Officials wrestle with whether it is ethical to withhold potential treatment from some groups, but also if it is acceptable to offer either false hope or true risk to vulnerable populations.
WASHINGTON — The World Health Organization has taken the unprecedented step of declaring that the use of experimental drugs — the efficacy and safety of which have yet to be proven — would be “ethical” to combat the current outbreak of Ebola in West Africa.
The multilateral agency’s unusual backing, announced Tuesday, will further complicate an issue that has suddenly become a major quandary for global health officials, the U.S. government and the very small number of private companies that have been working on Ebola research. Even as issues of access and equity have come to the fore, others are expressing concern that the discussion around experimental treatments could be a distraction.
The backing of the WHO followed a two-day emergency meeting of medical workers, ethicists and others.
“There was unanimous agreement among the experts that [due to] the special circumstances of this Ebola outbreak it is ethical to offer unregistered interventions as potential treatments or prevention,” Marie-Paule Kieny, an assistant director-general at the WHO, told journalists Tuesday, while also releasing an institutionalstatement on the discussions.
“There are caveats, though,” Kieny continued. “The panel said ethical criteria must always guide the provision of such intervention. These include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for person and preservation of dignity and with the involvement of the community.”
The move conforms to acall made early this month by three of the world’s top Ebola experts to extend the option for experimental treatments to West African governments.
At least four countries in West Africa are now experiencing the most severe outbreak of the Ebola virus in history. Last week, the WHO formally dubbed the situation an international public health emergency, a designation meant to alert United Nations member countries and donor governments that current efforts and funding are proving inadequate in combating the virus’s spread.
As of Wednesday, nearly 2,000 people had been confirmed infected with Ebola, resulting in some 1,069 deaths, according to the WHO. While past outbreaks of the virus have seen mortality rates as high as 90 percent, the current strain of the virus has been killing roughly 60 percent of its victims — still extraordinarily high for a modern disease.
No financial incentive
Despite these figures, there remain no Ebola treatments on the market, either in the form of vaccines or post-contact serums. Further, only a handful of companies are even working on the issue, and most of these have received support from the U.S. military — due to concerns over bioterrorism or the potential that U.S. troops could one day be exposed to the virus.
The current international attention being trained on West Africa notwithstanding, multinational pharmaceutical companies have simply never seen any real incentive to put money into Ebola research. For decades, after all, the virus has been seen as a disease that afflicts mainly the poor — and even then, only a relatively small number at any time.
Today’s mounting concern around what’s happening in West Africa, and its potential implications for the rest of the globe, underscore how wrongheaded, and dangerous, those assumptions can be.
“It’s not surprising that drug companies aren’t aggressively seeking treatments for Ebola. They wouldn’t be moneymakers,” Michael Carome, a physician and director of the Health Research Group at Public Citizen, a consumer advocacy group here, told MintPress News. “For this reason, this is exactly the type of area where we need government support, from U.S. agencies and from other governments.”
For now, however, the available options are extremely limited. And despite the WHO’s backing, the use of experimental drugs remains extremely divisive among public health officials and humanitarian responders.
“To use this drug without having any information on its human benefits or dangers runs the risk of mistakenly thinking it is either effective or not based upon anecdotal evidence, a difficulty that could prove disastrous for later in this outbreak or future ones,” Philip M. Rosoff, a professor of pediatrics and medicine and director of the Clinical Ethics Program at Duke University Hospital, said Wednesday in an e-mailed statement.
“Furthermore, the few patients who have been treated with this first-in-people drug for Ebola have all been white residents of Europe or the United States, a fact that could raise issues of preferential treatment.”
Regulators and rationing
As Rosoff notes, three Westerners — first two American missionaries, then a Spanish priest — have been given an experimental serum called ZMapp, manufactured by a California-based company. Yet until this week, African officials that had asked the U.S. government for access to ZMapp werereportedly turned down.
“I think we’ve got to let the science guide us. And I don’t think all the information is in on whether this drug is helpful,” President Barack Obamasaid Aug. 6, speaking here during a major summit between U.S. and African leaders.
“So … we’re focusing on the public health approach right now because we know how to do that. But I will continue to seek information about what we’re learning with respect to these drugs going forward.”
This week it emerged that ZMapp’s maker, Mapp Biopharmaceutical, appears to have given some of its last doses of the serum to the Liberian government. According to apress release from the Liberian government on Tuesday, the U.S. Food and Drug Administration gave its approval for an unnamed “experimental serum” to be given to two Liberian doctors. The release notes that the doctors had given their consent to be administered the treatment.
Also Tuesday, Mapp released a briefstatement noting the “available supply” of ZMapp had “been exhausted.” The company also stated that it had “complied with every request” for the drug “that had the necessary legal/regulatory authorization,” and clarified that that the samples had been provided “at no cost in all cases.”
While it is unclear whether the Liberian government received ZMapp samples or some other treatment, the new details only compound questions of how to ration, or even use, a risky drug in extremely short supply. ZMapp has not even passed through the first formal phase of testing — which would look at its safety — much less progressed to the second phase, on its efficacy.
Still, U.S. regulators do have the authority to speed up drug approvals on an emergency basis. But Obama has been tight-lipped on whether he would support fast-tracking ZMapp’s approval in the United States, if it were to be proven effective. “I think it’s premature for me to say that,” he said during the Africa summit in early August, “because I don’t have enough information.”
U.S. regulators, too, do not appear to be ready to move any more quickly on approvals of ZMapp or other pending Ebola treatments.
“Because no … approved vaccines are currently available, HHS agrees it is necessary to consider thoughtfully the ethics and principles of distributing experimental, unproven and scarce medical interventions when the supply is far less than the demand, as is the case with the current Ebola outbreak,” a spokesperson with the U.S. Department of Health and Human Service (HHS), which participated in the WHO discussions this week, told MintPress in a statement.
“Many ethical considerations still need to be deliberated. HHS remains committed to the highest ethical standards in our research and public health activities related to the Ebola outbreak.”
Fairness in benefit and risk
It’s important to note that the ethics go beyond simply equity of access. While officials will now need to wrestle with whether it is ethical to withhold potential treatment from some groups, they also need to consider whether it is acceptable to offer either false hope or true risk to vulnerable populations.
“This is a two-edged sword,” Public Citizen’s Carome said. “On the one hand, people are assuming they’re offering benefit to these three individuals, who were privileged to receive these doses perhaps because they come from industrial countries while these drugs are not available to the poor.”
On the other hand, he cautions, these three Westerners were being exposed to the risks inherent in an unproven drug. While the conditions of the two Americans are reportedly improving, after all, the Spanish priest is said to have died Tuesday.
“These are very complex questions — whether we are fairly distributing both benefits and risks, and whether we’re potentially taking advantage of any populations,” Carome said.
“Those suffering are likely desperate for anything, and can easily be taken advantage of … In the early stages of drug development, it’s likely that the risks outweigh the benefits. Many drugs don’t get beyond the early testing because they end up being ineffective and/or unsafe.”
Such concerns have led influential public health voices to warn against the use of experimental treatments in response to the Ebola outbreak. For instance, the medical relief group Doctors Without Borders, which remains intimately involved in the humanitarian response in West Africa, initially adopted such a stance.
And while it supports the recent WHO announcement, the group continues to caution against putting too much focus on the potential of experimental interventions.
“Our priority right now is to save the lives of people affected today and it is unclear how quickly a trial of a new treatment could feasibly be organized,” Stephan Goetghebuer, the organization’s deputy general director, told MintPress in a statement.
“The use of unregistered interventions for Ebola viral disease will not alone be the answer to combating the outbreak — that requires a massive scaling up of all the known measures such as community mobilization, education, effective contact tracing, early presentation of suspected Ebola patients at appropriately equipped treatment centers, training and equipping health workers, and effective coordination of the response.”
There is wide agreement today that, ultimately, overcoming the current Ebola outbreak will likely hinge on the robustness of these more mundane interventions. But some warn that the international community’s response has been weak in helping the governments of developing countries ensure the provision of such day-to-day safety standards, gear and knowledge.
“During the 1980s, the term ‘universal precautions’ was coined in the context of the spread of HIV in Africa, and it meant rubber gloves, masks, hand-washing — basically, that health workers should use the same procedures in poor countries that they were supposed to be using in rich countries,” Mead Over, a fellow at the Center for Global Development, a think tank here, told MintPress.
“Use of these precautions did spread, but still in the poorest parts of Africa health workers don’t have access even to rubber gloves. Likewise, germ theory is known by the people at the top of the health care system, but the majority of non-medical staff is not so trained — the cleaners and workers who are actually responsible for dealing with and cleaning up the bodily fluids.”
Over, who has long experience in the global response to HIV/AIDS, also worries about the tenor of the current response to the Ebola outbreak, both locally and internationally. One of the key education processes around the HIV epidemic, he notes, was to get people to understand both what was and was not considered dangerous behavior.
Weakening social taboos, after all, has been a key strategy in bolstering the broader public health response to HIV. Over says similar concerns are applicable in the context of Ebola.
“Really the importance of this issue is being blown out of proportion to what is likely to be its eventual impact,” he said.
“HIV/AIDS is equally gruesome, though it takes 10 years instead of 21 days to progress. The contrast between the media attention to the few thousand people who are so far endangered by Ebola versus the relative lack of attention to the 35 million infected with HIV is striking.”