Archive for Thursday, September 6, 2001

Diluted drug case poses questions about regulation

GOP asks if more scrutiny needed

September 6, 2001

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— The case of the Kansas City, Mo., pharmacist accused of diluting chemotherapy drugs has Republicans asking whether the government should boost its oversight of the practice.

Robert R. Courtney is charged with diluting chemotherapy medicine for cancer patients to pocket hundreds of dollars per dose. He pleaded innocent last week to 20 felony counts of altering the drugs Gemzar and Taxol.

It's troubling that a drug salesman helped uncover the alleged dilutions, Sen. Kit Bond, R-Mo., wrote Health and Human Services Secretary Tommy Thompson.

"In all likelihood he would have continued to escape detection by regulators," Bond wrote.

Bond wants Congress to pursue the issue as it tackles debate over a Medicare prescription drug benefit. He asked Thompson whether the Courtney case warrants a larger federal role in policing the pharmacy practice, which is licensed and regulated primarily at the state level.

Bond's fellow Republican senator, Sam Brownback of Kansas, said Wednesday that he supports the effort.

"It's almost that we got lucky in finding this," Brownback told reporters. "The prospect of that happening in other places, to other cancer patients, is frightening. I want to look into what is the proper degree of federal oversight."

In Missouri, one state where Courtney is licensed, the Missouri Board of Pharmacy has six inspectors responsible for overseeing 6,768 pharmacists, 1,551 pharmacies and 1,142 drug distributors, Bond said. The Food and Drug Administration has 150 enforcement agents, 11 of them in a Kansas City regional office responsible for 11 states.

Ensuring the adequacy of this safety net is essential as Congress considers prescription drug benefits, Bond said.

"Patients and doctors must have full faith and confidence in medicine dosages distributed by pharmacists," he said.

Thompson is working on a response, Health and Human Services spokesman Bill Pierce said. "The secretary shares Senator Bond's concern."

Hundreds of patients who received improper dosages could be affected in the case, federal investigators say. The charges also have drawn civil suits against Courtney as well as Eli Lilly and Co., maker of Gemzar, alleging the company suspected the dilutions last year but did not report them to law enforcement officials.

Lilly has denied the accusations, saying it helped reveal the alleged dilutions last May when its salesman told a doctor of his concerns about Courtney.

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