Lawmakers Say FDA Better Clean Up Its Act

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By Evelyn Pringle (about the author) Page 4 of 9 page(s)

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Another doctor who participated in the study was totally disqualified as an investigator and prohibited from conducting any clinical trials in the future, and another who signed up 150 patients was cited for 20 violations of the study's instructions.

Dr Anne Campbell, the doctor with the highest number of subjects in the study, was sentenced to nearly 5 years in prison in March 2004, after being charged in a 21-count indictment over her misconduct.

Senator Grassley is demanding a face-to-face interview with the FDA investigator who discovered the fraud and misconduct in the trials, who he contends "is key to understanding what the FDA did when it became clear that the safety study required by the FDA in order to approve the drug was fraudulent and faulty."

This investigator authored a March 25, 2004, memorandum from the Division of Scientific Investigations titled, "DSI Recommendations on Data Integrity," that states in part, that Study 3014 involved "multiple instances of fraud" and that "the integrity of data from all sites involved in [the] study ... cannot be assured with any degree of confidence."

After months of trying unsuccessfully to get an interview, Senator Grassley finally marched right over to the Department of Health and Human Services headquarters and asserted a congressional right to speak to the investigator.

After a brief conversation with senior officials, he left mad as a hornet. "This is extraordinary to me," he said outside HHS headquarters. "I haven't had to go to an agency like this since 1983 to get information I requested.

"I smell a cover-up," he stated.

On June 22, 2006, Senator Grassley publicly announced a not too subtle warning to officials at the agency. "Two years ago I called a congressional hearing to probe the FDA's handling of the withdrawn painkiller Vioxx," he said in a statement.

"It might be time," he warned, "to round up another oversight hearing after the runaround I got recently at the FDA."

"The FDA," he wrote, "refused to allow me to question an internal investigator who is leading an inquiry into alleged fraud involved with clinical trials for the antibiotic Ketek."

"So for only the second time in 23 years," he said, "I resurrected in June my unconventional means to fulfill my Constitutional oversight responsibilities."

He said, "I appeared at the FDA's doorstep," and noted that agency officials refused to let the investigator speak to him.

However, he warned, "Bureaucratic stonewalling won't deter this U.S. Senator."

"I won't rest," Senator Grassley said, "until the light of day exposes what ought to be available for public consumption."

"It all boils down to keeping the government accountable," he wrote, "to the people and strengthening the public trust in government."

In another statement released on June 29, 2006, he stated, "Ketek is another example where the F.D.A. accommodated a drug maker and turned a blind eye to serious safety concerns."

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