The Ebola drug given to two Americans and a Spanish priest has been sent to a West African country that requested it, and the supply of the medicine is now exhausted, its manufacturer said.
Mapp Biopharmaceutical Inc., based in San Diego, said it was told by U.S. health officials that the countries, includingNigeria and Liberia, had requested the drug, called ZMapp. The company said it has complied with every request for the drug that was authorized by legal and regulatory authorities. It said it provided the drug at no cost.
“It is our understanding that all patients offered treatment, treated, or expected to be treated were or are highly capable of providing informed consent for the use of an experimental drug not yet evaluated for safety in animals or people,” the company said in a statement.
The additional patients allocated the drug include medical doctors in two West African countries as well as the Americans and the Spanish priest.
The decision comes as a panel of ethicists convened today by the World Health Organizationweighs the use of experimental drugs that have shown early promise against a disease that’s killed almost 1,000 people this year. The panel is considering whether the drugs, which haven’t been widely tested for safety, should be used in an outbreak where 40 percent of infected people survive and, if so, who should get them from what may be a limited supply.
“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 andHong Kong have isolated and tested travelers with Ebola-like symptoms, before ruling out the disease. Medical experts have said the deadly virus could travel outside of West Africa.
The outbreak has killed 961 people of the 1,779 cases in West Africa, the WHO said on Aug. 8. While other diseases are much more common and deadly, the fact that there is no cure for Ebola and it has moved so quickly between countries has put the global health community in high alert. Widespread malaria, which killed more than 600,000 people last year, is both preventable and curable, according to the WHO.
U.S. regulators last week said a treatment by Tekmira Pharmaceuticals Corp. could be tested in infected patients, while Mapp’s ZMapp 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 or how much the drug helped.
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, Sierra Leone Chief Medical Officer Brima Kargbo said in a telephone interview today.
Other companies developing drugs for the deadly disease include Fujifilm Holdings Corp., BioCryst Pharmaceuticals Inc., and Sarepta Therapeutics Inc.
Ebola 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.
Aid Workers First
Erica Ollmann Saphire, a molecular biologist who works on Ebola treatments with the Scripps Research Institute, said it’s her belief the experimental drugs should go first to medical staff and aid workers.
“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.”
The limited supply of the drug could create problems, Caplan said, questioning whether a patient’s condition should matter in determing who gets treated.
“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’a molecular biologist who works on Ebola treatmentsre 80?” The WHO plans a news conference at 2 p.m. Geneva time tomorrow to discuss the meeting of the ethics panel.
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, which has recorded two Ebola-related deaths as of Aug. 8. 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.
G. Kevin Donovan, director of the Pellegrino Center for Clinical Bioethics at Georgetown University, said African doctors should be getting the same chance as the two Americans at potentially life-saving intervention.
Plucked from Danger
“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.”
Spain requested the Mapp drug on Aug. 8, after the doctor treating priest Miguel Pajares, a 75-year-old missionary who worked with Ebola patients, asked authorities to help him get it, the health ministry said. The treatment arrived in Madrid the next day, the ministry said.
The medicine arrived from Geneva, where a dose existed under an agreement with 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.
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