Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
Reuters NewMedia, Inc. - 20 Nov 1995
James Pierpoint / Reuters NewMedia
Capping a decade-long probe by the U.S. Food and Drug Administration (FDA), the indictment alleges Burzynski and his Burzynski Research Institute violated federal drug laws by producing and selling antineoplastin, an experimental drug originally derived from human urine.
In the indictment, the grand jury alleged that Burzynski, 53, and his clinic did not have FDA approval to administer the drug to more than 2,500 patients and defrauded insurers by filing misleading claims for payment.
"Antineoplastin has never been approved by the Federal Drug Administration for any use, and the drug has never been generally recognized by qualified medical and scientific experts as safe and effective," said U.S. Attorney Gaynelle Griffin Jones
Burzynski remained free. His attorney, Richard Jaffe, said in a telephone interview that he expected a summons to be issued next week for his client's arraignment.
Burzynski and his clinic have been targeted by four grand jury investigations over the past 10 years, company spokesman Dean Mouscher said. The first three adjourned without returning indictments, he said.
"I guess the lesson is if you ask enough grand juries to indict, you'll find one that will," Mouscher said.
Burzynski's treatment of a Michigan teen-ager with an inoperable tumor was the focus of a continuing congressional probe into allegations the FDA has harbored vendettas against firms challenging its decisions to withhold approval of certain drugs and medical devices.
The FDA, in a statement released with the indictment, said its primary mission was to assure that drugs were safe and effective. The agency did not comment on the Burzynski indictment.
Burzynski's Houston clinic was first raided in 1985. Federal investigators in 1993 seized materials from a nearby production facility, Mouscher said.
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