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Burzynski Clinic

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The Burzynski Clinic is a controversial clinic in Texas, United States offering cancer treatment. While the clinic does offer conventional chemotherapy and (via an associate center) radiotherapy, it is best known for its "antineoplaston therapy", a pharmacological treatment using compounds called 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.

Stanislaw Burzynski

Stanislaw Rajmund Burzynski (born January 23, 1943 in Lublin, Poland) 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. Since December 1976, Burzynski has administered peptides and their metabolites, which he calls antineoplastons, as treatments with alleged anti-cancer activity.

In 1967, at age 24, Burzynski graduated from the Medical Academy in Lublin, Poland, with an M.D. degree with distinction. In 1968, he received his doctorate, D.Msc. He was licensed to practice medicine in the United States in 1973 by the Texas State Board of Medical Examiners.[1]

From 1970 to 1972, Burzynski was employed as a research associate at Baylor College of Medicine in Houston, Texas. In 1972, he was named assistant professor of medicine at Baylor and remained in this position until 1977. In May that year, Burzynski founded the Burzynski Clinic in West Houston, Texas, treating his patients there.

He founded the Burzynski Research Institute in 1984.[2] Burzynski has authored various research publications on antineoplastons[3] and holds American patents on the treatments.[4]

Antineoplaston therapy

Main article: Antineoplaston

Antineoplaston is a name coined by Burzynski for a group of peptides, peptide derivatives, and mixtures that he uses as an alternative cancer treatment.[5] These compounds are not licensed as drugs but are instead sold and administered by Burzynski as part of what he calls "clinical trials", that he runs at his own establishments, the Burzynski Clinic and the Burzynski Research Institute in Houston, Texas.[6][7][8]

The consensus among the professional community, as represented by the American Cancer Society[9] and Cancer Research UK[10] 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, but it is itself a form of chemotherapy and there are known side effects.[11]

Controversies

Antineoplaston therapy has been offered in the US for at least 25 years but is not approved for general use due to lack of clinical evidence. Latterly treatment has only been offered as part of a series of a registered clinical trial, for this reason. To date the Burzynski Clinic has registered 60 Phase II clinical trials and one Phase III trial. No results of any of the trials have been published and the phase III trial has yet to recruit any patients.

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.[6] 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.[12][9] A 2004 medical review described antioneoplaston treatment as a "disproven therapy."[13]

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"[14]. In addition to questioning Burzynski's research methods, the oncologists found significant and possibly life-threatening toxicity in some patients treated with antineoplastons.[15]

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,[16] and Cancer Research UK states that “available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer.”[10]

The marketing of antineoplaston therapy as "personalized gene-targeted therapy" is also controversial as the treatment is not related to actual gene therapy.[11]

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,[17][18] and limits on the sale and advertising of the treatment were imposed as a result.Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer? 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.[19] In 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards.[20] 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 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.[21]

In December 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards.[20]

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.[22]

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.[23] 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.[24][25] 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.[26] One of the bloggers who received threatening e-mails from Stephens was Rhys Morgan,[27][28][29][30] a 17-year old sixth-form student from Cardiff, Wales previously noted for exposing the Miracle Mineral Supplement;[31][32] another was Andy Lewis, a skeptic and publisher of the Quackometer blog.[33][34][35] Cory Doctorow of Boing Boing summarized Stephens' threats and referred to the Streisand Effect.[36]

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”,[37] 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.[38]

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.[39] 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".[40] 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."[41] Prior to the debut of "Burzynski", Houston Press correspondent Cory Malisow mocked the film’s lack of objectivity, calling it "a puff-piece paean that cherrypicks facts and ignores any criticism", and criticized it for presenting only Burzynski's side of the story.[42]

References

  1. ^ 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.
  2. ^ "Burzynski Research Institute Home Page". Retrieved 2007-05-10.
  3. ^ "PubMed Search for "Burzynski SR"". Retrieved November 30, 2011.
  4. ^ http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=Burzynski&FIELD1=INNM&co1=AND&TERM2=Stanislaw&FIELD2=INNM&d=PTXT
  5. ^ Block, Keith I. (2004). "Antineoplastons and the Challenges of Research in Integrative Care". Integrative Cancer Therapies. 3 (1): 3–4. doi:10.1177/1534735404263274. PMID 15035867.
  6. ^ a b Antineoplastons National Cancer Institute
  7. ^ "Lessons from antineoplaston". The Lancet. 349: 741. 1997. doi:10.1016/S0140-6736(97)21011-1. PMID 9091754.
  8. ^ Burzynski, S. R.; Janicki, TJ; Weaver, RA; Burzynski, B (2006). "Targeted Therapy With Antineoplastons A10 and AS2-1 of High-Grade, Recurrent, and Progressive Brainstem Glioma". Integrative Cancer Therapies. 5 (1): 40–7. doi:10.1177/1534735405285380. PMID 16484713.
  9. ^ a b /PharmacologicalandBiologicalTreatment/antineoplaston-therapy "Antineoplaston Therapy". Retrieved 2011-12-11. {{cite web}}: Check |url= value (help)
  10. ^ a b "What is antineoplaston therapy?". Cancer Research UK. Retrieved November 25, 2011.
  11. ^ a b Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?, David Gorski, Science Based Medicine
  12. ^ "Antineoplastons". CA. 33 (1): 57–9. 1983. doi:10.3322/canjclin.33.1.57. PMID 6401577.
  13. ^ Vickers, A. (2004). "Alternative Cancer Cures: 'Unproven' or 'Disproven'?". CA. 54 (2): 110–8. doi:10.3322/canjclin.54.2.110. PMID 15061600.
  14. ^ Langford, Terri (October 1, 1998). "Oncologists criticize methods of controversial cancer treatment". Associated Press.
  15. ^ "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.
  16. ^ "Overall level of evidence for antineoplastons". National Cancer Institute. Retrieved April 18, 2011.
  17. ^ Texas State Board of Medical Examiners, Appellant v. Stanislaw R. Burzynski, M.D., Ph.D., Appellee Court judgement
  18. ^ 819 F.2d 1301 1987 judgment
  19. ^ No. 93-2071 July 28, 1994. United States Court of Appeals, Fifth Circuit summary judgment.
  20. ^ a b http://www.ministryoftruth.me.uk/wp-content/uploads/2011/11/tmbvsburzynski.pdf
  21. ^ "2009 Burzynski Research Institute Warning Letter". U.S. Food and Drug Administration. Retrieved 2011-11-22.
  22. ^ Cameron Langford. "Cancer Patient Says Doc Used Her as ATM." Courthouse News Service, Jan. 19, 2012
  23. ^ "The worst year of my life: cancer has my family in its grip" Luke Bainbridge. 20 November 2011
  24. ^ Stanislaw Burzynski's public record, Skeptical Humanities
  25. ^ Burzynski clinic the domain of scoundrels and quacks, Pharyngula (PZ Myers)
  26. ^ "Burzynski Clinic? Meet the Streisand Effect". Retrieved 2011-11-28.
  27. ^ Sample, Ian (November 29, 2011). "The schoolboy blogger who took on a US clinic". The Guardian. Retrieved November 29, 2011.
  28. ^ Malisow, Craig (November 29, 2011). "Burzynski Fanatic Threatens Bloggers 'Round the World". Houston Press. Retrieved November 29, 2011.
  29. ^ Plait, Phil (November 28, 2011). ""Alternative" cancer clinic threatens to sue high school blogger". Discover Magazine. Retrieved November 29, 2011.
  30. ^ Morgan, Rhys (November 20, 2011). "The Burzynski Clinic is using libel laws to silence critics of its cancer treatment". The Guardian. Retrieved November 20, 2011.
  31. ^ Robbins, Martin (September 15, 2010). "The man who encourages the sick and dying to drink industrial bleach". The Guardian. Retrieved December 1, 2011.
  32. ^ "The man who encourages the sick and dying to drink industrial bleach". The Richard Dawkins Foundation for Reason and Science. October 17, 2010. Retrieved December 1, 2011.
  33. ^ The Burzynski clinic: another crank tries to intimidate a blogger, Steve Novella
  34. ^ "Threats From The Burzynski Clinic".
  35. ^ Burzynski clinic threatens my family, The Quackometer
  36. ^ BoingBoing
  37. ^ "Press Release". Burzynski Clinic. Retrieved November 29, 2011.
  38. ^ Texan clinic threatens UK bloggers with legal action over criticisms of its treatments Margaret McCartney. BMJ. 2011;343:d7865
  39. ^ "A Texas Doctor With a Possible Cancer Cure". New York Times. 2010-06-04. Burzynski at IMDb
  40. ^ Ella Taylor (2010-06-01). "QUACK-QUACK Goes Burzynski - Page 1 - Movies - New York". Village Voice. Retrieved 2011-11-25.
  41. ^ Scheib, Ronnie (2010-06-03). "Variety Reviews - Burzynski - Film Reviews - New U.S. Release - Review by Ronnie Scheib". Variety.com. Retrieved 2011-11-25.
  42. ^ Malisow, Craig (2010-06-02). "Stanlislaw Burzynski: New Movie Proves He's A Cancer-Fighting Giant - Houston News - Hair Balls". Blogs.houstonpress.com. Retrieved 2011-11-25.

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