Dr Burzynski and antineoplastons, the missing proteins in cancer patients

Dr Burzynski and his antineoplastons

(Chris Woollams) This Alternative Cancer Treatment involves the work of Polish Doctor, Dr Stanislaw Burzynski, working in Texas in the USA. The man and his clinic are both extremely controversial. At CANCERactive we can see no advantage to a cancer patient in our charity either ignoring this treatment; or lauding it without any definitive, completed, independently monitored phase II or phase III clinical studies behind it. Our job is to provide information so that you can make more informed personal choices.
The fact is that after winning repeated battles with authorities in Texas and with the FDA, the treatment is still not definitively approved. Burzynski is only allowed to treat patients at his clinic as part of a clinical trial.
But where are the definitive results of that trial? Why are we still waiting? A BBC documentary exposed a major flaw - asked to provide some results he stated he was restricted by the FDA. They denied this and said he was free to provide results. He didnt.
After the death of a child at the clinic in 2012, Burzynski was not allowed to accept new child patients, and the FDA launched an investigation into standards and administration of the clinical trial. The results of this in 2013 are damning (see HERE).
One wonders why, today, he is still allowed to treat people after this report. But he is.
Next, there are the antineoplastons themselves. There is just no definitive study, no hard, independently obtained numbers and therefore no convincing evidence. However, the NCI website does seem to suggest there may be merits in these peptides, as does the FDA themselves probably based on some phase I and II clinical research.
Frankly, its a mess - cancer patients deserve much better than this, and it leaves us with an extremely uneasy feeling about a treatment at this clinic; especially given its expense.
A little background
Having studied the urine of healthy humans and those with cancer, he discovered the healthy humans had protein peptides that were missing in people with cancer.  So he set out to extract these missing peptides from healthy subjects, copy them and produce a peptide mix specific to different cancers. These peptides he named and patented as Antineoplastons.
Antineoplastons (which are supposedly non-toxic yet do seem to cause hypernatremia) were used in his early work with brain tumour patients and subsequently with other cancers. In his work in his own clinic he produced research results which he claims beat the statistics seen for standard radiotherapy and chemotherapy treatment: In recorded trials for adults with gliomas having chemotherapy and radiotherapy the comparable 5 year survival was 9 out of 54 for orthodox treatment; 5 out of 25 for antineoplastons. With children, the results were even more striking. Orthodox treatment say an immediate clear up of the tumour in only 1 case out of 107 (and that child did not survive 5 years). With antineoplastons 11 out of 40 patients were clear after treatment, all those 11 surviving 5 years.
Skeptics, of course, question this research and it has never been independently verified. But the National Cancer Institute in America now devotes several pages to antineoplastons. To quote them: 

Research studies have been reported on the effect of antineoplastons in certain types of cancer:

• The effect of antineoplastons A10 and AS2-1 on brain tumors was studied at Dr. Burzynskis clinic and at the Mayo Clinic. A brain tumor study done in Japan did not report the type of antineoplaston used.


• The effect of antineoplaston AS2-1 on prostate cancer was studied at Dr. Burzynskis clinic.


• The effect of antineoplaston A10 on liver cancer is discussed in a case report from Japan.

These studies reported mixed results, including some cancer remissions (signs and symptoms of cancer decreased or went away). Other investigators have not been able to obtain the same results reported by Dr. Burzynski and his team. Some of the patients in the reported studies received standard treatments in addition to the antineoplastons. In those cases, it is not known if responses and side effects were caused by antineoplaston therapy, the other treatments, or both. One additional independent report (a study from Japan) was completed but does not have the same findings as the Burzynski report.
The NCI do report that there have been phase I and phase II clinical trials, but never a phase III randomised, controlled clinical trial. Burzynski is currently treating a large number of cancer patients with a broad spectrum of cancers. The only way he can treat people is by claiming they are part of a clinical trial - however, the FDA report in 2013 mentioned above is damning, talking of incomplete reports, overdosing, and even destroyed documentation (see here). The truth is we await proper, completed research on the trials.
The NCI and FDA acknowledge that antineoplastons work, sometimes
The story runs as follows: Before he started his work, Burzynski took legal advice and was told he could practice in Texas where he could distribute antineoplastons to patients.
However, his early success prompted a hiatus amongst the American Orthodox community, and resulted in numerous court and FDA appearances across a ten year period. For example, Burzynski went through 4 Senate hearings and several other FDA hearings. In the end, the FDA gave up challenging the medicine of the treatment. Importantly, according to Burzynski, they acknowledged that the treatment was non-toxic and could help some patients beat their cancers.
The truth is that phase I clinical trials report side-effects that are minimal and short-term, but phase II clinical trials with brain tumours report side-effects such as seizures and sleepiness (but this could be a feature of brain tumours and their treatment anyway). Hypernatremia has been a serious cause of concern.

After a Congressional Subcommittee meeting which noted that after 4 Senate Hearings (which normally lead to an indictment), he had never once been indicted, the Chairman of the hearing told the FDA that they were wasting time and tax-payer money. So he was subsequently indicted on 75 counts. (This is all on film).
Despite patient witnesses, he was found guilty of breaking Texas Law. However, the judge suspended the verdict and allowed him to continue treating 300 or so patients, all of whom had testified that if they did not have access to antineoplastons they would die!
This muddle then resulted in another Congressional Sub-committee hearing (Feb 29, 1996), From this and public (and media) pressure, the FDA was pushed to provide a special task force to conduct clinical trials of standard treatment versus anteneoplastons. Despite the clinical trials progressing in 1997 and agreeing that the issue was NOT that these antineoplastons worked (that fact was accepted), the court trial still took place. The jury could not decide and the judge acquitted Burzynski.  The FDA over ten or more years spent over $60 million in what the media often termed a witch hunt.
The key question is: Is Burzynski on his way to a Nobel Prize, or is it all quackery?
Let us backtrack: In 1991 Dr Michael Friedman, of Memorial Sloan-Kettering, and probably the top brain cancer expert in the world, stated that antineoplastons deserved a closer look.
Dvorit Samid, who worked with Burzynski at one point, then tied up with a pharma company and the Cancer Centre at Johns Hopkins to develop a chemical compound, phenylacetate, that was known to underpin antineoplastons. However, phenylacetate does not work on its own, a fact that was discovered in their trials. Not surprisingly after this failure the FDA, the NCI, and a pharma company wanted the real thing.
So, while Burzynski was undergoing threats of court hearings and incarceration, official medical authorities were trying to steal his treatment.
Firstly, clinical trials were prepared and demands were made on Burzynski to supply the correct antineoplastons and doses. He refused and repeatedly wrote to the authorities predicting failure. Officialdom went ahead, using imperfect products and not knowing the correct doseage. 
Fluid retention became a huge problem and the trials were halted without conclusion. Burzynski later analysed the Trials and showed patients were given doses that were up to 36 times TOO LOW. He believes the patients should sue the NCI.
Worse was to come. Li-Chuan Chen of the National Cancer Institute has actually gone on record as saying the Burzynski Protocol was changed, with the inference that it could not possibly have worked.

Merit in antineoplastons?

Having studied the failures and lack of understanding of exactly what was in real anteneoplastons, the NCI, a Pharma Company and Samid went on in 1991 to file 11 patents on antineoplastons that Burzynski had already patented!! 
Burzynski takes the view that the continuing campaign against him which could have resulted in his imprisonment, was to pauper him and steal his patents. Readers should note that in the patent applications, supported by the National Cancer Institute and filed by the authorities, it says quite clearly that the antineoplastons work! And it says that current approaches like radiation and chemotherapy are toxic, unlike antineoplastons. 
Antineoplastons - your second immune system?
Since 2009 Burzynski has been allowed to treat patients at his clinic as long as they are part of a clinical trial. (He claims they are Phase III which means that it is acknowledged that the antineoplastons deliver an effect.) But, following the death of a child in 2012 he has not been allowed to take on any more child patients while an investigative report was carried out by the FDA into how well the Clinic behaved in auctioning the trials. It is this report in 2013 that has been damning.

The downside is that brain cancer patients must have already undertaken radiotherapy. The FDA says it would be unethical not to have given glioma patients radiotherapy. Burzynski fears it will hamper the work of the antineoplastons.
Burzynski has a major multi-million dollar plant now in Texas employing technicians, pharmacists, biochemists, scientists and doctors. In his view all the new developments in gene drugs aim to act on a single gene (he has studied the 25 on the market at the end of 2010). However, he says it is never a single gene that has gone wrong in cancer. Antineoplastons work on at least 100 genes. Burzynski says that they turn off oncogenes which spread cancers; while turning on tumour surpressor genes which stop cancers growing and spreading. He calls anteneoplastons your Second Immune System. There is no independent corroboration of this theory.
This whole body treatment has been now used to treat all manner of cancers from breast cancer to lymphoma.
The full article on Burzynski and antineoplastons from 2006 is available on clicking THIS LIVE LINK.
Our bottom line?
(Chris Woollams, CANCERactive) As we have been saying since 2012 - we are not convinced. And becoming less so.

But the treatment (antineoplastons) needs to be separated from the Clinic and the man. We bow to the FDAs acceptance of clinical data for the anteneoplastons.

But. We started by saying the work is controversial. While some may say "surely Burzynski would not be allowed by the FDA to treat people in his clinic if there was no evidence of effect", we worry that his clinic (and his beligerence) is a major part of the problem. A 2014 report damns his diligence and simple good medical practice at the clinic - we await FDA action.

The truth is still that there really are no randomised, definitive double-blind, placebo controlled phase III clinical trials behind the antineoplastons although the NCI talks of phase I and phase II clinical trials. As yet, there is really no convincing evidence this treatment works, Burzynski says so himself when he argues it doesnt always work and they are not sure why; and it is expensive.

Cant some other experts try using the product?
If Burzynskis claim that antineoplastons work for some and not others is correct, and if previous trials were compromised by using products with reduced effectiveness, Burzynski may well have an alternative cancer treatment that can deliver for some people. But its a big ask, and what are the criteria. At least with Herceptin, we understand the science and that a woman needs to be HER-2 positive, and theres a test. Nothing like this exists for antineoplastons.

And, of course, it is going to cost you money to be treated - he is a private Doctor. 

So, to repeat our message of the last 18 months: We need some proper, independent phase II and Phase III clinical trials on antineoplastons. These do not have to be done by Burzynski!

The Japanese are big fans - there are several places studying the treatments. And maybe, third parties would not expose the failings of the treatment, but make it work better. 

So, the bottom line, is we have no idea. Ten years after CANCERactive started and we cannot make any better judgements for patients. Indeed we are getting weary of it all.

Whilst it might be interesting for a cancer patient to explore this further, we urge extreme caution, especially given the expense of the treatment, and the fact that, at the moment, we agree with the American Cancer Society when they say Theres just no convincing evidence.