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The Burzynski Clinic is a clinic in Texas, United States founded in 1976 and offering controversial cancer treatment. The clinic is best known for its antineoplaston therapy, a controversial pharmacological treatment using compounds it calls antineoplastons, devised by the clinic's founder Stanislaw Burzynski in the 1970s.

The clinic has been the focus of much criticism due to the way the unproven antineoplaston therapy is promoted, the costs of participating in trials, the claims made for the efficacy, nature and supposed lack of side effects of the treatment, significant problems with the way the trials are run and legal cases brought as a result of the sale of the therapy without board approval, and for other causes.

There is no conclusive evidence to support the antineoplaston theory. Trials initiated in 1993 and sponsored by the National Cancer Institute were closed due to inability to recruit qualifying patients, and a Mayo Clinic study found no benefit. Some sixty phase 2 clinical trials have been registered by Burzynski since the mid 1990s, and one phase 3 trial, but none has been published. Scientific consensus is that antineoplastons are unproven and of little promise.

As Memorial Sloan-Kettering Cancer Center says, "Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans."

Stanislaw Burzynski

Stanislaw Rajmund Burzynski is a biochemist and a physician. He is founder, president and chairman of the controversial Burzynski Research Institute Inc. (Template:OTCBB), based in Houston and Stafford, Texas.

Early life

Burzynski was born on January 23, 1943 in Lublin, Poland. He enjoyed an early rise to prominence — at the time of his graudation, age 24, from the Medical Academy in Lublin, he had published fourteen scientific papers. The following year he earned his Ph.D. in biochemistry.

Burzynski immigrated to the United States in 1970 to pursue his research and – he claimed – to escape political persecution.

In America, 1970 – 1977

Burzynski's early years in America were productive and professionally rewarding. Burzynski became an American citizen, rose to the rank of assistant professor at the Baylor College of Medicine, and received distinguished-citizenship awards; between 1974 and 1976 he authored or co-authored six peer-reviewed journal articles on his cancer research activities. However in 1977 Burzynski found himself unable to secure further funding for his research, beginning what Smith describes as his slow transformation into a "medical outcast".

1977 – present

In 1977 Burzynski left Baylor College and established the Burzynski Research Laboratory, where he administered antineoplaston therapy, initially to 21 patients. Apparently himself convinced of the treatment's efficacy he launched a career selling antineoplaston therapy to patients as experimental treament, immediately opening himself up to "charges of unethical conduct and to the suspicion he had become a merchant of false hope".

Effectively having exiled himself from mainstream medicine, Burzynski pursued a course of promoting his offerings using publicity, and "aggressively out ... terminally ill cancer patients", leading to several instances of media controversy.

Burzynski founded the Burzynski Research Institute in 1984. He has authored various research publications on antineoplastons and holds American patents on the treatments.

Antineoplaston therapy

Antineoplaston is a name coined by Stanislaw Burzynski for a group of peptides, peptide derivatives, and mixtures that he uses as an alternative cancer treatment. The word is derived from neoplasm.

Antineoplaston therapy has been offered in the US since 1984 but is not approved for general use due to lack of clinical evidence. The compounds are not licensed as drugs but are instead sold and administered by as part of clinical trials at the Burzynski Clinic and the Burzynski Research Institute. Although Burzynski and his associates claim success in the use of antineoplaston combinations for the treatment of various diseases, there is no evidence of clinical efficacy of these methods. Oncologists have described Burzynski's studies as flawed, with one doctor stating that they are "scientific nonsense". In particular, independent scientists have been unable to reproduce the positive results reported in Burzynski's studies.

There is no convincing evidence from any randomized controlled trial that antineoplastons are useful for the treatment of cancer. The U.S. Food and Drug Administration (FDA) has not approved antineoplastons for the treatment of any disease. The American Cancer Society has found no evidence that antineoplastons have any beneficial effects in cancer, and it has recommended that people do not spend money on antineoplaston treatments. A 2004 medical review described this treatment as a "disproven therapy".

Burzynski stated that he began investigating the use of antineoplastons after detecting what he considered significant differences in peptides between the blood of cancer patients and a control group. Burzynski first identified antineoplastons from human blood. Since similar peptides had been isolated from urine, early batches of Burzynski's treatment were isolated from urine collected in a Texas park. Since 1980 he has been reproducing his compounds synthetically.

The first active peptide fraction identified was called antineoplaston A-10 (3-phenylacetylamino-2,6-piperidinedione). From A-10, antineoplaston AS2-1, a 4:1 mixture of phenylacetic acid and phenylacetylglutamine, was derived. The website of the Burzynski clinic states that the active ingredient of antineoplaston A10-I is phenylacetylglutamine.

Publications

Burzynski has published a few trials claiming effectiveness for antineoplastons, although reviewers have criticized these trials as being "of a rather unclear design," and the National Cancer Institute reports that no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals. Independent researchers have failed to reproduce the benefits reported by Burzynski. The evidence for use of antineoplaston therapy as a treatment for cancer is still, after more than 35 years, "inconclusive".

Phase II trials

A Phase II trial in patients with anaplastic astrocytoma or glioblastoma multiforme was conducted under the auspices of the National Cancer Institute. Due to recruitment criteria imposed by Burzynski, over the period of two years only nine patients were accrued, six of whom were evaluated for response. All six patients eligible for the study showed evidence of tumor progression after treatment durations of between 16 to 66 days. Neurologic side effects occurred in five patients. The mean time to treatment failure was 29 days. All nine patients died, eight of whom died due to tumor progression. Study authors concluded the study with the following statement: "The efficacy of antineoplastons A10 and AS2-1 remains uncertain. We were unable to document efficacy in any of six assessable patients."

Since Burzynski was forced to administer the treatment only as part of a registered trial, some sixty Phase II trials have been registered with clinicaltrials.gov. No results of any of these trials have been published.

Phase III trial

In December 2010, a planned Phase III trial was registered but it subsequently did not open for patient recruitment.

Efficacy

The consensus among the professional community, as represented by the American Cancer Society and Cancer Research UK among others, is that antineoplaston therapy is unproven, the Burzynski clinic is expensive, 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. At the same time, while the antineoplaston therapy is marketed as being non-toxic and an alternative to chemotherapy, it is in fact a form of chemotherapy and there are known side effects.

The clinical efficacy of antineoplaston combinations for various diseases has been the subject of many such trials by Burzynski and his associates, but these have not produced any clear evidence of efficacy. 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 in cancer and recommended that people do not buy these products since there could be serious health consequences to patients who use this therapy. A 2004 medical review described antioneoplaston treatment as a "disproven therapy."

In 1998, three prominent 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.

Independent scientists have been unable to reproduce the positive results reported in Burzynski's studies: the National Cancer Institute has 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."

The marketing of antineoplaston therapy as "personalized gene-targeted therapy" is also controversial as the treatment is not related to actual gene therapy.

Legal issues

FDA warnings

Burzynski’s use and advertising of antineoplastons as an unapproved cancer therapy were deemed to be unlawful by the U.S. Food and Drug Administration (FDA) and the Texas Attorney General, and limits on the sale and advertising of the treatment were imposed as a result.

In 2009, the FDA issued a warning letter to the Burzynski Research Institute, stating that an investigation had determined the Burzynski Institutional Review Board (IRB) "did not adhere to the applicable statutory requirements and FDA regulations governing the protection of human subjects." It identified a number of specific findings, among them that the IRB had approved research without ensuring risk to patients was minimized, had failed to prepare required written procedures or retain required documentation, and had failed to conduct required continuing reviews for studies, among others. The Institute was given fifteen days to identify the steps it would take to prevent future violations.

Another warning issued in October 2012 notes that the Burzynski Clinic is advertising investigational drugs as being "safe and effective", noting:

Promotion of an investigational new drug is prohibited under FDA regulations at 21 CFR 312.7(a), which states, “A sponsor or investigator, or any person acting on behalf of a 1 sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”

The websites, including the posted press releases and embedded videos, contain claims such as the following that promote Antineoplastons as safe and/or effective for the purposes for which they are being investigated or otherwise promote the drugs. Since Antineoplastons are investigational new drugs, the products’ indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established and are unknown at this time. Promoting Antineoplastons as safe and effective for the purposes for which they are under investigation, by making representations such as those noted above, is in violation of 21 CFR 312.7(a).

— FDA enforcement letter, Original

The letter requires cessation of noncompliant promotional activities, including use of testimonials and promotional interviews with Burzynski himself.

Lawsuits

In 1994, Burzynski was found guilty of insurance fraud for filing a claim for reimbursement by a health insurer for an illegally administered cancer treatment.

In 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards. An appeal against the advertising restrictions on the grounds of free speech was denied on the basis that this was commercial speech promoting an unlawful activity. In December 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards. This suit was eventually withdrawn in November 2012 after the judge allowed Burzynski to repudiate responsibility for the actions of staff at the clinic.

In January 2012, Lola Quinlan, an elderly, stage IV cancer patient, sued Dr Burzynski for using false and misleading tactics to swindle her out of $100,000. She also sued his companies, The Burzynski Clinic, the Burzynski Research Institute and Southern Family Pharmacy, in Harris County Court. She sued for negligence, negligent misrepresentation, fraud, deceptive trade and conspiracy.

Threats to online critics

In November 2011, a music writer and editor for the British newspaper The Observer sought help raising £200,000 to have his 4-year-old niece, who was diagnosed with glioma, treated at the Burzynski Clinic. Several bloggers reported other cases of patients who had spent similar amounts of money on the treatment, and had died, and challenged the validity of Burzynski's treatments. Marc Stephens, identifying himself as a representative of the Burzynski Clinic, sent emails accusing them of libel and demanding that coverage of Burzynski be removed from their sites. One of the bloggers who received threatening e-mails from Stephens was Rhys Morgan, a 17-year old sixth-form student from Cardiff, Wales, at the time, previously noted for exposing the Miracle Mineral Supplement. Another was Andy Lewis, a skeptic and publisher of the Quackometer blog. Cory Doctorow of Boing Boing summarized Stephens' threats and referred to the Streisand Effect.

Following the publicity fallout resulting from the legal threats made by Stephens against the bloggers, the Burzynski Clinic issued a press release on November 29, 2011 confirming that the Clinic had hired Stephens “to provide web optimization services and to attempt to stop the dissemination of false and inaccurate information concerning Dr. Burzynski and the Clinic”, apologizing for comments made by Stephens to bloggers and for the posting of personal information (e.g. a satellite image of Morgan's home), and announcing that Stephens “no longer has a professional relationship with the Burzynski Clinic.”

The story, including the threats against the bloggers, was covered by the BMJ (formerly the British Medical Journal). The chief clinician at Cancer Research UK expressed his concern at the treatment offered, and Andy Lewis of Quackometer and science writer Simon Singh, who had previously been sued by the British Chiropractic Association, said that English libel law harms public discussion of science and medicine, and thus public health.

2010 film, Burzynski – Cancer is Serious Business

The 2010 film, Burzynski, Cancer is Serious Business, directed, written, edited, and narrated by Eric Merola, an art director of television commercials, describes Burzynski's use of antineoplastons and his legal clashes with government agencies and regulators. The Village Voice commented that the movie "violates every basic rule of ethical filmmaking" and that by interviewing only Burzynski's supporters, the film’s producer "is either unusually credulous, or doesn't understand the difference between a documentary and an advertisement". Variety described the film as having the qualities of a "paranoid conspiracy theory" and likened it to the National Enquirer, adding that the film’s explanatory diagrams are "simplistic to the point of idiocy". The review concluded that "despite its infotainment look, Burzynski ultimately proves convincing." Prior to the debut of "Burzynski", Houston Press correspondent Craig Malisow mocked the film’s lack of objectivity, characterizing it as "a puff-piece paean that cherrypicks facts and ignores any criticism", and criticized the project for presenting only Burzynski's side of the story.

References

1. ^ Antineoplastons, Memorial Sloan-Kettering Cancer Center
2. Smith, Murray E. G. (1992). "The Burzynski Controversy in the United States and in Canada: A Comparative Case Study in the Sociology of Alternative Medicine". The Canadian Journal of Sociology. 17 (2). doi:10.2307/3341192.
3. Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.3322/canjclin.33.1.57, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.3322/canjclin.33.1.57 instead.
4. 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'."
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17. ^ Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1177/1534735405285380, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1177/1534735405285380 instead.
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20. ^ "Antineoplastons". CA. 33 (1): 57–9. 1983. doi:10.3322/canjclin.33.1.57. PMID 6401577. Cite error: The named reference "Antineoplastic1983" was defined multiple times with different content (see the help page).
21. ^ Vickers, A. (2004). "Alternative Cancer Cures: 'Unproven' or 'Disproven'?". CA. 54 (2): 110–8. doi:10.3322/canjclin.54.2.110. PMID 15061600.
22. Burzynski, SR (1986). "Antineoplastons: history of the research (I)". Drugs under experimental and clinical research. 12 (Suppl 1): 1–9. PMID 3527634.
23. Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1126/science.8091220, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1126/science.8091220 instead.
24. NCI Drug Dictionary, Definitions of antineoplastons A10 and AS2-1
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26. ^ Buckner, J C; Malkin, M G; Reed, E; Cascino, T L; Reid, J M; Ames, M M; Tong, W P; Lim, S; Figg, W D (1999). "Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma". Mayo Clinic Proceedings. 74 (2): 137–45. doi:10.4065/74.2.137. PMID 10069350.
27. "A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and/or Progressive Optic Pathway Glioma (ID:NCT01260103)". Clinicaltrials.gov. Retrieved 11/19/2012. {{cite web}}: Check date values in: |accessdate= (help)
28. ^ /PharmacologicalandBiologicalTreatment/antineoplaston-therapy "Antineoplaston Therapy". Retrieved 2011-12-11. {{cite web}}: Check |url= value (help)
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30. ^ Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?, David Gorski, Science Based Medicine
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32. Langford, Terri (October 1, 1998). "Oncologists criticize methods of controversial cancer treatment". Associated Press.
33. "The Antineoplaston Anomaly: How a Drug Was Used for Decades in Thousands of Patients, With No Safety, Efficacy Data". The Cancer Letter. September 25, 1998. Retrieved 26 August 2012.
34. Texas State Board of Medical Examiners, Appellant v. Stanislaw R. Burzynski, M.D., Ph.D., Appellee Court judgement
35. 819 F.2d 1301 1987 judgment
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37. Respectful Infuence, ScienceBlogs, November 7, 2012
38. No. 93-2071 July 28, 1994. United States Court of Appeals, Fifth Circuit summary judgment.
39. ^ http://www.ministryoftruth.me.uk/wp-content/uploads/2011/11/tmbvsburzynski.pdf
40. Texas State Office of Administrative Hearings via Stanislaw Burzynski gets off on a technicality, National Geographic ScienceBlogs
41. Cameron Langford. "Cancer Patient Says Doc Used Her as ATM." Courthouse News Service, Jan. 19, 2012
42. "The worst year of my life: cancer has my family in its grip" Luke Bainbridge. 20 November 2011
43. Stanislaw Burzynski's public record, Skeptical Humanities
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45. "Burzynski Clinic? Meet the Streisand Effect". Retrieved 2011-11-28.
46. Sample, Ian (November 29, 2011). "The schoolboy blogger who took on a US clinic". The Guardian. Retrieved November 29, 2011.
47. Malisow, Craig (November 29, 2011). "Burzynski Fanatic Threatens Bloggers 'Round the World". Houston Press. Retrieved November 29, 2011.
48. Plait, Phil (November 28, 2011). ""Alternative" cancer clinic threatens to sue high school blogger". Discover Magazine. Retrieved November 29, 2011.
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External links

• Burzynski Clinic
• American Cancer Society report on Antineoplaston Therapy
• Quackwatch on Burzynski
• Burzynski Research Institute, Inc. FORM 10-K For the fiscal year ended February 28, 2011. Legally-required financial statements and other filings with the Securities and Exchange Commission.

Template:Persondata

• Alternative cancer treatments
• Pseudoscience