Feds Inch Closer to Allowing Key H1N1 Drug

(CBS)  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.

Special Report: H1N1 Virus

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

[devilfly1]

I think I found an interesting news that talks about HINI virus. I hope that the key to cure the HINI virus would be a bit helpful.

I am going ahead to toss you a link where you can find out the information about Guillain-Barré Syndrome (GBS). It can cause a lot of damages in nervous system.

Taken from the CDC website. "In 1976, vaccination with the swine flu vaccine was associated with getting GBS. Guillain-Barré Syndrome makes your body attack it's own nerve cells."

http://www.cdc.gov/FLU/about/qa/gbs.htm

I hope there is a formula that can solve the virus,which I am looking for a good formula. I think there will be a solution.

[Virgil-1]

Why should I trust anything with the word "Feds"attached to it?

[jsilver2th]

While CDC etc has been claiming that H1N1 animal to human transmission is not possible, etc. please note today in Orego OHSU has confirmed case of human to animal (a ferret) transmission. http://www.koinlocal6.com/content/news/topstories/story/Ferret-gets-H1N1/qpwy1hdDHEOgbQ21yujnGA.cspx?rss=1100

This apparently was confirmed by USDA on October 9- 11 days ago-

Why delay in telling the public?

[SusanStoHelit]

They've got to find a way to properly loosen rules for drugs that work, save the dying when nothing else does, so they can be used on people who will die without them. I understand why they're careful about this - a quack drug can be sold to desperate families, and to let someone profit from the fears of the dying is an awful thing. But that's not the case here.