The Ebola drug given to two Americans and a Spanish priest has been sent to treat infected doctors in two West African countries, and the supply of the medicine is now gone, its manufacturer said.
Countries including Nigeria and Liberia had requested the drug, called ZMapp. Mapp Biopharmaceutical Inc., based in San Diego, said it has complied with every request for the drug that was authorized by legal and regulatory authorities. The drug was provided at no cost, according to Mapp.
“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 yesterday in a statement.
Mapp and its partners, Defyrus Inc. and a subsidiary of Reynolds American Inc., are working with the U.S. government to quickly increase production, the company said.
“Additional resources are being brought to bear on scaling up,” the company said. “The emergency use of an experimental medicine is a highly unusual situation.”
Providing a small amount of an experimental drug to West Africa won’t help control the outbreak, saidAnthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases. The focus needs to remain on basic public health and infection control measures, he said.
Too Little
“How can a couple of doses control an outbreak with hundreds and hundreds of people?” Fauci said by phone. “You don’t control the epidemic with two or three doses.”
Mapp, in its statement, didn’t identify which countries had received the remaining doses. The company said those who requested the drug can reveal their acquisition or use of the experimental drug.
The Ebola outbreak has killed 1,013 of the 1,848 people infected in West Africa as of Aug. 9, theWorld Health Organization said in a statement on its website. While other diseases are much more common and deadly, there is no cure for Ebola and it has moved quickly between countries, putting the global health community in high alert. Widespread malaria, which killed more than 600,000 people last year, is preventable and curable, according to the WHO.
A panel of ethicists convened by the WHO began meeting yesterday to weigh the use of experimental drugs that have shown early promise against Ebola. 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.
‘Long Overdue’
“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.
U.S. regulators last week said a treatment by Tekmira Pharmaceuticals Corp. could be tested in infected patients, while Mapp’s drug has already been used to treat two American aid workers Kent Brantly and Nancy Writebol, who were infected in Liberia. The pair were flown to Emory University Hospital in Atlanta, where relatives and supporters have said they are improving, though it remains unclear if or how much the drug helped.
Awaiting Decision
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.
Other companies developing treatments or vaccines 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.
Erica Ollmann Saphire, a molecular biologist who works on Ebola treatments with the Scripps Research Institute, said experimental drugs should go first to medical staff and aid workers.
‘Great Risk’
“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 determining 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’re 80?” The WHO plans a news conference at 2 p.m. Geneva time today to discuss the meeting of the ethics panel.
Researchers say the outbreak probably began in December with a 2-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. 9.
(via Bloomberg)
