Polish-born Dr. Stanislaw Burzynski is famous for his antineoplaston therapy – and for the controversy that surrounds it. He was one of the first people I heard proclaimed as having found an answer to cancer. Dr. Julian Whitaker did the honors, in a newsletter which then dominated the alternative health field. That was about 20 years ago.
Does Dr. Burzynski really deserve his place at or near the top of the alternative cancer pantheon? Here’s what I think. . .
Continued below…
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If you search Google for Burzynski, you’ll likely read little about the science behind his treatments … and more about the 15-year controversy and endless court cases between him, the FDA, and the Texas Medical Board.
Most of it is highly biased, written either by a group called “the Skeptics” who believe he’s a scamming quack … or by his grateful yet emotional patients and their families who defend him … or by starry-eyed proponents of alternative medicine who fervently believe in EVERY alternative cancer treatment, especially if the practitioner has been persecuted by the Feds.
Frankly, I don’t care about the drama — much of it is childish and poorly informed. What’s clear is that very few people truly understand what is going on and aren’t sharing the whole story. Everyone else is basing very strong opinions on little information.
If you’re interested in the drama, you can easily lose yourself for hours on the Internet or by watching the highly sensational (and biased) “documentaries” Burzynski and Burzynski Part II: Cancer is Serious Business.
What I care about is the science. If it turns out that Dr. Burzynski is a greedy quack, then we need to know. Ditto if he’s a saint who’s found a cancer cure. So let’s find out. . .
What are antineoplastons and are they safe?
Dr. Burzynski first discovered new peptides (short amino acid chains) in human blood in the late 1960s during his doctoral work in biochemistry at the Medical Academy in Lublin, Poland.
He found that these peptides, while present in healthy humans, were almost non-existent in the blood of patients with advanced cancer. He theorized that returning them to the bloodstream of cancer patients might fight the disease.
Initial studies in the U.S. in the 1970s showed the peptides exhibit anti-cancer activity in vitro (i.e. lab cultures) with little to no toxic side effects on healthy cells.
He was also able to reproduce the peptides synthetically while creating several different versions based on the varying types. The most common and widely studied are intravenous A10 and AS2-1, which can be delivered orally or through an IV.
He named the peptides antineoplastons (ANP), drawn from the word neoplast, meaning cancer cell. (The term is misleading; it implies the therapy works to cure all cancer in all cases, which, as you’ll soon see, it doesn’t.)
So, how do they work?
Dr. Burzynski’s research is based on the notion that cancer is caused biochemically, by “increased activity of oncogenes and decreased expression of tumor suppressor genes.” 1
“Antineoplastons work as molecular switches,” Dr. Burzynski wrote in a 2006 paper. They regulate two different genes, p53 and p21.
P53 is a tumor suppressor protein and p21 is an anti-proliferator, which essentially reminds cells to die. Antineoplastons also inhibit the uptake of l-glutamine and l-leucine, the amino acids cancer cells need to grow. 1
Phase I clinical trials to determine safety of the synthetic antineoplastons occurred in 1977. The participants suffered from difficult cancers like colon and bladder cancers.
Safety was also confirmed (at least once) by Japanese researchers in 1995. They also concluded that A-10 and AS2-1 are “less toxic than conventional chemotherapeutics.” In addition, they reported “disappearance or measureable shrinkage of the tumor” with significantly longer survival rates.2
But safety studies aren’t meant to prove efficacy.
Where’s the proof?
For many years, Dr. Burzynski’s major critics complained he hadn’t sufficiently proved that ANP therapy works — in other words, he had only published “anecdotal” case studies and preliminary reports of the 74 clinical trials the FDA has approved since 1994.
For example, there was the case study of a young boy who survived a rare childhood brainstem tumor, called diffuse intrinsic pontine glioma (DIPG), thanks to antineoplaston treatment.
Because of the way they grow, these cancers are impossible to completely remove with surgery. They grow in and among the glial cells, the supporting brain cells that keep neurons in place, deliver food and oxygen, and help protect them from disease.
Without treatment, life expectancy shortens to just months. DIPG patients have a 0% survival rate after 5 years.
This boy was treated with ANP therapy for nearly 7 years. His tumor stabilized, decreased, and then showed no further metabolic activity. He’s been in remission over 13 years, and only complains of residual neurological deficit resulting from his multiple surgeries.3
Despite this success, the medical and scientific communities at large don’t accept anecdotal case studies like this to be proof. They’re often written off as miracles or coincidence.
As I’ve often said, I respect case-study evidence, although I understand it’s not definitive. If even one or two people responded to a treatment and lived, it’s a valuable piece of information and one to consider.
Which still begs the question, are antineoplastons effective?
Phase II studies on humans are hopeful
In 2014, Dr. Burzynski published the results of 14 clinical trials begun in the 1990s. Many of them spanned over ten years. Why it took so long to publish isn’t explained … but the duration of effective ANP treatment plus 15 years of court cases could be an explanation. And if he was aiming for five-year (or better) survival rates, he had to wait at least that long, for each patient.
At first glance, the results don’t seem that impressive, but there are a few things to keep in mind:
The people Dr. Burzynski works with all have rare forms of brain cancer. They’re usually incurable or at the very least difficult to treat. These are “last chance” patients. Barring any miraculous remissions, these patients would have had a 0% survival rate.
Plus, patients are legally required to have “failed” chemo, surgery, or radiation before being allowed into the trial. They’d been living with their disease for some time while going through other -- often toxic -- side effects. Readers of this newsletter are well aware of the disastrous damage conventional treatments inflict, and how chemotherapy reduces a patient’s chance of survival.
So, in the cases of incurable, inoperable, advanced stage cancer, anything is better than 0%.
One study followed children with recurrent high-grade glioma. Out of the 15, two had a complete response, two had a partial response (50% decrease or higher), and three achieved stable disease. One patient survived 10 years after treatment.4
According to the authors, “4 out of 15 patients is a sufficient number of successful cases to show adequate antitumor activity for initiating phase III testing.”
Another study of 17 children with DIPG showed one complete response, four partial responses, two with stabilized disease, and eight who developed progressive disease. (Two cases were deemed impossible to evaluate.)5
A phase II study published in Cancer and Clinical Oncology in March 2015 was performed on recently diagnosed adults with anaplastic astrocytoma, a rare and nasty cancer with ten-year survival rates between 4% and 17% and low quality of life for patients who elect conventional treatment.
Of the patients in the trial, four were cured, five achieved stable disease, and nine experienced progressive disease. Those who survived had a high quality of life, and no chronic toxicity.6
What about side effects?
The studies always report “no chronic toxicity.” However, there are side effects such as serious sodium and potassium imbalances and drowsiness. These are reversible … and compared with the side effects of chemo and radiation, they seem minor.
But ANP isn’t the only thing that Dr. Burzynski offers his patients. As of publication, likely because of the phase II status, only 10% of patients who request it were allowed to receive antineoplaston therapy.
(Now that phase II is complete and phase III has been approved, I expect the number to increase.)
The other 90% of patients receive a different Burzynski treatment, targeted gene therapy.
Targeted gene therapy
Thanks to the completion of the Human Genome Project in 2003, we now have a 20,000-gene map of a healthy person, within 99.99% accuracy. Dr. Burzynski was one of the first to use the genome map of an individual’s tumor to identify and treat abnormal genes.
“Most oncologists … treat the name of the cancer,” he said. “They still don’t understand that cancer is caused by genes. With the available resources, they can already save the lives of numerous patients.”7
“These abnormal genes, they ‘hijack’ normal genes until they form a malignant network, typically composed of close to 3000 genes,” he said. “Unless you destroy this malignant network you are not going to win with cancer. That’s what we are trying to do.”8
And there’s some good news: Targeted gene therapy is surprisingly inexpensive. It costs only $6000 (covered by insurance) for a lab to analyze a tumor biopsy and map the genome. Dr. Burzynski then uses this map—and a cocktail of FDA approved drugs—to turn genes off and on.
As far as I can tell, Dr. Burzynski has not published papers about this method, though he’s written about gene silencing in general.
The approach seems to make sense, but as far as how effective it is or the extent of any side effects, I can’t say.
To ANP or not to ANP?
At this point, based on the data provided from small phase II trials, antineoplastons work for a significant number of people – not everybody – suffering from very specific types of cancer.
This is a fact Dr. Burzynski himself states in several interviews. It’s nothing new and certainly doesn’t suggest he tried to deceive people or inflate his claims.
In my experience, it’s his fans and admirers who exaggerate what his treatments can do. He has enjoyed the backing of some influential people in alternative medicine, and for this reason his name always seems to make the short list of alternative and integrative cancer doctors. I’m not sure that place is deserved.
Personally, I’m underwhelmed by antineoplaston therapy, and when it comes to his version of targeted gene therapy, I simply don’t know enough to say.
Cancer Defeated has NOT been a cheerleader for ANP therapy for the simple reason that it’s useful in only a limited way AND you have to get permission from the government to take part in the trials.
We’ve interviewed many alternative doctors – and their patients – and found many who are achieving results at least as good as Dr. Burzynski’s, with much less fuss -- and the treatments are available to anyone who walks in the door.
Dr. Burzynski’s low-to-middling batting average is not a problem as such. No cancer treatment works for everyone, and the trials have mostly been conducted with “hopeless” patients. But if you’re trying to pick a practitioner and a treatment, I think you can do better.
I’m happy for those who have been treated successfully, and I look forward to the results of larger, phase III trials with varying types of cancer … possibly with patients who are less difficult to treat and who have not been first “cut, poisoned, or burned.”
I’ll keep an eye out for further developments. Now that it looks like the controversy and harassment from the Texas Medical Board has ended, hopefully phase III won’t take as long as phase II trials.
