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PostPosted: Mon Aug 11, 2014 6:08 pm 
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Media reports describing White House and FDA approval of ZMapp for two doctors in Liberia.

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PostPosted: Mon Aug 11, 2014 6:10 pm 
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Liberia: President Obama Approves the Use of Experimental Drug on Two Liberian Doctors undergoing Treatment for Ebola

The White House and the United States Food and Drug Administration have approved the request for sample doses of experimental Serum to treat Liberian doctors who are currently infected with the deadly Ebola virus disease.

According an Executive Mansion release, the approval was in response to an August 8, 2014 communication sent to President Barrack Obama by President Ellen Johnson Sirleaf in which she requested the experimental Serum to be used on the affected Liberian doctors.

The experimental drugs are to be brought in the country by a representative of the U.S. Government later this week.

Meanwhile, the Executive Director of the World Health Organization, Dr. Margaret Chan, has authorized the dispatch of additional doses of the experimental Serum to Liberia to support the treatment of affected doctors. The experimental Serum from the WHO will be brought in by one of its experts later this week.

http://allafrica.com/stories/201408113458.html

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PostPosted: Mon Aug 11, 2014 7:05 pm 
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URGENT - Liberia Ebola ZMapp

Published 6:29 PM EDT Aug 11, 2014

(CNN) -- The government of Liberia said that the White House and the FDA approved its request for sample doses of ZMapp, an experimental Ebola drug, to treat doctors infected with the deadly virus. The drugs will be transported to Liberia this week, according to the office of the Liberian President. The company that makes the drug said earlier that its supply of ZMapp was exhausted after fulfilling the request of a West African county, which it did not name.


Read more: http://www.wptz.com/national/urgent-lib ... z3A7yLkQRd

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PostPosted: Mon Aug 11, 2014 7:21 pm 
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Ebola Drug Supply Is Exhausted After Doses Sent to Africa
By Caroline Chen and Robert Langreth Aug 11, 2014 7:03 PM ET

The Ebola drug given to two Americans and a Spanish priest has been sent to treat infected doctors in two West African countries, and the supply of the medicine is now exhausted, its manufacturer said.

Countries including Nigeria and Liberia had requested the drug, called ZMapp. Mapp Biopharmaceutical Inc., based in San Diego, said it has complied with every request for the drug that was authorized by legal and regulatory authorities. The drug was provided at no cost, according to Mapp.

“It is our understanding that all patients offered treatment, treated, or expected to be treated were or are highly capable of providing informed consent for the use of an experimental drug not yet evaluated for safety in animals or people,” the company said in a statement.

Mapp and its partners, Defyrus Inc. and a subsidiary of Reynolds American Inc., are working with the U.S. government to quickly increase production, the company said in the statement.

“Additional resources are being brought to bear on scaling up,” the company said. “The emergency use of an experimental medicine is a highly unusual situation.”

Providing a small amount of an experimental drug to West Africa won’t help control the outbreak, said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases. The focus needs to remain on basic public health and infection control measures, he said.

Too Little

“How can a couple of doses control an outbreak with hundreds and hundreds of people?” Fauci said by phone today. “You don’t control the epidemic with two or three doses.”

Mapp, in its statement, didn’t identify which countries had received the remaining doses. The company said it’s up to those who requested it to reveal their acquisition or use of the experimental drug.

The Ebola outbreak has killed 1,013 of the 1,848 people infected in West Africa as of Aug. 9, the World Health Organization said today in a statement on its website. While other diseases are much more common and deadly, there is no cure for Ebola and it has moved quickly between countries, putting the global health community in high alert. Widespread malaria, which killed more than 600,000 people last year, is preventable and curable, according to the WHO.

A panel of ethicists was convened today by the WHO to weigh the use of experimental drugs that have shown early promise against Ebola. The panel is considering whether the drugs, which haven’t been widely tested for safety, should be used in an outbreak where 40 percent of infected people survive and, if so, who should get them from what may be a limited supply.

‘Long Overdue’

“This is the first effort to have a long-overdue, transparent, public discussion about how to distribute life-saving medicines in an emergency,” said Arthur Caplan, director of the division of medical ethics at NYU Langone Medical Center, in a telephone interview. “A ton of attention is going to follow this panel.”

The urgency to access the treatments has increased as health officials in the U.S., Canada and Hong Kong have isolated and tested travelers with Ebola-like symptoms, before ruling out the disease. Medical experts have said the deadly virus could travel outside of West Africa.

U.S. regulators last week said a treatment by Tekmira Pharmaceuticals Corp. could be tested in infected patients, while Mapp’s drug has already been used to treat two American aid workers Kent Brantly and Nancy Writebol, who were infected in Liberia. The pair were flown to Emory University Hospital in Atlanta, where relatives and supporters have said they are improving, though it remains unclear if or how much the drug helped.

Awaiting Decision

Sierra Leone is awaiting the outcome of the WHO panel before pursuing ZMapp, and the country has approached Tekmira about getting access to its product, Sierra Leone Chief Medical Officer Brima Kargbo said today in a telephone interview.

Other companies developing treatments or vaccines for the deadly disease include Fujifilm Holdings Corp., BioCryst Pharmaceuticals Inc., and Sarepta Therapeutics Inc.

Ebola is normally treated by keeping patients hydrated, replacing lost blood and using antibiotics to fight off opportunistic infections. The hope is that a patient’s immune system will eventually fight off the virus’s aggressive attack.

Treatment Priorities

Erica Ollmann Saphire, a molecular biologist who works on Ebola treatments with the Scripps Research Institute, said experimental drugs should go first to medical staff and aid workers.

“They are taking care of others at great risk to themselves,” Saphire said in an e-mail. “If the treatments help them survive, they could return to care for other patients, so the effect of the treatment would be compounded. Further, the health-care workers that survive may even become immune, and much better able to help in the future.”

The limited supply of the drug could create problems, Caplan said, questioning whether a patient’s condition should matter in determining who gets treated.

“The more recently you’ve been infected, the more likely you’ll respond better than if you’re 20 days out,” he said. “How about young versus old? Do we care if you’re 10 or if you’re 80?” The WHO plans a news conference at 2 p.m. Geneva time tomorrow to discuss the meeting of the ethics panel.

Researchers say the outbreak probably began in December with a 2-year-old child in Guinea, and the disease has raced through Guinea, Liberia and Sierra Leone, and recently entered Nigeria, which has recorded two Ebola-related deaths as of Aug. 9.

Equitable Care

G. Kevin Donovan, director of the Pellegrino Center for Clinical Bioethics at Georgetown University, said African doctors should be getting the same chance as Brantly and Writebol at potentially life-saving intervention.

“There is no reason why African doctors shouldn’t be considered as eligible” to be flown to Western countries for treatment, Donovan said in a telephone interview. “The sad truth is they are working in their own countries which are terribly under-funded and terribly under-staffed. The reason it worked for these two Americans is their organizations had the will and resources to pluck them out of danger.”

The inability of West African aid workers to get top-notch treatment is “a reflection of the inherent inequalities in the world and it doesn’t make it right. It makes it sadder and even more admirable for these local doctors and nurses to be placing themselves in such a position.”

Spain requested the Mapp drug on Aug. 8, after the doctor treating priest Miguel Pajares, a 75-year-old missionary who worked with Ebola patients, asked authorities to help him get it, the health ministry said. The treatment arrived in Madrid the next day, the ministry said.

The medicine arrived from Geneva, where a dose existed under an agreement with the manufacturer, the WHO and Doctors Without Borders, the ministry said. Spokesmen for the WHO and Doctors Without Borders said their groups weren’t involved.

To contact the reporters on this story: Caroline Chen in New York at cchen509@bloomberg.net; Robert Langreth in New York at rlangreth@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Drew Armstrong, Andrew Pollack

http://www.bloomberg.com/news/2014-08-1 ... frica.html

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PostPosted: Mon Aug 11, 2014 8:10 pm 
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President Obama Approves the Use of Experimental Drug on Two Liberian Doctors undergoing Treatment for Ebola
Monday, 11th August 2014

Monrovia, Liberia - The White House and the United States Food and Drug Administration have approved the request for sample doses of experimental Serum to treat Liberian doctors who are currently infected with the deadly Ebola virus disease.

According an Executive Mansion release, the approval was in response to an August 8, 2014 communication sent to President Barrack Obama by President Ellen Johnson Sirleaf in which she requested the experimental Serum to be used on the affected Liberian doctors.

The experimental drugs are to be brought in the country by a representative of the U.S. Government later this week.

Meanwhile, the Executive Director of the World Health Organization, Dr. Margaret Chan, has authorized the dispatch of additional doses of the experimental Serum to Liberia to support the treatment of affected doctors. The experimental Serum from the WHO will be brought in by one of its experts later this week.
- See more at: http://www.emansion.gov.lr/2press.php?n ... 0SEzt.dpuf

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PostPosted: Mon Aug 11, 2014 10:45 pm 
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UPDATE 2-Liberia says U.S. authorities allow use of experimental Ebola drug
Mon Aug 11, 2014 9:41pm EDT

(Adds details on Mapp Biopharmaceutical's statement on exhausting of drug supply)

By Clair MacDougall and Daniel Flynn

Aug 11 (Reuters) - U.S. authorities have approved a request from Liberia's government to send sample doses of the experimental ZMapp drug to treat Liberian doctors infected with Ebola, the Liberian presidency said.

A statement on the Liberian presidency's website said the drug would be delivered to the West African country this week by a U.S. government representative.

However, a representative for the U.S. Health and Human Services (HHS) Department said U.S. authorities had simply assisted in connecting the Liberian government with the drug's manufacturer.

"Since the drug was shipped for use outside the U.S., appropriate export procedures had to be followed," the HHS representative said, adding the drug company had worked directly with the Liberian government.

The death toll from the world's worst outbreak of Ebola has climbed to 1,013 people, according to figures on Monday from the World Health Organization. The outbreak has been branded as an international health emergency.

The Liberian statement said the head of the WHO, Margaret Chan, had authorized the dispatch of additional doses of the experimental drug to Liberia.

A WHO spokesman did not immediately respond to requests for comment.

The two U.S. aid workers treated with ZMapp, who contracted Ebola in Liberia, have since shown some signs of improvement. They are now in a hospital in Atlanta, Georgia, after being medically evacuated.

Spain on Sunday also authorised the use of the ZMapp on 75-year-old Spanish priest Miguel Pajares - the first European infected in the outbreak - who was evacuated to Madrid last week.

Mapp Biopharmaceutical said on Monday its supply has been exhausted, after the company provided doses to a West African nation, according to a report published by the Wall Street Journal.(on.wsj.com/1kXTVlB)

Liberian Information Minister Lewis Brown told Reuters that it was not clear how many doses of the drug had been sent but it could be in Monrovia within the next 48 hours.

The WHO has said the epidemic will likely continue for months as the region's healthcare systems struggle to cope and has appealed urgently for funding and emergency medical staff.

A WHO medical ethics committee had discussed on Monday the use of experimental drugs to tackle the world's worst outbreak of the deadly virus. It is due to announce its findings on Tuesday.

Aside from the ethics of using experimental drugs in humans, the committee was also due to consider who should receive priority for the limited supplies of the drugs. (Additional reporting by Michele Gershberg, Tanvi Mehta in Bangalore, Editing by Ken Wills)

http://www.reuters.com/article/2014/08/ ... MD20140812

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PostPosted: Mon Aug 11, 2014 10:46 pm 
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Maker of Experimental 'ZMapp' Ebola Drug Says Its Supply Is Exhausted
Company Provided Doses to Unidentified West African Nation


By PETER LOFTUS CONNECT
Aug. 11, 2014 7:19 p.m. ET
The maker of the experimental Ebola drug that was given to two infected Americans said Monday that its supply has been exhausted after the company provided doses to a West African nation.

Mapp Biopharmaceutical Inc. said in a brief online statement it had complied with every request for the drug that had the necessary legal and regulatory authorization. The company said it provided the drug, called ZMapp, at no cost in all cases.

San Diego-based Mapp didn't name any countries that requested the drug, and didn't release additional details.

ZMapp's safety hasn't previously been established in humans but the drug has shown promise in monkey studies.

Last week, Mapp said it provided ZMapp to two Americans infected with Ebola in West Africa who have been taken to Atlanta for treatment. The company has said it is working with U.S. government agencies to increase production of ZMapp, which was in limited supply because the company was focused on animal testing and hadn't planned to start human testing until next year.

Health authorities in Liberia expressed concern last week that the drug had been provided to two Americans but not to infected Liberians. Liberian officials last week said they would explore getting the experimental drug for other patients.

The Defense Threat Reduction Agency, or DTRA, an arm of the Department of Defense responsible for developing countermeasures to weapons of mass destruction, plans to award a contract to Mapp to help the company begin clinical trials testing ZMapp in humans, according to a notice posted online July 22.

Write to Peter Loftus at peter.loftus@wsj.com

http://online.wsj.com/articles/maker-of ... 1407799150

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PostPosted: Tue Aug 12, 2014 11:06 pm 
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Opting Against Ebola Drug for Ill African Doctor
By ANDREW POLLACKAUG. 12, 2014

The doctor who had been leading Sierra Leone’s battle against the Ebola outbreak was now fighting for his own life, and his international colleagues faced a fateful decision: whether to give him a drug that had never before been tested on people.

Would the drug, known as ZMapp, help the stricken doctor? Or would it perhaps harm or even kill one of the country’s most prominent physicians, a man considered a national hero, shattering the already fragile public trust in international efforts to contain the world’s worst Ebola outbreak?

The treatment team, from Doctors Without Borders and the World Health Organization, agonized through the night and ultimately decided not to try the drug. The doctor, Sheik Umar Khan, died a few days later, on July 29.

Times Topic: The Ebola Outbreak in West Africa
The doses of the drug that were not used were eventually sent to Liberia, where other doctors made the opposite decision — and two American aid workers became the first people in the world to receive ZMapp. Both of them survived and are now being treated at Emory University Hospital in Atlanta.

“It’s a little political; that’s what it looks like to me,” Alhajie Khan, Dr. Khan’s brother, said of the decision. “Why would you not give it to him? The guy who helped all of these people.”

The provision of ZMapp, which is in extremely limited supply, to foreign aid workers has raised broad ethical questions about the disparities in treatment between white outsiders and the Africans who form the overwhelming majority of victims in the epidemic.

Those concerns were heightened further after Spanish officials confirmed that they had obtained a supply of ZMapp for a third patient, a 75-year-old Spanish priest who died Tuesday after having been evacuated to Madrid from Liberia.

The previously untold story of Dr. Khan, recounted by two doctors involved in discussions about whether to use ZMapp, offered an unusual glimpse into the wrenching ethical dilemma of when and how experimental drugs should be used to combat the Ebola epidemic in West Africa. Had the treatment team decided differently in his case, the first person treated with the drug would have been African.

On Tuesday, the World Health Organization endorsed the use of untested drugs to combat the outbreak, which has already killed more than 1,000 people and continues to spread. But ZMapp and other potential treatments are in such short supply that another politically charged question remains: Who should get them?

Marie-Paule Kieny, assistant director general of the World Health Organization, said at a news conference in Geneva on Tuesday that several drugs and vaccines had shown some promise in animal testing and might conceivably be used.

But none are “available in unlimited supplies right now,” Dr. Kieny said. “I don’t think that there could be any fair distribution of something which is available in such a small quantity.”

On Tuesday, Liberia’s government announced that it would receive ZMapp after its president, Ellen Johnson Sirleaf, requested the drug from the United States. It said the drug would be used to treat two doctors who have Ebola.

That would be the first known use of the drug to treat Africans, but it also might be the last for a while. The manufacturer, Mapp Biopharmaceutical, said that it had complied with a request from a West African nation, but noted in a statement that the available supply of the drug was now exhausted.

In the case of Dr. Khan, who has been called “the arrowhead of the fight” against Ebola in his country, the doctors involved said there was no intention to save the drug for Americans. They said it was not known that the American aid workers were sick at the time of the decision not to treat Dr. Khan, around July 23. Instead, they said, doctors feared stoking the considerable suspicion of Western medical institutions in the country, which was already making it harder to contain the outbreak.

“What they really didn’t want to do was kill Dr. Khan with their attempt at therapy,” said Dr. Armand Sprecher, a public health specialist at Doctors Without Borders. “If word got out that M.S.F. killed Dr. Khan, that would have implications for outbreak control,” he added, using the initials for the French name of the relief group.

Dr. Sprecher, who is involved in the procurement and use of drugs for Doctors Without Borders but was not directly treating Dr. Khan, said another factor was that Dr. Khan’s virus levels were so high it was believed the drug would probably not work.

He said the treatment team never discussed the option of using the drug with Dr. Khan himself, deciding it would do so only if it decided to go ahead with the treatment.

“There are an awful lot of people who are very traumatized by the whole event,” Dr. Sprecher said in a telephone interview from Brussels on Tuesday.

At the time the decision was made, less was known about ZMapp, which may have helped the two American relief workers, Dr. Kent Brantly and Nancy Writebol, who were initially treated in Liberia and then evacuated.

Dr. Sprecher said the Spanish priest, the Rev. Miguel Pajares, had received the first of three recommended doses of ZMapp. He said the drug sent to Spain had originally been obtained by Doctors Without Borders and the World Health Organization for use in emergencies. It was kept at the University Hospital of Geneva, which had the authority to decide how the drug was used.

http://www.nytimes.com/2014/08/13/world ... =auto&_r=0

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PostPosted: Wed Aug 13, 2014 8:30 am 
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Liberia doctors to get ‘untested’ ebola medication
By Clair MacDougall, Monrovia

Liberia said it would treat two infected doctors with the scarce experimental ebola drug ZMapp, the first Africans to receive the treatment, while authorities in Spain said a priest had died of the disease.

The death toll from the worst ever outbreak of the highly contagious disease has climbed to 1,013 since it was discovered in remote southeastern Guinea in March, according to the World Health Organisation.

It said ZMapp doses were very scarce, raising ethical questions of who should have priority.

Spanish authorities said a 75-year-old Spanish priest who contracted ebola in Liberia had died.

The government had announced on Sunday that Fr Miguel Pajares, the first European infected by the strain, would also be treated with ZMapp manufactured by California-based Mapp Biopharmaceutical.

The hospital would not confirm that he had been treated with the drug, but his order and Spain’s Health Ministry said earlier that he would be. His body will be cremated today to avoid any further public health risks.

ZMapp has already been administered to two US aid workers, who are now in a hospital in Atlanta, Georgia, after being medically evacuated and have shown some signs of improvement.

The virus — one of the deadliest diseases known to man — has spread to four African countries, infecting 1,848 people, according to the WHO. It has branded the outbreak an international health emergency.

The epidemic in one of the world’s poorest regions, where crumbling healthcare systems are unable to cope, has opened an ethical debate on the use of trial drugs on humans.

After a meeting with medical experts, the World Health Organisation declared it is ethical to use unproven ebola drugs and vaccines in the current outbreak in West Africa provided the right conditions are met.

Its statement, however, sidestepped the key questions of who should get the limited drugs and how that should be decided.

With medical staff lacking the equipment and training to tackle the first outbreak of ebola in West Africa, over 60 healthcare workers have died and dozens more been infected, severely hindering countries’ ability to cope with the disease.

Information Minister Lewis Brown said the Liberian government had received written consent from the two doctors — who he identified as Zukunis Ireland and Abraham Borbor — for the treatment, which has not been fully tested in humans.

"The drug maker could not export… the drug without the approval of the FDA so our authorities approached the FDA and received specific approval for the treatment of these two doctors."

He said the drug was expected to reach Liberia within the next 24 hours.

A spokesperson for the US Health and Human Services Department said US authorities had simply assisted in connecting the Liberian government with the drug’s manufacturer and followed procedures for the export of pharmaceuticals.

Mapp Biopharmaceutical said its supply of the drug has been exhausted, after the company provided doses to a West African nation, according to a report published by the Wall Street Journal.

The Liberian presidency statement said the head of the WHO, Margaret Chan, had authorised the dispatch of additional doses of the experimental drug to Liberia, but Brown said it was not clear if this was true.



This story appeared in the printed version of the Irish Examiner Wednesday, August 13, 2014

http://www.irishexaminer.com/archives/2 ... 79364.html

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PostPosted: Wed Aug 13, 2014 10:00 am 
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Video: Expert virologist plays down hopes of Ebola 'cure'

Video by Catherine NICHOLSON
Text by FRANCE 24
Latest update : 2014-08-13

Despite the World Health Organisation giving the go-ahead for untested drugs to be used in the fight against the ongoing Ebola outbreak in West Africa, one expert told FRANCE 24 Wednesday it will be “a constant battle” to create enough doses.

Jonathan Ball, Professor of Molecular Virology at Nottingham University in the UK, told FRANCE 24 that ZMapp, a drug that has so far only been tested on animals, was in such short supply that “it can’t be used to treat the several hundred people suffering from Ebola”.

“They have given all of their existing stocks for treatment, and this is only a handful of doses,” he said. “It will be a constant battle to create sufficient doses of the drug.”

The last of the drug is on its way to Liberia for two stricken doctors. Mapp, the US company that makes ZMapp said on Tuesday that the supply was “exhausted”. The same day, Canada said it would provide some of its experimental Ebola vaccine for use in West Africa.

A Spanish missionary priest was the third person to receive the experimental ZMapp treatment, but he died in Madrid on Tuesday. Two US aid workers who received it in recent weeks are said to be improving, although it remains unclear if this is because of the treatment. The disease has a 60 percent fatality rate.

Ebola was first identified in 1976. The lack of an effective treatment after so many years, Ball said, was largely because “outbreaks usually occur in the poorest countries” and drugs companies had little motivation “to invest significant amounts of money because there is simply not sufficient profit” to be made.

ZMapp, Ball explained, was not developed with altruistic zeal to solve an African problem: “All of the treatments and vaccines that we have were part[ly] funded by governments to fight a bio-terrorism threat.”

ZMapp worked with monkeys

The current outbreak is the biggest in history and has killed more than 1,000 people in Guinea, Sierra Leone, Liberia and Nigeria.

There is no proven treatment or vaccine for Ebola and ZMapp is so new that it has never been tested on humans, although an early version worked on some monkeys infected with Ebola.

“There is always a risk” using untested drugs, said Professor Ball. “That is why we have clinical trials and the first part is to check how safe they are.

“We are stepping into the unknown as to whether these drugs and vaccines will work and whether or not they will be safe,” he said, adding that he understood that Ebola sufferers given a glimmer of hope with an untested drug “are going to be willing to try anything.”

The WHO says 1,013 people have died so far in the Ebola outbreak in West Africa of the 1,848 suspected or confirmed cases recorded so far.

The killer virus is spread by direct contact with bodily fluids like blood, diarrhea and vomit.

The WHO said on Wednesday that using unproven treatments or vaccines was ethically sound if patients gave their informed consent and were guaranteed confidentiality and freedom of choice.

http://www.france24.com/en/20140813-vid ... emic-cure/

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