Trials of a Cancer Doc
Experimental drugs and a 20-year fight with the FDA
Andrea never made it home alive. On October 1 her brain swelled massively, just as her flight home was beginning its descent. Henry Friedman, a neuro-oncologist at Duke University, and Victor Levin, a brain-tumor specialist at MD Anderson Cancer Center in Houston, and Boehm, her neurosurgeon, say she should never have traveled any distance from a hospital emergency room. Counters Burzynski: "It's not up to us; that's up to the local physician." Boehm says the Burzynski clinic never called to ask him whether Andrea was fit to fly.
The patient history in Burzynski's report to the FDA states that Walsh did not die under his care. She is listed as having withdrawn from treatment September 30, two days before she died. But according to the Walshes and Briggs, a nurse, Andrea was still receiving antineoplastons just before she boarded the plane. "If she withdrew, why was she carrying a suitcase full of the medicine?" Tom asks. Burzynski says he listed Walsh as having withdrawn on September 30 because that was the last day she was treated.
The FDA's analysis of Burzynski's records is at odds with Burzynski's interpretations. In a preliminary summary of Burzynski's results released this spring, the agency calculated that the tumors of 36 of Burzynski's 828 patients showed a positive response while on his drugs. The FDA found no apparent effect on breast, prostate, and lung cancer. In brain tumors, the FDA found a 13.5 percent response to antineoplastons--not a 30 percent complete response rate, as Burzynski allegedly told the Walshes and others. (The FDA says that a response rate of 10 percent or less usually means that the drug is not effective.) Burzynski and his lawyer, Richard Jaffe, denounced the FDA for releasing the data and accused the agency of misrepresenting the true figures. In a letter to the Cancer Letter, Burzynski complains that the FDA did not count 72 patients who had "stable disease." That, however, is a measure that other researchers say does not necessarily indicate that the cancer has stopped growing. Burzynski told U.S. News his latest results are even better: Only 5 percent of brain tumors got bigger, while 60 percent disappeared completely or shrank by more than half.
If true, his data should bear that out. Says Thomas Garvey, a physician and consultant hired by Burzynski to help him present his data to the FDA: "The protocols [Burzynski's] are weird. They are naive, they are flawed, and there are a lot of them. But even a ball of worms can be disentangled. That's what we're trying to do."
Such debate over the meaning of his trials signals that cancer patients will remain in the dark as to whether Burzynski's antineoplastons will be judged more effective than other medicines. Some patient advocates are disappointed by what the oncologists found when they reviewed Burzynski's clinical trials for the Cancer Letter. "I am truly aghast because supposedly we have laws and regulations and a legal system in place to stop this from happening," says Fran Visco, president of the National Breast Cancer Coalition. "Resources should be allocated to an appropriate trial run in the right way. While we waste time in these trials, people die."