Dr. Nicholas Patronas, is currently the Senior Clinician, Chief. Section of Neuroradiology, Radiology and Imaging Sciences, National Institutes of Health, NIH Clinical Center
Court Testimony Of Nicholas Petronas, MD
(Board-Certified Radiologist Professor of Radiology at Georgetown University, and Founder of the Neuroradiology section of the National Cancer Institute)
Discussing the effectiveness of antineoplaston treatment vs. chemotherapy and radiation treatment in brain cancer
May 24, 1993
Administrative Hearing Docket .503-92-509
License No. D-9377
In The Matter Of The Complaint Against Stanislaw R. Burzynski, M.D.
Before The Texas State Board Of Medical Examiners
Before Earl A. Corbitt, Administrative Law Judge
Volume I of II
May 24, 1993
Q: Dr. Petronas, what is your profession?
A: I’m a radiologist, a medical doctor specializing in radiology
Q: Would you tell us briefly your educational background?
A: Well, after the medical school we have a year internship, four years residency in radiology, and in addition I had an entire year of training in neuroradiology
So my subspecialty is neuroradiology
It is the evaluation of the regions of the central nervous system
Q: And would you relate your work experience, please?
A: when I finished my training I was at the University of Chicago for seven years as a staff radiologist at the University Hospital
And then I moved to the National Institutes of Health where I worked from ’81 to ’85as a staff radiologist at the clinical center, which is the hospital of the National Institutes of Health
Then I moved to Georgetown University where I became full professor of radiology
And the National Institutes of Health contracted Georgetown radiological services, and I was sent from Georgetown back to NIH to cover the section.of Neuroradiology
Q: And so you work at the National Institutes of Health hospital; is that where you work?
A: Yeah, at the hospital initially as a federal employee from ’81to ’85, and then on contract from Georgetown University
So I am one of the 17 radiologists who provide radiological services to the National Institutes of Health
Q: What is the function or purpose of the hospital of the National Institutes of Health?
A: As you know, there are a lot of research protocols that
are going on, and people who are admitted to this facility are being admitted to try experimental treatment
As they are admitted to the hospital, the hospital requires an X-ray Department and radiologists to man the department
And so we evaluate the various lesions that are being admitted under these approved protocols, and we assess the effectiveness of the treatment given there, using imaging modalities such as MRI or CT scans and regular radiology
Q: And that would be for the various health departments or what’s called institutes?
A: Exactly, the various institutes, yes
Q: Like the National Cancer Institute, that’s one of them?
A: That’s the biggest of all, yeah
Q: What– Basically then, you do the, in layman’s terms, you do all the imaging work and interpretation for the National Cancer Institute testing of drugs?
Q: Because– and what happens is, they give the drugs to the people and you have to get– they have to have a scan before to see what they had–
Q: –then when they go into treatment they have to get scans to see what, if any, effect–
A: To see whether they are effective or not, yes
A: That’s my job, to assess the effectiveness of the drugs that are given there and to provide the diagnosis at the initial stage, upon admission
Q: Dr. Petronas, did there come a time when you became aware of Dr. Burzynski?
A: Yes, it was when Michael Hawkins from NCI asked me to join a group of other physicians and scientist and come to Houston on a site visit to Dr. Burzynski’s Institute in order to assess the best case scenario that he had to present us of his patients who were treated with antineoplastons
So that was the first time when I was aware that there was an anticancer agent
And I was called as an expert in assessing the images to evaluate, together with the rest, the other five members of that team, to evaluate the effectiveness of his treatment
Q: And did you have occasion to actually go down to Houston, Texas?
A: Yes, we spent about seven hours at the Burzynski Institute and we reviewed the material that was given to us
Q: What material did you review?
A: Initially there was a presentation of the cases by Dr. Burzynski; each different case was studied seperately
We were given the history, the pathology, the previous treatment and the timing of these treatments, and we have someone who recorded these data
Then the histological slides were presented to one of our neuropathologist, one neuropathologist who was also a guest consultant in the team
We reviewed the slides and confirmed the histological of the grade of the tumor that Dr. Burzynski was indicating in his presentation
Then there were assessments of the images, either CT scans or CAT scans, or MRI scans
They were serial studies in any given patient
So we were able to see how the tumor started and how it ended up under treatment
Q: How many patients did you concern yourself with at that time?
A : We reviewed the material of seven cases
We did not have more time to review more
These were the–
Q: So that basically took up the whole day?
A : The whole day. yes; one hour per case
Q: And what happened after you reviewed the cases?
A: Well, we took our notes and we discussed the findings, and there was a report that was issued indicating what we found
Q: We have marked for identification Exhibit 27
Will you see if you can identify that for us?
A: Yeah, I have seen this
Q: And is this– What exactly is this?
A: it was a letter to Dr. Burzynski from Dorothy Macfarlane, one of the people who was part of the team
And the memorandum shows or summarizes are findings for each individual patient
And this is exactly document that we came up with
Q: What was the basic conclusion of the– that you indicated?
A: The basic conclusion was that in five of the patients with brain tumors that were fairly large, the tumor resolved, disappeared
Q: Was that just happenstance?
I mean, was that just by some miracle of–
A: Well, since the treatment given was started after the previous conventional treatments which had failed previously, we took the position that this probably represents the result of this new treatment
And so there was only minimal residual tissue at the tumor bed, which looked like a sca, and had no fissures to support that there was a tumor in the majority of the cases
Two of seven patients did not do very well
One of them deceased
The tumor dissolved at least
microscopically; we could see it with the naked eye, but it recurred later, a year later
And the other, there was very, very minimal decrease in the size of the tumor
But the tumor was very big, the last one, the seventh, last two cases did not survive, although there was definite improvement in one of the two last cases
Q: I guess that would be called an objective response in that these patients–
A: exactly, because we were six people and we all looked at images and we saw the chronological order
We checked the names of the patients on the films, and the files were obtained at different institutions from the entire country, basically where the patients were located
And we had no reason to believe that these were not the results of the treatments
Q: Doctor, based on what you have testified to before about your background and credentials, it’s fair to say, isn’t it, that you have seen a lot of brain cancer patients?
A: Yes, in fact, we see a lot of these cases
Q: And that’s part of what you do at the hospital, is to evaluate treatments on brain cancer patients?
A: Well, different cancers, but since I am the neuroradiologist I see all brain tumors
And I see a large volume of then
Q: Now, with regard to at least the five patients, I think
you testified that five of the patients had their tumors resolved, they all–
Can you give us some kind of context of that?
How often does that happen with any– with no treatment, just by spontaneous remission, or by whatever it is that you–
A: I’m not aware that spontaneous remission occurs; I don’t think it does
And the available treatment only rarely produce results like that
The only medication– the only treatment, which I think is the last resort, is radiation therapy
Chemotherapy has very little to offer unless there is an experimental protocol somewhere
However, conventional chemotherapy is– provides very little, nothing, basically
Radiation, there are some reports indicating that radiation treatment in children particularly could lead to resolution of the tumors, although I don’t know whether it is a permanent one or temporary
So when this happens it is very rare
And I have seen only isolated here and there where that has happened with radiation
Q: With one case here or there–
Q: –an isolated report, you are talking about on a case by
Well, radiation should give these results, if it works at all, the first two months after completion of the treatment
In these cases, all the patients had already failed radiation because they were treated months, several months after radiation was
given and had failed
Q: What happens with these patients?
Lets say they failed radiation; what happens then to the patient with brain cancer?
A: Well, it depends on the grade of the tumor
If the tumor is low grade, astrocytoma, and we are talking about primary gliomas, if it is low grade, survival for years is possible
If it is an intermediate grade, the anaplastic, the mean survival is two years, and if it is the high grade glioma the mean survival is about 12 months
That’s it; they die in 12 months, they disappear
Q: Now– So are you saying basically for someone that’s failed radiation– It sounds like you are saying that if someone has already failed radiation, at least, that there’s not too much else–
A: nothing to offer, exactly
Q: –and that these people are going to eventually die of their disease, barring any unforeseen event or cure?
Q: and there is nothing that any– that you could do at NCI?
A: Nothing we can do, no; not at the present time
Q: All right
What about these five patients that are all basically doing– how come they lived?
A: Well, it’s amazing, the fact that they are living and some of them are doing well
They are not– they are not handicapped from the side effects of any treatment, and worse than the tumor itself
So these particular individuals not only survived, but they didn’t have major side effects
So I think it is impressive and unbelievable
Q: How many times have you ever seen this, in your experience, that someone comes with a drug like this, to have this kind of effect?
How often does that happen?
A: I don’t– I have not seen it at any time with the medication that is given systematically
We have done– we have an experimental protocol at the NIH where we inject a chemotherapeutic agent through the carotid artery, the artery that goes to the brain, and we have three survivals with this technique, by providing massive amounts of chemotherapeutic drugs to the brain that harbors the tumor
And we destroy the tumor, but we destroy a large part of the brain as well, and the patients became severely handicapped, and a life that’s not worth living
And so I have three cases with this particular experimental protocol which resulted in killing the tumor, but a large part of the healthy brain as well
So overall the protocol was abandoned and is not any more in effect because of the serious side effects that we witnessed
Q: Now, let me ask your opinion or advice
Based on what you have seen from these patients– I mean, I think the opinion actually, or the letter actually concludes that the site team concluded that there was antitumor effect from the antineoplastons
What would happen, let’s say for some reason Dr. Burzynski’s brain tumor patients can’t get the medicine any more and have to go off treatment
What’s going to happen to them, in your opinion?
A: I think these patients will die
Q: One of the patients you reviewed was F.M.; is that correct?
What happened in his case?
A: The tumor was very large and very involved the hypothalamus, a very sensitive part of the brain cannot be operated, and had both cystic components and fleshy components, mass like
And the lesion disappeared
This patient did not have previous treatment, if I recall, other than– previous chemotherapy or radiation, and the tumor disappeared under our eyes
It was a low grade astrocytoma, wich is comparable with long survival
However, even those low grade astrocytomas, when we see them, they don’t go away even though they may permit the person to live for many years
In this particular patients case the tumor disappeared, and there was a small, tiny remnant left, small percentage of the original size
And there has been several years since then and the patient is well, I’m told
Q: So at least for the patient you would not recommend that
he go off the treatment, would you?
Critiquing: Dr. Michael A. Friedman, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”: