Stanisław Burzyński

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Stanisław Rajmund Burzyński (born January 23, 1943 in Lublin , Poland ) is an American doctor and biochemist of Polish origin. He became known for antineoplastons , a group of peptides and their derivatives that he has been using as an alternative cancer treatment since 1976 . However, the effectiveness of these substances is controversial and most scientific organizations, including the American Food and Drug Administration, describe the treatment as scientifically unproven.

Life

In 1967 Burzyński graduated with honors from the Lublin Medical Academy with a degree in medicine . In the same year he carried out tests on the blood of cancer patients and noticed a difference in the peptides and metabolites compared to those from the blood of healthy people . He now viewed these altered substances as possible triggers for cancer growth. In 1968 he received the doctorate D. Msc. in biochemistry , becoming one of the youngest people to receive both MD and Ph. D. in Poland. From 1970 to 1977 he was a researcher and assistant professor at Baylor College of Medicine in Houston , where his research was partially funded by the National Cancer Institute . During this time he was the author and co-author of 16 publications, five of which dealt with peptides and their effects on cancer. He named these peptides antineoplastons because of their alleged effects on neoplastic or cancerous cells .

Burzyński Clinic

Burzyński Clinic is a clinic in Houston , Texas , USA that was founded in 1977 by Stanisław Burzyński and offers scientifically unproven cancer treatments . To date, more than 8,000 patients have been treated there. Stanisław Burzyński is President of the “Burzyński Research Institute”, which he founded in 1984. There he continues to conduct research on antineoplastons. He also holds numerous US patents on his treatment methods.

Therapy with antineoplastons

Antineoplastons are a group of peptides and their derivatives that Stanisław Burzyński uses for his alternative cancer treatment. It is a form of chemotherapy . The word is derived from neoplasia . He began researching antineoplastons after finding significant differences in the peptides in the blood of cancer patients and a control group. He identified antineoplastons first in human blood and later in urine. Early series of Burzyński's treatments were isolated from urine collected in a Texas park. The compounds have been produced synthetically since 1980.

The first group of peptides that Burzyński identified was called Antineoplaston A-10 (3-phenylacetylamino-2,6-pipedidinedione). Antineoplaston AS2-1, a mixture in the ratio of 4 parts of phenylacetic acid to one part of phenylacetylglutamine, was derived from A-10 . Phenylacetylglutamine is listed as the active ingredient on the Burzyński Clinic website.

Clinical studies

Antineoplaston therapy has been available since 1984 but is not approved for general use due to the lack of clinical evidence of its effectiveness. The chemical compounds are not licensed as drugs, but are administered as part of clinical trials in Burzyński's clinic and research institute . Although Burzyński claims that he has successfully treated a variety of diseases with antineoplaston combinations, there is no convincing evidence of the clinical effectiveness of this method. Oncologists described Burzyński's studies as inadequate. Independent scientists have not been able to replicate the results reported by Burzyński .

There is no scientifically proven evidence in the form of randomized placebo-controlled studies of the effectiveness of antineoplastons in the treatment of cancer. The Food and Drug Administration (FDA) has not approved antineoplastons for the treatment of a single disease. The American Cancer Society found no evidence of beneficial effects for antineoplastons in the treatment of cancer and has recommended that no money be invested in this treatment. A 2004 article describes the treatment as "disproved therapy".

Before 1997, patients at the Burzyński Clinic were simply treated without external observation. Following a mandate from the FDA that limited the delivery of antineoplastons to patients in clinical trials only, Burzyński designed a single large trial that included all of his patients. These activities were published by Burzyński's own attorney, who called the procedure a ruse to continue treating patients with antineoplastons. Furthermore, Burzyński personally created 72 protocols in order to be able to treat every type of cancer that has been treated so far or that Burzyński wanted to treat in the future. Of these studies, only one has been completed and this has not been published.

Publications

Burzyński published some positive studies on the effects of antineoplastons, which, however, were criticized by experts as "of unclear design". The National Cancer Institute reports that to date no positive randomized controlled trials have been published in peer-reviewed scientific journals . The evidence for the use of antineoplastons in cancer therapy is inconclusive, even after more than 35 years.

effectiveness

The scientific consensus, represented by the American Cancer Society and Cancer Research UK, among others, rates antineoplaston therapy as unproven, the Burzyński Clinic as expensive and the likelihood of the effectiveness of this treatment being low. The therapy is advertised as a harmless alternative to conventional cancer therapies, but it is a form of chemotherapy with significant side effects .

Burzyński tried to demonstrate the clinical effectiveness of antineoplaston combinations for a wide variety of diseases in clinical studies, but these have not produced any clear evidence of their effectiveness. The FDA has not approved any of these products for the treatment of any disease. The American Cancer Society has declared since 1983 that this therapy has not been shown to be effective in treating cancer and does not recommend the use of these products because of the serious health risks associated with their users. A medical report from 2004 describes the treatment with antineoplastons as "refuted therapy".

In 1998, three oncologists were commissioned by The Cancer Letter newsletter to conduct independent reviews of Burzyński's research. They came to the conclusion that the studies were poorly designed and not interpretable. They are “so poor that it cannot be determined whether the therapy is really working”. In addition to criticizing Burzyński's research methods, the oncologists found significant, possibly life-threatening poisoning in patients who used this form of therapy.

Legal issues

In Texas , Burzyński had to face trial for performing an FDA-unapproved treatment and selling antineoplastons. In 1998, a restriction was placed on the advertising of antineoplastons. Burzyński lay vocation and justified this with the right to freedom of speech . The Court of Appeal upheld the original judgment on the grounds that his advertisements used non-legal methods. He was also found guilty of fraud when he asked a health insurance company to finance an illegal cancer treatment.

FDA warnings

Burzyńskis use and application of antineoplastons as unapproved cancer therapy has been approved by the Food and Drug Administration and the Texas Attorney General's Office as illegal considered. The sale and promotion of treatment have been restricted.

In 2009, the FDA issued a warning to the Burzyński Research Institute stating that the Burzyński Institutional Review Board, the research institute's ethics committee , had not complied with the relevant state requirements and regulations of the FDA regarding the protection of the test person. The letter identified a number of specific shortcomings, including approving research without ensuring that the risk to patients was minimized. Furthermore, the institute had neither provided the required written records on the working methods and documentation , nor carried out the mandatory continuous reviews of the studies.

Another warning issued in 2012 criticized the fact that the Burzyński Clinic was promoting untested medicines as "safe and effective". The website, including press releases and embedded videos, contains claims promoting antineoplastons as safe and effective for those indications for which they are being reviewed. As a result, the indications , precautionary measures, side effects, dosages and administration forms have not yet been determined. The treatment should therefore not be advertised as safe and effective. The letter requires the discontinuation of non-compliant advertising activities, including testimonials and interviews with Burzyński himself.

In November 2013, the FDA approved the documentation of an inspection carried out between January and March 2013. Among other things, this showed that not all side effects reported by study participants were passed on to the sponsor. Furthermore, the well-being and safety of the patients was not guaranteed. 48 participants received 102 overdoses between January 1, 2005 and February 22, 2013 . Burzyński had not prepared or kept adequate case documentation. The tumor measurements of all study participants before and during treatment were destroyed and not available for review by the FDA. The declaration of informed consent failed to mention additional costs that would arise from participating in the study.

Threats to critics

In November 2011, a record producer and writer for the British newspaper The Observer attempted to raise £ 200,000 in donations to help fund treatment at Burzyński's clinic for his four-year-old niece, who had a brain tumor. Several bloggers reported other cases where similar amounts of money were invested in treatment and patients died. Marc Stephens, who described himself as a representative of the Burzyński Clinic, emailed the authors accused of defamation and requested that their reports on Burzyński be removed from their websites . One of the bloggers was Rhys Morgan, a 17 year old high school student from Wales. Another was Andy Lewis, who criticized the Burzyński Clinic on his “Quackometer” blog.

Documentaries

Two films were made about Stanisław Burzyński and the Burzyński Clinic in 2010 and 2013. Director , screenwriter and speaker was Eric Merola, an art director for television commercials . The first film, "Burzynski, Cancer is Serious Business", received harsh criticism from film critics . According to "The Village Voice" he violates every basic rule of ethical filmmaking and the producer is either unusually gullible or does not understand the difference between documentary and advertising because he only allows Burzyński's supporters to speak. "Variety" described the film as a paranoid conspiracy theory . "Houston Press" criticized the one-sided presentation of the antineoplaston therapy.

In June 2013, BBC Panorama broadcast a documentary about Stanisław Burzyński entitled “Curing cancer or 'selling hope' to the vulnerable?”. The film argues that Burzyński has been exploiting a loophole in the law for 20 years to be able to treat his patients with antineoplastons. He enrolls them in clinical studies so that he does not need a license for his treatment.

In May 2016, director Eric Merola released another documentary entitled: "Burzynski: The Cancer Cure Cover-Up". The film describes Burzynski's 40-year-old alleged odyssey to get his therapy approved. The FDA , the Texas Medical Board and the National Cancer Institute are trying to prevent the treatment from being commercialized because the effect is considered scientifically unproven.

Web links

Footnotes

  1. ^ Stanislaw R. Burzynski. Cancer Control Society
  2. ↑ Burzynski Clinic; Cancer Specialist, Cancer Drug Clinical Trials; Houston, Texas .
  3. ↑ a b c d Antineoplastons National Cancer Institute
  4. ^ Burzynski Research Institute Home Page . Retrieved January 23, 2014.
  5. ↑ Results of Search in US Patent Collection db for: IN / Burzynski AND IN / Stanislaw . USPTO. Retrieved January 23, 2013.
  6. ^ Keith I. Block: Antineoplastons and the Challenges of Research in Integrative Care . In: Integrative Cancer Therapies . 3, No. 1, 2004, pp. 3-4. doi : 10.1177 / 1534735404263274 . PMID 15035867 .
  7. ↑ a b Dr. Stanislaw Burzynski's "personalized gene-targeted cancer therapy": Can he do what he claims for cancer? , David Gorski, Science-Based Medicine
  8. ↑ Shannon Brownlee, Gary Cohen: Trials of a Cancer Doc: Experimental drugs and a 20-year fight with the FDA. Archived from the original on August 20, 2013. In: US News & World Report . 125, No. 13, 1998, pp. 28-30, 32, 35. PMID 10186429 .
  9. ^ SR Burzynski: Antineoplastons: history of the research (I) . In: Drugs under experimental and clinical research . 12, No. Suppl 1, 1986, pp. 1-9. PMID 3527634 .
  10. ^ Eliot Marshall: The politics of alternative medicine . In: Science . tape 265 , no. 5181 , 1994, p. 2000–2002 , doi : 10.1126 / science.8091220 , PMID 8091220 (English).
  11. ^ NCI Drug Dictionary, Definitions of antineoplastons A10 and AS2-1
  12. ↑ a b Burzynski, SR; Janicki, TJ; Weaver, RA; Burzynski, B .: Targeted Therapy with Antineoplastons A10 and AS2-1 of High-Grade, Recurrent, and Progressive Brainstem Glioma. In: Integrative Cancer Therapies . tape 5 , no. 1 , 2006, p. 40-47 , doi : 10.1177 / 1534735405285380 , PMID 16484713 (English).
  13. ^ The Lancet: Lessons from antineoplaston . In: Lancet . 349, No. 9054, 1997, p. 741. doi : 10.1016 / S0140-6736 (97) 21011-1 . PMID 9091754 .
  14. ↑ Terri Langford: Oncologists criticize methods of controversial cancer treatment . October 1st, 1998. Archived from the original on June 11th, 2014 Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. . Retrieved January 24, 2013. @1@ 2Template: Webachiv / IABot / www.highbeam.com 
  15. ↑ a b Overall level of evidence for antineoplastons . National Cancer Institute . Archived from the original on March 28, 2011. Retrieved January 24, 2013.
  16. ↑ a b Antineoplastons . In: CA . 33, No. 1, 1983, pp. 57-9. doi : 10.3322 / canjclin.33.1.57 . PMID 6401577 .
  17. ↑ a b A. Vickers: Alternative Cancer Cures: 'Unproven' or 'Disproven'? . In: CA . 54, No. 2, 2004, pp. 110-8. doi : 10.3322 / canjclin.54.2.110 . PMID 15061600 .
  18. ^ Richard Jaffe: Galileo's Lawyer: Courtroom Battles in Alternative Health, Complementary Medicine and Experimental Treatments . Thumbs UP, Houston, TX 2008, ISBN 978-0-9801183-0-8 , p. 107.
  19. ^ Clinical Trials . Clinicaltrials.gov. Retrieved January 24, 2014.
  20. ↑ Questions and Answers About Antineoplastons . National Cancer Institute. Retrieved January 24, 2014.
  21. ^ A b Antineoplaston Therapy . American Cancer Society. November 22, 2013. Retrieved January 24, 2014.
  22. ↑ What is antineoplaston therapy? . Cancer Research UK . Retrieved January 24, 2013.
  23. ↑ A. Vickers: Alternative Cancer Cures: 'Unproven' or 'Disproven'? . In: CA . 54, No. 2, 2004, pp. 110-8. doi : 10.3322 / canjclin.54.2.110 . PMID 15061600 .
  24. ↑ Terri Langford: Oncologists criticize methods of controversial cancer treatment . October 1, 1998. Archived from the original on November 30, 2011. Retrieved January 27, 2014. 
  25. ^ The Antineoplaston Anomaly: How a Drug Was Used for Decades in Thousands of Patients, With No Safety, Efficacy Data . In: The Cancer Letter , September 25, 1998. Retrieved January 27, 2014. 
  26. ^ SMU Law Review: A Publication of Southern Methodist University School of Law . In: Southern Methodist University School of Law (Ed.): SMU law review . 50, No. 2, 1997, ISSN  1066-1271 , p. 1293.
  27. ↑ Texas State Board of Medical Examiners, Appellant v. Stanislaw R. Burzynski, MD, Ph.D., Appellee Court judgment
  28. ↑ 819 F.2d 1301 1987 judgment
  29. ↑ 2009 Burzynski Research Institute Warning Letter . US Food and Drug Administration. Retrieved January 27, 2014.
  30. ↑ 2012 FDA Enforcement Letter . US Food and Drug Administration. Retrieved January 27, 2014.
  31. ↑ Respectful Insolence , ScienceBlogs, November 7, 2012
  32. ↑ 2013 FDA Inspection Letter . US Food and Drug Administration. Retrieved January 27, 2014.
  33. ^ Luke Bainbridge: "The worst year of my life: cancer has my family in its grip" Luke Bainbridge. November 20, 2011 . Guardian. Retrieved January 27, 2014.
  34. ^ Stanislaw Burzynski's public record , Skeptical Humanities
  35. ↑ Burzynski clinic the domain of scoundrels and quacks , Pharyngula ( PZ Myers )
  36. ↑ Burzynski Clinic? Meet the Streisand Effect . Retrieved January 28, 2014.
  37. ↑ Ian Sample: The schoolboy blogger who took on a US clinic . In: The Guardian , November 29, 2011. Retrieved January 27, 2014. 
  38. ↑ Craig Malisow: Burzynski Fanatic Threatens Bloggers' Round the World . In: Houston Press , November 29, 2011. Retrieved January 27, 2014. 
  39. ^ Phil Plait: "Alternative" cancer clinic threatens to sue high school blogger . In: Discover Magazine , November 28, 2011. Retrieved January 27, 2014. 
  40. ↑ Rhys Morgan: The Burzynski Clinic is using libel laws to silence critics of its cancer treatment . In: The Guardian , November 20, 2011. Retrieved January 27, 2014. 
  41. ↑ The Burzynski clinic: Another crank tries to intimidate a blogger , Steve Novella
  42. ^ Threats From The Burzynski Clinic . Retrieved March 24, 2014.
  43. ^ Burzynski clinic threatens my family , The Quackometer
  44. ↑ Ella Taylor: QUACK-QUACK Goes Burzynski - Page 1 - Movies - New York . Village Voice. June 1, 2010. Retrieved January 25, 2014.
  45. ^ Ronnie Scheib: Variety Reviews - Burzynski - Film Reviews - New US Release - Review by Ronnie Scheib . Variety.com. June 3, 2010. Retrieved January 25, 2014.
  46. ↑ Craig Malisow: Stanlislaw Burzynski: New Movie Proves He's A Cancer-Fighting Giant - Houston News - Hair Balls . Blogs.houstonpress.com. June 2, 2010. Retrieved January 25, 2014.
  47. ^ Richard Bilton: Curing cancer or 'selling hope' to the vulnerable? . Panorama (TV series). August 22, 2013. Retrieved January 27, 2014.
  48. ↑ Burzynski: The Cancer Cure Cover-Up in the Internet Movie Database .
personal data
SURNAME Burzyński, Stanisław
ALTERNATIVE NAMES Burzyński, Stanisław Rajmund (full name)
BRIEF DESCRIPTION American doctor and biochemist of Polish origin
DATE OF BIRTH January 23, 1943
PLACE OF BIRTH Lublin , Poland