Ebola Drug Market Shows Signs of Growth as Outbreak Continues

Following news that two American Ebola patients were successfully treated with ZMapp, an experimental medication that has not been tested in humans, advocates and aid groups have called for ZMapp and other experimental medications to be made available to the hundreds of patients in West Africa who are still battling the virus.

Following news that two American Ebola patients were successfully treated with ZMapp, an experimental medication that has not been tested in humans, advocates and aid groups have called for ZMapp and other experimental medications to be made available to the hundreds of patients in West Africa who are still battling the virus.

While there have been some questions about the ethical implications of using untested medications, the need to help the people directly affected has seemingly outweighed those concerns. The World Health Organization (WHO), which is directly involved with efforts to combat Ebola in Africa, said in a statement that it supports the use of these drugs that can help people in need.

A panel of experts convened by the WHO said that “ethical criteria must guide the provision of such interventions,” including “transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity, and involvement of the community.”

With the number of Ebola-related deaths passing 1,000, the panel noted, “Ebola outbreaks can be contained using available interventions like early detection and isolation, contact tracing and monitoring, and adherence to rigorous procedures of infection control.” They added, “However, a specific treatment or vaccine would be a potent asset to counter the virus.”

Although it acknowledged it is not ideal to treat Ebola with drugs that have not been fully vetted for safety and efficacy, the panel noted that the care of patients can serve as a firsthand test of whether the drugs work when needed most urgently.

The group advised that, “if and when [experimental medications] are used to treat patients, there is a moral obligation to collect and share all data generated, including from treatments for ‘compassionate use.’”

In a statement on its website, Mapp Biopharmaceutical, the manufacturers of the drug ZMapp that was used to treat the two Americans, claimed it has sent all of its supply of the medication to West Africa.

According to the statement, “the available supply of ZMapp has been exhausted. We have complied with every request for ZMapp that had the necessary legal/regulatory authorization. It is the requestors’ decision whether they wish to make public their request, acquisition, or use of the experimental drug. Any decision to use ZMapp must be made by the patients’ medical team. Drug has been provided at no cost in all cases.”

ZMapp was the first Ebola drug to be tested on patients during this current Ebola outbreak, but other pharmaceutical companies have announced they are working on drugs that could help infected patients in the future.

GlaxoSmithKline recently announced it will be conducting clinical tests on a new Ebola vaccine in partnership with the US National Institutes of Health’s Vaccine Research Center. The company noted that although it is in talks with regulators to initiate a phase 1 clinical trial later this year, it will be a while before full-scale testing can be done.

“Clinical development for a new vaccine is a long, complex process, often lasting 10 years or more,” the company said. ”It is difficult to accelerate this process because of the many important steps that a candidate vaccine must go through to ensure that it is safe and effective.”

A Reuters story reported that three emergency labs are ready to manufacture large quantities of vaccines and therapeutics if they are deemed safe and ready to be used. Known as Centers for Innovation in Advanced Development and Manufacturing, the labs are a joint effort between the US Department of Health and Human Services and private industry “to respond to pandemics or chemical, biological, radiological or nuclear threats.”

One facility located at the Texas A&M Health Science Center is described in the story as consisting of “a dozen bus-length mobile clean rooms, each supplied with sterile air, nutrient media for growing cells, and other clean-manufacturing requirements.”

“We are prepared to make any kind of vaccine,” said Brett Giroir, chief executive of the facility. “The whole idea is to take a process that may exist only on sticky notes at a small biotech company and scale it up as fast as possible.”

According to Giroir, the three labs could combine to make 50 million doses of a vaccine in 12 weeks in the event of a pandemic influenza, but the number of doses required for an Ebola outbreak would be much smaller.

“Even if Ebola were spreading here, it’s not an airborne transmissible disease like influenza so you wouldn’t need 50 million doses. At most you’d need a few thousand, maybe a million.”