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.
I am writing to you about the Houston cancer doctor Stanislaw Burzynski, who has been 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, often running into the hundreds of thousands of dollars. Despite opening over 60 clinical trials in the last 15 years ago, he has never published a single clinical trial.
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 (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 initiated. The FDA issued warning letters to Burzynski on the 11th of December, upholding most of the observations but adding the following shocking detail about how the Clinic handled Josia’s medical records during the investigation:
The records BRI submitted to FDA on (b)(6), were not in the files that you provided regarding Patient 022387 during the inspection. However, during the inspection, you provided other Case Report Forms for this patient, with the same titles and for the same visit date as noted above, but containing information that differed from that which BRI submitted to FDA.
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.’”
Since the exposé in USA Today, at least 3 more desperate and misinformed families have appealed to the press, raising money for Burzynski and looking for access to these unpromising drugs.
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 protect the most desperate cancer 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.