Make investigational Ebola drugs available, say ethicists
Drugs in development can be used for the treatment of Ebola, an international panel of ethics experts has recommended to the World Health Organization.
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Drugs in development can be used for the treatment or prevention of the Ebola virus, an international panel of ethics experts has recommended to the World Health Organization (WHO).
But the panel of scientists, researchers and ethicists have attached a number of caveats to their unanimous decision, including a commitment that patient consent should be sought and that there should be freedom of choice.
The panel also agreed there is a moral obligation to share all data in cases where experimental drugs are used and to move these drugs into clinical trials.
The 12-person panel was convened by the WHO and met on 11 August 2014 in Geneva to consider whether it is ethical to make experimental treatments available to people affected by the Ebola crisis, even though there have been no clinical trials to prove they are safe for human use.
Announcing the panel’s decision, the WHO’s assistant director general Marie-Paule Kieny told a press conference that for the first time there are a range of treatments and vaccines in development with the potential to help control Ebola.
Several have been proven to be effective in non-humans but not in humans.
“That doesn’t mean that they aren’t safe it’s simply that we don’t have the evidence from humans studies to say it’s certain that they are safe and efficacious,” Kieny said.
She said the move towards “compassionate use” of experimental treatments provided an opportunity to “right a wrong”.
“The fact that there is no drug for Ebola is a market failure because it is typically a disease of poor people in poor countries,” Kieny said. “If it hadn’t been for the investment of a few governments in the development of these drugs and vaccines we would be nowhere in this.”
Manufacturers have not invested in clinical trials because they are expensive, which is why there are no stockpiles of effective drugs, she said.
“The best we can do is accelerate the last steps of development and scale up the production of these drugs as quickly as possible,” Kieny added.
There are a number of vaccines and drugs in development, including Zmapp, which relies on the collection of serum from infected patients. There is also the possibility of developing products using horse serum – similar to the steps taken in drug development for rabies, Kieny said.
It is possible that the first clinical trials could be up and running by the end of September 2014, with products available by the end of the year, she told the press conference
The expert panel will meet again at the end of September to agree the ethical criteria for deciding who should be given priority for the drugs once they become available.
One of the key issues they will have to consider is whether health workers or the families of patients who have Ebola should be at the head of the queue, Kieny said.
The decision to make experimental drugs available for the treatment and prevention of Ebola was welcomed by pharmacist Lloyd Matowe, program director for Pharmaceutical Systems Africa, an organisation devoted to developing sustainable supply chains in developing countries.
“In this instance, the world has been made aware of the apparent life-saving nature of the experimental treatment,” he says. “Even though long-term effects of these drugs have not been established, the fact that today the two Americans [given the experimental treatment] live should weigh heavily towards scaling up this treatment for the hundreds of Africans who today lie at death’s door.”
Failure to make the drugs available, Matowe argues, would risk the perception that some of the world’s citizens are more equal than others.
“As pharmacists, we should support the argument for choice,” he says. “He who is at death’s door should choose between death or a potentially life-saving experiment.”
Apart from seeking patient consent, Matowe says no other condition should be attached to offering treatment and argues that those who are at the forefront of fighting the epidemic should be given priority for any new drugs that become available.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20066163
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