As of 2003, MRSA made up 60% of hospital S. aureus infections in the USA, so effective means to treat it are highly prized. Analysts predicated J&J could make nearly $500 million from ceftobiprole in 2010 alone, but now the drug may have to wait a long time before it is approved for sale.
The FDA’s investigation of the trial revealed that it had not been properly monitored, nor had thorough records been kept. Despite ascertains that the drug would be administered in a controlled environment, it was found that some patients had been self-medicating in their homes, which had also resulted in improper storage of the drug. The study was also found to have been improperly blinded, with the doses being prepared by the nurses who administered them and cared for the patients rather than a pharmacist who would be unaware of who was receiving the drug and the placebo. More seriously, the administration of the drugs was sometimes delayed, which could have resulted in the primary infection getting worse, or even the onset of sepsis and death. As well as responding to these concerns, the FDA letter asked J&J to establish procedures in any ongoing or future trials to make sure these mistakes are not repeated.
via The Lancet Student » Archive » FDA Issues Warning Letter to Johnson & Johnson.
