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Scientific Critique of FDA Whitewash of Starlink Corn AllergyScandal

Scientific Critique of FDA Whitewash of Starlink
Corn Allergy Scandal

Critique of FDA Whitewash of Starlink Corn Allergy Scandal
released by Genetically Engineered Food Alert <www.gefoodalert.org>

FDA's StarLink Investigation Flawed:
Hundreds of Allergy Reports Ignored, Questionable Test Used
Special Risks to Infants and Children Not Accounted For

The testing conducted by the FDA and CDC could easily miss possible
allergic reactions to StarLink's Cry9C protein due to three major flaws in
the test protocol:
1) The group that was tested is too small to be representative of the potentially
affected population;
2) The FDA used a questionable testing method; and
3) Special risks to infants, children and farm workers were not taken into
consideration. These issues, first raised by independent allergy experts on the
EPA's StarLink Scientific Advisory Panel (SAP), must be addressed
before the EPA decides whether or not to approve StarLink corn in the food
supply.

Group Tested for Allergic Reactions is Too Small; Hundreds of Allergy
Reports Not Investigated


The FDA has tested only 18-20 people, "a handful of self-reported cases."
Because millions of people have been exposed to StarLink, negative results
from just 18-20 cases only show that more testing is needed. This is why
the SAP called on the FDA to widen the scope of the investigation by
collecting additional corn-related allergic complaints from the medical and
allergy communities, and testing farm workers exposed to StarLink. The
FDA has not only disregarded these recommendations, it has also ignored
hundreds of allergy reports from the food industry.

Food company data submitted to the FDA show a dramatic increase in allergic
complaints after the first disclosure of StarLink contamination (Kraft Taco
Bell taco shells) on Sept. 18, 2000.

The food industry says these reports are media-driven. But Dr. Hugh Sampson,
a leading allergist who served on two expert StarLink panels, points out
that because normal corn is rarely allergenic, few people would have
suspected StarLink as the cause of their allergic reactions until news of
the contamination broke (SAP Transcript, p. 461).

In one set of data covering the two months after StarLink contamination
first became public: 210 consumers who reported allergic reactions to food
companies blamed corn products + This is over 5 times the number of
corn-related complaints reported over the preceding 2 _ years + 74 of these
people (35%) "sought medical treatment with a physician" + 20 (10%) "sought
medical attention in an emergency room" FDA Uses Flawed Test for Allergic
Reactions Three allergists on the StarLink panel questioned the FDA's choice
of the ELISA allergy test. Dr. Sampson recommended "immunoblotting." Drs.
Metcalfe and Rothenberg suggested skin prick tests. According to Dr.
Metcalfe, the skin test "gets around a lot of the complications of ELISAs."

In the ELISA test, the suspected allergen (i.e. allergy-causing protein) is
exposed to blood from allergy sufferers. If antibodies in the blood bind to
the allergen, that food probably caused the allergic reaction (food
challenge tests are used for confirmation). Antibody and allergen are like
lock and key. Even a slight change in the allergen (key) can prevent it from
binding to the antibody (lock). The suspected allergen in StarLink corn is
the Cry9C protein. Surprisingly, the FDA did not use Cry9C extracted
from StarLink corn in its allergy test. Instead, it used a bacterial surrogate
protein grown in E. coli bacteria. The bacterial version of Cry9C differs
in molecular weight and structure from StarLink's Cry9C, which appears
to have added sugar molecules (glycosylation) not present in the bacterial
protein. These extra sugar molecules increase the likelihood that StarLink
Cry9C is allergenic. In addition, antibodies to StarLink corn Cry9C may
not recognize the bacterial surrogate used in testing, resulting in "false
negatives." The FDA should have used StarLink-derived Cry9C in its tests.

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