Feature Article

FDA's War on Dr. Burzynski and His Patients: Physician and Pations Win!

Sue A. Blevins, RN, MPH

For many Americans, their fight against cancer is nothing compared to their battles with the Food and Drug Administration (FDA). Just ask the many patients of Dr. Stanislaw Burzynski. They'll tell you about their 14-year war with the FDA and that they won!


Yet, They Still Implore Congress to Reign in the FDA


Here's how their long battle evolved. Since 1977, more than 2,500 cancer patients have sought out an experimental drug named Antineoplaston (meaning anti-cancer) developed by Dr. Burzynski, a polish-born physician and biochemist. Many of the patients had been diagnosed with terminal cancer after chemotherapy and radiation failed to reduce their tumors. Others opted for Antineoplaston treatment as their first choice. Either way, patients (including patients who received Antineoplaston therapy only) and their physicians report that tumors were reduced following the experimental treatment. Some of the patients have even gone into complete remission and none report serious side-effects from the drug. Still, skeptics discount those claims, arguing that Dr. Burzynski's patients would have gone into remission anyway.

In 1983, the American Cancer Society placed Dr. Burzynski's therapy on its "unproven methods" list. That same year, the FDA sought an injunction to stop Dr. Burzynski from treating cancer patients because it had not approved the drug. Federal Judge Gabrielle McDonald denied the FDA's request. Instead, she ruled that Dr. Burzynski could continue to treat patients in Texas, but she prohibited him from shipping the unapproved drug across state lines.

What were the out-of-state cancer patients to do? They had two choices: Move to Texas or resort to their previously failed treatments. Most patients could not afford the move to Texas for Antineoplaston treatment. So they sought out Dr. Burzynski's initial treatment in Texas, and then shipped the drug across state lines themselves, according to Steve Siegel who heads an organization called "The Burzynski Patient Group." His wife, Mary Jo, opted for Antineoplaston therapy as her first choice for cancer treatment. She stresses "What's wrong with this picture? In the United States, the federal government would allow me to cross state lines to get an abortion, but I was not allowed to ship a life-saving treatment across state lines!"

Dr. Burzynski faced numerous battles with the federal government over the years. Between 1986 and 1994, he was subjected to three federal grand jury investigations. No indictments were ever handed down. However, during that time federal officials raided his research clinic and confiscated his patients' medical records.

Then in March 1995, Dr. Burzynski appeared on the CBS television show "This Morning," accompanied by three of his patients. That very afternoon, the FDA raided his clinic again. A fourth federal grand jury investigation got underway. By November 1995, the fourth grand jury charged Dr. Burzynski with 40 counts of distributing a non-FDA approved drug in interstate commerce, 34 counts of mail fraud, and one count of contempt of court for violating the order against interstate delivery of Antineoplastons. Rep. Joe Barton (R-TX) questioned whether the FDA used its power to retaliate against Dr. Burzynski. "It is extraordinarily rare for a grand jury to fail to indict at the request of a U.S. Attorney," Barton told The Washington Times. He noted that a grand jury's failure to indict someone after three attempts is "virtually unprecedented."

A federal trial got underway in January 1997. The trial ended with a hung jury on March 3, 1997. U.S. District Judge Sim Lake declared a mistrial and dropped the mail charges, ruling the federal government failed to prove mail fraud. Then federal prosecutors dropped the 40 counts of interstate commerce.

However, a second federal trial got underway May 19, 1997 to try Dr. Burzynski on the contempt of court charge. The federal government 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, however, argued that Dr. Burzynski treated patients who lived outside Texas, but that he didn't ship the drug to other states. A federal jury acquitted Dr. Burzynski on May 27, 1997.

Dr. Burzynski and his patients may have won this 14-year war with the FDA, but how many future doctors and patients are going to face similar battles? Any doctor who develops an experimental treatment would likely face similar battles. That is why Dr. Burzynski's patients continue to ask Congress to reign in the FDA.

For example, the House Committee on Government Reform and Oversight recently held hearings about FDA abuses (February 4, 1998). Jack Kunnari, the father of 6-year-old Dustin Kunnari, told the Committee "From the time we went to Dr. Burzynski [for Antineoplaston treatment], the biggest threat to Dustin's life was not cancer, it was the FDA. In February 1996, with cold disregard for the life of my son and Dr. Burzynski's other terminal cancer patients, FDA used legal maneuvers to stop them [cancer patients] from receiving Antineoplastons. If not for quick and compassionate action by Congressman Joe Barton and his Investigations and Oversight Subcommittee, FDA would have succeeded. And Dustin would not be here today," said Kunnari.

"FDA claims it is protecting cancer patients," he said. "We do not want your protection," Kunnari told the Committee. "Under your protection, cancer deaths climb every year. In my opinion, the actions of your [FDA] agency are un-American and unconstitutional...As members of Congress it is your duty to uphold the system of checks and balances. It is up to you to reign in this FDA."

Sue A. Blevins is president of the Institute for Health Freedom. Her address is Institute for Health Freedom, 1155 Connecticut Ave., N.W., Suite 300, Washington, DC 20036. (202) 429-6610. Web site: http://www.ihf-healthfreedom.org.

Originally published in the Medical Sentinel 1998;3(4):134-135. Copyright © 1998 Association of American Physicians and Surgeons (AAPS).