Outraged cancer patients protest FDA's deadly action.
Late Friday afternoon, U.S. District Court Judge Sim Lake told attorneys for Houston M.D. and Ph.D Stanislaw Burzynski that he will issue a decree this week forbidding him from treating patients who live outside of Texas. More than 90% of Dr. Burzynski's patients are not Texas residents.
The ruling sharply contrasted with a Dec. 8 hearing, at which Judge Lake said he would "not prohibit [Dr. Burzynski] from treating people when the government has had 12 years to bring this indictment."
It was not clear what was behind the judge's abrupt about-face.
The move is the latest development in a 13-year battle between the FDA and the Polish-born doctor, the inventor of what many consider the most promising cancer therapy to date. In 1991 a team of National Cancer Institute (NCI) experts reviewed the records of seven patients with normally incurable brain tumors and verified five complete remissions -- disappearances of tumor. In a 1993 hearing in Austin, the NCI's Chief of Neuroradiology testified that patients would die if deprived of Dr. Burzynski's drug, antineoplastons.
Dr. Burzynski first discovered his antineoplaston treatment in Poland while working on his Ph.D thesis. He found naturally-occurring non-toxic peptides in blood that in many cases can "re-program" cancer cells to die like normal cells, without the toxic effects of conventional chemotherapy. He moved to the U.S. in 1970 to escape communist oppression and seek freedom of conscience.
In 1983 the FDA filed civil suit in federal court to stop Dr. Burzynski from treating patients. Judge Gabrielle McDonald ruled that Dr. Burzynski may not ship his drugs out of state, but may continue to manufacture and use them within the State of Texas.
Robert Spiller, the FDA's associate chief counsel for enforcement, told the judge he would ignore her decision and do whatever necessary to stop Dr. Burzynski, "such as actions for seizure and condemnation of the drugs or criminal prosecutions..."
Since then, Dr. Burzynski has been the target of four federal grand jury investigations. The first three did not return indictments. The fourth grand jury investigation caught the attention of Rep. Joe Barton (R-TX), Chairman of a House Investigations Subcommittee.
Following hearings on FDA abuses of authority, Barton concluded that "Dr. Burzynski has been the victim of an extraordinary abuse of our legal system..." Committee member Richard Burr (R-NC) commented "the FDA is an agency out of control. Its lawyers have such a weak case it's not prosecution, it's persecution."
Ironically, Dr. Burzynski is currently conducting four Phase II clinical trials approved by the FDA, and is more than halfway through the FDA's approval process. His own manufacturing facility has passed FDA inspection as well.
Reports on Dr. Burzynski have been featured on or in: The New York Times US News and World Report Good Housekeeping ABC News Nightline CBS Evening News CBS This Morning CBS Street Stories Sally Jesse Raphael Gabe Pressman Investigative Reports 20/20
CONTACT: Burzynski Research Institute
Dean Mouscher, 713/597-0111
After hours call: 713/596-5355