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L-tryptophan, the pharmaceutical companies, and the FDA...

I've had a number of conversations and emails with several people about the merits and risks of L-Tryptophan.
Personally, I've found it to miraculous in handling my sleeping issues, bi-polar, and other struggles.
I really wish I had been introduced to it 17 years ago, instead of (insert list of 20+ different medications including by not limited to lithium, tegratol, prosac, wellbutrin, geodon, neurontin, and so many others) it would have saved a lot of complications and frustrations over the years.
I've basically just copied and pasted what I wrote to others, or some sent to me, so the information will be in the format of a conversation. I decided to post this because of a recent conversation with someone interested in nutrition and health, and also who is frustrated with the FDA and Pharmaceutical companies.

Click the "Read more" link to read all that I have posted.
Update (July 2006). I've added notes as an overall update, but here's a reply from someone who followed up on the reply in the Read More section of this article and how much it helped out (I've edited names out for their privacy): From C____: "I received this message from my sister-in-law, A____, a few days ago. I told her what Hawke told me about Tryptophan. She talked to her doctors about it and they had no idea where to get it in prescription form. They said they hadn't heard of it in prescriptions. So she found it in a nutrition store. She's been taking it for several months and apparently it has changed her life. Please forward my, and her, thanks to Hawke for telling me about tryptophan. " From A___ : "I wanted to Thank You so much for suggesting Tryptophan! It has helped me to be consistent in my business & have a better outlook on life!!!!! I feel like I owe my new life to you!!! I am finishing my first car & DIQ is not far behind!! I see a better future in so many ways so Thank You for helping me take my life back!! It has been huge!"

"
I can talk to you to give you a lot of personal information and experiences with it (L-tryptophan).
I did a lot of research before taking it, concerned about possible side-effects, but after doing the research it seemed the risks were about next to nill (which is other than the press, FDA, and Pharmaceutical companies would want you to believe).
But you should understand that IF those risks are legitimate they are severe. For my part however, it has been so helpful, it has been worth it. I have been on many, many medications over the years, and none have
worked as well as L-Tryptophan has for me. (update as of July 2006, still working wonderfully. Started taking in January 2005).

Here's three useful links giving varying perspectives on the pros and cons of taking large doses of L-Tryptophan:

The government's stance:
http://www.cfsan.fda.gov/~dms/ds-tryp1.html

A perspective still accusing of government actions but not as detailed and virulent as the third link:
http://www.ceri.com/trypto.htm

Below, the conspiracy theory perspective, I do not necessarily go along with this approach. Reality is probably somewhere between the extremes. I came across many other articles, and hope to post those in future articles, maybe around August 2006 I'll more time to perform a more comprehensive research project).
The "conspiracy theory" perspective:
http://www.seedsofdeception.com/Public/L-tryptophan/index.cfm

Through other sources, before using L-Trypto, I found out pretty much everything this article covers. Additionally, the article doesn't mention that the Japanese company responsible for genetically modifying the bacteria
to increase output, had in prior years actually "BLOWN UP" (sabotaged) one of their major labs in order to hide the evidence when inspectors were coming for some other
products they had created that were under investigation. I wish I could find where I had bookmarked that interesting article. Maybe when I have some time I'll look that up again and post it as well. This company had a years long reputation of dangerous products.
Also the articles don't mention, how the pharmaceutical companies that had lobbied to have L-Trypto taken off the market for the year prior to the EMS outbreak
(and the week it was taken off the market, Prosac and other SSRI, as well as other types of "competitive" drugs came onto the market publicly), then in 1994 one of these companies filed a PATENT using a modified version of L-Trypto (Danger Will Robinson! Danger!) they call LTP-5, to TREAT the EMS. Though many seem to feel LTP-5 is fine, and I've not seen too much bad about it, once again, I'm nervous about the modifications being "short cuts" for a natural process. Where L-Tryptophan lets the body decide whether to convert it to serotonin or a b vitamin, LTP-5 goes straight to the serotonin conversion step supposedly. Again, I haven't researched that yet, so my information could be mistaken at this point.
The sum of all this issue is that the dealings of the pharmaceutical companies and FDA has been blatantly crooked.
L-tryptophan works great for me, too bad so many others aren't getting to benefit because of the dirty pool being played. :(:(
I've been using it since January 2005.
I've fluctuated the dose between 500mg to 2000 mg, usually keeping it around 1,000 mg to 1,500 mg.
Update: Apparently now the access to L-Tryptophan has been lightened up somewhat since the FDA's 2001 status update, but it is still restricted state by state with different regulations. Apparently Washington state, where I'm now residing, has one of the more restrictive rules, supposedly because it was one of the "harder hit" states from the "bad batch" in '89. I have to get a prescription to get it, and it is only available at a local compounding pharmacy (I've been going to The Medicine Shoppe myself). And it costs about $60.00/30-45 day supply. :-(
Below is an article someone else sent recently, related to what I covered above, and then some...
I don't totally go along with all that is said, but it's more information to help others make their own decisions.

This article's main purpose is about GM/GE (Genetically Modified / Genetically Engineered) foods and focuses on a conspiracy theory approach to the FDA and the Pharmaceutical companies.

"Institute for Responsible Technology
Spilling the Beans, August 2005

----------------------------------------------------------------------
---

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 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.
"

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