ANTINEOPLASTONS

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Contents:

Overview
Patient experience
An update (October 1998)

Overview

Antineoplastons are peptide fractions derived from human blood and urine. (Peptides are short-chain amino acids.) They have been developed by Stanislaw Burzynski, a Polish biochemist and M.D. who emigrated to the US in 1970 and worked as a researcher and assistant professor at the Baylor College of Medicine until 1977. It was here that he developed his peptides, and formulated his theory that these peptides are important components of the body’s biochemical defense system, which can repair misprogrammed cells. They are not aimed at killing these misprogrammed cells. He feels that these peptides can be useful in all diseases that are caused by such misprogramming, not only cancer. He does not claim to cure cancer, but feels that antineoplastons can help treat it.

Burzynski published his findings, and they were initially well received. But later the political tide at Baylor turned against him when he made certain decisions: to start a clinical practice on the side where he could test antineoplastons on humans (they are human-specific and animal tests present problems) and to refuse an offer to move his research into another department. He lost his grant and was forced to leave.

He decided to undertake a huge task -- to develop his discoveries and to continue his research entirely on his own. He built an impressive state-of-the-art research and manufacturing plant in Houston, his clinic sees many patients every year and is reported to be fairly well run, and he has successfully survived years of ostracism and persecution by establishment medicine. It is quite an amazing story, well told in Michael Lerner’s Choices in Healing. Burzynski has shared his treatment concepts by publishing his results and in various cancer conferences.

In the last 2 years, Burzynski survived another challenge -- he was brought before another grand jury (after 3 or 4 others refused to indict him), was indicted, his clinic was closed for a time, many of his patient records were confiscated in a raid (again), and he faced a trial with many charges against him. The Feds tried to discontinue all his patients on the antineoplastons but the court permitted their treatment to continue. Eventually, most charges against him were dropped, and a mistrial was declared on the remaining charges. His current nightmare is over. (All this was going on at the same time he received an IND and official trials were being planned or in progress.) As you will see, I am somewhat skeptical of his treatment vis-a-vis lymphoma, but I want to say here that in my estimation, the government’s treatment of Burzynski is another particularly shameful and malicious episode in the annals of witch hunts against medical mavericks, a species of McCathyism that has no place in medicine and works against the interest of us patients.

The substance began to be independently tested in Japan, where preliminary trials on mice did show positive results (these mice were exposed to heavy and frequent doses to overcome the fact that the substance does not exist in mice naturally). They then moved to observing the effects on humans, since anti-neoplastons are generally non-toxic. They observed positive effects (arrested tumor growth and better quality of life) when they combined the antineoplastons with cisplatin against metastatic ovarian cancer. In the 90s, more studies have been undertaken in the U.S. and abroad, with some positive results -- reporting that antineoplastons can induce cancer cell differentiation (ie, normalization). Some very encouraging results were also reported from phase 2 trials on brain cancers. The FDA began granting INDs for trials. At present, there are 68 clinical trials listed as ongoing at the Burzynski Research Institute site. For more information, you can visit the Burzynski Research Institute site at http://cancermed.com. This site currently lists 5 lymphoma trials (including one for mantle zone, and one for low grade). Or contact the institute directly at Burzynski Research Institute, Inc., 12000 Richmond, Suite 260, Houston, TX 77082; (713) 597-0111; (281) 597-1166 (FAX). Antineoplastons are usually administered in pill form or intravenous, and some are synthetic, and some natural, derived from human urine. The trials specify treatment duration from 12 to 18 months. The substance is non-toxic at moderate doses -- side effects reported include stomach gas, slight to serious rashes, cracking skin, chills, fever, change in blood pressure, and/or unpleasant body odor during treatment.

There have been reports of lymphoma being one of the cancers that the antineoplastons are particularly useful for. Burzynski reported that in his practice, 80% of NHL tumors were reduced by 50%. His web page contains this account of some older results at his clinic: "From April, 1980 to September, 1993 a total of 73 patients with Non-Hodgkin's lymphoma received the treatment with A10 and AS2-1 injections. 37% of these patients were low grade, 47% intermediate grade, and 16% high grade. The majority of patients had advanced (Stage IV) disease. All patients had received and failed on combination cytotoxic chemotherapy and 12% relapsed from bone marrow transplantation. This group of patients were treated with a different protocol including oral administration, intravenous injections, and infusions. A number of patients received low dosage treatment with cytotoxic chemotherapy agents or alpha-Interferon in addition to the antineoplastons. From these treatment courses, toxicity was relatively nontoxic. Side effects included weakness, sleepiness, febrile reactions, muscle aches, hypokalemia, rash, mild neutropenia, nausea, hypertension, and one patient experienced hematuria. Of 55 patients evaluable for objective response (completed more than 6 weeks of treatment) there was a 53% objective response. 26% of patients achieved a complete response, 6 low grade, 7 intermediate grade, and 1 high grade. The majority of patients had long duration of the response from 2 1/2 to 11 years."

The Mayo clinic began a trial in 1995 of a substance similar to antineoplastons (phenylacetate, which is a metabolite of the amino acid phenylalanine, and composes 80% of antineoplaston A2S-1) on patients with lymphoma and multiple myeloma. And Burzynski’s NHL trials began in 1996. Unfortunately, it will be a while yet before the results are published on either. I ran a Medline search for antineoplastons and lymphoma, but nothing came up. There were 22 items for antineoplastons.

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Patient experience

After I was diagnosed, I ordered a customized report from Ralph Moss, a medical researcher who specializes in surveying the alternative scene. He recommended antineoplastons. I also spoke with a cancer researcher on Compuserve who was in touch with the Burzynski clinic regularly, and who told me that the clinic’s record-keeping is not up to par. She felt that their patient records are in such a poor state (particularly in follow-up) that it is not possible to reach any definite conclusion in such a long lived cancer such as low grade lymphoma. (In cases of brain cancer, where most patients die very quickly, the results are much more obvious.) I also found a NHL patient who was taking antineoplastons, reserving my judgment based on her results (see below). And I spoke with the husband of a woman who was on oral antineoplastons for a long time, getting CT scans every 3 month, with absolutely no results.

I followed the antineoplastons therapy of a young woman with low grade lymphoma manifesting in her abdominal area. When she was diagnosed, she did a lot of research -- traveled to several cancer centers for second and third opinions, and also looked into the alternatives. Her research into antineoplastons as well as conversations with several lymphoma patients who reported positive results convinced her to try this modality. Her insurance covered the (very expensive) treatment.

She was impressed with the clinic. She spent some time in Houston, and attended classes at the clinic where she learned to self-administer the antineoplastons. She opted for the intravenous version, because she heard that it may be more effective. She learned how to run the portable pump that is designed to allow continuous administration of the substance whereever a person goes. Her side effects were mild, mostly just the smell, and occasional nausea.

At first, her tumors were stable. Then there seemed to be evidence of some shrinkage, and she was very hopeful (this was after about 7 months, I think). But when I spoke with her next, she informed me that she discontinued the therapy after 17 months because her tumors began to grow again. I have lost track of her now, but someone who knew her told me she ended up doing chemo.
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I feel uneasy about the efficacy of antineoplastons. The overall research indicates that there is something to this substance, and if I had brain cancer, I would try it. But I will wait for the results of the lymphoma trials to see if the substance is developed enough at this point to warrant NHL patients’ trust. Perhaps it can potentiate chemo or interferon... perhaps it can work for some people while give no results in others. If the results are significant, it could be used as a first line, non-toxic treatment early in the course of the disease.

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An update (October 1998)

I wrote the above file in the winter of 1997. At that time, I gave it a rating of "B for interesting, but let's wait for real results (A in combination with present treatments)." I have since read two more accounts of NHL patients' experience with the antineoplastons. One of these can be found in "Our stories" (see Joanne's story). The other was published in Health magazine, September 1998. (See To Save My Life, by Cari Lynn, p 113). Cari elected antineoplastons after her diagnosis with low grade NHL. She not only followed the treatment faithfully for about 2 years, despite worsening side effects, but also became involved on behalf of Dr Burzynski during his latest legal ordeal. Interestingly, as her involvement deepened, she began to ask some difficult questions regarding Burzynski's former inability or unwillingness to carry out the FDA guidelines regarding testing his substance, as well as about the clinic's poor record-keeping habits. The article is well worth reading, particularly since she neither condemns the treatment, not endorses it. She simply describes her experiences as they unfolded and as her understanding of the complexity of the issues deepened. Cari's tumors shrank at first, and she was very hopeful. But in the end, she was unsuccessful in her antineoplaston treatment, and subsequently underwent chemo and radiolabeled monoclonals.

The Burzynski clinic is currently running a number of new trials, and while no official results for low grade lymphoma have been announced, the word is that about 10% of patients experience shrinkages, some 50% remain stable, and the rest progress. These are not encouraging results. Since low grade lymphomas wax and wane, and up to 30% of patients experience spontaneous remissions, their results are no better than doing nothing would bring. It is my very considered opinion that there is absolutely no reason for NHL patients to spend their life savings going to be treated at the Burzynski clinic.

On the other hand, antineoplastons may find a role in mainstream therapy eventually: the word is that the trial for brain cancer is going well. Who knows, perhaps antineoplastons could some day be of use to patients with CNS involvement, or be incorporated into chemotherapy regimens.

I will end with a quote from Cari Lynn's article: "For 15 years the FDA and Burzynski have chased each other, spending precious time and money on legal battles rather than on contributing to science. Had everyone involved focused on what was truly important, antineoplaston therapy could have been proven or disproven as a viable alternative by now. Instead, the cancer patient loses. And it should not take a brain surgeon, or an oncologist or the commissioner of the FDA, to figure this out."

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Recently, the following was posted on the nhl-other list. I include it here since it elucidates some of the problems with the treatment. (5-12-99) "I have mixed feelings about Burzysnki. Most of staff were nice, some very nice, but the bottom line is if the therapy is going to work for you, it will work fast and dramatically. So I feel they gave us false hope, knowing it probably would not do the trick in the long run, and so we became a revenue cow. That said, I know his therapy has saved some people, especially brain cancer people who would certainily haved died without it. Also, I believe his therapy deserves to be tested with other agents.

I learned, after the fact, that his numbers for lymphoma are not good (despite the rumours) so I would not recommend antineoplastons for anyone with nhl, unless ALL else has failed. The therapy, though non-toxic is NOT easy. It was much harder to deal with than CHOP because day in and day out you are on the pump, changing bags, changing dressing, needing water, electrolytes, getting blood tests, feeling quasi nauseous, tired, mushy minded, spiritless, and if you ever spill the small bag in your house you will have to live with the smell of urine forever."

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Researched and written by Vera Bradova © 1998
Updated 12-15-1998
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