After two American aid workers, one Spanish priest, one
Nigerian and two Liberian doctors have been treated with ZMapp, there has so
far been just one death – 1/6 is good odds in this Ebola outbreak. So why can’t more people be treated with this
promising drug? Well … because there is
none. And there won’t be any more for a
few months. This is not a limitation
that is exclusive to ZMapp – we can expect other drugs to be limited in their availability
to meet demand. So why is that?
Sad but true, the bottom line is cost. It takes a lot of money to go through the
process to develop and test new drugs, and someone has to pay for that. The immense costs associated with developing
and trialling drugs either comes through grants or is met by pharmaceutical
companies who will make a long-term profit gain if the drug is successful. In order to make a business case for this
process, either grant-funders or commercial organisations need to see a return
on investment. But previous outbreaks
have been small and contained – there simply have not been that many Ebola
cases in the past, certainly not enough to justify more than a modest
investment, horrible though the consequences are for those that are infected. So the money has not flowed in, the early
development work has been slow, and the drugs are not ready to cope with this
unprecedented level of demand.
Secondly, it’s easy for non-specialists like me to imagine
someone just has to turn on a machine in order to pump out whatever synthetic
products go into these drugs – but I understand it’s not like that. Taking ZMapp as an example, manufacturers
Mapp Bio explain that the humanised antibody proteins that make up the drug are
grown using a low-nicotine tobacco plant as a host. Once the plants mature, they are harvested
and the antibody proteins need to be extracted, purified and tested before they
can be made into a drug. This is not a
process of pulling a lever, it takes time to grow the basic components of the
drug. No matter how eager organisations
may be to invest in this process now, it still takes as long as a tobacco plant to grow before you get any results.
Finally, in order for a drug to be produced on any
significant scale it needs to be licenced, which means it first has to go
through a clinical trial. Clinical
trials happen in a number of stages – the first stage tests the drug for safety
using up to 100 health volunteers. That
is achievable – if the drug is produced.
Health volunteers are relatively easy to come by. But the second, third and fourth stages of
the trial require larger numbers of ill people, because they are not testing
only the safety of the drug, but also the effectiveness of the drug in treating
the disease it is designed to treat. To
conduct a phase two trial, usually several hundred people will be
involved. The problem with Ebola is, you only have
these people available in the context of an outbreak, and no one knows when or
where an outbreak may take place. There
is no precedent to the scale of this outbreak – there have already been more
than five times the number of cases that any previous outbreak of any Ebola
strain has accumulated. This outbreak could
provide a sufficient number of cases for a clinical trial to progress – but no
one could ever have known to be prepared.
No comments:
Post a Comment