Trials of a Cancer Doc
Experimental drugs and a 20-year fight with the FDA
To thousands of cancer patients who have failed to benefit from standard medical treatments and who have reached the end of hope, Dr. Stanislaw Burzynski possesses the cure of last resort. Burzynski runs a cancer clinic in Houston, where he has treated at least 3,000 cancer patients with experimental drugs he developed more than 20 years ago. Patients come from as far away as Turkey and Chile for his treatments, and pay up to $14,000 a month, hoping for a cure.
It's a hope that Burzynski himself has fueled assiduously. In appearances on television shows like 48 Hours he talks of his drugs curing cancer; his Web site claims few side effects. His supporters claim that his drugs can reduce a brain tumor from "the size of a grapefruit to smaller than a pea."
In interviews with the New York Times and U.S. News, and according to Justice Department papers, the doctor has said his experimental drugs, known as antineoplastons, can help patients with not only a wide array of different cancers, such as prostate, brain, breast and lung, but also a host of other diseases such as multiple sclerosis, arthritis, Parkinson's disease, HIV, and even baldness.
Loyal following. Patients who have taken Burzynski's antineoplastons and gotten better--and there are hundreds of them, he says--compose an intensely loyal following. Pam Murphy, of St. Peters, Mo., believes that antineoplastons have relieved the debilitating symptoms of a rare connective-tissue disease that afflicted her. The parents of 7-year-old Dustin Kunnari from Aurora, Minn., credit antineoplastons with curing their son's medulloblastoma, a type of brain tumor. Mary Jo Siegel, of Pacific Palisades, Calif., believes that antineoplastons cured her lymphoma in 1993. She is now his most vocal supporter. "Dr. B. is a miracle worker," she says. Without him, she says, "I wouldn't be here today." Some doctors also have been impressed by the apparent results of the treatment. Dieter Schellinger, a neuroradiologist at Georgetown University Medical Center, said he was "surprised" by some responses he saw when he reviewed the MRIs of nearly 40 patients whose brain tumors, Burzynski claims, responded to his drugs. "I don't know of any active agent that produces these results," said Nicholas Patronas, a radiologist at the National Cancer Institute, after reviewing five of Burzynski's brain-tumor cases.
Given such testimonials, the U.S. Food and Drug Administration, the agency that approves drugs for treatment and sale, would like to know if Burzynski is really on to something. But it has yet to see convincing scientific evidence that antineoplastons are either safe or effective. The FDA has spent 20 years and $2 million trying to force Burzynski to put his antineoplastons through standard testing regimens, called clinical trials, which are required to gauge whether drugs work.
These struggles have cost the doctor. The Justice Department prosecuted Burzynski in 1997 on a 75-count indictment for selling and administering antineoplastons without FDA approval. Texas medical authorities threatened to revoke his medical license for illegally marketing his drugs. But Burzynski has fought back with persistence and skill. With supportive patients lining courthouse steps and entreating judges on his behalf, he has beaten federal prosecutors, fended off the state of Texas, and held off the FDA. With new patients walking in the door nearly every day, Burzynski has become the most visible purveyor of an unapproved cancer treatment in the nation, with his clinic grossing, he acknowledges, an amount that "could" approach $9 million last year alone. (He says all revenues are used to run the clinic, and it ran at a loss last year.) Burzynski, says Michael Petty, a former FDA lawyer who now practices in Washington, D.C., "has beaten the system."