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PostPosted: Fri Aug 29, 2014 4:41 pm 
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Ebola outbreak: ZMapp protects sick monkeys
Findings warrant further development of cocktail for clinical use, Canadian researchers say
CBC News Posted: Aug 29, 2014 1:00 PM ET Last Updated: Aug 29, 2014 1:55 PM ET
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Gary Kobinger of the National Microbiology Laboratory in Winnipeg said the level of improvement in the infected monkeys treated with ZMapp exceeded his expectations. The drug cocktail may prove important in treat Ebola in West Africa.

Giving the ZMapp cocktail to rhesus macaque monkeys up to five days after infection with the Ebola virus completely protected the animals — a finding that a Canadian-led research team says supports compassionate use of the treatment during the current outbreak in West Africa.

ZMapp, developed with involvement of the Public Health Agency of Canada, is a cocktail of three monoclonal antibodies that is designed to bind to the protein of the Ebola virus, neutralizing the virus so it can’t do any further damage.

In Friday’s online issue of the journal Nature, researchers led by Gary Kobinger of the National Microbiology Laboratory in Winnipeg showed that giving ZMapp resulted in the survival of 18 rhesus macaques infected with the Ebola virus.

"The level of improvement was at least beyond my own expectation," Kobinger told reporters Friday from Montreal.

The researchers haven’t observed any long-term side-effects in the animals that received ZMapp.

"ZMapp exceeds the efficacy of any other therapeutics described so far, and results warrant further development of this cocktail for clinical use," the study’s authors concluded.

Kobinger cautioned that the animals received a very high dose of the Ebola virus that could resemble an accidental laboratory exposure, but differs from natural exposures in humans.

A Phase 1 safety study is scheduled to begin in healthy humans in early 2015. Mapp BioPharmaceuticals, which has licensed the drug, is conducting the next stages of research needed to seek regulatory approval for ZMapp.

If safety data from a Phase 1 trial in humans in the U.S. supports the compassionate use of ZMapp, Kobinger expects it could be used under Health Canada’s special access program possibly by spring. But scaling up production to stockpile thousands of doses is another matter.

In the study, the treatment reversed severe Ebola virus disease symptoms such as excessive bleeding, rashes and elevated liver enzymes.

In contrast, the three rhesus macaques that did not receive ZMapp all succumbed to the infection with a central African strain of Ebola virus by Day 8. Kobinger said the laboratory strain is comparable to one causing an outbreak now in West Africa.

There is no licensed vaccine or treatment against the Ebola virus. "Moving the most promising interventions forward is a matter of utmost urgency," Thomas Geisbert of the University of Texas medical branch in Galveston said in a journal commentary that accompanies the study.

Geisbert is working on another potential treatment for the Ebola virus, as well its cousin, Marburg virus.

Ebola could be treated with drug shown to fight cousin virus
"Crucially, the treatment protected monkeys even when it was administered as late as five days after exposure to the virus, at a time when the animals were severely ill," Geisbert said.

He called ZMapp’s success in treating monkeys at an advanced stage of Ebola infection "a monumental achievement."

So far, seven people infected with the Ebola virus have received ZMapp. Two have died, but it’s not clear how many doses they received. At least two doses are needed in non-human primates, Kobinger said.

If clinical trials are successful, the manufacture of ZMapp could require investment to make monoclonal antibodies at an industrial scale, assuming there is funding, Geisbert concluded.

The study was funded by the Defence Threat Reduction Agency, the U.S. National Institutes of Health and the Public Health Agency of Canada (PHAC), and a Canadian Safety and Security Program grant.

Lab worker safety

Meanwhile, PHAC says the Canadian scientists returning home from an Ebola virus lab in Sierra Leone over concerns for their health and safety aren't showing any signs of illness, and will come back to Canada on a private charter plane.

Belgium Ebola Virus
The Public Health Agency of Canada says three scientists will be assessed when their plane arrives back in the country. (Olivier Matthys/Associated Press)

The agency said the three workers are in good health and are returning as a precaution.

"The risk that any of them were infected is very low," the agency said in an email Thursday night. "As an added precaution, the employees will be returning on a private charter plane to Canada and will be monitored closely on their journey home and after they return."

Once they arrive, a quarantine officer and border officials will board the plane to assess their health.

Ebola outbreak: Canadians pulled from Sierra Leone as precaution
The agency announced late Tuesday that it was pulling the team from a World Health Organization outpost at Kailahun, in eastern Sierra Leone. The agency said three people at their hotel complex tested positive for the Ebola virus.

Once the workers have been cleared for entry, they will travel to private residences where they will stay in voluntary isolation for the rest of the 21-day incubation period, avoiding their families and the community.

Meinie Nicolai, who co-ordinates the Ebola outbreak response for Doctors Without Borders in Brussels, doesn't blame the team for leaving.

"If there's stress in a team, you'd better take them out because they can make mistakes and mistakes can be fatal," Nicolai said.

The agency has said it's committed to helping in the response to the outbreak and is preparing to send another team to Sierra Leone once appropriate steps have been taken to ensure a safe living environment.

With files from CBC's Amina Zafar and Karen Pauls

http://www.cbc.ca/news/world/ebola-outb ... -1.2750199

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PostPosted: Fri Aug 29, 2014 4:53 pm 
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August 29, 2014 Updated : August 29, 2014 | 4:08 pm
Winnipeg lab created, tested Ebola drug ZMapp
By Helen Branswell
The Canadian Press
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Abbas Dulleh/AP Liberia women walk, after praying for help with the Ebola virus, in the city of Monrovia, Liberia. Thursday, Aug. 14, 2014.
TORONTO – The experimental Ebola drug ZMapp was able to save infected monkeys even when treatment was started five days after the animals were infected, when some were suffering from advanced disease, a new study shows.

This is the first research to demonstrate that an Ebola therapy could save primates if given so late in the course of their illness — a circumstance that more closely reflects how an Ebola drug would be used in an outbreak than any other study conducted to date.

It also reveals for the first time that the work to create the drug known as ZMapp was done at the Public Health Agency of Canada’s National Microbiology Laboratory in Winnipeg.

The study is published online Friday in the journal Nature. The senior author of the work is Dr. Gary Kobinger, head of special pathogens research at the Winnipeg lab.

The compound is a cocktail of three monoclonal antibodies — proteins made by the immune system that target specific sites on the Ebola virus. ZMapp is a hybrid of two earlier monoclonal cocktails, one made by Kobinger’s team and the other by scientists at the U.S. Army Medical Research Institute of Infectious Diseases in Frederick, Md.

About eight months ago, with the agreement of the U.S. scientists, Kobinger’s team set out to produce a cocktail containing the best antibodies of the two precursors’ formulations. That became ZMapp.

“We of course expected an improvement. We were at least hoping for it. But the level of improvement was at least beyond my own expectations,” he said in a teleconference Friday.

“I was quite surprised that by extracting the best combination of all six we would be going as far and able to this time rescue (the monkeys) out to Day 5 — and all of them.”

Scientists have been working for years on vaccines and drugs to prevent or treat Ebola. A number hold significant promise. But most of the work to date has focused on giving the therapy shortly after monkeys are injected with Ebola virus.

That scenario mirrors what would happen in humans if there is a laboratory accident involving Ebola, or if a health-care worker had a dangerous exposure treating a known Ebola patient. But in the real world setting of Ebola outbreaks, people don’t know they are infected for days because symptoms are slow to set in. It’s only then that they seek care — if they do at all.

“Early studies were relatively artificial and oriented more towards laboratory accidents where you injected a monkey with a bunch of Ebola virus and then 30 minutes later you gave it a vaccine or a compound. And of course it has very little replicating virus so it’s not that hard at that point to inactivate that,” explained Dr. Daniel Bausch, an Ebola expert at Tulane University School of Public Health and Tropical Medicine in New Orleans, La.

“And so this is the study so far when they’ve been able to push it out to the farthest time point when an animal is sick and has a high level of viremia (virus in the blood). … And so that’s a very promising result.”

How promising?

“The simplest way I can put it is — and it’s not said lightly — but if I had Ebola and someone had ZMapp I would say, ‘Give it to me,'” Bausch said.

There is hope that if the drug works in people that it could be useful even later in the disease course. In primate studies the animals are given big injections of Ebola virus and they typically die around Day 8 after infection. It’s thought people aren’t generally exposed to such large doses of virus and death in fatal human cases is later, around Day 12 or 14.

That suggests the drug might be useful in some patients as late as Day 9 to Day 11, Kobinger said, but he noted there is a “point of no return” after which no drug will help.

Bausch also believes the primate research points to a longer treatment window in people.

“The way these experiments are done is really staking the cards against you, if you will. And so that makes any positive result perhaps all that much more promising,” he said. “We probably have a little more time in a human who’s getting less of a dose of Ebola.”

The antibodies in the drug target the Ebola Zaire virus, which is responsible for the current large outbreak in West Africa. The other Ebola serotypes that cause human outbreaks — Ebola Sudan and Ebola Bundibugyo — would need their own targeted antibody cocktails.

But even within the Ebola Zaire subtype, there is variation among viruses. The work was done using a virus from the first Ebola outbreak, in 1976, at Kitwit, Zaire (now the Democratic Republic of Zaire). The virus spreading in West Africa is a slightly different Ebola Zaire.

Still, Kobinger said there are preliminary data showing the difference between the two viruses doesn’t erode the drug’s efficacy. “It performed at least as well, if not better, in vivo,” he said, though that work was not outlined in the study and he did not specify which animal model was used in this early testing.

The work continues, Kobinger said. His group wants to see if the drug will save primates if given at Day 6 or Day 7. As well, they want to see if they can reduce the size of the doses, to get the maximum benefit from the least amount of drug per infection.

That would be a bonus for a drug that is in much demand but currently no supply. Kobinger said at one point there were 10 or 12 treatment courses of ZMapp, but some of the drug was used in the animal studies and some doses were given under emergency use provisions to seven people who have been infected with Ebola in the West African outbreak.

Two of those people succumbed to their infections anyway. At least one of the two, a Spanish priest, only received the first of three doses in the treatment course before he died.

Kobinger said he believes 20 to 40 doses of the drug can be made in a month, when production is up and running. The antibodies are grown in tobacco plants and work is underway to see if additional production capacity exists.

Kobinger said a Phase 1 clinical trial — which is designed to show the drug is safe for use in humans and to try to establish the necessary dose — will begin in early 2015. That work will be led by Mapp BioPharmaceuticals, which has licensed the drug and will push it through the regulatory process.

The research was financed by the U.S. Defense Threat Reduction Agency, the U.S. National Institutes of Health, the Public Health Agency of Canada and a Canadian Safety and Security Program grant to Kobinger and first author Xiangguo Qiu.

Follow @HelenBranswell on Twitter.
http://metronews.ca/news/canada/1140497 ... rug-zmapp/

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PostPosted: Fri Aug 29, 2014 5:30 pm 
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FRIDAY

Dr. Henry L. Niman, PhD
Ebola Racing Through
W Africa Now

Tonight's 10 PM EDT Interview will discuss ZMapp & Nature paper in detail

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PostPosted: Fri Aug 29, 2014 9:15 pm 
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niman wrote:
FRIDAY

Dr. Henry L. Niman, PhD
Ebola Racing Through
W Africa Now

Tonight's 10 PM EDT Interview will discuss ZMapp & Nature paper in detail

http://www.renseradio.com/listenlive.htm

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PostPosted: Fri Aug 29, 2014 9:17 pm 
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niman wrote:
niman wrote:
FRIDAY

Dr. Henry L. Niman, PhD
Ebola Racing Through
W Africa Now

Tonight's 10 PM EDT Interview will discuss ZMapp & Nature paper in detail

http://www.renseradio.com/listenlive.htm

Recent Ebola interview links to mp3s
http://www.recombinomics.com/audio.html

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PostPosted: Sat Aug 30, 2014 4:49 am 
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niman wrote:
FRIDAY

Dr. Henry L. Niman, PhD
Ebola Racing Through
W Africa Now

Tonight's 10 PM EDT Interview will discuss ZMapp & Nature paper in detail

http://rense.gsradio.net:8080/rense/spe ... 082914.mp3

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PostPosted: Sat Aug 30, 2014 5:39 am 
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MOSCOW, August 30 (RIA Novosti) - British scientists have yielded "encouraging" results from a test on monkey of a potential vaccine against the deadly Ebola virus, The Independent reported.
One of the people that discovered Ebola virus said the test result was “the most convincing evidence to date” that vaccine, ZMapp, could treat Ebola in humans, the paper wrote.
Scientists tested the drug on 18 monkeys, all of which recovered shortly after treatment.
Professor and director of the London School of Hygiene and Tropical Medicine, Peter Piot, said it was “critical that trials start as soon as possible,” according to the Independent.
US medication ZMapp was first tested on humans in this month. The drug has been administered to two US citizens and two doctors from Nigeria and Uganda whose condition has significantly improved since the treatment. There were exceptions: a Spanish priest and Liberian doctor Abraham Borbor, who had also received the ZMapp treatment, did not survive.
The Ebola virus, which has a 90-percent mortality rate, has been raging in West Africa for months, in its biggest outbreak in history. No licensed treatment or cure for Ebola has existed until now, although companies in the United States and Japan have been developing drugs to treat the disease.
Tokyo has plans to provide another experimental drug to more than 20,000 Ebola victims, should the World Health Organization (WHO) approve. The medication, Avigan, developed by Fujifilm Holdings, is a pill that was approved in March as an anti-influenza drug in Japan and is currently undergoing clinical trials in the United States.
Ebola has claimed 1,552 lives from 3,069 cases since December, according to the World Health Organization.
The worst Ebola epidemic in history and the first to have occurred in West Africa began in southern Guinea and soon spread to Liberia, Sierra Leone and Nigeria. A separate outbreak in the Democratic Republic of Congo has killed 13 people.
The WHO says it could infect some 20,000 people before it is brought under control.

http://en.ria.ru/society/20140830/19247 ... ports.html

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PostPosted: Sat Aug 30, 2014 5:48 am 
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Ebola Drug Saves Infected Monkeys
ZMapp is the first treatment to completely protect animals after they show symptoms of disease

Aug 29, 2014 |By Erika Check Hayden and Nature magazine
ebola drug


The drug — a cocktail of three purified immune proteins, or monoclonal antibodies, that target the Ebola virus — has been given to seven people.
Credit: CDC via Wikimedia Commons
ZMapp, the drug that has been used to treat seven patients during the current Ebola epidemic in West Africa, can completely protect monkeys against the virus, research has found.

The study, published online today in Nature, comes the day after the World Health Organization (WHO) warned that the Ebola outbreak, which has killed more than 1,500 people, is worsening and could infect 20,000 people before it ends. A fifth West African nation, Senegal, reported its first case of the disease on Friday.

Public-health experts say that proven measures, such as the deployment of greater numbers of health-care workers to stricken areas, should be the focus of the response. But ZMapp, made by Mapp Pharmaceutical in San Diego, California, is one of several unapproved products that the WHO has said could be used in the outbreak.

The drug — a cocktail of three purified immune proteins, or monoclonal antibodies, that target the Ebola virus — has been given to seven people: two US and three African health-care workers, a British nurse and a Spanish priest. The priest and a Liberian health-care worker who got the drug have since died. There is no way to tell whether ZMapp has been effective in the patients who survived, because they received the drug at different times during the course of their disease and received various levels of medical care.

In the study, designed and conducted in part by Mapp Pharmaceutical scientists, 18 monkeys were given three doses of the drug starting three, four or five days after they were infected with Ebola. All animals that received the drug lived, no matter when their treatment started; three monkeys that were not treated died.

The strain of Ebola virus used in the study is not the same as the one causing the current outbreak. But researchers showed that the antibodies in ZMapp recognize the current form of the virus in cell cultures, and the parts of the virus recognized by the drug are present in the strain of Ebola that has caused the outbreak.

Advanced disease
The findings make ZMapp the first drug shown to be highly effective against Ebola when given to monkeys that are already showing symptoms of infection, such as fever and abnormalities in proteins that aid blood clotting. That is important because unless a patient is known to have been exposed to the virus, symptoms such as fever are the first sign that he or she is infected and needs treatment.

Thomas Geisbert, a virologist at the University of Texas Medical Branch at Galveston, estimates that day 5 of infection in the monkeys studied is roughly equivalent to days 7 to 9 of a human infection. People can develop symptoms up to 21 days after they contract Ebola, although signs commonly develop between 8 and 10 days after infection.

The study authors say that ZMapp works in an “advanced” stage of the disease. The drug was able to save one monkey that had bleeding under the skin affecting more than 70% of its body, and other monkeys that had enough virus in their blood to cause severe symptoms in people, says study co-author Gary Kobinger, an infectious-disease researcher at the Public Health Agency of Canada in Winnipeg.

“In humans, the large majority are unable to walk or even sit with this level, and most will die within 24 hours,” Kobinger says.

But other researchers say that the findings should be interpreted with caution, because monkeys with Ebola are not a perfect analogue for humans with the disease. “I don’t think the data support that this drug is effective, even in the animal model, in individuals with advanced Ebola disease,” says infectious-disease physician Charles Chiu at the University of California, San Francisco.

Knowing when to give the drug may help guide its use in future outbreaks. But for now, Mapp says that no more ZMapp is available and will not be for months.

This article is reproduced with permission and was first published on August 29, 2014.

http://www.scientificamerican.com/artic ... d-monkeys/

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PostPosted: Sat Aug 30, 2014 5:55 am 
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Ebola Outbreak: Experimental Drug ZMapp Shows 100% Positive Result On Monkeys, Says Study
By Suman Varandani@suman09
on August 30 2014 5:43 AM
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Health workers wearing protective clothing prepare to carry an abandoned dead body presenting with Ebola symptoms at Duwala market in Monrovia Aug. 17, 2014. Reuters/2Tango

The experimental drug ZMapp, which was given to two American doctors stricken with Ebola in Africa, has shown 100 percent positive results on monkeys, a new study revealed. The study has given rise to hopes that the drug could be used to fight the deadliest outbreak of the virus, which has so far killed more than 1,500 people and infected more 3,069 people.

Canadian researchers announced Friday that the experimental drug cured a group of 18 monkeys of the deadly disease in the recent weeks. According to the study, published in the online version of the journal Nature, some of the monkeys had received the drug three to five days after they had been injected with the virus. According to reports, this was the first time the drug was tested on primates.

“It worked fantastically well,” Gary Kobinger, one of the researchers in the study, said according to The Globe and Mail. “We of course expected an improvement. We were hoping for it. But the level of improvement was actually beyond my own expectations. I was quite surprised.”

According to the study, three monkeys, who were not provided with the drug, which has been developed by Mapp Biopharmaceutical Inc. of San Diego, died by the eighth day.

"Before, ZMapp was a total mystery,” Jonathan Ball, a virologist at the University of Nottingham, told the BBC. "This is an incredible improvement on those earlier cocktails, to have 100% clearance and most importantly that clearance when they've started to show outward signs of infection."

The ZMapp drug has so far been given to seven people, including the two doctors. While two of them died, the rest are currently being treated, but there is no guarantee that they will survive.

"Clearly there is the caveat that all evidence in humans is anecdotal and no hard evidence has been released on what happens to the virus in those patients,” Ball reportedly said, referring to the seven patients.

The company developing the drug has reportedly said that they have no more doses of ZMapp, which takes months to manufacture.

According to the World Health Organization, or WHO, by the time the virus is brought under control, there could be at least 20,000 such cases coming to light.

On Friday, the deadly virus spread to another country, making Senegal the fifth to be affected after Liberia, Guinea, Sierra Leone and Nigeria.

"This well designed trial in non-human primates provides the most convincing evidence to date that ZMapp may be an effective treatment of Ebola infection in humans,” Peter Piot, the director of the London School of Hygiene and Tropical Medicine told BBC. "It is now critical that human trials start as soon as possible.”

http://www.ibtimes.com/ebola-outbreak-e ... dy-1674352

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PostPosted: Sat Aug 30, 2014 10:31 am 
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A Liberian health worker who recovered from Ebola after receiving an experimental drug urged the manufacturer to speed up its production and send it to Africa, while crowds celebrated in the streets Saturday after authorities reopened a slum that had been barricaded for more than a week to try to contain the disease.

Physician's assistant Kyndy Kobbah was expected to be released from hospital Saturday after she survived Ebola, which has been fatal in more than half the cases sweeping West Africa. Kobbah contracted the disease while working at a government-run hospital north of the capital.

In an interview with The Associated Press before her release, Kobbah urged the manufacturer of the experimental drug known as ZMapp to step up production. The company has said that all its supplies are exhausted and it will take months to make more.

"They need to make more Zmapp and send to us," she said.

Doctors have said there is no way to know whether ZMapp made a difference or if survivors like Kobbah recovered on their own, as about 45 percent of people infected in this outbreak have. The drug had never been tested in humans before it was given to two Americans who were infected with Ebola in Liberia. They survived Ebola and were released from an Atlanta hospital.

However, a study released online Friday by the journal Nature found that ZMapp healed all 18 monkeys infected with the deadly virus.

Meanwhile, tensions diminished Saturday in the West Point neighborhood of Liberia's capital after authorities lifted a blockade that had sparked unrest. Residents living in the area had feared running out of food and safe water on the peninsula.

Liberia's president had ordered the barricade on Aug. 19 after West Point residents stormed an Ebola health center several days earlier. Residents said they did not want sick people being brought into the community, although those staying at the center were only under observation during a 21-day incubation period.

Amid the melee, some protesters made off with blood-stained mattresses and other materials that could potentially spread the Ebola virus.

Lifting the quarantine Saturday morning doesn't mean there is no Ebola in the West Point slum, said Information Minister Lewis Brown. Authorities, though, are more confident now that they can work with residents to screen for the sick, he said.

"They're comfortable with the way the leadership and the community is working with the health team to make sure that the community remains safe," he said.

Liberia has been the hardest hit of the five countries with Ebola cases in West Africa, reporting at least 694 deaths among 1,378 cases. More than 3,000 cases have been reported across Liberia, Guinea, Sierra Leone and Nigeria, and on Friday Senegal announced its first case.

A student from Guinea who had been missing for several weeks showed up at a hospital in Dakar on Tuesday, seeking treatment but concealing that he had been in contact with other Ebola victims, Health Minister Awa Marie Coll Seck confirmed.

The next day, an epidemiological surveillance team in neighboring Guinea alerted Senegalese authorities that they had lost track of a person they were monitoring three weeks earlier, and that the person may have crossed into Senegal.

The student was tracked down in the Dakar hospital where he was confirmed with Ebola and immediately put into isolation where he is reported to be in satisfactory condition, Seck said. Authorities also sent out a team to disinfect the home where he was staying in Senegal.

———

Associated Press writer Babacar Dione in Dakar, Senegal contributed to this report.

http://abcnews.go.com/Health/wireStory/ ... l-25183370

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