fresh~horses
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 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
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."
~~~~~~~~~~~~~~~~~~~`
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:
1. 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.
2. Genetic engineering can cause mutations and deletions in the DNA,
altering its natural functioning and changing what is produced.
3. 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.
4. 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
the Rutgersarticle, "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 www.seedsofdeception.com/Public/L-tryptophan/index.cfm.
Spilling the Beans is a monthly column available at
www.responsibletechnology.org. Publishers and webmasters may offer this
article or monthly series to your readers at no charge, by emailing
column@responsibletechnology.org. Individuals may read the column each
month by subscribing to a free newsletter at
www.responsibletechnology.org.
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
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
www.seedsofdeception.com/utility/showArticle/?objectID=263.
© Copyright 2005 by Jeffrey M. Smith. Permission is granted to
reproduce this in whole or in part.
http://www.seedsofdeception.com/utility/showArticle/?objectID=284
Engineering
By Jeffrey M. Smith, author of the international bestseller Seeds of
Deception
"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
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."
~~~~~~~~~~~~~~~~~~~`
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:
1. 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.
2. Genetic engineering can cause mutations and deletions in the DNA,
altering its natural functioning and changing what is produced.
3. 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.
4. 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
the Rutgersarticle, "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 www.seedsofdeception.com/Public/L-tryptophan/index.cfm.
Spilling the Beans is a monthly column available at
www.responsibletechnology.org. Publishers and webmasters may offer this
article or monthly series to your readers at no charge, by emailing
column@responsibletechnology.org. Individuals may read the column each
month by subscribing to a free newsletter at
www.responsibletechnology.org.
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
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
www.seedsofdeception.com/utility/showArticle/?objectID=263.
© Copyright 2005 by Jeffrey M. Smith. Permission is granted to
reproduce this in whole or in part.
http://www.seedsofdeception.com/utility/showArticle/?objectID=284
