To: Mike O'Hara: Comunications Dept, the Mayo Clinic newsbureau@mayo.edu
Dear Mr. O'Hara- It is irresponsible for the Mayo Clinic to issue the
press
release (below) which alleges the finding of low levels of a contaminant
in
5 Hydroxy Tryptophan wihout simultaneously providing the peer reviewed
journal in which your finding has allegedly been reviewed. You say
that
your study has been published in the Sept. 1 issue of Nature Medicine,
yet
this isn't available for download and review. IT SHOULD BE, SIR- YOU
HAVE
SPLASHED YOUR STORY ALL OVER THE NETWORK TV NEWS.
My friend Durk Pearson, an MIT graduate who formulates dietary supplements
would like for you to email it to me so that I may fax it to him for
his
scrutiny as he is not online, as he and I wish to engage you in an
immediate dialogue. What is wrong about what you are doing is that
this
story of yours is all over the news, and there is no way for ANYONE
to
verify what you are saying regarding the "low levels of a potentially
harmful contaminant "peak x" -- which you allege "could" prove dangerous
if
taken in large quantities. You then extrapolate from this rather hazy
scenario to make additional allegations that "Mayo researchers have
previously raised similar questions about the purity of another popular
dietary supplement, melatonin." Sir,this is not science you are engaging
in, its known as...PROPAGANDA.
I am calling the Mayo Clinic on this due to the highly politicized climate
that existed in 1989-1990 when the FDA criminally violated the rights
of
the American people by railroading ALL L-tryptophan off the market,
essentially on the pretense of protecting people when in reality they
were
just doing the bidding of Eli Lilly, makers of Prozac, which had just
been
introduced to the market. As a naurally occurring dietary supplement,
l-tryptophan was the most popular supplement on the market at that
time.
Millions had benefitted from it as a natural sleep aid, and Eli Lilly
could
not tolerate its existence in the market place as a serotonin precursor
after spending millions to get Prozac through the FDA drug approval
process.
The is "Dejavu-- all over again" except the Mayo clinic is now being
cast
in the role that FASEB was in in 1990: to assist the Fraud and Drudge
Assn.
from a PR standpoint in an effort to "insure that the existence of
dietary
supplements in the marketplace does not act as a disincentive to new
drug
development." (To quote the now infamous words of FDA's Gary Dykstra-
author of the proposed rule from hell in the aftermath of the passage
of
the NLEA known as the "Dykstra Report" back in 1990 which so angered
the
American people that we flooded Congress with more mail on any issue
since
the Vietnam War.
Dykstra wanted to destroy consumer access to dietary supplements within
the
therapeutic range, and his Thugs with Guns were very busy back in those
days raiding dietary supplement companies and health food stores--
when
they SHOULD have been protecting the American people by defending us
against a contaminated blood supply and other truly serious problems
that
are FAR more worthy of our tax dollars.
The most shameful chapter in this sad saga came when the FDA held a
public
hearing in the Masur Auditorium at NIH on August 29, 1990 for the purpose
of hearing comments from the public regarding Dykstra's proposed rule
from
hell, when the FDA paraded a number of victims of the Showa Denko
contaminated Tryptophan up to the microphone as political pawns, with
zero
concern for their well being. I say this because they were being denied
the
life saving nutritional protocol developed by Dr.Christopher Caston
of
Spartenburg S.C., who's work was published in several peer reviewed
journals, including the June 1990 issue of Advances in Therapy, but
it was
ignored by NIH and by FDA because his patients were cured of eosinophilia
myalgia syndrome via a nutritional protocol which included...
L-TRYPTOPHAN. Meanwhile NIH hopsital was KILLING these patients by
putting
them on dangerous drugs such as Prednisone, while denying them the
nutrients they needed to heal-- and then they were paraded up to the
microphone as unwitting pawns- sent up by the FDA to denounce the dietary
supplement industry, when- IRONY OF IRONYS- Showa Denko is a PHARMACEUTICAL
COMPANY.
So, lets get REAL, Mayo Clinic. I see through your little "GAME" and
want
you all to know that I am DISGUSTED. You people aren't scientists.
You
don't care about the public health. You have a self serving agenda
which is
to try to assist the FDA in attacking the dietary supplement industry
in an
effort to force US harmonization to EEC 65/65, the Directive in the
EU
whereby all dietary supplements are regulated as "DRUGS". You are
attempting to team up with the FDA in an effort to force the supplement
industry to accept full pharmaceutical GMPs... HACCP GMPS, which would
drive all the small companies out of business. You subscribe to the
criminal view that the FDA has a constitutional RIGHT to regulate dietary
supplements, and the truth is that under the 10th amendment, all powers
not
specifically given to the Federal government by the Constitution are
reserved to the states-- and the Constitution never gave the Federal
Government ANY jurisdiction over what ANY American chooses to ingest
into
his or her body. Moreover, under 44 Liquormart, the Supreme Court stated
that any attempt by a government agency to manipulate the behavior
of
American Citizens based on denying information is unconstitutional-
so the
FDA has no legal right to block the making of truthful therapeutic
claims
on dietary supplements.
I therefor request that the Mayo Clinic IMMEDIATELY email me the PROOF
behind the strong allegations made in the press release below, so Durk
Pearson/Sandy Shaw and I may engage you in immediate dialogue, since
we
strongly question your MOTIVES as well as the so those of the THUGS
WITH
GUNS- the Fraud and Drudge Administration, for whom we hold nothing
but
open contempt.
Thank You,
John C. Hammell, legislative advocate
International Advocates for Health Freedom
Under the 10th amendment to the constitu
Mayo Clinic Rochester News
Monday, August 31, 1998
Potentially Harmful Contaminant Discovered in Popular
Dietary Supplement, 5-HTP
ROCHESTER, MINN. -- Mayo Clinic researchers report finding low levels
of a
potentially harmful contaminant in off-the-shelf samples of a popular
dietary supplement, 5-Hydroxy-L-Tryptophan (5-OH-Trp or 5-HTP).
The contaminant, called "peak x," was linked to symptoms suffered by
a
family exposed to 5-HTP in 1991. It also has a similar chemical structure
to contaminants found in batches of a related supplement, L-Tryptophan,
which were linked to a 1989 outbreak of eosinophilia myalgia syndrome
(EMS) that affected thousands of people.
The researchers say the finding is a "red flag" about the possibility
of
health risks from taking this supplement in large doses. Their report
will
be published in the September 1 issue of Nature Medicine.
Using sophisticated chemical analysis techniques, Mayo Clinic researchers
analyzed pills from six samples of 5-HTP produced by six different
manufacturers. Samples were purchased at health and nutrition stores
in New
York City and Rochester, Minn.
They found peak x in all six samples, both synthetic and natural extract
preparations. The levels of peak x were only a fraction (between 3
and 15
percent) of the level that caused the illness in the earlier incident.
The
researchers warn, however, that, "as the intake of supplements is not
medically supervised, the probability of increased doses of 5-OH-Trp
and
hence, peak x, being consumed is very real."
They point out that a current book (5-HTP: The Natural Way to Overcome
Depression, Obesity and Insomnia) recommends consumption of 300 to
900
milligrams per day of the supplement. They say that if followed, this
recommendation could bring the consumption level of peak x to levels
with
problems in the past.
The authors say that the potential health risks of dietary supplements
were
clearly demonstrated in the 1989 outbreak of EMS which killed at least
30
people and sickened more than 1,500. That outbreak was linked to
consumption of a contaminated batch of the supplement L-tryptophan.
Six
different contaminants were linked to illnesses. Mayo Clinic physicians
and
researchers diagnosed and treated many victims of that outbreak and
played
a key role in identifying the contaminants that were likely responsible
for
the illness.
Mayo Clinic researchers have characterized the chemical structure of
peak x
for the first time. They have discovered that peak x is, in fact, a
family
of nearly identical compounds. Their chemical structure is similar
to two
contaminants found in the L-tryptophan linked to EMS symptoms in 1989.
The Mayo researchers have previously raised similar questions about
the
purity of another popular dietary supplement, melatonin. In several
recent
publications, they report identification of contaminants in commercial
preparations of melatonin whose chemical structure is very similar
to some
of the contaminants implicated in the L-tryptophan outbreak, as well
as to
peak x from 5-HTP.
The Mayo research team, led by Stephen Naylor, Ph.D. and Gerald Gleich,
M.D., say that their study "emphasizes the need for tighter quality
control
for the production of both synthetic and 'naturally' produced nutritional
supplements" to prevent the possibility of another epidemic in the
future.
Mayo researchers have informed the Food and Drug Administration of their
findings. They also have provided a description of testing methods
used to
the six manufacturers of 5-HTP included in the study so that they could
confirm the study's findings.
This release and related information will be available on Mayo Clinic's
Websites, www.mayo.edu. and www.mayohealth.org.
Mike O'Hara
507-284-9522 (days)
507-284-2511 (evenings)
e-mail:
Related scientific articles
Message for Users of 5-HTP
Related information on Mayo Clinic Health Oasis
******************************************
International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St. Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,
jham@iahf.com http://www.iahf.com
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