A Deadly Epidemic and the Attempt to Hide its
Link to Genetic Engineering Spilling the Beans,
August 2005 Institute of Responsible Technology
introduction
In my book Seeds of Deception, I bring out new information
about the
genetically engineered food supplement L-tryptophan, which was
responsible for a deadly epidemic in the United States in the
1980s.
Much of the research for the chapter came from the work of
investigator William
Crist. The book cited Crist's report, which was expected to
have been posted on a website well in advance of my book's publication.
Unfortunately, Crist was unable to update his report at that
time. It is now available at
http://www.seedsofdeception.com/Public/L-tryptophan/index.cfm
and provides important new evidence, including ways in which
the U.S. government apparently hid information in order to protect
the biotech industry.
......
A Deadly Epidemic and the Attempt to Hide its Link to Genetic
Engineering
By Jeffrey M. Smith
Author of the international bestseller Seeds of Deception
In October, 1989, 44-year old Kathy Lorio arrived in the medical
office of Dr. Phil Hertzman in Los Alamos, New Mexico. Lorio,
who had been healthy and active, was suddenly struck with severe
pain and a host of debilitating symptoms. Blood tests revealed
that her eosinophil count had skyrocketed. The normal concentration
of this white blood cell is about 10 per CC. Allergies or asthma
can make it rise to 500. Lorio's was over 10,000.
In a coincidence that was destined to save lives, Hertzman
referred
her
to Santa Fe rheumatologist James Mayer, who happened to have
recently
seen another patient, Bonnie Bishop, with similar symptoms.
Bishop
was
in severe pain, her arms and legs were filled with fluid, she
had
trouble breathing, and her muscles were so weak she couldn't
even
sit up.
"She slumped like a rag doll."[1] And her eosinophil
count was
extremely
high.
Patient histories revealed that both Bishop and Lorio were
taking
the
food supplement L-tryptophan. Although it was the only supplement
common
to both patients, the doctors were hesitant to blame L-tryptophan
for
the disease. It is an essential amino acid, naturally found
in
turkey
and milk, and in supplement form had been consumed safely for
years
as a
treatment for stress, insomnia and depression
Hertzman checked the literature on eosinophils. One author's
name
kept
coming up - Dr. Gerald Gleich of the Mayo Clinic. Hertzman gave
him
a
call. Gleich told him that two cases weren't enough to draw
a
conclusion
about L-tryptophan. Better wait. They didn't wait long. That
same
day a
third case, also linked to L-tryptophan, was reported in New
Mexico.
Gleich called the Center for Disease Control (CDC) in Atlanta
and
told
them about the cluster of patients in New Mexico and the possible
link to
L-tryptophan.
Within two weeks, three other patients checked into the Mayo
Clinic
with serious symptoms - one needed a respirator to breathe.
All had
taken
L-tryptophan and they were from different parts of the country.
Gleich
called the CDC again. He told them it's not limited to New Mexico;
it's
out and it's deadly. An L-tryptophan alert went nationwide.
Articles began circulating about the mysterious disease. The
Albuquerque Journal ran a series about it that eventually won
the
Pulitzer Prize.
The New York Times covered it. As more articles appeared, the
phone
calls started coming in - first dozens, then hundreds, then
thousands:
individuals with incurable symptoms, doctors with incurable
patients, and
stories of horrific symptoms. Some had coughs, rashes, physical
weakness, pneumonia, breathing difficulties, hardening of the
skin,
mouth
ulcers, nausea, shortness of breath, muscle spasms, visual problems,
hair
loss, difficulty with concentration or memory, and paralysis.
Not
everyone had all the symptoms, but everyone seemed to be in
pain -
greater
pain than doctors had seen before. The disease was named
eosinophilia
myalgia syndrome, or EMS - eosinophilia because of the high
cell
count,
myalgia because of the muscle pain. In all, about 5,000 - 10,000
people
got sick; some are permanently disabled. About 100 people died.
Disease Traced to Genetic Modification
The Journal of the American Medical Association (JAMA) reported
on
July
11, 1990 that people only got EMS from pills made by Showa Denko,
one
of the six manufacturers whose L-tryptophan was imported into
the
U.S.
from Japan. Showa Denko's pills had several unique contaminants
that
were likely to be responsible for the epidemic. Moreover, the
manufacturer
was genetically engineering bacteria to produce the L-tryptophan
more
economically. Genes had been inserted into bacteria's DNA in
order
to
produce high concentrations of several enzymes used in its
production.
Epidemiologist Michael Osterholm, who helped track the source
of the
epidemic, said in a Newsday article on August 14, "This
obviously
leads
to that whole debate about genetic engineering." Two weeks
later,
FDA
spokesperson Sam Page was quoted in Science magazine "blasting"
Osterholm
for raising the issue of genetic engineering, "especially
given the
impact on the industry."[2]
Diverting Blame
There are numerous ways in which genetically engineered bacteria
might
lead to unpredicted contaminants. For example:
The process of inserting genes can create significant changes
in the
expression of natural genes throughout the DNA, causing changes
in
proteins (including enzymes) and their interactions.
Genetic engineering can cause mutations and deletions in the
DNA,
altering its natural functioning and changing what is produced.
The bacteria were engineered to produce ingredients in larger
concentrations than were normally part of the process to create
L-tryptophan.
These higher concentrations might interact in unpredictable
ways to
create new compounds.
The L-tryptophan is toxic to the bacteria that create it. As
a means
of
self-preservation, the bacteria might have modified the L-
tryptophan,
itself, or its environment.
The press reported that Showa Denko had introduced a GM strain
of
bacteria at Christmas time in 1988. Soon after, they also reduced
the
amount
of carbon in the filter of the manufacturing process from 20
kilos
to
10. This change in the filter was just what the young and vulnerable
biotech industry needed to protect its reputation. The alternative
story
diverted the blame away from genetic engineering. This explanation
circulated around the world. "The change in the filter
was
responsible
for
the epidemic." Or more simply put, "It was bad manufacturing
- not
genetic engineering."
In 1996, writer William Crist began what would become an eight-year
investigation into the cause of the EMS epidemic. "He contacted
the
FDA's
biotechnology coordinator, James Maryanski, who told him "We
can not
rule [genetic engineering] out. . . . However, we are aware
of close
to
two dozen cases of L-tryptophan-linked EMS that occurred before
Showa
Denko began using their engineered strain. So, there would have
to
be a
cause other than just the mere engineering of the strains. Now,
I
can't
say that definitively because we don't have a lot of information
on
these earlier cases." Maryanski asserted that "either
L-tryptophan
itself,
or L-tryptophan in combination with something that was the result
of
the purification process, was probably the more likely cause."
[3]
Crist decided to track down the EMS cases that Maryanski described
-
those caused by L-tryptophan produced before the genetically
altered
bacterium was introduced in December 1988. He quickly discovered
CDC
studies that identified about 100 pre-epidemic cases, not two
dozen.
And
since reported cases of EMS were far less than actual cases,
the
true
number, using the CDC's estimated ratio for unreported incidents,
was
in the
hundreds - all apparently from individuals who had ingested
Showa
Denko's pills manufactured before December 1988. This fact clearly
dismantled the change-in-the-filter theory as the cause of the
disease. But it
didn't explain how the contaminants got into Showa Denko's L-
tryptophan.
Crist spoke with several attorneys who represented EMS victims.
They
had gathered significant evidence for their lawsuits, which
were
eventually settled with Showa Denko for about $2 billion. In
one
company memo
obtained by an attorney, Crist discovered a significant fact.
The
bacterium introduced in December 1988 was called Strain 5. The
preceding
three strains, introduced starting on October 22, 1984, were
*all*
genetically modified. This was a revelation. It countered the
FDA's
argument
that illnesses "that occurred before Showa Denko began
using their
engineered strain" meant that "there would have to
be a cause other
than
[genetic engineering]". *But they were all engineered!*
As he looked at the memo, Crist wondered why the FDA didn't
know
about
the earlier GM strains. They had access to a lot more information
he
did. Then his eyes rose to the top of the document to see a
fax
imprint:
FDA September 17, 1990. It had been faxed by the FDA! They knew
back
in
1990 that the earlier strains were modified, but in 1996, the
FDA's
biotech coordinator James Maryanski was still claiming ignorance.
An even greater omission occurred when Douglas Archer, deputy
director
of the FDA's Center for Food Safety and Applied Nutrition, testified
before Congress in July 1991 about the epidemic. Not only did
he
*not*
discuss the earlier bacterial strains, he never even mentioned
genetic
engineering. Instead, he blamed the disease on "the dangers
inherent
in
the various health fraud schemes that are being perpetrated
upon
segments of the American public." The FDA used this logic
to take
all
L-tryptophan, GM or not, off the market.
According to a 2000 article in the Rutgers Law Journal, "Political
pressures have played a role in the FDA's decision to ban L-
tryptophan as
well as its desire to increase its regulatory power over dietary
supplements."[4] In its FDA Dietary Supplement Task Force
report on
June 15,
1993, it states, "The Task Force considered various issues
in its
deliberations, including ... what steps are necessary to ensure
that
the
existence of dietary supplements on the market does not act
as a
disincentive to drug development." According to the Rutgers
article,
"This is a
particularly disturbing issue," as it shows that developing
FDA
guidelines "has far more to do with eliminating competition
in the
pharmaceutical industry than preserving the public health."
In the
case of
L-tryptophan, the FDA simultaneously protected prescription
drugs for
stress,
insomnia and depression, as well as the entire biotech industry.
In
retrospect, when FDA's Sam Page told Science that it was better
not
to
discuss genetic engineering, "especially given the impact
on the
industry,"
it turns out he was describing the motivation and strategy that
would
guide the agency for years.
Sobering Lessons Unheeded
Many studies have verified that the process of genetic engineering
can
produce unpredicted toxins or allergens. Nevertheless, the FDA
does
not
require any additional safety testing for GM products, whether
they
are
food crops or supplements. Thus, if that same deadly L-tryptophan
were
first introduced today, it would get on the market.
The EMS epidemic took years to identify and was almost missed.
The
only
reason it was discovered was because the disease had three
concurrent
characteristics: it was rare, acute, and came on quickly. What
would
happen if all three characteristics had not been in place? What
if it
took
20 years for onset or only impacted the next generation? What
if it
produced only mild symptoms like frequent colds? What if it
created
serious diseases that were common, like cancer, heart-disease,
obesity or
diabetes? The epidemic might remain undiscovered for decades.
What then of the thousands of products currently being fed
to US
citizens that contain ingredients from genetic modification?
Might
they be
creating problems that don't have all three characteristics?
Are
they
contributing to the doubling of food-related illnesses in the
United
States between 1994 and 2001, corresponding to the time when
many of
these
products were introduced? We don't know, because no one is looking.
And
even if we were, derivatives from the four major GM crops, soy,
corn,
cottonseed, and canola, are found in the majority of processed
foods.
Unlike L-tryptophan, if common food ingredients were creating
health
problems, identifying the source might be impossible.
In spite of these facts, and ignoring the thousands of victims
of GM
L-tryptophan, U.S. regulators continue to make the baseless
statement
that "millions of people have been eating genetically engineered
products
for years and no one has gotten hurt."
Dissatisfied with the way that the FDA is protecting their
health,
more
and more people have chosen to protect themselves by avoiding
GM
foods
altogether. Here too, the FDA stands in the way. More than 90
percent
of Americans want GM foods labeled. Most industrialized nations
require
labeling. But the FDA has an official mandate to promote
biotechnology.
They know that more than half of those surveyed say they would
avoid
GM
foods if they were labeled. To protect industry profits, the
FDA
ignores the desires of nine out of ten Americans.
There is no indication that another EMS epidemic will emerge
from
another GM food or supplement. But with obesity, diabetes,
migraines,
allergies, and many other ailments skyrocketing in the U.S.,
there
is no
guarantee that another GM-related epidemic is not already upon
us.
To learn more about the potential dangers of GM foods, to find
out how to shop GM-free, and to read the excellent report by
William Crist, visit http://www.seedsofdeception.com/Public/L-tryptophan/index.cfm
Spilling the Beans is a monthly column available at http://www.responsibletechnology.org/
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References
[1] Barbara Deane, 'Anatomy of an Epidemic,' Reader's Digest,
April 1991
[2] P. Raphals, 'Does medical mystery threaten biotech?' Science,
vol. 249, no. 619, 1990
[3] William E. Crist, The Toxic L-Tryptophan Epidemic, see
http://www.seedsofdeception.com/Public/L-tryptophan/index.cfm
[4] Joshua H. Beisler, L-tryptophan Section from "Dietary
Supplements and Their Discontents: FDA Regulation and the Dietary
Supplement Health and Education Act of 1994, Rutgers Law Journal,
Winter 2000, see http://www.seedsofdeception.com/utility/showArticle/?objectID=263
Copyright 2005 by Jeffrey M. Smith. Permission is granted to
reproduce
this in whole or in part.
