THE THALIDOMIDE OF GENETIC 'ENGINEERING'

[Guest guest]

THE THALIDOMIDE OF GENETIC 'ENGINEERING'

L R B Mann, D Straton & W E Crist

http://www.connectotel.com/gmfood/trypto.html

-----

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

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 M.

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, 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. (Sounds like what mycotoxins from mold do) 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 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 Crist began what would become an eight-year

investigation into the cause of the EMS epidemic. " He contacted the

FDA's biotechnology coordinator, anski, 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. " anski 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 anski 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 anski was still claiming

ignorance.

An even greater omission occurred when 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 Crist,

visit http://www.seedsofdeception.com/Public/L-tryptophan/index.cfm

Spilling the Beans</em> is a monthly column available at

http://www.responsibletechnology.org/ . Publishers and webmasters

may offer this article or monthly series to your readers at no charge,

by emailing column@r... . Individuals may read the column each month by

subscribing to a free newsletter at http://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] E. Crist, The Toxic L-Tryptophan Epidemic, see

http://www.seedsofdeception.com/Public/L-tryptophan/index.cfm

[4] 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 M. . Permission is granted to

reproduce this in whole or in part.

--- End forwarded message ---

===8<===========End of original message text===========

--

Barth

TOXIC MOLD SURVEY: www.presenting.net/sbs/sbssurvey.html

PUBLISH YOUR STORY: www.presenting.net/sbs/sbsstoryform.html