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When FDA spots trial violations, reaction can vary

By KRIS HUNDLEY, Times Staff Writer
Published September 2, 2007

Pushing drugs to market
An occasional series about how pharmaceuticals are brought to market — and who profits along the way.

Stories in this series

The case of Dr. Carl R. Lang, an internist in suburban Chicago, illustrates how the Food and Drug Administration handles physicians when it catches them violating rules on drug studies.

Lang was one of several doctors the FDA cited in 2002 for violating clinical study rules on Ketek, a promising new antibiotic for the common cold.

For the drugs's final round of pre-approval testing, the manufacturer, Aventis Pharmaceutical, amassed a huge study involving 1,800 private physicians using the drug on nearly 25,000 patients.

FDA inspectors performed poststudy audits at the biggest study sites and found violations so flagrant that they called in the agency's criminal division. The FDA went ahead and reviewed the flawed data and approved Ketek. But after nearly three years on the market, the FDA sharply limited Ketek's use because of 53 reported cases of liver failure, including five deaths.

Meanwhile, the FDA pursued criminal fraud charges against Dr. Anne Kirkman Campbell, who enrolled the most patients in the Ketek study. She was sentenced to 57 months in prison.

Lang had enrolled the second-most patients. According to an FDA memo, an inspection of his site "identified some (although not all) of the same GCP (Good Clinical Practice) problems seen in the highest enrolling site (Dr. Kirkman Campbell)."

Among problems the FDA cited:

  • 251 patients enrolled; the approved limit was 50.Clinic staff enrolled in the study.
  • Patients enrolled who were nursing or who had drug allergies.
  • Significant discrepancies between source documents and Lang's memos.
  • Failure to obtain required lab tests.

In an interview, Lang said none of the deficiencies the FDA found were "medically related to patients' health."

He blamed the problems on his inexperience with clinical research and incomplete documentation. For example, he said the patient who had been nursing had stopped before the trial.

Lang's responses apparently satisfied the FDA, as well as pharmaceutical companies.

Since the Ketek trial, he has run eight drug studies. The FDA did not inspect any of them.

[Last modified September 2, 2007, 01:27:24]

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