Q: What is tryptophan? A: According to information
contained in the booklet of the 1991 Hearing on the dietary supplement L-tryptophan
before a congressional subcommittee, tryptophan is "the least abundant"
of the various amino acids but has been studied the most. Tryptophan is what is called
"an essential amino acid for protein synthesis and also serves as a precursor
for the synthesis of important small molecules, including serotonin and niacin."
Other statements of interest on tryptophan from page 207 of the report include the
following: "In animal studies, tryptophan was found to be one of the most toxic
of the common amino acids. A number of metabolic disturbances, including hypoglycemia,
have been described in certain animal species." Furthermore, the report on page
207 by Dr. L. Leiter suggests that tryptophan supplements may be unsafe in pregnancy
based upon the fact that pregnant hamsters fed tryptophan showed "a reduction
in embryo and neonate survival." Again, the analysis offered by Dr. Leiter acknowledges
that while tryptophan appears in clinical trials to be "relatively safe",
there are concerns that have been raised - one is that there might be a link between
tryptophan and bladder cancer "based on similarities between tryptophan metabolites
and aromatic amines that are recognized promoters of bladder tumour growth. Extensive
studies appear to indicate that certain metabolites of tryptophan may be procarcinogens,
especially in conditions such as chronic irritation of the bladder, or when abnormal
tryptophan metabolism occurs." Another concern noted is the occasional reporting
of the disease scleroderma in tryptophan users which might be associated with "abnormal
tryptophan metabolism." Please note that I also have a link to a page on tryptophan
in the "What is EMS?" section of this web site. What
is EMS?
from: FDA's Regulation of The Dietary Supplement L-Tryptophan,
Hearing before the Human Resources and Intergovernmental Relations Subcommittee of
the Committee on Government Operations, House of Representatives, One Hundred Second
Congress, First Session, July 18, 1991; [portion of hearing dealing with Health and
Welfare Canada, page 16, August, 1990, Dr. L. Leiter].
Q: How many cases of EMS occurred in the USA? A: Since the CDC
stopped counting at just over 1,500 cases in 1992, it's impossible to know for sure
how many actual cases occurred. Undoubtedly, many cases went unreported and undiagnosed.
Various estimates range from 5,000 to 10,000 cases in America, but the total number
of cases might be fewer or more. I don't think anybody knows for certain..
Q:
How many cases of EMS were recognized in Canada? A: In Canada, 11 cases have
been "confirmed" according to the authorities there. "All but one
of the victims had obtained the supply of L-tryptophan from U.S. sources" according
to the Canadian report submitted to Congress in July, 1991. Furthermore, tryptophan
was available only as a prescription drug in Canada and the "one product approved
for sale has not been associated with EMS to date [that is, July 1991]." This
prescription drug is known as Tryptan (registered name). One of the 11 EMS cases
in Canada did not involve contaminated LT but was associated with 5-hydroxy-tryptophan,
often called 5-HTP. Canada, so far as I know, made tryptophan, as a single amino
acid, a drug in 1985 and removed it from sale over the counter.
Q: In
what other countries did EMS occur? A: There were approximately 105 to 125
cases in Germany; at least 25 cases in France; at least 22 cases in Belgium; 11 cases
reported by 1991 in the UK and an additional 7 later (however, not all fit the criteria
for EMS), several in Italy and perhaps in one or more other European nations; several
in Israel; two cases in Australia; one case in New Zealand; and various reports in
Japan of from two to 10 or 12 cases, depending on the source. These are approximate
figures, and there may have been cases in other nations about which I have no knowledge.
My sources for these figures come from medical abstracts - which may be found on
PubMed - as well as correspondencewith various scientists or researchers.
Please contact me if you want to to know more about the abstracts.
Q: What
is eosinophilia? A: Eosinophilia is the state of having an excessive
percentage of eosinophils, which are a type of white blood cell. There are several
types of white blood cells which may be tested by a blood test. Usually, people have
0-5% of their total white blood cells as eosinophils. Some labs make the cut-off
3%, and a few make it as high as 7%. Therefore, if your total percentage of eosinophils
exceeds 5% to 7%, you have borderline eosinophilia or actual, progressing eosinophilia,
and may need to be re-tested, require treatment or investigation as to what is causing
the eosinophilia. Please see "What is EMS?" on this web site. I
have a link regarding eosinophils in that section. What is EMS?
Q:
What are the most usual causes of eosinophilia in America? A: In developed
nations such as the United States the most common causes of eosinophilia are allergic
conditions and parasitic infections. For instance, someone with asthma might experience
a rise in eosinophils during an attack or during allergy season. Sometimes eosinophilia
is connected with certain types of cancers. And, sometimes, no cause can be ascertained.
Eosinophilia can be transient or it may be life-threatening, if the count rises high
enough. In addition, anecdotal evidence points to the possibility that a few persons
may always run higher than normal eosinophil counts - but the count might be normal
for those persons. Of course, the higher counts would not be dangerously high!
Q:
What is myalgia? Is it the same as Fibromyalgia? A: Myalgia is muscle pain,
often accompanied by weakness. FM patients have many overlapping medical symptoms
with EMS patients, and one is muscle pain. Some with EMS have been diagnosed as having
FM secondary to EMS, while others might have had pre-existing FM before they got
EMS - perhaps as the result of a car accident or some other trauma. All the causes
of FM are not known (though trauma is thought to be one possible cause), just as
the exact cause(s) of EMS are not definitively known and outlined, except for its
association with contaminated over-the-counter L-tryptophan made by one Japanese
manufacturer, Showa Denko KK.
Q: How many with EMS died of it in the first
year or 18 months of the new disease? A: The official CDC figure is 37; however,
it is acknowledged by the authorities that deaths may have been missed during the
time that this counting was conducted. The figure 38 often seen on the Internet is
wrong and represents one death accidentally counted twice by the FDA, according to
sources at the CDC who wrote to me in response to a letter from me to the CDC about
the matter. I myself think the figure is much higher than 37 for the first several
yearsand certainly has grown over the years as people have died of causes
related to having had EMS.
Q: How many with EMS have died since the start
of the disease? A: People with EMS can die of many causes, like anyone - such
as being in an auto accident. Some with EMS have died of complications of the disease
later on in the chronic phase of the disease, and clearly certain deaths were associated
with having EMS, which contributed to the deaths, or caused premature death. In some
cases, it is hard to know whether or not EMS has played a role directly or indirectly
in cause of death. My personal opinion is that at least 125 persons
have died directly or indirectly due to EMS out of the 1,500+ cases counted by the
CDC. If you add in deaths from all causes, the total would be higher; however, we
can't know for sure how many have died because a registry to monitor deaths and the
course of chronic EMS was never set up by the government. In Spain, the government
set up a registry to follow victims of TOS (Toxic Oil Syndrome) throughout their
lives. It's too bad we do not have such a registry forpersons with EMS. One
would think that, with a novel disease like EMS, that the government would have wanted
to monitor those with EMS throughout their lives and facilitate research in this
way. Although a few researchers may have set up patient study cohorts, I am
not aware of any with more than a few hundred persons with EMS in their databases.
Such groups may do well for some studies, but cannot substitute for a real registry
of persons with EMS which ideally should have been put into place in the first years
ofEMS.
Q: What body systems are affected by EMS? A: You
can read the articles on the Information Page (web sites). Any body system may be
affected potentially in those with EMS, but it differs from person to person. Some
may have mild disease with only one or two systems somewhat affected, while others
may be extremely affected with multiple body systems affected due to EMS. To read
the articles on the Information Page by experts: Information
Page
Q: Is EMS contagious? A: EMS is not a contagious disease.
There should not be fears about that. Naturally, chronic diseases such as EMS may
have profound effects upon close family members of the sick person and might contribute
to feelings of depression, anxiety, problems with children accepting the illness,
or other physical and emotional conditions in loved ones. But this occurs with any
chronic illness that goes on for many years - which is what a chronic illness
is, an ongoing one.
Q: Have women with EMS become pregnant and had normal
babies? A: Yes, at least a few women with EMS reported to me that they had
normal children after getting EMS, and that the children have no symptoms of EMS
and appear to be healthy thus far. Many women were past the years of childbearing
when they got sick; others elected not to have children because of having EMS.. So,
there is not a lot of data to date on this particular question. Of course, some women
opted to adopt children because of having EMS.
Q: Did women who were pregnant
when using contaminated L-tryptophan have healthy babies? A: I know of perhaps
5 to 10 cases of women who believe that using contaminated tryptophan while pregnant
or nursing caused their children to have some symptoms of EMS, if not outright EMS.
If you used LT and have EMS and think your child has EMS, you may wish to contact
the national organization, write to me, or peruse my Support Page for links to these
and other support groups. Support Page
Q. What were the
age ranges of those getting EMS? A: I have read reports of a female child
who was four years old who got EMS (she was taking it upon advice of a pediatrician,
as I recall). Also, there were other children using it for various reasons, often
along with one or both parents. These persons are now in their teen years - there
are likely not many of them. And, as mentioned in the previous question, there were
at least a few persons who might have contracted EMS while in the womb or via nursing.
The oldest persons who got EMS were in their 80s at onset. Therefore, at thistime, the age range of those with EMS would befrom about age 12 to people
in their 80s. Naturally, I am only talking about persons with LT/EMS,
not EMS from 5-HTP or any other supplements or causes.
Q. Did more women
than men get EMS? A: Yes. At least 75% of those getting EMS were women. I
have seen figures that place the percentage higher.
Q: What diseases are
most like EMS? A: It varies from person to person, but EMS may be similar
to Fibromyalgia, Chronic Fatigue Syndrome, Lupus, Scleroderma, Multiple Sclerosis,
Toxic Oil Syndrome, and other similar autoimmune diseases.
Q. What is the
diagnostic code for EMS? A: The code is 710.5. If your doctor does
not know this, make him or her aware of it. Especially if you are contemplating getting
Social Security Disability or have to undergo reviews, it's good to have your doctor
use the code periodically when you see him so that the diagnosis is documented in
your records. .
Q: Should people with EMS donate blood or organs? A:
Probably not, according to medical experts. It is best not to donate blood or
be an organ donor, according to the medical authoritieswith whom I discussed
this issue. But I will add this:Although Dr. Callegari, a former member of
the NEMSN Medical Advisory Council, said that persons with EMS should NOT donate
blood, and probably should not donate organs, he did say that in some persons, there
might be two possible exceptions to organ donation: the kidneys and the eyes. Source:
Q & A in an old issue of "The National EMS Network Newsletter."
Q:
What were the most likely causes of death of persons with EMS during the acute phase? A:
Respiratory and cardiac conditions seemed to be the most likely causes of death:
heart and lung problems, pneumonia of various types, strokes, heart rhythm abnormalities
or sudden cardiac arrest, and so on. Ascending polyneuropathy killed some persons
(ascending paralysis). Obviously, if the eosinophil count was not brought down, it
could lead to death. Not being an expert, I can't explain how that process occurred.
A few persons also committed suicide in the acute phase of EMS. For more information
on this topic, please read the Emedicine article on my Information Page. Information
Page
Q: Are persons with EMS getting cancer at a rate higher than
the norm? A: This question is one I can't answer. We need persons who do
get cancer to report it to the national organization so that they can monitor the
types of cancer. We could know more about this topic, also, if the national organization
would analyze and publish the data in the long Questionnaire they took of
over 300 members back in 1999. Sadly, that information was never fully analyzed,
and only a portion of the results were published for members and the world to read.
It contained one or more questions pertaining to cancerthat persons with
EMS have developed since getting EMS.
Q: I used L-tryptophan in the 1980s
and think I've really had EMS all these years. What can I do, and is it too late
to file a lawsuit against SDKK? A: You can do the following: 1)
Try to find old medical records from doctors and see if you had medical tests done
in the late 1980s or about 1990 which show eosinophilia, myalgia, or some other onset,
usually abrupt, of a new illness. 2) Keep a journal of your daily symptoms
starting now. 3) Write down all the diseases with which you have been
diagnosed since you first got sick - and try to recall when you first
got sick. 4) Write a biographical sketch (brief) of what's happened
to you medically since you got sick and what you've done to try to find out what
is wrong with you. What doctors have you seen? 5) Do you have any of
the old LT in your cupboard or elsewhere? Do not give it all away to anyone. It's
evidence, needed for testing, if you are lucky enough to have a case. 6)
Contactthe national organization (see my Support Page) for information, getting
the newsletter, and possible referrals to lawyers in your state. Please realize that
it may not be possible to begin a lawsuit at this late date.Only a
qualified attorney can advise you. 7) If you think you can prove onset
of a new illness by medical records, find evidence of eosinophilia and/or myalgia
onset around the late 1980s and other EMS symptoms, in the absence of such problems
prior to that - then you should weigh carefully whether to try to have a lawsuit.
I am not a lawyer, (and that is my disclaimer), but I would suggest contacting a
lawyer recommended by someone, taking in your evidence, and seeing what doctor or
doctors they want you to see for possible diagnosis. It is not easy to get a diagnosis
at this late time because there is no disease-specific test to administer that proves
you have EMS now in the chronic phase of the disease. You might start
going from one doctor to another in a quest for a diagnosis for nothing and do more
harm than good. It might be better to talk to an attorney first. Initial consultations
are generally free of charge. I have no way of knowing if there are still cases today
but believe there must still be some unsettled cases - when they may have been brought,
I would not know. NEMSN, the national organization, could tell you if there are still
unsettled cases.
UPDATE August 2007: I don't know of any LT/EMS lawsuits
at this time. The MDL, for instance, that returned "rebates" to qualifying
patients who had sued Showa Denko paid out those rebates finally in early 2007, and
that is closed. I am only aware of one 5-HTP/EMS lawsuit at this time.
