EU Hysteria: Hold on - SmithKline owns the proprietary Antibiotic-Resistance data.

[Mort Zuckerman]

To: kathleen...@hhs.gov, francis...@nih.hhs.gov,
margaret...@fda.hhs.gov, dwh...@forbes.com,
ca...@drcarolgoodheart.com, lPick...@cdc.gov, Durlan...@yale.edu,
Aa...@columbia.edu, gary_w...@nymc.edu,
scientifi...@ostp.gov, pkru...@princeton.edu,
Stanle...@fiu.edu, margaret...@hhs.fds.gov,
emcsw...@niaid.nih.gov, afa...@niaid.nih.gov,
Spin...@yahoogroups.com, kshe...@calea.org, fit...@gmail.com,
patrick.f...@usdoj.gov, model...@sbcglobal.net,
jdr...@nejm.org, let...@courant.com, Jgerb...@cdc.gov,
michae...@ct.gov, con...@po.state.ct.us, executive-
edi...@nytimes.com, managin...@nytimes.com, news-
ti...@nytimes.com, biz...@nytimes.com, for...@nytimes.com,
nati...@nytimes.com, dv...@cdc.gov, brigidc...@optonline.net,
tr...@hotmail.com, illino...@aol.com, jle...@courant.com,
tinaj...@yahoo.com, jhorn...@fff.org, thomas...@usdoj.gov,
thoma...@ct.gov, kur...@washpost.com, georg...@washpost.com,
p...@allegorypress.com, commissi...@po.state.ct.us,
brans...@comcast.net, vts...@comcast.net, o...@po.state.ct.us,
freet...@charter.net, scott....@po.state.ct.us,
govern...@po.state.ct.us, attorney...@ct.gov,
randall...@usdoj.gov, Robert....@yale.edu, editor@greenwich-
post.com, harol...@yale.edu, sedm...@nswbc.org, rrmcg...@aol.com,
fr...@nytimes.com, saint....@sbcglobal.net
Cc: fra...@ucia.gov, dr-ahma...@president.ir,
eugener...@washpost.com, bmi...@newstimes.com, tr...@hotmail.com,
rast...@aol.com, billc...@gmail.com, amcg...@rms-law.com,
rjmu...@aol.com, paulcrai...@yahoo.com,
criminal...@usdoj.gov, karla.d...@usdoj.gov,
christophe...@usdoj.gov, richar...@yale.edu,
harol...@yale.edu, james.p...@yale.edu, inq...@aldf.com,
ly...@idsociety.org, meganm...@theatlantic.com

Subject: EU Hysteria: Hold on - SmithKline owns the proprietary
Antibiotic-Resistance data.

Date: Nov 21, 2011 9:56 AM

http://www.medpagetoday.com/InfectiousDisease/InfectionControl/29813

ARTICLE BELOW
========================

Hold on, now. SmithKline bought Corixa
which acquired a 11.5 million dollar
biodefense contract to lie about the
real outcomes of immunosuppressive
agents like the fungal antigen OspA:
http://www.actionlyme.org/EMBASSIES_CORIXA_TLR_13_JULY_06.htm
You can see ^^ their scanned in document
which has since been taken off the
web. The real culprit was OspA's
TLR2 agonism, which has massive
implications for Tb and all chronic
diseases:
http://www.actionlyme.org
http://www.slate.com/articles/health_and_science/the_mouse_trap/2011/11/lab_mice_are_they_limiting_our_understanding_of_human_disease_.html

Slate on the Failed LYMErix Disaster as re Tuberculosis, Molecular
Mice "Indeed, there's been no real breakthrough in treating
tuberculosis—no major pharmaceutical discoveries—since the early
1970s. The first antibiotic to have any success against the
tuberculosis mycobacterium, the first that could penetrate its waxy
coating, was discovered (and tested in guinea pigs) in the early
1940s. The best vaccine we have was first used in humans in 1921. (It
works pretty well against severe childhood forms of the disease, but
less so otherwise.) And the closest thing we have to a miracle cure—
the multidrug cocktail that doesn’t work against every strain and
requires a six-month course of treatment with severe side effects—was
finalized during the Nixon administration. Since then, almost every
new idea for how to treat TB has come from experiments on lab mice.
These have given us enough new data to drown the infected in a tsunami
of graphs and tables, to bury them in animal carcasses. Yet we've made
little progress—OK, no progress at all—in treating the human disease.
Tuberculosis causes more than 2 million deaths every year, and we're
using the same medicines we had in 1972."

- -

This is the paradigm shift in medicine: It's not about antibiotic
resistance. It's about LYMErix (TLR2-agonist)-induced
immunosuppression.
http://www.ncbi.nlm.nih.gov/pubmed/21947769

- - - - -

In other words, it is now recognized
that Yale inhibited discovery in all
these diseases by lying about the outcome
of LYMErix. now SmithKline (in the new
article below and linked above), says
they will invest in studying this.

They already have that information.

SmithKline bought Corixa with all the Smith-Kline/
Yale/Corixa FRAUD data, re the disease caused
by LYMErix (New Great Imitators):
http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6045804.PN.&OS=PN/6045804&RS=PN/6045804
"Additional uncertainty may arise if the vaccines are not completely
protective; vaccinated patients with multisystem complaints
characteristic of later presentations of Lyme disease may be difficult
to distinguish from patients with vaccine failure."



Meanwhile, we knew Dave Persing, Yale's
Robert Schoen (of the Yale/CORIXARICO
http://www.actionlyme.org/CORIXARICO.htm ),
and Dennis Parenti of SmithKline knew
about the "multi-system chronic illness
signs that are like chronic Lyme that
are caused by OspA or LYMErix:

And here are those proofs (again):
http://groups.google.com/group/sci.med.diseases.lyme/browse_thread/thread/a104a20c56109c33?hl=en#
http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3422t1.rtf

LUFT: "So I just wanted to kind of ask in regard to that, and I think
it goes back to an earlier question that I asked in regard to the
self-
reported events and ***whether there was any segregation that occurred
between the 10 percent of patients reporting that they were having
symptomatology, whether there was any difference between the vaccine
group and the placebo group independent of antibody or serologic
diagnosis."***

DR. PIETRUSKO: Dr. Parenti?

DR. PARENTI (SMITHKLINE): ***"Basically the two groups [Lyme and
LYMErix-Adverse Events-- KMD]had the same suspect symptoms.*** We
didn't put it through statistical rigor, but when you looked at what
it is that people came into the office with, what complaints, there
was basically the same complaints in both groups. So both groups were
being evaluated for the same things."
http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3422t1.rtf
- - -
and, the Corixa RICO patent with
Yale and Imugen (Steere's company):
-- -
http://www.actionlyme.org/CENTRAL_LYME_RICO_PATENTS.htm
http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6045804.PN.&OS=PN/6045804&RS=PN/6045804
"Additional uncertainty may arise if the vaccines are not completely
protective; vaccinated patients with multisystem complaints
characteristic of later presentations of Lyme disease may be difficult
to distinguish from patients with vaccine failure."

-------

They lied about the testing for Lyme
in order to falsify the LYMErix vaccine
outcome. They lied about the vaccine
results. SmithKline told the FDA that
they had no adverse events to LYMErix,
and meanwhile, they knew all along it
caused the EXACT SAME SYSTEMIC DISEASE
that they admitted Chronic Lyme is.

Now we know what those diseases are.
LYMErix-disease is an AIDS-like
acquired immune difficiency disease
associated with the activation of
Epstein-Barr (MS/CFIDS) and badly cloned
B-cells, for which stem cells and/or
antivirals and/or Rituximab is the
treatment, says the NIH:
http://www.actionlyme.org
See the bottom of the page:

"Characterization and treatment of chronic active Epstein-Barr virus
disease: a 28-year experience in the United States"
http://bloodjournal.hematologylibrary.org/content/117/22/5835.long



So, for SmithKline to suddenly say they're
interested, is a joke. They've known all
along.

No one has ever asked SmithKline for that
data Dennis Parenti talked about at the
1998 FDA Meeting... data they did not
publish about the Chronic Lyme-like
outcomes of OspA:

DR. PARENTI (SMITHKLINE): ***"Basically the two groups [Lyme and
LYMErix-Adverse Events-- KMD]had the same suspect symptoms.*** We
didn't put it through statistical rigor, but when you looked at what
it is that people came into the office with, what complaints, there
was basically the same complaints in both groups. So both groups were
being evaluated for the same things."
http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3422t1.rtf

Where is that data?

Why was it hidden for 15 years?

This is a "FRAUD on the GOVERNMENT."

The real deal is that there is no
issue of antiotic resistance except
in swine lagoons:
http://www.ncbi.nlm.nih.gov/pubmed/19921873

The issue is that the tough infections
like MRSA and Tb bear TLR2 agonists
like LYMErix that SUPPRESS THE IMMUNE
RESPONSE.

And as such could never be vaccines.

Molecular Mice aside, the bad guys *knew*.


KMDickson
http://www.actionlyme.org

==============================

Europeans Seek Lead in New Antibiotics
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: November 20, 2011

Click here to provide feedback

The European pharmaceutical industry has voiced its support for a
European Union-backed plan to combat antibiotic resistance and promote
the development of new antibiotics as reports of drug-resistant "super
bugs" increase throughout the region.

A new action plan issued by the European Union this week promised
streamlined regulations and other government support for diagnostic
and drug development aimed at combatting the rise of antibiotic-
resistant pathogens.

The report said that drug-resistant bacteria are responsible for
25,000 deaths in Europe each year, at a cost of $1.5 billion.

And a recent report from the European Centre for Disease Control and
Prevention (ECDC) said that in some countries, more than 50% of cases
of Escherichia coli infections were resistant to antibiotics, as were
more than 10% of pneumoniae cases. In addition, 25% of methicillin-
resistant Staphylococcus aureus infections were resistant to
antibiotics in in 8 eight of 28 European countries.

The European drug industry group -- the European Federation of
Pharmaceutical Industries and Associations (EFPIA) -- backed the EU's
plan, which calls for accurately diagnosing the presence of a bacteria
before starting the patient on antibiotics; putting in place ways to
prevent microbial infections and to stop them from spreading; and
strengthening research to develop new ways to stop antimicrobial
resistance.

"Antibiotic resistance is a major challenge throughout the world and
one that we need to take seriously," EFPIA President Andrew Witty said
in a press release. "It is a challenge that the pharmaceutical
industry wants to be part of solving."

Witty, who is also CEO of GlaxoSmithKline, said his group is committed
to working with stakeholders to re-stimulate research into new and
effective antibiotics "so that when we do have a fundamental bacterial
challenge we are able to protect ourselves."

An infectious disease expert in the U.S. told MedPage Today that while
news from Europe is nothing Earth-shattering, it does at least signify
that a group of countries formally recognizes the importance of
antimicrobial resistance.

"What's happening in Europe is a sign that a collective group of
governments understand the severity of the problem and have the
political will to make the necessary changes," said Brad Spellberg,
MD, of the University of California Los Angeles, and a member of
Infectious Diseases Society of America (IDSA) Antimicrobial
Availability Task Force.

That political will still seems to be a ways off in the U.S., he said.

Researchers here have long been calling for the creation of new
antibiotics in light of antibiotic resistance making older ones less
effective. But the pharmaceutical industry here doesn't show signs
clear of moving toward increased focus on new antibiotics.

A recent decision by Pfizer to shutter its major research facility in
England, shrink its central lab in Connecticut, and move its anti-
infective research to China was met with an outcry in the infectious
disease community who said the move would dampen already slow progress
toward developing new antibiotics.

There is currently legislation in Congress called GAIN, for Generating
Antibiotic Incentives Now, that would require the FDA to reevaluate
its guidelines for antibiotic drug trials, increase the period of
market exclusivity for qualified infectious disease products
(including diagnostics), and give them priority review. But that bill
hasn't moved in either the Senate of the House of Representatives
since it was introduced.

Writing in a column published in The Lancet, Laura Piddock, PhD, of
the University of Birmingham in England, highlighted the problem of
too few promising new antibiotics in the R&D pipeline.

"Human beings do not live in a sterile world," Piddock wrote. "Food
and water can be contaminated and many different events occur that
affect sharing of microorganisms between ecosystems and antibiotic-
resistance genes between pathogenic and commensal bacteria."

Although researchers have actively been publishing articles and
reports on antibiotic resistance, "the demise of antibacterial drug
discovery by large pharmaceutical companies has largely gone unnoticed
by governments," Piddock wrote. "Even when noted, little effort has
been made to resolve this situation."

In academe, the economic recession has led to reduced funding for
antibacterial research, Piddock wrote.

One major impediment to antibacterial development is that the drugs
don't offer a good return on investment. Unlike major money-makers
like cholesterol drugs -- which are taken by some people every day for
decades -- the standard course of treatment for antibiotics is about a
week. Plus, they are cheap. Piddock advocated higher prices for some
antibiotics.

"The price of antibiotics should relate to their value," she wrote.
"People in high-income countries expect to be given antibiotics
whenever they need them and ease of use has led to a perception of low
cost and therefore low value. The price of antibiotics needs to relate
to their value to society and should not relate to the price of
previous products."

Spellberg agreed.

"People will pay $50,000 for a course of chemotherapy that prolongs
life by a few weeks, but we don't even like to pay $100 for an
antibiotic that can save a life," he told MedPage Today.

The IDSA launched its "Bad Bugs, No Drugs," campaign in 2010 which
aims to get 10 new antibiotics on the market by 2020, and has been
active in lobbying for increased government research in antibiotics.

Spellberg said while the bills in Congress are a good start, they
don't offer enough incentives to drug companies to ramp up development
of antibiotics.

Even if new drugs were developed, the FDA makes it difficult to get a
new antibiotics approved, Spellberg said.

For instance, he explained, it's FDA policy for clinicians to enroll
patients in an agency-approved clinical trial before giving them a
single dose of the antibiotic that is being studied so they start with
no antibiotic in their systems. But Spellberg said most patients who
are sick with pneumonia or a skin infection would not wait the several
hours it takes to enroll in a trial before receiving the first dose of
antibiotics.

Those kinds of policies impede enrollment in the kind of large-scale
trials that would be necessary for the FDA to approve a new
antibiotic, Spellberg said.

"They need to stop being so rigidly adherent to these bizarre,
byzantine principles," he said of the agency.



KMDickson

[Lipanj]

On Nov 21, 10:00 am, Mort Zuckerman <morph...@yahoo.com> wrote:

>
> "They need to stop being so rigidly a

> KMDickson

DR. PARENTI (SMITHKLINE): ***"Basically the two groups [Lyme and
LYMErix-Adverse Events-- KMD]had the same suspect symptoms.*** We
didn't put it through statistical rigor, but when you looked at what
it is that people came into the office with, what complaints, there
was basically the same complaints in both groups. So both groups
were

being evaluated for the same things." WOW WHAT A SICKO STATEMENT SEE
BELOW:

MY COMMENT BELOW:
In ref to below: Nothing but a bunch of doubletalk, stupidity...waste
of tax payers money Bull S. job security idiots

http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3422t1.rtf



In ref to this website from this article: