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Spain Imports Ebola Drug for Priest; Ethicists Weigh Use

Spain has received the experimental Ebola drug used on two American aid workers to treat a Spanish priest who came down with the fatal viral illness. Nigeria and Liberia said they’ve also requested supplies of the medicine.

The requests come as ethicists are weighing how best to use a limited supply of experimental medicines that have shown early promise in fighting a disease that’s killed almost 1,000 people this year. Spain obtained a dose of the drug known as ZMapp and is treating a priest who was brought to Madrid Aug. 7 from Liberia, the Spanish health ministry said over the weekend.

A panel of ethicists convened by the World Health Organization today is considering whether drugs that haven’t been widely tested for safety should be used in an outbreak where about 40 percent of infected people survive with just supportive care. If so, the panel members must address who gets the medicines, which so far only exist in small amounts.

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“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 they wouldn’t bet against Ebola traveling outside of West Africa.

No Cure

U.S. regulators last week said a treatment by Tekmira Pharmaceuticals Corp. (TKMR) could be tested in infected patients, while the ZMapp drug made by Mapp Biopharmaceutical Inc. of San Diego has already been used to treat two Americans infected in Liberia. While relatives and supporters have said the two Americans are improving, it remains unclear if the drug helped.

The Deadliest Disease on Earth

There is no cure for Ebola. The disease 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.

If it’s decided an experimental drug should be used, the next question will be “under what conditions should people get it,” said Caplan, who isn’t part of the WHO panel. “Only people with informed consent? Do you think you’ll ever get informed consent from the poorest person in Guinea? Does the government say yes for them?”

Death Toll

The limited supply also creates problems, he said, questioning whether a patient’s condition should matter.

“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.

The outbreak has killed 961 people and sickened 1,779 in West Africa, the WHO said on Aug. 8. About 60 percent of those infected have died. Malaria, another common illness in sub-Saharan Africa, infected 207 million people in 2012, and about 627,000 people, or 0.3 percent, died that year. Malaria is both preventable and curable with antimalarial medicines, and a vaccine is in development, according to the WHO.

Aid Workers

The outbreak began in December with a two-year-old child in Guinea, and the disease has raced through Guinea, Liberia and Sierra Leone, and recently entered Nigeria. Health officials worldwide are on high alert for new cases.

Hopes for a treatment were raised when two American health workers, Kent Brantly and Nancy Writebol, were reported to have improved after receiving ZMapp, an antibody cocktail. Brantly and Writebol were flown to Atlanta, where they are being treated at Emory University Hospital.

Local and foreign aid workers like Brantly and Writebol, who made the decision to use the drug, should be first on the list to receive the new treatments, said Erica Ollmann Saphire, a molecular biologist at the Scripps Research Institute who works on Ebola treatments.

“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.”

African Doctors

G. Kevin Donovan, director of the Pellegrino Center for Clinical Bioethics at Georgetown University, said African doctors should be getting the same chance 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.”

The experiences of Spain, Liberia and Nigeria highlight the issues that the WHO panel is wrestling with.

Spain’s Request

In Spain, the doctor treating priest Miguel Pajares asked authorities to import the drug, the health ministry said. Pajares consented to try the experimental treatment, the ministry said in an e-mailed statement. Spain’s drug agency requested the medicine on Aug. 8, and the treatment arrived in Madrid the next day, the ministry said.

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

Pajares is a 75-year-old missionary who worked with Ebola patients, according to news reports in Spain.

Nigeria reiterated today it has asked the U.S. Centers for Disease Control and Prevention for access to the same drug. Health Minister Onyebuchi Chukwu sent a written request to the CDC, he said Aug. 6.

The CDC isn’t involved with decisions about access to ZMapp, said Barbara Reynolds, a CDC spokeswoman. The agency would refer any inquiries to the manufacturer or to the U.S. Department of Health and Human Services, she said.

No Role

The U.S. government wasn’t involved in providing the treatment to the Spanish government, a spokesman for the Health and Human Services Department said. Mapp declined to immediately comment. The company said in a statement on its website last week that it was “cooperating with appropriate government agencies to increase production as quickly as possible.”

In Liberia, President Ellen Johnson-Sirleaf also asked the U.S. government for the drug, she said in comments broadcast by radio today. “We heard the drug was administered to Americans who contracted the disease here and as such, Liberians will welcome it,” she said.

While ZMapp has been shown to be effective in treating monkeys, it hasn’t undergone clinical testing in humans.

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, Chief Medical Officer Brima Kargbo said in a telephone interview today.

Drugmakers Decide

Another question is whether the companies making drugs will let their treatments be used widely, Caplan said. The WHO can only make recommendations, and can’t compel drugmakers to share their treatments, he said.

“They may be nervous if they have a drug that needs to be refrigerated, transported, and may not be handled properly. If lots of people die, it’ll be held against their drug,” which could hurt the therapy’s chances of eventually reaching market, Caplan said. “They may be accused of experimenting on illiterate, poor people.”

Vancouver-based Tekmira’s treatment is stalled in clinical trials due to safety concerns. Still, the U.S. Food and Drug Administration said it could potentially be used in an emergency situation. The U.S. National Institutes of Health also is developing a vaccine with GlaxoSmithKline Plc (GSK), and enrollment in an early-stage clinical trial may begin this year.

Aid Organizations

Tekmira spokeswoman Julie Rezler didn’t return a call asking about treatment availability.

Other companies developing drugs for the deadly disease include Fujifilm Holdings Corp. (4901), BioCryst Pharmaceuticals Inc. (BCRX), and Sarepta Therapeutics Inc. (SRPT)

The WHO, which is organizing the ethics panel, has come under criticism from some aid organizations for not being aggressive enough in fighting the growing outbreak. On Aug. 8, the WHO designated the outbreak as an international public health emergency, eight months after it began.

“There is a lack of coordination among all the different partners,” Koen Henckaerts, a health expert at the European Commission’s humanitarian aid division, said in a telephone interview from the Liberian capital of Monrovia. “The WHO has a big responsibility to do more than just give technical advice.”

‘Massive’ Response

Doctors Without Borders, with almost 700 workers in the affected region, also was critical, saying in a statement that it has been repeating for weeks that “a massive medical, epidemiological and public health response is desperately needed to save lives and reverse the course of the epidemic.’

At this point, stopping further spread of the outbreak is the top priority, as available quantities of experimental treatments are too low to make an impact, Caplan said.

‘‘At this point, is it even worth arguing about it?’’ he said, referring to the WHO’s discussion on experimental treatment use. ‘‘Even if they ramped up production of the Mapp drug tomorrow, they may be able to get 30 doses of the drug. It’s not going to stop the outbreak.”

To contact the reporter on this story: Caroline Chen in New York at cchen509@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Phil Serafino, Robert Valpuesta

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