Ethics test: Who gets experimental Ebola drug?
by Ciaran Giles, Associated Press and Maria Cheng, Associated Press
August 11, 2014 04:15 PM | 1396 views | 0 0 comments | 3 3 recommendations | email to a friend | print
In this image taken Saturday, Aug. 9, 2014 a large billboard promoting the washing of hands to prevent the spread of the deadly Ebola virus in Monrovia, Liberia. Over the decades, Ebola cases have been confirmed in 10 African countries, including Congo where the disease was first reported in 1976. But until this year, Ebola had never come to West Africa. (AP Photo/Jonathan Paye-Layleh)
In this image taken Saturday, Aug. 9, 2014 a large billboard promoting the washing of hands to prevent the spread of the deadly Ebola virus in Monrovia, Liberia. Over the decades, Ebola cases have been confirmed in 10 African countries, including Congo where the disease was first reported in 1976. But until this year, Ebola had never come to West Africa. (AP Photo/Jonathan Paye-Layleh)
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In this photo taken on Saturday, Aug. 9, 2014, health workers stand as Liberia President Ellen Johnson Sirleaf, back left, arrives to deliver a speech imploring them to keep working at the health centers with government support, to combat the deadly Ebola virus that has spread through the country, including the city of Monrovia, Liberia. The World Health Organization declared the Ebola outbreak an international health emergency Friday. The growing unease in Liberia, where nearly 300 people have died from the gruesome disease, raises the specter of social unrest. (AP Photo/Abbas Dulleh)
In this photo taken on Saturday, Aug. 9, 2014, health workers stand as Liberia President Ellen Johnson Sirleaf, back left, arrives to deliver a speech imploring them to keep working at the health centers with government support, to combat the deadly Ebola virus that has spread through the country, including the city of Monrovia, Liberia. The World Health Organization declared the Ebola outbreak an international health emergency Friday. The growing unease in Liberia, where nearly 300 people have died from the gruesome disease, raises the specter of social unrest. (AP Photo/Abbas Dulleh)
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In this photo taken Saturday, Aug. 9, 2014, a health worker wearing a protective clothing spray disinfectant against the deadly Ebola virus at the Kenema Government Hospital in Kenema, 300 kilometers, (186 miles) from the capital city of Freetown, Sierra Leone. Over the decades, Ebola cases have been confirmed in 10 African countries, including Congo where the disease was first reported in 1976. But until this year, Ebola had never come to West Africa. (AP Photo/ Michael Duff)
In this photo taken Saturday, Aug. 9, 2014, a health worker wearing a protective clothing spray disinfectant against the deadly Ebola virus at the Kenema Government Hospital in Kenema, 300 kilometers, (186 miles) from the capital city of Freetown, Sierra Leone. Over the decades, Ebola cases have been confirmed in 10 African countries, including Congo where the disease was first reported in 1976. But until this year, Ebola had never come to West Africa. (AP Photo/ Michael Duff)
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MADRID (AP) — Now it's not just two Americans, but a Spaniard, as well: the three non-Africans known to have Ebola got some of the very few doses that exist of an experimental drug aimed at treating the deadly disease.

None of the more than 1,700 Africans sickened by Ebola have received this treatment.

This drug, "ZMapp," is so novel and unproven that not much is available and its effectiveness remains unknown. It could end up doing more harm than good. It would take months to produce the drug in any modest quantity, and even then, using it more widely would present other ethical dilemmas.

But many Africans are seeing a larger, bitter truth in the fact that two Americans and a Spaniard were able to get this treatment after being infected in West Africa, where the hemorrhagic fever has raged for months.

"There's no reason to try this medicine on sick white people and to ignore blacks," said Marcel Guilavogui, a pharmacist in Conakry, Guinea. "We understand that it's a drug that's being tested for the first time and that could have negative side effects. But we have to try it in blacks too."

The ethical questions posed by this situation have been so difficult that the U.N. health agency organized a teleconference Monday between about a dozen ethicists, infectious disease experts and patient representatives, including people from universities and the Doctors Without Borders group. Most of the participants are from developed countries, but Uganda and Senegal had people in the meeting.

The World Health Organization said it would hold a news conference Tuesday, but didn't announce whether it would make recommendations for which Ebola patients should get experimental therapies, and how.

"It certainly looks bad that only three Westerners have gotten the drug while most of the people with Ebola are African," said Art Caplan, director of bioethics at NYU Langone Medical Center.

The drugmaker should make its policy for distributing its treatment clear, said Caplan, who did not participate in the WHO teleconference. "I don't think this scarce resource should just be given to whoever is best connected."

The drug is made by Mapp Biopharmaceutical Inc., a small, San Diego-based company that did not respond to calls or emails from The Associated Press on Monday.

Companies can provide experimental drugs on a "compassionate use" basis, usually after they have been fully tested. In the US, such use must be approved by the Food and Drug Administration, but the FDA has no authority overseas. It is up to the company whether they want to share their drug.

Spain's Health Ministry said it obtained ZMapp this weekend with company permission to treat Miguel Pajares, a 75-year-old priest evacuated from Liberia and placed in isolation Thursday at Madrid's Carlos III Hospital.

The ministry said "the medicine was imported from Geneva where there was one dose available in the context of an accord between the laboratory that developed the medicine, WHO and (Doctors Without Borders)."

The ministry also said it invoked a Spanish law permitting unauthorized medication for patients with a life-threatening illness who cannot be treated satisfactorily by authorized drugs.

Spanish authorities refused to comment beyond the ministry's statement, but Geneva University Hospital told The Associated Press it was involved in getting the drug to Madrid.

The evacuated Americans, Dr. Kent Brantly and Nancy Writebol, have been improving at Atlanta's Emory University Hospital. They got the treatment after Samaritan's Purse asked the drug's manufacturer, Kentucky BioProcessing, which is producing the drug for Mapp Biopharmaceutical.

Mapp Pharmaceutical says on its website that "very little of the drug is currently available" and that it is working with government agencies to increase production as quickly as possible.

The treatment is a mixture of three antibodies engineered to recognize Ebola and bind to infected cells so the immune system can kill them.

Absent a known cure or licensed treatment, Ebola has killed more than 960 people since it emerged in Guinea in March and spread to Liberia, Sierra Leone and possibly Nigeria.

Nigeria's health minister, Onyenbuchi Chukwu, said last week that when he asked the U.S. Centers for Disease Control and Prevention about getting the drug, he was told the manufacturer would have to agree and that the CDC would not be involved. Guinea said Monday it too would like to have some of the drug.

"Guinean authorities would naturally be interested in having this medicine," said Alhoussein Makanera Kake, spokesman for the government committee fighting Ebola.

In Nigeria, where local officials say they have 10 confirmed cases, people are already sending tweets demanding the drug. WHO has publicly noted the Nigerian caseload, but has yet to confirm Ebola's spread there.

In other Ebola developments Monday:

— A Catholic humanitarian group based in Spain said another religious worker and colleague of the infected Spanish priest had died in from Ebola in Liberia.

— Nigerian health authorities confirmed another Ebola case Monday, a nurse who treated Patrick Sawyer, the Liberian-American who flew into Nigeria and died last month. That brings Nigeria's locally confirmed Ebola cases to 10, including the two who died, Sawyer and another nurse. Nigeria also is monitoring 177 contacts of Sawyer.

— 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.

— 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 recorded 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, Boubacar Diallo in Gonakry, Guinea and Bashir Adigun from Abuja, Nigeria, also contributed to this report.



Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.



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