Sunday, November 14, 2004

Saul Green Letter to Wash Post re: Burzynski

Doctor Indicted Over Cancer Drug

Washington Post Article
Dr. Saul Green's Letter to the Editor
About Dr. Saul Green


Doctor Indicted Over Cancer Drug
Mail Fraud, Rule Violations Alleged; Physician Claims FDA Retaliation
Washington Post, 11/21/95
by John Schwarts, Washington Post Staff Writer

A Houston physician who claims he is the victim of a retaliation campaign by the Food and Drug administration was indicted yesterday on 75 counts of mail fraud and violation of federal medical regulations.

U.S. Attorney Gaynelle Griffin Jones said that Stanislaw R. Burzynski and the Burzynski Research Institute introduced an unapproved anti-cancer drug into Interstate commerce, submitted false and misleading claims to health insurers for payment, and violated a federal court order prohibiting interstate trade in the drug without following FDA regulations.

The FDA has never certified Burzynski's drug, which he calls 'antineoplastins,' as safe or effective. Trading insuch unapproved drugs across state lines violates federal law. Byrzynski's critics say that he is playing on the fears of desperate cancer and AIDS patietns, and that he charged those patients $40 million for antineoplastons from 1998 to 1994.

Burzynski has sold the drugs for treatment of a wide range of conditions including several kinds of cancer, AIDS, lupus, multiple sclerosis, Elephant Man disease and baldness.

Last year, the 5th U.S. Circuit Court of Appeals in Nw Orleans ruled that Burzynski defrauded a patient's health insurer as to the legality of his treatments.

Burzynski's attorney, Rick Jaffe, said in an interview yesterday that "I haven't really read the indictment. We'll look at it carefully." He added, however, that he believes -- based on what he has heard of the charges -- that they are wrong, because his client treats patients in Texas and has not sent drugs outside of the Lone Star State without FDA approval.

Burzynski originally derived antineoplastons from human urine. His claims of successful treatment of supposedly hopeless cancer cases have been widely publicized on network television and in print.

Last July, one of Burzynski's patients, brain cancer survivor Paul Michaels, appearing before a congressional subcommittee investigating whether the FDA retaliates against its critics, testified that the doctor's treatments had saved his life. "It's like I'm at war against cancer, and the government keeps trying to take away the only weapon I have." Jaffe testified at the same hearng that his client was being persecuted by the FDA for going against the conventional wisdom of the medical establishment.

But researchers who have tried to duplicate Burzynski's findings have said that they could not do so -- in part because Burzynski has not cooperated fully with researchers. Michael A. Friedman, associate director of the National Cancer Institute's cancer therapy evaluation program at the time of the July hearings, told The Washington Post: "Our formal position has to be we just don't "know" about the treatment's effects. Friedman, now an official at the FDA, declined to comment yesterday because of the indictment.

Though the efficacy of antineoplastons has not been proved in independent clinical trials, Jaffe said that "FDA can't dispute that it's nontoxic -- it helps some people, and doesn't really hurt anybody."

December 1, 1995

John Schwartz
c/o The Washington Post
1150-15th St. NW
Washington, DC 20071

Letters Editor:

Doctor Indicted Over Cancer Drug" by John Schwartz (Washington Post, 11/21/95) only gives readers the briefest view of the mountain of information on Burzynski's treatment for cancer. A review I published in JAMA in 1992 covered most of the facts in detail and Rep. Barton (R., Texas) Chariman of the House Commerce/Oversight Subcommittee has been made aware of them. Barton's conclusion that the FDA is unfairly "retaliating" against Burzynski is not based on the facts he has.

Burzynski made up his theory that chemicals in urine "normalize" cancer cells in 1976, when he had no credentials in oncology, no proof his theory was true and no evidence that injection of urine extracts were safe. Less than one year later he had treated 21 cancer patients with extracts made from urine collected from underground tanks at public parks.

Burzynski has had FDA permission to do clinical trials on antineoplastons for years now. He has never carried out these trials which he himself proposed becuase, he said, he could not afford the cost. That is interesting in view of the fact that he admitted to Dan Rutz on CNN-TV in 1990 that he made $10 million dollars the previous year.

Burzynski claims the active agent in urine is phenylacetic acid (PA). His medicine, AS 2.1 (Lot # 224-P, EXO 891) contains 8 grams of PA. This amount of PA can be bought from Sigma Chemical Co. by anyone for 75 cents. So, Burzynski's patients, all of whom self-adminsiter about 25 grams of PA a day get about $19.00 worth. Rep. Barton, since there is no proof that AS 2.1 "normalizes" the patients' cancer cells, perhap you can tell these patients what they are paying $342.00 a day for?

At a July 25 FDA hearing, Barton heard the mother of one of Burzynski's 2500 patients endorse Burzynski. Where were the endorsements of Burzynski's other 2499 "satisfied customers"? One of them, Jimmy Kilinowski also had his brain tumor treated by Burzynski. Afterward, Jimmy visited the White House where his mother told the press "Burzynski's treatment had 'dissolved' three of the tumor's in Jimmy's brain." (N.Y. News, Oct. 24, 1990). Jimmy died some months later leaving the Kilinowski's in debt to Burzynski for more than $95,000. Ninetyfive thousand dollars, Rep. Barton!! For What?

There is a world of difference between the motives of desperately ill cancer patients, coldly objective scientists and politicans. But they all have one need in common. They need to know WHY THEY SHOULD BELIEVE BURZYNSKI?

Saul Green, Ph.D