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   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 University, 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 investigated:

   * 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.
     [1].
   * 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 [2] and that he
     had done no independent research while in medical school [3].
   * 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." [4]

       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)
     </01QuackeryRelatedTopics/OTA/ota05.html>
   * Limits Placed on Burzynski's Cancer Treatment (1998 news release)
     </04ConsumerEducation/News/burzynski.html>
   * The Antineoplastin Anomaly (Burzynski's "Clinical Trials")
     <burzynski2.html>

       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.

       References

  1. Nizanskowski R. Personal communication to Saul Green, Ph.D., Jan
     15, 1992.
  2. Kleinrock Z. Personal communication to Saul Green, Ph.D., Nov 22
     1993.
  3. Bielinski S. Personal communication to Saul Green, Ph.D., Nov 22,
     1987.
  4. Burzynski S. HEW grant application 1973, item 20 (credentials).
  5. Burzynski SR. Purified antineoplaston fractions and methods of
     treating neoplastic diseases. U.S. Patent No. 4,558,057, 1985.
  6. Burzynski SR. Preclinical studies on antineoplastons AS-2.1 and
     AS-2.5. /Drugs Exptl Clin Res Suppl/ 1, XII, 11-16, 1986.

This article was revised on November 21, 2006.

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