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"ALTERNATIVES IN CANCER THERAPY"
 
by Ross, R.Ph. Pelton, Lee Overholser

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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.


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