Burzynski Research (BZYR)

[sunspotter]

BZYR has been on the go for a long, long time.


But there are many red flags, not least this law suit from sixteen years ago:

8:12 PM 11/20/1995

Doctor indicted on fraud charges related to cancer drug

By DEBORAH TEDFORD
Copyright 1995 Houston Chronicle

A Houston doctor who developed a controversial cancer drug and was investigated for 12 years was indicted Monday on 75 charges of mail fraud, contempt and violations of U.S. Food and Drug Administration laws.

The protracted investigation of Stanislaw Burzynski and The Burzynski Research Institute had caused U.S. Rep. Joe Barton, R-Ennis, to say it smacked of a vendetta.

In September, Barton and his subcommittee on oversight and investigations began investigating charges the U.S. attorney's office here and the FDA have participated in a campaign of harassment against Burzynski since 1983.

However, U.S. Attorney Gaynelle Griffin Jones said Monday afternoon the investigation was so lengthy because the FDA has been attempting to work with Burzynski for years.

The charges stem from a cancer drug Burzynski developed -- antineoplaston -- that initially was made from human urine and is now made from a synthesized version.

The drug is manufactured in Stafford and dispensed through Burzynski's clinic at 12000 Richmond in Houston.

Prosecutors allege he used the non-FDA-approved drug on more than 2,500 patients for a variety of illnesses -- AIDS, arthritis, cancer, lupus, multiple sclerosis and Parkinson's disease. Forty of the counts charge Burzynski with introducing an unapproved new drug into interstate commerce.

Jones said her office's pursuit of the case demonstrates her commitment to investigating health care fraud and other health care-related offenses.

But Richard Jaffe, attorney for Burzynski, said there has been no fraud, that the Polish-born doctor has received FDA approval on Investigational New Drug (IND) applications for every drug he uses.

He also said Burzynski, 53, has FDA permission to ship the drug abroad in some cases, and also ships it in interstate commerce under compassionate use" INDs --again with FDA approval.

Elaine Crosby, director of compliance for the FDA, was present when Jones announced the indictments. Although Crosby read a brief statement reiterating the FDA's goal of protecting the public health, Jones blocked media attempts to ascertain exactly what approvals the FDA had given Burzynski.

Burzynski and the institute also are charged with 34 counts of mail fraud for allegedly submitting false claims for payment to health insurance providers.

In 1983, the FDA sought an injunction to keep Burzynski from treating advanced cancer patients with his antineoplaston drug. Then-U.S. District Judge Gabrielle McDonald denied the request, but forbade Burzynski from shipping the drug across state lines because it had not gone through the FDA approval process.

The doctor and the clinic are charged with being in contempt of McDonald's order because they allegedly delivered the drug into interstate commerce without following the FDA's regulations for experimental drugs.

The indictment further charges that delivery of the drug within Texas also was prohibited by state law.

In 1988, the Texas Department of Health said Burzynski's use of the unproven drug violated the Food, Drug and Cosmetic Act, and the state attorney general's office sued him in 1992.

That suit is on hold pending the outcome of a like case involving the Texas Board of Medical Examiners.

In that case, the board -- contrary to a finding by an administrative law judge -- said in 1994 it was illegal for Burzynski to treat patients in Texas, and placed his license on probation for 10 years.

A state district judge in Austin overturned the board's action and dismissed the case. It is currently under appeal.

Jones said Burzynski and the institute grossed more than $40 million from 1988 through 1994 from producing, prescribing and selling the non-approved drug.

The case was investigated by the FDA and the Postal Inspection Service"