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

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

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

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

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

The findings were horrifying

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

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

This means that his outcomes figures for these studies are inaccurate

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

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

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

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

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

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

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

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

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

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

Under cross examination by attorney Richard Jaffe, she admitted:

1. such codes do not have to be exact fits

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

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

The jury seemed riveted as Jaffe read:

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

The jury suddenly knew not only that:

1. treatment might actually work

2. prosecutors were trying to hide this fact from them

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

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

Ackerman probed,

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

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

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

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

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

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

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

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

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

The FDA (Federal Deposition Attorney) reported:

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

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

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

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

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

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

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

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

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

There are several similar witnesses

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

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

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

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

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

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

Wait !

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

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

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

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

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

“We see patients from various walks of life”

“We see great people”

“We see crooks”

“We have prostitutes”

“We have thieves”

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

20131209-192845.jpg
——————————————————————
“All you have to do is to read Saul Green’s reports on Quackwatch and in The Cancer Letter from the 1990s” [10]
——————————————————————
12/2002Interview [11]
——————————————————————
“One of your greatest critics is Saul Green (Ph.D. Biochemistry), a retired biochemist from Memorial Sloan Kettering

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

“An Unproved Cancer Therapy.”

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

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

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

“He’s like a hired assassin

“Not telling the truth”

“So really to argue with him is good for nothing

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

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

“He would do whatever they paid him to do”
——————————————————————
“Did Green ask to look at your patients’ files or even talk to any of your patients themselves?”
——————————————————————
“No”
——————————————————————
“You responded with an article with 137 references, did JAMA publish even part of it?”
——————————————————————
“JAMA refused to publish the article”

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

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

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

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

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

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

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

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

“Then Aetna got involved and Aetna sued us

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

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

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

“This was a 190 million dollar lawsuit against Aetna

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

“And they hired him to work on their behalf”

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

(Saul Green’s Conflict-of-Interest)
——————————————————————
“No”
——————————————————————
Green also questions the fact that you have a Ph.D.”

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“So certainly he was extremely active as a communist

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

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

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

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

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

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

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

5. GorskGeek, are you a hypocrite ?

20131209-234700.jpg
I am asking you to help me understand what happened at the FDA to allow “the man” to conduct criminal trials and almost bankrupt a patients’ doctor in the process despite years of alarming reviews by the Federal Congress

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

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

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

b. insurance company employee

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

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

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

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

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

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

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

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

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

c. Some showed out-of-state addresses

d. point was to impress jury with fact:

1) some patients lived outside of Texas

2) Burzynski knew this

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

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

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

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

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

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

he asked

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

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

b. “In other words,”

boomed the Texas lawyer,

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

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

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

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

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

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

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

She contended that legal decision’s actual language read

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

“Isn’t that the same thing? “

asked Ramsey

“No,”

said Ritchey

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

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

She contended the legal decision’s:

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

MEANT:

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

and likened it to:

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

United States postal inspector

does NOT mean:

United States District Court Judge

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

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

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

I think this was a government witch hunt,”

said juror Sharon Wray

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

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

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

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

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

Jury foreman, John Coan, favored acquittal:

Quoted in New York Times:

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

Coan said

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

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

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

5 years
x
34
=
170 years

$250,000
x
34
=
$8,500,000 MILLION
——————————————————————
up to 3 years in prison

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

3 years
x
40
=
120 years

$250,000
x
40
=
$10,000,000 MILLION
——————————————————————
TOTAL
——————————————————————
170 years (34 counts of mail fraud)
+
120 years (40 counts of violating the food, drug & cosmetic laws)
=
390 years
——————————————————————
$8,500,000 MILLION (34 counts of mail fraud)
+
$10,000,000 MILLION (40 counts of violating the food, drug & cosmetic laws)
=
$18,500,000 MILLION
——————————————————————
======================================
REFERENCES:
======================================
[1] – 12/7/2013 – How to Crank your Congressperson (according to “The Skeptics”: USA TODAY vs. Dr. Stanislaw Burzynski):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/12/07/how-to-crank-your-congressperson-according-to-the-skeptics-usa-today-vs-dr-stanislaw-burzynski/
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[2] – 2/4/1998Dr. Ralph MossGovernment Reform and Oversight Committee
——————————————————————
http://www.forhealthfreedom.org/Publications/Monopoly/Moss.html
——————————————————————
http://archive.is/gKNcL
======================================
[3]The FDA’s Vendetta Against Dr. Burzynski: By Dean Mouscher, Director, Clinical Trials, Burzynski Institute
——————————————————————
http://www.freerepublic.com/focus/fr/602961/replies?c=24
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[4]Reporters Committee for Freedom of the Press (A nonprofit association dedicated to providing free legal assistance to journalists since 1970): Sources and Subpoenas (Reporter’s Privilege) | Reporters – From the First Amendment Handbook
——————————————————————
http://www.rcfp.org/digital-journalists-legal-guide/sources-and-subpoenas-reporters-privilege
======================================
[5] – 4-5/2008 – From AJR, April/May 2008, A Flurry of Subpoenas, By Kevin Rector
——————————————————————
http://ajrarchive.org/article.asp?id=4511
======================================
[6] – Mass Media Law | Chapter Overview, Protection of News Sources/Contempt Power, Chapter Overview, Constitutional Protection of News Sources:
——————————————————————
http://highered.mcgraw-hill.com/sites/0072492171/student_view0/chapter10/chapter_overview.html
======================================
[7] – 9/18/2013Online News Association
——————————————————————
http://journalists.org/2013/09/18/ona-working-to-ensure-federal-shield-law-truly-protects-journalists/
======================================
[8] – 9/24/2013 – Desks and Blogs » Paying attention to the shield law’s critics – Journalists shouldn’t blindly support the shield law without taking in the whole picture, Posted on Tuesday Sep 24th at 10:50am, By Eric Newton
——————————————————————
http://cjr.org/303546/show/e0254cdea27dd5aabd57553cc5190110/?
——————————————————————
http://m.cjr.org/303546/show/e0254cdea27dd5aabd57553cc5190110/?
======================================
[9] – 11/21/2013 – Critiquing: Eric Merola and Stanislaw Burzynski respond to the FDA findings and the USA TODAY story. Hilarity ensues:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/21/httpscienceblogs-cominsolence20131118eric-merola-and-stanislaw-burzynski-respond-to-the-fda-findings-and-the-usa-today-story-hilarity-ensues/
======================================
[10] – 6/4/2013Stanislaw Burzynski versus the BBC:
——————————————————————
http://scienceblogs.com/insolence/2013/06/04/stanislaw-burzynski-versus-the-bbc/
======================================
[11] – 12/2002 – Interview with Dr. Burzynski, M.D., Ph.D. Biochemistry (12/2002):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/12/httpwww-cancerinform-orgaburzinterview-html/
======================================
[12] – 11/22/2013 – Is anyone attending the 4th Quadrennial Meeting of the Society of Neuro-Oncology in San Francisco right now?:
——————————————————————
http://scienceblogs.com/insolence/2013/11/22/is-anyone-attending-the-4th-quadrennial-meeting-of-the-society-of-neuro-oncology-in-san-francisco-right-now/
======================================
[13] – 12/4/2013 – USA TODAY and “The Skeptics” selling false hope to cancer patients:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/12/04/usa-today-and-the-skeptics-selling-false-hope-to-cancer-patients/
======================================
[14] – 9/1986 and 1/1987 – THE DISEASE OF INFORMATION: AN INTERVIEW WITH STANISLAW BURZYNSKI (The following interview was conducted in Sept., 1986, and January, 1987, and was first published in the Townsend Letter for Doctors, June 1989 – Reprinted with permission from the author):
——————————————————————
http://www.encognitive.com/node/4174
======================================
[15] – 7/4/1996– Cameron Frye Has a Big Idea (Bob Burtman):
——————————————————————
http://www.houstonpress.com/1996-07-04/news/cameron-frye-has-a-big-idea/full/
======================================
[16] – 1996 – Cancer doctor disregarded warnings, prosecutor says (Lubbock Avalanche-Journal):
——————————————————————
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
======================================

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

All’s fair in Drugs and War

======================================
GlaxoSmithKline
======================================
$3 BILLION
——————————————————————
7/2/2012
——————————————————————
(4/1998 – 8/2003)
——————————————————————
United States alleges GSK participated in
preparing
publishing
distributing

misleading medical journal article that misreported that clinical trial of drug demonstrated efficacy in treatment when study failed to demonstrate efficacy
——————————————————————
At same time, United States alleges, GSK didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
——————————————————————
(2001 – 2007)
——————————————————————
United States alleges GSK failed to include certain safety data about drug in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
——————————————————————
missing information included data regarding certain post-marketing studies
——————————————————————
data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
——————————————————————
United States alleges GSK stated drug had positive cholesterol profile despite having no well-controlled studies to support that message
======================================

======================================
Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc.
Janssen Pharmaceutica Products, L.P.
======================================
$2.2 BILLION +
——————————————————————
11/4/2013, Monday
——————————————————————
Johnson & Johnson (J&J) and Janssen
——————————————————————
complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
——————————————————————
For example, when J&J study of drug showed significant risk of strokes and other adverse events in patients, complaint alleges Janssen combined study data with other studies to make it appear there was lower overall risk of adverse events
——————————————————————
year after J&J received results of 2nd study confirming increased safety risk for patients taking drug, but hadn’t published data, one physician who worked on study cautioned Janssen
——————————————————————
“[a]t this point, so long after [the study] has been completedwe must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
——————————————————————
complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns
——————————————————————
When Janssen received initial results of studies indicating drug posed same risk as other antipsychotics, complaint alleges company retained outside consultants to re-analyze study results and ultimately published articles stating drug was actually associated with lower risk
——————————————————————
J&J and another of its subsidiaries, Scios Inc.
——————————————————————
8/2001 – FDA approved drug to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity
——————————————————————
approval based on study involving hospitalized patients experiencing severe heart failure who received infusions of drug over average 36-hour period
——————————————————————
complaint alleged Scios had no sound scientific evidence supporting medical necessity of outpatient infusions and misleadingly used small pilot study to encourage serial outpatient use of drug
======================================

======================================
Abbott Laboratories Inc.
======================================
$1.5 BILLION
——————————————————————
5/7/2012, Monday
——————————————————————
(2001 – 2006)
——————————————————————
company marketed drug in combination with atypical antipsychotic drugs even after its clinical trials failed to demonstrate adding drug was any more effective than atypical antipsychotic alone for that use
——————————————————————
1999 – forced to discontinue clinical trial of drug due to increased incidence of adverse events, including
somnolence
dehydration
anorexia
experienced by study participants administered drug
——————————————————————
funded 2 studies of use of drug
both failed to meet main goals established for the study
——————————————————————
When 2nd study failed to show statistically significant treatment difference between antipsychotic drugs used in combination with drug and antipsychotic drugs alone, waited nearly 2 years to notify sales force about study results and another 2 years to publish results
======================================

======================================
AstraZeneca LP / AstraZeneca Pharmaceuticals LP
======================================
$520 MILLION
——————————————————————
4/27/2010, Tuesday
——————————————————————
engaged doctors to conduct studies on unapproved uses of drug
——————————————————————
recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
——————————————————————
then used
studies
articles

as basis for promotional messages about unapproved uses of drug
======================================
REFERENCE:
======================================
11/26/2013 – United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/26/united-states-department-of-justice-versus-big-pharma-big-pharma-fought-the-law-and-the-law-won/
======================================

Critiquing: The Institute of Medicine report on cancer care: Is the system “in crisis”?

[1] – 9/19/2013 – “Americans love to fight, traditionally”

“All real Americans love the sting and clash of battle…When you, here, everyone of you, were kids, you all admired the champion marble player, the fastest runner, the toughest boxer, the big league ball players, and the All-American football players”

“Americans love a winner”

“Americans will not tolerate a loser”

– General George S. Patton, Jr., June.5, 1944

The above might as well be Greek to Dr. David H. Gorski a/k/a “Orac”

He’s the epitome of the word “loser”

Indeed, “Orac” described his work-place nemesis as “user hostile”

After 5 years, he still didn’t fully understand much of it, and he claims he’s not exactly computer illiterate

Gorski is that “guy” who couldn’t even find Burzynski’s publication:

[2] – 1997 – Burzynski. S.R. Antineoplastons. oncogenes and cancer

[3] – “Orac” batted the big “O” when he tried to find “the scientific rationale to expect that” antineoplastons “might have antitumor activity”

[4] – Gorski was geniusless when it came to finding “which genes are targeted by antineoplastons,“ proving that he really does NOT know Burzynski’s personalized gene-targeted therapy

In fairness, I will point out that he hasn’t put the time in to learn all the ins and outs of the system …

He pontidefecates about phase II clinical trials when his name isn’t even on a phase 2 trial, too

[5] – 9/19/2013 – He’s the “guy” who’s “mystified” as to how Stanislaw Burzynski “has managed to keep practicing for 36 years after he first began treating patients with an unapproved (not ordinary) chemotherapeutic drug (the concoction of peptides purportedly isolated from blood and urine that Burzynski dubbed “antineoplastons” because of their alleged ability to inhibit the growth of cancer)”

This is not an issue unique to Gorski; I’ve discussed other cases like this, such as Bobby Blaskiewicz, who used his man-crush relationship with Gorski to appear on the Skeptic Canary Show; Davey James, who was only recently stripped of his license to practice in several states of mind; Adam Jacobs, who went so far as to use his business influence to alter his Dianthus Mediclueless web-site in London to be more hack friendly, and an interventist who administered twerkpidity to posers who didn’t have common sense and defrauded minions for tens of millions of minutia

It’s a general problem

However, as far as doctors who should have been shut down a long time ago, “Orac” takes the cake

[6] – He has NOT yet figured out that Burzynski learned from the best

[7] – Who could do it better than someone like Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) who Burzynski had to deal with:

“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

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

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

20130920-220216.jpg

20130920-220507.jpg
After all, can we really take a person seriously, who claimed:
——————————————————————
[8] – 11/2/2012 – “Personally,