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Burzynski Clinic

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This is an old revision of this page, as edited by Orangemarlin (talk | contribs) at 07:32, 12 December 2011 (→‎Legal issues: A review of the document does not list these allegations. Per WP:BLP, I'm removing it.). The present address (URL) is a permanent link to this revision, which may differ significantly from the current revision.

Stanislaw Rajmund Burzynski (born January 23, 1943 in Lublin, Poland) is a biochemist and a physician. He is founder, president and chairman of 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.

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.[1] 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.[2][3] A 2004 medical review described antioneoplaston treatment as a "disproven therapy".[4] Oncologists have described Burzynski's research on antineoplastons as "flawed" and "scientific nonsense",[5] and independent scientists have been unable to reproduce the positive results reported in Burzynski's studies.[6]

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,[7][8][7] and limits on the sale and advertising of the treatment were imposed as a result. 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.[9] In 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards.[10]

Background

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.[11]

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 1977 Burzynski founded the Burzynski Clinic in West Houston, Texas, where he treats his patients. He founded the Burzynski Research Institute in 1984.[12] Burzynski has authored various research publications on antineoplastons[13] and holds US patents on the treatments.[14].

Antineoplaston therapy

Main article: Antineoplaston

Antineoplaston is a name coined by Burzynski for a group of peptides, derivatives, and mixtures that he uses as an alternative cancer treatment.[15] 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.[1][16][17] 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. Oncologists have described these studies as flawed, with one doctor stating that they are "scientific nonsense".[5] In particular, 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,[6] and Cancer Research UK states that “available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer.”[18]

Legal issues

In 1993, Burzynski was brought to court in Texas for treating patients with a treatment not approved by the Food and Drug Administration (FDA) and for selling antineoplastons in interstate commerce.[7][8] In 1998 the Texas Attorney General, Dan Morales, placed limits on his advertising of antineoplastons[19] and ordered him to cease and desist selling his products, without FDA supervised clinical trials.[9] Burzynski had appealed the limitations on his advertising on the grounds of free speech, but the appeal court upheld the decision, stating that "Burzynski's commercial speech does not concern a lawful activity."[7] Burzynski was also found guilty of fraud in 1994, as he claimed reimbursement from a health insurer for an illegally administered cancer treatment.[9]

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.[20]

In 2010, the Texas State Board of Medical Examiners filed a complaint against Burzynski consisting of several separate allegations.[10]

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.[21] 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".[22] 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."[23] Prior to the debut of "Burzynski", Houston Press correspondent Cory Malisow reviewed the pre-release press kit and, after being refused an interview with Mercola, 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.[24]

Burzynski Clinic's legal 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.[25] 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.[26][27] 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.[28] One of the bloggers who received threatening e-mails from Stephens was Rhys Morgan,[29][30][31][32] a 17-year old high school student from the United Kingdom previously noted for exposing the Miracle Mineral Supplement;[33][34] another was Andy Lewis, a skeptic and publisher of the Quackometer blog.[35][36][37] Cory Doctorow of Boing Boing summarized Stephens' threats and referred to the Streisand Effect.[38]

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”,[39] apologizing for comments made by Stephens to bloggers and for the posting of personal information (e.g. a satellite image of Morgan's house), 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. 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 was sued by the British Chiropractic Association, said that English libel law harms public discussion of science and medicine, and thus public health.[40]

References

  1. ^ a b Antineoplastons National Cancer Institute
  2. ^ "Antineoplastons". CA. 33 (1): 57–9. 1983. doi:10.3322/canjclin.33.1.57. PMID 6401577.
  3. ^ "Antineoplaston Therapy". Retrieved 2011-12-11.
  4. ^ Vickers, A. (2004). "Alternative Cancer Cures: 'Unproven' or 'Disproven'?". CA. 54 (2): 110–8. doi:10.3322/canjclin.54.2.110. PMID 15061600.
  5. ^ a b Langford, Terri (October 1, 1998). "Oncologists criticize methods of controversial cancer treatment". Associated Press.
  6. ^ a b "Overall level of evidence for antineoplastons". National Cancer Institute. Retrieved April 18, 2011.
  7. ^ a b c d Texas State Board of Medical Examiners, Appellant v. Stanislaw R. Burzynski, M.D., Ph.D., Appellee Court judgement
  8. ^ a b 819 F.2d 1301 1987 judgment
  9. ^ a b c No. 93-2071 July 28, 1994. United States Court of Appeals, Fifth Circuit summary judgment.
  10. ^ a b http://www.ministryoftruth.me.uk/wp-content/uploads/2011/11/tmbvsburzynski.pdf
  11. ^ CA: A Cancer Journal for Clinicians, American Cancer Society January/February 1983. Retrieved 09.26.2011
  12. ^ "Burzynski Research Institute Home Page". Retrieved 2007-05-10.
  13. ^ "PubMed Search for "Burzynski SR"". Retrieved November 30, 2011.
  14. ^ 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
  15. ^ 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.
  16. ^ "Lessons from antineoplaston". The Lancet. 349: 741. 1997. doi:10.1016/S0140-6736(97)21011-1.
  17. ^ 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.
  18. ^ "What is antineoplaston therapy?". Cancer Research UK. Retrieved November 25, 2011.
  19. ^ Texas Attorney General's Office (1998-02-10). "Limits Placed on Burzynski's Cancer Treatment" (courtesy copy). Retrieved 2007-05-10.
  20. ^ "2009 Burzynski Research Institute Warning Letter". U.S. Food and Drug Administration. Retrieved 2011-11-22.
  21. ^ "A Texas Doctor With a Possible Cancer Cure". New York Times. 2010-06-04. Burzynski at IMDb Edit this at Wikidata
  22. ^ Ella Taylor (2010-06-01). "QUACK-QUACK Goes Burzynski - Page 1 - Movies - New York". Village Voice. Retrieved 2011-11-25.
  23. ^ Scheib, Ronnie (2010-06-03). "Variety Reviews - Burzynski - Film Reviews - New U.S. Release - Review by Ronnie Scheib". Variety.com. Retrieved 2011-11-25.
  24. ^ 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.
  25. ^ "The worst year of my life: cancer has my family in its grip" Luke Bainbridge. 20 November 2011
  26. ^ Stanislaw Burzynski's public record, Skeptical Humanities
  27. ^ Burzynski clinic the domain of scoundrels and quacks, Pharyngula (PZ Myers)
  28. ^ Template:Cit web
  29. ^ Sample, Ian (November 29, 2011). "The schoolboy blogger who took on a US clinic". The Guardian. Retrieved November 29, 2011.
  30. ^ Malisow, Craig (November 29, 2011). "Burzynski Fanatic Threatens Bloggers 'Round the World". Houston Press. Retrieved November 29, 2011.
  31. ^ Plait, Phil (November 28, 2011). ""Alternative" cancer clinic threatens to sue high school blogger". Discover Magazine. Retrieved November 29, 2011.
  32. ^ 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.
  33. ^ Robbins, Martin (September 15, 2010). "The man who encourages the sick and dying to drink industrial bleach". The Guardian. Retrieved December 1, 2011.
  34. ^ "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.
  35. ^ The Burzynski clinic: another crank tries to intimidate a blogger, Steve Novella
  36. ^ Template:Cit web
  37. ^ Burzynski clinic threatens my family, The Quackometer
  38. ^ BoingBoing
  39. ^ "Press Release". Burzynski Clinic. Retrieved November 29, 2011.
  40. ^ Texan clinic threatens UK bloggers with legal action over criticisms of its treatments Margaret McCartney. BMJ. 2011;343:d7865.

External links

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