Evaluable Patients (Pgs. 40-43)
(8 males / 10 females / 2-42 / 10 – median age / Pgs. 42-43)

2 / 11% – # and % of Patients Showing Complete Response
2 / 11% – # and % of Patients Showing Partial Response
7 / 39% – # and % of Patients Showing Stable Disease
7 / 39% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

8. 10/2006

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B.G., Khan, M.I., Dolgopolov, V. Treatment of multicentric BRAINSTEM GLIOMAs with antineoplastons (ANP) A10 and AS2-1. Neuro-Oncology. 2006; 8:466.
http://www.burzynskiclinic.com/images/stories/Publications/2105.pdf
Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)

Brainstem gliomas and multicentric tumors (MBSG)

10/2006 – Protocol – Brainstem gliomas and multicentric tumors (MBSG)

19 – Evaluable Patients
3.9 – 40.8 years (9.2 – median age)
(90% less than 18 years old)

2 / 11% – # and % of Patients Showing Complete Response
1 / 5% – # and % of Patients Showing Partial Response
7 / 37% – # and % of Patients Showing Stable Disease
9 / 47% – # and % of Patients Showing Progressive Disease
======================================
2007
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
2004 – Protocol – small group of patients with progressive LGA, ANP
60% – % of Patients Showing Complete Response
10% – % of Patients Showing Partial Response
——————————————————————
2004 – Protocol – 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
10 – Evaluable Patients {(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}
60% (6) – % and # of Patients Showing Complete Response {24 (11) next closest}
10% (1) – % and # of Patients Showing Partial Response {60% (9) best other study}
30% (3) – % and # of Patients Showing Stable Disease + MR = minor response {70% (14) best other study}
0% (0) – % and # of Patients Showing 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
——————————————————————
2004 – Protocol – 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
30 – Evaluable Patients
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
27% (8) – % and # of Patients Showing Complete Response
20% (6) – % and # of Patients Showing Partial Response
23% (7) – % and # of Patients Showing Stable Disease
30% (9) – % and # of Patients Showing Progressive Disease
——————————————————————
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}
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

9. 4/2007 (NDBSG)

Burzynski, S.R., Weaver, R.A., Janicki, T.J., Jurida, G.F., Szymkowski, B.G., Kubove, E. Phase II studies of Antineoplastons A10 and AS 2-1 (ANP) in children with newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs. Neuro-Oncology 2007; 9:206.
http://www.burzynskiclinic.com/images/stories/Publications/4021.pdf
Volume 9 Issue 2 April 2007
Abstracts from the Twelfth International Symposium on Pediatric Neuro-Oncology

4/2007 – Protocol – newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs (NDBSG)

20 – Evaluable assessable children Patients
(3 months-20 years – age)

6 / 30% – # and % of Patients Showing Complete Response
2 / 10% – # and % of Patients Showing Partial Response
4 / 20% – # and % of Patients Showing Stable Disease
8 / 40% – # and % of Patients Showing Progressive Disease
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

Special exception (SE)

13. 12/2009 (DBSG)

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B., Burzynski, G.S. Phase II study of antineoplastons A10 and AS2-1 in patients with BRAINSTEM GLIOMA. Protocol BC-BT-11. Neuro-Oncology 2009, 11:951.
http://www.burzynskiclinic.com/images/stories/Publications/8639.pdf
Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO)
May 11-14, 2009
Yokohama, Japan

12/2009 – Protocol – BRAINSTEM GLIOMAs

40 – Patients Accrued
28 – Evaluable Patients
(23 children / 5 young adults)

5 / 18% – # and % of Patients Showing Complete Response
4 / 14% – # and % of Patients Showing Partial Response
12 / 43% – # and % of Patients Showing Stable Disease
7 / 25% – # and % of Patients Showing Progressive Disease
——————————————————————
Special exception (SE)

12/2009 – Protocol – BRAINSTEM GLIOMAs

52 – Evaluable Patients
(40 children / 12 young adults)

5 / 10% – # and % of Patients Showing Complete Response
2 / 4% – # and % of Patients Showing Partial Response
28 / 54% – # and % of Patients Showing Stable Disease
17 / 32% – # and % of Patients Showing Progressive Disease
——————————————————————
BT-11 and special exception (SE)
92% – diffuse intrinsic brainstem gliomas (DBSG)

Overall survival (OS) – 2 years:
42% – special exception (SE)
36% – BT-11

Overall survival (OS) – 5 years:
19% – special exception (SE)
25% – BT-11
======================================
Compare: standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al. 1999)

2% – % of Patients Showing Complete Response
31% – % of Patients Showing Partial Response

Mandell LR, Kadota R, Freeman C, et al. There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic brain stem tumors: results of pediatric oncology group phase III trial comparing conventional vs. hyperfractionated radiotherapy. Int J Radiat Oncol Biol Phys. 1999;43:959-964.
http://www.ncbi.nlm.nih.gov/pubmed/10192340/
Int J Radiat Oncol Biol Phys. 1999 Mar 15;43(5):959-64.
http://www.ncbi.nlm.nih.gov/m/pubmed/10192340/
International Journal of Radiation Oncology*Biology*Physics
Volume 43, Issue 5, 15 March 1999, Pages 959–964
http://www.sciencedirect.com/science/article/pii/S036030169800501X
Department of Radiation Oncology, Mount Sinai Medical Center, New York, NY, USA.
6/1992 – 10/1997

Overall survival (OS):
7% – 2 years
0% – 5 years
=====================================
COMBINED:
——————————————————————
Overall survival (OS) – 2 years:
——————————————————————
42% – antineoplastons: special exception (SE)

36% – antineoplastons: BT-11

7% – standard radiation therapy in combination with chemotherapy (RAT)
——————————————————————
Overall survival (OS) – 5 years:
——————————————————————
25% – antineoplastons: BT-11

19% – antineoplastons: special exception (SE)

0% – standard radiation therapy in combination with chemotherapy (RAT)
� � � � � � � � � � � � � � � � �
Break The Walls Down:

——————————————————————
And “THAT’s The BOTTOM LINE”
Because Stone Cold Said So

——————————————————————
IT’s GO TIME
Time To Play The Game:

——————————————————————
Break The Walls Down:

=====================================

IT MAY NOT BE SCIENCE: Critiquing “Curing cancer or ‘selling hope’ to the vulnerable?”

Recently, America was warned again:

“The British Are Coming”

“The British Are Coming”

Yes, Mr. and Mrs. America and all the Ships at SEA,
We were “blessed” with a visit from the “Bloody Well Right,” Panorama BBC
http://t.co/nFpwlQg275
By Richard Bilton
http://t.co/IY53fEpnBu
BBC Panorama
3 June 2013 Last updated at 00:03

As luck would have it, as I was researching my Critique for this article, BBC Panorama provided me with the title for it, in their YouTube Video:

“IT MAY NOT BE SCIENCE”

This was apropo since it quite possibly defines the entire Panorama article in a “nutshell’

The article states:

“But Dr Stanislaw Burzynski’s treatment has been dismissed by practitioners of mainstream medicine.”

From this, I take it that the viewer is supposed to conclude that the

“practitioners of mainstream medicine”

are:

1. Prof Richard Grundy

and

2. Dr Jeanine Graf

Let’s examine their claims, shall we?

1. Prof Richard Grundy

A. “He says it is “unethical” for Dr Burzynski not to share his findings:”

In my ‘opinion,’ it is “unethical” for Professor Grundy to throw MUD at Dr. Burzynski, when he has NOT shared his findings re Dr. Burzynski’s:

Drugs In R and D / Drugs in Research and Development:

Drugs R D. 2003;4(2):91-101
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2004;5(6):315-26
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Integrative Cancer Therapies

Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
2007
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html

B. “Unfortunately the results from Dr Burzynski’s clinic are not published in any form that’s acceptable to the scientific community.”

Professor Grundy, welcome to #MizTV

really?Really??REALLY???

Please expound

and

2. Dr Jeanine Graf

“She sometimes treats patients from the Burzynski Clinic who have become critically ill, but she has never known any of them survive.”

Dr. Graf, how many patients?

2 ?

“He must believe in what he’s doing, but I have not been convinced by the existing scientific literature that his therapy has any efficacy.

Dr. Graf, where is your “in-depth” review of Dr. Burzynski’s above-listed publications?

Dr. Graf, please provide your in-depth “opinion” on this:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-the-fdas-drug-review-process-ensuring-drugs-are-safe-and-effective/
“But the more I looked, the more complicated the picture became.”

“I was shown into the boardroom and, after 20 minutes waiting, the doctor was ready to see me.”

Mr. Bilton, I am sure that how long you had to spend waiting, might be important to you, but to the viewers:

Not So Much

This might be classified as a human interest story, but YOU are NOT the human whose story we are interested in

“He said the medical authorities in the US would not let him release this information:”

“Clinical trials, phase two clinical trials, were completed just a few months ago. I cannot release this information to you at this moment.”.

“But the FDA told us this was not true and he was allowed to share the results of his trials.”

I’m sure that after perusing the below, that you will be able to come to the conclusion that there are “trust” issues involved, so Dr. Burzynski is correct to be concerned

Burzynski: Managing social conflict in complementary and alternative medicine research: the case of antineoplastons:
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-managing-social-conflict-in-complementary-and-alternative-medicine-research-the-case-of-antineoplastons/
Antineoplastons: Has the FDA kept its promise to the American people ?
https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
Cancer: Hope for Sale? will be broadcast on Monday, 3 June at 20:30 BST on BBC One

BBC One – Panorama, Cancer: Hope for Sale?

Panorama prog on #Burzynski is there for posterity on YouTube
http://t.co/YOlSjCg1d0
BBC Panorama Burzynski investigation on Youtube
http://t.co/6cDJapt6eM
THIS IS IT!
Our debut on the BBC’s Panorama. I hope this reaches millions!!! SO Burzynski will be deprived of…
http://fb.me/LYCqmKrh
“On Panorama tonight

“The doctor who says that he can cure cancer

The Burzynski clinic says it doesn’t claim it can cure all cancers and that no patients are promised a cure.
https://stanislawrajmundburzynski.wordpress.com/2013/06/04/the-british-are-coming-the-british-are-coming-critiquing-curing-cancer-or-selling-hope-to-the-vulnerable/
Make up your mind, Panorama

The British are Coming, The British are Coming: Critiquing “Curing cancer or ‘selling hope’ to the vulnerable?”

By Richard Bilton
http://t.co/nFpwlQg275
BBC Panorama

3 June 2013 Last updated at 00:03

“Legal loophole”

“Dr Burzynski exploits a legal loophole:”

“the patients treated with antineoplastons do so as part of a clinical trial, so the drug does not need a licence.”

I am truly impressed, and mightily so

Who knew that if “BBC Panorama” had just investigated Dr. Burzynski, years ago, we could have gotten this all out of the way, long ago

Yes, Mr. and Mrs. America, and all the ships at sea, BBC Panorama has decided the question for us, once and for all

Clinical Trials-are, get ready for it, wait for it, “Legal loopholes

WOW

I KNOW

Who woulda thunk THAT?

Thank goodness they couldn’t put the Concorde on their expense account

The British Are Coming

The British Are Coming

And Mumsie, can we keep them?

“These trials have been taking place for 20 years.”

It’s good to find out that someone can get close to “1994” when Dr. Burzynski’s Securities and Exchange (SEC) filings indicate 2 phase 2 clinical trials were in progress

Maybe some of “The Skeptics” are learning to read?

“Despite years of research, Dr Burzynski has never published full results.”

BBC Panorama (@BBCPanorama) would that be because the phase 2 clinical trials were NOT done?

Would “results” normally be published after the clinical trials are finished?

Brave Maverick Welsh Schoolboy frantically waves hand at back of classroom, as if to say: “Pick Me, … Pick Me

All in all, it’s just another “Brick” in the Wall

“If he has discovered a breakthrough, he is not sharing it with the rest of the world.”

Perhaps that’s what those pesky phase 2 clinical trials preliminary reports from 2003, 2004, 2005, 2006, etc., are all about, me little lad

“If you don’t eat your meat, you can’t have any pudding”

Yes

Laddie

“Divided doctors”

“Prof Richard Grundy treats children with cancer, and runs one of the UK’s biggest research projects into brain tumours.”

“He says it is “unethical” for Dr Burzynski not to share his findings:”

Does Professor Richard Grundy know what a phase 2 clinical trial preliminary report looks like, and does he know how to read?

“”I understand that that draw is very attractive.”

“Unfortunately the results from Dr Burzynski’s clinic are not published in any form that’s acceptable to the scientific community.””

Oh, my

I wish I could have been there in person to hear that

Did he have a British stiff upper lip when he said it?

Was one of his pinky fingers pointing straight up?

Do tell

Exactly what is:

published in any form that’s acceptable to the scientific community“?

Cancer: Hope for Sale? will be broadcast on Monday, 3 June at 20:30 BST on BBC One

BBC One – Panorama, Cancer: Hope for Sale?

“From the start I had wanted to meet Dr Burzynski.”

“He rarely gives interviews nowadays and he refused our original requests, but while I was in Houston I was told he would meet me.”

“His clinic is a mirror-fronted office block in one of Houston’s better areas.”

I’m sure the Houston Tourism Board and Convention Center was ecstatic to hear this ….the part about Houston having “better areas,” that is

“Next some basic facts – how many patients has he treated with antineoplastons, and how many have survived?”

“He said the medical authorities in the US would not let him release this information:”

“”Clinical trials, phase two clinical trials, were completed just a few months ago.”

“I cannot release this information to you at this moment.””

“But the FDA told us this was not true and he was allowed to share the results of his trials.”

Really, old chap

And exactly who at the FDA told you that?

Or is it a secret, … secret secret?

“Dr Burzynski left the interview angry, apparently affronted that his great discovery was questioned.”

Dr. Burzynski seems to have some difficulties with “little men

How tall are you?

And have you heard of one Craig Masilow and one Dr. David H. Gorski?

“They see him as a maverick, an outsider fighting the traditional medical establishment.”

He is a maverick in much the same was as Dr. David H. Gorski, and his revolutionary “glucose / sugar does NOT feed cancer” “Oracolytes

“The American Food and Drug Administration (FDA) and the Texas Medical Board have been battling Dr Burzynski for decades.”

Indeed

Do you have any idea of how many millions upon millions of United States Taxpayer Dollars were used to criminally pursue Dr. Burzynski, when they had a civil remedy available to them?

Do you think they put it on their resumes?

“The Burzynski clinic says it doesn’t claim it can cure all cancers and that no patients are promised a cure.”

“They say 776 patients with brain tumours were treated in trials before 2008.”

“And that 15.5% had survived more than five years, which compares favourably to other treatments.”

OH … MY … GOODNESS

Data

How did you get THAT?

Ask?

Or was it freely given?

“But it is harder to understand how Dr Burzynski has been able to sell his experimental treatment to the vulnerable for so many years.”

Did you ask your “chums,” the great people at the United States Food and Drug Administration?

Panorama, Cancer: Hope for Sale?, BBC One, Monday 3 June at 20:30 BST and then available in the UK on the BBC iPlayer.