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Tuesday, Oct. 21, 2014

UN: OK to use untested Ebola drugs in outbreak

By Ciaran Giles, Associated Press

Published: Tue, Aug. 12 7:56 p.m. MDT

 A health worker assists a colleague with his protective gear, as they collect the body of a man suspected to have died from the ebola virus, in Monrovia, Liberia,  Tuesday, Aug. 12, 2014. The World Health Organization declared it’s ethical to use untested drugs and vaccines in the ongoing Ebola outbreak in West Africa although the tiny supply of one experimental drug handed out to three people has been depleted and it could be many months until more is available.

A health worker assists a colleague with his protective gear, as they collect the body of a man suspected to have died from the ebola virus, in Monrovia, Liberia, Tuesday, Aug. 12, 2014. The World Health Organization declared it’s ethical to use untested drugs and vaccines in the ongoing Ebola outbreak in West Africa although the tiny supply of one experimental drug handed out to three people has been depleted and it could be many months until more is available.

(Abbas Dulleh, Associated Press)

MADRID — The World Health Organization declared it's ethical to use untested drugs and vaccines in the ongoing Ebola outbreak in West Africa although the tiny supply of one experimental treatment has been depleted and it could be many months until more is available.

The last of the drug is on its way to Liberia for two stricken doctors, according to a U.K.-based public relations firm representing Liberia. The U.S. company that makes it said the supply is now "exhausted."

A Spanish missionary priest who died Tuesday in Madrid was the third person to receive the experimental treatment called ZMapp. Two U.S. aid workers who received it in recent weeks are said to be improving.

The outbreak has killed more than 1,000 people in Guinea, Sierra Leone, Liberia and Nigeria.

There is no proven treatment or vaccine for Ebola; several are in early stages of development. ZMapp, made by Mapp Pharmaceuticals, is so new that it has never been tested in humans although an early version worked in some monkeys infected with Ebola. It's aimed at boosting the immune system's efforts to fight off Ebola.

"If there are drugs that can save lives — as animal studies have suggested — shouldn't we use them to save lives?" Dr. Marie-Paule Kieny, an assistant director-general at WHO, told a press conference Tuesday.

But it is "very important to not give false hope to anybody that Ebola can be treated now. This is absolutely not the case," she added.

ZMapp is made in tobacco plants, and U.S. officials have estimated that only a modest amount could be produced in two or three months, unless some way to speed up production is found.

The U.N. health agency says 1,013 people have died so far in the Ebola outbreak in West Africa of the 1,848 suspected or confirmed cases recorded by authorities. The killer virus is spread by direct contact with bodily fluids like blood, diarrhea and vomit.

Some experts weren't convinced any novel drugs or vaccines would make a difference in ending the current outbreak.

Once they're put to the test, most experimental drugs that seemed promising in animal studies "don't turn out to benefit people," said Dr. Jesse Goodman, former chief scientist for the U.S. Food and Drug Administration, now at Georgetown University Medical Center.

He said some drugs prove harmful. "Unless we can ascertain that carefully, how do we really help people in the long run?"

After the two Americans received the experimental drug, officials in Liberia requested it. Officials in Sierra Leone and Guinea have expressed interest in getting experimental treatments but haven't yet asked.

"The Liberians can count on their government, but Guineans can only count on God in the face of Ebola," said Assiatou Diallo, a nurse in Conakry, Guinea's capital.

The Spanish missionary, 75-year-old Miguel Pajares, died in Madrid's Carlos III Hospital, the hospital and his order said. A doctor who was part of the team treating the priest confirmed he received the experimental drug. The doctor, an infectious diseases specialist, spoke on condition of anonymity, not being authorized to discuss the treatment.

Pajares' body will be cremated Wednesday to avoid any public health risks, the hospital said. He had worked for the San Juan de Dios hospital order, a Catholic group, helping to treat people with Ebola in Liberia when he became ill and was evacuated.

WHO said the size of the outbreak — the biggest in history and the first in West Africa — made the experimental use of drugs ethical even though there is no evidence they work and it is possible they could be dangerous. The agency convened an expert panel of ethicists, infectious disease experts and patient representatives to discuss the issue on Monday.

"We don't have enough people to rely on the traditional methods if we want to stop the outbreak as soon as possible," Kieny said.

WHO said it was OK to use unproven treatments if patients give their informed consent and are guaranteed confidentiality and freedom of choice.

There was no specific advice on who should get the drug; the panel only said more analysis and discussion was needed.

"I don't think there could be any fair distribution of something available in such small quantities," Kieny noted.

She said some companies were speeding up trials of their new Ebola vaccines and there might be some preliminary safety data by the end of the year.

WHO also said the world had "a moral duty" to collect evidence about the safety and effectiveness of Ebola treatments in scientific trials.

Canada's Tekmira Pharmaceuticals Corp. is developing a drug that targets Ebola's genetic material. The FDA had halted a small safety study with questions about a reaction in healthy volunteers. Last week, Tekmira announced that the FDA had modified its restriction, clearing a roadblock to possible experimental use in patients, and said it was "carefully evaluating options."

West African nations are struggling to control both the deadly outbreak and the fear it has created. Some airlines flying in and out of the region have suspended flights.

The Ivory Coast, which shares borders with Liberia and Guinea, banned direct flights from those countries and said it would increase health inspections at its borders. Guinea-Bissau also announced it was temporarily closing its border with Guinea because of the Ebola outbreak.

On Tuesday, Liberian President Ellen Johnson Sirleaf suspended all travel by executive branch officials for one month. She also ordered those already abroad to return home within a week "or be considered as abandoning their jobs," according to a statement.

Cheng reported from London. Jonathan Paye-Layleh in Monrovia, Liberia; Clarence Roy-Macaulay in Freetown, Sierra Leone; Jorge Sainz in Madrid, AP Medical Writer Lauran Neergaard in Washington, Lassana Cassama in Bissau, Guinea-Bissau and Boubacar Diallo in Conakry, Guinea, contributed to this report.

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1. Eliyahu
Pleasant Grove, UT,
Aug. 13, 2014

When a disease is almost always fatal and there is no known treatment or vaccine for it, I'm not clear on why there should be any roadblocks to trying treatments that have a chance of helping and that won't make things worse. Come to think of it, I'm not sure what would make things worse for people facing almost certain death. Ebola is fatal, painful and acts quickly. These people don't have the option of waiting until clinical trials are done before trying what they believe can help.

2. Brio
Alpine, UT,
Aug. 13, 2014

I totally agree with Eliyahu.

It has never made any sense to me why people with certain types of inoperable cancer that their doctors have determined is going to be surely fatal, are not allowed to try new clinical cancer treatment drugs that have yet to be fully tested and approved the FDA, which process often takes several years or longer to do... time that those people don't have.

Those people and the FDA have nothing to lose by trying those drugs. And if successful, the results would help to minimize the time it takes for official approval and thus get the potentially life saving drugs available to the public that much quicker... thus saving untold lives in the interim. It would then be considered win-win.

And if some particular new drugs don't end up working, that person was facing sure death anyway, so nothing was lost. In fact, it would then allow the FDA to then put their time and concentration on other new drugs yet to be tried. That in itself is still a public benefit.