Feds Inch Closer to Allowing Key H1N1 Drug
CBS News reported this week on an antiviral drug, Peramivir, that doctors say can save the lives of patients gravely ill with the H1N1 virus. The problem? Though shown to be safe, Peramivir is still in clinical trials and the FDA will only allow it use in a few special situations after doctors fill out hours of paperwork.
But on Wednesday health officials said that could change in a matter of days, CBS News correspondent Wyatt Andrews reports.
As more patients fall critically ill to H1N1, Congress - citing a a CBS News report from Monday - began asking about the emergency drugs the administration was supposed to prepare.
Sen. Joe Lieberman pressed Health and Human Services Secretary Kathleen Sebelius on why three antiviral drugs - Tamilflu, Relenza and Peramivir - have not yet been received emergency approval in for intravenous use, even though the administration has known since April that intensive care doctors would need them this fall.
"This will be a life and death decision," Lieberman said.
Sebelius' reply: "Yes, senator, all of that is correct and it is - it is imminent."
CBS News reported on the case of 51-year-old John Boudrot. Boudrot, a healthy adult all his life, was brought to the brink of death from H1N1 before his doctor sought and received permission to give him Peramivir intravenously -- saving his life.
The Food and Drug Administration told CBS News that it has approved 20 similar requests for experimental Peramivir nationwide under laws allowing the "compassionate use" of unapproved drugs. But many more doctors were clamoring for access to the drug.
An unofficial CBS News count found at least eight critically ill patients who recovered or are still recovering thanks to Peramivir.
Among the survivors was 11-year-old year Dalila Gonzalez, who was deathly ill with H1N1. She's an important case because of the alarmingly high number of children, 86, killed so far by the flu.
"She rapidly improved," said her doctor, Robert Armstrong. "The pneumonia got better every day."
60 Minutes: H1N1 Most Dangerous to Young People
Critical care physicians cautioned that Peramivir is not a miracle drug and that the FDA should be careful when releasing emergency drugs. But patients are dying, one doctor said, and the antivirals are needed now.
Related information:
CDC: Learn More About H1N1
CDC: What To Do If You Get Sick
Flu.gov: Where To Get Your Flu Shots