Malignant Law Enforcement

The FDA's war against an unorthodox cancer doctor.

Brian Doherty from the May 1997 issue

(Page 3 of 3)

Despite all his FDA troubles, Burzynski hasn't set up shop in Mexico, where desperate patients in search of alternative treatment already go for such supposed cancer cures as Laetrile. There, he could charge whatever he wanted, with no hassles from the authorities. And though he seems to be making a tidy living at his practice, Burzynski doesn't make wild promises to every patient who comes his way. He readily admits that there are certain cancers for which his treatment just doesn't seem to work. Mary Jo Siegel--who is now in total remission from a low-grade non-Hodgkin's lymphoma, a recovery for which she credits antineoplastons--learned about Burzynski from a fellow cancer support group member with ovarian cancer, who had gone to Burzynski for help but was turned away. Burzynski told her he'd had little luck with ovarian cancers.

Nor is Burzynski's treatment approach utterly implausible. In addition to radiation and chemotherapy, the National Cancer Institute recognizes "biological treatment"for cancer, which "uses materials made by your body or made in a laboratory to boost, direct, or restore your body's natural defenses against disease."In the 1980s, NCI scientists were interested enough in antineoplastons to check out some of Burzynski's best cases, and they were impressed enough by what they saw to begin trials, which ended inconclusively after Burzynski disapproved of their methods. The NCI shifted from a protocol on which both parties had agreed, Burzynski says, and began including patients whose tumors were too big and had spread too far for the doses of antineoplastons used. But NCI researcher Nicholas Patronas, a member of the team that looked into Burzynski's treatment, nevertheless testified during the Texas medical board hearings that the results he saw were "amazing."Antineoplastons seemed to have eliminated at least five patients' brain tumors, he said, and "they are not handicapped from the side effects,"whereas "side effects of the most aggressive previous treatments are worse than the tumor itself. I think it is impressive and unbelievable."

The NCI is even now studying a substance called phenylacetate, chemically similar to antineoplastons but not patented by Burzynski. One scientist who has worked with the NCI and the National Institutes of Health says he has done enough in vitro work to feel confident that Burzynski is on to something--that it is the particular combinations of amino acid chains in the antineoplaston treatment that work, much better than phenylacetate alone. Yet he insists that higher-ups in the NIH had no interest in pursuing this work because of animus against Burzynski, or at least because of the unsavory reputation his ongoing FDA fights have given him.

Several factors have made it hard for Burzynski to improve his reputation. He has a disturbing tendency to compare himself to Galileo and Pasteur, in classic quack style. He and his supporters tend to blame huge, vague, overarching conspiracies on the part of the establishment for his troubles. Because he has patented the antineoplaston formulas, Burzynski stands to profit even more handsomely than he has so far if the drugs pan out in clinical tests. He makes sweeping statements about the potential of antineoplastons, not only for treating various types of cancer but for curing ailments such as AIDS, lupus, multiple sclerosis, arthritis, and skin diseases--all of which he attributes, like cancer, to information processing failures.

Burzynski's public relations apparatus also engages in some questionable practices, such as circulating a letter, supposedly from the chairman of the Department of Neurosurgery at the University of Texas M.D. Anderson Cancer Center, recommending antineoplastons for a prominent Houston TV news anchor. The doctor is adamant that he never signed or approved the letter, which he says his secretary wrote at the patient's insistence. Finally, while it probably shouldn't be held against him, Burzynski's Polish-inflected speaking voice is eerily reminiscent of Dr. Nick Riviera, the recurring quack-for-all-seasons on The Simpsons.

In the end, none of this should be relevant. However disreputable Burzynski may seem, however much money he's making, the scientific issue of whether his treatment works still has to be resolved. By the same token, the anecdotes and testimonials from his patients do not count as proof. Most of Burzynski's patients see other doctors in their hometowns. Mary Jo Siegel is a patient of Dr. Peter Rosen at UCLA, who remains resolutely unimpressed by her remission. Spontaneous remissions, however rare, do happen, and he thinks that they explain Burzynski's apparent successes.

Dr. Carl Ott of the Memorial Clinic in Olympia, Washington--another doctor with a brain tumor patient, Richard Gribben, who has improved under antineoplaston therapy--still doesn't recommend it to patients generally, mostly because "people don't often come to me for advice on unconventional therapy. If [Gribben] had any real hope with conventional therapy, I would have tried hard to talk him out of [using an-tineoplastons]. Our oncologist on staff thinks Burzynski is a quack preying on the desperate. When he saw the results [with Gribben], he just kind of shrugged his shoulders."Might Gribben have undergone a spontaneous remission? "I've been in practice 10 years,"says Ott. "I see 10 people a year with similar problems, and I've never seen a spontaneous remission comparable to this. Some do better than others, but I've never seen advanced tumors disappear spontaneously like this. I hope they don't shut Burzynski down. He's been remarkably effective and nontoxic for my patient."

But if Burzynski is imprisoned, the research will come to an end. Steve Siegel asked U.S. Attorney Mike Clark whether the government had a contingency plan for the patients should Burzynski go to prison. "He said, 'That's not my responsibility,'"Siegel recalls. "He would assume that responsibility is with the FDA. But the Patient Group had a meeting with the FDA in early December. They said it wasn't their responsibility if the clinic closes down, either."Says Burzynski, almost nonchalantly, "If I am in prison, this whole thing would collapse and people will die."

Burzynski isn't going to prison--yet, anyway. Just before press time, the jury in his Houston trial announced that they couldn't reach a verdict. Six jurors wanted to acquit and five wanted to convict on all 75 counts. One juror was undecided. The judge then dismissed the charges of insurance fraud. U.S. Attorney Clark vowed to bring Burzynski to trial again in May on the FDA-related charges.

Burzynski's satisfied patients and would-be patients don't care whether he has dotted all his is to please FDA bureaucrats. They are sick; they are dying; in most cases, they've been told by a bevy of the best conventional doctors that they are as good as dead. (The path to Burzynski, for the patients I talked to, wound its way first through places like Stanford, UCLA, the Mayo Clinic, and the Dana Farber Cancer Center.) What possible harm, they wonder, is the FDA trying to prevent by keeping us from taking the substances we want, that we think give us some hope?

The FDA is not completely deaf to such appeals. Washington, D.C., lawyer Jonathan Emord represents patients petitioning the FDA's Center for Drug Evaluation and Research for "compassionate use"exceptions or slots in the clinical trials. Sometimes he succeeds; sometimes he fails. Emord is eagerly awaiting the Supreme Court's response to last year's rulings by two circuit courts declaring a right to die in certain circumstances. If upheld, those decisions could open the door to new arguments about the right of dying patients to take any treatment they choose.

When faced with a face, a name, a case, a specific impending death, the FDA often is capable of bureaucratic mercy. But patients wonder: Why must they make it so hard? Why must we come before them as supplicants? Why not just let us pay our money and take our chances?

"Sure, there's the safety valve of the compassionate use exception,"says the congressional staffer who works on the Burzynski case. "And the agency has told me off the record that they've approved 90 percent of compassionate use requests from Burzynski. But what about the 10 percent? I knew one 67-year-old man with prostate cancer and a heart condition. The FDA at first refused him, saying surgery could still work for him. The man didn't want surgery. He was afraid of dying on the table because of his heart condition. The patient didn't consider surgery a viable option for himself--but the FDA did. He eventually got his way, because the FDA wondered if they could defend this decision before Congress.

"That's a hell of a way to make decisions for terminally ill people."

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