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
Let’s say you’re one of “The Skeptics,”(“The Burzynski Skeptics,”) don’t have a life (but doesn’t that go without saying?), enjoy associating yourself with known liars, cowards, ethically and intellectually challenged individuals, so you grab a newspaper(It’s doubtful that USA TODAY would qualify), and if you do NOT know what a “Newsie” is, go online and select an article which has a plethora of innuendo and allegations, compose a missive to your member in Congressassembled about the nothingness you just reviewed, just don’t piss yourself silly when you shoot that zinger off, because you’ve just sent something to your Congressperson, exhibiting what a whacky weed tobaccoday tripper you are, and a prime example of what “Rocky Mountain High” really will mean, starting January1st, 2014
Congratulations, Colorado
My only suggestion is that you add something like:
“Dear Congressperson Y,
I know your time is valuable, but please allow me to waste some of you and your staff’s, as well as provide you with “fodder” you can hang up on the bathroom wall and laugh about for days!
In the next weeks I will be contacting you about all of the “conspiracy theories” in Jesse Ventura’s book, including; but not limited to:
Area 51
Aliens The Denver International Airport
…
Smoke ’em if ya got ’em !
======================================
Letter to Congress
Dear CONGRESSPERSON’S NAME:
My name is _______ 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, I 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 prices
On Friday November 15, Dr. Burzynski was the subject of a front-page exposé in the USA Today
Additionally, since I last contacted your office, the FDA has released site inspection notes into the electronic FOIA reading room 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, therapeutic response […] for 67% of study subjects reviewed during the inspection.”
This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.”
This means that his outcomes figures for these studies are inaccurate
Some patients admitted failed to meet the inclusion criteria for the study
Even though patients needed to have a physician back home to monitor their progress prior to enrolling in a trial, the FDA found a patient who began receiving treatment before a doctor had been found
The FDA told Burzynski:
“You failed to protect the rights, safety, and welfare of subjects under your care
Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted] Overdose [redacted]/Catheter Infection report
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 family members to administer the drugs via programmable pump on their own
Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list
The FDA reported:
“Your […] tumor 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 antineoplaston treatment
This means that Burzynski’s studies–which by last account cost $30,000 to begin and $7000 a month to maintain–are unpublishable
It will be stunning if this finding alone were not investigated by legal authorities
Patients who had Grade 3 or 4 toxic effects were supposed to be removed from treatment
One patient had 3 Grade 3 events followed by 3 Grade 4 events
Another patient had 7 disqualifying toxic events before he was removed from the study
Burzynski did not report all adverse events as required by his study protocols
One patient had 12 events of hypernatremia (high sodium), none of which was reported
There are several similar patients
Some adverse events were not reported to the Burzynski Clinic IRB for years
For instance one patient had an adverse event in 1998 and the oversight board did not hear about it until 2005.)
The FDA observed that the informed consent document did not include a statement of extra costs that might be incurred
Specifically, some informed consent documents were signed days to weeks before billing agreements, and in a couple of cases no consent form could be found
The clinic was unable to account for its stock of the investigational drug, an act that would get any other research lab shut down
Sadly, a child, Josia Cotto, had to die from apparent sodium overload before this investigation could be carried out
Despite these findings, when interviewed by USA Today, Burzynski actually said of his former cancer patients:
“As for criticism from former patients, Burzynski says, ‘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
And many of them would like to get money from us
They pretend they got sick and they would like to extort money from us.’”
I am asking you to help me understand what happened at the FDA to allow this man to conduct clinical trials and bankrupt patients in the process despite 10 years of alarming reviews by the FDA
I also ask you to support an investigation into this betrayal of over 8,000 patients and to push for legislation to prevent the most desperate patients from such unthinkable exploitation
I will be calling your office next week to touch base with you and I look forward to your response
USA TODAY Liz Szabo Michael Stravato Jerry Mosemak Robert Hanashiro
Before you write a Hack Piece Check Your Facts Please
——————————————————————
——————————————————————
The 3rd, and thankfully final segment of USA TODAY’s “hit-piece” of irresponsible yellow journalism about Dr. Stanislaw R. Burzynski [1], contains the following:
—————————————————————— “Patients stay in hotels while visiting him”
—————————————————————— Pete Cohen made this movie about his and Hannah Bradley’s trip to the Burzynski Clinic
It does NOT look like they stayed in a hotel [2]
——————————————————————
The article continues:
—————————————————————— “If children deteriorate, they often end up in the closest emergency room, said physician Jeanine Graf, director of the pediatric intensive care unit at Texas Children’s Hospital in Houston, who says she has treated at least a dozen of Burzynski’s patients“
——————————————————————
In the 2nd segment of USA TODAY’s yellow journalism “hit-piece,” the reader was advised that Burzynski had treated [3]:
—————————————————————— “ . . . more than 8,000 patients since 1977.”
—————————————————————— Physician Jeanine Graf, “says she has treated at least a dozen“ of Burzynski’s “more than 8,000 patients,”
This means that Dr. Graf has treated LESS THAN 0.15% of Burzynski’s patients
——————————————————————
The article indicates that:
—————————————————————— “Typically, Graf sees Burzynski’s patients after they have become unresponsive, unable to open their eyes or breathe on their own”
“Graf says she’s never seen Burzynski attending to them”
—————————————————————— Why would she ?
Does she ride in the ambulance to and from the clinic ?
As the article makes clear:
“While Burzynski often meets patients on their first trip to the clinic, Jaffe said he is”
“not the treating physician of the clinic’s patients”
“The doctors on Burzynski’s staff have admitting privileges at local hospitals and “attend to patients as needed,” Jaffe said”
——————————————————————
And she continues:
—————————————————————— “And describing her personal experience with Burzynski’s patients, Graf says,”
“I’ve never seen one survive long-term.”
——————————————————————
Are we supposed to believe that pediatric physician Jeanine Graf keeps track of the “more than 8,000 patients” that the articleclaims Burzynski has treated ?
——————————————————————
Continuing on, the article also claims:
—————————————————————— “The unlucky ones end up broke, spending everything on medicine, airfare, hotel rooms and meals while in Houston, Graf says“
“Burzynski’s attorney, Richard Jaffe, notes that all cancer care is expensive”
“I think the clinic’s policies are a lot more charitable than the big institutions,” Jaffe says”
—————————————————————— 6/25/2013 – Medical Bills Are the Biggest Cause of US Bankruptcies [4]
“Bankruptcies resulting from unpaid medical bills will affect nearly 2 million people this year—making health care the No. 1 cause of such filings . . . according to new data”
“. . . estimates that households containing 1.7 million people will file for bankruptcy protection this year”
“Even outside of bankruptcy, about 56 million adults—more than 20 percent of the population between the ages of 19 and 64—will still struggle with health-care-related bills this year . . .”
“Despite the anticipated 2013 dip, such bankruptcies represent about three out of every five filings”
—————————————————————— 2007 – How Many Americans Go Bankrupt Due to Medical Purposes Each Year? [5]
“2007, a Harvard study shows that at least 60% of bankruptcies are related to medical bills“
“Even people with health insurance are filing bankruptcy”
“Insurance premiums, deductibles, co-pay, and out of pocket expenses cause medical bills to drown individuals and families in medical debt”
“Harvard also discovered that 75% of those filing bankruptcy for medical reasons had health insurance“
“It is clear that having health insurance is no guarantee against carrying debt related to health care”
—————————————————————— Burzynski has treated more than 8,000 patients since 1977
8,000 divided by 36 years equals an average of:
222 patients per year
Burzynski is obviously NOT the problem
—————————————————————— Liz Szabo, Michael Stravato, Jerry Mosemak, and Robert Hanashiro
Don’t quit your day jobs
USA TODAY needs to generate readership somehow !!!
—————————————————————— Sarcasm . . . deal with it
====================================== REFERENCES:
====================================== [1] – 11/15/2013
—————————————————————— http://www.usatoday.com/story/news/nation/2013/11/15/jeanine-graf-cancer-children/2994675/
====================================== [2] – Hannah’s Anectdote:
——————————————————————
I gave Liz Szabo and USA TODAY the chance to act like a Spike Lee joint and “Do the Right Thing”, the same day their article came out [1]
I gave them the opportunity to prove that their article was a legitimate piece of journalism with some semblance of integrity, and NOT just akin to one of “The Skeptics™ phoned-in “rubber-stamped” yellow journalism hit pieces
Instead, it seems that Liz Szabo and / or USA TODAY decided to act as if they had rolled a Spike Lee joint
I sent an e-mail with 2 editorial corrections, and only one (correcting Lisa Merritt’s comment link from taking the reader to the 1999 Mayo Clinic report instead of to her comments), was corrected [2]
The 2nd correction which they #FAILED to do, earns them well deserved INSOLENCE
——————————————————————
The articleclaims:
—————————————————————— “Burzynski, 70, calls his drugs “antineoplastons” and says he has given them to more than 8,000 patients since 1977.”
——————————————————————
——————————————————————
However, if you select the “8,000 patients” link, the referenced page does NOT indicate that at all [2]
——————————————————————
—————————————————————— It advises:
—————————————————————— “That same year, Dr. Burzynski founded his clinic in Houston where he’s since treated over 8,000 patients.”[3]
——————————————————————
—————————————————————— Nowhere does it indicate that he “treated 8,000 patients” with antineoplastons
——————————————————————
——————————————————————
The question that Liz Szabo and USA TODAY should answer, is:
1. Who is your “fact-checker”, and 2. are they smarter than a 5th grader ?
——————————————————————
In fact, Burzynski’s 2002 Securities and Exchange Commission (SEC) filing advises:
” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, gene targeted therapy, immunotherapy and hormonal therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston clinical trials”[4]
——————————————————————
The article continues:
—————————————————————— “Individual success stories can be misleading, said Arthur Caplan, a professor and head of the division of bioethics at NYU Langone Medical Center”
——————————————————————
The question Arthur Caplan should be asking is:
Why has the United States Food and Drug Administration required Burzynski’s clinical trial patients to fail conventional therapies; such as surgery, chemotherapy, and radiation, BEFORE they are allowed to be treated with antineoplaston therapy ?
If the F.D.A. did NOT impose these restrictions upon Burzynski’s clinical trials, then the question Arthur Caplan raises would be moot
——————————————————————
The article quotes Dr. Jan Buckner as saying:
—————————————————————— “When I hear a story that is way out of the norm, the first question I ask is,
‘OK, is the diagnosis even correct?‘ ”
“Buckner said”
“If the diagnosis wasn’t right to start with, it doesn’t matter what the treatment was.”
“Brain tumors are notoriously difficult to diagnose, Buckner says”
“When dealing with rare brain cancer, doctors may disagree about how to interpret imaging results up to 40% of the time”
——————————————————————
I wonder if Dr. Jan Buckner would agree with David Gorski; who is a BREAST cancer oncology specialist, and NOT a BRAIN cancer oncology specialist, who has the presumptiveness to speculate that 3 different medical opinions could have misdiagnosed Tori Moreno in August 1998; who was diagnosed with a very large tumor, about 3 inches in the largest diameter and located in the brain stem, which was too risky for surgery, and about which her parents were told by ALL 3, that Tori’s brain cancer was fatal and, she would die in a few days or at the most, 2-6 weeks, and that there was nothing that could be done, and was finally put on Burzynski’s antineoplaston therapy in October, when she was about 3 ½ months old, and in such condition that they were afraid that she might die at any time, David H. Gorski, M.D., Ph.D., FACS; who claims, “I do know cancer science”, has the audacity, because of his “book learnin'” has the temerity to postulate his “science-based medicine theory” that Miller’s Children at Long Beach Memorial misdiagnosed Tori Moreno’s inoperable stage 4 BSG
David Gorski has the gall to profer that City of Hope misdiagnosed Tori Moreno’s inoperable stage 4 brain stem glioma
David Gorski has the chutzpah to pontificate that Dr. Fred Epstein in New York misdiagnosed Tori Moreno’s inoperable stage IV brainstem glioma [5]
——————————————————————
The article then quotes Peter Adamson, chair of the Children’s Oncology Group:
—————————————————————— “But these therapies may have delayed benefits, taking weeks or months to shrink a tumor“
“So patients treated by Burzynski may credit him for their progress, just because he was the last doctor to treat them, says Peter Adamson, chair of the Children’s Oncology Group, an NCI-supported research network that conducts clinical trials in pediatric cancer“
“Conventional cancer treatment can also cause tumors to swell temporarily, due to inflammation“
“A patient who isn’t familiar with this phenomenon may assume her tumor is growing“
“When that swelling subsides, patients may assume it’s because of Burzynski, Adamson says”
——————————————————————
This is laughable
In support of this “phenomenon”, the article provides a link to a Canadian web-site [6]
The site posits:
—————————————————————— “RT/TMZ is now widely practiced and the standard of care for appropriately selected patients, we are learning more about the consequences of RT/TMZ”
“One phenomena, termed Pseudo-Progression (psPD)…”
——————————————————————
The problem is that this only applies to “Glioblastoma Multiforme (GBM)”, and the article provides NO proof whatsoever, that any of Burzynski’s “Glioblastoma Multiforme (GBM)” patients have taken “RT/TMZ”
——————————————————————
Additionally, the site cites the reference as:
Sanghera, Perry, Sahgal, et al., “Sunnybrook Health Sciences Odette Cancer Centre” (in press, Canadian Journal of Neuroscience)
(“In press” refers to journal articles which have been accepted for publication, but have not yet been published)
However, the journal article in question was published 1/2010, so it has NOT been “in press” for over 3 years and 7 months [7]
Get your act together, aye, Canada!
——————————————————————
The articlerants and raves on and on about FDA inspection reports from as far back as 1998, but at least they did quote Richard A. Jaffe:
“The FDA has not yet issued final conclusions”
——————————————————————
The article posts this ridiculous claim:
—————————————————————— “Yet the National Cancer Institute says there is no evidence that Burzynski has cured a single patient, or even helped one live longer“
——————————————————————
That’s NOT what this seems to suggest [8]
——————————————————————
Then the article quotes pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia, in what will no doubt soon be known as a “classic”:
—————————————————————— “He’s a snake oil salesman,” says pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia”
——————————————————————
All I’d like to know is, which rock did this clown crawl out from under ?
Dr. Adamson, please advise which “snake oil” has been granted Orphan Drug Designation (“ODD”) from the United States Food and Drug Administration [9], and which “snake oil” has been approved for, and used in, phase III clinical trials ? [10]
—————————————————————— Q: Is it, it the phase 2 trial is finished ?
A:“Mhmm”
Q: but they’re still accepting people ?
A:“Yeah”
Q: on more like a special ?
A:“Special basis, and, um, sometimes compassionate grounds“
A:“(compassion exception)”
A:“Uh, exceptions“
Q: That’s normal ?
A:“Yes” “So”
A:“(Yes I guess it is a funding issue ?)”
Q: Right
A:“(Like FDA, during the 2nd phase of clinical trials they found the data to be, real, real one, and they gave him the ok to go for 3rd phase of clinical trials, but just to go through this process you would probably need $100,000)”
——————————————————————
——————————————————————
Oh, wait !!
Dr. Adamson, when you say “snake oil”, I take it you are referring to the low-dose chemotherapy that Burzynski uses ?
Dr. Adamson, do you know what a “hack” is ?
——————————————————————
In regards to the Merritt’s, the article has:
—————————————————————— “The couple say that Burzynski misled them about the type of treatment that would be offered, as well as the cost”
My questions about the Merritt’s are:
1. Where is their complaint to the Texas Medical Board ?
2. Where is their lawsuit ? Couldn’t they find an attorney to take their case pro bono ?
——————————————————————
The article continues:
—————————————————————— “Yet even Jaffe has acknowledged that the trial — now in its 17th year — was more about politics than science”
“In his 2008 memoirs, Galileo’s Lawyer, Jaffe called it “a joke.””
“”It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment,” Jaffe said“
——————————————————————
What Liz Szabo and her friends at USA TODAY fail to let the readers know, is that this only applied to one trial:
—————————————————————— Burzynski’s lawyer is obviously referring to the CAN-1 clinical trial mentioned in Burzynski’s 11/25/1997 Securities and Exchange Commission (SEC) filing [11]
—————————————————————— One trial that is retrospective is CAN-1 Clinical Trial
—————————————————————— CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
PATIENTS WITH REFRACTORY MALIGNANCIES
133 patients
—————————————————————— Clinical trial of patients treated by Dr. Burzynski through 2/23/1996
—————————————————————— FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
——————————————————————
The article continues in the same vein:
——————————————————————
“In an interview, Burzynski said developing new drugs is complex and takes time”
“Yet the FDA has approved 108 cancer drugs since Burzynski began his trial”
—————————————————————— Ms. Szabo and “pals” conveniently “forgets” to educate their audience that Burzynski was using Fleming’s One-sample multiple testing procedure for phase II clinical trials [13], which requires that if the 1st 20 patients meet certain criteria, 20 additional patients are added [14]
—————————————————————— “Well, we cannot publish until the time is right” (laughs)
Yeah
“If you would like to publish the results of, of a 10 year survival, for instance”
Mmm
“Which we have
Nobody has over 10 year survival in malignant brain tumor, but we do, and if you like to do it right, it takes time to prepare it, and that’s what we do now
What we publish so far
We publish numerous, uh, publications which were, interim reports when we are still continuing clinical trials
Now we are preparing, a number of publications for final reports“[15]
——————————————————————
Then Fran Visco, president of the National Breast Cancer Coalition makes an outlandish statement, which is quoted in the article:
—————————————————————— “Fran Visco, president of the National Breast Cancer Coalition, describes the FDA’s tolerance of Burzynski as “outrageous.””
“They have put people at risk for a long time,” says Visco, an attorney and breast cancer survivor”
“That’s completely unacceptable”
“How can anyone look at these facts and believe that there is a real clinical trial going on … rather than just using the FDA and the clinical trial system to make money?”
——————————————————————
I have a suggestion for Ms. Visco
Take your hypocrisy and ask the American Cancer Society if they are still engaged in this kind of activity:
1.AMERICAN CANCER SOCIETY: More Interested In Accumulating Wealth Than Saving Lives [15]
2.National Cancer Institute and American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest [16]
——————————————————————
Then, ask the American Cancer Society, why is it that 10 years ago, estimated breast cancer deaths were expected to be 39,800 (15%), and this year it was 39,620 (14%), which is ONLY 180 LESS than 10 years ago ?
—————————————————————— Estimated Breast Cancer Deaths (Women)-USA
—————————————————————— 2013☝39,620 (14%)
2012👇39,510 (14%)
2011👇39,520 (15%)
2010👇39,840 (15%)
2009👇40,170 (15%) 2008☝40,480 (15%)
2007👇40,460 (15%) 2006☝40,970 (15%)
2005👇40,410 (15%) 2004☝40,110 (15%)
2003☝39,800 (15%)
2002 – 39,600 (15%)
—————————————————————– American Cancer Society Cancer Facts & Figures (2002-2013)
—————————————————————–
And then ask the American Cancer Society, why is it that 10 years ago, the estimated NEW breast cancer cases were expected to be 211,300 (32%), and this year it was 232,340 (29%), which is 21,340 MORE than it was 10 years ago ?
—————————————————————— Estimated New Breast Cancer (Women) – USA
—————————————————————— 2013☝232,340 (29%)
2012👇226,870 (29%) 2011☝238,480 (30%)
2010☝207,090 (28%)
2009☝192,370 (27%)
2008☝182,460 (26%)
2007👇178,480 (26%) 2006☝212,920 (31%)
2005👇211,240 (32%) 2004☝215,900 (32%)
2003☝211,300 (32%)
2002_-_203,500 (31%)
—————————————————————– American Cancer Society Cancer Facts & Figures (2002-2013)
——————————————————————
And after that, ask Susan G. Komen how much is spent on legal action to protect her brand, compared to how much is spent on breast cancer research and prevention ?
—————————————————————— Visco, the breast cancer advocate
“I do NOT know why it took YOU so long.”
——————————————————————
The article continues with:
—————————————————————— “Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades”
——————————————————————
Yet, “The Skeptics™” refuse to discuss:
—————————————————————— 2/13/2013 – The frequency, cost, and clinical outcomes of hypernatremia in patients hospitalized to a comprehensive cancer center
Over 3 month period in 2006 re 3,446 patients, most of the hypernatremia (90 %) was acquired during hospital stay [19]
Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA
Department of General Internal Medicine, University of Texas MD Anderson Cancer Center
Division of Endocrinology, Mayo Clinic
—————————————————————— 9/1999 – The changing pattern of hypernatremia in hospitalized children [20]
Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas, USA
——————————————————————
So, after all that, my question for USA TODAY is, does Liz Szabo, Michael Stravato, Jerry Mosemak or Robert Hanashiro have a journalism degree ?
Because if any of them do, the institution they obtained it from most be so proud of this piece of “fish wrap” you produced
Thank you, USA TODAY, for censoring my 18 comments
I guess you must be (“intellectual”) cowards
At least Forbes had the GRAPEFRUITS to post some of my comments
—————————————————————— You’ve just been served, INSOLENTLY
—————————————————————— USA TODAY, GONE TOMORROW
——————————————————————
