Indian officials are raising fresh questions about the potential safety threat posed by clinical trials after the country's top drug regulator concluded that a three-month-old infant died in a vaccine trial for Wyeth after being inappropriately recruited for the study.
The regulator says the baby was sick and suffered from an underlying heart problem and should have been excluded from the trial of a new version of Wyeth's Prevnar. And if a multinational company like Wyeth has supervisory issues to deal with, says the regulator, what does that say about the burgeoning number of developers who come to India to host drug studies?
"We're very supportive of what Wyeth is doing," Surinder Singh, the drugs controller general of India, told the Wall Street Journal in an interview. But "if one of the best multinational companies in the world following the best ethical practices has these problems, what is going on down the line?"
For its part, Wyeth says it's taking steps to ensure that the same deadly situation isn't repeated. And the drug company has asked for permission to resume the trial at 11 Indian sites.
- read the article in the Wall Street Journal