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The following article appeared in The Wall Street Journal, June 2, 1997:

Fighting Cancer—and the FDA

by Sue A. Blevins
June 2, 1997

Paul Michaels is only 16, but he's endured enough battles to last a lifetime. When he was four, Paul was diagnosed with an inoperable brain tumor; doctors said he wouldn't live beyond 10. Rather than accept that verdict, his parents consulted a number of physicians across the country and eventually chose to treat him with an experimental drug called antineoplastons. The treatment appears to have worked. Paul's mother, Mary Michaels, says that MRI scans show Paul's tumor, once three inches in diameter, has shrunk to the size of a pea, and he leads a normal life. Paul remains on antineoplastons.

Pursuing that treatment, however, meant joining another battle, one that in some ways has been more frustrating than the fight against cancer: a battle against the Food and Drug Administration. Antineoplastons have not gone through the FDA's rigorous evaluation process, and therefore do not have the agency's approval. Paul's parents knew this when they decided on his therapy, but that's not enough to satisfy the regulators, who are dead set against allowing even terminally ill patients the freedom to choose therapies that lack the FDA's imprimatur. Paul and his mother have made several trips to Washington over the years, pleading with Congress to get the FDA off their backs. "It's like I'm at war against cancer, and the federal government keeps trying to take away the only weapon I have," Paul told one congressional subcommittee.

FDA Loses a Round

The FDA has lost one round in that battle. Last week a federal jury acquitted Stanislaw Burzynski, the doctor who manufactures antineoplastons. Dr. Burzynski, a Polish-born physician and biochemist, faced contempt-of-court charges for violating a 14-year-old injunction against shipping antineoplastons across state lines. In the 1983 case, the FDA had sought an injunction to stop Dr. Burzynski from using antineoplastons at all. Federal Judge Gabrielle McDonald turned the FDA down, holding that Dr. Burzynski could continue to treat patients with antineoplastons--but only in his home state of Texas. Once the drug crossed state lines, Judge McDonald declared, the FDA's federal jurisdiction kicked in.

Most of Dr. Burzynski's out-of-state patients couldn't afford to move to the Lone Star State. They traveled to Houston for initial treatment, and then moved the drug across state lines for their own personal long-term use, according to Steve Siegel, who heads an organization of Dr. Burzynski's patients. The patients also established a legal defense fund for Dr. Burzynski, knowing that unless he prevailed against the FDA, they would lose their cancer treatment.

The FDA continued its attempts to prosecute Dr. Burzynski. It took four grand jury investigations before an indictment was finally handed up. Dr. Burzynski was charged with 40 counts of distributing an unapproved drug in interstate commerce, 34 counts of mail fraud and one count of contempt of court for violating the 1983 court order. Dr. Burzynski was tried on those charges in February. A mistrial was declared in March, and the 34 counts of mail fraud were dropped. Federal prosecutors later dropped the 40 counts of interstate distribution of an unapproved drug. But on May 19 a second trial commenced on the contempt charge. Prosecutors claimed Dr. Burzynski violated the previous court order because he continued to treat patients who lived out of state, knowing they might ship the drug across state lines. The defense argued that Dr. Burzynski treated patients who lived outside Texas, but that he didn't ship the drug to other states. The jury deliberated for three hours before acquitting Dr. Burzynski.

The FDA, meanwhile, has approved antineoplastons for clinical trials. So Dr. Burzynski's patients are free to continue their treatment. But how many more cancer patients are going to face similar problems with the FDA? "I think it's safe to assume that most Americans don't even realize that they don't have the right to decide how they will cure their own disease," says Candace Campbell, executive director of the American Preventive Medical Association. "For instance, in California, it is illegal for a doctor to treat cancer with anything except [FDA-approved] chemotherapy, radiation and surgery."

That is why doctors and patients across the nation are pushing for federal legislation that would give Americans the right to use medical treatments not currently approved by the FDA. The Access to Medical Treatment Act, sponsored by Reps. Peter DeFazio (D., Ore.) and Joe Barton (R., Texas), would allow patients to be treated by a licensed health-care practitioner with any medical treatment, so long as they are informed about the risks and benefits of the treatment. "I want to get the thousand-pound gorilla known as the FDA off of the backs of people who want access to beneficial alternative health treatments, without compromising the public's safety," Rep. DeFazio says.

Supporters of the bill are not trying to eliminate the FDA's role entirely. Practitioners would be required to inform patients whether the agency has approved a drug. "There is a role for the FDA," says Ed Gochenour, a Georgia state senator who was recently treated with antineoplastons. "Ideally, I'd like the FDA to tell me whether or not a drug is toxic, but beyond that I'd like to make my own decisions on whether or not I want to use it."

Three Different Answers

Last November, the 44-year-old Mr. Gochenour was diagnosed with a brain tumor, and sought the advice of numerous neurosurgeons in the Atlanta area. "I got three different answers from three top doctors," says Mr. Gochenour. "One doctor suggested chemotherapy, then radiation and then gamma-knife treatment. The second recommended surgery, then radiation and then finally chemotherapy. The third recommended starting with chemotherapy, followed by radiation, and then told me that the gamma-knife treatment and surgery would destroy good cells and should be used as last resorts." After Mr. Gochenour's cancer made headlines in Georgia, he received some 40 letters and phone calls suggesting alternative treatments. Roughly half mentioned Dr. Burzynski's antineoplaston therapy.

As a result, Mr. Gochenour decided to meet Dr. Burzynski and undergo antineoplaston treatment. "Now my tumor is gone and I didn't even experience any toxic side effects from Dr. Burzynski's treatment," Mr. Gochenour says. Six months later, he remains comfortably on his antineoplaston regimen.

Cancer patients shouldn't have to break the law in order to use the medical treatment of their choice. And even though Dr. Burzynski's patients won one round with the FDA, how many future cancer patients must fight battles to gain access to the medical treatment of their choice? The only way to ensure that Americans are free to choose their own medical treatments is to recognize that health freedom is a basic right.

Ms. Blevins is president of the Washington-based Institute for Health Freedom.

Reprinted with permission of The Wall Street Journal. Copyright © 1997, Dow Jones & Company, Inc. All rights reserved.