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An American Affidavit

Tuesday, July 29, 2014

Dr. Stanislaw Burzynski’s Antineoplastons from Daniel Haley's "Politics in Healing."







































Most of this information was derived from Daniel Haley's book, "Politics In Healing." Ralph Moss's book, "The Cancer Industry", also has a lengthy chapter about Burzynski. All quotes have a bracketed page number by them. Page numbers refer to Haley's book unless otherwise stated. I have not read it yet, but have been told by Ric Schiff that Thomas Elias' recent book, "The Burzynski Breakthrough" is very good. Thank you. Gavin Phillips.

Dr. Stanislaw Burzynski’s Antineoplastons
Burzysnki was born in Poland in 1943. At age 24 Burzynski became the youngest person in Poland in the 20th century to earn two advanced degrees, an M.D. and Ph.D. (Biochemistry). Escaping the communist party he came to America in 1970. He quickly found a job as assistant professor at Baylor College of Medicine in Houston. Burzynski’s interest was peptides found in blood that he had identified. He thought that his peptides had anti-cancer activity because he’d noticed that one of them was missing in the blood of a cancer patient he’d seen in Poland. He called the peptides antineoplastons, which means anti-cancer.
It was difficult obtaining large quantities of blood, so Burzynski turned to human urine to obtain his peptides (“Premarin,” a drug derived from pregnant mares urine, is prescribed today for menopausal woman). Human urine gives important information about the body. As Burzynski says, urine “is not really waste material, but probably the most complex chemical mixture in the human body; it therefore can deliver virtually any information about the body.” (Ralph Moss “The Cancer Industry” p318)
Burzynski developed a theory that the peptides were transferring information to the cells. Burzynski says, “Cancer is really a disease of cells that are not programmed correctly. Antineoplastons simply reprogram them so that they behave normally again.”(p347)
Whilst testing the toxicity of antineoplastons, Burzynski was unable to establish an “LD-50” for antineoplastons because it is so nontoxic. LD-50 is a drug testing term for the dose at which half the test animals die from the drug. Burzynski did find out that his peptides are species specific; human peptides only help humans.
In 1977 Burzynski started his own private practice researching antineoplastons and their effect on cancer. At this time he was able to use his antineoplastons in Texas as long as he didn’t ship them outside of the state. The next step was finding somewhere to test them. Dr. William Mask agreed to run a clinical trial at his hospital in Jacksboro, Texas. The trial was a success. Mask testified in 1985 saying, “There’s no doubt in my mind. I’m convinced that in my 40 years of experience in seeing cancer, this (treatment) is the best.” (p350) Because of his success in Jacksboro, Burzynski was allowed to test his antineoplastons at Houston’s Twelve Oaks Hospital. When Burzynski reported “profound anti-tumor activity without any significant toxicity in 21 patients”. Twelve Oaks halted further testing.

In 1980, with the advent of mass spectrometry, Burzynski found a method of synthetically producing antineoplaston. It was still a fairly expensive (not even close to the cost of cancer causing chemotherapy/radiation therapies) treatment, costing patients around $342 a day. But if mass-produced, Burzynski predicted the cost would be reduced by about 75%. In 1981 ABC’s 20/20 ran a segment on him and the publicity brought new patients and interest from the NCI. The NCI has a standard test it runs when testing the efficacy of a new cancer drug called the “P388” mouse leukemia test. The NCI knew that antineoplastons are species specific and would be ineffective in this test but they insisted on it anyway. As predicted, antineoplastons had no effect in the mouse test.
In 1983 the FDA sued Burzysnki in civil court asking the court to “force permanent cessation of all…scientific and medical work on the development, manufacture, and administration of antineoplastons.”(p352)The FDA’s request was refused. Shortly afterwards Burzynski applied for an Investigational New Drug (IND) application. The FDA turned him down citing the NCI failed mouse test as the reason.
On July 17, 1985, there was an enormous raid by the FDA of Burzynski’s office. They seized over 200,000 medical documents including hundreds of confidential patient files. They literally went through every scrap of paper in his office. For Burzynski to gain access to his own patient files he had to install his own copying machine in the FDA’s offices and give them a day or two’s notice for them to find the file in question. A laborious and time consuming process when peoples lives are on the line. On some occasions they “lost” or misplaced a patients files. One patient, William Cody, demanded his medical records back, which contained vital information to his recovery. Cody says the FDA’s Compliance Officer Kenneth Ewing told him “those records were no longer my property…”  (“The Cancer Industry" p288) Cody went to Ewing’s superior in Dallas and was told he could have his records if he applied to the FDA in Houston. When he did so Ewing told him they could not be found. But later, when Burzynski’s lawyer as a witness before a federal judge called Cody, his records suddenly resurfaced.
The FDA started sending out false information about Burzynski to patients and insurance companies. The judge told them to cease. The FDA proceedings temporarily ran out of steam when a grand jury found no evidence that Burzynski had shipped antineoplastons across state lines.  In 1988 talk show host Jesse Raphaele had Burzynski on her show. The response was so strong that another show was planned. Bu the second show was canceled due to NCI protests.
In September 1988 the Texas State Board of Medical Examiners convened a hearing to decide whether or not to revoke Burzynski’s medical license. This type of proceeding is usually only brought at the behest of patient complaints. There were no complaints in the case of Burzysnki, so the Director brought the charges himself. As Ralph Moss writes in “The Cancer Industry “The board in effect would serve as both prosecutor and judge in the case of Stanislaw Burzynski.” (“The Cancer Industry” p330) But thanks to the efforts of Ron Wolin’s (died 1990) and Avis Lang’s grassroots group, the “Patient Rights Legal Action Fund” (PRLAF), hundreds of letters from Burzynski’s patients and supporters were sent to Executive Director of the board, Dr. Brindley, asking for the board to drop the charges. The mother of a seven-year-old boy with a brain tumor who was responding very well to antineoplastons wrote,
“Please do not do anything that would put our son’s life in jeopardy. Dr. Burzynski is a fine man. I trust him with my son’s life. I would get down on my knees and beg you to allow Dr. Burzynski to continue treating my son if that would help you to decide in our favor. I would do that for Paul’s life.”(“The Cancer Industry” p331)
After a split vote the board postponed making a decision. The NCI followed up in 1989 by distributing false data about antineoplastons based on their worthless mouse test. Meanwhile the FDA constantly demanded more and more data in reference to Burzynski’s IND application. Eventually, after mammoth foot dragging and bureaucratic stalling, they approved an IND for one of Burzynski’s antineoplastons, six years after the filing. Pharmaceutical companies IND’s are usually approved in 30 days.
In 1990 the FDA tried once again to indict Burzynski, subpoenaing thousands of documents and many of his employees. Again the grand jury returned no indictment. In the 1990 July/August issue of Oncology News the cover story was devoted to Burzynski and his antineoplastons. The information was based on a symposium held in Geneva. This led to what seemed like the breakthrough Burzynski was looking for because Elan Pharmaceutical showed interest in sponsoring some of the FDA trials of antineoplaston. Due to the enormous cost and time of the FDA Drug approval process, about 10 years and $200 million (today it’s about $400 million) Burzynski needed the help of a large pharmaceutical company.
Elan would have unrestricted access to all of Burzynski’s research and methodology. He introduced Dvorit Samid to Elan since she had knowledge of antineoplastons after she had carried out some research for him in the late 1980’s. Burzynski had patented some of the chemical identities of his antineoplastons. He had not bothered patenting one of them, identified as the chemical phenylacetate, because it was of little use in treating cancer compared to the other antineoplastons.  Three months later Elan decided against signing a contract with Burzynski stating the reason was because the lack of patent protection for phenylacetate. Dvorit Samid became the recipient of a grant from Elan to research phenylacetate.
In the fall of 1992 the NCI announced that it was going to run clinical trials on phenylacetate with Elan pharmaceuticals, the same treatment that Burzynski had concluded was far inferior to his other antineoplastons.  There was at least one scientist at the NCI who had found that Burzynski’s antineoplastons worked. On May 24, 1993, the NCI’s Chief of Neuroradiology, Dr. Nicholas Patronas, testified at a hearing that was contemplating suspending Burzynski’s license that “antineoplastons are the most effective treatment for brain tumors I have ever seen.”(p363) Patronas was severely reprimanded for supporting Burzynski and later withdrew a paper he was going to give about antineoplastons at a conference in Sweden. 
The NCI began antineoplaston trials in 1994 at the National Institutes of Health (NIH). Ingrid Shultz was one of the first patients enrolled. Dr. Alain Thibault treated her for six weeks.  Curiously, Thibault was also involved in the NCI’s phenylacetate trials. Ingrid shared a room with a woman named Didi. Didi failed to respond to antineoplastons. Ingrid’s husband, Lon, remembers his wife telling him that Thibault was “amazingly ecstatic” (p366) that antineoplastons had failed for Didi. Ingrid also failed to respond to antineoplastons. Lon says, “Ingrid felt Dr.Thibault was tremendously excited and pleased that it was not working.” (p366) Before going home Ingrid met with several doctors who told her “…She needed to go home and die. They emphasized that she needed to die, that it was the proper thing to do.”(p366
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