Burzynski – it’s all over now, surely?
A strange situation exists in America that is exploited by several top Cancer Hospitals: Take MD Anderson and Virotherapy or The Preston Robert Tisch Cancer Centre at Duke and Dendritic cell therapy. Both these treatments have some clinical evidence behind them to show there is potential. But, truthfully, that’s about all. So, when all other treatments fail, a phase III clinical trial is set up to give these therapies a whirl. And in some cases they have met with great success. Importantly, the ‘trial’ is well documented, even when people die.
The same ‘methodology and logic’ has been exploited by controversial Doctor Stanislaw Burzynski. The FDA gave some credibility to antineoplastons (complex peptides and peptide mixtures that seemed to be missing in cancer patients) and after nearly 20 years of fighting between the FDA and/or The Texas Medical Board and Burzynski, a lull in the storm saw Burzynski reach for the phase III clinical trial gambit, and continue to treat cancer patients at his clinic. The background to all this can be found here.)
But. Following a Panorama Programme where Burzynski refused to provide results to date saying the FDA forbade it, and the FDA saying he could provide data, I wrote several times to the Burzynski Clinic for clarification. Like Panorama, I received no satisfactory response.
Worse was then uncovered – An analysis of work to date seems to show that with several dozen phase II clinical trials started, he never published a completed phase II trial, although there have been a couple of preliminary reports.
A step change occurred in 2012, with an apparent treatment-related death of a child and this led the FDA to issue a partial clinical hold on the Burzynski Clinic, preventing him enrolling any new children on his clinical trials, although he could keep treating existing patients and enroll new adult patients.
This ‘hold’ was later extended to new adults when the FDA arrived to investigate the clinic. The result of the investigations? More bad news for Burzynski when he received a warning letter from the FDA. That warning covered issues such deficiencies in the Burzynski institutional review board (IRB), the committee responsible for making sure that the clinic falls in line with regulations designed to protect human subjects during ‘research’ (for example, by maintaining adequate documentation covering the functions and operations of the IRB.
This, to some, may just seem like a lack of red tape provisions. But these are supposed to be randomized clinical trials of human beings and the Burzynski clinic needs to be as meticulous as any drugs company, perhaps more so given previous controversies. What seems to have been happening is that the Burzynski has been using what are ‘expedited reviews’. However, taking single patient protocols for an investigational drug that is not FDA-approved does not fall into any of the categories for which expedited review is appropriate, particularly when so many of the patients involved are children.
But the question still remains – Let’s see the results.
And not just the positive ones; what about side-effects like hypernatremia? Again the FDA have presented two new reports and these include statements such as ‘Failure to monitor the progress of an investigation’ and ‘an investigation was not conducted in accordance with the signed statement of investigator and investigational plan’ and ‘failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation’.
All I can conclude from this is that we are very unlikely to get proper clinical trial data at all.
But it gets worse. The FDA noted that
1. ‘You did not have a QA monitor properly monitor CRFs [case report forms] and subject records’
2. ‘The investigator destroyed critical subject case history records (target tumor measurement worksheets) or misplaced case history records (original subject CRFs) for all subjects’
3. ‘Your MRI tumor measurements initially recorded at baseline and on-treatment MRI studies for all study subjects were destroyed and are not available for FDA inspectional review’
4. ‘You failed to monitor as required by Section 16 of your Monitoring Plan. The investigator did not report adverse events (AEs) experienced by study subjects, including 18 cases of hypernatremia’, and (worse still)
5. ‘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 Weekly List of Hospitalizations/SAE [REDACTED] Overdose [redacted]/Catheter Infection report. There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects’.
We last amended the write up in CANCERactive on Antineoplastons and The Burzynski Clinic after the Panorama report. At that time we asked ‘Where are the results?’ We shall shortly be revising it all again.
At CANCERactive we do not believe it correct to ignore ‘alternative’ cancer treatments. We try to explain what they are and what they are supposed to do, with research when it exists, but pointing out clearly if none exists. But the fact is the NCI has a review on its website about antineoplastons and the review seems positive. Wikipedia, even today, is surprisingly balanced. So, we will continue to tell patients what this is supposedly all about, but we will now answer our own question: Where are the results? And the answer is ‘Nowhere’.
People touched by cancer who contemplate spending large amounts of money to go to the Burzynski Clinic need to be absolutely clear on this latest information and factor it in to their decision making process.