What's your poison: a Mexican lab hopes its
anti-venoms take a bite out of hospital costs across the
globe.
by Jones, Forrest
Alfredo Chavez Haro, an emergency room doctor in southern central
Mexico, remembers well the six-year-old child who came into his Bed
Cross emergency room. Bitten by a scorpion--just one of 230,000 victims
he's seen in three decades treating every manner of calamity in his
home state of Guanajuato--the child was losing control of his lungs and
his throat had begun to shut. "He knew he was in the jaws of death
before he should have had even a notion of what death is," Chavez
says.
Scorpion stings can be fatal especially for children (this patient
survived), who account for most of the country's scorpion-related
fatalities. Even if the victim survives, the ordeal is traumatic. Yet
deaths from such stings could become a thing of the past. A Mexican
pharmaceutical company, Bioclon, has invented a drug that has cut yearly
scorpion-related deaths to 100 from 800. Of the 250,000 people stung
every year in Mexico, those who receive the drug--known as
Alacramyn--are in and out of a hospital in an hour.
Bioclon now wants to take the anti-venom to the United States,
where it is undergoing clinical studies to be approved by the Food and
Drug Administration (FDA) for regular distribution. In Arizona, the drug
is already authorized for use in emergencies. But public-health
officials say they need it now.
The new drug, developed at Mexico's National Autonomous
University (UNAM), cost just US$37, down from more than $350. "We
haven't had a death or serious side effects" using Alacramyn,
Chavez says. U.S. healthcare facilities rarely have to deal with
life-threatening scorpion bites since many hospitals have pediatric
intensive-care units, says Leslie Boyer, medical director at the Arizona
Poison and Drug Information Center at the University of Arizona.
However, a stay in such a facility to treat a sting normally lasts 24
hours and costs run as high as $8,000 to care for a victim. Alacramyn
can cut that cost to a fraction, says Boyer.
"We are actually relying on the charity of a private Mexican
organization to save the lives of rural Arizona children who would not
have access to this care;' says Boyer, who stumbled across Bioclon
by accident a few years ago when accompanying National Geographic
magazine reporters working on a story on venomous creatures in Mexico.
While on the road, Boyer came across a lab where UNAM researchers
were testing Alacramyn. Interested, Boyer withdrew a scorpion from her
bag and a lab scientist used it on a test animal. The animal went from
near death to recovery in about 10 minutes once it received Alacramyn,
says Boyer.
For years, Arizona hospitals have relied on homegrown anti-venom
that is inferior to Alacramyn. Then the manufacturer of that drug
announced in 2000 it would cease production. A five-year supply is
running out, and Boyer and other healthcare officials there want
Alacramyn distributed as soon as possible. "I couldn't stand
the thought of saying 'Sorry, we know of something good 200 miles
south of the border but you can't have any'," Boyer says.
Bioclon researchers are eager to repeat their results in the United
States and hope the U.S. government greenlights distribution soon.
"We calculate we will finish [clinical studies] this year and
present the results to the FDA and get the final biological license
application, which is the last stage;' says Jorge Paniagua, head of
research at Biodon, which also has begun testing antibodies to be
administered to people bitten by snakes and spiders. Tests on those
drugs should begin soon. "I think we are going to begin clinical
studies this year," says Paniagua.
Mexico always will be Bioclon's largest market due to the
sheer number of victims, but the company expects to export to Central
and South America as well as Africa and Asia, wherever venomous insects
and reptiles are a big problem. In the United States, only about 10,000
people suffer scorpion stings, and fatalities are very few and far
between. No anti-venoms exist on the market in part because
pharmaceutical companies must spend billions to bring new drugs to
market. For a large drug company, the return on an investment for
manufacturing and marketing anti-venoms just isn't there for a
scorpion anti-venom.
Side effects. Part of what makes the drug so attractive is its
ability to treat a patient with a very low risk of side effects, says
Lourival Possani, head of UNAM's biotechnology institute. The drug
is made by injecting venom into a horse and later extracting the
antibodies from the horse's blood. UNAM scientists say they have
successfully isolated only those molecules needed to fight off the
poisons. Doing so lowers the risks of side effects, like toxic shock
Today, UNAM is researching ways to derive anti-venoms from human blood
that would eliminate problems associated from using horse blood.
"People don't believe that, in a third-world country, you can
do things good enough to compete in a first-world country," Possani
says.
In the United States, one pharmaceutical company is ready to make
emerging-country drug discoveries more available. Rare Disease
Therapeutics produces pharmaceuticals and medical supplies targeted to
smaller groups of consumers. Such products, known as "orphan
drugs" in the industry, are designed to help the needs of people
that larger drug companies would otherwise overlook due to financial
considerations.
In 2001, Rare and Bioclon teamed up to bring Alacramyn into the
United States, where a dull-yellow scorpion that grows up to 20
centimeters, known as the bark scorpion, poses a threat to children in
the southwestern United States. The drug will be marketed under the name
Anascorp in the United States. "We're basically developing
that anti-venom for the state of Arizona;' says Rare Disease
Therapeutics President Milton Ellis. The bark scorpion is the first
creepy-crawly on its hit list. The company wants to take new Bioclon
products to market in the United States, including ones designed to
treat all types of rattlesnake bites as well as black widow spider
bites. Rare and Bioclon are also considering making an anti-venom to
treat bites from coral snakes in Florida.
Pharmaceuticals giant Merck already manufactures a drug to treat
black widow bites, although that company no longer wants to produce it
and is coordinating its market exit with Rare Disease Therapeutics to
fill the gap, Ellis says. Once approved, Rare will distribute the
Mexican anti-venoms across the United States and in Canada. One
short-term obstacle, however, is having enough venom in the first place:
Snakes, scorpions and spiders must be "milked" regularly to
create a supply of anti-venom. "The critters have to
cooperate," Ellis says.
FORREST JONES * MEXICO CITY
ONCE BITTEN
While scorpions sting thousands a year, high treatment costs can fall
with new drugs.
Number of people Average cost per
stung a year: treatment without Alacramyn:
Mexico 250,000 US $350
United States 10,000 US $6,000-US $8,000(E)
E = Estimate
SOURCE: UNAM, University of Arizona
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