"The drug has no proven efficacy for the treatment of influenza in the U.S. population, no proven effect on reducing person-to-person transmissibility, and no proven impact on preventing influenza," Elashoff wrote, adding that many patients would be exposed to risks "while deriving no benefit."
Source: http://www.latimes.com/nation/la-122001fda-story.html#page=1
http://www.divinedominoes.com/docs/How-a-New-Policy-Led-to-Seven-Deadly-Drugs-LA-Times.pdf
Excerpt from above article:
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"From the first drug I reviewed, I really got the sense that I was doing something worthwhile. I saw what a difference a single reviewer can make," said Elashoff, the son and grandson of statisticians.
Last year he was assigned to review Relenza, the new flu drug developed by Glaxo Wellcome. He recommended against approval.
"The drug has no proven efficacy for the treatment of influenza in the U.S. population, no proven effect on reducing person-to-person transmissibility, and no proven impact on preventing influenza," Elashoff wrote, adding that many patients would be exposed to risks "while deriving no benefit."
An agency advisory committee agreed and on Feb. 24 voted 13 to 4 against approving Relenza.
After the vote, senior FDA officials upbraided Elashoff. They stripped him of his review of another flu drug. They told him he would no longer make presentations to the advisory committee. And they approved Relenza as a safe and effective flu drug."