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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.
Throughout the process, Burzynski's patients picketed outside the courthouse and testified before Congress. As far as they were concerned, the FDA was persecuting a noble man who merely wanted to offer a nontoxic alternative to radiation and chemotherapy.
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.
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