Why should the drug companies spend tons of money testing drugs and then go through the process of getting final approval from the FDA to market their drugs WHEN you can INSTEAD get the CDC (and possibly the FDA as well) to give the drug companies the freedom to test UNAPPROVED drugs on THE PEOPLE!

This story below is nothing more and nothing less then a drug company getting approval from the CDC (and possibly the FDA also) to USE the public as guinea pigs!! Personal comments in brackets "[...]"

The unapproved antiviral that saved a teen's life is now more widely available in emergencies.

He was a healthy teenager from another country, visiting friends and relatives in Minnesota, when he got sick.

In early September, he wound up at Hennepin County Medical Center in Minneapolis, near death with complications from H1N1 flu. But his doctors there were able to get their hands on an experimental antiviral drug that saved his life. A month after he was admitted, the teenager walked out of the hospital and was able to go home to his own country.

The 17-year-old boy, who has not been identified, was among the first H1N1 patients in the United States to get the new drug, Peramivir. On Friday, the U.S.Centers for Disease Control and Prevention (CDC) took the unusual step of making the unapproved drug available to hospitals across the country for emergency use in just such cases.

Peramivir is similar to other antivirals, such as Tamiflu. What makes it unique is that it can be given intravenously. Other, similar drugs have to be swallowed or inhaled with an inhaler, and are widely used both in and out of hospitals.

When patients are near death or in organ failure like the 17-year-old at HCMC, an intravenous drug is the only option, said the boy's doctor, Dr. Stacine Maroushek, a pediatric infectious-disease specialist at the medical center.

"I don't think he could have been any closer to death without dying," Maroushek said. He had severe bleeding in his digestive track, almost every organ had failed, and he was on a ventilator to help him breathe. Doctors could not have gotten any other antiviral into his system, she said.

But Maroushek was familiar with an experimental drug made by a small company called BioCryst of Birmingham, Ala. She had to get permission from the U.S. Food and Drug Administration to use the drug in the boy's case. That meant she had to fill out numerous forms, get permission, then contact the company, which sent it to her.

"We were able to get it within 24 hours," she said. "After he was on the medicine for a day and a half or two days, he started turning around."

Like all antivirals, the drug works by suppressing the growth of the virus in the body, allowing the immune system to fight off the infection.

Since early September, the drug has been available on what's known as a "compassionate use" basis around the country for hospitalized patients with severe H1N1 infections. Maroushek said the teenager at HCMC was the third person and the first pediatric patient in the country to receive it.

The same drug reportedly was given without success to Michael Milbrath, the Waseca hospital executive who died Saturday of complications from H1N1. On Friday, his family said on his CaringBridge website that Milbrath, 54, had received "the new experimental drug" at Immanuel St. Joseph's hospital in Mankato.

Milbrath had been hospitalized Oct. 14 in intensive care with complications of the flu, according to the CaringBridge site. As his condition worsened, doctors received permission on Oct. 22 to use Peramivir, and the drug was flown in from the East Coast overnight, the family reported. He received the drug Friday, but died the following day. His funeral will be held today in Waseca.

A spokesman for the medical center declined to comment on Milbrath's treatment, citing patient confidentiality laws.

[ When the drug works they're happy to say "IT WORKED!" BUT when it doesn't work they're not too happy to make public WHY it didn't work. Bottom line: They don't know WHAT the drug will do - work or not work! Nice, eh? Wanna play guinea pig? ]

Under the new emergency-use designation, doctors can get Peramivir directly from the CDC in Atlanta, Maroushek said. It is designated for patients who have run out of other options, either because other treatments failed or they can't use other antiviral medications.

Doctors must report any side effects or complications to the federal government.