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PostPosted: Sun Aug 10, 2014 3:11 pm 
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With hundreds of Africans dying from the outbreak of Ebola, some activists have said it is wrong that extremely scarce supplies of an experimental drug went to two white American aid workers.

But others wonder: What if the first doses of the drug — which had never been used in people and had not even finished the typical animal safety testing — had been given to African patients instead?

“It would have been the front-page screaming headline: ‘Africans used as guinea pigs for American drug company’s medicine,’ ” said Dr. Salim S. Abdool Karim, director of Caprisa, an AIDS research center in South Africa.

A history of controversy about drug testing in Africa is just one of the complexities facing public health authorities as they wrestle with whether and how to bring that drug and possibly other experimental ones to the countries afflicted with Ebola. Who should get such a scarce supply of medicine? Health workers? Children? The newly infected who are not yet as sick?

There are virtually no remaining supplies of the drug, called ZMapp, that was used to treat the two Americans, United States officials say. And even a few months from now, according to various estimates, there may be no more than a few hundred doses.

The World Health Organization, which on Friday declared an international health emergency on Ebola, will convene a meeting of ethicists early next week to discuss this delicate and difficult predicament involving the drugs. The United States government is also forming a group to consider these issues, said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases.

At least two of the countries affected by the Ebola outbreak, Liberia and Nigeria, have asked for the drug, according to a spokesman for the Centers for Disease Control and Prevention.

A perception in the region of unfairness in distributing the medicine could undermine the already shaky willingness of some Africans to trust the Western relief efforts. Dr. Armand Sprecher, a public health specialist for the aid group Doctors Without Borders, said it was unfortunate that the first doses went to white Americans “because it confirms all the suspicions people have.” But, he said, he did not foresee that perception as undermining the relief effort, adding that if effective drugs were available, it could bolster the effort’s credibility and give people an incentive to seek medical care.

“At the moment, our big problem is finding the patients in a timely way and convincing them to come to the treatment center,” he said. “If you don’t have a carrot to hang out there and bring people in, then you can’t contain it.”

Other experimental medicines might be available, but also probably in small amounts, like one from Tekmira Pharmaceuticals that has so far been tested only in healthy volunteers. Tekmira said Thursday that the Food and Drug Administration had determined the drug
ZMapp is reported to have helped the two aid workers, Dr. Kent Brantly and Nancy Writebol, who were initially treated in Liberia and are now at Emory University Hospital in Atlanta. But experts said it was too soon to conclude that it was truly effective. Dr. Brantly on Friday released a statement from his isolation room at the hospital, saying, “I am growing stronger every day.”

Continue reading the main story
ZMapp is being developed by Mapp Biopharmaceutical, a nine-person company in San Diego that was doing animal studies with a view to beginning human safety testing next year. But plans are now changing to help make the drug available faster to patients.

According to federal officials, ZMapp was given to the two Americans because Samaritan’s Purse, the aid organization that employed Dr. Brantly, found out about it and asked for it, not because of any favoritism to Americans.

Still, Maina Kiai, a human rights activist in Kenya, said the seeming inequity was discussed on the sidelines of the summit meeting of African leaders held in Washington this week.

“There was a sense of the same pattern,” he said, that “the life of an African is less valuable.”

The federal authorities say that when more ZMapp becomes available, it should be given to patients as part of research into the drug’s safety and efficacy.

“You’ve got to balance the compassionate-use aspect with trying to figure out whether it works,” Dr. Fauci said.

Doing such a study in the midst of an outbreak could be difficult, especially in parts of Africa with limited medical infrastructure.

If the outbreak is not extinguished soon, there would be enough drug for only a small percentage of infected people.

Some bioethicists said health care workers should be among those given priority. They can best understand the risks of taking a drug not yet tested in people and give informed consent. Offering doctors and nurses priority can encourage them to undertake the grave dangers of caring for people with a deadly, contagious disease. And if they get better, they might go back to caring for patients.


“I think there are very special commitments that we must make ethically to the health care providers that are willing to go in and serve,” said Nancy Kass, a professor of bioethics and public health at Johns Hopkins University.

At the government hospital in Kenema, Sierra Leone, health care workers struggle to contain the Ebola epidemic, which has killed almost 1,000 people across West Africa. Video Credit By Ben C. Solomon on Publish Date August 7, 2014. Image CreditTommy Trenchard for The New York Times
Others say more recently infected patients would be more likely to be helped by the drug.

A senior official at the Food and Drug Administration said priority might go to those who had access to other supportive care because they were most likely to benefit. But that could mean that the limited supplies might go to relatively privileged Africans.

This, of course, assumes that people will want the drug. That might not always be the case because of suspicions about health care in general and Western pharmaceutical companies in particular. Many patients stricken in the current outbreak are fleeing rather than going to clinics.

“There are just an awful lot of Africans who are afraid of the health care system right now,” said Dr. G. Kevin Donovan, director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center.

Northern Nigeria has a history of resisting the campaign to eradicate polio, for example, with rumors circulating that vaccinations are a plot to sterilize Muslim women. At least nine polio immunization workers were shot to death there in February 2013.

Continue reading the main storyContinue reading the main story
There have been some controversies over testing of drugs in Africa and other developing regions, with critics saying that participants are exploited or not treated properly and that they help develop drugs that if on the market, might not even be affordable in poor countries.

ZMapp would be provided free in studies, and it is too early to say how much it would cost if it ever got to market.

Pfizer settled charges and lawsuits that accused it of improprieties in testing an experimental antibiotic during a 1996 meningitis outbreak in northern Nigeria. Eleven children in the trial died. Five were given Pfizer’s drug, and the others received a comparator drug. Pfizer denied any wrongdoing and said the deaths were from the disease, not its drug.

Arthur L. Caplan, director of the division of medical ethics at NYU Langone Medical Center, said that in the end, experimental drugs against Ebola were likely to make little difference in the current outbreak, and that resources would be better spent trying to stamp out the epidemic using quarantines and other public health measures.

“Morally, everyone is keenly interested in who should get the drug,” he said. But the most important moral question is, “What is the best thing to do to bring that outbreak to a close? And I don’t think it’s drugs.”

A version of this article appears in print on August 9, 2014, on page A1 of the New York edition with the headline: Ebola Drug Could Save a Few Lives. But Whose?. Order Reprints|Today's Paper|Subscribe

http://www.nytimes.com/2014/08/09/healt ... world&_r=0

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PostPosted: Mon Aug 11, 2014 8:39 am 
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Petitioning Makers of ZMapp, United Nations and CDC
The experimental drug ZMapp should be made available immediately in Guinea, Sierra Leone, Liberia and Nigeria.
Image

Petition by
Ify Asogwa
London, United Kingdom

The latest Ebola virus outbreak has quickly become a continental epidermic and countries in Africa are struggling to contain the spread. There is a danger that if not contained it could spread like wildfire resulting in the needless loss of valuable human lives in the countries in West Africa that have reported cases of infections.

We have read with interest and dismay of the 2 Americans and 1 Spanish that were infected with Ebola and have been evacuated by their countries then treated with the experimental drug ZMapp. ZMapp has been successful in helping their recovery from the Ebola virus which is known to have a 90% mortality rate. The countries where these individuals are from were able to procure this expereimental drug ZMapp quickly enough to prevent the loss of their lives. This is in contrast with the lives of people in West Africa that are dying everyday as the disease continues to spread and the health authorities struggle to contain it.

Guinea, Sierra Leone, Liberia and Nigeria , the four countries in Africa battling with the Ebola outbreak have requested access to ZMapp and instead of this live saving medicine being provided immediately in order to save lives and prevent the outbreak of a epidermic that would be a contiental disaster, they are still embroiled in the bureaucratic processes which were obviously waivered for Spain and the US citizens.

I invite you to stand with me and the people in Guinea, Sierra Leone, Liberia and Nigeria who are under immediate threat from this global epidermic and sign this petition calling on the makers of ZMapp, the United Nation and The Centers for Disease Control and Prevention , United States to provide immediate access to this life saving medicines.

We believe Every human life is VALUABLE and deserves to be fought for. If you believe the same then please sign this petition and share it on social media.

LET'S GET THE WORLD TO ACT NOW TO SAVE LIVES.

To:
Makers of ZMapp, United Nations and CDC, LeafBio, Inc. 6160 Lusk Blvd. #C104 San Diego, CA 92121 VM/Fax 858 625 0335
Ban Ki-moon, Secretary General, United Nations, 1st ave. and 46th street New York, NY 10017 USA
CDC, Dr. Tom Frieden, Centers for Disease Control and Prevention 1600 Clifton Rd. Atlanta, GA 30333 USA
Dr Gro Harlem Brundtland, Director General , WHO, Avenue Appia 20 CH-1211 Geneva 27
The experimental drug ZMapp should be made available immediately in Guinea, Sierra Leone, Liberia and Nigeria.
Sincerely,
[Your name]

http://www.change.org/en-GB/petitions/m ... e_petition

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PostPosted: Mon Aug 11, 2014 3:43 pm 
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Spanish Missionary Priest Gets Experimental Ebola Drug, Sparking Ethical Questions
The Associated Press | By CIARAN GILES and MARIA CHENG
Posted: 08/11/2014 1:46 pm EDT Updated: 1 hour ago
Image
MADRID (AP) — In a development that raises a host of ethical issues, Spain announced it had obtained a scarce U.S.-made experimental Ebola drug to treat a Spanish missionary priest infected with the killer virus.

The Health Ministry statement came less than a week after the U.S. Centers for Disease Control and Prevention said there were virtually no doses available of the drug that was used to treat two Americans with the disease.

The drug's maker, Mapp Pharmaceutical Inc. of San Diego, says "very little of the drug is currently available" and that is cooperating with government agencies to increase production as quickly as possible.


Nigerian officials say they had asked U.S. health authorities about getting the Ebola drug but were apparently not helped.

There is no known cure or licensed treatment for Ebola, which has killed over 960 people in the current outbreak in West Africa. The World Health Organization has called the Ebola outbreak — which emerged in Guinea in March and has since spread to Liberia, Sierra Leone and possibly Nigeria — an international health emergency and urged nations worldwide to battle the disease.

The ethical questions surrounding experimental Ebola drugs and vaccines were being debated Monday during a teleconference of medical ethicists and other experts organized by the U.N. health agency.

In a statement provided Monday, the Spanish Health Ministry said the ZMapp drug was obtained in Geneva this weekend with permission from the company and brought to Madrid to treat Miguel Pajares. The 75-year-old priest was evacuated from Liberia and placed in isolation Thursday at Madrid's Carlos III Hospital.

Two Americans diagnosed with Ebola in Liberia and evacuated back to the United States have been treated with the drug. One of them, Dr. Kent Brantly, said last week that his condition was improving and the husband of the aid worker being treated with Brantly said the same thing. Both are in isolation at an Atlanta hospital.

It was not exactly clear how Spain got the drug.

Spain said it obtained permission from the laboratory developing the drug and, under an agreement between WHO and the Doctors Without Borders charity group, imported the drug from Geneva where it said a dose had been available. The ministry said Spain sought the drug under legislation permitting use of unauthorized medication in patients suffering from a life-threatening illness who cannot be treated satisfactorily with any authorized drug.

WHO spokesman Gregory Hartl, however, told The Associated Press on Monday that the U.N. agency had no role in helping Spain obtain the experimental drug.

At least one country in West Africa has expressed interest in the Ebola drug. Nigeria's health minister, Onyenbuchi Chukwu, said last week he had asked U.S. health officials about access but was told the manufacturer would have to agree.

Dr. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention, said "there are virtually no doses available," a CDC spokesman said last week.

Because the ZMapp drug has never been tested in humans, scientists say there's no way to tell if it has made any difference to the two American aid workers who have received it.

The drug is a mixture of three antibodies engineered to recognize Ebola and bind to infected cells so the immune system can kill them. Scientists culled antibodies from laboratory mice and ZMapp's maker now grows the antibodies in tobacco plants and then purifies them. It takes several months to even produce a modest amount of the drug.
In other Ebola developments:

— Nigerian health authorities confirmed another Ebola case Monday, a nurse who was treating Patrick Sawyer, the Liberian-American who flew into Nigeria with the disease and died of it last month. That brings the locally confirmed Ebola cases in Nigeria to 10, including two who have died, Sawyer and another nurse. Nigerian authorities now have 177 contacts of Sawyer under surveillance. WHO has not yet confirmed the Ebola cases in Nigeria.

— The hemorrhagic disease is ravaging some of the world's poorest countries, and their ill-equipped health systems have struggled to keep up. Liberia announced that a donation of protective gear from China was arriving Monday. A shortage of full-body suits and even clean surgical gloves has left health workers exposed to the virus and prompted some to refuse to treat Ebola patients.

— Residents in central Liberia rioted over the weekend, claiming the government had left some highly infectious bodies of Ebola victims in the streets for days without picking them up.

— George Weah, a former FIFA world player of the year from Liberia, has joined the efforts to spread awareness about the disease and how to prevent it. He recording a song titled "Ebola is real," and proceeds are going to the Liberian Health Ministry.

___
Medical writer Cheng reported from London. AP writers Jonathan Paye-Layleh from Monrovia, Liberia and Bashir Adigun from Abuja, Nigeria, also contributed to this report.

http://www.huffingtonpost.com/2014/08/1 ... mg00000067

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PostPosted: Mon Aug 11, 2014 3:46 pm 
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Emergency meeting on the role of experimental therapies in outbreak response

On Monday 11 August, WHO is holding an emergency meeting with ethicists, scientific experts and lay people from affected countries to assess the role of experimental therapies in the Ebola outbreak response. Issues to be considered include the ethics surrounding use of therapies when safety is unproven, ethics governing priority setting for access to these therapies and principles for fair distribution.

http://www.who.int/csr/disease/ebola/ov ... t-2014/en/

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PostPosted: Mon Aug 11, 2014 3:55 pm 
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Spain to use experimental Ebola drug on priest
There is no known cure or licensed treatment for Ebola, which has killed more than 1,000 people in the current outbreak in West

Roman Catholic priest Miguel Pajares, who contracted the deadly Ebola virus, is transported from Madrid's Torrejon air base in this file photo from Aug.7, 2014.

By: Ciaran Giles And Maria Cheng Associated Press, Published on Mon Aug 11 2014
MADRID—Spain has imported a U.S.-made experimental Ebola drug to treat a Spanish missionary priest evacuated from Liberia last week after testing positive for the killer virus.
The Health Ministry announced Monday that the ZMapp drug, made by Mapp Biopharmaceutical Inc. of San Diego, was obtained in Geneva this weekend and brought to Madrid to treat Miguel Pajares. The 75-year-old priest was placed in isolation Thursday at Madrid’s Carlos III Hospital.

There is no known cure or licensed treatment for Ebola, which has killed more than 1,000 people in the current outbreak in West Africa. The World Health Organization has called the Ebola outbreak — which emerged in Guinea in March and has since spread to Liberia, Sierra Leone and possibly Nigeria — an international health emergency and urged nations worldwide to donate resources to battle the disease.
The ethical questions surrounding experimental Ebola drugs and vaccines were being debated Monday during a teleconference of medical ethicists and other experts organized by the UN health agency.
Two Americans diagnosed with Ebola in Liberia and evacuated back to the United States have been treated with the drug. One of them, Dr. Kent Brantly, said last week that his condition was improving and the husband of the aid worker being treated with Brantly said the same thing. Both are in isolation at an Atlanta hospital.
Spain said it obtained permission from the laboratory developing the drug and, under an agreement between WHO and the Doctors Without Borders charity group, imported the drug from Geneva where it said a dose had been available. The ministry said Spain sought the drug under legislation permitting use of unauthorized medication in patients suffering from a life-threatening illness who cannot be treated satisfactorily with any authorized drug.
Despite Spain’s statement, WHO spokesman Gregory Hartl told The Associated Press on Monday that the UN agency had no role in helping Spain obtain the experimental drug.
At least one country in West Africa has expressed interest in the experimental drug. Nigeria’s health minister, Onyenbuchi Chukwu, said last week he had asked U.S. health officials about access but was told the manufacturer would have to agree.
Dr. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention, said “there are virtually no doses available,” a CDC spokesman said last week, before the announcement that Spain was also using the drug.
Because the ZMapp drug has never been tested in humans, scientists say there’s no way to tell if it has made any difference to the two American aid workers who have so far received it.
The drug is a mixture of three antibodies engineered to recognize Ebola and bind to infected cells so the immune system can kill them. Scientists culled antibodies from laboratory mice and ZMapp’s maker now grows the antibodies in tobacco plants and then purifies them. It takes several months to even produce a modest amount of the drug.
Nigerian health authorities, meanwhile, confirmed another Ebola case Monday, a nurse who was treating Patrick Sawyer, the Liberian-American who flew into the country with the disease and died of it last month. That brings the locally confirmed Ebola cases in Nigeria to 10, including two who have died, Sawyer and another nurse. Nigerian authorities have 177 contacts of Sawyer now under surveillance.
WHO has not yet confirmed the Ebola cases in Nigeria.
Medical writer Cheng reported from London.

http://www.thestar.com/news/world/2014/ ... riest.html

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