By Sean Pendergast
By Sean Pendergast
By Sean Pendergast
By Jeff Balke
By Richard Connelly
By Jeff Balke
By Casey Michel
By Craig Hlavaty
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.
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.
"This is taking a long time," Goldberg told the Press in an e-mail. "Sure, drug approval is a technical, time-consuming and costly process. Nonetheless, thousands of anticancer compounds have been shown to be effective — or dismissed as ineffective — over the decades since Dr. Burzynski initiated his experiments."
Henry Friedman, a neuro-oncologist at the Duke University Medical Center, was one of the independent doctors who reviewed the data for Goldberg. He doesn't say that antineoplastons don't work — only that Burzynski has failed to prove otherwise.
"Despite thousands of patients treated with the antineoplastons, no one has yet shown in a convincing fashion, [through] the rigorous requirements for peer review, that the therapy works," he says, adding later, "You have to understand how incredible that is. Because normally, you can do a cancer study of as few as 30 [or] 40 patients...and begin to get an idea of whether there is activity or not. And then you can do larger studies, and you can really prove the merits or the lack of merit of the therapeutic strategy."
When asked why, if Burzynski's protocols were so lacking, he received orphan status from the FDA, Friedman says, "It is a Grand Canyon's distance between somebody getting orphan disease status and getting approval for the drug."
Moreover, he says, Burzynski "has been making a fortune...on patients he's treated with antineoplastons. I find that of questionable ethics."
"If there were something there, it would be fairly easy to prove," he says. "And you don't have to do it in any unique way other than a routine, careful Phase II trial, or, with thousands of patients, he could have done a randomized study."
"He's selling hope at a high price," Gorski says.
But what about all those patients who credit Burzynski with saving their lives? Don't they count for anything?
"How many people are there who feel like [televangelist] Benny Hinn saved their lives?" he says, adding that "People who are dead do not get up and say, 'Burzynski did nothing for me.'"
Also, Gorski says, bold and unproven claims are "a problem for cancer in particular, because as soon as you get cancer, you've got a big target on your back [for] quacks to come and get you."
So while mainstream oncologists might believe that Burzynski orbits the quackosphere, he has achieved near-messiah status among journalists, pseudoscientists and armchair oncologists who believe in an omnipotent Cancer Industry determined to quash any treatments that threaten the standard regimens of surgery, radiation or chemo. Often, the cornerstone of their belief is that every oncologist in the country is absolutely fine with children dying gruesome deaths because they are somehow making money off standard treatments.
And while Burzynski's patients say the antineoplastons worked where other treatment failed, these patients — or their surviving family members — often operate under the belief that any success is attributable to antineoplastons alone, and any deaths are strictly the fault of previous chemo or radiation.
While speaking with these family members, or reading their testimonies, is often heartbreaking, Burzynski has not been able to translate these anecdotes into sound science.
This may be because Burzynski doesn't seem interested in persuading colleagues, only patients. And on that level, he's wildly successful.
Patient testimonies almost always contain the phrase "treated like family." His warm bedside manner, and that of his staff, is often in stark contrast to patients' experiences in mainstream hospitals. Also, his CV is long, and, depending on what you consider relevant to the practice of medicine, contains the vital information that Burzynski is a "hereditary count" and the fact that he holds hundreds of patents in dozens of countries. (According to the U.S. Patent Office, these include a patent for a cancer-fighting toothpaste, as well as antineoplaston treatments for patients with AIDS, Parkinson's disease and neurofibromatosis. The 1991 patent for AIDS treatment describes remarkable results achieved with three patients, but Burzynski doesn't appear to have continued this research.)
Burzynski can also point to the hundreds of articles he's published, which also reassures patients and makes them comfortable enough to write big checks. Some of these articles are interesting reading, such as the 2004 one titled "Antineoplastons in Dairy Products," which revealed the dramatic finding that the level of antineoplastons in whey is greater than that found in feta cheese. (Caveat, per the study: "The analysis of feta cheese was more difficult to perform due to the high content of fat.")
This feta cheese revelation unfortunately occurred after the publication of the Burzynski bible, i.e., The Burzynski Breakthrough: The Most Promising Cancer Treatment and the Government's Campaign to Squelch It, but there's no telling if it will make future editions. But the book's author, syndicated columnist Thomas Elias, remains convinced that the FDA persecuted Burzynski because he threatened the livelihood of the doctors on the agency's review boards.
"These are the very people who stand to lose the most if Burzynski's drug is proved," he says. "These are the people who radiate kids' brains at St. Jude's regularly...These are the people who are the enemies of this drug, because they have the most to lose from it...If this drug is approved, it will basically say that what they've been doing for all these decades is junk, and wasting money and lives."
Elias says that he did not set out with the intent of writing a book hailing Burzynski, but the more he researched, the more the data pointed to one conclusion. He says he randomly selected patients throughout the country to interview and follow up on. Most of those who followed the treatment plan were alive and improving, he says. "But the ones who gave up on the treatment, they were dead. Without exception."
While Elias believes Burzynski tried from the beginning to work within the system, Gorski believes otherwise: "The guy's like Leona Helmsley," he says. "Medical research and doing things by the book and having evidence and facts and so on, that's for the little people. Burzynski can do as he pleases."
And, Gorski says, claims of a drug's potential ring hollow without scientific support.
"Let's put it this way," he says. "Until it's really thoroughly tested, there's potential that when you take an antibiotic, if you jump up and down when you're taking it and say, 'ollie-ollie-oxen-free,' then it'll work better than if you don't do that, right?"
Gorski believes that, at this point, Burzynski is so convinced in his treatment's infallibility that "he is no more going to stop using his antineoplastons than the Pope is going to convert to Islam...It's an ideological commitment that has got nothing to do with facts and reason."
Generally, Burzynski's patients pay a $6,000 deposit before beginning treatment. Technically, the drug itself is free because it's only used under Phase II trials, but patients pay for incidentals, including consultations, supplies and classes on how to administer the drug. This runs about $7,500-$9,000 a month — out of pocket. Ostensibly, after paying salaries, this money goes straight into more research.
But in recent years, the Burzynski train appears to have gone off the tracks. Namely, he has taken it upon himself to rescue patients afflicted with the other Big C: Crow's-feet.
Burzynski has launched a line of creams and capsules under the brand name Aminocare, which is described as "The Genetic Solution for Anti-Aging." Aminocare Cream has allegedly been subjected to rigorous clinical trials, although the resulting publication looks a bit different from his cancer articles. For one, it contains photographs of smiling middle-aged couples, basking in the glow of their new-found freedom from wrinkles. The study indicates that Aminocare showed a reduction of "complexity," "wrinkle depth" and "wrinkle volume."
The study was commissioned by Aminocare, and Burzynski settled on an unexpected choice in the scientists he trusted: researchers at the University Victor Segalen in Bordeaux, France. It appears to have been led by the university's Alain Jacquet, whose title is listed as "toxicologist." However, according to Jacquet's CV, he is what in Europe is called a "stomatologist" and in the U.S. is called a "dentist." (Jacquet later blessed another antiaging miracle drug, manufactured by Inversion Femme, that involves using shark cartilage to "combat the excess of free radicals.")
Burzynski presents his fountain-of-youth breakthroughs at worldwide conferences held by the American Academy of Anti-Aging Medicine. The Chicago-based organization was founded by Ronald Klatz and Robert Goldman, who received their medical degrees in Belize but are not legally allowed to identify themselves as "M.D.s" in Illinois, per orders by that state's Department of Professional Regulation.
While Goldman may not be able to call himself an M.D. in Illinois, his credentials are still impressive. According to the academy Web site, he is a Chinese weapons expert with the ability to perform "13,500 consecutive sit-ups and 321 consecutive handstand pushups." For proof of the latter, Goldman has included photos of himself standing on his hands, clad in a snug stars-and-stripes-patterned swimsuit.
As for Klatz, he is the developer of the "Model of Practical Immortality," in which he predicts that by 2029, people will have lifespans of at least 150 years.
While Burzynski told the Press that Aminocare does not sponsor these conferences, the company is listed as a sponsor on the academy's Web site.
And it's best not to push the subject. In speaking with Burzynski, you need to understand some basics: If you in any way question his methods, remark on his affiliation with dubious doctors or try to understand why, after 30 years, antineoplastons are not accepted by mainstream medicine, you're in for trouble.
In his first interview, Burzynski is cordial and accommodating.
After a brief wait in his clinic lobby, lined with photographs of celebrities who were never Burzynski's patients, such as Mel Brooks and Gregory Peck, the Press follows an assistant to the doctor's well-appointed office. Burzynski may not be tall, but his white doctor's coat and impeccably managed dark brown hair and mustache lend a presence of authority. He speaks softly, in a thick accent, often punctuating sentences with a smile.
Ever an optimist, Burzynski has been excited about nearing the end of Phase II trials. Phase III should be right around the corner, a remarkable achievement for a cancer drug. Asked to explain why the FDA seems less antagonistic these days, he says, "It's like a bully on the block. You beat him, and he could become your friend."
He's used to the first round of questions — he's answered these for decades — so his answers are quick, if not altogether sensible. History is replete with renegades who were first ridiculed, then hailed. He says that respected publications were so resistant to Einstein's early groundbreaking theories that he was forced to take out ads in The New York Times, a statement unsupported by historical evidence.
"Everyone who discovers something [meets] resistance," he says. "Why should I be any different?"
Take, for example, that mid-1990s NCI study — the one in which doctors administered doses lower than Burzynski approved of — that was just another "cover-up."
"They're lucky they're not behind the bars," Burzynski says.
But a second interview does not go as smoothly.
When asked if showing three-dimensional topographies of crow's-feet in places like Dubai took time away from that whole cancer thing, Burzynski bristles at what he considers to be an irrelevant question, responding in somewhat broken English.
"I have the right to do whatever research I want, okay?" he says, followed closely by, "I spent 42 years practicing medicine, doing research, and you are little man for asking such question, okay? Maybe in three years I get Nobel Prize, and you'll look like a shit, okay, asking me such stupid questions, okay?"
The Press explains that the reasoning behind the questions is this: Is Burzynski convinced that he's done everything possible to get antineoplastons federally approved, and thus covered by insurance, thus giving a chance to those dying children whose parents can't afford the steep payments? But when pressed as to why — even after the prolonged litigation with the FDA — he still hasn't been able to prove his treatment's efficacy, he is equally offended.
"You know why?" he says. "Because I came to this country with $15 in my pocket, okay? Because I didn't speak English when I came to this country. I learned it by myself. And in order for me to do what I am doing now, I needed to establish a pharmaceutical company. I needed to establish the research institute, okay, from the scratch, okay? And I need to do all of this from my own money, which I am, okay? How many years it would take for you to do it if you come to the country [from] like, say, Afghanistan?"
The Press also asks why, if one of the biggest barriers to sharing a promising cancer treatment with the rest of the world is his language skills, he hasn't enlisted the help of English-speaking scientists.
Burzynski laughs that one off. "Listen your little brain to this thing: I came to this country with $15, okay? How can you enlist somebody, paying him $5 [out of] $15, okay?"
Which leads to one of the most troubling aspects of the Burzynski saga: Why have no credible oncologists stood up for him? Why don't oncologists regularly refer their patients to his clinic? Why aren't the greatest minds in medicine calling for the swift approval of antineoplastons?
If they are out there, the Press needs to hear from them. Burzynski obliges as best he can, throwing out the name of perhaps his biggest ally in medicine (using that term loosely). That is Julian Whitaker, an alternative medicine practitioner who claims to be "board-certified in antiaging medicine." That could be true — it's just a question of which board he's talking about. One thing is for sure: It's not the American Board of Medical Specialties, which is what most doctors are talking about when they say "board-certified." The ABMS does not recognize "anti-aging" as a medical specialty. When asked for the names of supporting doctors who don't have Web sites featuring "Rollback Savings!" on their lines of nutritional supplements, Burzynski eventually comes up with Bruce Cohen, a brain tumor specialist at the Cleveland Clinic. Cohen did not return calls.
"Certainly, some doctors don't like me, because they would like to do whatever I did, okay?" Burzynski says. "Everybody would like to establish his own pharmaceutical company...They are begging for scraps from the government. They are living on grants. I did it [by] myself."
And that appears to be the other side of the story, the one that Burzynski would probably say wouldn't belong in his biography. The story of how, as objectionable as the bureaucracy behind drug approval can be, it is the only way of getting lifesaving medicine to those in need. A doctor who plays outside the system — no matter how righteously — risks losing his right to practice medicine altogether.
So, for Burzynski, the real story does not appear to be the system, or necessarily medicine itself. It appears to be a story of independence and financial success. Of not relying on the help of other people to achieve your dream. To Burzynski, it's a powerful story.
"Why are you not enthused?" he asks. Here's the real story, he says: "'That's the poor guy who came from Poland without any money, who was able to build his own company. He was able to move all the way to the approval process, and with a little luck, he can get the approval of FDA'...It's a great American story, okay? And then you are talking to the guys who are old cronies, who hate me guts because they would dream to do whatever I do, but...they never had the guts to do it."
He's right. It's one hell of a story.
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