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Kidney Failure News

Report Issued on Drug Testing Gone Bad

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At a glance:

The UK Health Regulator has issued a report on the drug-testing fiasco that occurred in London this year.  
 
Six men suffered multiple organ failure and became extremely ill after taking an experimental drug. One remains in hospital, recovering, three months after taking the drug. 
 
The report says that there was no errors in the manufacture of the drug or its administration, but that the Massachusetts-based company that ran the trial, Parexel, broke several regulations: they did not have adequate health care providers on hand, there was inadequate screening of participants and inadequate insurance coverage for them.

Parexel Drug Trial Had Shortfalls, UK Probe Finds

Bloomberg - 5/25/2006 5:11 PM

May 25 (Bloomberg) -- Parexel International Corp., which ran a drug trial in London that left six men with multiple organ failure earlier this year, didn't have a doctor with adequate training screening the patients, the U.K. health regulator said.
 
Parexel, based in Waltham, Massachusetts, also failed to have a contract in place with the drug's developer, TeGenero AG, the Medicines and Healthcare products Regulatory Agency said today in an e-mailed statement. There was also no formal system to provide 24-hour medical cover, and Parexel didn't complete medical checks of patients, the London-based agency said.
 
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