Friday, July 8, 2011

Doctor finds cure for Cancer but is shut up by Feds

Cancer Doctor Stanislaw Burzynski Sees Himself as a Crusading Researcher, Not a Quack

He's treated thousands of people from all over the world, so why can't he get FDA approval?

Houston Press 

by Craig Malisow

If you were writing the story of Dr. Stanislaw Burzynski, he'd probably want you to start with him leaving Poland for America with $15 and a dream. He'd want it to end with him curing cancer.

Dr. Stanislaw Burzynski has battled the Food and Drug Administration for 30 years trying to get its approval for his cancer treatment.

Dr. Timothy Gorski says Burzynski is "selling hope at a high price."

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.

Burzynski also recruited his brother Tadeusz, a construction supervisor with degrees from Poland's Academy of Mining and Metallurgy and Brazil's Federal University. His job title: Director and Vice President in Charge of Technical Operations. The fourth original director was then-Harris County Attorney Mike Driscoll.

By 1983, FDA officials were convinced Burzynski was engaged in nose-­thumbing of the highest order. The agency sought an injunction in federal court banning the use of antineoplastons. In a motion for summary judgment that might be described as part extortion, part chutzpah, the prosecutor warned the judge, "If the court declines to grant this injunctive relief sought by the government, thus permitting continued manufacture and distribution of antineoplastons, the government would then be obliged to pursue other less efficient remedies, such as actions for seizure and condemnation of the drugs or criminal prosecution of individuals."

Hell, yeah: The FDA wasn't going to put up with anyone trying to cure cancer without its say-so.

But the FDA walked away with only a partial victory. While the judge ruled that Burzynski could not ship antineoplastons across state lines, the ruling did not prevent intrastate distribution. Later, in 1985, acting on the belief that he was still shipping antineoplastons outside Texas, FDA officials made good on their threat and raided Burzynski's office. They took whatever documents they could — including patient files — and dragged patients into grand jury hearings. Instead of securing indictments, the FDA only succeeded in making thousands of people feel their privacy had been violated.

The FDA wouldn't wrangle an indictment until 1995 — and that was a doozy: Seventy-five counts, mostly for mail fraud and shipping an unapproved drug across state lines, that would've put Burzynski behind bars for nearly 300 years.

Bizarrely enough, as a part of Burzynski's bond agreement, federal judge Sim Lake ordered Burzynski and the FDA to agree on protocols for Phase II trials of antineoplastons — trials to measure the drug's efficacy. So while the FDA, via a federal prosecutor, was trying to imprison Burzynski, it was also monitoring his clinical trials.

When the trial began in 1997, the jury deadlocked, and Lake declared a mistrial. He then tossed the 34 mail fraud counts, citing lack of evidence. For its part, the FDA dropped 40 counts, leaving — 12 years after the raid and seizure of patient records — only one count of contempt. Burzynski was promptly acquitted.

This network of supporters grew even more outraged when, in the years after the trial, several sets of parents were told by the FDA that they could not take their dying children to Burzynski. The rationale was this: The treatment had never been properly tested, so it might be unsafe. No, the FDA said, it's better to take that kid with the walnut-sized brain tumor to a doctor who will zap him like Hiroshima, or pump him with drugs that might turn him into a bald, anemic wraith with just enough energy to handle the incessant vomiting.
If FDA officials wanted to send a message to people about the potential dangers of antineoplastons, it would be hard to imagine how they could have done a worse job. Instead of making Burzynski a criminal, they made him a hero.
The whole saga might have been more spectacular if there were any compelling evidence that antineoplastons actually worked.

The only person who seems able to publish studies showing the treatment's positive results is Burzynski, the only person with a financial interest in the drug. The one time Burzynski agreed to an independent study under the auspices of the National Cancer Institute, it ended in acrimony. Between 1991 and 1995, the NCI spent nearly $1 million funding Phase II trials of patients treated by doctors at the Mayo Clinic and Memorial Sloan-­Kettering. Because of slow patient accrual, the doctors decided to expand the agreed-upon parameters of the protocol, ultimately allowing two patients with brain tumors larger than originally called for. Then, after several of the patients experienced side effects, including seizures, edema, confusion and drowsiness, the doctors responded by lowering the patients' dosages. Convinced the doctors were deliberately sabotaging the trials, Burzynski pulled the plug.

A 1995 Phase I trial by Japanese researchers showed promise, but Phase II trials were never initiated.

None of this lack of outside support has prevented Burzynski from publishing studies (mostly in obscure journals) and presenting abstracts at medical conferences worldwide. Yet after all these presentations, and after decades of research, Burzynski seems to have amassed exactly zero outspoken allies in conventional medicine. (While outspoken critics aren't hard to find, some oncologists don't seem interested in discussing him at all. The Houston Press's request to speak with experts at M.D. Anderson fell on deaf ears.)

In 1998, Paul Goldberg, editor of The Cancer Letter, a D.C.-based newsletter covering cancer research and drug approval, investigated Burzynski's claims up to that point. He asked three renowned and independent researchers to examine Burzynski's scientific protocols — all three said they could not make sense of the data, saying it did not resemble any commonly accepted models. Ten years later, Goldberg and two of those doctors don't feel any differently.

Read the rest of this article at the Houston Press

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