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Possible Chemo Under-Dosing Probed in Fla.

FDA warns prostate cancer patients as criminal investigation of doctor begins

WEDNESDAY, Nov. 28, 2001 (HealthDayNews) -- Health officials are warning prostate cancer patients in south Florida that they may have received inadequate doses of chemotherapy, and law enforcement officials say they've opened a criminal investigation.

The Food and Drug Administration says that men undergoing treatment at Urology P.A. in Pompano Beach should see their primary care doctor immediately because they may have been given short doses of the drug Lupron Depot, which suppresses testosterone and helps shrink tumors. There are no reports yet that anyone has been harmed, officials say.

R. Douglas Fabel, an FDA agent in Florida, says law enforcement officials are looking into whether a doctor at the clinic, Victor Souaid, may have tampered with the Lupron he gave to his patients. Souaid has not been charged with any crime at this point.

The U.S. Attorney's office in Ft. Lauderdale, which has jurisdiction over Pompano Beach, has notified about 100 men who may have been given inadequate injections of Lupron. "We're assuming that there are many more than that," Fabel says.

Fabel would not discuss details of the investigation. But he said the case was similar to that involving a pharmacist in Kansas City, Mo., who has been charged with distributing diluted doses of cancer therapies.

Marvelle McIntyre-Hall, a lawyer with the U.S. Attorney's office in Ft. Lauderdale, which is handling the inquiry, says investigators served Souaid a search warrant at his clinic last week. The nature of the warrant is under seal, and McIntyre-Hall would not discuss its contents.

Miami attorney Jon Sale, who is representing Souaid, calls the FDA letter "disturbing," and says his client denies any wrongdoing. "His position is that he provides the highest quality of medical care, consistent with mainstream urological practices," Sale says. "The allegations that the FDA are making by their own admission are unproven," he adds.

In addition to the FDA warning, investigators have hand-delivered letters to Souaid's patients cautioning them about the possible under-dosing, the South Florida Sun-Sentinel reported Saturday. "Although the government does not know if your treatment was affected in any way, the government is taking these allegations very seriously," the paper quotes the letter as saying.

Dr. Edward Gheiler, a University of Miami urologist, says he has been asked to counsel men potentially affected in the case, but he declined to say whether he'd already spoken with any patients. "You have to look at each one" to assess how serious under-treatment may be, Gheiler says.

Lupron is a top-selling prostate drug that chemically "castrates" men by quashing testosterone. The drug is marketed by TAP Pharmaceutical Products, a Lake Forest, Ill.-based joint venture of Abbot Laboratories and Takeda Chemical Industries of Japan. Lupron costs $600 or more per injection and is given either monthly or at three- or four-month intervals.

Jacqueline Strax, who publishes "PSA Rising," an online prostate cancer newsletter, says the latest case may involve a loophole in Lupron's FDA approval that could potentially encourage fraud with the medication. Other countries have approved the drug at a dose of 3.75 milligrams, but the FDA has approved a 7.5 mg dose for prostate cancer (it's available at the lower dose for women with uterine problems).

An unscrupulous doctor could thus administer half the FDA-approved dose and produce a clinical effect, yet bill the patient or his insurance for a full dose, Strax says. "There's a space there for fraud," she notes.

Lupron isn't new to controversy. Last month, TAP settled a criminal and civil case with the Justice Department for $875 million -- the largest such payout in history -- over allegations that it had been defrauding Medicare and Medicaid for several years with billing for the drug.

At the same time, a federal grand jury has charged a doctor and six TAP executives with offering kickbacks to physicians and customers to promote the use of Lupron, and with conspiring to bilk the two government insurance programs.

The American Cancer Society estimates that 198,000 American men will be diagnosed with prostate cancer this year, and more than 31,000 will die from the disease.

What To Do

The FDA is advising men who underwent prostate cancer treatment at Urology P.A. to call the U.S. Attorney's office in Ft. Lauderdale at (800) 379-4643 for more information.

To find out more about prostate cancer, click on the Prostate Cancer Research Institute, the National Cancer Institute or the Centers for Disease Control and Prevention.

For more on Lupron, try TAP.

SOURCES: Interviews with R. Douglas Fabel, special agent in charge, U.S. Food and Drug Administration Office of Criminal Investigations, Ft. Lauderdale, Fla., Jon Sale, attorney, Miami, Edward Gheiler, M.D., assistant professor of urology, University of Miami, Miami, Fla., Marvelle McIntyre-Hall, attorney, U.S. Attorney's office, Ft. Lauderdale; Jacqueline Strax, "PSA Rising," New York; Oct. 4, 2001, U.S. Attorney's Office news release; Nov. 24, 2001, South Florida Sun-Sentinel; Food and Drug Administration news release; American Cancer Society
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