The first impression on meeting Dr. Stanislaw Burzynski of Houston, Texas, is strength, cheerfulness, and calm. He's needed them in double measure. In 1983, the FDA began a harassment of Dr. Burzynski that included the summoning of four grand juries, an indictment, and a trial which the FDA lost.
Growing up in post-World War II Communist Poland, Stanislaw Burzynski seemed headed for an academic career. Studying at the University of Lublin, Burzynski prepared his PhD thesis on a series of blood analyses. Putting his nose to the grindstone, he found that the blood fractions not previously identified were a series of peptides, which are clusters of amino acids, the building blocks of protein. He breezed through the exam and won his PhD Stanislaw Burzynski earned both his MD and his PhD by age 24, the youngest person in Poland to gain both degrees in the 20th century. He came to the United States in 1970 at age 25 with $20 in his pocket - and his analyses of the blood peptides.
Shortly after his arrival in the US, he landed a job as assistant professor at the Baylor College of Medicine in Houston, working under Dr. George Ungar in the Anesthesiology Department. Ungar was interested in the use of peptides for the purpose of enhancing memory. Had Burzynski been given a job in the cancer section, his research would have been to do what he was told to do; under Dr. Ungar, however, he was free to follow his own inclinations. In 1974, he won a grant from the National Cancer Institute (NCI); this enabled him to purchase equipment that did not exist in Poland, and thus to carry his peptide research much further.
In Poland, Burzynski had found 39 peptides; in Houston, he was able to break these down into 119 peptides of 1015 amino acids each. Until Dr. Burzynski came along, peptides had been largely ignored on the presumption that they were waste products, or artifacts, a term scientists sometimes use to pass over what they don't understand. In the eyes of many researchers, Burzynski said, "they were some type of chemical UFO's which some people were seeing and some people were not seeing" (The Cancer Industry, by Ralph Moss, PhD). He had suspected while in Poland that his peptides had anticancer activity after noticing that one of them was almost totally lacking in the blood of a prostate cancer patient. In Houston, he carried out a series of experiments to test for the peptides' biological significance. In 1974, he and Dr. Ungar published an article reporting that they had found the peptides to cause up to 97% inhibition of DNA synthesis and cell division in cancer cells in tissue cultures. In other words, if the DNA were inactivated and the cells did not divide, cancer cells could not spread. He called the peptides Antineoplastons, a term meaning anti-cancer and noted that they were species-specificthose from animals do not work in humans and vice versa.
Burzynski's mentor in Poland was Dr. Marian Mazur, an expert on cybernetics, the theory of messages. Mazur's work led Burzynski to develop a theory that antineoplastons were, in fact, transferring messages to the cells. Where they existed in abundance, there was no cancer. Cancer patients almost invariably had smaller quantities of peptides than healthy persons. Rather than thinking of peptides just as substances, Burzynski says "I looked on them as words, pieces of information" (Lang, 1987). Cancer, then, would be "a disease of information processing", i.e., a virus in a body's computer. Peptides would be the program which, when in abundance, would keep cells from becoming abnormal. Or, if in short supply, when supplied, they would tell errant cells to return to normal. As Dr. Burzynski puts it, "Cancer is really a disease of cells that are not programmed correctly. Antineoplastons simply reprogram them so that they behave normally again." (Burzynski Breakthrough, Tom Elias)
Conducting numerous lab tests on cancer cells, Dr. Burzynski published studies in the 1970's showing that he had found antineoplastons "active against every type of human neoplasm we tested, including myeloblastic leukemia, osteosarcoma, fibrosarcoma, chrondrosarcoma, cancer of the uterine cervix, colon cancer, breast cancer, lung cancer, and lymphoma. All antineoplastons inhibited up to 100% of the growth of neoplastic cells with less inhibitory effect on normal cells" (Moss, op. cit.). In addition, Burzynski reported, effectiveness of the peptides was dose-related; the more given, the better the results, i.e., the opposite of toxic chemotherapy.
In 1976, Dr. Burzynski presented a paper in Anaheim, California at a convention of the Federation of American Societies for Experimental Biology (FASEB). In The Cancer Industry, Dr. Moss reports, "Out of 3,700 papers, Burzynski's became the lead Associated Press (AP) story from the conference:
In 1980, Dr. Burzynski, an eternal researcher, learned how to synthesize antineoplastons. This became possible after the development of mass spectrometry technology. This, in combination with high performance liquid thermatography, enabled him to identify every single molecule. Once that was done, he could make antineoplastons from standard amino acids, a huge breakthrough. Until then, he had had to make arrangements with public places to collect urine, which was then purified and processed into a white powder.
In January 1983, the American Cancer Society (ACS) attacked Dr. Burzynski in their magazine Ca. In their usual language, the ACS stated that it "does not have evidence that treatment with antineoplastons results in objective benefit". Yet, Ralph Moss pointed out in Cancer Industry, "ACS included in its article data which undercut its own conclusions. For instance, it reported that in Burzynski's 1977 study, 'twentyone faradvanced cancer patients were treated with Antineoplaston A' and 'some degree of clinical improvement was noted in 18 of the 21 (86%)'. It also stated that there were 'minimal or no side effects' and presented without criticism a chart showing complete remission in four cases, or 19%, and partial remission in another four."
Side effects of antineoplastons were minor. "About half the patients reported . . . transient rashes, headaches, flushing or dizziness, but generally of only one or two days duration during treatment that lasted from 42 to 872 days" (Moss, op. cit.). No hair fell out, the immune system wasn't destroyed, and the patient was not in danger of dying later from the effects of the treatment. The side effects were small compared to those from treatments already approved by the FDA.
On July 17, 1985, Ron Wolin was taking antineoplastons at Dr. Burzynski's when the FDA raided the office. Waving search and seizure warrants, FDA agents, accompanied by a US marshall, loaded up eleven four-drawer file cabinets and carted them off to the FDA office. Some of the files were urgently needed for treating current cases. Under order of Judge McDonald, Dr. Burzynski was allowed to install a Xerox in the FDA office and to send staff to make copies when needed. Ron Wolin and his companion, Avis Lang, quickly organized a Patients Rights Legal Action Fund which sued the FDA for the return of the files, but the case was lost in lower court. Then a three-judge panel in the US court of Appeals took the side of the FDA, in effect giving it the right to seize doctors' confidential patient records. The court said, "This court . . . must not allow sympathy for the plight of persons suffering from cancer to cause us to interfere hastily with the mission of the FDA." The Supreme Court refused to hear the case. As we enter the 21st century, the FDA still has not returned Dr. Burzynski's files. Doctor-patient files are considered confidential and privileged.
On January 13, 1988, the FDA wrote Dr. Burzynski stating that it now believed antineoplastons had shown anticancer activity, thus acknowledging what had been known for ten years. However, it again denied his request for an IND, demanding more data. During 1988, while the FDA was asking for more data, another 400,000 Americans died of cancer.
In 1989, the NCI began distributing incorrect and false data about antineoplastons based on its ineffectiveness in the P388 mouse test, which by this time the NCI itself had abandoned. Le Trombetta, Dr. Burzynski's spokesperson, wrote the NCI a strong protest.
Elsewhere in 1989, the Polish equivalent of the FDA awarded Dr. Burzynski a special medal for his achievements in the field of cancer chemotherapy. Antineoplastons were indeed chemotherapy, but nontoxic chemotherapy.
While one branch of FDA investigated him, Dr. Burzynski persisted with his IND application at another part of the agency, which also did not make things easy for him. No matter what he submitted on the IND, a request would come back asking for more data. He would painstakingly comply, only to receive another request. The IND application was in the name of the Burzynski Research Institute (BRI), since no pharmaceutical company, large or small, had yet shown interest. If antineoplastons were to be developed, either Burzynski would do it, or the job wouldn't get done. In 1982, Dr. Richard J. Crout, then Director of the FDA's Bureau of Drugs, minced no words when he stated, "I never have and never will approve a new drug to an individual, but only to a large pharmaceutical company with unlimited finances" (Spotlight, January 18, 1982).
There was some good news in 1990. The JulyAugust issue of Oncology News put on its front page an article about a "completely new type of antitumor agent that is non-toxic and seems to make malignant cells revert to normal." The report came from the 9th International Symposium on Future Trends in Chemotherapy, which was held March 2628, 1990, in Geneva, Switzerland. Mutual Benefit Life's Winter 1991 issue of Discoveries in Medicine told its readers:
QUOTE The new agents are called antineoplastons, naturally occurring peptides and amino acid derivatives which were first isolated in human blood and then in urine. They are currently being synthesized by a biotechnology research facility in Texas. Research indicates that there is a marked deficiency of these peptides in cancer patients. Research also indicates that antineoplastons are components of a biochemical defense system. Unlike the immune system which protects us by destroying invading agents or defective cells, the biochemical defense system protects us by reprogramming or normalizing defective cells.
A special session was devoted to antineoplastons, where seven papers were presented, including preclinical and clinical results by researchers from Japan, Poland, China, and the US.
Some of the most exciting preclinical research was reported by Dvorit Samid, PhD, from the Uniformed Services University of Health Sciences in Bethesda, Maryland. She reported that 'Antineoplaston AS2-1 profoundly inhibits oncogene expression and the proliferation of malignant cells without exhibiting any toxicity toward normal cells.' Dr. Samid explained that AS2-1 does not kill cancer cells, rather it reprograms them to behave like normal cells.
The Geneva session was the culmination of 23 years of research by Dr. Stanislaw R. Burzynski, MD, PhD, who first identified these peptides in 1967. UNQUOTE
On October 4, 1991, Dr. Burzynski received a visit from six NCI scientists, who spent a day reviewing the records of seven terminal brain tumor patients treated with antineoplastons. After returning to Washington, they began making favorable noises. In an internal memo, Dr. Michael Friedman, then associate director of NCI's Cancer Therapy Evaluation Program (CTEP), wrote the director of NCI's Division of Cancer Treatment that "Antineoplastons deserve a closer look. It turns out that the agents are well-defined, pure chemical entities . . . The human brain tumor responses are real. We will keep you informed."
In December, Dr. Burzynski made a presentation at the NCI at their invitation. On January 6, 1992, NCI announced that it had indeed found antitumor responses in antineoplastons during its October site visit. NCI also stated that it would sponsor them through the FDA approval process, with clinical trials to start as early as March.
Three weeks after the NCI announcement, the Texas Department of Health filed suit against Dr. Burzynski and his lab, seeking a permanent injunction against the selling and distribution of antineoplastons in Texas. It also asked the court to order that all antineoplastons be destroyed. The Health Department's suit was based on the 1985 change (requested by the FDA) in the Texas Health Law which prohibited the distribution in Texas of any drug not approved by the FDA.
On June 3, 1992, another blow fell. The JAMA published an article on antineoplastons by Dr. Saul Green. There was no mention whatsoever of the many cases where antineoplastons worked, such as the successes reported at the Geneva conference in 1990, as well as the NCI findings announced earlier in 1992. Green suggested that Dr. Burzynski did not really have a PhD, and never bothered to place one phone call to ask about Dr. Burzynski's Polish degree. Green stated that "the FDA would not confirm that it had stated in writing that Burzynski's plant was in conformance with Good Manufacturing Practices." Another phone call would have revealed that Dr. Burzynski had such a letter from the FDA dated October 30, 1985. Green referred to a 1990 NCI test indicating ineffectiveness of antineoplastons, but omitted to note that the test was conducted at 10,000 times less than the recommended dose. Green also omitted to report that in 1992, NCI repeated the tests at the recommended dosage, which then demonstrated anticancer effect.
On March 23, 1995, FDA agents made an unscheduled visit to Burzynski brain tumor patient Domenick Pugliese on Long Island. They had no search warrant but aggressively insisted on searching the house, telling the Puglieses that they had been trying to "get" Burzynski for years. The agents insisted that antineoplastons were ineffective and that Pugliese should seek other treatment. (Health and Healing, op. cit.)
The next morning, Dr. Burzynski was on the CBS Morning Show with three patients in remission. Hours later, the FDA raided his clinic again, once more confiscating boxloads of records and confidential patients' medical records.
On November 15, 1995 Congressman Joe Barton held a hearing on what the FDA was doing with Dr. Burzynski. FDA Commissioner David Kessler was questioned harshly over having convened four grand juries to investigate a nontoxic therapy without being able to find anything wrong. Barton put pressure on Kessler and secured commitments that current Burzynski patients would continue to receive antineoplastons.
One week after the Barton hearings, David Kessler's FDA secured an indictment against Dr. Burzynski on 75 criminal charges, which would put him in jail for 229 years if convicted. Ironically, while the FDA had indicted Burzynski under its new definition of interstate commerce, by this time he actually was shipping antineoplastons across state lines quite legally as part of the clinical trials which another branch of the FDA had approved. The FDA said that when a patient took antineoplastons out of Texas that this put Dr. Burzynski in interstate commerce.
In January 1996, FDA government lawyers sought to bar Dr. Bursynski from treating any of his patients who did not qualify for the FDA clinical trials. When Dr. Burzynski pointed out that patients would die, the FDA attorney called any resulting harm to patients "irrelevant."
Appalled by the "irrelevant" quote, Texas Congressman Barton called another hearing on FDA Abuses of Authority. Under pressure from Barton, Commissioner Kessler agreed to permit Dr. Burzynski to continue treating current patients and to expand the clinical trials. (FDA clinical trials were a long-standing Burzynski goal.)
In April, the FDA again tried to cut off the flow of new patients, suggesting that while the treatment was safe for current patients, it would not be safe for new ones. Dr. Burzynski's team felt that this move was an attempt to strangle him financially by cutting off his cash flow. Then, under continuing Congressional pressure, the FDA lifted its clinical "hold" on May 1, 1996.
The trial opened in January 1997. Numerous government witnesses were there under coercion; the FDA threatened to prosecute them for aiding and abetting Dr. Burzynski's supposed infractions of interstate commerce laws unless they testified. They were little help to the prosecution, for not one would speak against Dr. Burzynski. No one denied having frequently picked up medicine at the clinic and then mailing it to patients, and no one believed this was a crime. Most were aware that FDA regulations permit patients returning from Mexico to bring back medical supplies. Why then, they wondered, was it legal to bring home medicine from Mexico but not from Texas?
On March 3, 1997, Judge Lake declared a mistrial. The jury was hopelessly deadlocked, 6 to 6, on all counts and could not reach a verdict on anything. The judge overruled the jury and threw out the 34 counts of insurance and mail fraud stating "there is no evidence of insurance or mail fraud in this case." The FDA immediately scheduled another trial for May on the remaining interstate commerce charges.
Shortly after the March verdict, Robert Spiller threw out the remaining interstate commerce charges, which were not selling very well to jurors. The remaining charge to be considered at the May trial was contempt of court. In 1983, Judge Gabrielle McDonald had specifically permitted Dr. Burzynski to treat patients in Texas but had forbidden him from engaging in interstate commerce. The FDA charged that since Dr. Burzynski had engaged in interstate commerce by letting people take antineoplastons out of state, he thereby had violated Judge McDonald's order. Therefore, said the FDA, he was in contempt of court, a criminal offense.
The trial lasted three days. It took the jury just two hours to acquit Dr. Burzynski. After the trial, Michael Clark said, "It concerns me as a government employee to see a trend toward government bashing, and this was part of it." (Elias) But the government bashed first. Perhaps a government prosecutor would have a hard time understanding what was expressed by juror Stephanie Shapiro, a Houston attorney, "I found the government behavior offensive. A lot of people felt it was. This was a Big Brother issue." (Elias, op. cit.)
Over the years, Dr. Burzynski has noted that the attitude of the FDA and Official Medicine has swung back and forth like a pendulum, first repressive, then favorable, then back. In June 1998, Dr. Burzynski was invited to speak at a major conference on alternative medicine in Washington where several other presentations on antineoplastons were made. At the end of the conference, Dr. Robert Temple, an FDA official in new drug approval, stated that the time may be coming for the approval of antineoplastons. This was the most favorable comment ever heard from anyone in FDA.
Then the pendulum swung back. In September, 1998, a publication called The Cancer Letter put out a collection of observations on antineoplastons. There were criticisms on the design of Dr. Burzynski's protocols and complaints about hypernatremia, (excess of salt) following administration of antineoplastons. Dr. Temple gave remarks for the publication indicating that he was nowhere near considering approval of antineoplastons. There was one significant difference from the JAMA article of six years before; unlike JAMA, The Cancer Letter printed Dr. Burzynski's rebuttal. He pointed out that excessive salt build-up happens in only a handful of patients and is readily corrected by lowering dosage. As to his protocols, he reminded The Cancer Letter that his protocols were designed by Memorial Sloan Kettering.
Antineoplastons do not work all the time nothing does. But there is enough data and case histories to demonstrate conclusively that these medicines do represent a breakthrough. The bottom line is simple; many of those who have cancer are very low in the chemicals Dr. Burzynski identified, the more effective of which he patented. When these chemicals are given to people with cancer, many of them recover, particularly when they are given before a patient has been treated with radiation and chemotherapy. In the February 1999 Townsend Letter, Dr. Burzynski explains that "antineoplastons represent a type of gene therapy that targets the signal path of errant ras oncogenes and the p53 tumor suppressor gene. Malfunctions in these (ras) genes are believed responsible for up to 60% of all human cancers." Dr. Burzynski has evidence that the signal of the ras gene is interrupted by antineoplastons.
In a better world, a freer world, Dr. Burzynski and researchers dealing with nontoxic therapies simply would be let alone to develop their medicines to the maximum as long as they don't hurt anyone. Hippocrates' first rule Do No Harm is still what counts. If this were the case, Dr. Burzynski would be free to offer another improvement he has developed which appears to be one thousand times more potent than his current medicine and still nontoxic. In lab tests, this product causes cancer cells to revert back to normal and then die at the next normal cell division. To attempt to offer this breakthrough anytime in the near future would mean starting all over again with the FDA. Would they again take six years to approve an IND for this new antineoplaston? Dr. Burzynski does not have the resources to try to push two products through the FDA simultaneously. Meanwhile, one American dies of cancer every minute. It is said that Roman Emperor Nero fiddled while Rome burned. What will history say of the FDA and the NCI?
When there is a free market for all nontoxic therapies, then there can be open competition between antineoplastons, glyoxylide, krebiozen, the Hoxsey treatment, DMSO/hematoxylon, electrical therapies, others presently unknown, and ones to come. In such a free market, we can compare therapies in a new field of study to be called comparative therapeutics. In that free market, radiation and chemotherapy will also compete, and there may well be cases where those harsh therapies are useful and appropriate. Let them all compete on a level field, so a free market can indicate which works best.
Incredibly, against unbelievable odds, the stalwart Stanislaw Burzynski has survived and his therapy continues to help sufferers considered hopeless by conventional medicine. His story is the latest chapter in the war between toxic and nontoxic therapies, in which he has been forced to become a general in a war of attrition. Dr. Victor Penzer wrote of him, "Bright, intelligent, inventive, luckily he is also tough, very tough."
Shontelle Hiron of Mandurah, Australia was chosen to carry the torch into the opening ceremonies of the 2000 Olympic Games in Australia, and Dr. Stanislaw Burzynski was invited to accompany her. In 1993, Shontelle was given three months to live after an inoperable astrocytoma brain tumor was discovered. When her parents learned about Dr. Burzynski, the town of Mandurah helped them raise money to send her to Houston. As soon as antineoplastons were started, the tumor began to shrink and eventually disappeared. So in an emotional and rare moment of public recognition, Dr. Burzynski accompanied the Olympic torch, since he had saved the life of the woman who carried it. (Health and Healing, September 2000)
Many who are aware of Dr. Burzynski's struggle do not realize that politics in healing has been discouraging imaginative pioneers for many years, since the same story, in varying details, has been repeated many times. The same institutions (different people) seem determined to do the same thing over and over; showing no tolerance for nontoxic cancer therapies.
Dr. Burzynski once said: "the fiercest battle always comes just before the end of the war." Is Dr. Stanislaw Burzynski's case the fiercest battle of the long war between toxic and nontoxic therapies? If it is, does this mean that the end of the war is near? If so, who will win?
in Healing: The Suppression and Manipulation of American Medicine