Trials of a Cancer Doc
Experimental drugs and a 20-year fight with the FDA
According to the FDA's analysis of the data, the therapy contributed to the deaths of at least seven people through its most common side effect, hypernatremia--a potentially life-threatening condition associated with high levels of sodium in the therapy. The FDA reported that 65 percent of Burzynski's patients had hypernatremia, a finding seemingly at odds with Burzynski's claim on his Web site that his drugs are "normally free from serious side effects." Burzynski contends the patients died of other causes and when there was hypernatremia, it was "due to the fact that the patient wasn't drinking fluids."
Not all of Burzynski's patients are comfortable with his representations. On July 9, the parents of 11-year-old Christina Bedient, of Lockport, N.Y., filed suit against Burzynski and his clinic, claiming the doctors made misrepresentations to them about the efficacy of antineoplastons, "the effect that the treatment was having on Christina's tumor, and about her prognosis." They say they believed the alleged misrepresentations. They also claim that Burzynski and his clinic were negligent and treated their daughter "in a manner that violated the standards of acceptable medical practice." Christina died June 17, 1996. Burzynski says the lawsuit is frivolous. "The bottom line is they signed an informed consent form," he says. He says Christina's "big tumor was decreasing" but that another tumor was increasing. "There was no negligence," he says. "There was no treatment for this child. At the same time, we have patients who respond and whose tumors disappear completely, so there was [a] chance."
Another couple has raised similar complaints. In June 1997, 26-year-old Andrea Walsh, a registered nurse from Jordanville, N.Y., was diagnosed with a glioblastoma, the same cancer Christina Bedient had; after surgery, her doctors said chemotherapy and radiation might extend her life a few months, but no more. That August, Andrea's mother, Jean, and her brother Bill took Andrea to Burzynski's clinic, where they say they were told by a clinic doctor that antineoplastons could cure a third of glioblastomas. The Walshes borrowed $16,000 to start treatment.
High fevers. Over the following six weeks, Jean Walsh says, her daughter suffered side effects ranging from disorientation and high fevers to constant thirst. She and her husband, Tom, repeatedly complained to clinic personnel. Each time, she says, "the nurses were jubilant. They said this [side effect] was a sign the tumor was breaking up." On September 22, an MRI scan showed that Andrea's tumor had doubled in size, says her local neurosurgeon, Frank Boehm. He told the parents that Andrea had very little time left. Still, the parents say, a Burzynski clinic doctor insisted that the young woman come to Houston to be examined or she would have to be dropped from the clinical trial. Burzynski says that the clinic has no record of such a conversation. Andrea left on September 28 in the company of Mary Briggs, her best friend.
After they arrived, according to Briggs and the Walshes, another doctor at the Burzynski clinic told the two women the tumor was dissolving. That doctor called Andrea's parents on September 29, telling them the tumor was shrinking and their daughter would be back to work. "I can't tell you how happy we were," says Jean. She and Tom ran up their credit cards to come up with the $7,000 for the next month's treatment.