Stanislaw Rajmund Burzynski, Stanislaw R. Burzynski, Stanislaw Burzynski, Stan R. Burzynski, Stan Burzynski, S. R. BURZYNSKI, S. Burzynski, Arthur Burzynski, Hippocrates Hypocrite Hypocrites Critic Critics Critical HipoCritical
GorskiGeekstarts off his soapbox stump speech:
—————————————————————— “I was very pleased last Friday, very pleased indeed”
——————————————————————
Of course he was
After all, it was as if USA TODAY was quoting directly from “The Skeptics™”fave Fahrvergnügen pharyngula and GorskGeeks’sjackedJulyjabberwocky at “The Amazing Meeting”2013 (TAM 2013 #TAM2013) Twitter Twaddle-fest
Given the normal subject matter of this blog, in which I face a seemingly unrelenting infiltration of pseudononsensepseudononscience and hackery into even the most hallowed halls of hacademic medicine, against which I seem to be fighting a mostly uphill battle, having an opportunity to see such an excellent non-deconstruction of science and medicine in a large badmainstream news outlet like USA TODAY, GONE TOMORROW is rare and ungratifying
GorskGeek gambits:
—————————————————————— “As you might recall, USA TODAY reporter Liz Szabo capped off a months-long investigation of Dr. Stanislaw Burzynski and his Burzynski Clinic with an excellent (and surprisingly long and detailed) report, complete with sidebars explaining why cancer experts don’t think that Burzysnki’s anecdotes are compelling evidence that his treatment, antineoplastons, has significant anticancer activity and a human interest story about patients whom Burzynski took to the cleaners”
——————————————————————
My question ?
GorskGeek, how do you know it was a:
“months-long investigation” ?
The article does NOT indicate HOW LONG the USA TODAY“investigation” took
From this, I can only conclude, as I did after 1st reading the article, that based on the comments of Dr. David H. Gorski“Orac”, that there must have been collusion between “The Skeptics™” and USA TODAY
Most of this, of course, is no news to my readers, as I’ve been writing about Dr. Burzynski on a fairly regular basis for over 8 months now
—————————————————————— GorskGeek goofs:
—————————————————————— “It’s just amazing to see it all boiled down into three articles and ten short videos in the way that Szabo and USA TODAY did, to be read by millions, instead of the thousands who read this blog“
—————————————————————— Thousands read his blog ?
Does he mean over the 2 year period he’s been writing about Burzynski ?
GorskGeekInspector Gadgets:
—————————————————————— “Szabo also found out who the child was who died of hypernatremia due to antineoplastons in June 2012, a death that precipitated the partial clinical hold on Burzynski’s bogus clinical trials, about which both Liz Szabo and I have quoted Burzynski’s own lawyer, Richard Jaffe, from his memoir, first about Burzynski’s “wastebasket” trial, CAN-1“
—————————————————————— GorskGeek and USA TODAY both hashtag Failed to point out that a boy, the same age as Josia Cotto, survived a serum sodium (Na+) level of 234 mEq/L
If GorskGeek actually knew how to do real “science-based medicine” research, and if Liz Szabo and Jerry Mosemak had really actually done a “months-long investigation”, maybe USA TODAY and “Orac” could have had enough time to have figured the above out, as well as the clinical trialBurzynski’sattorney, Rick Jaffe, was referring to, was the CAN-1, which even you did NOT display any knowledge of in the July TAMmany Twaddle [3], and your 11/15/2013article[4]
——————————————————————
Naturally, upon reading Liz Szabo’s “ story,” I wondered how long it would be before there would be a response from GorskGeek or his minions
Both responses contain the same sorts of tropes, misinformation, and pseudononscience that I’ve come to expect from GorskGeek[1-2+4]
USA TODAY is biased and in the pocket of “The Skeptics™”
It was a “Shite Muslim Militia” piece
—————————————————————— GorskGeekdreamsicles:
—————————————————————— “I’ve deconstructed these, and many more, of Merola’s nonsense over the last two years”
“Odd how @BurzynskiMovie pretends I haven’t deconstructed his “evidence” in depth before”?
Really ?
GorskGeek is so much a monumental myopic Mythomaniac
GorskGeek all you did was “cherry-pick” what you wanted to blather about, and selectively ignored everything else
——————————————————————
What actually surprised me was the viscousness of the counterhackattack
For example, in counterhackattackingEric Merola’s letter to Liz Szabo, GorskGeek tries unsuccessfully to claim that Merola actually hopes that her child will get cancer, so that Burzynski supporters can gloat about it and Szabo will have to apologize to her children for her “perfidy” (in GorskGeek’s eyes, at least):
—————————————————————— GorskGeek gesticulates:
—————————————————————— “He denies that he hopes Szabo’s children will develop brain cancer, but then gloats gleefully over the possibility that she would have to face them after having—again in his mind—”helped to destroy the only thing that could have helped” them”
——————————————————————
In the dictionary, under the definition of “spin bowel movement (SBM),” there should be a picture of “Dr.” (and I use that term very “loosely”) David Gorski
GorskGeek would have fit in holistically as the propagandist for Hitler, Lenin, Mussolini, Pol Pot, Stalin, etc.
Then, just when I thought GorskGeek couldn’t go any lower, he does, this time in his longer response on his blog
—————————————————————— “Eric Merola and Stanislaw Burzynski respond to the FDA findings and the USA TODAY story. Hilarity ensues”
——————————————————————
Obviously, to “Orac” asking GorskGeek to follow normal rules regulating medical ethics and human subject protections in critical trolls’ blog trials is exactly like murdering millions of people’s brain cells, carrying out horrible medical experimentation on common sense and sensibility, making untold numbers of Africans, slaves to his stupendousmess, and harassing, gratuitously, families of soldiers “killed” by his word salad battle
Didn’t anyone ever teach GorskGeek that you need to build up to that sort of climax ?
Of course, the big difference between Hitler’s propaganda chief Joseph Goebbels, unfortunately, is that compared to “Orac,” he had talent, and David GorskGeek does NOT
GorskGeek is a hack and is only funny by accident because he has no filters that tell him when he’s going way under the top
To him, Burzynski is an infidel
I do not share his belief, but, even worse, I have the temerity to criticize his god“Orac,” or, to mix metaphors shamelessly, to point out that GorskGeekhas no clothes
Since I’ve dealt with so many of the tropes included in GorskGeek’snot-so-little rant, I hardly see the need to repeat myself
However, as a breast cancer surgeon’s skeptic, I find one of GorskGeek’slies to be as despicable, or perhaps more so, than his ad hominem comparisons
—————————————————————— GorskGeek, the Hitler of hipocracy, came up with this hit parade of paranoia and “conspiracy theory”:
—————————————————————— “I don’t know what sort of attacks on the UK bloggers who produce the bulk of the skeptical blog posts about Burzynski are coming in Burzynski II, but when it comes to me no doubt Merola is referring to this bit of yellow journalism in 2010 from an antivaccine propagandist named Jake Crosby, entitled David Gorski’s Financial Pharma Ties: What He Didn’t Tell You” [5]
—————————————————————— GorskGeek then ad hocs ad nauseum about ad hominem fallacy
“In this fallacy, rather than addressing the actual evidence and science that demonstrate their favorite brand of woo to be nothing more than fairy dust, the idea is to preemptively attack and discredit the person“
“The ad hominem is not just insults or concluding that someone is ignorant because, well, they say ignorant things and make stupid arguments (in which case calling someone stupid or ignorant might just be drawing a valid, albeit impolitic, conclusion from observations of that person’s behavior), but rather arguing or insinuating that you shouldn’t accept someone’s arguments not because their arguments are weak but because they have this personal characteristic or that or belong to this group or that“[6]
—————————————————————— GorskGeek, the huckster of hackery laments that “The Skeptics™” are subject to character assassination, NOT because of their “science-based medicine”, but, alas, for being biased, lying, cowards
So, he must justify that as to why he then ad hominems those who he harangues:
—————————————————————— “In Burzynski The Movie, Dr. Whitaker has his nose embedded so far up Dr. Burzynski’s rectum that Dr. Burzynski wouldn’t need a colonoscopy if Merola just strapped a light to Dr. Whitaker’s face“[7]
——————————————————————
—————————————————————— “In the meantime, I realized that seeing Josh Duhamel stick his proboscis firmly up Burzynski’s posterior was not enough to explain the disturbance that I was feeling“[8]
——————————————————————
—————————————————————— GorskiGeek seems to have an unhealthy infatuation with ASS
My suppositorsition is that GorskiGeek, the highfalutin’ He-Man of hypocrisy, does wax on, wax off, waxes phonetic about ASS, because he is the apex of ASSmuchness
——————————————————————
In essence, he denies the toxicity of water in terms I’ve never seen anyone try to downplay before:
Water… is toxic?
This was perhaps the most stunningly malicious use of emotion to manipulate the reader in any of the propaganda pieces against H2O in history
—————————————————————— GorskGeekclaims:
—————————————————————— “Josia, as readers of Liz Szabo’s report will know, was the six year old boy with an inoperable brain tumor who died of hypernatremia (elevated sodium levels in the blood) as a result of Burzynski’s therapy“
—————————————————————— GorskGeek gassticulates:
—————————————————————— “As I pointed out last Friday and Szabo reported in her story, before his death Josia’s serum sodium was measured at 205 mEq/L, way above the normal range of 136-145 mEq/L and well into the lethal range”
“As I pointed out then, I’ve never seen a sodium level anywhere near that high“
“During my residency, the highest I recall ever seeing was maybe around 180 mEq/L”
——————————————————————
As I already pointed out previously in this article:
GorskGeek and USA TODAY both hashtag Failed to point out that a boy, the same age as Josia Cotto, survived a serum sodium (Na+) level of 234 mEq/L
GorskGeekclaims that Josiadied of hypernatremia (elevated sodium levels in the blood) as a result of Burzynski’s therapy
GorskGeek does NOT provide ANY citation(s), reference(s), and / or link(s) in support of his claim, and does NOT provide a copy of the autopsy
GorskGeek’s brain cells must be “sleeping in excess”, hence the symptoms of lethargy progressing ignorance of adverse events which approach critical black hole levels
Of course, none of this is new information
—————————————————————— GorskGeek hacks:
—————————————————————— “I also note that one of Burzynski’s most famous patients, Hannah Bradley, who with her partner Pete Cohen proclaims herself cured of her brain cancer, thanks to Burzynski, suffered some pretty serious toxicities from antineoplastons herself, including high fevers to 103.9° F, shaking chills, and severe rashes“
“Pete even documented how badly Hannah reacted to antineoplastons in his YouTube documentary Hannah’s Anecdote”
—————————————————————— GorskGeekflummoxes in that he erred to elucidate that the “rash” which Hannah experienced, even entailed epilepsy anti-seizure medication [4]
GorskGeekgambols the gabroni gambit by giving nothing but glib reasons for his genetically challenged gestation of Hannah’svlogs after gears up for Great Britain
Yes, GorskGeek is gabless about Hannah’sprogress in the G.B. as a germinating gerbil, as far as flu or fever, perhaps fearing his failure to feature any fact-checking facilitation a fanboy of Fanectdotes should fittingly fictionalize
——————————————————————
The rest of GorskGeek’srant reads like a greatest hits compilation from cancer hacks
You get the picture
That’s the whack-n-hack counterhackfensive trying to shore up Liz Szabo’ssorryarticle
—————————————————————— GorskGeekblowshard and long about the FDA Form 483′s findings, but does NOT heed his massive failure to be persuaded that:
“The FDA has not yet issued final conclusions”
——————————————————————
Who would doubt that if GorskGeek were to blog about Burzynski’s1997 criminal trial, that he would NOT list each and every one of the 34 counts of mail fraud, 40 counts of violating Food and Drug Administration regulations, and the 1 contempt-of-court charge; all “allegations”, which netted the U.S. Gubment absolutely NOTHING ? [9]
—————————————————————— GorskGeekidolizes the Burzynski Research Institute(BRI)IRB, because of Burzynski’sscientific publications, which indicate:
—————————————————————— 2003 – Membership of the Institutional Review Board(IRB) was in agreement with the Food and Drug Administration(FDA) [10]
—————————————————————— 3/2004 – Membership of the Institutional Review Board(IRB) was in agreement with the Food and Drug Administration(FDA) [10]
—————————————————————— 9/2004 – Membership of the Institutional Review Board(IRB) was in agreement with the Food and Drug Administration(FDA) [10]
—————————————————————— 2004 – Membership of Institutional Review Board(IRB) was in compliance with FDA guidelines [10]
—————————————————————— 6/2005 – Membership of the Institutional Review Board(IRB) was in agreement with the Food and Drug Administration(FDA) [10]
—————————————————————— GorskGeek then does a piss-poor“slight of hand job”, jerking the reader off about Pseudoprogression, pseudoresponse, so-called pseudoprogression, and “One phenomena, termed Pseudo-Progression (psPD)”
GorskGeekfalls flat face first for failing to show this phenomenon has factually happened [11]
I’ve made no secret of how much I dispute David H. Gorski, a la “Orac”, the “self-proclaimed”brain cancer doctor and brain cancer researcher who has been treating readers with an unproven, unapproved, NOT ordinarychemotherapeutic agent since Jesus just left Chicago, bound for Nawlins, seemingly Elaphe longissimaslithering around, under, over, and past all attempts to intestate him and shut him up
Along the way, GorskGeek has become a hero to the cancer hackery industry, touted as the man who can cure incurable insomnia that science-based medicine can’t, even though his treatment, insolence, allegedly pop tarts isolated from bloopers and Uranus that normally keep insomnia in check in healthy people, are by any reasonable definition NOT ordinary chemotherapy
Indeed, they are toxic, with a number of side effects reported, the most common and dangerous of which being life-threatening hyperactivity (elevated sugar levels in the blood)
All you have to do is to type GorsGeek’s name into the search box of this blog, and you’ll find copious documentation of the abuses of patience, science, and critical trials perpetrated by “Orac” and the cult of impersonality that has evolved around him
He’s even acquired his very own film perpougendist, a credulous fellow named Bob Blaskiewicz, who has made 2 astoundingly bad hackumentaries that are nothing more than unabashed hagiographies of the brave maverick doctor curing insolence where no one else can
They’re chock full of misinformation, pseudononsense, spin, and obvious emotional manipulation, and the 2nd one, at least, was very popular
For the longest time, I’ve been hoping that major mainstream news organizations would take this story on
—————————————————————— GorskGeekclaims:
“Now, thanks to Liz Szabo at USA Today, we know from her article Doctor accused of selling false hope to families [1]:
“Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades”
—————————————————————— GorskGeek, of course, does NOT care to mention the 2 hypernatremia studies that I listed in the 2nd of my 3 critiques on USA TODAY’s“hatchet job” of Burzynski[2], because, as he accuses others:
THEY DO NOT FIT HIS NARRATIVE
—————————————————————— GorskGeek continues:
—————————————————————— “showed a blood sodium level of 205 millimoles per liter, a level that is typically fatal“
“I was astounded to see that number“
“I’ve never, ever seen a sodium level that high“
“Typically, normal is typically between 135 and 145 mEq/L, with slight variations of that range depending on the lab”
“Burzynski’s excuse, which I’ve heard at various times as being due to an “improper blood draw” or as described above, is purest nonsense”
“Unless the technician spiked Josia’s sample with 3% saline or something like that, there’s no way to get the leve that high”
“Josia almost certainly died because of hypernatremia from antineoplaston therapy“
“To me, this is the biggest revelation of the story:”
“The story and identity of the child who was killed by Burzynski’s treatments“
——————————————————————
I did NOT know that GorskGeek was the Medical Examiner for the United States Food and Drug Administration
—————————————————————— GorskGeek is mistaken, as the “purest nonsense” is his nonsensical claim:
“I’ve never, ever seen a sodium level that high“
The reasonGorskGeek has:
“never, ever seen a sodium level that high”
is because he’s a “hack”, who’s more interested in churning out as many blogsplats as he can, rather than doing real“science-based medicine”research
As evidence of MY claim, I submit:
—————————————————————— 9/2004 – A Non-Fatal Case of Sodium Toxicity (Hypernatremia)
—————————————————————— “6 year old boy who was taken to the hospital following a seizure attack, and lab analyses revealed a serum sodium (Na+) levels of 234 mEq/L”
“A search of the boy’s house led to the discovery of rock salt in the cabinet and a container of table salt”
“Extrapolating from the serum sodium (Na+) level, it was estimated that the child had ingested approximately 4 tablespoons of rock salt, leading to the acute toxicity“
“A literature search revealed that the serum sodium (Na+) concentration in the present report was the highest documented level of sodium in a living person“
Non-Fatal 193-209 mEq/L have been reported previously [3]
——————————————————————
We also learn that—surprise! surprise!—GorskGeek is an enormous tool
(as opposed to having “an enormous tool” His cranium is too small to have “enormous tool”)
—————————————————————— GorskGeek then hacks:
—————————————————————— “Look at him dismiss his critics, particularly former patients, many of whom, let’s recall, have terminal cancer, many of whom are dead:”
“Burzynski dismisses criticism of his work, referring to his detractors as “hooligans” and “hired assassins.””
—————————————————————— GorskGeek, you are a “hooligan”, liar, lame, loser, et al.
—————————————————————— GorskGeek proceeds:
—————————————————————— “You know, whenever I hear Burzynski fans like Eric Merola accuse skeptics of attacking cancer patients, of accusing them of horrible things”
“I think I will throw this quote right back in their faces”
“Here’s Burzynski calling his patients prostitutes, thieves, and mafia bosses, and “not the greatest people in the world,” while accusing them of wanting to “extort money from us.””
—————————————————————— GorskGeek, LAME attempt at another LIE
Burzynski did NOT CALL his patients what YOU claim he called them
Let me repeat it for YOU, because I have the sneaking suspicion that YOU are “intellectually challenged”
BurzynskiSAID:
“We see patients from various walks of life”
“We see great people”
“We see crooks”
“We have prostitutes”
“We have thieves”
“We have mafia bosses”
“We have Secret Service agents”
“Many people are coming to us, OK?”
“Not all of them are the greatest people in the world”
—————————————————————— GorskGeek, just in case you did NOT learn this at the University of Michigan, there is a difference between SAYING“WE SEE” and / or “WE HAVE”, and CALLING someone something
Allow me to provide you with a great example
If I SAY that YOU are the BIGGEST POMPOUS ASS I’ve ever seen, and YOU are NOT a BIG POMPOUS ASS, then THAT is derogatory
However, if I CALL YOU the BIGGEST POMPOUS ASS that I have ever seen, because you really and truly are a BIG POMPOUS ASS; as you are, then THAT is NOT derogatory
—————————————————————— GorskGeek tries again:
—————————————————————— “Not surprisingly, he also liberally uses the Galileo gambit, but that’s not surprising, as he’s repeatedly made the hilariously arrogant and scientifically ignorant claim that he is a pioneer in genomic and personalized cancer therapy and that M.D. Anderson Cancer Center and other world-class cancer centers are “following his lead.””
“Indeed, he claimed to have invented the field 20 years ago”
“Sadly, his publication record does not support such grandiose claims“
—————————————————————— GorskGeek, how would you know ?
You proved that you weren’t smarter than a 5th grader when you could NOT find Burzynski’s1997 Antineoplastons, oncogenes and cancer [4]
—————————————————————— “Curious as to just what the heck Burzynski was talking about here, I searched PubMed for this alleged review article”
“I couldn’t find it on PubMed“
“Perhaps Burzynski proposed this “revolutionary” new idea in a peer-reviewed article that’s not indexed in PubMed, but if he did I couldn’t find it using Google and Google Scholar“[5]
So why should ANYONE believe that you were able to locate the rest of his publications
and review all of them?
Now THAT would be a “grandiose claim”
—————————————————————— GorskGeek was also the village “idiot savant” (minus the “savant”) who face planted:
“how Burzynski never explains which genes are targeted by antineoplastons … “[6]
GorskGeek must have fumed for days when he found I “fact-checked” his fluff and found it false: [7-8]
—————————————————————— GorskGeekhopes to wreak havoc when he harrumphs:
—————————————————————— “For instance, experts are saying the same things I’ve been saying for a couple of years now about Burzynski’s anecdotes of “miracle cures,” such as Hannah Bradley and Laura Hymas”
“The reasons for these anecdotes include:”
“Burzynski often relies on anecdotes, which don’t tell the full story”
“Burzynski’s therapies are unproven“
“Burzynski’s patients may have been misdiagnosed“
“Burzynski’s patients may have been cured by previous therapy“
“There’s a reason why I’ve spent so much time deconstructing Burzynski anecdotes, and it’s for all of those reasons plus that anecdotes are often interpreted incorrectly by patients without medical training”
“Even doctors who are not oncologists sometimes interpret such anecdotes incorrectly to indicate that the cancer therapy chosen is the therapy that cured the patient“
“It’s not just Burzynski patient anecdotes, but it’s any cancer cure anecdote“
“That’s why clinical trials are necessary to differentiate all these confounding effects from actual effects due to the treatment”
—————————————————————— GorskiGeek displays what an abject #FAIL he is, as the question he should be asking is:
Why is the Food and Drug Administration FORCING patients to #FAIL conventional treatments; such as surgery, chemotherapy, and radiation therapy, before being allowed to utilize antineoplaston therapy ?
If the FDA was NOT doing this, then GorskGeek and the “so-called experts” would NOT have this crutch to fall back on
GorskGeek, please list all the other phase II clinical trials where the F.D.A. has done this, and please also explain what would you do if the FDA did this to YOUR clinical trials ?
I know this might require some “Grapefruits” on your part, but do try and see if you can find yours in order to pull this off, if you’re NOT the coward I think you are
And when you’re done with that, please try to explain away the case of Jessica Ressel-Doeden
GorskGeekwinds up for the pitch of bullshit
He ratchets back his right arm and rockets it right into his rectum, reaches ’round and pulls out this righteousness:
—————————————————————— “Not coincidentally, Hannah Bradley had surgery, chemotherapy, and radiation, and Laura Hymas had radiation and chemotherapy”
GorskGeek, Hannah Bradley NEVER had chemotherapy, unless you are now going to claim that by “chemotherapy” you meant antineoplastons [9]
Hannah specifically mentioned:
“Chemotherapy also mentioned but not strong enough for that” [10]
—————————————————————— GorskGeek:
“Even doctors who are not oncologists sometimes interpret such anecdotes incorrectly” ?
I think you meant, even breast cancer oncologist specialists who are NOT brain cancer oncology specialists interpret incorrectly, you JackASS
====================================== [4] – 1997 – Burzynski. S.R. Antineoplastons. oncogenes and cancer. Anti-Aging Medical Therapeutics, Vol.1. Klatz RM.
Goldman R. (Ed). Health Quest Publication 1997; Marina del Rey, CA. USA
Pg. 24
——————————————————————
I’ve made no secret of my opinion of a certain cancer “research” doctor named David H. Gorski, MD, PhD, of Wayne State University School of Medicine and Barbara Ann Karmanos Cancer Center / Institute, Detroit, Michigan fame
After a couple of winks I changed my characterization to say that it would have made Penn and Teller vomit in revulsion at its sheer incompetence
Be that as it may, I view Gorski as highly unethical and pseudononsense, an incompetent purveyor of “personalized MUD-targeted medicine for dummies,” and someone who might at one time have been on to something but, like all hacks, just couldn’t let go when it became clear that his personalized MUD-targeted Skeptic therapy was far more toxic than advertised and way less efficacious, if it’s even efficacious at all, which is highly doubtful.
Gorski claimed:
“[I]f I had screwed up, I would have admitted it”
Data talks
BS walks
And there’s no doubt that Gorski, too, is pure BS
In fact, I think I’m being too kind
I have yet to see his admission that he lied when he posted:
What science based medicine publication(s) does Gorski cite in support of his “theory”?
NONE !!!
What do the science based medicine publications indicate?
====================================== [1] 4/1/1992 PHENYLACETATE-novel NONTOXIC inducer of tumor cell differentiation
—————————————————————— Sodium PHENYLACETATE found to affect growth and differentiation of tumor cells in vitro at concentrations achieved in humans WITH NO SIGNIFICANT ADVERSE EFFECTS
—————————————————————— PHENYLACETATE is effective in inducing tumor cell maturation and FREE OF CYTOTOXIC AND CARCINOGENIC EFFECTS, a combination that warrants attention to potential use in cancer intervention
—————————————————————— Sodium PHENYLACETATE is investigational new drug approved for human use by U.S. Food and Drug Administration
—————————————————————— DRUG ALREADY ESTABLISHED AS SAFE AND EFFECTIVE … we propose use may be extended to cancer preventation and therapy
====================================== [2] 8/20/1992 Difficulties may be overcome through exploitation of recent discovery of sodium PHENYLACETATE as NONTOXIC inducer of differentiation …
—————————————————————— (pro-drug) Sodium 4-PHENYLBUTYRATE can be given in oral doses of 0.3 to 0.6 g per kilogram of body weight per day with NO ADVERSE REACTIONS
——————————————————————
Drug rapidly metabolized to PHENYLACETATE and PHENYLACETYLGLUTAMINE
—————————————————————— PHENYLACETATE (but not PHENYLACETYLGLUTAMINE) … CAN POTENTIATE EFFICACY OF OTHER DIFFERENTIATING AGENTS, such as cytotoxic drugs …
====================================== [3] 9/15/1992 we explored efficacy of PHENYLACETATE, an amino acid derivative with LOW TOXICITY INDEX WHEN ADMINISTERED TO HUMANS
—————————————————————— PHENYLACETATE, used alone or in combination with other drugs, might offer safe and effective new approach to treatment …
====================================== [4] 5/1993 NONTOXIC differentiation inducer, sodium PHENYLACETATE (NaPA)
——————————————————————
In vitro antineoplastic activity was observed with drug concentrations that have been achieved in humans with NO SIGNIFICANT TOXICITIES, suggesting PA, used alone or in combination with other antitumor agents, warrants evaluation in treatment of advanced prostatic cancer
====================================== [5] 10/1/1993 Sodium PHENYLACETATE (NaPA) and its precursor, sodium 4-PHENYLBUTYRATE (NaPB), can enhance HbF production in cultured erythroid progenitor derived from normal donors and patients with SS anemia or beta-thal, when used at pharmacologic concentrations
—————————————————————— NaPA and NaPB, BOTH ALREADY PROVEN SAFE AND EFFECTIVE IN TREATMENT OF CHILDREN …
====================================== [6] 2/15/1994 sodium PHENYLACETATE can induce cytostasis and reversal of malignant properties of cultured human glioblastoma cells, when used at pharmacological concentrations that are WELL TOLERATED BY CHILDREN AND ADULTS
——————————————————————
Systemic treatment of rats bearing intracranial gliomas resulted in significant tumor suppression with NO APPARENT TOXICITY to host
====================================== [7] 4/1/1994 Pg. 1690
—————————————————————— protocol underwent several modifications over 6-month period
——————————————————————
Interest in PHENYLACETATE as anticancer agent generated by reports that ANTINEOPLASTON AS2-1, a preparation which by weight is 80% PHENYLACETATE, displayed clinical antitumor activity (13)
—————————————————————— 17 patients (16 men / 1 woman) (36-75) median age 57
—————————————————————— Pg. 1693
—————————————————————— Clinical Toxicities. NO TOXICITY associated with bolus administration of drug
——————————————————————
Drug-related TOXICITY clearly related to serum
PHENYLACETATE concentration
——————————————————————
3 episodes of Central Nervous System (CNS)
TOXICITY, limited to CONFUSION
and LETHARGY and often preceded by emesis, occurred in patients treated at dose levels 3 and 4
—————————————————————— Symptoms resolved within 18 h of terminating drug infusion in all instances
—————————————————————— Pg. 1694
—————————————————————— PHENYLACETATE serum concentrations … were typically associated with CNS toxicity
——————————————————————
While ability to cross blood-brain barrier may underlie clinical improvement seen in patient with glioblastoma, could also explain dose-limiting side-effects of drug, i.e., nausea, vomiting, sedation, and confusion
——————————————————————
Limited experience with 150-mg/kg i.v. boluses suggests serum PHENYLACETATE concentrations occurring transiently
above 500 ug/ml are well tolerated
—————————————————————— Intermittent drug infusion should permit some drug washout to occur, thereby minimizing drug accumulation
——————————————————————
Predicts wide range of peak drug concentrations will be observed
——————————————————————
Possible these would be sufficiently transient so as not to produce CNS toxicity and troughs not prolonged as to abrogate antitumor activity of drug
—————————————————————— Dosing alternatives should be explored, our study indicates PHENYLACETATE can be safely administered by CIVI and result in clinical improvement in some patients with hormone-refractory
prostatic carcinoma and glioblastoma multiforme who failed conventional therapies
====================================== [8] 6/1/1994 PHENYLACETATE is naturally occurring plasma component that suppresses growth of tumor cells and induces differentiation in vitro
——————————————————————
Treatment with PHENYLACETATE extended survival … WITHOUT ASSOCIATED ADVERSE EFFECTS
====================================== [9] 9/1994 PHENYLACETATE, NONTOXIC differentiation inducer, can suppress growth of other neuroectodermal tumors, i.e., gliomas, in laboratory models and humans
====================================== [10] 4/1995 PHENYLACETATE, an inducer of tumor cytostasis and differentiation, shows promise as RELATIVELY NONTOXIC antineoplastic agent in models and humans
====================================== [11] 6/15/1995 Growth-inhibiting and differentiating effects of sodium PHENYLACETATE against hematopoietic and solid tumor cell lines has aroused clinical interest in use as anticancer drug
——————————————————————
In Phase I trial of PHENYLACETATE … commonly resulted in drug accumulation and REVERSIBLE DOSE-LIMITING NEUROLOGIC TOXICITY
——————————————————————
18 patients
—————————————————————— DOSE-LIMITING TOXICITY, consisting of REVERSIBLE CENTRAL NERVOUS SYSTEM DEPRESSION, observed for 3 patients at 2nd dose level
====================================== [12] 10/12/1995 aromatic fatty acid PHENYLACETATE, a common metabolite of phenylalanine, shows promise as a RELATIVELY NON-TOXIC drug for cancer treatment
====================================== [13] 10/1995 investigated effects of a NONTOXIC differentiation inducer, PHENYLACETATE (PA), on neuroectodermal tumor-derived cell lines
====================================== [14] 1995 Antineoplastons, firstly described by Burzynski, are naturally occurring peptides and amino acid derivatives which control neoplastic growth
—————————————————————— toxicological study of Antineoplastons A-10 and AS2-1 in combination with other anticancer agents or radiation in 42 patients 46 tumors with terminal stage cancer
—————————————————————— Antineoplaston A-10 oral formulation
14 – patients A-10 injectable formulation
25 – patients
—————————————————————— Antineoplaston AS2-1 oral formulation
33 – patients AS2-1 injectable formulation
10 – patients
—————————————————————— Major adverse effects that may have been related to agents used in combination with other conventional chemotherapeutic agents or radiation:
liver dysfunction
myelosuppression
general weakness THESE EFFECTS WEREN’T SEEN WHEN EITHER ANTINEOPLASTON WAS ADMINISTERED ALONE
—————————————————————— MINOR ADVERSE EFFECTS OBSERVED IN SINGLE USE OF EITHER ANTINEOPLASTON A-10 OR AS2-1:
reduced albumin
increased alkaline phosphatase
increased amylase
reduced cholesterol
peripheral edema
eosinophilia
fingers rigidity
excess gas
headache
hypertension
maculopapullar rash
palpitation adverse effects didn’t limit to continuation of either agent
—————————————————————— Antineoplaston A-10 and AS2-1 LESS TOXIC THAN CONVENTIONAL CHEMOTHERAPIES and useful in maintenance therapy for cancer patients
====================================== [15] 1996 Antineoplastons, first described by Burzynski, are naturally occurring peptides and amino acid derivatives which control neoplastic growth
——————————————————————
reported cytostatic inhibitory effect of A10 on human hepatocellular carcinoma cells and differentiation inducing effect of AS2-1 on various tumor cells suggest potential benefit for treatment of human hepatocellular carcinoma since tumor recurs frequently despite initial successful treatment
——————————————————————
Clinical experience of hepatocellular carcinoma (HCC) patient whose tumor, after incomplete trancathere arterial embolization (TAE) for a 7cm 7cm HCC, has been stable for more than 15 months during which time he has been taking Antineoplaston AS2-1 continuously WITHOUT ANY SERIOUS ADVERSE EFFECTS
====================================== [16] 5/1996
——————————————————————
In pursuit of alternative treatments for chemoresistant tumor cells, tested response of multidrug-resistant (MDR) tumor cell lines to aromatic fatty acids phenylacetate (PA) and phenylbutyrate (PB), 2 differentiation inducers currently in clinical trials
—————————————————————— Both compounds induced cytostasis and maturation of multidrug-resistant breast, ovarian, and colon carcinoma cells with no significant effect on cell viability
——————————————————————
MDR cells generally more sensitive to growth arrest by PA and PB than their parental counterparts
—————————————————————— PA and PB potentiated cytotoxic activity of doxorubicin against MDR cells
—————————————————————— Taken together, in vitro data indicate PA and PB, differentiation inducers of aromatic fatty acid class, may provide alternative approach to treatment of MDR tumors
====================================== [17] 12/1996 PHENYLACETATE (PA) and related aromatic fatty acids constitute novel class of RELATIVELY NONTOXIC antineoplastic agents
====================================== [18] 8/1997 aromatic fatty acids PHENYLACETATE (PA) and PHENYLBUTYRATE (PB) are novel antitumor agents currently under clinical evaluation
————————————————————
ability to induce tumor differentiation in laboratory models and LOW CLINICAL TOXICITY PROFILE makes them promising candidates for COMBINATION WITH CONVENTIONAL THERAPIES
====================================== [19] 1997 PHENYLACETATE and analogs represent new class of pleiotropic growth regulators that alter tumor cell biology by affecting gene expression at both transcriptional and post transcriptional levels
————————————————————
Based on findings, NaPA and NaPB entered clinical trials at National Cancer Institute
————————————————————
Ongoing phase I studies with NaPA, involving adults with prostate and brain cancer, confirmed therapeutic levels can be achieved WITH NO SIGNIFICANT TOXICITIES, and provide preliminary evidence for benefit to patients with advanced disease (Thibault et al., submitted)
====================================== [20] 10/1997 Sodium PHENYLACETATE (PA) and sodium PHENYLBUTYRATE (PB) are aromatic fatty acids that can effect differentiation in a variety of cell lines at doses that may be clinically attainable
—————————————————————— Pg. 1760
—————————————————————— PB has been successfully administered to patients with urea acid cycle disorders and sickle cell anemia for extended periods of time, and NO HEMATOLOGICAL TOXICITY has been reported
—————————————————————— Significant HEMATOLOGICAL TOXICITY was not reported in a Phase I trial of PA in patients with malignancy
—————————————————————— Pg. 1761
——————————————————————
Because of its ATTRACTIVE CLINICAL TOXICITY PROFILE, PB represents an excellent candidate for clinical trials in this group of disorders
====================================== [21] 11.–.12/1997 Antineoplaston AS2-1 exhibits cytostatic growth inhibition of human hepatocellular carcinoma cells in vitro and SHOWED MINIMUM ADVERSE EFFECTS in phase I clinical trial
====================================== [22] 6/1999 Burkitt’s lymphoma (BL) is readily treated malignancy, recurrences, as well as disease arising in immunosuppressed patients, are notoriously resistant to conventional therapeutic approaches
——————————————————————
Using in vitro models of EBV-transformed lymphoblastoid as well as BL cell lines, we demonstrate increased expression of genes coding for HLA class I and EBV latent proteins by differentiation inducer PHENYLBUTYRATE (PB)
—————————————————————— Aromatic fatty acid also caused cytostasis associated with sustained declines in c-myc expression, a direct antitumor effect that was independent of EBV status
——————————————————————
Findings may have clinical relevance because in vitro activity has been observed with PB concentrations that are
WELL TOLERATED and nonimmunosuppressive in humans, a desirable feature for different patient populations afflicted with this disease
====================================== [23] 8/2001 PHENYLBUTYRATE (PB) is aromatic fatty acid with multiple mechanisms of action including histone deacetylase inhibition
—————————————————————— Overall DRUG WELL TOLERATED with most common TOXICITIES being grade 1-2 DYSPEPSIA and FATIGUE
——————————————————————
Nonoverlapping dose-limiting TOXICITIES of NAUSEA/VOMITING and HYPOCALCEMIA were seen at 36 g/day
—————————————————————— PB (p.o.) IS WELL TOLERATED and achieves concentration in vivo shown to have biological activity in vitro
====================================== [24] 10/2001 Sodium PHENYLBUTYRATE (PB) demonstrates potent differentiating capacity in multiple hematopoietic and solid tumor cell lines
——————————————————————
Pharmacokinetics performed during and after first infusion period using validated high-performance liquid chromatographic assay and single compartmental pharmacokinetic model for PB and principal metabolite, PHENYLACETATE
—————————————————————— 24 patients with hormone refractory prostate cancer being predominant tumor type
—————————————————————— All evaluable for TOXICITY and response
——————————————————————
Dose escalated 150 to 515 mg/kg/day
——————————————————————
One patient at 515 mg/kg/day and one at 345 mg/kg/day experienced this DLT
——————————————————————
Maximum tolerated dose 410 mg/kg/day for 5 days
——————————————————————
Recommended Phase II dose 410 mg/kg/day for 120 h
—————————————————————— Dose-limiting TOXICITY (DLT) was neuro-cortical, exemplified by EXCESSIVE SOMNOLENCE and CONFUSION and accompanied by clinically significant HYPOKALEMIA, HYPONATREMIA, and HYPERURICEMIA
——————————————————————
Other TOXICITIES mild, including FATIGUE and NAUSEA
—————————————————————— DLT in Phase I study for infusional PB
given for 5 days every 21 days is neuro-cortical in nature
—————————————————————— TOXICITY resolved < or =12 h of discontinuing infusion
====================================== [25] 2003 Case of survival for nearly 8 years after treatment of unresectable multiple liver metastases from colon cancer, using microwave ablation and NONTOXIC ANTITUMOR AGENT, ANTINEOPLASTONS
——————————————————————
72-year-old man diagnosed with adenocarcinoma of ascending colon and 14 bilateral liver metastases underwent right hemicolectomy combined with microwave ablation of 6 metastatic liver tumors
—————————————————————— Antineoplaston A10 given intravenously, followed by oral antineoplaston AS2-1
——————————————————————
Patient underwent 2nd and 3rd microwave ablation of recurrent tumors, and has survived for nearly 8 years WITHOUT SUFFERING ANY SERIOUS ADVERSE EFFECTS
—————————————————————— Currently FREE FROM CANCER
——————————————————————
Demonstrates potential effectiveness of NONTOXIC ANTITUMOR AGENT, ANTINEOPLASTONS, for controlling liver metastases from colon cancer
====================================== [26] 4/2005 Determined maximum tolerated dose (MTD), TOXICITY profile of … oral sodium PHENYLBUTYRATE (PB) in patients with recurrent malignant gliomas
——————————————————————
All PB doses of 9, 18, and 27 g/day WELL TOLERATED
——————————————————————
At 36 g/day, 2 of 4 patients developed dose-limiting grade 3 FATIGUE and SOMNOLENCE
——————————————————————
At MTD of 27 g/day, one of 7 patients developed reversible grade 3 SOMNOLENCE
====================================== [27] 4/2007 PHENYLBUTYRATE (PBA), and its metabolite PHENYLACETATE (PAA), induce growth inhibition and cellular differentiation in multiple tumor models
——————————————————————
Conversion of PBA to PAA and PHENYLACETYLGLUTAMINE (PAG) documented without catabolic saturation
—————————————————————— THERAPY WELL TOLERATED OVERALL
——————————————————————
Common ADVERSE EFFECTS included grade 1 NAUSEA/VOMITING, FATIGUE, and LIGHTHEADEDNESS
—————————————————————— Dose limiting TOXICITIES were SHORT-TERM MEMORY LOSS, SEDATION, CONFUSION, NAUSEA, and VOMITING
——————————————————————
Administration of PBA twice-daily infusion schedule is SAFE
======================================
None of the above publications indicate that antineoplastons are toxic as Gorski would have people believe
12/12/2011 Gorski published his attempt at trying to explain why antineoplastons are supposedly toxic
====================================== What Dr. Stanislaw Burzynski doesn’t want you to know about antineoplastons
—————————————————————— http://scienceblogs.com/insolence/2011/12/12/what-dr-stanislaw-burzynski-doesnt-want/
====================================== Gorski posited:
“He’s also prescribing huge doses of antineoplastons (up to 25 g/kg/d for A10 and 80 mg/kg/d for AS-2.1, as we have seen). both of these are so far above the maximal tolerated dose of 300 mg/kg/d determined in the phase I trial I cited above as to be terrifying”
In support of his “theory”, Gorski provided a link to the National Cancer Institute (NCI) at the National Institutes of Health (NIH):
—————————————————————— http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/Table1
——————————————————————
However, as is the case with a lot of Gorski’s lame research, he makes you search for what he is referring to:
[14]Ba Primitive neuroectodermal tumor (13)
A10/AS2-1
Max dose: A10: 25 g/kg/d; AS2-1: 0.6 g/kg/d
Does this support Gorski’s “toxic theory”?
====================================== [28] 2005
—————————————————————— 5 years 7 months (1-11) median age
—————————————————————— 13 / 100% – children with recurrent disease or high risk
—————————————————————— 5 / 38% – weren’t treated earlier with radiation therapy or chemotherapy
—————————————————————— 3 / 23% – Complete Response
1 / 8% – Partial Response
4 / 31% – Stable Disease
5 / 38% – Progressive Disease
—————————————————————— 6 / 46% – Survived 5+ years from initiation of ANP
—————————————————————— Serious side effects:
1 – anemia
1 – fever
1 – granulocytopenia
—————————————————————— average dosage of A10 was 10.3 g/kg/d and of AS2-1 was 0.38 g/kg/d
—————————————————————— REDUCED TOXICITY MAKES ANP PROMISING for very young children, patients at high risk of complication of standard therapy, and patients with recurrent tumors
======================================
The above sure does NOT support Gorski’s “toxic theory”
When science based medicine keeps saying the following:
====================================== [9] 9/1994 increasing incidence of melanoma and POOR RESPONSIVENESS OF DISSEMINATED DISEASE TO CONVENTIONAL TREATMENT CALL FOR DEVELOPMENT OF NEW THERAPEUTIC APPROACHES
====================================== [29] 9/27/1995 (7/17/2006) Alterations in expression of ras oncogenes are characteristic of wide variety of human neoplasms
—————————————————————— Accumulating evidence has linked elevated ras expression with disease progression and FAILURE OF TUMORS TO RESPOND TO CONVENTIONAL THERAPIES, INCLUDING RADIOTHERAPY AND CERTAIN CHEMOTHERAPIES
—————————————————————— observations led us to investigate response of ras-transformed cells to differentiation-inducer PHENYLACETATE (PA)
—————————————————————— Interestingly, IN CONTRAST TO THEIR RELATIVE RESISTANCE TO RADIATION and doxorubicin, ras-transformed cells were significantly more sensitive to PA than their parental cells
====================================== [30] 5/1996 CYOTOXIC CHEMOTHERAPIES OFTEN GIVE RISE TO MULTIDRUG RESISTANCE, WHICH REMAINS MAJOR PROBLEM IN CANCER MANAGEMENT
———————————————————— IN PURSUIT OF ALTERNATIVE TREATMENTS FOR CHEMORESISTANT TUMOR CELLS, we tested response of multidrug-resistant (MDR) tumor cell lines to aromatic fatty acids PHENYLACETATE (PA) and PHENYLBUTYRATE (PB), 2 differentiation inducers currently in clinical trials
====================================== [15] 1996 Antineoplastons, first described by Burzynski, are naturally occurring peptides and amino acid derivatives which control neoplastic growth
——————————————————————
reported cytostatic inhibitory effect of A10 on human hepatocellular carcinoma cells and differentiation inducing effect of AS2-1 on various tumor cells suggest potential benefit for treatment of human hepatocellular carcinoma since TUMOR RECURS FREQUENTLY DESPITE INITIAL SUCCESSFUL TREATMENT
====================================== [31] 7/1997 Children with malignant GLIOMAS THAT PROGRESSED AFTER CONVENTIONAL THERAPY
—————————————————————— 0 / 0% – EXHIBITED CLEAR-CUT TUMOR regression
====================================== [32] 2000 treatment combination PRODUCED NO SIGNIFICANT CHANGE in overall POOR prognosis of patients
—————————————————————— Most tumors responded initially to treatment but RECCURED as study progressed
—————————————————————— Based on POOR RESULTS, recommend ALTERNATIVE TREATMENTS be tested in patients with this type of tumor
====================================== [33] At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survival
====================================== [34] 12/2000 NO CLEAR PROOF OF EFFICACY
—————————————————————— NO BETTER THAN SURVIVAL BEFORE THE INTRODUCTION OF temozolomide
====================================== [35] 2002 p53 tumor suppressor gene plays important role in protecting cells from developing undesirable proliferation
—————————————————————— Mutant p53 gene or malfunctioning p53 protein found in more than 50% of cancer cells impedes DNA repair or apoptosis induction
—————————————————————— MAY BE WHY SOME CANCERS GAIN RESISTANCE TO CHEMOTHERAPY AND RADIATION AND BECOME MORE RESISTANT AFTER FREQUENT CANCER TREATMENTS
====================================== [36] 2004 outcome for patients with either type of tumor is POOR when STANDARD multimodality THERAPY IS USED
—————————————————————— children are ideal candidates for INNOVATIVE TREATMENT approaches
—————————————————————— 33 / 100% – DIED OF DISEASE PROGRESSION
—————————————————————— administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children
====================================== [37] 2/2008 addition of vincristine and oral VP-16 to standard external beam radiation causes moderate toxicity and DOESN’T IMPROVE SURVIVAL OF CHILDREN WITH DIFFUSE INTRINSIC BRAIN STEM GLIOMA
====================================== [38] 5/6/2009 Currently, NO DATA available from randomized controlled trials demonstrating improvement in disease-related symptoms or increased survival with Avastin in GLIOBLASTOMA
====================================== [39] 10/12/2011 Afinitor (ubependymal giant cell ASTROCYTOMA (SEGA) brain tumor)
—————————————————————— none of their tumors went away completely
====================================== [18] 8/1997 aromatic fatty acids PHENYLACETATE (PA) and PHENYLBUTYRATE (PB) are novel antitumor agents currently under clinical evaluation
————————————————————
ability to induce tumor differentiation in laboratory models and LOW CLINICALTOXICITY PROFILE makes them promising candidates for COMBINATION WITH CONVENTIONAL THERAPIES
======================================
So what does Gorski think is going to fill the void?
His clinical trial drug ?
The potentially profitable drug Gorski is in the process of conducting a clinical trial for is the ALS drug Riluzole, made by Sanofi-Aventis and marketed as Rilutek
Apparently, David Gorski has had his eye on that drug for a long time, but as a possible treatment for breast cancer
As suggested by a 2008-2009 webpage of a breast cancer website:
“Three years ago in another cancer (melanoma), Dr. Gorski’s collaborators found that glutamate might have a role in promoting the transformation of the pigmented cells in the skin (melanocytes) into the deadly skin cancer melanoma”
“More importantly for therapy, it was found that this protein can be blocked with drugs, and, specifically, in melanoma cell lines and tumor models of melanoma using a drug originally designed to treat ALS and already FDA-approved for that indication (Riluzole) can inhibit the growth of melanoma.”
———————————————————— http://www.ageofautism.com/2010/06/david-gorskis-financial-pharma-ties-what-he-didnt-tell-you.html
———————————————————— Better luck next time with your personal MUD-targeted Skeptic therapy Gorski
Blood 82(7):2203–2209 Department of Hematology, Hadassah University Hospital, Jerusalem, Israel
Fibach E, Prasanna P, Rodgers GP, SAMID D SAMID D References: 15, 19-21 and 32
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Clinical Pharmacology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
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Clinical Pharmacology Branch, National Cancer Institute, NIH, Bethesda, Maryland
Shack S, Miller A, Liu L, Prasanna P, Thibault A, SAMID D http://clincancerres.aacrjournals.org/content/2/5/865
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Laboratory of Cellular and Molecular Biology, Gerontology Research Center, National Institute on Aging, NIH, Baltimore, Maryland, USA
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Miller AC, Whittaker T, Thibault A, et al: (SAMID D)
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DOI
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Advances in Experimental Medicine and Biology Volume 400, 1997, pp 501-505
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD USA D D SAMID, W R WR Hudgins, … C E CE Myers
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