Life-Saving H1N1 Drug Unavailable to Most

Doctors Say Intravenous Drug Peramivir Effective in Serious Cases; But It's in Trials and FDA Makes Few Exceptions

(CBS)  New doses of the H1N1 flu vaccine will arrive across the country this week. But what about those who are already infected?

The virus can make healthy people suddenly very ill. Some doctors say they'd use an experimental drug to help rescue patients on the brink - if only they were allowed, CBS News correspondent Wyatt Andrews reports.

Last month, 51-year-old John Boudrot was so sick from the H1N1 virus he was in intensive care, on a ventilator and suffering organ failure. Not in 30 years of practice had his doctor seen a patient decline so quickly - from perfect health to the doorstep of death.

"He was going on a curve like this," said Dr. Robin Dretler, indicating a steep decline. "Life in immediate danger."

As a last resort, Dretler got the Food and Drug Administration's permission to try a promising, but still experimental, drug called Peramivir.

Peramivir is an antiviral drug like Tamiflu and Relenza. But unlike those drugs, it's being specifically studied as an intravenous treatment for critically ill patients. Human clinical trials in the U.S. and Japan have called Peramivir safe and effective.

Special Report: H1N1 Virus

Sure enough, four days after John Boudrot got Peramivir he began to improve.

"I am a lucky son of gun to be here, no question about it," Boudrot said.

Dretler said he strongly believes it was Peramivir that made the difference.

The FDA tells CBS News that it has approved 20 similar requests for experimental Peramivir nationwide under laws allowing the "compassionate use" of unapproved drugs.

Patient records are not public, but an unofficial CBS News count found at least eight critically ill patients who recovered or are still recovering on Peramivir. We found two who died.

But among the survivors is 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.

60 Minutes: H1N1 Most Dangerous to Young People

"She rapidly improved," said her doctor, Robert Armstrong. "The pneumonia got better every day."

But as more patients die in intensive care, doctors want the FDA to speed up the delivery of emergency anti viral drugs. The current process for "compassionate use" takes at least four hours of paperwork time from doctors trying to treat sick patients.

The FDA has said it will consider what's called an EUA, or Emergency Use Authorization, for Peramivir, allowing the government to stockpile the drug and reduce the most paperwork. The FDA says the changes are coming "fairly soon" - but doctors say they're needed now. Sometimes, Armstrong said, "it's only a matter of hours to keep them alive."

As John Boudrot left Dekalb Medical center near Atlanta, it was clear every nurse who cared for him had expected the worst.

"This is the best part about getting better," he said, hugging the nurses.

Experts caution its too early to see Peramivir as a miracle drug, but there's no doubting the drugs connection to some miraculous results.

Related information:

CDC: Learn More About H1N1
CDC: What To Do If You Get Sick
Flu.gov: Where To Get Your Flu Shots

[SS_433]

This reminds me of when my father had a massive stroke, and he wouldn't be given the 'experimental' clot-buster drug because a technical factor excluded him. As a result, he lost speech, mobility, and enjoyment of life. Today, that 'technical factor' isn't a factor in treatment, as far as I know.
If a party who is medically responsible for the patient, or the patient himself wants to waive liability from those who care for them in a desperate situation, shouldn't it be allowed? I realize that even when someone signs an agreement that essentially says, "I won't sue this Dr., etc." they may still be able to do so. Should there be some specialized law allowing protection of caregivers so that they may be able to offer 'last line' or 'experimental' treatment in a desperate situation?

[thinkitthrough]

I don't think the issue here is liability per se. Peramivir is available now via compassionate use (emergency investigational drug)- which includes an informed consent waiver, which addresses most liability issues. An EUA offers blanket liability protection when the drug is used according to the conditions of the EUA.

Another note- the doctor in the article notes that 'hours' are critical, but even with an EUA - there is no guarantee the drug will be available in hours. Remember, this drug is investigational - with no market presence or established supply chain. There is no way to get this drug to all or even most hospitals all over the country within hours - EUA or not.

Yes CBS keep pampering your biggest advertiser and push these poisons for Big Pharma. Vaccines have a dismissal past and they are the "snake oil" of western medicine. Posted by Baileyccc

[stn_sage]

Isn't THIS interesting?

Neither Peramivir...the drug the article was about...OR, the currently fast-tracked H1N1 vaccine has received much of a legitimate trial period to verify efficacy and safety!

Yet, the H1N1 vaccine has been authorized for immediate use and Peramivir has NOT! Which begs the question: WHY one and NOT the other?!

Could it be that the H1N1 vaccine will be mass produced hundreds of millions of units? That such mass production represents HUGE profits for the drug companies manufacturing it? And, politicians are well invested in these comapanies and will reap large windfall financial returns off the H1N1 vaccine?

Yep, could be!

So, now we see what the winning recipe is for getting a fraudulently tested drug to market...GREED!

[cjvii]

The FDA has been working on the EUA (Emergency Use Authorization) for Peramivir for over 6 months. Everything is in place except for actually issuing the EUA. EVERY person that dies of the swine flu is someone who most likely would have lived if they had been given Peramivir. I do not understand why the FDA is waiting to issue the EUA. Hospitals need an inventory of Peramivir to cure their sickest patients. Is it politics? Is it pressure from the big pharmaceutical companies that supply competitive products such as Tamiflu and Relenza? Whatever it is, in my opinion it is criminal that the FDA has not acted! This is worse than the government's lack of response to Katrina! People need to pressure their representatives and the FDA to get the EUA issued and Peramivir into hospitals.

[thinkitthrough]

It is incorrect to say that everything is in place. There are myriad issues to address for this investigational agent, which we should note has no market presence, no established supply chain, no accountability mechanism in place, no data management and outcomes reporting system in place, extremely limited large-scale clinical experience, etc.
You claim, "EVERY person that dies of the swine flu is someone who most likely would have lived if they had been given Peramivir" - which is a claim that is completely unsupported by any published data.
In the spring, EUAs for Tamiflu and Relenza were rapidly issued; however, these were drugs that the vast majority of clinicians are familiar with, which have a long clinical history with an established safety profile, and which have an established market presence and supply chain.
What is criminal is people with a very limited knowledge of the issues accusing FDA of committing another Katrina. I suspect that if there are unforeseen adverse events related to this drug, people will next be enraged at the negligence of the government in rushing this investigational drug to the population.

[WherestheIVantiviral]

thinkitthrough,
please tell me how patients that are not able to swallow tamiflu or inhale relenza are to get antivirals in to there system? Should they reconstitute Relenza and put them it through the ventilators? We all know how that ends up. The White House several months back told the FDA that approval of an IV antiviral was a necessity. Senator Lieberman's comments 2 days ago also support that this is an essential need. The FDA was aware of the need eon's ago. That is why they gave Biocryst 180 million dollars to develop it. No one has ever died from taking Peramivir and safety has never shown to be an issue in any trial. I guess if it were up to you we shouldn't give our doctors the choice of an IV antiviral for those who need it. We should just let them die. There is plenty of information out there regarding this drug and anything short of a full EUA is a travesty!

[jsd330]

Not enough profit in it for the drug companies. Of course since it's in short supply they can raise the price. now that's big business playing with the health of Americans.

[SpiderJJ]

What is WRONG with the FDA not to approve a time critical life saving drug that will help save Children ???

Is Obama's FDA = Bush's FEMA ???

[thinkitthrough]

Are you sure it will help save children - in comparison to what other treatment?!?! Based on what data do you make that claim? I am aware of no data on the use of peramivir in children.
As well, what data can you (or cjvii above) share that would indicate this drug is in any way superior to currently authorized Tamiflu for the treatment of hospitalized adult patients? There are published peer-reviewed scientific articles on the positive treatment effect of tamiflu in hospitalized adult patients - there are no such studies for peramivir. A published abstract at a recent conference made the claim that peramivir is noninferior to tamiflu in hospitalized adult patients - but that scientific finding has not been peer-reviewed and published. Note - in any case - it does not claim superiority.

[searingtruth]

"My dead child was profit."
SearingTuth

A Future of the Brave