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Biotech / Medical : Burzynski Research Institute (BZYR) -- Ignore unavailable to you. Want to Upgrade?

To: paul j. gourley who wrote (13)2/11/1998 1:29:00 PM
From: bebu  Read Replies (1) | Respond to of 15
7:45 PM 2/10/1998

Burzynski agrees not to distribute cancer drug in Texas
Copyright 1998 Houston Chronicle Medical Writer

The Texas Attorney General's office and a controversial Houston physician formally agreed Tuesday that the doctor will not distribute his unapproved cancer drug in the state or treat patients who are not in a federally approved study.

However, it is unlikely the accord will limit Dr. Stanislaw Burzynski's use of the medicine antineoplastons.

Robert Reyna, chief of the Dallas consumer protection office for the attorney general, and Richard Jaffe, Burzynski's lawyer, said the court agreement will have little effect because most of the doctor's patients are in one of 72 studies approved by the U.S. Food and Drug Administration.

Burzynski has agreed to pay $50,000 to the Texas Attorney General's office and the Texas Department of Health to reimburse the agencies for attorneys' fees and the costs of investigations, Reyna said.

The agreement stipulates that Burzynski:

ú Refrain from distributing his unapproved drug antineoplastons in Texas.

ú Use antineoplastons only to treat people enrolled in one of his 72 clinical trials being conducted with the approval of the U.S. Food and Drug Administration.

ú Not advertise antineoplastons cancer treatment.

úPlace a disclaimer on his Web site and other material stating that the safety and effectiveness of antineoplastons have not been established.

Burzynski now practices under a 10-year probationary order from the Texas State Board of Medical Examiners. Those requirements are similar to the agreement with the attorney general.

He had appealed the state board's order, but he lost his case last year before the Texas Supreme Court.

By signing the agreement with the attorney general, Burzynski admitted that the drug never had been legally sold in Texas, Reyna said.

The medical board will monitor Burzynski's practice and investigate any patient complaints, said Reyna.

The attorney general's office will monitor use of antineoplastons in Texas.

Jaffe said he is satisfied with the agreement. "It is the first time since 1983 that Burzynski has been without pending state or federal action against him," Jaffe said.

Burzynski began using antineoplastons in the late 1970s. At that time, the drug was not approved for study or use by the FDA.

Texas officials did not take action against Burzynski at that time, saying he could do what he wished in his own practice.

But in 1983, a federal judge in Houston told Burzynski he could not send the drug across state lines.

In 1991, the National Cancer Institute agreed to oversee studies of antineoplastons at institutions unrelated to Burzynski.

However, few patients enrolled in the studies that began in 1993. They were ended in 1995 when the NCI and the physician could not agree on how to change patient qualifications so that more people could participate.

In 1995, Burzynski was indicted on federal fraud charges related to use of the drug, but some charges were dismissed by the federal judge in the case. Juror were deadlocked on the remaining counts.

Subsequently, government prosecutors dropped all but one remaining charge against Burzynski. In May, the doctor was acquitted on that count of violating a 1983 federal court order prohibiting him from sending his drug across state lines.

In 1996, the FDA approved at least 60 new clinical trials of antineoplastons to be run by Burzynski and the Burzynski Research Institute.