April 6, 2000 BOSTON (Boston Globe) - US Attorney Donald K. Stern has charged a second man in what authorities say was a scam involving a phony cancer drug made in an unlicensed facility in suburban Woburn in the mid-1990s, and shipped to doctors and patients across the United States.
The defendant, Thomas M. Rodgers Jr., 56, of Atlanta, was charged Wednesday with three violations of the Food, Drug and Cosmetic Act in a report filed by the US Attorney and the federal Food and Drug Administration's Office of Criminal Investigations.
Rodgers appears to be the man referred to as "Mr. X" in an indictment filed in January charging a Cape Cod man with fraud in connection with the same purported cancer drug. Thomas Ronald Theodore, 54, of Sandwich was charged with defrauding investors in Private Biologicals Corp., the Woburn company named Wednesday in the court document referring to Rodgers.
Investigators said Theodore was posing as a doctor as he solicited investments in Private Biologicals. Theodore was convicted of mail fraud in 1987, after being charged with falsely claiming he had graduated from a medical "diploma mill" in the Caribbean.
At the center of the alleged scheme are the drug - Lymphokine-200, or LK-200 - and the manufacturing company, which authorities say was turning out the drug in the Woburn plant from 1993 to 1995.
Rodgers was chairman of the board of directors and a majority shareholder of Private Biologicals Corp., according to the court document. During that time, according to the earlier indictment, Theodore and "Mr. X" falsely told investors that they had discovered or developed LK-200 and that they intended to patent the drug. Through this and other alleged misrepresentations, the indictment says, the pair raised some $2 million from investors and received payments for consulting services.
FDA officials allege that the Woburn facility was never licensed to produce drugs and that LK-200, which was not approved for sale by the FDA, was illegally shipped in interstate commerce. In addition, the charges say that the drug was stored under unsanitary conditions and was not manufactured with good manufacturing practices.
The documents say that the two defendants created a "charade" that LK-200 was being made legally outside the United States and was shipped from the Bahamas to customers.
In fact, the indictment against Theodore says, the defendants arranged to have the drug shipped from Woburn to the Bahamas and from the Bahamas to pharmacists, physicians, and patients around the United States.
Although the charges against Rodgers do not make the connection, LK-200 is the name of a drug that figures in the decades-long saga of Dr. Stanislaw Burzynski, a physician who has operated a clinic in Houston since 1977, where he treats patients with what he calls "anti-neoplastons." These substances, extracted from urine and processed into a drug, are manufactured under the LK-200 name.
Burzynski says the drug has cured some cancers, but many mainstream specialists are skeptical. The National Cancer Institute scrutinized some of his cases and agreed, along with Burzynski, to perform clinical tests. That agreement fell apart in a disagreement over procedures.
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