Burzynski clinic

As a young doctor in the 1970s, Burzynski began treating patients with antineoplastons, a collection of peptides, amino acids and amino acid derivatives he originally isolated from blood and urine. Since then, by his reckoning, he’s used the drugs to treat over 2,300 cancer patients—though he isn’t trained as an oncologist. He’s been the subject of laudatory documentaries and promoted by the likes of Dr. Mehmet Oz, the famous surgeon and TV personality, and Suzanne Somers, the actress-turned-naturopathic-medicine-advocate. “No one has worked harder, and no one has been more persecuted for his maverick approach,” Somers wrote in her book Knockout: Interviews With Doctors Who Are Curing Cancer.

But there's no verifiable evidence antineoplastons work. Nor are they the gentle treatment Burzynski claims them to be. He has run Food and Drug Administration–approved clinical trials on the drugs since the 1990s, during which time at least six study participants died from hypernatremia, or high levels of sodium in the blood—likely due to the sodium-rich antineoplastons. Among the victims was a 6-year-old boy.

Over the years, Burzynski has been the subject of numerous investigations and legal proceedings, brought by grand juries, the FDA and the Texas Medical Board. As it’s become more difficult to continue registering his patients in antineoplaston trials, Burzynski has treated patients in other ways, still outside the medical mainstream. He uses chemotherapy drugs in combinations that have not been scientifically tested—and whose toxicities, according to the medical board, pose an unwarranted threat to patients.

Now the Texas Medical Board has brought yet another case against Burzynski, seeking to revoke his license. As the hearing got underway in Austin in November, some of the doctor’s former patients and admirers gathered to support him and to protest with placards...
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But then Lisa heard about Burzynski. The Merritts went down to his clinic, where they learned Wayne didn’t qualify for antineoplastons but might respond to some other drugs. The couple made it very clear, Lisa said, that Wayne didn’t want chemo. They saw Burzynski for 10 minutes, then were turned over to his staff. Lisa says Wayne had a daily appointment with a woman wearing a name tag that said “Dr.,” and whom the other staff called “doctor”—but who, the Texas Medical Board says, isn’t licensed to practice medicine in Texas.

Back home in Armuchee, Georgia, they got a shock. On their next visit with their local oncologist, she looked at the clinic’s prescriptions and dropped three bombshells: One, Wayne was indeed on chemotherapy, among other drugs; two, the medications would cost about $30,000 a month—not the $3,000 to $6,000 a month they had been told; three, his medication regimen was dangerous. “It was devastating,” Lisa says. “We felt like we got dropped on our face.”...

On its website, the Burzynski Clinic says it offers “personalized cancer therapy,” using genetic analysis to customize treatment for each patient. But in expert testimony for the medical board, Dr. Cynthia Wetmore, director of the Center for Clinical and Translational Research at Emory–Children’s Pediatric Research Center in Atlanta, said, “There’s not a possible way to tell what drug is helping and what drug is not helping. The drugs are given in unstandard [ sic ] combinations that never have been tested. They’re given in unstandard doses that are not known to be effective or safe. And combining them is experimenting on humans, which cannot be done outside a clinical study. That’s unethical. ”...

The board concluded that because of Burzynski’s actions and those of his subordinates, “each of the patients in this case either suffered considerable toxicity effects or were put at significant risk of considerable toxicity effects.”

Burzynski takes a different view—he says the drug combinations are evidence of his innovative approach to medicine. In an email to his former lawyer, Richard Jaffe, in January 2015, he wrote, “It takes a single pioneer to abolish dogma and save countless lives. This is our contribution to medical science.” Burzynski argued that it’s unfeasible to restrict practitioners only to tested drug combinations, because with almost 100 cancer drugs, testing every combination of five agents would result in “hundreds of thousands of trials.” (Burzynski and his lawyers did not respond to a request for comment.)...

The most reliable scientific sources agree with the board’s assessment of antineoplastons. The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), says in its summary guidance for health professionals, “No randomized controlled trials showing the effectiveness of antineoplastons have been published in the peer-reviewed scientific literature.”

Because of the lack of strong scientific evidence, there is little concrete information about the toxicity or side effects of the drugs. On the one hand, says Dr. Wayne Jonas, who reviewed antineoplastons for NCI, the drugs probably have a lower toxicity than some chemotherapies prescribed for brain cancer. But on the other, studies of antineoplastons have observed serious side effects, including severe neurological toxicity, bone marrow suppression, hypernatremia, fatigue, stupor and coma, and potassium deficiency in the blood.

As far back as 1994, an FDA inspection found that Burzynski was misrepresenting side effects as minimal. Eighteen years later, a 6-year-old boy in one of Burzynski’s trials died with hypernatremia. When the FDA found out, they put a partial hold on his trials, forbidding him from enrolling children. Later, the agency expanded the hold to include adults. As part of his effort to lift the hold, Burzynski sent the FDA an analysis of 2,185 trial subjects. Nearly half had suffered hypernatremia; the FDA argued that Burzynski had underestimated the number of cases caused by antineoplastons in this analysis and especially in his trial brochure, which claimed, “Most cases were not related to antineoplaston therapy.”...

When you cut through all the grandiose claims, Burzynski’s drug trials appear to be a smokescreen. His goal, it seems, isn’t to prove his invention through the scientific process but only to treat as many patients with antineoplastons as he can. That claim doesn’t come from his critics—it comes from his former lawyer, Richard Jaffe. “As far as clinical trials go, it was a joke,” he wrote of one trial’s design in his book, Galileo’s Lawyer . “It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment.”

Given this startlingly frank admission, many critics ask why Burzynski is still allowed to run his clinic and to enroll patients in trials. “The FDA has inspected him quite a few times, and they always find stuff, but they never can quite seem to shut down his clinical trials,” says David Gorski, a surgical oncologist at the Barbara Ann Karmanos Cancer Institute, and a blogger who’s written extensively about Burzynski. Gorski says he’s asked the FDA why it hasn’t shut down Burzynski, and they’ve never explained. When Newsweek asked the agency the same question, it responded with a general statement, making no reference to Burzynski, saying simply that it takes action based on its most recent inspections, using all available information.

Sandra Cohen is a Burzynski success story—sort of. She went to him seeking antineoplastons, and when she didn’t qualify, she reluctantly started on chemotherapy and later agreed to surgery. Five years later, she is cancer-free. “Dr. Burzynski saved my life,” Cohen says.

http://www.newsweek.com/stanislaw-burzynski-cancer-medical-malfeasance-429057
Courtesy of a colleague