Questions have been raised over pharma’s current R&D model after the World Health Organization said it was ethical to use unapproved treatments to tackle the deadly outbreak of the Ebola virus currently spreading across West Africa.
The experimental ZMapp drug, which is untested in humans, has been used to treat several non-African Ebola patients, three of whom have survived, though it is not clear whether this is down to the drug. Meanwhile, amid renewed calls for more experimental drugs to be made available, GlaxoSmithKline’s pre-clinical vaccine has been fast tracked into trials, and the UK Government, alongside the Wellcome Trust, has launched a £6.5 million initiative for emergency Ebola research.
But with mortality rates for the current outbreak at 55%, and the number of cases expected to rise to 20,000, Marie-Paule Kieny, WHO’s assistant director-general, told CNN that the lack of a drug for Ebola is “a market failure”.
Introducing government prizes has been put forward as a possible way to incentivise pharma innovation in low-return areas and to better reward medicines that offer a wider public benefit, but many experts believe this concept is flawed. Professor Trevor Jones, previously Group R&D director at Wellcome and Commissioner at the World Health Organization, suggests the system would be unworkable. “How many prizes should there be for each disease? What would the projected total prize money be and, given the time it takes for discovery and development, are governments likely to be willing to commit to those totals over, say, at least a 10-15 years period?” he asks. “And crucially,” he says, “could we be sure the process of selection and judging would be free from political bias?”
Aside from a lack of licensed medicines to treat the condition, the Ebola outbreak raises an ethical dilemma over access to medicines. The treatment of two American missionaries and a British nurse airlifted to the West, while infected Liberian nurses stay and receive supportive care alone, raises the same questions as those faced by the HIV epidemic in the 1990s, comments Dr Bruce Gordon, executive chairman of the Institutional Review Boards and chairman of the joint pediatric IRB.
Even if ZMapp or TKM-Ebola (being jointly developed by Tekmira Pharmaceuticals and the US Department of Defense) are made available and tested on desperately ill patients in the African region, he questions whether those affected countries would be able to distribute and pay for the therapy. “This was a feature of the early testing of tremendously expensive antiretroviral drugs for HIV in this region, with the benefits going primarily to affluent Western nations,” he notes.
This story was published in the September issue of PharmaTimes Magazine. You can access the digital issue to read this and more stories here. Also check out tomorrow's PharmaTimes World News online for an interview with Professor Trevor M Jones CBE, on the Ebola issues.