*An appeal to encourage Congress to investigate this follows Hannah’s story*
On Oct 18, 2005, 4-year old Hannah H. began complaining of a headache after her mother took her to skating class. Her mom took her to the doctor who suggested that they go to the hospital to rule out anything serious. By the time they reached the hospital, however, Hannah was slurring her speech and was weak on one side. Very quickly it was determined that she had two brain tumors and one had started to bleed. The first tumor, a benign papaloma in the left ventricle, was removed with surgery, the other, however, was on the brain stem. According to her mom:
They had to biopsy to see what it was – they had 6 Dr.’s in the operating room and were in there for about 4 hours. She came out of surgery fine with no problems and they were able to get a piece of tumour.
It was a diffuse intrinsic pontine glioma, one of the few diagnosed via biopsy. Hannah was in the hospital through Halloween, as was reported in the Vancouver Sun on Nov 1st.
The family continues conventional therapies (timodal and nemotuzamab) for the next year, but in mid-August 2006, the family is clearly looking for new options. They reached out to Justin B’s family (Justin died in 2007):
We’ve tried the standard treatments and while things have remained reasonably stable, with a few ups and downs, we are always looking out for alternate treatments. We’re hearing lots more about Dr. Burzynski’s treatment and would like to ask you some questions about it
We have found the same thing with Hannah and the Dexamethazone (what they call Decadron in Canada) we have found that her muscles have gotten way weaker, so her walking is really suffering and her speech has declined a great deal – we are also trying new things to get her off the dex… however we’re finding it really hard to do, we use the liquid and can get her down to .25 of a mg and then we have to go up again because we can’t understand what she’s saying… its been like that for about month now…
On Sept 22, the family announces that they will be flying down to Houston for antineoplaston therapy on the 24th and hope to start treatment on Monday:
Well, we have decided to take our daughter Hannah to Houston and have her treated at the Burzynski clinic. Of the choices offered to Hannah for treatment, this seems to offer the best hope for long term survival. The various chemo treatments had what seemed to be good results for short term survival but Antineoplastons had the better long term numbers.
We’ll be be flying down from Vancouver on Sunday morning and get started on Monday with treatment. we’re making all the necessary arrangements now and hopefully things will go smoothly.
The statement about long-term numbers is not borne out by the evidence. In fact, there is no good evidence that antineoplastons work. Over 60 trials have been started by Burzynski, but none has been satisfactorily published. These are the trials that might have established anything like survival rates, so with no finished, published studies there is no basis for anyone to assert that a “rate” exists. Of course, maybe the clinic was sharing preliminary data, but the problem with that is a recent inspection found that 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.” As a result, his outcome figures for these studies are inaccurate. Furthermore, all the baseline measurements for all patients whose files were reviewed by the FDA were destroyed and not available to investigators. Basically, his results can’t be reviewed. This is part of a pattern of sloppy “research” that stretches back for at least a decade.
The family goes through the customary training period at the clinic, because Burzynski’s treatment requires patients to fend for themselves. This likely contributed to the over 100 overdoses and serious but often unreported toxic events that the FDA uncovered during their inspection. For the record, the FDA told Stanislaw 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]
This would have shut down any research institution that received government funds. We’re talking about entire universities, here, not individual studies. Yet Burzynski still treats patients.
While on treatment, Hannah experiences the overwhelming thirst that comes with ANP’s massive sodium doses, with the attendant side effect of urination, and this causes all sorts of problems and consternation:
We’ve had Hannah on the ANP treatment for almost 2 weeks. Things have been going pretty well with treatment and Hannah hasn’t shown any bad reaction to the medication yet.
We’ve had Hannah in diapers for about 3 weeks and what we’ve had a problem with is all the diaper changes and leaks when Hannah is sleeping. There doesn’t seem to be many times when we are able to get her changed at night and often during the day when she doesn’t have a really big pee and fills her diaper and then leaks. This can only get worse the the projected fluid increase as she continues on the treatment.
Ultimately the family decides to line child diapers with adult diapers. That much fluid is going through the poor little girl.
The family had just returned to Vancouver from Houston when we hear that Hannah has died. She died at the same hospital where she was diagnosed a year earlier. I see no mention of any positive results of Burzynski’s antineoplastons in Hannah’s case.
One of the lasting effects of Hannah’s experiences has been the establishment of Hannah’s Heroes, which funds legitimate cancer research and operates to this day. One of the sad facts is that the rare tumor that Hannah had is not well understood and there are not many good therapeutic options. Hannah’s Heroes are trying to fill the research gap in the area of brain stem tumors.
Usually, this is where we would put an appeal to donate to St. Jude’s. You may still do that, if you like, but we are now actively campaigning for an investigation into how the FDA decided to allow Burzynski not only to continue his ridiculous trials, but to actually get a phase III trial after a decade of abominable site visits. Go to thehoustoncancerquack.com and you will find the resources you need to put primary documents–the FDA inspection notes–into the hands of your representatives so they can conduct an investigation. All appeals to understand this made to the FDA have failed, so now we need to press the issue onto the committees that oversee the FDA. Please help us uncover what went wrong so we can fix it and so this never happens again.