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En excerpt from the book :
"ALTERNATIVES IN CANCER THERAPY"
by Ross, R.Ph. Pelton, Lee Overholser
Antineoplastons
THE LEAD STORY in the July-August 1990 issue of Oncology News, "Antineoplastons: New Antitumor Agents
Stir High Expectations," described "a completely new type ofantitumor agent that is nontoxic and seems to make
malignant cancer cells revert to normal." (1) Stanislaw Burzynski, M.D., Ph.D., an internationally recognized
physician and biochemist, has been working with these potential anticancer compounds since 1967.
Background
Antineoplastons are protein compounds, mainly peptides and amino acid derivatives, which occur naturally in the
human body. Burzynski first isolated them from human blood and later from urine. Two are now synthesized at the
Burzynski Research Institute in Houston, Texas.
Dr. Burzynski's story is that of another dedicated scientist who has developed what appears to be a promising,
nontoxic, anticancer therapy and has encountered strong resistance from the FDA, the NCI, and powerful members
of the medical industry.
Dr. Stanislaw R. Burzynski was born and educated in Poland. In 1967, at the age of twenty-four, he graduated from
medical school with honors. The following year he earned his doctorate in biochemistry, becoming one of the
youngest people in Poland to hold both degrees.
In medical school, Burzynski developed a passionate interest in the biochemistry of amino acids, the basic protein
units. He was originally interested in determining if differences in amino acid levels in the blood could be used to
diagnose diseases. During his studies, he learned that there were certain unidentified proteins in the blood that were
similar to amino acids.
Burzynski discovered that these previously unidentified compounds were peptides. Peptides, like more complex
proteins, are built from amino acids. Then he found that one of his patients, who was suffering from advanced
prostate cancer, had very low blood levels of these peptides. Tests showed that other cancer patients had similar
peptide deficiencies. Based on this Burzynski has developed a new theory of how the body defends itself against
cancer. (2)
Biochemical Defense System
Dr. Burzynski has proposed that, in addition to our immune system, there is another body defense system, which he
calls the biochemical defense system. The immune system's job is to protect an organism against external invaders,
such as bacteria and other microorganisms. Dr. Burzynski believes that the biochemical defense system constitutes
the body's internal defense system against defective cells.
The active molecules in the immune system are large proteins made up of hundreds to thousands of amino acids.
These proteins help the immune system identify and destroy invading bacteria and viruses. But the primary
components of the biochemical defense system are the peptides and organic acids that Burzynski calls
antineoplastons. The peptides are much smaller molecules, containing fewer than fifty amino acids.
Burzynski's research indicates that the biochemical defense system functions by reprogramming defective cells.
Instead of killing cells, the biochemical defense system works to change the program inside defective cells so that
they begin to function normally again.
In the past, many scientists believed that peptides were simply a type of intercellular debris that resulted from the
breakdown of proteins. Burzynski thinks that the peptides may represent a biochemical communications system in
the body. To him, these peptides can be seen as "molecular words" or pieces of information, and cancer can be
considered a kind of defective information processing.
Antineoplastons
When Burzynski came to the United States, he began work at the Baylor College of Medicine in Texas as a young,
fast-rising star in the field of cancer research. His research was funded by the National Cancer Institute, and he
worked with some of the highly respected cancer researchers at the famous M. D. Anderson Hospital and Tumor
Institute in Houston.
Burzynski focused on studying the little-known peptides in the blood, with the intent of finding out what role they
might play in cancer. At first he used his own blood and that of his friends. However, the blood contained only small
amounts of the peptides, and he constantly needed more blood.
When he noticed that his friends were avoiding him due to his repeated requests for blood donations, Burzynski
looked for another peptide source. Using the sophisticated new technology of free-flow electrophoresis, Burzynski
was able to isolate substantial amounts of the peptides from urine. Eventually he isolated 119 previously unknown
peptides.
Research scientists at the M. D. Anderson Hospital and Tumor Institute tested samples of the isolated peptides in
tissue cultures with cancer cells and normal cells. Some of the peptides had selective activity against cancer cells
without harming normal cells. It is the dream of every cancer researcher to find an agent that selectively inhibits the
growth of cancerous cells without being toxic to normal cells.
One group of the peptides, named antineoplaston A, was effective against a variety of different types of cancer,
including breast cancer, lymphoma, leukemia, and bone cancer. Other anti-neoplastons were found to have more
specific effects. For example, antineoplaston L is named for its specific activity against leukemia, and
antineoplaston 0 is effective against osteosarcoma.
For practical reasons Burzynski concentrated on studying antineoplaston A, because it showed activity against a
variety of cancers. Animal studies of antineoplaston A that gave beneficial results without toxicity led to the
decision to begin human clinical trials.
The Burzynski Clinic
In 1977 Dr. Burzynski lost his funding, and was forced to choose between teaching and research and continuing the
burgeoning private practice that was developing as a result of his cancer research. He decided to turn his back on
academic life and devote his time to his private practice, which he hoped would provide the funds to continue his
cancer research.
Dr. Burzynski has often been criticized by members of the cancer establishment for going into private practice. They
have portrayed him as a clever opportunist, exploiting a mysterious and ineffective cancer "cure" that is bizarre,
expensive, useless, and possibly dangerous. His patients see him as a dedicated physician who cares deeply about
his patients and strongly resent the government's attempt to restrict his research and practice. (5)
Since 1977 Dr. Burzynski has treated thousands of patients with various types of advanced cancer, reporting that his
antineoplaston treatments have saved or prolonged hundreds of lives.
Phase I Clinical Trial
Burzynski has made every effort to play by the rules and comply with the FDA's requirements for testing new drugs.
In 1977 he completed and published the results of what the FDA calls Phase I Clinical Trials. The antineoplastons
tested showed a lack of toxicity while producing notable objective results, including complete and partial
remissions. Twenty percent of the patients survived at least five years. Promising results were obtained with prostate
cancer, bladder cancer, and cases of primary malignant brain tumors. (3)
NCI Study
In 1984 the U.S. National Cancer Institute agreed to test three of Burzynski's antineoplastons. The NCI decided to
use the P388 mouse leukemia model in these tests, over Dr. Burzynski's objections that a model similar to solid
human tumors would be better. At the conclusion of the test the NCI reported that antineoplastons failed to have any
effect.
Dr. Burzynski's doubts about the value of the mouse leukemia model were well founded. In 1983 one of NCI's top
scientists published an article reporting that fourteen other drugs that had previously tested negative in the P388
mouse leukemia model had shown "significant activity" when retested in cell culture assays. (5)
In a talk delivered at the World Research Foundation Congress in October 1990, Burzynski stated that "a number of
these original patients obtained partial and complete remission and some of them, thirteen years later, are well and
alive and free from cancer and, of course, are not taking medicine anymore." (4)
Mechanism of Action
Dr. Burzynski sees cancer as a disease of cellular information processing. Antineoplastons seem to correct the
program inside the cell and can change a cancerous cell back to a normal cell. Dr. Burzynski described a study
carried out at the Department of Pathology for the Department of Defense in Bethesda, Maryland. The study showed
that using antineoplaston AS2-1 in tissue culture caused cancer cells to change back into normal cells after
approximately two to three days. (1)
Healthy cells specialize as they develop. After a specific number of cellular divisions, these specialized cells are
programmed to die. Cancer cells, due to incorrect programming, undergo uncontrolled cellular proliferation. They
keep multiplying without limit until they finally kill the patient. Dr. Burzynski has postulated that antineoplastons
reprogram cancer cells so they behave like normal cells, with a limited life span.
The antineoplastons have to be administered continually and for a long enough time to allow the previously
cancerous cells to go through their life cycle to cellular death. If the therapy is slowed down or stopped too soon, the
cell (which still has an incorrect program) will start behaving like a cancerous cell again.
Since antineoplastons occur normally in humans but are present in low levels in cancer patients, Dr. Burzynski
believes that testing the level of antineoplastons can be used to diagnose cancer in the future.
Clinical Trials
Astrocytoma is a particularly fast-growing type of brain tumor that often occurs in young children. In 1988 Dr.
Burzynski treated twenty patients with advanced-stage astrocytoma, using two different synthetically manufactured
antineoplastons.
The patients received a continuous intravenous infusion of the medications for seven hours. All were treated on an
outpatient basis, receiving the IV drip during the night while sleeping.
Most of the patients improved rapidly; after six weeks the children were able to return to school, and a number of
the adults returned to part-time work. Nearly 80 percent of the patients responded well, and a four-year follow-up
showed that a number of the patients were tumor free and had resumed normal activities.
In one case history presented at the 1990 World Research Foundation Congress, Dr. Burzynski showed MRI slides
of a woman thirty-six years old with a fast-growing astrocytoma. After two months of treatment there was some
noticeable tumor shrinkage, and after six months of treatment the tumor was entirely gone. Dr. Burzynski
emphasized the importance of the finding that there was perfect reconstruction of the brain tissue in the space
occupied by the tumor. Today, five years later, the patient remains symptom free and is enjoying a normal life.
Glioblastomas
Glioblastomas are a very aggressive type of malignant brain tumor. Patients usually don't live longer than nine
months after diagnosis. Dr. Burzynski found that his seven-hour nighttime IV drip was not effective in treating
glioblastomas so he developed a small pump that is attached to the patient's clothing or belt. This pump allows the
medicine to be delivered continuously twenty-four hours a day.
In 1990 Dr. Burzynski presented slides of a ten-year-old boy who was one of the first patients with a brain stem
glioblastoma to be treated with this new method. The location of the tumor made it inoperable. Radiation had
initially shrunk the tumor, but when his parents brought the boy to Dr. Burzynski, the tumor was again growing.
After four weeks on the new, continuous pump-delivery system, MRI scans showed that the tumor was completely
gone and was apparently replaced by normal brain tissue. In the three years following treatment there has been no
tumor recurrence.
The new, continuous delivery system reportedly has produced favorable results in approximately 60 percent of the
patients who have been treated with it.
International Interest
At the Eighth International Symposium on Future Trends in Chemotherapy, held in Italy in March 1988, twelve
different papers on Dr. Burzynski's antineoplastons were presented.
At the Ninth International Symposium on Future Trends in Chemotherapy, held in Geneva, Switzerland, in March
1990, seven papers on antineoplastons were presented, including preclinical and clinical results by researchers from
Japan, Poland, China, and the United States. Dr. Dvorit Samid reported, "Antineoplaston AS2-1 profoundly inhibits
oncogene expression and the proliferation of malignant cells without exhibiting any toxicity toward normal cells."
Dr. Samid also explained that her research with AS2-1 shows that it does not kill cancer cells, but rather it
reprograms them to behave like normal cells. (1)
Dr. Samid concluded that "antineoplaston therapy restores to the body those natural compounds that have anticancer
activity. Because they are natural compounds, the body tolerates them well, and therefore we minimize the problem
of adverse effects. Antineoplastons could be a very valuable, effective and safe approach to cancer therapy."
Burzynski's Fight to Survive
Dr. Burzynski's reputation and his antineoplaston therapy have been under attack since he decided to leave the
traditional medical research establishment.
In a paper published in the Canadian Journal of Sociology the author asks, "Is Stanislaw Burzynski a charlatan or a
major innovator, a common swindler or a courageous pioneer?" The author contends that the opposition to Dr.
Burzynski by the medical profession is apparently not based on scientific evidence. Instead he has been ostracized
for his failure to play by the customary rules of the game, as set by the medical establishment. (6)
International respect for Dr. Burzynski's work continues to grow. Synthetic antineoplastons are being manufactured
in Switzerland, Taiwan, the Philippines, Italy, China, and Japan. In 1989 the government of Poland honored Dr.
Burzynski and gave him a special medal, acknowledging his "achievements in the field of cancer chemotherapy."
Yet in the United States, Dr. Burzynski has had to devote considerable time, effort, and money to fight political and
legal battles brought against him by the FDA, the American Cancer Society, the National Cancer Institute, large
insurance companies, the medical board and health department of Texas, and even the postal service, which charged
him with mail fraud.
Dr. Burzynski's struggles are an example of the difficulties that alternative cancer therapies often encounter in the
United States. For instance, in July 1985 agents from the FDA and the Harris County sheriffs office forcibly entered
Burzynski's clinic and seized eleven filing cabinets containing over 200,000 medical and insurance billing records.
The stated purpose of the raid was suspicion of interstate shipment of antineoplastons. As of March 1993 (almost
eight years later), the FDA had still not brought any charges against Dr. Burzynski, and yet the medical records and
documents have not been returned.
Worldwide Research
Dr. Burzynski's work with antineoplastons is gaining worldwide recognition. Scientists at the Medical College of
Georgia, the Imperial College of Science and Technology of London, the University of Kurume Medical School in
Japan, the University of Turin Medical School in Italy, and the Shandong Medical Academy in China have been
involved in replicating and expanding various aspects of Burzynski's research.
Researchers from the University of Kurume Medical School in Japan and the Burzynski Research Institute have
completed studies showing that low doses of orally administered synthetic antineoplaston A 10 help prevent lung,
breast, and liver cancers in animal models. (7)
Clinical trials with antineoplastons are currently being conducted with patients in Japan, Poland, and the Netherlands
as well as in the United States.
Side Effects
Treatment with antineoplastons has not demonstrated any major side effects or toxicity. A small percentage of
patients has had mild reactions, such as stomach gas, slight change in blood pressure, mild skin rash, and chills or
fever.
Antineoplastons do not appear to interfere with traditional forms of cancer therapy or with other types of alternative
cancer therapy.
Dosage
All patients are treated on an outpatient basis, and patients are taught to administer their own therapy. During the
first several weeks of treatment, patients are usually seen approximately twice weekly and then at intervals of every
four to eight weeks. The brochure for the Burzynski Clinic, located in Houston, Texas, indicates that the minimum
length of time for treatment is from four months to one year.
There are three main routes for administering antineoplaston treatments:
1. Intravenous drip with an ambulatory pump
2. Intravenous injections through a catheter
3. Orally, in capsule form
Dosage levels and the means of administration are determined by the type of cancer and the condition of the
individual patient.