By Keir Liddle
Skeptics have uncovered more documents and patient blogs that highlight the concerns many hold regarding the practices and ethics of The Burzynski Clinic, it’s staff and it’s proprietor Dr Stanislaw Burzynski. We have previously covered the problems with Burzynskis claims that his therapy is gene targeted, natural and non-toxic. We have previously found his claims to hold a PhD questionable in the extreme and we have analysed what little there is of his published research.
Tragically we also covered those who bought into Burzynskis treatment, literally and mentally, whom his treatment failed.
Supporters of Burzynski still appear blind to the concerns raised repeatedly by skeptics that the research conducted by the clinic and Burzynski research Institute is unethical, poorly designed and has never been published in a reputable journal of oncology. Critics of Burzynski have uncovered many documents that detail problems in Burzynskis research method, his ethical procedures and shocking documents that show his reported efficacy to the FDA is nowhere near the efficacy reported to his patients.
What is shocking about these documents is that they have by and large not been published recently. They span the whole of Doctor Burzynskis thirty plus year failed “crusade” to prove antineoplastons (ANP) work. The latest document discovered dates from 2001 and it’s contents may have many critics scratching their heads wondering just what exactly Dr. B. has to do for the authorities to intervene.
The latest document is a letter to Burzynskis Institutional Review Board (IRB) - the body responsible for assuring that research conducted is safe, ethical and properly designed. Supporters of Burzynski have attempted to deflect criticism based around letters to the Burzynski IRB by misleading people into believing that they are a separate company and that IRB stands for “independent review board” but this is far from the case.
A 2009 warning letter by the FDA lists IRB chairman , Carlton F. Hazlewood, Ph.D. as a clinical investigator in studies concerning ANP. Hazlewood is also listed as being on the board of directors of the Burzynski research institute.
Which is very far from being independent as supporters would have us believe.
The letter raises the following concerns following an inspection of the IRB:
- Failure to keep a copy of the [redacted] study protocol and informed consent form.
- Failure to recieve and/or require a final report from the principal investigatorfor the [redacted] study prior to removing the study from IRB list of active studies
- Failure to assure that FDA approval was obtained by the principal investigator prior to the treatment of a patient under a special exemption
Another warning letter was sent in 2009 that seems to imply not much has changed since that letter, and others like it, were sent. Despite the Clinic and research institutes assurances to the contrary. The 2009 letter raises the following concerns:
- The IRB approved research without determining that the following criteria were met: That risks to subjects were minimized and That risks to subjects were reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result
- The IRB Failed to prepare, maintain, and follow written procedures for conducting its initial and continuing review of research
- The IRB failed to ensure that informed consent would be sought from each prospective subject or the subject’s legally authorized representative
- The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest
- The IRB failed to conduct continuing reviews
These are not letters to be taken lightly. They show a complete failure by the IRB to ensure research is conducted ethically and reported properly. Most worrying is that the clinic seems uninterested in insuring informed consent is obtained from those they go on to “treat”.
Combined with testimony from patients (link Hxxp’d) it paints a worrying picture of a clinic and researcher playing at best “fast and loose” with research ethics and at worst someone who believes themselves to be above such concerns.
The blog describes how a patient raised concerns about the treatment regimen (non ANP) that the clinic was offering, one that cost thousands of dollars and appears to be a cocktail of expensive chemo drugs. The patient was “having none of it” and they returned to the clinic next day to request an alternative protocol. They were
"Immediately ushered into the financial counselor’s office again. She asked us if we were prepared to pay the treatment deposit, and if we had filled out all the financial aid forms. We gleefully said that we hadn’t filled out the forms because we had decided not to take synthetic drugs as part of the treatment. She just stared blankly at us for a few seconds."
They were then passed onto a doctor Sano who informed them that the MRI scan they had just had done showed “lesions” on the brain tumour and that due to this “change in circumstance” they would have to meet with Doctor Sano to discuss what to do next. She:
"wanted to know exactly where we stood financially and what we wanted to do about the medications, so she could tell the doctor exactly where we stood. And we were totally honest with her. We can’t afford the meds. We just can’t do it. She told us that it was now possible that Dr. Burzynski might want to put Adam in the clinical trial. Now he had a "persistant" tumor, and there was something measurable. If he was given permission by the FDA to receive the antineoplaston treatment, now there was material they could measure and watch it shrink. This is essential to be considered for the trial."
They were shown the lesions on a zoomed in MRI. We have no reason to question whether this is the case but the manner in which they were moved from a cocktail of chemotherapy agents to an ANP “trial”. The timing is convenient to say the least, but such coincidences are possible and without further evidence one has to give the clinic the benefit of the doubt in this instance.
What is worrying about this is the amount of time the patient spent with Burzynski to confirm they would take part in the trial: ten minutes. Which seems a remarkably quick time in which to complete a proper and ethical informed consent process…
In fairness there isn’t much we can take from this single patient blog other than insinuation, which is not evidence of wrongdoing. Skeptics and critics will likely agree that this seems dodgy and supporters will see it as a slur. However skeptics have uncovered a lot more than simple slurs against Burzynski. We have uncovered documents that show his treatment is nowhere near as effective as he claims, we have exposed ANPs as neither natural or non-toxic, we have shown Burzynski does not have the expertise needed to conduct gene-targeted therapy and we have shown the majority of patients that attend the clinic either vanish or die.
This is not a debate that will be settled by insinuation and character assassination. It will only be settled by the clinic releasing it’s results, procedures and protocols to proper scientific scrutiny.
The ball is in Doctor Burzynskis court. Put up or shut up.