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44 Americans Claim StarLink Corn Made Them Ill

By Julie Vorman

WASHINGTON (Reuters) - Forty-four Americans have complained
that they became ill after eating foods containing StarLink bio-corn, but
investigators may never be able to pinpoint whether the genetically modified
maize was to blame, federal officials said Tuesday.

Scientists with the Centers for Disease Control and the Food and Drug
Administration said they were investigating the claims that Aventis SA's
gene-spliced StarLink corn might have caused rashes, diarrhea, vomiting,
itching and life-threatening anaphylactic shock.

"We're continuing to follow these people and are trying to get as much
medical information as we can," Dr. Karl Klontz, an FDA epidemiologist,
said.

In the absence of the specific laboratory tests that the CDC would like to
see developed, Klontz presented summaries of the illnesses to a panel of
independent scientists. The Environmental Protection Agency asked the group
to assess whether StarLink, modified to repel destructive pests, presents a
health risk to humans.

StarLink was approved for use only as animal feed in 1998 because of
concerns that its special protein might cause allergic reactions in humans.
Traces of the corn turned up in taco shells in September, triggering a
recall of more than 300 kinds of foods and widespread genetic testing by
food manufacturers.

The EPA is now considering whether to grant Aventis SA temporary approval to
use StarLink in human food. The company faces potentially huge liability
costs if the agency maintains its restrictions on StarLink.

Klontz said all 44 cases of illness were reported to the FDA following a
flurry of September news reports about StarLink contamination. All of the
complaints were self-reported, not submitted by a physician or public health
official.

THIRTEEN PEOPLE WENT TO DOCTORS

Of the 44 people who blamed StarLink for their illness, 13 went to a doctor
for treatment. They included a man who was rushed to a hospital emergency
room for anaphylactic shock after eating corn chips, Klontz said. The man
later told investigators he had no history of allergies.

A 13-year-old boy was also treated by emergency room physicians when his
face and tongue swelled after he ate flour tortillas.

The incidents are likely to play an important role in helping the EPA decide
whether StarLink and its unique protein, Cry9C, still pose a health risk.

Aventis, the maker of the gene-spliced corn, contends that its scientific
data shows that only a miniscule amount has entered the human food supply
and a typical American would consume nowhere near enough to cause allergic
reactions. Environmental and consumer activists, however, argue that not
enough data is yet available to clear StarLink of health risks.

Of the illnesses reported to the FDA, 59 percent were deemed to be
"compatible" with food allergy symptoms, Klontz said. That means StarLink --
or another allergen -- could have caused the itching, hives and other
allergic symptoms.

Some 16 percent of the illnesses were categorized as "unlikely" to be linked
to the bio-corn. These included cases such as an entire family which
suffered from vomiting and diarrhea three days after eating tacos, Klontz
said. Those symptoms were more likely to be caused by some kind of foodborne
illness than by a food allergy, he said.

And the remainder of the cases were classified as "unknown" by the FDA
investigators because of conflicting symptoms or a lack of information.

"We don't know if these reactions were truly allergic or not," Klontz said.

The inconclusive cases included that of a man who reported intense itching
after eating four corn muffins. The man's doctor later said, however, he
believed the allergic reaction might have been caused by a new prescription
drug.

BETTER TESTS NEEDED

Carol Rubin, a veterinarian at the Centers for Disease Control, told the
panel that federal investigators may never be able to determine if any of
the illnesses were caused by StarLink unless the government develops a
highly specific laboratory test.

"No matter how thoroughly we review these adverse event reports ... we still
will not be able to determine if the reported symptoms were due to
consumption of products containing StarLink," Rubin said.

The CDC analyzed the FDA data using stricter criteria and found that 11
people had allergic symptoms, she said. The CDC scientists classified a case
as an allergic reaction only if a consumer reported anaphylactic shock
within one hour of eating a corn food, or reported itching, swelling,
vomiting, or diarrhea within 12 hours.

CDC scientists planned to interview the 11 people further and to collect
more detailed information, Rubin said.

The EPA-appointed panel of 15 physicians, toxicologists and other scientists
is scheduled to submit its recommendations on StarLink and allergenicity to
the EPA Friday and the agency is expected to act soon after that.

17:01 11-28-00

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