Robert Courtney, 48, has been charged with one felony count of misbranding and adulterating a drug, and is being held without bail pending a hearing Aug. 20. The federal government alleges he repeatedly diluted doses of two injected cancer compounds, Taxol and Gemzar, and passed them along to doctors who prescribed through his Kansas City pharmacy, Research Medical Tower Pharmacy.
Both drugs cost several thousand dollars over the course of treatment, so watering them down can be a highly profitable, though illegal and potentially life-threatening, scam, officials say."In a regimen, you would quickly run into the thousands, so every time you cut it a bit, you're making big bucks," says Jan Longenecker, a special agent in the Food and Drug Administration's Office of Criminal Investigations in Kansas City, Kan.
The FBI has set up a recorded hot line for doctors and patients, (816) 421-8639, who believe they may have prescribed or used the tainted drugs.
Bridget Patton, a spokeswoman for the FBI's Kansas City office, says at least 400 people have called the hotline since Tuesday evening.
Agents are in the process of taking down the messages and contacting the people, but so far have no idea if any were affected by the scam, she says.
"We are viewing all 400 phone calls as potential victims," she adds.
Chris Whitley, a spokesman for the U. S. attorney's office in Kansas City, Mo., says the charges were brought after a sting operation involving a local doctor. The doctor was reportedly alerted to billing irregularities at the pharmacy last spring by a sales agent for Gemzar's maker, Eli Lilly & Co. and then prescribed but did not pass along an intravenous bag of Taxol. Instead, the doctor turned the sample over to an independent lab, which discovered that it contained only about a third as much drug as it should have, according to authorities.
The unidentified doctor then contacted the FBI and the FDA, which launched a sting operation. Additional tests turned up drug concentrations ranging from less than 1 percent to 39 percent in the bags, with the balance made up of salt solution or other inactive filler, Whitley says.
The feds have been investigating Courtney since the end of July, Whitley says, and they seized records from the pharmacy on Monday before arresting Courtney on Tuesday.
"Our main priority is to go through those records meticulously and quickly and try to identify who may have received these drugs and how many doctors may have prescribed them," Whitley says.
Courtney has so far been charged only with tampering, which carries a maximum sentence of three years in prison and a $250,000 fine. Whitley says a federal grand jury may decide other charges are warranted.
Courtney's attorney, Jean Paul Bradshaw, said his client will plead innocent, according to Wednesday's Kansas City Star. Bradshaw, who also told the paper that the government's inquiry centers on one doctor and "fewer than 50" patients, did not return a call seeking comment today.
Whitley says "it's entirely likely" that other doctors who prescribed the diluted chemotherapy will be identified.
Gemzar is used to treat lung and pancreatic cancers. Taxol, made by Bristol-Myers Squibb Co., is given to patients with breast, ovarian and lung tumors as well as those with Kaposi's sarcoma.
Bill Dunnett, a Bristol-Myers spokesman, says the incident "seems to be a local, isolated event that's being handled by local authorities." More than 800,000 cancer patients worldwide have used Taxol, Dunnett says.
Kevin Kinkade, executive director of the Missouri Board of Pharmacy in Jefferson City, says records show that Courtney was placed on probation for a year in 1992 for practicing while his state pharmacy license had lapsed. Research Medical Tower has never been disciplined, says Kinkade. He adds that he has "never seen a case like this before."
An employee at the Research Medical Tower Pharmacy refused to comment on the case.
Dr. William Beeson, an Indianapolis plastic surgeon and a board member of the National Patient Safety Foundation, calls the incident an "atrocity" but an isolated one.
"It's almost beyond comprehension that someone would violate the trust and ethical principle of caring for people -- especially people who are in a dire situation like that, and especially if they're doing it for their own avarice," he says.
Not only could such deception prove harmful or even deadly to patients, says Beeson, but it shatters their confidence in the health-care system.