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PostPosted: Thu Aug 14, 2014 4:16 pm 

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
Experimental Ebola drug Zmapp arrives in Africa but only TWELVE doses
ZMapp drug poses ethical dilemma for authorities over who to treat
WHO figures show 1,069 have died of Ebola and 1,975 more are sick
Chinese health workers are held in quarantine in Sierra Leone
Doctors Without Borders defend not using Zmapp on patient last month
PUBLISHED: 09:10 EST, 14 August 2014 | UPDATED: 11:41 EST, 14 August 2014

Liberia is facing an excruciating choice - deciding which handful of Ebola patients will receive an experimental drug that could prove either life-saving or life-threatening.
ZMapp, the untested Ebola drug, arrived in the West African country late yesterday.
Liberia's Minister of Foreign Affairs, Augustine Ngufuan, couriered the two boxes of Zmapp himself on a commercial flight from the U.S. to Monrovia, where it was unloaded at a VIP terminal.
Precious cargo: Liberian Foreign Affairs Minister Augustine Ngafuan hand-carries boxes of the experimental, untested Ebola-fighting drug ZMapp on a Delta Airlines flight from New York's JFK airport to Monrovia
Precious cargo: Liberian Foreign Affairs Minister Augustine Ngafuan hand-carries boxes of the experimental, untested Ebola-fighting drug ZMapp on a Delta Airlines flight from New York's JFK airport to Monrovia
Important delivery: The drug will be taken to a hospital in Monrovia, the Liberian capital, and administered to Zukunis Ireland and Abraham Borbor, two Liberian doctors who caught Ebola virus while treating patients
An airport worker carries the Zmapp from the plane: With only around 10 to 12 doses of Zmapp available, and no knowledge about the drug's potential side effects, there are difficult ethical questions to be considered

Experimental Ebola drug arrives in Africa

Assistant health minister Tolbert Nyenswah said three or four people would begin getting it today. The government has said two doctors will receive the treatment, but it was unclear who else would.
These are the last known doses of ZMapp left in the world. The US-based company that developed it has said it will take months to build up even a modest supply.

American Ebola patient's son says she's getting better and doctors are 'very optimistic' about recovery
Husband of Ebola-infected missionary returns to U.S. from Liberia and immediately put back into quarantine
West Africa's Ebola virus outbreak has overwhelmed the region's already strained health systems and sparked an international debate over the ethics of giving drugs that have not yet been tested for safety or efficacy to the sick.
The charity group Doctors Without Borders, which is running many of the Ebola treatment centres and whose staff have tussled with whether to provide ZMapp, said such choices present 'an impossible dilemma'.
WHO backs use of experimental Ebola drugs in outbreak

Now Liberian officials are facing those questions. The first Liberian patients expected to be given Zmapp will be Zukunis Ireland and Abraham Borbor, two doctors who caught Ebola virus while treating patients.
'The criteria of selection is difficult, but it is going to be done,' said Dr Moses Massaquoi, who helped Liberia obtain the drug from Mapp Biopharmaceutical.
'We are going to look at how critical people are. We are definitely going to be focusing on medical staff.' Dr Massaquoi said people who were past the 'critical phase' and looked likely to survive would not be treated with it.
The World Health Organisation told Reuters only around 10 to 12 doses of the drug have been made and this raises difficult ethical questions about who should get priority access.
The worst-ever outbreak of Ebola has already claimed the lives of 1,069 people and there are 1,975 probable and suspected cases, the vast majority in Guinea, Liberia and Sierra Leone, according to the UN health agency.
The doctors will be the first Africans to receive the treatment, though it has already been given to a Spanish priest who later died and two U.S. aid workers who are reported to have shown signs of recovery.
Authorities are also concerned that ZMapp's unproven status could leave them open to the charge that humans are being used as guinea pigs.
'This is not the panacea to the problem. It is at the risk of the patient,' Liberia's Assistant Health Minister Tolbert Nyenswah told journalists at Monrovia's main airport.
Information Minister Lewis Brown told Reuters the drug merely offered a 'glimmer of hope' and its use was little more than a gamble.

Even so, the clamour for it is strong given that the contagious haemorrhagic disease is killing more than half of its victims and there is no known cure or vaccine.
'I welcome it. It is very good. Our nurses are dying. If you bring them the medication it will make them stronger to fight Ebola,' said stationery seller James Liburd, in Monrovia.
But highlighting the dilemma, Melvin Korkor, the first Liberian doctor to survive Ebola, said he would not have used ZMapp when he was fighting for his life because U.S. authorities said they were not responsible for any adverse effects.
'Any drug that has not been approved by FDA should not be administered,' he told Reuters.
And doctors treating a Sierra Leonean physician, Dr Sheik Humarr Khan, defended their decision not to give him the experimental drug, saying today they feared it was too risky.
Calling it 'an impossible dilemma,' Doctors Without Borders explained in detail last month's decision in response to a New York Times story on the case.
It would have been the first time the experimental drug was tried in humans but at the time that the experimental treatment was being considered for Dr Khan, his immune system was already starting to produce antibodies suggesting he might recover, Doctors Without Borders said in a statement.
Dr Khan was also due to be transferred to a European hospital that would be more capable of handling problems that might arise, it said.

One of the epidemic's most tragic consequences is the toll on health care workers who have become infected themselves due to inadequate protection or diagnoses of patients that came too late or were inaccurate.
The World Health Organization said this week that 170 health care workers had been infected and at least 81 had died. Another Sierra Leonean doctor, Modupeh Cole, became the latest medical practitioner to die of Ebola, a health ministry spokesman said on Tuesday.

He contracted the disease after treating a patient who later proved to have the virus and died.
His death followed that of Dr Khan, Sierra Leone's leading Ebola doctor, who was offered Zmapp, only for medics from Doctors Without Borders to decide no to give it to him.

The experimental drug, ZMapp, is designed to boost the immune system to help it fight the virus. Since Dr Khan's body was already producing an immune response, the doctors may have feared that any boost would kick it into overdrive.
In the end, the treating physicians decided against using the drug. They never told Dr Khan of its existence because they felt it would be unethical to tell him of a treatment they might not use.
Shortly after their decision, however, Dr Khan's condition worsened, the statement said, and the company providing the medical evacuation decided not to transfer him. He died a few days later, on July 29.
Trying an untested drug is a very difficult decision, particularly in the light of the "do no harm" principle
Doctors Without Borders statement
'Every day, doctors have to make choices, sometimes difficult, about treatment for their patients,' said the Doctors Without Borders statement.
'Trying an untested drug on patients is a very difficult decision, particularly in the light of the "do no harm" principle.'
Meanwhile, eight Chinese health workers are in quarantine in Sierra Leone because they may have contracted Ebola, according to the spokesman for the Chinese embassy in Freetown, Xu Zhou.
The seven doctors and one nurse treated patients at two Chinese-run hospitals in Freetown who later died from Ebola. One of the doctors has emerged from quarantine after a 21-day observation period, Mr Zhou told Reuters.

Despite the stir caused by ZMapp, preventive public health measures will be crucial to containing the outbreak, according to the U.N. health agency.
As a result, West African and other governments, including some which have seen no cases of the virus, have taken measures intended to prevent the spread of the disease.
Guinea-Bissau has decided to close its frontier with eastern neighbour Guinea, Prime Minister Domingos Simoes Pereira told a news conference. Germany on today urged its nationals to leave Liberia, Guinea and Sierra Leone, though the request did not apply to medical workers or German diplomatic staff, a foreign ministry spokesman said.
The outbreak has brought fresh attention to efforts to find a cure. Scientists in the U.S. studying Ebola say they have found how it blocks and disables the body's ability to battle infections in a discovery that should help the search for potential cures and vaccines.
The scientists found that Ebola carries a protein called VP24 that interferes with a molecule called interferon, which is vital to the immune response.
'One of the key reasons that Ebola virus is so deadly is because it disrupts the body's immune response to the infection,' said Chris Basler of the Icahn School of Medicine at Mount Sinai, New York, who worked on the study.

Read more: http://www.dailymail.co.uk/news/article ... z3AOo5f3WN
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PostPosted: Thu Aug 14, 2014 7:33 pm 

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
WHO pushes back against Ebola-related flight bans
Filed Under: Ebola
Lisa Schnirring | Staff Writer | CIDRAP News | Aug 14, 2014

With some airlines suspending flights to West Africa's Ebola outbreak region, the World Health Organization (WHO) today restated its position that the risk of disease transmission during air travel remains low, as a few doses of an investigational drug reached Africa.

Korean Air Lines (KAL) announced today that it would suspend flights to Nairobi, Kenya, starting Aug 20 to prevent the spread of Ebola virus disease (EVD), according to a report today from Reuters. KAL operates three return flights from Nairobi each week. Kenya has not reported any Ebola cases and does not border the affected area, though the WHO has urged it to take extra precautions, given the volume of travel between it and the outbreak countries.

Earlier this month, British Airways said it was suspending service to Liberia and Sierra Leone because of the EVD outbreak. Emirates Airlines, based in Dubai, has also suspended flights to Guinea.

So far, only one travel-related illness has been detected, in an airline passenger from Liberia who was sick upon his arrival in Nigeria, an event that sparked a transmission chain in the capital, Lagos. However, some airlines are concerned about the safety of passengers and staff who might need to seek care in a medical facility in outbreak countries.

WHO repeats advice against flight suspensions
Isabelle Nuttall, MD, director of the WHO Global Capacity Alert and Response, said in a WHO statement today that unlike flu and tuberculosis, Ebola doesn't spread through the air. "It can only be transmitted by direct contact with the body fluids of a person who is sick with the disease."

The WHO added that on the small chance that someone on a plane is sick with Ebola, the likelihood of other passengers and crew having contact with their body fluids is even smaller. Typically, when a person is sick with Ebola, they are so unwell that they can't travel. Health experts also say people who are infected with Ebola can't shed the virus until they have symptoms.

Last week the WHO's emergency committee on Ebola said the outbreak developments in West Africa qualify as a public health emergency of international concern (PHEIC), and it recommended a set of measures to curb the spread of the disease. The panel urged no bans on international travel or trade and that countries make sure they have the capacity to identify and care for travelers from Ebola-affected areas who arrive at travel hubs or destinations with unexplained fevers or other symptoms.

On its Twitter account today, the WHO said international airlines in affected countries are putting systems in place to screen passengers for possible infections. Global health officials have said exit screening in outbreak countries is likely to be more effective for flagging illnesses than entry screening in destination countries, because nonstop flights from African countries aren't the most common route, and it's more difficult to track passengers when they take multi-leg flights.

The WHO also tweeted that it is disappointed when airlines stop flying to West Africa: "Hard to save lives if we and other health workers cannot get in." (??)

Treatment, vaccine developments
In treatment developments, the first three doses of the experimental drug Zmapp arrived in Liberia last night, with two of them earmarked for two of the country's doctors who are in an isolation center at a hospital in Monrovia, the capital, AllAfrica reported today.

A Liberian health official said the government negotiated with the company, with the approval of the US Food and Drug Administration (FDA), to explore how the drugs could be given to the patients in Liberia. He also said negations are underway with other firms developing experimental Ebola drugs, including the Canadian company Tekmira, which makes the only Ebola treatment that has entered clinical trials.

Meanwhile, the president of NewLink Genetics Corp., which is developing an experimental Ebola vaccine based on technology developed by Canadian government researchers , said at least two contract manufacturers have been found to produce "tens of thousands" of doses in the next month or two, according to Reuters.

Charles Link, MD, told Reuters that the company's subsidiary has received funding from the US Department of Defense to speed up clinical trials and manufacturing. Canada's government recently announced that it will donate 800 to 1,000 doses of the vaccine that it has on hand to the WHO for use in battling the outbreak.

In another move that could speed development of an experimental treatment, BioCryst Pharmaceuticals, based in Research Triangle Park, N.C., announced yesterday that it has received an additional $4.1 million from the National Institute of Allergy and Infectious Diseases (NIAID) to conduct a phase 1 clinical trial of an intramuscular treatment for Ebola and other viral hemorrhagic fever diseases.

The additional funding for the treatment, called BXC4430, will also cover studies in nonhuman primates to gauge effective dose ranges and schedules.

The NIAID made its initial grant to BioCryst , valued at up to $22 million over 5 years, in September 2013.

In other developments, the FDA today warned consumers about online companies that are selling products to prevent or treat Ebola. In a statement it said it has received consumer complaints about a variety of products.

Though Ebola vaccines and treatments are under development, in early stages with very limited supply, there are no approved products that have been tested for safety or effectiveness, the FDA noted. The agency added that by law, dietary supplements can't claim to prevent or cure disease.

The FDA also mentioned that the CDC doesn't view the outbreak as a significant threat to the US public and noted that during outbreaks, fraudulent products that purport to prevent or treat the disease often appear on the market.

Latest African developments
Guinea's government has declared a national health emergency to tamp down the spread of Ebola, BBC News reported today, based on information from Guinea's state radio. The action is meant to trigger tighter border controls, order the immediate isolation of people with suspected infections, and prevent the movement of dead bodies from one town to another.

When the WHO declared a PHEIC on Aug 8, it urged the outbreak countries to declare national emergencies. Sierra Leone, Liberia, Nigeria had already declared national emergencies.

Sierra Leone has lost its second top doctor to EVD, Dr Modupeh Cole, who died yesterday at a Doctors Without Borders treatment center in Kailahun, the New York Times reported.

The health ministry said he was exposed to the virus while working in a hospital in Freetown, the capital, according to the Times report.

Nigerian health officials also today reported another death of a health worker, a nurse who had helped care for the country's first EVD case, a man whose illness was detected in Lagos after he had flown in from Liberia, the Associated Press (AP) reported today.

See also:

Aug 14 Reuters story

Aug 14 WHO statement

WHO Twitter feed

Aug 14 AllAfrica story

Aug 13 Reuters story

Aug 14 FDA statement

Aug 14 BBC News story

Aug 13 Times story

Aug 14 AP story
http://www.cidrap.umn.edu/news-perspect ... light-bans


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