Tag: WHO

For the outbreak of Ebola in West Africa, many experimental drugs will still stay in the laboratories for years, writes Forbes

The World Health Organisation said last Thursday that the scope of the Ebola outbreak may be vastly underestimated, and will grow worse before they are able to get the epidemic under control.

Amid these dire warnings, and facing a virus with no proven remedies, treatments, or vaccines, a panel of WHO ethicists approved the use of experimental therapies in stricken patients.

It was the right decision for a host of reasons. In fact, it shouldn’t have been ethicists who reached such a conclusion. Drug regulators should have taken this decision.

Patients facing a deadly virus with no proven treatments deserve access to experimental drugs that have already established some basic proof of safety, and where there is plausible reason to believe that the drugs could provide some benefit.

But there’s another reason to forward deploy these experimental treatments. It’s the only way we are ever going to find out if they work, and put them to wider use.

In fact, regulatory policies in the U.S. allow for drugs to be approved on the basis of studies in animals alone when there is no ethical way to test a medicine in sick patients. In the case of Ebola, you can’t purposely infect someone with the virus so that you have a subject to test a treatment on. You need to wait for an outbreak.

The only way we’re going to find out for sure if these experimental Ebola drugs are effective is to use them in sick patients. Given the state of science, this initial use is going to based on little more than information about their effectiveness in animals.

FDA issued a so-called “animal rule” almost a decade ago (amid fears of bioterrorism after the anthrax attacks) outlining how a drug could be approved on the basis of only efficacy studies in animals. It was rightly acknowledged that animal testing alone would have to form the basis of approval when we were dealing with therapeutics that targeted rare and deadly diseases that could be used as weapons.

For drugs targeted to Ebola, where these medicines have already proven some benefit in animal testing (and where some measure of their safety has been established) it’s imperative that we get these medicines into the field.

Regulators, for their part, should be making sure these drugs are delivered in a way where we can learn about whether they are working, and use this information to form the basis of potential regulatory approvals. There simply is no other way to test medicines against deadly and rare pathogens like Ebola.

So what are the treatments that are furthest along, and could be deployed in an expanding epidemic? Some of the drugs, like the antibody treatment from Mapp Pharmaceuticals, have already garnered a lot of attention. Mapp’s experimental Ebola treatment Z-Mapp was already administered a Spanish priest who later died and two U.S. aid workers who are reported to have shown signs of recovery.

Here are some of the other experimental treatments that are in development. Some of these compounds could be forward deployed if the outbreak continues:

There are at least three vaccines in development for Ebola that are garnering attention. One of the vaccines, developed by a government laboratory in Canada, has already been shipped to the World Health Organization, presumably for use in Africa. About 1,000 doses of the vaccine, licensed to NewLink Genetics, a company in Ames, Iowa, may be tested in first responders, including healthcare providers, according to reports. Charles Link, the chief executive, said NewLink could manufacture tens of thousands of doses over the next couple of months.

The NIH and GlaxoSmithKline (a company I advise on unrelated matters as a member of GSK’s Product Investment Board) are developing another vaccine. There are 400 doses available now, according to reports — enough for a clinical trial in healthy adults, federal official are saying.

The United Kingdom’s Telegraph reports that GSK is planning to test the vaccine on a small group of people at the NIH Vaccine Research Centre in Maryland later this year. As part of this process, the NIH will recruit health volunteers to inject them with the experimental vaccine. The aim of this early stage testing is see if the product is safe and helps people mount an immune response that would confer protection against a future exposure to Ebola. This process normally takes up to six months. GSK is hoping to report the results by the end of the year.

Bavarian-Nordic, (NASDAQ:BIVA) a biotechnology company located in Denmark, also has a vaccine in development that can protect against multiple hemorrhagic fevers, including Ebola.  The vaccine is based on the same platform that the company used to develop its smallpox vaccine Imvamune.

Among the companies developing therapeutics, a lot of the early attention has focused on Mapp Pharmaceutical’s product ZMAPP. This is a antibody drug (developed in a tobacco plant) that directly attacks the virus. It has already been studied in monkeys. In those trials, macaque monkeys were able to survive infection with Ebola, and develop a robust and durable immune response against the virus.

It is based on these studies, some of the most advanced with any available treatment for Ebola, that ZMapp has already been used (amidst some controversy) in a number of doctors who were infected with Ebola during the current outbreak. However manufacturing the antibody drug is a time consuming process, and Mapp does not have a facility capable of making the drug at large scale. As a result, existing supplies of the drug have already been exhausted, and it will take several months to develop a new stock.

The biotech company Tekmira (NASDAQ:TKMR) has also received attention for an Ebola treatment that it is developing under the FDA’s Animal Rule. The product, which uses RNA interference to directly target the virus, is currently in Phase I clinical studies.

In a paper published in the medical journal Lancet, Tekmira showed that the product consistently conferred post-exposure protection in primates exposed to Ebola. However, in these primate studies the drug also caused some serious (but temporary) side effects, which seemed to be a consequence of cytokine release, a marker of an immune response that the drug was generating in the monkeys. Temira, a public company, has an existing contract with the U.S. Department of Defense to develop the experimental Ebola compound that is worth $140 million.

Another private biotechnology company, MediVector, has developed a compound against invluenza (Favipiravir) that it believes can also be used as a treatment against Ebola. The compound is believed to be effective against a wide variety of RNA viruses, which is what’s raising hopes that it could be used against Ebola. The company has a contract with the U.S. DoD. MediVector has been asked to prioritize animal studies evaluating Favipiravir against Ebola. It has studies underway with Ebola-infected monkeys, and expects to have the initial results this fall.

SIGA (NASDAQ:SIGA) is an anti-infective company headquartered in New York is working closely with federal agencies to develop a range of compounds that target diseases that could be used as bioweapons, such as smallpox. The company has one compound that it is developing to target filo-viruses such as Ebola.

SIGA uses analytical tools to evaluate the bacterial and viral genomes to find new targets against these bugs. The company is currently testing three different experimental drugs. SIGA’s compounds work by trying to prevent the Ebola virus from entering host cells. This would block the ability of the virus to replicate.

The biotech company Sarepta (NASDAQ:SRPT) also developed a potential treatment for Ebola that had success in combatting the disease in primates. The drug’s development stopped two years ago when government funding dried up, but Barrons reports that Sarepta still has enough of the drug on hand to treat a few dozen patients.

Some scientists also think statins, a drug already in widespread use for lowering cholesterol, could help combat Ebola. The statins don’t attack the virus directly. The theory is that the statins help reduce the extent of the immune system reaction that Ebola triggers in infected people. It’s the immune response that we mount to the virus that inflicts a lot of the lethal damage that the virus causes to our bodies.

In all of these cases, if these experimental drugs are going to see action in the current outbreak, the companies involved (and drug regualtors) should make sure that we are collecting information on how these drugs perform. The results of this unfortunate but perhaps necessary use of these agents may be the best information we’re going get to support the regulatory approval of one of these treatments.

 

The World Health Orgamisation (WHO) yesterday reported 56 new deaths from Ebola. It added that there are 128 newly reported cases in the two days to August 11, raising the overall death toll in the virus’ world outbreak to 1,069.

Since March, there have been a total of 1,975 confirmed, probable and suspected Ebola cases in Guinea, Liberia, Sierra Leone and Nigeria, the United Nations health agency said in a statement.

In Spain, Several hundred mourners joined a funeral service yesterday for Spanish priest Miguel Pajares, 75, who died from Ebola after being infected in Liberia.

He became the first European victim of this worst-ever outbreak of the virus.

A black hearse transported an urn containing missionary Miguel Pajares’s ashes to the chapel of the San Rafael hospital in Madrid, which was decorated with floral arrangements, including one sent by Spain’s royal family.

The priest’s remains were incinerated in a sealed coffin shortly after he died on Tuesday. No autopsy was conducted so as to reduce the risk of contagion.

Pajares had been in isolation at Madrid’s Carlos III hospital since landing in Spain on a military jet last Thursday and was treated with an experimental US serum, ZMapp.

The Spanish priest contracted Ebola at the Saint Joseph Hospital in the Liberia capital Monrovia, where he worked with infected patients.

Many in Spain consider him to be a hero and the crowd at the funeral services included ordinary Spaniards who did not know him along with government and religious officials.

“We are all human, we need each other, we give our lives for others,” said Ana Maria, a 67-year-old from Madrid who attended with her sister Irene Gonzalez-Arnau Campos, 63, who came from Spain’s Canary Islands for the funeral service.

Health Minister Ana Mato, who has been criticized for her absence from Madrid while Pajares was in hospital, offered her condolences to the family at the service and said the hospital room where Pajares died was being thoroughly disinfected.

“All protocols are being followed to the letter,” she told reporters.

A leading physician in Sierra Leone’s fight against Ebola has died from the disease, an official said Wednesday. He had been considered to receive an experimental drug but did not get it before he died.

Doctors considered giving ZMapp to Sheik Humarr Khan, the chief doctor treating Ebola in Sierra Leone who had come down with the dreaded disease, but eventually decided against it, officials at the World Health Organization said in an email to The Associated Press on Wednesday.

WHO then tried to airlift Khan out of the country, but “his condition had deteriorated too much to be transported safely.”

Doses of ZMapp for two Liberian doctors were being expected in Liberia, according to Liberian Health Minister Walter Gwenigale. They would be the first Africans to receive the treatment.

The number one  global health authority,World Health Organisation (WHO), yesterday declared the Ebola outbreak ravaging   West Africa  an international public health emergency.

It said the situation  requires an extraordinary response to stop its spread.

It is the largest and longest outbreak ever recorded of Ebola with  a death rate of about 50 per cent.

The death toll so far stands at  961 in Liberia,Sierra Leone and Guinea.

A Nigerian nurse who attended to  the Liberian-American, Patrick Sawyer, at a Lagos hospital two weeks ago has also died of the virus.

The  authorities are monitoring seven other cases among people who had contact with Sawyer.

WHO declared similar emergencies for the swine flu pandemic in 2009 and for polio in May.

The WHO chief, Dr. Margaret Chan, said the announcement is “a clear call for international solidarity,” although she acknowledged that many countries would probably not have Ebola cases.

“Countries affected to date simply do not have the capacity to manage an outbreak of this size and complexity on their own,” Chan said at a news conference in Geneva and urged  the international community to “provide this support on the most urgent basis possible.”

The agency had convened an expert committee this week to assess the severity of the continuing epidemic.

The current outbreak of Ebola emerged in Guinea in March and has since spread to Sierra Leone and Liberia, with a suspected cluster in Nigeria. Since it was first identified in 1976, there have been more than 20 outbreaks in central and eastern Africa; this is the first one to affect West Africa.

The impact of the WHO declaration is unclear; the declaration about polio doesn’t yet seem to have slowed the spread of virus.

“Statements won’t save lives,” said Dr. Bart Janssens, director of operations for Doctors Without Borders. “For weeks, we have been repeating that a massive medical, epidemiological and public health response is desperately needed.  Lives are being lost because the response is too slow.”

“I don’t know what the advantage is of declaring an international emergency,” added Dr. David Heymann, who directed WHO’s response to the SARS outbreak and is now a professor at the London School of Hygiene and Tropical Medicine.

“This could bring in more foreign aid, but we don’t know that yet,” he said.

In the United States, the Centre for Disease Control and Prevention already recommends against travelling to West Africa. The agency has also put US hospitals on alert for symptoms to spot potential cases as quickly as possible.

Two Americans infected with Ebola recently received a drug never before tested in people and seem to be improving slightly, according to the charity they work for.

Next week, WHO will hold another meeting to discuss whether it’s ethical to use experimental treatments and drugs in the current outbreak. There’s no evidence in people that the experimental treatments work and it would take months even to have a modest amount. There is no licensed drug or treatment for Ebola.

Other experts hoped the WHO declaration would send more health workers to West Africa.

“The situation is very critical and different from what we’ve seen before,” said Dr. Heinz Feldmann, chief of virology at the U.S. National Institute of Allergy and Infectious Disease. “There are so many locations with transmission popping up and we just need more people on the ground.”

WHO did not recommend any travel or trade bans, but said people who had close contact with Ebola patients should not travel internationally. For countries with Ebola, WHO issued various recommendations, including exit screening at international airports and border crossings to spot potential cases. It also discouraged mass gatherings.

WHO said countries without Ebola should heighten their surveillance and treat any suspected case as a health emergency.

The World Health Organisation (WHO) says the death toll from the Ebola outbreak in West Africa has risen to 932.

The new figures came yesterday as authorities in Nigeria confirmed the death of a nurse of Ebola. Saudi Arabia also announced one death of a person with Ebola-like symptoms.

The outbreak emerged in March in Guinea and shows no sign of slowing down. Most of the new deaths are coming from Liberia and Sierra Leone.

There now have been 363 deaths in Guinea, 282 in Liberia, 286 in Sierra Leone and one confirmed death in Nigeria, according to WHO’s statistics as of August 4.

A Saudi man who was being treated for Ebola-like symptoms has died at a hospital in Jeddah, Saudi Arabia’s health ministry says.

If confirmed, this would be the first Ebola-related death outside Africa in an outbreak that has killed more than 900 people this year.

The man recently visited Sierra Leone, one of four countries in the outbreak.

World Health Organisation (WHO) experts are meeting in Geneva, Switzerland, to discuss a response to the outbreak.

The two-day meeting will decide whether to declare a global health emergency.

Ebola, a viral haemorrhagic fever, is one of the deadliest diseases known to humans, with a fatality rate of up to 90%.

A WHO statement said 932 patients had died of the disease in West Africa so far, with most of the latest fatalities reported in Liberia.

Concern has also been growing over a number of new cases in Nigeria, West Africa’s most populous nation. On Wednesday, a nurse who treated an Ebola patient became the second person to die of the disease there.

Nigeria’s Health Minister Onyebuchi Chukwu described the outbreak as a national emergency, adding that “everyone in the world is at risk” because of air travel

The Saudi man who was suspected of contracting the disease died of cardiac arrest, according to the website of the country’s health ministry.

The 40-year-old is said to have returned from a recent business trip to Sierra Leone.

The ministry’s website said he was being tested for Ebola, but did not say if the tests had concluded that he had the disease.

The website said the man had been treated in an isolation ward and would be buried according to Islamic tradition, while following precautions set out by world health authorities.

Earlier this year, Saudi Arabia stopped issuing visas to Muslims from several West African countries, amid concerns that visiting pilgrims could spread the disease.