Malignant Law Enforcement

The FDA's war against an unorthodox cancer doctor.

Mary Michaels is pleased to tell me that her 16-year-old son, Paul, is in front of their house in Troy, Michigan, washing the car. More pleased than you might imagine. Nearly a dozen years ago, the 4-year-old Paul was diagnosed with an astrocytoma, the most common type of brain tumor. The prognosis was grim. Doctors warned that the tumor was too entwined in Paul's brain and optic nerve for debulking surgery--where doctors saw through the skull and physically remove the cancer--to do any good.

More bad news followed. Radiation and chemotherapy are the main weapons of mass destruction in the cancer doctor's arsenal. But they've got their own problems. Chemotherapy powerful enough to annihilate Paul's tumor would probably kill him too. The radiation would likely blind him, stunt his growth, and make him incessantly nauseated, and in the end might not give him much more time.

"We started thinking, 'Why would we do this?'"Mary says. "It would be torturing Paul. But the doctors' attitude was, 'You have to treat it somehow.'"So the Michaelses turned to the grab bag of alternative cancer treatments popular among those mistrustful of standard medicine: "We became macrobiotic. The tumor grew. We went to Mexico for Laetrile. The tumor still grew. As crushed as you are coping with a malignant, inoperable tumor, it takes a lot for hope to die."

Then Mary saw an episode of the Sally Jesse Raphael show about a Polish-born cancer doctor named Stanislaw Burzynski. Some of Burzynski's patients had suffered from astrocytomas that apparently had been cured by his unorthodox treatment. "The people on the show were so healthy-looking,"Mary recalls. "I couldn't believe they were cancer patients."By that time, doctors at the prestigious Mayo Clinic had given Paul a definite death sentence. He had the largest brain tumor they'd seen in anyone that age, they said, larger than an egg. In a last-ditch effort, Mary sent Dr. Burzynski her son's scans and medical history. Burzynski thought he might be able to help.

That was more than a decade ago. Whether Burzynski in fact helped Paul remains an open question. But after years of treatment with Burzynski's patented substances, antineoplastons, Paul is 16. Back in the early years of his cancer, every doctor assured Mary that Paul wouldn't make it past the age of 10. The egg-sized tumor is now pea-sized, and, unlike heavy users of chemotherapy and radiation, Paul is neurologically normal and healthy in every way. The cancer, for now, seems under control. (Tumors are often known to return with a vengeance after seeming remission, however.) The biggest danger now to Paul's continued life and health, his mother says, is the U.S. Food and Drug Administration.

The FDA has a long-standing dispute with Stanislaw Burzynski that has embroiled both parties in legal maneuvers for 14 years and earned the agency the ire of Burzynski's patients. As Paul Michaels is wont to tell the press, echoing many other patients, "The government is trying to take away the only weapon I have against cancer."In the struggle for the hearts and minds of politicians and journalists, Burzynski and his patients are at least holding their own. Rep. Joe Barton (R-Tex.), chairman of the House Subcommittee on Oversight and Investigations, has led sympathetic congressional hearings. While the print press tends to be skeptical, Burzynski has been presented in a mostly positive light on TV shows ranging from Hard Copy to CBS's 48 Hours and ABC's Nightline.

Depending on your point of view, the FDA officials battling Burzynski are mindless bureaucrats blocking access to a promising new therapy or dedicated public servants trying to prevent a quack from taking advantage of desperate patients. The truth probably lies somewhere in between. On the one hand, the government has been hard pressed to cite any serious danger from allowing Burzynski to continue treating patients with antineoplastons. On the other hand, despite numerous dramatic anecdotes and testimonials, the effectiveness of Burzynski's approach has yet to be demonstrated. Whatever the merits of antineoplastons, Burzynski's dispute with the FDA starkly poses the question of who should get to weigh the costs and benefits of experimental treatments: the patients whose lives are at stake or regulators acting on their behalf.

Ever since the late 1970s, when Burzynski was a researcher at Baylor College of Medicine in Houston and just beginning to work out his theories on antineoplastons, the FDA has been skeptical of this foreign doctor who dared suggest he had discovered something that might--sometimes, under some circumstances--be a cure for cancer. The FDA has protocols for bringing new drugs to market, and Burzynski has a long history of flouting them. He left Baylor in 1977 amid controversy over antineoplastons--amino acid chains that he believes can communicate "switching off"signals to multiplying cancer cells. Without jumping through the FDA's hoops, Burzynski began treating patients with the substances. He originally extracted his antineoplastons from human urine--a point that has proven priceless for those seeking to cast Burzynski and his drugs in an uncharitable light--but now synthesizes them in a lab.

Burzynski gives me a rough explanation of his theory by telephone during a day off from the latest battlefield of his war with the FDA: a federal courtroom in Houston where he faces up to 290 years in prison for allegedly violating FDA regulations concerning experimental drugs and misinforming insurance companies about the nature of his therapy. "The theory is that cancer is a disease of information processing,"he says. "The cancer cells are mistakenly programmed to multiply all the time. There are various switches where you can turn them off, that define 'to be or not to be' for cancer cells. All the antineoplastons do is turn off that switch. But different cancers are caused by different oncogenes. Our switches seem to work on two different genes, and we can't help everyone."

The conflict between the FDA and Burzynski is complicated by the fact that both sides are now sleeping with the enemy. Even as Burzynski fights to stay out of prison for breaking the agency's rules, the FDA has approved and is supervising a set of Phase II clinical trials to test the value of antineoplastons. (Technically, the FDA does not supervise clinical trials, as they will tell you. In practice, however, anyone who wants the approval of the new drug application at the end of the trials will take the advice and obey the whims of the FDA, says former FDA Chief Counsel Peter Barton Hutt.) As a result, Burzynski might get the equivalent of a life sentence for technical violations of FDA regulations, while simultaneously being hailed for discovering a powerful cancer-fighting tool.

The FDA first tried to stop Burzynski from treating patients with antineoplastons in 1983, when it filed a lawsuit against him in federal court. U.S. District Judge Gabrielle McDonald ruled that, while interstate trafficking in the unapproved drugs would have to stop, Burzynski could still treat patients in Texas without FDA interference. During that case, the government side made a motion for summary judgment, which read in part: "If the court declines to grant this injunctive relief sought by the government, thus permitting continued manufacture and distribution of antineoplastons, the government would then be obliged to pursue other less efficient remedies, such as actions for seizure and condemnation of the drugs or criminal prosecution of individuals."This court would then be faced with ordering the government not to undertake such enforcement actions, if the court truly desired to allow the continued manufacture and distribution of the drugs."

The government has followed through on that threat, illustrating a tendency cited by former FDA Chief Counsel Hutt: "When the FDA loses a case, it has a mind like an elephant.... Once the FDA makes a collective decision, trying to make it let go is almost impossible. These are 'FDA crusades.' In a real sense, they're vendettas."(See "Clinical Trials,"May 1995.)

In 1985, the FDA got a search warrant for Burzynski's office, based on the suspicion that he was violating the ban on interstate distribution of antineoplastons. Agents confiscated thousands of patient records. FDA officials allowed Burzynski access to the records only at their convenience and forced him to photocopy them before leaving the agency's Houston office. Burzynski, various patients, and several of his associates were called up before three different grand juries from 1985 to 1994. No indictment followed.

These repeated attempts to incriminate Burzynski led Rep. Barton to send an angry letter to Attorney General Janet Reno in September 1995. "It would appear,"he wrote, "that the FDA and the Justice Department are abusing the grand jury process to harass and punish Dr. Burzynski for persuading a federal judge that he is not violating the law by practicing medicine within the State of Texas."Barton asked for all the documentation regarding the government's fight against Burzynski. With political pressure on the FDA regarding more than a decade of harassment with no criminal indictment, in November 1995 a fourth grand jury finally gave the government what it wanted: a 75-count indictment against Burzynski, which led to the trial in Houston.

The government tried to prove that Burzynski treated out-of-state patients with antineoplastons, in violation of Judge McDonald's order. It also alleged that he committed mail fraud against insurance companies by not informing them about the experimental nature of the work for which he was charging them. Most of the patients I interviewed said their insurance companies didn't pay for antineoplaston treatments anyway. Burzynski has been in court many times in civil suits with insurance companies over payment for his treatment. He's won some and lost some.

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