What should happen if a massive
viral outbreak appears out of
nowhere and the only possible
treatment is an untested drug? And
who should receive it? The two
American missionaries who
contracted the almost-always-fatal
virus in West Africa were given
access to an experimental drug
cocktail called ZMapp. It consists of
immune-boosting monoclonal
antibodies that were extracted from
mice exposed to bits of Ebola DNA.
Now in isolation at an Atlanta
hospital, they appear to be doing
well.
It’s an opportunity the 900 Africans
who’ve died so far never had. Is
there a case to suspend ethical
norms if lives might be saved by
deploying an experimental drug?
The reasons for different treatment
are partly about logistics, partly
about economics and, partly about a
lack of any standard policy for
giving out untested drugs in
emergencies. Before this outbreak,
ZMapp had only been tested on
monkeys. Mapp, the tiny, San Diego
based pharmaceutical company that
makes the drug stated two years
ago: “When administered one hour
after infection [with Ebola], all
animals survived…Two-thirds of the
animals were protected even when
the treatment, known as Zmapp, was
administered 48 hours after
infection.”
But privileged humans were always
going to be the first ones to try it.
ZMapp requires a lot of refrigeration
and careful handling, plus close
monitoring by experienced doctors
and scientists—better to try it at a
big urban hospital than in rural West
Africa, where no such infrastructure
exists.
And because of the drug’s
experimental nature, it’s unclear that
it should go to anyone else. Even if
the drug is cooled correctly, success
in a few monkeys (less than 20) tells
us little about what will happen in a
lot of humans who’d had the
infection for more than two days. No
one knows how much drug to give,
how often, what other pre-existing
medical conditions might influence
its efficacy or even what route is
best, be it IV, pill, syrup, or even
surgically right into the liver.
With an untested drug, there is
always a chance you will kill the
first human subject who might
otherwise have lived. And the two
Americans who got it in Africa had
been infected for more than a week,
making its efficacy completely
unknown. Still, because they are a
small group in such a carefully
controlled setting, they are better
candidates for the drug than others
might be.
But it’s about more than logistics.
Drugs based on monoclonal
antibodies usually cost a lot—at
least tens of thousands of dollars.
This is obviously far more than poor
people in poor nations can afford to
pay; and a tiny company won’t
enthusiastically give away its small
supply of drug for free. It is likely
that if they were going to donate
drugs, it would be to people who
would command a lot of press
attention and, thus, investors and
government money for further
research—which is to say, not to
poor Liberians, Nigerians or
Guineans.
The medical missionaries got the
experimental drug because the
evangelical Christian International
Relief organization they work for,
Samaritan’s Purse, reached out to
the CDC and the NIH to find out if
there was any drug to give to them.
They were referred to Mapp
Pharmaceuticals and evidently struck
some kind of deal to get the drug to
their employees who were in Africa
at the time. (Technically, African
health ministries could make a
similar request.) The FDA has little
oversight over what goes on abroad,
and the federal government has no
program to consider appeals for use
—much less payment—of
experimental drugs that have only
been tried on animals. Without an
organization pushing, no one might
have received access to any sort of
treatment. The chance of a poor
African getting an experimental drug
is about the same as Donald Trump
contracting Ebola (which is
apparently his greatest current fear).
Even if logistical and economic
obstacles could be surmounted, is
there a case for giving Zmapp to
Africans still dying from Ebola? Many
Africans were infected more recently
than the Americans now being
treated in Atlanta, so they better fit
the conditions in which the drug
was tried in the monkey lab.
But there is no accepted set of rules
for a sick person to request
compassionate access to drug that
is experimental, expensive, and in
short supply. And access to
experimental drugs remains a long
shot full of risk. While the American
Ebola patients gave their consent,
and while most people would want
to do something rather than nothing,
the decision about gaining access is
more in the hands of the drug
manufacturer than the would-be
subject. The dying may feel more
cavalier about entering a drug
experiment—the rewards (life) could
justify the risks (since death
approaches anyway)—but a company
may still withhold a drug from a
willing volunteer for fear that it will
fail and reduce investor interest or
increase attention from malpractice
attorneys.
An ethical case can surely be made
for an organization that puts health-
care workers in harm’s way to
acquire access to experimental drugs
and bring staff home to get the best
possible care. But that is neither a
fair nor just policy for deciding what
to do when an emergency arises and
rationing is the only option. This
Ebola outbreak has taught us two
things: that we need to act quickly
to shut down emerging epidemics
wherever they occur, and it is long
past time to have a transparent
public policy about what to do whennot everyone gets a chance to live.
#God save Africa
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