Nature
Published online: 23 August 2005
Alertness drug arouses fears about 'lifestyle' misuse
'Brain booster' found to reverse effects of sleep deprivation.
Jim Giles
Ethicists fear that people might misuse a new drug, known as CX717,
to work long hours.
A drug being studied as a potential treatment for Alzheimer's
can also counter the effects of sleep deprivation, a new study
suggests. The finding has sparked debate over the use of 'lifestyle'
drugs, which people take to make themselves feel smarter or more
alert, rather than for a specific medical condition.
Developers of the drug, known as CX717, say it is meant to treat
a range of debilitating mental conditions. But bioethicists point
out that it could easily follow in the footsteps of other treatments
that are being prescribed 'off-label', such as modafinil, a narcolepsy
drug that is gaining popularity as a pick-me-up pill.
On 22 August, researchers at Wake Forest University Baptist Medical
Center in Winston-Salem, North Carolina, published the results
of trials of CX717 in monkeys. Animals that had been deprived
of sleep for up to 36 hours - equivalent to 72 hours in humans
- experienced cognitive deficits that virtually disappeared after
taking the drug (L. J. Porrino et al. PLoS Biol. doi:10.1371/journal.pbio.0030299)1.
Rested animals that were given CX717 also did better on cognitive
tests than control animals. The drug works by boosting the uptake
by brain receptors of the neurotransmitter glutamate.
The results in monkeys support findings from an unpublished human
trial, funded by the company that makes the drug. In that study,
16 men kept awake overnight did better on a range of memory and
attention tests when dosed with CX717; those suffering the most
from tiredness received the biggest boost in performance. "We
didn't see any adverse events," says Julia Boyle, who ran
the study at the University of Surrey in Guildford, UK.
The drug's developer, Cortex Pharmaceuticals of Irvine, California,
is pushing ahead with trials in patients with Alzheimer's and
attention deficit hyperactivity disorder, as well as with people
working night shifts. Bioethicists say that the drug may find
other 'lifestyle' uses, perhaps by allowing workaholics to work
longer days.
In a similar case, modafinil (sold under trade names including
Provigil) was licensed in the United States as a treatment for
sleepiness caused by narcolepsy in 1998 by Cephalon of Frazer,
Pennsylvania, and later for other specific sleep disorders.
If CX717 can keep users awake as well as modafinil, with an
added cognitive boost, experts worry that it could be misused
by tired office workers or students with essay deadlines. "This
could coerce people into staying awake an extra two hours,"
says Arthur Caplan, a bioethicist at the University of Pennsylvania
in Philadelphia.
The US Defense Advanced Research Projects Agency is already funding
studies designed to assess whether CX717 could help soldiers stay
more alert.
Roger Stoll, chairman of Cortex Pharmaceuticals, says that his
company is focusing only on clinical disorders in which CX717
might help. Still, he admits, "we don't know what everyone
will do with it". |