Things that used to be on a blog.
Burzynski's "research" - Part 1
July 21, 2012
Stanislaw Burzynski has 61 clinical trials listed on the
http://clinicaltrials.gov/ct2/results?term=burzynski. Here is an
analysis of the progress so far:
|Not yet started
His supporters love to point to evidence of his success and can
become quite abusive when anybody questions them. One piece of
evidence they continually offer is the fact that he has a Phase 3
trial listed, but unfortunately that's not really evidence of
anything as it's the trial that hasn't even started recruiting
subjects yet. My guess is that Burzynski has no intention of ever
starting that trial and it is just there for advertising purposes.
No results have been published for the single completed trial,
although it was supposedly finished in 2006.
Over the last two weeks his supporters have been calling all his
detractors liars for saying that he doesn't publish anything and
therefore there is no evidence of him curing anybody of anything. Oh
yes, there are countless anecdotes and many web sites begging for
money to send terminally ill children to Texas for a miracle cure.
As Burzynski has been using
web sites begging for money to save sick kids as an advertising
gimmick for years not a lot has changed. What we want to see are
papers in reputable peer-reviewed journals reporting on the results
of double-blind randomised trials. You know, the sort of stuff we
expect everyone else to do.
Why we are liars is because he has actually published something
and I have been given
links to it on at least a dozen occasions so I assume it's the
best they've got. (One surprising thing is that some of his
supporters seem to think that PubMed is a medical journal. It's an
index to publications, so saying "He's been published in PubMed" is
like saying "He must be legitimate. He's in the phone book".) Here
Integr Cancer Ther. 2006 Mar;5(1):40-7.
Targeted therapy with antineoplastons A10 and AS2-1 of
high-grade, recurrent, and progressive brainstem glioma.
Burzynski SR, Janicki TJ, Weaver RA, Burzynski B.
Department of Internal Medicine, Burzynski Clinic,
Houston, Texas 77055, USA. firstname.lastname@example.org
BACKGROUND: Brainstem glioma carries the worst prognosis
of all malignancies of the brain. Most patients with
brainstem glioma fail standard radiation therapy and
chemotherapy and do not survive longer than 2 years.
Treatment is even more challenging when an inoperable tumor
is of high-grade pathology (HBSG). The objective of this
report is to summarize the outcome of patients with HBSG
treated with antineoplastons in 4 phase 2 trials. Patients:
The following group of 18 patients was evaluable: 4 patients
with glioblastomas and 14 patients with anaplastic HBSG.
Fourteen patients had diffuse intrinsic tumors. Twelve
patients suffered from recurrence, and 6 patients did not
have radiation therapy or chemotherapy.
METHODS: Antineoplastons, which consist of antineoplaston
A10 (A10I) and AS2-1 injections, were given in escalating
doses by intravenous injections. The median duration of
antineoplaston administration was 5 months, and the average
dosage of A10I was 9.22 g/kg/d and of AS2-1 was 0.31 g/kg/d.
Responses were assessed by gadolinium-enhanced magnetic
resonance imaging and positron emission tomography.
RESULTS: The overall survival at 2 and 5 years was 39%
and 22%, respectively, and maximum survival was more than 17
years for a patient with anaplastic astrocytoma and more
than 5 years for a patient with glioblastoma.
Progression-free survival at 6 months was 39%. Complete
response was achieved in 11%, partial response in 11%,
stable disease in 39%, and progressive disease in 39% of
patients. Antineoplastons were tolerated very well with 1
case of grade 4 toxicity (reversible anemia).
CONCLUSION: Antineoplastons contributed to more than a
5-year survival in recurrent diffuse intrinsic glioblastomas
and anaplastic astrocytomas of the brainstem in a small
group of patients.
So let's summarise that.
- Publication in high-impact journals is always better. The
Integrative Cancer Therapies can be expected to be
sympathetic to outlandish alternative medicine claims. In 2011
it had an Impact Factor of 2.136 and was cited 687 times. By
Clinical Oncology had an Impact Factor of 18.970 and
gets cited about 114,000 times each year. (Nature has
an IF of 36.280. That's where the Nobel Prize stuff gets
- It is not normal practice to divide the abstract up into the
sections that are found in the main paper. I was taught that in
my first year at university.
- The paper was published in 2006, which is a long time ago in
"cutting edge" medicine.
- This is not a paper giving the results of a double-blind,
randomised clinical trial.
- It includes subjects from four trials, although which trials
they are is not stated. It is not normal practice to aggregate
trial data unless explicitly doing a meta-analysis and if that
was the case the presentation of results would be completely
different to what is given here.
- There were only 18 patients in total across all four trials.
I remember having sample size beaten into my head in my first
year studying statistics and research methods.
- "Fourteen patients had diffuse intrinsic tumors". What did
the other four have?
- "Twelve patients suffered from recurrence" so only six
improved (and Burzynski counts not getting worse as an
- "6 patients did not have radiation therapy or chemotherapy"
so twelve did, simultaneously with Burzynski's treatment. (Many
patients have to have had this sort of treatment before.
Burzynski only accepts patients when all other options seem
closed off. Desperate people are more ready to hand over money.)
- There is nothing to say if the twelve patients who didn't
get better were the ones having radiation or chemotherapy, but
if they were then the maximum number of patients who could have
"improved" with Burzynski's treatment alone is six. I suspect it
|All 18 subjects
But wait -
|All 18 subjects
|Progression-free 6 months
By remarkable coincidence, those numbers add up to 100%, despite
the fact that the rows are not independent (each figure includes the
one on the row below it). Also, as everyone in the 2-year survival
group must have made it beyond six months this seems to indicate
that nobody ever gets worse after six months. This seems highly
unlikely. The numbers are also inconsistent with the numbers in the
first table - surely "Complete response" should not be only half of
If this is the best research that Burzynski can come up with then
I would hate to see the worst. In summary, a cobbled-together paper
published in a low-impact journal six years ago which aggregates the
results of four non-blinded trials with a small total number of
subjects and which includes suspicious statistics is not about to
get anyone the trip to Sweden that a cure for cancer would
guarantee. If I had to rewrite the conclusion section of the paper
it would say something like this:
CONCLUSION: We tried to find evidence that the treatments we
have been selling at very high price for many years actually
have an effect on the progression of certain forms of cancer.
None of the clinical trials (that we pretend to do to get around
the FDA's ruling about unproven treatments) were good enough on
their own to show efficacy so we cherry-picked some of them, put
them together as if they were independent studies suitable for
meta-analysis and then added some numbers to make things look
good. We reported the numbers in two inconsistent ways, hoping
that nobody would notice that we didn't actually find any
evidence of a cure. We even included an outlier to make the
numbers look better, but we know that most people citing this
paper will not know what that means or why it might be a