The Burzynski Clinic is an American clinic selling an unproven cancer treatment, which has been characterized as harmful quackery. It was founded in 1976 and is located in Houston, Texas, in the United States. It offers a form of chemotherapy originally called "antineoplaston therapy" devised by the clinic's founder Stanislaw Burzynski in the 1970s. Antineoplaston is Burzynski's term for a group of urine-derived peptides, peptide derivatives, and mixtures. There is no accepted scientific evidence of benefit from antineoplaston combinations for various diseases, and the Clinic's claimed successes have not been replicated by independent researchers. The therapy has been rebranded in various ways over the years to mirror fashions in medicine, for example as a kind of "immunotherapy". The therapy is administered through the ruse of running a large numbers of clinical trials, which long-time Burzynski lawyer Richard Jaffe described as "a joke".
The clinic has been the focus of criticism primarily due to the way its antineoplaston therapy is promoted, the costs for people with cancer participating in trials of antineoplastons and problems with the way these trials are run. Legal cases have been brought as a result of the sale of the therapy without regulatory approval.
Burzynski is also the president and founder of a pharmaceutical company, the Burzynski Research Institute, which manufactures his antineoplaston drugs.
Stanislaw Burzynski
Stanislaw Rajmund Burzynski was born in 1943. In 1967, Burzynski graduated from the Medical Academy in Lublin, Poland. In 1968, he received another degree. Burzynski claims this degree was a Ph.D. in biochemistry, but cancer researcher Saul Green found evidence indicating he received a D.Msc. (Doctor of Medical Science) after a one-year project and passage of a test.Smith, p. 136 "He earned his Ph.D. in biochemistry with a thesis entitled 'Investigations on amino acids and peptides in blood serum of healthy people and patients with chronic renal insufficiency'."
Burzynski moved to the United States in 1970 and worked at Baylor College of Medicine until 1977. That year, he established the Burzynski Research Laboratory, where he began administering so-called antineoplaston therapy. Initially, the protocol was administered to 21 patients, but it was later offered more widely as an "experimental" therapy. This opened him up to "charges of unethical conduct and to the suspicion he had become a merchant of false hope", which led to several instances of media controversy.
Burzynski incorporated his pharmaceutical company, the Burzynski Research Institute, in 1984. Reviewers of his scientific papers have disputed the design of the trials and scientific validity of the published results.
In February 2017, following lengthy hearings, the Texas Medical Board recommended Burzynski's medical license be revoked, with the revocation suspended, and a fine of $360,000 for billing irregularities and other violations.
Burzynski was married to Barbara Burzynski, also a physician, until her death in 2021. They had three children, including Gregory Burzynski, a physician. Both Gregory and Barbara became board members of the Burzynski Research Institute and worked at the Burzynski Clinic.
Antineoplaston therapy
Antineoplaston is a name coined by Burzynski for a group of peptides, peptide derivatives, and mixtures that he uses as an alternative cancer treatment. The word is derived from neoplasm. A Reuters fact-check concluded that "Online claims that the drugs are a cancer 'cure' and that any of them has been FDA-approved, are misleading."
Although the therapy is promoted as natural and benign, it is in reality a form of chemotherapy with harmful side effects including severe neurotoxicity.
Though Burzynski first injected patients with his peptides in 1977, antineoplastons have never been approved for general use. The compounds are not licensed as drugs but are instead sold and administered as part of clinical trials at the Burzynski Clinic and the Burzynski Research Institute.
Burzynski stated that he began investigating the use of antineoplastons after detecting what he considered significant differences in the presence of peptides between the blood of cancer patients and a control group. He first identified antineoplastons from human blood. Since similar peptides had been isolated from urine, early batches of Burzynski's treatment were isolated from urine. Burzynski has since produced the compounds synthetically.
The first active peptide fraction identified was called antineoplaston A-10 (3-phenylacetylamino-2,6-piperidinedione). From A-10, antineoplaston AS2-1 was derived – a 4:1 mixture of phenylacetic acid and phenylacetylglutamine.NCI Drug Dictionary, Definitions of antineoplastons A10 and AS2-1 The Burzynski Clinic website states that the active ingredient of antineoplaston A10-I is phenylacetylglutamine.
Since 2011, the clinic has marketed itself as offering "personalized gene-targeted cancer therapy", which has stirred further controversy. David Gorski argues that the concept of "personalised cancer therapy" is "more of a marketing term than a scientifically meaningful description".Dr. Stanislaw Burzynski's "personalized gene-targeted cancer therapy": Can he do what he claims for cancer?, David Gorski, Science Based Medicine According to Gorski, a research oncologist, it appears unlikely that the Burzynski clinic would indeed be able to actually personalise gene-targeting therapies, i.e., "identify who would benefit from specific targeted therapies simply from blood tests," as Burzynski claims, since there are no proven methods to achieve this. Consequently, many reject Burzynski's claim of offering personalized medicine, because in reality his patients are administered untested combinations of various approved and unapproved medications, without a sound rationale for a given combination and without "any concern for potential adverse reactions".David Gorski for Science-Based Medicine. December 12, 2011 Dr. Stanislaw Burzynski, antineoplastons, and the selling of an orphan drug as a cancer cure Quote: " it's not the concept of "personalized gene-targeted therapy" to which I object. It's how Burzynski does it and how he corrupts the very concept through his "everything but the kitchen sink" approach to throwing "targeted" therapies at cancer patients willy-nilly without a systematic rationale for picking them or, it seems, any concern for potential adverse reactions due to combining drugs that have not been tested adequately in combination."Sharon Hill for The Skeptical Inquirer. January 10, 2014 Burzynski Clinic: A Scientifical Year Of Fail
the Clinic refreshed the branding of its offering to include the word "immunotherapy" in an attempt to leverage the popular excitement around cancer immunotherapy. The treatment however remains the same, using antineoplastons.
Clinical trials
According to the National Cancer Institute, as of August 2019, "no phase III randomized, controlled trials of antineoplastons as a treatment for cancer have been conducted. Publications have taken the form of case reports, phase I clinical trials, toxicity studies, and phase II clinical trials", and "for the most part, these publications have been authored by the developer of the therapy, Dr. Burzynski, in conjunction with his associates at the Burzynski Clinic. Although these studies often report remissions, other investigators have not been successful in duplicating these results."
From 1991 to 1995, the NCI initiated multiple phase II trials of antineoplastons. In 1995, after over $1 million had been spent on these trials, they were stopped due to fundamental conflicts between NCI investigators and Burzynski and his employees, notably around Burzynski's insistence on approving all protocols in the NCI trial.
Since the mid-1990s, Burzynski registered some sixty clinical trials of antineoplastons and, in December 2010, a Phase III trial that did not open for patient recruitment. The results of these trials are seldom published in reputable journals, and the few that have been do not confirm the worth of the clinic's treatments. The aim of registering so many trials, according to the 2008 book of long-time Burzynski lawyer Richard Jaffe, was to allow for treating any cancer Burzynski might want to treat.
The largest trial Burzynski registered was called CAN-1 and aimed to cover all clinic patients at that time. Jaffe wrote that CAN-1 was "a joke" of a clinical trial and explained the legal maneuvering:
All trials were paused (no new patients allowed) following a 2013 FDA inspection which found (for the third consecutive time) significant issues with his Institutional Review Board, and, according to reporting published in November 2013, substantial issues with the conduct of both the clinic and Burzynski as principal investigator.
Efficacy
Although Burzynski and his associates claim success in the use of antineoplaston combinations for the treatment of various diseases, and some of the clinic's patients say they have been helped, there is no clinical evidence of the efficacy of these methods. The consensus among the professional community, as represented by the American Cancer Society and Cancer Research UK is that antineoplaston therapy is unproven, and the overall probability of the treatment turning out to be as claimed is low due to lack of credible mechanisms and the poor state of research after more than 35 years of investigation. Antineoplaston treatments have significant known side effects including severe neurotoxicity. Hypernatremia is also a significant risk given the high levels of sodium in antineoplaston infusions.
Independent scientists have been unable to reproduce the positive results reported in Burzynski's studies: NCI observed that researchers other than Burzynski and his associates have not been successful in duplicating his results, and Cancer Research UK states that "available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer."
There is no convincing evidence from randomized controlled trials in the scientific literature that antineoplastons are useful treatments of cancer, and the U.S. Food and Drug Administration (FDA) has not approved these products for the treatment of any disease. The American Cancer Society has stated since 1983 that there is no evidence that antineoplastons have any beneficial effects on cancer and recommended that people not buy these products since there could be serious health consequences. A 2004 medical review described antineoplaston treatment as a "disproven therapy".
In 1998, three oncologists were enlisted by the weekly Washington newsletter The Cancer Letter to conduct independent reviews of Burzynski's clinical trial research on antineoplastons. They concluded that the studies were poorly designed, not interpretable, and "so flawed that it cannot be determined whether it really works". One of them characterized the research as "scientific nonsense". In addition to questioning Burzynski's research methods, the oncologists found significant and possibly life-threatening toxicity in some patients treated with antineoplastons.
In 2018 an article in The Lancet Oncology said "This quackery has continued for 40 years and caused serious harm to desperate patients. Enough is enough!".
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