WHO calls on drug industry, governments to get Ebola therapies to patients

Ebola virus under an electron microscope--Courtesy of CDC

In a desperate attempt to control the ongoing Ebola outbreak in West Africa, the World Health Organization is appealing to drug companies and international regulatory bodies to work together to get experimental therapies and vaccines out of the lab and into the clinic as soon as possible.

As the death toll related to the current Ebola outbreak tops 1,900 victims--more than the total number of people who died from the disease in all previous outbreaks combined--the need for therapies to help stop the spread of the disease is critical.

To address this demand, WHO held a meeting Thursday and Friday in Geneva with stakeholders--including healthcare workers, government officials, industry representatives, ethicists and researchers--to determine which experimental therapies might be use to contain the Ebola outbreak. The meeting picked up where a panel convened by WHO in August left off, in which experts explored the ethical question of whether to offer investigational products as potential treatments or preventive methods.

In a background document on such drugs, WHO offers a cautious view on using unproven therapies to treat patients, emphasizing the possible health risks to recipients of experimental drugs and the difficult and demanding task of administering such medicines.

"It is to be underlined that the potential compassionate use and further investigation of these compounds should not detract attention to the implementation of effective clinical care, rigorous standards of practice in infection prevention and control, careful contact tracing and follow-up, effective risk communication, and social mobilizations, which will be crucial to terminate the epidemic," the WHO document says.

Big Pharma players GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ) have responded to the epidemic swiftly, with regulators giving the green light for Glaxo to begin a trial for an experimental Ebola vaccine this month. Working with Danish company Bavarian Nordic and the National Institute of Allergy and Infectious Diseases, a branch of the National Institutes of Health, J&J is hastening development of its Ebola vaccine in hopes of enrolling the first patients in a trial in early 2015. NewLink Genetics ($NLNK) will also begin a vaccine trial in early 2015.

Meanwhile, WHO reports that doses of Mapp Biopharmaceutical's ZMapp--which has been given to the two American patients as well as a few others--have already been exhausted. A few hundred doses may be available by the end of the year.

The FDA has authorized emergency use of Tekmira Pharmaceuticals' therapy, which the FDA has authorized for emergency use in Ebola-infected patients. Only a limited number of treatment doses are currently on hand, WHO reports, but potentially 900 may be available by early 2015.

- here's the WHO announcement about the meeting
- and the background document on investigational Ebola therapies and vaccines (PDF)

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