As Stanislaw Burzynski heads to court again to answer charges made by the Texas Medical Board on behalf of a variety of patients, he is doubtlessly preparing by getting the testimony of current and former patients. In anticipation of this pony’s one trick, we are telling the stories of patients who have testified on Burzynski’s behalf over the course of his long, dubious career and see where they are now.
Janet C. was diagnosed with neuroblastoma at age five. According to her father, who testified for Burzynski in front of Congress in 1998, two years after her diagnosis:
Over a period of 17 months beginning on February 28, 1996 she has suffered through 10 months of very aggressive chemotherapy, 6 days of ablation chemotherapy, 3 days of total body radiation therapy. Twice each day. And then a very gruesome bone marrow transplant resulting in the doctors telling us on February 17 and 18, 1997 that our daughter had only hours to live […].
She was discharged, in remission only to incur 3 life threatening secondary infections. She has been in relatively good health since August 1997. That may sound like good news, but this disease has 93% rate of recurrence which results in death. Most medical journals do not give survival rates after 2 years. They know what happens.
At this point, we need to understand that Janet has been put in remission by grueling yet effective conventional chemotherapy. She had been given more time, but that is, understandably, not enough for a parent who will see anything but a child living a full life to be a failure. It is at this point, when she is remission, that the family starts looking at Burzynski’s treatment. At this point, in order to receive antineoplastons, Burzynski’s unproven treatment, originally isolated from human urine and blood, Janet will need to be on a clinical trial.
It sounds like Janet’s dad had an awful time getting a timely response or even acknowledgement from the FDA that his daughter’s case was being considered for a clinical trial. This is not to the agency’s credit and is a part of the Congressional record. Once everything is filed, of course, as is usually the case, the reply was back very quickly, according to Janet’s father:
The protocol package was sent to the FDA via fax. It was returned to the Doctor’s office, disapproved in less than five hours. The Doctor’s office called and said the FDA had disapproved the protocol and would not allow the Doctor to treat Janet prophylactically. I was shocked by this response from the FDA.
The important thing here is that Janet’s dad wanted to treat the disease prophylactically. This poses some methodological problems for a clinical trial. Let’s say that Janet doesn’t progress. Does that mean that the antineoplaston worked? Or does it mean that she was one of the 7% who happened to not relapse? Well, you can’t in principle know. But the situation here is even less secure, and it’s understandable to see why the FDA would slap the proposal to pump ANP into Janet down so quickly. It’s not even meant to be used as a prophylactic treatment, but only for present disease. This radical departure from normal protocol more than justifies rejection of this particular proposal (not that Burzynski has ever been particularly scrupulous about adhering to protocols):
The father despaired:
The morning after I called Mr. Zimmerman at this home I received a call from Mr. David Banks, also from the FDA. I cried and begged both of these men to at least give my daughter a fighting chance at life. My pleas fell on deaf ears. Mr. Banks sent me a write-up apparently from the Journal of the American Medical Association by a Dr. Green. It was dated 1992 I recall. It was a smear of the treatment I was seeking and the Doctor who invented it.
I called Mr. Banks back He told me to cal a Dr. Blaney at the Texas Children’s Cancer Center. I was referred to a Dr. Stacey Berg. WE discussed janet’s cancer. Dr. Berg stated that a patient in remission was not eligible to participate in the clinical trial for obvious reasons — nothing to measure.
And there you have it. An eminently reasonable explanation. Further, they explained what one of the most important medical journals had to say about Burzynski. Though to the desperate, that gets waved away as a “smear.” The father goes on to say that this Dr. Berg said that Janet had nothing to lose by going on the ANP. If true, it’s a bad thing to say to a patient’s father. What happens if Janet is in the 7% who do not relapse and she has a toxic event like Josia C’s? Prophylactic treatment might possibly kill her for nothing (presumably safe and effective doses for prophylactic treatment hadn’t been figured out anyway). Or what if she is in the 7% and has one of the numerous toxic events the FDA observed to have been ignored or unreported in Burzynski’s studies in 2013? Quality of life or life itself could easily be lost. With no reason to expect that antineoplaston would have any prophylactic effect, why submit a child (a protected class of patient) to unknown dangers?
Not only did the family appear before the House committee to testify for Burzynski, but the father went on TV with John Stossel to make his case to the public.
STOSSEL: Consider Janet [C]. While she looks healthy, Janet has a form of cancer that’s likely to kill her before she becomes an adult. Her parents want to take her to this Texas clinic, run by Dr Stanislaw Burzynski. He has a treatment that might help her. It’s now being studied by the Food and Drug Administration. But only the FDA gets to decide who can be treated, and the agency turned Janet down. They say it’s not safe if people pursue medical treatments the government hasn’t sanctioned. […]
LYLE [C]: My daughter has a terrible disease called neuroblastoma cancer. I know what the survival rates are, which is essentially zero, and I’m trying to do something that may save my daughter’s life. We have absolutely nothing to lose and everything to gain.
We know, of course, that these last statements are not, strictly speaking, true. Further, there is no mention of the fact that the father wanted to give the drugs in a way that they are not being studied to be given or any sense of real risks that actually exist, which a desperate father would be willing to overlook. By April 15th, 1999, when the interview with Janet’s dad aired, we know that the FDA had caved to the pressure of the Congress. Again. Janet got the antineoplastons.
According to the page that used to be up at the Burzynski Patient Group, but has disgracefully been removed:
Janet is now 8 years old, and she continues to be in remission. After only 6 months of antineoplaston therapy, it is still not certain if she has beaten the odds against cancer. It is known, however, that she and her family have won the fight to decide for themselves how they can best save their child’s life.
[Lyle C.] says, “This was and still is the greatest struggle of our lives. I spent 42 years of my life defending this country, 26 years as a soldier and 16 years as a civilian employee. I find it ironic that I served the same government that attempted to deny my daughter a treatment that may very well save her life.”
It apparently did not save her life. Janet died on October 21, 2001 at age 11.