
Lena
Sanchez Editor
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"A NATURAL ENVIRONMENTAL HEALTH FACTS Ezine"
Here to Inform and Help You Become Healthier and Happier while Achieving Quality
Longevity!
http://www.antibiotic-alternatives.com
Email Lena
928-636-9425
Wednesday July 12, 2006
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Watch for Monday's "Ask Lena Health Q & A edition.
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Tuesday's & Thursday's "Your Home Business Coach"
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============================
=> IN THIS ISSUE!
============================
==> Editors' Ranting & or Warnings
==> Something To Think About
==> Health Thought for the day!
==> Showcase Health Spotlight
==> Monthly Spotlight Ads
==> Today's Health Tip
==> Food of The
Week (Sunday only)
==> Health Today
==> Environmental Report
==> Life Changing Information
+++++++++++++++++++++
EDITORS' RANTING
+++++++++++++++++++++
Greetings and thank you for
being an optin subscriber!
I keep trying to par the
ezine publication dates down to once or twice a week but there is simply
too many things out there that I want the world to know about and find
it impossible to cut back. My life could be so much simpler if it were
possible. Maybe someday but I don't see that happening very soon!
This middle of the week finds
me preparing for the onslaught of children and grandchildren that will
be around off and on for the the rest of this month. With six
grandchildren it takes really working to find menus that will appeal to
all and still stay healthy and preparing bedrooms that I normally don't
enter until company is coming... This month finds us, most days, with a
houseful and noise of grandchildren and neighborhood children staying
bonded and catching up from all they missed the last year... Such
challenges in life but very much worth it. So I will hurry this along in
order to get back to preparing for them... Enjoy the rest of your week!
Take charge of you and your family's health before it takes charge of
you!
Lena
If you have a question or comment (good or
not so good) send it to me...
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Remember ANEH Facts archives now exist
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Ask Lena Health Q & A Archives Click
Here
Your Home Business Coach Archives
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Here
TidBits Of Info
==>
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==================================
Something To Think About
============================
FDA's Monitoring of Reports
Questioned
Jul 7, 2006
By KEVIN FREKING
WASHINGTON (AP) - Drug makers routinely fail to file status reports with
the federal government that show what kind of progress they have made in
conducting safety studies.
That's the conclusion of a review from the inspector general for the
Health and Human Services Department. Investigators found that 35
percent of status reports that drug makers were supposed to file in
fiscal year 2004 were missing entirely or contained no information on
agreed-to studies.
"Monitoring postmarketing study commitments is not a top priority at the
(Food and Drug Administration)," the investigators concluded.
Such studies are considered important because they can shed light on the
safety and effective use of drugs. The FDA requires all new drugs to
undergo clinical testing, but trials often involve relatively small
numbers of people, so the FDA frequently ask drug makers to conduct
postmarketing studies.
Indeed, about half of new drug applications approved from 1990 through
2004 involved at least one commitment for a postmarketing study. Yet,
the FDA cannot readily identify what kind of progress drug companies are
making with their studies, the investigators said.
The FDA disagreed with that assessment.
"While we embrace several recommendations for improvement that are
outlined in the report, we do not agree that FDA cannot readily identify
whether or how timely postmarketing study commitments are progressing,"
said Andrew von Eschenbach, the FDA's acting commissioner.
Investigators said that even completed status reports often lacked
information that would be useful in monitoring the progress of studies.
But von Eschenbach said the agency cannot instruct drug applicants to
provide additional, meaningful information in their status reports. "A
provision for additional information would require that new regulations
be written," he said.
However, a database was being redesigned to improve data entry and
retrieval involving the status reports, von Eschenbach said.
An official at the trade group that represents drug makers, the
Pharmaceutical Research and Manufacturers of America, said the
organization did not have immediate comment on the report.
HHS Inspector General report
=======================
THOUGHT FOR THE DAY!
=======================
If you eat a ham sandwich for lunch, just hope that your office
doesn't spring a random drug test when you get back. You're likely to
fail. According to Rapid Communications in Mass Spectrometry, a ham
sandwich may be enough to show a positive test for androgens, which are
male sex hormones that are banned in some sports. When three volunteers
ate 10 ounces each of pork from an uncastrated boar, their urine samples
showed positive tests for androgen supplements within 10 hours of the
meal. The values returned to normal a day later.
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We accept all advertisements in good
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and accuracy of their advertisements. We do not give any warranties and
accept no responsibility. The editor and publisher suggest that you
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Attention vegetarians!
Bet you didn't know you
and/or your family may have been mainlined animal products without
your knowledge and no labels available to tell you that fact...
How you ask?
If you have been received preventative vaccines, is how! Most ALL
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I have a question to the drug companies making those vaccines?
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Gene Therapy Update
The CAM community has been aware of 53
vaccines for some time now. These vaccines have long been
available at, among other places, the very unorthodox
International BioCare (IBC) hospital in Tijuana, Mexico. It is
impossible to make any conclusive statements regarding the
efficacy of these vaccines, however.
Meanwhile, in the US, Introgen has a product called Advexin
which is very similar to the Chinese product Gendicine. It too
is under regulatory review by the FDA for head and neck squamous
cell carcinoma and it may be approved within the next year or
two. Relations between Introgen and the Chinese company, SiBiono,
have been rocky at times, but in the end, insiders say, Introgen
may wind up licensing Gendicine for US distribution (Red Herring
2006). Advexin has yet to win approval from the FDA and the
company's stock (NASDQ-INGN) is trading near its historic low.
Two UK-based companies also have their own cancer-targeted gene
therapies in the pipeline. Oxford BioMedica's drug MetXia is now
in phase II clinical trials for pancreatic cancer, while the
London-based Ark Therapeutics' gene therapy product, CerePro,
has completed phase III trials for brain cancer; the results are
under review by the European Medicines Agency.
Toxicity Concerns
However, progress in this field has not been smooth. Although
the growth-oriented Chinese government has speeded up the
introduction of Gendicine, safety concerns have led authorities
in the US and Europe to slow the development of gene therapy.
This burgeoning field suffered its first major setback when
Jesse Gelsinger, an 18-year old with the rare liver condition
ornithine transcarbamylase (OTC) deficiency, died while
participating in a University of Pennsylvania gene therapy
clinical trial in September 1999. His death was a direct result
of the gene therapy: he had a severe immune system reaction and
suffered fatal multi-organ failure. That was only the beginning
of gene therapy's troubles. Congressional hearings, sparked by
his death, revealed that the National Institutes of Health (NIH)
had received "delayed reports" of more than 600 other serious
adverse events in similar gene therapy trials that had been
underway since 1993 (Lehrer 2000).
There have also been documented cases of patients developing
second cancers as a result of gene therapy, and the US Food &
Drug Administration (FDA) has halted a number of clinical
trials. Researchers at the Salk Institute, La Jolla, recently
reported that a human gene therapy treatment that until now has
been considered largely successful, is, in fact, riskier than
previously realized. Researcher Inder Verma, PhD, reported in
the journal Nature that "the healthy copy, which replaces the
defective gene can itself promote cancer development," at least
in animals.
Her team followed mice that were treated with the IL2RG gene for
three times longer than any previous study. They found that
one-third of the animals developed lymphoma later in life. The
IL2RG gene is the same one that is being given to patients who
have X-linked severe combined immune deficiency (X-SCID - also
known as the "bubble boy" syndrome) in clinical trials in
France, the United States, the United Kingdom, and Australia.
One Salk scientist concluded: "These results suggest that curing
X-SCID by replacing IL2RG in the manner it is currently being
done puts patients at an increased risk of developing cancer" (Kirchweger
2006).
Dr. Peng says that the side effects of the Chinese drug
Gendicine are minimal and that the drug is "safe and
efficacious." He says that some patients experience
self-limiting mild fevers lasting approximately three hours.
But, he says, "no other serious side effects were observed." He
also insists that Gendicine is "genetically nontoxic," and "will
not replicate in the infected cells and is incapable of
multi-cycle infection and of spreading to the neighboring
cells." Nevertheless, historically, gene therapy has had
unanticipated dangers.
--Ralph W. Moss, Ph.D.
LENA'S COMMENT: The controversy on this isn't over so watch
for more info.
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ENVIRONMENTAL REPORT
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Fossil Fuel Use Affects
Marine Life, Report Says
From the Associated Press
July 6, 2006
WASHINGTON — Corals and other marine creatures are threatened by
chemical changes in the ocean caused by the carbon dioxide from burning
fossil fuels, a panel of scientists warned Wednesday.
Much of this added carbon dioxide is dissolving in the oceans, making
them more acidic. Such a change can damage coral and other sea life,
according to the panel of researchers convened by the National Science
Foundation, National Oceanic and Atmospheric Administration and U.S.
Geological Survey.
"A most fundamental property of ocean chemistry, pH, is changing and
will continue to change as long as CO2 emissions are increasing. That is
not debatable," Joan Kleypas, the report's lead author and a scientist
at the National Center for Atmospheric Research in Boulder, Colo., said
in a briefing.
The pH scale measures how acidic or alkaline a substance is.
"In the oceans pH is a relatively constant property, and it has not
changed over time scales of hundreds of thousands and probably even
millions of years," Kleypas said.
"The pH changes that are occurring in the ocean today are truly
extraordinary," she added. "It is vital to develop research strategies
to better understand the long-term vulnerabilities of sensitive marine
organisms to these changes."
The researchers estimated that between 1800 and 1994, oceans absorbed
118 billion metric tons of carbon, reducing the natural alkalinity of
seawater. A metric ton is 2,205 pounds.
Richard Feely, an oceanographer at NOAA's Pacific Marine Environmental
Laboratory in Seattle, said, "This is leading to the most dramatic
changes in marine chemistry in at least the past 650,000 years."
Chris Langdon at the University of Miami said studies show that coral
calcification decreases as the oceans become more acidic. That means
these organisms will grow more slowly, or their skeletons will become
less dense, a process similar to osteoporosis in humans.
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