Trials of a Cancer Doc
Experimental drugs and a 20-year fight with the FDA
In dealing with the FDA, Burzynski took several tacks. Responding to the agency's demands, he sent voluminous letters in reply. He did some pre-clinical animal tests, but they never met the agency's requirements. When the FDA took Burzynski to federal court in an attempt to close down his clinic, a horde of loyal patients pleaded with the judge on their doctor's behalf. The judge allowed the clinic to remain open if Burzynski would test his drugs according to standard FDA procedures. After more wrangling, Burzynski finally was granted permission in 1989 to conduct clinical trials; he sent out press releases announcing that he would begin testing antineoplastons on women with advanced breast cancer. But he never did. "After we got permission, we didn't have the money," Burzynski told U.S. News. "It costs millions of dollars to do clinical trials."
While the fight dragged on, Burzynski's business grew, nourished by his flair for publicity. Burzynski distributed fact sheets to patients and owners of his penny stock, attacking the FDA and touting his company's product. An appearance on Sally Jessy Raphael in 1988 brought a flood of new customers. Stories about Burzynski soon followed in such publications as Good Housekeeping, The New York Times, and the Washington Post, many of which portrayed him as a victim of an overzealous FDA. Three members of Congress, two critical of the FDA, took up his cause.
Burzynski also benefited from a shift in the regulatory mood. When thousands of frustrated AIDS and cancer patients besieged Congress, the FDA accelerated the process for approving new drugs and allowed patients broader access to experimental medicines. At the same time, the National Institutes of Health began programs for testing alternative drugs. In 1991, the National Cancer Institute sent six scientists, including its own Patronas, to review a "best-case series" of seven of Burzynski's brain cancer patients. In five of those, Patronas said, radiographs indicated that a large tumor had disappeared after treatment by Burzynski. The NCI offered Burzynski the chance to do free trials. He had only to provide the drugs and approve the experiment's design. By the end of the year, however, the collaboration had dissolved in acrimony, and the NCI halted the research.
By 1997, the FDA's struggle with Burzynski reached the federal criminal courts. That year the Justice Department prosecuted him on behalf of the FDA, charging him with, among other things, mail fraud for illegally shipping his drug across state lines. The trials resulted in acquittal on 35 counts, and the prosecution dropped the other 40.
Still, the FDA got one thing from the court. In 1996, U.S. District Judge Simeon T. Lake III had ordered Burzynski to begin testing his drugs in clinical trials as a condition of his pre-trial release. Burzynski began submitting records for patients already under his care, and he placed new cancer patients in 72 clinical trials.
These trials, if done properly, might finally answer the question of whether antineoplastons really work. Burzynski sent a complete copy of the report he submitted to the FDA to the Cancer Letter, a newsletter for doctors, researchers, and patients. Editor Paul Goldberg sent the data to three nationally known oncologists-the first examination of Burzynski's data by independent experts. Among their conclusions: Burzynski's protocols, or trials, are poorly designed, making data impossible to interpret. "They have all the trappings of protocols," Howard Ozer, director of the Allegheny Cancer Center in Philadelphia, told U.S. News, "but they cannot be analyzed statistically." They also noted that many patients withdrew from the study, even though Burzynski reported that they were responding to treatment. "Usually, people keep taking medicine that's working," says Peter Eisenberg, a Marin County, Calif., oncologist, "unless the side effects outweigh the benefit."