Antineoplaston

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The Antineoplaston-Therapy (ANP) according to Stanisław Burzyński is an unconventional cancer treatment using so-called „antineoplaston remedies“. Burzyński invented the name for a group of peptides. The pseudomedical therapy is known in US since 1977, evidence for efficacy is not available as of yet. Several fatalities are associated with the therapy[1], it is regarded as inappropriate for the treatment of cancer.[2][3] Critics of the method must expect threats by marketers or users of this method.[4]

Stanisław Burzyński

Stanisław Burzyński

Inventor is the physician Stanisław Rajmund Burzyński (born January 23, 1943 in Lublin, Poland) living in Houston, Texas.[5]). Burzyński claims to have achieved both M.D. and Ph.D. degrees in medicine in Lublin in 1967. These claims are dubitable since that university does not have a doctoral program. Additionally, his dissertation cannot be traced.[6][7]

Burzyński migrated to the United States in 1970 and was employed at Baylor University in Houston, isolating peptides from rat brains for three years. He received a licence to practice medicine in USA in 1973 and was awarded a three-year grant to study the effects of urinary peptides as an assistant professor. When the grant was not renewed, Burzyński founded his own clinic in Houston.

In 1994 Burzyński was convicted for tax insurance fraud.[8] The Texas Medical board summoned him for a hearing on April, 11 2012 which will debate the revocation of his medical licence.[9]

Composition of Antineoplastons

Antineoplastons are a group of organic chemical compounds which are usually found in urine and blood. They consist mostly of amino acids, the building blocks of proteins and peptides, compounds made of two or more amino acids.

In 1985 he presented peptides which he called A1, A2, A3, A4 and A5. He detected that A2 had the highest effects on tumor cells and named its active ingredient A10. Chemically speaking, A10 is 3-N-phenylacetyl-amino-piperidine-2,6-dione. He developed the products AS 2.5 and AS 2.1 from this peptide. Burzyński first prepared them from human blood, later from human urine. He developed and patented a manufacturing process for the peptides allowing him to produce them without taking them from human urine. This method is based on synthesis of glutamine and phenylacetyl chloride. Since 1980, the preparation can thus be manufactured synthetically using inexpensive substances commercially available.[10][11]

In alternative medicine, tributyrat PA and PB are known as a kind of preliminary version of Burzyński's antineoplastons.

The Therapy

The therapy is available only from Burzyński at the "Burzynski Clinic" in West Houston, Texas. He offers the treatment as part of studies, since the compounds used are not approved. In order to qualify, a patient must have been non-respondent to standard therapies, or the tumour must have been rated incurable. The compound is either injected or taken orally. If a patient's condition improves due to intravenous adminstration, patients may switch to oral administration. During intravenous administration, antineoplastones must be given constantly, thus requiring a programmable pump which patients carry on them.

Costs

An according therapy is estimated at approximately $ 100,000 per year of treatment. Patients have to pay $ 6,000 prior to the start of treatment and instalments of $ 7,500 to $ 9,000 per month. Most insurance companies consider the therapy unproven and do not reimburse costs.[12][13][14]

Clinical Trials

Burzyński and his assistants tried to prove clinical efficacy of antineoplastons with several clinical studies. The U.S. government register of clinical trials displays 60 entries (as of November 2011) by Burzynski Research Institute.[15] The studies are criticized by oncologists due to "flawed research methods" and rated "scientific nonsense".[16][17] Randomized, controlled surveys could not replicate the Burzyński's results. Between 1991 and 1995, more than a million dollars were spent on independent studies at Mayo Clinic and Memorial Sloan Kettering.[18][19] The studies were cancelled prematurely for ethical reasons because of the method's poor efficacy.[20][21]

In December 2007, FDA granted https://en.wikipedia.org/wiki/Orphan_drug orphan drug] status to Burzyński's concoctions for the treatment of gliomas, a group of brain tumors hard to treat.[19] In 2009, FDA issued a caution against the institute due to violations of regulations for the protection of patients.[22]

An independent review by American Cancer Society also arrived at negative results and recommended patients not to spend money on antineoplaston treatments since there is no evidence of positive effects in treatment of cancer. A 2004 medical review described this treatment as a "disproven therapy".[23].

The products are not approved by FDA and may only be used as part of clinical studies.

The movie "Burzynski - Cancer is Serious Business"

In 2010, Eric Merola (a former director of TV commercials) did a movie "Burzynski - Cancer is Serious Business" which dealt with Burzyński's conflicts with authorities. Critics panned the film as one-sided, poorly produced propaganda promoting Burzyński's treatment. Village Voice commented:

violates every basic rule of ethical filmmaking: Merola interviews only Burzynski's supporters, produces no patient records other than the doctor's own, and offers no credible proof of the drug's success and no data about its side effects, even as he slams chemotherapy and radiation.[24]

Houston Press dishes out derision:

We're not sure which dictionary Merola has consulted for his understanding of the word "objective," but hey -- we don't necessarily think a puff-piece paean that cherrypicks facts and ignores any criticism of a documentary's subject is a truly horrible thing, as long as viewers understand they're just getting one side of the story.[25]

The cases of cured patients presented in the movie meant to serve as evidence of the efficacy of the treatment particularly excel with fragmentary facts. A thorough analysis of facts known in the three cases concludes they provide no proof for the efficacy of antineoplaston therapy.[26]

Versions of this article in other languages

Links

References

  1. http://www.ncahf.org/nl/1998/9-10.html
  2. Goldberg P, The Antineoplaston Anomaly: How a Drug Was Used for Decades in Thousands of Patients, With No Safety, Efficacy Data, The Cancer Letter 1998 vol 24, 36
  3. http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/burzynski2.html
  4. The Burzynski Clinic Threatens My Family., Quackometer, 24. November 2011
  5. Short biography Stanisław Burzyński, accessed November 25, 2011
  6. Stanisław Burzyński and "Antineoplastons", Saul Green, Ph.D., Quackwatch
  7. Comment and Opinion, Burzynski Research Institute, The Millenium Project, Peter Bowditch
  8. United States Court of Appeals, Fifth Circuit summary judgment, July 28, 1994
  9. http://www.burzynskimovie.com/index.php?option=com_content&view=article&id=126 Burzyński moviesite, accessed November 26, 2011
  10. ISBN 1-881025-09-8, Ralph Moss, "The Cancer Industry", 1996
  11. Questions and Answers About Antineoplastons, National Cancer Institute
  12. Aetna Clinical Policy Bulletin, Antineoplaston Therapy and Sodium Phenylbutyrate
  13. Blue Cross/Blue Shield Medical Policy, Antineoplaston Therapy
  14. Big business in Texas, Zeno's Blog, November 26, 2011
  15. Overview: clinical surveys of Burzynski Research Institute
  16. Oncologists criticize methods of controversial cancer treatment, Terri Langford, Associated Press, Oktober 1, 1998
  17. Alternative cancer cures: "unproven" or "disproven"?, Vickers A., PubMed
  18. Managing Social Conflict in Complementary and Alternative Medicine Research: The Case of Antineoplastons, Mitchell R. Hammer, PhD, Wayne B. Jonas, MD, doi: 10.1177/1534735404263448, Integr. Cancer Therapies March 2004 vol. 3 no. 1 59-65
  19. 19.0 19.1 http://www.houstonpress.com/2009-01-01/news/cancer-doctor-stanislaw-burzynski-sees-himself-as-a-crusading-researcher-not-a-quack/
  20. Burzynski SR, Efficacy of antineoplastons A10 and AS2-1, 1999 Mayo Clin. Proc., vol 74 6 Seiten 641-2 PMID 10377942
  21. Buckner JC, Malkin MG, Reed E, Cascino TL, Reid JM, Maes MM, Tong WPY, LIM S, Figg WD: Phase II study of Antineoplaston A10 (NSC 648539) and AS 2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin Proc, 74, 137-145, 1999
  22. Warning letter FDA - Burzynski Research Institute / IRB
  23. Antineoplastons - American Cancer Society on Antineoplastons CA Cancer J Clin 1983;33;57-59, DOI: 10.3322/canjclin.33.1.57
  24. QUACK-QUACK Goes Burzynski, Village Voice, June 1, 2010, accessed November 25, 2011
  25. Stanlislaw Burzynski: New Movie Proves He's A Cancer-Fighting Giant, Houston News, June 2, 2011, accessed November 25, 2011
  26. Burzynski The Movie: Does It Prove The Efficacy of Antineoplastons Against Cancer?, accessed November 25, 2011