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WHO Experts Decide It Is Ethical to Offer Patients Experimental Ebola Treatments

Because standard measures have not effectively contained this outbreak, WHO advisors believe patients should have access to untested drugs.

by Kayla Ruble
Aug 12 2014, 7:30pm

Photo by NIAID

When two American aid workers contracted the Ebola virus while volunteering in Liberia during the devastating West Africa outbreak — the largest in history — much was made of reports that they had been given an experimental serum never tested on humans and only available through special dispensation from the Federal Drug Administration.

As the health of Dr. Kent Brantly and Nancy Writebol has improved, discussion has focused on whether others afflicted with the hemorrhagic fever should receive similar experimental treatments or vaccines. After the World Health Organization convened an advisory panel of ethicists, researchers, regulators, and advocates from around the world to discuss the use of unapproved treatments for the virus, it announced today that it believes it would be ethical to offer them to patients.

The spread of the Ebola virus is officially an international health emergency. Read more here.

"The panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention," a WHO statement said, stressing that any application be guided by transparency, informed consent, and respect for the patient.

In a press conference on Tuesday, Dr. Marie-Paule Kieny, the WHO assistant director-general for health systems and innovation, explained that the panel had arrived at this conclusion largely because standard control measures like contact tracing, hospital care, and quarantine have not been as effective in containing the virus as they have in previous outbreaks.

Kieny said that community leaders would help educate villagers about the drugs. If patients are not able to decide for themselves whether to take an experimental drug, their relatives or even community members will make that determination.

Fears and rumors have circulated among locals terrified by the outbreak, which has claimed more than 1,000 lives since last December. The use of experimental drugs could prompt more suspicion and confusion, so it will be essential for medical workers to keep the public informed.

There's no cure for Ebola yet — but there is an experimental serum. Read more here.

WHO is optimistic about ZMapp, the antibody serum given to Brantly and Writebol, although Mapp Biopharmaceutical, the company behind the drug, has already distributed its entire limited supply to West Africa. Other untested treatments could include vaccines and antiviral medications that have shown efficacy in animal trials.

Some observers have expressed concern that the emphasis on experimental drugs might marginalize the pressing need to develop adequate public health services in the region.

"What gets lost while focusing on the magic bullet is what needs to be done on the ground," Jonathan Moreno, a biomedical ethics professor at the University of Pennsylvania, told VICE News. "All this focus on ZMapp is fine, but it should not be permitted to distract us from fundamental public health needs."

'I think this may be the silver lining... We might finally get a drug for this thing."

While scarce supplies are an issue, Kieny said that researchers "are in a much better position with these drugs than we were a few years ago." She estimated that some of the most promising drugs will be in production by September.

"One of the panelists pointed out that this is an opportunity to right a wrong of history, that it is only relatively recently in the last decade that researchers have begun investigating interventions for Ebola," she said, referring to the failure to develop a treatment for a disease first identified in 1976. "Now is the time to catch up."

Bringing a medical treatment or vaccine to market is expensive, and drug companies typically prioritize common illnesses over rarer infectious diseases.

"There's no money in it and there's a huge liability. If you're a drug company, there's no reason from a market standpoint to go into a disease like this," Moreno explained, adding that government subsidies and liability coverage can compensate for this inertia and incentivize drug development.

Nevertheless, the Ebola outbreak has prompted enough attention worldwide that we might soon have an established treatment for the illness.

How aid workers are tracking West Africa's unprecedented Ebola outbreak. Read more here.

"What we're now seeing is probably the global coordinated response that the WHO was looking for," Ben Neuman, a virologist at University of Reading, told VICE News, referring to the early days of the outbreak when concern was limited. "I think this may be the silver lining. A large outbreak has attracted enough attention that we might finally get a drug for this thing."

Neuman said that he expects many Ebola treatments to be tested and developed before the end of this outbreak, resulting in at least one whose efficacy is proven and tested. GlaxoSmithKline will soon begin clinical trials on a vaccine in development, while Tekmira Pharmaceuticals saw its stock value spike 45 percent the day after it announced that a new FDA designation could potentially allow its experimental Ebola drug to be used.

'Each round burns itself out, but the same virus always comes back from the jungle eventually.'

Neuman and Moreno both agreed that it was unlikely that any new vaccine or treatment would be produced in sufficient quantities in time for this outbreak. But because Ebola, unlike many other viruses, doesn't appear to weaken following an outbreak, Neuman believes the persistent threat it poses will bolster the pursuit of a medical cure.

"The case for treating Ebola is that the virus isn't going anywhere — it exists across Africa, and it's not practical to go catch every bat and monkey," he said, referring to the fact that Ebola is initially transmitted by infected wild animals. While each outbreak eventually burns out, he added, "the same virus always comes back from the jungle."

While Tuesday's announcement helps pave the way for doctors and patients to access experimental treatments, Kieny said the panel has not yet formulated guidelines on how patients should be prioritized. Some experts believe infected medical workers in the field should receive priority based on reciprocity for putting their lives in danger, while others have posited that relatives of patients and community members should be prioritized because they essentially face the same risks. WHO will convene another advisory panel next month to discuss the allotment of experimental treatments.

"This problem of allocation of strained resources is not new, but the panic is new because Ebola is so horrible," Moreno said.

Follow Kayla Ruble on Twitter: @RubleKB

Photo via Flickr