USA TODAY investigation finds experts questioning why Houston doctor is allowed to continue to offer his alternative cancer treatment with antineoplastons.

Video at http://www.usatoday.com/story/news/nation/2013/11/15/stanislaw-burzynski-cancer-controversy/2994561/ 





LINDEN, N.J. — On the last day of his life, Josia Cotto's parents gave him a choice.
The 6-year-old boy had been fighting an inoperable brain tumor for 10 months. When his mother, Niasia Cotto, found him in his bed, unresponsive and unable to open his eyes, "we knew there was nothing else that we could do," she said.
An ambulance took Josia to a hospice room at a local hospital. His parents covered him in a soft, blue-and-white blanket, hugged him and held his small hand for the last time.
"We told him the choice was his, whether to keep fighting or be in peace with God," said his mother. "He chose."
Josia's parents would have paid any price to save him.
A Texas doctor, two months, earlier, had given them one: $25,000 upfront, by cash or check.
Clinging to hope, the Linden, N.J., couple took Josia to see Stanislaw Burzynski, a Houston doctor claiming to be able to do what no one else can: cure inoperable pediatric brainstem tumors.
Virtually any other doctor might have recited the same sad statistics: Although doctors can now cure 83% of pediatric cancers in the U.S., there is usually no hope for kids with Josia's tumor. Perhaps 5% survive five years.



Burzynski — an internist with no board certification or formal training in oncology — has said publicly that he can cure half of the estimated 200 children a year diagnosed with brainstem tumors. The Cottos were told that treatment could cost over $100,000, mostly out of pocket, because insurance plans often refuse to cover Burzynski Clinic treatments.
Burzynski, 70, calls his drugs "antineoplastons" and says he has given them to more than 8,000 patientssince 1977.
He originally synthesized these sodium-rich drugs from blood and urine — the urine collected from public parks, bars and penitentiaries. Although they've been made in a lab since 1980, they still carry a distinctive and unpleasant odor. And while the experimental drugs have not been approved by the Food and Drug Administration, Burzynski has described them like the holy grail of cancer therapy: safe, natural and highly effective. He has also prescribed them as a treatment for AIDS, lupus and other conditions.
Some patients are convinced that he saved their lives.
Mary Jo Siegel of Ventura, Calif., says she believes Burzynski cured her lymphoma. James Treadwell from Coronado, Calif., credits Burzynski with curing his brain tumor. Jenny Gettino of Syracuse, N.Y., says Burzynski cured her daughter of an infant brain tumor.




Yet the National Cancer Institute says there is no evidence that Burzynski has cured a single patient, or even helped one live longer. He has not backed up his claims by publishing results from a randomized, controlled trial — considered the gold standard of medical evidence — in a respected, peer-reviewed journal.
And Burzynski's drugs pose a risk of serious harm, including coma, swelling near the brain and death, according to the NCI and informed consent documents that patients sign before beginning treatment. While Burzynski has touted his treatments as an alternative to chemotherapy, a 1999 NCI study found that antineoplastons can cause many of the same side effects as conventional chemo: nausea, vomiting, headaches, muscle pain, confusion and seizures.
Many blame the system for failing to protect patients.
"He's a snake oil salesman," says pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children's Hospital of Philadelphia. "This has gone on for so many years, it's really unbelievable."
For 36 years, critics say, Burzynski has been selling false hope to desperate families at the most vulnerable time of their lives.
"When you want so hard to believe something, you end up listening to your heart and not your head," says Lisa Merritt of Armuchee, Ga., whose husband, Wayne, wastreated briefly by Burzynski in 2009. The couple say that Burzynski misled them about the type of treatment that would be offered, as well as the cost. Burzynski, she says, is "the worst kind of predator."
There are many reasons why Burzynski has been able to stay in business so long. He has benefited from state laws that limit the Texas Medical Board's authority to remove his license, as well as the ability of terminally ill patients to collect damages. His devoted followers are willing to fight for him. He also has exploited the public's growing fascination with alternative medicine and suspicion of the medical establishment.
At times, Burzynski also has had an especially influential ally: the Food and Drug Administration.
FDA CHANGES COURSE
Although "there were some stormy relations with the FDA" in the past, Burzynski said in an interview, "now, we have a productive relationship."
For years, the FDA tried to prevent Burzynski from prescribing unapproved drugs.
In 1995, a federal grand jury indicted Burzynski on 75 felony charges, including criminal contempt, mail fraud and violations of the Food, Drug and Cosmetic Act. As a condition of his bail, a judge ordered him to stop prescribing antineoplastons. For a time, it looked as if Burzynski might never treat another patient.
Dozens of Burzynski's patients flocked to Washington to defend him, arguing that taking away antineoplastons was akin to a death sentence. Siegel, who credits Burzynski with curing her lymphoma 22 years ago, has testified on his behalf five times — once at his criminal trial and four times at hearings on Capitol Hill.
Facing both a political and public relations firestorm, the FDA in 1996 abruptly changed course. It offered to allow Burzynski to continue treating patients, but only through an official trial.
"With one stroke of the pen, the FDA made legal what it had previously said was illegal," says Burzynski's attorney, Richard Jaffe.
Yet even Jaffe has acknowledged that the trial — now in its 17th year — was more about politics than science. In his 2008 memoirs, Galileo's Lawyer, Jaffe called it "a joke."
"It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski's treatment," Jaffe said.
"With political help, you can get the FDA to say yes," says Siegel, 63.
The indictments led to two trials. In 1997, one of Burzynski's criminal trials ended in a hung jury; the other, an acquittal.
Today, the FDA refuses to comment on Burzynski.