Tuesday, March 31, 2015
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Ethics test: Who gets experimental Ebola drug?

By
August 12, 2014 |

MADRID — 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 even modest quantities. 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, killing 961 people and counting.

“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.”

Some are using Twitter to demand that the drug be made available in Africa.

“We can’t afford to be passive while many more die,” said Aisha Dabo, a Senegalese-Gambian journalist who was tweeting using the hashtag “GiveUsTheSerum”on Monday. “That’s why we raise our voice for the world to hear us.”

The ethical dilemmas involved prompted the U.N. health agency to consult Monday with ethicists, infectious disease experts, patient representatives and the Doctors Without Borders group. Most participants in the closed teleconference were from developed countries, but Uganda and Senegal had people in the meeting.

The World Health Organization said it would describe the results of the discussion at a news conference Tuesday, but didn’t announce whether it would make recommendations for deciding which Ebola patients should get experimental therapies.

“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, who was not involved in Monday’s consults.

The drugmaker should clarify its policy, said Caplan. “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 humans. The Food and Drug Administration approves such uses in the U.S., but has no authority overseas.

Ultimately, the companies alone decide whether or not to share their products, and it wasn’t clear Monday whether the governments of these West African countries have asked them directly.

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 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 said, invoking a Spanish law permitting unauthorized medication for patients with life-threatening illnesses.

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 Kentucky BioProcessing, which produces it 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 mixes 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 keeps killing more than half of the people it has sickened since it emerged in Guinea in March and spread to Liberia, Sierra Leone and possibly Nigeria.

A Sierra Leone official said they had not asked for the drug, but the other governments said they want any treatment that might help patients recover, despite the risks of unproven medicines.

“The alternative for not testing this is death, a certain death,” Liberia’s information minister, Lewis Brown, told The AP in an interview.

Guinea said Monday it wants some, too.

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

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 won’t get involved.

In other Ebola developments Monday:

— An African nun who worked with the infected Spanish priest died from Ebola in Liberia, their Catholic aid group said.

— A nurse who treated Patrick Sawyer, the Liberian-American who flew into Nigeria and died last month, also died of Ebola, Nigerian health authorities said, raising the number of locally confirmed Ebola cases to 10. Nigeria is monitoring 177 contacts of Sawyer to contain the outbreak. The WHO has yet to confirm any Ebola cases in Nigeria.

— 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. Soldiers enforced a quarantine of two counties in “Operation White Shield.”

— Ivory Coast, which shares borders with Liberia and Guinea, banned direct flights from the infected countries and said it would increase health inspections and enforcement of its borders, but stopped short of closing them entirely.

— George Weah, a Liberian former FIFA world player of the year, joined awareness efforts by recording a song titled “Ebola is real,” with proceeds going to the Liberian Health Ministry.

 

The Associated Press

The Associated Press

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