Stanislaw Burzynski and "Antineoplastons"
Saul Green, Ph.D.Unlike most "alternative medicine" practitioners, Stanislaw R. Burzynski has published profusely. The sheer volume of his publications impresses patients, but unless they understand what they are reading, they cannot judge its validity. To a scientist, Burzynski's literature contains clear evidence that his data do not support his claims.
Burzynski's Background and Credentials
Burzynski attended the Medical Academy in Lubin, Poland, where he received an M.D. degree in 1967 and an D.Msc. degree in 1968. He did not undergo specialty training in cancer or complete any other residency program. His bibliography does not mention clinical cancer research, urine, or antineoplastons during this period.
In 1970, Burzynski came to the United States and worked in the department of anesthesiology at Baylor College of Medicine, Houston, for three years, isolating peptides from rat brains. (Peptides are low-molecular-weight compounds composed of amino acids bonded in a certain way.) He got a license to practice medicine in 1973 and, with others, received a three-year grant to study the effect of urinary peptides on the growth of cancer cells in tissue culture. The grant was not renewed.
In 1976, with no preclinical or clinical cancer research experience, Burzynski announced a theory for the cure of cancer based on his assumption that spontaneous regression occurs because natural anticancer peptides, which he named antineoplastons, "normalize" cancer cells. Since urine contains lots of peptides, he concluded that there he would find antineoplastons. Less than one year later and based only on these assumptions, Burzynski used an extract from human urine ("antineoplaston A") to treat 21 cancer patients at a clinic he opened. His shingle read, "Stanislaw R. Burzynski, M.D., Ph.D."
Burzynski's claim to a Ph.D. is questionable. When I investigated, I found:
- An official from the Ministry of Health in Warsaw informed me that when Burzynski was in school, medical schools did not give a Ph.D. .
- Faculty members from at the Medical Academy at Lubin informed me that Burzynski received his D.Msc. in 1968 after completing a one-year laboratory project and passing an exam  and that he had done no independent research while in medical school .
- In 1973, when Burzinski applied for a federal grant to study "antineoplaston peptides from urine," he identified himself as "Stanislaw Burzynski, M.D, D.Msc." 
Analysis of Antineoplaston Biochemistry
Tracing the biochemistry involved in Burzynski's synthesis of antineoplastons shows that the substances are without value for cancer treatment.
By 1985, Burzynski said he was using eight antineoplastons to treat cancer patients. The first five, which were fractions from human urine, he called A-1 through A-5. From A-2 he made A-10, which was insoluble 3-N-phenylacetylamino piperidine 2,6-dione. He said A-10 was the anticancer peptide common to all his urine fractions. He then treated A-10 with alkali, which yielded a soluble product he named AS-2.5. Further treatment of AS-2.5 with alkali yielded a product he called AS-2.1. Burzynski is currently treating patients with what he calls "AS-2.1" and "A-10."
In reality, AS-2.1 is phenylacetic acid (PA), a potentially toxic substance produced during normal metabolism. PA is detoxified in the liver to phenylacetyl glutamine (PAG), which is excreted in the urine. When urine is heated after adding acid, the PAG loses water and becomes 3-N-phenylacetylamino piperidine 2,6-dione (PAPD), which is insoluble. Normally there is no PAPD in human urine.
What Burzynski calls "A-10" is really PAPD treated with alkali to make it soluble. But doing this does not create a soluble form of A-10. It simply reinserts water into the molecule and regenerates the PAG (Burzynski's AS-2.5). Further treatment of this with alkali breaks it down into a mixture of PA and PAG. Thus Burzynski's "AS-2.1" is nothing but a mixture of the naturally occurring substances PA and PAG.
Burzyski claims that A-10 acts by fitting into indentations in DNA. But PAG is too big a molecule to do this, and Burzynski himself has reported that PAG is ineffective against cancer [5,6].
PA may not be safe. In 1919, it was shown that PA can be toxic when ingested by normal individuals. It can also reach toxic levels in patients with phenylketonuria (PKU); and in a pregnant woman, it can cause the child in utero to suffer brain damage.
Burzynski has never demonstrated that A-2.1 (PA) or "soluble A-10" (PA and PAG) are effective against cancer or that tumor cells from patients treated with these antineoplastons have been "normalized." Tests of antineoplastons at the National Cancer Institute have never been positive. The drug company Sigma-Tau Pharmaceuticals could not duplicate Burzynski's claims for AS-2.1 and A-10. The Japanese National Cancer Institute has reported that antineoplastons did not work in their studies. No Burzynski coauthors have endorsed his use of antineoplastons in cancer patients.
These facts indicate to me that Burzynski's claims that his "antineoplastons" are effective against cancer are not credible.
For Additional Information
- Office of Technology Assessment Report (1990)
- Limits Placed on Burzynski's Cancer Treatment (1998 news release)
- The Antineoplastin Anomaly (Burzynski's "Clinical Trials")
- The OTHER Burzynski Patient Group (analysis of patient outcomes)
- FDA Notice about Improper Promotional Claims (2012)
- Burzynski Escapes Disciplinary Action (2012)
About the Author
Dr. Green (1925-2007) was a biochemist who did cancer research at Memorial Sloan-Kettering Cancer Center for 23 years. He consulted on scientific methodology and had a special interest in unproven methods. This article was adapted from his presentation at the American Association for Clinical Chemistry Symposium in Atlanta in July 1997.
- Nizanskowski R. Personal communication to Saul Green, Ph.D., Jan 15, 1992.
- Kleinrock Z. Personal communication to Saul Green, Ph.D., Nov 22 1993.
- Bielinski S. Personal communication to Saul Green, Ph.D., Nov 22, 1987.
- Burzynski S. HEW grant application 1973, item 20 (credentials).
- Burzynski SR. Purified antineoplaston fractions and methods of treating neoplastic diseases. U.S. Patent No. 4,558,057, 1985.
- Burzynski SR. Preclinical studies on antineoplastons AS-2.1 and AS-2.5. Drugs Exptl Clin Res Suppl 1, XII, 11-16, 1986.
This page was revised on January 19, 2013.