Wednesday November 29 10:53 AM ET

44 Americans Claim StarLink Corn Made Them Ill

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 on Tuesday.

Scientists with the Centers for Disease Control and Prevention (news - web sites) and the Food and Drug Administration (news - web sites) 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% 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% of the illnesses were categorized as "unlikely'' to be linked to the bio-corn. These included cases such as an entire family that 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 and Prevention, 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 on Friday and the agency is expected to act soon after that.