By Camilo Smith
By Craig Malisow
By Jeff Balke
By Angelica Leicht
By Jeff Balke
By Sean Pendergast
By Sean Pendergast
By Jeff Balke
The events in between would describe a man leaving behind an oppressive regime for what he thought was a sanctuary for medical research — only to discover that U.S. authorities were even worse than the Communists. Page after page would show authorities trying to shut him down, trying to put him in jail. But he would persevere, bolstered by the testimonies of patients who come to his Houston clinic from all around the globe. Husbands, wives, sons, daughters — condemned to death by conventional medicine, but saved by Burzynski.
The preferred ending — the one where the U.S. Food and Drug Administration approves his treatment — would be about vindication after 30 years of fighting the system. It would show how closed-minded bureaucrats with a grudge cost thousands upon thousands of lives.
He wouldn't want you to suggest there's plenty of blame to go around. He wouldn't want you to stand that scenario on its head, to where it's Burzynski, not the government, refusing to share his treatment with the world unless he was able to do it his way, and his way only. Then, all the money he's made from patients who mortgaged homes and held fund-raisers in order to see him might not seem so justified.
But what he really wouldn't want is an alternate ending. One where, when you swap testimony for science, his treatment isn't effective after all. Because then people might pin those thousands of lost lives on him.
Last December, the FDA granted orphan drug status to Burzynski for the treatment of gliomas, a group of brain tumors that are hard to treat and quick to kill.
Generally, orphan status provides extra benefits — such as extended patent protection — to drug developers targeting diseases affecting fewer than 200,000 people.
It's the latest highlight of a saga that began in 1967, when a 24-year-old Burzynski identified certain peptides — chains of amino acids — in blood and urine. He found that people suffering with cancer typically had lower levels of these peptides, and he hypothesized that these agents might be the foundation of a nontoxic cancer treatment.
He called the peptides "antineoplastons," and the more he researched, the more optimistic he became. He continually drew his own blood, and that of his extremely accommodating family members, to the point where the volume couldn't keep up with his research needs. So he collected urine samples, at one point taking them from public restrooms, until he figured out a way to synthesize the antineoplastons. (Some critics laugh at this pee-based research; one wonders if, in another age, they would have snickered at the scientist who became oddly enamored of the bacteria-fighting ability he supposedly found in some mold in a petri dish he forgot to clean).
In 1970, three years after graduating from the Medical Academy of Lublin, Burzynski emigrated to the United States and took a position as researcher and associate professor at the Baylor College of Medicine in Houston. With the help of a grant from the National Cancer Institute, Burzynski continued his antineoplaston research. But when a grant renewal was denied in 1976, Burzynski decided that if he wanted to see his theory through to the end, he would have to do it on his own.
But first he had to find out if it was even legal to manufacture, sell and administer antineoplastons in Texas. As a later court order would detail, Burzynski asked officials at the Texas Department of State Health Services if he could legally treat patients with antineoplastons.
The court order, which included a history of the steps he took in opening the clinic, states that the officials gave him a verbal green light, but never gave written consent.
Based on what the officials told him, he opened a private practice and research lab in a business park near the Westchase area. His work was not exactly inconspicuous; urine was delivered to a warehouse via tank trailer, dumped into an outdoor 3,500-gallon container, then filtered and transferred to an uncovered 450-gallon mixing tank. From there, it went through a more complex synthesization process. At another facility in Stafford, the stuff went through additional testing before it was bottled.
In 1978, two FDA officials visited Burzynski and told him he was breaking federal law: The agency believed that antineoplastons could only be administered via Phase I clinical trials, which measure a drug's safety. Neither party realized it, but that visit was the beginning of a convoluted 20-year legal battle that would be fought in state and federal courts.
After the 1978 warning, Burzynski took an unexpected course for a man under FDA scrutiny. As, for example, appearing on 20/20 with Geraldo Rivera. And then, in 1983, upgrading the Stafford facility, which was rebranded the Burzynski Research Institute, Inc.
Besides allowing the write-off of certain expenses, the Institute provided employment for his wife Barbara, a fellow Medical Academy of Lublin graduate and former research assistant in Baylor's pediatrics department. Husband and wife became co-directors.