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 Congress assembled 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 tobacco day tripper you are, and a prime example of what “Rocky Mountain High” really will mean, starting January 1st, 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 !
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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
Sincerely,
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REFERENCE:
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Letter to Congress:
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https://docs.google.com/document/d/1Hx3KJ6mmCd8MTdlbdXb2r2qrN9l3JjrzdJrHh0VIJXo/mobilebasic?pli=1
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Burzynski: court cases
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https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-court-cases/
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Main Page – Stanislawrajmundburzynski
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http://stanislawrajmundburzynski.wiki-site.com/index.php/Main_Page
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Didymus Judas Thomas' Hipocritical Oath Blog 