Burzynski: the false promise of antineoplastons

With the support of their local communities, cancer patients are still fundraising to travel to America for antineoplastons, a reportedly pioneering treatment not available in the UK.

In fact this treatment isn’t available anywhere except the Burzynski Clinic, and only to patients who are already on it. Antineoplastons disappeared from the clinic website in January. It is believed that following a recent inspection, the US FDA have closed the “clinical trials” loophole that had been allowing Burzynski to sell these old, unproven drugs to terminal cancer patients.

If this is the case, it is not a fact anyone seems keen to share with families still hoping for a miracle cure. Patients are misled and misinformed at every turn – by the clinic themselves, by lazy and cowardly journalism, by conspiracy theorist cranks, and even by registered charities.

Descriptions of antineoplastons are usually misleading and often demonstrably false. The British charities Yes to Life and CANCERactive both describe them as “non-toxic” on their websites. According to the London Evening Standard, antineoplastons are a “life saving operation” which aims to “switch on genes for cancer suppression”. On ITV Daybreak, Dr Hilary Jones described Burzynski’s work as “pioneering research” and this article from the North Devon Gazette, dated March of this year (after the Burzynski Clinic stopped advertising antineoplastons), even suggests a patient who is still undergoing this treatment has been cured.

Antineoplastons are not pioneering, not natural and not alternative. They are not an operation, nor are they gene targeted. They are old fashioned chemotherapy. The main differences between antineoplastons and other types of chemotherapy are that antineoplastons have never been proven to work and that they are made by companies owned by Stanislaw Burzynski.

The Burzynski Clinic directly misinforms prospective patients. They send out false and misleading information. They recommend dubious websites. Concerns are swept under the carpet as patients are deceived by increasingly familiar arguments, which never seem to change no matter how many times they are shown to be wrong.

Consider the reply by the Burzynski Sales Consultant, Michael Hamilton, to Michele Marshall, included in her comment here. Michele, whose husband Gary is fundraising for antineoplastons, had written to the Burzynski Clinic after reading negative comments.

Hamilton did not take this opportunity to tell the Marshalls that antineoplastons might not ever be available to Gary, no matter how much money he can raise. He did appear to address concerns, but his answers were confusing, misleading and untruthful.

The four main issues were:

• The publication of trial data (or lack thereof)
• Lawsuits filed by former patients or their bereaved relatives
• Investigations by regulators
• Claims that critics are malicious and make false accusations

Has Burzynski published?

Hamilton seemed to be making the rather implausible claim that all Burzynski’s clinical trials were simultaneously completed just a few months ago and are at various stages of peer review. I find that very difficult to imagine.

Despite the impressively long list of Scientific Publications on the Burzynski Clinic website and despite having treated patients with antineoplastons at his clinic since the 1970s, Burzynski has never published any reliable evidence that these treatments work. There are over sixty Burzynski trials listed at clinicaltrials.gov. Of these, only one has been completed (in 2005) and none have been published. There is a single phase III trial, often mentioned in an attempt to give Burzynski unearned credibility. This was approved in 2010 but never opened for recruitment.

We have seen interim data, conference abstracts and barely relevant foreign studies, but no convincing evidence of efficacy. It has even been pointed out that there are public SEC filings of interim trial data available for us to analyse. SEC filings are financial statements which provide nowhere near enough information to draw any reliable conclusions.

Has Burzynski been sued by patients?

Yes. The following patients (or their families) have all sued Burzynski: Kay Wimberley, Christina Bedient, Gail Middleton, Lilly Louise Adams, Lola Quinlan, Robin Reid (and more recently, Meridee Richert). Hamilton was wrong to claim that these lawsuits were all frivolous and accusatory and all dismissed. For example, Kay Wimberley’s parents, Stanley and Bernice Zabodyn, received a $300, 000 settlement.

Further details of these cases are available from Harris County District Clerk, alongside several others. Together with the patient accounts on the OTHER Burzynski Patient Group site and in the Texas Medical Board complaint (see below), these give the strong impression that patients have been treated negligently and routinely misled.

Investigations by regulators

The Marshalls were told:

Our clinic has had virtually every regulatory agency that is involved in healthcare matters investigate us on a monumental scale dating back to the 1980’s. They continue to do so today. Therefore to call our clinic “a large medical scandal” is preposterous to the point of it being comical if it were not maliciously delivered

The Burzynski Clinic has indeed been investigated time and time again and has always found a way to carry on. This doesn’t mean all was well.

Supporters of the clinic (including the Burzynski Patient Group) still describe antineoplastons as “non-toxic”, yet in 1998, the FDA noted hypernatraemia (excess sodium) in 65% of the 404 patients participating in a study. This may have contributed to the deaths of at least seven patients. The clinic had submitted data on 828 patients, 36 of whom had responded to treatment (according to Burzynski). Eleven of these apparent success stories had died.

The Texas Medical Board’s complaint of 2010 – 2012 gave shocking details of how two patients had been treated. Burzynski was charged with negligence in performing medical services, failure to disclose reasonably foreseeable side effects, failure to disclose reasonable alternative treatments to a proposed procedure or treatment, failure to obtain informed consent, and more. The case was eventually dropped because Burzynski argued he was not responsible for his staff.

The ultimate outcome of the recent FDA inspection remains to be seen.

Claims that critics are malicious and not to be trusted

Hamilton claimed:

A small subgroup of individuals have gone after any and every patient they hear is attempting to get treatment from us with more or less the same false accusations such as those we’ve addressed in this letter.

Attempting to intimidate and discredit critics is one of the main tactics Burzynski supporters use. It is virtually impossible to write about Burzynski without being insulted, accused of twisting the truth, and of “attacking patients”. And it works. It draws critics into squabbles with patients and shifts the focus away from the main issues. This is a tactic which has been used to its fullest by Eric Merola in his latest film Burzynski: Cancer Is Serious Business, Part II.

And let’s remember what brought about the only real criticism of Burzynski we have seen in the mainstream British media so far: it wasn’t the selling of false hope to desperate families, but the clumsy libel threats made by Marc Stephens, a former representative of the clinic.

Attacking critics doesn’t make up for the lack of evidence that antineoplastons work. It doesn’t explain away Burzynski’s many and varied brushes with the law over the last few decades, or any of the shocking details that came to light during those cases. Nor does it explain how or why regulators have allowed the clinic to get away with it for so long. It is indeed a “large medical scandal”.

Burzynski has been misleading patients and slithering away from justice for decades. We need to see decisive action. And we need to see some intelligent, informed journalism.

Further Reading

Should you wish to explore any of these issues in more detail, my Burzynski Master List contains a comprehensive and up to date list of links.