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/
======================================
[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
======================================
[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):
——————————————————————
http://lubbockonline.com/news/010997/cancer.htm
======================================
[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):
——————————————————————
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
======================================
[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
======================================
[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
======================================

Advertisements

[19] – 1995 (6/6/1995) Dr. Michael A. Friedman to Burzynski (3 pgs.)

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[19] – 1995 (6/6/1995) – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health and Human Services (HHS), Public Health Service, National Institutes of Health (NIH) 3 page letter to Burzynski

This letter is intended to respond to the major issues which have been raised in your recent correspondence of 4/20/1995 and 5/16/1995

Your accusations are serious and require comment

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

2 patients were treated at the National Cancer Institute

Patient .26-77-03-9 had evidence of focal glioblastoma multiforme on the biopsy reviewed at the NCI

A different specimen submitted to Dr. Rorke may or may not be relevant

This patient, however, had a brain scan 3 weeks prior to study entry

Patient .27-53-76-5 had a tumor which was 0.8 cm larger than the eligibility criteria dictated

Although pharmacologic data were obtained on both, neither patient is counted in an assessment of response

Both patients had objective tumor progression and are now off study

With respect to the other patients, I am including specific patient summaries from the treating investigators which address your other concerns; in particular, a response to your serious and unfounded statement that patient #196370 was treated in an unethical manner

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

(see 3/9/1994 letter)

Having provided this information, I must convey my deep pessimism about the potential for continued interactions with you regarding these trials

Given recent events and your clearly articulated bias that the Mayo Clinic, Memorial Sloan Kettering Hospital and even the National Cancer Institute could not fairly test your product

(please see your letters of 10/26/1993 and 4/20/1995),

I now see a diminishing chance for a productive dialogue with you

Historically, the NCI has demonstrated pragmatism and flexibility in working with a wide variety of individuals and organizations to explore diverse interventions of potential benefit to the cancer patient

However, such a fruitful collaboration may simply not be possible with you

Pg. 2

The decision to suspend the NCI antineoplaston studies was reached by the investigators and the NCI and was explained in our letter of 5/12/1995

(see enclosed)

While we have frequently solicited your advice, we are in no way obligated to obtain your consent

Our interactions with you have been similar to those with pharmaceutical companies or other independent investigators

In the interest of testing antineoplastons, we have consistently considered your advice and recommendations but that in no way cedes control of these studies to you

(please refer to our letters of 7/15/1993, 10/20/1993, and 11/2/1993)

Your insistence on dictating the manner in which we conduct our review of these clinical trials is both presumptuous and inappropriate

The future of these trials rests entirely with the investigators and the NCI, since our primary obligation is to the American public

Recognizing your potential conflict of interest as the developer and the most visible proponent of antineoplastons, we could not responsibly act in any other manner

In contrast to the tenor of your unsupported statements, the NCI bases its position on scientific data

You have stated that you have a vast clinical experience with antineoplastons and we have generally been deferential to your demands despite the lack of substantive data

However, our scientific standards are broadly applied to all studies

The data and level of proof we require from you is much the same as that for other professional collaborators who make such claims

The 7 case records initially examined by the NCI hardly constitute a definition scientific result

It is naive and misleading for you to suggest that the experience of 2 of those patients who had tumors in excess of 5 cm provides adequate proof for all your contentions about tumor size, dose, etc., unless these were the only 7 brain tumor patients from your entire experience who had any hint of benefit

To be precise, in order to responsibly and properly assess your claims and accusations (as per your 4/20/1995 letter), we request that you provide the following information:

1. Exactly how many adult patients with primary brain tumors have you evaluated and treated with antineoplastons?

2. When analyzed by histological type, performance status, prior therapy, concurrent therapy (including chemotherapy), disease size and focality, how many adult brain tumor patients had objective responses?

Please characterize the quality and magnitude and duration of these responses

3. What dose, duration, schedule, and composition of antineoplastons did these patients receive?

Which of these patients benefited objectively?

What toxicities were encountered?

Do you have pharmacokinetic or pharmacodynamic data to support your contention that certain types of brain tumor patients require specific regimens?

4. For these patients, what statistical analyses relate patient or tumor characteristics with exact treatment regimen and outcome?

Pg. 3

If you provide such specific data, we can properly assess your claims

Lacking such information, we cannot

Moreover, your charges that patients received inappropriate care are not supportable without such detailed information

If, after careful consideration, the investigators at Memorial Sloan Kettering and Mayo Clinic do not reopen their studies, it is unlikely that the NCI will attempt to conduct further antineoplaston trials

Any unused antineoplaston material will, of course, be returned to you

Since we can make no judgement about the benefit or toxicity of antineoplastons at this time, we will be interested in the published outcome of peer reviewed studies that you or others may perform

If the NCI investigators choose to continue these studies, you will be so informed

In either circumstance, we will continue to sponsor clinical research of small molecules that may have differentiating properties (such as pure phenylacetate and phenylbutyrate)

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Wayne Jonas
Mr. Robert Lanman
Ms. Mary McCabe
Dr. Mark Malkin
Dr. Tony Murgo
Dr. Ralph Moss
Dr. David Parkinson
Dr. Edward Sondik
Dr. Mario Sznol
Dr. Dorothy Tisevich
Dr. Alan Trachtenberg
Mr. Frank Wiewel
Dr. Robert Wittes
——————————————————————

======================================
1993 (10/26/1993) – Burzynski to
1994 (3/9/1994) –
1994 (7/1994) – Burzynski to Theradex
1995 (4/20/1995) – Burzynski to
1995 (5/12/1995) – to Burzynski
1995 (5/16/1995) – Burzynski to
======================================

[18] – 1995 (5/16/1995) – Burzynski to Dr. Michael A. Friedman

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[18] – 1995 (5/16/1995) – Burzynski letter to Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH)

Thank you for your letter of 5/12/1995

You are correct in asserting that I raise issues of ethical misconduct, failure to obtain adequate informed consent and scientific misjudgment

To be exact, my letter points out specific violations of the clinical trial protocol made by the current investigators

I provided careful documentation of some of the most egregious violations, including the removal of a patient from the study who had no increase in tumor size and the inclusion of a patient with tumor pathology that did not meet the entry criteria

It seems possible that, in at least one one of these cases, failure to follow the protocol resulted in the patient’s unnecessary death

In this case, the patient was removed from the study following an MRI dated 5/2/1994

The conclusion of neuroradiologist Jim Cain, MD, is that this MRI shows that the tumor had not grown, and no new tumors are present

As you know, the protocol calls for patients to be taken off treatment if the tumor grows 50% or more, or a new tumor is present

This is, as you point out, a most serious matter, and I was hoping that you could allay my concerns by showing me where they are unfounded

However, your letter conspicuously fails to address them

You also make reference to “numerous factual misstatements” but fail to identify any of them, much less provide documentation to show they are false

Pg. 2

Contrary to another of your statements, I did provide “specific clinical data which support” my contention that patients with large tumors do not respond well to the current protocol

Let me repeat from here

In the 1991 NCI review of 7 brain tumor cases, the only 2 patients with tumor size greater than 5.1 cm were also the only 2 patients to have less than 50% reduction of their tumor

The correlation between large tumor size and failure to respond is obvious

I am happy to learn that the trials have been put on hold

I must insist that they not be re-activated until I am satisfied that new investigators have been found who are capable of following the protocol — the original protocol on which we both agreed

As you know, the protocol was changed without anyone bothering to seek my advice, and certainly without my consent

I am glad that you plan to “thoroughly examine the accusations” I have made

However, this review must not be done by the people responsible for the violations being investigated

This would amount to a whitewash of the whole affair, and is unacceptable

The review must be done by an independent body of experts acceptable to both of us

Otherwise it will be meaningless

I still have not received the complete data on the 1st 5 patients, which was promised in your letter of 4/3/1995

I hope to receive the data soon

I also eagerly await a substantiative response to the points raised in my letter of 4/20/1995

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Wayne Jonas
Mr. Robert Lanman
Ms. Mary McCabe
Dr. Mark Malkin
Dr. Tony Murgo
Dr. Ralph Moss
Dr. David Parkinson
Dr. Edward Sondik
Dr. Mario Sznol
Dr. Dorothy Tisevich
Dr. Alan Trachtenberg
Mr. Frank Wiewel
Dr. Robert Wittes
——————————————————————

======================================
1995 (5/16/1995) – Burzynski to [15]
(2 pgs.)
1991 NCI review of 7 brain tumor cases
1994 – 5/2/1994 – MRI
1995 (4/3/1995) – Dr. Michael A. Friedman to Burzynski
1995 (4/20/1995) – Burzynski to
1995 (5/12/1995) – Dr. Michael A. Friedman to Burzynski
======================================

[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol
——————————————————————
Mario Sznol, M.D., Department of Health and Human Services, National Institutes of Health

Dear Dr. Sznol,

Your letter of 4/3/1995

(copy attached)

does not provide adequate justification for the changes in the protocol for

“Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced
Recurrent Astrocytomas.”

Let me make perfectly clear that, as the discoverer and developer of antineoplastons and the individual with nearly 20 years clinical experience using them, it is my professional opinion that the drugs will not produce substantial benefit in such advanced patients

The current protocol has had success only in patients who have tumors not exceeding 5 cm in diameter and who do not have multiple tumors or leptomeningeal or systemic metastases

As the Senior Investigator of NCI requested, patients should have Karnofsky Performance Status of not lower than 70%

(letter attached)

As I have repeatedly informed you, it is exactly because of the current protocol’s failure to benefit advanced patients that we developed new and more aggressive protocols for such advanced tumors, for example, provides antineoplaston A10 in doses 3 times greater than that specified in the protocol currently being used

In order to make such dosing possible, we are using a much higher concentration of A10 — 300mg/mL instead of 80mg/mL

The dosing schedule being used for such advanced tumors is also quite different

Instead of injections of each antineoplaston every 30 minutes, patients receive a much greater amount every 4 hours

Pg. 2

The acceptance of very advanced brain tumor patients to the current protocol would be highly unethical because there is no realistic chance they will have a meaningful response

The list attached to your letter of 4/3/1995 (enclosed), proves my observation that patients who had tumors substantially larger than 5 cm do not respond well under the current protocol

There were only 2 such patients, with the largest tumor diameter corresponding to 5.5 and. 6.5 cm

Both had less than 50% decrease in the size of their tumors

According to the existing protocol, patients should have more than a 50% decrease in tumor size to be classified as responders

Please bear in mind that the point of this trial is not to prove once again that this protocol does not work in patients with very large tumors, multifocal tumors, and low Karnofsky scores

We have already established this fact

Moreover, the informed consent form as currently written falsely implies that the discoverer of antineoplastons believes such advanced patients may benefit substantially from the current protocol

In fact, I have specifically informed you on several occasions that I do not believe advanced patients will obtain substantial benefit

Please be forewarned that you may face legal liability resulting from these unethical misrepresentations

We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995

Based on the limited information received from Theradex on the 1st 7 cases, we have reason to believe that the protocol has been violated in every case

5 cases have been accepted in violation of inclusion criteria

Due to interruptions in the treatment schedule and the time necessary to escalate the dosage, one of these patients received less than 3 weeks of full dose treatment

Such duration of treatment was not sufficient to show the effectiveness of the therapy

Finally, 2 additional patients were removed from the study and said to have progression of disease when in fact no progression was documented

One of these patients, #4369975, underwent tumor resection 3 weeks after discontinuation of the treatment with antineoplastons

Microscopic examination of the tumor specimen confirmed absence of viable tumor cells

It is clear that what was classified as tumor progression corresponded to extensive necrosis or tumor death

What I thought was especially inexcusable and unethical is that the 30 year old patient #196370, who clearly did not have progression of the tumor, was removed from the study against the criteria for removal listed in the protocol

This patients died a few months later
I strongly believe that if the patient had continued the treatment under the protocol, his life would have been saved

Attached to this letter, you will find a list of

Pg. 3

violations of the protocol

Based on these violations, it is clear that the current investigators are unable to conduct this study under the current protocol

I hereby request that:

1) The National Cancer Institute immediately terminate the current investigators and appoint mew investigators at different medical institutions acceptable to Burzynski Research Institute

2) Patient accrual must cease until such investigators and institutions are appointed

Until you appoint the new investigators, I will provide free treatment and medical care under my supervision as long as necessary to the patients currently being treated under the protocol

SRB/cf

Enclosure

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkly Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Daniel Eskinazi
Dr. Michael Friedman
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Mark Malkin
Ms. Mary McCabe
Dr. Ralph Moss
Dr. David Parkinson
Ms. Dorothy Tisevich
Mr. Frank Wiewel
——————————————————————

======================================
1995 (4/20/1995) – Burzynski to [14]
1995 (4/20/1995) – Burzynski to [15] (3 pgs.)
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
======================================