Burzynski Clinic: A Scientifical Year Of Fail

Sharon Hill

Looking back on 2013, what was the most flawed sciencey story of the year? I pick antineoplastons—touted as a miracle cancer cure with little to no

The tagline for this column is “Unmasking ‘scientifical’ claims, sham inquiry, and science impostors in popular culture.” There was no doubt in my mind who
was top of the heap for conducting sham inquiry rather than solid research, and making “scientifical” claims to the detriment of society: Dr. Stanislaw
Burzynski of the Burzynski Clinic and Burzynski Research Institute.

Since 1977, the Burzynski Clinic has been operating as a cancer treatment center in Texas. Its claim (from its website) is that it has “grown to a
world-renowned cancer center that provides advanced and cutting-edge cancer treatments. The clinic is nationally as well as internationally recognized.”

Oh, it's recognized, alright. But not in a positive way, lately. And remember who writes the stuff on these websites. (It's rather biased.)

It All Falls Down

This past year, the media coverage for Dr. B. has been a parade of bad news. Several skeptical blogs and projects have focused on the serious problems with
his clinic and their treatments. The criticism then went mainstream. The popular web magazine Boing Boing featured news of Burzynski's troubles many times over the past two years. In June, BBC's
Panorama show explored the clinic in their show Cancer: Hope for Sale. Forbes
magazine contrasted the Burzynski Clinic
to an actual respected medical facility.

The encircling critics closed in around Burzynski in a big way in November as USA Today took a comprehensive
look at the Burzynski clinic, its claims, patients, and critics that sent Dr. B into a tailspin. Adding to that, information was revealed regarding
violations from an FDA inspection, and patients’ stories emerged from two groups highly critical of the Burzynski methods and tactics—Burzynski Scam and The Other Burzynski Patient Group.

Does Dr. B. merit the negative exposure and “quack” label that he has been given? Let's take a look by examining four threads of the Burzynski machine:

  1. The chemicals: antineoplastons
  2. Clinical trials
  3. “Personalized treatment and gene therapy”
  4. His Institutional Review Board


Burzynski, a medical doctor, not a cancer doctor (oncologist), claims to be able to cure cancer patients that have received less than hopeful prognoses
from their conventional oncologists, with an unapproved, experimental drug treatment called “antineoplastons.”

According to the American Cancer Society webpage, antineoplastons are peptides and amino acids derived from human blood and urine
(3-phenylacetylamino-2,6-piperidinedione, phenylacetic acid, phenylacetylglutamine and phenylacetylisoglutamine). Given orally or injected, the
antineoplastons supposedly replenish the body's supply of these naturally occurring materials that are thought to “induce cancer cells to stop growing and
to develop features that resemble normal cells.” [Source]

Antineoplastons sound impressive—like a miracle treatment. There is a hint of legitimacy to their use from long ago that the Clinic has blown into a
massive promise but, as we will see, has failed to deliver.

The Clinic clearly states that antineoplastons are nontoxic. That is untrue. The most obvious issue that has arisen is hypernatremia—an overload of sodium
in the blood, which will cause serious complications. Seizures and swelling of the brain were also reported. This treatment is a form of chemotherapy. The
body is being overloaded with something that is not normally present. There will be side effects. It is not nontoxic.

The Burzynski Research Institute (BRI) studies and synthesizes antineoplastons. In the forty years that antineoplastons have been known, there has yet to
be definitive evidence that shows this treatment works as described. That's a long time. Where's the evidence?

Where Are The Clinical Trials?

Because antineoplastons have not yet been approved for treatment, Burzynski has only been able to use them as part of a registered clinical trial. While he
published the results of some preliminary trials, there have been no randomized controlled trials (RCTs) done, the gold standard of medical research
studies. Why there have not been RCTs is a highly relevant question that Dr. B. has dodged.

He has not walked the walk or done the work necessary to constitute solid scientific research. His preliminary trials for antineoplastons were problematic. [Source] Over sixty trials (called Phase II trials) have been registered in the
appropriate databases, yet only one was stated to be complete and nothing has been published on any of them. Where are the rest? The trials continue.

The lack of official approval for antineoplaston treatment has prompted Burzynski backers to petition the government to fast track the process for approval
of what they believe is a miracle treatment. This is ironic. Three decades of trials is plenty of time for Dr. B. to have published this work if the
evidence is indeed there. His gigantic missteps should not constitute a crisis on the part of the FDA to provide special approval. In fact, the red flags
of crank-tastic pseudoscience are all over Dr. B. and his antineoplastons theory. One major red flag has been that he charges patients large
amounts of money to participate in his trials. That is rare and arguably unethical.

Many other drug advances for cancer have gone through peer review and been approved for use during this same time period. Why not antineoplastons? Ignoring
all the surrounding controversy about the Clinic, Burzynski has failed society since he has not done the work required to get this supposed miracle drug
treatment approved. Or, could it be that the data is not there to support the conclusions?

Dr. B. was able to avoid having his medical license revoked in Texas and has countered FDA allegations so far. Considering the costs of his treatment and
his lifestyle, it appears he makes a comfortable living off of this
process. [Source] Is
this a case of having a good thing going so why ruin it by being tested? One can't help but see that as a possibility.

For a research institution, the BRI website is remarkably void of useful
information. There is no good description of what the purpose is and most obviously, no references to any research! The “Research and Development”
portion of the site is one small paragraph including this very sciencey bit: “Antineoplastons are molecules that cause cytostasis (stop cancer cell growth)
and apoptosis (cell death) by targeting multiple cellular pathways which cause cancer cells to grow uncontrollably.” [Source] Sounds impressive. Yet, the
BRI has been around since 1984 and they don't appear to have any worthwhile work to list here for nearly thirty years! Very odd.

“Personalized Treatment and Gene Therapy”

Dr. B. did not put all his eggs in one basket when it comes to services at his clinic. Maybe he foresaw the difficulties in using the unapproved
antineoplastons and branched out into what the Clinic calls “personalized treatment and gene therapy.” This is described as using genetic profiles to match
the best forms of treatment to each patient for maximum effect and minimal side effects. Another very sciencey and promising claim! This method of
describing personalized gene therapy is not new and
has been viewed more as a “marketing” term
than as having any real scientific meaning.

Dr. B is not a geneticist. He promotes his methods not in any credible journals or conferences, but in a book by celebrity health activist Suzanne Somers,
in public relations materials, and in documentaries produced by staunch supporters. As noted on the
website Science-Based medicine (by an actual oncologist): “Dr. Burzynski was claiming that he could identify who would benefit from specific targeted therapies simply from blood tests. If he could do this for
real, Burzynski could easily publish in high impact journals like Clinical Cancer Research, the Journal of Clinical Oncology, or another high impact
clinical cancer journal.”

This personalized therapy used by Dr. B. is not clearly described. It could be routine, it could mean nothing. This procedure has not even been shown to
improve cancer treatment outcomes. Yet, he promotes it. Why is he not open and forthcoming? Why not tell the world and serve society at large? Curious,

His Institutional Review Board

I could barely begin to touch on the extensive and damning history of Stanislaw Burzynski, his clinic, and his cult-like proponents. There is
certainly enough info for a tell-all book of how not to look credible in the medical community but still make money. I don't have room to mention
public harassment of those who speak out against Dr. B
(including myself to a small degree), even his own patients. Or that
his lawyer admits very unflattering things
about his own client and methods. Or the patients that have sued him.

This insight into his Institutional Review Board (IRB) might be the
most obvious revelation about the soulless workings of the Clinic. An IRB approves the medical research protocols for an organization or facility. It is a
committee that also serves as an ethical review board and monitors the work to ensure it meets regulations. However, IRBs can fall to conflicts of interest
rather easily; oversight by the FDA is lax. In the situation of the Burzynski structure, we see more than one incident that shows lack of concern for
patients’ safety. For example, Burzynski's IRB was chaired by a member who also serves on the Board of Directors for the Research Institute that is
manufacturing antineoplastons—a clear conflict of interest.

The FDA this year pointed out numerous deficiencies and violations of the work at the clinic that reflects poorly on everyone involved, especially the IRB,
which is supposed to prevent such egregious oversights that caused real and potential harm to patients.
They failed.

Rules are established for a reason. Burzynski and his crew push the limits.
He likes to be seen as an underdog, a maverick, suppressed by big industry and mainstream medical. You can see many other signs of pseudoscience in
Burzynski's methods and modes of operation. When you start dodging the feds, believing the laws don't apply to you, pleading your special case, making
excuses, and show no progress after forty years, something is off. The observant and the critics can't miss the reasonable conclusion: antineoplaston
treatment is quackery.

The growing body of claims from several patients, their families, and medical commentators regarding the research resulted in pressure on the FDA to
investigate the Burzynski Clinic. In June of 2012, a child died during treatment. Upon FDA inspection after this incident, many serious violations were
discovered, prompting the FDA to suspend the process of adding new people to the antineoplaston trials. Regardless, the Clinic remains in operation and Dr.
B. remains in business treating patients by other means.

Finally, one accomplishment worth mentioning may seem trivial but is incredibly valuable in the Burzynski story: the Wikipedia page of Burzynski's Clinic
includes extensive information and citations of his failure to produce evidence, his failure to follow regulations, and the consensus that scientists and
cancer organizations have discredited the doctor and his treatments. When people search for information on Burzynski's antineoplaston treatments, they now
find warnings about his claims and methods. Thanks to the skeptical advocacy of people like Dr. David Gorski, Robert Blaskiewicz, Susan Gerbic and her
project Guerrilla Skepticism, and coverage on blogs and social media all over the world by rational people, a vocal few have changed the way Burzynski is
seen by the public. The behavior of the people behind the Burzynski empire has been unfair to the patients that seek out this treatment. They have acted
unacceptably in the name of scientific research. By highlighting the whole story of the Burzynski clinic, (namely all the warts they are desperately
attempting to hide), we hope to prevent others from buying into the hollow promises of a miracle cure.

Dr. B., you sound sciencey and it all looks legitimate, but it's not.

Sharon Hill

Sharon Hill is a scientific and technical consultant for the Committee for Skeptical Inquiry and creator of DoubtfulNews.com. Read more at SharonAHill.com.