‘The Burzynski Breakthrough’ and ‘Burzynski: the Movie’
Thomas D. Elias, author of The Burzynski Breakthrough, believes that the U.S. government and pharmaceutical industry have for decades used all the means at their disposal to quash the most promising cancer treatment in the world.
If this story sounds far-fetched, consider Elias’s background. After taking a master’s degree from Stanford he was the West coast editor for Howard Scripps news service for 15 years. His syndicated columns now appear in 70 newspapers.
Elias is a veteran journalist with a nose for a story. He questions everything. When he first heard about Burzynski, he wanted nothing to do with the story. He explains, “As a reporter, I had been confronted on a regular basis by cranks claiming to have unique or scandalous stories. They virtually never pan out.” Burzynski’s patients prevailed upon him though, and so Elias took another look and did a few stories. He has published millions of words in his lifetime, but only two topics have ever compelled him to make sure a full book length treatment got into the public record: the O.J. Simpson trial and Dr. Stanislov Burzynski’s antineoplaston treatment for cancer.
Burzynski was born in 1943 in Lublin, Poland which was occupied by the Nazis during World War II and quickly turned communist in the years after the war. His father was harassed and jailed for teaching Jews, and his older brother, Zygmunt, joined the resistance and died from a gunshot wound.
Young Stan always excelled in academic pursuits, especially science, and upon graduation from secondary school he was sent to medical school. Burzynski became an assistant to biochemist researchers working in the developing field of chromatography, which used chemicals to produce colors that determine the molecular structure of a substance.
They were researching peptides, a class of very small molecules which are building blocks for larger molecules such amino acids and proteins. Burzynski’s teachers were interested in agricultural applications, basically the potential to develop better food supplies. While it was assumed that these classes of molecules also had important functions in the body, exactly what those functions were was still being worked out, and in fact is still being researched to this day as the biochemistry of the human body continues to amaze scientists.
Burzynski had a natural talent for isolating the peptides using the tricky art of chromatography and had soon identified 39 substances that seemed to be uncataloged. He’d later learn that some British researchers had noted a few of them, but nobody seemed to think these particular ones were significant, or worth studying further.
Burzynski needed an interesting topic for his doctoral thesis, so he kept working on the peptides, and noticed that they appeared less frequently in the blood and urine of cancer patients. He surmised that giving them to cancer patients might help them. He determined to explore the possibilities, not then understanding that this quest would become a calling and a lifelong battle with the medical establishment and government authorities.
Dr. Burzynski was one of the two youngest people in Poland to receive M.D. and Ph.D. degrees. He was recruited by the communist party and promised a prestigious university position, but turned it down. Authorities sought to quash his independence by drafting him into the army to be sent to North Vietnam to aid the Vietcong, the fate of many Polish doctors.
An influential Polish scientist intervened and Burzynski mysteriously received a passport, which was nearly impossible to get. He left Poland hastily and the military police showed up at his home hours later. He carried just $20 and documentation about the peptides, arriving in New York in the fall of 1970.
Upon arriving in the United States, Burzynski quickly landed a job in Houston at Baylor College of Medicine, which in those days was receiving large grants for its pioneering research in anesthesiology and heart transplants. Some of the money also funded research on peptides effects on the brain and memory. Baylor had some of the best equipment in the world for chromatography. Burzynski’s expertise was welcomed, and he worked out an agreement where he was allowed to spend half his time working on the peptides he’d discovered.
With a more sophisticated laboratory, Burzynski now was able to break the substances down even more precisely into 119 different molecules. The nearby MD Anderson cancer center had just begun receiving huge infusions of federal funding, and Burzynski managed to work out an arrangement with colleagues there, so he could test the peptides on cancer cells grown in labs. Sure enough, they found a few that shrunk tumors, and began publishing the results in medical journals.
In these early years of research he met his wife, Barbara, a fellow Polish immigrant and medical doctor. They have been inseparable since, and occupy side by side offices to this day.
When President Nixon announced a “war on cancer” Burzynski applied for a grant from the National Cancer Institute, and with the help of influential allies at M.D. Anderson, his research was funded from 1974-1977. His understanding of the substances was refined, and he saw anti-cancer properties with some, while eliminating others. An experiment on breast cancer cells produced very promising results, and then he found a few peptides that seemed to work on every kind of cancer cell they encountered. He and his colleagues continued to publish results and were becoming convinced that the body had a biochemical defense system. A small group of polypeptides seemed to act as controllers that could simply turn off the malignant growth of cancer cells. Burzynski dubbed them antineoplastons because “neoplasia,” the Greek word meaning “new growth,” was the technical term for cancer.
Burzynski was excited that it was time to start trying antineoplastons on people, but he soon encountered major obstacles. Two hospitals would not grant him permission to conduct a trial on humans, and his time was consumed filing paperwork and trying to work out legal issues. Meanwhile, internal politics at Baylor caused some high level personnel changes, and his projects were suddenly out of favor. At this critical juncture, Marian Mazur, a Polish scientist who had helped Burzynski in their homeland, suddenly turned up in Houston and stayed at his house. Mazur suggested that if his treatment was good, income from patients alone would support the work. Just a year earlier Burzynski would never have dreamed of going into business for himself, especially since in Poland academics despised business people. However, after a hospital finally did agree to sanction Burzynski’s trial, he struck out on his own with only $5000, a pittance compared to the funding he’d been receiving, which was necessary to do the extensive research.
Human urine was the only source for the necessary peptides, so Burzynski collected it from the hospital and several other sources where friends helped him out. Churches, seminaries, and convents in the Polish-American Catholic community contributed, and even the Texas prison system. About 10 gallons for each patient for each day of treatment was needed to get the necessary peptides. The majority of his first trial of 22 patients achieved either significant tumor reduction or stabilization. Four saw their tumors completely dissipate.
Burzynski garnered some national and international attention with the papers he continued to publish. Mass spectrometry was becoming more widely available in the early 1980s, making it possible for Burzynski to begin the difficult work of synthesizing the peptides so they could be manufactured instead of extracted from urine. He began patenting the antineoplastons in 1984. At first it was all funded by Burzynski’s part time job in a private practice and loans he secured. As word began to get out, more and more patients came.
Dr. Burzynski’s has now been working on antineoplastons for more than three decades. He’s been reversing cancers without side effect, refining the protocols for different kinds of cancers and the treatment methods for specific patient cases, all the while publishing larger studies that establish the validity of antineoplaston treatment. He now oversees a 46,000 square foot research institute that employs five engineers, four chemists, three pharmacists, four medical doctors, and four researchers.
Some aspects of Burzynski’s work still cause general astonishment, and skeptical declarations that it couldn’t possibly be true. Whereas chemotherapy and radiation treatments have severe side effects, there are none with antineoplastons since they are just a naturally occurring substances in the body. Antineoplastons have reversed some of the nastiest cancers, such as brainstem tumors in children that are known to be almost universally fatal. Dr. Burzynski has much more than just a few anecdotal cases of brain cancer success. He published the data of his trials showing the high rates of success. With chemotherapy and radiation however, successful treatment protocols for childhood brain cancers basically don’t exist. Doctors often recommend that patients with severe cases be sent to hospice care and given pain relievers as they wait to die, since the life expectancy is minimal even if the treatment kills the cancer and the suffering caused by aggressive chemotherapy and radiation treatment can be horrific.
Another amazing aspect of antineoplaston therapy is that it has been shown to be effective on every kind of cancer imaginable, again with unheard of rates of success. In contrast, chemotherapy and radiation protocols vary greatly depending on the doctor’s opinion as to what might work best. There are multiple options even for the same types of cancer.
Even though Burzynski’s success is well documented in the medical literature and press going back decades, he’s been opposed by the government and powerful financial interests from several industries. This story is powerfully told in a recently released documentary available at BurzynskiMovie.com (the first 36 minutes of the movie is available free on the site). The Federal Drug Administration (FDA) first sought an injunction to shut him down in 1983, and when a judge rejected it, the FDA threatened that it would resort to harsher measures: seizing records, a publicity campaign, and criminal charges that could land Burzynski in jail. The FDA had declared war on Burzynski.
Over the next 15 years at least 3 and as many as 5 grand juries were convened that failed to indict Burzynski. Twice his facilities were raided and medical records were seized—endangering the patients’ lives—but prosecutors never could make charges stick. At first the justification for the attacks were allegations of the inefficacy or danger of his treatments, even though he had never had a single patient complaint. Agents tracked his patients down all over the country, spending tens of millions of taxpayer dollars, but they still couldn’t find a single malcontent.
After the first grand jury, Burzynski applied for and received Investigational New Drug permits from the FDA to try to prevent more harassment, but to no avail. The charges were shifted to accusations that he was violating laws by shipping medicines across state lines. Leaving aside the injustice of a law prohibiting someone from selling a product across a line drawn on a map, in the cases where Burzynski was shipping the medicines, he had received compassionate use exceptions from the FDA for patients in life threatening situations.
In the midst of these legal harassments, Burzynski had even more troubles. Just when pharmaceutical companies were beginning to show interest in funding his work, they backed off because the FDA’s hostility. A few years later another company decided to fund Burzynski anyway, and quickly agreed to financing, licensing, and royalty arrangements. However, the company enticed away one of the doctors Burzynski employed, and backed out of the deal at the last minute.
There was one minor ingredient in some of the antineoplastons that Burzynski had not patented because lawyers had counseled him that it was so common and well known that a patent would never be granted. The company took this ingredient to the National Cancer Institute (NCI), where the doctor who had defected from the Burzynski clinic was quickly made section chief. They quickly received FDA approval for trials while Burzynski continued to be stonewalled in his attempts to receive FDA approval for trials. Burzynski had determined 12 years earlier that the ingredient was insignificant, and only needed to be included in one of the antineoplastons. He publicly predicted the trial would not work. Burzynski was frustrated by the bureaucratic corruption but with his background, not too surprised, and he soldiered on.
When the National Cancer Institute’s trials failed, associate director Michael Freidman came back to Burzynski and offered to do trials with his antineoplastons, but only if he would agree to make major changes to the protocols that he’d spent decades developing. At first he refused, and Freidman threatened to find other sources for antineoplastons. Burzynski fired back that federal employees shouldn’t contemplate patent infringement. The NCI finally agreed that Burzynski’s protocols would be followed.
The protocols were simple and routine for cancer trials. Patients with very large tumors, multiple tumors, and metastases were to be excluded. These protocols are designed to rule out complicating factors that can skew results. When a year passed with no patients being enrolled, Burzynski suspected something was amiss. The NCI said it had trouble finding patients, and then altered the protocols to include the complex cancers behind the back of Burzynski, who could have changed the instructions for dosages to treat such advanced cancers if he had known. The dosages would have had to have been increased at least three times. As the conflict escalated the NCI quit sending data to Burzynski who had to resort legal means to get access to the results of the trial using his own medications. He went on TV and said that he had gotten the distinct impression that the NCI wanted the patients to die so the trial would be over as soon as possible.
When Dr. Burzynski finally got the data for the trial, he learned that there were only nine patients enrolled and they had suffered from severe fluid retention, something that he monitored and was able to prevent with his patients. He suspected that the antineoplastons were being diluted. The FDA later added insult to injury by publishing in a medical journal that the antineoplastons did not have cancer treatment potential. Some researcher made the mistake of including figures that showed the antineoplastons in the patients’ blood were 3 to 170 times less than the Burzynski clinic typically measured. The trial had been sabotaged.
The battles came to a head in the late 1990s when Texas congressmen Joe Barton organized an oversight committee to hold hearings about why the FDA continued to harass Burzynski. Jurors from previous hearings and throngs of former patients showed up to protest. By this time Burzynski had saved the lives of more than 300 people who were supposed to have been dead. Due to public pressure the FDA agreed to accept Burzynski patients into 72 different Phase II trials, but that wasn’t the end of the conflict. A couple years later the FDA did manage to indict Burzynski on the interstate commerce charge, making it the first time in history that it was suing a doctor whose treatments it had approved. There were more rallies and press coverage, and the jury quickly voted to acquit.
After all of the dust had settled even more corruption came to light from internal memos. Going back all the way to 1991 the US Department of Health and Human Services had been filing patents on the one ingredient Burzynski had not patented, claiming that the rights to manufacture, use, and license it belonged solely to the government. Shortly after the patents were filed, Michael Freidman, who had obstructed Burzynski’s trials at the National Cancer Institute, became deputy commissioner at the FDA, working directly under the commissioner who’d declared war on Burzynski. This breathtaking audacity did take Burzynski aback. Powerful government officials and the pharmaceutical industry had been conspiring to steal his invention.
Burzynski has survived and the threat of more lawsuits now seems to have gone away, with the last one now 13 years behind him. Recently he was quoted in the Wall Street Journal as saying he now has a good working relationship with the FDA that is getting better. He is now conducting phase III trials on antineoplastons in the United States. There are also trials in progress in Japan and Europe, and he’s even explored possibilities in China. Burzynski continues to put money made from treating patients back into research and development, which is very expensive. A single trial can cost as much $25 million and the average cost for bring a new pharmaceutical product to market is $1.5 billion.
Samaritan's Anthony Hopp's May 25 visit with Dan Celia of Financial Issues
Dan Celia of FinancialIssues.org talks with Samaritan's Anthony Hopp monthly about health care sharing. Here's their May 25 visit.…