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

Turkey Lurkey Thanksgiving Title

Traditionally, Thanksgiving is best known as the Holiday that the Detroit Lions get the “stuffing” knocked out of them

However, this year, it’s time to tender the tainted twisted trophy of Thanksgiving Turkey-Lurkey to Detroit’s toasted triumvirate treat of two-faced twerk-salad troll turpitude, and I have the temerity to tinker and tamper until I pay tribute with therapeutic levels of Thoreauness in response to GorskGeek’s misinformation, disinformation, and MisDisInformation (Missed ‘Dis Information)

Wednesday, 12/21/2005, Indianapolis, Indiana-based Eli Lilly and Company was treated to truthification, in connection with their illegal promotion (misbranding) of pharmaceutical drug EVISTA; (FDA approved for prevention and treatment of osteoporosis in post-menopausal women), in the:

a. prevention in risk of breast cancer

b. reduction in risk of breast cancer

Alleged in information, promoted drug as effective for reducing risk of breast cancer EVEN AFTER PROPOSED LABELING FOR THIS USE SPECIFICALLY REJECTED by FDA [1]

GorskGeek, being the breast cancer oncology specialist he claims to be, and so concerned about breast cancer patients that he is that “guy” who speaks out passionately about issues like the 10-year American Cancer Society Cancer Facts & Figures, “Estimated Breast Cancer Deaths for Women”, which reflect that in 2002, 39,600 (15%) women were estimated to die from breast cancer, and this year, 2013, the estimate is 39,620 (14%), which is 20 women MORE than 10-years ago, and who rails tirelessly about the ACS’s “Estimated New Breast Cancer cases in Women”, which 10-years ago was 203,500 (31%) in 2002, and now, in 2013 is 232,340 (29%), which is ONLY
28,840 MORE
than 10-years ago [2]

Now THAT’s progress !

GorskGeek, of course, must accomplish all this under his breath

But I’m sure you’re wondering, dear reader, what was GorskGeek’s outraged blog about this American pharmaceutical manufacturer coughing up $36 MILLION ?

Well, let me tell you … just as soon as I find it

Wait for it

Wait for it

Wait for it

GorskGeek was unable to bring himself to blog about Evista until exactly one year later, on 12/21/2006, and even then, he was “mum’s the word” about the breast cancer claims [3]

Perhaps GorskGeek just “knew” that eventually Evista would finally be approved by the FDA for Eli Lilly’s preventing or reducing risk of breast cancer claims on 9/13/2007, and who were those paper-pushing FDA apparatchiks to prevent Lilly from implementing their “Internal business plan” ? [4-9]

GorskGeek wouldn’t want to damage his slim and non-existent chance of getting some Eli Lilly money for research, by blogging anything that might in any way be possibly construed as him saying anything negatory about the BIG Pharma teat he longs to suck off of

After all, Bob ‘n’ Weave Blaskiewicz (who sees every molehill as a mountain), did say about GorskGeek, 9/28/2013 [10]:
——————————————————————
1:58:04
——————————————————————
“But he is a, the thing is, the thing is, you thing you have to understand is Gorski, Gorski is a genuine expert, in matters re re regarding on oncology studies

“I mean, he has a”

“He, He’s able to convince people, he’s able to convince people, on the strength of his record, to give him money to carry out research

“People who know what they’re talking about”

“To give him money to carry out his research”

“Right ?”
——————————————————————
1:59:00
——————————————————————
Yeah, right

Bobby 🙂

GorskGeek is hoping for a Happy Thanksgiving Golden Parachute; which is where he helps whistleblow about illegal BIG Pharma activity regarding some drug(s), which leaves him as the beneficiary of some funds like Mr. H. Dean Steinke, former Merck employee and his $68,190,000 MILLION from the federal government and states share of settlement amounts:
——————————————————————
$44,690,000 MILLIONMr. H. Dean Steinke, former Merck employee from federal share of settlement amount (1997 – 2001)
——————————————————————
$23.5 MILLIONMr. H. Dean Steinke, former Merck employee from the states share of settlement amount (1997 – 2001)
——————————————————————
Next, GorskGeek goes off on his fave autism prescription antipsychotic drug Risperdal, and the 11/4/2013, Monday, allegations concerning Global health care giant Johnson & Johnson (J&J) and its subsidiaries, $2.2 BILLION + fine regarding J&J Subsidiary Janssen (1999 – 2005) actions [11]
======================================
REFERENCES:
======================================
[1] – 12/21/2005
——————————————————————
EVISTA (FDA approved for prevention and treatment of osteoporosis in post-menopausal women)
——————————————————————
Eli Lilly and Company, Indianapolis, Indiana-based company
——————————————————————
12/21/2005, Wednesday
——————————————————————
$36 MILLION
——————————————————————
In connection with illegal promotion of pharmaceutical drug
——————————————————————
Pleading guilty to criminal count of violating Food, Drug, and Cosmetic Act by misbranding drug
——————————————————————
In addition to criminal plea
agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction
——————————————————————
Charged in criminal information filed with violation of Food, Drug, and Cosmetic Act, following investigation by Food and Drug Administration’s (FDA) Office of Criminal Investigations
——————————————————————
Plea agreement signed by Lilly and United States

Complaint for permanent injunction

Consent decree of permanent injunction signed by company and United States
——————————————————————
Information alleges 1st year’s sales of drug in U.S. were disappointing compared to original forecast
——————————————————————
According to information
10/1998 – company reduced forecast of drug’s 1st year’s sales in U.S. from $401 million to $120 million
——————————————————————
Internal business plan noted:

“Disappointing year versus original forecast.”
——————————————————————
Information alleges in order to expand sales of drug, Lilly sought to broaden market for drug by promoting it for unapproved uses
——————————————————————
Information alleges strategic marketing plans and promotion touted drug as effective in preventing and reducing risk of diseases for which drug’s labeling lacked adequate directions for use
——————————————————————
According to information: Evista
1. brand team
2. sales representatives
promoted drug for:
a. prevention in risk of breast cancer
b. reduction in risk of breast cancer
c. reduction in risk of cardiovascular disease
——————————————————————
Under provisions of Food, Drug, and Cosmetic Act, drug misbranded when labeling didn’t bear adequate directions for each of intended uses
——————————————————————
Alleged in information, promoted drug as effective for reducing risk of breast cancer even after proposed labeling for this use specifically rejected by FDA
——————————————————————
Information alleges executed illegal conduct using number of tactics, including:

1. One-on-one sales pitches by sales representatives promoting drug to physicians about off-label uses of drug

2. Sales representatives trained to prompt or bait questions by doctors in order to promote drug for unapproved uses

3. Encouraging sales representatives promoting drug to send unsolicited medical letters to promote drug for unapproved use to doctors on their sales routes

4. Organizing “market research summit’ during which drug was discussed with physicians for unapproved uses, including reducing risk of breast cancer

5.
a. Creating
b. distributing
to sales representatives “Evista Best Practices” videotape, in which sales representative states “Evista truly is the best drug for the prevention of all these diseases” referring to:

1). osteoporosis
2). breast cancer
3). cardiovascular disease
——————————————————————
Complaint for permanent injunction alleges executed illegal conduct using number of tactics, including:

1. Training sales representatives to promote drug for prevention and reduction in risk of breast cancer by use of medical reprint in way that highlighted key results of drug and thereby promoted drug to doctors for unapproved use

2. Some sales representatives were instructed to hide disclosure page of reprint which noted:

a. “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,”

b. “The prescribing information provides that “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.””

3. Organizing “consultant meetings” for physicians who prescribed drug during which unapproved uses of drug discussed

4. Calculating incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998

5. advisory board meetings included discussion of unapproved uses for drug

6. By measuring and analyzing incremental new prescriptions for doctors who attended advisory board meetings, Lilly was using this intervention as tool to promote and sell drug
——————————————————————
In addition to agreeing to plead guilty to criminal information and plea agreement signed by Lilly, settlement with United States includes following components:

(a) agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction

(1). As part of consent decree, agreed to comply with terms of permanent injunction, which will require company to implement effective training and supervision of marketing and sales staff for drug, and ensure any future off-label marketing conduct is detected and corrected

(2). agreed to be permanently enjoined from directly or indirectly promoting drug for use in:

a. preventing or reducing risk of breast cancer

b. reducing risk of cardiovascular disease

c. or for any other unapproved use in manner that violates Food, Drug, and Cosmetic Act unless and until FDA approves drug for additional use or uses
——————————————————————
(b) as part of consent decree, agreed to hire and utilize independent organization to conduct reviews to assist Lilly in assessing and evaluating Lilly’s

1. systems
2. processes
3. policies
4. procedures
relating to promotion of drug and company’s compliance with consent decree
——————————————————————
FDA made following announcement to postmenopausal women who have taken drug for prevention or treatment of osteoporosis:
——————————————————————
“No postmenopausal woman who has taken Evista for the prevention or treatment of osteoporosis is affected by this action, as this matter today relates only to unapproved uses of Evista.”
——————————————————————
Defendant agreed to plead guilty to charge in information
——————————————————————
Defendant agreed to resolve complaint for permanent injunction by agreeing to consent decree of permanent injunction
——————————————————————
http://www.justice.gov/opa/pr/2005/December/05_civ_685.html
======================================
[2] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
======================================
[3] – 12/21/2006 – On the messiness of evidence-based medicine
——————————————————————
http://scienceblogs.com/insolence/2006/12/21/the-messiness-of-evidencebased-medicine/
======================================
[4] – 9/13/2007FDA Approval for Raloxifene Hydrochloride (Brand name(s): Evista®): Approved for breast cancer risk reduction:
——————————————————————
http://www.cancer.gov/cancertopics/druginfo/fda-raloxifene-hydrochloride
======================================
[5] – 9/14/2007FDA Approves New Uses for Evista: Drug Reduces Risk of Invasive Breast Cancer in Postmenopausal Women:
——————————————————————
http://www.fda.gov/newsevents/newsroom/pressannouncements/2007/ucm108981.htm
======================================
[6] – 9/17/2007Evista Approved for Reducing Breast Cancer Risk:
——————————————————————
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048474.htm
======================================
[7] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf
======================================
[8]
——————————————————————
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
======================================
[9] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022042lbl.pdf
======================================
[10] – 10/18/2013 – Deconstructing Dr. David H. (Orac) Gorski – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/deconstructing-dr-david-h-orac-gorski-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[11] – 11/4/2013
——————————————————————
http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html
======================================

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

20131021-200529.jpg

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

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

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

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

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

“And it’s always been his burden of proof

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

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

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

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

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

Subpart F–Confidentiality of Information

Sec. 601.50

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

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

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

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

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

Burzynski ?

FDA ?

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

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

“It is Burzynski’s job to be convincing”

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

“In decades”

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

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

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

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

“It’s ultimately Burzynski”

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

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

“That doesn’t”

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

“How long would it take ?”

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

“Years ?”

“How long ?”

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

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

“I can do that”

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

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

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

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

“You’re you’re you’re assuming”

“You’re you’re you’re assuming that”

“You’re assuming that”

“Um, I’m not assuming that”

“There is a correct answer here”

“You don’t know”

“You don’t know”

“You need to look into it”

“Alright ?”

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

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

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

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

“I try to fight against it, constantly”

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

“He withdrew the the phase 3 clinical trial”

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

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

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

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

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

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

“What about the the Public Library of Science?”

“It’s not the only journal there”

“What about BMC Cancer ?”

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

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

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

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

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

So

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

“How long will it take ?”

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

“We can’t find it anywhere”

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

“We can’t find that anywhere”

“We’ve asked”

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

“And, and it hasn’t come to us

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

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

1. Annals of Oncology 2010;21:viii221 ?

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

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

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

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

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

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

“We’re talking about life”

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

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

“This is important stuff”

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

“It’s nothing”

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

“You know”

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

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

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

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

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

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

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

You know, I don’t necessarily agree with that

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

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

“You know”

“They’re just saying, “No thanks””

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

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

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

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

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

“Is that what you’re saying ?”

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

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

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

“I mean you just can’t

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

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

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

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

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

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

“Right ?”

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

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

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

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

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

“Right ?”

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

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

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

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

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

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

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

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

“The FDA’s in control”

“They sign off on these things”

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

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

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

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

“That’s important”

“That that that’s really important

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

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

“And that’s important”

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

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

“Gorski has made it abundantly clear”

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

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

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

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

You know

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

“Send me that”

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

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

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

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

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

Bob, who approves “Accelerated Approval” ?

1. FDA ?

2. A peer-reviewed scientific journal ?

3. The Skeptics™ ?

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