U.S. military officials are expressing enthusiasm about an
experimental drug that they say could protect the health of troops,
police officers and emergency medical personnel who respond to
terrorist attacks involving nuclear weapons or radiation-spewing
"dirty bombs."
The drug being developed by Hollis-Eden Pharmaceuticals Inc. of
San Diego appears to offer significant protection from radiation
sickness, which would kill many more people in nuclear attacks than
the initial blast, military officials and experts said.
"We want it on the fast track," said Navy Adm. James A. Zimble, a
top military health official who is president of the Uniformed
Services University of the Health Sciences in Bethesda. "We've been
very encouraged by the very positive results" of tests on animals,
he added.
Experts cautioned that more research needs to be done to prove
the drug's effectiveness and safety when administered to humans. The
vast majority of new drugs that appear promising in animal studies
never gain approval for humans. But radiation specialists said tests
on this drug with mice, dogs and monkeys suggest that it will work
in people and will not prove toxic.
Since the 1950s, military researchers have scrutinized thousands
of compounds in a search for something that could protect troops in
a nuclear war zone, but have failed. This drug is the first to hold
such promise, said Mark H. Whitnall, a top researcher at the Armed
Forces Radiobiology Research Institute in Bethesda, which is working
closely with Hollis-Eden on the drug.
"My personal opinion is any agency dealing with emergency
response to terrorist events should be interested" in the new drug,
Whitnall said.
U.S. military officials are encouraged by results from animal
studies that appear to demonstrate that the drug, called HE-2100,
offers protection when administered before radiation exposure as
well as a few hours after exposure, or even later. This suggests it
could be given to military personnel or firefighters when it is
known that they will be entering a radiated zone or as they are
leaving one. Currently, there is no safe medicine to give people
after they are exposed to dangerous levels of radiation, experts in
the field said.
Radiation severely compromises the body's immunity to disease, so
most fatalities caused by a nuclear explosion or dirty bomb blast
would come from infections, including influenza and pneumonia,
beginning a week to six weeks after detonation, medical experts
said. A dirty bomb is a conventional explosive attached to
radioactive material, which is spread when the device goes off.
HE-2100 buttresses the immune system, in particular the
infection-fighting powers of bone marrow, which is most vulnerable
to radiation. The drug protects the bone marrow's ability to
continue creating infection-fighting cells called neutrophils even
after radiation exposure. The loss of too many of these cells brings
on a condition called neutropenia, which leads to infections and
possibly death.
HE-2100 stimulates neutrophil production by causing cells that
become neutrophils to mature and to be released into the
bloodstream.
In a Hollis-Eden study completed earlier this year, monkeys that
received a near-lethal radiation dose and did not receive the drug
suffered severe neutropenia 50 percent of the time over the next 21
days. By contrast, monkeys given HE-2100 about three hours after
being dosed with radiation, and then for the following seven days,
suffered the same effects only 9 percent of the time. None of the
monkeys suffered ill effects from HE-2100, the firm said.
By staving off radiation-related infection and illness in the
weeks after a nuclear event, HE-2100 can, it appears, "bring people
over that hump in time, where, without it, they would die," said
David Grdina, a professor of radiation and cellular oncology at the
University of Chicago.
"There are definitely applications for homeland security in this
drug," Grdina said. Even so, Hollis-Eden is pursuing the drug's
development through the U.S. military, as it has for several years,
rather than switching to the Department of Homeland Security.
Some civilian officials say developing medical protections
against radiation is less of a priority than working on cures for
bioterror agents, which they view as the gravest current terrorist
threat.
In any case, Whitnall added that the fact that HE-2100 has shown
such encouraging results in tests involving three different species
suggests it will be successful in humans.
"It protects against radiation damage; there's no doubt about
that," said William McBride, a radiation biologist at the University
of California in Los Angeles. "The question is: How much can you
give a person" before it proves toxic? "It seems non-toxic so far.
It's encouraging they got it into primates."
The only other drug that has been shown to protect animals from
radiation, ethyol, must be given before radiation exposure, and can
be highly toxic. Hollis-Eden and military officials said HE-2100 is
the only compound on the horizon that has its potential.
The firm estimates that an eight-day course of the drug would
cost as much as $100. Military officials said the idea is to
stockpile enough doses across the country to treat both first
responders and as many people in the general population as could be
radiated in an attack.
The Food and Drug Administration has decided the firm can seek
approval of the drug under a new set of streamlined procedures for
substances believed to protect people in nuclear-biological-chemical
attacks. Because it would be unethical to irradiate human beings to
determine whether the drug works, the FDA says the company can rely
on the animal studies to show its efficacy, and give the HE-2100 to
people to test for adverse reactions.
The drug is being developed in injection form, but Hollis-Eden is
looking into developing it in pill form.
Other drugs also protect humans in radioactive crises, but only
from a limited range of radioactive isotopes. Potassium iodide
pills, if given within hours of a radioactive event, can protect the
thyroid gland, which is extremely sensitive to radiation damage. The
World Health Organization recommends that the drug be stockpiled in
homes near nuclear power plants.
A compound called Prussian blue also can be used to treat people
who receive high doses of the radioactive element cesium, which
terrorism experts say could be disseminated in a dirty bomb. Only
one small European firm makes the drug, and the FDA has asked U.S.
companies to apply to manufacture it.
But for now, military officials see the greatest possible benefit
in HE-2100. "We're a long way from having a product," Zimble said,
"but we think we can protect troops with it."