Secret serum likely saved Ebola patients

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Secret serum likely saved Ebola patients
updated 9:52 AM EDT, Mon August 4, 2014

http://www.cnn.com/2014/08/04/health/experimental-ebola-serum/index.html?hpt=hp_t1

(CNN) -- Three top secret, experimental vials stored at subzero temperatures were flown into Liberia last week in a last-ditch effort to save two American missionary workers who had contracted Ebola, according to a source familiar with details of the treatment.

On July 22, Dr. Kent Brantly woke up feeling feverish. Fearing the worst, Brantly immediately isolated himself. Nancy Writebol's symptoms started three days later. A rapid field blood test confirmed the infection in both of them after they had become ill with fever, vomiting and diarrhea.

It's believed both Brantly and Writebol, who worked with the aid organization Samaritan's Purse, contracted Ebola from another health care worker at their hospital in Liberia, although the official Centers for Disease Control and Prevention case investigation has yet to be released.

A representative from the National Institutes of Health contacted Samaritan's Purse in Liberia and offered the experimental treatment, known as ZMapp, for the two patients, according to the source.

The drug was developed by the biotech firm Mapp Biopharmaceutical Inc. The patients were told that this treatment had never been tried before in a human being but had shown promise in small experiments with monkeys.

According to company documents, four monkeys infected with Ebola survived after being given the therapy within 24 hours after infection. Two of four additional monkeys that started therapy within 48 hours after infection also survived. One monkey that was not treated died within five days of exposure to the virus.

Brantly and Writebol were aware of the risk of taking a new, little understood treatment; informed consent was obtained from both Americans, according to two sources familiar with the care of the missionary workers. In the monkeys, the experimental serum had been given within 48 hours of infection. Brantly didn't receive it until he'd been sick for nine days.

The medicine is a three-mouse monoclonal antibody, meaning that mice were exposed to fragments of the Ebola virus and then the antibodies generated within the mice's blood were harvested to create the medicine. It works by preventing the virus from entering and infecting new cells.

The Ebola virus causes viral hemorrhagic fever, which refers to a group of viruses that affect multiple organ systems in the body and are often accompanied by bleeding.

Early symptoms include sudden onset of fever, weakness, muscle pain, headaches and a sore throat. They later progress to vomiting, diarrhea, impaired kidney and liver function -- and sometimes internal and external bleeding.

Vials reach hospital in Liberia

The ZMapp vials reached the hospital in Liberia where Brantly and Writebol were being treated Thursday morning. Doctors were instructed to allow the vials to thaw naturally without any additional heat. It was expected that it would be eight to 10 hours before the medicine could be given, according to a source familiar with the process.

Brantly asked that Writebol be given the first dose because he was younger and he thought he had a better chance of fighting it, and she agreed. However, as the first vial was still thawing, Brantley's condition took a sudden turn for the worse.

Brantly began to deteriorate and developed labored breathing. He told his doctors, "I am going to die," according to a source with firsthand knowledge of the situation.

Knowing his dose was still frozen, Brantly asked if he could have Writebol's now-thawed medication. It was brought to his room and administered through an IV. Within an hour of receiving the medication, Brantly's condition was nearly reversed. His breathing improved; the rash over his trunk faded away. One of his doctors described the events as "miraculous."

By the next morning, Brantly was able to take a shower on his own before getting on a specially designed Gulfstream air ambulance jet to be evacuated to the United States.

Writebol also received a vial of the medication. Her response was not as remarkable, according to sources familiar with the treatment. However, doctors on Sunday administered Writebol a second dose of the medication, which resulted in significant improvement.

She was stable enough to be evacuated back to the United States and is expected to arrive before noon Tuesday.

ZMapp has not been approved for human use, and has not even gone through the clinical trial process, which is standard to prove the safety and efficacy of a medication. The process by which the medication was made available to Brantly and Writebol is highly unusual. It may have fallen under the U.S. Food and Drug Administration's "compassionate use" regulation, which allows access to investigational drugs outside clinical trials.

Getting approval for compassionate use is often long and laborious, but in the case of Brantly and Writebol, they received the medication within seven to 10 days of their exposure to the Ebola virus.

On July 30, the Defense Threat Reduction Agency, an arm of the military responsible for any chemical, biological, radiological, nuclear and high-yield explosive threats, allotted additional funding to MAPP Biopharmaceutical due to "promising results."
 
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Very cool that an antidote has been found and it was possible to get past the FDA BS so it could actually be used...

my following thoughts were a bit more concerning...
why does a private company have access to ebola..
why does a private company have a BSL-4 lab...

Well, NIH who made the offer has a BSL-4 lab, but it's only operated at BSL-3 level...
The company is located in California... and there isn't a BSL-4 anywhere near it...
There is a privately owned BSL-4 lab in Texas... surprise, surprise!
Turns out it was developed at Ft Detrick - the only US Gvmt fafility that kinda scares me... I'm downwind from it and you just KNOW it's on everyone elses first strike list.

The really, really scary thing I discovered... I gotta change my pants scary... DHS is building 2 BSL-4 labs that they intend to operate... :eek:

http://en.wikipedia.org/wiki/Biosafety_level#List_of_BSL-4_facilities

http://www.mappbio.com/ebola.html

-t
 
Very cool that an antidote has been found and it was possible to get past the FDA BS so it could actually be used...

my following thoughts were a bit more concerning...
why does a private company have access to ebola..
why does a private company have a BSL-4 lab...

Some really good questions, without us knowing what their research and testing process is we can probably only guess, but I would imagine that any test samples are not actually done by the private company instead the test materials are sent to approved entities like the US Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick or some other BSL-4 location for actual testing based on first reports of the results.

http://www.mappbio.com/PettittAug2013.pdf
http://www.sciencedaily.com/releases/2013/08/130821152059.htm
 
Remember - these are the same Einsteins that built a BSL-3 or 4 lab below sea level. It turned into a submarine during Katrina...' A flooded submarine at that!

-t
 
The medicine is a three-mouse monoclonal antibody, meaning that mice were exposed to fragments of the Ebola virus and then the antibodies generated within the mice's blood were harvested to create the medicine. It works by preventing the virus from entering and infecting new cells.

Just as a side, this is not an unusual process. Many genetically engineered antibody drugs are "manufactured" via rodents.
 
While this does sound like good news, it's always possible that Dr. Brantly was one of the people who was going to recover on his own. One or two patients does not prove efficacy, but it's a good start.
 
While this does sound like good news, it's always possible that Dr. Brantly was one of the people who was going to recover on his own. One or two patients does not prove efficacy, but it's a good start.

Very good point!

Still he was rapidly getting worse when he got the medicine and made a significant improvement within 24 hours.

The other aid worker also turned around within 48 hours, so I would say there is something to this new treatment.

-t
 
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http://www.newsweek.com/us-sitting-promising-ebola-vaccines-262870

One reason Ebola inspires so much public fear is that it is, right now, essentially untreatable. And yet a vaccine could be ready in as little as two years, according to Heinz Feldmann of the U.S. National Institute of Allergy and Infectious Diseases, a branch of the National Institutes of Health. If only the disease could generate as much funding and political will as it does panic.

“What is frustrating is that we have another outbreak where potentially none of these treatment options are being used,” Feldmann says. “The thinking has to change now. We can’t just wait and wait and wait. Some of these vaccines have been stuck in this position for 10 years.”

The lack of funding is largely due to a lack of interest shown by pharmaceutical companies, for whom a rural, relatively low-kill African disease presents no lucrative market.

So those brown people in Africa aren't worth spending research dollars on... but bring it to the Americas and suddenly the money will pour in??
 
It is cost/ benefit for the companies. Ebola is still extremely rare so the market for a vaccine would also be pretty small meaning not much profit after millions needed for research and testing.

The lack of funding is largely due to a lack of interest shown by pharmaceutical companies, for whom a rural, relatively low-kill African disease presents no lucrative market.
 
Well they failed their secret information control given the company made a press release on the material a year ago.

XNN
 
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